A PHASE-II TRIAL OF WEEKLY HIGH-DOSE FOLINIC ACID AND 5-FLUOROURACIL IN COMBINATION WITH EPIRUBICIN AS SALVAGE CHEMOTHERAPY IN ADVANCED BREAST-CANCER

Twenty-five patients with advanced breast cancer (ABC) who had failed from first-line chemotherapy entered into a phase II study employing w eekly 5-fluorouracil (FU) 350 mg/m(2), folinic acid (FA) 500 mg/m(2), and epirubicin (EPI) 35 mg/m(2), for a maximum of 18 cycles. Twenty-th ree patients were evaluable for response. One achieved a complete resp onse and 7 showed a partial response, for an objective response rate o f 35%; 7 (31%) patients achieved a stabilization of the disease, while 8 (35%) patients progressed under treatment. The median duration of r esponse was 6 months and median survival amounted to 10.6 months. Side effects were in general mild with grade III leukopenia in 5 patients and grade IV leukopenia in 1 patient. Other toxicity included nausea a nd vomiting (88%), diarrhea (26%), stomatitis (40%) and alopecia (84%) , but all of them mainly restricted to WHO grade I and II. Our results suggest that the combination of high-dose FA, FU, and EPI can be safe ly administered in the investigated schedule and represents an attract ive alternative in the search for second-line therapies that combine e ffectiveness with acceptable toxicity in the treatment of refractory A BC.