State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, 510060, Guangdong, P. R. China.
Department of Hepatobiliary and Pancreatic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, 510060, Guangdong, P. R. China.
Cancer Commun (Lond). 2018 Oct 10;38(1):61. doi: 10.1186/s40880-018-0331-y.
The optimal strategy for adjuvant therapy after curative resection for hepatocellular carcinoma (HCC) patients with solitary tumor and microvascular invasion (MVI) is controversial. This trial evaluated the efficacy and safety of adjuvant transcatheter arterial chemoembolization (TACE) after hepatectomy versus hepatectomy alone in HCC patients with a solitary tumor ≥ 5 cm and MVI.
In this randomized, open-labeled, phase III trial, HCC patients with a solitary tumor ≥ 5 cm and MVI were randomly assigned (1:1) to receive either 1-2 cycles of adjuvant TACE after hepatectomy (Hepatectomy-TACE) or hepatectomy alone (Hepatectomy Alone). The primary endpoint was disease-free survival (DFS); the secondary endpoints included overall survival (OS) and adverse events.
Between June 1, 2009, and December 31, 2012, 250 patients were enrolled and randomly assigned to the Hepatectomy-TACE group (n = 125) or the Hepatectomy Alone group (n = 125). Clinicopathological characteristics were balanced between the two groups. The median follow-up time from randomization was 37.5 months [interquartile range 18.3-48.2 months]. The median DFS was significantly longer in the Hepatectomy-TACE group than in the Hepatectomy Alone group [17.45 months (95% confidence interval [CI] 11.99-29.14) vs. 9.27 months (95% CI 6.05-13.70), hazard ratio [HR] = 0.70 (95% CI 0.52-0.95), P = 0.020], respectively. The median OS was also significantly longer in the Hepatectomy-TACE group than in the Hepatectomy Alone group [44.29 months (95% CI 25.99-62.58) vs. 22.37 months (95% CI 10.84-33.91), HR = 0.68 (95% CI 0.48-0.97), P = 0.029]. Treatment-related adverse events were more frequently observed in the Hepatectomy-TACE group, although these were generally mild and manageable. The most common grade 3 or 4 adverse events in both groups were neutropenia and liver dysfunction.
Hepatectomy followed by adjuvant TACE is an appropriate option after radical resection in HCC patients with solitary tumor ≥ 5 cm and MVI, with acceptable toxicity.
对于单个肿瘤且存在微血管侵犯（MVI）的肝细胞癌（HCC）患者，根治性切除术后辅助治疗的最佳策略仍存在争议。本试验评估了在单个肿瘤≥5cm 且存在 MVI 的 HCC 患者中，与单纯肝切除术相比，肝切除术后辅助经导管动脉化疗栓塞（TACE）的疗效和安全性。
在这项随机、开放标签、III 期临床试验中，将单个肿瘤≥5cm 且存在 MVI 的 HCC 患者按 1:1 随机分配接受肝切除术后 1-2 个周期的辅助 TACE（肝切除术-TACE 组）或单纯肝切除术（肝切除术组）。主要终点是无病生存期（DFS）；次要终点包括总生存期（OS）和不良事件。
2009 年 6 月 1 日至 2012 年 12 月 31 日期间，共纳入 250 例患者，并随机分配至肝切除术-TACE 组（n=125）或肝切除术组（n=125）。两组的临床病理特征均衡。自随机分组起的中位随访时间为 37.5 个月[四分位间距 18.3-48.2 个月]。肝切除术-TACE 组的中位 DFS 明显长于肝切除术组[17.45 个月（95%置信区间 11.99-29.14）比 9.27 个月（95%置信区间 6.05-13.70），风险比（HR）=0.70（95%置信区间 0.52-0.95），P=0.020]。肝切除术-TACE 组的中位 OS 也明显长于肝切除术组[44.29 个月（95%置信区间 25.99-62.58）比 22.37 个月（95%置信区间 10.84-33.91），HR=0.68（95%置信区间 0.48-0.97），P=0.029]。肝切除术-TACE 组更常发生与治疗相关的不良事件，但这些不良事件通常为轻度且可管理。两组中最常见的 3 级或 4 级不良事件均为中性粒细胞减少和肝功能障碍。
对于单个肿瘤≥5cm 且存在 MVI 的 HCC 患者，根治性切除术后辅助 TACE 是一种合适的选择，具有可接受的毒性。
