TY - JOUR
T1 - Improved Disease Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer.
T2 - Final Results of the POUT Trial
AU - Birtle, Alison
AU - Jones, Robert
AU - Chesterman, John
AU - Lewis, Rebecca
AU - Biscombe, Katie
AU - Johnson, Mark
AU - Blacker, Anthony
AU - Bryan, Richard
AU - Catto, James WF
AU - Choudhury, Ananya
AU - Das, Prantik
AU - Jagdev, Satinder
AU - Powles, Thomas
AU - Wagstaff, John
AU - Cheung, Ka Ching
AU - Cafferty, Fay
AU - Hall, Emma
PY - 2024/2/13
Y1 - 2024/2/13
N2 - POUT was a phase III, randomised, open-label trial, including 261 patients with muscle-invasive or lymph-node positive, non-metastatic upper tract urothelial cancer (UTUC) randomly assigned following radical nephroureterectomy to platinum-based chemotherapy (132) or surveillance (129). Primary outcome analysis demonstrated that chemotherapy improved disease free survival (DFS). At that time, the planned secondary outcome analysis of overall survival (OS) was immature. By February 2022, 50 and 67 DFS events had occurred in the chemotherapy and surveillance groups respectively, at median follow-up 65 months. Five-year DFS was 62% vs 45%, univariable HR=0.55 (95% CI 0.38-0.80, p=0.001). Restricted mean survival time (RMST) was 18 months longer (95% CI 6-30m) in the chemotherapy arm. There were 46 and 60 deaths in the chemotherapy and control arms respectively. Five-year OS was 66% vs 57%, univariable HR=0.68 (0.46-1.00, p=0.049) and RMST difference 11m (1-21m). Treatment effects were consistent across chemotherapy regimens (carboplatin or cisplatin) and disease stage. Toxicities were similar to those previously reported and there were no clinically relevant differences in quality of life between arms. In summary, although OS was not the primary outcome measure, the updated results add further support for the use of adjuvant chemotherapy in patients with UTUC, suggesting long-term benefits.
AB - POUT was a phase III, randomised, open-label trial, including 261 patients with muscle-invasive or lymph-node positive, non-metastatic upper tract urothelial cancer (UTUC) randomly assigned following radical nephroureterectomy to platinum-based chemotherapy (132) or surveillance (129). Primary outcome analysis demonstrated that chemotherapy improved disease free survival (DFS). At that time, the planned secondary outcome analysis of overall survival (OS) was immature. By February 2022, 50 and 67 DFS events had occurred in the chemotherapy and surveillance groups respectively, at median follow-up 65 months. Five-year DFS was 62% vs 45%, univariable HR=0.55 (95% CI 0.38-0.80, p=0.001). Restricted mean survival time (RMST) was 18 months longer (95% CI 6-30m) in the chemotherapy arm. There were 46 and 60 deaths in the chemotherapy and control arms respectively. Five-year OS was 66% vs 57%, univariable HR=0.68 (0.46-1.00, p=0.049) and RMST difference 11m (1-21m). Treatment effects were consistent across chemotherapy regimens (carboplatin or cisplatin) and disease stage. Toxicities were similar to those previously reported and there were no clinically relevant differences in quality of life between arms. In summary, although OS was not the primary outcome measure, the updated results add further support for the use of adjuvant chemotherapy in patients with UTUC, suggesting long-term benefits.
UR - https://www.scopus.com/pages/publications/85188555739
U2 - 10.1200/JCO.23.01659
DO - 10.1200/JCO.23.01659
M3 - Article
SN - 0732-183X
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
ER -
