Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer

Joint analysis of data from NCCTG N9831 and NSABP B-31

Edith A. Perez, Edward H. Romond, Vera J. Suman, Jong Hyeon Jeong, Nancy E. Davidson, Charles E. Geyer, Silvana Martino, Eleftherios P. Mamounas, Peter A. Kaufman, Norman Wolmark

Research output: Contribution to journalArticle

476 Citations (Scopus)

Abstract

Purpose: Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). The clinical benefits of adjuvant trastuzumab have been demonstrated in interim analyses of four large trials. Initial data of the combined analysis of the North Central Cancer Treatment Group (NCCTG) N9831 Intergroup trial and National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 trial were reported in 2005. Long-term follow-up results on disease-free survival (DFS) and overall survival (OS) have been awaited. Patients and Methods: Patients with HER2-positive operable breast cancer were randomly assigned to doxorubicin plus cyclophosphamide followed by paclitaxel with or without trastuzumab in the NCCTG N9831 and NSABP B-31 trials. The similar design of both trials allowed data from the control and trastuzumab-containing arms to be combined in a joint analysis. Results: At 3.9 years of median follow-up, there continues to be a highly statistically significant reduction in DFS event rate in favor of the trastuzumab-containing arm (P < .001). Similarly, there continues to be a statistically significant 39% reduction in death rate in favor of the trastuzumab-containing arm (P < .001). Conclusion: These data demonstrate consistent DFS and OS advantages of adjuvant trastuzumab over time, with the longest follow-up reported to date. The clinical benefits continue to outweigh the risks of adverse effects.

Original languageEnglish (US)
Pages (from-to)3366-3373
Number of pages8
JournalJournal of Clinical Oncology
Volume29
Issue number25
DOIs
StatePublished - Sep 1 2011

Fingerprint

Adjuvant Chemotherapy
Breast
Breast Neoplasms
Neoplasms
Disease-Free Survival
Arm
Therapeutics
Antibodies, Monoclonal, Humanized
Survival
Paclitaxel
human ERBB2 protein
B 31
Trastuzumab
Doxorubicin
Cyclophosphamide
Survival Rate
Mortality

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer : Joint analysis of data from NCCTG N9831 and NSABP B-31. / Perez, Edith A.; Romond, Edward H.; Suman, Vera J.; Jeong, Jong Hyeon; Davidson, Nancy E.; Geyer, Charles E.; Martino, Silvana; Mamounas, Eleftherios P.; Kaufman, Peter A.; Wolmark, Norman.

In: Journal of Clinical Oncology, Vol. 29, No. 25, 01.09.2011, p. 3366-3373.

Research output: Contribution to journalArticle

Perez, Edith A. ; Romond, Edward H. ; Suman, Vera J. ; Jeong, Jong Hyeon ; Davidson, Nancy E. ; Geyer, Charles E. ; Martino, Silvana ; Mamounas, Eleftherios P. ; Kaufman, Peter A. ; Wolmark, Norman. / Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer : Joint analysis of data from NCCTG N9831 and NSABP B-31. In: Journal of Clinical Oncology. 2011 ; Vol. 29, No. 25. pp. 3366-3373.
@article{d1e5490434c4447a878ae3848a5f7a0e,
title = "Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: Joint analysis of data from NCCTG N9831 and NSABP B-31",
abstract = "Purpose: Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). The clinical benefits of adjuvant trastuzumab have been demonstrated in interim analyses of four large trials. Initial data of the combined analysis of the North Central Cancer Treatment Group (NCCTG) N9831 Intergroup trial and National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 trial were reported in 2005. Long-term follow-up results on disease-free survival (DFS) and overall survival (OS) have been awaited. Patients and Methods: Patients with HER2-positive operable breast cancer were randomly assigned to doxorubicin plus cyclophosphamide followed by paclitaxel with or without trastuzumab in the NCCTG N9831 and NSABP B-31 trials. The similar design of both trials allowed data from the control and trastuzumab-containing arms to be combined in a joint analysis. Results: At 3.9 years of median follow-up, there continues to be a highly statistically significant reduction in DFS event rate in favor of the trastuzumab-containing arm (P < .001). Similarly, there continues to be a statistically significant 39{\%} reduction in death rate in favor of the trastuzumab-containing arm (P < .001). Conclusion: These data demonstrate consistent DFS and OS advantages of adjuvant trastuzumab over time, with the longest follow-up reported to date. The clinical benefits continue to outweigh the risks of adverse effects.",
author = "Perez, {Edith A.} and Romond, {Edward H.} and Suman, {Vera J.} and Jeong, {Jong Hyeon} and Davidson, {Nancy E.} and Geyer, {Charles E.} and Silvana Martino and Mamounas, {Eleftherios P.} and Kaufman, {Peter A.} and Norman Wolmark",
year = "2011",
month = "9",
day = "1",
doi = "10.1200/JCO.2011.35.0868",
language = "English (US)",
volume = "29",
pages = "3366--3373",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "25",

