Introduction

The use of total neoadjuvant therapy (TNT) for locally advanced rectal cancer has been increasing in recent years, but the long-term overall survival characteristics of this approach is currently unknown.

Methods

We performed a retrospective study of patients with clinical stage II/III rectal cancer within the National Cancer Database. Patients who received TNT (defined as chemotherapy, followed by CRT, followed by surgery) were propensity score matched to patients who received adjuvant therapy (defined as CRT, followed by surgery, followed by chemotherapy). We compared overall survival (OS) and rates of pathologic complete response (pCR) between the 2 arms.

Results

Of the 4300 patients in our cohort, 3502 (81%) received adjuvant therapy and 798 (19%) received TNT. At baseline, patients who received TNT were more likely to have higher clinical T and N stages (P< .001). The 5-year OS was 77% for both TNT and adjuvant therapy patients (hazard ratio [HR] 1.06, 95% confidence interval [CI], 0.88-1.28, P = .57). After propensity score matching and adjusting for potential confounders, there were no significant differences in OS (HR_adj 1.00, 95% CI, 0.71-1.40, P = .99). After propensity score matching, there were higher pCR rates among TNT patients (16.1%) compared to adjuvant therapy patients (12.0%) (P = .037).

Conclusion

In this observational study, we found TNT was not associated with a lower OS compared to standard adjuvant chemotherapy. This finding potentially reassures clinicians choosing TNT as an alternative to adjuvant chemotherapy. However, future prospective data are needed to confirm these findings.

中文翻译：

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局部晚期直肠癌全新辅助治疗与标准辅助化疗的疗效比较

介绍

近年来，局部晚期直肠癌使用全新辅助治疗（TNT）的情况越来越多，但这种方法的长期总体生存特征目前尚不清楚。

方法

我们对国家癌症数据库中的临床 II/III 期直肠癌患者进行了回顾性研究。接受 TNT（定义为化疗，然后是 CRT，然后是手术）的患者与接受辅助治疗（定义为 CRT，然后是手术，然后是化疗）的患者进行倾向评分匹配。我们比较了两组之间的总生存期 (OS) 和病理完全缓解率 (pCR)。

结果

在我们队列的 4300 名患者中，3502 名 (81%) 接受了辅助治疗，798 名 (19%) 接受了 TNT。在基线时，接受 TNT 的患者更有可能具有更高的临床 T 和 N 分期 ( P < .001)。TNT 和辅助治疗患者的 5 年 OS 均为 77%（风险比 [HR] 1.06，95% 置信区间 [CI]，0.88-1.28，P  = .57）。倾向评分匹配和调整潜在的混杂因素后，有在OS没有显著差异（HR _ADJ 1.00，95％CI，0.71-1.40，P  = 0.99）。倾向评分匹配后，与辅助治疗患者 (12.0%) 相比，TNT 患者 (16.1%) 的 pCR 率更高 ( P  = .037)。

结论

在这项观察性研究中，我们发现与标准辅助化疗相比，TNT 与较低的 OS 无关。这一发现可能使临床医生选择 TNT 作为辅助化疗的替代方法放心。然而，需要未来的前瞻性数据来证实这些发现。