TOP May 2015 | Vol 8 | No 2

MAY 2015

www.TheOncologyPharmacist.com

CONFERENCE NEWS

CANCER CENTER PROFILE

Virginia K. Crosson Cancer Center, St. Joseph’s Healthcare System

T

he Virginia K. Crosson Cancer Center is part of the larger St. Jude Crosson Comprehensive Can­ ­cer Center. The Virginia ­­K.­ Crosson Cancer Center op­ ­ erates under the umbrella of the St. Joseph’s Healthcare System, which is located in Southern California. Within the Virginia K. Crosson Can­­ cer Center, board-certified medical oncologists and he­­ matologists practice medi­ cine, and are devoted to offer­ ing lifesaving, life-changing Colleagues at Virginia K. Crosson Cancer Center cancer care.

Well-trained cancer ex­ ­ (left to right): Hi (Jenny) An, PharmD; Han Ngo, perts combine their medical PharmD; Arsupol Chowtham, PharmD. practice with advanced infu­ sion capabilities—providing patients with ongoing research and the latest breakthroughs in biotherapy, chemotherapy, and immunology. As part of St. Jude Medical Center’s comprehensive cancer services, Virginia K. Continued on page 12

KIDNEY CANCER

ASSURE Trial: No Role for Adjuvant Sorafenib or Sunitinib in Locally Advanced Kidney Cancer Phoebe Starr

Orlando, FL—Surprisingly, the use of adjuvant sorafenib (Nexavar) and sunitinib (Sutent) failed to extend disease­-free survival (DFS) in patients with locally advanced kidney cancer who are at high risk for recurrence, according to initial results of the ASSURE study. The ASSURE trial is the first and largest study investi­ gating the use of adjuvant tyrosine kinase inhibitors/vascular endothelial growth factor (VEGF) inhibitors in kidney cancer.

The results surprised the lead inves­ tigator, Naomi B. Haas, MD, Cancer

VOL 8, NO 2

Ther­ apeutics Program Co-Leader, Abramson Cancer Center, University of Pennsylvania, Philadelphia. She discussed the results at the 2015 Genitourinary Cancers Symposium.

Disappointing Results Sorafenib and sunitinib are both wide­ ly effective in metastatic kidney cancer, and the investigators of ASSURE hoped that these drugs would also provide ben­ efits for patients in the adjuvant setting.

However, the findings of this random­ ized, placebo-controlled trial suggest that close observation should remain

The Pharmacist’s Role in Hospice and Palliative Care And other news from HOPA’s 11th annual meeting Meg Barbor

Austin, TX—Pharmacists can play an active role in hospice and palliative care through a wide variety of approaches, including medication order assessments and counseling the hospice team, accord­ ing to research presented by Bradi Frei, PharmD, MS, BCOP, BCPS, at the 11th annual Hematology/Oncology Pharmacy Association (HOPA) conference.

ASHP Statement on Pharmacists’ Role According to the American Society of Health-System Pharmacists (ASHP), the

pharmacist’s role in hospice care involves assessing the appropriateness of medication orders for patients, ensuring timely provi­ sion of effective medications for symptom control and management, counseling and educating the hospice team about support­ ive care through the use of medication therapy, and ensuring that patients and caregivers understand and adhere to the directions provided with medications.

“Pharmacists involved in hospice care should also work to provide efficient mechanisms for extemporaneous com­ pounding of nonstandard dosage forms, Continued on page 8

BEST PRACTICES

Biosimilar Effective for Chemotherapy-Induced Anemia in Patients with Colorectal Cancer Chase Doyle

San Francisco, CA—An interim sub­ analysis of an ongoing French national observational study (OncoBOS) demon­ strated the real-life clinical efficacy and safety of the biosimilar epoetin alfa (HX575, Binocrit) for the treatment of chemotherapy-induced anemia (CIA) in patients with colorectal cancer receiv­ ing chemotherapy, according to data presented at the 2015 Gastrointestinal

Cancers Symposium.

“These results demonstrate the ability of HX575 to safely correct anemia and maintain hemoglobin levels, in line with current recommendations, using a week­ ly dosing regimen,” noted the lead author of the study, Jean-Philippe Metges, MD, Institut de Cancérologie et d’Hématolo­ gie, CHU Morvan, Brest, France.

As Dr Metges observed, anemia is a Continued on page 22

I N S I D E FDA NEWS. . . . . . . . . . . . . . . . . . . . . . . . . 5 BEST PRACTICES . . . . . . . . . . . . . . 14 Shift Work, Sleep Deprivation, and Cancer Risk

Dinutuximab FDA-Approved for Pediatric Patients with High-Risk Neuroblastoma

SURVIVORSHIP CARE . . . . . . . . .

Pharmacists Can Play an Active SIDE EFFECTS Role in Survivorship Care MANAGEMENT. . . . . . . . . . . . . . . . . .

Colorectal Cancer Survivors Frequently Report Bowel Dysfunction

Continued on page 20 © 2015 Green Hill Healthcare Communications, LLC

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21

NEW FDA APPROVAL CYRAMZA® (ramucirumab), in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDAapproved therapy for these aberrations prior to receiving CYRAMZA.

ADVANCING THE SECONDLINE TREATMENT OF METASTATIC NSCLC1 CYRAMZA is the first antiangiogenic agent FDA approved in combination with docetaxel for the second-line treatment of metastatic NSCLC, including nonsquamous and squamous histologies.1

IMPORTANT SAFETY INFORMATION FOR CYRAMZA WARNING: HEMORRHAGE CYRAMZA increased the risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.

Permanently discontinue CYRAMZA in patients who experience severe bleeding.

Warnings and Precautions Hemorrhage • CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage including severe and sometimes fatal hemorrhagic events. In Study 3, which evaluated CYRAMZA plus docetaxel in metastatic non-small cell lung cancer (NSCLC), the incidence of severe bleeding was 2.4% for CYRAMZA plus docetaxel and 2.3% for placebo plus docetaxel. Patients with NSCLC receiving therapeutic anticoagulation or chronic therapy with NSAIDs or other antiplatelet therapy other than once-daily aspirin or with radiographic evidence of major airway or blood vessel invasion or intratumor cavitation were excluded from Study 3; therefore, the risk of pulmonary hemorrhage in these groups of patients is unknown. Permanently discontinue CYRAMZA in patients who experience severe bleeding.

Arterial Thromboembolic Events Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia occurred in clinical trials including 1.7% of 236 patients who received CYRAMZA as a single agent for gastric cancer in Study 1. Permanently discontinue CYRAMZA in patients who experience a severe ATE.

•

Hypertension An increased incidence of severe hypertension occurred in patients receiving CYRAMZA plus docetaxel (6%) as compared to placebo plus docetaxel (2%). Control hypertension prior to initiating treatment with CYRAMZA. Monitor blood pressure every 2 weeks or more frequently as indicated during treatment.

Temporarily suspend CYRAMZA for severe hypertension until medically controlled. Permanently discontinue CYRAMZA if medically significant hypertension cannot be controlled with

•

antihypertensive therapy or in patients with hypertensive crisis or hypertensive encephalopathy.

Infusion-Related Reactions • Prior to the institution of premedication recommendations across clinical trials of CYRAMZA, infusion-related reactions (IRRs) occurred in 6 out of 37 patients (16%), including 2 severe events.

The majority of IRRs across trials occurred during or following a first or second CYRAMZA infusion. Symptoms of IRRs included rigors/tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia. In severe cases, symptoms included bronchospasm, supraventricular tachycardia, and hypotension. Monitor patients during the infusion for signs and symptoms of IRRs in a setting with available resuscitation equipment. Immediately and permanently discontinue CYRAMZA for Grade 3 or 4 IRRs. Gastrointestinal Perforations CYRAMZA is an antiangiogenic therapy that can increase the risk of gastrointestinal perforation, a potentially fatal event.

In Study 3, the incidence of gastrointestinal perforation was 1% for CYRAMZA plus docetaxel versus 0.3% for placebo plus docetaxel. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.

•

Impaired Wound Healing CYRAMZA has not been studied in patients with serious or nonhealing wounds. CYRAMZA is an antiangiogenic therapy with the potential to adversely affect wound healing. Withhold CYRAMZA prior to surgery. Resume CYRAMZA following the surgical intervention based on clinical judgment of adequate wound healing.

If a patient develops wound healing complications during therapy, discontinue CYRAMZA until the wound is fully healed.

•

Clinical Deterioration in Child-Pugh B or C Cirrhosis Clinical deterioration, manifested by new onset or worsening encephalopathy, ascites, or hepatorenal syndrome, was reported in patients with Child-Pugh B or C cirrhosis who received single-agent CYRAMZA. Use CYRAMZA in patients with ChildPugh B or C cirrhosis only if the potential benefits of treatment are judged to outweigh the risks of clinical deterioration.

•

CYRAMZA PLUS DOCETAXEL DEMONSTRATED A STATISTICALLY SIGNIFICANT IMPROVEMENT IN OVERALL SURVIVAL VS DOCETAXEL1 OVERALL SURVIVAL: MEDIAN - MONTHS (95% CI) CYRAMZA + docetaxel (n=628)

1.0

10.5

Demonstrated improvements across all three efficacy outcomes (OS, PFS, ORR)1

15% INCREASE IN MEDIAN OS

MONTHS

0.8

OS PROBABILITY

MAJOR OUTCOME MEASURE

(9.5, 11.2) Hazard Ratio (95% CI)=0.86 (0.75, 0.98); P=0.024

0.6

CYRAMZA + docetaxel

0.4

Placebo + docetaxel

9.1

0.2

Placebo + docetaxel (n=625)

MONTHS (8.4, 10.0)

0.0 0

3

6

12

15

18

21

24

27

30

33

36

TIME FROM RANDOMIZATION (MONTHS)

Number at Risk

CYRAMZA + docetaxel 628 Placebo + docetaxel 625

9

• The percentage of deaths at the time of analysis was 68% (428 patients) and 73% (456 patients) in the CYRAMZA plus docetaxel and placebo plus docetaxel arms, respectively 1

527

415

329

231

156

103

70

45

23

11

2

0

501

386

306

197

129

86

56

36

23

9

0

0

• Median PFS with CYRAMZA plus docetaxel was 4.5 months (95% CI: 4.2, 5.4) vs 3.0 months (95% CI: 2.8, 3.9) with placebo plus docetaxel (hazard ratio 0.76 [95% CI: 0.68, 0.86]; P<0.001) — The percentage of events at the time of analysis was 89% (558 patients) and 93% (583 patients) in the CYRAMZA plus docetaxel and placebo plus docetaxel arms, respectively • ORR with CYRAMZA plus docetaxel was 23% (95% CI: 20, 26) vs 14% (95% CI: 11, 17) with placebo plus docetaxel (P<0.001)* CI=confidence interval; OS=overall survival; PFS=progressionfree survival; ORR=objective response rate. *ITT population. Disease progression and tumor response were assessed by investigators in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.2 ORR is defined as complete plus partial response.

REVEL TRIAL DESIGN (N=1253) The phase III REVEL trial evaluated the efficacy and safety of CYRAMZA plus docetaxel vs placebo plus docetaxel in patients with metastatic NSCLC with disease progression on or after platinum-based chemotherapy. Major efficacy outcome measure was OS. Supportive efficacy outcome measures were PFS and ORR. All patients were required to have Eastern Cooperative Oncology Group performance status 0 or 1. Patients were randomized 1:1 (N=1253) to receive either CYRAMZA 10 mg/kg or placebo, in combination with docetaxel at 75 mg/m2 every 21 days.1

VISIT www.CYRAMZAHCP.com Reversible Posterior Leukoencephalopathy Syndrome (RPLS) • RPLS has been reported at a rate of <0.1% in clinical studies with CYRAMZA. Confirm the diagnosis of RPLS with MRI and discontinue CYRAMZA in patients who develop RPLS. Symptoms may resolve or improve within days, although some patients with RPLS can experience ongoing neurologic sequelae or death.

Use in Specific Populations •

Pregnancy Category C: Based on its mechanism of action, CYRAMZA may cause fetal harm. Advise females of reproductive potential to avoid getting pregnant, including use of adequate contraception, while receiving CYRAMZA and for at least 3 months after the last dose of CYRAMZA. Animal models link angiogenesis, VEGF and VEGF Receptor 2 to critical aspects of female reproduction, embryofetal development, and postnatal development. There are no adequate or well-controlled studies of ramucirumab in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus.

•

Nursing Mothers: It is recommended to discontinue nursing or discontinue CYRAMZA due to the potential risks to the nursing infant.

•

Females of Reproductive Potential: Advise females of reproductive potential that CYRAMZA may impair fertility.

Most Common Adverse Reactions •

•

The most commonly reported adverse reactions (all grades; Grade 3/4) occurring in ≥5% of patients receiving CYRAMZA plus docetaxel and ≥2% higher than placebo plus docetaxel in Study 3 were neutropenia (55% vs 46%; 49% vs 40%), fatigue/asthenia (55% vs 50%; 14% vs 11%), stomatitis/mucosal inflammation (37% vs 19%; 7% vs 2%), epistaxis (19% vs 7%; <1% vs <1%), febrile neutropenia (16% vs 10%; 16% vs 10%), peripheral edema (16% vs 9%; 0% vs <1%), thrombocytopenia (13% vs 5%; 3% vs <1%), lacrimation increased (13% vs 5%; <1% vs 0%), and hypertension (11% vs 5%; 6% vs 2%).

The most common serious adverse events with CYRAMZA plus docetaxel in Study 3 were febrile neutropenia (14%), pneumonia (6%), and neutropenia (5%). The use of granulocyte colonystimulating factors was 42% in CYRAMZA plus docetaxel-treated patients versus 37% in patients who received placebo plus docetaxel.

•

Treatment discontinuation due to adverse reactions occurred more frequently in CYRAMZA plus docetaxel-treated patients (9%) than in placebo plus docetaxel-treated patients (5%).

The most common adverse events leading to treatment discontinuation of CYRAMZA were infusion-related reaction (0.5%) and epistaxis (0.3%).

•

Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA plus docetaxel-treated patients in Study 3 were hyponatremia (4.8% CYRAMZA plus docetaxel versus 2.4% for placebo plus docetaxel) and proteinuria (3.3% CYRAMZA plus docetaxel versus 0.8% placebo plus docetaxel).

Drug Interactions •

No pharmacokinetic interactions were observed between ramucirumab and docetaxel.

Please see Brief Summary of Prescribing Information for CYRAMZA, including Boxed Warning for hemorrhage, on the next page.

RB-L HCP ISI 17DEC2014 References: 1. CYRAMZA (ramucirumab) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2014. 2. Garon EB, Ciuleanu T-E, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384(9944):665-673.

RB94721 01/2015 PRINTED IN USA © Lilly USA, LLC 2015.

ALL RIGHTS RESERVED. CYRAMZA® is a registered trademark of Eli Lilly and Company.

CYRAMZA® (ramucirumab) injection BRIEF SUMMARY: For complete safety, please consult the full Prescribing Information.

INDICATIONS AND USAGE Non-Small Cell Lung Cancer: CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.

in placebo plus docetaxel-treated patients (5%). The most common adverse events leading to treatment discontinuation of CYRAMZA were infusion-related reaction (0.5%) and epistaxis (0.3%). For patients with non-squamous histology, the overall incidence of pulmonary hemorrhage was 7% and the incidence of ≥Grade 3 pulmonary hemorrhage was 1% for CYRAMZA plus docetaxel compared to 6% overall incidence and 1% for ≥Grade 3 pulmonary hemorrhage for placebo plus docetaxel. For patients with squamous histology, the overall incidence of pulmonary hemorrhage was 10% and the incidence of ≥Grade 3 pulmonary hemorrhage was 2% for CYRAMZA plus docetaxel compared to 12% overall incidence and 2% for ≥Grade 3 pulmonary hemorrhage for placebo plus docetaxel. The most common serious adverse events with CYRAMZA plus docetaxel were febrile neutropenia (14%), pneumonia (6%), and neutropenia (5%). The use of granulocyte colony-stimulating factors was 42% in CYRAMZA plus docetaxel-treated patients versus 37% in patients who received placebo plus docetaxel. In patients ≥65 years, there were 18 (8%) deaths on treatment or within 30 days of discontinuation for CYRAMZA plus docetaxel and 9 (4%) deaths for placebo plus docetaxel. In patients <65 years, there were 13 (3%) deaths on treatment or within 30 days of discontinuation for CYRAMZA plus docetaxel and 26 (6%) deaths for placebo plus docetaxel. Table 4 provides the frequency and severity of adverse reactions in Study 3.

CONTRAINDICATIONS None.

Table 4: Adverse Reactions Occurring at Incidence Rate ≥5% and a ≥2% Difference Between Arms in Patients Receiving CYRAMZA in Study 3

WARNING: HEMORRHAGE CYRAMZA increased the risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.

Permanently discontinue CYRAMZA in patients who experience severe bleeding.

