Skip to main content

Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer.

Publication ,  Journal Article
Miller, KD; Chap, LI; Holmes, FA; Cobleigh, MA; Marcom, PK; Fehrenbacher, L; Dickler, M; Overmoyer, BA; Reimann, JD; Sing, AP; Langmuir, V; Rugo, HS
Published in: J Clin Oncol
February 1, 2005

PURPOSE: This randomized phase III trial compared the efficacy and safety of capecitabine with or without bevacizumab, a monoclonal antibody to vascular endothelial growth factor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. PATIENTS AND METHODS: Patients were randomly assigned to receive capecitabine (2,500 mg/m2/d) twice daily on day 1 through 14 every 3 weeks, alone or in combination with bevacizumab (15 mg/kg) on day 1. The primary end point was progression-free survival (PFS), as determined by an independent review facility. RESULTS: From November 2000 to March 2002, 462 patients were enrolled. Treatment arms were balanced. No significant differences were found in the incidence of diarrhea, hand-foot syndrome, thromboembolic events, or serious bleeding episodes between treatment groups. Of other grade 3 or 4 adverse events, only hypertension requiring treatment (17.9% v 0.5%) was more frequent in patients receiving bevacizumab. Combination therapy significantly increased the response rates (19.8% v 9.1%; P = .001); however, this did not result in a longer PFS (4.86 v 4.17 months; hazard ratio = 0.98). Overall survival (15.1 v 14.5 months) and time to deterioration in quality of life as measured by the Functional Assessment Of Cancer Treatment--Breast were comparable in both treatment groups. CONCLUSION: Bevacizumab was well tolerated in this heavily pretreated patient population. Although the addition of bevacizumab to capecitabine produced a significant increase in response rates, this did not translate into improved PFS or overall survival.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

February 1, 2005

Volume

23

Issue

4

Start / End Page

792 / 799

Location

United States

Related Subject Headings

  • Quality of Life
  • Oncology & Carcinogenesis
  • Neoplasm Metastasis
  • Middle Aged
  • Humans
  • Fluorouracil
  • Female
  • Deoxycytidine
  • Capecitabine
  • Breast Neoplasms
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Miller, K. D., Chap, L. I., Holmes, F. A., Cobleigh, M. A., Marcom, P. K., Fehrenbacher, L., … Rugo, H. S. (2005). Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol, 23(4), 792–799. https://doi.org/10.1200/JCO.2005.05.098
Miller, Kathy D., Linnea I. Chap, Frankie A. Holmes, Melody A. Cobleigh, P Kelly Marcom, Louis Fehrenbacher, Maura Dickler, et al. “Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer.J Clin Oncol 23, no. 4 (February 1, 2005): 792–99. https://doi.org/10.1200/JCO.2005.05.098.
Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005 Feb 1;23(4):792–9.
Miller, Kathy D., et al. “Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer.J Clin Oncol, vol. 23, no. 4, Feb. 2005, pp. 792–99. Pubmed, doi:10.1200/JCO.2005.05.098.
Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, Dickler M, Overmoyer BA, Reimann JD, Sing AP, Langmuir V, Rugo HS. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005 Feb 1;23(4):792–799.

Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

February 1, 2005

Volume

23

Issue

4

Start / End Page

792 / 799

Location

United States

Related Subject Headings

  • Quality of Life
  • Oncology & Carcinogenesis
  • Neoplasm Metastasis
  • Middle Aged
  • Humans
  • Fluorouracil
  • Female
  • Deoxycytidine
  • Capecitabine
  • Breast Neoplasms