Renal & Urology News - Nov-Dec 2017 edition

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PCa Incidence Lower in TRT Users Testosterone replacement therapy also found to be associated with less severe prostate cancer TRT AND PROSTATE CANCER In a study, hypogonadal men who received testosterone replacement therapy (TRT) had a lower incidence of prostate cancer compared with those who did not.

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Source: Haider A, Haider K, Saad F. Poster presented at the Sexual Medicine Society of North America 18th Fall Annual Meeting in San Antonio, Texas, October 26-29, 2017. Poster 131.

BY JODY A. CHARNOW HYPOGONADAL MEN who receive testosterone replacement therapy (TRT) have a lower incidence of prostate cancer (PCa) than those not receiving TRT, according to study findings presented at the Sexual Medicine Society of North America 18th Annual Fall Scientific Meeting in San Antonio, Texas. In addition, PCa diagnosed in TRT recipients is less severe than PCa diagnosed in men not exposed to TRT. Ahmad Haider, MD, in private urology practice in Bremerhaven, Germany, and colleagues studied 400 hypogo3 40 51 62 73 84 5 0 6 20 7 8 40 0 60 20 80 nadal men (testosterone level of 350 ng/ dL or less) who received testosterone undecanoate 1000 mg every 3 months for up to 10 years and 376 hypogonadal

FDA Approves Adjuvant Sunitinib AS Mandatory THE FDA has approved the tyrosine cancer returning,” said Richard Pazdur, Following PCa kinase inhibitor sunitinib (Sutent) for MD, director of the FDA’s Oncology the adjuvant treatment of renal cell car- Center of Excellence in the Center for Focal Ablation cinoma (RCC).

Drug Evaluation and Research, accord“This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with this disease who have a nephrectomy are often at high risk of the

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ing to a news release. “There is now an 1 approved therapy for patients who0 previously did not have options to potentially reduce cancer recurrence.” continued on page 9

DIALYSIS CARE DURING A NATURAL DISASTER

Hurricane Harvey flooding challenged dialysis providers.

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men who opted against TRT (control group). During a median follow-up of 8 years, 9 men in the TRT group (2.3%) were diagnosed with PCa compared with 26 (6.9%) in the control group.

The incidence was 31 per 10,000 years in the TRT group compared with 95 per 10,000 years in the control group.

All men in the TRT group underwent radical prostatectomy (RP), and all but 1 patient had a Gleason score of 6 or less. All had a predominant Gleason score of 3 and all had a tumor grade of G2 and tumor stage T2. In 80the 100 control group, 18 under40 100 60 went RP alone, 6 underwent RP and radiation, and 2 had radiation alone.

All 26 patients had a Gleason score continued on page 9

IN THIS ISSUE 2

IMRT use for prostate cancer radiation therapy rises sharply

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Prostate cancer risk is lower among men who take NSAIDs

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Kidney graft failure is linked to recurrent UTIs

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BY0 JODY A. CHARNOW 0 0 ACTIVE surveillance of untreated regions of the prostate is mandatory for men undergoing focal ablation for prostate cancer (PCa) based on multiparametric magnetic resonance imaging (mpMRI) and systematic biopsy, researchers concluded.

In a study of 59 prostate specimens from men who underwent radical prostatectomy and fulfilled criteria for focal ablation (FA), a team at New York University School of Medicine led by Herbert Lepor, MD, found that 15 (25.4%) specimens had at least 1 Gleason pattern 4 extra-focal disease (GP4EFD). This was defined as PCa with any Gleason pattern 4 not detected by mMRI and transrectal ultrasound systemic biopsy but which was observed outside a specified ablation zone.

The investigators identified 20 GP4EFD, of which 7 (35%) were ipsilateral and 13 (65%) were contralateral to the mpMRI-detected lesion (MRI-L). continued on page 9

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Radical surgery versus radiation for high-risk prostate cancer

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Second-line enzalutamide benefits some mCRPC patients

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ADT for prostate cancer found to increase cardiac risks

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‘Aquablation’ for BPH better for sexual function than TURP

Overuse of radiologic imaging for the initial staging of low-risk PCa may be declining.

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IMRT for Prostate Cancer Radiation Therapy Soars OVER AN 11-YEAR period from 2002 to 2012, the largest increase in the use of various radiation therapy modalities occurred with intensity-modulated radiation therapy (IMRT) for prostate cancer (PCa), researchers concluded.

Among men undergoing radiation therapy for PCa, the proportion

of those receiving IMRT rose from 3.5% in 2002 to 64% in 2012, Robert C. Miller, MD, MBA, Department of Radiation Oncology at Mayo Clinic in Jacksonville, Florida, and colleagues reported online in the International Journal of Radiation Oncology Biology Physics. Among adults with malignan-

XTANDI® (enzalutamide) capsules for oral use Initial U.S. Approval: 2012 BRIEF SUMMARY OF PRESCRIBING INFORMATION The following is a brief summary. Please see the package insert for full prescribing information.

INDICATIONS AND USAGE XTANDI is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

CONTRAINDICATIONS Pregnancy XTANDI can cause fetal harm and potential loss of pregnancy.

WARNINGS AND PRECAUTIONS Seizure Seizure occurred in 0.5% of patients receiving XTANDI in clinical studies. In these trials patients with predisposing factors for seizure were generally excluded. Seizure occurred from 31 to 603 days after initiation of XTANDI. Patients experiencing seizures were permanently discontinued from therapy and all seizure events resolved.

In a single-arm trial designed to assess the risk of seizure in patients with pre-disposing factors for seizure, 8 of 366 (2.2%) XTANDI-treated patients experienced a seizure. Three of the 8 patients experienced a second seizure during continued treatment with XTANDI after their first seizure resolved. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following pre-disposing factors: the use of medications that may lower the seizure threshold (~ 54%), history of traumatic brain or head injury (~ 28%), history of cerebrovascular accident or transient ischemic attack (~ 24%), and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, past history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection (all < 5%). Approximately 17% of patients had more than one risk factor.

Advise patients of the risk of developing a seizure while receiving XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others.

Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of posterior reversible encephalopathy syndrome (PRES) in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). Discontinue XTANDI in patients who develop PRES. ADVERSE REACTIONS Clinical Trial 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.

Three randomized clinical trials enrolled patients with metastatic prostate cancer that has progressed on androgen deprivation therapy (GnRH therapy or bilateral orchiectomy), a disease setting that is also defined as metastatic CRPC. Two trials were placebo-controlled (Studies 1 and 2), and one trial was bicalutamidecontrolled (Study 3). In Studies 1 and 2, patients received XTANDI 160 mg or placebo orally once daily. In Study 3, patients received XTANDI 160 mg or bicalutamide 50 mg orally once daily. All patients continued androgen deprivation therapy. Patients were allowed, but not required, to take glucocorticoids.

The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI-treated patients from the two randomized placebo-controlled clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo.

cies other than prostate cancer, IMRT use increased from 1.7% to 16.4%.

The findings are from a retrospective study using the OptumLabs Data Warehouse claims database of more than 100 million commercially insured US enrollees. Dr Miller’s team identified 474,533 patients treated with radiStudy 1: XTANDI versus Placebo in Metastatic CRPC Following Chemotherapy Study 1 enrolled 1199 patients with metastatic CRPC who had previously received docetaxel. The median duration of treatment was 8.3 months with XTANDI and 3.0 months with placebo. During the trial, 48% of patients on the XTANDI arm and 46% of patients on the placebo arm received glucocorticoids.

Grade 3 and higher adverse reactions were reported among 47% of XTANDI-treated patients and 53% of placebo-treated patients. Discontinuations due to adverse events were reported for 16% of XTANDI-treated patients and 18% of placebo-treated patients. The most common adverse reaction leading to treatment discontinuation was seizure, which occurred in 0.9% of the XTANDI-treated patients compared to none (0%) of the placebo-treated patients. Table 1 shows adverse reactions reported in Study 1 that occurred at a ≥ 2% higher frequency in the XTANDI arm compared to the placebo arm.

Table 1. Adverse Reactions in Study 1 XTANDI Placebo N = 800 N = 399 Grade Grade Grade Grade a 3-4 1-4 3-4 1-4 (%) (%) (%) (%) General Disorders Asthenic 50.6 9.0 44.4 9.3 Conditionsb Peripheral 15.4 1.0 13.3 0.8 Edema Musculoskeletal And Connective Tissue Disorders Back Pain 26.4 5.3 24.3 4.0 Arthralgia 20.5 2.5 17.3 1.8 Musculoskeletal 15.0 1.3 11.5 0.3 Pain Muscular 9.8 1.5 6.8 1.8 Weakness Musculoskeletal 2.6 0.3 0.3 0.0 Stiffness Gastrointestinal Disorders Diarrhea 21.8 1.1 17.5 0.3 Vascular Disorders Hot Flush 20.3 0.0 10.3 0.0 Hypertension 6.4 2.1 2.8 1.3 Nervous System Disorders Headache 12.1 0.9 5.5 0.0 Dizzinessc 9.5 0.5 7.5 0.5 Spinal Cord Compression and Cauda 7.4 6.6 4.5 3.8 Equina Syndrome Paresthesia 6.6 0.0 4.5 0.0 Mental 4.3 0.3 1.8 0.0 Impairment Disordersd Hypoesthesia 4.0 0.3 1.8 0.0 Infections And Infestations Upper 10.9 0.0 6.5 0.3 Respiratory Tract Infectione Lower Respiratory 8.5 2.4 4.8 1.3 Tract And Lung Infectionf Psychiatric Disorders Insomnia 8.8 0.0 6.0 0.5 Anxiety 6.5 0.3 4.0 0.0 Renal And Urinary Disorders Hematuria 6.9 1.8 4.5 1.0 Pollakiuria 4.8 0.0 2.5 0.0 Injury, Poisoning And Procedural Complications Fall 4.6 0.3 1.3 0.0 Non-pathologic 4.0 1.4 0.8 0.3 Fractures Skin And Subcutaneous Tissue Disorders Pruritus 3.8 0.0 1.3 0.0 Dry Skin 3.5 0.0 1.3 0.0 Respiratory Disorders Epistaxis 3.3 0.1 1.3 0.3 a b c d

CTCAE v4.

Includes asthenia and fatigue.

Includes dizziness and vertigo.

Includes amnesia, memory impairment, cognitive disorder, and disturbance in attention. e Includes nasopharyngitis, upper respiratory tract infection, sinusitis, rhinitis, pharyngitis, and laryngitis. f Includes pneumonia, lower respiratory tract infection, bronchitis, and lung infection.

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ation therapy from 2002 to 2012. In 2002, 34.5%, 63.4%, 2.1%, 0.0%, and 0.1% of patients were treated with 3D conformal radiation therapy, 2D radiation therapy/brachytherapy, IMRT, stereotactic body radiation therapy, and proton beam radiation therapy, respectively. n Study 2: XTANDI versus Placebo in Chemotherapynaïve Metastatic CRPC Study 2 enrolled 1717 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy, of whom 1715 received at least one dose of study drug. The median duration of treatment was 17.5 months with XTANDI and 4.6 months with placebo. Grade 3-4 adverse reactions were reported in 44% of XTANDI-treated patients and 37% of placebo-treated patients. Discontinuations due to adverse events were reported for 6% of XTANDI-treated patients and 6% of placebo-treated patients. The most common adverse reaction leading to treatment discontinuation was fatigue/asthenia, which occurred in 1% of patients on each treatment arm. Table 2 includes adverse reactions reported in Study 2 that occurred at a ≥ 2% higher frequency in the XTANDI arm compared to the placebo arm.

