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

Ann Surg Oncol. 2017 Jul;24(7):1853-1860. doi: 10.1245/s10434-016-5662-9. Epub 2016 Nov 18.

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Anthracyclines / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Bevacizumab / administration & dosage
  • Breast Neoplasms / drug therapy
  • Breast Neoplasms / pathology
  • Breast Neoplasms / surgery*
  • Combined Modality Therapy
  • Docetaxel
  • Female
  • Follow-Up Studies
  • Humans
  • Mammaplasty / adverse effects
  • Mastectomy / adverse effects*
  • Prognosis
  • Prospective Studies
  • Surgical Wound Infection / etiology*
  • Survival Rate
  • Taxoids / administration & dosage

Substances

  • Anthracyclines
  • Taxoids
  • Docetaxel
  • Bevacizumab