title: Gemcitabine (GEM) plus oxaliplatin, folinic acid, and 5-fluorouracil (FOLFOX-4) in patients with advanced gastric cancer.
abstract: OBJECTIVE
  oxaliplatin in combination with folinic acid (FA) and infusional 5-fluorouracil (5-FU) has shown significant anti-tumor activity in gastric cancer patients (FOLFOX). Previous studies have shown that gemcitabine (GEM), a new fluorinated anti-metabolite, enhances the individual anti-tumor activity of either 5-FU or oxaliplatin. We have therefore designed a multi-center phase II trial in order to test a novel GEM+FOLFOX-4 regimen in patients with metastatic gastric cancer.
  
  
  METHODS
  we enrolled 36 patients, 28 males and 8 females, with an average age of 64.4 years (range 37-78), who received bi-weekly treatment with GEM (1,000 mg/m2 on day 1), levo-FA (100 mg/m2 on days 1 and 2), a 5-FU (400 mg/m2) bolus injection followed by 22-h continuous infusion (800 mg/m2) on days 1 and 2, and oxaliplatin 85 mg/m2 in a 4-6 h intravenous (i.v.) infusion before the second FUFA administration on day 2.
  
  
  RESULTS
  the most frequent side effect was grade 1-2 hematological toxicity and late sensorial neurotoxicity. Two patients developed hypersensitivity to oxaliplatin while another developed an aseptic eosinophilic pneumonitis. Two patients refused to continue the treatment after two cycles of chemotherapy and were lost at the follow-up. Among the remaining 34 patients four achieved a complete response, 15 a partial response, 12 had a stable disease and three progressed.
  
  
  CONCLUSIONS
  these results may grant the rationale to evaluate this multi-drug combination in randomized phase III trials in advanced gastric cancer.
authors.affiliation: Section of Medical Oncology, Human Pathology and Oncology Department, Siena University School of Medicine, Viale Bracci 11, 53100, Siena, Italy. correale@unisi.it
authors.forename: Pierpaolo
authors.initials: P
authors.lastname: Correale
authors.forename: Fabio
authors.initials: F
authors.lastname: Fulfaro
authors.forename: Stefania
authors.initials: S
authors.lastname: Marsili
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cicero
authors.forename: Eugenia
authors.initials: E
authors.lastname: Bajardi
authors.forename: Chiara
authors.initials: C
authors.lastname: Intrivici
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Vuolo
authors.forename: Antonio Ferdinando
authors.initials: AF
authors.lastname: Carli
authors.forename: Michele
authors.initials: M
authors.lastname: Caraglia
authors.forename: Salvatore
authors.initials: S
authors.lastname: Del Prete
authors.forename: Ettore
authors.initials: E
authors.lastname: Greco
authors.forename: Nicola
authors.initials: N
authors.lastname: Gebbia
authors.forename: Guido
authors.initials: G
authors.lastname: Francini
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000473:pathology; D006402:Hematologic Diseases / Q000139:chemically induced / Q000473:pathology; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D020258:Neurotoxicity Syndromes / Q000209:etiology / Q000473:pathology; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D009944:Organoplatinum Compounds; D003841:Deoxycytidine; D002955:Leucovorin; D005472:Fluorouracil; D000093542:Gemcitabine