Renal & Urology News - Nov/Dec 2019 Issue

NOV EMBER/DECEMBER 2019

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VOLUME 18, IS SUE NUMBER 6

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Adjuvant RT for PCa Shows No Benefit

© PHANIE / BURGER / MEDICALIMAGES.COM

Findings support delaying radiotherapy until biochemical recurrence after radical prostatectomy

RADIOTHERAPY AFTER RP for high-risk prostate cancer may be unnecessary.

BY JODY A. CHARNOW RADIATION THERAPY (RT) following radical prostatectomy (RP) for highrisk localized prostate cancer offers no advantage in terms of biochemical recurrence compared with delaying radiation therapy until development of biochemical recurrence, study findings presented at the European Society for Medical Oncology (ESMO) annual congress in Barcelona, Spain, show.

Consequently, many men will be able to avoid the adverse effects of radiotherapy, which include urinary incontinence and urethral stricture, according to investigators.

The study, RADICALS-RT, is the largest trial to date looking at postoperative radiotherapy for prostate cancer.

Immunotherapy May Up AKI Risk Early ADT

BY NATASHA PERSAUD of sustained AKI occurred a mean Use After RP ACUTE KIDNEY injury (AKI) com- 106 days after checkpoint inhibitor monly occurs in patients taking initiation.

Challenged immune checkpoint inhibitors to treat Patients received either a CTLA-4 cancer, a new study shows.

In an analysis of 1016 patients who received checkpoint inhibitor therapy during 2011 to 2016 at Massachusetts General Hospital in Boston, 17% experienced any AKI within 12 months of initiating an inhibitor, 8% had sustained AKI lasting 3 days or longer, and 3% had AKI potentially related to immune checkpoint inhibitor use, Meghan Sise, MD, MS, of Massachusetts General Hospital, and colleagues reported in the Clinical Journal of the American Society of Nephrology. The first episode

inhibitor (ipilimumab), PD-1 inhibitor (pembrolizumab, nivolumab) or a PD-L1 inhibitor (atezolizumab, avelumab, durvalumab), with only a few receiving a combination of CTLA-4 or PD-1 (ipilimumab and nivolumab).

Among confirmed inhibitor-related AKI cases, 80% of stage 1 AKI occurred in patients receiving PD-1 inhibitors, whereas 56% of stage 3 AKI occurred in patients receiving ipilimumab. Among cases potentially related to immune checkpoint inhibitors, 73% of stage 1 AKI occurred in patients continued on page 8

BY JOHN SCHIESZER FINDINGS FROM a recent study challenge the early use of androgen deprivation therapy (ADT) for men who experience biochemical recurrence of prostate cancer following radical prostatectomy (RP).

“We found that the median overall survival and metastasis-free survival from time of diagnosis of prostate cancer is quite long in men with biochemically recurrent prostate cancer and is comparable to the overall survival estimated in contemporary clinical trials,” lead investigator Catherine Handy Marshall, MD, of Johns Hopkins University School of Medicine in Baltimore, told Renal & Urology News. “Early ADT, at time of biochemical relapse, does not clearly prolong overall survival or improve quality of life, and when to start this therapy is still a matter of debate.”

Dr Handy Marshall’s team retrospectively studied 2930 men with a median age of 61 years and median follow-up continued on page 8

It enrolled 1396 patients following RP from the United Kingdom, Denmark, Canada, and Ireland. Investigators randomly assigned patients to receive postoperative RT or the standard approach with observation, with RT an option if patients experienced PSA failure, defined as a post-RP PSA level of 0.1 ng/mL or higher or 3 consecutive PSA rises.

At a median follow-up of 5 years, biochemical progression-free survival rates were 85% in the RT group and 88% in the observation arm, a difference that was not statistically significant, the investigators reported. The RT group also had a significantly higher proportion of patients who had Radiation Therapy Oncology continued on page 8

IN THIS ISSUE 2

Some RCC surgery cases require follow-up beyond 5 years

4

New study supports use of renal mass biopsies before surgery

10

Q&A: Genetic testing has a role in PCa active surveillance

11

Transperineal prostate biopsies found to be safer

15

Bladder cancer linked to higher intake of stewed or roasted meat

20

Kidney stone history predicts worse PCI outcomes

20

Elevated levels of IGF-I and free testosterone up PCa risk

Vitamin K may be a promising therapy for calciphylaxis.

PAGE 13

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Longer Follow-Up After RCC Surgery May Be Needed PATIENTS WHO undergo surgery for intermediate- and high-risk renal cell carcinoma (RCC) should be followed up beyond 5 years because the risk of recurrence remains significant, according to investigators.

Existing guidelines for the follow-up of patients after surgery for ­intermediate-

and high-risk disease are based on wellestablished risk-stratification models that provide clear and structured 5-year postoperative surveillance plans, Marcus L. Jamil, MD, of the Vattikuti Urology Institute at Henry Ford Health System in Detroit, and colleagues stated in European Urology. No clear

instructions exist for follow-up beyond 5 years, with postoperative surveillance left to physicians’ discretion, they noted.

In a post-hoc analysis of the ASSURE trial, Dr Jamil’s team found that the major drop in recurrence occurs when patients have been recurrence-free for 2 years following surgery. After that time,

the risk remains virtually stable, even 5 years from surgery.

“This implies that immediate postoperative recurrence estimates do not reflect the risk of recurrence after a certain period of postoperative survivorship and that this immediate postoperative risk is not adequate in providing both

www.renalandurologynews.com NOVEMBER/DECEMBER 2019

the physician and the patient with the necessary information for counseling on long-term follow-up,” the authors wrote.

Recurrence developed in 730 of the 1943 patients in the original cohort. The 36-month cumulative incidence of recurrence was 31% from the time of surgery. The cumulative incidence changed to 26.0% for patients who did not have recurrence at 12 months from surgery, 18.8% at 24 months, 16.1% at 36 months,

18.9% at 48 months, and 20.3% at 60 months, the investigators reported.

In addition, at 0 months from surgery, age, pathologic T3/4 stage, pathologic N1/2 stage, and Fuhrman grades 3 and 4 independently predicted recurrence.

None of these variables predicted ­recurrence at 60 months, according to the researchers.

Dr Jamil’s team noted that their highly selective patient population—

those with intermediate- and high-risk disease with negative surgical margins—is an important limitation. In addition, they stated that their study “can only provide a diagnostic benefit and not any insight into any potential therapeutic benefit.”

“Larger prospective studies are still required to identify the optimal surveillance protocol and duration of follow-up,” the authors concluded. “This

Renal & Urology News 3

will become increasingly important as ­future trials assess the benefit of adjuvant immunotherapy.”

The ASSURE trial was a randomized, double-blind, placebo-controlled phase 3 trial comparing disease-free survival among patients with i­ntermediateto high-risk RCC (T1b or greater).

Investigators randomly assigned p ­ atients to receive adjuvant sunitinib, sorafenib, or placebo following surgical resection. ■

4 Renal & Urology News

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Renal Mass Biopsy Does Not Up Postop Problems RENAL MASS BIOPSY (RMB) prior to nephrectomy does not influence the risk of postoperative complications and markedly reduces the likelihood that patients with benign masses are taken to surgery, according to a new study.

Christopher J.D. Wallis, MD, of the University of Toronto, and colleagues

compared 1663 patients who underwent RMB prior to nephrectomy (679 partial nephrectomy [PN] and 984 radical nephrectomy [RN]) with 23,718 patients who underwent nephrectomy (5499 PN and 18,219 RN) without prior RMB. Multivariate analysis revealed no significant association between RMB and

aggregate postoperative complications, according to the investigators. The median operative time was significantly longer for patients who underwent RMB prior to surgery (PN patients: 5.3 vs 4.8 h; RN patients: 5.2 vs 4.8 h), Dr Wallis and his collaborators reported in European Urology.

Further, RMB recipients were significantly more likely to have cancer found on final histology (PN patients: 84% vs 62%; RN patients: 70% vs 58%), according to the investigators.

RMB was not associated with rates of mortality, operative and nonoperative interventions, hospitalization, or emergency department visits among patients who underwent PN, but among patients who underwent RN, RMB recipients were more likely to require a percutaneous drain insertion or hospitalization, Dr Wallis and his collaborators reported.

Study limitations included selection bias because the underlying reason for biopsy could not be assessed; lack of surgical details; and lack of radiographic data, including renal mass size, location, and complexity.

“Although renal mass biopsy can produce some very minor scarring and in very rare instances can result in hematoma which could increase surgical difficulty, any surgeon who ­operates on

The procedure was associated with a small increase in nephrectomy time. patients following renal mass biopsy will attest to the fact that in the vast majority of cases it is difficult to detect a noticeable difference in surgical difficulty level for patients who were previously biopsied,” said Alexander Kutikov, MD, who has conducted research on the use of RMB but was not involved in the new study.

As the authors noted, the differences likely stem from a case-mix of patients who did and did not undergo RMBs, he said. Indeed, the 22% of patients who harbored benign masses and thus did not have surgery in the RMB group were much more likely to have a quicker operation than patients with an aggressive tumor, said Dr Kutikov, Chief of the Division of Urologic Oncology at Fox Chase Cancer Center and Professor of Surgical Oncology at Temple University Health System in Philadelphia.

Furthermore, he said, the selection bias acknowledged in the new report is consistent with recent data from Canada that underscores heterogeneous practice patterns with regard to RMB use at various Canadian Centers. ■

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Renal & Urology News 5

FROM THE MEDICAL DIRECTOR EDITORIAL ADVISORY BOARD 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, PhD, MPH Professor & Chief Division of Nephrology & Hypertension UC Irvine School of Medicine Orange, CA

Nephrologists

Urologists

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

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

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

R. John Honey, MD Head, Division of Urology, Endourology/Kidney Stone Diseases St. Michael’s Hospital University of Toronto Stanton Honig, MD Department of Urology Yale University School of Medicine New Haven, CT J. Stephen Jones, MD Chief Executive Officer Inova Health System Falls Church, VA Professor and Horvitz/Miller Distinguished Chair in Urologic Oncology (ret.)

Cleveland Clinic Lerner College of Medicine Cleveland Jaime Landman, MD Professor of Urology and Radiology Chairman, Department of Urology UC Irvine School of Medicine Orange, CA

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 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. Denver

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

Rulan Parekh, MD, MS Associate Professor of Pediatrics and Medicine University of Toronto Robert Provenzano, MD Chief, Section of Nephrology St. John Hospital and Medical Center Detroit

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

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

Renal & Urology News Staff Editor Web editor Production editor Group creative director, medical communications Production manager Vice president, sales operations and production Director of audience insights National accounts manager Associate director, editorial services

Jody A. Charnow Natasha Persaud Kim Daigneau Jennifer Dvoretz Brian Wask Louise Morrin Boyle Paul Silver William Canning Lauren Burke

Basic Science: The Tail That Wags the RCC Dog

I

recently had reason to survey the progress made in renal cell cancer (RCC) over the last 70 or more years. In 1950, a patient who presented with metastatic RCC had a 0%-5% overall response rate (ORR) to the therapies of the time, with an anticipated overall survival (OS) of approximately 10 months. By 2005, those numbers had changed marginally, signifying no progress in more than 60 years despite honest efforts.

Although the introduction of more effective therapies stagnated, scientists toiled tirelessly to understand the genetics and subsequent pathways of this highly angiogenic and immunogenic cancer, so that after the turn of the millennium, novel therapies were ready for clinical testing. Since 2005, dozens of treatments have been tested and approved after hundreds of trials involving thousands of patients.

The results are nothing less than staggering. In the span of 14 years and after a sustained period of what I call “progresslessness,” there has been a nearly 10-fold increase in ORR and 5-fold improvement in median OS survival. These results over such a short period of time are on par with breakthrough discoveries in medical sciences that our physician predecessors lived through, including development of vaccines and antibiotics.

It may be easy to dismiss the progress made in treatment when facing a patient whose disease marches on despite these therapies, but one should keep in mind the new therapies that have come along to fight cancer pioneered by basic scientists in the kidney cancer space, including monoclonal antibodies against VEGF; tyrosine kinase inhibitors; mTOR inhibitors; checkpoint inhibitors; and oral inhibitors of hypoxia inducible factors. Basic science has converted the most recalcitrant of all advanced urologic tumors to among the most treatable, and in so doing is causing a frame shift in the management of many solid malignancies. Today, these agents meaningfully slow and occasionally cure disseminated disease, bending previously dismal survival curves on our way to converting cancer to a chronic disease state.

