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Journal of Clinical Oncology, Vol 23, No 4 (February 1), 2005: pp. 792-799
© 2005 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2005.05.098
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Randomized Phase III Trial of Capecitabine Compared With Bevacizumab Plus Capecitabine in Patients With Previously Treated Metastatic Breast Cancer

Kathy D. Miller, Linnea I. Chap, Frankie A. Holmes, Melody A. Cobleigh, P. Kelly Marcom, Louis Fehrenbacher, Maura Dickler, Beth A. Overmoyer, James D. Reimann, Amy P. Sing, Virginia Langmuir, Hope S. Rugo

From the Indiana University, Indianapolis, IN; University of California Los Angeles, Los Angeles; Kaiser Northern California, Vallejo; Genentech Inc, South San Francisco; University of California San Francisco, San Francisco, CA; US Oncology, Houston, TX; Rush-Presbyterian-St Luke's Medical Center, Chicago, IL; Duke University, Durham, NC; Memorial Sloan Kettering Cancer Center, New York, NY; Case Western University, Cleveland, OH

Address reprint requests to Kathy D. Miller, MD, Indiana University Cancer Pavilion, 535 Barnhill Dr, RT-473, Indianapolis, IN 46202; e-mail: kathmill{at}iupui.edu

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.

Supported by Genentech Inc. A full list of participating investigators and institutions can be found in the Appendix.

Presented in part at the San Antonio Breast Cancer Symposium, San Antonio, TX, December 11-14, 2002.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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T. A. Traina, L. Norton, K. Drucker, and B. Singh
Nasal Septum Perforation in a Bevacizumab-Treated Patient with Metastatic Breast Cancer
Oncologist, November 1, 2006; 11(10): 1070 - 1071.
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 Clin. Cancer Res.Home page
J. Ruan, E. Hyjek, P. Kermani, P. J. Christos, A. T. Hooper, M. Coleman, B. Hempstead, J. P. Leonard, A. Chadburn, and S. Rafii
Magnitude of Stromal Hemangiogenesis Correlates with Histologic Subtype of Non-Hodgkin's Lymphoma.
Clin. Cancer Res., October 1, 2006; 12(19): 5622 - 5631.
[Abstract] [Full Text] [PDF]

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 JCOHome page
M. S. Gordon, D. Matei, C. Aghajanian, U. A. Matulonis, M. Brewer, G. F. Fleming, J. D. Hainsworth, A. A. Garcia, M. D. Pegram, R. J. Schilder, et al.
Clinical Activity of Pertuzumab (rhuMAb 2C4), a HER Dimerization Inhibitor, in Advanced Ovarian Cancer: Potential Predictive Relationship With Tumor HER2 Activation Status
J. Clin. Oncol., September 10, 2006; 24(26): 4324 - 4332.
[Abstract] [Full Text] [PDF]

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 J Oncol Pharm PractHome page
S. M Gressett, B. L Stanford, and F. Hardwicke
Management of hand-foot syndrome induced by capecitabine
Journal of Oncology Pharmacy Practice, September 1, 2006; 12(3): 131 - 141.
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 Ann OncolHome page
R Leonard, J O'Shaughnessy, S Vukelja, V Gorbounova, C. Chan-Navarro, D Maraninchi, N Barak-Wigler, J. McKendrick, W. Harker, A. Bexon, et al.
Detailed analysis of a randomized phase III trial: can the tolerability of capecitabine plus docetaxel be improved without compromising its survival advantage?
Ann. Onc., September 1, 2006; 17(9): 1379 - 1385.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
D. Cameron, R. Bell, M. Aapro, and C. Zielinski
What Are the Current Standards of Care and Recent Developments in the Management of Breast Cancer?
Oncologist, September 1, 2006; 11(suppl_1): 1 - 3.
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 The OncologistHome page
A. Wardley
Capecitabine: Expanding Options for the Treatment of Patients with Early or Locally Advanced Breast Cancer
Oncologist, September 1, 2006; 11(suppl_1): 20 - 26.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
K. Gelmon, A. Chan, and N. Harbeck
The Role of Capecitabine in First-Line Treatment for Patients with Metastatic Breast Cancer
Oncologist, September 1, 2006; 11(suppl_1): 42 - 51.
[Abstract] [Full Text] [PDF]

