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Cetuximab in combination with weekly 5-fluorouracil/folinic acid and oxaliplatin (FUFOX) in untreated patients with advanced colorectal cancer: a phase Ib/II study of the AIO GI Group.
Arnold, D; Höhler, T; Dittrich, C; Lordick, F; Seufferlein, T; Riemann, J; Wöll, E; Herrmann, T; Zubel, A; Schmoll, H-J.
Afiliación
  • Arnold D; Department of Oncology and Hematology, Martin-Luther-University Halle-Wittenberg, Halle.
  • Höhler T; Johannes-Gutenberg University Hospital, Mainz, Germany.
  • Dittrich C; ACR-ITR VIEnna and LBI-ACR VIEnna, Kaiser Franz Josef-Spital, Vienna, Austria.
  • Lordick F; Klinikum rechts der Isar, Technische Universitaet, Muenchen.
  • Seufferlein T; Universitaets-Klinikum, Ulm.
  • Riemann J; Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany.
  • Wöll E; University Hospital Innsbruck, Innsbruck, Austria.
  • Herrmann T; Department of Internal Medicine IV and National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg.
  • Zubel A; Clinical Research and Development, Merck KGaA, Darmstadt, Germany.
  • Schmoll HJ; Department of Oncology and Hematology, Martin-Luther-University Halle-Wittenberg, Halle. Electronic address: hans-joachim.schmoll@medizin.uni-halle.de.
Ann Oncol ; 19(8): 1442-1449, 2008 Aug.
Article en En | MEDLINE | ID: mdl-18441330
BACKGROUND: This two-part phase Ib/II study investigated the feasibility of administering cetuximab in combination with oxaliplatin and infusional 5-fluorouracil (5-FU)/folinic acid (FA) in a weekly schedule (AIO FUFOX protocol) as first-line treatment in patients with epidermal growth factor receptor-detectable advanced colorectal cancer. PATIENTS AND METHODS: Cetuximab was administered weekly: 400 mg/m(2) initial dose, then 250 mg/m(2) and FUFOX: oxaliplatin 50 mg/m(2), FA 500 mg/m(2) and 5-FU as a 24-h infusion at either 1500 or 2000 mg/m(2) administered for 4 weeks followed by a 1-week rest (one cycle). RESULTS: Dose-limiting toxicity (grade 3 diarrhea) occurred in 3 of 14 assessable patients receiving 5-FU at standard 2000 mg/m(2). This dose was administered to a further 25 patients. Cetuximab combined with FUFOX was generally well tolerated with the most common grade 3/4 adverse events being diarrhea (27%) and paresthesia (16%). The confirmed response rate for patients receiving 5-FU at standard 2000 mg/m(2) (N = 41) was 56%, with a median duration of 9.3 months. Median progression-free and overall survival times including all 49 patients were 8.1 (95% confidence interval 6.0-9.7) and 28.2 months, respectively. Cetuximab pharmacokinetics seemed not to be different for combination with FUFOX compared with cetuximab/irinotecan combinations. CONCLUSION: This protocol is well tolerated and shows promising efficacy supporting further investigation.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Colorrectales / Protocolos de Quimioterapia Combinada Antineoplásica Tipo de estudio: Clinical_trials / Guideline Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2008 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 Tipo de estudio: Clinical_trials / Guideline Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2008 Tipo del documento: Article Pais de publicación: Reino Unido