Survival benefit in EGFR-wild and ALK negative NSCLC patients who participate in clinical trials compared to standard-of-care: Propensity-matched analysis.

Objectives: Advanced non-small cell lung cancer patients harboring EGFR mutation or ALK fusion have achieved significant survival benefit with targeted agents. In contrast, EGFR-wild type and ALK negative lung adenocarcinoma still have poor survival outcome. This study assessed the impact of participating in clinical trials on clinical outcomes in patients with EGFR-wild-type and ALK-negative lung adenocarcinoma.
Materials and Methods: This study included patients with advanced EGFR-wild-type and ALK-negative lung adenocarcinoma who received systemic treatment between March 2017 and June 2022. We compared clinical outcomes between patients who participated in clinical trials and those treated with standard-of-care (SOC) using propensity score matching (PSM).
Results: Overall, 1,686 patients with EGFR-wild-type and ALK-negative advanced lung adenocarcinoma were included in the final analysis. Of these, 1,380 (81.9 %) received SOC only and 306 (18.1 %) patients were enrolled in at least one clinical trial during their cancer journey. After PSM (1:1), 612 patients were matched to the SOC (n = 306) and clinical trial (n = 306) groups. Among those who participated in clinical trials, 27.8 % and 72.2 % were included in clinical trials involving targeted therapy and immunotherapy respectively. In the clinical trial group, more patients received targeted therapy (31.7 % vs. 5.5 %, p < 0.001) and immunotherapy (88.6 % vs. 62.8 %, p < 0.001) compared to the SOC group. The median overall survival was 17.1 months (95 % confidence interval [CI], 13.2-21.4) in the SOC group and 27.3 months (95 % CI, 22.1-32.4) in the clinical trial group (hazard ratio = 0.71, [95 % CI, 0.58-0.88, P = 0.002]).
Conclusions: This study demonstrated that participating in clinical trials resulted in a survival benefit that reduced the risk of death by 29.6% compared to receiving SOC in EGFR-wild-type and ALK-negative lung adenocarcinoma.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: MJ Ahn reports grants and personal fees from MSD, AstraZeneca, BMS, and Roche, outside of the submitted work. JS Ahn reports personal fees from Amgen, Pfizer, AstraZeneca, Menarini, Roche, Eisai, Boehringer Ingelheim, BMS-Ono, MSD, Janssen, and Samsung Bioepis, outside of the submitted work. S-H Lee reports grants and personal fees from MSD, Novartis, AstraZeneca, BMS, and Roche, outside of the submitted work. JM sun reports grants and personal fees from MSD, outside of the submitted work. HA Jung reports grants and personal fees from Yuhan outside of the submitted work.
(Copyright © 2024. Published by Elsevier B.V.)