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

Abstract

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.

Successful Hepatic Arterial Infusion of Chemotherapy in a Patient with Advanced Hepatocellular Carcinoma and Impending Liver Failure

“…Consequently, treatment with sorafenib was possible after the disease progressed on HAIC treatment. This patient survived for more than 2 years, which is much longer than the reported median survival of patients with advanced HCC and CP class C liver reserve (1.5–4.0 months) [4]. …”

“…Among patients who received sorafenib, the median survival was approximately 5.2 and 2.6 months for patients with CP class B and C liver reserve, respectively [4]. HAIC has been reported to provide a numerically comparable median survival in patients with CP class B or C liver reserve [6, 7].…”

Prediction of post-progression survival in patients with advanced hepatocellular carcinoma treated with sorafenib by using time-dependent changes in clinical characteristics

“…Clinical trials of sorafenib showed the drug's efficacy in patients with a Child-Pugh score of ≤ 6. However, global [25] and Japanese [26] observational studies revealed that sorafenib treatment was often initiated in patients with a Child-Pugh score of 7 in clinical practice. Third, the target population of this study was heterogenous and included patients with BCLC-B and -C. However, sorafenib treatment is often used for HCC patients with BCLC-B who are refractory to TACE in clinical practice.…”

Postsorafenib systemic treatments for hepatocellular carcinoma: questions and opportunities after the regorafenib trial

“…These patients have a grim prognosis and, at the same time, are not usually accepted in second-line trials to minimize the risk of noncancer-related death due to progressive hepatic failure [52]. In general, the opportunity of systemic treatments (including sorafenib) in Child-Pugh B patients is still a controversial issue [17,18,53]. These aspects leave Child-Pugh B patients as an orphan category (at the present time only a dedicated cohort of the nivolumab trial is enrolling these patients in a frontline and second-line setting [33]).…”

“…Additionally, a number of studies suggested that a carefully selected subset of the Child-Pugh B population may benefit from sorafenib (i.e., Child-Pugh B7) [17,18]. Consequently, the search for second-line systemic treatments able to prolong life expectancy of Child-Pugh B7 patients has a scientific rationale and represents an open problem.…”