新辅助放化疗与手术间隔时间对直肠癌复发和生存的影响：一项随机临床试验的长期结果。

Effect of interval between neoadjuvant chemoradiotherapy and surgery on disease recurrence and survival in rectal cancer: long-term results of a randomized clinical trial.

机构信息

Department of General Surgery, Ege University School of Medicine, Izmir, Turkey.

Department of Pathology, Ege University School of Medicine, Izmir, Turkey.

出版信息

BJS Open. 2022 Sep 2;6(5). doi: 10.1093/bjsopen/zrac107.

DOI:10.1093/bjsopen/zrac107

PMID:36254732

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9577542/

Abstract

BACKGROUND

The optimal timing of surgery following chemoradiotherapy (CRT) is controversial. This trial aimed to assess disease recurrence and survival rates between patients with locally advanced rectal adenocarcinoma (LARC) who underwent total mesorectal excision (TME) after a waiting interval of 8 weeks or less (classic interval; CI) versus more than 8 weeks (long interval; LI) following preoperative CRT.

METHODS

This was a phase III, single-centre, randomized clinical trial. Patients with LARC situated within 12 cm of the anal verge (T3-T4 or N+ disease) were randomized to undergo TME within or after 8 weeks after CRT.

RESULTS

Between January 2006 and January 2017, 350 patients were randomized, 175 to each group. As of February 2022, the median follow-up time was 80 (6-174) months. Among the 322 included patients (CI, 159; LI, 163) the cumulative incidence of locoregional recurrence at 5 years was 10.1 per cent in the CI group and 6.9 per cent in the LI group (P = 0.143). The cumulative incidence of distant metastasis at 5 years was 30.8 per cent in the CI group and 18.6 per cent in the LI group (sub-HR = 1.78; 95 per cent c.i. 1.14 to 2.78, P = 0.010). The disease-free survival (DFS) in each group was 59.7 and 69.9 per cent respectively (P = 0.157), and overall survival (OS) rates at 5 years were 73.6 versus 77.9 per cent (P = 0.476).

CONCLUSION

Incidence of distant metastasis decreased with an interval between CRT and surgery exceeding 8 weeks, but this did not impact on DFS or OS.

REGISTRATION NUMBER

NCT03287843 (http://www.clinicaltrials.gov).

摘要

背景

放化疗（CRT）后手术的最佳时机存在争议。本试验旨在评估经术前 CRT 后 8 周或更长时间（长间隔；LI）行全直肠系膜切除术（TME）与 8 周内（经典间隔；CI）行 TME 的局部晚期直肠腺癌（LARC）患者之间疾病复发和生存率的差异。

方法

这是一项 III 期、单中心、随机临床试验。距肛缘 12cm 以内（T3-T4 或 N+疾病）的 LARC 患者被随机分配在 CRT 后 8 周内或之后行 TME。

结果

2006 年 1 月至 2017 年 1 月，共 350 例患者被随机分配到两组，每组 175 例。截至 2022 年 2 月，中位随访时间为 80（6-174）个月。在纳入的 322 例患者中（CI 组 159 例，LI 组 163 例），CI 组 5 年局部区域复发的累积发生率为 10.1%，LI 组为 6.9%（P=0.143）。CI 组 5 年远处转移的累积发生率为 30.8%，LI 组为 18.6%（亚 HR=1.78；95%置信区间 1.14-2.78，P=0.010）。两组的无病生存率（DFS）分别为 59.7%和 69.9%（P=0.157），5 年总生存率（OS）分别为 73.6%和 77.9%（P=0.476）。