Lonidamine has been demonstrated to potentiate the cytotoxic activity of se
veral antineoplastic drugs, for example anthracyclines. Moreover, epirubici
n is considered one of the most active drugs in advanced breast cancer, alt
hough optimal dose and schedule remains to be defined.
In the present study we have treated 51 patients with advanced breast cance
r with a combination of lonidamine (450 mg/day orally from day 1 throughout
treatment) and epirubicin (25 mg/m(2) IV) administered according to a week
ly schedule for 24 weeks. Objective responses were observed in 29 out of 51
patients (57; CR 16%, PR 41%). Liver metastases responded in eight out of
12 evaluable patients (67%). Average response duration was 12.4 months and
median overall survival was 23 months (range 1-90+). Toxicity was negligibl
e.
The combination of weekly epirubicin and lonidamine is feasible and active
in advanced breast cancer patients.