title: 5-fluorouracil administered as a 48-hour semiintermittent infusion in combination with leucovorin, cisplatin and epirubicin: phase II study in advanced gastric cancer patients.
abstract: The main objective of this study was to determine the feasibility and the antitumor activity of a chemotherapy regimen with a 48-hour infusion of 5-fluorouracil (5-FU), leucovorin (LV), cisplatin (CDDP), and epirubicin (EPIDX) administered every 3 weeks in patients with locally advanced or metastatic gastric cancer. Thirty-three patients received CDDP 60 mg/m2 over 30 minutes followed by 1-LV 250 mg/m2 over 2 hours followed by EPIDX 60 mg/m2 over 5 minutes (bolus) and followed by 5-FU 3,800 mg/m2 as a 48-hour semiintermittent continuous infusion, with 67% of total daily dose administered between 4 pm and midnight. Four patients had a locally advanced disease and 29 had metastatic disease. A total of 171 cycles were administered. Most relevant toxicities were stomatitis (grade III in 2% of cycles and 12% of patients) and neutropenia (grade III-IV in 8% of cycles and 28% of patients) with 3 (9%) patients experiencing 1 episode of febrile neutropenia. No toxic deaths occurred. Thirty-one patients were evaluable for response. In 3 patients (9.6%) a complete response and in 11 patients (35.4%) a partial response was observed, for an objective response rate of 45% (95% C.I. 27-64%). Median progression-free and overall survival were 5.9 and 9.8 months, respectively. In conclusion, this regimen is feasible in an outpatient setting with acceptable and manageable toxicities, and it is associated with promising antitumor activity, time to progression, and survival.
authors.affiliation: Division of Medical Oncology, Department of Oncology, Civil Hospital, Livorno, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Allegrini
authors.forename: Alfredo
authors.initials: A
authors.lastname: Falcone
authors.forename: Roberta
authors.initials: R
authors.lastname: Di Marsico
authors.forename: Monica
authors.initials: M
authors.lastname: Lencioni
authors.forename: Gianluca
authors.initials: G
authors.lastname: Masi
authors.forename: Costanza
authors.initials: C
authors.lastname: Galli
authors.forename: Samanta
authors.initials: S
authors.lastname: Cupini
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Pfanner
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Marcucci
authors.forename: Pier Franco
authors.initials: PF
authors.lastname: Conte
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / 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*; D016019:Survival Analysis
chemical_list: D015251:Epirubicin; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil