Pancreatic and biliary tract carcinomas are very chemoresistant. After a first-line treatment with a gemcitabine-based regimen, no second-line scheme is consolidated in clinical practice. The aim of this study was to evaluate the toxicity and the activity of the FOLFIRI regimen as first-line or second-line chemotherapy in patients with pancreatic or biliary tract tumors. Fifty-four patients (30 with pancreatic tumor, nine with gallbladder tumor, and 15 with biliary tract tumor) were treated with FOLFIRI (irinotecan 180 mg/m2, day 1; leucovorin 100 mg/m2 intravenously, days 1 and 2; 5-fluorouracil 400 mg/m2 intravenous bolus, days 1 and 2; and 600 mg/m2 in 22 h intravenously, continuous infusion days 1 and 2; every 14 days). Toxicity was recorded at each cycle according to the NCI-CTC V3.0 criteria, the response rate was verified each four cycles according to the RECIST criteria, and the progression-free survival rates as well as the overall survival rates were calculated according to the Kaplan–Meier method. Overall, the toxicity was mild. Grade 3–4 neutropenia occurred in 42.6% of patients. Grade 3–4 gastrointestinal toxicity was rare. FOLFIRI as a first-line treatment produced a response rate of 25%. In the second-line group, 9/21 patients (42.9%) obtained a stable disease as best response. In the entire population, the median progression-free survival rates were 3.1 months [95% confidence interval (CI), 1.9–4.4] and 3.5 months (95% CI, 2.6–4.4), respectively, in the first-line and the second-line cohort of patients. The median overall survival rates were 14.5 months (95% CI, 7.0–22.1) and 6.2 months (95% CI, 5.4–7.0), respectively, in the first-line and the second-line cohort of patients. FOLFIRI is feasible and well tolerated in patients with pancreatic or biliary tract tumors; it has a good activity in first line and mostly in patients with pancreatic cancer.
Department of Clinical Medicine and Surgery, Division of Medical Oncology, University ‘Federico II’ of Naples, Naples, Italy
Correspondence to Roberto Moretto, MD, Department of Clinical Medicine and Surgery, School of Medicine, Division of Medical Oncology, University ‘Federico II’ of Naples, Pansini Road, No 5, Naples 80131, Italy Tel: +39 817 463 660; fax: +39 812 203 147; e-mail: firstname.lastname@example.org
Received May 31, 2013
Accepted July 8, 2013