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 Jean 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 Anne Zujewski, Norman Wolmark

Research output: Contribution to journalArticle

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Abstract

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
Volume32
Issue number33
DOIs
StatePublished - Nov 20 2014

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

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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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 Jean; 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 Anne; Wolmark, Norman.

In: Journal 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, JA & 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, vol. 32, no. 33, pp. 3744-3752. https://doi.org/10.1200/JCO.2014.55.5730 2014
Perez, Edith A. ; Romond, Edward H. ; Suman, Vera Jean ; 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 Anne ; 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. 2014 ; Vol. 32, No. 33. pp. 3744-3752.
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abstract = "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.",
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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 Jean

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 Anne

AU - Wolmark, Norman

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N2 - 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 - 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.

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