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

被引：852

作者：

Perez, Edith A. ^{[1
]}

Romond, Edward H. ^{[3
]}

Suman, Vera J. ^{[4
]}

Jeong, Jong-Hyeon ^{[5
]}

Sledge, George ^{[8
]}

Geyer, Charles E., Jr. ^{[10
]}

Martino, Silvana ^{[9
]}

Rastogi, Priya ^{[5
]}

Gralow, Julie ^{[11
]}

Swain, Sandra M. ^{[12
]}

Winer, Eric P. ^{[13
]}

Colon-Otero, Gerardo ^{[1
]}

Davidson, Nancy E. ^{[6
]}

Mamounas, Eleftherios ^{[2
]}

Zujewski, Jo Anne ^{[14
]}

Wolmark, Norman ^{[7
]}

机构：

[1] Mayo Clin, Jacksonville, FL 32224 USA

[2] Univ Florida, Hlth Canc Ctr Orlando Hlth, Orlando, FL USA

[3] Univ Kentucky, Lexington, KY USA

[4] Mayo Clin, Rochester, MN USA

[5] Univ Pittsburgh, Pittsburgh, PA 15260 USA

[6] Univ Pittsburgh, Inst Canc, Pittsburgh, PA 15260 USA

[7] Allegheny Gen Hosp, Pittsburgh, PA 15212 USA

[8] Stanford Univ, Sch Med, Stanford, CA 94305 USA

[9] Angeles Clin & Res Inst, Santa Monica, CA USA

[10] Virginia Commonwealth Univ, Massey Canc Ctr, Richmond, VA USA

[11] Univ Washington, Seattle Canc Care Alliance, Seattle, WA USA

[12] MedStar Washington Hosp Ctr, Washington, DC USA

[13] Dana Farber Canc Inst, Boston, MA 02115 USA

[14] NIH, Rockville, MD USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2014年 / 32卷 / 33期

基金：

美国国家卫生研究院;

关键词：

FOLLOW-UP; TRIAL; DOXORUBICIN; PACLITAXEL;

D O I：

10.1200/JCO.2014.55.5730

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

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. (C) 2014 by American Society of Clinical Oncology

引用

页码：3744 / +

页数：10

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