WARNINGS AND PRECAUTIONS Hemorrhage CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. In Study 1, the incidence of severe bleeding was 3.4% for CYRAMZA and 2.6% for placebo. In Study 2, the incidence of severe bleeding was 4.3% for CYRAMZA plus paclitaxel and 2.4% for placebo plus paclitaxel. Patients with gastric cancer receiving nonsteroidal anti-inflammatory drugs (NSAIDs) were excluded from enrollment in Studies 1 and 2; therefore, the risk of gastric hemorrhage in CYRAMZAtreated patients with gastric tumors receiving NSAIDs is unknown. In Study 3, the incidence of severe bleeding was 2.4% for CYRAMZA plus docetaxel and 2.3% for placebo plus docetaxel. Patients with NSCLC receiving therapeutic anticoagulation or chronic therapy with NSAIDS or other anti-platelet therapy other than once daily aspirin or with radiographic evidence of major airway or blood vessel invasion or intratumor cavitation were excluded from Study 3; therefore, the risk of pulmonary hemorrhage in these groups of patients is unknown.

Permanently discontinue CYRAMZA in patients who experience severe bleeding.

Arterial Thromboembolic Events Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia occurred in clinical trials including 1.7% of 236 patients who received CYRAMZA as a single agent for gastric cancer in Study 1. Permanently discontinue CYRAMZA in patients who experience a severe ATE. Hypertension An increased incidence of severe hypertension occurred in patients receiving CYRAMZA as a single agent (8%) as compared to placebo (3%) and in patients receiving CYRAMZA plus paclitaxel (15%) as compared to placebo plus paclitaxel (3%) and in patients receiving CYRAMZA plus docetaxel (6%) as compared to placebo plus docetaxel (2%). Control hypertension prior to initiating treatment with CYRAMZA. Monitor blood pressure every two weeks or more frequently as indicated during treatment. Temporarily suspend CYRAMZA for severe hypertension until medically controlled. Permanently discontinue CYRAMZA if medically significant hypertension cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis or hypertensive encephalopathy.

Infusion-Related Reactions Prior to the institution of premedication recommendations across clinical trials of CYRAMZA, infusion-related reactions (IRRs) occurred in 6 out of 37 patients (16%), including two severe events. The majority of IRRs across trials occurred during or following a first or second CYRAMZA infusion. Symptoms of IRRs included rigors/tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia.

In severe cases, symptoms included bronchospasm, supraventricular tachycardia, and hypotension. Monitor patients during the infusion for signs and symptoms of IRRs in a setting with available resuscitation equipment.

Immediately and permanently discontinue CYRAMZA for Grade 3 or 4 IRRs. Gastrointestinal Perforations CYRAMZA is an antiangiogenic therapy that can increase the risk of gastrointestinal perforation, a potentially fatal event. Four of 570 patients (0.7%) who received CYRAMZA as a single agent in clinical trials experienced gastrointestinal perforation. In Study 2, the incidence of gastrointestinal perforations was also increased in patients that received CYRAMZA plus paclitaxel (1.2%) as compared to patients receiving placebo plus paclitaxel (0.3%). In Study 3, the incidence of gastrointestinal perforation was 1% for CYRAMZA plus docetaxel and 0.3% for placebo plus docetaxel. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.

Impaired Wound Healing CYRAMZA has not been studied in patients with serious or non-healing wounds. CYRAMZA is an antiangiogenic therapy with the potential to adversely affect wound healing. Withhold CYRAMZA prior to surgery. Resume following the surgical intervention based on clinical judgment of adequate wound healing. If a patient develops wound healing complications during therapy, discontinue CYRAMZA until the wound is fully healed.

Clinical Deterioration in Patients with Child-Pugh B or C Cirrhosis Clinical deterioration, manifested by new onset or worsening encephalopathy, ascites, or hepatorenal syndrome was reported in patients with Child-Pugh B or C cirrhosis who received single-agent CYRAMZA. Use CYRAMZA in patients with Child-Pugh B or C cirrhosis only if the potential benefits of treatment are judged to outweigh the risks of clinical deterioration.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) RPLS has been reported with a rate of <0.1% in clinical studies with CYRAMZA. Confirm the diagnosis of RPLS with MRI and discontinue CYRAMZA in patients who develop RPLS. Symptoms may resolve or improve within days, although some patients with RPLS can experience ongoing neurologic sequelae or death.

CYRAMZA plus docetaxel (N=627) All Grades Grade 3-4 (Frequency %) (Frequency %) Blood and Lymphatic System Disorders Febrile neutropenia 16 16 Neutropenia 55 49 Thrombocytopenia 13 3 Gastrointestinal Disorders Stomatitis/Mucosal 37 7 inflammation Eye Disorders Lacrimation increased 13 <1 General Disorders and Administration Site Disorders Fatigue/Asthenia 55 14 Peripheral edema 16 0 Respiratory, Thoracic, and Mediastinal Disorders Epistaxis 19 <1 Vascular Disorders Hypertension 11 6 Adverse Reactions (MedDRA) System Organ Class

Placebo plus docetaxel (N=618) All Grades Grade 3-4 (Frequency %) (Frequency %) 10 46 5

10 40 <1

19

2

5

0

50 9

11 <1

7

<1

5

2

Clinically relevant adverse drug reactions reported in ≥1% and <5% of the CYRAMZA plus docetaxel-treated patients in Study 3 were hyponatremia (4.8% CYRAMZA plus docetaxel versus 2.4% for placebo plus docetaxel) and proteinuria (3.3% CYRAMZA plus docetaxel versus 0.8% placebo plus docetaxel).

Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity. In 19 clinical trials, 70/2131 (3.3%) of CYRAMZA-treated patients with post baseline serum samples tested positive for treatment-emergent antiramucirumab antibodies by an enzyme-linked immunosorbent assay (ELISA). Neutralizing antibodies were detected in 12 of the 70 patients who tested positive for treatment-emergent anti-ramucirumab antibodies. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to CYRAMZA with the incidences of antibodies to other products may be misleading.

DRUG INTERACTIONS No pharmacokinetic (PK) interactions were observed between ramucirumab and docetaxel.

CYRAMZA Administered in Combination with Docetaxel Study 3 was a multinational, randomized, double-blind study conducted in patients with NSCLC with disease progression on or after one platinum-based therapy for locally advanced or metastatic disease.

Patients received either CYRAMZA 10 mg/kg intravenously plus docetaxel 75 mg/m2 intravenously every 3 weeks or placebo plus docetaxel 75 mg/m2 intravenously every 3 weeks. Due to an increased incidence of neutropenia and febrile neutropenia in patients enrolled in East Asian sites, Study 3 was amended and 24 patients (11 CYRAMZA plus docetaxel, 13 placebo plus docetaxel) at East Asian sites received a starting dose of docetaxel at 60 mg/m2 every 3 weeks. Study 3 excluded patients with an ECOG PS of 2 or greater, bilirubin greater than the upper limit of normal (ULN), uncontrolled hypertension, major surgery within 28 days, radiographic evidence of major airway or blood vessel invasion by cancer, radiographic evidence of intratumor cavitation, or gross hemoptysis within the preceding 2 months, and patients receiving therapeutic anticoagulation or chronic anti-platelet therapy other than once daily aspirin. The study also excluded patients whose only prior treatment for advanced NSCLC was a tyrosine kinase (epidermal growth factor receptor [EGFR] or anaplastic lymphoma kinase [ALK]) inhibitor. The data described below reflect exposure to CYRAMZA plus docetaxel in 627 patients in Study 3. Demographics and baseline characteristics were similar between treatment arms. Median age was 62 years; 67% of patients were men; 84% were White and 12% were Asian; 33% had ECOG PS 0; 74% had non-squamous histology and 25% had squamous histology. Patients received a median of 4.5 doses of CYRAMZA; the median duration of exposure was 3.5 months, and 195 (31% of 627) patients received CYRAMZA for at least six months. In Study 3, the most common adverse reactions (all grades) observed in CYRAMZA plus docetaxel-treated patients at a rate of ≥30% and ≥2% higher than placebo plus docetaxel were neutropenia, fatigue/asthenia, and stomatitis/mucosal inflammation. Treatment discontinuation due to adverse reactions occurred more frequently in CYRAMZA plus docetaxel-treated patients (9%) than

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C Risk Summary Based on its mechanism of action, CYRAMZA may cause fetal harm. Animal models link angiogenesis, VEGF and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development. There are no adequate or well-controlled studies of ramucirumab in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus.

Animal Data No animal studies have been specifically conducted to evaluate the effect of ramucirumab on reproduction and fetal development. In mice, loss of the VEGFR2 gene resulted in embryofetal death and these fetuses lacked organized blood vessels and blood islands in the yolk sac. In other models, VEGFR2 signaling was associated with development and maintenance of endometrial and placental vascular function, successful blastocyst implantation, maternal and feto-placental vascular differentiation, and development during early pregnancy in rodents and non-human primates. Disruption of VEGF signaling has also been associated with developmental anomalies including poor development of the cranial region, forelimbs, forebrain, heart, and blood vessels.

Nursing Mothers It is not known whether CYRAMZA is excreted in human milk. No studies have been conducted to assess CYRAMZA’s impact on milk production or its presence in breast milk. Human IgG is excreted in human milk, but published data suggests that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because many drugs are excreted in human milk and because of the potential risk for serious adverse reactions in nursing infants from ramucirumab, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use The safety and effectiveness of CYRAMZA in pediatric patients have not been established. In animal studies, effects on epiphyseal growth plates were identified. In cynomolgus monkeys, anatomical pathology revealed adverse effects on the epiphyseal growth plate (thickening and osteochondropathy) at all doses tested (5-50 mg/kg). Ramucirumab exposure at the lowest weekly dose tested in the cynomolgus monkey was 0.2 times the exposure in humans at the recommended dose of ramucirumab as a single agent.

Geriatric Use Of the 563 CYRAMZA-treated patients in two randomized gastric cancer clinical studies, 36% were 65 and over, while 7% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Of the 1253 patients in Study 3, 455 (36%) were 65 and over and 84 (7%) were 75 and over. Of the 627 patients who received CYRAMZA plus docetaxel in Study 3, 237 (38%) were 65 and over, while 45 (7%) were 75 and over. In an exploratory subgroup analysis of Study 3, the hazard ratio for overall survival in patients less than 65 years old was 0.74 (95% CI: 0.62, 0.87) and in patients 65 years or older was 1.10 (95% CI: 0.89, 1.36).

Renal Impairment No dose adjustment is recommended for patients with renal impairment based on population PK analysis.

Hepatic Impairment No dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin within upper limit of normal [ULN] and aspartate aminotransferase [AST] >ULN or total bilirubin >1.0-1.5 times ULN and any AST)

CYRAMZA® (ramucirumab) injection

CYRAMZA® (ramucirumab) injection

ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

RB-L HCP BS 17Dec2014

RB-L HCP BS 17Dec2014

based on population PK analysis. Clinical deterioration was reported in patients with Child-Pugh B or C cirrhosis who received single-agent CYRAMZA. Females and Males of Reproductive Potential Fertility Advise females of reproductive potential that CYRAMZA may impair fertility.

Contraception Based on its mechanism of action, CYRAMZA may cause fetal harm. Advise females of reproductive potential to avoid getting pregnant while receiving CYRAMZA and for at least 3 months after the last dose of CYRAMZA. DOSAGE AND ADMINISTRATION Do not administer CYRAMZA as an intravenous push or bolus.

Recommended Dose and Schedule The recommended dose of CYRAMZA is 10 mg/kg administered by intravenous infusion over approximately 60 minutes on day 1 of a 21-day cycle prior to docetaxel infusion. Continue CYRAMZA until disease progression or unacceptable toxicity Premedication Prior to each CYRAMZA infusion, premedicate all patients with an intravenous histamine H1 antagonist (e.g., diphenhydramine hydrochloride). For patients who have experienced a Grade 1 or 2 infusion reaction, also premedicate with dexamethasone (or equivalent) and acetaminophen prior to each CYRAMZA infusion.

Dose Modifications Infusion-Related Reactions (IRR) • Reduce the infusion rate of CYRAMZA by 50% for Grade 1 or 2 IRRs. • Permanently discontinue CYRAMZA for Grade 3 or 4 IRRs. Hypertension • Interrupt CYRAMZA for severe hypertension until controlled with medical management.

• Permanently discontinue CYRAMZA for severe hypertension that cannot be controlled with antihypertensive therapy.

Proteinuria • Interrupt CYRAMZA for urine protein levels ≥2 g/24 hours. Reinitiate treatment at a reduced dose of 8 mg/kg every 2 weeks once the urine protein level returns to <2 g/24 hours. If the protein level ≥2 g/24 hours reoccurs, interrupt CYRAMZA and reduce the dose to 6 mg/kg every 2 weeks once the urine protein level returns to <2 g/24 hours.

• Permanently discontinue CYRAMZA for urine protein level >3 g/24 hours or in the setting of nephrotic syndrome.

Wound Healing Complications • Interrupt CYRAMZA prior to scheduled surgery until the wound is fully healed.

Arterial Thromboembolic Events, Gastrointestinal Perforation, or Grade 3 or 4 Bleeding • Permanently discontinue CYRAMZA. For toxicities related to docetaxel, refer to the current respective prescribing information.

PATIENT COUNSELING INFORMATION Advise patients: • That CYRAMZA can cause severe bleeding. Advise patients to contact their health care provider for bleeding or symptoms of bleeding including lightheadedness.

• Of increased risk of an arterial thromboembolic event.

• To undergo routine blood pressure monitoring and to contact their health care provider if blood pressure is elevated or if symptoms from hypertension occur including severe headache, lightheadedness, or neurologic symptoms.

• To notify their health care provider for severe diarrhea, vomiting, or severe abdominal pain.

• That CYRAMZA has the potential to impair wound healing. Instruct patients not to undergo surgery without first discussing this potential risk with their health care provider.

• Of the potential risk for maintaining pregnancy, risk to the fetus, or risk to postnatal development during and following treatment with CYRAMZA and the need to avoid getting pregnant, including use of adequate contraception, for at least 3 months following the last dose of CYRAMZA. • To discontinue nursing during CYRAMZA treatment.

Additional information can be found at www.CYRAMZAhcp.com.

Eli Lilly and Company, Indianapolis, IN 46285, USA Copyright © 2014, Eli Lilly and Company. All rights reserved.

CYRAMZA® (ramucirumab) injection

Dinutuximab FDA-Approved for Pediatric Patients with High-Risk Neuroblastoma

The US Food and Drug Admin­ istration (FDA) has recently ap­ ­ proved dinutuximab (Unituxin; United Therapeutics Corporation), an antibody that binds to the surface of neuroblastoma cells, for the treat­ ment of pediatric patients with highrisk neuroblastoma. It is approved ­­for use as part of a multimodal regi­­ men, including surgery, chemothera­ py, and radiation therapy in patients who achieved at least partial response to previous first-line, multiagent, multimodality therapy. Dinu­tuximab received priority review and orphan product designation. It also received a rare pediatric disease priority review voucher.

Dinutuximab was approved based on the safety and efficacy data from a clinical trial of 226 pediatric patients with high-risk neuroblastoma with tumors that shrunk or disappeared after treatment with multidrug che­ motherapy and surgery, followed by intensive chemotherapy, bone mar­ row transplantation support, and radi­ ation therapy. As part of the trial, participants were randomly assigned to receive isotretinoin, an oral reti­ noid drug, or dinutuximab in combi­ nation with interleukin-2 and granu­ locyte-macrophage colony-stimulating factor. Sixty-three percent of patients who received combination therapy with dinutuximab were alive and free of tumor growth or recurrence after 3 years, compared with 46% of patients who received isotretinoin alone.

Updated survival data demonstrated that 73% of patients who received the combination therapy were alive, com­ pared with 58% of patients who were treated with isotretinoin.

The FDA announcement notes that dinutuximab comes with a boxed warning. It is associated with irritation of nerve cells leading to severe pain requiring treatment with intravenous narcotics. Dinutuximab has also been shown to cause nerve damage and life-threatening infusion reactions (eg, upper airway swelling, difficulty breath­ ing, and low blood pressure), during or shortly following completion of the infusion.

Serious side effects associated with dinutuximab include infections, eye problems, electrolyte abnormalities, and bone marrow suppression. The most common side effects of the drug were pain, fever, low platelet counts, infusion reactions, low blood pres­ sure, hyponatremia, elevated liver enzymes, anemia, vomiting, diarrhea, low potassium levels, capillary leak syndrome, neutropenia, lymphope­ nia, hives, and low calcium levels.

First HDAC Inhibitor, Panobinostat, Approved for Patients with Multiple Myeloma

The FDA approved panobinostat (Farydak; Novartis Pharmaceuticals) for the treatment of patients with mul­ tiple myeloma. Panobinostat works ­­by inhibiting the histone deacetylase (HDAC) enzymes, which slow and/ or kill the excess production of plasma cells in the bone marrow that leads to the development of multiple myeloma.

Panobinostat was approved under the FDA’s priority review and accelerat­ ed approval programs and carries an orphan drug designation.

Panobinostat is the first HDAC inhibitor approved by the FDA. Panobin­ostat is approved for the treat­ ment of myeloma in patients who have received at least 2 previous standard myeloma therapies, including bor­ tezomib and an immunomodulatory agent (eg, lenalidomide). Panobinostat should be used in combination with bortezomib and dexamethasone.

“Farydak has a new mechanism of action that distinguishes it from prior drugs approved to treat multiple myelo­ ma, making it a potentially attrac­ tive candidate agent for the treatment of multiple myeloma,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Farydak’s approval is particularly impor­tant, because it has been shown to slow the progression of multiple myeloma.”

