Adjuvant transarterial chemoembolization for hepatocellular carcinoma following curative resection: A randomized, open-label, phase 3 trial.

approach_and_results

In this randomized phase 3 trial, histologically confirmed patients with HCC (American Joint Committee on Cancer TNM stage I and II) were randomly assigned (1:1) to adjuvant TACE or observation groups.

在这项随机的III期试验中，经组织学证实的HCC患者（美国癌症联合委员会TNM分期I和II期）被随机分配（1:1）到辅助性TACE组或观察组。

The primary endpoint was recurrence-free survival (RFS) in the intention-to-treat(ITT) population.

主要终点是在意向治疗(ITT)人群中无复发生存(RFS)。

The secondary endpoints included overall survivaland safety.

次要终点包括总生存和安全性。

A total of 332 patients (ITT population) were randomly assigned to the TACE group (n=166) or the observation group (n=166) between March 2014 and June 2021.

在2014年3月至2021年6月期间，共有332名患者（意向治疗人群）被随机分配到TACE组（n=166）或观察组（n=166）。

The RFS was comparable between the 2 groups from the ITT population (median, both unreached; HR, 0.88; 95% CI: 0.62-1.24; p =0.468).

从意向治疗人群来看，两组之间的无复发生存期（RFS）相当（中位数均未达到；风险比，0.88；95%置信区间：0.62-1.24；p=0.468）。

The RFS rates at 1, 3, and 5 years were 87.3% (95% CI: 81.2-91.5), 70.7% (95% CI: 63.0-77.0), and 60.6% (95% CI: 51.9-68.3) in the adjuvant TACE group and 84.8% (95% CI: 78.3-89.5), 69.3% (95% CI: 61.6-75.8), and 58.1% (95% CI: 49.5-65.8) in the observation group, respectively.

在辅助TACE组中，1年、3年和5年的无复发生存（RFS）率分别为87.3%（95%置信区间：81.2-91.5）、70.7%（95%置信区间：63.0-77.0）和60.6%（95%置信区间：51.9-68.3），而在观察组中，相应的无复发生存率分别为84.8%（95%置信区间：78.3-89.5）、69.3%（95%置信区间：61.6-75.8）和58.1%（95%置信区间：49.5-65.8）。

The overall survivalwas comparable between the TACE group and the observation group in the ITT population (median, both unreached, HR, 1.06; 95% CI: 0.63-1.76; p =0.838).

在意向治疗（ITT）人群中，TACE组与观察组的总生存（OS）相当（中位数均未达到，风险比HR为1.06；95%置信区间：0.63-1.76；p=0.838）。

There was no grade ≥ 3 adverse eventor treatment-related death in either group.

在两组中均未观察到3级或以上的不良事件或与治疗相关的死亡。

Conclusions

Postoperative adjuvant TACE was not associated with prolonged RFS or overall survivalin patients with American Joint Committee on Cancer TNM stage I or II HCC.

对于美国癌症联合委员会TNM分期I期或II期的肝细胞癌患者，术后辅助TACE与无复发生存期或总生存期的延长无关。