Thymosin α1 therapy subsequent to radical hepatectomy in patients with hepatitis B virus-associated hepatocellular carcinoma: A retrospective controlled study

Liang, Yongrong; Guo, Zhe; Jiang, Jing‐Hang; Xiang, Bang‐De; Li, Le‐Qun

doi:10.3892/ol.2016.5121

Cited by 6 publications

(5 citation statements)

References 21 publications

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“…Although these clinical outcomes were not systematically reviewed, one study included in this meta-analysis reported that ETV plus Tα1 combination group had a lower incidence of HCC after treatment of 51 weeks, and yet had no bene ts in clinical outcomes regarding ascites, hepatic encephalopathy, variceal hemorrhage and liver stiffness, in comparison with ETV alone group [26]. The results were consistent with the study of Liang YR, which indicated that Tα1 therapy improves liver function and obviously extend recurrence-free and overall survival for patients with HBV-related HCC [37]. Unfortunately, the participants of RCTs were from Chinese mainland.…”

Section: Discussionsupporting

confidence: 71%

The Clinical Efficacy and Adverse Effects of Entecavir plus Thymosin alpha-1 Combination Therapy versus Entecavir Monotherapy in HBV-related Cirrhosis: A Systematic Review and Meta-analysis

Peng

Huang

et al. 2020

Preprint

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Background Previous studies have demonstrated the benefits of thymosin alpha-1 (Tα1) in anti-virus, immunological enhancement and anti-inflammation. However, it is controversial about the efficacy and safety of entecavir (ETV) plus T α1 combination therapy versus ETV monotherapy in cirrhotic patients with hepatitis B virus (HBV) infection. Methods The systematic review and meta-analysis of randomized clinical trials (RCTs) were performed to evaluate the efficacy and safety of ETV plus Tα1 combination therapy versus ETV monotherapy in HBV -related patients with cirrhosis. We performed a systematic literature search on seven databases. Relative risk (RR) and standardized mean difference (SMD) with a fixed- or random- effect model were calculated. Heterogeneity was assessed through a Cochrane Q-test and I 2 values. Results Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis. Compared with ETV monotherapy, ETV plus Tα1 combination therapy led to a higher complete response. In post treatment for 24 weeks, the HBV DNA undetectable rate and HBeAg loss rate were higher in ETV plus Tα1 group than in ETV alone group. However, after 48 and 52 weeks of treatment, there was no significant difference between the combination therapy and ETV monotherapy. At week 52 of treatment, the HBsAg loss rate of ETV plus Tα1 group was no significance with that of ETV alone group. In comparison with ETV alone, the some biochemical parameters and liver fibrosis were obviously improved by ETV plus Tα1 , and there was significant heterogeneity. In addition, the number of adverse events was significantly reduced by ETV plus Tα1, compared to ETV alone. Conclusions ETV plus Tα1 might lead to a higher clinical response and a lower comprehensive adverse reaction rate in HBV-related patients with cirrhosis, compared to ETV alone. However, the whole patients included in this meta-analysis were from Chinese mainland, so that more worldwide RCTs with a larger sample size are needed to verify the current findings.

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Section: Discussionsupporting

confidence: 71%

The Clinical Efficacy and Adverse Effects of Entecavir plus Thymosin alpha-1 Combination Therapy versus Entecavir Monotherapy in HBV-related Cirrhosis: A Systematic Review and Meta-analysis

Peng

Huang

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

“…Although these clinical outcomes were not systematically reviewed, one study included in this meta-analysis reported that ETV plus Tα1 combination group had a lower incidence of HCC after treatment of 51 weeks, and yet had no benefits in clinical outcomes regarding ascites, hepatic encephalopathy, variceal hemorrhage and liver stiffness, in comparison with ETV alone group [26]. The results were consistent with the study of Liang YR, which indicated that Tα1 therapy improves liver function and obviously extend recurrence-free and overall survival for patients with HBV-related HCC [37]. Unfortunately, the participants of RCTs were from Chinese mainland.…”

Section: Discussionsupporting

confidence: 69%

The clinical efficacy and adverse effects of Entecavir plus Thymosin alpha-1 combination therapy versus Entecavir Monotherapy in HBV-related cirrhosis: a systematic review and meta-analysis

