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- Title
A phase II trial of second-line axitinib following prior antiangiogenic therapy in advanced hepatocellular carcinoma.
- 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.
- Abstract
BACKGROUND 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. METHODS 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). RESULTS 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. CONCLUSIONS 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. Cancer 2015;121:1620-1627. © 2015 American Cancer Society.
- Subjects
LIVER cancer; PROTEIN-tyrosine kinase inhibitors; VASCULAR endothelial growth factors; DISEASE progression; CANCER patients; HYPERTENSION; PREVENTIVE medicine
- Publication
Cancer (0008543X), 2015, Vol 121, Issue 10, p1620
- ISSN
0008-543X
- Publication type
Article
- DOI
10.1002/cncr.29227