The safety and efficacy of panobin­ ostat were based on a clinical trial with 193 patients with myeloma who received at least 2 previous treat­ ments, including bortezomib and an immunomodulatory agent. The patients were randomized to a combi­ nation of panobinostat, bortezomib, and dexamethasone, or to bortezo­ mib and dexamethasone alone. The 3-drug combination of panobino­ stat, bortezomib, and dexametha­ sone extended the progression-free survival (PFS) by 4.10 months; it was approximately 10.6 months with the 3-drug combination compared with only 5.8 months with bortezomib and dexamethasone alone. In addition, the response rate was 59% among the patients receiving the 3-drug com­ bination versus 41% among those receiving bortezomib and dexameth­ asone without panobinostat.

The most common side effects seen with panobinostat were diar­ rhea, tiredness, nausea, swelling in the arms or legs, decreased appetite, fever, vomiting, and weakness. The most common laboratory abnormali­ ties were hypophosphatemia, hypoka­ lemia, hyponatremia, increased creat­ Continued on page 12

RB-L HCP BS 17Dec2014

www.TheOncologyPharmacist.com

FDA NEWS

RB-L HCP BS 17Dec2014

MAY 2015 I VOL 8, NO 2

5

EDITORIAL BOARD EDITOR-IN-CHIEF

Patrick Medina, PharmD, BCOP Oklahoma University College of Pharmacy Tulsa, OK

Anjana Elefante, PharmD, BSc, BSc Pharm, RPh

Dwight Kloth, PharmD, FCCP, BCOP

Timothy G. Tyler, PharmD, FCSHP

Beth Faiman, PhD, MSN, APRN-BC, AOCN

Jim Koeller, MS

John M. Valgus, PharmD, BCOP

Christopher Fausel, PharmD

Christopher J. Lowe, PharmD

Roswell Park Cancer Institute Buffalo, NY

Fox Chase Cancer Center Philadelphia, PA

Desert Regional Medical Center Palm Springs, CA

ASSOCIATE EDITOR-IN-CHIEF

Steve Stricker, PharmD, MS, BCOP Samford University McWhorter School of Pharmacy Birmingham, AL

John F. Aforismo, BSc Pharm, RPh, FASCP

University of Texas at Austin San Antonio, TX

Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Drug Knowledge Wethersfield, CT

Indiana University Simon Cancer Center Indianapolis, IN

Indiana University Hospital Indianapolis, IN

David Baribeault, BS, BCOP

Rebecca S. Finley, PharmD, MS

Emily Mackler, PharmD, BCOP

Betty M. Chan, PharmD, BCOP

David C. Gammon, BSPh

Laura Boehnke Michaud, PharmD, BCOP, FASHP

Boston, MA

USC/Norris Cancer Hospital Los Angeles, CA

Jefferson School of Pharmacy Philadelphia, PA

OncologyPharmacist.net Warwick, RI

University of Michigan Health System & College of Pharmacy Ann Arbor, MI

The University of Texas MD Anderson Cancer Center Houston, TX

University of North Carolina Hospitals and Clinics Chapel Hill, NC

Gary C. Yee, PharmD, FCCP, BCOP University of Nebraska College of Pharmacy Omaha, NE

Burt Zweigenhaft, BS

Onco360/OncoMed New York, NY

Marlo Blazer, PharmD, BCOP James Cancer Hospital & Solove Research Institute Columbus, OH

Heidi D. Gunderson, PharmD, BCOP Mayo Clinic Cancer Center Rochester, MN

Steven L. Dâ&#x20AC;&#x2122;Amato, RPh, BCOP Maine Center for Cancer Medicine Scarborough, ME

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MAY 2015 I VOL 8, NO 2

Lew Iacovelli, BS, PharmD, BCOP, CPP

Moses H. Cone Health System Greensboro, NC

LeAnn Best Norris, PharmD, BCPS, BCOP South Carolina College of Pharmacy Columbia, SC

Kamakshi V. Rao, PharmD, BCOP University of North Carolina Hospitals and Clinics Chapel Hill, NC

www.TheOncologyPharmacist.com

FROM THE EDITORS

PUBLISHING STAFF Senior Vice President, Sales & Marketing Nicholas Englezos nenglezos@the-lynx-group.com Vice President/Group Publisher Russell Hennessy rhennessy@the-lynx-group.com Vice President/Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Publisher Cristopher Pires cpires@the-lynx-group.com Editorial Director Frederique H. Evans fevans@the-lynx-group.com Copyeditor Hina Khaliq Production Manager Cara Nicolini

THE LYNX GROUP President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Director, Strategy & Program Development John Welz Director, Quality Control

Barbara Marino

Editor-in-Chief Patrick Medina, PharmD, BCOP

In this month’s issue of The Oncology Pharmacist (TOP), we present our coverage of the news from the 11th annual Hematology/Oncology Pharmacy Association (HOPA) conference. TOP was there, and we highlight presenta­ tions about the role of pharmacists in hospice and pallia­ tive care, the disposal of oral cancer drugs, and opportuni­ ties in survivorship care.

In this issue’s reader poll (see below), we ask about shift work and sleep deprivation, and the risk of cancer. Please visit our website, www.TheOncologyPharmacist.com, and let us know if this is a trend that you have observed. You can also send comments to info@TheOncologyPharmacist. com. “There is a very strong link between shift work and lack of sleep, and few hours of sleep can translate to a higher risk for obesity and disease,” according to Eva S. Schernhammer, MD, DrPh, who recently spoke at the

Have you observed a correlation between sleep deprivation and cancer risk? o Yes o No

Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs

Jr Digital Media Specialist Charles Easton IV Web Content Manager Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Mezzacappa Project Managers Deanna Martinez Jeremy Shannon Project Coordinator Rachael Baranoski IT Manager Kashif Javaid Administrative Team Leader Allison Ingram Administrative Assistant Amanda Hedman Office Coordinator Robert Sorensen

Green Hill Healthcare Communications, LLC 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-656-7935 • fax: 732-656-7938

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American Association for Cancer Research International Conference on Frontiers in Cancer Prevention Research (see “Shift Work, Sleep Deprivation, and Cancer Risk,” on page 14).

We also report on the recent US Food and Drug Administration (FDA) approval of dinutuximab for the treatment of pediatric patients with high-risk neuroblasto­ ma (see page 5), and other FDA news. In this issue’s side effects management column, we discuss the hardships sur­ vivors of colorectal cancer continue to have 1 to 3 months after sphincter-preserving surgery or anastomosis (see “Colorectal Cancer Survivors Frequently Report Bowel Dysfunction,” on page 13).

We encourage you to read through this issue and send us your feedback about the different sections of the journal.

We want to hear from you! l

READER POLL

Quality Control Assistant Theresa Salerno

Creative & Design Assistants Lora LaRocca Wayne Williams

Associate Editor-in-Chief Steve Stricker, PharmD, MS, BCOP

Data suggest that shift work and sleep deprivation may be associated with cancer.

“More refined exposure assessments that take into account external as well as internal clocks will likely enable us to more finely delineate chronic disease risk, including that of cancer,”

according to Eva Schernhammer, MD, DrPh (see page 14). Have you observed a correlation between sleep deprivation and cancer risk?

Tell us about your methods for addressing sleep deprivation in patients, and provide your feedback on this article.

Go to www.TheOncologyPharmacist.com to answer the question and add your comments.

The Oncology Pharmacist®, ISSN 1944-9607 (print); ISSN 1944-9593 (online) is published 4 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright © 2015 by Green Hill Healthcare Communications, LLC. All rights reserved. The Oncology Pharmacist® logo is a registered trademark of Green Hill Healthcare Com­munications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America.

EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DIRECTOR, The Oncology Pharmacist®, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. E-mail: info@TheOncologyPharmacist.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issues, $17.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Commun­i­cations, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. The ideas and opinions expressed in The Oncology Pharmacist® do not necessarily reflect those of the Editorial Board, the Editorial Director, or the Publisher. Publication of an advertisement or other product mentioned in The Oncology Pharmacist® should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the Editorial Director.

MAY 2015 I VOL 8, NO 2

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CONFERENCE NEWS

The Pharmacist’s Role in Hospice and Palliative Care Continued from cover and should find ways to get those for the patient,” explained Dr Frei, Associate Professor of Pharmacy Practice, Feik School of Pharmacy, University of the Incarnate Word, San Antonio, TX, and Clinical Instructor, University of Texas Health Science Center at San Antonio.

Addressing financial concerns specif­ ically related to medication, ensuring safe and legal disposal of all medications after a patient’s death, and establishing and maintaining proficient communica­ tion with regulatory and licensing agen­ cies are additional roles defined by the ASHP for pharmacists in hospice care.

Furthermore, the ASHP determines that pharmacists should have a defined scope of practice in hospice and palliative care settings. “What we’re doing should be written down, particularly our activi­ ties and the limitation of those activities, as well as referral and communication guidelines,” said Dr Frei. Documentation of services is vital, and should include medical record notes. In addition, phar­ macists should have a role in interdisci­ plinary team meetings, and should sign off on patient reviews there, she stressed.

Palliative Care Guidelines “Palliative care specialists and interdis­ ciplinary palliative care teams, including board-certified palliative care physicians, advanced practice nurses, and physi­ cian assistants, should be readily avail­ able to provide consultative or direct care to patients/families who request or require their expertise,” according to the National Comprehensive Cancer Networks Guidelines.1

The National Consensus Project for Quality Palliative Care’s Clinical Practice Guidelines for Quality Palliative Care includes no mention of pharma­ cists. “However, they say other health care practitioners could be involved,” Dr Frei added.

More Research Is Needed “The research we have available right now concerning the pharmacist’s role really comes from Australia and Canada,” Dr Frei explained. “It doesn’t seem [like] there’s much being published about pharmacy services in hospice or palliative care in the United States.”

The reported clinical duties of pharmacists in palliative care sites in Australia and Canada involve medica­ tion review, which Dr Frei noted is the most common involvement of pharma­

“Palliative care specialists and interdisciplinary palliative care teams should be readily available.” cists in palliative care, as well as provid­ ing advice on pharmacotherapy, admin­ istration, treatment, adverse effects and incompatibilities, and educating patients. Additional duties involve par­ ticipating in conferences, publications, and research, although this participation is infrequent.

“Pharmacists involved in hospice care should also work to provide efficient mechanisms for extemporaneous compounding of nonstandard dosage forms, and should find ways to get those for the patient.”

Bradi Frei, PharmD, MS, BCOP, BCPS

Drug-Related Problems in Palliative Care An Australian study by Hussainy and colleagues in 2011 examined the role of a pharmacist in a community pallia­ tive care multidisciplinary team.2 “This study examined what pharmacists could be doing as patients were discharged from an inpatient service into the hospice program,” Dr Frei explained.

Pharmacist responsibilities in the proj­ ect included creating patient education materials, conducting team educational sessions on palliative care topics, and medication review for patients enrolled in the program.

Screening patients for medication misadventure was also a cornerstone of the project. Pharmacists screened most patients (88.4%) referred to the pallia­ tive care service for risk of medication misadventure, and it was found that 14% of the patients screened needed medica­ tion reviews by the pharmacist. Eightyeight percent of medication reviews were conducted in the patients’ homes, and 113 drug-related problems were identified; the most common problems

detected were that the “patient requests drug information” (25%), and that their “condition [was] not adequately treated” (22%). “An important role of pharma­ cists in the project was coming back to the hospice program and updating the records to reflect what the patients were actually doing compared to what they thought they were doing,” said Dr Frei.

Results of this study suggest that the inclusion of a pharmacist in a community palliative care team can improve the medication-related knowledge and skills of its members and lead to better patient medication management. Although the study by Hussainy and colleagues fur­ thered understanding about the role of the pharmacist in palliative and hospice care, much more research is needed in the United States to fully define the role. l References

1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): palliative care. Version 2.2013. www. nccn.org/professionals/physician_gls/PDF/palliative.pdf.

Published June 5, 2013. Accessed April 9, 2015.

2. Hussainy SY, Box M, Scholes S. Piloting the role of a pharmacist in a community palliative care multidis­ ciplinary team: an Australian experience. BMC Palliat Care. 2011;10:16.

NOTEWORTHY NUMBERS

Ovarian Cancer In 1962, President John F. Kennedy challenged Americans to go to the moon within a decade. Apollo 11 accomplished that goal 7 years later. In 2012, inspired by that challenge, the University of Texas MD Anderson Cancer Center launched the Moon Shots Program. This ambitious plan aims to convert scientific discoveries into clinical advances quickly to improve survival rates for several of the deadliest cancers including ovarian cancer, which is our focus this month.1 • One in 72 women will develop ovarian cancer in her lifetime. Ovarian cancer is the 11th most common cancer and the 5th leading cause of death due to cancer in women. It is the number 1 cause of death due to gynecologic cancers.2 • There are 21,980 new ovarian cancer cases diag­ nosed in the United States annually. More than 15,500 of those diagnosed will have the highgrade serous subtype, which causes nearly 90% of ovarian cancer deaths.3 • Early detection is vital to surviving ovarian can­ cer, but only 20% of ovarian cancers are found at an early stage.4 Diagnosis is difficult because symp­

8

MAY 2015 I VOL 8, NO 2

toms of ovarian cancer are nonspecific and screen­ ing is problematic. Some studies indicate that routine use of transvaginal sonography (TVS) as a screening device is not effective.4 However, since 1987, researchers affiliated with the University of Kentucky Markey Cancer Center have conducted free TVS screenings for ovarian cancer. More than 43,000 participants have received more than 255,000 free TVS screens in this program, which delivers over 1000 screens each month. At least 86 malignancies have been discovered.5,6 • The total National Cancer Institute research budget for fiscal year 2013 was $4.79 billion, down

from an average of $5.8 billion for the years 2010 through 2012. Of the 2013 budget, $100.6 million was spent on ovarian cancer research.7 Sources 1. www.mdanderson.org/newsroom/news-releases/2014/year-two-moonshots-program.html.

2. www.ovariancancer.org.

3. www.cancermoonshots.org/cancer-­types/ovarian/.

4. www.cancer.org/cancer/ovariancancer/­detailedguide/ovarian-cancerdetection.

5. http://ovarianscreening.info/.

6. www.kentucky.com/2013/10/22/­2889633_researchers-tout-effective­ ness.html?rh=1.

7. www.cancer.gov/researchandfunding/snapshots/ovarian.

www.TheOncologyPharmacist.com

CONFERENCE NEWS

The Ins and Outs of Disposing Oral Cancer Drugs Meg Barbor

Austin, TX—Handling and disposing of oral cancer therapies can be hazardous, and certain protocols should be followed to reduce risks, according to Lisa Holle, PharmD, who spoke at the 11th annual Hematology/Oncology Pharmacy As­so­­ ciation (HOPA) conference.

“Oral cancer therapies are very much like [intravenous] cancer therapies in that there is a risk of exposure; the type of exposure depends upon the qualities of the medication,” noted Dr Holle, Assistant Clinical Professor, University of Connecticut School of Pharmacy, Storrs. “Most oral cancer therapies are cytotoxic agents, but there are many other ways that drugs can be hazard­ ous,” she added.

Carcinogenicity, teratogenicity (or other developmental toxicity) repro­ ductive toxicity, organ toxicity at low doses, and genotoxicity are other poten­ tially hazardous drug properties. Drugs can also have structure and toxicity profiles that mimic existing hazardous properties, and can be toxic, ignitable, corrosive, or reactive.

Current Regulations In the United States, the National Institute for Occupational Safety and Health and the American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards provide the guidelines most often referred to for the handling of hazardous drugs, Dr Holle noted.

Manufacturing and handling guide­ lines on package inserts can also serve as a guideline, but only some drug inserts provide guidance for how patients, family members, caregivers, or health­ care professionals should handle them.

“With new drugs we should probably just assume they’re hazardous even if they’re not documented yet,” she said.

Handling Hazardous Drugs Storage, preparation and handling, administration, and disposal of hazard­ ous drugs can all result in exposure.

Healthcare professionals should use per­

sonal protective equipment when cut­ ting, crushing, manipulating, or admin­ istering tablets or capsules, as well as during the compounding or administra­ tion of oral liquids.

“We know that personal protective equipment is effective at reducing risk for healthcare providers, but we don’t really talk about the risk for family members who might be handling these medications on the outside,” Dr Holle stated.

Patients should wash their hands after administration, use separate pillbox­ es when possible, swallow medications whole, and wash their hands after using the toilet or vomiting, she advised.

Caregivers should always wash their hands and wear gloves when admin­ istering drugs, and pregnant or breast­ feeding caregivers, along with children, should not handle drugs or waste.

Hazardous Drug Disposal Improper disposal of hazardous drugs pollutes the water and ground, and is toxic to plants, animals, and humans.

“The thing about oral cancer thera­ pies is that under the Environmental Protection Agency [EPA], the guidance for how you handle any sort of waste depends on how the waste was gen­ erated,” Dr Holle explained. “Once a medication is dispensed to a patient, it is actually considered a household waste and therefore falls under different regulations in terms of who manages the waste and how it can be disposed.”

Household waste management is gov­ erned by local and state environmental agencies, and is exempted under the Resource Conservation and Recovery Act (RCRA). RCRA is the principal federal law in the United States govern­ ing the disposal of solid and hazardous wastes, and classifies drugs according to their potentially hazardous natures.

