Information from the abstract
Background Perioperative chemoimmunotherapy is emerging as a global standard for nonmetastatic gastroesophageal cancers. Event-free survival (EFS) is a common endpoint in perioperative trials; however, its validity as a surrogate for overall survival (OS) in randomized controlled trials in the era of chemoimmunotherapy is not well established. Materials and methods We carried out a systematic review to identify randomized controlled trials evaluating neoadjuvant or perioperative therapy for gastroesophageal adenocarcinomas. Weighted linear regression of the published hazard ratios (HRs) was used to evaluate the correlation between EFS and OS. Criteria from the Institute for Quality and Efficiency in Health Care defined surrogacy strength. Sensitivity analyses evaluating heterogeneous tumor locations, perioperative systemic therapy only, and trials with clearly defined EFS were carried out. Results Thirty trials comprising 11 453 participants were included in the main analysis. Trial-level analysis identified a positive relationship between EFS and OS ( P < 0.001), corresponding to a correlation coefficient ( R ) of 0.83. Surrogate threshold effect analysis identified an HR for EFS of 1.18 or lower as a threshold at which the lower bound of the 95% confidence interval for OS HR excluded 1.0. EFS correlation with OS was preserved across sensitivity analyses. Conclusions EFS is a valid surrogate for OS at the trial level in randomized controlled perioperative trials in modern nonmetastatic gastroesophageal trials, supporting the validity of intermediate endpoints for use in development of novel treatment strategies and regulatory considerations in gastroesophageal adenocarcinomas.
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Related topics: Esophageal Cancer Research and Treatment · Cancer, Stress, Anesthesia, and Immune Response · Gastric Cancer Management and Outcomes
Thai researcher and institutional participation
N. Teeyapun · Chulalongkorn University
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