Gemcitabine (GEM) plus oxaliplatin, folinic acid, and 5-fluorouracil (FOLFOX-4) in patients with advanced gastric cancer.

Abstract:

BACKGROUND AND AIMS: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

Correale P,Fulfaro F,Marsili S,Cicero G,Bajardi E,Intrivici C,Vuolo G,Carli AF,Caraglia M,Del Prete S,Greco E,Gebbia N,Francini G

doi

10.1007/s00280-005-1024-1

keywords:

subject

Has Abstract

pub_date

2005-12-01 00:00:00

pages

563-8

issue

6

eissn

0344-5704

issn

1432-0843

journal_volume

56

pub_type

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