Phase II Study of Gemcitabine in Combination With Regional Arterial Infusion of Nafamostat Mesilate for Advanced Pancreatic Cancer
Phase II Study of Gemcitabine in Combination With Regional Arterial Infusion of Nafamostat Mesilate for Advanced Pancreatic Cancer
复制标题
DOI：
10.1097/coc.0b013e31823a53b2
复制
发表时间：
2013-02-01
影响因子：
2.6
通讯作者：
Yanaga, Katsuhiko
中科院分区：
文献类型：
--
作者：
Uwagawa, Tadashi;Misawa, Takeyuki;Yanaga, Katsuhiko
目的：评估合成丝氨酸蛋白酶抑制剂甲磺酸萘莫司他联合吉西他滨区域动脉灌注治疗不可切除的局部晚期或转移性胰腺癌患者的疗效。材料和方法：单臂，单中心，机构审查委员会批准的II期试验进行。38例连续患者中的35例被纳入研究。患者在第1、8和15天接受甲磺酸萘莫司他（4.8 mg/kg连续区域动脉输注）和吉西他滨（1000 mg/m2静脉注射）。每隔28天重复该处理。主要终点是评估总生存率和1年生存率。次要终点是评估治疗反应和临床获益反应。结果：全组中位生存时间为10.0个月，1年生存率为40.0%。有效率为17.1%，疾病控制率为88.6%。在需要阿片类药物治疗癌症相关疼痛的患者中，只有25%的患者可以减少阿片类药物的摄入量，37.1%的患者显示出健康的体重增加。转移性胰腺癌患者中位生存期为9.0个月，1年生存率为32.0%。建议的方案提供了一个经济上的优势，最近的治疗方案，已显示出显着改善中位生存率超过标准化疗与gemcitabine.Conclusions：不可切除的胰腺癌，特别是转移性胰腺癌的替代方案，提出了基于可接受的生存时间，临床效益和成本优势。
Purpose: To evaluate the efficacy of regional arterial infusion of the synthetic serine protease inhibitor nafamostat mesilate combined with gemcitabine for the treatment of patients with unresectable locally advanced or metastatic pancreatic cancer.Materials and Methods: A single-arm, single center, institutional review board-approved phase II trial was conducted. Thirty-five of 38 consecutive patients were included in the study. Patients received nafamostat mesilate (4.8 mg/kg continuous regional arterial infusion) with gemcitabine (1000 mg/m(2) intravenously) on days 1, 8, and 15. This treatment was repeated at 28-day intervals. The primary endpoints were to evaluate overall survival and 1-year survival rate. The secondary endpoints were to assess therapeutic response and clinical benefit response. Overall survival times were estimated by the Kaplan-Meier survival analysis.Results: The median survival time was 10.0 months, and the 1-year survival rate was 40.0%. The response rate and disease control rate were 17.1% and 88.6%, respectively. A fraction of 25% of the patients who required opioids for cancer-related pain could reduce their opioid intake, and 37.1% of the patients showed healthy weight gain. Among the patients with metastatic pancreatic cancer, the median survival time was 9.0 months, and the 1-year survival rate was 32.0%. The proposed regimen offers an economic advantage compared with recent therapy regimens that have shown significant improvements in median survival over standard chemotherapy with gemcitabine.Conclusions: An alternative regimen for unresectable pancreatic cancer, especially for metastatic pancreatic cancer, is proposed based on acceptable survival time, clinical benefit, and cost advantage.