Table 2. Adverse Reactions in Study 2 XTANDI Placebo N = 871 N = 844 Grade Grade Grade Grade 3-4 1-4 3-4 1-4a (%) (%) (%) (%) General Disorders Asthenic 46.9 3.4 33.0 2.8 Conditionsb Peripheral 11.5 0.2 8.2 0.4 Edema Musculoskeletal And Connective Tissue Disorders Back Pain 28.6 2.5 22.4 3.0 Arthralgia 21.4 1.6 16.1 1.1 Gastrointestinal Disorders Constipation 23.2 0.7 17.3 0.4 Diarrhea 16.8 0.3 14.3 0.4 Vascular Disorders Hot Flush 18.0 0.1 7.8 0.0 Hypertension 14.2 7.2 4.1 2.3 Nervous System Disorders 11.3 0.3 7.1 0.0 Dizzinessc Headache 11.0 0.2 7.0 0.4 Dysgeusia 7.6 0.1 3.7 0.0 Mental 5.7 0.0 1.3 0.1 Impairment Disordersd Restless Legs 2.1 0.1 0.4 0.0 Syndrome Respiratory Disorders 11.0 0.6 8.5 0.6 Dyspneae Infections And Infestations Upper 16.4 0.0 10.5 0.0 Respiratory Tract Infectionf Lower Respiratory 7.9 1.5 4.7 1.1 Tract And Lung Infectiong Psychiatric Disorders Insomnia 8.2 0.1 5.7 0.0 Renal And Urinary Disorders Hematuria 8.8 1.3 5.8 1.3 Injury, Poisoning And Procedural Complications Fall 12.7 1.6 5.3 0.7 Non-Pathological 8.8 2.1 3.0 1.1 Fracture Metabolism and Nutrition Disorders Decreased 18.9 0.3 16.4 0.7 Appetite Investigations Weight 12.4 0.8 8.5 0.2 Decreased Reproductive System and Breast Disorders 1.4 3.4 0.0 0.0 Gynecomastia a b c d

CTCAE v4.

Includes asthenia and fatigue.

Includes dizziness and vertigo.

Includes amnesia, memory impairment, cognitive disorder, and disturbance in attention. e Includes dyspnea, exertional dyspnea, and dyspnea at rest. f Includes nasopharyngitis, upper respiratory tract infection, sinusitis, rhinitis, pharyngitis, and laryngitis. g Includes pneumonia, lower respiratory tract infection, bronchitis, and lung infection.

Study 3: XTANDI versus Bicalutamide in Chemotherapynaïve Metastatic CRPC Study 3 enrolled 375 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy, of whom 372 received at least one dose of study drug. The median duration of treatment was 11.6 months with XTANDI

Q2

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Renal & Urology News 3

NSAID Users Have Lower Prostate Cancer Risk

BY JODY A. CHARNOW USE OF NON-STEROIDAL antiinflammatory drugs (NSAIDs) is associated with a decreased risk of prostate cancer (PCa), according to researchers. The protective effect is more pronounced among men with a history of prostatitis. and 5.8 months with bicalutamide. Discontinuations with an adverse event as the primary reason were reported for 7.6% of XTANDI-treated patients and 6.3% of bicalutamidetreated patients. The most common adverse reactions leading to treatment discontinuation were back pain and pathological fracture, which occurred in 3.8% of XTANDItreated patients for each event and in 2.1% and 1.6% of bicalutamide-treated patients, respectively. Table 3 shows overall and common adverse reactions (≥ 10%) in XTANDItreated patients.

Table 3. Adverse Reactions in Study 3 XTANDI Bicalutamide N = 183 N = 189 Grade Grade Grade Grade 1-4a 3-4 1-4a 3-4 (%) (%) (%) (%) Overall 94.0 38.8 94.2 37.6 General Disorders Asthenic 31.7 1.6 22.8 1.1 Conditionsb Musculoskeletal And Connective Tissue Disorders Back Pain 19.1 2.7 18.0 1.6 Musculoskeletal 16.4 1.1 14.3 0.5 Painc Vascular Disorders Hot Flush 14.8 0.0 11.1 0.0 Hypertension 14.2 7.1 7.4 4.2 Gastrointestinal Disorders Nausea 14.2 0.0 17.5 0.0 Constipation 12.6 1.1 13.2 0.5 Diarrhea 11.5 0.0 9.0 1.1 Infections And Infestations Upper 12.0 0.0 6.3 0.5 Respiratory Tract Infectiond Investigational Weight Loss 10.9 0.5 7.9 0.5 a b c d

CTCAE v 4.

Including asthenia and fatigue.

Including musculoskeletal pain and pain in extremity.

Including nasopharyngitis, upper respiratory tract infection, sinusitis, rhinitis, pharyngitis, and laryngitis.

Laboratory Abnormalities In the two randomized placebo-controlled clinical trials, Grade 1-4 neutropenia occurred in 15% of patients treated with XTANDI (1% Grade 3-4) and in 6% of patients treated with placebo (0.5% Grade 3-4). The incidence of Grade 1-4 thrombocytopenia was 6% of patients treated with XTANDI (0.3% Grade 3-4) and 5% of patients treated with placebo (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of patients treated with XTANDI (0.2% Grade 3-4) and 16% of patients treated with placebo (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of patients treated with XTANDI (0.1% Grade 3-4) and 2% of patients treated with placebo (no Grade 3-4).

Infections In Study 1, 1% of patients treated with XTANDI compared to 0.3% of patients treated with placebo died from infections or sepsis. In Study 2, 1 patient in each treatment group (0.1%) had an infection resulting in death.

Falls and Fall-related Injuries In the two randomized placebo-controlled clinical trials, falls including fall-related injuries, occurred in 9% of patients treated with XTANDI compared to 4% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in patients treated with XTANDI and included non-pathologic fractures, joint injuries, and hematomas.

Hypertension In the two randomized placebo-controlled trials, hypertension was reported in 11% of patients receiving XTANDI and 4% of patients receiving placebo.

No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms.

Hypertension led to study discontinuation in < 1% of patients in each arm.

Post-Marketing Experience The following additional adverse reactions have been identified during post approval use of XTANDI. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Body as a Whole: hypersensitivity (tongue edema, lip edema, and pharyngeal edema)

An analysis of data from the EPICAP (EPIdemiology of Prostate CAncer) case-control study showed that men who had ever used NSAIDs had a significant 23% decreased risk of PCa compared with men who never used NSAIDs, investigators reported online in Cancer Medicine. Men who used Gastrointestinal Disorders: vomiting Neurological Disorders: posterior reversible encephalopathy syndrome (PRES) Skin and Subcutaneous Tissue Disorders: rash DRUG INTERACTIONS Drugs that Inhibit CYP2C8 Co-administration of a strong CYP2C8 inhibitor (gemfibrozil) increased the composite area under the plasma concentration-time curve (AUC) of enzalutamide plus N-desmethyl enzalutamide by 2.2-fold. Co-administration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If co-administration of XTANDI with a strong CYP2C8 inhibitor cannot be avoided, reduce the dose of XTANDI. Drugs that Induce CYP3A4 Co-administration of rifampin (strong CYP3A4 inducer and moderate CYP2C8 inducer) decreased the composite AUC of enzalutamide plus N-desmethyl enzalutamide by 37%. Co-administration of strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine) with XTANDI should be avoided if possible. St John’s wort may decrease enzalutamide exposure and should be avoided. If co-administration of a strong CYP3A4 inducer with XTANDI cannot be avoided, increase the dose of XTANDI. Effect of XTANDI on Drug Metabolizing Enzymes Enzalutamide is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. At steady state, XTANDI reduced the plasma exposure to midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate). Concomitant use of XTANDI with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin) should be avoided, as enzalutamide may decrease their exposure. If co-administration with warfarin cannot be avoided, conduct additional INR monitoring.

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary XTANDI is contraindicated for use in pregnant women because the drug can cause fetal harm and potential loss of pregnancy. XTANDI is not indicated for use in females.

There are no human data on the use of XTANDI in pregnant women. In animal reproduction studies, oral administration of enzalutamide in pregnant mice during organogenesis caused adverse developmental effects at doses lower than the maximum recommended human dose.

Animal Data In an embryo-fetal developmental toxicity study in mice, enzalutamide caused developmental toxicity when administered at oral doses of 10 or 30 mg/kg/day throughout the period of organogenesis (gestational days 6-15). Findings included embryo-fetal lethality (increased post-implantation loss and resorptions) and decreased anogenital distance at ≥ 10 mg/kg/day, and cleft palate and absent palatine bone at 30 mg/kg/day. Doses of 30 mg/kg/day caused maternal toxicity. The doses tested in mice (1, 10 and 30 mg/kg/day) resulted in systemic exposures (AUC) approximately 0.04, 0.4 and 1.1 times, respectively, the exposures in patients. Enzalutamide did not cause developmental toxicity in rabbits when administered throughout the period of organogenesis (gestational days 6-18) at dose levels up to 10 mg/kg/day (approximately 0.4 times the exposures in patients based on AUC).

Lactation Risk Summary XTANDI is not indicated for use in females. There is no information available on the presence of XTANDI in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.

Enzalutamide and/or its metabolites were present in milk of lactating rats.

Females and Males of Reproductive Potential Contraception Males Based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the final dose of XTANDI. Infertility Based on animal studies, XTANDI may impair fertility in males of reproductive potential.

Pediatric Use Safety and effectiveness of XTANDI in pediatric patients have not been established.

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NSAIDs that preferentially inhibited COX-2 activity had a significant 52% decreased risk. Use of non-aspirin NSAIDs was associated with a significant 28% decreased risk of PCa overall and a 51% decreased risk of high-grade PCa, defined as Gleason score 7 (4 + 3) or higher.

Geriatric Use Of 1671 patients who received XTANDI in the two randomized placebo-controlled clinical trials, 75% were 65 and over, while 31% were 75 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Patients with Renal Impairment A dedicated renal impairment trial for XTANDI has not been conducted. Based on the population pharmacokinetic analysis using data from clinical trials in patients with metastatic CRPC and healthy volunteers, no significant difference in enzalutamide clearance was observed in patients with pre-existing mild to moderate renal impairment (30 mL/min ≤ creatinine clearance [CrCL] ≤ 89 mL/min) compared to patients and volunteers with baseline normal renal function (CrCL ≥ 90 mL/min).

No initial dosage adjustment is necessary for patients with mild to moderate renal impairment. Severe renal impairment (CrCL < 30 mL/min) and end-stage renal disease have not been assessed.

Patients with Hepatic Impairment Dedicated hepatic impairment trials compared the composite systemic exposure of enzalutamide plus N-desmethyl enzalutamide in volunteers with baseline mild, moderate, or severe hepatic impairment (ChildPugh Class A, B, or C, respectively) versus healthy controls with normal hepatic function. The composite AUC of enzalutamide plus N-desmethyl enzalutamide was similar in volunteers with mild, moderate, or severe baseline hepatic impairment compared to volunteers with normal hepatic function. No initial dosage adjustment is necessary for patients with baseline mild, moderate, or severe hepatic impairment.

OVERDOSAGE In the event of an overdose, stop treatment with XTANDI and initiate general supportive measures taking into consideration the half-life of 5.8 days. In a dose escalation study, no seizures were reported at ≤ 240 mg daily, whereas 3 seizures were reported, 1 each at 360 mg, 480 mg, and 600 mg daily. Patients may be at increased risk of seizure following an overdose.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of enzalutamide.

Enzalutamide did not induce mutations in the bacterial reverse mutation (Ames) assay and was not genotoxic in either the in vitro mouse lymphoma thymidine kinase (Tk) gene mutation assay or the in vivo mouse micronucleus assay.

Based on nonclinical findings in repeat-dose toxicology studies, which were consistent with the pharmacological activity of enzalutamide, male fertility may be impaired by treatment with XTANDI. In a 26-week study in rats, atrophy of the prostate and seminal vesicles was observed at ≥ 30 mg/kg/day (equal to the human exposure based on AUC). In 4-, 13-, and 39-week studies in dogs, hypospermatogenesis and atrophy of the prostate and epididymides were observed at ≥ 4 mg/kg/day (0.3 times the human exposure based on AUC).

