A phase II trial of second‐line axitinib following prior antiangiogenic therapy in advanced hepatocellular carcinoma. Issue 10 (6th January 2015)

• Record Type: Journal Article
• Authors: McNamara, Mairéad G.; Le, Lisa W.; Horgan, Anne M.; Aspinall, Alex; Burak, Kelly W.; Dhani, Neesha; Chen, Eric; Sinaei, Mehrdad; Lo, Glen; Kim, Tae Kyoung; Rogalla, Patrik; Bathe, Oliver F.; Knox, Jennifer J.
• Is Part Of: Cancer. Volume 121:Issue 10(2015)
• Page Start: 1620
• Page End: 1627
• Publication Date: 2015-01-06
• Subjects: Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.29227
• Languages: English
• ISSNs: 0008-543X

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="cncr29227-sec-0001" sec-type="section"> <title>BACKGROUND</title> <p>Second‐line treatment options in advanced hepatocellular carcinoma (HCC) are limited. Axitinib, a selective potent tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor VEGF) receptors 1, 2, and 3, merits exploration in HCC.</p> </sec> <sec id="cncr29227-sec-0002" sec-type="section"> <title>METHODS</title> <p>This was a single‐arm phase II trial of axitinib in advanced HCC. Eligible patients were Child‐Pugh A/B7, with measurable progressive disease after TKIs/antiangiogenic drugs. Axitinib was started at 5 mg twice daily orally, titrated from 2 to 10 mg twice daily as tolerated. The primary end point was tumor control at 16 weeks by RECIST1.1; secondary end points were response rate, comparing response by RECIST1.1 to Choi and modified RECIST, exploring dynamic contrast‐enhanced imaging models, safety, progression‐free (PFS), and overall survival (OS).</p> </sec> <sec id="cncr29227-sec-0003" sec-type="section"> <title>RESULTS</title> <p>Thirty patients were treated. Of 26 patients evaluable for response, there were 3 partial responses (PR) per RECIST1.1; 13 PR by Choi, 6 PR and 1 complete response by modified RECIST. Tumor control rate at 16 weeks was 42.3%. Two‐week perfusion changes were noted on functional imaging. Of 21 patients with evaluable α‐fetoprotein response, 43% had >50% decrease from baseline. Most common axitinib‐related grade 3/4 adverse events (AEs) were hypertension, thrombocytopenia and diarrhea. Of 11 patients with any grade hypertension, 7 had disease control >36wks. Four patients discontinued treatment due to AEs. Median PFS was 3.6months. Median OS was 7.1months.</p> </sec> <sec id="cncr29227-sec-0004" sec-type="section"> <title>CONCLUSIONS</title> <p>With 42.3% tumor control at 16weeks, primary endpoint was met. Axitinib has shown encouraging tolerable clinical activity in VEGF‐pretreated HCC patients but further study should be in a selected population incorporating potential biomarkers of response. <bold><italic>Cancer</italic> 2015;121:1620–1627</bold>. © <italic>2015 American Cancer Society</italic>.</p> </sec> </abstract>