Department of Clinical Medicine and Surgery, Division of Medical Oncology, University 'Federico II' of Naples, Italy.
Anticancer Drugs. 2013 Oct;24(9):980-5. doi: 10.1097/CAD.0b013e328364e66b.
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.
胰腺和胆道肿瘤对化疗非常耐受。在一线使用吉西他滨为基础的方案治疗后，在临床实践中没有二线方案得到巩固。本研究旨在评估 FOLFIRI 方案作为胰腺或胆道肿瘤患者一线或二线化疗的毒性和活性。54 名患者（30 名胰腺肿瘤患者、9 名胆囊肿瘤患者和 15 名胆道肿瘤患者）接受 FOLFIRI（伊立替康 180mg/m²，第 1 天；亚叶酸钙 100mg/m² 静脉注射，第 1 天和第 2 天；5-氟尿嘧啶 400mg/m² 静脉推注，第 1 天和第 2 天；600mg/m² 在 22 小时内静脉输注，第 1 天和第 2 天持续输注；每 14 天）。根据 NCI-CTC V3.0 标准记录每个周期的毒性，根据 RECIST 标准每四个周期验证缓解率，根据 Kaplan-Meier 方法计算无进展生存期和总生存期。总体而言，毒性较轻。42.6%的患者发生 3-4 级中性粒细胞减少症。3-4 级胃肠道毒性罕见。FOLFIRI 作为一线治疗产生 25%的缓解率。在二线组中，21 名患者中有 9 名（42.9%）作为最佳反应获得稳定疾病。在整个人群中，一线和二线患者的中位无进展生存期分别为 3.1 个月[95%置信区间（CI），1.9-4.4]和 3.5 个月（95%CI，2.6-4.4）。一线和二线患者的中位总生存期分别为 14.5 个月[95%CI，7.0-22.1]和 6.2 个月[95%CI，5.4-7.0]。FOLFIRI 对胰腺或胆道肿瘤患者是可行且耐受良好的；它在一线有很好的活性，主要在胰腺癌患者中。