It has been said that science is an endurance sport as there are decades where nothing happens followed by moments where decades happen. We should be no less astonished by the pace of progress than the physicians 80 years ago administering penicillin for the first time to bacteremic patients. The survival curves are bending downward at long last and physicians have a front row seat.

Vice president, content, medical communications Kathleen Walsh Tulley General manager, medical communications President, medical communications Chairman & CEO, Haymarket Media Inc.

James Burke, RPh Michael Graziani Lee Maniscalco

Renal & Urology News (ISSN 1550-9478) Volume 18, 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.

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without the prior written permission of Haymarket Media, Inc. Copyright © 2019.

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

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Contents

NOVEMBER/DECEMBER 2019

Urology 9

ONLINE

11

this month at renalandurologynews.com Clinical Quiz Test your knowledge by taking our latest quiz at renalandurologynews.com/ run-quiz

16

18

HIPAA Compliance Read timely articles on various issues related to keeping protected health information secure.

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

PCa Salvage Combo Benefits Confirmed Adding short-term androgen suppression to radiotherapy in men with rising PSA after radical prostatectomy prolongs progressionfree survival vs radiotherapy alone.

Testosterone Therapy Increases VTE Risk Testosterone therapy is associated with 2-fold increased odds for venous thromboembolism in men with or without hypogonadism.

12

Intradialytic Hypotension, PAD Linked The presence of IDH in 30% or more of hemodialysis sessions is significantly associated with a 36% increased risk of peripheral artery disease in an adjusted analysis.

13

LDK Transplant Rate Declining Among Women From 1998-2000 to 2016-2018, the overall rate of live kidney donor transplantation among women declined from 41.9% to 36.7%.

13

News Coverage Visit our website for daily reports on the latest developments in clinical research.

Transperineal PCa Biopsy May Be a Safer Approach Transrectal and transperineal prostate biopsies have similar cancer detection rates, but the transperineal approach is associated with a lower rate of infection-related complications.

VOLUME 18, ISSUE NUMBER 6

CALENDAR 2020 Annual Dialysis Conference Kansas City February 8–11 Genitourinary Cancers Symposium San Francisco February 14–16 European Association of Urology Annual Congress 2020 Amsterdam, The Netherlands March 20–24 National Kidney Foundation 2020 Spring Clinical Meetings New Orleans March 25–29 American Urological Association Annual Meeting Washington, DC May 15–18 ERA-EDTA 57th Congress Milan, Italy June 6–9

Nephrology

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

Low RCC Recurrence Rate Found With RPN Only 8 (2.9%) of 269 patients found to have renal cell carcinoma after robotic partial nephrectomy had recurrence after a median follow-up of 31 months.

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Vitamin K Found to Ease Calciphylaxis The first randomized controlled trial of a calciphylaxis treatment showed that vitamin K therapy was associated with a decreased risk of death and reductions in pain and lesion size.

Post-Tx Gout May Worsen Outcomes New-onset gout among kidney transplant recipients increases the risk of transplant complications and return to maintenance hemodialysis, new data show.

Caution against hyponatremia may be needed in SSRI users, especially among those with

concurrent thiazide diuretic use.

See our story on page 13

24

Departments 5

From the Medical Director Today’s kidney cancer therapies are a tribute to basic science research

9

News in Brief Opioid drugs for postvasectomy pain are likely unnecessary

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Ethical Issues in Medicine Conflict of interest disclosures are crucial to professional integrity

24

Practice Management Patient engagement staff can improve healthcare delivery

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Adjuvant RT for PCa continued from page 1

Group grade 3/4 urethral stricture at any time (8% vs 5%) and reported urinary incontinence at 1 year (5.3% vs 2.7%).

“The results suggest that radiotherapy is equally effective whether it is given to all men shortly after surgery or given later to those men with recurrent disease,” first author Christopher C. Parker, MD, of The Royal Marsden NHS Foundation Trust and Institute of Cancer Research in London, said in an

Immunotherapy, AKI risk continued from page 1

receiving PD-1 inhibitors, while 60% of stage 3 AKI occurred in patients receiving ipilimumab. In all, 4 patients required dialysis. Results were not significant. Potential checkpoint inhibitorrelated AKI was based on subspecialist evaluation, unexplained sustained AKI concurrent with another immunerelated adverse event, or kidney biopsy.

Previous research has shown that acute interstitial nephritis (AIN) is the most common biopsy-proven diagnosis in patients on checkpoint inhibitors who develop AKI. The American Society of Clinical Oncology guidelines recommend interrupting checkpoint inhibitor therapy and evaluating any patient whose serum creatinine rises

Early ADT challenged continued from page 1

of 10 years. Metastasis developed in 595 men (20%), and all of them received ADT. As measured from the time of RP, median metastasis-free survival (MFS) for the entire study population was not reached, she and her colleagues reported in a poster presentation at the European Society for Medical Oncology’s 2019 Congress in Barcelona, Spain. In the metastasis-only group, median MFS was 6 years. Median overall survival for the study population as a whole was 21 years.

“We did this retrospective analysis because 3 recent clinical trials [PROSPER, SPARTAN, and ARAMIS] showed improvement in MFS for men with non-metastatic castration resistant prostate cancer treated with novel anti-androgens,” Dr Handy Marshall said. “We were interested in this because those trials, and the nonmetastatic c­astration-resistant state, result from the non-­validated initial implementation of ADT for biochemically recurrent prostate cancer.”

ESMO press release. “There is a strong case now that observation should be the standard approach after surgery and radiotherapy should only be used if the cancer comes back.”

In a separate presentation, investigators presented the results of the ARTISTIC meta-analysis of 3 randomized trials—including the RADICALS-RT trial—that confirm the findings of Dr Parker and his team.

The meta-analysis looked at data from 2151 men across the 3 trials. Of these, 1074 and 1077 patients were randomly

assigned to receive adjuvant RT and early salvage RT, respectively. The meta-analysis found no statistically significant difference between the adjuvant RT and salvage RT arms with respect to PSA-driven event-free survival.

“Results of the ARTISTIC meta-analysis confirm those of RADICALS, and provide greater evidence to support the routine use of observation and early salvage therapy,” first author Claire Vale, PhD, of University College London, stated in the same release.

Commenting on the new findings, Xavier Maldonado, MD, of Hospital Universitari Vall d’Hebron in Barcelona, observed: “These are the first results to suggest that postoperative radiotherapy for prostate cancer could be omitted or delayed in some patients. This will shorten the duration of treatment for these patients and allow better use of resources since today’s radiotherapy is technically sophisticated and therefore expensive. However, strict followup will be needed to identify patients requiring salvage radiotherapy.” ■

1.5-fold above baseline (i.e., stage 1 or higher AKI).

The investigators also examined use of concomitant medications that may cause AKI. Proton pump inhibitor (PPI) use at baseline was associated with a 2.85-fold higher risk for s­ ustained AKI. By comparison, immune checkpoint inhibitor use was associated with a 2.2fold higher risk.

“As the clinical spectrum of checkpoint inhibitor use continues to grow, the study of associated toxicities becomes increasingly important,” Dr Sise and colleagues commented.

c­ heckpoint inhibitor-acute interstitial nephritis. Accurately diagnosing these events may sometimes require kidney biopsy. In this cohort, mean estimated ­glomerular ­filtration rate (eGFR) at

receiving immunotherapy for cancer,” Dr Sise said in an American Society of Nephrology news release. “We believe that nephrologists are going to be increasingly called upon to determine the cause of AKI in patients on immune checkpoint inhibitors, and making an accurate diagnosis has huge implications for therapy for a patient’s cancer treatment going forward.”

In an editorial accompanying the new report, Christopher Carlos, MD, MAS, and Raymond K. Hsu, MD, MAS, of the University of California, San Francisco, commented that the study “represents a significant step forward in the field of immune checkpoint inhibitor-associated nephrotoxicity and in onconephrology in general.” They agreed that certain questions about diagnosis and management still need to be answered. ■

Diagnosis may require biopsy According to the investigators, there are neither consistent symptoms nor urinary findings to facilitate a non-­ i nvasive diagnosis of immune Kevin Courtney, MD, PhD, Associate Professor of Internal Medicine in the Division of Hematology/Oncology and Co-Leader of the Genitourinary Oncology Disease Oriented Team at the University of Texas Southwestern

New study shows ADT can be delayed safely in men with BCR after surgery.

Medical Center in Dallas, said 81% of the men in this study had low- or intermediate-risk disease, which may need to be taken into account in future analyses. Various studies have looked at whether ADT should be started in patients with biochemical recurrence in the absence of tumor.

Consistent with previous research “This [study] shows you can safely delay ADT in men with biochemical recurrence after prostatectomy. That

Checkpoint inhibitor use was associated with a 2.2-fold higher risk of AKI. baseline was 82 mL/min/1.73 m2, and very few patients had an eGFR less than 30 mL/min/1.73 m2.

“It is important for nephrologists and oncologists to recognize the incidence and factors that associate with AKI and checkpoint nephritis in patients

is consistent with what has been found in previous work. However, there are challenges in extrapolating these findings to patients with nonmetastatic castration-resistant prostate cancer (M0 CRPC).”

Paul Mathew, MD, a genitourinary oncologist at Tufts Medical Center in Boston, said the findings of Dr Handy Marshall’s group are relevant, but he is concerned that the men in the study may not be biologically comparable to the men who participated in the trials of novel antiandrogens. “It is difficult to know if these populations are equivalent,” Dr Mathew said. “There is probably a subgroup of patients with BCR [biochemical recurrence] for whom early implementation of ADT would impact overall survival favorably, but this is likely to be a small fraction of the overall population for which we do not have reliable tools for definition.”

Clinicians already are concerned about using the novel antiandrogens because they are extremely expensive and can adversely impact quality of life with adverse effects such as chronic

fatigue. “Another criticism is that there is no overall survival advantage documented, although this may materialize with more mature follow-up,” Dr Mathew said. “If I had started a patient on ADT for BCR, and their PSA was rising rapidly, I would use a first-generation ­antiandrogen such as bicalutamide first because it is cheap and has few side-effects.”

Better head-to-head trials needed “It is going to take better head-to-head trials looking at deferred ADT and defining the true benefits of these novel agents and at what stage they should be implemented in terms of overall survival,” said Soroush Rais-Bahrami, MD, Associate Professor of Urology and Radiology at the University of Alabama at Birmingham and Co-Director of the UAB Program for Personalized Prostate Cancer Care. Advances in targeted imaging techniques, such as prostate-specific positron emission tomography tracers, that pinpoint tumor sites also could help clinicians decide when to begin ADT, he said. ■

www.renalandurologynews.com NOVEMBER/ DECEMBER 2019

Renal & Urology News 9

News in Brief

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

Short Takes Low RCC Recurrence Rate Found With RPN

ticipants in the 2007 to 2014 ­National

Robotic partial nephrectomy (RPN)

Health and Nutrition Examination

offers good cancer control and a high

Surveys who had a history of passing

cure rate when used to treat renal

at least 1 kidney stone, Yaofei Sun, MD,

cell carcinoma (RCC) presenting as

and colleagues at Weifang People’s

small renal masses, investigators at

Hospital in Weifang, China, found that

West Virginia University in Morgantown

each per-quartile increment in caffeine

concluded in a paper published online

intake was significantly associated with

in Urology Annals.

15% increased odds of recurrent kidney

In an analysis of data from adult par-

stones after multivariable adjustment.

Of 269 patients found to have RCC after undergoing RPN for small recurrence after a median follow-up of

Study: ARBs Up Suicide Risk vs ACE Inhibitors

31 months, according to Mohamed

Angiotensin receptor blockers (ARBs)

W. Salkini, MD, and colleagues. Of the

may be associated with a higher risk of

8 patients, 2 had trocar site recur-

suicide than ACE inhibitors, according

rence, 1 patient had locoregional

to new findings from a real-world study.

renal masses, 8 (2.9%) experienced

recurrence, and three had recurrence

Using claims data, Tony Antoniou,

at the resection bed. In 2 patients, a

PharmD, PhD, of St Michael’s Hospital

second primary tumor developed in the

in Toronto, and colleagues compared

other kidney. No cancer-related deaths

964 older adults (aged 66 years or

­occurred during the follow-up period.

older; 80% male) who died by suicide with 3856 controls matched by age,

Recurrent Kidney Stones Linked to Caffeine Intake

sex, and the presence of ­diabetes and

Increasing intake of caffeine is

taking ACE inhibitors, those taking

­associated with an increasing risk of

ARBs had a 63% higher risk of dying

recurrent kidney stones, according to

from suicide within 100 days of pre-

study findings published online in the

scription, according to results published

European Journal of Nutrition.

in JAMA Network Open.

hypertension. Compared with patients

Kidney Disease in the US In 2018, nearly 6 million people aged 18 years or older in the United States reported having kidney disease,* according to findings from the National Health Interview Survey. Here is a breakdown of the frequency (in thousands) of reported kidney disease by age group: 1985

2000

1672

1645

65–74

75+

1500 1000

658 500

0

18–44

45–64

AGE GROUP

* For the survey, participants were asked if they had been told in the last 12 months by a doctor or other health professional that they had weak or failing kidneys (excluding kidney stones, bladder infections, or incontinence).

