Single-Arm Phase II Trials of Combination Therapies: A Review of the CTEP Experience 2008-2017.

ABSTRACT: Designing and interpreting single-arm phase II trials of combinations of agents is challenging because it can be difficult, based on historical data, to identify levels of activity for which the combination would be worth pursuing. We identified Cancer Therapy Evaluation Program single-arm combination trials that were activated in 2008-2017 and tabulated their design characteristics and results. Positive trials were evaluated as to whether they provided credible evidence that the combination was better than its constituents. A total of 125 trials were identified, and 120 trials had results available. Twelve had designs where eligible patients were required to be resistant or refractory to all but one element of the combination. Only 17.8% of the 45 positive trials were deemed to provide cr

SUBMITTER: Foster JC 

PROVIDER: S-EPMC7019095 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature