20 Renal & Urology News
SEPTEMBER/OCTOBER 2021 www.renalandurologynews.com
Study Challenges ADT Use at PSA Relapse Waiting until metastasis to start treatment has minimal impact on overall survival, investigators found OVERALL SURVIVAL is not meaningfully prolonged for patients with biochemically recurrent (BCR) prostate cancer who receive continuous androgen deprivation therapy (ADT) at the time of PSA relapse rather than metastasis, according to investigators. “Metastasis-free survival and overall survival of men with BCR who delay hormone therapy is long. This underscores the need to reevaluate when to start primary ADT in this patient population,” Catherine Handy Marshall, MD, of Johns Hopkins University School of Medicine in Baltimore, Maryland, and her colleagues team concluded in a report published online in The Journal of Urology. Dr Marshall’s team studied 806 highrisk patients (mean age 61 years; 16% Black) from Johns Hopkins Hospital and Walter Reed National Military
Medical Center in Bethesda, Maryland, who experienced BCR after radical prostatectomy and delayed ADT initiation until metastasis. From the time of local treatment, median metastasis-free
Long survival time observed for men with biochemical recurrent PCa who delay ADT. survival (MFS) was 144 months and 192 months for men with a PSA doubling time of less than 6 months and less than 10 months, respectively, the investigators reported. Median overall survival (OS) from the time of local treatment was 168 and 204 months, respectively. Older age, higher pathologic T stage,
Study: Biomarkers May Predict COVID-19 Death Risk in KTRs AMONG KIDNEY TRANSPLANT recipi-
The 60-day survival rate was as high
ents (KTRs) infected with SARS CoV-2,
as 92% among patients without eleva-
those who have elevations in biomark-
tion in any of the 3 biomarkers, but the
ers of inflammation, cardiac injury, and
rate declined to 77% among those with
coagulation appear more likely to die.
elevation of at least 1 of the biomarkers.
In a French nationwide registry of
The 60-day survival rate declined to 58%
494 KTRs with COVID-19 during the first
and 40% among patients with elevations
wave of the pandemic, 101 (20%) died.
in 2 and 3 biomarkers, respectively.
Patients with levels of serum creatinine
Several studies in the adult general
above 150 μmol/L, C-reactive protein
population have found an association
above 50 mg/L, procalcitonin above
between elevation of cardiac injury,
0.3 mg/L, hs-troponin I above 20 ng/L,
coagulation, and inflammatory biomark-
lactate dehydrogenase above 280
ers and COVID-19-related mortality, the
UI/L, and D-dimer above 1500 UI/L
investigators noted.
were at increased risk for COVID-19related mortality. On multivariate analysis, only procalcitonin and troponin I remained
“If independently validated, the use of biomarkers may help to guide therapeutic decision making in transplant patients,” Dr Caillard’s team concluded.
independently associated with a signifi-
Of the 494 KTRs (approximately 5%
cant 3.7- and 2.9-fold increased risk for
dual organ transplants) with COVID-19,
mortality, respectively, Sophie Caillard,
83% were admitted to the hospital
MD, PhD, of the Strasbourg University
and 30.6% of these were sent to an
Hospital in Strasbourg Cedex, France,
intensive care unit. Mechanical ventila-
and colleagues reported in Kidney
tion was required by 26% of the cohort.
International Reports. Subgroup analy-
Overall, acute kidney injury occurred in
ses additionally identified D-dimer as a
57.8%, and renal replacement therapy
prognostic biomarker.
was initiated in 15.6%. ■
higher Gleason sum, and faster PSA doubling time were all associated with higher likelihood of death. Dr Marshall and her collaborators compared their results with MFS and OS times from pivotal trials of highrisk patients with nonmetastatic castration-resistant prostate cancer who were treated with surgery, radiation, or primary ADT alone. Estimated median MFS was 136 vs 110 months in the apalutamide and placebo arms, respectively, of the SPARTAN trial, and 127 vs 103 months in the darolutamide and placebo arms, respectively, of the ARAMIS trial. Estimated median OS was 169 vs 154 months in the apalutamide and placebo arms, respectively, of the SPARTAN trial and not reached in the ARAMIS trial. OS times from these trials are comparable to those from the current study.
In an accompanying editorial, David VanderWeele, MD, PhD, and Maha Hussain, MD, of the Robert H. Lurie Comprehensive Cancer Center at the Northwestern University Feinberg School of Medicine, in Chicago, Illinois, agreed that the risks of early ADT in men with biochemically recurrent prostate cancer may not outweigh the benefits. “These data provide context for patients with BCR and providers on whether to undergo ADT for years despite unproven benefit and quality of life impact,” they wrote. “New imaging may help or further add to the controversy, since BCR patients may have metastases on newer imaging. Until definitive data are available, men with BCR should be counselled regarding the lack of data to support ADT benefit in nonmetastatic BCR.” ■
Finerenone’s Benefits Span CKD Spectrum
data from of data from 13,026 patients in the FIDELIO-DKD and FIGARODKD randomized trials. CKD severity was defined according to categories of estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR). The primary endpoint was time to first occurrence of a composite of cardiovascular (CV) death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. The secondary endpoint was time to first occurrence of a composite of kidney failure, decrease in eGFR by 57% or more, or renal death. Over a median of 3.0 years of follow-up, the composite CV endpoint occurred in a lower proportion of patients receiving finerenone compared with placebo: 12.7% vs 14.4%, according to investigators. Finerenone reduced the risk for the CV outcome by a significant 14%. The composite renal endpoint also occurred in a smaller proportion of patients receiving finerenone vs placebo: 5.5% vs 7.1%. Finerenone reduced the risk for the renal outcome by a significant 23%. Hyperkalemia was more common with finerenone than placebo: 14.0% vs 6.9%. Discontinuation of treatment due to hyperkalemia occurred in 1.7% of the finerenone and 0.6% of the placebo group. ■
FINERENONE REDUCES the risk for cardiovascular and renal outcomes in patients with type 2 diabetes who have mild to advanced chronic kidney disease (CKD) and those with diagnosed diabetic kidney disease, investigators announced at the 2021 congress of the European Society of Cardiology. The nonsteroidal mineralocorticoid receptor antagonist (MRA) carries an increased risk for hyperkalemia. “The FIDELITY analysis demonstrates that finerenone reduced the risk of cardiovascular and kidney outcomes compared with placebo across the spectrum of chronic kidney disease in patients with type 2 diabetes,” study author Gerasimos Filippatos, MD, of the National and Kapodistrian University of Athens Medical School in Greece stated in an ESC congress press release. “The cardiovascular benefits of the drug were consistent across eGFR and UACR categories, indicating that treatment should be initiated in the early stages of renal disease.” In FIDELITY, a prespecific metaanalysis combining individual patient
