000 04790nam a22006977a 4500
008 221213s20172017 xxu||||| |||| 00| 0 eng d
022 _a0732-183X
024 _a10.1200/JCO.2016.71.4147 [doi]
024 _aPMC5549453 [pmc]
040 _aOvid MEDLINE(R)
099 _a28398846
245 _aAnthracyclines in Early Breast Cancer: The ABC Trials-USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 (NRG Oncology).
251 _aJournal of Clinical Oncology. 35(23):2647-2655, 2017 Aug 10.
252 _aJ Clin Oncol. 35(23):2647-2655, 2017 Aug 10.
253 _aJournal of clinical oncology : official journal of the American Society of Clinical Oncology
260 _c2017
260 _fFY2018
260 _p2017 Aug 10
265 _sppublish
265 _tMEDLINE
266 _d2022-12-13
501 _aAvailable online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2008
520 _aPurpose 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.
546 _aEnglish
650 _a*Antineoplastic Combined Chemotherapy Protocols/tu [Therapeutic Use]
650 _a*Breast Neoplasms/th [Therapy]
650 _a*Carcinoma, Ductal, Breast/th [Therapy]
650 _a*Carcinoma, Intraductal, Noninfiltrating/th [Therapy]
650 _aAnthracyclines/ad [Administration & Dosage]
650 _aBreast Neoplasms/ch [Chemistry]
650 _aBreast Neoplasms/pa [Pathology]
650 _aBridged-Ring Compounds/ad [Administration & Dosage]
650 _aCarcinoma, Ductal, Breast/ch [Chemistry]
650 _aCarcinoma, Ductal, Breast/sc [Secondary]
650 _aCarcinoma, Intraductal, Noninfiltrating/ch [Chemistry]
650 _aChemotherapy, Adjuvant
650 _aCyclophosphamide/ad [Administration & Dosage]
650 _aDisease-Free Survival
650 _aDocetaxel
650 _aDoxorubicin/ad [Administration & Dosage]
650 _aFemale
650 _aFollow-Up Studies
650 _aHumans
650 _aLymphatic Metastasis
650 _aMastectomy
650 _aMiddle Aged
650 _aProspective Studies
650 _aReceptor, ErbB-2/an [Analysis]
650 _aReceptors, Estrogen/an [Analysis]
650 _aReceptors, Progesterone/an [Analysis]
650 _aTaxoids/ad [Administration & Dosage]
651 _aWashington Cancer Institute
657 _aClinical Trial, Phase III
657 _aComparative Study
657 _aJournal Article
657 _aRandomized Controlled Trial
700 _aSwain, Sandra M
790 _aAsmar L, Blum JL, Brufsky AM, Colangelo LH, Dang CT, Fehrenbacher L, Flynn PJ, Geyer CE Jr, Gomez HL, Hopkins JO, Jacobs SA, Jeong JH, Jones SE, Lyss AP, Mamounas EP, O'Shaughnessy JA, Paul D, Robert NJ, Swain SM, Vukelja SJ, Wolmark N, Yothers G
856 _uhttps://dx.doi.org/10.1200/JCO.2016.71.4147
_zhttps://dx.doi.org/10.1200/JCO.2016.71.4147
942 _cART
_dArticle
999 _c5
_d5