Neoadjuvant treatment for resectable pancreatic cancer: Time for phase Ⅲ testing?

作     者：Michele Reni 

作者机构：Medical Oncology UnitDepartment of OncologySan Raffaele Scientific Institute 

出 版 物：《World Journal of Gastroenterology》 (世界胃肠病学杂志（英文版）)

年 卷 期：2010年第16卷第39期

页      面：4883-4887页

核心收录：

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

主　　题：Pancreatic cancer Neoadjuvant therapy Phase Ⅲ trial Chemotherapy 

摘      要：This paper discusses the rationale for phaseⅢtesting of neoadjuvant therapy in patients affected by resectable pancreatic *** therapeutic management of patients affected by resectable pancreatic cancer is particularly troublesome due to the aggressiveness of the disease and to the limited efficacy and sometimes unfavourable risk-benefit ratio of the available therapeutic *** data on the role of adjuvant chemoradiation have been reported,while adjuvant single-agent chemotherapy significantly improved overall survival(OS)when compared to surgery alone. However,the OS figures for adjuvant chemotherapy remain *** effect,pancreatic cancer exhibits a prominent tendency to recur after a brief median time interval from surgery and extra-pancreatic dissemination represents the predominant pattern of disease *** treatment has a strong rationale in this disease but limited information on the efficacy of this approach is available from single arm trials with low levels of ***,in spite of two decades of investigation there is currently no evidence to support the routine use of pre-surgical therapy in clinical practice. To foster knowledge on the optimal management of this disease,and to produce evidence-based treatment guidelines,there is no alternative to well designed randomized *** chemotherapy is a candidate for testing because it is supported by a more robust rationale than *** chemotherapy regimens with elevated activity in advanced disease warrant *** would suggest the running of an exploratory phaseⅡrandomized trial before embarking on a large phase Ⅲ study.