LONIDAMINE AS A POTENTIATING AGENT OF THE FAC REGIMEN IN THE TREATMENT OF ADVANCED BREAST-CANCER - RESULTS OF A MULTICENTRIC RANDOMIZED CLINICAL-STUDY

A total of 265 patients with metastatic breast cancer were included in a multicentric randomized clinical study with the FAC with or without lonidamine (LND). Objective clinical responses (CR+PR) were observed in 46.7% of the FAC-treated patients (group A) and in 62.1% of the FAC +LND-treated patients (group B) (p=0.002). Time to progression was 6.3 versus 9.2 months (p=0.003) and median survival 17.9 versus 18.7 mont hs (N.S.) but in the postmenopausal subgroup patients the median survi val was 14.8 versus 18.9 months (p=0.018) for group A versus B, respec tively. Group B patients showed no significant increase of toxicity, e xcept for myalgia (WHO grade greater than or equal to 2 in 24.8% of th e LND-treated patients) and epigastralgia (WHO grade greater than or e qual to 2 in 15.0% of the LND-treated patients). These results demonst rate that LND can potentiate the FAC regimen and suggest the need for further investigations of LND combined with other polychemotherapy reg imens in breast cancer.