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VOLUME 20, IS SUE NUMBER 6
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RT for Oligometastatic RCC Promising
© IMAGE COURTESY OF CHAD TANG, MD
Serial radiation therapy could provide an alternative to standard-of-care systemic therapy
LUNG METASTASIS in oligometastatic RCC before (left) and after SBRT.
ICPi-AKI Predictors Identified BY JODY A. CHARNOW LOWER BASELINE kidney function, use of proton pump inhibitors (PPIs), and extrarenal immune-related adverse events are independent risk factors for acute kidney injury related to immune checkpoint inhibitors (ICPi-AKI), according to study data presented at the American Society of Nephrology’s Kidney Week 2021. The study included 429 patients diagnosed with ICPi-AKI at 30 sites across North America, Europe, and Asia. ICI-related AKI developed at a median of 16 weeks after ICPi initiation. Investigators compared these patients with 429 controls who received ICPi therapy contemporaneously but did not experience ICPi-AKI.
Compared with a baseline estimated glomerular filtration rate (eGFR, in mL/ min/1.73 m2) of 90 or higher, values of 45-59 and less than 45 were significantly associated with 2.2- and 2.6-fold increased odds of ICPi-AKI, respectively, in adjusted analyses, first author Shruti Gupta, MD, MPH, of Brigham and Women’s Hospital in Boston, Massachusetts, reported. PPI use was significantly associated with 2.4-fold increased odds of ICI-related AKI compared with nonuse. Prior or concomitant extrarenal immune-related adverse events were significantly associated with 2.1-fold increased odds of ICPi-AKI. Renal recovery, defined as a nadir serum creatinine level less than or equal continued on page 6
BY JOHN SCHIESZER SERIAL RADIATION therapy appears to be safe and effective as an alternative treatment to systemic therapy for oligometastatic renal cell carcinoma (RCC), recent study findings suggest. The findings challenge a widely held belief in radiation oncology that RCC is biologically radioresistant, said lead investigator Chad Tang, MD, an assistant professor of radiation oncology at The University of Texas MD Anderson Cancer Center, Houston, Texas. Radiation has mostly been used as a palliative approach to relieve pain or manage symptoms in patients with metastatic RCC. Trial results, which were published in The Lancet Oncology, show that serial
DFS Predicts OS After First Nephrectomy LONGER DISEASE-FREE survival (DFS) following initial nephrectomy for intermediate-high risk and high-risk renal cell carcinoma (RCC) predicts longer overall survival (OS), investigators reported at the International Kidney Cancer Symposium (IKCS) 2021. The finding suggests that DFS can be useful as a predictor of OS in the RCC adjuvant setting when the OS data are immature, they concluded. The investigators, Naomi B. Haas, MD, of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues, stated that as far as they are aware, their study is the first to assess the association between DFS and OS among patients with intermediate-high risk and highrisk RCC post-nephrectomy using realworld patient-level data. Dr Haas’ team conducted a retrospective observational study using 20072016 data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare continued on page 6
radiation therapy offered progressionfree survival (PFS) similar to frontline systemic therapy, but with much less toxicity, Dr Tang said. The trial also provided evidence of the biologic effectiveness of radiotherapy at the histologic level in paired biopsy samples. Dr Tang and colleagues analyzed the use of stereotactic body radiation therapy (SBRT) as an alternative treatment to standard-of-care systemic therapy for oligometastatic RCC. The researchers enrolled 30 patients between July 2018 and September 2020 who were diagnosed with clear cell RCC and had 5 or fewer metastatic lesions. The trial consisted of 20 Whites (67%), 7 Hispanics (23%), 2 Blacks (7%), and 1 Native continued on page 6
IN THIS ISSUE 4
Prostate cancer found to lower kidney transplant odds
5
Video shows promise in informing men about PCa genetic testing
12
Reasons why men drop PCa active surveillance identified
12
Air pollution may worsen kidney transplant outcomes
13
Partial, radical cystectomy for MIBC may offer similar survival
15
Chest imaging after surgery for RCC T1a tumors not warranted
15
Few patients stay on PTNS therapy for OAB long term
Long-term aspirin use is associated with a lower risk for CKD progression. PAGE 3
www.renalandurologynews.com
Contents
NOVEMBER/DECEMBER 2021
NOVEMBER/DECEMBER 2021
Urology 4
ONLINE
this month at renalandurologynews.com
12
Why Men Drop PCa Active Surveillance Tumor grade reclassification is the leading cause of converting to treatment.
13
PC, RC May Offer Similar Survival in MIBC Patients Patients undergoing either partial or radical prostatectomy using a minimally invasive vs open procedure had a significant 66% decreased risk for death.
Clinical Quiz Test your knowledge by taking our latest quiz at renalandurologynews.com/ run-quiz
15
HIPAA Compliance Read timely articles on various issues related to keeping protected health information secure.
Drug Information
3
Long-Term Aspirin Use Associated With Lower CKD Progression Risk Veterans who used aspirin for at least 90 days had a significant 45% lower risk for progressing to dialysis or a 40% or greater decline in eGFR.
3
Intensive BP Control May Increase Death Risk A mean systolic blood pressure less than 120 vs 130 mm Hg or more raised all-cause mortality risk by 26% in adjusted analyses.
4
PCa Possibly Delays Kidney Transplants Study reveals a 22% decreased likelihood of receiving a kidney transplant.
Job Board
News Coverage Visit our website for daily reports on the latest developments in clinical research.
Chest Imaging After RCC Surgery Not Warranted In a study of 463 patients who underwent surgical excision of T1a tumors, pulmonary recurrence was not detected in any patient.
VOLUME 20, ISSUE NUMBER 6
CALENDAR Editor’s note: The 2022 conference listings below include information provided by the sponsoring organizations on their websites as this issue went to press. Genitourinary Cancers Symposium San Francisco, CA February 17-19 42nd Annual Dialysis Conference Virtual Meeting March 5-6 European Association of Urology 37th Annual Congress Amsterdam, The Netherlands March 18-21 National Kidney Foundation Spring Clinical Meetings Boston, MA April 5-9 European Renal Association 59th Congress Paris, France, and Virtual May 19-22 American Transplant Congress Boston, MA June 4-8
Nephrology
Search a comprehensive drug database for prescribing and other information on more than 4000 drugs.
Be sure to check our latest listings for professional openings across the United States.
Neoadjuvant Chemotherapy Benefits BCG Progressors The treatment decreased the odds of pathologic upstaging by 81% and 74% among patients with progressive and de novo muscle-invasive bladder cancer, respectively.
■
Renal & Urology News 1
12
Fluoroquinolones Tied to Higher SCD Risk in HD Patients Respiratory fluoroquinolone therapy was significantly associated with a 2-fold higher risk for sudden cardiac death within 5 days compared with amoxicillin.
