ALBI grade: Evidence for an improved model for liver functional estimation in patients with hepatocellular carcinoma
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Abstract:
Hepatocellular carcinoma (HCC) usually arises in the context of a chronically damaged liver. Liver functional estimation is of paramount importance in clinical decision making. The Child-Pugh score (CPS) can be used to categorise patients into 3 classes (A to C) based on the severity of liver functional impairment according to 5 parameters (albumin, bilirubin, prothrombin time, presence of ascites and hepatic encephalopathy). The albumin-bilirubin (ALBI) grade has emerged as an alternative, reproducible and objective measure of liver functional reserve in patients with HCC, defining worsening liver impairment across 3 grades (I to III). The ALBI score can identify different subgroups of patients with different prognoses across the diverse Barcelona Clinic Liver Cancer stages and CP classes, making it an appealing clinical predictor. In patients treated with potentially curative approaches (resection, transplantation, radiofrequency ablation, microwave ablation), ALBI grade has been shown to correlate with survival, tumour relapse, and post-hepatectomy liver failure. ALBI grade also predicts survival, toxicity and post-procedural liver failure in patients treated with transarterial chemoembolisation, radioembolisation, external beam radiotherapy as well as multi-kinase inhibitors (sorafenib, lenvatinib, cabozantinib, regorafenib) and immune checkpoint inhibitor therapy. In this review, we summarise the body of evidence surrounding the role of ALBI grade as a biomarker capable of optimising patient selection and therapeutic sequencing in HCC.Keywords:
Lenvatinib
Regorafenib
Hepatic Encephalopathy
Liver Cancer
Cabozantinib
Regorafenib
Second line treatment
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There is a paucity of comparative data on the use of sorafenib and lenvatinib for unresectable hepatocellular carcinoma. We assessed the real-world treatment outcomes between using sorafenib and lenvatinib for unresectable hepatocellular carcinoma in the multiple molecular-targeted therapy era.We enrolled 386 patients treated with sorafenib or lenvatinib as the first-line therapy for unresectable hepatocellular carcinoma at multiple centers. Propensity score matching was performed to adjust for differences in baseline and tumor characteristics between the two groups. Propensity score matching identified 110 patients in each treatment group. The median overall survival was similar between lenvatinib and sorafenib (14.8 and 13.0 months, respectively; P = 0.352). The median progression-free survival was longer with lenvatinib than with sorafenib (7.6 and 3.9 months, respectively; P < 0.001). The overall response rate (P < 0.001) and disease control rate (P = 0.015), as defined by the modified Response Evaluation Criteria in Solid Tumors, were significantly better with lenvatinib than with sorafenib. The median overall survival was longer in patients who received subsequent treatment than in those who did not in the sorafenib group (23.1 and 5.7 months, respectively; P < 0.001), whereas the median overall survival with or without subsequent treatment did not differ significantly in the lenvatinib group (17.8 and 14.7 months, respectively; P = 0.439).Overall survival with sorafenib and lenvatinib was not significantly different. However, patients who received subsequent treatments had longer overall survival than those who received only first-line treatment with sorafenib, whereas lenvatinib did not show this effect.
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Abstract Background Although sorafenib was recommended as a first-line systemic therapy to prolong overall survival time in unresectable hepatocellular carcinoma (HCC), two randomized phase 3 noninferiority trials demonstrated that lenvatinib was noninferior to sorafenib in unresectable HCC. Methods This study included three trials containing 1462 patients identified by a database search using standard terms. We conducted the data analysis in Review Manager version 5.3 software. Results The outcomes showed that there were nonsignificant differences in OS of 6, 12, 18, 30 and 36 months, PFS of 18, 24, 30 and 36 months and AEs (grade < 3) between the lenvatinib group and the sorafenib group, and there were significant differences in OS of 24 months (p = 0.01), PFS of 6 (p < 0.00001) and 12 (p < 0.00001) months, ORR (p < 0.00001) and DCR (p < 0.00001) between the lenvatinib group and the sorafenib group. Conclusions Lenvatinib was not superior to sorafenib in terms of OS and AEs, and lenvatinib was superior to sorafenib in terms of secondary endpoints, including PFS, ORR and DCR, in unresectable HCC.
