Epirubicin, folinic acid, fluorouracil, and etoposide in the treatment of advanced gastric cancer: Phase II study of the southern italy oncology group (GOIM)

In the authors' previous experience, the addition of epidoxorubicin to the FA-FU regimen obtained a better response rate than that of FA-FU alone in patients with advanced gastric cancer. Furthermore, considering the good efficacy and mild toxicity observed with the addition of etoposide to the FA-FU combination in the German study, the authors conducted a trial to explore the efficacy and tolerability of the ELFE regimen (epirubicin, folinic acid, fluorouracil, and etoposide) in previously untreated advanced gastric cancer patients. Of the 55 patients entered, 51 were evaluable for efficacy. Four complete responses (8%) and 21 partial responses (41%) were observed, with an overall response rate of 49% (95% CI: 35-63%). The median duration of response and survival were 6 and 8 months, respectively. Responder patients showed a significantly better median survival duration than nonresponders (12 vs. 4 months, respectively; p < 0.0001). Toxicity was evaluated in all patients: only 1 patient refused to continue therapy despite low toxicity. As expected, the major toxicities observed were gastrointestinal disturbance, leukopenia, and loss of hair. In conclusion, the ELFE combination regimen appears to be effective and well tolerated for the treatment of advanced gastric cancer patients.