Multicycle dose-intensive chemotherapy for women with high-risk primary breast cancer: results of International Breast Cancer Study Group Trial 15-95.

摘要: PURPOSE: To compare adjuvant dose-intensive epirubicin and cyclophosphamide chemotherapy administered with filgrastim progenitor cell support (DI-EC) standard-dose anthracycline-based (SD-CT) for patients early-stage breast cancer a high risk of relapse, defined as stage II disease 10 or more positive axillary nodes; an estrogen receptor-negative III tumor five nodes. PATIENTS AND METHODS: Three hundred forty-four were randomized after surgery to receive seven cycles SD-CT over 22 weeks, three DI-EC (epirubicin 200 mg/m2 plus 4 gm/m2 support) 6 weeks. All assigned tamoxifen at the completion chemotherapy. The primary end point was disease-free survival (DFS). RESULTS: After median follow-up 5.8 years (range, 3 8.4 years), 188 DFS events had occurred (DI-EC, 86 events; SD-CT, 102 events). 5-year 52% 43% hazard ratio compared 0.77 (95% CI, 0.58 1.02; P = .07). overall 70% 61% 0.79 0.56 1.11; .17). There eight cases (5%) anthracycline-induced cardiomyopathy (two fatal) among those who received DI-EC. Women hormone receptor-positive tumors benefited significantly from CONCLUSION: trend in favor respect survival. A larger trial meta-analysis will be required reveal true effect therapy.