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

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

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1-8
Number of pages8
JournalAnnals of Surgical Oncology
DOIs
StateAccepted/In press - Nov 18 2016

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Breast Neoplasms
Drug Therapy
docetaxel
Wounds and Injuries
Bevacizumab
Mammaplasty
Anthracyclines
Incidence

ASJC Scopus subject areas

  • Surgery
  • Oncology

Cite this

The Effect on Surgical Complications of Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer : NRG Oncology/NSABP Protocol B-40. / Bear, Harry D.; Tang, Gong; Rastogi, Priya; Geyer, Charles E.; Zoon, Christine K.; Kidwell, Kelley M.; Robidoux, André; Baez-Diaz, Luis; Brufsky, Adam M.; Mehta, Rita S.; Fehrenbacher, Louis; Young, James A.; Senecal, Francis M.; Gaur, Rakesh; Margolese, Richard G.; Adams, Paul T.; Gross, Howard M.; Costantino, Joseph P.; Paik, Soonmyung; Swain, Sandra M.; Mamounas, Eleftherios P.; Wolmark, Norman.

In: Annals of Surgical Oncology, 18.11.2016, p. 1-8.

Research output: Contribution to journalArticle

Bear, HD, Tang, G, Rastogi, P, Geyer, CE, Zoon, CK, Kidwell, KM, Robidoux, A, Baez-Diaz, L, Brufsky, AM, Mehta, RS, Fehrenbacher, L, Young, JA, Senecal, FM, Gaur, R, Margolese, RG, Adams, PT, Gross, HM, Costantino, JP, Paik, S, Swain, SM, Mamounas, EP & Wolmark, N 2016, 'The Effect on Surgical Complications of Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer: NRG Oncology/NSABP Protocol B-40', Annals of Surgical Oncology, pp. 1-8. https://doi.org/10.1245/s10434-016-5662-9
Bear, Harry D. ; Tang, Gong ; Rastogi, Priya ; Geyer, Charles E. ; Zoon, Christine K. ; Kidwell, Kelley M. ; Robidoux, André ; Baez-Diaz, Luis ; Brufsky, Adam M. ; Mehta, Rita S. ; Fehrenbacher, Louis ; Young, James A. ; Senecal, Francis M. ; Gaur, Rakesh ; Margolese, Richard G. ; Adams, Paul T. ; Gross, Howard M. ; Costantino, Joseph P. ; Paik, Soonmyung ; Swain, Sandra M. ; Mamounas, Eleftherios P. ; Wolmark, Norman. / The Effect on Surgical Complications of Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer : NRG Oncology/NSABP Protocol B-40. In: Annals of Surgical Oncology. 2016 ; pp. 1-8.
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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.",
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T1 - The Effect on Surgical Complications of Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer

T2 - NRG Oncology/NSABP Protocol B-40

AU - Bear, Harry D.

AU - Tang, Gong

AU - Rastogi, Priya

AU - Geyer, Charles E.

AU - Zoon, Christine K.

AU - Kidwell, Kelley M.

AU - Robidoux, André

AU - Baez-Diaz, Luis

AU - Brufsky, Adam M.

AU - Mehta, Rita S.

AU - Fehrenbacher, Louis

AU - Young, James A.

AU - Senecal, Francis M.

AU - Gaur, Rakesh

AU - Margolese, Richard G.

AU - Adams, Paul T.

AU - Gross, Howard M.

AU - Costantino, Joseph P.

AU - Paik, Soonmyung

AU - Swain, Sandra M.

AU - Mamounas, Eleftherios P.

AU - Wolmark, Norman

PY - 2016/11/18

Y1 - 2016/11/18

N2 - 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.

AB - 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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