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Annals of Surgical Oncology
Published in: Annals of Surgical Oncology 7/2017

01-07-2017 | Breast Oncology

The Effect on Surgical Complications of Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer: NRG Oncology/NSABP Protocol B-40

Authors: Harry D. Bear, MD, PhD, Gong Tang, PhD, Priya Rastogi, MD, Charles E. Geyer Jr., MD, Christine K. Zoon, MD, Kelley M. Kidwell, PhD, André Robidoux, MD, Luis Baez-Diaz, MD, Adam M. Brufsky, MD, PhD, Rita S. Mehta, MD, Louis Fehrenbacher, MD, James A. Young, MD, Francis M. Senecal, MD, Rakesh Gaur, MD, MPH, Richard G. Margolese, MD, CM, Paul T. Adams, MD, Howard M. Gross, MD, Joseph P. Costantino, DrPH, Soonmyung Paik, MD, Sandra M. Swain, MD, Eleftherios P. Mamounas, MD, Norman Wolmark, MD

Published in: Annals of Surgical Oncology | Issue 7/2017

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Abstract

Background

NRG Oncology/NSABP trial B-40 tested the impact of adding bevacizumab (bev) to neoadjuvant chemotherapy for operable breast cancer. Secondary endpoints included rates of surgical complications after surgery in patients who did or did not receive bev.

Methods

A total of 1206 women with HER2-negative operable breast cancer were randomly assigned to receive one of three different docetaxel-plus-anthracycline-based regimens, without or with bev (15 mg/kg every 3 weeks) for the first 6 of 8 cycles and for 10 doses postoperatively. Surgical complications were assessed from date of surgery through 24 months following study entry.

Results

Early surgical complications were significantly more frequent in the bev group (25.4 vs. 18.9%; trend test p = 0.008), but most were grade 1–2. Early noninfectious wound dehiscences were infrequent and not significantly different (5.4 vs. 3.1%; trend test p = 0.15). Long-term noninfectious wound complications were significantly higher for patients receiving bev (11.8 vs. 5.1%; trend test p = 0.0007), but the incidence of grade ≥3 wound dehiscence was low in both groups (<1%). Among 193 patients undergoing expander or implant reconstructions, 19 (19.6%) of 97 in the bev-receiving group versus 10 (10.4%) of 96 in the non-bev group had grade ≥3 complications (Pearson, p = 0.11).

Conclusions

Overall, adding bev increased surgical complications, but most serious complications were not significantly increased. In particular, the need for surgical intervention in patients undergoing breast reconstruction with prosthetic implants was higher with bev but was not statistically significantly different. With precautions, bev can be used safely perioperatively in patients undergoing surgery for breast cancer.
Appendix
Available only for authorised users
Footnotes
1
Current USPI labelling for bev states: “Discontinue in patients with wound dehiscence. Discontinue at least 28 days prior to elective surgery. Do not initiate Avastin for at least 28 days after surgery and until the surgical wound is fully healed.”
 
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Metadata
Title
The Effect on Surgical Complications of Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer: NRG Oncology/NSABP Protocol B-40
Authors
Harry D. Bear, MD, PhD
Gong Tang, PhD
Priya Rastogi, MD
Charles E. Geyer Jr., MD
Christine K. Zoon, MD
Kelley M. Kidwell, PhD
André Robidoux, MD
Luis Baez-Diaz, MD
Adam M. Brufsky, MD, PhD
Rita S. Mehta, MD
Louis Fehrenbacher, MD
James A. Young, MD
Francis M. Senecal, MD
Rakesh Gaur, MD, MPH
Richard G. Margolese, MD, CM
Paul T. Adams, MD
Howard M. Gross, MD
Joseph P. Costantino, DrPH
Soonmyung Paik, MD
Sandra M. Swain, MD
Eleftherios P. Mamounas, MD
Norman Wolmark, MD
Publication date
01-07-2017
Publisher
Springer International Publishing
Published in
Annals of Surgical Oncology / Issue 7/2017
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-016-5662-9

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