“There are a few oral cancer therapies, primarily those that are cytotoxic, that fall under RCRA, but those are exempt, too, because they’re considered house­ hold waste,” she noted.

Proper Disposal of Oral Cancer Therapies Cancer.Net, an American Society of Clinical Oncology resource for patients and care providers, recommends con­ versations between healthcare pro­ viders and patients regarding proper disposal of oral cancer therapies, and

Manufacturing and handling guidelines on package inserts can also serve as a guideline, but only some drug inserts provide guidance for how patients, family members, caregivers, or healthcare professionals should handle them. advises returning any unused drugs and/ or containers and other chemotherapy waste to providers for proper disposal, never flushing them down the toilet or disposing of them in the trash.

When hazardous waste is generated within a facility, different regulations apply. RCRA drugs must be disposed of very specifically because they can be potentially hazardous to the envi­ ronment. Individual state departments of energy and environmental protec­ tion outline additional state-depen­ dent designations. Within institutions, disposal of hazardous waste is regulat­ ed by the Occupational Safety and Health Administration and The Joint Commission, as well as by any addition­ al institutional guidance, depending on how much hazardous waste is generated by an establishment.

“All of these guidelines are not neces­

sarily complementary to the others,” Dr Holle stated. “Sometimes they can be discordant, and then you have to figure out which guidance you’re going to fol­ low and which you might deviate from, which can make things challenging.”

Oral Cancer Therapy Disposal at UConn Health Dr Holle and colleagues conduct­ ed a 12-month pilot program at the University of Connecticut Health Cen­ ter’s (UConn Health) Carole and Ray Neag Comprehensive Cancer Cen­ ter, from March 31, 2014, to March 31, 2015, where patients were instructed—via written and verbal communication—to bring their unused or expired oral can­ cer therapies, as well as their packaging and empty bottles, back to a licensed healthcare professional at the facility for proper disposal. “Educating patients on the importance of proper disposal in this program will hopefully lead to the development of state guidelines,” she said. Patients received recommendations for alternative collection sites for the disposal of all other medications.

Although Dr Holle and colleagues could only accept drugs from patients of their clinic—because of guidance from EPA and the Division of Drug Control—she said, “I think we should open up to anybody who needs this ser­ vice, since it is not available [widely].”

Dr Holle and colleagues found the program to be beneficial to their patients, and because of their small patient population and lack of exces­ sive waste, the program was not a cost burden to the facility. “I think one of the barriers that we run into is just trying to get other providers to see the value in educating [their] patients and making sure that they do have the opportunity to bring drugs back to [them] for proper disposal,” she added.

“There should be a method for patients to be able to return their medications for proper disposal so that these drugs don’t end up within the environment affecting other people.” l

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MAY 2015 I VOL 8, NO 2

9

CONFERENCE NEWS

Folinic Acid a Good Adjunct to Methotrexate for GVHD Prophylaxis And other clinical pearls from the 2015 ABMT and BMT annual meetings

San Diego, CA—At the American Society for Blood and Marrow Transplantation’s (ASBMT) 2015 BMT Tandem Meetings, 4 studies were named the “Best Pharmacy Abstracts,” and are summarized here for our readers.

Investigators from the Mayo Clinic described their guidelines for using folinic acid rescue following methotrex­ ate as prophylaxis for graft-versus-host disease (GVHD). Folinic acid may reduce the occurrence of mucositis and improve the probability of day +11 methotrexate dosing.

“In an effort to reduce the incidence of mucositis to improve the likelihood of administering day +11 metho­trexate, and to provide a consistent treatment guideline, the Hemato­ poietic Cell Transplant (HCT) program director enlisted the help of the HCT pharma­ cist to review the data and recommend guidelines,” explained Jeffrey Betcher, BSPharm, Clinical Pharmacy Specialist and Cancer Center Pharmacy Super­ visor, Mayo Clinic, Phoenix, AZ. The investigators reviewed the litera­ ture for post-methotrexate folinic acid use and developed recommendations for dosing, time of initiation, and sched­ ule and number of doses. The recom­ mendations call for giving folinic acid 10 mg/m2 intravenously every 6 hours for 3 doses, starting 12 hours after each methotrexate dose (days +1, +3, +6, and +11). Patients also received mye­ loablative conditioning (MAC) regi­ mens and tacrolimus.

The study compared data from 27 patients treated in 2013 according to

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the guidelines with data from 31 patients receiving methotrexate regi­ mens prior to the folinic acid guidelines, and observed a number of improved outcomes after the guidelines were initi­ ated. Patients treated according to the guidelines were: (1) more likely to receive full-dose day +11 methotrexate, compared with controls (85.2% vs 48.4%; P = .0025), which has been reported to be important in reducing the risk of acute GVHD, and (2) less likely to require patient-controlled analgesia for mucositis (63.0% vs 87.1%; P = .03).

There were no significant differenc­ es in rates of total parenteral nutri­ tion, development of grade II-IV acute GVHD at day 100 or chronic GVHD, cumulative incidence of relapse, transplant-related mortality at 1 year, and overall survival at 1 year, with a median follow-up of 465 days for the folinic acid group and 670 days for the controls. “[These] end points trended in a favor­ able direction, but did not reach statisti­ cal significance,” discussed Mr Betcher.

“The development and utilization of the program [guidelines] improved consistency of care, improved staff satisfaction, and decreased patient dis­ comfort,” he said. “HCT pharmacists play an important role in the review of literature and development of pro­ gram guidelines.”

Antithymocyte Globulin Increases Risk of Infection Mixed results have been reported for

the incorporation of antithymocyte globulin (ATG) into allogeneic stemcell transplant conditioning regimens as a means of preventing acute GVHD. A study from the University of North Carolina Hospitals and Clinics, Chapel Hill evaluated the impact of ATG on infection, occurrence of GVHD, inci­ dence of relapse, and mortality rates in adult patients.

The investigators retrospectively re­­ viewed charts of 250 patients treated between 2006 and 2013. The cohort included 125 unrelated/mismatched donor recipients who received ATG and 125 matched related donors who did not.

In the analysis, ATG use actually increased the rate of infection, with a greater impact on patients receiving reduced-intensity conditioning (RIC), compared with MAC, reported lead author Katie Kaminski, PharmD. Patients receiving ATG had a median of 3 infections, versus 2 for those not receiving ATG (P = .0003).

This increase was more pronounced in the RIC group, which had a medi­ an of 3 infections if they received ATG, versus 1 without ATG. Less difference was observed among pa­ tients receiving MAC.

“The development and utilization of the program [guidelines] improved consistency of care, improved staff satisfaction, and decreased patient discomfort.”

Jeffrey Betcher, BSPharm

In both the RIC and MAC groups, the use of ATG was associated with increased numbers of infections with cytomegalo­ virus (112 vs 61), human herpesvirus 6 (47 vs 13), and herpes simplex virus (32 vs 8). The relative increase in these infections was much greater among RIC than MAC recipients.

The ATG and non-ATG groups had similar rates of severe acute GVHD through day 180, indicating a potential protective effect of ATG in unrelated/ mismatched transplants. Rates of death and relapse were not different between ATG groups, nor was mean time to

relapse. At 180 days, survival rates were 71.4% for patients receiving ATG and 83.2% for the non-ATG group (P = .0426).

“Although relapse rates were similar between groups, the 180 day mortality for [patients receiving] ATG was signifi­ cantly greater than [without] ATG, suggesting that infectious complications may impact mortality associated with ATG,” Dr Kaminski said.

Support Shown for CBV Regimen Over Busulfan/Cyclophosphamide Two preparative regimens for patients with lymphoma receiving autologous hematopoietic stem-cell transplantations (HSCTs) were com­ pared by pharmacists at Wake Forest University Baptist Medical Center, Winston-Salem, NC, who reported trends favoring the use of carmustine/ etoposide/cyclophosphamide (CBV) in older patients.

“Current literature supports the use of HSCT over salvage chemotherapy for patients with lymphoma who have recurrent disease or are at high risk of relapse,” noted the study’s lead author, LeAnne Kennedy, PharmD. “Few stud­ ies have been published directly com­ paring preparative regimens, thus, most institutions select regimens based on associated toxicities.”

At their institution, she said, busul­ fan/cyclophosphamide (Bu-Cy) was his­ torically used as the preparative regi­ men for patients with lymphoma, but clinicians transitioned toward use of the “theoretically less toxic” CBV regimen in older patients in 2009. This study retrospectively compared CBV to Bu-Cy in terms of tolerability and effi­ cacy in patients aged ≥60 years receiv­ ing autologous HSCT. Of 75 patients, 23 received Bu-Cy and 52 received CBV. Patients who received Bu-Cy experienced an average of 1.6 severe or life-threatening toxici­ ties per person, compared with 1.7 in patients who received CBV, Dr Kennedy and colleagues reported.

At 60 days, there was no difference in progression-free survival (86% with Bu-Cy vs 95% with CBV), or overall survival (96% with Bu-Cy vs 94% with CBV). A trend was ob­ served, however, toward increased progres­ sion-free survival with CBV at 3 years (31% with Bu-Cy vs 68% with CBV; P = .44), and this trend was supported by the significantly in­­creased time to relapse (22.7 months with Bu-Cy vs 61.2 months with CBV; P = .0498).

“This review demonstrates no differ­ Continued on page 11

www.TheOncologyPharmacist.com

CONFERENCE NEWS

ASBMT Pharmacy SIG Reports Growth, Opportunities for Pharmacists Caroline Helwick

San Diego, CA—The American So­­ ciety for Blood and Marrow Trans­ plantation (ASBMT) Pharmacy Spe­ cial Interest Group (SIG) is rapidly growing in both membership and opportunities, according to Jamie F. Shapiro, PharmD, BCOP, Clinical Pharmacy Coordinator, Stem Cell Transplant, and Chair of the ASBMT Pharmacy SIG. Dr Shapiro, Clinical Pharmacy Coordinator of Stem Cell Transplant at Moffitt Cancer Center, Tampa, FL, pre­ sented a SIG update at the ASBMT’s 2015 BMT Tandem Meetings, held February 11 to 15. “Our membership is rapidly growing,” Dr Shapiro said in an interview with The Oncology Pharmacist.

“We increased from 99 members last year to 240 now, a 41% growth in just 1 year.” She attributed the increase to outreach that informs oncology phar­ macists of the benefits of membership in the Pharmacy SIG, which was initiated 3 years ago.

Recruitment initiatives are ongo­ ing. One of these initiatives is greater exposure through a booth exchange between the Pharmacy SIG and Hematology/Oncology Pharmacy Ass­ ociation (HOPA); each organization waives the $6000 booth fee for the other at their respective meetings. The Pharmacy SIG also sends letters to postgraduate second-year directors, highlighting the benefits of member­ ship, which include—in addition to opportunities for networking and lead­ ership—reduced membership fees for residents in training. ASBMT, as a whole, has now followed the lead of

the Pharmacy SIG and reduced its membership fees for trainees.

This is just one example of trends that are being set by the Pharmacy SIG as it assumes a larger role within ASBMT, Dr Shapiro explained. “The ASBMT board is extremely happy with what our SIG has done, and they are supporting our new initiatives,” she said. “They are looking to use us as one of the leaders among all the SIGs. We have been paving the way for many things that other commit­ tees have adopted.” For example, the Pharmacy SIG was the first to devel­ op a First Practitioner Award and a Lifetime Achievement Award, which other SIGs now have.

Strengthening the Pharmacist’s Role in FACT Through the Pharmacy SIG’s efforts, the role of the pharmacist in the Foundation for the Accreditation of Cellular Therapy (FACT) will be strengthened. In the new, sixth edi­ tion of FACT, which sets standards for transplant centers, the responsibilities and contributions of the oncology phar­ macist as part of the multidisciplinary team have become more well-defined.

This is an improvement over past edi­ tions, where these roles were weak and vague, she explained.

The new edition also indicates that a pharmacist’s training will include an overview of cellular processes, ther­ apeutic drug monitoring, and adjust­ ment of drugs for organ dysfunction.

It also recommends that pharmacists be involved in the development of

guidelines and standard operating procedures. The pharmacist’s role has therefore been made more clinical, according to Dr Shapiro.

Advocacy Efforts The Board of Pharmacy Specialties (BPS) recently solicited feedback regarding its report on BPS Pharmacy Specialty Structure and Framework,

“We have been paving the way for many things that other committees have adopted.”

Jamie F. Shapiro, PharmD, BCOP

and its proposal for the creation of subspecialty designations within the stem-cell transplant community. “Our Advocacy and Policy Committee want­ ed to speak on behalf of pharmacists working in transplant, so we surveyed bone marrow transplant pharmacists via a Listserv to get their thoughts on the issue,” Dr Shapiro explained. “We had 81 responses; 45 in favor of subspecialty designation, and 36 against it.” Based on the survey responses, the Pharmacy SIG commented that: • A subspecialty designation will rec­ ognize that practicing in transplant does require additional knowledge and practice, beyond that of BoardCertified Oncology Pharmacist • Subspecialty designation is not like­ ly to create new job opportunities,

justify more full-time employees, or increase compensation • Members would rather earn more continuing education credits, versus taking an examination • Members would consider added quali­ fications if subspecialty designation is not adopted.

“We indicated to BPS that we recog­ nize that obtaining subspecialty desig­ nation requires additional knowledge, although most respondents did not feel that this would create more job oppor­ tunities,” Dr Shapiro said.

Other Accomplishments The main accomplishment of the Communications Committee was to publish 3 newsletters during the year, and to maintain and update the content on the ASBMT Pharmacy SIG website.

A new initiative will be a monthly e-mail update, which will be a review of recent literature relevant to transplant.

“As we grow, we are also adding new opportunities for learning,” Dr Shapiro commented.

The Education Committee held its third Fundamentals of Transplant course after the March HOPA meet­ ing. The 2014 course attracted a 34% increase in attendees over the previous year. There is also an online case series housed on the Pharmacy SIG website that is associated with lectures given at the BMT Pharmacists’ Conference, a part of the Tandem Meetings. Future educational initiatives will further diversify the ways that Pharmacy SIG members can stay up to date, she added. l

Folinic Acid a Good Adjunct to Methotrexate for GVHD... Continued from page 10 ence in terms of tolerability or efficacy between Bu-Cy and CBV; however, there is a trend towards improved relapse-free survival with CBV,” Dr Kennedy indicated. “Future studies are needed to compare other utilized pre­ parative regimens.”

Stick with Standard-Dose G-CSF After Autotransplant Different doses of granulocyte colo­ ny-stimulating factors (G-CSFs) have not been directly compared in terms of their effects on engraftment in autolo­ gous HSCT, thus, the optimal G-CSF dose remains unknown. Investigators at Northwestern Memorial Hospital,

www.TheOncologyPharmacist.com

“This review demonstrates no difference in terms of tolerability or efficacy between Bu-Cy and CBV; however, there is a trend towards improved relapse-free survival with CBV.” LeAnne Kennedy, PharmD

Chicago, IL, developed a clinical initia­ tive of dose-escalated G-CSF to deter­ mine whether the duration of neutrope­ nia can be reduced by using a higher G-CSF dose.

At the San Diego meeting, Steven Trifilio, BSPharm, presented the results of an observational study com­ paring standard-dose to dose-escalat­ ed G-CSF for the resolution of neu­ tropenia following autologous HSCT. The study included patients who had received a single daily dose of filgras­ tim (5 mcg/kg) and others treated with twice-daily doses of filgrastim (total daily dose 10 mcg/kg). All patients started G-CSF 5 days after

stem-cell infusion.

The analysis included 172 single-dose and 162 twice-daily dose recipients.

The groups were balanced except for more CD34-positive stem cells infused in the twice-daily cohort.

Mr Trifilio reported that time to engraftment was 12 days with the single dose and 11 days with twice-daily dos­ ing, while length of stay was 16 days per arm. In-hospital deaths occurred in 3 and 4 patients, respectively.

“In this study, a single 5 mcg/kg G-CSF dose was as effective as twice-daily 5 mcg/kg G-CSF doses for accelerating stem cell engraftment,” he said.—CH l

MAY 2015 I VOL 8, NO 2

11

CANCER CENTER PROFILE

Virginia K. Crosson Cancer Center...

Crosson Cancer Center offers patients advanced diagnostic and treatment options, including the latest improve­ ments in radiation therapy and inno­ vative surgical techniques.

The combined expertise of St. Jude Heritage Medical Group and St. Jude Medical Center provides quality care and supports patients through the entire cancer journey, including the oppor­ tunity to participate in clinical trials and multidisciplinary reviews of each cancer case, and receive emotional and spiritual support.

The Oncology Pharmacist spoke with Hi (Jenny) An, PharmD, Pharmacy Supervisor at the Virginia K. Crosson Cancer Center, St. Joseph’s Healthcare System, in Fullerton, CA. Tell me about your job responsibilities.

Jenny An (JA): I am the pharmacy supervisor at an outpatient cancer cen­ ter. We have 3 full-time pharmacists, including myself.

My responsibilities are broad and include staffing, training, competence, and scheduling, as well as compli­ ance with regulations, including, but not limited to, US Pharmacopeial Convention General Chapter 797.

