Bladder cancer: adjuvant chemotherapy shows benefit in phase 3

  • Birtle A & al.
  • Lancet
  • 5 Mar 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Gemcitabine-platinum combination chemotherapy initiated within 90 days after nephroureterectomy significantly improves disease-free survival (DFS) in patients with locally advanced upper tract urothelial carcinoma (UTUC).

Why this matters

  • Adjuvant platinum-based chemotherapy should be considered a new standard of care after nephroureterectomy in these patients.

Study design

  • Phase 3, parallel group, POUT trial.
  • 261 patients with UTUC undergoing nephroureterectomy were randomly assigned to either surveillance or adjuvant chemotherapy (gemcitabine+cisplatin/carboplatin) within 90 days after surgery.
  • Primary endpoint: DFS (time to first recurrence in the tumor bed, first metastasis, or death from any cause).
  • Funding: Cancer Research UK.

Key results

  • Median follow-up was 30.3 months.
  • Adjuvant chemotherapy significantly prolonged DFS vs surveillance (median, not reached vs 29.8 months; HR, 0.45; P=.0001).
  • 3-year DFS estimates were 71% (95% CI, 61%-78%) in chemotherapy and 46% (95% CI, 36%-56%) in surveillance groups.
  • Metastasis-free survival was longer with chemotherapy (HR, 0.48; P=.0007).
  • Grade ≥3 treatment-emergent adverse event rates were higher with chemotherapy (44% vs 4%; P<.0001>
  • No treatment-related deaths were reported

Limitations

  • Open-label design.