Anthracyclines in Early Breast Cancer: The ABC Trials-USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 (NRG Oncology).
Citation: Journal of Clinical Oncology. 35(23):2647-2655, 2017 Aug 10.PMID: 28398846Institution: Washington Cancer InstituteForm of publication: Journal ArticleMedline article type(s): Clinical Trial, Phase III | Comparative Study | Journal Article | Randomized Controlled TrialSubject headings: *Antineoplastic Combined Chemotherapy Protocols/tu [Therapeutic Use] | *Breast Neoplasms/th [Therapy] | *Carcinoma, Ductal, Breast/th [Therapy] | *Carcinoma, Intraductal, Noninfiltrating/th [Therapy] | Anthracyclines/ad [Administration & Dosage] | Breast Neoplasms/ch [Chemistry] | Breast Neoplasms/pa [Pathology] | Bridged-Ring Compounds/ad [Administration & Dosage] | Carcinoma, Ductal, Breast/ch [Chemistry] | Carcinoma, Ductal, Breast/sc [Secondary] | Carcinoma, Intraductal, Noninfiltrating/ch [Chemistry] | Chemotherapy, Adjuvant | Cyclophosphamide/ad [Administration & Dosage] | Disease-Free Survival | Docetaxel | Doxorubicin/ad [Administration & Dosage] | Female | Follow-Up Studies | Humans | Lymphatic Metastasis | Mastectomy | Middle Aged | Prospective Studies | Receptor, ErbB-2/an [Analysis] | Receptors, Estrogen/an [Analysis] | Receptors, Progesterone/an [Analysis] | Taxoids/ad [Administration & Dosage]Year: 2017Local holdings: Available online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2008ISSN:- 0732-183X
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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Journal Article | MedStar Authors Catalog | Article | 28398846 | Available | 28398846 |
Available online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2008
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.
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