Tamoxifen after adjuvant chemotherapy for premenopausal women with lymph node-positive breast cancer: International Breast Cancer Study Group Trial 13-93.

摘要: PURPOSE: The value of adjuvant tamoxifen after chemotherapy for premenopausal women with breast cancer has not been adequately assessed. PATIENTS AND METHODS: Between 1993 and 1999, International Breast Cancer Study Group Trial 13-93 enrolled 1,246 assessable axillary node-positive, operable cancer. All patients received (cyclophosphamide plus either doxorubicin or epirubicin four courses followed by immediate delayed classical cyclophosphamide, methotrexate, fluorouracil three courses), which was (20 mg daily) 5 years no further treatment. primary end point disease-free survival (DFS). Tumors were classified as estrogen receptor (ER) -positive (n = 735, 59%) if immunohistochemical (IHC) ligand-binding assays (LBA) clearly positive. ER-negative group included all other tumors 511, 41%). A subset the defined ER absent 108, 9%) IHC staining none LBA result 0 fmol/mg cytosol protein. median follow-up time 7 years. RESULTS: Tamoxifen improved DFS in ER-positive cohort (hazard ratio [HR] v 0.59; 95% CI, 0.46 to 0.75; P < .0001) but (HR 1.02; 0.77 1.35; .89). had a detrimental effect on ER-absent compared an unplanned exploratory analysis 2.10; 1.03 4.29; .04). Patients who achieved chemotherapy-induced amenorrhea significantly outcome 0.61; 0.44 0.86; .004), whether they tamoxifen. CONCLUSION: treatment endocrine-responsive disease, its use therapy is recommended.