Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial
Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial
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槐耳颗粒对肝癌根治性切除术后复发的影响：多中心、随机临床试验
DOI：
10.1136/gutjnl-2018-315983
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发表时间：
2018-11-01
期刊：
影响因子：
24.5
通讯作者：
Chen, Xiao-Ping
中科院分区：
文献类型：
--
作者：
Chen, Qian;Shu, Chang;Chen, Xiao-Ping
目的肝细胞癌（HCC）根治性手术切除后的辅助治疗提高无复发生存期（RFS）或总生存期（OS）的证据很少。我们进行了一项多中心、随机、对照的IV期试验，评估了槐儿颗粒（Trametes robinophila Murr）水提取物的益处，以解决这一未满足的需求。设计和结果共1044例患者按2:1的比例随机分组，接受怀尔或不接受进一步治疗（对照组），最长为96周。主要终点为RFS。次要终点包括OS和肿瘤肝外复发率（ERR）。怀尔组（n=686）和对照组（n=316）的平均RFS分别为75.5周和68.5周（HR 0.67; 95% CI 0.55 ~ 0.81）。怀尔组与对照组RFS率的差异分别为62.39%和49.05% (95% CI 6.74 ~ 19.94; p=0.0001)；这导致怀尔组和对照组的OS率分别为95.19%和91.46% （95% CI 0.26 ~ 7.21; p=0.0207）。怀尔组和对照组的肿瘤发生率分别为8.60%和13.61% （95% CI为- 12.59 ~ - 2.50;p=0.0018）。这是第一个全国性的多中心研究，涉及39个中心，1044例患者，证明怀尔颗粒作为肝切除术后肝癌辅助治疗的有效性。怀尔组RFS明显延长，肝外复发明显减少。试验注册编号NCT01770431；试。
Objective 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 Trametes robinophila Murr (Huaier granule) to address this unmet need. Design and results 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. Conclusions 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. Trial registration NCT01770431; Post-results.