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, 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

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.

Figures

Figure 1
Figure 1
Estimated 21-month cumulative probability of survival and time to treatment progression in 61 AGC patients. Shown are TTP (□□□□□□) and OS (▪▪▪▪▪) in the 61 AGC patients treated with the FOLFOX-4 regimen.
Figure 2
Figure 2
Estimated 21-month cumulative probability of survival in 61 AGC patients. Shown are OS in the 36 AGC patients treated with second-line chemotherapy (□□□□□□) and in the 25 patients treated with best supportive care (○○○○○) following disease progression. The figure also depicts OS in the 61 patients (▪▪▪▪▪).

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