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.


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.
Cervantes
A
A
Dept. of Hematology and Medical Oncology, Hospital Clínico Universitario, Facultad de Medicina, Valencia, Spain.
Villar-Grimalt
A
A
Abad
A
A
Antón-Torres
A
A
Belón
J
J
Dorta
J
J
Tres
A
A
Camps
C
C
Fonseca
E
E
Massutí
B
B
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*
D015251:Epirubicin; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil