Abstract
Background:The combination of intravenous paclitaxel (three-times weekly administration at a dose of 175 mg/m2) and oral capecitabine has been shown to be highly active in the treatment of advanced or metastatic breast cancer. Currently, there is much interest in the use of relatively low dose weekly paclitaxel infusions in this clinical setting.
Aim:To assess the activity and safety of capecitabine plus weekly paclitaxel at a dose of 60 mg/m2in heavily pretreated metastatic breast cancer patients.
Patients and methods:Patients were required to have pretreated metastatic breast cancer with measurable/ evaluable disease and a performance status of 0–2 (Eastern Cooperative Oncology Group score). Capecitabine was administered orally at a dosage of 1000 mg/m2twice daily on days 1–14, followed by a 7-day rest period. Paclitaxel was administered as a 1-hour intravenous infusion on a weekly basis at a dose of 60 mg/m2. Twenty-one days of therapy represented one cycle.
Results:The hypothesis of activity of the capecitabine-paclitaxel combination at the level of clinical interest (40% response rate) was accepted when the 15th response was observed and 33 patients were enrolled. The median progression-free survival and median overall survival estimates were 9.2 and 19.6 months, respectively. Therapy was generally well tolerated and manageable on an outpatient basis. The following grade 3/4 adverse events were observed: hand-foot syndrome (21.2%), neutropenia (12.1%), anemia, nausea/vomiting, stomatitis/ mucositis, and nail disorders (all occurred in 9.0%), and vascular/coagulation disorders (<1%).
Conclusions:Oral capecitabine plus weekly paclitaxel at a dose of 60 mg/m2has a favorable activity and tolerability profile and is suitable for the treatment of heavily pretreated advanced breast cancer patients.
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Acknowledgments
Capecitabine was provided by Roche, Italy. No sources of funding were used to plan and conduct this study. The authors have no conflicts of interest that are directly relevant to the content of this study.
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Bari, M., D’Andrea, M.R., Azzarello, G. et al. Salvage Therapy with Capecitabine Plus Weekly Paclitaxel in Heavily Pretreated Advanced Breast Cancer. Am J Cancer 4, 307–313 (2005). https://doi.org/10.2165/00024669-200504050-00003
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DOI: https://doi.org/10.2165/00024669-200504050-00003