14
Departments 2
From the Medical Director Structural racism in kidney care must come to an end
7
News in Brief The efficacy of post-RP botulinum toxin varies by OAB type
14
Ethical Issues in Medicine An equity approach may help to address health care disparities
16
Practice Management Hackers can target vulnerabilities in health care apps
Respiratory fluoroquinolones should still
be prescribed to patients receiving hemodialysis when an amoxicillin-based antibiotic would be suboptimal. See our story on page 12
2 Renal & Urology News
NOVEMBER/DECEMBER 2021 www.renalandurologynews.com
FROM THE MEDICAL DIRECTOR EDITORIAL ADVISORY BOARD
Time to End Structural Racism in Kidney Health
F
or 20 years, race, a social interpretation of how one looks, has been a core component of leading equations used to calculate estimated glomerular filtration rate (eGFR). These equations were meant to replace the Cockcroft-Gault (CG) equation, a race-neutral approach that used age, sex, and weight to estimate creatinine clearance. The first widely used eGFR equation—the Modification of Diet in Renal Disease (MDRD) study equation—was introduced to replace the CG equation because the latter was criticized for not incorporating body surface area indexing. The assumption was that Black individuals have higher serum creatinine with the same level of kidney function as Whites because on average they have more muscle mass. Even if this is biologically plausible, it was wrong to use racial profiling as a surrogate for higher muscle mass. The CKD-EPI equation that followed a decade later kept the race index in the eGFR calculation. There is now little doubt that both the MDRD and CKD-EPI equations have contributed to structural racism in medicine and public health. How health care providers embraced these race-based equations for 2 decades is unclear. These equations resulted in eGFR values 16% to 21% higher for Black patients than White patients. Patients have continued to receive differential treatments because of their race. Black patients of the same age and sex as White patients and who had the same serum creatinine concentration would not be waitlisted for kidney transplantation because their eGFR values would be higher than the expected threshold for waitlisting eligibility. If this is not structural racism, then what is it? The lesson from this experience is that we should be careful before discrediting well-established methods for estimating kidney function and replacing them with new ones. We should never allow race or other social constructs such as sexual orientation or place of birth to be used for any type of profiling. Clinical pharmacists, to their credit, have never given up using the CG equation for drug dosing. Recently, some colleagues who were also involved with the creation of the MDRD and CKD-EPI equations in the past rushed to introduce a new race-neutral eGFR equation based on data from studies of several thousand people. So far, I have decided not to use it. Rather, I use the current equations without the race index: the CG equation that has a weight adjustor, and increasingly, cystatin C-based equations that are inherently race-neutral. Let us never forget that race is a social construct that should have no place in addressing biologic variability in anything, including kidney function or muscle mass. Kam Kalantar-Zadeh, MD, PhD, MPH Professor & Chief, Division of Nephrology, Hypertension & Kidney Transplantation UC Irvine School of Medicine, Orange, CA Twitter/Facebook: @KamKalantar
Medical Director, Urology
Medical Director, Nephrology
Robert G. Uzzo, MD, MBA, 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 & Kidney Transplantation UC Irvine School of Medicine Orange, CA
Nephrologists Anthony J. Bleyer, MD, MS Professor of Internal Medicine/Nephrology Wake Forest University School of Medicine Winston-Salem, NC
Urologists 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
Csaba P. Kovesdy, MD Chief of Nephrology Memphis VA Medical Center Fred Hatch Professor of Medicine University of Tennessee Health Science Center Memphis
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 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 Kenneth Pace, MD, MSc Assistant Professor, Division of Urology St. Michael’s Hospital University of Toronto Vancouver, Canada
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 Rulan Parekh, MD, MS Associate Professor of Pediatrics and Medicine University of Toronto Robert Provenzano, MD Associate Professor of Medicine Wayne State University School of Medicine Detroit Vice President of Medical Affairs, DaVita Healthcare Denver
Renal & Urology News Staff Editor
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Renal & Urology News (ISSN 1550-9478) Volume 20, 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). For reprint/licensing requests, contact Customer Service at custserv@haymarketmedia.com. 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 © 2021.
www.renalandurologynews.com NOVEMBER/DECEMBER 2021
■ KW 2021
Renal & Urology News 3
American Society of Nephrology’s Kidney Week 2021
Long-Term Aspirin Use Associated With Lower CKD Progression Risk Beneficial effect observed in patients taking the drug for at least 90 days
AKI Increases Readmission, Mortality Risk ACUTE KIDNEY injury (AKI) is an inde-
BY JODY A. CHARNOW LONG-TERM ASPIRIN (ASA) use may be associated with slower deterioration of renal function and decreased risk for death among patients with chronic kidney disease (CKD), according to new study findings. In a study of 856 US veterans with nondialysis CKD, a team led by Csaba P. Kovesdy, MD, of the University of Tennessee Health Science Center in Memphis, examined the association of long-term ASA use (90 days or more) with mortality and a combined renal endpoint of dialysis initiation or a 40% or greater decline in estimated glomerular filtration rate (eGFR). The study population consisted of 653 patients on long-term ASA therapy and 203 ASA nonusers (controls). The groups had mean ages of 68.1 years and 64.2 years, respectively. Of the 653 ASA patients, 7.8% did not receive low-dose ASA (less than 200 mg per day). Over a median follow-up period of 4.8 years, 315 patients (36.7%) reached
Long-term aspirin use may have renoprotective effects, a recent study found.
the combined renal endpoint (236 in the ASA group and 79 in the control arm) and 373 patients (43.5%) died (277 in the ASA group and 96 in the control arm). In a fully adjusted model, patients in the ASA group had a significant 45% lower risk for the renal endpoint and
47% lower risk for death compared with nonusers, Dr Kovesdy and colleagues reported. The investigators adjusted for demographics, body mass index, smoking status, comorbidities, steroid use, baseline eGFR, proteinuria, medication adherence, and other potential confounders. “Microinflammation may be a mechanism contributing to adverse outcomes in patients with CKD,” Dr Kovesdy told Renal & Urology News. “Low-dose ASA is usually used as an antiplatelet agent for cardiovascular indications, but may also have beneficial effects by reducing microinflammation. We found an association between longterm ASA and lower risk of a composite renal outcome and mortality in a single center cohort of patients with CKD. These results will have to be replicated in larger and more diverse cohorts and potentially in future clinical trials, before we can recommend ASA for renoprotection.” ■
pendent risk factor for rehospitalization and death both in the short- and long-term, investigators reported. Ivonne H. Schulman, MD, program director in the Division of Kidney, Urologic, and Hematologic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and colleagues compared 594,509 patients hospitalized with AKI and 594,509 propensity-score matched patients hospitalized for other causes from the 2007-2020 Optum Clinformatics database. AKI was significantly associated with a 77% adjusted increased rate of any hospital readmission within 90 days of initial discharge compared with no AKI, the investigators reported. AKI was also significantly associated with a 1.6-, 3.1-, 3.2-, and 7.9-fold increased risk for pneumonia, sepsis, heart failure, and end-stage kidney disease, respectively, within 90 days of discharge.