Manufactured for and Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Pfizer Inc., New York, NY 10017 Revised: July 2017 16K089-XTA-WPI Rx Only © 2017 Astellas Pharma US, Inc. XTANDI® is a registered trademark of Astellas Pharma Inc.

076-2626-PM

Compared with men who did not use NSAIDs, those who took 1 or more NSAID pill per day had a 62% decreased risk of PCa. The study also found that the protective effect of NSAIDs was greater among men with a history of prostatitis. In these patients, use of any NSAIDs and use of non-aspirin NSAIDs were associated with a 68% and 79% decreased risk of PCa, respectively, compared with nonusers. By comparison, among men without a history of prostatitis, the use of any NSAIDs and use of non-aspirin NSAIDs were associated with a 15% and 18% decreased risk of PCa, respectively.

The study, led by Florence Menegaux, MD, PhD, of the Center for Research in Epidemiology and Population Health, Team Cancer and Environment, INSERM, Université Paris-Sud, Villejuif, France, enrolled 819 men aged less than 75 years with newly diagnosed PCa and 879 age-matched controls.

Use of non-steroidal anti-inflammatory drugs found to lower PCa risk by 23%.

The researcher concluded that their study “provides convincing evidence” that frequent and chronic use of NSAIDs decreases the risk of PCa, especially aggressive PCa. The decreased risk observed among men with a history of prostatitis is additional evidence that targeting chronic inflammation may help prevent prostate carcinogenesis, they noted.

For the study, the investigators defined overall users of NSAIDs as men who took aspirin or non-aspirin NSAIDs at least once a month. They considered men who never took NSAIDs or took them less frequently than once a month to be non-users.

The study by Dr Menegaux and colleagues is not the first to demonstrate an association between NSAID use and a lower risk of PCa. In a study of participants in the REDUCE (Reduction

by Dutasteride of Prostate Cancer Events) trial published in Clinical Cancer Research (2015;21:756-762), researchers showed that use of aspirin and/or NSAIDs was associated with a significant 13% and 20% decreased odds of total PCa and high-grade PCa (Gleason 7 or higher), respectively. They found no association with low-grade PCa risk. n

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FROM THE MEDICAL DIRECTOR EDITORIAL ADVISORY BOARD

The Adrenal Gland: The Forgotten Urologic Organ

T

he adrenal glands are easily overlooked. Distinguished anatomists from centuries ago such as Aelius Galen, Leonardo da Vinci, and Andreas Vesalius omitted the adrenals in their early descriptions of the retroperitoneum. The critical importance of the adrenal gland was recognized in the mid-19th century

by Thomas Addison and CharlesÉdouard Brown-Séquard, who demonstrated that bilateral adrenalectomy uniformly resulted in death. This led to the discovery and isolation of adrenaline, cortisol and subsequently aldosterone in the 1930’s, 1940’s, and 1950’s, and a 1950 Nobel Prize for Edward C. Kendall, Philip S. Hench, and Tadeus Reichstein.1 Today, specialists in the retroperitoneum too easily overlook the adrenal glands, perhaps because they are rarely the focal point of pathology.

Oncologically, primary adrenal cortical carcinomas are rare (1 per million or about 200 cases/year in the U.S.). While metastatic disease to the adrenal gland is common, it only occasionally occurs in isolation, rendering it more suitable for systemic therapies.

Incidental adrenal abnormalities (“incidentalomas”) are quite common, however. Adrenal adenomas are found in up to 7% of adults aged 70 years or more, with similar trends observed in historical autopsy series.

While the overwhelming majority of adrenal incidentalomas display no evidence of metabolic activity, a small percentage of them can exhibit metabolic activity representing “surgical” lesions.

When followed serially, about 9% of incidental adrenal lesions increase in size and 2% become metabolically active during follow-up, prompting recommendations from a National Institute of Health panel for annual metabolic hormonal screening for the first 3 to 4 years following diagnosis, especially for masses 3 cm or larger. Moreover, current guidelines advise surgical resection of adrenal masses regardless of radiographic characteristics if the lesion is 4 cm or larger, although the exact cutoff remains debated.

In an era of routine imaging, incidental or bystander lesions offer insights not only into biology and epidemiology of adrenal abnormalities, but, perhaps more importantly, into our interpretation of screening, disease, lead time bias, and the effectiveness of our therapeutic interventions. While over diagnosis may lead to over management, under diagnosis sometimes represents a missed opportunity. In the case of the adrenal glands, the former may predominate. For the discriminating urologist, however, the art of medicine is to discern the difference.

Robert G. Uzzo, MD, FACS G. Willing “Wing” Pepper Chair in Cancer Research Professor and Chairman, Department of Surgery Fox Chase Cancer Center Temple University School of Medicine, Philadelphia 1. Kutikov A, Crispen PL, Uzzo RG: Chapter 65: Pathophysiology, Evaluation, and Medical M ­ anagement of Adrenal Disorders. In: Campbell-Walsh Urology. Edition 11. (Wein AJ, et al, eds). Elsevier, Philadelphia, PA, 2015

Medical Director, Urology

Medical Director, Nephrology

Robert G. Uzzo, MD, FACS G. Willing “Wing” Pepper Chair in Cancer Research Professor and Chairman Department of Surgery Fox Chase Cancer Center Temple University School of Medicine Philadelphia

Kamyar Kalantar-Zadeh, MD, MPH, PhD Professor & Chief Division of Nephrology & Hypertension University of California, Irvine School of Medicine Orange, Calif.

Urologists

Nephrologists

Christopher S. Cooper, MD Director, Pediatric Urology Children’s Hospital of Iowa Iowa City

Anthony J. Bleyer, MD, MS Professor of Internal Medicine/Nephrology Wake Forest University School of Medicine Winston-Salem, N.C.

R. John Honey, MD Head, Division of Urology, Endourology/Kidney Stone Diseases St. Michael’s Hospital University of Toronto

David S. Goldfarb, MD Professor, Department of Medicine Clinical Chief New York University Langone Medical Center Chief of Nephrology, NY Harbor VA Medical Center

Stanton Honig, MD Department of Urology Yale University School of Medicine New Haven, CT J. Stephen Jones, MD, FACS President, Cleveland Clinic Regional Hospitals & Family Health Centers Professor & Horvitz/Miller Distinguished Chair in Urological Oncology Jaime Landman, MD Professor of Urology and Radiology Chairman, Department of Urology University of California Irvine

Csaba P. Kovesdy, MD Chief of Nephrology Memphis VA Medical Center Fred Hatch Professor of Medicine University of Tennessee Health Science Center, Memphis Edgar V. Lerma, MD, FACP, FASN, FAHA Clinical Associate Professor of Medicine Section of Nephrology Department of Medicine University of Illinois at Chicago College of Medicine, Chicago Allen Nissenson, MD Emeritus Professor of Medicine The David Geffen School of Medicine at UCLA, Chief Medical Officer, DaVita Inc.

James M. McKiernan, MD John K. Lattimer Professor of Urology Chair, Department of Urology Director, Urologic Oncology Columbia University College of Physicians and Surgeons, New York City

Rulan Parekh, MD, MS Associate Professor of Pediatrics and Medicine University of Toronto

Kenneth Pace, MD, MSc, FRCSC Assistant Professor, Division of Urology St. Michael’s Hospital University of Toronto

Robert Provenzano, MD Chief, Section of Nephrology St. John Hospital and Medical Center Detroit

Ryan F. Paterson, MD, FRCSC Assistant Professor Division of Urologic Sciences University of British Columbia Vancouver, Canada

Robert S. Rigolosi, MD Director, Regional Hemodialysis Center Holy Name Hospital, Teaneck, N.J.

Renal & Urology News Staff Editor Web editor Production editor

Jody A. Charnow Natasha Persaud Kim Daigneau

Group art director, Haymarket Medical

Jennifer Dvoretz

Production manager

Krassi Varbanov

Production director Circulation manager National accounts manager Group Publisher Editorial director

Kathleen Millea Grinder Paul Silver William Canning Chad Holloway Kathleen Walsh Tulley

General manager, medical communications

Jim Burke, RPh

CEO, Haymarket Media Inc.

Lee Maniscalco

Renal & Urology News (ISSN 1550-9478) Volume 16, Number 6. Published bimonthly by Haymarket Media, Inc., 275 7th Avenue, 10th Floor, New York, NY 10001. For Advertising Sales & Editorial, call (646) 638-6000 (M–F, 9am–5pm, ET). Postmaster: Send address changes to Renal & Urology News, c/o Direct Medical Data, 10255 W. Higgins Rd., Suite 280, Rosemont, IL 60018.

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Contents

NOVEMBER/DECEMBER 2017

NOVEMBER/ DECEMBER 2017 ■ VOLUME 16, ISSUE NUMBER 6

Urology 10

ONLINE

this month at renalandurologynews.com

13

26

Clinical Quiz Test your knowledge by taking our latest quiz at renalandurologynews.com/ ClinicalQuiz

HIPAA Compliance How to balance security with employee access to information.

27

Drug Information Search a comprehensive drug database for prescribing and other information on more than 4000 drugs.

BPH ‘Aquablation’ Better for Sexual Function Use of high-pressure waterjets to ablate prostate tissue in patients with BPH is associated with a lower risk of ejaculatory dysfunction compared with TURP. Overuse of PCa Scans May Be Easing Although contemporary data are sparse, some evidence suggests a downward trend.

Recurrent UTIs May Worsen Transplant Outcomes Kidney transplant recipients with recurrent UTIs had a 2-fold increased risk of graft failure compared with those who had no UTIs.

16

In-hospital Death Linked to High, Low Phosphorus Admission serum phosphate levels below 2.5 and above 4.2 mg/dL are associated with an increased risk of dying in the hospital.

18

CALENDAR Genitourinary Cancers Symposium San Francisco February 8–10, 2018 Annual Dialysis Conference Orlando, Florida March 3–6 European Association of Urology 2018 Congress Copenhagen, Denmark March 16–20.

National Kidney Foundation Spring Clinical Meeting Austin, Texas April 10–14 American Urological Association Annual Meeting San Francisco, CA May 18–21 Canadian Urological Association Annual Meeting Halifax, Nova Scotia June 23–26.

Ferric Citrate Reduces FGF23 in CKD Patients, Study Finds Decreases in fibroblast growth factor 23 occurred even in patients who had no change in serum phosphorus.

News Coverage Visit our website for daily reports from the 2018 Genitourinary Cancers Symposium in San Francisco, February 8-10.

Second-line Enzalutamide Shows Antitumor Effect The drug benefited some mCRPC patients previously treated with abiraterone.

14

Job Board Be sure to check our latest listings for professional openings across the United States.

RP vs Radiation for High-risk Prostate Cancer The optimal approach remains controversial, with no clear guidance from the medical literature.

Nephrology 8

Renal & Urology News 7

Dialysis Care in an Emergency: Lessons from Hurricane Harvey Flooding in the Houston area challenged the ability of dialysis centers to deliver care.

As a high volume radical prostatectomist and

urologic oncologist, I feel that a modern-day radical prostatectomy yields better long-term overall quality-of-life than radiotherapy.

