【评论】术前序贯短程放疗+FOLFOX化疗与术前长程放化疗治疗局部进展期直肠癌的疗效评价:一项多中心随机对照试验(SOLAR试验)  

Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer:a multicenter,randomized controlled

作　　者：王雨晨 李建男[1] Wang Yuchen;Li Jiannan

机构地区：[1]吉林大学第二医院结直肠及肛门外科,吉林长春130021

出　　处：《结直肠肛门外科》2024年第1期90-92,共3页Journal of Colorectal & Anal Surgery

摘　　要：背景术前放(化)疗是一种可显著降低盆腔复发率的治疗局部进展期直肠癌(locally advanced rectal cancer,LARC)的有效方法。由于早期应用强化化疗相比辅助化疗具有更多优势,人们对全程新辅助治疗(total neoadjuvant therapy,TNT)的应用效果进行评价,以明确它是否能够增强肿瘤反应或改善疗效。本研究的目的是探讨短程放疗(short-course radio⁃therapy,SCRT)+强化化疗相比传统的术前长程放化疗而言,是否能够改善患者的肿瘤学预后。方法本研究是一项包含364例LARC患者(cT3~4,cN+,或者存在壁外血管侵犯)的多中心随机Ⅱ期试验,将患者按照1∶1的比例随机分配至试验组或对照组。试验组的新辅助治疗方案是先进行SCRT(总剂量25 Gy,分5次进行,每天1次,每次5 Gy),再进行4个周期FOLFOX(奥沙利铂、5-氟尿嘧啶和亚叶酸)化疗。对照组患者接受传统的术前长程放疗(总剂量45~50.4 Gy,分25~28次进行,每周5次)并同时接受卡培他滨或5-氟尿嘧啶化疗。所有患者均接受全直肠系膜切除术(total mesorectal excision,TME),试验组患者接受TME的时机是末次周期化疗结束后的2~5周内,对照组患者则是在放疗结束后的6~8周内。主要研究终点是3年无病生存情况,次要研究终点包括肿瘤反应、总生存情况、毒性反应、生活质量和成本—效益。讨论这是韩国第一项针对LARC比较以SCRT为基础的TNT与传统术前长程放化疗疗效的随机对照试验,经验丰富的结直肠外科医师的参与确保了高质量的手术操作。该试验的预期结果是,SCRT+FOLFOX化疗相比放化疗,能够改善患者的无病生存情况,在肿瘤反应、生活质量和成本—效益方面也具有潜在优势。Background Preoperative(chemo)radiotherapy has been widely used as an effective treatment for locally advanced rectal cancer(LARC),leading to a significant reduction in pelvic recurrence rates.Because early administration of intensive chemotherapy for LARC has more advantages than adjuvant chemotherapy,total neoadjuvant therapy(TNT)has been introduced and evaluated to determine whether it can improve tumor response or treatment outcomes.This study aims to investigate whether short-course radiotherapy(SCRT)followed by intensive chemotherapy improves oncologic outcomes compared with traditional preoperative long-course chemoradiotherapy(CRT).Methods A multicenter randomized phaseⅡtrial involving 364 patients with LARC(cT3-4,cN+,or presence of extramural vascular invasion)will be conducted.Patients will be randomly assigned to the experimental or control arm at a ratio of 1:1.Participants in the experimental arm will receive SCRT(25 Gy in 5 fractions,daily)followed by four cycles of FOLFOX(oxaliplatin,5-fluorouracil,and folinic acid)as a neoadjuvant treatment,and those in the control arm will receive conventional radiotherapy(45-50.4 Gy in 25-28 fractions,5 times a week)concurrently with capecitabine or 5-fluorouracil.As a mandatory surgical procedure,total mesorectal excision will be performed 2-5 weeks from the last cycle of chemotherapy in the experimental arm and 6-8 weeks after the last day of radiotherapy in the control arm.The primary endpoint is 3-year disease-free survival,and the secondary endpoints are tumor response,overall survival,toxicities,quality of life,and cost-effectiveness.Discussion This is the first Korean randomized controlled study comparing SCRT-based TNT with traditional preoperative LC-CRT for LARC.The involvement of experienced colorectal surgeons ensures high-quality surgical resection.SCRT followed by FOLFOX chemotherapy is expected to improve disease-free survival compared with CRT,with potential advantages in tumor response,quality of life,and cost-effectiveness.

关 键 词：直肠恶性肿瘤 新辅助放疗 短程放疗 巩固化疗 无病生存 随机对照Ⅱ期试验 试验方案 

分 类 号：R735.3[医药卫生—肿瘤]