title: High doses of 5-fluorouracil and epirubicin with or without cisplatin in advanced gastric cancer: a randomized study.
abstract: BACKGROUND
  A prospective randomized clinical study was performed in patients with locally advanced or metastatic gastric cancer. The purpose of the study was to determine the activity of high doses of 5-fluorouracil and epirubicin (FE) vs. the same combination + cisplatin (FEP), and particularly the value of cisplatin in the combination.
  
  
  METHODS
  A total of 122 patients was included in the study; 110 of them were assessable. In the FE arm, the treatment involved 1000 mg/m2 in a 6-hr infusion of 5-fluorouracil on days 1, 2, 3, 4 and 5 and 120 mg/m2 of epirubicin i.v. on day 1. In the FEP arm, the same combination of cytostatics + cisplatin (30 mg/m2) was administered on days 2 and 4. The cycles were repeated after 4 weeks. Altogether, 468 cycles of chemotherapy were given (FE, 240; FEP, 228).
  
  
  RESULTS
  In the FE arm, 56 patients were assessable, with 2 complete and 14 partial remissions (28.6%); in the FEP arm, 4 complete and 19 partial remissions (42.6%) were observed in 54 assessable patients. Median survival in the FE group was 7.1 months and in the FEP group 9.6 months. The survival difference was statistically significant (Cox's test, P<0.05). The most frequent side effects included grade 2 and 3 alopecia (FE, 93%; FEP, 94%) and grade 2 and 3 vomiting (FE, 20%; FEP, 35%). Grade 3 and 4 leukopenia was observed in 9% of patients in the FE group and in 13% of patients in the FEP group, with 6 cases of febrile neutropenia (FE, 4%; FEP, 7%). Stenocardia was registered in 1 patient in the FE group and in 2 patients in the FEP group. No treatment-related death was registered.
  
  
  CONCLUSIONS
  The addition of cisplatin to high doses of 5-fluorouracil and epirubicin resulted in a statistically significant better survival of treated patients.
authors.affiliation: University Hospital for Tumors, Zagreb, Croatia.
authors.forename: A
authors.initials: A
authors.lastname: Roth
authors.forename: K
authors.initials: K
authors.lastname: Kolaric
authors.forename: D
authors.initials: D
authors.lastname: Zupanc
authors.forename: V
authors.initials: V
authors.lastname: Oresic
authors.forename: A
authors.initials: A
authors.lastname: Roth
authors.forename: Z
authors.initials: Z
authors.lastname: Ebling
mesh_terms: D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D015251:Epirubicin; D002945:Cisplatin; D005472:Fluorouracil