Neoadjuvant Chemotherapy With CAPOX Versus Chemoradiation for Locally Advanced Rectal Cancer With Uninvolved Mesorectal Fascia (CONVERT): Final Results of a Phase III Trial.

However, which patients deserve most from the nCT need further clarify.

然而，哪些患者最能从nCT中获益需要进一步明确。

This trial aimed to assess the non-inferiority of nCT with capecitabine plus oxaliplatin (CAPOX) versus nCRT with capecitabine in LARC with uninvolved mesorectal fascia (MRF).

本试验旨在评估未侵犯直肠系膜筋膜(MRF)的局部晚期直肠癌(LARC)患者接受卡培他滨加奥沙利铂(nCT)化疗与卡培他滨同步放化疗(nCRT)的非劣效性。

Methods

Patients with LARC within 12 cm from the anal verge and uninvolved MRF were randomly assigned to receive 4 cycles of CAPOX chemotherapy alone (nCT group) or CRT with concurrent Capecitabine (nCRT group).

距离肛门边缘12厘米以内的LARC患者，且MRF未受侵犯，被随机分配接受4个周期的CAPOX化疗(nCT组)或卡培他滨同步放化疗(nCRT组)。

The primary end point is 3-year locoregional recurrence-free survival (LRRFS).

主要终点是3年局部区域无复发生存率（LRRFS）。

Secondary end points, such as 3-year disease-free survival (DFS), 3-year overall survival(OS), and adverse events (AEs), were also reported.

次要终点，包括3年无病生存率（DFS）、3年总生存（OS）和不良事件（AEs），也已报告。

Results

A total of 663 patients were enrolled and 589 patients received the allocated treatment (nCT, n = 300; nCRT, n = 289).

共有663名患者入组，其中589名患者接受了分配的治疗（nCT组，n=300；nCRT组，n=289）。

LRRFS was analyzed with a median follow-up of 48 months. 3-year LRRFS was 97.4% (95% CI, 95.5 to 99.3) in the nCRT group and 96.3% (95% CI, 94.0 to 98.6) in the nCT group, resulting in a hazard ratio(HR) of 1.40 (95% CI, 0.53 to 3.68).

在中位随访48个月时对局部区域无复发生存率（LRRFS）进行了分析。nCRT组的3年LRRFS为97.4%（95%置信区间，95.5%至99.3%），而nCT组为96.3%（95%置信区间，94.0%至98.6%），导致风险比（HR）为1.40（95%置信区间，0.53至3.68）。

The nCT and nCRT achieved similar 3-year DFS (89.2% v 87.9%; HR, 0.88 [95% CI, 0.54 to 1.44]) and 3-year OS (95.0% v 94.1%; HR, 0.86 [95% CI, 0.42 to 1.76]).

新辅助化疗(nCT)和新辅助放化疗(nCRT)在3年无病生存率(DFS)上相似(89.2%对比87.9%; 风险比[HR], 0.88 [95% 置信区间, 0.54到1.44])，以及在3年总生存率(OS)上也相似(95.0%对比94.1%; HR, 0.86 [95% 置信区间, 0.42到1.76])。

The nCT group showed a lower incidenceof grade 2 to 4 long-term AEs (16.0% v 26.3%, P = 0.002) and proctitis (33.6% v 41.7%, P = 0.049) compared with nCRT group.

与nCRT组相比，nCT组的2至4级长期不良事件(AEs)发生率较低(16.0%对比26.3%，P = 0.002)，直肠炎的发生率也较低(33.6%对比41.7%，P = 0.049)。

Conclusions

The non-inferiority of nCT was not confirmed with a very low incidenceof local recurrence in both group.

nCT的非劣效性未得到证实，因为两组的局部复发发生率都非常低。

But nCT offers comparable DFS and OS while mitigating the burden of toxicity as compared to nCRT.

然而，与nCRT相比，nCT提供了可比的无病生存期（DFS）和总生存期（OS），同时减轻了毒性负担。

These insights shed light on a potential paradigm shift in the treatment for LARC with uninvolved MRF.

这些见解为LARC（局部晚期直肠癌）伴有未受累的MRF（中间直肠系膜筋膜）治疗提供了一种潜在的范式转变。