Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial
| Autor: | Lianxin Liu, Chao-Liu Dai, Yan Chen, Xi-Hu Qin, Xiaoping Chen, L Zhang, Qiang Li, Bao-Cai Xing, Xi-Yan Wang, Yi-Jun Wang, Qi-Shun Zhang, Bao-Gang Peng, Hao Wen, Qian Chen, Yi Mu, Jingfeng Liu, Zhiren Fu, Ping Bie, Li Bo, Weiping Zhou, Xin-Yu Peng, Arian Laurence, Jian-Qiang Cai, Yi-Tao Ding, Ping Yin, Chang Shu, Ge-Liang Xu, Zhi-Wei Zhang, Zuo-Jun Zhen, Qi-Chang Zheng, Shou-Wang Cai, Yu-Bao Zhang, Le-Qun Li, Bin Jiang, Hai-Xin Qian, Xue-Wen Zhang |
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| Rok vydání: | 2018 |
| Předmět: |
Male
0301 basic medicine Curative resection medicine.medical_specialty Carcinoma Hepatocellular Complex Mixtures Gastroenterology Resection law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine medicine Clinical endpoint Adjuvant therapy Hepatectomy Humans Aged Trametes business.industry Liver Neoplasms Huaier Granule Middle Aged medicine.disease Survival Analysis Clinical trial Treatment Outcome 030104 developmental biology Liver Chemotherapy Adjuvant 030220 oncology & carcinogenesis Hepatocellular carcinoma Female Neoplasm Recurrence Local business |
| Zdroj: | Gut. 67:2006-2016 |
| ISSN: | 1468-3288 0017-5749 |
| DOI: | 10.1136/gutjnl-2018-315983 |
| Popis: | ObjectiveThere 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 resultsA 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.ConclusionsThis 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 registrationNCT01770431; Post-results. |
| Databáze: | OpenAIRE |
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