Transurethral resection then gemcitabine, cisplatin, plus nivolumab with intact bladder in selected patients studied in phase 2 trial
MONDAY, June 7, 2021 (HealthDay News) — For patients with muscle-invasive bladder cancer, transurethral resection and combination treatment with gemcitabine, cisplatin, plus nivolumab with bladder sparing is feasible in selected patients, according to a study presented at the annual meeting of the American Society of Clinical Oncology, held virtually from June 4 to 8.
For the study, Matt D. Galsky, M.D., from the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai in New York City, and colleagues enrolled 76 patients with cT2-T4aN0M0 urothelial bladder cancer. Patients received four cycles of gemcitabine, cisplatin, plus nivolumab and 64 completed post-cycle 4 clinical restaging. Those achieving clinical complete response (cCR) were eligible to proceed without cystectomy and receive nivolumab followed by surveillance.
The researchers found that 31 patients (48 percent) achieved a cCR and were followed for a median of 13.7 months. One cCR patient opted to undergo cystectomy immediately. Overall, 100 percent of those with cCR and 87.7 percent without cCR were alive at one year; 81.2 and 11 percent, respectively, were alive with bladder intact; and 100 and 79.5 percent, respectively, were alive and metastasis-free. Local recurrence occurred in eight of 31 cCR patients and six underwent cystectomy.
“One-year bladder intact survival is possible though the durability of responses, and role of genomic biomarkers in management algorithms requires longer follow-up,” the authors write.
Several authors disclosed financial ties to the biopharmaceutical industry.
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