Correlation between tumor size change and outcome in a rare cancer immunotherapy basket trial.

ABSTRACT:

Background

RECIST criteria for progressive disease, partial response, and complete response, reflecting +20%, -30%, and -100% tumor size changes, respectively, are critical outcome variables in oncology clinical trials. Herein, we evaluated post-immunotherapy tumor size change correlation with outcomes.

Methods

We used a unique clinical trial data resource, a multicenter basket trial in patients with rare solid tumors treated with nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) between 2017 and 2023 (National Cancer Institute/Southwest Oncology Group-sponsored DART trial [NCT02834013]) (open at 1083 sites at its peak). Outcome associations were evaluated by survival analysis techniques including Martingale residuals.

Results

In 638 evaluable patients, we found stro

SUBMITTER: Othus M 

PROVIDER: S-EPMC11077308 | biostudies-literature | 2024 May

REPOSITORIES: biostudies-literature