Dataset Information

Defining the Ideal Patient with Hepatocellular Carcinoma for Second-Line Treatment.

ABSTRACT: Background:Second line of treatment of hepatocellular carcinoma (HCC) has notably changed in recent years as three novel drugs with a different mechanism of action have demonstrated to improve survival compared to placebo; thus, there is a need to better define the profile of optimal candidates to second-line treatment with these drugs in order to maximize clinical benefit. Materials and Methods:We performed a pooled analysis from the subgroup analysis of all published phase III trials for approved targeted therapy in the second line of treatment for HCC, with the aim to discover possible clinical-pathological predictive factors. Results:Four studies were included in the analysis for a total of 2137 cases whose results supported the use of these novel agents in male patients with ECOG: 0, extrahepatic metastases, and HBV infection. Conclusions:Future studies are awaited to define best candidates for novel agents approved in the second line of treatment for HCC.

SUBMITTER: Roviello G

PROVIDER: S-EPMC7321521 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Defining the Ideal Patient with Hepatocellular Carcinoma for Second-Line Treatment.

Roviello Giandomenico G Casadei-Gardini Andrea A Nobili Stefania S Mini Enrico E Fancelli Sara S

Journal of oncology 20200619

<h4>Background</h4>Second line of treatment of hepatocellular carcinoma (HCC) has notably changed in recent years as three novel drugs with a different mechanism of action have demonstrated to improve survival compared to placebo; thus, there is a need to better define the profile of optimal candidates to second-line treatment with these drugs in order to maximize clinical benefit.<h4>Materials and methods</h4>We performed a pooled analysis from the subgroup analysis of all published phase III t ...[more]

PMID: 32655640

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Project description:: Background: Recent advances in the development of tyrosine kinase inhibitors (TKIs) have enabled patients with unresectable hepatocellular carcinoma (HCC) to receive multiple TKIs in sequence. The aim of this study was to identify predictors of good candidates for second-line treatment after disease progression during sorafenib treatment. Methods: This is a retrospective cohort study of 190 consecutive HCC patients who were treated with sorafenib in our hospital. Three criteria of good candidates for second-line TKI at the time of disease progression during sorafenib treatment were defined as follows: criterion 1 was the same as the inclusion criteria of the regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE) study, criterion 2 was the inclusion criteria of the RESORCE study plus Child-Pugh score 5, and criterion 3 was the inclusion criteria of the RESORCE study plus albumin-bilirubin (ALBI) grade 1. Factors at baseline and at week 4 during sorafenib treatment were used to predict patients fulfilling each of these three criteria. Results: The distribution of patients was 29%, 13%, and 6% in criteria 1, 2, and 3, respectively. Significant factors for meeting criterion 1 was the combination of baseline albumin >3.7 g/dL (odds ratio (OR) 2.7) plus degree of decrease in albumin (?albumin) at week 4 <0.2 g/dL (OR 2.6), or the combination of baseline ALBI score <-2.33 (OR 2.5) and ?ALBI at week 4 <0.255 (OR 4.9). For criterion 2, the value of baseline albumin and ALBI score was identical to criterion 1; however, ?albumin (<0.1 g/dL) and ?ALBI score (<0.19) became stricter. For criterion 3, the value of baseline albumin (>3.8 g/dL) and ALBI (<-2.55) became stricter, as did ?albumin (<0.1 g/dL) and ?ALBI (<0.085). Furthermore, tumor burden (>11) was selected as an additional predictor (OR 5.4). Conclusion: Predictors to satisfy the RESORCE study inclusion criteria were as follows: preserved liver function at baseline, as reflected by albumin or ALBI score, and small deterioration of liver function early during sorafenib therapy, as reflected by ?albumin or ?ALBI at week 4. Liver function at baseline and degree of change in liver function during sorafenib treatment need to be stricter for better outcomes of liver function with disease progression.

Dataset Information

Defining the Ideal Patient with Hepatocellular Carcinoma for Second-Line Treatment.

Publications

Defining the Ideal Patient with Hepatocellular Carcinoma for Second-Line Treatment.

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