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 JNCI J Natl Cancer InstHome page
W. P. McGuire
Is it time for some new approaches for treating advanced ovarian cancer?
J Natl Cancer Inst, August 2, 2006; 98(15): 1024 - 1026.
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 Clin. Cancer Res.Home page
C. A. Hudis and E. P. Winer
Cancer and leukemia group B breast committee: decades of progress and plans for the future.
Clin. Cancer Res., June 1, 2006; 12(11): 3576s - 3580s.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
B. Ramaswamy, A. D. Elias, N. T. Kelbick, A. Dodley, M. Morrow, M. Hauger, J. Allen, C. Rhoades, K. Kendra, H. X. Chen, et al.
Phase II Trial of Bevacizumab in Combination with Weekly Docetaxel in Metastatic Breast Cancer Patients.
Clin. Cancer Res., May 15, 2006; 12(10): 3124 - 3129.
[Abstract] [Full Text] [PDF]

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 JCOHome page
D. A. Sica
Angiogenesis Inhibitors and Hypertension: An Emerging Issue
J. Clin. Oncol., March 20, 2006; 24(9): 1329 - 1331.
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 JCOHome page
S. B. Wedam, J. A. Low, S. X. Yang, C. K. Chow, P. Choyke, D. Danforth, S. M. Hewitt, A. Berman, S. M. Steinberg, D. J. Liewehr, et al.
Antiangiogenic and Antitumor Effects of Bevacizumab in Patients With Inflammatory and Locally Advanced Breast Cancer
J. Clin. Oncol., February 10, 2006; 24(5): 769 - 777.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
D. G. McNeel, J. Eickhoff, F. T. Lee, D. M. King, D. Alberti, J. P. Thomas, A. Friedl, J. Kolesar, R. Marnocha, J. Volkman, et al.
Phase I Trial of a Monoclonal Antibody Specific for {alpha}v{beta}3 Integrin (MEDI-522) in Patients with Advanced Malignancies, Including an Assessment of Effect on Tumor Perfusion
Clin. Cancer Res., November 1, 2005; 11(21): 7851 - 7860.
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 JCOHome page
D. R. D'Adamo, S. E. Anderson, K. Albritton, J. Yamada, E. Riedel, K. Scheu, G. K. Schwartz, H. Chen, and R. G. Maki
Phase II Study of Doxorubicin and Bevacizumab for Patients With Metastatic Soft-Tissue Sarcomas
J. Clin. Oncol., October 1, 2005; 23(28): 7135 - 7142.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
A. Goldhirsch, J. H. Glick, R. D. Gelber, A. S. Coates, B. Thurlimann, H.-J. Senn, and and Panel Members
Meeting Highlights: International Expert Consensus on the Primary Therapy of Early Breast Cancer 2005
Ann. Onc., October 1, 2005; 16(10): 1569 - 1583.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
J. O'Shaughnessy
Extending Survival with Chemotherapy in Metastatic Breast Cancer
Oncologist, October 1, 2005; 10(suppl_3): 20 - 29.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
W. P. Tew, D. P. Kelsen, and D. H. Ilson
Targeted Therapies for Esophageal Cancer
Oncologist, September 1, 2005; 10(8): 590 - 601.
[Abstract] [Full Text] [PDF]

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 Am J Health Syst PharmHome page
S. Motl
Bevacizumab in combination chemotherapy for colorectal and other cancers
Am. J. Health Syst. Pharm., May 15, 2005; 62(10): 1021 - 1032.
[Abstract] [Full Text] [PDF]

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 JCOHome page
R. S. Herbst, A. Onn, and A. Sandler
Angiogenesis and Lung Cancer: Prognostic and Therapeutic Implications
J. Clin. Oncol., May 10, 2005; 23(14): 3243 - 3256.
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 JCOHome page
J. Feliu, P. Escudero, F. Llosa, M. Bolanos, J.-M. Vicent, A. Yubero, J.-J. Sanz-Lacalle, R. Lopez, L. Lopez-Gomez, E. Casado, et al.
Capecitabine As First-Line Treatment for Patients Older Than 70 Years With Metastatic Colorectal Cancer: An Oncopaz Cooperative Group Study
J. Clin. Oncol., May 1, 2005; 23(13): 3104 - 3111.
[Abstract] [Full Text] [PDF]


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