Source: National Center for Health Statistics

Smoking Duration Predicts Risk of PCa Recurrence I

nvestigators who studied men who underwent radical treatment for prostate cancer (PCa) found that smoking duration of 10 or more years among those who had ever smoked was associated with an increased risk of biochemical recurrence of the disease.

“Smoking duration is a modifiable risk factor and could be used to identify the ever-smokers at highest risk for prostate cancer recurrence,” Saira Khan, PhD, MPH, of the University of Delaware in Newark, and colleagues concluded in a paper published in Annals of Epidemiology.

Dr Khan’s team conducted a prospective cohort study of 1641 men with PCa treated with radical prostatectomy or radiation. Of these men, 773 were ever-smokers.

In the full cohort, the investigators found no association between ever-smoking and biochemical recurrence. Among the ever-smokers, however, smoking duration of 10 years or more compared with less than 10 years was significantly associated with a 2.3fold higher risk of biochemical recurrence after adjusting for potential confounders.

Vitamin B12 Levels Moderate Folic Acid’s Effect on CKD F

olic acid added to enalapril, compared with enalapril alone, is associated with a decreased risk for chronic kidney disease (CKD) progression among hypertensive patients with mild to moderate CKD and higher vitamin B12 levels, new data suggest.

The finding is from a post-hoc analysis of 1374 hypertensive adults with mild to moderate CKD and B12 measurements at baseline from the kidney disease substudy of the China Stroke Primary Prevention Trial. Among participants with higher baseline vitamin B12 levels (248 pmol/L or higher), treatment with folic acid plus enalapril was significantly associated with 83% decreased odds of CKD progression compared with recipients of enalapril alone, Youbao Li, MD, of Southern Medical University in Guangzhou, China, and colleagues reported online in the American Journal of Kidney Diseases.

Opioids Possibly Unnecessary for Post-Vasectomy Pain R

outinely prescribing opioids to men undergoing vasectomy may be unnecessary, researchers reported in the Journal of Urology.

David W. Barham, MD, and colleagues from Tripler Army Medical Center in Honolulu reviewed the medical charts of 228 patients from a urology clinic who underwent vasectomy by 8 urologists during 2017 to 2018. At the time of the procedure, 102 patients received opioid prescriptions (for 5 to 20 pills) and 126 did not. Of the 8 urologists, 2 routinely prescribed opioids for post-vasectomy pain and 6 relied entirely on alternative pain control strategies, such as over-the-counter acetaminophen and ibuprofen, scrotal support, and ice. Results showed that 12.7% of opioid users vs 18.4% of nonusers contacted a health care provider about pain within 30 days of their vasectomy, a nonsignificant difference between the groups.

Significantly more men who received opioids after vasectomy reported persistent opioid use at 3 to 6 months: 7.8% vs 1.5%, respectively.

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Germline Testing for Prostate Cancer AS Brian T. Helfand, MD, PhD, is Clinical Associate Professor, Richard Melman Family Chair of Prostate Cancer, and Clinical Lead for the Program for Personalized Cancer Care at NorthShore University HealthSystem in Evanston, Illinois. He gave a presentation on germline testing for prostate cancer prognosis and its implications for active surveillance (AS) at the recent 2019 Philadelphia Prostate Cancer Consensus Conference: Implementation of Genetic Testing for Inherited Prostate Cancer, which was sponsored by the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia.

You have proposed germline testing for all patients at the time of prostate cancer diagnosis, even those with lowrisk disease. Why?

Dr Helfand: As clinicians, we do a relatively bad job at identifying who is at high risk of prostate cancer. When you look at prostate cancer in general from the time of diagnosis to the time of biopsy and treatment, there are so many inherent errors that are built into the most common tests that we utilize. This starts with taking a family history—which is currently the recommended standard for obtaining germline genetic testing.

A large proportion of men do not know their family history. Therefore, it is not surprising that when you look at published studies, 60% of men who actually report no risk factors like family history of prostate cancer will harbor a mutation. These studies have included prostate cancer patients with advanced and localized prostate cancer. That’s why I believe universal testing should be recommended for all men diagnosed with cancer of any grade or stage.

Genetic testing has become inexpensive, and the stakes are so high, that I believe genetic testing is worthwhile for all men with high- and low-risk disease.

On The Web

Is there a PCa genetic testing protocol at your institution?

Dr Helfand: We offer every man diagnosed with prostate cancer the opportunity for genetic testing. Usually, as a urologist, I initially discuss that testing with my patients. We talk about the risk and benefits of genetic testing and its relevance to prostate cancer decision-making. And ultimately, I order the test and if they test positive for mutations or have a variant of unknown significance, I continue to counsel them regarding the implications for prostate cancer management and also coordinate care with genetic counselors. The genetic counselors discuss implications and screening strategies for other cancers.

In addition, they initiate discussions with the family members for cascade testing. If our genetic counselors identify male family members with germline mutations associated with prostate cancer risk and aggressiveness (for example, BRCA2 or ATM mutations), they will refer them to our clinic for patients who are at high genetic risk for prostate cancer for screening discussions. Interim results from the IMPACT trial (Identification of Men with a genetic predisposition to Prostate Cancer: Targeted screening

in men at higher genetic risk and controls) have shown that earlier screening of men with mutated BRCA2 genes identifies more men with higher-grade disease.1 How could genetic testing results be incorporated in AS decision-making?

Dr Helfand: One of the big issues in prostate cancer is overall risk assessment and distinguishing who has high-grade disease and who doesn’t.

There are really no perfect tests by which we can currently ascertain that information.

For active surveillance, I foresee that we would focus on a relatively small panel of genes that have been associated reproducibly with aggressiveness.

These genes like BRCA2, ATM, and probably MSH2 that pretty reproducibly have an association with aggressive, metastatic and lethal prostate cancer.2,3,4 The findings could inform decisions about whether to recommend a patient for active surveillance. As such, genetic testing has already been included as part of our assessment in our active surveillance program.

What would you advise a patient with Grade Group 1 disease who might otherwise be a candidate for AS, but has a BRCA2 mutation?

Dr Helfand: If you take all men with Grade Group 1 prostate cancer cancer, over 30% to 40% of them will progress or be reclassified over time while on active surveillance. Just by having that BRCA2 mutation, a patient will have an almost 5-fold higher risk of being reclassified as Grade Group 3 or higher during active surveillance compared with men who have the same initial biopsy pathology. I tend to steer these patients towards earlier treatments because of the data demonstrating that these mutations are significantly associated with higher frequencies of higher grade tumors, metastatic and lethal cancers.

Should genetic testing results be used to guide follow-up protocols for patients on AS?

Dr Helfand: I believe genetic testing should be used routinely as part of surveillance protocols. Specific mutations such as BRCA2 and ATM have reproducibly been associated with worse clinical outcomes. As such, I have an informed conversation that discusses the risks of these mutations with my active surveillance patients. However, despite the increasing evidence, I recognize that not all men and clinicians are accepting of upfront treatment in the AS setting among mutation carriers. Therefore, at a minimum I would recommend closer surveillance (eg, more frequent biopsies) for relevant germline mutation carriers who desire to continue active surveillance. ■ REFERENCES

All prostate cancer patients should undergo genetic testing.

—Brian T. Helfand, MD, PhD

1. Page EC, Bancroft EK, Brook MN, et al. Interim results from the IMPACT study: Evidence for prostate-specific antigen screening in BRCA2 mutation carriers [published online September 16, 2019].

Eur Urol. doi: 10.1016/j.eururo.2019.08.019 2. Na R, Zheng SL, Han M, et al. Germline mutations in ATM and BRCA1/2 distinguish risk for lethal and indolent prostate cancer and are associated with early age at death. Eur Urol. 2017;71: 740-747.

3. Carter HB, Helfand B, Mamawala M, et al. Germline mutations in ATM and BRCA1/2 are associated with grade reclassification in men on active surveillance for prostate cancer. Eur Urol. 2019;75: 743-749.

4. Na R, Zheng SL, Han M, et al. Germline mutations in ATM and BRCA1/2 distinguish risk for lethal and indolent prostate cancer and are associated with early age at death. Eur Urol. 2017;71:740-747.

Continue the conversation online! We have many experts who weigh in on controversial topics important to you. Catch our discussions at www.renalandurologynews/expertqa.

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Renal & Urology News 11

Transperineal PCa Biopsy May Be a Safer Approach TRANSRECTAL (TR) AND transperineal (TP) prostate biopsy approaches have similar cancer detection rates, but TP biopsies are associated with a lower rate of infection-related complications, according to investigators.

In a single-center preliminary study, Guan-Lin Huang, MD, and colleagues at Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine in Kaohsiung, Taiwan, studied 238 men who met criteria for a prostate cancer (PCa) biopsy.

Of these, 130 underwent TP biopsy and 108 underwent TR biopsy, the most common prostate biopsy approach used in the United States. The TP and TR groups had similar mean ages (66.6 and 67.1 years, respectively) and similar

Study: RRT Used Less in Women ALTHOUGH MORE WOMEN than men worldwide have chronic kidney disease, fewer women receive renal replacement therapy (RRT) such as dialysis and kidney transplants, according to a new study published in the Clinical Journal of the American Society of Nephrology.

A team led by Manfred Hecking, MD, PhD, and Marlies Antlanger, MD, of the Medical University of Vienna in Austria, analyzed data from the European Renal Association-European Dialysis and Transplant Association registry representing 9 European countries: Austria, Finland, the Netherlands, Iceland, Scotland-United Kingdom, Greece, Norway, and Spain (Andalusia and Catalonia). Over the 5 decades spanning 1965 to 2015, a total of 230,378 patients initiated RRT, of whom 39% were female.

Over the 50-year study period, RRT increased from 12 to 173 per million population in men but just 8 to 98 per million population in women.

Male-to-female ratios for incident and prevalent RRT patients also increased with age (range 1.2 to 2.4) and were consistent over time and across countries. These trends were observed across all RRT modalities. ■

median PSA levels (9.3 and 10.9 ng/mL, respectively).

The TP and TR groups had similar PCa detection rates (45% vs 49%, respectively), the investigators reported online in BMC Urology. In the TR group, 7.4% were hospitalized because of post-biopsy complication,

6.4% experienced sepsis, and 6.4% experienced a fever above 101.3˚ F. None of the patients in the TP group experienced these problems. A significantly higher proportion of TR than TP patients experienced urinary tract infections (12% vs 2.2%) and gross hematuria (13.8% vs 5.3%).

“Taken together, these results suggest that patients undergoing transperineal prostate biopsy are at lower risk of postbioptic complications,” the authors wrote.

Study limitations include the recruitment of a relatively small study population from a single center and the lack of randomization, they noted. ■

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Intradialytic Hypotension, PAD Linked Peripheral artery disease risk rises along with the proportion of hemodialysis sessions with IDH INTRADIALYTIC hypotension (IDH) —which may decrease systemic circulation to the lower extremities— is associated with an elevated risk of peripheral artery disease (PAD), according to one of multiple studies of IDH presented at the conference.

“Our study suggests that patients with more frequent IDH may warrant a careful examination for PAD through a focused history and physical exam including foot checks, and other diagnostic testing as indicated,” said lead investigator Tara I. Chang, MD, of Stanford University School of Medicine in Palo Alto, California.

In an analysis of data from the US Renal Data System, Dr Chang and her collaborators found that as the proportion of HD sessions with IDH increases, so does the risk of PAD. The presence of IDH in 1% to 14%, 15% to 29%, and 30% or more of HD sessions is significantly associated with a 6%, 16%, and 36% increased risk of PAD in adjusted analyses compared with the absence of IDH, according to the investigators.

The investigators adjusted for baseline characteristics, comorbidities, laboratory values, and healthcare use.

The study, which Dr Chang presented during an oral session, examined data from 45,489 HD patients without preexisting PAD who initiated HD from 2006 to 2011. Dr Chang’s team defined IDH as nadir systolic blood pressure below 90 mm Hg. They assessed the proportion of HD sessions in which IDH occurred in 30-day intervals. The study’s primary outcome was incident PAD in the subsequent 30-day interval. Incident PAD developed in 8111 patients during 61,842 person-years of follow-up.

