BACKGROUND.
A combination of etoposide, 5-fluorouracil, and folinic acid (ELF) remains popular for the treatment of patients with gastric carcinoma and has been reported to result in a response rate of up to 40% with good patient tolerance. The authors elected to add granulocyte-macrophage-colony stimulating factor (GM-CSF) to ELF to determine whether the response rate could be increased in patients with untreated advanced gastric carcinoma.
METHODS.
Previously untreated patients with measurable metastatic tumor were studied. Outpatient therapy was comprised of etoposide, 120 mg/m 2 intravenously (i.v.), on Days 1-3; 5-fluorouracil, 500 mg/m 2 i.v., on Days 1-3; and folinic acid, 300 mg/m 2 i.v., on Days 1-3. Courses were repeated every 21 days. GM-CSF (at a dose of 250 g/m 2 /day for 14 days from Day 4) was added after the first course of ELF if patients developed Grade 4 neutropenia in a previous course.
RESULTS.
Thirty patients were enrolled and 29 were evaluable for response. Four patients (14%) achieved a partial response (median duration of response, 6.5 months). The median duration of survival was 7.8 months. Grade 4 neutropenia occurred in 16 patients who then received GM-CSF. A similar rate of neutropenic fever was observed in courses both with or without GM-CSF (15% in courses without GM-CSF and 16% in courses with GM-CSF); however, a higher nadir absolute granulocyte count (1300 cells/L) occurred in courses with GM-CSF compared with courses without GM-CSF (300 cells/L).
CONCLUSIONS.
The ELF regimen resulted in a much lower response rate than reported in the literature. The attempt to improve the efficacy of this regimen by the addition of GM-CSF did not prove successful. The authors believe this regimen cannot be recommended for the treatment of patients with advanced gastric carcinoma outside of a protocol setting.