title: [Combination of 5-FU, high dose methotrexate, epirubicin and cisplatin (FEMTX-P protocol) in non surgical or locally recurrent metastatic gastric cancers].
abstract: In this phase II study, fifty patients with unresectable locally advanced and/or metastatic gastric carcinoma were treated with methotrexate 1.5 g/m2 iv and 5-fluorouracil 1.5 g/m2 iv on day 1; leucovorin rescue 15 mg/m2 orally every 6 h for 8 doses on day 2 and 3; epirubicin 60 mg/m2 iv and cisplatin 50 mg/m2 iv on day 15, q 4 weeks. The median age of the patients was 59 years and their median performance status 1. In forty-eight patients evaluable for response, five (10.4%) of the patients achieved a complete response and seventeen (35.6%) obtained a partial response (total response rate 46%; 95% confidence interval: 32%-60%). The median duration of response was 8+ months (range: 5-25 months). The median duration of survival of all patients was 10 months (range: 1-25+ months). Toxicities > grade 2 included vomiting grade 3 (31%), leucopenia grade 4 (18%) and thrombocytopenia grade 4 (4%). Treatment postponement or dose reduction for hematologic toxicity was necessary in 54% of patients. Median survival was 10 months. In conclusion, the FEMTX-P regimen is an active treatment in advanced gastric carcinoma with acceptable toxicity.
authors.affiliation: Département d'oncologie médicale, Centre Alexis-Vautrin, Vandoeuvre-lès-Nancy, France.
authors.forename: T
authors.initials: T
authors.lastname: Conroy
authors.forename: J
authors.initials: J
authors.lastname: Wils
authors.forename: B
authors.initials: B
authors.lastname: Paillot
authors.forename: D J
authors.initials: DJ
authors.lastname: Wagener
authors.forename: J T
authors.initials: JT
authors.lastname: Burghouts
authors.forename: M M
authors.initials: MM
authors.lastname: Fickers
authors.forename: A
authors.initials: A
authors.lastname: de Graeff
authors.forename: F M
authors.initials: FM
authors.lastname: Lalisang
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D013274:Stomach Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D015251:Epirubicin; D002945:Cisplatin; D005472:Fluorouracil; D008727:Methotrexate
vernacular_title: Association de 5-FU, méthotrexate à haute dose, épirubicine et cisplatine (FEMTX-P) dans les cancers gastriques métastatiques, inopérables ou en récidive locale.