© GRACE CARY / GETTY IMAGES
At 1 year, the cumulative incidence
Intensive BP Control May Increase Death Risk
of all-cause rehospitalization was
INTENSIVE BLOOD pressure control targeting a systolic blood pressure (SBP) level of less than 120 mm Hg may increase mortality risk among older veterans, investigators reported. Investigators created a model based on blood pressure readings from 1,959,003 mostly male (96%) veterans who had high rates of chronic diseases, such as diabetes (36%), coronary artery disease (21%), chronic lung disease (15%), sleep apnea (11%), advanced chronic kidney disease (CKD; 7.7%), and atrial fibrillation (7.7%). Having a mean SBP of less than 120 mm Hg was significantly associated with an adjusted 26% increased risk for all-cause mortality, compared with a mean SBP of 130 mm Hg or more, Diana I. Jalal, MD, Masaaki Yamada, MD, and colleagues from The University of Iowa Roy J and Lucille A Carver College of Medicine in Iowa City reported. Death risk increased with age
sion, twice as many patients with
category and was significantly stronger among veterans aged 70 years and older. Results from this retrospective study contrast with findings from the landmark SPRINT trial due to the different populations, use of routine office vs standardized blood pressure measurement, and other factors. Among ambulatory adults aged 75 years or older in SPRINT2, treating to an SBP target of less than 120 mm Hg compared with an SBP target of less than 140 mm Hg resulted in significantly lower rates of major cardiovascular events and death from any cause. However, half of treated patients did not attain SBP of less than 120 mm Hg. In an interview with Renal & Urology News, Dr Yamada explained that findings from their observational study should be interpreted cautiously. “Based on the collective evidence, we believe that the current recommendations by ACC/AHA 2017 are reasonable; that is,
to target a SBP of less than 130 mm Hg in elderly community dwellers, while exercising caution in those with lifelimiting conditions,” Dr Yamada said. The KDIGO 2021 guideline, however, recommends a target of systolic BP less than 120 mm Hg for those with CKD with and without diabetes, Dr Yamada continued. In addition, KDIGO stipulates that it may be harmful to target SBP less than 120 mm Hg based on non-standardized blood pressure measurements. Both guidelines acknowledge that intensive blood pressure management may not be warranted in individuals with life-limiting conditions. “It is important for clinicians to apply the guidelines with a deep understanding of their own outpatient BP measurement procedures and to individualize treatment goals for each patient based on their patients’ overall health and treatment goals,” Dr Yamada said. ■
significantly higher in the AKI group. In the 2 years before the index admisAKI (55.9%) than without (26.5%) had been hospitalized. All-cause mortality rates in the AKI group were a significant 3.0- and 2.4-fold higher at 90 days and 1 year, respectively, compared with the noAKI group. In an interview with Renal & Urology News, Dr Schulman pointed out that sepsis, heart failure, and recurrent AKI — which were significantly more common in the AKI group — were the primary causes of rehospitalization within 90 days and 1 year. “While the best post-AKI clinical management regimen is yet to be determined, these results underscore the immediate need for close posthospitalization monitoring of individuals with AKI,” Dr Schulman said. ■
4 Renal & Urology News
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AVFs Often Require Intervention to Mature Almost one-third of patients needed interventions to facilitate maturation or treat a complication INTERVENTION is commonly re quired to foster maturation of arteriovenous fistulas (AVFs), maintain patency, and treat complications, according to a new study. “The findings of our study may help optimize clinical care by providing a benchmark for AVFs,” Thomas S. Huber, MD, PhD, of the University of Florida College of Medicine in Gainesville, and colleagues reported in JAMA Surgery. In the prospective, multicenter Hemo dialysis Fistula Maturation cohort study, AVF maturation rates among 380 patients with kidney failure were 29%, 67%, and 76% at 3, 6, and 12 months, respectively. Among 535 patients with nondialysis chronic kidney disease (CKD), AVF maturation rates were expectedly lower at 10%, 38%, and 58% at the respective time points. Median time to maturation was 105 days for the kidney
PCa Possibly Delays Kidney Transplants PROSTATE CANCER (PCa) reduces the likelihood of kidney transplantation and increases the risk for death among men with end-stage kidney disease (ESKD) receiving dialysis, according to a recent study. Among 588,478 men aged 40-79 years on dialysis who were identified using 1999-2015 data in the US Renal Data System (USRDS), prostate cancer developed in 18,162 (3.1%). Investigators
Study finds a 22% decreased likelihood of receiving a kidney transplant. propensity score matched 15,554 patients with PCa with 15,554 control patients without prostate cancer at the time of their counterparts’ diagnosis. Survival rates were 76%, 48%, and 30% at 1, 3, and 5 years in the PCa group, respectively, compared with 80%, 51%, and 33% in the control group. Men in the PCa group had a
failure group and 170 days for the CKD group. Sixty-four percent of all AVFs were created in the upper arm, most commonly using the brachial/ulnar/ radial-cephalic configuration.
AVF stenosis was the top reason for intervention, recent study finds. In the kidney failure and CKD groups, 37.7% and 34.6%, respectively, required interventions to foster maturation or manage complications before maturation, according to the investigators. AVF stenosis was the most common reason for intervention in both the kidney failure (26.3%) and CKD (22.5%) groups.
significant 11% higher risk for death and 22% decreased likelihood of kidney transplantation compared with controls, Nagaraju Sarabu, MD, MPH, of University Hospitals Cleveland Medical Center in Ohio, and colleagues reported in Kidney Medicine. Kidney transplantation lowered the risk for premature death by a significant 80% in both patients with and without PCa. The 5-year relative survival of 91% for patients on dialysis with vs without PCa is lower than a previously reported rate of 98% for the general population with vs without PCa, the investigators noted. They discussed several possible contributors to the higher mortality rate: Advanced PCa is more common among the men with ESKD compared with general population. Comorbidities characteristic of patients with ESKD may result in less aggressive PCa treatment. Complications of PCa treatments might be worse with ESKD. Finally, a delay in kidney transplantation due to PCa may increase the chances of death. The USRDS database lacked details on individual PCa cases, precluding analysis. “Future studies should investigate the underpinnings of increased mortality and impact of delay in transplant in balancing risks of increased mortality associated with remaining on dialysis and benefits of avoiding progression of the cancer due to immunosuppression,” the investigators wrote. ■
The kidney failure group required a tunneled dialysis catheter for a mean 2.9 months before access ascertainment. Approximately one-third of patients required hospitalization before AVF was usable: 37.7% of the kidney failure group and 33.5% of the CKD group. The functional patency for all of the AVFs that matured at 1 year was 87% and at 2 years, 75%, Dr Huber’s team reported. Patency rates were not affected by intervention. The investigators found that 47.5% of the AVFs that matured required further intervention to maintain patency or treat complications. The top reasons for intervention were AVF stenosis (38.6%), central vein stenosis (14.6%), and thrombosis (13.4%). More than half of patients in both groups required hospitalization. Overall survival rates for the kidney failure and CKD groups
were 92% vs 84% at 12 months, 74% vs 97% at 24 months, and 85% vs 76% at 36 months, respectively. “The AVF functional patency following maturation was reasonable, with a 2-year rate of 75%, but almost half of the study participants underwent some type of intervention to maintain use,” Dr Huber’s team concluded. “The associated participant morbidity in terms of [tunneled dialysis catheter] use, inpatient hospitalizations, and mortality was substantial.” The authors acknowledged study limitations. They pointed out, for example, that the study’s primary objective “was to identify predictors of AVF maturation, and accordingly, the participants were all deemed to be reasonable candidates for AVF creation. It is conceivable that the criteria for enrollment were liberalized and participants with a low likelihood of successful maturation were enrolled.” ■
Neoadjuvant Chemotherapy Benefits BCG Progressors PATIENTS WHO PROGRESS on bacillus
colleagues reported in The Journal
Calmette-Guérin (BCG) therapy to
of Urology. Further, NAC treatment
muscle-invasive bladder cancer (MIBC)
increased the odds of complete
have worse outcomes than patients
pathologic response 4.5- and 4.3-fold,
with de novo MIBC and warrant neoad-
respectively. The NAC regimen varied.
juvant chemotherapy (NAC), according to investigators. In a review of 801 patients who under-
According to the investigators, the data suggest a comparable “window of cure” exists for patients with progres-
went radical cystectomy (RC) for cT2-3
sive MIBC and justify their inclusion
N0M0 disease, 20.3% had progressive
in risk-stratified approaches to NAC
MIBC and 79.7% had de novo MIBC.
patient selection.