The scope of my job involves filling prescriptions, entering orders electron­ ically, checking the final products, and making sure the right patient gets the right medication.

Also, our cancer center is one of the study sites of the TORI (Translational Oncology Research International) network and St. Jude Clinical Trials.

Our pharmacy compounds clinical trial

medications for all of the study patients, and we currently have more than 40 trials open at our site.

What are the biggest challenges you face?

JA: I am always multitasking; involved in patient counseling, teaching, and clinical trials.

My biggest challenge is having enough time to fulfill all my jobs. Since I took this job, it has expanded because I took on

Continued from cover

involves more paperwork and more record keeping.

What are your biggest rewards?

JA: My biggest rewards come from being involved with my patients and talking to them.

Ultimately, my job is about patient service, and providing quality service to our patients. Also, there are so many new cancer therapies in the pipeline and newly approved oncology medica­

“There are so many new cancer therapies in the pipeline and newly approved oncology medications that I need to keep up with. It’s challenging, but at the same time, it forces me to learn and I consider that one of the biggest rewards of being an oncology pharmacist in an ever-evolving healthcare environment.”

Hi (Jenny) An, PharmD

more responsibility. I believe pharmacists can do more for patients—for example, patient counseling.

The regulatory environment in the state of California is also changing, and we have increasing requirements that take up our time. For example, now we need a compound license, whereas we didn’t need this in the past, and this

tions that I need to keep up with. It’s challenging, but at the same time, it forces me to learn and I consider that one of the biggest rewards of being an oncology pharmacist in an ever-evolv­ ing healthcare environment.

estrogen receptor (ER)-­positive, HER2negative cancer who have not received any endocrine-­based therapy.

According to Dr Pazdur, “The addi­ tion of palbociclib to letrozole provides a novel treatment option to women diag­ nosed with metastatic breast cancer. The FDA is committed to expediting market­ ing approval of cancer drugs through our accelerated approval regulations.”

The FDA expedited the approval of palbociclib under its accelerated and priority review programs, and designat­ ed it as a breakthrough therapy based on the strength of the preliminary clinical evidence, which shows that the drug may offer an improvement for patients compared with current therapies.

Palbociclib’s efficacy was demonstrat­ ed in a clinical trial of 165 postmeno­

pausal women with ER-positive, HER2-­ negative metastatic breast cancer who had not received treatment for meta­ static disease. Patients were randomized to palbociclib plus letrozole or to letro­ zole alone. PFS was 20.2 months with the combination of palbociclib and letrozole compared with approximately 10.2 months in patients receiving letro­ zole alone. Overall survival (OS) data are not yet available.

The most common side effects were neutropenia, leukopenia, fatigue, ane­ mia, upper respiratory infection, nausea, stomatitis, hair loss, diarrhea, throm­ bocytopenia, decreased appetite, vom­ iting, asthenia, peripheral neuropathy, and nose bleeding.

The recommended dose is 125 mg for the first 21 days, followed by 7 days

How did you get into this field?

JA: My first job after pharmacy school

was working at CVS Health, a large retail pharmacy. I didn’t like it. Fortunately, I was able to get a job at the Winship Cancer Institute, which is part of Emory University in Atlanta, GA. I was lucky to get that job, and from the minute I started, I loved it. Then my husband got a job in El Segundo, CA, and we had to move from Georgia.

My passion was to find a job at a can­ cer center. It wasn’t easy, but I found the job I was looking for. My previous experience at Winship made me an excellent candidate, and I felt like the job was tailor-made for me.

What advice would you give to someone who wants to become an oncology pharmacist?

JA: If you are a pharmacy student, try to get a rotation clerkship at a cancer center and see if you like it. Not every­ one likes working at a cancer center, but then again, not everyone gets exposed to this environment during training. Find what you like to do, not what you have to do. We all work hard but you can’t beat having a job that you enjoy doing.

If you are already a pharmacist, you would need to have an oncology res­ idency. It is now much harder to get a job as an oncology pharmacist. The field is much more crowded than it was when I became a pharmacist. There is an oversupply for the demand.

What would you do if you won the lottery?

JA: I was an art major in college, and I always felt that experience was unfin­ ished, so I would go to art school and learn something new. l

FDA NEWS Continued from page 5

inine, thrombocytopenia, leukopenia, and anemia.

Panobinostat carries a boxed warning about the risk for severe diarrhea and fatal cardiac events. The FDA requires a Risk Evaluation and Mitigation Strategy program to inform providers of these risks.

Palbociclib Approved for Metastatic Breast Cancer in Postmenopausal Women

The FDA granted approval to pal­bocic­ lib (Ib­rance; Pfizer) for the treatment of postmenopausal women with metastatic breast cancer. Palbociclib works by block­ ing the activity of the cyclin-­dependent kinases 4 and 6, which promotes cancer cell growth. Palbociclib is indicated in combination with letrozole for the treat­ ment of postmenopausal women with

12

MAY 2015 I VOL 8, NO 2

without treatment. Patients’ complete blood count should be monitored before the start of therapy, at the beginning of each treatment cycle, and on day 14 of the first 2 cycles.

FDA Expedites Approval of Lenvatinib for Refractory Differentiated Thyroid Cancer

The FDA approved lenvatinib (Len­ vima; Eisai), a multitargeted tyrosine kinase inhibitor (TKI), for the treatment of patients with progressive, differenti­ ated thyroid cancer that is refractory to therapy with radioactive iodine (also known as 131I), a common treatment used for patients with advanced thyroid can­ cer. The FDA expedited its review of len­ vatinib under its priority review program, based on data suggesting that lenvatinib

www.TheOncologyPharmacist.com

SIDE EFFECTS MANAGEMENT

Colorectal Cancer Survivors Frequently Report Bowel Dysfunction Chase Doyle

A

ccording to a recent assessment of bowel dysfunction–related needs, the hardships for col­ orectal cancer (CRC) survivors con­ tinue long after leaving the operat­ ing room, and survivors desire more information and strategies to help cope with unexpected changes to their bowel patterns, researchers said at the 2015 Gastrointestinal Cancers Symposium held in San Francisco, CA. “Many colorectal cancer survivors struggle with unpredictable bowel func­ tion continually for the rest of their lives” said Virginia Sun, RN, PhD, Division of Nursing Research and Education, Department of Population Sciences at City of Hope, Duarte, CA. “And many never find any set of management strat­ egies” to help them with this situation.

The study included 37 CRC survivors who were within 1 to 3 months after sphincter-preserving surgery or anas­ tomosis to complete questionnaires on bowel function, fecal incontinence, and bowel dysfunction needs. To further explore unmet needs, the study ran­ domly selected 6 of these participants for personal interviews. The sample was taken from a single National Cancer Institute–designated comprehensive cancer center.

According to Dr Sun, the mean num­ ber of daily bowel movements reported was 5.5 (range 2-10), and many survivors reported problems with incomplete fecal evacuation and the ability to control gas.

“I was pretty much restricted to the home area…for almost a month after the

operation,” shared one of the survivors interviewed for this assessment. “You are always thinking about it, at work especial­ ly,” said another survivor. “I am always on guard or on edge because of that.”

Given the severity of complications detailed, it should come as no sur­ prise that lower quality-of-life scores were observed for the impact of fecal incontinence on lifestyle and coping behavior. Yet, many survivors reported feeling uninformed and unprepared to face these common changes.

“I think it would have been better if they just came out and said, ‘hey, the reality is…you’re going to have an acci­ dent,’” said one of the patients surveyed.

“I think they have a general idea that it is going to affect 99% [of survivors], and they should come straight out and say it.”

Echoed another survivor: “They should give you a heads up ahead of time.…If you are going home from the hospital and they tell you this last min­ ute, I don’t think that is very helpful because you are already being bombard­ ed by other information.”

Despite the prevailing side effect of bowel dysfunction, Dr Sun observed that surgery remains one of the most com­ mon and effective treatments for CRC. However, the troubling fact remains that there are few evidence-based pro­ tocols to support positive adjustments to changes in bowel function.

Survivors desired more information on managing bowel function in an emergency as well as what type of food helps with bowel function, and they also

wished for the opportunity to talk to others who share the same experience.

“They could have said, ‘you are going to have to dash to the bathroom, but we will have diapers or something for you.’ I [wish they] had a process of helping you get through that,” revealed another patient.

Of those surveyed, 39% preferred information on bowel dysfunction to be given before surgery, while 50% desired information prior to discharge.

The majority of survivors (63%) asked to participate in a bowel rehabilitation/

support program following surgery.

“Evidence-based interventions that are timely and personalized are needed to support positive adjustments to bowel changes following surgery,” concluded Dr Sun. “Survivors need more informa­ tion on managing bowel function.” l Reference

Sun V, Smith DD, Lai LL, et al. Bowel dysfunctionrelated needs assessment in colorectal cancer survivors.

J Clin Oncol (ASCO Annual Meeting Abstracts). 2015;­33 (suppl 3):Abstract 715. Poster presented at: 2015 Gastrointestinal Cancers Symposium; January 15-17, 2015; San Francisco, CA. http://meetinglibrary.asco.org/ content/140160-158. Accessed February 2, 2015.

HAVE YOU EVER WANTED TO WRITE AN ARTICLE FOR TOP ?

We’re interested in articles about the everyday issues that affect pharmacists—everything from chemotherapy safe handling to supportive care for patients to challenging cases.

Contact info@TheOncologyPharmacist.com for information FDA NEWS

provides significant improvement in safe­ ty or efficacy in terms of the treatment of differentiated thyroid cancer, the most common type of thyroid cancer.

The National Cancer Institute esti­ mates that 62,980 Americans were diagnosed with thyroid cancer in 2014, and more than 1800 patients died from the disease. Lenvatinib is the fourth TKI approved by the FDA in the past decade for the treatment of patients with refractory thyroid cancer.

“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” said Dr Pazdur. “Today’s approval gives patients and healthcare professionals a new ther­ apy to help slow the progression of DTC [differentiated thyroid cancer].”

Lenvatinib also received orphan drug

designation, because thyroid cancer is considered a relatively rare disease.

The FDA’s approval of lenvatinib was based on a phase 3 clinical trial with 392 patients with progressive, radioactive iodine therapy–refractory differentiated thyroid cancer who were randomized to lenvatinib or to placebo.

The median PFS was 18.3 months in the lenvatinib arm compared with a median PFS of 3.6 months in the pla­ cebo arm. In addition, 65% of patients receiving lenvatinib had a reduction in their tumor size compared with only 2% in patients in the placebo arm. The majority of the patients in the placebo arm were switched to lenvatinib thera­ py upon disease progression.

The most common side effects of lenvatinib were hypertension, fatigue,

diarrhea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, sto­ matitis, headache, vomiting, protein­ uria, swelling and pain in the palms, palmar-­ plantar erythrodysesthesia syn­ drome, and dysphonia.

Lenvatinib is associated with serious side effects, including cardiac failure, arterial thromboembolic events, hep­ atotoxicity, renal failure and impair­ ment, gastrointestinal perforation or fistula formation, QT interval prolonga­ tion, hypocalcemia, reversible posterior leukoencephalopathy syndrome, hem­ orrhage, and risks to an unborn child.

Nivolumab First Immuno­ therapy to Get FDA Approval for Metastatic Lung Cancer

The FDA approved a new indica­

tion for the immunotherapy nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients with metastatic squamous non–small-cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemo­ therapy. Nivolumab is the first immu­ notherapy to receive FDA approval for patients with lung cancer. It was initially approved late last year for the treatment of patients with unresectable or metastatic melanoma.

Nivolumab is a monoclonal anti­ body that binds to the PD-1 receptor; it blocks the interaction of PD-1 with its ligands 1 and 2, which inhibits an antitumor immune response.

This new indication is based on results from an open-label, multicenter, mul­ tinational randomized trial in patients Continued on page 14

www.TheOncologyPharmacist.com

MAY 2015 I VOL 8, NO 2

13

BEST PRACTICES

Shift Work, Sleep Deprivation, and Cancer Risk Meg Barbor

“T

here is a very strong link between shift work and lack of sleep, and fewer hours of sleep can trans­ late to a higher risk for obesity and dis­ ease,” according to Eva S. Schernhammer, MD, DrPH, who spoke at the recent American Association for Cancer Research International Conference on Frontiers in Cancer Prevention Research.1 There is evidence that obesity is significantly more common among people with shift work experience, according to data collected from more than 20 epidemiologic studies. Further, Dr Schernhammer said, the Nurses' Health Study (NHS)2 found that among 107,663 women, each 5-year increase in rotating shift work translat­ ed to a gain of 0.45 kg in weight.

Impact on the Circadian System “Up to 15 million Americans work alternative shifts, but shift work is not the only factor contributing to the reduction in sleep hours among many Americans,” said Dr Schernhammer, Associate Professor of Medicine at Harvard Medical School in Boston, MA. Frequent flyers and city dwellers are other typically night-active cohorts who regularly expose themselves to external light at night, potentially impacting their circadian systems. According to the World Health Organization cancer mortality database, the most industrial­ ized, or most lit-up, areas of the world have the highest cancer rates.

“Furthermore, we don’t know yet how PCs, tablets, and TV right before bed affect the circadian system,” Dr Schernhammer added.

When sleeping and eating are not aligned with the body’s internal clock, changes in appetite and metabolism can occur, which can lead to weight gain, she explained. People who go to bed late and sleep late eat more calories in the evening, eat more fast food and fewer fruits and vegetables, and weigh more than people who go to sleep early and wake up early.

“The circadian system is an internal clock that works on its own but can be affected by external light,” said Dr Schernhammer. It controls a number of functions besides waking and sleep­ ing activity in the body, including temperature, hormones, immune sys­ tem, and gene activity and expression.

The Mismatch Between Internal and External Clocks Chronotype, which is determined by the individual’s internal clock system, categorizes people by whether they have a little more or a little less than a 24-hour rhythm. Those with a rhythm more than 24 hours are colloquial­ ly referred to as “night owls”; those with less are called “morning larks.”

The most frequently used measure for chronotype is the MorningnessEveningness Questionnaire, which measures whether a person’s peak alert­

ness is in the morning, the evening, or in between. “Young individuals tend to fall into evening types, and as they get older they fall into morning types,” Dr Schernhammer noted.

Both chronotype (internal) and shift work (external) affect the circadian

“Evidence so far from the NHS suggests that the women in the study encounter higher cancer risks, in particular breast cancer and more recently lung cancer.”

Eva S. Schernhammer, MD, DrPH

system. “There is clearly some type of interaction between chronotype and shift workers. Evening types fare bet­ ter working night shifts because their attitudes are high compared to inter­ mediate types and morning types,” Dr Schernhammer explained. “When you put an evening type on a shift schedule, it’s as if they are working according to their internal clock.”

Dr Schernhammer further referenced a 2012 study by Hansen and Lassen,2 which used a more refined definition

of circadian disruption and found that women with morning preference who work night shifts have a higher breast cancer risk than evening types. This underlines the need for better assess­ ment of chronotype, she stressed.

Translating to Disease Risk “Evidence so far from the NHS suggests that the women in the study encounter higher cancer risks, in particular breast cancer and more recently lung cancer,” she said. The evidence also suggests that the longer the duration of night work among nurses in the study, the higher their risk for cancer.

Moving forward, “more refined exposure assessments that take into account external as well as internal clocks will likely enable us to more finely delineate chronic disease risk, including that of cancer,” said Dr Schernhammer. “Future prevention strategies and work schedules likely ought to target a reduction in mis­ match between biological (internal) and social (external) time.” l References

1. Schernhammer ES. Sleep, shift work, obesity, and can­ cer risk. Presented at: 13th Annual American Association for Cancer Research International Conference on Frontiers in Cancer Prevention Research; September 28-October 1, 2014; New Orleans, LA. 2. Hansen J, Lassen CF. Nested case-control study of night shift work and breast cancer risk among women in the Danish military. Occup Environ Med. 2012;69: 551-556.

FDA NEWS Continued from page 13

with metastatic squamous NSCLC with disease progression during or after chemo­ therapy with a platinum-based regimen.

Patients were randomized to nivolumab (N = 135) 3 mg/kg intravenously every 2 weeks or to docetaxel (N ­­ = 137) 75 mg/m2 intravenously every 3 weeks. The major efficacy outcome was OS. The OS was 9.2 months with nivo­­ lumab compared with 7.3 months with docetaxel, a significant improvement (P = .002).

Additional efficacy support was pro­ vided from a single-arm, multinational, multicenter trial in 117 patients with metastatic squamous NSCLC whose ­disease progressed after platinum-based chemotherapy and ≥1 additional sys­ temic regimens. Objective response rate, the major efficacy outcome, was 15%. At the time of analysis, the response duration was ≥6 months in 59% of the responding patients.

Adverse events were similar to pre­

14

MAY 2015 I VOL 8, NO 2

vious trials with nivolumab. Immune-­ mediated adverse reactions included pneumonitis, colitis, hepatitis, nephri­ tis/renal dysfunction, hypothyroidism, and hyperthyroidism.

Lenalidomide Combined with Dexamethasone Receives Expanded Indication for Patients with Newly Diagnosed Myeloma

The FDA approved an expanded i­ndication for lenalidomide (Revlimid; Celgene Corporation) in combination with dexamethasone for the treatment of patients with newly diagnosed mul­ tiple myeloma. This combination was previously approved for the treatment of patients with multiple myeloma who had received ≥1 therapies before.

