As reported in the Journal of Clinical Oncology by Alison Jane Birtle, MD, MBBS, MRCP, FRCR, and colleagues, final results of the UK-based phase III POUT trial showed survival benefits with adjuvant platinum-based chemotherapy vs surveillance after radical nephroureterectomy in patients with upper tract urothelial cancer.
Alison Jane Birtle, MD, MBBS, MRCP, FRCR
Study Details
In the open-label multicenter trial, 261 patients with muscle-invasive or lymph node–positive nonmetastatic upper tract urothelial cancer were randomly assigned between June 2012 and November 2017 to receive adjuvant gemcitabine with either cisplatin or carboplatin (n = 132) or surveillance (n = 129) after radical nephroureterectomy. Primary analysis of the trial showed that use of chemotherapy in this patient population was associated with improved disease-free survival. Overall survival was a secondary endpoint; data were not mature at the time of primary analysis.
Key Findings
By February 2022, with a median follow-up of 65 months, disease-free survival events had occurred in 50 patients in the chemotherapy group and 67 patients in the surveillance group. Disease-free survival at 5 years was 62% vs 45% (hazard ratio [HR] = 0.55, 95% confidence interval [CI] = 0.38–0.80, P = .001). Nonproportional hazards were observed; restricted mean survival time was prolonged by 18 months (95% CI = 6–30 months, P = .003) in the chemotherapy group (72 vs 54 months).
Among patients with disease recurrence, systemic treatment for recurrence was received by 23 (49%) of 47 in the chemotherapy group and by 45 (63%) of 71 in the surveillance group.
Death occurred in 46 patients in the chemotherapy group and 60 in the surveillance group. Overall survival at 5 years was 66% vs 57% (HR = 0.68, 95% CI = 0.46–1.00, P = .049). Nonproportional hazards were observed; restricted mean survival time was prolonged by 11 months (95% CI = 1–21 months, P = .036) in the chemotherapy group (78 vs 67 months).
Treatment effects were consistent across carboplatin- and cisplatin-based regimens and disease stage. Adverse events were similar to those previously reported. No clinically relevant differences in quality of life were observed between the two treatment groups.
The investigators concluded, “Although overall survival was not the primary outcome measure, the updated results add further support for the use of adjuvant chemotherapy in patients with upper tract urothelial cancer, suggesting long-term benefits.”
Dr. Birtle, of Lancashire Teaching Hospitals NHS Foundation Trust, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Cancer Research UK. For full disclosures of the study authors, visit ascopubs.org.
