POUT
Upper tract urothelial carcinoma · Medical · Adjuvant
Population/treatment
261 patients with pT2–T4 and/or node-positive disease after nephroureterectomy. Four cycles of gemcitabine plus cisplatin or carboplatin according to renal function versus surveillance.
Outcomes
Five-year DFS 62% vs 45%; HR 0.55 (95% CI 0.38–0.80; P=0.001). Five-year OS 66% vs 57%; HR 0.68 (95% CI 0.46–1.00; P=0.049).
Absolute effect and harms
Five-year DFS absolute difference 17 points; approximate NNT 6 using rounded rates. Acute grade ≥3 treatment-emergent adverse events occurred in 44% of patients starting chemotherapy.
Primary source
NCT01993979. Check final follow-up and contemporary guidelines before application.