See our story on page 10

American Society of Nephrology Kidney Week New Orleans October 23–28

28

Departments 4

From the Medical Director The Adrenal Gland: The Forgotten Urologic Organ

8

News in Brief RCC histologic subtypes affect post-surgery outcomes

28

Practice Management Shopping around for better deals can boost the bottom line

8 Renal & Urology News

NOVEMBER/ DECEMBER 2017 www.renalandurologynews.com

News in Brief

Please visit us at www.renalandurologynews.com for the latest news updates from the fields of urology and nephrology

Short Takes Expanded Indication Sought for Cysview

MD, of the University of Texas South-

THE FDA HAS ACCEPTED a supple-

and colleagues found that among

mental New Drug Application (NDA)

subjects with CKD, those in the low-

for Cysview (hexaminoluvinate HCl)

est tertile of serum magnesium had

on a priority review basis. Photocure,

a 2.3-fold increased risk of all-cause

the Oslo, Norway-based company that

mortality compared with individuals

developed and is marketing the drug-

without CKD; those in the highest

device system, wants to expand the

tertile had a non-significant 15%

labeling indication to include use of

increased risk.

western Medical Center in Dallas,

the product in the outpatient setting. for use in the cystoscopic detection of

Baldness Associated With Aggressive PCa

non-muscle-invasive papillary blad-

AGGRESSIVE PROSTATE cancer (PCa)

der cancer in patients suspected or

and benign prostatic hyperplasia

known to have lesions on the basis of

(BPH) are linked to male pattern bald-

prior cystoscopy. A decision on the

ness, investigators reported online

NDA is expected in the first half of

ahead of print in Urologic Oncology.

In July 2010, FDA approved Cysview

2018, according to Photocure.

In a meta-analysis of 17 studies comprising 68,448 participants, Tao

Low Mg Ups Death Risk in CKD Patients

Jin, MD, PhD, of West China Hospital,

LOW SERUM MAGNESIUM levels are

and colleagues found that male pattern

independently associated with an

baldness is associated with a signifi-

increased risk of death from any cause

cant 59% and 26% increased odds of

among patients with chronic kidney

aggressive PCa and BPH. Vertex bald-

disease (CKD), according to study find-

ness is associated with a significant

ings published online ahead of print in

18% increased odds of PCa. The inves-

Nephrology Dialysis Transplantation.

tigators found no significant associa-

In a study of 3551 participants in

tion between BPH and the vertex and

Sichuan University, Chengdu, China,

the Dallas Heart Study, Silvia Ferrè,

frontal plus vertex hair loss pattern.

AKI After CABG, PCI On the Rise Acute kidney injury after coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) procedures increased in incidence from 2004 to 2012, according to a study of 274,464 hospitalized patients who had a first-time CABG or PCI for multi-vessel disease.

14.2%

15

n 2004 n 2012

12

8.8%

9 6

4.9% 2.7%

3 0

CABG

PCI

Source: Shen W, Bhandary S, Jaeil A. Temporal trends in the incidence of AKI after coronary revascularization in a nationwide study.

Presented in poster format at Kidney Week 2017 in New Orleans (Oct. 31 to Nov. 5). Abstract SA-PO002.

Recurrent UTIs May Worsen Kidney Transplant Outcomes R

ecurrent urinary tract infections (UTIs) are associated with poorer graft and patient outcomes compared with noncurrent UTIs, according to a retrospective study of 2469 kidney transplant recipients by Nicholas S. Britt, MD, and colleagues at Barnes-Jewish Hospital in St. Louis, Missouri. Of these patients, 1835 patients (74.3%) had no UTIs, 465 (18.8%) had non-recurrent UTIs, and 169 (6.8%) had recurrent UTIs. Recipients with recurrent UTIs had a 1.4-fold and 2-fold increased risk of graft failure than those with non-recurrent and no UTIs, respectively, Dr Britt’s group reported online in Nephrology Dialysis Transplantation (2017;32:1758-1766). Patients with recurrent UTIs had an 87% increase risk of death compared with those who had non-recurrent UTIs.

RCC Subtypes Influence Post-Surgery Outcomes C

ancer-specific mortality among patients who undergo surgery for non-metastatic renal cell carcinoma (RCC) vary according to histologic subtypes of the malignancy, new findings suggest.

Compared with clear cell RCC, papillary RCC is associated with a significant 24% reduced risk of cancer-specific mortality, and papillary RCC type 1 is associated with a significant 69% decreased risk of all-cause mortality, Nina Wagener, MD, of Mannheim Medical Center in Mannheim, Germany, and colleagues reported online in PLoS One. They found no difference in cancer-specific mortality between papillary RCC type 2 and clear cell RCC. As a result of the study’s findings, the authors concluded there is an urgent need to consider histopathologic entities and their subtypes when deciding on follow-up or targeted therapy for RCC patients.

The study included 7543 European and North American patients who underwent radical or partial nephrectomy for RCC. The group consisted of 1943 patients with papillary RCC and 5600 with clear cell RCC. The median followup was 64.6 months.

Ferric Citrate Is Approved For Anemia in CKD Patients T

he FDA has approved ferric citrate (Auryxia) for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD) but not dialysis. The drug, made by Keryx Biopharmaceuticals, Inc., of Boston, originally was approved in September 2014 for the control of serum phosphorus in dialysis patients.

The expanded indication was approved based on results from a 24-week placebo-controlled phase 3 clinical trial involving 234 adults with stage 3-5 CKD who were intolerant to or had an inadequate response to prior treatment with oral iron supplements. Results showed that 52.1% of patients treated with ferric citrate had a 1 g/dL or greater increase in hemoglobin levels at any point during the 16-week efficacy period compared with 19.1% of placebo recipients. The most commonly reported adverse events were diarrhea (21%), constipation (19%), discolored feces (15%), nausea (11%), abdominal pain (6%), and hyperkalemia (7%).

www.renalandurologynews.com NOVEMBER/DECEMBER 2017

TRT and PCa incidence continued from page 1

above 6, and 2, 20, and 4 had a predominant Gleason score of 3, 4, and 5, respectively. Tumor grade was G2 in 6 patients (23%) and G3 in 20 (77%).

One patient (4%) had tumor stage T2 and 25 had tumor stage T3.

“In the testosterone group, all prostate cancers were diagnosed within the first year and a half, suggesting that cancers had been present prior to initiating testosterone therapy,” Dr Haider said. “Because low testosterone is associated with low PSA, hypogonadism may contribute to reduced detectability of prostate cancer. Normalizing testosterone may have brought out the occult cancer.”

He added: “Our registry is ongoing, and we keep following our patients year

Adjuvant sunitinib continued from page 1

The new approval was based on a phase 3 randomized S-TRAC (Sunitinib as Adjuvant Treatment for Patients at High Risk of Recurrence of Renal Cell Carcinoma Following Nephrectomy) trial, which included 615 patients (72% male) with resected locoregional RCC at high risk for disease recurrence.

Sunitinib was taken for 4 weeks on and 2 weeks off for 1 year or until recurrence, secondary malignancy, toxicity, or patient withdrawal. The sunitinib group had a longer median duration of disease-free survival than did placebo recipients (6.8 vs. 5.6 years). At 5 years, 59.3% of patients treated with sunitinib were free from recurrence and were alive compared with 51.3% of patients receiving placebo. Study findings were

Focal ablation continued from page 1

Sixteen (80%), 2 (10%), and 2 (10%) of the GPEFD were Gleason score 3+4, 4+3, and 4+4, respectively.

Of the 20 GP4EFD, 10 (50%) exhibited a maximum linear cross-sectional length of less than 5 mm. Ablating only the MRI-L lesion plus 10 mm or performing an ipsilateral hemi-ablation would leave residual Gleason pattern 4 tissue in 14 (23.7%) and 11 (18.6%) of the 59 patients, respectively, Dr Lepor’s group reported online ahead of print in Urology.

Criteria for FA included single reported MRI-L concordant with biopsy Gleason score less than 8, no gross extra-prostatic extension on MRI,

Renal & Urology News 9

after year. The results are getting more robust with advancing time.”

The next update will be presented at the Genitourinary Cancers Symposium in San Francisco in February 2018.

The new findings add to those from previous studies showing a protective effect of TRT against PCa. Earlier this year, Stacy Loeb, MD, of New York University, and colleagues published the results of a case-control study in the Journal of Clinical Oncology (2017;35:1430-1436) showing that men who received TRT had a decreased risk of aggressive PCa. Using the National Prostate Cancer Register of Sweden, the investigators compared 38,570 patients with PCa and 192,838 agematched men without PCa (controls).

Of these, 284 patients with PCa (1%) and 1378 (1%) controls filled TRT prescriptions. In multivariable analysis,

the investigators found no association between TRT and overall PCa risk.

Patients who received TRT had a significant 35% increased odds of more favorable-risk PCa and 50% decreased odds of aggressive PCa compared with patients not exposed to TRT.

In a population-based matched cohort study of men aged 66 years or older in Ontario, Canada, Christopher J.D. Wallis, MD, PhD, and colleagues from the University of Toronto found that TRT recipients in the highest tertile of

testosterone exposure had a significant 40% decreased risk of a PCa diagnosis compared with controls, according to a paper published in Lancet Diabetes Endocrinology (2016;4:498-506). The study included 10,311 men who received TRT and 28,029 controls. Median follow-up was 5.3 years in the TRT group and 5.1 years in the control group.

Further, in a study published in the Aging Male (2017;20:125-133), Aksam Yassin, MD, from the Institute of Urology and Andrology, Segeberger Kliniken, Norderstedt, Germany, and colleagues found that hypogonadal men who received TRT had a lower rate of PCa found on prostate biopsy compared with hypogonadal men not exposed to TRT and eugonadal men (16.7% vs 51.8% vs 37.8%, respectively). They also were less likely to have less severe PCa as determined grading and staging. n

reported in the New England Journal of Medicine (2016;375:2246-2254). The study was funded by Pfizer, which markets the drug.

The drug carries a boxed warning for hepatoxicity. Severe adverse effects (AEs) include liver damage, low left ventricular

The most common AEs include fatigue, diarrhea, mucositis/stomatitis, nausea, decreased appetite, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding, dysgeusia, dyspepsia, and thrombocytopenia.

Sunitinib should be discontinued if necrotizing fasciitis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis occurs. It is contraindicated in pregnant women.

“The FDA’s approval of the first adjuvant treatment for patients with renal cell carcinoma returning after a nephrectomy is a lifesaving advancement and important news for many of us who treat patients with kidney cancer,” Neal D. Shore, MD, president of the Large Urology Group Practice Association, said in a press statement.

“With no other FDA-approved agent targeting recurrence, this ground-

breaking treatment will have widespread implications for thousands of patients per year.

“As leaders in advancing quality care for patients,” Dr Shore continued, “I anticipate that LUGPA’s member practices will begin implementing this treatment immediately into the care paradigm of patients for whom it is most appropriate. This will serve as one of the many tools we use in conjunction with others, such as immunotherapy and targeted molecular therapies, to achieve the best possible outcomes for patients. We applaud the FDA’s bold decision to approve this treatment, which will solve a major unmet need in health care.”

Sunitinib received FDA approval for metastatic RCC and imatinib-resistant gastrointestinal stromal tumor on January 26, 2006. n

MRI is highly accurate in predicting the index lesion, as defined by the highest grade/highest volume tumor, which was successfully predicted in

who has studied the use of mpMRI/ ultrasound fusion-guided biopsy and its application to PCa focal therapy.

“It is also well known that prostate MRI is not as sensitive in detecting small volume tumors, some of which will harbor clinically significant disease,” Dr Gordetsky told Renal & Urology News. “As such, this study is in line with the current literature that demonstrates a small but significant number of patients undergoing focal therapy will be left with potentially clinically significant prostate cancer.

Focal therapy should not be considered a curative approach for prostate cancer and those undergoing this procedure require continued surveillance and repeat MRI-targeted prostate biopsy.” n

Median disease-free survival time was longer with sunitinib therapy vs placebo. ejection fraction, myocardial ischemia, prolonged QT intervals, hypertension, bleeding, tumor lysis syndrome, thrombotic microangiopathy, proteinuria, thyroid dysfunction, hypoglycemia, osteonecrosis, and poor wound healing.

no Gleason score 6 core length greater than 5 mm contralateral to the reported MRI-L lesion on systematic biopsy.

