Neoadjuvant Chemoradiotherapy and Surgery Versus Surgery Alone in Resectable Pancreatic Cancer: A Single-Center Prospective, Randomized, Controlled Trial Which Failed to Achieve Accrual Targets
Neoadjuvant Chemoradiotherapy and Surgery Versus Surgery Alone in Resectable Pancreatic Cancer: A Single-Center Prospective, Randomized, Controlled Trial Which Failed to Achieve Accrual Targets
复制标题
DOI：
10.1007/s11605-015-2890-4
复制
发表时间：
2015-10-01
影响因子：
3.2
通讯作者：
Minni, Francesco
中科院分区：
文献类型：
--
作者：
Casadei, Riccardo;Di Marco, Mariacristina;Minni, Francesco
本研究的目的是评价新辅助放化疗在可切除胰腺癌中的有效性。对可切除胰腺癌患者进行单中心随机对照试验，包括A组(单纯手术)和B组(新辅助放化疗加手术)。主要终点是R0切除；次要终点是毒性；完成新辅助治疗的患者数量；放化疗后的放射学和病理反应；以及pTNM分期、术后发病率、死亡率、总体和无病生存。研究提前结束，38例患者被随机分为A组20例和B组18例。两组R0切除率差异无统计学意义(意向处理，OR=1.91，P=0.489)。新辅助放化疗完成14例(77.8%)，放射学有效率为72.3%，病理有效率为90.9%。新辅助放化疗是可行、安全和有效的，但由于招募病人困难，新辅助放化疗效果不明显。未来需要更多的多中心RCT。
The objective of the study is to evaluate the usefulness of neoadjuvant chemoradiotherapy in resectable pancreatic cancer.A single-center RCT of patients affected by resectable pancreatic adenocarcinoma which included arm A (surgery alone) and arm B (neoadjuvant chemoradiation and surgery). The primary endpoint was R0 resection; the secondary endpoints were toxicity; number of patients who completed the neoadjuvant therapy; radiological and pathological response after chemoradiation; and pTNM stage, postoperative morbidity, mortality, and overall and disease-free survival. A sample size of 32 patients was required for each group.The study was terminated early, and 38 patients were randomized: 20 in arm A and 18 in arm B. There was no significant difference regarding R0 resection rate in the two groups (intention-to-treat, OR = 1.91, P = 0.489). Neoadjuvant chemoradiotherapy was completed in 14 out of 18 cases (77.8 %) and the radiological and pathological response was efficacious in 72.3 and 90.9 % of cases, respectively.Neoadjuvant chemoradiation was feasible, safe, and efficacious, although non-significant results were obtained as a result of the underpowered data due to the difficulty in recruiting patients. Additional multicenter RCTs are needed in the future.