PROPHYLACTIC FILGRASTIM (G-CSF) DURING MITOMYCIN-C, MITOXANTRONE, ANDMETHOTREXATE (MMT) TREATMENT FOR METASTATIC BREAST-CANCER - A RANDOMIZED STUDY

Patients with metastatic breast cancer were randomly assigned to recei ve as second-line chemotherapy either MMM (mitomycin 8 mg/m(2) day 1; mitoxantrone 8 mg/m(2) days 1 and 22; methotrexate 35 mg/m(2) days 1 a nd 22) alone or in combination with filgrastim (5 mu g/kg s.c. days 4- 17, 24-37). The courses were repeated every 42 days for a maximum of s ix courses. Thirty-one patients are evaluable for safety and efficacy. The 16 patients in the filgrastim arm received a total of 42 cycles c ompared with 34 cycles in the 15 control patients. Tumor responses wer e few in both patient groups (one partial response in the filgrastim g roup and two partial responses in control group). Nevertheless, a diff erence in survival was seen (filgrastim median 10.7 months, control me dian 6.5 months; p = 0.02 log rank). The treatment was well tolerated. Doses were reduced six times in the filgrastim arm and eleven times i n the control arm. Grade IV neutropenia was seen in four patients in t he filgrastim arm and in twelve patients in the control arm. The obser ved survival benefit needs to be confirmed in a larger patient group.