Capecitabine plus paclitaxel as first- Or second-line therapy: A multicenter phase II study in metastatic breast cancer

L. A. Meza, B. Amin, T. Hill, Y. M. Chen, S. A. Petralia, W. J. Gradishar

Research output: Contribution to journalArticlepeer-review

3 Scopus citations


Capecitabine (Xeloda), a novel oral fluoropyrimidine indicated for the treatment of patients with heavily pretreated metastatic breast cancer, is converted to 5-FU predominantly at the tumor site by exploiting the higher activity of thymidine phosphorylase (TP) in malignant tissues. TP levels are further upregulated after exposure to various antitumor agents, including taxanes. The combination of Capecitabine plus paclitaxel is synergistic in pre-clinical models, whereas 5-FU or UFT plus paclitaxel have only additive antitumor activity. Methods: This multicenter phase II study evaluated the efficacy and safety of the combination of Capecitabine (825 mg/m2 twice daily, d1-14, q3 weeks) and paclitaxel (175 mg/m2 d1q3w) as first- or second-line therapy in women with metastatic breast cancer. Results: Of the 48 patients enrolled, 47 patients were evaluable for this analysis. Four patients are still receiving study treatment. Of the 47 evaluable patients, 34 received study treatment as first-line and 13 as second-line therapy. Patient characteristics at baseline were median age 52 years (range 35-76 years), median Karnofsky Performance Status 90 (range 70-100). Patients received a median of 7 treatment cycles (range 120). To date, 6(13%) complete responses (5 among first- and 1 among second-line treatment), and 14 (30%) partial responses (8 among first- and 6 among second-line treatment) have been confirmed, for an overall objective response rate of 43%. Eighteen (38%) patients experienced stable disease (SD). Median time to response for confirmed responders to date was 7 weeks (range 5-17). Based on Kaplan-Meier estimate, median time to tumor progression was greater than 44 weeks. Median survival has not been reached. The most common grade 3/4 adverse reactions were neutropenia (n= 7, 15%), hand-foot syndrome (grade 4 not applicable) (n= 6, 13%), and alopecia (n=6, 13%). Conclusion: These data indicate that the combination of Capecitabine and paclitaxel is effective and safe as first or second line therapy in patients with metastatic breast cancer.

Original languageEnglish (US)
Number of pages1
JournalBreast Cancer Research and Treatment
Issue number3
StatePublished - Jan 1 2001

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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