Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma: final results of a GERCOR multicenter phase II study
| Autor: | C. Louvet, T. André, G. Lledo, P. Hammel, H. Bleiberg, C. Bouleuc, E. Gamelin, M. Flesch, E. Cvitkovic, A. de Gramont |
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| Rok vydání: | 2002 |
| Předmět: |
Adult
Male Cancer Research Dose-Response Relationship Drug Organoplatinum Compounds Adenocarcinoma Middle Aged Deoxycytidine Survival Analysis Gemcitabine Oxaliplatin Pancreatic Neoplasms Treatment Outcome Oncology Antineoplastic Combined Chemotherapy Protocols Humans Female Infusions Intravenous Aged |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 20(6) |
| ISSN: | 0732-183X |
| Popis: | PURPOSE: Based on preclinical in vitro synergy data, this study evaluated the activity and toxicity of a gemcitabine/oxaliplatin combination in patients with metastatic and locally advanced pancreatic adenocarcinoma. PATIENTS AND METHODS: Previously untreated metastatic and locally advanced unresectable pancreatic adenocarcinoma patients were enrolled onto this multicenter phase II study. Patients received gemcitabine 1,000 mg/m2 as a 10-mg/m2/min infusion on day 1 and oxaliplatin 100 mg/m2 as a 2-hour infusion on day 2 every 2 weeks. Patients with metastatic disease were treated until evidence of progressive disease, whereas patients with locally advanced disease received six cycles in the absence of progression, followed when appropriate by concomitant radiochemotherapy. RESULTS: Among 64 eligible patients included in eight centers, 30 had locally advanced and 34 had metastatic disease. Response rate for the 62 patients with measurable disease was 30.6% (95% confidence interval, 19.7% to 42.3%), 31.0% for locally advanced and 30.3% for metastatic patients. Among 58 assessable patients, 40% had clinical benefit. Median progression-free survival and median overall survival (OS) were 5.3 and 9.2 months, respectively, with 36% of patients alive at 1 year. Median OS for patients with metastatic disease and locally advanced disease were 8.7 and 11.5 months, respectively. With 574 treatment cycles (median per patient, nine; range, zero to 27), grade 3/4 toxicity per patient was 11% for neutropenia and thrombocytopenia, 14% for nausea or vomiting, 6.2% for diarrhea, and 11% for peripheral neuropathy, with no toxic deaths. CONCLUSION: Palliative effects, response rate, and survival observed with this well-tolerated gemcitabine/oxaliplatin combination deserve additional evaluation. A comparative study of combination therapy versus gemcitabine alone is ongoing. |
| Databáze: | OpenAIRE |
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