Among patients with low-risk disease
“Our data suggest that, until underly-
who did not receive NAC, progressive
ing molecular rationale — and validated
MIBC was significantly associated with
molecular markers — allow for person-
greater pathologic upstaging (64.9%
alized therapy (as is being studied in
vs 42.7%) and worse overall survival
various prospective trials), NAC should
(median 51.5 vs 95.1 months), cancer-
be offered to patients who have pro-
specific survival (median not reached),
gressed to MIBC after BCG therapy.”
and recurrence/metastasis-free
In an accompanying editorial, LaMont
survival (median 49.3 vs 87.9 months),
J. Barlow, MD, and Gary D. Steinberg,
compared with de novo MIBC.
MD, of NYU Langone Health in New
NAC treatment significantly
York, New York, commented: “The
decreased the odds of pathologic
present study adds to a growing body of
upstaging by 81% and 74% in the
literature attempting to elucidate the bio-
progressive and de novo MIBC groups,
logical and clinical differences between
respectively, Ashish M. Kamat, MD, of
patients initially diagnosed with MIBC
The University of Texas, MD Anderson
and patients experiencing progression
Cancer Center in Houston, and
from nonmuscle-invasive disease.” ■
www.renalandurologynews.com NOVEMBER/DECEMBER 2021
Renal & Urology News 5
Video Informs Men About PCa Genetic Testing MEN PONDERING prostate cancer genetic testing may find a pretest educational video preferable to genetic counseling (GC), according to a recent study published in JCO Precision Oncology. Thousands of men are eligible for prostate cancer genetic testing to inform precision therapy, screening, and hereditary cancer risk, but a shortage of trained genetic counselors is a barrier to testing. Counseling patients with an educational video could address this issue. “This is the first study with real-world data to publish on a pretest video in a male population in the context of prostate cancer germline testing,” said lead investigator Veda N. Giri, MD, a medical oncologist at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia, Pennsylvania, where she is director of Cancer Risk Assessment and Clinical Cancer Genetics. “Results are supportive of practice change for alternate delivery of pretest information for men to make an informed decision for genetic testing.”
(62.2%) and preference or ability to do the visit from home. The 11-minute video addressed cancer inheritance, purpose of testing, risks and benefits of testing, multigene panel options, and types of potential results. It also included implications of results for treatment, screening, and
cancer management, implications of hereditary cancer risk for blood relatives, genetic discrimination laws, and possible reproductive implications. A link to the video was sent to men who chose it. The men had an opportunity to ask questions of a study investigator before proceeding with genetic testing.
“Urology practice is now a critical doorway into hereditary cancer information for men and their families, and genetic testing is essential to consider for men due to the impact on precision medicine, emerging impact on active surveillance, and prostate cancer & said. Urology News ■ screening,”Renal Dr Giri
Educational video could address a shortage of trained genetic counselors.
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The findings are from the Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWER) Study, which included 127 men asked to choose between pretest video-based genetic education (VBGE) or GC. Of these, 90.6% had prostate cancer and 85.7% had a family history of cancer. A higher proportion of patients chose VBGE over GC (71% vs 29%). The VBGE group had a higher proportion of patients who intended to share genetic testing results (96.4% vs 86.4%). Both the VBGE and GC groups had high rates of genetic testing (94.4% and 92.0%). Cancer genetics knowledge improved to a similar extent in both groups. Major reasons for choosing the video included greater convenience (62.2%), less time commitment (37.8%), and absence of waiting time to view the video (20.2%). Individuals in the GC arm received personalized counseling by telehealth or telephone. Major reasons for choosing GC included ability to ask questions of a genetics provider
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RT for RCC continued from page 1
American (3%). The median age was 65 years, and 24 were men.
Good Tolerability All patients were treated with SBRT, but if such high doses were deemed not safe, they received hypofractionated intensity-modulated radiation therapy, Dr Tang said. Further rounds of radiotherapy were permitted for treating subsequent sites of progression. Serial SBRT as monotherapy demonstrated antitumor activity and achieved a median PFS of 22.7 months. Tolerability was good, with all patients completing at least 1 round of radiation therapy without requiring dose reduction or discontinuation due to toxicities. Only 6 patients (20%) experienced a grade 2 or less adverse event, 2 patients experienced a grade 3 event (pain and muscle weakness), and 1 patient experienced a grade 4 event (hyperglycemia). Biopsy samples collected 3 months after treatment confirmed that radiation therapy was effective in eliminating viable
ICPi-AKI predictors continued from page 1
to 1.5 times the baseline value within 90 days following ICPi-AKI, occurred in 276 (64.3%) patients. Treatment with corticosteroids was significantly associated with 2.6-fold increased odds of renal recovery, Dr Gupta reported. Among patients treated with corticosteroids, treatment within 3 days of ICPiAKI was significantly associated with 2-fold higher odds of renal recovery compared with later treatment.
Steroid treatment increased the odds of renal recovery 2.6-fold, data show. She noted that 28% of patients were rechallenged with an ICPi after an episode of ICI-related AKI. Of these, recurrent ICPi-AKI developed in only 16.5% of them, “which shows that rechallenge should be considered in these patients,” she said. Although the study is the largest investigation of ICPi-AKI to date, Dr Gupta and colleagues acknowledged limitations. They noted that not all patients underwent a kidney biopsy to confirm the diagnosis. They also did not collect data on
tumor cells. The team conducted computed tomography-guided biopsies on 14 patients at first follow-up and found that 6 patients (43%) tested negative for viable malignancy. A meaningful reduction in tumor cell proliferation occurred in the remaining patients, dropping from 15% before radiation therapy to 6% after treatment. Upon final analysis, 23 patients (77%) remained off systemic therapy. The trial has been extended and is enrolling 100 patients. The findings from the phase 2 trial, however, suggest this strategy could be used for treatment de-escalation to delay, avoid, or hold systemic therapy in patients with oligometastatic RCC. Contemporary retrospective studies suggest this approach can produce local control rates exceeding 90% in patients with RCC; similar rates were identified in the current study (97% local control at the data cutoff date). Jason Hearn, MD, a clinical associate professor of radiation oncology at the University of Michigan Medical School in Ann Arbor, said this is a reasonable strategy that may produce a host of benefits. “It is possible that this approach might be associated with fewer side
effects than systemic therapy, especially in some patients, though this study does not directly provide such a comparison,” Dr Hearn said. “A randomized trial comparing this approach to systemic therapy would be informative as to comparative toxicity and efficacy. A cost effectiveness analysis comparing common systemic therapies to radiotherapy would also be useful.” John T. Barrett, MD, PhD, interim chair of the department of radiation oncology at the Medical College of Georgia at Augusta University, said the latest study joins other important series demonstrating the efficacy of aggressive radiotherapy for oligometastases in RCC and other relatively radioresistant tumors. Systemic therapy for metastatic RCC with tyrosine kinase inhibitors can be poorly tolerated and significantly impact quality of life for a majority of patients, Dr Barrett noted. He noted these findings are consistent with the results of the National Cancer Institute’s phase 1 NRG-BR001 trial, which showed that SBRT in standard doses is safe for patients with a median of 3 metastases. “In the NCI trial, there were
no dose-limiting toxicities and over 50% of trial participants were alive at 2 years following treatment,” Dr Barrett said.
