title: Sequential chemotherapy with cisplatin, leucovorin, and 5-fluorouracil followed by docetaxel in previously untreated patients with metastatic gastric cancer: a phase II study.
abstract: BACKGROUND
  The combination of docetaxel, cisplatin, and 5-fluorouracil (5-FU) has demonstrated a survival advantage over cisplatin and 5-FU, but with substantial hematological toxicity. We aimed to evaluate the efficacy and toxicity of a sequential regimen with cisplatin, leucovorin, and 5-FU (PLF) followed by docetaxel in metastatic gastric cancer patients.
  
  
  METHODS
  Treatment consisted of 4 cycles of biweekly PLF (cisplatin 50 mg/m(2) as a 30-min infusion on day 1, leucovorin 200 mg/m(2) in a 2-h infusion, and 5-FU 2,800 mg/m(2) in a 48-h continuous infusion starting on day 1) followed, in cases of response or stable disease, by 3 cycles of docetaxel (75 mg/m(2), every 3 weeks).
  
  
  RESULTS
  Thirty-four patients were enrolled, with an average age of 64 years (range 34-69). The main cumulative grade 3-4 toxicities were: neutropenia (38.2%), febrile neutropenia (11.8%), and fatigue (14.7%). After the planned 7 cycles of treatment, the overall response rate was 38.2% (95% confidence interval [CI] 21.9-54.6), with 3 complete and 10 partial responses. Median progression-free survival and overall survival were 4.8 and 10.6 months, respectively.
  
  
  CONCLUSIONS
  For patients with metastatic gastric cancer, the sequential administration of cisplatin, leucovorin, 5-FU, and docetaxel may be an effective palliative option and offers a far more favorable toxicity profile than the simultaneous use of docetaxel, cisplatin, and 5-FU.
authors.affiliation: U.O.C. Oncologia, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio San Salvatore, Via Lombroso, 61122 Pesaro, Italy. catalano_v@yahoo.it
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Catalano
authors.forename: Bruno
authors.initials: B
authors.lastname: Vincenzi
authors.forename: Paolo
authors.initials: P
authors.lastname: Giordani
authors.forename: Francesco
authors.initials: F
authors.lastname: Graziano
authors.forename: Daniele
authors.initials: D
authors.lastname: Santini
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Baldelli
authors.forename: Paolo
authors.initials: P
authors.lastname: Alessandroni
authors.forename: Gaia
authors.initials: G
authors.lastname: Schiavon
authors.forename: David
authors.initials: D
authors.lastname: Rossi
authors.forename: Virginia
authors.initials: V
authors.lastname: Casadei
authors.forename: Silvia
authors.initials: S
authors.lastname: D'Emidio
authors.forename: Stefano
authors.initials: S
authors.lastname: Luzi Fedeli
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tonini
authors.forename: Giammaria
authors.initials: G
authors.lastname: Fiorentini
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; 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* / Q000401:mortality* / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil