Postmenopausal Patients with Node-Positive Resectable Breast Cancer

Abstract

In 1986 the true benefit of adjuvant medical treatment in postmenopausal patients with pathological node-positive breast adenocarcinoma was still controversial. The French Adjuvant Study Group (FASG) initiated a randomised trial to elucidate the respective roles of adjuvant chemo-and/or hormonotherapy in this group of patients. Of the 776 patients who have been included between 1986 and 1990, 741 were fully eligible for evaluation. Inclusion criteria were postmenopausal patients aged between 50 and 70 years with adenocarcinoma of the breast, positive pathological nodes and no distant metastasis. Patients were randomised to 1 of 4 treatment arms: Group A (n = 192) received tamoxifen 30 mg/day orally for 3 years; Group B (n = 183) received FEC 50 (fluorouracil 500 mg/m², epirubicin 50 mg/m² plus cyclophosphamide 500 mg/m²) for 6 cycles; Group C (n = 182) received tamoxifen 30 mg/day orally for 3 years plus FEC 50 for 6 cycles; Group D (n = 184) received no medical adjuvant treatment. Surgery was either modified radical mastectomy (n = 363) or tumorectomy (n = 378), and postoperative irradiation was given to all patients. All major prognostic factors were well balanced between the 4 patient groups. Toxicity was evaluated in 348 patients in Groups B and C who received a total of 1983 chemotherapy cycles. Median epirubicin dose intensity (mg/m²/week) was 15.8 in Group B and 15.7 in Group C. Grade 3 to 4 neutropenia was observed in 4.7% of cycles for Group B and 3.7% for Group C. Grade 3 to 4 nausea/vomiting were seen in 18% of treatment cycles in Group B and 15% in Group C. Grade 3 alopecia was observed in 18.5% of patients in Group B and 23% in Group C. In 4 patients, chemotherapy was interrupted because of cardiac abnormalities. At a median follow-up of 37 months, relapse occurred in 40 patients in Group A, 48 patients in Group B, 27 patients in Group C and 59 patients in Group D. There were significantly fewer relapses in Group C than in other treatment groups. Disease-free survival (DFS) was marginally better among patients receiving chemotherapy (Groups B + C) than those receiving hormonotherapy (Group A) or no treatment (Group D) [p = 0.042]. DFS was clearly better for patients receiving tamoxifen (Groups A + C) than those not receiving hormonotherapy (Groups B + D) [p = 0.0004]. The number of deaths in Groups A to D were 28, 20, 18 and 33, respectively, and no statistically significant differences were detected between treatment groups. Significantly fewer deaths (p = 0.019) occurred among patients receiving chemotherapy (Groups B + C) than those not receiving chemotherapy (Groups A + D), although the number of events is too low to draw any conclusion on survival.