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Real-world effectiveness of approved anticancer agents among Medicare beneficiaries (306664)
Peter Bach, Memorial Sloan Kettering Cancer Center*Michael Curry, Memorial Sloan Kettering Cancer Center
Angela Green, Memorial Sloan Kettering Cancer Center
Sham Mailankody, Memorial Sloan Kettering Cancer Center
Keywords: Survival, Clinical Trials, Observational Research, Cancer
Determining the extent to which results of cancer clinical trials leading to Food and Drug Administration (FDA) approval reflect real-world outcomes is critical for reliable therapeutic decision-making. Using the SEER-Medicare database, we identified patients treated with FDA approved cancer drugs from 2008-2012 for advanced or metastatic solid tumors. We compared their duration of therapy and overall survival after initiating treatment to subjects in the approval trial. Fourteen different indications were evaluated. The median duration of therapy among Medicare beneficiaries was shorter than clinical trial treatment arms for all indications (median difference -3.0 months). Median overall survival among Medicare patients was shorter than that reported in the clinical trial for 12 indications (median difference -7.4 months). Medicare patients treated with FDA approved cancer drugs experience poorer survival than subjects in the clinical studies. This underscores uncertainty surrounding the ability of cancer clinical trials to predict outcomes for the broader US population of patients, particularly older adults with advanced cancer.