“While encouraging and perhaps oncologically acceptable, these data indicate that men undergoing an ablation template that includes the MRI-L + 10 mm margin or hemi-ablation must be followed with an active surveillance protocol after FA,” Dr Lepor and his colleagues wrote. “The frequency with which MRI and biopsy are conducted in follow-up remains a matter of active debate.”

Jennifer B. Gordetsky, MD, associate professor of surgical pathology at the University of Alabama at Birmingham, who was not involved in the new study, said the study by Dr Lepor and colleagues demonstrated that prostate

Normalizing testosterone may have brought out occult cancer.

Gleason 4 disease outside the focal ablation zone may be missed. more than 90% of cases. Similar to other studies, the authors found that the majority (72.9%) of patients in their study had multifocal PCa, which can be problematic for patients undergoing focal therapy, said Dr Gordetsky,

10 Renal & Urology News

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T:21” S:14”

RP vs Radiation for High-risk Prostate Cancer

BY JOHN SCHIESZER HIGH-RISK prostate cancer (PCa) is well defined, but opinions vary on whether radical prostatectomy or radiation therapy is the best treatment approach.

“As a high volume radical prostatectomist and urologic oncologist, I feel that a modern-day radical prostatectomy yields better long-term overall quality-of-life than radiotherapy,” said Judd Moul, MD, professor of surgery and anesthesiology in the division of urology at Duke University Medical Center in Durham, North Carolina.

“However, I am also a die-hard fan and believer in multi-disciplinary care for men with prostate cancer and feel that all men with localized prostate cancer deserve to be seen by both a surgeon and a radiation oncologist and ideally a medical oncologist if applicable before making an informed decision.”

more of ADT. In my mind, this sampling error and ascertainment error in clinical risk assessment is the biggest selling point for surgery, particularly for men who are characterized as highrisk by biopsy alone,” Dr Moul said.

The ProtecT (Prostate Testing for Cancer and Treatment) trial is the only

randomized controlled trial showing no difference between surgery and radiotherapy at 10-year follow up. The trial, however, was not applicable to high-risk patients (N Engl J Med. 2016;375:14151424). Sam S. Chang, MD, MBA, ­professor of urologic surgery and oncology at Vanderbilt University Medical

Center in Nashville, Tennessee, said although there are no head-to-head data specifically for high-risk patients, it is possible to look at multiple studies that used propensity score matching.

“Prostatectomy seems to have ­better cancer outcomes,” Dr Chang said.

“Large randomized trials of localized

The evidence to date does not provide a definitive answer on optimal treatment.

High-risk PCa is defined as bilaterally clinically palpable tumors extending beyond the prostatic capsule, with PSA levels of 20 ng/mL or higher or a Gleason score of 8 or higher. Dr Moul and colleagues have examined which approach may be the best and found that treatment options for high-risk disease continue to be refined and remain controversial (Oncol Res Treat. 2015;38:639-644).

Among the best arguments in favor of surgery over radiation is the use of androgen deprivation therapy (ADT), particularly for most intermediate and high-risk men. “I applaud the radiation oncology community for doing outstanding randomized clinical trials showing a benefit of adding ADT to radiotherapy alone, but this is also an Achilles’ heel regarding quality-of-life,” Dr Moul told Renal & Urology News.

In a recently published study of 1424 men who underwent open or roboticassisted RP from 2004 to 2015, Dr Moul and collaborators found that 61.5% of patients with clinical Gleason 8 disease on prostate biopsy were downgraded on RP, with 58.8% downgraded to Gleason 7 (Can J Urol. 2017; 24:8982-8989).

“If all of these clinical high-risk men had elected radiotherapy, they could have been subjected to 18 months or

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Renal & Urology News 11

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prostate cancer as a large group show no benefit of one treatment over the other with different side effects.”

In patients who are appropriate candidates for surgery, the pathologic data obtained allows better risk stratification, Dr Chang said. Such data may obviate the need for multimodality therapy. “Newer diagnostic tools such as multiparametric MRI as well as genetic prognostic tests may help us

better individualize the appropriate therapy,” he said.

According to Suneil Jain, MD, from the Centre for Cancer Research & Cell Biology at Queen’s University Belfast in Belfast, Northern Ireland, only 2% of patients in the ProtecT study had high-risk disease, so no conclusions can be drawn from it. Still, he believes the evidence for the use of radiotherapy to treat high-risk PCa is stronger

than for surgical treatments. “Wellpowered clinical trials have clearly demonstrated that radiation plus ADT improves overall survival compared to ADT alone,” Dr Jain said.

Retrospective and population-based studies are subject to multiple biases, including gatekeeper bias, he said.

Data from the STAMPEDE study presented at the European Society for Medical Oncology (ESMO) 2017 con-

ference in September demonstrated the best results for high-risk localized PCa to date. Investigators reported data from patients with high-risk localized PCa randomized to radiotherapy and ADT or radiotherapy, ADT, and 2 years of abiraterone with prednisone.

“Amazingly, 3-year failure free survival improved from 80% to 98% with the addition of abiraterone,” Dr Jain said. continued on page 12

12 Renal & Urology News

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RP vs radiation for PCa continued from page 11

Michael Zelefsky, MD, professor of radiation oncology and chief of brachytherapy at Memorial Sloan Kettering Cancer Center in New York, said there is no Level I evidence to support one form of therapy over the other for patients with high-risk disease.

“Nevertheless, the retrospective data

comparing surgery and radiotherapy suggesting inferior survival outcomes among patients receiving radiotherapy are flawed because of the very different patient populations and their comorbidities and age as well as the less intense radiation dose levels used years ago,” Dr Zelefsky said.

In a study of high-risk patients who were excluded from the ProtecT trial, he noted, investigators found no

­ ifference in PCa-specific or overall d survival between surgery and radiation therapy (Eur Urol. 2017;71:381-388).

Prior studies of high-risk patients only compared surgery to external beam radiation therapy (EBRT), Dr Zelefsky said. Recently published results from the ASCENDE-RT (Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy) trial—which compared ­external beam

radiation therapy (EBRT) alone and brachytherapy plus EBRT in highrisk patients—demonstrated a marked improvement in the 10-year PSA relapse free survival for the combined regimen. “It is not surprising that radiotherapy in the prior comparison studies didn’t do as well,” Dr Zelefsky said.

“The studies never compared surgery with the most optimal form of radiotherapy for high-risk disease.” n

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Renal & Urology News 13

Second-line Enzalutamide Shows Antitumor Effects ENZALUTAMIDE may benefit some men with metastatic castration-resistant prostate cancer (mCRPC) whose disease progresses while on treatment with abiraterone plus prednisone, according to a new study.

In a prospective, open-label, single-arm, multicenter study, Johann S. De Bono,

MD, of the Institute of Cancer Research in London, and colleagues examined the outcomes of 214 mCRPC patients treated with enzalutamide after their disease progressed while on abiraterone plus prednisone for at least 24 weeks.

The primary study outcome was radiographic progression-free survival (rPFS).

The median duration of enzalutamide treatment was 5.7 months for the overall study population, with 30% of patients remaining on treatment at 9 months, the researchers reported online ahead of print in European Urology. The median duration of enzalutamide treatment was similar for patients

who received prior chemotherapy and those who did not (5.5 vs 5.9 months).

The median rPFS was 8.1 months and median time to PSA progression was 5.7 months.

Radiographic progression occurred in 101 (72%) of the 141 patients who experienced disease progression. Forty deaths occurred before radiographic progression.

Reported adverse events “were consistent with the established safety profile of enzalutamide and were as expected for the study population,” according to the investigators.

Abiraterone and enzalutamide are novel androgen receptor (AR)-targeted agents, and retrospective analyses suggest some cross-resistance between these drugs when used sequentially, the authors noted, adding that findings from robust, prospective studies have not yet been reported.

“Currently, there is no expert consensus on the use of second-line treatment with enzalutamide or abiraterone in symptomatic men who develop resistance after first-line abiraterone or enzalutamide, respectively, due in part to the absence of prospective clinical data in these settings,” the authors wrote.

The prospective data from their study demonstrate the antitumor activity of enzalutamide in patients who progressed following 24 weeks or more of abiraterone treatment and support the use of enzalutamide in some patients in the post-abiraterone setting, they stated.

Overall, the authors noted, a better understanding of the biology of abiraterone and enzalutamide resistance is key to optimizing use of these agents.

In an accompanying editorial, Kazutaka Saito, MD, and Yasuhisa Fujii, MD, of Tokyo Medical and Dental University in Japan, said the new study provides further important findings on the antitumor activity of enzalutamide as a second-line AR-targeted agent in a prospective, multicenter study. “A next step would be to identify predictive variables for appropriate patient selection for a trial of second-line enzalutamide following abiraterone in a suitable disease setting,” they wrote.

They also observed: “In the setting of sequential therapy for mCRPC, it would be of current interest to investigate whether or not resistance to AR-targeted agents is attenuated by inserting taxane therapy after disease progression on AR-targeted agents.” n

14 Renal & Urology News

■ ASN 2017, New Orleans

NOVEMBER/DECEMBER 2017 www.renalandurologynews.com

American Society of Nephrology's Kidney Week 2017, New Orleans

Tolvaptan Eases Later-Stage ADPKD Use of the drug was associated with a 35% decrease in the annual rate of eGFR decline versus placebo TOLVAPTAN SLOWS the rate of kidney function decline in patients with later-stage autosomal dominant polycystic kidney disease (ADPKD), according to study findings presented at Kidney Week 2017 and published online concomitantly in the New England Journal of Medicine.

In the randomized, double-blind, placebo-controlled phase 3 REPRISE (Replicating Evidence of Preserved Renal Function: an Investigation of Tolvaptan Safety and Efficacy in ADPKD) trial, patients with later-stage ADPKD who received tolvaptan for 12 months experienced a significant 35% reduction in the annual rate of estimated glomerular filtration rate (eGFR) decline compared with placebo recipients, lead investigator Vicente E. Torres, MD, PhD, of Mayo Clinic in Rochester, Minnesota, reported.

Patients Are Initiating HD at Older Ages

BY JODY A. CHARNOW PATIENTS WITH end-stage renal disease are starting hemodialysis (HD) at increasingly older ages and with more diabetes and hypertension, according to a study of 20-year data. Nevertheless, they are living longer and are experiencing a decline in peripheral vascular disease (PVD) and stroke. The prevalence of cardiovascular disease has remained flat.

The study, which used data from the U.S. Renal Data System (USRDS), included 1,864,386 patients who initiated HD from 1996 to 2015. A team led jointly by Rita McGill, MD, MS, of the University of Chicago and Jennifer Bragg-Gresham, MS, PhD, from the USRDS Coordinating Center at the University of Michigan, found that the mean age of HD patients at dialysis initiation increased from 61.5 years in 1996 to 63.8 years in 2015. From 1995 to 2015, the prevalence of hypertension and diabetes at HD initiation increased from 67.9% to 87.6 % and from 43.1%

In the previous TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes) 3:4 trial, tolvaptan decreased kidney growth and eGFR decline in patients with relatively early ADPKD (minimum eGFR of 60 mL/min/1.73 m2). In the TEMPO 4:4 trial, the benefit with regard to eGFR was maintained after 2 additional years of open-label treatment, researchers reported.

REPRISE enrolled 1370 ADPKD patients aged 18–55 years with an eGFR of 25–65 mL/min/1.73 m 2 or aged 56–65 years with an eGFR of 25–44 mL/min/1.73 m2. Investigators randomly assigned patients to receive tolvaptan or placebo for 12 months.

From pre-treatment baseline to post-treatment follow-up, the eGFR declined by 2.34 mL/min/1.73 m 2

to 59.6%, respectively. During that same period, the prevalence of PVD and stroke decreased from 14.6% to 10.9% and from 9.2% to 8.8%, respectively.

