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On-Treatment Albumin-Bilirubin Grade: Predictor of Response and Outcome of Sorafenib-Regorafenib Sequential Therapy in Patients with Unresectable Hepatocellular Carcinoma.

ABSTRACT: In the RESORCE study, regorafenib after sorafenib therapy improved survival in patients with advanced hepatocellular carcinoma (HCC). In total, 88 patients with unresectable HCC who received sorafenib-regorafenib sequential therapy were enrolled. The objective response rate and disease control rate were 19.3% and 48.9%, respectively, for regorafenib therapy (median duration: 8.1 months). Median progression-free survival (PFS) after regorafenib therapy was 4.2 months (95% CI: 3.2-5.1). The median overall survival (OS; from initiation of either sorafenib or regorafenib) was not reached in this cohort. According to multivariate Cox regression analyses, albumin-bilirubin (ALBI) grade at the initiation of regorafenib therapy is an independent predictor of disease control, PFS, and OS. Moreover, the combination of ALBI grade 2 and an alpha-fetoprotein (AFP) level of ≥20 ng/mL was an independent predictor of PFS (hazard ratio (HR): 3.088, 95% CI: 1.704-5.595; p < 0.001) for regorafenib therapy, and OS for both regorafenib (HR: 3.783, 95% CI: 1.316-10.88; p = 0.014) and sorafenib-regorafenib sequential (HR: 4.603, 95% CI: 1.386-15.29; p = 0.013) therapy. A combination of ALBI grade and AFP level can be used to stratify patients with unresectable HCC by PFS and OS probability for sorafenib-regorafenib sequential therapy.

SUBMITTER: Wang HW

PROVIDER: S-EPMC8345148 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background and aimsRegorafenib has demonstrated its survival benefit for unresectable hepatocellular carcinoma (uHCC) patients in a phase III clinical trial. We aimed to assess the efficacy and tolerability of regorafenib and the predictors of treatment outcomes in Taiwanese patients.MethodsWe analyzed the survival, best overall response, predictors of treatment outcomes, and safety for uHCC patients who had tumor progression on sorafenib therapy and received regorafenib as salvage therapy between March 2018 and November 2020.ResultsEighty-six patients with uHCC were enrolled (median age, 66.5 years; 76.7% male). The median regorafenib treatment duration was 4.0 months (95% confidence interval [CI], 3.6-4.6). The most frequently reported adverse events were hand-foot skin reaction (44.2%), diarrhea (36.0%), and fatigue (29.1%). No unpredictable toxicity was observed during treatment. The median overall survival (OS) with regorafenib was 12.4 months (95% CI, 7.8-17.0) and the median progression-free survival (PFS) was 4.2 months (95% CI, 3.7-4.7). Of 82 patients with regorafenib responses assessable, 4 patients (4.9%) achieved a partial response, and 33 (40.2%) had stable disease, leading to a disease control rate (DCR) of 45.1% (n = 37). Patients possessing baseline AFP < 400 ng/ml exhibited a markedly longer median OS, median PFS, and higher DCR compared with their counterparts (15.7 vs. 8.1 months, 4.6 vs. 3.7 months, 60.9% vs. 27.5%, respectively). Despite possessing high baseline AFP levels, patients with early AFP response (>10% reduction at 4 weeks or >20% reduction at 8 weeks after regorafenib administration) exhibited comparable treatment outcomes to those with baseline AFP < 400 ng/ml.ConclusionsThe results of this real-world study verified the tolerability and efficacy of regorafenib treatment for uHCC patients who failed prior sorafenib therapy, especially for those with lower baseline AFP levels or with early AFP response.