tumor response to ICPi therapy. Further, patients in their study were disproportionately treated at US sites, which may affect the generalizability of the findings. The latest study adds to a growing medical literature on the association between ICPi therapy and AKI. A study of 138 patients with ICPi-AKI and 276 control patients who received ICPi therapy but did not experience AKI also demonstrated that lower baseline eGFR and PPI use were independently associated with an increased risk for ICPi-AKI, Frank B. Cortazar, MD, of Massachusetts General Hospital in Boston, and colleagues reported in the Journal of the American Society of Nephrology. The median time from ICPi initiation to AKI was 14 weeks. Complete and partial recovery after ICPi-AKI occurred in 40% and 45% of cases, respectively. Recurrent ICPi-AKI occurred in 23% of patients who were rechallenged with an ICPi. In a study of 676 patients treated with ICPi therapy, AKI developed in 96 patients (14.2%). Of these, 32 patients (33.3%) had ICPi-AKI, which occurred at a median of 15 weeks after ICPi initiation and was mostly low-grade, Marije S. Koks, MD, of University Medical Center Utrecht in the Netherlands, and colleagues reported in PLOS One in June. Although patients with all-cause AKI had a 2-fold increased risk of death, ICPiAKI was not associated with increased mortality, according to investigators. ■
DFS predicts OS
In landmark analyses, patients with recurrence by each landmark point had shorter subsequent OS compared with those who did not have recurrence. The median OS at 1, 3, and 5 years was 2.4, 4.5, and 5.7 years, respectively, for the recurrence group and 9.7 years, not reached, and not reached, respectively, for the group without recurrence. Patients without recurrence at 1, 3, and 5 years after initial nephrectomy had a significant 3.5-, 3.0-, and 2.7-fold greater likelihood of survival compared with patients who had recurrence at those landmark points. Further, OS at year 5 since the landmark points favored the group without recurrence. For patients who had recurrence at 1, 3, and 5 years following initial nephrectomy, the OS rates 5 years later were 37%, 42.3%, and 53.2%, respectively. For patients without recurrence at those landmark points, the OS rates 5 years later were 70.1%, 72.8%, and 78.6%, respectively. Patients with recurrence had significantly higher inflation-adjusted all-cause medical and pharmacy costs per patient per month compared with patients without recurrence, on average $4924 and $1387 higher, respectively, Dr Haas’ team reported. This approach using landmark analysis can also be applied to other datasets to hone the populations most at risk for limited DFS and OS, according to the investigators. ■
continued from page 1
database to assess the association between DFS and OS in patients with newly diagnosed, completely resected, intermediate-high (pT2N0 Grade4/pT3N0) or high-risk (pT4N0/pTanyN1) RCC post-nephrectomy. They also compared mean monthly all-cause medical and pharmacy costs per patient between the recurrence and non-recurrence cohorts.
Study included intermediate-high risk and high-risk RCC patients. Overall, 643 post-nephrectomy RCC patients, 269 with recurrence and 374 without recurrence, were included in the study. Patient demographics and disease characteristics were well balanced across the cohorts. In both cohorts, the mean age was approximately 75 years, and most patients were White (each 86%). Among patients with and without recurrence, 96.3% and 98.9% had intermediate-high risk RCC and 3.7% and 1.0% had high-risk RCC, respectively. Among patients with recurrence, 10.8% had locoregional recurrence and 89.2% had distant metastatic recurrence.
Possible Improved Quality of Life Joseph Salama, MD, a professor in the department of radiation oncology at Duke University School of Medicine in Durham, North Carolina, said the latest findings are important for patients as it is a way to treat their cancer directly, safely, and without unpleasant side effects. “It will allow patients to hopefully have improved quality of life with their cancer controlled with less time on therapy, saving effective therapies when they are truly needed,” Dr Salama said. The patients in the current study were carefully selected and had good performance status and normal baseline laboratory tests, but often it is the patients with poor performance status and abnormal laboratory tests who are not able to tolerate systemic therapies. These are the patients for whom this approach of metastasis-directed therapy may be most useful, Dr Salama said, adding that he would like to see serial radiation therapy validated in this patient population. ■
www.renalandurologynews.com NOVEMBER/DECEMBER 2021
Renal & Urology News 7
News in Brief
Please visit us at www.renalandurologynews.com for the latest news updates from the fields of urology and nephrology
Short Takes Chronic Hypertension Tied to Preterm Delivery
were significantly associated with 36%
Preterm delivery is associated with an
respectively, Marco Trevisan, PhD
increased risk for chronic hyperten-
candidate at Karolinska Institutet in
sion, researchers reported in JAMA
Stockholm, Sweden, and colleagues
Cardiology.
reported in the Clinical Kidney Journal.
and 16% increased odds of MACE,
The study included 36,511 adults
The finding is from a national cohort
with stage 3 to 5 CKD.
study of 2,195,989 women in Sweden who had singleton deliveries. Preterm weeks) and extremely preterm delivery
Moderate Physical Activity May Decrease UI Risk
(gestational age 22-27 weeks) were
Moderate physical activity may de-
significantly associated with a 1.7-
crease the risk of urinary incontinence
and 2.2-fold increased risk of hyper-
(UI) in women, according to study
tension within 10 years after delivery,
findings published in Urology.
delivery (gestational age less than 37
in adjusted analyses, compared with
The study, by Michelle M. Kim, MD,
full-term deliveries, Casey Crump, MD,
PhD, Massachusetts General Hospital
PhD, of the Icahn School of Medicine
in Boston, and colleagues, included
at Mount Sinai in New York, New York,
30,213 women who participated in
and colleagues reported.
the 2008-2018 National Health and Nutrition Examination Survey cycles.
MACE Linked to Chronic, Transient Hyperkalemia
Of these, 23.1%, 23.2%, and 8.4%
Both transient and chronic hyperka-
UI, respectively. Women who reported
lemia in patients with nondialysis-de-
moderate recreational activity had
pendent chronic kidney disease (CKD)
significant 21% and 34% decreased
are associated with major adverse
odds of stress and urge UI, respec-
cardiovascular events (MACE) and
tively. Women who reported moderate
death, recent findings suggest.
work-related activity had significant
reported having stress, urge, and mixed
Compared with normal potassium lev-
16%, 16%, and 34% decreased odds of
els, transient and chronic hyperkalemia
stress, urge, and mixed UI, respectively.
BCG Therapy and OAB Symptoms The prevalence of overactive bladder (OAB) symptoms requiring medical treatment increases along with the duration of intravesical bacillus Calmette-Guérin (BCG) immunotherapy for nonmuscle-invasive bladder cancer, a study found.
6 weeks: 13.1%
12 months or less: 30.4%
More than 12 months 52.2% 0
10
20
30
40
50
Duration of BCG treatment Source: Yucetas U et al. The effect of intravesical BCG treatment on recurrence and bladder overactivity in bladder tumor. Presented at the International Continence Society 2021 annual meeting. Abstract 380.
60
Effect of Post-RP Botulinum Toxin Varies by OAB Type I
ntravesical botulinum toxin treatment for overactive bladder (OAB) following radical prostatectomy (RP) appears most effective for patients with pure detrusor overactivity, according to preliminary data presented at the 2021 International Continence Society annual meeting. Among 24 patients with post-RP incontinence who received intravesical botulinum toxin treatment, 10 had pure detrusor overactivity, 1 had pure stress urinary incontinence with OAB symptoms, and 13 had mixed urinary incontinence. Significant clinical improvement was found only in the group with pure detrusor overactivity, Nataniel Tan, MD, of St George’s Hospital in London, UK, reported. In this group, mean total 24-hour pad use significantly declined from 2.9 pads per day before treatment to 1.6 pads per day at 3 months. Based on the ICIQ-OAB questionnaire responses, symptom severity scores significantly decreased 41% from 10.1 to 5.7 and bother scores decreased 26% from 26.9 to 19.9.