In adjusted analyses, each successive 5-year period was associated with a significant 34% and 16% higher odds of hypertension and diabetes, respectively, and a 9% and 2% lower odds of PVD and stroke, respectively. The log hazard of first-year mortality decreased during this period, “suggesting improving

Patients also are starting hemodialysis with more diabetes and hypertension. health status of incident HD patients over time, which also may be related to decreasing first-year mortality rates,” the authors noted.

“The really exciting thing,” Dr McGill told Renal & Urology News, “is that even though patients initiating hemodialysis have more and more traditional cardiovascular risk factors, their atherosclerosis outcomes are improving, which suggests that care may be improving.” n

per year in the tolvaptan group and by 3.61 mL/min/1.73 m 2 per year in placebo recipients, a significant 1.27 mL/min/1.73 m 2 difference in the annual rate of decline. Assuming that tolvaptan treatment would continue

Tolvaptan may delay progression to stage 5 chronic kidney disease. to slow the decrement in the eGFR by 1.27 mL/min/1.73 m 2 per year, the time to CKD stage 5 would be extended from 6.2 to 9.0 years, according to Dr Torres and his colleagues.

With respect to safety, Dr Torres reported that transaminase elevations

greater than 3 times the upper limit of normal occurred in 5.6% of tolvaptantreated patients compared with 1.2% of placebo recipients. Transaminase levels in tolvaptan-treated patients returned to normal after withdrawal of the drug.

Tolvaptan is not the only promising drug for ADPKD in the pipeline.

In a 2-year, phase 2, placebo-controlled study, bosutinib, an oral drug approved for treating certain cases of chronic myeloid leukemia, slowed cyst growth in patients with ADPKD. Patients treated with bosutinib 200 mg/day experienced a significant 66% reduction in the annual rate of kidney enlargement compared with placebo recipients (1.63% vs 4.74%), investigators reported online ahead of print in the Journal of the American Society of Nephrology. n

Ferric Citrate Reduces FGF23 in CKD Patients, Study Finds FERRIC CITRATE, an oral phosphate

After 16 weeks of treatment, intact

binder, can lower fibroblast growth

FGF23 levels significantly decreased

factor 23 (FGF23) levels in patients with

in those with transferrin saturation

non-dialysis dependent chronic kidney

(TSAT) above or below 20% and across

disease (NDD-CKD) and iron deficiency

all strata of baseline phosphorus

anemia, regardless of change in serum

other than those with levels below 3.5

phosphorus levels, new study findings

mg/dL. C-terminal FGF23 decreased

suggest.

significantly in both TSAT strata (less

The drug, which is FDA approved for

than 20% and 20% or higher) and in

controlling serum phosphorus levels in

all baseline phosphorus strata except

patients on dialysis, previously has been

for levels of 5.5 mg/dL or above. The

shown to improve hemoglobin and iron

changes in FGF23 occurred even in

parameters in patients with NDD-CKD

those who had no change in serum

and iron deficiency anemia (IDA).

phosphorus, further supporting the

The latest study, led by Geoffrey Block

view that ferric citrate acts via several

MD, director of clinical research at

distinct and potentially complementary

Denver Nephrology, examined data from

mechanisms to reduce FGF23, accord-

233 patients with NDD-CKD and IDA ran-

ing to Dr Block and colleagues.

domly assigned to receive ferric citrate

“FGF23 is emerging as an important

(117 patients) or placebo (116 patients)

biomarker of chronic kidney disease,”

for 16 weeks. Ferric citrate was initiated

Dr Block said. “A potential oral treat-

at 3 1-g tablets per day and titrated to

ment option for iron deficiency anemia

achieve a 1 g/dL or greater increase

in patients with non-dialysis dependent

in hemoglobin levels from baseline

CKD, which also reduces FGF23, could be

(maximum dosing 12 g/day).

important in the management of CKD.” n

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■ ASN 2017, New Orleans

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American Society of Nephrology's Kidney Week 2017, New Orleans

In-hospital Death Linked to High, Low Phosphate HOSPITALIZED patients with low and high serum phosphate levels are at elevated risk for dying in the hospital.

In a study of 42,336 hospitalized patients at Mayo Clinic in Rochester,

Minnesota, lead authors Michael A. Mao, MD, and Wisit Cheungpasitporn, MD, and collaborators found a greater likelihood of in-hospital mortality among patients with admission serum

phosphate levels below 2.5 and above 4.2 mg/dL. Compared with patients who had admission serum phosphate levels of 3.1 to 3.6 mg/dL (reference group), patients who had levels below

2.5 and 4.9 mg/dL or higher had 1.6fold and 3.9-fold greater odds of inhospital mortality, respectively, after adjusting for potential confounders.

Among patients with an admission serum phosphate level of 4.9 mg/dL or above, in-hospital mortality risk was greater among patients with versus without chronic kidney disease (CKD) and those with versus without cardiovascular disease (CVD). Patients with CKD had 4-fold greater odds of inhospital mortality compared with the reference group, whereas those without CKD had 3-fold greater odds. Patients with CVD had 5-fold greater odds of in-hospital mortality, whereas those without CVD had 3-fold greater odds.

“The beneficial data on the use of phosphate binders in the general hospitalized patients with hyperphosphatemia are limited,” Dr Cheungpasitporn told Renal & Urology News. “In addition, although phosphate replacement for hypophosphatemia is suggested to be safe, there is a paucity of evidence whether correction of hypophosphatemia can improve clinical outcomes.” ■

PTH Levels Affect AVF Success Rate ELEVATED parathyroid hormone (PTH) levels may increase the risk of arteriovenous fistula (AVF) maturation failure.

Of 408 patients (mean age 57 years, 56% male) who had an AVF created for maintenance hemodialysis during 2004 to 2017 at his hospital, 59 (14.5%) experienced maturation failure, Chung-te Liu, MD, of Wanfang Hospital in Taipei, reported. These patients were more likely to have diabetes, elevated glucose, and increased PTH. On multivariable analysis, only PTH significantly correlated with maturation failure. “This finding indicates that secondary hyperparathyroidism may have a detrimental effect on successful rate of AVF creation,” Dr Liu said. “It might be helpful to lower PTH levels during CKD stages 4 to 5 to improve the AVF maturation rate.” ■

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Resistant HTN Increases Risks of CV Events, ESRD RESISTANT hypertension (RH) is associated with an increased risk of cardiovascular events and end-stage renal disease (ESRD), but not mortality, according to a study of US veterans in the Million Veteran Program (MVP).

Patients with RH had a 23%, 31%, and 144% higher risk of myocardial infarction, stroke, and ESRD, respectively, compared with patients who did not have RH, after adjusting for baseline demographics, comorbid conditions, and estimated glomerular filtration rate.

“Better BP control in patients with RH may alleviate the higher risk of MI and stroke,” the investigators, led by Csaba P. Kovesdy, MD and Adriana M. Hung, MD, at the Memphis and Nashville VA Medical Centers, respectively, concluded.

The study included 27,381 U.S. veterans with RH and a comparison group of 268,520 patients without RH. Both groups had a mean age of 61.6 years.

The RH and non-RH groups had a mean BP of 143/81 and 134/79 mm Hg, respectively.

The investigators defined RH as failure to achieve an outpatient BP

Survival Odds Better After CABG vs PCI CORONARY artery bypass grafting (CABG) is associated with a lower risk of death after initiation of dialysis compared with percutaneous coronary intervention (PCI).

In a study of 815 U.S. veterans who underwent CABG or PCI up to 5 years before dialysis initiation, Abduzhappar Gaipov, MD, of the University of Tennessee Health Science Center in Memphis, and colleagues found that the all-cause postdialysis mortality rate after CABG and PCI were 301/1000 patientyears and 436/1000 patient-years, respectively. In multivariate analysis, patients who underwent CABG had a statistically significant 28% lower risk of death from any cause compared with those who underwent PCI, Dr Gaipov’s team reported. ■

below 140/90 mm Hg with 3 antihypertensive drugs (including 1 thiazide diuretic), or success with 4 or more drugs, excluding BP when a pain score was higher than 5, when interfering

medications were prescribed, and excluding patients with confounding medical conditions.

The objective of the MVP, which is an initiative of the Department of

Veterans Affairs, is to advance precision medicine. It is currently among the world’s largest biobanks, with more than 600,000 participants from 63 VA hospitals. ■

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Dialysis Care in an Emergency: Lessons from Hurricane Harvey

BY JODY A. CHARNOW PREPAREDNESS FOR THE care of dialysis patients during disasters paid off in late August when Hurricane Harvey slammed into the Texas Gulf Coast, dropping up to 51.88 inches of rain in places and turning parts of Houston, a city of around 2.4 million people, into lakes. Patients needing dialysis were able to get it, although not necessarily at their usual dialysis center. Still, the monster storm showed that delivery of care could be improved.

A ‘work in progress’ “Our emergency preparedness program is always a work in progress,” Stephen Z. Fadem, MD, a nephrologist and medical director of DaVita Medical Center in Houston, a facility with 72 dialyzing stations, told Renal & Urology News. “With this flood, we learned that we didn’t have enough staff in the dialysis unit area to dialyze all the patients who were coming in.”

His center, one of approximately 150 DaVita dialysis centers in the path of the storm, was not flooded and did not suffer a power outage. Dr Fadem and his team dialyzed more than 500 patients over 3 days during the hurricane, including 192 patients new to the center because they could not get to the one where they usually dialyze.

“We actually had staff sleeping in the dialysis center,” he said. In the future, his center plans to rent a block of rooms at a nearby hotel the next time a major hurricane threatens the Houston area, said Dr Fadem, a clinical professor of medicine at Baylor College of Medicine in Houston.

Doctors were texting one another with regard to which roads were open or closed, he related, and this provided guidance for going to and from the DaVita Medical Center. “I took routes to work that I never traveled before,” he said.

Absence of medical records Another problem he encountered was absence of medical records. Even though patients are supposed to bring their records with them in emergency

situations such as hurricanes, flooding made it difficult to access them, he said.

“One of the biggest delays we had was that we didn’t have any information about a patient,” said Dr Fadem, who added that he spent a lot of time on the telephone trying to reach patients’ doctors and others who could provide clinical information.

He said this experience makes a case for all dialysis centers in the city

shelters and hospitals whereby patients who needed dialysis were brought to the center. “So we had a way of dialyzing patients from all over the city who needed care and weren’t able to get it because their own dialysis units were flooded, or their houses were flooded and they were rescued.” However, many individuals unaffected by flooding, and thus not in need of rescue, had difficulty getting to a dialysis cen-

Devastating flooding in the Houston area in late August caused by Hurricane Harvey challenged the ability of dialysis facilities to provide care.

to cooperate in establishing an emergency online database that contains each patient’s clinical information needed to provide dialysis.

Priority given to sickest patients Dr Fadem triaged patients based on their condition. If they had signs of fluid overload or hyperkalemia, they would be dialyzed immediately. Other patients were triaged on a first-come-first-served basis as long as they were healthy.

Hurricane Harvey also exposed problems in getting patients to dialysis centers. “We do need to figure out a better transportation system for patients,” Dr Fadem said.

Individuals rescued from flooded areas were brought to higher ground, where a bus picked them up and took them to a shelter, or a family member took them to a different place to live.

His center had an arrangement with

ter because they do not drive or have a car and the public transportation system had shut down because of severe flooding.

Dr Fadem praised DaVita, which serves 6700 dialysis patients in Houston, for providing medical supplies and support, including a “popup” pharmacy. “DaVita was outstanding in providing a pharmacy so that we had medications for these patients from the get-go,” he said. DaVita also provided a gasoline truck to provide fuel for staff vehicles.

Nephrologist Sarah Shearer, MD, of Renal Specialists of Houston and medical director for Fresenius Kidney Care Museum District in Houston, said her center, which has 24 dialyzing stations, was unaffected by flooding and did not lose power. Emergency preparations made long before the hurricane hit worked largely as intended. “We’ve

learned the hard way from previous storms and hurricanes,” Dr Shearer said.

