Combination chemotherapy with granulocyte-macrophage-colony stimulating factor in patients with locoregional and metastatic gastric adenocarcinoma

BACKGROUND. A combination of etoposide, 5-fluorouracil, and folinic acid (E LF) remains popular for the treatment of patients with gastric carcinoma an d has been reported to result in a response rate of up to 40% with good pat ient tolerance. The authors elected to add granulocyte-macrophage-colony st imulating factor (GM-CSF) to ELF to determine whether the response rate cou ld be increased in patients with untreated advanced gastric carcinoma. METHODS. Previously untreated patients with measurable metastatic tumor wer e studied. Outpatient therapy was comprised of etoposide, 120 mg/m(2) intra venously (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 ev ery 21 days. GM-CSF (at a dose of 250 mu g/m(2)/day for 14 days from Day 4) was added after the first course of ELF if patients developed Grade 4 neut ropenia 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 respons e, 6.5 months). The median duration of survival was 7.8 months. Grade 4 neu tropenia occurred in 16 patients who then received GM-CSF. A similar rate o f 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 hig her nadir absolute granulocyte count (1300 cells/mu L) occurred in courses with GM-CSF compared with courses without GM-CSF (300 cells/mu L). CONCLUSIONS. The ELF regimen resulted in a much lower response rate than re ported in the literature. The attempt to improve the efficacy of this regim en by the addition of GM-CSF did not prove successful. The authors believe this regimen cannot be recommended for the treatment of patients with advan ced gastric carcinoma outside of a protocol setting. Cancer 1999;85:2336-9. (C) 1999 American Cancer Society.