Prior Nephrectomy Does Not Affect ICI Efficacy in mRCC P
rior nephrectomy does not affect the efficacy of first-line immune checkpoint inhibitor (ICI)-based therapy for metastatic renal cell carcinoma (mRCC) relative to sunitinib, according to a recent systematic review and meta-analysis published online ahead of print in Urologic Oncology. Raj Satkunasivam, MD, MS, of Houston Methodist Hospital in Houston, Texas, and colleagues analyzed data from 6 randomized phase 3 trials involving 5121 patients, of whom 3968 (77%) had a prior nephrectomy. Compared with sunitinib, ICI-based therapy was significantly associated with a 25% and 26% decreased risk for death among patients who had prior nephrectomy and those who had not, respectively. Similar results were found for progression-free survival.
Cabozantinib May Be Effective for RCC Brain Metastases C
abozantinib may be an effective treatment for patients with brain metastases from renal cell carcinoma, according to a recent retrospective study. The study included 88 cabozantinib-treated patients divided into 2 cohorts. Cohort A included 33 patients with progressing brain metastases without concomitant brain-directed local therapy, and cohort B included 55 patients with stable or progressing brain metastases treated concomitantly with brain-directed local therapy. The median follow-up was 17 months. The intracranial radiologic response rate, the study’s primary outcome, was 55% in cohort A compared with 47% in cohort B, Laure Hirsch, MD, of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute in Boston, Massachusetts, and colleagues reported in JAMA Oncology. Cabozantinib was well tolerated, with no unexpected toxic effects or neurologic adverse events and no treatment-related deaths reported. “These findings show considerable intracranial activity and an acceptable safety profile of cabozantinib in patients with renal cell carcinoma and brain metastases,” the authors concluded.
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Why Men Drop PCa Active Surveillance Tumor grade reclassification is the leading cause of switching to treatment, study finds THE APPEARANCE of higher-risk tumor features often triggers the conversion from active surveillance or watchful waiting (AS/WW) of prostate cancer to treatment, a new study finds. Although Black men commonly convert to definitive treatment, race was not a significant factor in conversion. The study quantifies the degree to which demographic and clinicopathological parameters are associated with the time to conversion to treatment across a broad spectrum of risk groups, according to the investigators. Among 6775 men who initially chose prostate cancer AS/WW at 28 community clinics in the US, Canada, the Netherlands, and Australia during 1991-2018, 2260 men (33.4%) converted to treatment over a median 6.7 years. The reasons for conversion to treatment included tumor grade reclassification (48.8%), volume progression
(7.2%), and PSA progression (8.5%), inclusive of men with overlapping factors; another 5% of men chose treatment due to anxiety alone, William J. Catalona, MD, of Northwestern University Feinberg School of Medicine
The likelihood of converting from AS to treatment increases with age. in Chicago, Illinois, and colleagues reported in The Journal of Urology. Compared with men with Gleason Grade Group (GG) 1 tumors, men with GG 2 and GG 3-5 tumors had significant 57% and 77% increased risks for conversion, respectively. Every 5 ng/mL increment in serum PSA was
significantly associated with an 18% higher risk for conversion. Compared with cT1 tumors, cT2 and cT3-4 tumors were significantly associated with 1.6and 4.4-fold increased likelihood of treatment, respectively. As the number of biopsy cores with cancer increased from 1 or 2 to 3 and 4 or more, the risk of treatment increased significantly by 1.6- and 3.3-fold, respectively. In a novel finding, men with high-volume GG1 tumors were similar to men with high-risk tumors and converted to treatment quicker. “High-volume (≥4 cores) GG1 patients converted to treatment sooner than their low-volume (≤3 cores) and intermediate-risk tumor counterparts but at a similar interval to patients with high-risk tumors,” Dr Catalona’s team wrote. Every 5-year increase in age was significantly associated with a 4% lower risk of conversion, indicating that
Fluoroquinolones Tied to Higher Air Pollution May Worsen SCD Risk in HD Patients SUDDEN CARDIAC death (SCD)
event during a 5-day follow-up period for
accounts for 1 in every 3 deaths
every 2273 respiratory fluoroquinolone
among patients receiving hemodialysis
treatments. Respiratory fluoroquinolone
(HD), according to the US Renal Data
use also was significantly associated
System. Now a new study finds that
with a 1.9-fold increased risk for a
their underlying risk for SCD increases
composite of SCD or hospitalization
even more when a fluoroquinolone
for ventricular arrhythmia and 1.9- and
rather than an amoxicillin-based
2.2-fold increased risks for cardiovas-
antibiotic is used to treat respiratory
cular mortality and all-cause death,
infections.
respectively, within 5 days. Increased
In an analysis of 264,968 Medicare beneficiaries receiving in-center maintenance HD, 626,322 antibiotic
risks for all outcomes were also found at 7, 10, and 14 days. Clinicians need to perform a thorough
treatment episodes occurred, of which
medication review and consider phar-
251,726 (40.2%) involved respiratory
macodynamic drug interactions before
fluoroquinolone treatment and 374,596
prescribing new drug therapies for any
(59.8%) involved amoxicillin-based
condition, the authors stated.
treatment.
“Respiratory fluoroquinolones should
Respiratory fluoroquinolone therapy
still be prescribed to patients receiv-
was significantly associated with a 2-fold
ing hemodialysis when an amoxicillin-
higher risk of SCD within 5 days of treat-
based antibiotic would be suboptimal,”
ment compared with amoxicillin treat-
Dr Flythe’s team wrote. “When pre-
ment, Jennifer E. Flythe, MD, MPH, of
scribing respiratory fluoroquinolones,
the University of North Carolina Kidney
clinicians should consider electrocar-
Center in Chapel Hill, North Carolina, and
diographic monitoring before and dur-
colleagues reported in JAMA Surgery.
ing therapy, especially among high-risk
The absolute risk was 1 additional SCD
individuals.” ■
KT Outcomes AIR POLLUTION IS associated with increased risks of acute rejection, graft loss, and death in recipients of a kidney transplant (KT), a new national study finds. Ambient air pollution containing fine particulate matter of 2.5 μm or less in aerodynamic diameter (PM2.5) has been previously linked with cardiovascular and respiratory diseases and diabetes, and more recently with chronic kidney disease and end-stage kidney disease. In this study, investigators retrospectively examined air pollution exposure in the year before transplantation and the years following transplantation for 112,098 adult KT recipients from the 2004-2016 Organ Procurement and Transplantation Network. Compared with patients residing in areas with the lowest quartile of PM2.5 (1.2 to less than 8.3 μg/m3) prior to transplant surgery, patients residing in areas with the quartiles 3 and 4 (9.8 to less than 11.9 μg/m3 and 11.9 to less than 22.4 μg/m3) had significant 11% and 13% increased odds of acute kidney rejection, respectively, in adjusted analyses,
younger men commonly switched to treatment, according to the investigators. A more recent year of diagnosis also predicted treatment. In a preliminary analysis, selfreported race coupled with genetic ancestry data did not significantly predict quicker conversion. The study was limited by a lack of data on PSA density, biopsy-based genomics, multiparametric magnetic resonance imaging, and confirmatory and surveillance biopsies. In an accompanying editorial, Christopher E. Barbieri, MD, of Weill Cornell Medicine, New YorkPresbyterian Hospital, New York, New York, commented: “The multi-institutional cohort with ‘real-world’ site-tosite variations in practice patterns adds real value in that it reinforces critical clinical parameters associated with progression to definitive therapy.” ■
a team led by Tarek Alhamad, MD, MS, of Washington University School of Medicine in St. Louis, Missouri, reported in JAMA Network Open. Posttransplant air pollution exposure was significantly associated with a 17% increased risk for death-censored graft failure and a 21% increased risk for allcause mortality per 10 μg/m3 increase in annual mean PM2.5 level. The investigators estimated that the national burden of kidney graft failure associated with PM 2.5 levels greater than the Environmental Protection Agency limit of 12 μg/m3 was 57 failures per year. They found the highest graft failure rates in densely populated areas with a high degree of air pollution, such as the Southwest and East North Central regions of the United States. According to Dr Alhamad’s team, these findings suggest that “consistent exposure to fine particulate matter air pollution is associated with increased risk of worse transplant outcomes among recipients of [kidney transplants], including kidney rejection, kidney graft failure, and all-cause death.” They suggested that air pollutants, such as organic compounds, free radicals, and transition metals of PM2.5 or less may increase systemic inflammation and oxidative stress. Kidney transplant recipients may want to move to areas with lower levels of PM2.5 for better graft function and longevity, according to the investigators. ■
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Renal & Urology News 13
PC, RC May Offer Similar Survival in MIBC Patients PARTIAL AND RADICAL cystectomy for muscle-invasive bladder cancer (MIBC) are associated with similar survival outcomes in selected patients, according to study findings presented at the AUA2021 Virtual Experience. If confirmed, partial cystectomy (PC) may be a viable option to treat MIBC, according to investigators Rainjade Chung, MD, of Columbia University in New York, New York, and colleagues. “While radical cystectomy is the gold standard for muscle-invasive bladder cancer, there is some data showing that partial cystectomy can be an effective alternative in select patients,” Dr Chung told attendees. “Patients are usually reluctant to have their bladder removed, and the interest in bladder-sparing options lies in the ability for nerve preservation for potency, to maintain continence, to preserve continuity of the urinary tract, and all the benefits of improved body image and decreased morbidity from surgery.”
