title: The Effect on Surgical Complications of Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer: NRG Oncology/NSABP Protocol B-40.
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.
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA. harry.bear@vcuhealth.org.|Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA. harry.bear@vcuhealth.org.
authors.forename: Harry D
authors.initials: HD
authors.lastname: Bear
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Gong
authors.initials: G
authors.lastname: Tang
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|University of Pittsburgh Cancer Institute School of Medicine, Pittsburgh, PA, USA.
authors.forename: Priya
authors.initials: P
authors.lastname: Rastogi
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Geyer
authors.affiliation: Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA.
authors.forename: Christine K
authors.initials: CK
authors.lastname: Zoon
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|University of Pittsburgh, Pittsburgh, PA, USA.|Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Kelley M
authors.initials: KM
authors.lastname: Kidwell
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, QC, Canada.
authors.forename: André
authors.initials: A
authors.lastname: Robidoux
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|San Juan MBCCOP, San Juan, PR, USA.
authors.forename: Luis
authors.initials: L
authors.lastname: Baez-Diaz
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|University of Pittsburgh/Magee Womens Hospital, Pittsburgh, PA, USA.
authors.forename: Adam M
authors.initials: AM
authors.lastname: Brufsky
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|School of Medicine, Chao Family Comprehensive Cancer Center, University of California at Irvine, Orange, CA, USA.
authors.forename: Rita S
authors.initials: RS
authors.lastname: Mehta
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|Kaiser Permanente Oncology Clinical Trials, Northern California, Vallejo, CA, USA.
authors.forename: Louis
authors.initials: L
authors.lastname: Fehrenbacher
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|CCOP, Colorado Cancer Research Program, Colorado Springs, CO, USA.
authors.forename: James A
authors.initials: JA
authors.lastname: Young
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|CCOP, North-West Medical Specialties, Tacoma, WA, USA.
authors.forename: Francis M
authors.initials: FM
authors.lastname: Senecal
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|Kansas City Clinical Oncology Program, Kansas City, MO, USA.
authors.forename: Rakesh
authors.initials: R
authors.lastname: Gaur
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|Jewish General Hospital, McGill University, Montréal, QC, Canada.
authors.forename: Richard G
authors.initials: RG
authors.lastname: Margolese
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|Genesys Regional Medical Center, Grand Blanc, MI, USA.
authors.forename: Paul T
authors.initials: PT
authors.lastname: Adams
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|Dayton CCOP, Dayton, OH, USA.
authors.forename: Howard M
authors.initials: HM
authors.lastname: Gross
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Costantino
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|Severance Biomedical Science Institute and Department of Medical Oncology, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Soonmyung
authors.initials: S
authors.lastname: Paik
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|Washington Cancer Institute, Washington Hospital Center, Washington, DC, USA.|Georgetown University Medical Center, Washington, DC, USA.
authors.forename: Sandra M
authors.initials: SM
authors.lastname: Swain
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|UF Health Cancer Center at Orlando Health, Orlando, FL, USA.
authors.forename: Eleftherios P
authors.initials: EP
authors.lastname: Mamounas
authors.affiliation: NRG Oncology and the National Surgical Adjuvant Breast and Bowel Project (NSABP) (NSABP legacy trials are now part of the NRG Oncology portfolio), Pittsburgh, PA, USA.|Allegheny Health Network Cancer Institute, Pittsburgh, PA, USA.
authors.forename: Norman
authors.initials: N
authors.lastname: Wolmark
mesh_terms: D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D000068258:Bevacizumab / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D003131:Combined Modality Therapy; D000077143:Docetaxel; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016462:Mammaplasty / Q000009:adverse effects; D008408:Mastectomy / Q000009:adverse effects*; D011379:Prognosis; D011446:Prospective Studies; D013530:Surgical Wound Infection / Q000209:etiology*; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D018943:Anthracyclines; D043823:Taxoids; D000077143:Docetaxel; D000068258:Bevacizumab