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Annals of Oncology Advance Access published online on November 9, 2009
Annals of Oncology, doi:10.1093/annonc/mdp512
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

North Central Cancer Treatment Group (NCCTG) N0432: phase II trial of docetaxel with capecitabine and bevacizumab as first-line chemotherapy for patients with metastatic breast cancer

E. A. Perez1,*, D. W. Hillman2, T. Dentchev3, N. A. Le-Lindqwister4, L. H. Geeraerts5, T. R. Fitch6, H. Liu2, D. L. Graham7, S. P. Kahanic8, H. M. Gross9, T. A. Patel1, F. M. Palmieri1 and A. C. Dueck6

1 Multidisciplinary Breast Clinic and Breast Cancer Program, Mayo Clinic, Jacksonville, FL
2 Mayo Clinic, Rochester, MN
3 Altru Health Systems, Grand Forks, ND
4 Illinois Oncology Research Association Community Clinical Oncology Program, Peoria, IL
5 Community Clinical Oncology Program, MeritCare Hospital, Fargo, ND
6 Mayo Clinic, Scottsdale, AZ
7 Carle Cancer Center, Urbana, IL
8 Siouxland Hematology–Oncology Associates, Sioux City, IA
9 Hematology and Oncology of Dayton, Inc., Dayton, OH, USA

* Correspondence to: Dr E. A. Perez, Multidisciplinary Breast Clinic and Breast Cancer Program, Mayo Clinic, 4500 San Pablo Road, Jacksonville, FL 32224, USA. Tel: +1-904-953-7283; Fax: +1-904-953-1412; E-mail: perez.edith{at}mayo.edu

Background: Docetaxel (T; Taxotere) with capecitabine (X) is active against metastatic breast cancer (MBC); bevacizumab (BV) has demonstrated efficacy with taxanes in the first-line setting. This study was conducted to assess the safety and efficacy of TX-BV in patients with MBC.

Patients and methods: In this single-arm, multicenter phase II study, patients received first-line bevacizumab 15 mg/kg and docetaxel 75 mg/m2 on day 1 and capecitabine 825 mg/m2 twice per day on days 1–14 every 21 days. Primary and secondary end points were tumor response rate (RR), overall survival (OS), progression-free survival (PFS), and toxicity.

Results: A total of 45 assessable patients received TX-BV for a median of seven cycles. Two complete and 20 partial responses were observed (overall RR 49%); nine patients had stable disease >6 months, for a clinical benefit rate of 69%. Median response duration was 11.8 months. Median OS and PFS were 28.4 and 11.1 months, respectively. Grade 3/4 adverse events included hand–foot syndrome (29%), fatigue (20%), febrile neutropenia (18%), and diarrhea (18%). In cycles 3–10, median dose levels of docetaxel and capecitabine were 60 mg/m2 and 660 mg/m2, respectively.

Conclusion: TX-BV demonstrated significant activity; dose modifications were required to manage drug-related toxic effects.

bevacizumab, capecitabine, chemotherapy, docetaxel

Received for publication September 11, 2009. Accepted for publication September 29, 2009.


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