Survival among patients treated with total mesorectal excision or selective watch-and-wait after total neoadjuvant therapy: a pooled analysis of the CAO/ARO/AIO-12 and OPRA randomized phase II trials.

patients_and_methods

The CAO/ARO/AIO-12 and OPRA trials were multicenter, phase II trials that randomized patients with stage II/III rectal cancer to receive either induction or consolidation chemotherapy as part of TNT.

CAO/ARO/AIO-12和OPRA试验是多中心的II期试验，将II/III期直肠癌患者随机分配接受诱导化疗或巩固化疗作为TNT的一部分。

All patients in the CAO/ARO/AIO-12 trial underwent TME within 6 weeks of completing TNT.

CAO/ARO/AIO-12试验中的所有患者在完成TNT治疗后6周内接受了全直肠系膜切除术（TME）。

The OPRA trial allowed patients with a complete or near-complete response to enter WW while those with an incomplete response proceeded to TME.

OPRA试验允许对TNT治疗有完全或接近完全反应的患者进入等待观察（WW），而对治疗反应不完全的患者则继续进行全直肠系膜切除术（TME）。

The primary endpoint of the present pooled analysis was disease-free survival (DFS).

本综合分析的主要终点是无病生存期（DFS）。

Secondary endpoints included distant recurrence-free survival (DRFS), local recurrence-free survival (LRFS) and overall survival(OS).

次要终点包括远处复发无病生存期（DRFS）、局部复发无病生存期（LRFS）和总生存（OS）。

Results

This pooled analysis included 628 patients (n = 304 CAO/ARO/AIO-12; n = 324 OPRA).

这项汇总分析包括了628名患者（n = 304 CAO/ARO/AIO-12; n = 324 OPRA）。

Median follow-up was 3.6 [interquartile range (IQR) 1.13] years and 5.1 (IQR 2.2) years, respectively.

中位随访时间分别为3.6年（四分位数间距1.13年）和5.1年（四分位数间距2.2年）。

Patients in the CAO/ARO/AIO-12 trial were more likely to have cT3/4 and cN-positive disease while patients in the OPRA trial had tumors closer to the anal verge.

在CAO/ARO/AIO-12试验中的患者更可能患有cT3/4和cN阳性疾病，而在OPRA试验中的患者肿瘤更靠近肛门齿状线。

Compliance to TNT and rates of grade 3+ adverse events were similar between studies.

两研究中TNT的依从性和3级及以上不良事件的发生率相似。

There were no differences in DFS, DRFS, LRFS or OS based on treatment strategy or TNT treatment arm.

基于治疗策略或TNT治疗组，无差异的无病生存期（DFS）、远处复发生存期（DRFS）、局部复发生存期（LRFS）或总生存期（OS）。

Conclusions

This pooled analysis demonstrated equivalent oncologic outcomes between patients treated with mandatory TME and selective WW strategies following TNT.

这项汇总分析显示，在TNT后，强制性全直肠系膜切除（TME）和选择性等待观望（WW）策略治疗的患者之间，肿瘤学结果是等效的。

These results strengthen available evidence indicating that WW is a safe treatment option for patients with an excellent response to neoadjuvant therapy.

这些结果加强了现有证据，表明对于新辅助治疗反应极佳的患者，WW是一种安全的治疗选择。