Adjuvant trial for stage II receptor-positive breast cancer: CMF vs. CMF + tamoxifen in a single centre.
The purpose of a randomized trial achieved in a single centre (Fondation Bergonié, Bordeaux, France) was to compare chemotherapy alone (intravenous CMF) versus chemotherapy and hormonotherapy (CMF plus tamoxifen-30 mg per day during 2 years), for patients with stage II breast carcinoma and positive values of estrogen and/or progesterone receptor (EPR) (greater than 10 and greater than 15 fmoles mg protein-1 respectively). Three hundred and thirty four women treated by surgery +/- radiotherapy are included in this trial from 06.01.81 to 12.31.84. No patient is lost for follow-up. Eight are excluded. Three hundred and twenty six patients are evaluable with a 38 month median follow-up. For EPR assay, the dextran charcoal micromethod was used in the same centre. The two groups are identical as far as age, hormonal status, TNM, EPR values, and histological features are concerned. Analysis of results shows a significant improvement of relapse free survival (p = 0.018) and also overall survival (p = 0.04) for the CMF+ tamoxifen group.
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000032:analysis / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009367:Neoplasm Staging; D011897:Random Allocation; D011960:Receptors, Estrogen / Q000032:analysis; D011980:Receptors, Progesterone / Q000032:analysis; D013629:Tamoxifen / Q000008:administration & dosage / Q000627:therapeutic use*
D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D013629:Tamoxifen; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate