Authors

John W. Smith, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Columbia River Oncology Program
Marc E. Buyse, International Drug Development Institute
Priya Rastogi, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, University of Pittsburgh Cancer Institute
Charles E. Geyer Jr., National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Virginia Commonwealth University Massey Cancer Center
Samuel A. Jacobs, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, University of Pittsburgh Cancer Institute
Erica J. Patocskai, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Centre hospitalier de l'Université de Montreal
André Robidoux, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Centre hospitalier de l'Université de Montreal
Alison K. Conlin, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Western Oncology Research Consortium
Bilal Ansari, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Community Clinical Oncology Program Northern Indiana Cancer Research Consortium
George P. Keogh, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Roper St Francis Cancer Care
Philip J. Stella, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Community Clinical Oncology Program (CCOP) Michigan Cancer Research Consortium Community
Howard M. Gross, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Community Clinical Oncology Program (CCOP) Dayton
Raymond S. Lord, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation,Community Clinical Oncology Program (CCOP) Kalamazoo, the West Michigan Cancer Center
Jonathan A. Polikoff, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Kaiser Permanente
Celine Mauquoi, International Drug Development Institute
Eleftherios P. Mamounas, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, UF Cancer Center at Orlando Health
Sandra M. Swain, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Washington Cancer Institute, Georgetown University Medical Center
Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project (NSABP) Foundation, Allegheny Cancer Center at Allegheny General Hospital

Document Type

Article

Original Publication Date

2017

Volume

17

Issue

1

DOI of Original Publication

10.1016/j.clbc.2016.07.008

Comments

Originally published at https://doi.org/10.1016/j.clbc.2016.07.008

Date of Submission

June 2017

Abstract

Background

The purpose of this study was to determine the cardiac safety and clinical activity of trastuzumab and bevacizumab with docetaxel after epirubicin with cyclophosphamide (EC) in patients with HER2-positive locally advanced breast cancer (LABC) or pathologic stage 3 breast cancer (PS3BC).

Patients and Methods

Patients received every 3 week treatment with 4 cycles of EC (90/600 mg/m2) followed by 4 cycles of docetaxel (100 mg/m2). Targeted therapy with standard-dose trastuzumab with bevacizumab 15 mg/kg was given for a total of 1 year. Coprimary end points were (1) rate of cardiac events (CEs) in all patients defined as clinical congestive heart failure with a significant decrease in left ventricular ejection fraction or cardiac deaths; and (2) pathologic complete response (pCR) in breast and nodes in the neoadjuvant cohort. An independent cardiac review panel determined whether criteria for a CE were met.

Results

A total of 105 patients were accrued, 76 with LABC treated with neoadjuvant therapy and 29 with PS3BC treated with adjuvant therapy. Median follow-up was 59.2 months. Among 99 evaluable patients for cardiac safety, 4 (4%; 95% confidence interval [CI], 1.1%-10.0%) met CE criteria. The pCR percentage in LABC patients was 46% (95% CI, 34%-59%). Five-year recurrence-free survival (RFS) and overall survival (OS) for all patients was 79.9% and 90.8%, respectively.

Conclusion

The regimen met predefined criteria for activity of interest with an acceptable rate of CEs. Although the pCR percentage was comparable with chemotherapy regimens with trastuzumab alone the high RFS and OS are of interest in these high-risk populations.

Rights

© 2016 Elsevier Inc. All rights reserved

Is Part Of

VCU Massey Cancer Center Publications

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