Low dose capecitabine plus weekly paclitaxel in patients with metastatic breast cancer: A multicenter phase II study KBCSG-0609

Tetsuya Taguchi, Daigo Yamamoto, Norikazu Masuda, Koji Oba, Takahiro Nakayama, Takuya Nagata, Masaya Nomura, Katsuhide Yoshidome, Hiroshi Yoshino, Nobuki Matsunami, Masaru Miyashita, Yoshihiko Furuya, Takanori Ishida, Kazuyuki Wakita, Junichi Sakamoto, Shinzaburo Noguchi

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)


Purpose: The combination of capecitabine and paclitaxel (XP) has demonstrated synergistic antitumor activity in preclinical models. The purpose of this phase II study was to evaluate the efficacy and safety of a monthly XP regimen in patients with metastatic breast cancer (MBC). Methods: Eligible patients had received one or fewer prior chemotherapy regimens for MBC. Patients received oral capecitabine of low dose (828 mg/m2 twice daily, days 1-21) plus paclitaxel (80 mg/m2, i.v., over 60 min, days 1, 8 and 15) every 28 days until disease progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Progression-free survival (PFS), overall survival (OS) and safety were secondary endpoints. An exploratory analysis of efficacy according to hormone receptor (HR) status was performed. Results: Forty-four patients were enrolled, and 43 patients were evaluable. ORR was 46.5 %. PFS and OS were 8.3 and 22.9 months, respectively. ORR was 45.5 % in patients with HR-positive tumors and 50 % in HR-negative cases. The most frequently observed grade 3/4 adverse events were neutropenia (27.9 %), leukopenia (11.6 %), hand-foot syndrome (HFS, 9.3 %) and fatigue (7.0 %). There were no discontinuations due to HFS. Conclusions: Monthly XP was an effective and well-tolerated regimen for the first- or second-line treatment for MBC.

Original languageEnglish
Pages (from-to)741-747
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Issue number3
Publication statusPublished - 2013 Mar


  • Capecitabine
  • Metastatic breast cancer
  • Paclitaxel
  • Phase II

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)


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