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Article first published online: 8 MAR 2011
Copyright © 2011 American Cancer Society
Volume 117, Issue 18, pages 4125–4131, 15 September 2011
How to Cite
Gajria, D., Feigin, K., Tan, L. K., Patil, S., Geneus, S., Theodoulou, M., Norton, L., Hudis, C. A. and Traina, T. A. (2011), Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer. Cancer, 117: 4125–4131. doi: 10.1002/cncr.25992
Presented in part at the 30th Annual San Antonio Breast Cancer Symposium, San Antonio, Texas, December 13-16, 2007; at the 44th Annual Meeting of the American Society of Clinical Oncology, Chicago, Illinois, May 30 to June 3, 2008; and at the 31st Annual San Antonio Breast Cancer Symposium, San Antonio, Texas, December 10-14, 2008.
We thank Carol Pearce for her formatting of this article.
Fax: (646) 888-4917
- Issue published online: 2 SEP 2011
- Article first published online: 8 MAR 2011
- Manuscript Accepted: 19 JAN 2011
- Manuscript Revised: 17 JAN 2011
- Manuscript Received: 29 SEP 2010
- metastatic breast cancer;
Capecitabine has antitumor activity in metastatic breast cancer (MBC); however, its optimal dose and schedule remain unclear. Mathematical modeling predicts that a capecitabine schedule 7 days of treatment followed by 7 days of rest (7—7) will improve efficacy and minimize toxicity. Bevacizumab has demonstrated the ability to improve outcomes when it is added to chemotherapy, including capecitabine, in the first-line and second-line settings.
Patients with measurable MBC received oral capecitabine (2000 mg twice daily; 7—7), and intravenous bevacizumab (10 mg/kg every 2 weeks). The primary endpoint was the response rate. Secondary endpoints included toxicity, the clinical benefit rate, and progression-free survival (PFS).
Forty-one patients were treated. After a median of 7 cycles (range, 1-32 cycles), partial responses were observed in 20% of patients, and stable disease for ≥6 months was noted in 35% patients. The median PFS was 8 months. The most common treatment-related toxicities were hand-foot syndrome (49% grade 2, 20% grade 3/4) hypertension (12% grade 2, 10% grade 3/4), and fatigue (12% grade 2, 2% grade 3/4). Diarrhea (5% grade 2, 0% grade 3/4), nausea (0% grade 2-4), and vomiting (0% grade 2-4) were rare.
Capecitabine administered for 7 days followed by a 7-day rest in combination with bevacizumab had modest efficacy and an acceptable toxicity profile in patients with MBC. Gastrointestinal toxicity with this schedule was minimal. Cancer 2011;. © 2011 American Cancer Society.