Original Article

Cancer Chemotherapy and Pharmacology

, Volume 64, Issue 2, pp 361-369

First online:

Open Access This content is freely available online to anyone, anywhere at any time.

Phase II study of capecitabine and trastuzumab combination chemotherapy in patients with HER2 overexpressing metastatic breast cancers resistant to both anthracyclines and taxanes

  • Takanori IshidaAffiliated withDepartment of Surgical Oncology, Tohoku University School of Medicine
  • , Takayoshi KibaAffiliated withTranslational Research Informatics Center
  • , Motohiro TakedaAffiliated withDepartment of Surgical Oncology, Tohoku University School of Medicine
  • , Kotone MatsuyamaAffiliated withTranslational Research Informatics CenterDepartment of Clinical Trial Design and Management, Graduate School of Medicine, Kyoto University
  • , Satoshi TeramukaiAffiliated withTranslational Research Informatics CenterDepartment of Clinical Trial Design and Management, Graduate School of Medicine, Kyoto University
  • , Ryota IshiwataAffiliated withTranslational Research Informatics Center
  • , Norikazu MasudaAffiliated withDepartment of Surgery, Osaka National Hospital
  • , Yuichi TakatsukaAffiliated withDepartment of Surgery, Kansai Rosai Hospital
  • , Shinzaburo NoguchiAffiliated withDepartment of Breast and Endocrine Surgery, Graduate School of Medicine, Osaka University
    • , Chikashi IshiokaAffiliated withDepartment of Clinical Oncology, Institute of Developing, Aging and Cancer, Tohoku University
    • , Masanori FukushimaAffiliated withTranslational Research Informatics CenterDepartment of Clinical Trial Design and Management, Graduate School of Medicine, Kyoto University
    • , Noriaki OhuchiAffiliated withDepartment of Surgical Oncology, Tohoku University School of Medicine Email author 

Abstract

Purpose

The purpose of this study was to investigate the activity of capecitabine and trastuzumab in patients with HER2-overexpressing metastatic breast caner resistant to both anthracyclines and taxanes.

Method

From June 2003 and May 2006, 40 female patients with measurable or assessable metastatic breast cancer were enrolled and data from 38 patients were reviewed extramurally and analyzed. Patients were treated with weekly trastuzumab given at a dose of 2 mg/kg/day over 90 min (4 mg/kg/day on the first infusion) and capecitabine given at a dose 1,657 mg/m2/day during 21 days with a subsequent pause of 7 days. This cycle was repeated every 28 days. The primary endpoint was overall survival and secondary endpoints were progression-free survival and response rate.

Result

A median of 4.5 cycles (range 1–9 cycles) were delivered. The median age was 53 (range 30–69 years). Median overall survival and progression-free survival was 22.3 and 4.1 months, respectively. Survival rate at 1 and 2 year was 81.6 and 47.4%, respectively. Response rate was 18.4% (95% CI, 7.7–34.3%). All evaluable patients have responded with two CR (5.3%), 5 PR (13.2%), 20 SD (52.6%), 8 PD (21.1%) and 3 NE (7.9%). Regarding the hematological toxicities, grade 1/2/3 neutropenia, grade 1/2 anemia, grade 1 thrombocytopenia and grade 1/2 liver dysfunction were also common. No treatment-related death was reported.

Conclusion

The combination of capecitabine and trastuzumab is active and well-tolerated in patients with HER2-overexpressing breast caner resistant to both anthracyclines and taxanes.

Keywords

Phase II study Capecitabine Trastuzumab Metastatic breast caner