Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma

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dc.authoridChan, Stephen Lam/0000-0001-8998-5480
dc.authoridCicin, Irfan/0000-0002-7584-3868
dc.authoridPressiani, Tiziana/0000-0001-6919-1536
dc.authoridRimassa, Lorenza/0000-0001-9957-3615
dc.authoridzagonel, vittorina/0000-0002-0829-2525
dc.authorwosidChan, Stephen Lam/F-9149-2011
dc.authorwosidCicin, Irfan/AAQ-5575-2020
dc.authorwosidPressiani, Tiziana/HDN-8476-2022
dc.authorwosidRimassa, Lorenza/N-4884-2016
dc.authorwosidzagonel, vittorina/F-4226-2014
dc.contributor.authorAbou-Alfa, G. K.
dc.contributor.authorMeyer, T.
dc.contributor.authorCheng, A. -L.
dc.contributor.authorEl-Khoueiry, A. B.
dc.contributor.authorRimassa, L.
dc.contributor.authorRyoo, B. -Y.
dc.contributor.authorCicin, I.
dc.date.accessioned2024-06-12T11:19:01Z
dc.date.available2024-06-12T11:19:01Z
dc.date.issued2018
dc.departmentTrakya Üniversitesien_US
dc.description.abstractBACKGROUND Cabozantinib inhibits tyrosine kinases, including vascular endothelial growth factor receptors 1, 2, and 3, MET, and AXL, which are implicated in the progression of hepatocellular carcinoma and the development of resistance to sorafenib, the standard initial treatment for advanced disease. This randomized, double-blind, phase 3 trial evaluated cabozantinib as compared with placebo in previously treated patients with advanced hepatocellular carcinoma. METHODS A total of 707 patients were randomly assigned in a 2:1 ratio to receive cabozantinib (60 mg once daily) or matching placebo. Eligible patients had received previous treatment with sorafenib, had disease progression after at least one systemic treatment for hepatocellular carcinoma, and may have received up to two previous systemic regimens for advanced hepatocellular carcinoma. The primary end point was overall survival. Secondary end points were progression-free survival and the objective response rate. RESULTS At the second planned interim analysis, the trial showed significantly longer overall survival with cabozantinib than with placebo. Median overall survival was 10.2 months with cabozantinib and 8.0 months with placebo (hazard ratio for death, 0.76; 95% confidence interval [CI], 0.63 to 0.92; P = 0.005). Median progression-free survival was 5.2 months with cabozantinib and 1.9 months with placebo (hazard ratio for disease progression or death, 0.44; 95% CI, 0.36 to 0.52; P<0.001), and the objective response rates were 4% and less than 1%, respectively (P = 0.009). Grade 3 or 4 adverse events occurred in 68% of patients in the cabozantinib group and in 36% in the placebo group. The most common high-grade events were palmar-plantar erythrodysesthesia (17% with cabozantinib vs. 0% with placebo), hypertension (16% vs. 2%), increased aspartate aminotransferase level (12% vs. 7%), fatigue (10% vs. 4%), and diarrhea (10% vs. 2%). CONCLUSIONS Among patients with previously treated advanced hepatocellular carcinoma, treatment with cabozantinib resulted in longer overall survival and progression-free survival than placebo. The rate of high-grade adverse events in the cabozantinib group was approximately twice that observed in the placebo group.en_US
dc.description.sponsorshipExelixisen_US
dc.description.sponsorshipFunded by Exelixisen_US
dc.identifier.doi10.1056/NEJMoa1717002
dc.identifier.endpage63en_US
dc.identifier.issn0028-4793
dc.identifier.issn1533-4406
dc.identifier.issue1en_US
dc.identifier.pmid29972759en_US
dc.identifier.scopus2-s2.0-85049629953en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage54en_US
dc.identifier.urihttps://doi.org/10.1056/NEJMoa1717002
dc.identifier.urihttps://hdl.handle.net/20.500.14551/25054
dc.identifier.volume379en_US
dc.identifier.wosWOS:000437254200009en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherMassachusetts Medical Socen_US
dc.relation.ispartofNew England Journal Of Medicineen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectHepatocyte Growth-Factoren_US
dc.subjectC-Meten_US
dc.subjectSorafeniben_US
dc.subjectMetastasisen_US
dc.subjectEverolimusen_US
dc.subjectActivationen_US
dc.subjectExpressionen_US
dc.subjectReceptoren_US
dc.subjectVegfr2en_US
dc.subjectCanceren_US
dc.titleCabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinomaen_US
dc.typeArticleen_US

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