HIGH-DOSE EPIRUBICIN IN LOCALLY ADVANCED OPERABLE NONINFLAMMATORY BREAST-CANCER - A FEASIBILITY TRIAL

Aims and background: Anthracyclines are among the most active agents f or the treatment of patients with locally advanced breast cancer. The aim of our study was to evaluate the feasibility and activity of a rel atively high-dose regimen with 4-epirubicin plus normal doses of cyclo phosphamide over a short period of time without the use of hematologic growth factors as adjuvant in resected locally advanced breast cancer . Methods. Between January 1990 and June 1992, 43 consecutive patients , premenopausal or postmenopausal <60 yrs, were surgically resected an d then treated with epirubicin plus cyclophosphamide for at least 4 cy cles (maximum 6). Electron beam (6-10 MeV energy) radiotherapy was del ivered on the chest wall in patients with pathological skin infiltrati on (pT4b), Results: Median age was 46 years (range, 27-59); 37 were pr emenopausal and 6 postmenopausal. The total number of administered cyc les was 202 (6 in 15 patients and 4 in 28 patients); 195/202 (96.5%) w ere administered at full dose, and 7 (3.5%) were reduced to 75% of the planned dosage. The three-year disease-free survival was 67% for stag e IIIa and 61% for stage IIIb patients. The three-year overall surviva l was 88% and 79%, respectively. Local relapse only was reported in on e patient (2%), distant relapse in 11 patients (25%), and local and di stant relapse in four patients (9%). Toxicity was acceptable and mainl y hematologic. Conclusions. Our trial showed that the regimen is feasi ble without the use of hematologic growth factors. In this era of cost containment, the use of this short-term, high-dose induction course i nstead of repetitive courses of conventional dose regimens merits furt her evaluation, possibly in a large randomized trial.