Division of Gastroenterology, Department of Internal Medicine at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (HUST), Wuhan, China.
Department of Epidemiology and Biostatistics and State Key Laboratory of Environment Health, School of Public Health, Tongji Medical College, HUST, Wuhan, China.
Gut. 2018 Nov;67(11):2006-2016. doi: 10.1136/gutjnl-2018-315983. Epub 2018 May 25.
There is little evidence that adjuvant therapy after radical surgical resection of hepatocellular carcinoma (HCC) improves recurrence-free survival (RFS) or overall survival (OS). We conducted a multicentre, randomised, controlled, phase IV trial evaluating the benefit of an aqueous extract of Murr (Huaier granule) to address this unmet need.
A total of 1044 patients were randomised in 2:1 ratio to receive either Huaier or no further treatment (controls) for a maximum of 96 weeks. The primary endpoint was RFS. Secondary endpoints included OS and tumour extrahepatic recurrence rate (ERR). The Huaier (n=686) and control groups (n=316) had a mean RFS of 75.5 weeks and 68.5 weeks, respectively (HR 0.67; 95% CI 0.55 to 0.81). The difference in the RFS rate between Huaier and control groups was 62.39% and 49.05% (95% CI 6.74 to 19.94; p=0.0001); this led to an OS rate in the Huaier and control groups of 95.19% and 91.46%, respectively (95% CI 0.26 to 7.21; p=0.0207). The tumour ERR between Huaier and control groups was 8.60% and 13.61% (95% CI -12.59 to -2.50; p=0.0018), respectively.
This is the first nationwide multicentre study, involving 39 centres and 1044 patients, to prove the effectiveness of Huaier granule as adjuvant therapy for HCC after curative liver resection. It demonstrated a significant prolongation of RFS and reduced extrahepatic recurrence in Huaier group.
NCT01770431; Post-results.
根治性肝切除术后辅助治疗对肝细胞癌（HCC）患者无复发生存（RFS）或总生存（OS）的改善作用证据有限。我们开展了一项多中心、随机、对照、四期临床试验，旨在评估槐耳颗粒（一种 Murr 的水提物）对这一未满足需求的获益。
共 1044 例患者按 2:1 的比例随机分为槐耳组（n=686）和对照组（n=316），分别接受槐耳或不进行进一步治疗（对照组），最多治疗 96 周。主要终点为 RFS。次要终点包括 OS 和肿瘤肝外复发率（ERR）。槐耳组和对照组的中位 RFS 分别为 75.5 周和 68.5 周（HR 0.67；95%CI 0.55 至 0.81）。槐耳组和对照组的 RFS 率差异为 62.39%和 49.05%（95%CI 6.74 至 19.94；p=0.0001），OS 率差异为 95.19%和 91.46%（95%CI 0.26 至 7.21；p=0.0207）。槐耳组和对照组的肿瘤 ERR 分别为 8.60%和 13.61%（95%CI-12.59 至-2.50；p=0.0018）。
这是第一项全国多中心研究，纳入 39 个中心的 1044 例患者，证明了槐耳颗粒作为根治性肝切除术后 HCC 辅助治疗的有效性。它显示槐耳组可显著延长 RFS，并降低肝外复发率。
NCT01770431；post-results。