Partial cystectomy can be a viable option for selected patients, data show. Their study included 637 patients with MIBC identified using the National Cancer Database (2003-2015). Of these, 79 (12%) underwent partial cystectomy (PC). The PC patients were older than those in the radical cystectomy (RC) group. They were more likely to have positive surgical margins (19% vs 10%) but had a lower rate of positive lymph nodes on surgical pathology (5% vs 27%). Investigators found no significant difference in the rate of upstaging to pT3-4 (67% in RC vs 71% in PC) or in overall survival. “Based on our findings, partial cystectomy appears to afford similar survival outcomes to radical cystectomy in a large population-based data set,” Dr Chung said.
Mortality Risk Factors On multivariable analysis, patients undergoing either PC or RC using a minimally invasive approach had a significant 66% decreased risk for death compared with those having an open procedure, according to investigators. The presence of positive surgical margins, compared with their absence, was significantly associated with a 2.7-fold
increased risk for death. Compared with node-negative disease, node- positive disease was significantly associated with a 3.1-fold increased risk.
Patient Selection Key “This study suggests that partial cystectomy in select patients may have
comparable overall survival to radical cystectomy, but it is worth emphasizing the patient selection is key,” Matthew Wszolek, MD, a urologic oncologist at Massachusetts General Hospital and an assistant professor at Harvard Medical School in Boston, who was not involved in the study. “Further, the one long-
term concern for partial cystectomy is future-life threatening recurrence of bladder cancer … that may occur 5, 10, 15 years in the future, and this risk is not accounted for in this study.” He noted that most urologic oncologists use PC in selected patients, and the current study supports the practice. ■
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Ethical Issues in Medicine M
ore than other diseases, COVID-19 has revealed the significant racial disparities in care in the US. COVID-19 did not create those health disparities, but the national conversations and expanded literature around disparities has clearly been influenced by this global pandemic. Greater recognition of the role of health disparities and the differential effect of certain diseases in some populations have led to more discussions about equity both inside and outside of health care. During the peak of the pandemic, there were significant racial disparities in rates of COVID-19 testing, infection, and hospitalization for Black and Hispanic populations. Rather than mistakenly concluding that there was a biologic basis for this disparity, the medical community recognized that the differences were likely related to social determinants of health. In this case, patients from these populations were more likely to be essential workers who could not work remotely, had to use public transportation to commute, and lived in multigenerational families where isolating with COVID-19 or quarantining after exposure was difficult. Early recognition and attention to these disparities resulted in a targeted strategy to address the problem. This
resources should be distributed not as a commodity, but according to need, so that everyone has a fair chance to be healthy.1 Advancing health equity is also justified because when everyone has a chance to be healthier, everyone benefits. A healthier population promotes prosperity by enabling more people to contribute to the workforce, enhancing productivity, preserving opportunity, and lowering health costs. Healthier people can more easily participate in the democratic process. The best metaphor for this concept, provided on the website culturalorganizing.org in an article titled “The problem with the equity vs. equality graphic you’re using,” is an image of 3 people of equal height standing on sloping ground trying to watch a baseball game from behind a fence. The metaphor uses people of equal height, suggesting that the disparity in being able to watch the game is not biologically determined. An equality approach to managing the problem would be to provide each of the observers with the same size box to see over the fence, but it would not solve the problem for the person at the lowest point on the ground. An equity approach provides the person at the lowest point on the ground the tallest box, thus providing them with what they need to achieve the
Equality assures that everyone receives the same thing, but equity assures that everyone gets what they need. meant outreach to highly affected populations by enhancing access to testing at the beginning of the pandemic and prioritization for vaccination later. From an ethics perspective, this was an approach that centered on equity, not equality. Equality assures that everyone receives the same thing, but equity assures that everyone gets what they need. There is a place for equality for sure. Everyone should equally possess certain rights. From an ethics perspective, health care
same outcome as the others. Giving a person a taller box does not take anything away from the other two and allows everyone access to see the game. There remains debate about championing equity. Some may assert that the cultural and economic history of the US promotes the primary value of individual responsibility and that the obligation of institutions or governments is to promote equality, not necessarily achieve equity. Others might tend toward an
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An equity approach offers a way to transform how the nation addresses health disparities BY DAVID J. ALFANDRE, MD, MSPH
Policies designed to help selected groups can benefit society at large.
equality approach believing that equity is a zero-sum game, and that by giving something to one group means taking it away from another. Deciding what is fair and how to achieve it remains a source of considerable debate in our society. Countering the equality-based arguments is the concept of the “curb cut” effect, which is described in an article by Cory Collins on the Learning for Justice website titled “The curb-cut effect and championing equity.” Curb cuts are the ramps built into sidewalks beginning in the 1970s to create more livable outdoor spaces for people who use wheelchairs. Curb cuts were initially developed to enhance access for people who use wheelchairs, but after their widespread adoption, it became clear that many more people benefitted from the sidewalk design modification, including older people with assistive devices for walking, people pushing strollers, travelers pulling suitcases, and skateboarders. When we extend this metaphor to health care, there are numerous examples of the benefits of promoting equity. When we commit to better understanding, addressing, and managing the significantly higher rates of maternal mortality among Black women, not just they, but all women of reproductive potential benefit. When we prioritized
COVID-19 vaccination among communities of color, we helped to reduce health disparities for disadvantaged populations at the same time as keeping other communities safe by reducing COVID-19 incidence. From a public health perspective, seat belt legislation was originally developed to protect children in automobiles but the legislation resulted in more widespread adoption that saved the lives of all passengers. An equity approach has the potential to transform how we address health disparities and help everyone have an equal opportunity to be healthy. Progress in this area begins with having more conversations about, and grappling with, what is “fair.” ■
David J. Alfandre, MD, MSPH, is a health care ethicist and an Associate Professor in 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 VA National Center for Ethics in Health Care or the US Department of Veterans Affairs. REFERENCE 1. Braveman P. What are health disparities and health equity? We need to be clear. Public Health Rep. 2014;129(Suppl 2):5-8.
