Baseline and Early Predictors of Good Patient Candidates for Second-Line after Sorafenib Treatment in Unresectable Hepatocellular Carcinoma

• Main Authors: Hitomi Takada, Masayuki Kurosaki, Kaoru Tsuchiya, Yasuyuki Komiyama, Jun Itakura, Yuka Takahashi, Hiroyuki Nakanishi, Yutaka Yasui, Nobuharu Tamaki, Chiaki Maeyashiki, Shun Kaneko, Kenta Takaura, Mayu Higuchi, Mao Okada, Wan Wang, Leona Osawa, Shuhei Sekiguchi, Yuka Hayakawa, Koji Yamashita, Nobuyuki Enomoto, Namiki Izumi
• Format: Article
• Language: English
• Published: MDPI AG 2019-08-01
• Series: Cancers
• Subjects: hepatocellular carcinoma; tyrosine kinase inhibitor; Child–Pugh score; albumin–bilirubin grade
• Online Access: https://www.mdpi.com/2072-6694/11/9/1256

<i>Background:</i> 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. <i>Methods:</i> 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&#8722;Pugh score 5, and criterion 3 was the inclusion criteria of the RESORCE study plus albumin&#8722;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. <i>Results:</i> 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 &gt;3.7 g/dL (odds ratio (OR) 2.7) plus degree of decrease in albumin (&#916;albumin) at week 4 &lt;0.2 g/dL (OR 2.6), or the combination of baseline ALBI score &lt;&#8722;2.33 (OR 2.5) and &#916;ALBI at week 4 &lt;0.255 (OR 4.9). For criterion 2, the value of baseline albumin and ALBI score was identical to criterion 1; however, &#916;albumin (&lt;0.1 g/dL) and &#916;ALBI score (&lt;0.19) became stricter. For criterion 3, the value of baseline albumin (&gt;3.8 g/dL) and ALBI (&lt;&#8722;2.55) became stricter, as did &#916;albumin (&lt;0.1 g/dL) and &#916;ALBI (&lt;0.085). Furthermore, tumor burden (&gt;11) was selected as an additional predictor (OR 5.4). <i>Conclusion:</i> 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 &#916;albumin or &#916;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.