新辅助mFOLFIRINOX联合/不联合大分割放疗对临界可切除胰腺癌患者Ⅱ期随机对照临床研究:A021501研究解读

Phase Ⅱ Randomized Clinical Trial of Neoadjuvant m FOLFIRINOX With/Without Hypofractionated Radiotherapy for Borderline Resectable Pancreatic Cancer:Interpretation of A021501 Study

A021501是一项前瞻性、多中心、随机的Ⅱ期临床试验,旨在评估mFOLFIRINOX联合/不联合大分割放疗的新辅助治疗对临界可切除胰腺癌(BRPC)患者的疗效。该研究共纳入了126例患者,其中A组(mFOLFIRINOX组)70例,B组(mFOLFIRINOX-RT组)56例。研究的主要终点是18个月的总生存率,次要研究终点包括无事件生存期(EFS)和不良反应发生率。研究结果显示,A组18个月生存率为66.1%,高于预先设定的历史对照数据(50%),中位生存时间为29.8个月,EFS为15.0个月;而B组在期中分析后关闭,不满足得出疗效结论的统计学要求,Kaplan-Meier估计的18个月生存率为47.3%,中位生存时间为17.1个月,EFS为10.2个月。此研究结果提示,mFOLFIRINOX方案的新辅助化疗与BRPC患者良好的生存时间相关,但mFOLFIRINOX联合大分割放疗的作用仍有待进一步探究。

A021501 study is a preopective, multicenter, randomized phase Ⅱ clinical trial for evaluating the efficacy of neoadjuvant treatment with mFOLFIRINOX with/without hypofractionated radiotherapy in patients with borderline resectable pancreatic cancer(BRPC). The study enrolled 126 patients, of whom 70 in arm A(mFOLFIRINOX group) and 56 in arm B(mFOLFIRINOX-RT group). The primary endpoint was the 18-month overall survival(OS) rate, and secondary endpoints included event-free survival(EFS) and rate of adverse events. The results demonstrated that the 18-month OS rate in arm A was 66.1%, which was over the historical control rate of 50%, with a median OS of 29.8 months and EFS of 15 months. In contrast, the 18-month OS in arm B was 47.3%(closed after mid-term analysis for failing to meet the statistical requirements of drawing efficacy conclusions), with a estimated median OS of 17.1 months and EFS of 10.2months. It suggested that neoadjuvant mFOLFIRINOX was associated with favorable OS in patients with BRPC,but the role of mFOLFIRINOX in combination with hypofractionated radiotherapy remained undefined.