Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial
Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial
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DOI：
10.1200/jco.19.02274
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发表时间：
2020-06-01
影响因子：
45.3
通讯作者：
van Tienhoven, Geertjan
中科院分区：
文献类型：
--
作者：
Versteijne, Eva;Suker, Mustafa;van Tienhoven, Geertjan
患者和方法在16个中心的随机III期试验中，患有可切除或边缘可切除胰腺癌的患者被随机分配接受术前放化疗，其包括3个疗程的吉西他滨，第二组联合15 × 2.4戈伊放疗，随后手术并辅助吉西他滨治疗4个疗程或立即手术并辅助吉西他滨治疗6个疗程。主要终点是意向治疗的总生存率。结果2013年4月至2017年7月，246例符合条件的患者被随机分配; 119例被分配到术前放化疗，127例立即手术。术前放化疗组的中位总生存期为16.0个月，即刻手术组为14.3个月（风险比，0.78; 95%CI，0.58 - 1.05; P = 0.096）。切除率分别为61%和72%（P = 0.058）。术前放化疗组R 0切除率为71%（51/72），即刻手术组R 0切除率为40%（37/92）（P <0.001）。术前放化疗与显著更好的无病生存率和局部无失败间隔以及显著更低的病理淋巴结、神经周围浸润和静脉浸润率相关。对接受肿瘤切除术并开始辅助化疗的患者进行的生存分析显示，术前放化疗改善了生存率（35.2 vs 19.8个月; P = 0.029）。发生严重不良事件的患者比例分别为52%和41%（P = 0.096）。结论术前放化疗对可切除或交界性可切除的胰腺癌没有显示出显着的总生存率的好处。虽然次要终点和预定义亚组分析的结果表明新辅助治疗方法的优势，但还需要更多的证据。
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 x 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 analysis of patients who underwent tumor resection and started adjuvant chemotherapy showed improved survival with preoperative chemoradiotherapy (35.2 v 19.8 months; P = .029). The proportion of patients who suffered serious adverse events was 52% versus 41% (P = .096).CONCLUSION Preoperative chemoradiotherapy for resectable or borderline resectable pancreatic cancer did not show a significant overall survival benefit. Although the outcomes of the secondary end points and predefined subgroup analyses suggest an advantage of the neoadjuvant approach, additional evidence is required.