Cantore M, Pederzoli P, Cornalba G, Fiorentini G, Guadagni S, Miserocchi L, Frassoldati A, Ceravolo C, Smerieri F, Muchmore J H
Department of Oncology C Poma Hospital, Manatova, Italy.
Ann Oncol. 2000 May;11(5):569-73. doi: 10.1023/a:1008335331516.
A phase II trial of a new intra-arterial chemotherapy regimen for unresectable pancreatic cancer (UPC).
Ninety-six patients with UPC were treated with intra-arterial chemotherapy at three-weekly intervals. The schedule used was FLEC: 5-fluorouracil 1000 mg/m2, folinic acid 100 mg/m2, carboplatin 300 mg/m2; epirubicin 60 mg/m2.
The overall response rates by CT-scan evaluation were: 15% partial response (PR), 44% stable disease (SD), 17% progressive disease (PD). The overall median survival was 9.9 months, and 10.6 and 6.8 for UICC stage III and IV, respectively. Pain reduction occurred in 42% of patients. A weight gain > 7% from baseline occurred in 8% of patients. A total of 341 courses of FLEC were administered. Grade 3-4 hematological toxicity was seen in 25% of patients; ematemesis in 4%; grade 3 gastrointestinal toxicity in 3%; and grade 3 alopecia in 16%. One sudden death, a pre-infarction angina, and a transitory ischemic attack were observed. The only complication related to the angiographic procedure was an intimal dissection of the iliac artery.
The intra-arterial FLEC regimen was well tolerated and active. It requires only one day of hospitalization. Efficacy could only be assessed in a randomized study against a gemcitabine containing regimen.
一项针对不可切除胰腺癌(UPC)的新型动脉内化疗方案的II期试验。
96例UPC患者接受每三周一次的动脉内化疗。使用的方案为FLEC:氟尿嘧啶1000mg/m²、亚叶酸100mg/m²、卡铂300mg/m²;表柔比星60mg/m²。
通过CT扫描评估的总体缓解率为:15%部分缓解(PR),44%疾病稳定(SD),17%疾病进展(PD)。总体中位生存期为9.9个月,UICC III期和IV期分别为10.6个月和6.8个月。42%的患者疼痛减轻。8%的患者体重较基线增加>7%。共给予341个疗程的FLEC。25%的患者出现3-4级血液学毒性;4%的患者出现呕吐;3%的患者出现3级胃肠道毒性;16%的患者出现3级脱发。观察到1例猝死、1例梗死前心绞痛和1例短暂性脑缺血发作。与血管造影操作相关的唯一并发症是髂动脉内膜剥离。
动脉内FLEC方案耐受性良好且有效。仅需住院一天。疗效只能在与含吉西他滨方案的随机研究中进行评估。