Many patients came to the center with their emergency dialysis packets, “which made all the difference in the world,” she said. The packet contains important clinical information such as dialysis prescription, laboratory test results, hepatitis status, and disaster diet plan.

Patients arrived at her center by bus from the George R. Brown convention center and the Houston police and fire departments. In addition to providing a caravan of boats to transport patients, Fresenius brought in emergency staff to handle the added patient load.

Fresenius has 51 dialysis clinics— including 4 home dialysis clinics— in the Houston area serving 3082 patients.

Dr Shearer said she and her team started triaging on the basis of 2–3 hour treatments. “Our priority was making sure the [dialysis] chair was always full.” She gave priority to patients referred by a hospital based on objective criteria (such as the presence of hyperkalemia or congestion on an x-ray) suggesting the patients should receive dialysis “sooner rather than later.” The vast majority of patients, however, came to the center without that assessment. For these patients, she conducted a physical examination, measured interdialytic weight gain, and otherwise evaluated patients’ health status. Patients with the worse signs and symptoms—such as those with worrisome interdialytic weight gain—received priority.

Hurricane Harvey differed from other hurricanes that have hit the Houston area, she related. Weather forecasters were uncertain when the hurricane was going to hit, and when it did, it hovered over the Houston area for an unexpectedly long period.

In addition, the timing of the storm’s landfall was bad from a dialysis care standpoint. The hurricane struck on a weekend, when dialysis patients normally would have their longest time between treatments. “We need to talk to God before the next one,” Dr Shearer said. n

© KARL SPENCER / GETTY IMAGES

Staff shortages and lack of medical records surface as problems

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n SPECIAL FEATURE

Key Considerations in Selecting a Partner Physicians should attempt to learn the culture and governing structure of a potential partner

BY ROBERT PROVENZANO, MD, FACP, FASN, MARK HOVERMANN, MBA, AND LANNY TEETS

the business model that seems to be the best fit for your practice.

© MIKEY_MAN / GETTY IMAGES

Examining your partner

Editor’s note: This is the final article in a 3-part series on divesting a medical practice.

C

onsidering a new practice business model to stay competitive in today’s shifting landscape is a highly individualized decision that can have a big impact on your future. As you begin to examine different types of strategic partnerships, some options will rise to the top. It is important to continue to be thorough during the due diligence process to ensure you select the best option for you and your practice.

In part 1 of this series, we discussed how several challenges — including the shift away from fee-for-service to value-based payments — are pushing physicians to consider different business models. Part 2 outlined the various pros and cons of several options: staying independent, partnering with a hospital, partnering with a large kidney care provider and merging with another independent nephrology group. The next and often final step is to further investigate

Regardless of the business model you are considering, it is important to have a good understanding of your potential partner. Taking the following steps may help yield invaluable information as you further evaluate your options.

• Identify their leader. This is especially important when you are considering merging with another independent nephrology group, where individual personalities and experience can disproportionately impact how the organization functions.

• Identify their interests. Why is the potential partner looking to grow?

For example, in the case of a hospital, is the organization looking to merge to fill out their roster of physicians, or does it have a specific strategy for nephrology? Is their focus on chronic kidney disease or more exclusively on transplants? The answers to these types of questions can help determine whether the partner’s interests align with your priorities.

• Understand their culture. Diving deeper into a potential partner’s strategy, mission and values can help determine whether the synergy necessary for a successful partnership exists.

• Understand the governing structure.

How are decisions made? Will you, for example, have a say in quality reporting?

Understanding compensation Divesting your practice will likely bring along a change in compensation.

Payment arrangements fall along a wide

continuum — from being entirely based on productivity to 100% salary. In this era of integrated care and risk-based arrangements, it is also important to understand whether you are able to participate in the upside of meeting specified clinical and financial goals.

Of course, the purchase of your practice is also no small matter. Keep in mind that some organizations require a fair market valuation opinion. This can slow the divestiture process due to the accompanying regulatory requirements.

Regardless, consider how the purchase price will be structured. Are there incentives for staying on? Any restrictions?

Deals vary greatly so it is important to understand these details.

In addition, be wary of an offer that appears out of line with the partner’s acquisition costs. An inflated price likely comes with a lot strings attached. Look for a valuation process that is compliant, consistent and transparent.

Robert Provenzano, MD

A new frontier Historically, nephrologists had just a few options when considering business opportunities: working for a hospital, working for themselves, or merging with another nephrology group. Only recently have larger dialysis providers started employing nephrologists, and this lesser-known option warrants further examination.

Here are some issues to consider: • Motivation. Is the entity actively trying to grow nephrology and chronic kidney disease opportunities? How does this fit with their larger strategy and yours?

• Experience. Does the provider have experience managing ­practices continued on page 22

Mark Hovermann, MBA

Lanny Teets

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Point-of-Care Ultrasound May Help Detect Stones POINT-OF-CA R E u ltrasou nd (POCUS) has moderate accuracy for urolithiasis diagnosis, according to a new systematic review. While not necessarily the best option for diagnosis, it can be a useful tool for imaging symptomatic emergency department patients. Ultrasound allows faster

Partner selection continued from page 20

s­ eparate and independent from dialysis facilities? How about the management team? Do they have experience locally, regionally or nationally?

• Infrastructure. From the Meritbased Incentive Payment System (MIPS) to the Medicare Access and Chip Reauthorization Act of 2015 (MACRA), nephrologists have a lot on their plate. What technology platform do they use, and what infrastructure is available to support payment and reporting requirements?

Evolving to survive Like many industries, health care is evolving rapidly and must keep pace with new demands. The alternative — maintaining the status quo amid rapid market changes — can

Asking the right questions will help set you on a path to future success. decimate any business. Remember the Blockbuster chain? The good news is there are several viable options for nephrologists and their practices. As you consider positioning yourself for the future, it never hurts to examine your options. Indeed, it is what all healthy businesses should do. Asking the right questions will help set you on a path to future success. n Robert Provenzano, MD, is vice president for medical affairs at DaVita Kidney Care in Denver. He also is on the editorial advisory board of Renal & Urology News. Mark Hovermann, MBA, is Senior Director, Corporate ­Development, and Lanny Teets is D ­ irector, Transactions & Growth I­nitiatives, at Nephrology Practice ­Solutions.

imaging than computed tomography (CT) without ionizing radiation, and it likely costs less.

“Given equivalent outcomes in the prevailing literature, it would be reasonable to use POCUS as a first line of imaging in the evaluation of patients with suspected urolithiasis,” Samuel Lam, MD,

MPH, of the University of California, San Diego, and collaborators wrote in a paper published online ahead ofprint the Journal of Emergency Medicine.

In the review of 8 prospective and 2 retrospective studies (including 1 randomized controlled trial), the investigators found that POCUS displayed

moderate sensitivity and specificity in diagnosing kidney stones compared with intravenous pyelography and/or CT, for example. Complication rates including death, missed serious diagnoses, and hospitalization were comparable for ultrasound and CT used for initial imaging. n

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Prostate Cancer ADT May Increase Cardiac Risks ANDROGEN-deprivation therapy (ADT) for localized prostate cancer is associated with an increased risk for heart failure among men without pre-existing cardiovascular disease (CVD) and higher risks for arrhythmia and conduction disorder among ADT recipients with preexisting CVD, according to a new study.

“This study provides the basis for identifying high-risk men treated with ADT who might benefit from regular cardiac monitoring and lifestyle modification recommendations,” Reina Haque, PhD, MPH, of Kaiser Permanente Southern California in Pasadena, and colleagues concluded in

a report published in the British Journal of Cancer (2017;117:1233-1240).

The investigators prospectively studied 7637 men with newly diagnosed with localized prostate cancer from 1998 to 2008 and followed up through 2010. Of these, 30% had received ADT. Compared with men not exposed to

ADT, ADT recipients without preexisting CVD had a significant 81% increased risk of heart failure, after adjusting for potential confounders.

ADT recipients with pre-existing CVD had a significant 44% increased risk of arrhythmia and 3-fold increased risk of conduction disorder. n

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Urinary Stone Risk Higher In Wetter Climates GREATER PRECIPITATION, and not just higher temperatures, in a region may place its residents at increased risk for urinary stone disease, investigators concluded.

In a study of 63,994 patients who underwent stone procedures in California from 2010 to 2012, Kai B.

Dallas, MD, of Stanford University School of Medicine in Stanford, California, and colleagues found that each 1-inch increase in rainfall was associated with an average of 0.019 surgeries per 1000 persons, according to a report published online ahead of print in the Journal of Endourology.

Each 1-degree Fahrenheit increase in mean temperature was associated with an average of 0.029 surgeries per 1000 persons, according to the researchers.

For the study, Dr Dallas’ group extracted data from the California Office of Statewide Health Planning and Development databases. They

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obtained climate information from the National Oceanic and Atmospheric Administration. They used patients’ zip codes to map their county of residence.

The investigators explained that a landmark study characterizing stone prevalence in the United States established the concept of a “stone belt.” The

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study, published in Kidney International (1994;46:893-899), demonstrated an increasing prevalence of urinary stone disease moving from north to south and west to east. “Many have interpreted the stone belt maps to support the conclusion that higher temperatures are associated with increased risk of stone disease,” the authors wrote. “This is postulated to occur secondary to insensible water loss from perspiration,

which leads to dehydration, urine concentration, and urine supersaturation.”

They pointed out, however, that higher temperatures do not fully explain the stone belt phenomenon.

“If temperature alone was the primary environmental driving factor, the American Southwest should have a similar stone prevalence to the Southeast.”

The researchers postulate that the increased urinary stone burden found

INJE17DDBH7224_JournalAd_INFUSING_Asize_BS_r4.indd 3

in warmer places with higher precipitation could be related to increase inefficiency of human body thermoregulation in wet versus dry heat, “leading to greater insensible fluid losses.”

In a discussion of study strengths, Dr Dallas and colleagues noted that California is a large state with multiple microclimates, “making it an ideal region to explore the impact of climate variation on urinary stone disease.” In

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addition, they controlled for countylevel patient intrinsic urinary stone factors, such as median age, sex, and prevalence of obesity and diabetes mellitus.

With regard to study limitations, the investigators noted that they could not fully account for climate variation within a county. In addition, patients’ reported zip code may not reflect where they actually live or spend most of their time. ■

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BPH ‘Aquablation’ Better for Sexual Function AN EXPERIMENTAL treatment called “Aquablation,” which uses highpressure waterjets to ablate prostate tissue, is associated with better sexual function outcomes compared with transurethral resection of the prostate (TURP) in men with moderate-tosevere lower urinary tract symptoms in

men with benign prostatic hyperplasia, ­researchers reported at the Sexual Medicine Society of North America annual meeting in San Antonio, Texas.

The novel procedure provides TURPlike results but with a lower risk of ejaculatory dysfunction and significantly improved overall sexual satisfaction

compared with TURP. Aquablation showed superior efficacy compared with TURP in men with large prostates (50 to 80 mL).

In a randomized, blinded phase 3 trial, Mohamed Bidair, MD, from San Diego Clinical Trials and a clinical professor at the University of

California, San Diego, and colleagues compared 117 men treated with robotically-assisted waterjet ablation and 67 who underwent TURP with standard electrosurgery. At baseline, the Aquablation and TURP groups were similar with respect to mean scores on the International Prostate Symptom Score (IPSS) question (22.9 and 22.2, respectively), mean prostate volume (54 and 52 mL, respectively), and demographic factors. Operative times were equivalent for the Aquablation and TURP groups (32.8 and 35.5 minutes, respectively), but mean resection time was significantly lower in the Aquablation group (4 vs 28 minutes).

Risk of retrograde ejaculation is lower than with TURP, researchers report.

The primary safety endpoint (ClavienDindo grade 1 persistent or grade 2 or higher event in the first 3 months) occurred in 29 Aquablation recipients (25%) versus 26 TURP patients (40%).