“The approval of Revlimid as an option for use in all patients with multi­ ple myeloma represents a new paradigm in the management of this disease,”

said Kenneth Anderson, MD, Director, Jerome Lipper Multiple Myeloma Center, Dana-Farber/Brigham and Women’s Cancer Center. “We now have clinical evidence demonstrat­ ing that starting and keeping newly diagnosed multiple myeloma patients on Revlimid significantly improves progression-­free survival.”

The approval was based on the results of several phase 3 clinical trials, includ­ ing the FIRST trial. This trial evaluated the continuous use of a regimen of lena­ lidomide plus dexamethasone (Rd) until disease progression compared with the regimen of melphalan, prednisone, and thalidomide (MPT) for 18 months as the primary analysis; a secondary analysis evaluated the use of Rd at a fixed dura­ tion of 18 cycles in 1623 patients with newly diagnosed myeloma who were not candidates for stem-­­cell transplant.

The primary end point in this ran­ domized, open-label, 3-arm trial was

median PFS. The PFS was significantly longer among patients who received the continuous Rd regimen (25.5 months) than among patients who received the MPT regimen (21.2 months; hazard ratio [HR], 0.72; ­­P = .001).

Based on an interim OS analysis, the median OS was 58.9 months with con­ tinuous Rd and 48.5 months with the MPT regimen (HR, 0.75; 95% confi­ dence interval, 0.62-0.90). Furthermore, patients in the continuous Rd arm had a 25% reduction in mortality risk com­ pared with patients in the MPT arm.

The most common grade 3 or 4 events reported in the continuous Rd arm (until disease progression) included neutropenia (27.8%), anemia (18.2%), thrombocytopenia (8.3%), pneumo­ nia (11.3%), asthenia (7.7%), fatigue (7.3%), back pain (7%), hypokalemia (6.6%), rash (7.3%), cataract (5.8%), dyspnea (5.6%), deep-vein thrombosis (5.6%), and hyperglycemia (5.3%). l

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LETTER

FROM THE

EDITOR-IN-CHIEF

Over the past decade, significant progress has been made in the management of multiple myeloma, including new standards of care and the development and approval of several novel, effective agents. Despite this progress, more work needs to be done and numerous questions remain regarding the application and interpretation of recent clinical advances.

In this sixth annual “Considerations in Multiple Myeloma” newsletter series, we continue to explore unresolved issues related to the management of the disease and new directions in treatment. To ensure an interprofessional perspective, our faculty is comprised of physicians, nurses, and pharmacists from leading cancer institutions, who provide their insight, knowledge, and clinical experience related to the topic at hand. In this second issue, experts from Dana-Farber Cancer Institute answer questions related to the management of patients in the maintenance setting.

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Sincerely, Sagar Lonial, MD Professor Vice Chair of Clinical Affairs Department of Hematology and Medical Oncology Winship Cancer Institute Emory University School of Medicine Atlanta, GA

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Discussions in Personalized Treatment for Lymphoma: Do We Have Consensus?

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BREAST CANCER

More Bad News for Erythropoiesis-Stimulating Agents in Chemotherapy-Induced Anemia Charles Bankhead

cer, transfusion would be the preferred approach,” said Dr Leyland-Jones. “If epoetin alfa is to be used in the more advanced settings of metastatic breast

clinical trial of darbepoetin alpha (Aransep) versus best supportive care for anemia in platinum-treated non– small-cell lung cancer is expected to

“For the management of anemia in the first- or second-line chemotherapy treatment of metastatic breast cancer, transfusion would be the preferred approach. If epoetin alfa is to be used in the more advanced settings...this should be done very cautiously.”

Photo by © SABCS/Todd Buchanan 2014

San Antonio, TX—Adding an erythro­ poiesis-stimulating agent (ESA) to best supportive care failed to demonstrate noninferiority for progression-free sur­ vival (PFS) compared with best sup­ portive care alone in patients with metastatic breast cancer, in a clinical trial known as EPO-ANE-3010 that was requested by the FDA. Standard care alone or in combina­ tion with epoetin alfa (Epogen; Procrit) resulted in a median PFS of 7.4 months, as defined by investigator-assessed pro­ gressive disease. A separate analysis based on independent review showed identical PFS of 7.6 months in the 2 treatment groups. Moreover, investi­ gator-determined time to progression showed a troubling increase in the risk for disease progression in patients who received the ESA. The findings bring to full circle the use of ESAs for the treatment of chemotherapy-induced anemia, which has gone from enthusiastic support to disappointment, said Brian LeylandJones, MD, PhD, a medical oncolo­ gist at the Avera Cancer Institute, Sioux Falls, SD, who presented the trial results at the 2014 San Antonio Breast Cancer Symposium.

“For the management of anemia in the first- or second-line chemothera­ py treatment of metastatic breast can­

Brian Leyland-Jones, MD, PhD

cancer, this should be done very cau­ tiously, in limited circumstances, only after a careful assessment of risks and benefits for epoetin alfa and alternative treatments—transfusion, interruption or cessation of chemotherapy—and with the patient fully involved in the decision-making process.”

An ongoing randomized, phase 3

provide additional information about the benefit-risk profile of ESAs, Dr Leyland-­Jones added.

For more than a decade, concern has surrounded the use of ESAs in chemotherapy-­related anemia. Two ear­ lier studies of ESAs in metastatic breast cancer showed higher on-study mortality, no difference in time to progression, and

a higher incidence of thrombotic events in patients who received ESAs. In 2004, the US Food and Drug Administration requested a trial to confirm findings from the EPO-INT-76 trial, which showed a 37% increased risk for on-study mortality in patients with metastatic breast cancer who received epoetin alfa but no differ­ ence in time to progression.

A principal investigator in the EPOINT-76 trial, Dr Leyland-Jones pre­ sented the results from the new EPOANE-3010 trial, which was conducted at sites in 19 countries and enrolled 2098 patients receiving first- or second-line chemotherapy for metastatic breast can­ cer and a hemoglobin level of ≤11 g/dL. The patients’ median age was 52 years; 25% of the patients had a body mass index of ≥30; 55% were postmeno­ pausal; and the median hemoglobin level was 10.4 to 10.5 g/dL. Patients received a median of 8 doses of epoetin alfa, and the median weekly dose was 32,316.7 IU. The overall survival was 17.2 months with epoetin alfa and 17.4 months with standard of care, a difference that did not meet criteria for noninferiority. The adverse event profiles were similar in the 2 treatment groups.

These results further question the use of ESAs in the treatment of anemia associated with chemotherapy. l

IN THE LITERATURE Anti-CD19 CAR T-Cells Show Promise in B-Cell Cancer

Patients with chemotherapy-refrac­ tory diffuse large B-cell lymphoma (DLBCL) have limited treatment options and a median survival of only a few months. Although recent advances have improved the treat­ ment of B-cell malignancies, new treatments for chemotherapy-refrac­ tory cases are needed. Previous reports showed that a single infusion of autol­ ogous T-cells that express anti-CD19 chimeric antigen receptor (CAR) in patients with indolent B-cell malig­ nancies led to lengthy remissions. In what is believed to be the first study of its kind, researchers evaluated the safety and efficacy of autologous antiCD19 CAR T-cells in patients with advanced CD19-positive B-cell malig­ nancies (Kochenderfer JN, et al. J Clin Oncol. 2015;33:540-549).

The study included 15 patients with advanced B-cell malignancies.

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MAY 2015 I VOL 8, NO 2

Of these, 9 patients had DLBCL, with 3 different subtypes: 4 patients had primary mediastinal B-cell lymphoma, 4 patients had DLBCL not otherwise specified, and 1 patient had DLBCL transformed from chronic lymphocyt­ ic leukemia (CLL). In addition, 2 patients had indolent lymphomas, and 4 had CLL. All patients received an initial conditioning chemotherapy regimen consisting of cyclophosphamide at a total dose of 120 mg/kg to 60 mg/ kg followed by 5 daily infusions of fludarabine 25 mg/m2. A day later, patients received a single infusion of anti-CD19 CAR T-cells.

Of the 15 patients, 8 achieved com­ plete remission, 4 achieved partial remission, 1 had stable disease, and 2 were not evaluable for response. In the subgroup of 9 patients with DLBCL, 4 of 7 evaluable patients with chemother­ apy-refractory DLBCL had complete remission; 3 of these 4 patients are in

ongoing complete remission, with dura­ tions ranging from 9 to 22 months.

Of the patients with DLBCL, 2 achieved partial response, and 1 achieved stable disease. In the sub­ group of 6 patients with indolent B-cell malignancies, all patients achieved a complete remission or partial remission; 3 of 4 patients with CLL are in ongoing complete remission ranging from 14 to 23 months.

The peak level of CAR-positive blood cells varied among patients from 9 to 777 CAR-positive cells/µL. These levels peaked between 7 and 17 days after infusion. Grade 3 and 4 acute toxicities included fever, hypo­ tension, delirium, and other neuro­ logic toxicities; these toxicities were transient and resolved within 3 weeks after cell infusion.

This is the first study to show a successful treatment of DLBCL with ­ anti-­CD19 CAR T-cells. The majority of patients with chemotherapy-refrac­

tory DLBCL and indolent B-cell malig­ nancies achieved complete remission; these findings demonstrate the feasi­ bility and effectiveness of treating this patient population with anti-CD19 CAR T-cells.

Infusion with anti-CD19 CAR T-cells may offer a powerful new treat­ ment option for patients with chemo­ therapy-refractory B-cell malignan­ cies. The researchers recommended further development of this approach for advanced B-cell malignancies.

Lenvatinib Prolongs Progression-Free Survival in Advanced Thyroid Cancer

Lenvatinib (Lenvima) is a novel oral multitargeted tyrosine kinase inhibitor (TKI) that inhibits vascular endothe­ lial growth factor receptors 1, 2, and 3; fibroblast growth factor receptors 1 to 4; platelet-derived growth fac­ tor receptor alpha; RET; and KITsignaling networks. In a phase 2 study

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LEUKEMIA

Vosaroxin, a Quinolone Derivative, Extends Survival in Older Patients with Acute Myeloid Leukemia Wayne Kuznar

intravenous vosaroxin 90 mg/m2 on days 1 and 4 for induction and 70 mg/ m2 for subsequent cycles.

The median OS times were 7.5 months in the vosaroxin arm and 6.1 months in the placebo arm, with a

© American Society of Hematology. All rights reserved.

A

n investigational first-in-class anticancer quinolone deriva­ ­ tive, vosaroxin, extended me­­ dian over­­all survival (OS) when used with cytar­­abine (Cytosar-U) in a phase 3 clinical trial of patients with relapsed or refrac­­ tory acute myeloid leukemia (AML), although the difference was not significant.

The benefit was more pronounced in older patients aged >60 years, a group in which the favorable effect of vosaroxin did achieve significance, according to Farhad Ravandi, MD, Professor of Medicine, Department of Leukemia, M.D. Anderson Cancer Center, Houston.

Vosaroxin intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-specific DNA damage, G2 arrest, and apop­ tosis. The FDA has granted orphan drug status to vosaroxin for AML, and a fast track designation for the potential treatment of relapsed or refractory AML in combination with cytarabine.

Dr Ravandi discussed data from a 124-site international randomized trial of 711 patients with relapsed or unresponsive AML. All patients received intravenous cytarabine 1 g/ m2 on days 1 to 5, and were random­ ized to the addition of placebo or

hazard ratio (HR) of 0.865 (P = .06). A predefined analysis of OS censoring for stem-cell transplantation showed that patients randomized to the vosaroxin arm had a median OS of 6.7 months compared with 5.3 months in the pla­ cebo arm (HR, 0.809; P = .02). The secondary end point of complete remis­

sion rate of vosaroxin versus placebo was 30.1% versus 16.3%, respectively (P <.001).

The trial also stratified patients by age ≥60 years and <60 years. Within a predefined analysis of patients aged <60

“These data provide support that the vosaroxin/cytarabine combination is the most effective approach to date for treatment of older patients with this challenging condition.”

Farhad Ravandi, MD

years, the combination of vosaroxin and cytarabine had a median OS of 9.1 months compared with 7.9 months for placebo plus cytarabine, a nonsignifi­ cant difference.

In patients aged ≥60 years, the medi­ an OS was 7.1 months in the vosaroxin arm compared with 5.0 months in the

placebo arm (HR, 0.755; P = .006).

“Although it is clear that we still have a long way to go to improve outcomes for such patients, these data provide support that the vosaroxin/ cytarabine combination is the most effective approach to date for treatment of older patients with this challenging condition,” said Dr Ravandi.

David P. Steensma, MD, a hema­ tologist/oncologist at Dana-Farber Cancer Institute, Boston, called these results “underwhelming” and “not a great leap forward.” Dr Steensma noted, “AML is a really difficult popu­ lation, no question about it, but there’s also no question that 7.5 months is pretty crummy, and we need to do better than that.”

Dr Ravandi countered that 1-month and 2-month improvements in sur­ vival are exciting in the treatment of solid tumors, “and I don’t see why we shouldn’t be excited in AML as well,” he said. “In my opinion, these data support the use of this therapy in older patients with AML.” As expected, the vosaroxin arm had greater toxicity, “because if you use 2 cytotoxic agents, you are going to see more myelosuppression,” Dr Ravandi said. The toxicity with vosaroxin was mainly related to myelosuppression, with no increase in organ toxicity. l

IN THE LITERATURE of patients with radioactive iodine therapy–refractory differentiated thy­ roid cancer, lenvatinib demonstrated clinical benefit. Based on these results, researchers conducted a phase 3 study to assess progression-free survival (PFS) among patients who received lenvatinib compared with placebo (Schlumberger M, et al. N Engl J Med. 2015;372:621-630).

The SELECT study was a ran­ domized, double-blind, placebo-con­ trolled, multicenter, phase 3 study involving 392 patients with progres­ sive differentiated thyroid cancer that was refractory to radioactive iodine therapy. Patients were randomized in a 2:1 ratio to lenvatinib 24 mg daily in 28-day cycles (N = 262) or to pla­ cebo (N = 131). Pretreatment with 1 previous TKI regimen was permitted.

At disease progression, patients in the placebo group could receive open-­ label lenvatinib. The median duration of treatment was 13.8 months for the

lenvatinib group and 3.9 months for the placebo group.

The primary end point was PFS, and the secondary end points were response rate, overall survival, and safety.

The median PFS was 18.3 months among the patients who received len­ vatinib compared with 3.6 months with placebo, a 14.7-month PFS extension with active treatment (haz­ ard ratio for disease progression or death, 0.21; 99% confidence interval, 0.14-0.31; P <.001). This is the longest improvement in PFS observed in stud­ ies comparing active drug therapy and placebo in patients with differentiated thyroid cancer.

The PFS benefit associated with lenvatinib was observed in all prespec­ ified groups. Lenvatinib was associated also with a significantly greater patient response rate compared with placebo­­ —­­ 64.8% versus 1.5%, respectively.

Furthermore, more complete and par­ tial responses were observed with len­

vatinib than with placebo (4 and 165 vs 0 and 2, respectively). The median overall survival was not reached in either group.

Adverse events of any grade, which occurred in >40% of patients in the lenvatinib group, included hyper­ tension (67.8%), diarrhea (59.4%), fatigue or asthenia (59.0%), decreased appetite (50.2%), decreased weight (46.4%), and nausea (41.0%). The most frequently reported grade ≥3 ­adverse events reported in the len­ vatinib group included hypertension (41.8%), proteinuria (10.0%), decreased weight (9.6%), fatigue (9.2%), and diarrhea (8.0%).

A total of 37 patients in the lenvati­ nib group and 3 patients in the placebo group discontinued treatment because of adverse events.

The 10-year survival rate for patients with differentiated thyroid cancer refractory to radioactive iodine therapy is 10% from time of metasta­

sis. Lenvatinib was associated with significant improvement in PFS and response rate among patients with progressive, radioactive iodine–refrac­ tory, differentiated thyroid cancer, which offers a new treatment option for this patient population. Although the toxic effects of lenvatinib therapy were considerable, most toxic effects were managed with dose modification and medical therapy. Based on these results, in February 2015, the FDA approved lenvatinib for the treatment of patients with differentiated thyroid cancer that is refractory to radioactive iodine therapy.

Ruxolitinib More Effective Than Standard Therapy in the Treatment of Polycythemia Vera

Polycythemia vera, a myeloprolifera­ tive neoplasm characterized by elevated red blood cell levels, poses an increased risk for thrombotic and cardiovascular Continued on page 18

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MAY 2015 I VOL 8, NO 2

17

LEUKEMIA

Monitoring Response to TKI Therapy by PCR Improves Outcomes in Chronic Myeloid Leukemia Wayne Kuznar

D

isease progression is slower and overall survival (OS) is greater in patients with chron­ ic myeloid leukemia (CML) who are being monitored for their response to tyrosine kinase inhibitor (TKI) therapy and show good adherence. However, few clinicians monitor response and adherence to oral TKI treatment in patients with CML. Data from 245 patients with newly diagnosed chronic-phase CML cared for ­­in the Southern California Permanente Medical Group show that although most patients start TKI therapy within 90 days of diagnosis, only approximately 66% show high adherence to therapy, and using polymerase chain reaction (PCR) monitoring to evaluate response to treatment can improve outcomes.

