Phase II study of weekly oxaliplatin plus infusional fluorouracil and folinic acid (FUFOX regimen) as first-line treatment in metastatic gastric cancer

F. Lordick, S. Lorenzen, J. Stollfuss, U. Vehling-Kaiser, F. Kullmann, M. Hentrich, R. Zumschlinge, H. Dietzfelbinger, J. Thoedtmann, M. Hennig, T. Seroneit, R. Bredenkamp, J. Duyster, C. Peschel

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87 Scopus citations

Abstract

Oxaliplatin plus fluorouracil/folinic acid (5-FU/FA) every 2 weeks has shown promising activity in advanced gastric cancer. This study assessed the efficacy and safety of weekly oxaliplatin plus 5-FU/FA (FUFOX regimen) in the metastatic setting. Patients with previously untreated metastatic gastric cancer received oxaliplatin (50 mg m-2) plus FA (500 mg m-2, 2-h infusion) followed by 5-FU (2000 mg m-2, 24-h infusion) given on days 1, 8, 15 and 22 of a 5-week cycle. The primary end point of this multicentre phase II study was the response rate according to RECIST criteria. A total of 48 patients were enrolled. Median age was 62 years and all patients had metastatic disease, with a median number of three involved organs. The most common treatment-related grade 3/4 adverse events were diarrhoea (17%), deep vein thrombosis (15%), neutropenia (8%), nausea (6%), febrile neutropenia (4%), fatigue (4%), anaemia (4%), tumour bleeding (4%), emesis (2%), cardiac ischaemia (2%) and pneumonia (2%). Grade 1/2 sensory neuropathy occurred in 67% of patients but there were no episodes of grade 3 neuropathy. Intent-to-treat analysis showed a response rate of 54% (95% CI, 39-69%), including two complete responses. At a median follow-up of 18.1 months (range 11.2-26.2 months), median survival is 11.4 months (95% CI, 8.0-14.9 months) and the median time to progression is 6.5 months (95% CI, 3.9-9.2 months). The weekly FUFOX regimen is well tolerated and shows notable activity as first-line treatment in metastatic gastric cancer.

Original languageEnglish
Pages (from-to)190-194
Number of pages5
JournalBritish Journal of Cancer
Volume93
Issue number2
DOIs
StatePublished - 25 Jul 2005

Keywords

  • First-line
  • Fluorouracil
  • Metastatic gastric cancer
  • Oxaliplatin

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