Andr? T.Vernerey D.Im S.A.Bodoky G.Buzzoni R.Reingold S.Rivera F.McKendrick J.Scheithauer W.Ravit G.Fountzilas G.Yong W.P.Isaacs R.?sterlund P.JIN-TUNG LIANGCreemers G.J.Rakez M.Van Cutsem E.Cunningham D.Tabernero J.de Gramont A.2021-05-032021-05-0320200923-7534https://www.scopus.com/inward/record.uri?eid=2-s2.0-85078554434&doi=10.1016%2fj.annonc.2019.12.006&partnerID=40&md5=73065e78804e9a990cfe096abfdc2bd5https://scholars.lib.ntu.edu.tw/handle/123456789/558573Background: The bevacizumab-Avastin? adjuVANT (AVANT) study did not meet its primary end point of improving disease-free survival (DFS) with the addition of bevacizumab to oxaliplatin-based chemotherapy in stage III colon cancer (CC). We report here the long-term survival results (S-AVANT). Patients and methods: Patients with curatively resected stage III CC were randomly assigned to FOLFOX4, FOLFOX4-bevacizumab, or XELOX-bevacizumab. Results: A total of 2867 patients were randomized: FOLFOX4: n = 955, FOLFOX4-bevacizumab: n = 960, XELOX-bevacizumab: n = 952. With a median of 6.73 years follow-up (interquartile range 5.51–10.54), 672 patients died, of whom 198 (20.7%), 250 (26.0%), and 224 (23.5%) were in the FOLFOX4, FOLFOX4-bevacizumab, and XELOX-bevacizumab arms, respectively. The 10-year overall survival (OS) rates were 74.6%, 67.2%, and 69.9%, (P = 0.003) and 5-year disease-free survival (DFS) rates were 73.2%, 68.5%, and 71.0% (P = 0.174), respectively. OS and DFS hazard ratios were 1.29 [95% confidence interval (CI) 1.07–1.55; P = 0.008] and 1.16 (95% CI 0.99–1.37; P = 0.063) for FOLFOX4-bevacizumab versus FOLFOX4 and 1.15 (95% CI 0.95–1.39; P = 0.147) and 1.1 (95% CI 0.93–1.29; P = 0.269) for XELOX-bevacizumab versus FOLFOX4, respectively. CC-related deaths (n = 542) occurred in 157 (79.3%) patients receiving FOLFOX4, 205 (82.0%) receiving FOLFOX4-bevacizumab, and 180 (80.4%) receiving XELOX-bevacizumab (P = 0.764), while non-CC-related deaths occurred in 41 (20.7%), 45 (18.0%), and 44 (19.6%) patients, respectively. Cardiovascular-related and sudden deaths during treatment or follow-up were reported in 13 (6.6%), 17 (6.8%), and 14 (6.3%) patients, in the FOLFOX4, FOLFOX4-bevacizuamb, and XELOX-bevacizumab arms, respectively (P = 0.789). Treatment arm, sex, age, histological differentiation, performance status, T/ N stages, and localization of primary tumor were independent prognostic factors of OS in stage III. Conclusions: S-AVANT confirms the initial AVANT report. No benefit of the bevacizumab addition to FOLFOX4 adjuvant therapy in patients with stage III CC was observed in terms of DFS with a negative effect in OS, without increase in non-CC related deaths. Clinical trial identification: NCT00112918. ? 2019 European Society for Medical Oncologyadjuvant; bevacizumab; colon cancer; FOLFOX; XELOX[SDGs]SDG3bevacizumab; capecitabine; fluorouracil; folinic acid; oxaliplatin; antineoplastic agent; bevacizumab; fluorouracil; folinic acid; platinum complex; adult; aged; Article; cancer adjuvant therapy; cancer grading; cancer prognosis; cancer staging; cancer survival; colon cancer; colorectal cancer; comorbidity; controlled study; disease free survival; drug withdrawal; female; hazard ratio; human; long term care; major clinical study; male; monotherapy; overall survival; phase 3 clinical trial; primary tumor; priority journal; randomized controlled trial; sudden death; toxicity; treatment planning; adjuvant chemotherapy; clinical trial; colon tumor; pathology; Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Chemotherapy, Adjuvant; Colonic Neoplasms; Disease-Free Survival; Fluorouracil; Humans; Leucovorin; Neoplasm Staging; Organoplatinum Compoundsjournal article10.1016/j.annonc.2019.12.006319593412-s2.0-85078554434