J Clin Oncol:国内多中心III期研究表明局部进展期直肠癌术前短程放疗+化疗(TNT)是可行的治疗方案

2022-03-15 网络 网络

研究表明,对于局部进展期直肠癌患者,术前短程放疗+化疗(TNT)是可行的治疗方案。

为了探索在局部进展期直肠癌中,术前短程放疗+化疗是否非劣效于标准的长程同步放化疗。国内团队开展了一项多中心、随机对照临床研究STELLAR,相关研究成果发表在Journal of Clinical Oncology杂志上。

该研究纳入远端或三分之一,T3-4期和/或N+的直肠癌患者。患者随机分配(1:1)短期放疗(25 Gy,分为5次超过1周),随后4个周期化疗(完全新辅助治疗[TNT])或放化疗(50 Gy, 分为25次超过5周,同期使用卡培他滨[放化疗;CRT])。术前治疗6 - 8周后进行手术,术后TNT组进行2周期CAPOX方案化疗,而CRT组行6周期CAPOX化疗。主要研究终点是3年的无病生存率(DFS)。次要终点为OS,无远处转移生存期(MFS)和局部复发率(LRR)。

在2015年8月-2018年8月期间,共有599名患者被随机分配到TNT (n=302)或CRT (n=297)。TNT组所有患者均完成放疗(5gy 3 5),未减剂量;只有少数患者在CRT组经历剂量减少(1.4%)或放疗中断(2.4%)。CRT组分别有4例(1.4%)和20例(7.8%)患者减少了放疗和化疗剂量。

在接受手术的465名患者中,TNT组和CRT组中分别有91.5%和87.8%的患者接受了R0切除术(p=0.189)。此外,TNT组中71.1%的病例观察到ypN0,而CRT组为68.7% (p=0.578)。TNT组总pCR率和持续cCR率为21.8%,显著高于CRT组(12.3%,p=0.002)。

在中位随访35.0个月时,TNT组和CRT组的3年DFS率分别为64.5%和62.3%((HR=0.883; 单边95% CI, 未达到1.11; 非劣效P<0.001)。TNT组3年OS率为86.5% (95% CI, 82.1-90.8),而CRT组为75.1% (95% CI, 69.4-80.8)(HR= 0.67, 95% CI, 0.46-0.97;log-rank, P=0.033)。两组间MFS和LRR无显著差异。TNT组3年MFS为77.1% (95% CI, 71.7 - 82.6), CRT组为75.3% (95% CI, 70.0 - 80.7) (log-rank, p=0.475)。TNT组3年LRR为8.4% (95% CI, 4.6-12.2), CRT组为11.0% (95% CI, 6.5-15.5) (log-rank, P=0.461)。

亚组分析显示,无论临床病理预后因素如何,治疗对OS和PFS的影响相似。

在术前治疗期间,TNT组的急性III-V级毒性发生率为26.5%,而CRT组为12.6% (P<0.001)。

综上,研究表明,对于局部进展期直肠癌患者,术前短程放疗+化疗(TNT)是可行的治疗方案。

 

原始出处:

Jin J, Tang Y, Hu C, et al. Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR). J Clin Oncol. 2022 Mar 9:JCO2101667. doi: 10.1200/JCO.21.01667. Epub ahead of print. PMID: 35263150.

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    2022-04-14 minlingfeng
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    2022-11-10 juliusluan78
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    2022-03-17 chg122
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