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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorChibaudel, Benoist
dc.contributor.authorHenriques, Julie
dc.contributor.authorRakez, Manel
dc.contributor.authorBrenner, Baruch
dc.contributor.authorKim, Tae Won
dc.contributor.authorMartínez-Villacampa, Mercedes
dc.contributor.authorTabernero Caturla, Josep
dc.date.accessioned2021-09-22T13:06:38Z
dc.date.available2021-09-22T13:06:38Z
dc.date.issued2020-10-19
dc.identifier.citationChibaudel 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.
dc.identifier.issn2574-3805
dc.identifier.urihttps://hdl.handle.net/11351/6342
dc.descriptionChemotherapy; Disease-Free Survival; Colon Cancer
dc.description.abstractImportance 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.
dc.language.isoeng
dc.publisherAmerican Medical Association
dc.relation.ispartofseriesJama Network Open;3(10)
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceScientia
dc.subjectCòlon - Càncer
dc.subjectQuimioteràpia combinada
dc.subjectAvaluació de resultats (Assistència sanitària)
dc.subject.meshColonic Neoplasms
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.mesh/therapeutic use
dc.subject.meshDisease-Free Survival
dc.titleAssociation 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
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1001/jamanetworkopen.2020.20425
dc.subject.decsneoplasias del colon
dc.subject.decsprotocolos de quimioterapia antineoplásica combinada
dc.subject.decs/uso terapéutico
dc.subject.decssupervivencia sin enfermedad
dc.relation.publishversionhttps://jamanetwork.com/journals/jamanetworkopen/fullarticle/2771857
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[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
dc.identifier.pmid33074326
dc.identifier.wos000586427500004
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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