In a separate study, which was presented in a poster, investigators Ning Su, MD, and colleagues at The Sixth Affiliated Hospital of Sun Yat-sen University in Guangzhou, China, found that high serum calcium and parathyroid hormone (PTH) levels are risk factors for IDH in HD patients. Their retrospective study of 922 HD patients in China demonstrated that 21.1% of patients with high serum calcium (8.67 mg/dL [the

median for the entire study population] or higher) and high PTH (intact PTH [iPTH] above 300 pg/mL) had IDH compared with 9.6% of patients with low serum calcium (less than 8.67 mg/dL) and low PTH (iPTH 300 pg/mL or less).

IDH in at least 30% of dialysis sessions found to increase risk of PAD by 36%.

After adjusting for age, sex, presence of diabetes mellitus, dialysis vintage, and other potential confounders, hypercalcemia by itself was significantly associated with nearly 2.5-fold increased odds of IDH. Hypercalcemia accompanied by high iPTH was significantly associated with 2.6-fold increased odds of IDH. In addition, the investigators found that increasing ultrafiltration was significantly associated with nearly 1.4-fold increased odds of IDH, whereas ­hemodiafiltration

was significantly associated with an almost 56% decreased odds of IDH. In another poster presentation, Krista Frances Rossum, MD, of the University of Manitoba in Winnipeg, and collaborators reported that IDH rates did not differ among HD patients who cycled during the first or second half of their dialysis treatment. Intradialytic cycling improves physical function and quality of life in HD patients and appears safe, but experts recommend that the exercise be completed during the first half of treatment due to concerns about increased IDH, Dr Rossum’s team pointed out.

Their study showed that the IDH rate per 100 HD hours was 35.7 and 37.6 for patients who cycled during the first and second half of HD, respectively.

“Exercise late in hemodialysis will facilitate expansion of intradialytic cycling programs by optimizing resource use and will enable the use of cycling as a potential non-pharmacological means of improving hemodialysis-related symptoms,” the authors concluded in their study abstract. ■

AKI-Related Outpatient HD Renal Outcomes Probed YOUNGER AGE, FEMALE sex, and lower serum creatinine are among the demographic and biochemical variables most strongly associated with recovery of kidney function after initiation of outpatient hemodialysis (HD) for acute kidney injury (AKI), according to new study findings. Higher serum creatinine is most strongly associated with transition to end-stage renal disease (ESRD).

“It’s very significant to finally have national data on individuals with acute kidney injury treated in outpatient dialysis facilities,” investigator Franklin W. Maddux, MD, Global Chief Medical Officer at Fresenius Medical Care North America (FMCNA), told Renal & Urology News. “We have been undertaking studies to further understand the clinical course of acute kidney injury necessitating outpatient dialysis care.”

This particular research, which is one of several studies of AKI that FMCNA is presenting at the conference, is helping the company to better identify factors

associated with either recovery of kidney function or transition to ESRD, he said.

Dr Maddux added, “We will continue to conduct research that improves our understanding of the treatment of AKI in the outpatient dialysis setting in order to create more personalized care that increases the likelihood of recovery of

Younger age, female sex, and lower serum creatinine predict renal function recovery. kidney function or supports the transition to end stage kidney disease when recovery of kidney function is not possible.”

The new study included 12,221 patients who initiated outpatient HD for AKI at a Fresenius Kidney Care dialysis facility from May 1, 2017 to December 31, 2018. During follow-up, 4786 (39%) recovered kidney function, 5606 (46%)

transitioned to ESRD, and 1136 (9%) died, the investigators reported in a poster presentation. Results showed that each standard deviation (SD) increase in age (14.6 years) was significantly associated with a 22% decreased likelihood of recovering kidney function and a 5% increased risk of transitioning to ESRD in adjusted ­analyses. Female sex was significantly associated with a 24% increased likelihood of recovering kidney function compared with male sex and a 14% decreased likelihood of transitioning to ESRD. Each SD increase in serum creatinine (2.3 mg/dL) was significantly associated with a 35% decreased likelihood of recovering kidney function and 27% increased risk of transitioning to ESRD. Additionally, each SD increase in serum potassium (0.6 mEq/L) was significantly associated with a 15% decreased likelihood of recovering kidney function and 12% increased risk of transitioning to ESRD. Each SD increase in serum ­phosphorus (1.5 mg/ dL) was significantly associated with a

31% increased likelihood of recovering kidney function and 16% decreased risk of transitioning to ESRD. “In patients initiating outpatient dialysis for the treatment of AKI, we found that age, sex, lower serum creatinine, and higher serum phosphorus—with biochemistry measured during the first week of outpatient dialysis—were all strongly associated with recovery of enough kidney function to discontinue dialysis,” said first author Eric D. Weinhandl, PhD, MS, Senior Director of Epidemiology and Biostatistics at FMCNA. “In contrast, higher serum creatinine was associated with transition to end-stage kidney disease. Unmeasured factors, including the presence of chronic kidney disease and the cause of AKI, certainly influence the likelihood of recovery of kidney function. Still, these results show that physicians and patients may be able to incorporate information from early biochemical measurements into their assessment of the potential for resolution of AKI.” ■

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Renal & Urology News 13

Vitamin K Found to Ease Calciphylaxis Small study is the first randomized placebo-controlled trial of a treatment for the serious condition VITAMIN K HAS shown promising efficacy in the treatment of calciphylaxis, according to the findings of the first randomized placebo-controlled trial of a treatment for this serious medical problem. No approved medication exists for treating calciphylaxis, a rare and potentially fatal condition that occurs predominantly among patients on dialysis.

In a 12-week phase 2 study that enrolled 26 patients with calciphylaxis, Sagar U. Nigwekar, MD, MMSc, of Massachusetts General Hospital in Boston, and colleagues found that patients treated with oral phytonadione, a form of vitamin K, was associated with a significantly lower mortality rate compared with placebo at 12 weeks (0% vs 31%). In addition, phytonadione-treated patients experienced significant decreases in the size of a patient’s largest skin lesion, the combined size of all lesions, and pain intensity compared with placebo.

vitamin K deficiency increases the risk of calciphylaxis through reduced activity of matrix Gla protein (MGP). The protein blocks calcification, but it requires vitamin K for its activation. “So, in patients who are vitamin K deficient or are on treatments such as warfarin, this protein does not remain active, and patients are left with a predisposition for calcification,” Dr Nigwekar told Renal & Urology News. The trial showed that phytonadione significantly decreased levels of inactive MGP. The median change in the level of inactive MGP between baseline and 12 weeks was −1014 pmol/L in the phytonadione group compared with −753 among the placebo recipients.

In a paper published in the Journal of the American Society of Nephrology in 2016, a team led by Dr Nigwekar reported on a study showing that warfarin use at hemodialysis (HD) initiation was associated with a greater than 3-fold increased risk of calciphylaxis.

For the study, the investigators compared 1030 HD patients with calciphylaxis matched by age, sex, and race to 2060 patients without calciphylaxis.

In the same journal in 2017, Dr Nigwekar and colleagues reported finding a link between vitamin K deficiency and lower levels of activated MGP in a study that compared 20 HD patients with calciphylaxis and 20 HD patients without calciphylaxis (controls) matched by age, sex, race, and warfarin use. The prevalence of vitamin K deficiency was 90% among calciphylaxis cases compared with 50% among controls. On multivariable analysis, vitamin K deficiency was significantly associated with lower levels of activated MGP. In addition, the study found that each 0.1 unit reduction in relative active MGP concentration was significantly associated with approximately 2.7-fold increased odds of calciphylaxis. ■

LDK Transplant Study: SSRI Use Is Associated With Higher Hyponatremia Risk Rate Declining Among Women

and 12% greater odds of LDK transplantation, respectively. Women on dialysis had significant 21% decreased odds of LDK transplantation compared with those who had not started dialysis.

The investigators found that sensitized women had a significantly increased likelihood of receiving an LDK. A PRA value greater than 20% was significantly associated with 3.5fold increased odds of receiving an LDK than a value of 20% or less.

In addition, women had significant 19% decreased odds of receiving an LDK from an unrelated donor than a related donor.

“The findings in this analysis suggest that the disparity in living donor receipt by women has worsened over the past 20 years, and that in fact, women who are sensitized are more likely to receive a living donor kidney than those who are not,” Dr Markell told Renal & Urology News. “In addition, the observation that the disparity differs across regions, and that women on dialysis are less likely to receive a live donor kidney, and women in general are less likely to receive an unrelated live donor kidney suggest that practice patterns may be more important than biological factors, which have been implicated in the past.” ■

Previous studies have suggested that many patients who experience calciphylaxis had received treatment with warfarin—a vitamin K antagonist.

Dr Nigwekar’s team hypothesized that

USE OF SELECTIVE serotonin reuptake

­measurement in the first 3 months, and

inhibitors (SSRIs) is associated with a

the risk for mild and moderate hypona-

higher short-term risk of hyponatremia

tremia was 7.3% and 1.2%, respectively.

compared with use of serotonin-norepi-

After propensity score matching, the

nephrine reuptake inhibitors (SNRIs),

odds of mild and moderate hyponatre-

according to researchers.

mia, respectively, were significantly

The finding is from a study of 69,551

28% and 46% greater among those

patients prescribed an SSRI and

prescribed an SSRI compared with those

30,089 patients prescribed an SNRI.

prescribed an SNRI. Among patients on

Of those prescribed an SSRI, only

concurrent thiazide diuretic therapy, SSRI

17,066 (25%) had at least one outpa-

use was significantly associated with a

tient sodium measurement in the 3

45% increased risk of hospitalization with

months following prescription, and the

hyponatremia compared with SNRI use.

risks for mild and moderate hyponatre© IMAGE COURTESY OF PARTNERS CALCIPHYLAXIS BIOBANK

No approved medication exists for treating calciphylaxis, a potentially fatal condition.

“Despite a potentially higher hypo-

mia (serum sodium levels below 135

natremia risk, the monitoring of blood

and below 130 mEq/L, respectively)

sodium is uncommon among patients

among these patients were 11.2% and

who were prescribed an SSRI,” Dr Luo

2.5%, Shengyuan Luo, MBBS, MHS, of

said. “Caution against hyponatremia

Johns Hopkins University in Baltimore,

may be needed in SSRI users, espe-

and colleagues reported in a poster

cially among those with concurrent thia-

presentation. By comparison, 7,527

zide diuretic use. There may be a need

(25%) of the patients prescribed an

to reassess optimal antihypertensive

SNRI had at least 1 outpatient sodium

therapy in those receiving an SSRI.” ■

RATES OF LIVE donor kidney (LDK) transplantation among women decreased from 1998 to 2018, widening the gender gap in receipt of an LDK, investigators reported.

Among 106,260 primary adult LDK transplants reported to the United Net­work for Organ Sharing/Organ Procurement and Transplantation Net­ work from 1998 to 2018, the overall rate of LDK transplantation was 38.9% for women and 61.1% for men, Mariana Markell, MD, and Angelika Gruessner, MS, PhD, of SUNY Downstate Medical Center in Brooklyn, reported in a poster presentation. From 1998-2000 to 20162018, the overall rate of LDK transplantation for women declined significantly from 41.9% to 36.7%.

Results also showed that white women were less likely to receive an LDK than non-white women. Compared with white women, black women and other non-white women had significant 32%

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Factors That Prompt CRRT Identified

BY NATASHA PERSAUD SEPSIS IS THE most common cause of acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) in critically ill patients, and volume overload is the most common specific indication for the treatment, according to new study findings.

To evaluate and assess the casemix, acuity, diagnosis, clinical course, and outcomes of patients undergoing CRRT, Oleksa G. Rewa, MD, MSc, of the University of Alberta in Canada, and colleagues employed CRRTnet, a data registry of 1226 adults (mean age 59 years; 55% male; 30% with chronic kidney disease) treated with CRRT for more than 24 hours who attended 5 academic medical centers in the United States and Canada.

Patients were most often admitted to the intensive care unit (ICU) for cardiovascular emergency (20.6%), sepsis (16.2%), surgical reasons (14.4%),

Post-Tx Gout May Worsen Outcomes Higher risk of complications and return to hemodialysis reported

BY NATASHA PERSAUD NEW-ONSET GOUT among kidney transplant recipients increases the risks of transplant complications and return to maintenance hemodialysis (HD), findings from separate studies suggest.

