Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial

作者：Eva Versteijne, Mustafa Suker, Karin Groothuis, Janine M. Akkermans-Vogelaar, Marc G. Besselink, Bert A. Bonsing, Jeroen Buijsen, Olivier R. Busch, Geert‐Jan Creemers, Ronald M. van Dam, Ferry A.L.M. Eskens, Sebastiaan Festen, Jan Willem B. de Groot, Bas Groot Koerkamp, Ignace H. J. T. de Hingh, Marjolein Y.V. Homs, Jeanin Elise van Hooft, Emile D. Kerver, Saskia A. C. Luelmo, Karen J. Neelis, Joost J.M.E. Nuyttens, Gabriel Paardekooper, Gijs A. Patijn, Maurice J.C. van der Sangen, Judith de Vos‐Geelen, Johanna W. Wilmink, Aeilko Having Zwinderman, Cornelis J.A. Punt, Casper H.J. van Eijck, Geertjan van Tienhoven, for the Dutch Pancreatic Cancer Group · 发表于：Journal of Clinical Oncology · 年份：2020 · DOI：10.1200/jco.19.02274 · 被引用次数：1101 · 研究领域：Pancreatic and Hepatic Oncology Research、Renal cell carcinoma treatment、Pancreatitis Pathology and Treatment

PURPOSE Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven. PATIENTS AND METHODS In this randomized phase III trial in 16 centers, patients with resectable or borderline resectable pancreatic cancer were randomly assigned to receive preoperative chemoradiotherapy, which consisted of 3 courses of gemcitabine, the second combined with 15 × 2.4 Gy radiotherapy, followed by surgery and 4 courses of adjuvant gemcitabine or to immediate surgery and 6 courses of adjuvant gemcitabine. The primary end point was overall survival by intention to treat. RESULTS Between April 2013 and July 2017, 246 eligible patients were randomly assigned; 119 were assigned to preoperative chemoradiotherapy and 127 to immediate surgery. Median overall survival by intention to treat was 16.0 months with preoperative chemoradiotherapy and 14.3 months with immediate surgery (hazard ratio, 0.78; 95% CI, 0.58 to 1.05; P = .096). The resection rate was 61% and 72% ( P = .058). The R0 resection rate was 71% (51 of 72) in patients who received preoperative chemoradiotherapy and 40% (37 of 92) in patients assigned to immediate surgery ( P < .001). Preoperative chemoradiotherapy was associated with significantly better disease-free survival and locoregional failure-free interval as well as with significantly lower rates of pathologic lymph nodes, perineural invasion, and venous invasion. Survival analy...