Phase II study of the etoposide, leucovorin and fluorouracil combination for patients with advanced gastric cancer unsuitable for aggressive chemotherapy.

Many patients with advanced gastric cancer cannot be treated with intensive chemotherapy. In an attempt to provide a feasible regimen for such patients, the combination of etoposide, leucovorin and fluorouracil (ELF) has been developed with promising results. The present study involved 42 patients with advanced gastric cancer who where unsuitable for cisplatin- or anthracycline-containing regimens because of their age (24 patients over 65 years), poor performance status (12) or the presence of concomitant illness (6). The treatment consisted of etoposide 120 mg/m2 i.v., 1-leucovorin 150 mg/m2 i.v. and fluorouracil 500 mg/m2 i.v. for 3 consecutive days every 3 weeks. Among the 41 evaluable patients, there was a 32% objective response rate (95% confidence interval 19-48%), with 7% of complete remissions. The median response duration was 4 months, the median time to progression in all patients was 5 months and the median overall survival was 10 months. No drug-related deaths or WHO grade 4 side effects were observed. On the basis of these results, we concluded that the ELF regimen is feasible and that its activity warrants randomized studies comparing the ELF combination with fluorouracil plus folinic acid.