Comparable effects of Jiedu Granule,a compound Chinese herbal medicine,and sorafenib for advanced hepatocellular carcinoma: A prospective multicenter cohort study |
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| Affiliation: | 1. School of Traditional Chinese Medicine, Naval Medical University, Shanghai 200433, China;2. Department of Integrated Traditional Chinese and Western Medicine, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai 200433, China;3. Department of Integrative Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China;4. The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai 200433, China;1. Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran;2. Department of Electrical Engineering, Amirkabir University of Technology, Tehran, Iran;1. Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China;3. Liver Cancer Program, Recanati/Miller Transplantation Institute, Icahn School of Medicine at Mount Sinai, New York, New York;4. Department of Surgery, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong SAR, China;1. School of Chinese Medicine, Hong Kong Baptist University, China;2. Changchun University of Traditional Chinese Medicine, Changchun 130117, Jilin, China;3. Istituto Paracelso, Rome 00153, Italy;4. School of Life Sciences, University of Technology Sydney, Sydney 2007, New South Wales, Australia;1. Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China;2. Department of Emergency, Zhongshan Hospital, Fudan University, Shanghai 200032, China;3. China-Canada Centre of Research for Digestive Diseases, Shanghai 200032, China;1. Department of Hepatic Surgery IV, the Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China;2. Department of Hepatic Surgery II, the Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China;3. Department of Clinical Database, the Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China |
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| Abstract: | ObjectiveSorafenib has been extensively used for the treatment of advanced hepatocellular carcinoma (HCC), and Chinese herbal medicine has also been used to manage advanced HCC. The present work evaluates the effectiveness and safety of Jiedu (JD) Granule, a compound of traditional Chinese herbal medicine, side-by-side with sorafenib for the treatment of advance HCC.MethodsPatients with advanced HCC receiving treatment with JD Granule or sorafenib were enrolled from December 2014 to March 2018. The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS) and safety. Propensity score matching (PSM) analysis was used to control for possible selection bias from the study group allocation process.ResultsOf the 325 patients included, 161 received JD Granule and 164 received sorafenib. No significant differences were found in OS or PFS among patients receiving JD Granule compared to sorafenib (P > 0.05). Median OS of the two study groups was 6.83 months (95% confidence interval [CI]: 5.83–9.47) in the group receiving JD Granule and 8 months (95% CI: 6.67–9.80) in the group receiving sorafenib, with half-, 1- and 2-year survival rates of 53.6%, 31.2% and 13.2% vs 60.1%, 35.5% and 14.2%, respectively. Even after PSM, the median survival time did not differ between the JD Granule group (9.03 months; 95% CI: 6.37–14.2) and the sorafenib group (7.93 months; 95% CI: 6.5–9.97), with comparable half-, 1- and 2-year survival rates. The most common adverse events (AEs) were diarrhea (13.7%) and fatigue (5.6%) in the JD Granule group, and hand-foot skin reaction (46.3%) and diarrhea (36.6%) in the sorafenib group. The JD Granule was more cost-effective than sorafenib treatment for advanced HCC.ConclusionCompared to sorafenib, JD Granule was more cost-effective and caused fewer AEs for the treatment of Chinese patients with advanced HCC. |
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| Keywords: | Carcinoma, hepatocellular Jiedu Granule Sorafenib Chinese herbal medicine |
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