In one study, Megan Francis-Sedlak, PhD, and colleagues from Horizon Therapeutics in Forest, Illinois, identified 6085 kidney transplant recipients within the Humana Research Claims Database, including 909 who experienced gout before transplant and 595 who experienced gout (a mean 1.8 years) afterward. Gout patients tended to be older, male (68%-69%), and white (56%-58%).

Patients with gout had a significant 28% higher risk for transplant-related complications than those without gout: 40.4% vs 35.3%, respectively, after matching for age, sex, and race.

Recipients with new-onset gout after transplantation drove the higher rates of complications: 50.9% for post-transplant gout vs 33.4% for pre-transplant gout vs 34.6% for no gout, according to the investigators.

In addition, patients with posttransplant gout had twice the risk of experiencing complications than patients without gout. In particular, those with post-transplant gout were more likely to experience graft failure: 16.2% vs 10.9% and 11.6% for posttransplant, pre-transplant, and no gout, respectively.

Graft failure is more likely to occur in patients who develop post-transplant gout.

Although a smaller proportion of patients with pre- than post-transplant gout had complications, complications developed more quickly in those with pre-transplant gout: mean 245 vs 510 days, the researchers noted.

“An increased focus on awareness and screening of renal transplant patients for gout is warranted,” Dr FrancisSedlak and colleagues noted.

In the other study, which included 21,553 patients in the US Renal Data System who received a primary kidney transplant during 2008 to 2016, newonset gout developed in 7%, 19% died, and 11% returned to HD 6 or more months after transplant.

Patients with post-transplant gout had a significant 38% higher risk of returning to HD than those without gout, Justin W. Li, BA, of Trinity Partners in Waltham, Massachusetts, and colleagues reported. The risk of returning to HD among patients with post-transplant gout increased by 49%, 30%, 29%, 49%, and 53% at years 1 through 5 after transplant, respectively.

The findings suggest new-onset gout may predict longer-term renal dysfunction in kidney transplant recipients, Li’s team stated. Hyperuricemia in kidney transplant recipients is known to be associated with use of the calcineurin inhibitor immunosuppressants, cyclosporine A, and tacrolimus, the investigators noted.

The studies were funded by Horizon Therapeutics. ■

and respiratory failure (14.3%).

AKI most commonly occurred as a result of sepsis (43.8%), and to lesser extents cardiogenic causes (10.9%), hypovolemia (8.6%), hepatorenal insults (5.1%), and other reasons (17.7%). CRRT was most commonly initiated to alleviate fluid overload/ edema (48.8%), oligo-anuria (14.4%), hyperkalemia (5.6%), metabolic acidosis (3.5%), and uremia (2.0%).

On average, patients stayed in the ICU and hospital for 21.1 and 43.1 days, respectively. At discharge, 25.8% and 17.3% of ICU and hospital patients, respectively, required renal replacement therapy.

“In this large multi-center prospective registry of critically ill patients treated with CRRT, the most common etiology of AKI requiring CRRT was sepsis and the most common specific indication was volume overload,” Dr Rewa told Renal & Urology News.

“A substantial proportion of patients treated with CRRT were still receiving RRT at hospital discharge. ■

Frail Hemodialysis Patients Deteriorate Over Time

BY NATASHA PERSAUD NEW RESEARCH SUGGESTS that frailty, which is common among patients on hemodialysis (HD), is associated with deteriorating quality of life over time in this patient population.

A team led by Bhanu Prasad, MD, of Regina General Hospital in Regina, Saskatchewan, Canada, assessed frailty in 100 prevalent HD patients at their institution (mean age 63 years; 51% diabetic; 58% male; 73% white) over 1 year. At baseline, two-thirds of patients were frail, with a Fried score of 3, 4, or 5 out of 5 physical criteria. A total of 69% had cognitive impairment based on the Montreal Cognitive Assessment tool, and 53% screened positive for depressive symptoms on the Geriatric depression scale. The median EuroQol5-Dimensions-3 Levels (EQ-5D-3L) utility score was 0.81 and EQ-Visual Analog Scale (EQ-VAS) was 60.

Most patients (82%) were fully independent, whereas 17% were independent with family support. Only 1% of

patients received home care. Sixty-five patients completed a follow-up assessment at 1 year.

Difficulty with mobility At 1 year, more patients overall had difficulty with mobility (83.1% vs 67.7%) and self-care (18.5% vs 6.2%).

Fewer were fully independent (63.1% vs 81.5%) and median quality of life was lower (0.77 vs 0.81). Patients who had cognitive impairment at baseline showed further decline at 1 year, which potentially affected their ability to adhere to HD schedules and fluid and dietary restrictions.

Dependency on family members By 1 year, more patients met frailty criteria (67.7% vs 64.6%). At this point, frail patients were more likely than nonfrail patients to be dependent on family members or require multiple support systems. Frail patients were also more likely to have difficulty with self-care, daily activities, mobility, pain,

and a­ nxiety. Of the 22 patients who died, 62% were deemed frail.

“The collective impact of multiple comorbidities, depression, cognitive impairment, reduced quality of life, and frailty on HD patients, and its consequent impact on healthcare delivery will have to be proactively addressed in a multidisciplinary manner,” Dr Prasad told Renal & Urology News. “Understanding how frailty affects health outcomes in hemodialysis patients could assist in the development of management strategies to improve outcomes for this vulnerable patient group. We suggest sequential frailty measurements in hemodialysis units to improve care delivery of patients.”

The medical literature shows that multicomponent exercise training improves physical function, mood, and sarcopenia, which are important components of frailty, the investigators noted. “Our study supports the need for similar interventions to be initiated in HD patients as they are high users of emergency rooms and community resources.” ■

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Bladder Cancer Tied to Stewed, Roasted Meat HIGH INTAKE OF STEWED or roasted meat is associated with increased odds of bladder cancer, according to a new study.

In contrast, high intake of vegetables and milk/yogurt is associated with reduced odds of the malignancy.

The findings are from an Italian multicenter case-control study that included 690 bladder cancer cases and 665 controls matched by sex, 5-year age groups, and hospital. The highest quartile of total meat consumption was significantly associated with 57% increased odds of bladder cancer compared with the lowest quartile, but the odds of bladder cancer varied by meat preparation method, Matteo Di Maso, a PhD student at the University of Milan in Italy, and collaborators reported in Cancer Epidemiology. Compared with the lowest quartile, the highest quartile of consumption of stewed or roasted meat was

High FGF23, Death Linked in Diabetics ELEVATED LEVELS OF fibroblast growth factor 23 (FGF23) increase the risks for a major adverse cardiovascular event (MACE) and death in patients with type 2 diabetes and normal to mildly impaired kidney function, researchers reported in Diabetes Care.

Martin H. de Borst, MD, PhD, of the University of Groningen in the Netherlands, and colleagues analyzed plasma c-terminal FGF23 levels in 310 patient with type 2 diabetes (mean age 62 years; 58% men) with an estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m2 or higher from the Diabetes and Lifestyle Cohort Twente (DIALECT). During 5.8 years of followup, 47 patients experienced a MACE and 28 patients died. Each doubling of FGF23 was significantly associated with a 1.7- and 2.8-fold increased risk for MACE and all-cause mortality, respectively, in adjusted analyses.

In a subset of patients with eGFR of 90 mL/min/1.73 m2 or higher, each doubling of FGF23 was significantly associated with a 3.3-fold higher risk for all-cause mortality. ■

significantly associated with 47% and 41% increased odds of bladder cancer, respectively. The investigators found no association between consumption of boiled, fried, or preserved meat and bladder cancer risk.

The highest quartile of vegetable and milk/yogurt consumption each

was significantly associated with 38% reduced odds of bladder cancer, respectively, compared with the lowest quartile.

The authors concluded that their findings “consolidate the concept of a role for diet” in bladder cancer etiology.

The study population consisted of hospitalized patients. During patients’

hospital stay, trained interviewers administered validated food-frequency questionnaires as well as structured questionnaires to collect information on demographic characteristics, anthropometric measurements, occupational exposure to chemicals, medical history, and drug use. ■

16 Renal & Urology News

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PCa Salvage Combo Benefits Confirmed Short-term ADT plus radiotherapy prolongs PFS vs radiotherapy alone FINAL RESULTS OF a phase 3 trial confirm the progression-free survival (PFS) benefit of adding short-term androgen suppression to radiotherapy as salvage treatment for men who experience rising PSA following radical prostatectomy for prostate cancer (PCa), investigators concluded in a paper published in Lancet Oncology.

In a post-hoc analysis of men in the GETUG-AFU 16 trial, the 120-month PFS rates were 64% for men treated with radiotherapy plus 6 months of androgen deprivation therapy (ADT) with goserelin compared with 49% for those who received radiotherapy alone. The combined treatment was significantly associated with a 46% reduction in the risk of disease progression—the study’s primary end point—compared with radiotherapy alone. The investigators, led by Christian Carrie, MD, of Léon Bérard Center and the University of Lyon in France, defined PFS as the time from randomization to documented biologic recurrence or clinical progression (or both), death from any cause, or censoring at the date of last follow-up.

In addition, the investigators found that the combined treatment offered an advantage in terms of metastasis-free survival (MFS), a prespecified secondary end point of the trial. The 120-month MFS rates were 75% for the combined treatment arm compared with 69% for the radiotherapy-alone arm. The combined treatment was significantly associated

Benefits of combined therapy were greater in men with low-risk disease, study finds. with a 27% decreased risk of metastasis compared with radiotherapy alone.

Overall survival rates at 120 months did not differ significantly between the combined treatment and radiotherapy-alone arms (86% vs 85%). When adding ADT to salvage radiotherapy, 14 patients would need to be treated to spare 1 patient from experiencing metastasis or death in the 10 years after salvage therapy, according to the investigators.

Subgroup analyses found that the beneficial effect of the combined treatment on PFS was significantly greater for patients with low-risk than highrisk cancer. The investigators found no significant difference in MFS between treatment arms when they stratified patients according to risk group.

“Our results confirm the benefit of adding short-term androgen deprivation therapy to salvage radiotherapy on metastasis-free survival in patients with biological recurrence after radical prostatectomy,” the authors wrote.

The GETUG-AFU 16 trial enrolled patients from October 19, 2006 to March 30, 2010. Investigators randomly assigned 743 men with rising PSA following radical prostatectomy to receive radiotherapy alone (374 patients) or radiotherapy in addition to goserelin (369 patients). One patient in the radiotherapy-alone group later withdrew consent, leaving 373 patients in that group.

The median follow-up was 112 months.

In the first analysis of the trial, which was published in 2016, only the first progression event was collected, so MFS could not be analyzed, the authors noted. ■

Men with IBD Have a Higher Risk of PCa MEN WITH inflammatory bowel disease (IBD), especially ulcerative colitis, have an increased risk of prostate cancer (PCa), according to new study findings published in Prostate Cancer and Prostatic Diseases.

In a meta-analysis of 6 cohort studies including 86,137 IBD patients from Europe and Asia, the presence of IBD was significantly associated with a 33% increased risk for PCa over 4 to 40 years of follow-up. A subgroup analysis showed that men with ulcerative colitis (UC) had a significant 58% higher risk for PCa, whereas men with Crohn’s disease had a 12% higher risk. In 3 case-control studies that included 22,760 IBD cases and 300,851 IBD-free controls from the United States and the United Kingdom, men with IBD had an 81% higher risk for PCa. “If confirmed in larger studies, future efforts should focus on understanding the basis for the link between IBD and total PCa or clinically significant PCa risk,

PCa Active Surveillance Appropriate for Blacks ACTIVE SURVEILLANCE (AS) is an appropriate management strategy for black men with favorable-risk prostate cancer (PCa) who adhere to a standardized protocol of regular PSA tests and biopsies, investigators reported.

The prospective, multi-institutional cohort Canary Prostate Cancer Active Surveillance Study (PASS), which included 1315 men on AS, found that black men were at no higher risk of adverse pathologic reclassification on subsequent prostate biopsies than white men, a team led by Jeannette M. Schenk, PhD, RD, a senior staff scientist at the Fred Hutchinson Cancer Research Center in Seattle reported online in The Journal of Urology. In addition, blacks who eventually underwent radical prostatectomy did not have a higher risk of adverse pathologic findings by delaying treatment.

The study supports the use of a standardized AS protocol among black men with favorable-risk PCa, Dr Schenk and her colleagues concluded.

The appropriateness of AS for black men has been unclear. Black men, who

have a higher PCa incidence and mortality and greater potential for underlying aggressive disease than white men, have been underrepresented in patient cohorts demonstrating favorable AS outcomes for men with low-risk PCa, the authors pointed out.

Delaying treatment does not increase their risk of adverse pathologic findings.

