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Donafenib Versus Sorafenib in First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma: A Randomized, Open-Label, Parallel-Controlled Phase II-III Trial.
Qin, S, Bi, F, Gu, S, Bai, Y, Chen, Z, Wang, Z, Ying, J, Lu, Y, Meng, Z, Pan, H, et al
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021;(27):3002-3011
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Abstract
PURPOSE Donafenib, a novel multikinase inhibitor and a deuterated sorafenib derivative, has shown efficacy in phase Ia and Ib hepatocellular carcinoma (HCC) studies. This study compared the efficacy and safety of donafenib versus sorafenib as first-line therapy for advanced HCC. PATIENTS AND METHODS This open-label, randomized, parallel-controlled, multicenter phase II-III trial enrolled patients with unresectable or metastatic HCC, a Child-Pugh score ≤ 7, and no prior systemic therapy from 37 sites across China. Patients were randomly assigned (1:1) to receive oral donafenib (0.2 g) or sorafenib (0.4 g) twice daily until intolerable toxicity or disease progression. The primary end point was overall survival (OS), tested for noninferiority and superiority. Efficacy was primarily assessed in the full analysis set (FAS), and safety was assessed in all treated patients. RESULTS Between March 21, 2016, and April 16, 2018, 668 patients (intention-to-treat) were randomly assigned to donafenib and sorafenib treatment arms; the FAS included 328 and 331 patients, respectively. Median OS was significantly longer with donafenib than sorafenib treatment (FAS; 12.1 v 10.3 months; hazard ratio, 0.831; 95% CI, 0.699 to 0.988; P = .0245); donafenib also exhibited superior OS outcomes versus sorafenib in the intention-to-treat population. The median progression-free survival was 3.7 v 3.6 months (P = .0570). The objective response rate was 4.6% v 2.7% (P = .2448), and the disease control rate was 30.8% v 28.7% (FAS; P = .5532). Drug-related grade ≥ 3 adverse events occurred in significantly fewer patients receiving donafenib than sorafenib (125 [38%] v 165 [50%]; P = .0018). CONCLUSION Donafenib showed superiority over sorafenib in improving OS and has favorable safety and tolerability in Chinese patients with advanced HCC, showing promise as a potential first-line monotherapy for these patients.
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[Clinical study of Fuzheng Yiliu Recipe combined with microwave ablation on hepatocellular carcinoma].
Zhao, HJ, Du, J, Chen, X
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2012;(1):32-4
Abstract
OBJECTIVE To explore the clinical value of Fuzheng Yiliu Recipe (FYR) combined with microwave ablation on hepatocellular carcinoma. METHODS Sixty patients with hepatocellular carcinoma were randomly assigned to the control group and the treatment group according to the random digit table, 30 in each group. Patients in the control group received microwave ablation therapy, while those in the treatment group received FYR three days after microwave ablation. The therapeutic course was 6 months. By the end of the treatment, the short-term objective therapeutic efficacy, the liver function, the hepatic fibrosis index, the cellular immune function were statistically analyzed between the two groups. RESULTS The indices of the liver function, the hepatic fibrosis, and the cellular immune function were more significantly improved in the treatment group than in the control group (P < 0.05). The CD4+ level and the ratio of CD4+/CD8+ of the treatment group were remarkably higher than those of the control group (40.38 +/- 12.47 vs 28. 19 +/- 6.59, 1.49 +/- 0.41 vs 1.22 +/- 0.31). The tubercle recurrence rate of the treatment group (14.0%, 7/50) was significantly lower than that of the control group (33.3%, 15/45) after 6 months of treatment (P < 0.05). CONCLUSION FYR combined with microwave ablation could elevate the therapeutic efficacy, enhance the patients' immunity, improve the liver function and the hepatic fibrosis degree.