Project description:BackgroundThe Child-Pugh score has been used extensively to assess hepatic function and predict post-treatment outcomes in patients with hepatocellular carcinoma (HCC). Recently, the albumin-bilirubin (ALBI) grade has been put forward as an objective method of evaluating liver function and predicting overall survival (OS) in HCC patients. Transarterial chemoembolization (TACE) is considered to be effective in prolonging OS among intermediate-stage HCC patients. This study aimed to explore and compare the performance of ALBI grade and Child-Pugh score in predicting outcomes for HCC patients who underwent TACE.MethodsThere were a total of 221 consecutive HCC patients enrolled in this study, all of whom received TACE and were enrolled retrospectively. The Kaplan-Meier method and time-dependent receiver operating curves (ROC) were used to estimate the discriminatory ability and survival prediction accuracy of ALBI grade and Child-Pugh score in predicting postoperative OS. Univariate and multivariate Cox regression analyses were performed to evaluate the prognostic factors for OS.ResultsOf the patients enrolled in the study, 106 (48.0%) were ALBI grade 1 and 115 (52.0%) were ALBI grade 2. Overall survival differed significantly between patients with ALBI-1 and ALBI-2 [hazard ratio (HR), 3.032; 95% CI, 2.019-4.555, P<0.001]. With regard to Child-Pugh scores, 160 (72.4%) patients had a score of A5 and 61 (27.6%) had a score of A6. There was also a difference in overall survival between patients with Child-Pugh-A5 and Child-Pugh-A6 (HR, 1.548; 95% CI, 1.066-2.247, P=0.022). In multivariate analyses, both ALBI grade and Child-Pugh score could significantly stratify the patients with different OS (HR, 2.994 and 1.545, P<0.001 and P=0.026 for ALBI grade and Child-Pugh score, respectively). Furthermore, time-dependent ROC analysis and its subgroup analyses demonstrated that the ALBI grade had a better discriminatory ability than Child-Pugh score in predicting survival.ConclusionsIn stratifying prognosis for HCC patients who had received TACE therapy, the ALBI grade provided better prognostic performance and discrimination of liver function than Child-Pugh score. These results suggest that ALBI grade could provide an alternative liver function grading system for stratification of patients with HCC.

Project description:BackgroundEvidence about the relationship between albumin-bilirubin (ALBI) grade and sequential systemic therapy for advanced hepatocellular carcinoma in real-world Japanese clinical practice is limited.ObjectiveThe objective of this study was to investigate ALBI grades and sequential treatment for advanced hepatocellular carcinoma in Japanese clinical practice.MethodsWe conducted a retrospective cohort study using a Japanese hospital-based administration database to assess treatment sequence in patients with confirmed advanced hepatocellular carcinoma and first prescription (index line) of lenvatinib (July 2014-June 2019; N = 1558) or sorafenib (July 2014-June 2016 [sorafenib-A; N = 1511] or June 2017-June 2019 [sorafenib-B; N = 1276]). Transition to subsequent line was assessed in patients who completed the index line without transarterial chemoembolization. The ALBI grade and sequential treatment relationships were analyzed in patients with baseline and/or end of index line ALBI scores.ResultsTransition to a subsequent line was low (sorafenib-A [n = 1320]: 12.6%; sorafenib-B [n = 1049]: 40.7%; lenvatinib [n = 786]: 27.2%). In patients with baseline ALBI data (combined cohorts; n = 385), overall treatment duration was shorter in those with baseline ALBI grade 2b or 3 vs grade 1 or 2a (median: 7.1, 6.7, 4.5, and 3.0 months for grades 1, 2a, 2b, and 3, respectively). In patients with baseline and end of index line ALBI data (combined cohorts; n = 222), ALBI grade worsened during index line regardless of baseline grade. Of these patients in the sorafenib-B or lenvatinib cohorts who completed the index line without transarterial chemoembolization (n = 120), transition to a subsequent line was higher with the end of index line grade 1/2a (66.7/68.4%) than with grade 2b/3 (34.0/11.1%).ConclusionsAdequate liver function, indicated by ALBI grade, at the start and end of first-line treatment is associated with successful sequential therapy in Japanese clinical practice.

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On-Treatment Albumin-Bilirubin Grade: Predictor of Response and Outcome of Sorafenib-Regorafenib Sequential Therapy in Patients with Unresectable Hepatocellular Carcinoma.

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