ASCO 2021: Neoadjuvant Therapy and Transurethral Resection of Bladder Cancer
Posted: Tuesday, June 22, 2021
Matt D. Galsky, MD, of the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, and colleagues investigated the efficacy of combining cisplatin and gemcitabine plus nivolumab with selective bladder-sparing surgery for muscle-invasive bladder cancer. During the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, they reported that this treatment regimen achieved a closely defined clinical complete response in a large subset of patients (Abstract 4503).
“One-year bladder-intact survival is possible, though the durability of responses, and the role of genomic biomarkers in management algorithms, requires longer follow-up,” the investigators concluded.
A total of 76 patients with cT2–T4aN0M0 urothelial bladder cancer who were cisplatin-eligible were enrolled in this trial. Participants were administered four cycles of gemcitabine, cisplatin, plus nivolumab with subsequent clinical restaging. Individuals who achieved clinical complete response received nivolumab followed by surveillance and those who did not undergo a cystectomy.
The median patient age was 69, with a majority (79%) being male. Clinical stage II, III, and IV cancer affected 56%, 32%, and 12% of participants, respectively, and 84% (n = 64) completed restaging.
At the median follow-up of 13.7 months, 31 patients achieved a clinical complete response; 1 patient underwent immediate cystectomy. Local recurrence was observed in eight patients, and six underwent cystectomy.
The estimate of all participants alive at 1 year was 92.4%, including 100% of patients who achieved clinical complete response and 87.7% of individuals who did not. Of those who reached clinical complete response, the estimate of individuals who would be bladder intact, metastasis free, and local recurrence free was 81.2%, 100%, and 78%, respectively; 11% and 79.5% of individuals who did not improve were expected to be bladder intact and metastasis free.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.