A RANDOMIZED COMPARISON OF HIGH-DOSE EPIRUBICIN VERSUS HIGH-DOSE EPIRUBICIN PLUS LONIDAMINE IN ADVANCED BREAST-CANCER PATIENTS - FIRST RESULTS FROM A COOPERATIVE GROUP-STUDY

A multicenter prospective randomized trial was performed to determine if the addition of lonidamine to high dose epirubicin could increase t he response rate of epirubicin as single agent in patients with advanc ed breast cancer. From May 1991 to May 1993, 207 patients were enrolle d in this cooperative study and randomized to receive intravenous epir ubicin (EPI) (60 mg/m(2) on days 1,2) alone or with lonidamine (LND) ( 600 mg orally/day). EPI administration was repeated every 21 days unti l tumor progression or for a maximum of 8 cycles. Up to September 1993 , 183 patients were fully assessable of whom 92 were randomized to EPI alone and 91 were randomized to EPI + LND. Response rate was signific antly superior for the EPI + LND scheme compared with the single agent EPI(59.4% vs 40.2%, p<0.01). Toxicity was moderate and except for mya lgia, no adjunctive toxicity was observed in the EPI-LND arm.