PHASE-II STUDY OF MITOXANTRONE, 5-FLUOROURACIL, AND LEVO-LEUCOVORIN (MLF) IN ELDERLY ADVANCED BREAST-CANCER PATIENTS

We have carried out a phase II trial to evaluate the efficacy and toxi city of a combination therapy consisting of mitoxantrone 10 mg/sqm i.v . on day 1, levo-leucovorin 250 mg/sqm administered over 2 hours and 5 -fluorouracil 500 mg/sqm i.v. push after the first hour of levo-leucov orin infusion, on days 15-16 (MFL) in patients aged more than 65 years . 24 patients with advanced breast cancer entered the study: 16 aged 6 5-70 yrs, 4 patients 70-75 yrs, and 4 > 75 yrs. Median PS was 1 (range 0-2); sites of metastases were: bone 14 patients, viscera 14 patients , soft tissue 11 patients, and CNS 1 patient. A median number of 6 cyc les (range 3-9) was administered. All patients were evaluable for resp onse and toxicity; partial response was obtained in 12 (50%) patients (95% C.I30-70), stable disease was observed in 9 patients (37.5%), whi le 3 patients (12.5%) progressed. Median progression-free survival and survival were 9 months (range 2-14) and 14 months (range 5-36), respe ctively. Toxicity was generally mild and the most frequently observed side-effects were WHO gr. 1-2 leukopenia in 6/24 (25%) patients and gr . 1-2 emesis in 10/24 (41.6%) pts. 1 patient pretreated with doxorubic in cumulative dose of 240 mg/sqm showed clinical signs of congestive h eart failure (NYHA grade 1) after the fifth cycle of treatment. MFL is a well tolerated regimen and could represent a safe and effective tre atment in older advanced breast cancer patients.