Department of Immunology, Genetics and Pathology, Uppsala University, Sweden.
Department of Immunology, Genetics and Pathology, Uppsala University, Sweden.
Radiother Oncol. 2021 Apr;157:70-77. doi: 10.1016/j.radonc.2021.01.002. Epub 2021 Jan 14.
The Neoadjuvant rectal (NAR) score is a new surrogate endpoint to be used in clinical trials for early determination of treatment response to different preoperative therapies. The aim is to further validate the NAR-score, primarily developed using chemoradiotherapy (CRT) with a delay to surgery 6-8 weeks, and explore its value using other schedules.
The study included all 9978 patients diagnosed with non-metastasized RC in 2007-2015 that had undergone surgery and was registered in the Swedish Colorectal Cancer Registry. The patients of interest had either short-course radiotherapy (scRT)/CRT + delayed surgery, long-course radiotherapy (RT) + delayed surgery, (C)RT + additional chemotherapy, primary surgery, or scRT + immediate surgery. The scRT/CRT + delayed surgery groups were further divided based on time to surgery.
Mean NAR-score differed significantly (p < 0.0001) between different treatments. (C)RT + additional chemotherapy had the lowest mean score of 16.3 and CRT + delayed surgery had 17.7. There was a significant difference (p < 0.05) in overall survival (OS) and time to recurrence (TTR) of patients with a Low NAR-score (<8) compared to those with a High score (>16) for both CRT- and scRT, with a stronger correlation for CRT-patients. C-index for the NAR-score model (0.623) was not superior to when only pathological T- and N-stage was used (0.646).
The NAR-score is prognostic, but it is not better than pT- and pN-stage. However, the NAR-score can still discriminate between two treatments that have different cell killing effect and may still be of value in clinical trials as an easier method than pT- and N-stage.
新辅助直肠(NAR)评分是一种新的替代终点,可用于临床试验以早期确定不同术前治疗的治疗反应。目的是进一步验证主要使用 6-8 周延迟手术的放化疗(CRT)开发的 NAR 评分,并探索其使用其他方案的价值。
该研究纳入了 2007-2015 年间在瑞典结直肠癌登记处登记的所有 9978 例非转移性 RC 患者,这些患者均接受了手术。研究对象接受了短程放疗(scRT)/CRT+延迟手术、长程放疗(RT)+延迟手术、(C)RT+辅助化疗、原发手术或 scRT+即刻手术。scRT/CRT+延迟手术组根据手术时间进一步分为两组。
不同治疗方法的 NAR 评分均值差异显著(p<0.0001)。(C)RT+辅助化疗的评分最低,平均为 16.3,CRT+延迟手术的评分为 17.7。低 NAR 评分(<8)的患者的总生存(OS)和复发时间(TTR)与高 NAR 评分(>16)的患者相比差异有统计学意义(p<0.05),CRT 患者的相关性更强。NAR 评分模型(0.623)的 C 指数并不优于仅使用病理 T 期和 N 期(0.646)。
NAR 评分具有预后价值,但不如 pT 期和 pN 期。然而,NAR 评分仍然可以区分两种具有不同细胞杀伤作用的治疗方法,作为比 pT 期和 pN 期更简单的方法,它在临床试验中仍然具有价值。