A pilot phase II study of chemotherapy with oxaliplatin, folinic acid, 5-fluorouracil and irinotecan in metastatic gastric cancer

Aims and background. Previous phase II studies have reported that combinations of oxaliplatin, folinic acid and 5-fluorouracil or irinotecan, folinic acid and 5-fluorouracil are associated with good efficacy and an acceptable safety profile in metastatic gastric cancer. The aim of this study was to evaluate chemotherapy with oxaliplatin, folinic acid, 5-fluorouracil and irinotecan (COFFI regimen) in metastatic gastric cancer. Methods: Patients received oxallplatin (85 mg/m(2) d 1), irinotecan (140 mg/m(2) d 1), and L-folinic acid (200 mg/m(2) d 1) followed by 5-fluorouracil bolus (400 mg/m(2) d 1) and then 5-fluorouracil (2,400 mg/m(2) 48-h continuous infusion), every 14 days. Results: Seventeen patients with metastatic gastric cancer were enrolled. Eight patients were pretreated for advanced disease. Of the 9 chemo-naive patients, 8 were evaluated for response (1 patient was lost to follow-up): one complete response, 5 partial responses and 2 progressions of disease occurred, giving an overall response rate, at intention-to-treat analysis, of 67%. Of the 8 pretreated patients, 6 were evaluated for response (2 patients had nonmeasurable disease): one partial response, 2 disease stabilizations and 3 progressions of disease occurred, giving an overall response rate, at intention-to-treat analysis, of 12%. Median progression-free and overall survival in chemo-naive patients were 8.2 and 10.2 months, respectively, and in pretreated patients 2.7 and 3 months. Grade 3-4 neutropenia occurred in 55% of chemonaive patients. Thrombocytopenia, and anemia were observed in 18% and 29%, respectively. Grade 3 nausea/vomiting occurred in 12% and grade 3 diarrhea in 6%. Conclusions: The COFFI regimen is active and well tolerated, therefore phase III studies are warranted.