Background

Optimal treatment of hepatocellular carcinoma (HCC) beyond the Milan criteria (MC) is debated. The aim of the study was to assess overall-survival (OS) and disease-free-survival (DFS) for HCC beyond MC when treated by trans-arterial-chemoembolization (TACE) or surgical resection (SR).

Method

between 2005 and 2015, all patients with a first diagnosis of HCC beyond MC(1 nodule>5 cm, or 3 nodules>3 cm without macrovascular invasion) were evaluated. Analyses were carried out through Kaplan–Meier, Cox models and the inverse probability weighting (IPW) method to reduce allocation bias. Sub-analyses have been performed for multinodular and single large tumors compared with a MC-IN cohort.

Results

226 consecutive patients were evaluated: 118 in SR group and 108 in TACE group. After IPW, the two pseudo-populations were comparable for tumor burden and liver function. In the SR group, 1–5 years OS rates were 72.3% and 35% respectively and 92.7% and 39.3% for TACE (p = 0.500). The median DFS was 8 months (95%CI:8–9) for TACE, and 11 months (95%CI:9–12) for SR (p < 0.001). TACE was an independent predictor for recurrence (HR 1.5; 95%CI: 1.1–2.1; p = 0.015). Solitary tumors > 5 cm and multinodular disease had comparable OS and DFS as Milan-IN group (p > 0.05).

Conclusion

Surgery allowed a better control than TACE in patient bearing HCC beyond MC. This translated into a significant benefit in terms of DFS but not OS.

中文翻译：

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超出米兰标准的肝细胞癌治疗。手术切除与化疗栓塞的加权比较研究。

背景

超出米兰标准 (MC) 的肝细胞癌 (HCC) 的最佳治疗存在争议。该研究的目的是评估经动脉化疗栓塞术 (TACE) 或手术切除术 (SR) 治疗后 MC 以外的 HCC 的总生存期 (OS) 和无病生存期 (DFS)。

方法

在 2005 年至 2015 年期间，对所有首次诊断为 HCC 的 MC 以外的患者（1 个结节>5 cm，或 3 个结节>3 cm 无大血管侵犯）进行了评估。通过 Kaplan-Meier、Cox 模型和逆概率加权 (IPW) 方法进行分析，以减少分配偏差。与 MC-IN 队列相比，已经对多结节和单个大肿瘤进行了亚分析。

结果

连续评估了 226 名患者：SR 组 118 名，TACE 组 108 名。在 IPW 之后，这两个假人群在肿瘤负荷和肝功能方面具有可比性。在 SR 组中，1-5 年 OS 率分别为 72.3% 和 35%，TACE 为 92.7% 和 39.3%（p = 0.500）。TACE 的中位 DFS 为 8 个月 (95%CI:8-9)，SR 为 11 个月 (95%CI:9-12) (p < 0.001)。TACE 是复发的独立预测因子（HR 1.5；95%CI：1.1-2.1；p = 0.015）。孤立性肿瘤 > 5 cm 和多结节病的 OS 和 DFS 与 Milan-IN 组相当（p > 0.05）。

结论

在 MC 以外的 HCC 患者中，手术比 TACE 可以更好地控制。这在 DFS 而非操作系统方面转化为显着优势。