Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer

planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831

Edith A. Perez, Edward H. Romond, Vera J. Suman, Jong Hyeon Jeong, George Sledge, Charles E. Geyer, Silvana Martino, Priya Rastogi, Julie Gralow, Sandra M. Swain, Eric P. Winer, Gerardo Colon-Otero, Nancy E. Davidson, Eleftherios Mamounas, Jo A nne Zujewski, Norman Wolmark

Research output: Contribution to journalArticle

Abstract

PURPOSE: Positive interim analysis findings from four large adjuvant trials evaluating trastuzumab in patients with early-stage human epidermal growth factor receptor 2 (HER2) -positive breast cancer were first reported in 2005. One of these reports, the joint analysis of North Central Cancer Treatment Group NCCTG N9831 (Combination Chemotherapy With or Without Trastuzumab in Treating Women With HER2-Overexpressing Breast Cancer) and the National Surgical Adjuvant Breast and Bowel Project NSABP B-31 (Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2), was updated in 2011. We now report the planned definitive overall survival (OS) results from this joint analysis along with updates on the disease-free survival (DFS) end point.

METHODS: In all, 4,046 patients with HER2-positive operable breast cancer were enrolled to receive doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in both trials. The required number of events for the definitive statistical analysis for OS (710 events) was reached in September 2012. Updated analyses of overall DFS and related subgroups were also performed.

RESULTS: Median time on study was 8.4 years. Adding trastuzumab to chemotherapy led to a 37% relative improvement in OS (hazard ratio [HR], 0.63; 95% CI, 0.54 to 0.73; P <.001) and an increase in 10-year OS rate from 75.2% to 84%. These results were accompanied by an improvement in DFS of 40% (HR, 0.60; 95% CI, 0.53 to 0.68; P <.001) and increase in 10-year DFS rate from 62.2% to 73.7%. All patient subgroups benefited from addition of this targeted anti-HER2 agent.

CONCLUSION: The addition of trastuzumab to paclitaxel after doxorubicin and cyclophosphamide in early-stage HER2-positive breast cancer results in a substantial and durable improvement in survival as a result of a sustained marked reduction in cancer recurrence.

Original languageEnglish (US)
Pages (from-to)3744-3752
Number of pages9
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume32
Issue number33
DOIs
StatePublished - Nov 20 2014

Fingerprint

Adjuvant Chemotherapy
Survival Analysis
Breast Neoplasms
Disease-Free Survival
Paclitaxel
Doxorubicin
Cyclophosphamide
Survival
Survival Rate
Combination Drug Therapy
human ERBB2 protein
B 31
Trastuzumab
Neoplasms
Breast
Recurrence
Drug Therapy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer : planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. / Perez, Edith A.; Romond, Edward H.; Suman, Vera J.; Jeong, Jong Hyeon; Sledge, George; Geyer, Charles E.; Martino, Silvana; Rastogi, Priya; Gralow, Julie; Swain, Sandra M.; Winer, Eric P.; Colon-Otero, Gerardo; Davidson, Nancy E.; Mamounas, Eleftherios; Zujewski, Jo A nne; Wolmark, Norman.

In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Vol. 32, No. 33, 20.11.2014, p. 3744-3752.

Research output: Contribution to journalArticle

Perez, EA, Romond, EH, Suman, VJ, Jeong, JH, Sledge, G, Geyer, CE, Martino, S, Rastogi, P, Gralow, J, Swain, SM, Winer, EP, Colon-Otero, G, Davidson, NE, Mamounas, E, Zujewski, JAN & Wolmark, N 2014, 'Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831', Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 32, no. 33, pp. 3744-3752. https://doi.org/10.1200/JCO.2014.55.5730
Perez, Edith A. ; Romond, Edward H. ; Suman, Vera J. ; Jeong, Jong Hyeon ; Sledge, George ; Geyer, Charles E. ; Martino, Silvana ; Rastogi, Priya ; Gralow, Julie ; Swain, Sandra M. ; Winer, Eric P. ; Colon-Otero, Gerardo ; Davidson, Nancy E. ; Mamounas, Eleftherios ; Zujewski, Jo A nne ; Wolmark, Norman. / Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer : planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2014 ; Vol. 32, No. 33. pp. 3744-3752.
@article{d07b904958944a3e837c925f461c2801,
title = "Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831",
abstract = "PURPOSE: Positive interim analysis findings from four large adjuvant trials evaluating trastuzumab in patients with early-stage human epidermal growth factor receptor 2 (HER2) -positive breast cancer were first reported in 2005. One of these reports, the joint analysis of North Central Cancer Treatment Group NCCTG N9831 (Combination Chemotherapy With or Without Trastuzumab in Treating Women With HER2-Overexpressing Breast Cancer) and the National Surgical Adjuvant Breast and Bowel Project NSABP B-31 (Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2), was updated in 2011. We now report the planned definitive overall survival (OS) results from this joint analysis along with updates on the disease-free survival (DFS) end point.METHODS: In all, 4,046 patients with HER2-positive operable breast cancer were enrolled to receive doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in both trials. The required number of events for the definitive statistical analysis for OS (710 events) was reached in September 2012. Updated analyses of overall DFS and related subgroups were also performed.RESULTS: Median time on study was 8.4 years. Adding trastuzumab to chemotherapy led to a 37{\%} relative improvement in OS (hazard ratio [HR], 0.63; 95{\%} CI, 0.54 to 0.73; P <.001) and an increase in 10-year OS rate from 75.2{\%} to 84{\%}. These results were accompanied by an improvement in DFS of 40{\%} (HR, 0.60; 95{\%} CI, 0.53 to 0.68; P <.001) and increase in 10-year DFS rate from 62.2{\%} to 73.7{\%}. All patient subgroups benefited from addition of this targeted anti-HER2 agent.CONCLUSION: The addition of trastuzumab to paclitaxel after doxorubicin and cyclophosphamide in early-stage HER2-positive breast cancer results in a substantial and durable improvement in survival as a result of a sustained marked reduction in cancer recurrence.",
author = "Perez, {Edith A.} and Romond, {Edward H.} and Suman, {Vera J.} and Jeong, {Jong Hyeon} and George Sledge and Geyer, {Charles E.} and Silvana Martino and Priya Rastogi and Julie Gralow and Swain, {Sandra M.} and Winer, {Eric P.} and Gerardo Colon-Otero and Davidson, {Nancy E.} and Eleftherios Mamounas and Zujewski, {Jo A nne} and Norman Wolmark",
year = "2014",
month = "11",
day = "20",
doi = "10.1200/JCO.2014.55.5730",
language = "English (US)",
volume = "32",
pages = "3744--3752",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "33",

