Efficacy and safety of REGORAFENIB in real life in the treatment of hepatocellular carcinoma. Multicenter experience

Fraile, María; Ferrer, María Teresa Martínez; Matilla, Ana; Lledó, José Luis; Mínguez, Beatriz; Hernández, Anjara; Perelló, Christie; Fernández-Castroagudín, Javier; Lope, Carlos Rodríguez de; Aguilar, M. D. Espinosa; Montoliu, Silvia; Sala, María; Romero-Gutiérrez, Marta; Pascual, S.; Urquijo, Juan José; Arraez, D.E.M.; Rodríguez, Miguel; Varela, M.

doi:10.1016/s0168-8278(18)30247-2

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“…We analyzed the safety profile for each major agent as well as the cumulative toxicity of the sequential treatment regimen. As reported [6, 7, 10, 19, 20], the TEAE profile of SOR and REG were dominated by HFS reactions with 38 and 30%, respectively. Interestingly, and probably due to a selection of SOR-tolerating patients for treatment with REG, toxicity was rather mild and did not lead to cessation or conversion of the treatment towards immunotherapy.…”

Section: Discussionsupporting

confidence: 70%

Sequential Systemic Treatment in Advanced Hepatocellular Carcinoma Is Able to Prolong Median Survival to More than 3 Years in a Selected Real-World Cohort

et al. 2020

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Introduction: The number of efficacious systemic agents for advanced hepatocellular carcinoma (HCC) has rapidly increased over the past 3 years. However, guidance for optimal sequential systemic treatment in patients with advanced disease and experience with outcome and safety profiles are lacking. Objective: We aimed to assess efficacy and tolerability of sequential systemic therapy of advanced HCC. Methods: Our single-center study prospectively followed 14 patients who received multiple, sequential systemic therapies after progression or intolerance to sorafenib. Endpoints were overall and progression-free survival (OS, PFS), objective response rate (ORR), and treatment-emergent adverse events (TEAE). Results: Patients had well-compensated liver function and good performance status at start of each systemic therapy. Agents included sorafenib (n = 14), regorafenib (n = 10), immunotherapy with nivolumab or pembrolizumab (n = 10), lenvatinib (n = 3), ramucirumab (n = 2), and others, with a median of 3 lines of systemic therapy per patient. Median OS was 37.4 months from initiation of first-line therapy with sorafenib. PFS and ORR for sorafenib, regorafenib, and immunotherapy were 6.6, 5.3, and 6.6 months, and 15.4, 11.1, and 22.2%, respectively. TEAE were frequent (46–80%), but mostly manageable during tyrosine kinase inhibitor therapy and without the need for termination in most patients. However, TEAE due to immunotherapy (60%) led to cessation of treatment in 40% of the patients. Conclusions: Sequential systemic therapy is able to prolong median OS in selected patients with advanced HCC to more than 3 years. TEAE are frequent, but manageable, and the quality of adverse events depends on the respective agent. Further investigation of potential predictive biomarkers for treatment allocation is needed.

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