In Reply We thank Dr Mizutani for his praise of the GO2 phase 3 randomized clinical trial1 as a modern trial tailored to reflect the preferences and clinical needs of older and frailer patients. He is of course right that patient selection included an element of subjectivity: the limits of what constitutes unsuitability for full-dose combination chemotherapy because of advanced age and/or frailty vary among individual clinicians, among cultures, and over time. However, we should remember that every trial we conduct is subject to the same or greater subjectivity because, no matter how apparently objective the eligibility criteria are in a protocol, the decision to approach or not approach a potential participant who meets those criteria is one of clinical judgment. Similarly, decisions about the application of “standard” dosing schedules to individuals are a matter of subjective clinical judgment: national surveys during the preparation for both FOCUS2 in colorectal cancer2 and GO2 in gastroesophageal cancer1 showed marked inconsistency in those decisions. In contrast to most trials, the GO2 trial1 was exceptionally inclusive, embracing real-world clinical judgment in patient selection, but we then applied a careful multidimensional baseline health assessment, which has allowed us to define the trial population far more objectively than in other trials and to look for interactions between different dimensions of baseline fitness and the effect of treatment.
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Hall PS, Cairns DA, Seymour MT. Quantifying and Interpreting Efficacy of Reduced-Intensity Chemotherapy With Oxaliplatin and Capecitabine on Cancer Control for Advanced Gastroesophageal Cancer Among an Older Population—Reply. JAMA Oncol. 2021;7(11):1725. doi:10.1001/jamaoncol.2021.4010
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