Original Article

You have full text access to this OnlineOpen article

Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer†‡

  1. Devika Gajria MD, MPH1,
  2. Kim Feigin MD2,
  3. Lee K. Tan MD3,
  4. Sujata Patil PhD4,
  5. Stephanie Geneus BA1,
  6. Maria Theodoulou MD1,
  7. Larry Norton MD1,
  8. Clifford A. Hudis MD1,
  9. Tiffany A. Traina MD1,5,§,*

Article first published online: 8 MAR 2011

DOI: 10.1002/cncr.25992

Issue

Cancer

Cancer

Volume 117, Issue 18, pages 4125–4131, 15 September 2011

Additional Information

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

Author Information

  1. 1

    Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, New York, New York

  2. 2

    Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, New York

  3. 3

    Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, New York

  4. 4

    Department of Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, New York

  5. 5

    Weill Medical College, Cornell University, New York, New York

  1. §

    Fax: (646) 888-4917

*Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, 300 East 66th Street, New York, NY 10065

  1. †

    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.

  2. ‡

    We thank Carol Pearce for her formatting of this article.

  3. §

    Fax: (646) 888-4917

Publication History

  1. Issue published online: 2 SEP 2011
  2. Article first published online: 8 MAR 2011
  3. Manuscript Accepted: 19 JAN 2011
  4. Manuscript Revised: 17 JAN 2011
  5. Manuscript Received: 29 SEP 2010

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (172K)

Keywords:

  • metastatic breast cancer;
  • bevacizumab;
  • capecitabine

Abstract

BACKGROUND:

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.

METHODS:

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).

RESULTS:

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.

CONCLUSIONS:

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.

View Full Article (HTML) Get PDF (172K)