Anthracyclines in Early Breast Cancer: The ABC Trials-USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 (NRG Oncology)

被引：210

作者：

Blum, Joanne L. ^{[1
,3
]}

Flynn, Patrick J. ^{[5
]}

Yothers, Greg ^{[6
,7
]}

Asmar, Lina ^{[1
,2
]}

Geyer, Charles E., Jr. ^{[5
,12
]}

Jacobs, Samuel A. ^{[5
,8
]}

Robert, Nicholas J. ^{[1
,13
]}

Hopkins, Judith O. ^{[5
,14
]}

O'Shaughnessy, Joyce A. ^{[1
,3
]}

Dang, Chau T. ^{[15
,16
]}

Gomez, Henry Leonidas ^{[11
,17
]}

Fehrenbacher, Louis ^{[5
,18
]}

Vukelja, Svetislava J. ^{[1
,4
]}

Lyss, Alan P. ^{[5
,19
]}

Paul, Devchand ^{[1
,20
]}

Brufsky, Adam M. ^{[5
,9
]}

Jeong, Jong-Hyeon ^{[6
,7
]}

Colangelo, Linda H. ^{[6
,7
]}

Swain, Sandra M. ^{[5
,21
,22
]}

Mamounas, Eleftherios P. ^{[5
,23
]}

Jones, Stephen E. ^{[1
]}

Wolmark, Norman ^{[5
,10
]}

机构：

[1] US Oncol Res, Houston, TX USA

[2] McKesson Specialty Hlth, The Woodlands, TX USA

[3] Baylor Univ, Med Ctr, Texas Oncol Baylor Charles A Sammons Canc Ctr, Dallas, TX USA

[4] Texas Oncol Tyler, Tyler, TX USA

[5] NRG Oncol, Natl Surg Adjuvant Breast & Bowel Project, Philadelphia, PA USA

[6] NRG Oncol, Philadelphia, PA USA

[7] Univ Pittsburgh, Pittsburgh, PA 15260 USA

[8] Univ Pittsburgh, Sch Med, Univ Pittsburgh Canc Inst, Pittsburgh, PA 15260 USA

[9] Univ Pittsburgh, Med Ctr, Magee Womens Hosp, Pittsburgh, PA 15260 USA

[10] Allegheny Gen Hosp, Allegheny Canc Ctr, Pittsburgh, PA USA

[11] Amer Coll Radiol Imaging Network, Eastern Cooperat Oncol Grp, Philadelphia, PA USA

[12] Virginia Commonwealth Univ, Massey Canc Ctr, Richmond, VA 23284 USA

[13] Virginia Canc Specialists, Fairfax, VA USA

[14] Southeastern Med Oncol Ctr, Goldsboro, NC USA

[15] Alliance, Boston, MA USA

[16] Mem Sloan Kettering Canc Ctr, New York, NY USA

[17] Inst Nacl Enfermedades Neoplas, Lima, Peru

[18] Kaiser Permanente Oncol Clin Trials Northern Cali, Vallejo, CA USA

[19] Missouri Baptist Canc Ctr, Heartland Canc Res Natl Canc Inst Community Oncol, St Louis, MO USA

[20] Rocky Mt Canc Ctr, Denver, CO USA

[21] Georgetown Univ, Med Ctr, MedStar Washington Hosp Ctr, Washington, DC 20057 USA

[22] Georgetown Univ, Med Ctr, Washington Canc Inst, Washington, DC 20057 USA

[23] Orlando Hlth, UF Canc Ctr, Orlando, FL USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2017年 / 35卷 / 23期

关键词：

DOXORUBICIN PLUS CYCLOPHOSPHAMIDE; FOLLOW-UP; ADJUVANT CHEMOTHERAPY; PACLITAXEL; DOCETAXEL; REGIMEN;

D O I：

10.1200/JCO.2016.71.4147

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose Docetaxel and cyclophosphamide (TC) was superior to doxorubicin and cyclophosphamide (AC) in a trial in early breast cancer. However, activity of TC relative to AC regimens with a taxane (TaxAC) is unknown. Methods In a series of three adjuvant trials, women were randomly assigned to TC for six cycles (TC6) or to a standard TaxAC regimen. US Oncology Research (USOR) 06-090 compared TC6 with docetaxel, doxorubicin, and cyclophosphamide (TAC6). National Surgical Adjuvant Breast and Bowel Project (NSABP) B-46-I/USOR 07132 compared TC6, TAC6, or TC6 plus bevacizumab. NSABP B-49 compared TC6 with several standard AC and taxane combination regimens. Before any analysis of individual trials, a joint efficacy analysis of TC versus the TaxAC regimens was planned, with invasive disease-free survival (IDFS) as the primary end point. Patients who received TC6 plus bevacizumab on NSABP B-46-I/USOR 07132 were not included. A hazard ratio (HR) from a stratified Cox model that exceeded 1.18 for TC6 versus TaxAC was predefined as inferiority for TC6. The prespecified interim monitoring plan was to report for futility if the HR was. 1.18 when 334 IDFS events were observed (50% of 668 events required for definitive analysis). Results A total of 2,125 patients were randomly assigned to receive TC6 regimens and 2,117 patients were randomly assigned to receive TaxAC regimens. The median follow-up time was 3.3 years. There were 334 IDFS events, and the HR for TC6 versus TaxAC was 1.202 (95% CI, 0.97 to 1.49), which triggered early reporting for futility. The 4-year IDFS was 88.2% for TC6 and was 90.7% for TaxAC (P =.04). Tests for treatment interaction by protocol, hormone receptor status, and nodal status were negative. Conclusion The TaxAC regimens improved IDFS in patients with high-risk human epidermal growth factor receptor 2-negative breast cancer compared with the TC6 regimen. (C) 2017 by American Society of Clinical Oncology

引用

页码：2647 / +

页数：11

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