5-FLUOROURACIL, FOLINIC ACID, EPIDOXORUBICIN AND CISPLATIN (FLEP) COMBINATION CHEMOTHERAPY IN ADVANCED MEASURABLE GASTRIC-CANCER - A PHASE-II TRIAL OF THE SPANISH COOPERATIVE GROUP FOR GASTROINTESTINAL TUMOR-THERAPY (TTD)

Background: Metastatic disease is a common problem in gastric cancer and the development of better chemotherapeutic regimens is a clear priority in-gastrointestinal oncology. Patients and methods: Ninety consecutive, previously untreated patients with unresectable or measurable metastatic gastric cancer were included in a multicenter phase II trial with a combination of folinic acid (200 mg/m2) and 5-fluorouracil (400 mg/m2) days 1-3, with epidoxorubicin (60 mg/m2) and cisplatin (100 mg/m2) on day 2. Results: A total of 376 courses of FLEP were given, with a median of four courses per patient. Objective responses were observed in 32 (35%) patients (CI at 95%: 25.7%-46.3%). Eight (9%) patients experienced clinical complete remissions. Median time to progression was 25 weeks for the entire group of patients and 38 weeks for responders. Myelosuppression was the primary toxicity. WHO grade 3 leukopenia appeared in 26 patients (29%). Ten presented episodes of febrile neutropenia requiring hospitalization, but no toxic deaths were observed. Grades 3 and 4 thrombocytopenia were seen in 8 and 1 patients, respectively. Median survival time was 8 months for all treated patients and 11 months for responders. Conclusions: The FLEP regimen is an active combination in advanced gastric cancer with moderate toxicity that warrants further testing in a phase III trial.