- 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.
- 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.
- 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
- Open-label design.