TREATMENT OF ADVANCED GASTRIC-CANCER WITH THE COMBINATION FLUOROURACIL, LEUCOVORIN, ETOPOSIDE, AND CISPLATIN - A PHASE-II STUDY OF THE ONCOPAZ COOPERATIVE GROUP

A phase II study was performed to assess the efficacy and toxicity of the combination of 5-fluorouracil (5-FU), leucovorin (LV), etoposide, and cisplatin (FLEP) in patients with advanced gastric carcinoma. A to tal of 46 consecutive, previously untreated patients with unresectable , measurable gastric carcinoma were treated with 300 mg/m(2) LV, 100 m g/m(2) etoposide, 500 mg/m(2) 5-FU, and 30 mg/m(2) cisplatin on days 1 -3 every 28 days. All courses were given on an outpatient basis. A tot al of 169 courses of treatment were given. In all, 18 of the 46 patien ts (39%) had an objective response [95% confidence interval (CI), 25%- 54%] and 2 (4%) patients experienced a clinical complete response. The median duration of response was 5 months. The main side effects were hematological and gastrointestinal. Grade 3-4 toxicity was encountered as follows: leukopenia, in 9.5% of the courses; anemia, in 3%; thromb ocytopenia, in 3%; nausea/vomiting, in 4%; and diarrhea, in 5%. Hospit alization due to fever and granulocytopenia was required in 5 patients , 3 of whom died of sepsis. In conclusion, FLEP shows moderate activit y in patients with advanced gastric carcinoma, albeit at the cost of a high degree of toxicity. For this reason we do not recommend its use.