Author:
Moser Justin C.,Bhatia Shailender,Amin Asim,Pavlick Anna C.,Betts Keith A.,Du Ella Xiaoyan,Poretta Tayla,Shelley Karishma,Srinivasan Swetha,Sakkal Leon Alan,Palaia Jennell,Lobo Maurice,Pe Benito Melanie,Linton Joshua A.,Chen Yan,Xu Churong,Yin Lei,Sundar Manasvi,Weber Jeffrey
Abstract
Abstract
Objectives
Nivolumab is approved as adjuvant therapy for resected stage III/IV melanoma based on the phase 3 CheckMate 238 trial. This analysis compared outcomes from CheckMate 238 with those from the real-world Flatiron Health electronic health record-derived de-identified database in patients with resected stage III melanoma (per AJCC-8) treated with adjuvant nivolumab.
Materials
Outcomes included baseline characteristics, overall survival (OS) in the CheckMate 238 cohort (randomization until death or last known alive), and real-world overall survival (rwOS) in the Flatiron Health cohort (nivolumab initiation until death or data cutoff). rwOS was compared with OS using unadjusted and adjusted Cox proportional hazards models. Inverse probability of treatment weighting (IPTW) was combined with the adjusted model to reduce baseline discrepancies.
Results
The CheckMate 238 and real-world cohorts included 369 and 452 patients, respectively (median age, 56.0 and 63.0 years; median follow-up, 61.4 vs. 25.5 months). rwOS was not different from OS in the unadjusted (hazard ratio [HR] 1.27; 95% CI 0.92–1.74), adjusted (HR 1.01; 95% CI 0.67–1.54), and adjusted IPTW (HR 1.07; 95% CI 0.70–1.63) analyses. In the adjusted analysis, 2-year OS and rwOS rates were 84%. Median OS and rwOS were not reached. After IPTW, OS and rwOS were not different (HR 1.07; 95% CI 0.70–1.64).
Conclusions
In this comparative analysis, OS in the CheckMate 238 trial was similar to rwOS in the Flatiron Health database after adjustments in patients with resected stage III melanoma (per AJCC-8) treated with adjuvant nivolumab, validating the trial results.
Publisher
Springer Science and Business Media LLC
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