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

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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.

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Authors and Affiliations

  1. Section of Medical Oncology, Human Pathology and Oncology Department, Siena University School of Medicine, Viale Bracci 11, 53100, Siena, Italy

    Pierpaolo Correale, Stefania Marsili & Guido Francini

  2. Division of Oncology, Palermo University, Palermo, Italy

    Fabio Fulfaro, Giuseppe Cicero, Eugenia Bajardi, Chiara Intrivici & Nicola Gebbia

  3. Surgical Science Division, Siena University, Siena, Italy

    Giuseppe Vuolo & Antonio Ferdinando Carli

  4. Oncology Operative Unit, Frattamaggiore Hospital, Naples, Italy

    Michele Caraglia & Salvatore Del Prete

  5. Oncology Operative Unit, Lamezia Terme Hospital, Lamezia Terme, Italy

    Ettore Greco

Authors
  1. Pierpaolo Correale
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  2. Fabio Fulfaro
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  3. Stefania Marsili
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  4. Giuseppe Cicero
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  5. Eugenia Bajardi
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  6. Chiara Intrivici
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  7. Giuseppe Vuolo
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  8. Antonio Ferdinando Carli
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  9. Michele Caraglia
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  11. Ettore Greco
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  12. Nicola Gebbia
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  13. Guido Francini
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Correspondence to Guido Francini.

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Correale, P., Fulfaro, F., Marsili, S. et al. Gemcitabine (GEM) plus oxaliplatin, folinic acid, and 5-fluorouracil (FOLFOX-4) in patients with advanced gastric cancer. Cancer Chemother Pharmacol 56, 563–568 (2005). https://doi.org/10.1007/s00280-005-1024-1

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  • DOI: https://doi.org/10.1007/s00280-005-1024-1

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