}

TY - JOUR

T1 - Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer

T2 - planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831

AU - Perez, Edith A.

AU - Romond, Edward H.

AU - Suman, Vera J.

AU - Jeong, Jong Hyeon

AU - Sledge, George

AU - Geyer, Charles E.

AU - Martino, Silvana

AU - Rastogi, Priya

AU - Gralow, Julie

AU - Swain, Sandra M.

AU - Winer, Eric P.

AU - Colon-Otero, Gerardo

AU - Davidson, Nancy E.

AU - Mamounas, Eleftherios

AU - Zujewski, Jo A nne

AU - Wolmark, Norman

PY - 2014/11/20

Y1 - 2014/11/20

N2 - PURPOSE: Positive interim analysis findings from four large adjuvant trials evaluating trastuzumab in patients with early-stage human epidermal growth factor receptor 2 (HER2) -positive breast cancer were first reported in 2005. One of these reports, the joint analysis of North Central Cancer Treatment Group NCCTG N9831 (Combination Chemotherapy With or Without Trastuzumab in Treating Women With HER2-Overexpressing Breast Cancer) and the National Surgical Adjuvant Breast and Bowel Project NSABP B-31 (Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2), was updated in 2011. We now report the planned definitive overall survival (OS) results from this joint analysis along with updates on the disease-free survival (DFS) end point.METHODS: In all, 4,046 patients with HER2-positive operable breast cancer were enrolled to receive doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in both trials. The required number of events for the definitive statistical analysis for OS (710 events) was reached in September 2012. Updated analyses of overall DFS and related subgroups were also performed.RESULTS: Median time on study was 8.4 years. Adding trastuzumab to chemotherapy led to a 37% relative improvement in OS (hazard ratio [HR], 0.63; 95% CI, 0.54 to 0.73; P <.001) and an increase in 10-year OS rate from 75.2% to 84%. These results were accompanied by an improvement in DFS of 40% (HR, 0.60; 95% CI, 0.53 to 0.68; P <.001) and increase in 10-year DFS rate from 62.2% to 73.7%. All patient subgroups benefited from addition of this targeted anti-HER2 agent.CONCLUSION: The addition of trastuzumab to paclitaxel after doxorubicin and cyclophosphamide in early-stage HER2-positive breast cancer results in a substantial and durable improvement in survival as a result of a sustained marked reduction in cancer recurrence.

AB - PURPOSE: Positive interim analysis findings from four large adjuvant trials evaluating trastuzumab in patients with early-stage human epidermal growth factor receptor 2 (HER2) -positive breast cancer were first reported in 2005. One of these reports, the joint analysis of North Central Cancer Treatment Group NCCTG N9831 (Combination Chemotherapy With or Without Trastuzumab in Treating Women With HER2-Overexpressing Breast Cancer) and the National Surgical Adjuvant Breast and Bowel Project NSABP B-31 (Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2), was updated in 2011. We now report the planned definitive overall survival (OS) results from this joint analysis along with updates on the disease-free survival (DFS) end point.METHODS: In all, 4,046 patients with HER2-positive operable breast cancer were enrolled to receive doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in both trials. The required number of events for the definitive statistical analysis for OS (710 events) was reached in September 2012. Updated analyses of overall DFS and related subgroups were also performed.RESULTS: Median time on study was 8.4 years. Adding trastuzumab to chemotherapy led to a 37% relative improvement in OS (hazard ratio [HR], 0.63; 95% CI, 0.54 to 0.73; P <.001) and an increase in 10-year OS rate from 75.2% to 84%. These results were accompanied by an improvement in DFS of 40% (HR, 0.60; 95% CI, 0.53 to 0.68; P <.001) and increase in 10-year DFS rate from 62.2% to 73.7%. All patient subgroups benefited from addition of this targeted anti-HER2 agent.CONCLUSION: The addition of trastuzumab to paclitaxel after doxorubicin and cyclophosphamide in early-stage HER2-positive breast cancer results in a substantial and durable improvement in survival as a result of a sustained marked reduction in cancer recurrence.

UR - http://www.scopus.com/inward/record.url?scp=84964698046&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84964698046&partnerID=8YFLogxK

U2 - 10.1200/JCO.2014.55.5730

DO - 10.1200/JCO.2014.55.5730

M3 - Article

VL - 32

SP - 3744

EP - 3752

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 33

ER -