纳米白蛋白结合型紫杉醇联合吉西他滨作为可切除边缘胰腺癌新辅助治疗的I期研究
Phase I Study of Nab-Paclitaxel plus Gemcitabine as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer.
作者信息
Okada Ken-Ichi, Hirono Seiko, Kawai Manabu, Miyazawa Motoki, Shimizu Atsushi, Kitahata Yuji, Ueno Masaki, Hayami Shinya, Yamaue Hiroki
机构信息
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan
出版信息
Anticancer Res. 2017 Feb;37(2):853-858. doi: 10.21873/anticanres.11389.
BACKGROUND/AIM: The aim of this study was to investigate the safety and feasibility of neoadjuvant nab-paclitaxel plus gemcitabine therapy for patients with borderline resectable pancreatic carcinoma (BRPC).
PATIENTS AND METHODS
The study was a prospective single-center phase I trial for patients with BRPC. The primary endpoint was the toxicity, and secondary endpoints were the resection rate, the R0 resection rate and quality of life (QOL) regarding the peripheral sensory neuropathy (PSN). This trial was registered on the UMIN Clinical Trials Registry (UMIN000018382) and on ClinicalTrials.gov (NCT02506803).
RESULTS
The overall rate of any grade and grade 3-4 events (CTCAE ver. 4.0 criteria) were 100% and 90%. The majority of these adverse events represented expected neutropenia. The resection and R0 resection rates were 80% and 70%, respectively.
CONCLUSION
We found that neoadjuvant nab-paclitaxel plus gemcitabine therapy was safe and feasible without stringent selection of patients with BRPC.
背景/目的：本研究旨在探讨新辅助白蛋白结合型紫杉醇联合吉西他滨治疗临界可切除胰腺癌（BRPC）患者的安全性和可行性。
患者与方法
本研究是一项针对BRPC患者的前瞻性单中心I期试验。主要终点为毒性，次要终点为切除率、R0切除率以及关于周围感觉神经病变（PSN）的生活质量（QOL）。本试验已在日本大学医学情报网络（UMIN）临床试验注册中心（UMIN000018382）和美国国立医学图书馆（ClinicalTrials.gov，编号NCT02506803）注册。
结果
任何级别和3 - 4级事件（依据美国国立癌症研究所不良事件通用术语标准第4.0版）的总发生率分别为100%和90%。这些不良事件大多为预期的中性粒细胞减少。切除率和R0切除率分别为80%和70%。
结论
我们发现新辅助白蛋白结合型紫杉醇联合吉西他滨治疗BRPC患者无需严格筛选，是安全可行的。
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