A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients

F. De Vita, M. Orditura, E. Matano, R. Bianco, C. Carlomagno, S. Infusino, V. Damiano, E. Simeone, M. R. Diadema, E. Lieto, P. Castellano, S. Pepe, S. De Placido, G. Galizia, N. Di Martino, F. Ciardiello, G. Catalano, A. R. Bianco

Research output: Contribution to journalArticle

Abstract

The aim of the study was to assess the toxicity and the clinical activity of biweekly oxaliplatin in combination with infusional 5-fluorouracil (5-FU) and folinic acid (FA) administered every 2 weeks (FOLFOX-4 regimen) in patients with advanced gastric cancer (AGC). A total of 61 previously untreated AGC patients were treated with oxaliplatin 85 mg m-2 on day 1, FA 200 mg m-2 as a 2 h infusion followed by bolus 5-FU 400 mg m-2 and a 22 h infusion of 5-FU 600 mg m-2, repeated for 2 consecutive days every 2 weeks. All patients were assessable for toxicity and response to treatment. Four (7%) complete responses and 19 partial responses were observed (overall response rate, 38%). Stable disease was observed in 22 (36%) patients, with progressive disease in the other six (10%) patients. Median time to progression (TTP) and median overall survival (OS) were 7.1 and 11.2 months, respectively. National Cancer Institute Common Toxicity Criteria grade 3 and 4 haematologic toxicities were neutropenia, anaemia and thrombocytopenia in 36, 10 and 5% of the patients, respectively. Grade 3 peripheral neuropathy was recorded in three (5%) patients. FOLFOX-4 is an active and well-tolerated chemotherapy. Response rate (RR), TTP and OS were comparable with those of other oxaliplatin-based regimens, suggesting a role for this combination in gastric cancer.

Original languageEnglish
Pages (from-to)1644-1649
Number of pages6
JournalBritish Journal of Cancer
Volume92
Issue number9
DOIs
Publication statusPublished - May 9 2005

Keywords

  • 5-fluorouracil
  • Advanced gastric cancer
  • Chemotherapy
  • Oxaliplatin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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    De Vita, F., Orditura, M., Matano, E., Bianco, R., Carlomagno, C., Infusino, S., Damiano, V., Simeone, E., Diadema, M. R., Lieto, E., Castellano, P., Pepe, S., De Placido, S., Galizia, G., Di Martino, N., Ciardiello, F., Catalano, G., & Bianco, A. R. (2005). A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients. British Journal of Cancer, 92(9), 1644-1649. https://doi.org/10.1038/sj.bjc.6602573