Cancer Chemotherapy and Pharmacology

, Volume 71, Issue 3, pp 741–747

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
  • Kinki Breast Cancer Study Group (KBCSG)
Original Article

DOI: 10.1007/s00280-012-2068-7

Cite this article as:
Taguchi, T., Yamamoto, D., Masuda, N. et al. Cancer Chemother Pharmacol (2013) 71: 741. doi:10.1007/s00280-012-2068-7

Abstract

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.

Keywords

Capecitabine Paclitaxel Metastatic breast cancer Phase II 

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Tetsuya Taguchi
    • 1
  • Daigo Yamamoto
    • 2
  • Norikazu Masuda
    • 3
  • Koji Oba
    • 4
  • Takahiro Nakayama
    • 5
  • Takuya Nagata
    • 6
  • Masaya Nomura
    • 7
  • Katsuhide Yoshidome
    • 8
  • Hiroshi Yoshino
    • 9
  • Nobuki Matsunami
    • 10
  • Masaru Miyashita
    • 11
  • Yoshihiko Furuya
    • 12
  • Takanori Ishida
    • 13
  • Kazuyuki Wakita
    • 14
  • Junichi Sakamoto
    • 15
  • Shinzaburo Noguchi
    • 5
  • Kinki Breast Cancer Study Group (KBCSG)
  1. 1.Department of Endocrine and Breast SurgeryKyoto Prefectural University of MedicineKyotoJapan
  2. 2.Department of SurgeryKansai Medical University Hirakata HospitalOsakaJapan
  3. 3.Department of SurgeryNational Hospital Organization Osaka National HospitalOsakaJapan
  4. 4.Translational Research and Clinical Trial CenterHokkaido University HospitalHokkaidoJapan
  5. 5.Department of Breast and Endocrine SurgeryOsaka University Graduate School of MedicineOsakaJapan
  6. 6.Department of Surgery II, Graduate School of Medicine and Pharmaceutical SciencesUniversity of ToyamaToyamaJapan
  7. 7.Department of SurgeryOsaka General Medical CenterOsakaJapan
  8. 8.Department of SurgeryOsaka Police HospitalOsakaJapan
  9. 9.Department of General and Gastroenterological SurgeryIshikawa Prefectural Central HospitalIshikawaJapan
  10. 10.Department of SurgeryOsaka Rosai HospitalOsakaJapan
  11. 11.Department of SurgeryKonan HospitalHyogoJapan
  12. 12.Department of SurgeryOsaka Saiseikai Nakatsu HospitalOsakaJapan
  13. 13.Department of Surgical OncologyTohoku University Graduate School of MedicineMiyagiJapan
  14. 14.Chayamachi Breast ClinicOsakaJapan
  15. 15.Graduate School of Medicine, Social Life Science, Young Leaders’ ProgramNagoya UniversityAichiJapan

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