To provide decision-focused estimates of the benefit of perioperative durvalumab in cisplatin-eligible muscle-invasive bladder cancer using Bayesian modeling of reconstructed individual patient data (rIPD) from the phase 3 NIAGARA trial.
Individual patient data were reconstructed from published Kaplan-Meier curves and event counts (durvalumab, n = 533; control, n = 530). Bayesian piecewise-exponential models with prespecified intervals (0-12, 12-24, 24-36, and 36-60 months) were used to estimate interval-specific hazards, posterior probabilities of benefit, absolute survival differences, number needed to treat (NNT), and restricted mean survival time (RMST).
For event-free survival (EFS), the overall hazard ratio (HR) was 0.68 (95% credible interval [CrI], 0.56-0.82). The absolute improvement in EFS with durvalumab was 6.3%, 8.5%, and 10.8% at 12, 24, and 36 months, respectively, corresponding to median NNT values of 15.8, 11.7, and 9.2. The gain in RMST for EFS was 2.48 months over 36 months and 5.98 months over 60 months. For overall survival (OS), the overall HR was 0.74 (95% CrI, 0.59-0.93). The absolute improvement in OS was 2.7%, 7.3%, and 7.5% at 12, 24, and 36 months, respectively, with a median NNT of 13.8 at 24 months. The gain in RMST for OS was 1.66 months over 36 months and 3.31 months over 60 months.
This Bayesian rIPD reanalysis complements the primary NIAGARA report by translating relative effects into clinically meaningful absolute benefits over prespecified perioperative time points, supporting perioperative counseling and institutional decision-making.
Japanese journal of clinical oncology. 2026 Apr 29 [Epub ahead of print]
Kohei Hirose, Soichiro Yoshida, Wei Chen, Shugo Yajima, Hiroyuki Sato, Akihiro Hirakawa, Kenji Tanabe, Motohiro Fujiwara, Hiroshi Fukushima, Yosuke Yasuda, Hajime Tanaka, Hitoshi Masuda, Yasuhisa Fujii
Department of Urology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba 277-8577, Japan., Department of Urology, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan., Department of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan., Department of Urology, Teikyo University Hospital, Mizonokuchi, 5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa 213-8507, Japan.