Surgery Versus Ablation for Hepatocellular Carcinoma: A Randomized Controlled Trial (SURF-RCT Trial) and a Nonrandomized Prospective Observational Trial (SURF-Cohort Trial).

Simultaneously, eligible patients who dissented from random assignment were enrolled in a nonrandomized prospective observational trial (SURF-Cohort).

同时，对于那些不同意随机分配的符合条件的患者，我们让他们参与了一项非随机的前瞻性观察性试验（SURF-Cohort）。

We aimed to report the final analyses of overall survival(OS) and updated recurrence-free survival (RFS) in the SURF-RCT and SURF-Cohort trials.

我们旨在报告SURF-RCT和SURF-Cohort试验的最终总生存(OS)和更新的无复发生存(RFS)分析结果。

Methods

The trials were conducted in 49 institutions in Japan.

这些试验在日本的49个机构进行。

Patients with a largest HCC diameter of ≤3 cm and ≤3 HCC nodules were eligible.

最大直径≤3厘米的肝细胞癌（HCC）患者和≤3个HCC结节的患者符合入选条件。

The co-primary end points were RFS and OS.

共同的主要终点是无复发生存（RFS）和总生存（OS）。

Results

During 2009-2015, 1,094 patients were registered.

在2009-2015年间，共有1,094名患者被登记注册。

After excluding ineligible patients, 302 and 753 patients were included in the SURF-RCT (surgery, n = 150; RFA, n = 152) and SURF-Cohort trial (surgery, n = 382; RFA, n = 371), respectively.

在排除不符合条件的患者后，分别有302名和753名患者被纳入SURF-RCT试验（手术组，n=150；射频消融组，n=152）和SURF队列试验（手术组，n=382；射频消融组，n=371）。

In the SURF-RCT trial, 90% of patients had solitary HCC, and approximately 65% had an HCC diameter of ≤2.0 cm.

在SURF-RCT试验中，90%的患者患有单发性肝细胞癌，大约65%的患者肝细胞癌直径≤2.0厘米。

Serious adverse effects occurred in 3.3% of the surgery group and none in the RFA group.

手术组中有3.3%的患者出现了严重不良反应，而射频消融（RFA）组中没有出现。

The 5-year OS was 74.6% in the surgery group and 70.4% in the RFA group (hazard ratio[HR], 0.96; adjusted P = .84).

手术组的5年总生存率为74.6%，射频消融（RFA）组为70.4%（风险比[HR]，0.96；调整后P = .84）。

The 5-year RFS was 42.9% in the surgery group and 42.7% in the RFA group (HR, 0.90; adjusted P = .84).

手术组的5年无复发生存率为42.9%，射频消融（RFA）组为42.7%（风险比[HR]，0.90；调整后P = .84）。

In the surgery group, 86 patients had recurrences; 14 (16.3%) underwent surgery, and 50 (58.1%) underwent RFA.

在手术组中，86名患者出现复发；其中14名（16.3%）接受了手术治疗，50名（58.1%）接受了射频消融（RFA）治疗。

In the RFA group, 95 patients had recurrences; 8 (8.4%) underwent surgery, and 55 (57.9%) underwent RFA.

在射频消融（RFA）组中，95名患者出现复发；其中8名（8.4%）接受了手术治疗，55名（57.9%）接受了射频消融（RFA）治疗。

In the SURF-Cohort trial, baseline factors were imbalanced between groups.

在SURF队列试验中，各组之间的基线因素存在不平衡。

After adjusting with the inverse probability of treatment weighting analysis, OS and RFS showed no significant difference (P = .77 and P = .08).

在使用逆概率治疗加权分析进行调整后，总生存期(OS)和无复发生存期(RFS)未显示出显著差异（P = .77和P = .08）。

Conclusions

The SURF trial did not demonstrate that surgery was superior to RFA for small HCC.

SURF 试验未显示手术对于小肝细胞癌（HCC）的疗效优于射频消融（RFA）。