Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin Versus Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation: A Trial of the ECOG-ACRIN Research Group (E5204).
A Bapsi ChakravarthyFengmin ZhaoNeal J MeropolPatrick J FlynnLynne I WagnerJeffrey SloanRobert B DiasioEdith P MitchellPaul CatalanoBruce J GiantonioRobert B CatalanoDaniel G HallerRashid A AwanMary F MulcahyTimothy E O'BrienRoger SantalaChristine CrippsJohn R WeisJames N AtkinsCynthia G LeichmanNicholas J PetrelliFrank A SinicropeJames D BrierleyJoel E TepperPeter J O'DwyerElin R SigurdsonStanley R HamiltonDavid CellaAl B BensonPublished in: The oncologist (2019)
At 17% of its planned accrual, E5204 was terminated early owing to poor accrual. At a median follow-up of 72 months, there was no significant difference in 5-year overall survival (88.3% vs. 83.7%) or in 5-year disease-free survival (71.2% vs. 76.5%) between the two arms. Despite significant advances in the treatment of rectal cancer, especially in improving local control rates, the risk of distant metastases and the need to further improve quality of life remain a challenge. Strategies combining novel agents with chemoradiation to improve both distant and local control are needed.