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Adjuvant Fluorouracil, Leucovorin, and Oxaliplatin in Stage II to III Colon Cancer: Updated 10-Year Survival and Outcomes According to BRAF Mutation and Mismatch Repair Status of the MOSAIC Study

André, Thierry, de Gramont, Armand, Vernerey, Dewi, Chibaudel, Benoist, Bonnetain, Franck, Tijeras-Raballand, Annemilaï, Scriva, Aurelie, Hickish, Tamas, Tabernero, Josep, Van Laethem, Jean Luc, Banzi, Maria, Maartense, Eduard, Shmueli, Einat, Carlsson, Goran U., Scheithauer, Werner, Papamichael, Demetris, Möehler, Marcus, Landolfi, Stefania, Demetter, Pieter, Colote, Soudhir, Tournigand, Christophe, Louvet, Christophe, Duval, Alex, Fléjou, Jean-François, de Gramont, Aimery·2015·Journal of Clinical Oncology

DOI 10.1200/jco.2015.63.4238

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Abstract

Purpose: The MOSAIC (Multicenter International Study of Oxaliplatin/Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer) study has demonstrated 3-year disease-free survival (DFS) and 6-year overall survival (OS) benefit of adjuvant oxaliplatin in stage II to III resected colon cancer. This update presents 10-year OS and OS and DFS by mismatch repair (MMR) status and BRAF mutation. Methods: Survival actualization after 10-year follow-up was performed in 2,246 patients with resected stage II to III colon cancer. We assessed MMR status and BRAF mutation in 1,008 formalin-fixed paraffin-embedded specimens. Results: After a median follow-up of 9.5 years, 10-year OS rates in the bolus/infusional fluorouracil plus leucovorin (LV5FU2) and LV5FU2 plus oxaliplatin (FOLFOX4) arms were 67.1% versus 71.7% (hazard ratio [HR], 0.85; P = .043) in the whole population, 79.5% versus 78.4% for stage II (HR, 1.00; P = .980), and 59.0% versus 67.1% for stage III (HR, 0.80; P = .016) disease. Ninety-five patients (9.4%) had MMR-deficient (dMMR) tumors, and 94 (10.4%) had BRAF mutation. BRAF mutation was not prognostic for OS (P = .965), but dMMR was an independent prognostic factor (HR, 2.02; 95% CI, 1.15 to 3.55; P = .014). HRs for DFS and OS benefit in the FOLFOX4 arm were 0.48 (95% CI, 0.20 to 1.12) and 0.41 (95% CI, 0.16 to 1.07), respectively, in patients with stage II to III dMMR and 0.50 (95% CI, 0.25 to 1.00) and 0.66 (95% CI, 0.31 to 1.42), respectively, in those with BRAF mutation. Conclusion: The OS benefit of oxaliplatin-based adjuvant chemotherapy, increasing over time and with the disease severity, was confirmed at 10 years in patients with stage II to III colon cancer. These updated results support the use of FOLFOX in patients with stage III disease, including those with dMMR or BRAF mutation.

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Authors: André, T., de Gramont, A., Vernerey, D., Chibaudel, B., Bonnetain, F., Tijeras-Raballand, A., Scriva, A., Hickish, T., Tabernero, J., Van Laethem, J. L., Banzi, M., Maartense, E., Shmueli, E., Carlsson, G. U., Scheithauer, W., Papamichael, D., Möehler, M., Landolfi, S., Demetter, P., Colote, S., Tournigand, C., Louvet, C., Duval, A., Fléjou, J.-F., & de Gramont, A.
Affiliations: Inserm (FR)
Thierry André and Jean-François Fléjou, Hôpital St Antoine; Thierry André and Jean-François Fléjou, University Pierre et Marie Curie Paris VI; Thierry André, Benoist Chibaudel, Annemilaï Tijeras-Raballand, Soudhir Colote, and Aimery de Gramont, Groupe Coopérateur Multdisciplinaire en Ocologie (GERCOR) Oncology Multidisciplinary Group and GERCOR-Innovative Research Consortium; Christophe Louvet, Institut Mutualiste Montsouris; Alex Duval, L'Institut National de la Santé et de la Recherche Médicale UMRS...
ORCID: André, Thierry
Chibaudel, Benoist
Hickish, Tamas
Tabernero, Josep
Banzi, Maria
Shmueli, Einat
Papamichael, Demetris
Landolfi, Stefania
Demetter, Pieter
Tournigand, Christophe
Louvet, Christophe
Duval, Alex
Fléjou, Jean-François
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2015-12-10
Volume: 33
Issue: 35
Pages: 4176-4187
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2015.63.4238
OpenAlex: W1960485012
Cited by: 683
References: 32
Citations by year: 2026: 43 · 2025: 56 · 2024: 75 · 2023: 65 · 2022: 74 · 2021: 92 · 2020: 97 · 2019: 47 · 2018: 59 · 2017: 41 · 2016: 32
FWCI: 19.22
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
IRIS (submittedVersion)
SERVAL (Université de Lausanne) (submittedVersion)
Funders: European Society for Medical Oncology
Topics: Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
Health Sciences › Medicine › Pathology and Forensic Medicine › Genetic factors in colorectal cancer
Keywords: colon cancer, adjuvant chemotherapy, oxaliplatin, FOLFOX4, 5-fluorouracil, leucovorin, BRAF mutation, mismatch repair deficiency, overall survival, disease-free survival, prognostic factors, stage II colon cancer, stage III colon cancer, mosaic studies, long-term follow-up, microsatellite instability, mismatch repair proteins
MeSH terms: Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Leucovorin, Colonic Neoplasms, Female, Fluorouracil, Follow-Up Studies, Humans, Infusions, Intravenous, Injections, Intravenous, Male, Middle Aged, Mutation, Neoplasm Staging, Organoplatinum Compounds, Prognosis, Valine, Odds Ratio, Treatment Outcome, Chemotherapy, Adjuvant, Disease-Free Survival, Glutamic Acid, Proto-Oncogene Proteins B-raf, Kaplan-Meier Estimate, DNA Mismatch Repair

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Adjuvant Fluorouracil, Leucovorin, and Oxaliplatin in Stage II to III Colon Cancer: Updated 10-Year Survival and Outcomes According to BRAF Mutation and Mismatch Repair Status of the MOSAIC Study

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