1. Results of a phase I trial of intravenous vinorelbine plus oral capecitabine as first-line chemotherapy of metastatic breast cancer
- Author
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Françoise Mayer, Sylvie Zanetta, Jérome Garnier, Bruno Chauffert, Fabienne Biville, Laure Favier, Pierre Fumoleau, Nicolas Isambert, Emmanuelle Ferrant, and Bruno Coudert
- Subjects
Oncology ,medicine.medical_specialty ,Antimetabolites, Antineoplastic ,Neutropenia ,medicine.medical_treatment ,Administration, Oral ,Breast Neoplasms ,Vinorelbine ,Vinblastine ,Deoxycytidine ,Drug Administration Schedule ,Capecitabine ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Neoplasm Metastasis ,Infusions, Intravenous ,Aged ,Chemotherapy ,Dose-Response Relationship, Drug ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Metastatic breast cancer ,Antineoplastic Agents, Phytogenic ,Surgery ,Regimen ,Toxicity ,Female ,Fluorouracil ,France ,business ,Febrile neutropenia ,medicine.drug - Abstract
The management of metastatic breast cancer becomes increasingly intricate, requiring new drugs and combinations. We present here the results of a phase I study evaluating the maximal tolerated dose of vinorelbine combined with capecitabine as first-line chemotherapy. Vinorelbine was administered intravenously on days 1 and 15, and capecitabine was given orally twice daily from day 1 to 14 (three cycles every 21 days). Three out of six patients receiving vinorelbine at 25 mg/m2/day and capecitabine at 2000 mg/m2/day presented with a dose-limiting toxicity, consisting of protracted grade 3 neutropenia, hand–foot syndrome and/or liver test disturbances. Despite of a dose reduction in vinorelbine (20 mg/m2/day), one patient among four developed a dose-limiting febrile neutropenia. This regimen cannot be recommended as first-line treatment of metastatic breast cancer. These findings are not in agreement with previous publications of this schedule, or with promising results using both drugs orally.
- Published
- 2006