www.renalandurologynews.com NOVEMBER/DECEMBER 2020
Renal & Urology News 13
Avelumab Ups Survival in Advanced UC Study shows benefit of adding the drug to best supportive care as part of first-line maintenance therapy BY JODY A. CHARNOW FIRST-LINE maintenance therapy with avelumab plus best supportive care (BSC) significantly prolongs overall survival (OS) compared with BSC alone among patients with unresectable locally advanced or metastatic urothelial carcinoma (UC) who had disease that did not progress while on first-line chemotherapy, according to study findings presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and published concurrently in the New England Journal of Medicine. In the phase 3 JAVELIN Bladder 100 trial in which investigators randomly assigned 700 patients to receive avelumab, an immunotherapeutic drug, plus BSC or BSC alone, OS at 1 year was 71.3% in the avelumab group compared with 58.4% in the BSC-only arm, study investigator Petros Grivas, MD, PhD, of the University of Washington (UW) in Seattle, reported in a video
SU vs NU for Ureteral Tumors BY JODY A. CHARNOW SEGMENTAL ureterectomy (SU) may be an appropriate alternative to radical nephroureterectomy (NU) for the treatment of high-risk ureteral tumors. A retrospective analysis using data from 2006 to 2013 from the National Cancer Database (NCDB) revealed no significant difference in overall survival (OS) between patients treated with SU or NU after adjusting for multiple variables, Patrick M. Lec, MD, of the David Geffen School of Medicine at the University of California, Los Angeles, and colleagues reported in Urologic Oncology. The study included 1962 patients with clinically localized high-risk ureteral tumors. Selection criteria aimed to approximate the European Association of Urology (EAU) definition of highrisk upper tract urothelial carcinoma (UTUC) within the limits of the NCDB, the researchers explained. Of the 1962 patients included, 1421 (72.4%) underwent radical NU and 541 (27.6%) underwent SU. Lymph adenectomy was performed in only
Survival Rates at 1 Year First-line maintenance therapy with avelumab plus best supportive care (BSC) vs BSC alone significantly increased 1-year overall survival (OS) rates among patients with unresectable locally advanced or metastatic urothelial carcinoma whose disease had not progressed while on first-line chemotherapy, including a subset of patients with PD-L1-positive disease. 80
71.3%
79.1%
60
n Entire cohort
58.4%
nP D-L1-positive patients
60.4%
40 20 0
BSC alone Avelumab + BSC 1-Year Survival Rates
Source: Grivas P, Park SH, Voog E, et al. Avelumab first-line (1L) maintenance + best supportive care (BSC) vs BSC alone with 1L chemotherapy (CTx) for advanced urothelial carcinoma (UC): Subgroup analyses from JAVELIN Bladder 100. Presented at: ESMO Virtual Congress 2020. Abstract 704MO
presentation. Median OS was 21.4 months in the avelumab group compared with 14.3 months in the control group. Avelumab treatment was significantly associated with a 31% decreased risk of death, according to Dr Grivas,
446 patients (22.7%). Among the 1092 patients with advanced pathology, 271 (24.8%) received adjuvant chemotherapy. The median follow-up time was 33.2 months for the radical NU group and 31.6 months for the SU group. In the NU group, lymphadenectomy was associated with a 42% decreased risk of death when more than 3 nodes were removed, the authors reported. Receipt of adjuvant chemotherapy for advanced pathology had no effect on OS in either treatment group. “This retrospective cohort study supports the performance of lymphadenectomy and SU in patients with high-risk ureteral tumors,” the authors concluded. Dr Lec and colleagues stated that their study had limitations that derive from shortcomings of data extraction methods in the NCDB. Although they were able to restrict their analysis to ureteral tumors, they were not able to discriminate between tumor locations along the ureter or other factors such as multifocality and hydronephrosis “that fall within the EAU definition of highrisk UTUC,” the investigators wrote. “This invites some degree of selection bias, as some of these features technically dictate NU (i.e., proximal location) and others reflect more aggressive disease biology that favor performance of radical extirpative surgery.” ■
associate professor of oncology at UW and director of UW Medicine’s Genitourinary Cancers Program. In addition, avelumab significantly prolonged OS among PD-L1–positive patients. OS at 1 year was 79.1% in the
avelumab group and 60.4% in the control group. Avelumab was significantly associated with a 44% decreased risk of death. The median progression-free survival (PFS) was 3.7 months in the avelumab group and 2.0 months in the control group in the study population as a whole and 5.7 months and 2.1 months, respectively, in the PD-L1-positive population. Avelumab was significantly associated with a 38% and 44% decreased risk for disease progression or death in the study population as a whole and the PD-L1-positive population, respectively, according to the investigators. The incidence of adverse events (AEs) from any cause was 98.0% in the avelumab group and 77.7% in the control arm, the study found. The incidence of grade 3 or higher AEs was 47.4% and 25.2%, respectively. The study was sponsored by Pfizer, and is part of an alliance between Pfizer and Merck KGaA, Darmstadt, Germany. ■
Earlier Surrogate for Survival After RP Relapse Possibly ID’d CASTRATION-RESISTANT prostate
Drs Freedland and Klaassen and their
cancer (CRPC)-free survival among men
colleagues conducted a retrospective
with biochemical failure following radical
cohort study that included 210 men who
prostatectomy (RP) is closely correlated
had biochemically recurrent PCa after
with metastasis-free survival (MFS), sug-
RP, a PSA doubling time of less than 9
gesting the former could be an interme-
months, and no evidence of metastasis
diate endpoint in clinical trials, research-
at the time of starting androgen depriva-
ers concluded in a poster presentation
tion therapy (ADT). The primary outcome
during the European Society for Medical
was the correlation between CRPC-free
Oncology Virtual Congress 2020.
survival (CRPC-FS) and MFS.
MFS is a surrogate for overall survival
During a median follow-up of 79.4
in men with localized prostate cancer,
months after initiation of ADT, CRPC
but this endpoint may take years to
or death occurred in 131 patients
develop in patients with nonmetastatic
and metastasis developed in 132
castration-sensitive disease, a team
patients. The median CRPC-FS and
co-led by Stephen J. Freedland, MD,
MFS was 100 months and 104 months,
of Cedars-Sinai Medical Center in Los
respectively. When limited to men with
Angeles, and Durham VA Medical Center
a PSA at ADT initiation greater than
in Durham, North Carolina, and Zachary
1 ng/mL and those with a Charlson
Klaassen, MD, of Augusta University
Comorbidity Index of 2 or less, there
in Augusta, Georgia, explained. “Other
was an approximately 85% and 88%
evidence-based intermediates that occur
correlation between CRPC-FS and MFS,
earlier in the disease course are needed
respectively, and 76% and 74% correla-
for clinical trial design to expedite
tion between time to CRPC and time to
evaluating new therapies,” they noted.
metastasis, respectively. ■
