Harry D Bear1,2, Gong Tang3,4, Priya Rastogi3,5, Charles E Geyer3,6, Christine K Zoon6, Kelley M Kidwell3,4,7, André Robidoux3,8, Luis Baez-Diaz3,9, Adam M Brufsky3,10, Rita S Mehta3,11, Louis Fehrenbacher3,12, James A Young3,13, Francis M Senecal3,14, Rakesh Gaur3,15, Richard G Margolese3,16, Paul T Adams3,17, Howard M Gross3,18, Joseph P Costantino3,4, Soonmyung Paik3,19, Sandra M Swain3,20,21, Eleftherios P Mamounas3,22, Norman Wolmark3,23. 1. 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. 2. Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA. harry.bear@vcuhealth.org. 3. 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. 4. University of Pittsburgh, Pittsburgh, PA, USA. 5. University of Pittsburgh Cancer Institute School of Medicine, Pittsburgh, PA, USA. 6. Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA. 7. Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA. 8. Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, QC, Canada. 9. San Juan MBCCOP, San Juan, PR, USA. 10. University of Pittsburgh/Magee Womens Hospital, Pittsburgh, PA, USA. 11. School of Medicine, Chao Family Comprehensive Cancer Center, University of California at Irvine, Orange, CA, USA. 12. Kaiser Permanente Oncology Clinical Trials, Northern California, Vallejo, CA, USA. 13. CCOP, Colorado Cancer Research Program, Colorado Springs, CO, USA. 14. CCOP, North-West Medical Specialties, Tacoma, WA, USA. 15. Kansas City Clinical Oncology Program, Kansas City, MO, USA. 16. Jewish General Hospital, McGill University, Montréal, QC, Canada. 17. Genesys Regional Medical Center, Grand Blanc, MI, USA. 18. Dayton CCOP, Dayton, OH, USA. 19. Severance Biomedical Science Institute and Department of Medical Oncology, Yonsei University College of Medicine, Seoul, Korea. 20. Washington Cancer Institute, Washington Hospital Center, Washington, DC, USA. 21. Georgetown University Medical Center, Washington, DC, USA. 22. UF Health Cancer Center at Orlando Health, Orlando, FL, USA. 23. Allegheny Health Network Cancer Institute, Pittsburgh, PA, USA.
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.
RCT Entities:
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.
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