All men in Canary PASS had a PCa diagnosis within 5 years of enrollment.

Men underwent PSA measurements every 3 months and clinic visits every 6 months. They also underwent ultrasound-guided confirmatory prostate biopsies from 6 to 12 months after diagnosis followed by a biopsy at 24 months after diagnosis and at 2-year intervals thereafter. The study population included 89 (7%) black men and 1226 (93%) white

men. The primary outcome was disease reclassification on subsequent biopsy.

The median follow-up among men with no pathologic reclassification was 3.9 years. Overall, the study demonstrated no difference in reclassification-free survival between black and white men. Black race was not significantly associated with reclassification risk after adjusting for diagnostic biopsy and clinical variables.

With regard to study limitations, the authors noted that although the number of black men in their study is the largest to date, it is still modest and the number of black men who underwent surgery is small. They pointed out that racial disparity in the intensity of surveillance (such as the frequency of PSA tests and biopsies), or how surveillance was conducted (such as whether biopsies included the use of multiparametric magnetic resonance imaging), and differences in pathologic review could have impacted the likelihood of detecting progression events on AS. The investigators found no indication of these biases in their cohort. ■

including the possibility that IBD leads to an altered microbiome that increases PCa risk,” Yuqiu Ge, of the Wuxi School of Medicine, Jiangnan University, Wuxi, Jiangsu, China, and colleagues concluded.

The authors cited a study published in February in Nature Reviews Urology showing that pathogenic microorganisms involved in IBD may be introduced into the prostate via the circulatory system and stimulate cancer-promoting prostatic inflammation.

The investigators said their findings suggest that increased PCa screening may be warranted for men with IBD. Study strengths included the use of data from population-based studies, inclusion of case-control studies as well as prospective cohort studies, and a large sample size. In a discussion of study limitations, Ge and colleagues said their analysis did not take into account certain confounders, such as family history of PCa, which may influence PCa risk. ■

www.renalandurologynews.com NOVEMBER/DECEMBER 2019

Renal & Urology News 17

Uncontrolled Gout Increases Death Risk Failure to achieve recommended uric acid levels doubles the likelihood of all-cause and CV mortality

BY NATASHA PERSAUD PATIENTS WITH GOUT who fail to achieve guideline-recommended serum uric acid target levels of less than 6 mg/ dL are at increased risk for all-cause and cardiovascular (CV) mortality, according to new study findings.

The study included 1193 prevalent gout patients (mean age 60 years; 92% male) attending a Spanish specialty clinic during 1992 to 2017. Patients received colchicine prophylaxis (0.5 to 1 mg/d) for 6 to 12 months or prednisone (2.5 mg twice per day) and uratelowering therapy. For first-line treatment, 62.2% received allopurinol, 17.9% benzbromarone, and 8.7% febuxostat; 11.2% received no treatment.

A total of 158 patients died over a mean follow-up of 48.6 months, including 82 from CV causes. Crude mortality rates were significantly higher for patients with serum uric levels of 6 mg/ dL or higher than for those with lower levels: 80.9 vs 25.7 per 1000 patient-

© DR P. MARAZZI / SCIENCE PHOTO / GETTY IMAGES

Percutaneous Biopsy Found Safe in UTUC PERCUTANEOUS image-guided coreneedle biopsy (PCNB) is a safe and effective diagnostic tool for patients undergoing radical nephroureterectomy for upper tract urothelial carcinoma (UTUC), according to the results of a small study.

The procedure has a high histologic yield and grade concordance, with no cases of tract seeding identified after more than 2 years of follow-up, a team at Mayo Clinic in Rochester, Minnesota, led by Aaron M. Potretzke, MD, reported in Urology.

The study included 42 patients who underwent PCNB prior to radical nephroureterectomy (RNU) for UTUC. The patients had a median tumor size of 3.8 cm, with all lesions arising from the pelvicalyceal system. Of the 42 lesions, 20 (47.6%) were associated with hydronephrosis and 39 (92.9%) were associated with an upper tract filling defect. Radiologists used computed tomography and ultrasound guidance in 52% and 48% of cases, respectively.

years. Compared with levels below 6 mg/dL, levels of 6 mg/dL or higher were significantly associated with 2.3and 2.0-fold increased risks for allcause and CV mortality, respectively, after adjusting for age, sex, CV risk factors, previous CV events, and observation period.

“The findings from this study add credence to the hypothesis that elevated UA concentrations above 6 mg/ dL contribute substantially to mortality and to shortened life spans,” Fernando Pérez-Ruiz, MD, PhD, of Hospital Universitario Cruces in Spain, and colleagues wrote in RMD Open: Rheumatic & Musculoskeletal Diseases.

Patients with tophi, diabetes, or a history of a previous CV event had higher risks for CV mortality in multivariable analysis. In the cohort, 1 in 3 patients had tophi and the same proportion had a previous CV event, whereas 1 in 5 had diabetes. Gouty erosions detected on radiography, rather than

Relative to surgical pathology, the rate of histologic diagnosis of UTUC by PCNB was 95.2% In addition, 69% of PCNBs provided histologic grade, with a 90% concordance with surgical pathology.

Investigators identified no cases of radiographic tract seeding at a median follow-up of 28.2 months after biopsy.

“To our knowledge, we report on the largest series of PCNB for UTUC prior to RNU,” Dr Potretzke and his colleagues wrote. “We found that PCNB for UTUC offers a high rate of histology and grade concordance compared to RNU. PCNB appears is safe, both from the perspective of periprocedural morbidity and from that of oncologic tract seeding.”

Study limitations include selection bias, as investigators only looked at patients with PCNB who ultimately underwent RNU. “Thus, we have not assessed patients with PCNB who did not subsequently undergo RNU, who may possess a different perioperative and oncologic outcome profile.”

If the study findings are validated, use of PCNB may have broader application in cases where ureteroscopic biopsy is not diagnostic or not feasible, or when confirmation of high-grade disease may affect decisions regarding neoadjuvant chemotherapy, the authors noted. ■

Guidelines recommend target uric acid levels below 6 mg/dL in gout sufferers.

tophi themselves, predicted mortality, the researchers explained.

International guidelines recommend targeting serum urate levels to less than 6 mg/dL to reduce the frequency of morbidity and gout flares in patients who experienced 3-4 flares, on average,

in the previous year. The new findings indicate a survival benefit.

Urate-lowering therapy and strategies that reduce serum uric levels to less 6 mg/dL are likely to confer a survival advantage beyond gout control, according to the investigators.

Citing a possible mechanism described in a previous report published in Annals of Rheumatic Diseases, Dr Pérez Ruiz and his collaborators explained that hyperuricemia causes a shift in the interleukin-1β/interleukin-1Ra balance produced by peripheral blood mononuclear cells after exposure to monosodium urate (MSU) crystals and toll-like receptors-mediated stimuli. This process may reinforce an enhanced state of chronic inflammation.

“In our study, we confirm the beneficial impact of allopurinol and benzbromarone in reducing overall mortality, as each of these was associated with improved survival,” Dr Pérez-Ruiz’s team stated. ■

Study: Microwave Ablation Is An Alternative for cT1b RCC MICROWAVE ABLATION is an alternative

The rate of local recurrence was

to nephrectomy in selected patients

1.2% (4 patients) overall. The rate was

with clinically localized renal cell carci-

5% in the microwave ablation group,

noma (RCC) tumors that are 4 to 7 cm

1.4% in the PN group, and 0.5% in the

in diameter, according to investigators.

RN group.

In a study of 325 patients with clinical

No patient in the microwave ablation

T1b RCC—of whom 40, 74, and 211

group died from RCC, but 3 PN patients

underwent percutaneous microwave

(4.1%) and 12 RN patients (5.7%) died

ablation, partial nephrectomy (PN), and

from RCC at a median of 123.6 months

radical nephrectomy (RN), respectively—

and 61.7 months, respectively.

estimated 5-year local recurrence-free

The median length of hospitalization

survival (LRFS) was 94.5% for micro-

was shorter for the microwave ablation

wave ablation compared with 97.9% for

group than the PN and RN patients: 1

PN and 99.2% for RN. The difference in

day vs 4 days and 4 days, respectively.

LRFS between microwave ablation and

In addition, the estimated glomerular

RN was significant, but the differences

filtration rate (eGFR) at 3 months postop-

between microwave ablation and PN and

eratively decreased by a median of 4.5%

between PN and RN were not, a team led

in the microwave ablation group, 3.2% in

by E. Jason Abel, MD, of the University of

the PN group, and 29% in the RN group.

Wisconsin School of Medicine in Madison,

The change in eGFR did not differ signifi-

reported in Urology.

cantly between the microwave ablation

Five-year metastasis-free survival and

and PN patients, but the reduction in

cancer-specific survival did not differ

eGFR in the RN group was significantly

among the treatment arms.

greater than in the other 2 groups. ■

18 Renal & Urology News

NOVEMBER/DECEMBER 2019 www.renalandurologynews.com

Testosterone Therapy Increases VTE Risk Study finds 2-fold increased odds of venous thromboembolism in men with or without hypogonadism TESTOSTERONE therapy increases the short-term risk of venous thromboembolism (VTE) among men regardless of hypogonadism status, according to a new study.

In a case-crossover study, testosterone therapy was associated with significant 2.3- and 2.0-fold increased odds of VTE in men with and without hypogonadism, respectively, after adjusting for age, Rob F. Walker, MPH, and colleagues reported in JAMA Internal Medicine.

Using the IBM MarketScan Commercial Claims and Encounter Data-base and the Medicare Supplemental Database, the investigators identified 39,622 men with VTE cases who were free of cancer at baseline and had 12 months of continuous enrollment in an insurance plan before the VTE event.

“To our knowledge, we had the largest number of cases included in a study

BMI Affects Hemodialysis Adequacy LOW OR HIGH body mass index (BMI) influences hemodialysis (HD) adequacy, according to new study findings published online in BMC Nephrology.

Yu-Ji Lee, MD, of Samsung Changwon Hospital in South Korea, and his peers analyzed data from 18,242 maintenance HD patients on a twice- or thrice-weekly schedule from the Korean Society of Nephrology registry January 2001 to June 2017. Of these, 4824 died over a median 5.2 years. Baseline spKt/V was divided into 6 categories for analysis: less than 1.0, 1.0 to less than 1.2, 1.2 to less than 1.4, 1.4 to less than 1.6, 1.6 to less than 1.8, and 1.8 or higher. Cox regression analysis confirmed that, compared to the target range spKt/V of 1.2 to 1.4, lower and higher spKt/V were associated with greater and lower risks for allcause mortality, respectively.

BMI modified this relationship, Dr Lee’s team found. They grouped patients by their baseline BMI (in kg/ m2): less than 20 (low), 20 to less than 23 (normal), and 23 or more (high). Higher spKt/V was associated with lower ­all-cause mortality in patients with low to

evaluating testosterone therapy as a potential VTE risk factor,” the investigators wrote.

Of the 3110 men with hypogonadism, 1330 (42.8%) were prescribed testosterone in the 12 months before their VTE event. Of the 36,512 men without

How testosterone is administered has no effect on VTE risk, a study found. ­ ypogonadism, 374 (1.0%) were preh scribed testosterone in the 12 months prior to their VTE event.

The investigators defined exposure case periods of 6 months, 3 months, and 1 month before the incident VTE event,

normal BMI. Survival in the high-BMI group, however, was not significantly improved at higher doses of dialysis.

Patients with low BMI had a higher risk for all-cause mortality at all spKt/V levels than those with normal BMI and spKt/V within target. The mortality gap narrowed at higher spKt/V values.

High BMI appeared protective.

Patients with high BMI and spKt/V less than 1.2 were not at increased risk for mortality despite low dialysis adequacy compared with patients with a normal BMI and target range spKt/V. Patients with a high BMI with spKt/V of 1.2 or greater were actually at lower risk for all-cause mortality than reference patients with a normal BMI and target range spKt/V. Increasing spKt/V above target did not provide any additional survival benefit in high-BMI patients.

Malnutrition-inflammation complex syndrome and protein energy wasting likely account for the relationship between lower BMI and greater mortality among dialysis patients, Dr Lee’s team stated. Smaller patients, who have a lower urea distribution volume, also tend to experience higher post-dialysis urea rebound and greater generation of uremic toxins per unit of body mass, they noted.

High BMI, however, may indicate good nutritional status and outweigh the influence of dialysis adequacy, Dr Lee’s team explained. ■

with equivalent exposure control periods starting 6 months before the corresponding case period. Each case patient served as his own control. Walker and his collaborators defined case periods based on the time that testosterone therapy is thought to affect pathophysiologic factors known to increase VTE risk.

