Long term follow-up of women treated with 16-week, dose-intensive adjuvantchemotherapy for high risk breast carcinoma

BACKGROUND. A Phase II study was performed evaluating the disease free and overall survival rates associated with a dose-intensive, 16-week, doxorubic in-based adjuvant chemotherapy regimen in women with breast carcinoma and g reater than or equal to 10 involved axillary lymph nodes. METHODS, Eligible patients underwent staging with computed tomography and b one scanning and were treated with a 16-week, dose-intensive chemotherapy r egimen, comprised of 8 2-week courses of cyclophosphamide, 100 mg/m(2) oral ly, on Days 1-7; doxorubicin, 40 mg/m(2) intravenously (i.v.), on Day 1; me thotrexate, 100 mg/m(2) i.v., on Day I with leucovorin rescue, 10 mg/m(2), every 6 hours for 6 doses orally on Day 2; vincristine, 1 mg i.v. on Day 1; 5-fluorouracil (5-FU), 600 mg/m(2) i.v, on Day 2 over 2 hours; and 5-FU, 3 00 mg/m(2)/day continuous i.v. on Days 8 and 9. Tamoxifen, 20 mg daily, was administered to patients with estrogen receptor positive tumors treated af ter October 1988. All patients were offered locoregional radiation therapy. RESULTS. Sixty-four women were treated on protocol. The median follow-up of 27 surviving patients was > 8 years at last follow-up. Three patients were lost to follow-up. The median time to progression was 54 months, the Kapla n-Meier estimate of event free survival at 5 years was 44% (95% confidence interval [CI], 31-56%), and the Kaplan-Meier estimate of overall survival a t 5 years was 57% (95% CI, 44- 69%). At 98 months the Kaplan-Meier estimate of freedom from recurrence was 31% (95% CI, 19-43%) and the Kaplan-Meier e stimate of survival at 111 months was 36% (95% CI, 23-49%). CONCLUSIONS. Despite the use of dose-intensive, doxorubicin-based, adjuvant chemotherapy, and intensive staging prior to study entry, the results of t he current study are similar to those of previous reports for standard dose chemotherapy and appear inferior to those reported for high dose therapy. (C) 1999 American Cancer Society.