American Association for Cancer Research

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Table S3 from Treatment-Related Adverse Events Predict Improved Clinical Outcome in NSCLC Patients on KEYNOTE-001 at a Single Center

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posted on 2023-04-03, 23:26 authored by Aaron Lisberg, D. Andrew Tucker, Jonathan W. Goldman, Brian Wolf, James Carroll, Ariana Hardy, Karolyn Morris, Paulina Linares, Carlos Adame, Marshall L. Spiegel, Courtney Wells, Jordan McKenzie, Blanca Ledezma, Melody Mendenhall, Phillip Abarca, Krikor Bornazyan, Jaime Hunt, Nima Moghadam, Natalie Chong, Danielle Nameth, Caitlin Marx, John Madrigal, Sitaram Vangala, Narek Shaverdian, David Elashoff, Edward B. Garon

Table S3: The occurrence of a treatment related AE (trAE) in the 97 patients treated at UCLA on the KEYNOTE-001 clinical trial, stratified by a history of thoracic radiation therapy (TRT) or prior radiation therapy to any location. P values computed via Fisher's exact test.


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We retrospectively analyzed non–small cell lung cancer (NSCLC) patients from a single center treated with pembrolizumab on the KEYNOTE-001 trial and evaluated the association between treatment-related adverse events (trAEs) and clinical outcomes. Investigators reported AEs on trial and graded them according to Common Terminology Criteria for Adverse Events v4.0, labeling them as unlikely, possibly, or probably treatment-related. AEs labeled as possibly/probably related were considered trAEs for this analysis. The relationship between the incidence of a trAE and clinical outcomes was evaluated. Ninety-seven NSCLC patients treated on KEYNOTE-001 at the University of California, Los Angeles were evaluated. Ten percent (85/826) of AEs were trAEs, occurring in 40% (39/97) of patients. The most frequent trAEs were rash (21% patients), fatigue (6% patients), and hypothyroidism (6% patients). The 39 patients that experienced a trAE had increased objective response rate (ORR, 38.5%), progression-free survival (PFS: median, 248 days), and overall survival (OS: median, 493 days), compared with the 58 patients that did not (ORR: 8.9%, PFS: median 60 days, OS: median 144.5 days). The observed association between trAEs and improved clinical outcome persisted when using Cox proportional hazards regression models to assess the confounding effect of covariates and mitigate guarantee-time bias. The association also remained when data were substratified by grade, degree of association, and treatment-related select AE designation. This single-center analysis revealed that trAEs predicted for improved clinical outcome with pembrolizumab, and when controlling for guarantee-time bias and plausible confounders, this association remained. This observed relationship adds to our understanding of anti–PD-1 therapy and could aid clinicians in identifying patients most likely to benefit from therapy. Cancer Immunol Res; 6(3); 288–94. ©2018 AACR.

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