Among men without hypogonadism, testosterone prescriptions were more common in the 6 months immediately before the VTE event (294 men) than in the control period (177 men). Testosterone use in the 1-, 3-, and 6-month case periods was significantly associated with 1.96-, 2.02-, and 2.46fold increased odds of VTE, respectively, compared with testosterone use in the equivalent control periods in adjusted analyses.

Among men with ­hypogonadism, testosterone use also was higher

­uring the 6-month case period d (1069 men) than in the control period (697 men). Testosterone use in the 1-, 3-, and 6-month case periods was significantly associated with 1.66-, 2.28-, and 2.32-fold increased odds of VTE, respectively, compared with the control periods 6 months earlier after adjusting for confounding variables. The study found no significant difference in VTE risk among the various routes of testosterone administration.

“Men experiencing common symptoms that result from natural aging have considered testosterone therapy as a treatment; however, men without hypogonadism should assess cardiovascular disease risk with their physicians before prescription to minimize adverse cardiovascular outcomes,” Walker’s team concluded. ■

Elevated Levels of Vitamin D Binding Protein Up RCC Risk HIGH SERUM LEVELS of vitamin D bind-

have a college degree. Men had lower

ing protein (DBP) are associated with an

DBP levels than women. Current smok-

increased risk of renal cell carcinoma

ers were more likely to have higher DBP

(RCC), according to a new study.

levels, whereas former smokers were

In a nested case-control study that included participants in the Prostate,

more likely to have lower DBP. The findings from this study contrast

Lung, Colorectal, and Ovarian Screening

with those of previous investigations

(PLCO) trial, individuals in the highest

(the Alpha-Tocopherol, Beta-Carotene

quartile of DBP had significant 4.1-fold

Cancer Prevention Study and the

increased odds of RCC compared

American Cancer Society Prevention

with those in the bottom quartile after

Study-II Cohort), which demonstrated

adjusting for history of diabetes, history

an inverse association between DBP

of hypertension, family history of kidney

and RCC, Dr Mondul’s group noted.

cancer, and other variables, Alison M.

Genetic differences is one possible

Mondul, PhD, MSPH, of the University

explanation, they stated.

of Michigan School of Public Health in

Study strengths included a relatively

Ann Arbor, and colleagues reported in

large sample size, the prospective

the International Journal of Cancer.

nature of the cohort, and the availability

The study population included 323

of detailed information on many poten-

cases matched by age, sex, race, and

tial confounders that could be adjusted

date of blood collection to 323 controls.

for in multivariable models, Dr Mondul

Case patients were more likely than

and her colleagues noted. With regard

controls to have a higher body mass

to study limitations, the investigators

index, to have smoked, and to have

pointed out that their study population

a history of hypertension and history

was largely white, possibly limiting their

of diabetes mellitus, the investigators

ability to generalize their findings to

reported. They also were less likely to

other racial groups. ■

20 Renal & Urology News

NOVEMBER/DECEMBER 2019 www.renalandurologynews.com

Prostate Cancer May Be Linked to Higher Levels of 2 Hormones

Stone Formers Have Worse PCI Outcomes

Insulin-like growth factor-I and free testosterone may be modifiable risk factors

PATIENTS WHO HAVE a history of kidney stones are more likely to have adverse outcomes following percutaneous coronary intervention (PCI), new data suggest.

Chao-Han Lai, MD, PhD, of National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan, and colleagues identified adult patients undergoing first-time PCI at Vanderbilt University Medical Center (VUMC) in Nashville, Tennessee, and the National Health Insurance Research Database (NHIRD) in Taiwan. The VUMC and NHIRD cohorts included 11,289 and 155,762 patients, of whom 294 and 12,286 had a history of kidney stones, respectively.

The median follow-up periods were 2.5 years in the VUMC cohort and 3.7 years in the NHIRD cohort.

After matching patients by propensity score, stone formers at VUMC had nearly 2.8-fold increased odds of 30-day in-hospital mortality (the study’s primary outcome) and 1.6- and 1.4-fold increased risks of myocardial infarction (MI) at 1 and 3 years, respectively, according to a paper published online ahead of print in Urology. In the NHIRD group, kidney stone history was significantly associated with significant 12% and 14% increased risks of MI at 1 and 3 years.

BY JOHN SCHIESZER NEW RESEARCH SUGGESTS it may be possible for men to lower their risk for prostate cancer (PCa) by altering serum levels of insulin-like growth factor-I (IGF-I) and free testosterone.

Researchers investigated PCa incidence and mortality in a study of up to 200,452 men who were free of cancer at baseline. A subset of 7794 men provided a second blood sample at a later date to help the researchers account for natural fluctuations in hormone levels.

A total of 5,412 men were diagnosed with PCa and 296 died from the cancer during a mean follow-up of 6.9 years.

Results showed that each 5 nmol/L increase in IGF-I was associated with a 9% increased likelihood of PCa diagnosis and a 15% increased risk of prostate cancer death. Each 50 pmol/L of free testosterone was associated with a 10% increase in PCa risk, but was not related to prostate cancer death.

The researchers concluded men with the highest levels of IGF-I had a 25% greater risk of PCa compared with

Study links prostate cancer to higher levels of IGF-I and free testosterone. those who had the lowest levels. Men with the highest free testosterone levels had an 18% greater risk of PCa compared to those who had the lowest levels. Higher levels of sex hormone binding globulin (SHBG) were associated with a lower risk. Neither higher total testosterone levels nor higher SHBG was associated with PCa mortality. Total testosterone concentration was not associated with PCa incidence or mortality.

“This is the first time we have seen a higher risk of prostate cancer with higher blood levels of free testosterone.

Our previous work had shown that men with very low levels of free testosterone had a lower risk, but not increasing risk with raised free testosterone,” said study investigator Ellie Watts, a research fellow with the Nuffield

Key Points • The highest vs lowest levels of free testosterone and IGF-I were associated with 18% and 25% increased risks of prostate cancer (PCa), respectively.

• Higher levels of sex hormone binding globulin were associated with a lower PCa risk.

• Higher total testosterone and SHBG levels were not associated with PCa death.

Department of Population Health, University of Oxford, UK. The findings, which were presented at the 2019 National Cancer Research Institute Cancer Conference in Glasgow, UK, suggest there are 2 new potentially modifiable risk factors for PCa. The next step is to gain a fuller understanding of the determinants of these hormones and to find ways to modify these hormones through lifestyle and dietary changes, Watts said. “We know, for example, that vegans have lower levels of IGF-I and also have a lower risk of prostate cancer.”

Because blood tests were taken many years prior to the development of PCa, the researchers theorize it is likely that the hormones increase PCa risk rather than the other way around. Owing to the large size of the study, the researchers could account for other factors that can influence cancer risk, including body size, socioeconomic status, and diabetes.

Previous studies conflicting William J. Catalona, MD, Professor of Urology and the Director of the Clinical Prostate Cancer Program at the Northwestern University School of Medicine in Chicago, said numerous previous studies examining a possible association of IGF-I levels with PCa risk and aggressiveness have yielded conflicting results. Some studies showed no significant relationship. This large study, however, has more statistical power than previous investigations. “The role of testosterone and the androgen receptor is well established in the development,

progression, and treatment of prostate cancer, although ­hypogonadal men also can develop aggressive disease,” Dr Catalona told Renal & Urology News.

“In my view, there could be something important in this association, but it will take more research to determine whether these observations could have a meaningful impact on prevention, early detection, or treatment of this disease.”

Michael S. Leapman, MD, Assistant Professor of Urology at the Yale School of Medicine in New Haven, Connecticut, said the current study findings are congruent with several prior studies and could be clinically relevant. “Given the global burden of the disease, this work is important and may provide additional insight about the mechanisms that contribute to prostate cancer development,” Dr Leapman said.

Intervention trial needed While these findings are hypothesisgenerating and suggest an etiologic association between serum IGF-I and free testosterone levels and PCa risk, an intervention trial is needed for confirmation. “If it can be shown that changes in IGF-I and free testosterone levels can modify prostate cancer risk, this would create a tremendous opportunity to counsel patients on specific interventions such as diet, lifestyle or pharmacotherapies that might reduce risk or improve outcome,” Dr Leapman said.

Michael Whalen, MD, Assistant Professor of Urology at the George Washington School of Medicine and Health Sciences in Washington, DC, said the new study is well-powered and the methodology of repeating the blood sample to account for hormonal fluctuations was prudent. The authors’ conclusions that the finding of elevated free testosterone and IGF-1 prior to development of the PCa is the cause of PCa may be flawed because a man’s PCa risk increases as he ages. “Depending on the mean age of the participants, many men may have been too young to mature into the age range when prostate cancer would be commonly diagnosed,” Dr Whalen said. “Also, the follow-up time of 6 to 7 years is likely too short to derive meaningful conclusions about prostate cancer incidence.” ■

Recent study reveals higher in-hospital mortality and 1-year and 3-year MI risks.

“We demonstrate that kidney stone patients undergoing PCI have increased risks of early and late adverse cardiac outcomes,” Dr Lai and colleagues concluded. “These findings suggest that kidney stone history may be a clinical indicator to risk-stratify patients undergoing PCI to better inform more aggressive secondary cardiac prevention measures. Our study adds to the growing body of literature linking kidney stone disease and coronary artery disease.”

The authors wrote that it “is plausible to speculate that kidney stone disease is a marker of the presence of more severe clinical or subclinical cardiovascular risk factors leading to poorer outcomes following PCI.” ■

www.renalandurologynews.com NOVEMBER/DECEMBER 2019

Renal & Urology News 21

Apalutamide Plus ADT Maintains HRQoL Men with mCSPC did not experience worsening pain and fatigue with apalutamide adjunctive therapy

BY NATASHA PERSAUD APALUTAMIDE USED AS adjunctive therapy to androgen deprivation therapy (ADT) improves survival and maintains health-related quality of life in men with metastatic castration-sensitive prostate cancer (mCSPC), according to a new analysis.

In previously published findings from the phase 3 TITAN randomized trial, adding apalutamide, a nonsteroidal androgen receptor inhibitor, to ADT significantly improved overall survival by 33% and radiographic progression or death by 52% compared with placebo plus ADT in 1052 men with mCSPC. Time to initiation of cytotoxic chemotherapy was also prolonged by a significant 61% with apalutamide.

In an online report published in The Lancet Oncology, Neeraj Agarwal, MD, of the University of Utah in Salt Lake City, and colleagues presented patient-

RC Techniques Offer Similar 5-Yr Outcomes LAPAROSCOPIC, robotic-assisted, and open radical cystectomy are associated with similar long-term oncologic outcomes among patients with ­muscleinvasive or high-risk ­nonmuscle-invasive bladder cancer, according to findings from the CORAL study, the only randomized trial comparing the 3 surgical approaches.

In the study, investigators randomly assigned patients with muscle-invasive bladder cancer (MIBC, 38 patients) or high-risk nonmuscle-invasive bladder cancer (HRNMIBC, 21 patients) to undergo laparoscopic radical cystectomy (LRC, 19 patients), roboticassisted radical cystectomy (RARC, 20 patients), or open radical cystectomy (ORC, 20 patients).

The 5-year recurrence-free survival (RFS) rates associated with these procedures were 71%, 58%, and 60%, respectively, Muhammad Shamim Khan, MBBS, of Guy’s & St Thomas’ NHS Foundation Trust in London and MRC Centre for Transplantation, King’s College London, and colleagues

reported outcomes from TITAN. Participants completed the Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EuroQoL 5D questionnaire 5 level (EQ-5D-5L) at baseline, 4,

Findings are based on patient-reported outcomes from the TITAN trial.

8, and 12 months, and other specified time points.

The men were mostly asymptomatic at baseline, with low reported levels of pain and fatigue. Median pain scores on a scale of 0 to 10 on the BPI-SF were 1.14 for apalutamide vs 1.00 for

reported in European Urology. The 5-year cancer-specific survival (CSS) rates were 69%, 68%, and 64%, respectively. The 5-year overall survival (OS) rates were 61%, 65%, and 55%, respectively.

The median follow-up for patients in the LRC, RARC, and ORC arms was 83.8, 86.6, and 65.6 months, respectively. The median follow-up for survivors was 91.4, 102.7, and 104.7 months, respectively.

Dr Khan and his team concluded that the 3 surgical approaches demonstrated no significant differences in 5-year RFS, CSS, and OS. “Minimally invasive techniques achieved similar oncological outcomes to the gold standard of ORC,” they wrote. “However, the results need to be interpreted with caution due to the small sample size.”

Findings should provide some reassurance to clinicians and patients, according to the investigators.

