Clinical Study

British Journal of Cancer (2007) 96, 1043–1046. doi:10.1038/sj.bjc.6603644 www.bjcancer.com
Published online 13 March 2007

Oxaliplatin, 5-fluorouracil/leucovorin and epirubicin as first-line treatment in advanced gastric carcinoma: a phase II study

B Neri1, P Pantaleo1, E Giommoni1, R Grifoni1, C Paoletti1, V Rotella1, D Pantalone2, A Taddei2, A Mercatelli3 and P Tonelli3

  1. 1Department of Oncology, Centre of Experimental and Clinical Oncology, University of Florence, Florence, Italy
  2. 2Unit of General Surgery, Department of Critical Medicine, University of Florence, Florence, Italy
  3. 3Unit of General Surgery, 'Azienda Ospedaliero-Universitaria Careggi', Florence, Italy

Correspondence: Professor B Neri, Department of Oncology, Centre of Experimental and Clinical Oncology, University of Florence, Careggi, V.le Morgagni 85, I-50139 Florence, Italy. E-mail: bruno.neri@unifi.it

Received 15 May 2006; Revised 24 January 2007; Accepted 29 January 2007; Published online 13 March 2007.

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Abstract

The association between oxaliplatin and 5-fluorouracil (5-FU) has been extensively reported to improve prognosis of gastric cancer patients. The present study is aimed at evaluating response rate and the toxicity profile of the association with oxaliplatin, 5-FU/lecovorin and epirubicin in gastric cancer patients with locally advanced or metastatic disease. Thirty-six patients have been enrolled and 35 evaluated. The treatment schedule was oxaliplatin (100 mg m-2), 5-FU (400 mg m-2), leucovorin (40 mg m-2) and epirubicin (60 mg m-2) intravenously. administered every 3 weeks for 6 months, for a total of 185 therapy cycles . Response rate and toxicity were assessed according to the international WHO criteria. Every patient received a mean of 5.3 therapy cycles in a day-hospital setting. Sixteen of 35 patients (46%) showed an objective response, two complete response and 14 partial response. Median time to progression was 33 weeks with an overall median survival of 49 weeks. During the study, anaemia grade 3 and neutropenia grade 3 were observed in 9 and 11% of patients respectively. A grade 3 periferic sensorial neuropathy was observed in 6% of patients. No life threatening or cardiac toxicity was recorded. The regimen used showed anticancer activity against gastric carcinoma, a tolerable toxicity profile and excellent patient compliance.

Keywords:

chemotherapy, epirubicin, 5-fluorouracil, gastric cancer, leucovorin, oxaliplatin

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