}

TY - JOUR

T1 - Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer

T2 - Joint analysis of data from NCCTG N9831 and NSABP B-31

AU - Perez, Edith A.

AU - Romond, Edward H.

AU - Suman, Vera J.

AU - Jeong, Jong Hyeon

AU - Davidson, Nancy E.

AU - Geyer, Charles E.

AU - Martino, Silvana

AU - Mamounas, Eleftherios P.

AU - Kaufman, Peter A.

AU - Wolmark, Norman

PY - 2011/9/1

Y1 - 2011/9/1

N2 - Purpose: Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). The clinical benefits of adjuvant trastuzumab have been demonstrated in interim analyses of four large trials. Initial data of the combined analysis of the North Central Cancer Treatment Group (NCCTG) N9831 Intergroup trial and National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 trial were reported in 2005. Long-term follow-up results on disease-free survival (DFS) and overall survival (OS) have been awaited. Patients and Methods: Patients with HER2-positive operable breast cancer were randomly assigned to doxorubicin plus cyclophosphamide followed by paclitaxel with or without trastuzumab in the NCCTG N9831 and NSABP B-31 trials. The similar design of both trials allowed data from the control and trastuzumab-containing arms to be combined in a joint analysis. Results: At 3.9 years of median follow-up, there continues to be a highly statistically significant reduction in DFS event rate in favor of the trastuzumab-containing arm (P < .001). Similarly, there continues to be a statistically significant 39% reduction in death rate in favor of the trastuzumab-containing arm (P < .001). Conclusion: These data demonstrate consistent DFS and OS advantages of adjuvant trastuzumab over time, with the longest follow-up reported to date. The clinical benefits continue to outweigh the risks of adverse effects.

AB - Purpose: Trastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). The clinical benefits of adjuvant trastuzumab have been demonstrated in interim analyses of four large trials. Initial data of the combined analysis of the North Central Cancer Treatment Group (NCCTG) N9831 Intergroup trial and National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 trial were reported in 2005. Long-term follow-up results on disease-free survival (DFS) and overall survival (OS) have been awaited. Patients and Methods: Patients with HER2-positive operable breast cancer were randomly assigned to doxorubicin plus cyclophosphamide followed by paclitaxel with or without trastuzumab in the NCCTG N9831 and NSABP B-31 trials. The similar design of both trials allowed data from the control and trastuzumab-containing arms to be combined in a joint analysis. Results: At 3.9 years of median follow-up, there continues to be a highly statistically significant reduction in DFS event rate in favor of the trastuzumab-containing arm (P < .001). Similarly, there continues to be a statistically significant 39% reduction in death rate in favor of the trastuzumab-containing arm (P < .001). Conclusion: These data demonstrate consistent DFS and OS advantages of adjuvant trastuzumab over time, with the longest follow-up reported to date. The clinical benefits continue to outweigh the risks of adverse effects.

UR - http://www.scopus.com/inward/record.url?scp=80052728749&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80052728749&partnerID=8YFLogxK

U2 - 10.1200/JCO.2011.35.0868

DO - 10.1200/JCO.2011.35.0868

M3 - Article

VL - 29

SP - 3366

EP - 3373

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 25

ER -