Peng

Xing

et al. 2020

BMC Gastroenterol

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Background Previous studies have demonstrated the benefits of thymosin alpha-1 (Tα1) in anti-virus, immunological enhancement and anti-inflammation. However, it is controversial about the efficacy and safety of entecavir (ETV) plus Tα1 combination therapy versus ETV monotherapy in cirrhotic patients with hepatitis B virus (HBV) infection. Methods The systematic review and meta-analysis of randomized clinical trials (RCTs) were performed to evaluate the efficacy and safety of ETV plus Tα1 combination therapy versus ETV monotherapy in HBV-related patients with cirrhosis. We performed a systematic literature search via PubMed, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Science and Technology Journals Database (VIP), and Chinese Biological Medicine database (CBM). Relative risk (RR) and standardized mean difference (SMD) with a fixed- or random- effect model were calculated. Heterogeneity was assessed through a Cochrane Q-test and I2 values. Results Seven RCTs involving 1144 subjects were included in the systematic review and meta-analysis. Compared with ETV monotherapy, ETV plus Tα1 combination therapy led to a higher complete response (RR = 1.18; 95% CI, 1.07–1.30). In post treatment for 24 weeks, the HBV DNA undetectable rate and HBeAg loss rate were higher in ETV plus Tα1 group than in ETV alone group (RR = 1.91; 95% CI, 1.56–2.35; RR = 2.05; 95% CI, 1.62–2.60). However, after 48 and 52 weeks of treatment, there was no significant difference between the combination therapy and ETV monotherapy (RR = 1.07; 95% CI, 0.96–1.18; RR = 1.17; 95% CI, 0.89–1.55). At week 52 of treatment, the HBsAg loss rate of ETV plus Tα1 group was no significance with that of ETV alone group (RR = 1.03; 95% CI, 0.15–7.26). In comparison with ETV alone, the some biochemical parameters and liver fibrosis were obviously improved by ETV plus Tα1, and there was significant heterogeneity. In addition, the number of adverse events was significantly reduced by ETV plus Tα1, compared to ETV alone (RR = 0.48; 95% CI, 0.24–0.95). Conclusions ETV plus Tα1 might lead to a higher clinical response and a lower comprehensive adverse reaction rate in HBV-related patients with cirrhosis, compared to ETV alone. However, the whole patients included in this meta-analysis were from Chinese mainland, so that more worldwide RCTs with a larger sample size are needed to verify the current findings.

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“…As compared to patients that received only liver resection, patients treated with Tα1 had higher overall survival and recurrence-free survival, together with a reduced neutrophil-to-lymphocyte ratio, pointing to the use of Tα1 in patients at high risk for recurrence after resection (71). The administration of Tα1 also proved effective in improving liver function and increasing overall survival and recurrence-free survival in a retrospective study evaluating patients with HBV-associated HCC after radical hepatectomy (72).…”

Section: Thymosin α1 and Hepatocellular Carcinomamentioning

confidence: 99%

A Reappraisal of Thymosin Alpha1 in Cancer Therapy

et al. 2019

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Thymosin alpha1 (Tα1), an endogenous peptide first isolated from the thymic tissue in the mid-sixties, has gained considerable attention for its immunostimulatory activity that led to its application to diverse pathological conditions, including cancer. Studies in animal models and human patients have shown promising results in different types of malignancies, especially when Tα1 was used in combination with other chemo- and immune therapies. For this reason, the advancements in our knowledge on the adjuvant role of Tα1 have moved in parallel with the development of novel cancer therapies in a way that Tα1 was integrated to changing paradigms and protocols, and tested for increased efficacy and safety. Cancer immunotherapy has recently experienced a tremendous boost following the development and clinical application of immune checkpoint inhibitors. By unleashing the full potential of the adaptive immune response, checkpoint inhibitors were expected to be very effective against tumors, but it soon became clear that a widespread and successful application was not straightforward and shortcomings in efficacy and safety clearly emerged. This scenario led to the development of novel concepts in immunotherapy and the design of combination protocols to overcome these limitations, thus opening up novel opportunities for Tα1 application. Herein, we summarize in a historical perspective the use of Tα1 in cancer, with particular reference to melanoma, hepatocellular carcinoma and lung cancer. We will discuss the current limitations of checkpoint inhibitors in clinical practice and the mechanisms at the basis of a potential application of Tα1 in combination protocols.

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Thymosin α1 therapy subsequent to radical hepatectomy in patients with hepatitis B virus-associated hepatocellular carcinoma: A retrospective controlled study

Cited by 6 publications

References 21 publications

The Clinical Efficacy and Adverse Effects of Entecavir plus Thymosin alpha-1 Combination Therapy versus Entecavir Monotherapy in HBV-related Cirrhosis: A Systematic Review and Meta-analysis

The Clinical Efficacy and Adverse Effects of Entecavir plus Thymosin alpha-1 Combination Therapy versus Entecavir Monotherapy in HBV-related Cirrhosis: A Systematic Review and Meta-analysis

The clinical efficacy and adverse effects of Entecavir plus Thymosin alpha-1 combination therapy versus Entecavir Monotherapy in HBV-related cirrhosis: a systematic review and meta-analysis

A Reappraisal of Thymosin Alpha1 in Cancer Therapy

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