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Abstract: Hepatocellular carcinoma (HCC) is the second-most common cause of cancer-related death in the world. In spite of HCC surveillance with repeated imaging, about 50% of patients are diagnosed at an advanced stage and are not amenable to curative treatment options. Sorafenib, a multikinase inhibitor, remains the standard of care for advanced HCC. Over the last 5 years, several other medications have been tested in Phase III trials. However, they have not shown any added benefit over sorafenib. Regorafenib, another multikinase inhibitor, has demonstrated inhibition of a broader range of kinases, along with higher inhibition potential in preclinical models. After its safety and pharmacological properties was studied in Phase I trials, a Phase II study evaluating the role of Regorafenib in patients with advanced HCC who progressed on sorafenib therapy demonstrated efficacy and a manageable safety profile. A Phase III trial is ongoing, and its result will help us better evaluate the role of Regorafenib in patients with advanced HCC. Keywords: Regorafenib, hepatocellular carcinoma, HCC, advanced HCC, multikinase inhibitors
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Aim Sequential administration of sorafenib followed by regorafenib or lenvatinib is effective against advanced hepatocellular carcinoma (HCC). In this study, we compared the safety profiles and anti‐tumor effects of sequential sorafenib and regorafenib or lenvatinib therapy in patients with HCC. Methods We investigated adverse events, treatment responses and dose intensities in patients with HCC who were consecutively treated with sorafenib followed by regorafenib or lenvatinib at the individual level. Results Each group included 20 patients. The safety profiles of regorafenib and sorafenib were similar. The severity of hypophosphatemia, palmar‐plantar erythrodysesthesia syndrome, and decreased neutrophil counts associated with regorafenib or sorafenib was similar in 12 patients. Conversely, the incidences and grades of adverse events differed between sorafenib and lenvatinib treatment. The anti‐tumor effects of regorafenib and lenvatinib compared with sorafenib were significantly different for each patient. The response to treatment and progression‐free survival were comparable for regorafenib and lenvatinib. The median relative dose intensities during the first 56 days of regorafenib and lenvatinib treatment were 83.6 and 80.0%, respectively. Conclusions Similar adverse events were experienced by patients during consecutive treatment with sorafenib and regorafenib, which was not observed during treatment with sorafenib and lenvatinib. The obtained safety profile of sorafenib provided meaningful insights for selecting sequential therapy for patients with advanced HCC.
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Sorafenib has been used as a clinical targeted therapy for hepatocellular carcinoma (HCC) for more than a decade. In 2017, regorafenib was approved for HCC treatment and has since been reported to prolong the survival of advanced HCC patients after treatment failure with sorafenib. However, there has been no direct systematic comparison of the therapeutic effects of regorafenib and sorafenib against HCC. In this study, we comprehensively compared the therapeutic effects of sorafenib and regorafenib against HCC in vitro and in vivo using multimodality molecular imaging, which can show molecular and cellular differences at early stages. The side effects of sorafenib and regorafenib were also systematically evaluated. The data showed that compared with sorafenib treatment, regorafenib exerted stronger antitumor and antiangiogenic effects and significantly increased the survival rate of HCC mice. Sorafenib but not regorafenib treatment caused body weight loss and liver and kidney dysfunction, while regorafenib but not sorafenib treatment caused hypertension. Our study may provide an experimental basis for the guidance of clinical HCC targeted treatment with regorafenib and sorafenib.
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Hepatocellular carcinoma (HCC) is the second cause of cancer-related death worldwide with almost 1 million new cases per year. At the diagnosis, 70% of patients have only access to a palliative treatment with few therapeutic options mostly represented by tyrosine kinase inhibitors such as sorafenib and lenvatinib in first line; regorafenib and cabozantinib in second line.
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Ramucirumab
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