Abstract
4007 Background: We previously validated 3 yr DFS as an endpoint in adjuvant colon cancer clinical trials (ACCCT), based on associations with 5 yr OS outcomes, in patients treated in the 5-FU alone era. New therapies (rx) (oxaliplatin, irinotecan, bevacizumab, cetuximab, panitumumab) have extended survival following rec from 1 yr with 5-FU alone to approximately 2 yrs. We used the ACCENT database to examine the impact of this improvement on ACCCT endpoints. Methods: The dataset assembled by ACCENT, a collection of individual pt data from 18 trials and over 20,800 pts testing 5-FU based adjuvant rx for pts with stage II and III colon cancer, was analyzed. To estimate the effect of longer survival following rec, in an exploratory fashion, for each pt who recurred, their time from rec to death was doubled (hypothetical dataset), with all other factors remaining identical. Analyses assume newer rx may affect the rec rate, but not the time- patterns of rec. Results: 7269 of 20,898 (35%) of pts experienced rec....
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