North Central Cancer Treatment Group (NCCTG) N0432: Phase II trial of docetaxel with capecitabine and bevacizumab as first-line chemotherapy for patients with metastatic breast cancer

E. A. Perez, D. W. Hillman, T. Dentchev, N. A. Le-Lindqwister, L. H. Geeraerts, T. R. Fitch, H. Liu, D. L. Graham, S. P. Kahanic, H. M. Gross, T. A. Patel, F. M. Palmieri, A. C. Dueck

Research output: Contribution to journalArticle

25 Scopus citations

Abstract

Background: Docetaxel (T; Taxotere) with capecitabine (X) is active against metastatic breast cancer (MBC); bevacizumab (BV) has demonstrated efficacy with taxanes in the first-line setting. This study was conducted to assess the safety and efficacy of TX-BV in patients with MBC. Patients and methods: In this single-arm, multicenter phase II study, patients received first-line bevacizumab 15 mg/kg and docetaxel 75 mg/m2 on day 1 and capecitabine 825 mg/m2 twice per day on days 1-14 every 21 days. Primary and secondary end points were tumor response rate (RR), overall survival (OS), progression-free survival (PFS), and toxicity. Results: A total of 45 assessable patients received TX-BV for a median of seven cycles. Two complete and 20 partial responses were observed (overall RR 49%); nine patients had stable disease >6 months, for a clinical benefit rate of 69%. Median response duration was 11.8 months. Median OS and PFS were 28.4 and 11.1 months, respectively. Grade 3/4 adverse events included hand-foot syndrome (29%), fatigue (20%), febrile neutropenia (18%), and diarrhea (18%). In cycles 3-10, median dose levels of docetaxel and capecitabine were 60 mg/m2 and 660 mg/m2, respectively. Conclusion: TX-BV demonstrated significant activity; dose modifications were required to manage drug-related toxic effects.

Original languageEnglish (US)
Article numbermdp512
Pages (from-to)269-274
Number of pages6
JournalAnnals of Oncology
Volume21
Issue number2
DOIs
StatePublished - Nov 9 2009

Keywords

  • Bevacizumab
  • Capecitabine
  • Chemotherapy
  • Docetaxel

ASJC Scopus subject areas

  • Oncology
  • Hematology

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