“We found that patients who had any monitoring by PCR had better outcomes than those who did not undergo monitoring, and this was independent of their insurance level,” said Reina Haque, PhD, MPH, Cancer Epidemiologist and Research Scientist II, Kaiser Permanente, Pasadena, CA. “To avoid bad outcomes, patients must be monitored.”

Dr Haque and colleagues collected data from electronic health records and chart reviews, including TKI use and adherence, healthcare utilization, and clinical outcomes.

Adherence to TKI therapy was measured by medication possession

ratio (MPR), the number of days a medication is supplied divided by the number of days between the first and last drug dispensing date. Patients were classified into good adherence (MPR ≥90%) and poor adherence (MPR <90%). The mean MPR for TKI use was 88%.

More than 90% of the cohort start­ ed TKI therapy within 3 months of diagnosis. Virtually all patients (96%) began therapy with imatinib (Gleevec).

Despite full pharmacy coverage, only 63% of patients showed good adher­ ence. The reasons for first-line treat­ ment discontinuation included: • Adverse effects: 41 patients • Incomplete cytogenetic or molecular response: 38 patients • Drug nonresponse, provider recom­­ mendation, or nonadherence: 21 patients • Bone marrow/stem-cell transplant: 7 patients.

Disease progression and OS were evaluated in patients diagnosed in 2001-2006 who received imatinib.

With a mean follow-up of 5.1 years (maximum, 13 years), the rate of chronic-­ phase CML progression to accelerated phase or blast crisis phase was lower in patients with good adher­ ence (10.0 per 1000 person-years) than in those with poor adherence (14.2 per 1000 person-years).

Patients with high adherence had a lower mortality rate than those

with low adherence (25.9 per 1000 vs 39.2 per 1000 person-years). OS was better in patients with high adher­ ence, although the difference did not achieve significance.

PCR Monitoring and Outcomes The key to outcomes, however, was PCR monitoring. “We found that patients who underwent PCR monitor­ ing had a significantly reduced risk of a composite outcome of progression, bone marrow or stem-cell transplant, or mor­ tality, regardless of their TKI adherence status, whereas MPR was not associated with the outcomes,” said Dr Haque.

Specifically, the hazard ratio for the composite outcome was 0.6 with PCR monitoring in patients with MPR ≥90% and 0.10 in patients with MPR <90%.

Education Intervention Persuades Clinicians In a separate study, an educational intervention was successful in persuad­ ing healthcare professionals to discuss the impact of nonadherence to TKI on CML outcomes.

Sara R. Fagerlie, PhD, Director of Scientific Services at Educational Concepts Group in Atlanta, mea­ sured the impact of 1-hour educa­ tional interventions that addressed frontline treatment and treatment for relapse of CML. The programs edu­ cated 631 providers in the community setting. Participants were asked about communication and follow-up with patients with CML before and after the intervention.

Before the education, “more than half were not evaluating adherence for a CML patient who missed major response milestones,” said Dr Fagerlie, and only 60% reported always discuss­ ing the impact of TKI nonadherence on clinical outcomes in CML. “With just the 1-hour interven­ tion, practitioners were recogniz­ ing when they needed to evaluate adherence, and 86% were planning to discuss the impact of adherence with their patients,” Dr Fagerlie said.

Education also resulted in a 13% increase in providers incorporating technology, such as texting, e-mail, or cell phone application as a patient adherence tool. l

32 compared with standard therapy (19.6%). In addition, 38.2% and 0.9% of patients in the 2 groups, respectively, had at least a 35% reduction in spleen volume. Ruxolitinib was also associated with a significantly higher rate of com­ plete hematologic response compared with standard therapy (23.6% vs 8.9%, respectively).

Overall, 49% of patients in the rux­ olitinib group had at least a 50% reduc­ tion in the MPN-SAF total symptom score at week 32 versus 5% in the standard therapy group. The ruxolitinib group also maintained their primary response at week 32 through week 48 compared with the standard therapy group (19.1% vs 0.9%, respectively).

In terms of safety, ruxolitinib was associated with a greater incidence of grade 3 or 4 anemia and thrombocyto­ penia (2% and 5%, respectively) com­

pared with standard therapy (0% and 4%, respectively). Grade 1 and 2 her­ pes zoster infection occurred in 6% of patients receiving ruxolitinib versus no patients in the standard therapy group.

However, through week 32, more patients (N = 6) in the standard ther­ apy group had thromboembolic events compared with the ruxolitinib group (N = 1).

Overall, the RESPONSE trial showed that ruxolitinib was well-tolerated and significantly more effective than stan­ dard therapies in controlling hemat­ ocrit, reducing spleen volume, and im­­ proving polycythemia vera–related symptoms in patients who had an inad­ equate response to or had unacceptable side effects from hydroxyurea. The FDA approved ruxolitinib for the treatment of patients with polycythemia vera in December 2014. l

“Patients who had any monitoring by PCR had better outcomes than those who did not undergo monitoring.…To avoid bad outcomes, patients must be monitored.”

Reina Haque, PhD, MPH

IN THE LITERATURE Continued from page 17

events and a significant clinical bur­ den. If untreated, polycythemia vera can transform to myelo­ fibrosis or to acute myeloid leukemia. Based on earli­ er results of a phase 2 study, researchers conducted a new phase 3 clinical study to evaluate the clinical benefit of rux­ olitinib (Jakafi), a Janus kinase (JAK) 1 and 2 inhibitor, versus standard therapy in patients with polycythemia vera that was resistant to standard therapy with hydroxyurea (Vannucchi AM, et al. N Engl J Med. 2015;372:426-435).

The study included 222 patients with polycythemia vera requiring phlebot­ omy for hematocrit control, a spleen volume of ≥450 cm3, and no previous treatment with a JAK inhibitor partic­ ipating in the RESPONSE trial. The RESPONSE study was an internation­ al, randomized, open-label, multicenter, phase 3 clinical trial that randomized

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MAY 2015 I VOL 8, NO 2

phlebotomy-dependent pa­­tients with splenomegaly in a 1:1 ratio to a 10-mg twice-daily dose of ruxolitinib (N = 110) or to standard therapy (N = 112) selected by the investigator.

The primary end point was hemat­ ocrit control through week 32 and at least a 35% reduction in spleen volume at week 32. The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) was used to evaluate symptom outcomes.

The median exposure time to therapy was 81 weeks in the ruxolitinib group and 34 weeks in the standard thera­ py group. Significantly more patients receiving ruxolitinib achieved the pri­ mary end point versus the standard therapy group (20.9% vs 0.9%, respec­ tively). Furthermore, ruxolitinib was associated with a higher rate (60%) of hematocrit control through week

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WEALTH MANAGEMENT

How to Make the Best of Your 401(k) Plan W. Ben Utley, CFP, and Lawrence B. Keller, CFP, CLU, ChFC, RHU, LUTCF Mr Utley, CFP®, is the lead advisor with Physician Family Financial Advisors. Mr Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF, is the founder of Physician Financial Services.

W

e see a number of changes you might make to improve your financial security, but one item is usually beyond your control: your 401(k) plan. Unless you are self-employed, there is practically noth­ ing you can do if your 401(k) has limit­ ed investment options, low contribu­ tion limits, or tax consequences.

If your 401(k) is your main (or maybe your only) investment vehicle for retirement, we have good news for you: It is possible to work around your 401(k) plan’s limitations so you can get on track toward retirement.

1

Low Limits You may be operating under the mistaken belief that, if you max out your 401(k) plan contri­ butions, you will be all set for retire­ ment. Pharmacists, nurse practitioners, and physician assistants should strive to save 20% of their gross income toward retirement—starting the day they begin working. For example, a pharmacist earning $100,000 should strive to save $20,000 annually. But did you know that the maximum amount of money you can elect to defer into your 401(k) this year is only $17,500 ($23,000 if you will be aged 50 years or older by December 31)?

Although it is true that if you start early, you can save less, saving 20% provides flexibility for years where you may not be able to save as much, to allow for poor investment returns, or for a personal or financial catastrophe such as divorce or disability. If all goes well and none of these scenarios materialize, then you will be left with a wonderful choice: retire earlier or retire wealthier.

Using the Rule of 72, it is easy to cal­ culate approximately how long it is going to take for your money to double. You just take the number 72 and divide it by the interest rate you hope to earn on your investment. Therefore, assuming a 6% rate of return on your investment, your money will double in 12 years.

Another rule of thumb often used by financial planners is that you can safely withdraw about 4% of your nest egg each year of retirement. This rule says, in essence, that you must save about 25

times your annual expenses, or that you can withdraw approximately 4% of your portfolio in the first year of retirement and then adjust that amount for infla­ tion each year, with little chance of running out over a 30-year retirement.

To improve your odds of reaching your retirement goal, you can save out­ side your 401(k) plan. Even if you cannot deduct the contributions you make to a traditional IRA, you can still contribute $5500 this year ($6500 if you will be aged 50 years or older by December 31), and if you max out your own IRA, your spouse can also contribute up to $5500 to his or her IRA ($6500 if he or she will be aged 50 years or older by December 31) even if he or she is not earning an income.

fund operating expenses, your plan’s costs are draining an unfair share of your retirement savings. To get this under control, you need to review your plan carefully.

It’s more common to see an invest­ ment lineup consisting mostly, if not entirely, of actively managed mutual funds. At a time when most prudent investors recognize that passively man­ aged index funds have been shown to have delivered better results at a lower cost than the average actively managed fund, there’s no good reason that your plan should continue to limit you to subpar investment options.

To work around these issues, look at your retirement investments holistically.

“Even if your 401(k) plan has limitations, you can still make the best of the situation.”

Lawrence B. Keller, CFP, CLU, ChFC, RHU, LUTCF

Depending upon your tax situation, it might also make sense to convert these contributions to a Roth IRA, doing what is known as a “backdoor” Roth IRA contribution. Once the money is in a Roth IRA, it can grow tax-free for the rest of your life. Of course, this still might not be enough to allow you to retire comfortably, so you should consider investments outside of your 401(k) plan and IRAs.

2

Limited Options You probably hav­ en’t read the fine print behind your 401(k) plan, but you are betting that your employer or human resources de­ partment has carefully vetted both your 401(k) plan provider and the invest­ ments offered inside your plan. Don’t rely on it!

If your plan charges more than 50 basis points (0.50%) on top of mutual

Think about your 401(k) plan, your traditional IRAs, and your after-tax ac­ counts (mutual funds and brokerage ac­ counts), as if they were all 1 “retirement portfolio.” Then use the best investment options available in your 401(k) and pair them with the best options avail­ able within other accounts that make up the balance of your portfolio.

3

Tax Time Bomb You already know that you pay more than your fair share of taxes. But did you know that you are probably setting yourself up to pay more taxes on your 401(k) than you really should? That’s right. There’s a perverse little wrinkle in the tax code that can turn your 401(k) plan into a tax time bomb.

To understand this trap, you need to know a little bit about how investments are taxed. Withdrawals from your

401(k) plan will be taxed at your mar­ ginal income tax rate, which may be as high as 39.6% for federal income tax.

At the same time, capital gains and qualified dividends from mutual funds held in taxable accounts outside your 401(k) plan are taxed at a maximum federal rate of 23.8% (which is 20% plus the new 3.8% Medicare surtax).

This means that your 401(k) nearly doubles the tax rate you pay on capital gains and qualified income by effectively converting these tax-favored returns into tax-trapped ordinary income. Con­ sider holding equity mutual funds in a taxable account, or better yet, own them in your Roth IRA or the Roth subac­ count of your 401(k), if you have one.

If your 401(k) is a lousy place to stash your stock funds, what should you hold there instead? Consider lowgrowth, income-producing invest­ ments, including bond funds and stable value funds. If you have an appetite for more aggressive fare, consider highyield (“junk”) bond funds or emerging market bond funds. Outside your 401(k) plan, these investments may be taxed at your highest marginal rate, so it’s a good idea to protect their income by keeping it inside the tax shelter of your 401(k) plan.

Again, the best workaround for this tax trap is to view your entire retirement portfolio—including your 401(k) plan, your IRAs, and your other accounts that are earmarked for retirement—as 1 port­ folio. Choose to own the best invest­ ments in the accounts that make the most sense from the standpoint of ex­ pense, risk, return, and taxation.

Summary Even if your 401(k) plan has limita­ tions, you can still make the best of the situation. All you have to do is take a look at the big picture, think outside the box, and make smart moves to put yourself on track for a solid retirement.

Since there are many variables that need to be taken into consideration, you may even want to consult with a Certified Public Accountant and/or fi­ nancial advisor to help you make deci­ sions based on your specific situation. l

TAKE ACTION: GET YOUR CANCER CENTER PROFILED! We are looking to interview oncology pharmacists from cancer centers around the country.

It’s an easy process—a short phone interview and you need to submit some photos.

Contact info@TheOncologyPharmacist.com for information. www.TheOncologyPharmacist.com

MAY 2015 I VOL 8, NO 2

19

KIDNEY CANCER

ASSURE Trial: No Role for Adjuvant Sorafenib or Sunitinib... Continued from cover the standard of care, Dr Haas said.

“No one could be more disappoint­ ed in these results than me, except for patients with kidney cancer. Even though these drugs provide benefit in the metastatic setting, they did not reduce disease recurrence in the adju­ vant setting, while they did increase side effects,” said Dr Haas.

She added that analysis of tumor specimens collected during the trial may provide some clues as to whether specific subsets of patients may derive a treatment benefit from adjuvant thera­ py with sorafenib or sunitinib.

Study Details ASSURE enrolled 1943 patients who underwent complete resection and were categorized as having inter­ mediate- or high-risk for disease recur­ rence according to tumor size and grade, and lymph node involvement.

The treatment arms were well-bal­ anced for the type of kidney cancer, type of surgery, performance status, and risk for disease recurrence.

Patients were randomized in a 1:1:1 ratio to receive sorafenib, sunitinib, or placebo for 1 year. After 1322 patients were accrued, the starting doses of the active drugs were lowered and titrated according to the side effects, which reduced the rates of discontinuation in the experimental arms from approxi­ mately 26% for patients starting with full doses to 14% for those starting with reduced doses.

Dr Haas said that the dosing adjust­ ments could have relevance for reduc­ ing discontinuation of these drugs in other settings.

Interim analysis revealed similar rates (approximately 40%) of recurrence in all 3 groups and similar rates (5.6-5.7 years)

of DFS, the primary end point of the trial.

The 5-year recurrence-free survival rates were 53.8% with sunitinib and 52.8% with sorafenib, which was similar

Based on these interim findings, the Data Safety and Monitoring Committee recommended release of the results.

The most common side effects with

“No one could be more disappointed in these results than me, except for patients with kidney cancer. Even though these drugs provide benefit in the metastatic setting, they did not reduce disease recurrence in the adjuvant setting, while they did increase side effects.”

“The fact that this is a negative trial [in] no way diminishes its importance. Tyrosine kinase inhibitors may not be as effective as chemotherapy in the adjuvant treatment of solid tumors. This study supports my current practice of not using these drugs in the adjuvant setting.”

Naomi B. Haas, MD

Charles Ryan, MD

to the 55.8% in the placebo arm. Overall survival was not significantly different between arms, ranging from 77% ­­to 81%.

the 2 active drugs included grade ≥3 hypertension (16% each for sorafenib and sunitinib vs 4% for placebo), hand-

foot reaction (sorafenib, 33%; sunitinib, 14%; placebo, 1%), rash (15%, 2%, and 1%, respectively), and fatigue (7%, 17%, and 3%, respectively).

Final analysis of disease recurrence and survival will be presented in the future.

“The findings suggest that patients with locally advanced kidney cancer treated with surgery should not receive adjuvant sorafenib or sunitinib,” Dr Haas said.

All patients in the trial exceeded the 4.6-year DFS projected in the null hypothesis when the trial was designed, she added.

At a question and answer session after Dr Haas’ presentation for the press, Charles Ryan, MD, of the University of California, San Francisco, who mod­ erated the discussion, noted that some oncologists are using adjuvant VEGF therapy with no supportive evidence. In his view, the interim results of ASSURE provide convincing evidence against this practice.

“The fact that this is a negative trial [in] no way diminishes its importance.

Tyrosine kinase inhibitors [VEGF inhibitors] may not be as effective as chemotherapy in the adjuvant treat­ ment of solid tumors,” Dr Ryan stated.

“This study supports my current prac­ tice of not using these drugs in the adjuvant setting.”

Other Adjuvant Trials Other adjuvant trials are ongoing in kidney cancer. These include a study of the tyrosine kinase/VEGF inhibitor axitinib (Inlyta), and a study of the mTOR inhibitor everolimus (Afinitor); both trials are currently accruing patients. Adjuvant trials of immuno­ therapy and other targeted approaches are being considered. l

COLORECTAL CANCER

Investigational Drug for Cachexia Appears to Improve Survival Chase Doyle

R

esults of a phase 3 study of an investigational monoclonal anti­ body, MABp1 (Xilonix; XBio­ ­ ­ tech), evaluated for cachexia in meta­ static colorectal cancer (CRC), revealed a surprising finding: patients in the experimental arm showed a trend toward increased overall survival (an end point difficult to reach in any treatment-re­ fractory cancer), with pharmacodynam­ ics activity consistent with this result, investigators reported at the 2015 Gastrointestinal Cancers Symposium, held in San Francisco, CA.

