title: 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).
abstract: BACKGROUND
  Metastatic disease is a common problem in gastric cancer and the development of better chemotherapeutic regimens is a clear priority in gastrointestinal oncology.
  
  
  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.
authors.affiliation: Dept. of Hematology and Medical Oncology, Hospital Clínico Universitario, Facultad de Medicina, Valencia, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Cervantes
authors.forename: A
authors.initials: A
authors.lastname: Villar-Grimalt
authors.forename: A
authors.initials: A
authors.lastname: Abad
authors.forename: A
authors.initials: A
authors.lastname: Antón-Torres
authors.forename: J
authors.initials: J
authors.lastname: Belón
authors.forename: J
authors.initials: J
authors.lastname: Dorta
authors.forename: A
authors.initials: A
authors.lastname: Tres
authors.forename: C
authors.initials: C
authors.lastname: Camps
authors.forename: E
authors.initials: E
authors.lastname: Fonseca
authors.forename: B
authors.initials: B
authors.lastname: Massutí
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000188:drug therapy*
chemical_list: D015251:Epirubicin; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil