Final Results Of Prodige 9, A Randomized Phase Iii Comparing No Treatment To Bevacizumab Maintenance During Chemotherapy-Free Intervals In Metastatic Colorectal Cancer.

JOURNAL OF CLINICAL ONCOLOGY(2016)

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摘要
3531Background: Conflicting results are reported for maintenance treatment with bevacizumab (bev) during chemotherapy free intervals (CFI) in metastatic colorectal cancer (mCRC). Methods: The objective was to compare the tumor control duration (TCD) by either bev maintenance (Arm A) or no treatment during CFI (Arm B) after induction chemotherapy (CT) (12 cycles of FOLFIRI + bev). CT was reintroduced at progression (8 cycles) and then a new CFI. The randomization was performed before induction CT. TCD was defined by the time between randomization and tumor progression during a CT sequence (Aparicio T et al, Dig Liver Dis, 2015). Per Protocol (PP) population was defined as patients (pts) with at least one CT reintroduction after first progression during CFI. We present the final analysis of the trial. Results: From March 2010 to July 2013, 491 pts were randomized. The median age was 64.6 years [range: 27 - 89], 64% of the pts were men, 93% of the pts were OMS 0-1 and 218 (44%) pts had a non-resected primary...
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