20

MAY 2015 I VOL 8, NO 2

“Interim survival and quality of life, ­­ analyzed at the conclusion of enroll­ ment, showed a 39% shorter median overall survival (2.0 vs 2.8 months) for patients receiving megestrol ace­­ tate versus Xilonix and a trend in in­­ creased risk of death (hazard ratio, 2.17; P = .17),” noted George A. Fisher, MD, Stanford University School of Medicine, California, the author of ­­the study.

The objective of the open-label, multicenter, phase 3 randomized trial was to evaluate the efficacy and safety

of MABp1 in CRC complicated with cachexia.

According to an interview with Michael Stecher, MD, medical direc­ tor at XBiotech, MABp1 is the first drug of its kind—a true human mono­ clonal antibody that targets interleukin-­ 1α (IL-1α).

“A true human antibody is different than a fully human antibody,” explained Dr Stecher, “in that it’s cloned directly from a human B cell; it hasn’t been developed in a mouse….To our knowl­ edge there are no other antibodies in

the clinic that have been cloned direct­ ly from a human.”

Patients with metastatic CRC who were eligible for this trial had failed 1 cytotoxic line of therapy (either oxal­ iplatin or irinotecan) and lost greater than 5% of total body weight in the previous 6 months.

“With a cachectic population,” explained Dr Stecher, “we didn’t want to randomize the placebo, so we ran­ domized megestrol. Thus, the trial was Xilonix the antibody (3.75 mg/kg intra­ venously every 2 weeks) versus mege­

www.TheOncologyPharmacist.com

SURVIVORSHIP CARE

Pharmacists Can Play an Active Role in Survivorship Care Meg Barbor

Austin, TX—Cancer survivors with chronic diseases are falling through the cracks, said Sarah Scarpace, PharmD, MPH, BCOP, at the 11th annual Hematology/Oncology Pharmacy As­ ­ sociation conference. When oncologists are no longer managing chronic diseases like diabetes and hypertension, a win­ dow of opportunity exists for pharmacists to become involved in multidisciplinary cancer survivorship team models.

Opportunities for Innovation and Entrepreneurship There is a general lack of information about survivorship clinics, particularly in relation to the role of the pharma­ cist, said Dr Scarpace, Assistant Dean for Pharmacy Professional Affairs and Associate Professor at the Albany College of Pharmacy and Health Sciences, NY. The lack of survivorship care standard­ ization has become an important talking point within cancer care, she stated.

“Everybody is doing something a lit­ tle bit differently, and not every insti­ tution has these clinics,” explained Dr Scarpace. “We’re trying to figure out what survivorship care should look like because there is so much variability.”

“In the National Comprehensive Cancer Network and American Society of Clinical Oncology guidelines, which looked at the survivorship care team, the pharmacist was blatantly missing from the list of providers who could be helpful to survivors; this is very dis­ turbing,” she emphasized. Furthermore, “pharmacists” were mentioned only once in the National Academies Press 535-page report, From Cancer Patient to Cancer Survivor: Lost in Transition.

“Pharmacists are certainly underrepre­

sented,” Dr Scarpace added.

Physicians currently provide approxi­ mately 73% of all survivorship care, but pharmacists are not the only underrep­ resented cohort. “Only about a quarter of survivorship care is provided by other mid-level providers, not pharmacists,” Dr Scarpace stated. “So again, there is this opportunity for the oncologist to get back to diagnosing patients [with cancer] and coming up with treatment plans, and having mid-levels take on more of a role.”

Coordinating with Primary Care Providers “We talk about how to integrate care with primary care physicians, but what about the primary care pharmacist?” she queried. “As oncology pharmacists, we can play a very important role in making sure that patients, throughout their can­ cer treatment program, are interacting with the community-based pharmacist they are still seeing for their diabetes and hypertension, and other disease states.

Patients should understand the need to have that conversation [about their can­ cer plan] with their primary care pharma­ cist. So that’s another really important opportunity for the oncology pharma­ cist—not just the interaction with the physicians, but also with the primary care pharmacists who are taking care of our patients once they get into surveillance.”

Fragmentation of care is a noted concern in the realm of cancer survi­ vorship; therefore, long-term follow-up is crucial. Follow-up can be executed through surveillance care plans, proper documentation of cancer treatment his­ tory, interventions to manage ongoing problems and toxicities resulting from cancer treatment, and ensuring that

patients still get their age-/sex-appropri­ ate healthcare and screenings. General health promotion is another important facet of long-term follow-up. “Those initial consultations with your patients in which you discuss how to manage and

Although practice and research opportunities exist for pharmacists in survivorship care, the pharmacist’s role is yet to be defined. prevent side effects from chemo[ther­ apy], those still need to continue once they complete treatment,” Dr Scarpace stated. Adherence to vaccination sched­ ules should be promoted, and tobacco cessation should be encouraged, as the efficacy of oral therapies can be reduced from smoking, she added. Contributing to patients’ end-of-treatment consulta­ tion notes is another opportunity for pharmacist involvement.

“It’s obviously very important for pharmacists to be involved right at the beginning—at diagnosis—to make sure that we’re a part of the conversation in coming up with the initial treatment plan,” she emphasized. “And it’s just as important at the end, during the dis­ charge component and the celebration of their last dose of chemo. We want to make sure that we know what the plan is afterwards, because we can’t assume that other people are going to be as detailed as we are.”

Research Opportunities One research opportunity for phar­ macists in the scope of cancer survivor­ ship includes evaluating patterns of sup­ plementary/complementary alternative medicine use among different popula­ tions of cancer survivors. “Once some­ body goes through a cancer diagnosis, they will sometimes scramble for ways to boost their immune system and prevent cancer from coming back,” Dr Scarpace noted. “They’ll do a lot of research on their own, and they’ll experiment with different therapies, so that’s an oppor­ tunity for us to get involved, monitor these patients, track their outcomes, and publish [information about] it.”

Evaluating adherence behaviors to medications and nonpharmacologic recommendations among cancer survi­ vors is another opportunity for research.

“Some people have significant problems coping with the significance of having a cancer diagnosis,” she explained. “So they sometimes go through periods of experimentation and noncompliance.”

Monitoring and reporting late toxicities from long-term use of targeted therapies has the potential to improve future patient outcomes, Dr Scarpace suggest­ ed, and the effectiveness of survivorship programs—particularly those involving pharmacists—should be appraised.

Moving Forward Although practice and research oppor­ tunities exist for pharmacists in survivor­ ship care, the pharmacist’s role is yet to be defined. According to Dr Scarpace, the key needs lie in the pharmacist’s coordi­ nation with primary care providers, as well as the management of long-term medical problems related to cancer treatment. l

COLORECTAL CANCER strol (oral 800 mg daily)—1:1 random­ ization with a primary end point of overall survival.”

In patients treated with MABp1, physical and role function did not decline during therapy; however, these functions worsened in those patients receiving megestrol (median change, –13.3 and –16.7, respectively; P = .02 vs MABp1). Furthermore, MABp1 pa­ tients had a treatment-related reduction in platelet counts compared with those in the megestrol group (median reduc­ tion, –60,000/mm3 vs 10,000/mm3, respectively; P = .03).

According to Dr Fisher, platelet count is a key pharmacodynamic mea­ sure. Because platelets support tumor

www.TheOncologyPharmacist.com

growth and metastasis, increasing plate­ let numbers in advanced cancer are often prognostic of poor survival. “IL1α on platelets, which may mediate pro-tumor effects, is a target of antibody therapy,” noted Dr Fisher, although the precise mechanics of the drug remain somewhat of a mystery.

“This may be an effect of IL-1α on the surface of platelets that the anti­ body’s binding to,” Dr Stecher hypothesized regarding platelet reduc­ tion, “or it may be through a reduc­ tion in IL-6, which we had seen in previous trials.”

While the reasons behind its success continue to be explored, the most important outcome of the drug could

not be denied—the trend toward improved survival between the 2 arms.

“In the Xilonix group,” iterated Dr Stecher, “we had a median survival of 2.8 months versus 2 months’ survival in the megestrol arm. That didn’t reach significance—it was .17—but it’s a very good trend.”

The study enrolled 40 patients between March 2013 and July 2014, at which time it was halted to revise inclusion criteria to reduce screen failures. Investigators are currently using an amended phase 3 protocol to simplify enrollment for an ongoing study of MABp1 in an advanced CRC population.

“It was a difficult trial to accrue

because of the cachexic component,” said Dr Stecher. “Finding colorectal cancer patients who had lost 5% of their total body weight in 6 months was challenging, so we decided to change the criteria. We’ve changed the proto­ col to be a traditional third-line proto­ col, double-blind placebo-controlled… so the population is going to be totally different. They’re not going to have weight loss.” l Reference

Fisher GA. A phase III study of Xilonix in refractory colorectal cancer patients with weight loss. J Clin Oncol (ASCO Annual Meeting Abstracts). 2015;33 (suppl 3):­ Abstract 685. Poster presented at: 2015 Gastro­intestinal Cancers Symposium; January 15-17, 2015; ­­San Francisco, CA. http://meetinglibrary.asco. org/content/140631-158. Accessed January 27, 2015.

MAY 2015 I VOL 8, NO 2

21

CLINICAL TRIALS

Full Clinical Trial Data Sharing Moves Closer to Reality Rosemary Frei, MSc

A

January 14, 2015, report published by the Institute of Medicine (IOM)1 walks a fine line between the competing clinical-­ data-sharing comfort zones of phar­ maceutical companies, physician asso­ ciations, patient groups, and other advocacy organizations.

The 249-page report lays out 4 rec­ ommendations for increased clini­ cal trial data sharing. These include suggesting a maximum 18-month lag between study completion and sharing of all the data—with some exceptions for trials being used to support a regula­ tory application—and no more than 6 months between study publication and sharing of the analytic data set.

“While individual stakeholders can take steps to foster clinical trial data sharing, a broad range of stakeholders must act together to build an ecosystem in which responsible data sharing is expected, flourishes and continuously improves,” concluded report-committee chair Bernard Lo, MD, of the Greenwall Foundation, New York, in a summary of the report published in JAMA.2 Richard L. Schilsky, MD, Chief Med­ ical Officer of the American Society of Clinical Oncologists (ASCO) said the report responds to all of the concerns ASCO President Clifford Hudis, MD, expressed in a March 2014 comment to the report committee.3 “ASCO has long recognized that increasing the availability of clinical trial data is in the public interest. We

encouraged the committee to recom­ mend harmonizing international rules on data sharing and ensuring that the frame­ work developed is broadly applicable to all clinical trials,” said Dr Schilsky in an e-mail. “We support the report’s recom­ mendations and urge the report’s spon­ sors to swiftly convene a group to begin

cal officer of Johnson & Johnson.

The goal of AllTrials is to have all past and present clinical trials by both industry and nonindustry research­ ers registered and to have their full methods and summary results reported, without exceptions. GlaxoSmithKline (GSK) officials agreed to do so 2 years

“The IOM report is a huge step forward for medicine….Their affirming of the value of trial registration and data sharing is a recognition that the historical moment has changed.”

Trevor Butterworth

developing the infrastructure and policies that will foster responsible data sharing.”

However, members of a group called AllTrials point out on their web­ site4 that—other than the suggested timeframes for sharing data from tri­ als that have been completed and/or published—there are no other hard timelines, actionable steps, or proposed penalties for noncompliance laid out by the report’s authors, which include the editor-in-chief of the New England Journal of Medicine and the chief medi­

ago,5 and they have been true to their word. No other pharmaceutical compa­ nies have followed in GSK’s footsteps, although Johnson & Johnson last year gave data from all of its drug trials to Yale University researchers.6 Most com­ panies are opting instead to comply with the much more lax data-sharing regu­ lations from the European Federation of Pharmaceutical Industry Associations and the Pharmaceutical Research and Manufacturers of America.

The leaders of AllTrials know, howev­

er, that poking giants can be tricky, and hence they are opting for a softer sell.

“The IOM report is a huge step forward for medicine. And one has to accept that institutional change is often slow,” said Trevor Butterworth.

Mr Butterworth heads Sense About Science USA, which is championing the AllTrials initiative in the United States. “Their affirming of the value of trial registration and data sharing is a recognition that the historical moment has changed—that transparency is the new intellectual currency. And the goal of AllTrials is to persuade all pharma companies to do what GSK did.” l References

1. Institute of Medicine (IOM) Committee on Strategies for Responsible Sharing of Clinical Trial Data. IOM website. https://www.iom.edu/Reports/2015/SharingClinical-Trial-Data.aspx. Published January 14, 2015.

Accessed February 2, 2015.

2. Lo B. Sharing clinical trial data: maximizing benefits, minimizing risk. JAMA. Published online January 16, 2015. Accessed February 2, 2015.

3. ASCO comments on IOM discussion framework for clinical trial data sharing. American Society of Clinical Oncology (ASCO). www.asco.org/asco-comments-iomdiscussion-framework-clinical-trial-data-sharing.

Published March 26, 2014. Accessed February 2, 2015.

4. America’s Institute of Medicine says sharing data from clinical trials should “become the norm.” AllTrials. www. alltrials.net/news/americas-institute-of-medicine-sayssharing-data-from-clinical-trials-should-become-thenorm/. Published January 14, 2015. Accessed February 2, 2015.

5. GSK announces support for AllTrials campaign for clinical data transparency [news release]. London, UK. GlaxoSmithKline plc; February 2013. www.gsk. com/en-gb/media/press-releases/2013/gsk-announcessupport-for-alltrials-campaign-for-clinical-data-transpar ency/. Accessed February 2, 2015.

6. Johnson & Johnson gives clinical trial data to researchers: a “game changer.” AllTrials. www.alltrials. net/news/johnson-johnson-gives-clinical-trial-data-toresearchers-a-game-changer/. Published January 30, 2014. Accessed February 2, 2015.

BEST PRACTICES

Biosimilar Effective for Chemotherapy-Induced... common condition in patients with cancer receiving chemotherapy because of the cytotoxic effect of chemother­ apy on erythroid precursors in bone marrow and cells in the kidney that are responsible for erythropoietin pro­ duction. It also has a negative impact on recovery. Studies in patient popula­ tions with solid tumors and hematolog­ ic malignancies have shown that CIA symptoms, including extreme fatigue, reduced physical capacity, and impaired cognitive function, can negatively impact patients’ quality of life (QoL).

HX575—the first biosimilar recombi­ nant human erythropoietin to be grant­ ed marketing authorization—has been licensed in 30 countries worldwide, not including the United States, since 2007.

As of October 2014, the estimated expo­ sure to HX575 was 300,000 patient-years.

22

MAY 2015 I VOL 8, NO 2

“OncoBOS is an ongoing, national, prospective, non-interventional, lon­ gitudinal, observational study exam­ ining HX575 use in routine practice in France,” Dr Metges explained. “Its primary objective is to describe the conditions of use of HX575 for the cor­ rection of hemoglobin levels in patients receiving chemotherapy treatment for solid tumors, lymphoma, or myeloma.

A key secondary objective is to describe the efficacy and safety of HX575 in real life clinical practice.”

The interim subanalysis included 96 patients with colorectal cancer, recruited from 28 French centers (university/aca­ demic hospitals, and public and private care units) between September 2011 and April 2014. Patient characteristics, data on CIA and CIA management, and the main factors considered by the

clinician when prescribing HX575 were recorded at 3 different intervals: treat­ ment initiation; 3 to 4 weeks; and 12 (±1) weeks posttreatment.

Assessed hemoglobin outcomes included the proportion of patients achieving hemoglobin increases of ≥1 g/ dL and ≥2 g/dL, and mean hemoglobin changes from baseline.

“Clinicians considered QoL (n = 47, 49%), fatigue (n = 23, 24%), and avoidance of blood transfusion (n = 15, 15.6%) as the predominant factors influencing prescription of treatment for CIA,” Dr Metges elaborated on the results. “The 3 most common factors influencing prescription of treatment with HX575 were cost decrease (n = 59, 61.5%), product efficacy (n = 21, 21.9%), and maintenance of chemo­ therapy dose (n = 14, 14.6%).”

Continued from cover

The mean and median range hemo­ globin levels at baseline were 9.9 g/dL and 10 g/dL, respectively. The mean level increased to 11.0 g/dL at weeks 3 to 4, and 11.7 g/dL at week 12 (both P <.001 vs baseline).

A hemoglobin increase of ≥1 g/dL from baseline was achieved by 56.8% of patients at weeks 3 to 4, and 77.6% at week 12. An increase of hemoglobin ≥2 g/dL was achieved by 17.9% and 47.4% of patients at the same time points, respectively. The mean dose of HX575 was 31,458 IU/week. Patients received a median HX575 dose of 30,000 IU/week, and only 4 (4.2%) of the 96 patients required a dose increase. Two patients required a blood transfusion at weeks ­3 to 4, and only 1 blood transfusion was required at week 12. No treatment-­ related adverse events were recorded. l

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Reference: 1. Melcher A, Parato, K, Rooney CM, Bell JC. Mol Ther. 2011;19:1008-1016. Š 2015 Amgen Inc. All rights reserved. 2/15 USA-678-102309

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