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Chest Imaging After RCC Surgery Not Warranted SURVEILLANCE chest imaging for patients following surgical excision for localized renal cell carcinoma (RCC) is not warranted, investigators reported during the AUA2021 Virtual Experience. “There seems to be minimal clinical value in surveillance for pulmonary recurrence after resection of T1a renal cell carcinoma,” investigator David K. Charles, MD, of the Medical College of Wisconsin in Milwaukee, said during an oral presentation. Cancer recurs in 20% to 30% of these patients, with 50% to 60% of recurrences being lung metastases, according to the investigators. Previous studies have revealed an extremely low incidence
of lung metastases in T1-T3 RCC following surgical excision, they noted. Still, clinical guidelines from the National Comprehensive Cancer Network and the AUA recommend that patients who undergo surgical excision of localized RCC have surveillance chest X-rays performed at least annually for 5 years.
Dr Charles and his collaborators retrospectively analyzed 463 patients who underwent surgical excision of T1a RCC from January 2000 to January 2020. The study excluded patients with pathology otherB:7.25" than RCC and those with pulmonary T:7" nodules on baseline S:6.75" had a mean age imaging. The patients
of 58.3 years. The mean follow-up duration was 47.6 months. On the most recent pulmonary surveillance imaging, 335 patients (72.4%) had a chest X-ray and 128 (27.6%) had chest computed tomography scans. Regardless of imaging modality, pulmonary recurrence was not detected in any patient. ■
Few Patients Stay on PTNS Long Term PATIENTS RARELY continue percutaneous tibial nerve stimulation (PTNS) for overactive bladder (OAB) after 3 years, according to new study findings presented during the AUA2021 Virtual Experience. Of 146 patients treated with PTNS from 2014 to 2017 at Stony Brook
the initial 12-week course of therapy, but only 76 (52%) continued with monthly maintenance therapy. After 3 years, only 16 patients (11%) still underwent PTNS, Chris Du, MD, and colleagues from Stony Brook Medicine reported in a poster presentation. The median duration of PTNS therapy was 147 days. In multivariate analysis, only symptom improvement and neurological history were significantly associated with continuing PTNS. Symptom improvement was reported by 100% of patients who remained on PTNS at 3 years compared with 60% of patients who dropped out. The most commonly cited reasons for cessation included worsening of urinary symptoms (51 patients), time commitment (12), request for alternative treatment (12), medical comorbidities (10), and insurance issues (7). ■ 18762_HCP_DSE_Journal_Ad_7x10_Renal_and_Urology_News_Mech_v1.indd 1
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File Name: 18762_HCP_DSE_Journal_Ad_7x10_Renal_and_Urology_News_Mech_v1.indd Bleed:
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B:10.25"
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Medical Center in Stony Brook, New
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Practice Management O
n September 15, 2021, the Federal Trade Commission (FTC) issued a policy statement affirming that health apps and connected devices that collect or use consumers’ health information must comply with the Health Breach Notification Rule. The rule requires vendors of personal health records and related entities to notify consumers, the FTC, and in some cases the media of information breaches. Health apps, which can track everything from glucose levels and heart health to fertility and sleep, collect sensitive and personal data from individuals. These apps must meet requirements to ensure that the information they collect is secure. Still, hackers have been successfully targeting health apps. “Modern health care apps, like other apps, generally rely upon not only the client component, but also a cloud backend,” said Drew Bagley, Vice President and Counsel for Privacy and Cyber Policy for CrowdStrike, a cybersecurity technology company based in Sunnyvale, California. “We’ve observed many instances of adversaries taking full advantage of software supply chains. Adversaries target vulnerabilities using legitimate software packages. So, when an attack occurs, it is difficult to detect and mitigate stealthy propagation
sensitive health information is breached. To make it harder for hackers to breach a network used by an app, Bagley said sectors such as health care should integrate behavioral-based attack detection solutions into their security systems, improve controls for managing privileged credentials, and embrace real-time vulnerability management. “Ultimately, consumers should scrutinize the security and privacy practices of health applications,” Bagley said. The Department of Health and Human Services’ Health Sector Cybersecurity Coordinating Council (HC3) provides a number of suggestions for defending against hackers. These include implementing whitelisting technology to ensure that only authorized software is used and providing access control based on the principle of least privilege. The latest surveys suggest that spending on app security is expected to increase 12.2% this year, from $3.3 billion to $3.7 billion, according to Seth Robinson, Senior Director for Technology Analysis at CompTIA, a nonprofit trade association that issues professional certifications for the information technology industry. “The amount being spent on application security, while growing tremendously, still probably falls short. This
‘The amount being spent on application security, while growing tremendously, still probably falls short,’ a cybersecurity specialist says. techniques that infect other systems across the network.” Congress included specific provisions to strengthen privacy and security protections for web-based businesses under the American Recovery and Reinvestment Act of 2009. The law directed the FTC to ensure that companies contact customers in the event of a security breach. The Health Breach Notification Rule ensures that entities not covered by HIPAA face accountability when consumers’
is largely because so many companies have been operating for such a long time in a secure perimeter mindset, and the concepts of securing individual applications or developing applications with security built-in are still not widely adopted across the business landscape,” Robinson said. Keatron Evans, Principal Security Researcher for Madison, Wisconsinbased Infosec Institute, which provides role-based security awareness
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Hackers targeting vulnerabilities in health apps can gain access to confidential medical information BY JOHN SCHIESZER
When choosing a health app, clinicians should ensure that it meets HIPAA requirements.
and training solutions for businesses, said application program interfaces (APIs) being used by the apps are a bigger problem than the apps themselves. These APIs enable the apps to share information with other apps, such as a person’s location. “In some cases, they’re also accepting or ingesting information from other apps, locations or entities,” Evans said. “They are generally insecure and must be locked down out of the box. However, this locking down process rarely happens.” Since physicians need access to information right away, Evans said performance, speed, accessibility, and ease of use take precedence over security in most health care environments. “In some cases, the physicians drive insecurity because of the expectations to have faster and easier access,” Evans said. This might be the case, for example, of a physician who wants 3 gigabyte X-ray or computed tomography images for the greater visual detail they provide compared with the resolution of 200 megabyte resolution. “However, getting the 3 gigabyte image to show up on a physician’s WiFi-connected iPad across the network, in the quick rendering time they’re expecting, means some security controls have to be removed or at least relaxed,” Evans said.
In some cases, physicians have to make a tradeoff between complying with HIPAA or detecting life-threatening diseases sooner. Evans suggests physicians advise patients on cybersecurity concerns and inform them about the potential risks associated with adding apps. “However, a physician advising a patient of this could cause that patient to be hesitant to use the apps or not use them at all. There is always a constant battle of functionality, ease of use and security,” Evans said. There have been HIPAA violations with health care apps, but these usually were associated with health care providers, not the apps. When choosing an app, physicians should ensure it meets HIPAA requirements and has the proper business associate agreement in place per HIPAA, Evans said. He also suggests asking the app vendor if they have their app security tested regularly. “I would strongly recommend they ask for the results of those tests and have a security expert involved in the conversation around the security of any selected or potential app before bringing it into the organization as a service or offering,” Evans said. ■ John Schieszer is a freelance medical writer based in Seattle, Washington.
