Phase II Study of Adjuvant Chemotherapy With Gemcitabine and Nafamostat Mesilate for Pancreatic Cancer
Phase II Study of Adjuvant Chemotherapy With Gemcitabine and Nafamostat Mesilate for Pancreatic Cancer
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DOI：
10.1097/mpa.0000000000001767
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发表时间：
2021-03-01
期刊：
影响因子：
2.9
通讯作者：
Yanaga, Katsuhiko
中科院分区：
文献类型：
--
作者：
Uwagawa, Tadashi;Sakamoto, Taro;Yanaga, Katsuhiko
目的探讨以吉西他滨（GEM）诱导的核因子κ B为靶点的联合化疗方案作为胰腺癌辅助治疗的有效性。方法2011年6月至2017年4月期间，计划在胰腺癌根治性手术（残留肿瘤分类R 0或R1）后接受6个周期的甲磺酸萘莫司他联合GEM区域动脉灌注辅助化疗的患者入选这项单中心、机构审查委员会批准的II期试验（UMIN 000006163）。Kaplan-Meier法用于估计无病生存期和总生存期。结果32例患者[男/女：18/14;年龄：中位数，65.5岁（范围：48-77岁）;病理分期（国际癌症控制联盟第八届）：IA/IB/IIA/IIB/III，分别为2/2/9/18/1]符合入选标准的患者，中位总生存期和无病生存期为36.4个月（95%置信区间，31.7-48.3）和16.4个月（95%置信区间，14.3-22.0）。在5例患者（15.6%）中观察到4级治疗相关血液学毒性（均为中性粒细胞减少症）。1例患者发生3级非血液学毒性（皮疹）。结论胰头癌根治术后局部动脉灌注甲磺酸萘莫司他和吉西他滨辅助化疗是安全的，可作为胰腺癌根治术后辅助化疗的一种选择。
Objectives The aim of this study was to clarify the effectiveness of combination chemotherapy targeting gemcitabine (GEM)-induced nuclear factor kappa B as adjuvant therapy for pancreatic cancer. Methods Patients who were planned after curative surgery (residual tumor classification R0 or R1) for pancreatic cancer to receive six cycles of adjuvant chemotherapy of regional arterial infusion of nafamostat mesilate with GEM between June 2011 and April 2017 were enrolled in this single-center, institutional review board-approved phase II trial (UMIN000006163). The Kaplan-Meier method was used to estimate disease-free survival and overall survival. Results In 32 patients [male/female: 18/14; age: median, 65.5 years (range, 48-77 years); pathological stage (Union for International Cancer Control 8th): IA/IB/IIA/IIB/III, 2/2/9/18/1, respectively] who met the eligibility criteria, the median overall survival and disease-free survival were 36.4 months (95% confidence interval, 31.7-48.3) and 16.4 months (95% confidence interval, 14.3-22.0), respectively. Grade 4 treatment-related hematological toxicities were seen in 5 patients (15.6%) (all neutropenia). One patient developed grade 3 nonhematological toxicities (rash). Conclusions Adjuvant chemotherapy with regional arterial infusion of nafamostat mesilate and GEM is safe and has potential as an option in adjuvant setting after curative surgery for pancreatic cancer.