Because the ELF regimen (etoposide, leucovorin and 5-FU) in advanced gastric cancer was recently advocated as an active, non-toxic schedule, and drug scheduling of etoposide proved to be important, we performed a pilot study using the original ELF regimen (A), followed by a phase II study of a modified ELF schedule (B) using oral etoposide.
Toxicity was mild in ELF (A): grade III leukopenia in 6/63 cycles. The ELF (B) caused slightly more myelosuppression: grade III leukopenia in 4/102 and grade IV in 2/102 cycles, resulting in septicaemia in two patients, and toxic death in one. No severe thrombocytopenia was seen. Hemorrhage (4 cases) was exclusively related to tumor progression. Response rates were 7% (0%-21%) and 28% (10%-46%) for ELF (A) and ELF (B), respectively. Subjective response, however, leading to a clinically significant decrease of dysphagia and pain, was seen in 53% and 56% of the patients.
Of the 40 patients entered in the consecutive trials 15 were treated according to the original ELF (A) and 25 according to the modified ELF regimen (B). The primary tumor was originally in the stomach in 22 and the oesophago-cardiac junction in 18. In 6 there was locally advanced and in 34 metastatic disease.
The modified ELF regimen (B) can be applied safely on an out-patient basis, and shows moderate activity in advanced gastric cancer which leads to an improved quality of life.
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