Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx): final results of a multicenter randomized phase II trial in advanced pancreatic cancer.

Boeck, S; Hoehler, T; Seipelt, G; Mahlberg, R; Wein, A; Hochhaus, A; Boeck, H-P; Schmid, B; Kettner, E; Stauch, M; Lordick, F; Ko, Y; Geissler, M; Schoppmeyer, K; Kojouharoff, G; Golf, A; Neugebauer, S; Heinemann, V

Boeck, S; Hoehler, T; Seipelt, G; Mahlberg, R; Wein, A; Hochhaus, A; Boeck, H-P; Schmid, B; Kettner, E; Stauch, M; Lordick, F; Ko, Y; Geissler, M; Schoppmeyer, K; Kojouharoff, G; Golf, A; Neugebauer, S; Heinemann, V.

Afiliación

Boeck S; Medizinische Klinik und Poliklinik III, Klinikum Grosshadern, Ludwig-Maximilians-Universität München, Germany.

Ann Oncol ; 19(2): 340-7, 2008 Feb.

Article en En | MEDLINE | ID: mdl-17962204

RESUMEN

BACKGROUND: To compare the efficacy and safety of three different chemotherapy doublets in the treatment of advanced pancreatic cancer (PC). PATIENTS AND METHODS: At total of 190 patients were randomly assigned to receive capecitabine 1000 mg/m(2) twice daily on days 1-14 plus oxaliplatin 130 mg/m(2) on day 1 (CapOx), capecitabine 825 mg/m(2) twice daily on days 1-14 plus gemcitabine 1000 mg/m(2) on days 1 and 8 (CapGem) or gemcitabine 1000 mg/m(2) on days 1 and 8 plus oxaliplatin 130 mg/m(2) on day 8 (mGemOx). Treatment cycles were repeated every three weeks. The primary end point was progression-free survival (PFS) rate at 3 months; secondary end points included objective response rate, carbohydrate antigen 19-9 response, clinical benefit response, overall survival and toxicity. RESULTS: The PFS rate after 3 months was 51% in the CapOx arm, 64% in the CapGem arm and 60% in the mGemOx arm. Median PFS was estimated with 4.2 months, 5.7 months and 3.9 months, respectively (P = 0.67). Corresponding median survival times were: 8.1 months (CapOx), 9.0 months (CapGem) and 6.9 months (mGemOx) (P = 0.56). Grade 3/4 hematological toxicities were more frequent in the two Gem-containing arms; grade 3/4 non-hematological toxicity rates did not exceed 15% in any arm. CONCLUSION: CapOx, CapGem and mGemOx have similar clinical efficacy in advanced PC. Each regimen has a distinct but manageable tolerability profile.

Asunto(s)

Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación; Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos; Neoplasias Pancreáticas/tratamiento farmacológico; Neoplasias Pancreáticas/mortalidad; Adolescente; Adulto; Anciano; Capecitabina; Desoxicitidina/administración & dosificación; Desoxicitidina/efectos adversos; Desoxicitidina/análogos & derivados; Supervivencia sin Enfermedad; Relación Dosis-Respuesta a Droga; Esquema de Medicación; Femenino; Fluorouracilo/administración & dosificación; Fluorouracilo/efectos adversos; Fluorouracilo/análogos & derivados; Estudios de Seguimiento; Humanos; Inmunohistoquímica; Infusiones Intravenosas; Estimación de Kaplan-Meier; Masculino; Dosis Máxima Tolerada; Persona de Mediana Edad; Estadificación de Neoplasias; Compuestos Organoplatinos/administración & dosificación; Compuestos Organoplatinos/efectos adversos; Oxaliplatino; Neoplasias Pancreáticas/patología; Probabilidad; Medición de Riesgo; Método Simple Ciego; Análisis de Supervivencia; Resultado del Tratamiento; Gemcitabina

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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Pancreáticas / Protocolos de Quimioterapia Combinada Antineoplásica Tipo de estudio: Clinical_trials / Etiology_studies / Observational_studies / Prognostic_studies Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2008 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido

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