The authors noted that minimally invasive techniques provide benefits such as decreased blood loss, more rapid recovery, shorter hospital stay, and a reduction in wound complications. “However, aside from these perioperative benefits, there is as yet little evidence to suggest that these approaches yield superior oncological outcomes, which are largely dependent on the local stage and biology of the disease, and perhaps the experience of the surgeons performing the procedures.” ■

placebo recipients. Median fatigue scores on the BFI were 1.29 vs 1.43, respectively. These symptoms remained stable or improved over nearly 2 years of the study. Median time to worst pain intensity progression was 19.09 vs 11.99 months, respectively, favoring apalutamide by 11%. Median time to pain interference progression was not reached in either group. The 25th percentiles for time to pain interference progression were longer with apalutamide: 9.17 vs 6.24 months, respectively.

In addition, HRQoL was preserved in both groups based on FACT-P total scores and EQ-5D-5L data. Median time to deterioration was 8.87 vs 9.23 months, respectively, a nonsignificant difference.

The improvements in survival and maintenance of HRQoL demonstrated in the TITAN study “indicated that treatment with apalutamide plus ADT should

be considered a new option for standard of care for a broad range of patients with metastatic castration-sensitive prostate cancer,” Dr Agarwal’s team wrote.

Suzanne Chambers, PhD, of the University of Technology Sydney in Australia, and colleagues concurred in an accompanying editorial, but noted that additional QoL data are still needed.

“These results suggest that apalutamide is well tolerated in these patients, and therefore it seems to be a favourable option for patients from the points of view of both survival and quality of life. However, as noted by Agarwal and colleagues, other relevant patient outcomes, such as mood disturbance, insomnia, and cognitive deficits, were not assessed, meaning that the evaluation of quality of life was not extensive.”

The TITAN studies were funded by Janssen Research & Development, the makers of apalutamide (Erleada). ■

Segmental Ureterectomy An Option in Some UTUC Cases RADICAL nephroureterectomy (RNU)

and 38% decreased odds of having

is the gold standard for patients with

high-grade tumors than RNU patients.

upper tract urothelial carcinoma

All of these differences between the

(UTUC), but segmental ureterectomy

SU and RNU groups were statistically

(SU) may be an alternative approach

significant.

for some patients, according to new

After surgery, the estimated glo-

study results published in Clinical

merular filtration rate (eGFR) rose by a

Genitourinary Cancer.

mean 10.97 mL/min/1.73 m2 higher

Riccardo Autorino, MD, PhD, of VCU

in the SU group. SU patients, however,

Health Richmond in Virginia, and his col-

had significant 36% decreased odds of

leagues conducted a systematic review

5-year relapse-free survival compared

and meta-analysis of 18 nonrandom-

with RNU patients.

ized studies published from 2000 to

Overall, 16% of SU patients and 15%

2019 comparing the 2 procedures. The

of RNU patients received adjuvant

meta-analysis included a total of 1313

chemotherapy. Metastasis-free and

SU and 3484 RNU patients with similar

cancer-specific survival at 5 years did

baseline characteristics.

not differ between the groups.

SU patients were twice as likely as

“SU can be considered as a treat-

RNU patients to have a history of blad-

ment option for patients with UTUC in

der cancer. They had 7.5-fold greater

selected cases as it offers better pres-

odds of ureteral tumors, but 48%

ervation of renal function,” Dr Autorino’s

decreased odds of presenting with

team concluded. “However, a strict

preoperative hydronephrosis com-

follow-up is mandatory in these cases

pared with RNU patients. In addition,

to avoid jeopardizing the oncologic out-

SU patients had 34% decreased odds

come. In advanced high-risk disease,

of having stage pT2 or higher cancer

RNU remains the standard of care.” ■

www.renalandurologynews.com NOVEMBER/DECEMBER 2019

Renal & Urology News 23

Ethical Issues in Medicine P

hysicians are required to complete conflicts of interest (COI) disclosures for a variety of activities, such as providing continuing medical education, submitting an article to a journal for publication, or considering financial relationships with industry. If completing COI disclosures sometimes feels like a tiresome bureaucratic exercise or if it is not always entirely clear what constitutes a COI, why they are relevant, or why they should be disclosed, you are probably not alone.

Good reasons exist for disclosing COIs, notably that such disclosure promotes the good of patients and the profession.

Openess against potential bias With regard to practicing physicians, a COI refers to a situation in which a physician’s judgment regarding a patient’s wellbeing—the primary interest—is at risk of being biased by a secondary interest that can harm patients.1 Secondary interests could include financial gain, but they can also refer to an interest in career advancement, ability to obtain grant funding, professional recognition, and personal interests like work-life balance. This is relevant because rules and policies for COI disclosures in some health systems may be limited to financial matters.

A COI does not require either patient harm or proof that a physician’s professional judgment is or was biased. It only requires that the judgment regarding a patient’s well-being is at risk of being biased by a secondary interest.

Using this definition, scholars and others have thus broadened the perspective on what is considered a COI. Unfortunately, some physicians may be apprehensive that this suggests that one’s professional judgment can be impugned simply by association.

Having a COI, however, is not necessarily ethically problematic, but having a COI and not disclosing or managing it can be. This gets to the reason why disclosing COI is so important.

Fundamentally, failure to identify and manage a COI adequately may undermine the trust that patients have in their physicians and the medical

profession. In other words, if patients believe physicians are making decisions that promote other interests over their own, they will lose what is arguably a central aspect of the patient-physician relationship: trust.2 Furthermore, in some health systems, failing to disclose COIs may have legal implications when existing rules and regulation prohibit financial COIs. COIs vary by the likelihood and magnitude of harm that might occur if they are not managed adequately.

For example, consider the situation in which a physician has been asked to serve on the board of a start-up pharmaceutical company because the physician has significant experience with the patient population that would be served by a drug the company is developing. The company has offered to pay the ­physician $20,000 over the next 6 months to review development materials and attend board meetings. The physician is eager to consider this board seat because it provides an opportunity to learn about running complex organizations and to translate professional work into treatment.

© TANG YAU HOONG / GETTY IMAGES

Physicians’ disclosure of conflicts of interest protects their professional integrity and ensures patient trust BY DAVID J. ALFANDRE, MD, MSPH

consult with their ethics committee or legal counsel if they have specific questions about their particular situations.)

Financial compensation Financial compensation for serving on the board presents a more significant, ethically problematic COI that

Physicians must be open about secondary interests such as financial gain that have the potential to bias their clinical judgment.

The likelihood and magnitude of the harm from either serving on the board or accepting financial compensation are likely to be different. In both cases, because the time, attention, or reimbursement may risk biasing the physician’s professional judgment regarding patient care, both situations represent a COI. Serving on the board, however, may not have the same likelihood or magnitude of risk of biasing a physician’s judgment, and thus could be managed and ethically justifiable. In other words, serving on a board may still be a COI that should be disclosed, but it may not necessarily be prohibited.3 (Physicians should

may be more likely to bias professional ­judgment and be more difficult to manage. In accepting money, a physician establishes an implicit “quid pro quo” relationship (already well-established in the social science literature)4 that may, for example, lead the physician to be more likely to recommend the class of medication the company is developing or medication in general.

Disclosing COIs is part of a physician’s professional and ethical responsibility to ensure that patients trust that their medical needs and well-being are their physicians’ top concern. Having a COI does not necessarily pose an ethical concern if

it is managed adequately and is not likely to harm patients or impair judgment.

Physicians need not feel defensive for having such a COI. Having a COI that has a high likelihood and magnitude of harm to patients can be problematic, however.

Figuring out the difference between the two (often with help from an ethics and/or legal consultation) helps protect the integrity of the profession and may help the physician to sleep better at night.

In the next column, I will discuss managing COIs. ■ David J. Alfandre MD, MSPH, is a healthcare ethicist for the National Center for Ethics in Health Care (NCEHC) at the Department of Veterans Affairs (VA) and an Associate Professor in the Department of Medicine and the Department of Population Health at the NYU School of Medicine in New York. The views expressed in this article are those of the author and do not necessarily reflect the position or policy of the NCEHC or the VA. REFERENCES 1. McCoy MS, Emanuel E. Why there are no “potential” conflicts of interest. JAMA. 2017;317:1721-1722.

2. Fineberg HV. Conflict of interest: Why does it matter?

JAMA. 2017;317:1717-1718.

3. Lo B. Serving two masters—conflicts of interest in academic medicine. N Engl J Med. 2010;362:669-671.

4. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA. 2003;290:252-255.

24 Renal & Urology News

NOVEMBER/DECEMBER 2019

www.renalandurologynews.com

Practice Management S

ue Jacques of Calgary, Alberta, an author and speaker on professionalism, civility, and respect in the workplace, learned to appreciate patient engagement after 2 medical procedures. In one office, a staff member was assigned to her during a procedure and personally followed up after.

After bilateral eye surgery, her ophthalmologist phoned to ensure she was all right and inquire if she had questions.

“I had never had an experience like that before, and I needed it in that moment,” Jacques said. “Healthcare can be intimidating, and having someone who can speak a patient’s language and act as a liaison to ask questions and follow up with is good.”

The role of patient engagement staff is to improve the care process and facilitate communication between patients and staff. “They are there to listen, respond, and make sure patients’ concerns are dealt with in a compassionate and thoughtful manner,” Jacques said.

“You don’t just assign this to someone and walk away,” said Jacques, who has a background in forensics and emergency room nursing. “It takes time and effort and a lot of care to decide how this works for each practitioner.”

The patient engagement staffer’s responsibilities, for instance, will be different for a practice that has a lot of patient turnover than for one whose patients have a lot of complex chronic conditions.

One option for a patient engagement representative is to make calls after procedures to check in on patients, answer questions, and schedule follow-up visits.

Another is to have someone who calls patients and lets them know about schedule changes or delays in their visit time.

“It takes a bit of time, but it can change the outcome of an entire exam if patients are notified,” she said. “Your whole attitude is different when you know you will be waiting or can come in late instead of it happening unexpectedly.”

“They are there to listen, respond, and make sure patients’ concerns are dealt with in a compassionate and thoughtful manner.”

She added, “Medicine has become a business, and a good business makes sure there is strong customer support.”

What they do The duties of a patient engagement staff member are going to vary among practices. It is important, however, to ensure that this person’s role and responsibilities are well outlined. The staffer also needs to understand when they can help patients and when to pass concerns or issues to a doctor or another staff member.

Finally, she said a good way to use this staffer is as a point person for patients with chronic illnesses. They can relay patient issues to doctors, nurses, or pharmacists. This not only keeps the patient from having to talk with various people for care, but it keeps the provider in the loop with each patient.

“I manage the entire patient experience,” said Michael Taylor, the practice manager and patient engager for Ashutosh Tewari, MD, a urologist and

Upcoming News

© ANDERSEN ROSS PHOTOGRAPHY / GETTY IMAGES

Patient engagement staff can improve healthcare delivery and facilitate communication between patients and staff BY TAMMY WORTH

The role of patient engagers includes facilitating communication between patients and staff.

prostate cancer specialist at Mount Sinai Health System in New York. “I really take the lead to make sure everyone is comfortable and allow the medical staff to do what they do best.”

He said he “hand holds” patients who are having surgery, assisting them with radiologic imaging, biopsies, and follow-up appointments. He even sat in a waiting room talking with anxious spouses to “make them feel like family.”

He nearly took a cab to a hospital in neighboring New Jersey to get pathology slides for a patient to avoid cancelling a surgery (the slides were found before he made the trip). He even gives his cell phone number to patients in case they have questions or concerns.

In hiring patient engagers, providers should look for such customer service qualities as positivity, patience, and good problem-solving and communication skills, Jacques said. She also recommends hiring people with some medical background. These individuals do not necessarily need to be in the

practice all day. A good candidate for the position of patient engager might be someone wanting to ease into retirement by cutting back hours or working a flexible schedule.

“It could be the perfect opportunity for someone who is happy to make follow-up calls between 6 and 9 in the evening,” she said.

Getting back to basics Having a good patient engagement representative could be a way to get back to the basics of healthcare and “make sure the soul of the patient is being cared for,” Jacques said.

“This is an opportunity to blend professionalism with civility and provide good care for people in their times of concern, trouble, worry or pain for them,” she said. “And if you can provide that kind of emotional care, it will enhance the care you are providing all around.” ■ Tammy Worth is a freelance medical journalist based in Blue Springs, MO.

Renal & Urology News will be covering the 2020 Genitourinary Cancers Symposium in San Francisco, February 13–15. Go to www.renalandurologynews.com for daily reports on noteworthy studies.