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The New England Journal of MedicineNivolumab plus Gemcitabine–Cisplatin in Advanced Urothelial Carcinoma

No new agent has improved overall survival in patients with unresectable or metastatic urothelial carcinoma when added to first-line cisplatin-based chemotherapy — could this be one?

A recent phase 3, multinational, open-label trial has shown that the combination of nivolumab and gemcitabine–cisplatin significantly improves outcomes in patients with previously untreated advanced urothelial carcinoma compared to gemcitabine–cisplatin alone.

Study Design

  • The study involved 608 patients with previously untreated unresectable or metastatic urothelial carcinoma.
  • Patients were randomly assigned to receive either intravenous nivolumab (at a dose of 360 mg) plus gemcitabine–cisplatin every 3 weeks for up to six cycles, followed by nivolumab (at a dose of 480 mg) every 4 weeks for a maximum of 2 years, or gemcitabine–cisplatin alone every 3 weeks for up to six cycles.
  • The primary outcomes were overall and progression-free survival, with the objective response and safety as exploratory outcomes.

Key Findings

  • At a median follow-up of 33.6 months, overall survival was longer with nivolumab-combination therapy than with gemcitabine–cisplatin alone (hazard ratio for death, 0.78; 95% confidence interval [CI], 0.63 to 0.96; P=0.02).
  • The median survival was 21.7 months with nivolumab-combination therapy as compared with 18.9 months with gemcitabine–cisplatin alone.
  • Progression-free survival was also longer with nivolumab-combination therapy than with gemcitabine–cisplatin alone (hazard ratio for progression or death, 0.72; 95% CI, 0.59 to 0.88; P=0.001).
  • The overall objective response was 57.6% (complete response, 21.7%) with nivolumab-combination therapy and 43.1% (complete response, 11.8%) with gemcitabine–cisplatin alone.
  • Grade 3 or higher adverse events occurred in 61.8% and 51.7% of the patients, respectively.

According to the American Cancer Society, about 83,730 new cases of bladder cancer (approximately 64,280 in men and 19,450 in women) will be diagnosed in the United States in 2023. About 17,200 deaths (approximately 12,260 in men and 4,940 in women) from this disease will occur this year.

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