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Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study.
Bokemeyer, C; Bondarenko, I; Hartmann, J T; de Braud, F; Schuch, G; Zubel, A; Celik, I; Schlichting, M; Koralewski, P.
Afiliación
  • Bokemeyer C; Department of Oncology, Hematology, BMT with Section Pneumology, University Hospital, Hamburg-Eppendorf, Germany. Electronic address: c.bokemeyer@uke.uni-hamburg.de.
  • Bondarenko I; City Clinical Hospital #4, Dnepropetrovsk State Medical Academy, Dnepropetrovsk, Ukraine.
  • Hartmann JT; Department of Medical Oncology, Hematology, Immunology, Rheumatology, and Pulmonology, South West German Comprehensive Cancer, University Hospital Tübingen, Tübingen, Germany.
  • de Braud F; Division of Clinical Pharmacology and New Drugs, Istituto Europeo di Oncologia, Milan, Italy.
  • Schuch G; Department of Oncology, Hematology, BMT with Section Pneumology, University Hospital, Hamburg-Eppendorf, Germany.
  • Zubel A; Global Clinical Development Unit-Oncology.
  • Celik I; Global Clinical Development Unit-Oncology.
  • Schlichting M; Global Biostatistics, Merck KGaA, Darmstadt, Germany.
  • Koralewski P; Oncology, Rydygier Memorial Hospital, Krakow-Nowa Huta, Poland.
Ann Oncol ; 22(7): 1535-1546, 2011 Jul.
Article en En | MEDLINE | ID: mdl-21228335
BACKGROUND: The randomized phase II OPUS (Oxaliplatin and Cetuximab in First-Line Treatment of Metastatic Colorectal Cancer) study showed that tumor KRAS mutation status was predictive for outcome in patients receiving cetuximab plus FOLFOX-4 (oxaliplatin/5-fluorouracil/folinic acid) as first-line therapy for metastatic colorectal cancer (mCRC). PATIENTS AND METHODS: The biomarker analysis was extended through the use of additional DNA samples extracted from stained tissue sections. KRAS and BRAF tumor mutation status was determined for new (and for BRAF, existing) samples using a PCR technique. Clinical outcome was reassessed according to mutation status. Overall survival data are presented. RESULTS: Of 315 KRAS evaluable patient samples (93%), 179 tumors (57%) were KRAS wild type. Eleven of 309 (4%) KRAS/BRAF evaluable tumors (all KRAS wild type) carried BRAF mutations. The addition of cetuximab to FOLFOX-4 significantly improved progression-free survival (hazard ratio 0.567, P = 0.0064) and response (odds ratio 2.551, P = 0.0027) in patients with KRAS wild-type tumors. A favorable effect on survival was also observed. CONCLUSIONS: These results confirm the efficacy of cetuximab plus FOLFOX-4 in the first-line treatment of patients with KRAS wild-type mCRC and confirm KRAS mutation status as an effective predictive biomarker. The small number of tumors with BRAF mutations precluded the drawing of definitive conclusions concerning the predictive or prognostic utility of this biomarker.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Colorrectales / Protocolos de Quimioterapia Combinada Antineoplásica / Biomarcadores de Tumor / Proteínas Proto-Oncogénicas / Proteínas ras / Neoplasias Hepáticas / Mutación Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2011 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Colorrectales / Protocolos de Quimioterapia Combinada Antineoplásica / Biomarcadores de Tumor / Proteínas Proto-Oncogénicas / Proteínas ras / Neoplasias Hepáticas / Mutación Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2011 Tipo del documento: Article Pais de publicación: Reino Unido