EFFICACY, TOXICITY, AND APPLICABILITY OF HIGH-DOSE SEQUENTIAL CHEMOTHERAPY AS ADJUVANT TREATMENT IN OPERABLE BREAST-CANCER WITH 10 OR MORE INVOLVED AXILLARY NODES - 5-YEAR RESULTS

Purpose: To assess the efficacy, toxicity, and applicability of high-d ose therapy administered as adjuvant initial treatment to women with b reast cancer with extensive nodal involvement. Patients and Methods: S ixty-seven patients with stage II to III breast cancer involving great er than or equal to 10 axillary nodes received a novel high-dose seque ntial (HDS) regimen, including the high-dose administration of three n on-cross-resistant drugs (cyclophosphamide, methotrexate, and melphala n) given within the shortest interval of time as possible with hematol ogic and nonhematologic toxicity. Results: Sixty-three patients comple ted the program as planned, one patient died of acute toxicity, and th ree patients were switched to standard-dose adjuvant therapy. After a median follow-up duration of 48.5 months and a lead follow-up of 78 mo nths, actuarial relapse-free survival for all 67 registered patients i s 57% and overall survival is 70%, respectively. Comparison with a his torical control group of 58 consecutive patients showed a significantl y superior rate of freedom from relapse for the HDS-treated group (57% v 41%, respectively), in particular when two subgroups of patients, m ore homogeneous for their number of involved nodes, were compared (65% v 42%), Overall, treatment was of short duration (median, 70 days), r equired a median of 32 days of hospital stay, and was associated with only a few severe side effects (the most distressing being oral mucosi tis after melphalan therapy), Conclusion: HDS therapy emerges as an ef fective and applicable regimen, whose major toxicity was occasional. F inal assessment of its value in a randomized, multicenter trial is pre sently underway. (C) 1997 by American Society of Clinical Oncology.