The difference in the primary endpoint safety rate was driven primarily by retrograde ejaculation. Among the men who were sexually active at both baseline and study visits, persistent retrograde ejaculation in the first 6 months occurred in 8 Aquablation patients (11.3%) and 16 TURP patients (36.4%). According to the investigators, the upper confidence limit was less than zero, demonstrating superiority of Aquablation versus TURP. Among men who were sexually active at both baseline and study visits, the quality and quantity of ejaculate, as measured by the Male Sexual Health Questionnaire-EjD, increased slightly but not significantly from baseline levels in the Aquablation patients, but decreased significantly by about 2 points in the TURP group. The International Index of Erectile Function (IIEF-5) showed no change in erection quality from baseline in either group. At 6 months, the Aquablation and TURP groups had similar decreases in mean scores on the International Prostate System Score (IPSS) questionnaire (−16.9 vs −15.1 points). In a subgroup of patients with a prostate volume of 50 to 80 mL, the Aquablation group had a significantly greater decline in mean IPSS score than the TURP group (−17.4 vs −13.3 points). n

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Overuse of PCa Scans May Be Easing Efforts to curb inappropriate use of radiologic imaging for initial disease staging could be paying off published in the Journal of Urology (2011;185:1645-1649), found that 36.2% of men diagnosed with low-risk PCa underwent imaging studies.

Downward trend explained Speaking on behalf of the AUA, Matthew J. Resnick, MD, MPH, Assistant Professor of Urologic Surgery and Health Policy at Vanderbilt University Medical Center in Nashville, Tennessee, said ample evidence suggests overuse of imaging for low-risk PCa, but the magnitude of overuse appears to be declining. Reasons for this trend, he said, include development and diffusion of clinical practice guidelines discouraging radiologic imaging for low-risk PCa, as well as initiatives such as the Choosing Wisely campaign, which aim to promote discussions centered on the use of low-value health care services. “Importantly, however, as we continue to learn more about the indolent natural history of low-risk prostate cancer, both providers and patients have become increasingly comfortable withholding imaging,” Dr Resnick said.

The Choosing Wisely campaign is an initiative of the ABIM Foundation.

As part of the campaign, AUA in 2013 included in a list of commonly used tests and treatments of questionable value a statement that a routine bone scan is unnecessary for men with low-risk PCa. The 2017 AUA guidelines for managing low-risk and very-low-risk localized PCa state that clinicians should not perform abdomino-pelvic CT or routine bone scans. In a paper titled “Challenges and Recommendations for Early Identification of Metastatic Disease in Prostate Cancer,” which was published in Urology (2014;83:664-669), members of the Prostate Cancer Radiographic Assessments for Detection of Advanced Recurrence (RADAR) Group recommended against radiologic scanning for newly diagnosed low-risk patients and most intermediate-risk patients.

The Michigan experience In some places, overuse of imaging for low-risk PCa declined following interventions to discourage it. For example, earlier this year, researchers reported on a study of men with newly diagnosed low-risk PCa in Michigan showing that the proportion of those

© DR. P. MARAZZI / SCIENCE SOURCE

BY JODY A. CHARNOW STUDIES PUBLISHED in the past few years have documented overuse of radiologic imaging, such as bone and computed tomography (CT) scans, for the initial staging of low-risk prostate cancer (PCa), but the findings of most studies were based largely on data captured up to a decade or more ago. Since then, a growing body of evidence has led to widespread acceptance that lowrisk prostate tumors rarely lead to metastatic disease, and most patients with these tumors do not require treatment.

Responding to the research, physician organizations, such as the American Urological Association (AUA), have updated clinical practice guidelines to discourage radiologic imaging in patients with low-risk PCa. Although contemporary data on physician use of radiologic imaging for these patients are sparse, some evidence points to a downward trend. For example, a study of men diagnosed with PCa from 2004 to 2011 within the Colorado and Northwest regions of Kaiser Permanente found 35% of men with low-risk disease received non-indicated imaging at diagnosis. Compared with men diagnosed in 2004, however, those diagnosed in 2011 had 70% reduced odds of receiving non-indicated imaging at diagnosis, investigators reported in the Journal of Oncology Practice (2017;13:e441-e450).

Some urology thought leaders believe overuse of radiologic imaging for low-risk PCa is declining. Neal D. Shore, MD, president of the Large Urology Group Practice Association and Director, CPI, Carolina Urologic Research Center in Myrtle Beach, South Carolina, said he has not seen recent trend data on inappropriate radiologic imaging for low-risk PCa, but noted: “My expectation is that it’s decreased substantially. I’m not aware that it’s still a significant issue. The evidence-based literature is pretty clear on the lack of need to get [radiologic imaging] for patients with low-risk disease.”

Jim C. Hu, MD, MPH, of Weill Cornell Medical College in New York, who led a study showing widespread overuse of radiologic imaging for lowrisk PCa based on 2004–2005 data, said an analysis of more recent data likely would show a decrease in the overuse of bone scans and CT scans. His study,

Clinical guidelines discourage radiologic imaging of men with low-risk prostate cancer.

who received inappropriate bone scans and CT scans decreased from 11% and 14.7%, respectively, in 2012–2013 to 6.5% and 7.7%, respectively, in 2015 following implementation of statewide interventions designed to improve imaging utilization for PCa staging.

The findings, published in the Journal of Urology (2017;197:1222-1228), are from an analysis of data from 10,554 patients in the Michigan Urological Surgery Improvement Collaborative registry. The collaborative comprises 42 diverse practices representing 85% of the urologists in Michigan.

Evidence suggests that provider factors such as intuition, experience, and medicolegal concerns as well as patient preference play key roles in driving the provision of low-value care, Dr Resnick said. “Financial incentives underlying the current health care system fail to discourage the delivery of imaging overuse from either the patient or provider perspective,” Dr Resnick said.

“Nonetheless, as we transition to health care accountability and continue to assume increasing financial risk for the care we deliver, financial incentives will likely re-orient clinical practice towards minimizing overuse.”

Emergence of MRI Meanwhile, amid hints and predictions of a decline in overuse of radiologic imaging for patients with low-risk PCa, magnetic resonance imaging (MRI), especially multiparametric MRI (mpMRI), appears to be emerging as a useful tool for managing this patient population. Dr Shore said he is ­starting to see a significant increase in the use

of MRI for patients who have had a forcause biopsy that was negative, but may require a second biopsy because of continued concern about the presence of cancer. “The evidence for using MRI is particularly good in that patient population,” he said.

Dr Hu said he believes MRI use will increase in part because of wider adoption of active surveillance as a management strategy for low-risk PCa. By enabling more accurate risk stratification, MRI can aid in the appropriate selection of men for active surveillance. After men are placed on active surveillance, MRI can be used to look for changes in cancerous tissue over time and to assist in deciding whether to perform repeat biopsy to monitor for cancer upgrading and upstaging. Dr Hu noted that during the 2004–2005 period looked at in his study, “MRI just was not that good for localizing and staging prostate cancer at that time.”

In addition, he predicts clinicians will order MRI scans more frequently prior to a first biopsy in men who have abnormal PSA values or digital rectal examination findings, with the goal of identifying suspicious lesions for a targeted biopsy. This approach has the potential for reducing the number of unnecessary prostate biopsies, as suggested by the PROMIS study.

According to findings published in Lancet (2017;389(10071):815-822), the use of mpMRI in men with elevated PSA might allow 27% of men to avoid primary biopsy and decrease the diagnosis of clinically insignificant cancer by 5%. n

28 Renal & Urology News

NOVEMBER/DECEMBER 2017

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Practice Management A

lthough medical practices typically focus on billing and collections to maintain and increase income, they should not forget about reducing what they pay for pharmaceuticals, medical supplies and equipment, and other aspects of running a practice.

“For every dollar you bill, you get back 50 cents, but for every dollar you save, you get a dollar,” said Chris Zaenger, principle at Z Management Group Ltd., in Elgin, Illinois.

Zaenger said he got involved with helping doctors cut costs years ago when working with a large physician’s office that did some of its own lab work and contracted out the rest. The doctors billed patients and the lab billed the doctors. The doctors then paid the lab for the tests. He found many mistakes.

He went through 3 months of bills and found $30,000 in missed charges on $100,000 worth of labs. He also found incorrect lab codes and charges on the lab’s bill for tests not ordered.

“Clinical costs are going up in virtually every practice, and there is opportunity to save money on those costs,” Zaenger said. “One of the biggest areas where doctors have problems that can get away from them is clinical supply costs.”

If multiple vendors supply a certain medication, practices should shop around

preparations for urinary incontinence, for example, changes frequently, Zaenger noted, so it is important to track. If the cost goes up quarterly and payers are charged the same rate for a few years, a practice can go from making 20% over cost to 20% under, he said. Practices can get an idea of costs charges using the Centers for Medicare & Medicaid Services (CMS) website, which publishes the amount CMS pays for medications regularly. Expensive medications like botulinum toxin should be turned over quickly to keep carrying costs down, Zaenger said. Physicians need to pay attention to pharmaceutical expiration dates, rotation of stock, and spoilage, he said. Some practices have an inventory management program to do this, but most will probably have to track inventory manually. Practices should never let pharmaceutical vendors into their inventory, as vendors’ drugs tend to get moved to the front of the inventory area and competitors’ drugs are shifted to the back where they expire, Zaenger said.

Inventory control Debra Phairas, president of San Francisco’s Practice & Liability Consultants LLC, stresses creation of an inventory control standard for supplies. For example, practices need to decide how

‘Clinical costs are going up in virtually every practice, and there is opportunity to save money on those costs.’ to find less expensive alternatives, such as generics, or to identify a competing vendor (which is not always possible) or group purchasing organization that sells it at a lower price, he said.

Practices need to keep up with costs. The price of botulinum toxin

On The Web

much of a supply they need (say, 3 cases of cotton balls) and at the end of the month, take inventory and order only up to the control standard.

Practices also should look at how many different types of a certain supply are being stocked and whether

© RAPIDEYE / GETTY IMAGES

Shopping around for less costly drugs and buying used medical supplies and equipment can boost the bottom line BY TAMMY WORTH

Buying used office furniture is among the ways medical practices can save money.

this can be winnowed down to reduce inventory. For instance, it may be necessary to keep a supply of gloves in different sizes, but not in different colors.

Group purchasing Taking part in group purchasing organizations or buying through associations is another way to cut costs. For instance, a benefit of joining the Association of Independent Doctors is its AID-SAVE program with McKesson Corp., of San Francisco, a distributor of medical supplies and pharmaceuticals. The program offers discounts upwards of 15% on supplies.

Various national and state associations—including the California Medical Association—have negotiated discounted rates on everything from supplies and equipment to liability insurance and waste disposal. These organizations typically offer a better deal, but practices should look over contracts before joining, Zaenger said.

Some require physicians to use only certain product lines or purchase only through that organization.

Second-hand goods In addition, practices may want to consider used furniture and office and medical equipment. On numerous websites, including dotmed.com and Ebay, furniture and equipment can be purchased at half price or more, Phairas said. Ebay even offers a money-back guarantee if equipment does not work. Companies going out of business want to unload their furniture and equipment, and they often try to sell it on Ebay. Phairas paid $300 for a conference table and desk and $200 for lateral files that would have cost about $700 and $500 new, respectively.

Other cost-saving strategies Clinical supplies, malpractice, furniture and equipment are but a few places to save. Other target areas, Zaenger said, include telephone service, biohazardous waste disposal, and staff expenses—from paid time off and overtime, to insurance benefits, retirement plan contributions, and time-clock management. ■ Tammy Worth is a freelance medical journalist based in Blue Springs, MO.

Want to improve your practice? Look for our tips on how to handle equipment issues, adjust to EHRs, comply with HIPAA, and more at www.renalandurologynews.com/practice.