Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

Ji, Youxin; Zhang, Zhongfa; Lan, Ketao; Nie, Keke; Geng, Chang‐Xin; Liu, Shichao; Zhuang, Xun; Zou, X.M; Sun, Lei; Zhang, Zong-chun

doi:10.1016/s1001-9294(14)60017-1

Cited by 15 publications

(21 citation statements)

References 14 publications

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“…The poor OS, paired with an higher rate of serious adverse events (AEs) compared to the more compensated patients, questioned the overall risk/benefits balance 10 . Previous reports 11 – 13 had also reached similar conclusions.…”

Section: Introductionsupporting

confidence: 84%

Metronomic capecitabine vs. best supportive care in Child-Pugh B hepatocellular carcinoma: a proof of concept

Lorenzo

Tovoli

Barbera

et al. 2018

Sci Rep

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There is a relative lack of evidence about systemic treatments in patients with hepatocellular carcinoma (HCC) and moderate liver dysfunction (Child-Pugh B). In this multicenter study we retrospectively analyzed data from Child-Pugh B-HCC patients naïve to systemic therapies, treated with MC or best supportive care (BSC). To reduce the risk of selection bias, an inverse probability of treatment weighting approach was adopted. Propensity score was generated including: extrahepatic spread; macrovascular invasion; performance status, alphafetoprotein > 400 ng/ml, Child- Pugh score [B7 vs. B8–9]. We identified 35 MC-treated patients and 70 controls. Median overall survival was 7.5 [95% CI: 3.733–11.267]in MC-patients and 5.1 months [95% CI: 4.098–6.102] in the BSC group (p = 0.013). In patients treated with MC, median progression-free survival was 4.5 months (95% CI: 2.5–6.5). The univariate unweighted Cox regression showed a 42% reduction in death risk for patients on MC (95%CI: 0.370–0.906; p = 0.017). After weighting for potential confounders, death risk remained essentially unaltered. In the MC group, 12 patients (34.3%) experienced at least one adverse event, the most common of which were: fatigue (17.1%), hand-foot syndrome (8.5%), thrombocytopenia (8.5%), and neutropenia (5.7%). MC seems a safe option for Child-Pugh B-HCC patients. Its potential antitumour activity warrants prospective evaluations.

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Section: Introductionsupporting

confidence: 84%

Metronomic capecitabine vs. best supportive care in Child-Pugh B hepatocellular carcinoma: a proof of concept

Lorenzo

Tovoli

Barbera

et al. 2018

Sci Rep

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“…However, because of the observational nature of the GIDEON study and lack of a control, the efficacy of sorafenib in Child-Pugh B patients cannot be assessed. Previous reports suggest that while Child-Pugh B patients have poorer outcomes compared with Child-Pugh A, sorafenib may offer clinical benefit in carefully selected Child-Pugh B patients [24,26,27].…”

Section: Discussionmentioning

confidence: 99%

Observational registry of sorafenib use in clinical practice across Child-Pugh subgroups: The GIDEON study

Marrero

Kudo

Venook

et al. 2016

Journal of Hepatology

314

295

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The GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib) study is a large prospective registry of patients with liver cancer who were treated with sorafenib. The aims were to evaluate the safety and tolerability of sorafenib among those in which the liver was not functioning properly. The study showed that the safety profile of sorafenib was consistent across patients with preserved liver function and those in which the liver was not functioning properly, and therefore, suggesting that sorafenib may be a valid treatment for some patients with liver impairment.

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“…Finally, 57 records (representing 50 trials) were included in the SLR. These 50 trials included 34 trials in the 1L setting (six single arm [30][31][32][33][34][35], six RCTs comparing against a recommended treatment or placebo [36][37][38][39][40][41][42][43], one trial with both single arm and randomized groups [44], and 26 RCTs comparing against a non-recommended treatment ) and 11 trials in the 2L setting (five single arm [71][72][73][74][75][76], five RCTs comparing against placebo [77][78][79][80][81][82], and one trial with both single arm and randomized groups [83][84][85][86]).…”

Section: Resultsmentioning

confidence: 99%

Systematic Literature Review of Trials Assessing Recommended Systemic Treatments in Hepatocellular Carcinoma

et al. 2021

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Aim: To identify and evaluate the similarity of all trials assessing recommended treatments for advanced hepatocellular carcinoma. Materials & methods: Single arm and randomized trials from any phase and published any time up to February 2021 were systematically searched. Results: From 5677 records reviewed, 50 trials were included in the review, and 24 for assessed for similarity. In the first-line (1L) setting, several trials assessing sorafenib were noted for enrolling patients with more severe disease and/or performance status than other 1L trials; trials within the second-line (2L) setting were generally similar. Median survival was <2 years in all trial arms. Conclusions: Trials assessing recommended treatments are largely similar and appropriate for quantitative comparisons of several efficacy and safety outcomes.

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Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

Abstract: Sorafenib is safe in patients with liver function impaired advanced HCC. It is effective in terms of progression-free survival and overall survival compared with best supportive care. Liver functions are the important predictive factors.

Cited by 15 publications

References 14 publications

Metronomic capecitabine vs. best supportive care in Child-Pugh B hepatocellular carcinoma: a proof of concept

Metronomic capecitabine vs. best supportive care in Child-Pugh B hepatocellular carcinoma: a proof of concept

Observational registry of sorafenib use in clinical practice across Child-Pugh subgroups: The GIDEON study

Systematic Literature Review of Trials Assessing Recommended Systemic Treatments in Hepatocellular Carcinoma

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