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Association of Bevacizumab Plus Oxaliplatin-Based Chemotherapy With Disease-Free Survival and Overall Survival in Patients With Stage II Colon Cancer: A Secondary Analysis of the AVANT Trial Henriques, Julie Brenner, Baruch Martínez-Villacampa, Mercedes Tabernero Caturla, Josep Chibaudel, Benoist Kim, Tae Won Rakez, Manel Institut Català de la Salut [Chibaudel B] Department of Medical Oncology, Franco-British Hospital–Fondation Cognacq-Jay, Levallois-Perret, France. Statistical Unit, Aide et Recherche en Cancérologie Digestive, Foundation, Levallois-Perret, France. [Henriques J] Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche 1098, Besançon, France. [Rakez M] Statistical Unit, Aide et Recherche en Cancérologie Digestive, Foundation, Levallois-Perret, France. [Brenner B] Institute of Oncology, Davidoff Cancer Center, Rabin Medical Center, Petah Tiqva, Tel Aviv University, Tel Aviv, Israel. [Kim TW] Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. [Martinez-Villacampa M] Department of Medical Oncology, Institut Català d'Oncologia-Bellvitge Institute for Biomedical Research, L’Hospitalet, Barcelona, Spain. [Tabernero J] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Universitat de Vic–Universitat Central de Catalunya, International Oncology Bureau–Quiron, Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Còlon - Càncer Quimioteràpia combinada Avaluació de resultats (Assistència sanitària) DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms::Colonic Neoplasms ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Clinical Protocols::Antineoplastic Protocols::Antineoplastic Combined Chemotherapy Protocols Other subheadings::Other subheadings::/therapeutic use ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome::Disease-Free Survival ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias intestinales::neoplasias colorrectales::neoplasias del colon TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::protocolos clínicos::protocolos antineoplásicos::protocolos de quimioterapia antineoplásica combinada Otros calificadores::Otros calificadores::/uso terapéutico TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento::supervivencia sin enfermedad Quimioteràpia; Supervivència sense malaltia; Càncer de còlon Quimioterapia; Supervivencia sin enfermedad; Cáncer de colon Chemotherapy; Disease-Free Survival; Colon Cancer Importance In the pivotal Multicenter Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer (MOSAIC) trial, patients with high-risk stage II colon cancer (CC) had 5-year and 10-year overall survival (OS) rates of 88% and 75%, respectively, with adjuvant fluorouracil and oxaliplatin–based chemotherapy; the Bevacizumab-Avastin Adjuvant (AVANT) trial did not demonstrate a disease-free survival (DFS) benefit of adding bevacizumab to oxaliplatin-based chemotherapy in stage III CC and suggested a detrimental effect on OS. The Long-term Survival AVANT (S-AVANT) study was designed to collect extended follow-up for patients in the AVANT trial. Objective To explore the efficacy of adjuvant bevacizumab combined with oxaliplatin-based chemotherapy in patients with high-risk, stage II CC. Design, Setting, and Participants This prespecified secondary end point analysis of the AVANT and S-AVANT studies included 573 patients with curatively resected high-risk stage II CC and at least 1 of the following criteria: stage T4, bowel obstruction or perforation, blood and/or lymphatic vascular invasion and/or perineural invasion, age younger than 50 years, or fewer than 12 nodes analyzed. The AVANT study was a multicenter randomized stage 3 clinical trial. Data were collected from December 2004 to February 2019, and data for this study were analyzed from March to September 2019. Intervention Patients were randomly assigned to receive 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX4), FOLFOX4 with bevacizumab, or capecitabine and oxaliplatin (XELOX) with bevacizumab. Main Outcomes and Measures The primary end points of this secondary analysis were DFS and OS in patients with high-risk stage II CC. Results The AVANT study included 3451 patients, of whom 573 (16.6%) had high-risk stage II CC (192 [33.5%] randomized to FOLFOX4 group; 194 [33.9%] randomized to FOLFOX4 with bevacizumab group; 187 [32.6%] randomized to XELOX with bevacizumab group). With a median (interquartile range) age of 57.0 (47.2-65.7) years, the study population comprised 325 men (56.7%) and 248 women (43.3%). After a median (interquartile range) follow-up of 6.9 (6.1-11.3) years, the 3-year DFS and 5-year OS rates were 88.2% (95% CI, 83.7%-93.0%) and 89.7% (95% CI, 85.4%-94.2%) in the FOLFOX4 group, 86.6% (95% CI, 81.8%-91.6%) and 89.7% (95% CI, 85.4%-94.2%) in the FOLFOX4 with bevacizumab group, and 86.7% (95% CI, 81.8%-91.8%) and 93.2% (95% CI, 89.6%-97.0%) in the XELOX with bevacizumab group, respectively. The DFS hazard ratio was 0.94 (95% CI, 0.59-1.48; P = .78) for FOLFOX4 with bevacizumab vs FOLFOX4 and 1.07 (95% CI, 0.69-1.67; P = .76) for XELOX with bevacizumab vs FOLFOX4. The OS hazard ratio was 0.92 (95% CI, 0.55-1.55; P = .76) for FOLFOX4 with bevacizumab vs FOLFOX4 and 0.85 (95% CI, 0.50-1.44; P = .55) for XELOX with bevacizumab vs FOLFOX4. Conclusions and Relevance In this secondary analysis of data from the AVANT trial, adding bevacizumab to oxaliplatin-based chemotherapy was not associated with longer DFS or OS in patients with high-risk stage II CC. The findings suggest that the definition of high-risk stage II CC needs to be revisited. This study was funded by Roche. 2021-09-22T13:06:38Z 2021-09-22T13:06:38Z 2020-10-19 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Chibaudel B, Henriques J, Rakez M, Brenner B, Kim TW, Martinez-Villacampa M, et al. Association of Bevacizumab Plus Oxaliplatin-Based Chemotherapy With Disease-Free Survival and Overall Survival in Patients With Stage II Colon Cancer. JAMA Netw Open. 2020 Oct 19;3(10):e2020425. 2574-3805 https://hdl.handle.net/11351/6342 10.1001/jamanetworkopen.2020.20425 33074326 000586427500004 eng Jama Network Open;3(10) https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2771857 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf application/pdf American Medical Association Scientia