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Clinical use of lenvatinib in combination with everolimus for the treatment of advanced renal cell carcinoma

Authors Leonetti A, Leonardi F, Bersanelli M, Buti S

Received 26 April 2017

Accepted for publication 29 May 2017

Published 30 June 2017 Volume 2017:13 Pages 799—806

DOI https://doi.org/10.2147/TCRM.S126910

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Amy Norman

Peer reviewer comments 3

Editor who approved publication: Professor Garry Walsh

Alessandro Leonetti, Francesco Leonardi, Melissa Bersanelli, Sebastiano Buti

Medical Oncology Unit, University Hospital of Parma, Parma, Italy

Introduction:
Renal cell carcinoma (RCC) represents 2%–3% of all cancers in adults, and its pathogenesis is mainly related to altered cellular response to hypoxia. Lenvatinib, a novel multitarget tyrosine kinase inhibitor (TKI), represents a therapeutic option, in combination with mammalian target of rapamycin (mTOR) inhibitor everolimus, for the treatment of metastatic RCC (mRCC).
Aim: The objective of this article is to review the evidence about the treatment of mRCC with combination of lenvatinib plus everolimus.
Evidence review: Phase I studies supported clinical activity of lenvatinib in mRCC. A randomized, Phase II, open-label, multicenter trial demonstrated the clinical efficacy of combination treatment with lenvatinib plus everolimus in patients with progressive mRCC after prior therapy with TKI. Median progression-free survival was improved by 9 months with the combination therapy compared to the single-agent everolimus, with an overall response rate of 43% for the experimental regimen. Lenvatinib plus everolimus appeared to be slightly less toxic than single-agent lenvatinib and more toxic than single-agent everolimus; grade 3–4 adverse events occurred in 71% of patients. Currently, lenvatinib plus everolimus has US Food and Drug Administration approval for its use in mRCC after failure of previous treatment with TKI.
Conclusion: The combination therapy with lenvatinib plus everolimus might be a promising choice for second-line treatment of mRCC patients. Based on the results of the Phase II trial, it is possible to speculate that the combination therapy could be appropriate for patients with high disease burden or strongly symptomatic patients.

Keywords: lenvatinib, everolimus, evidence-based review, renal cell carcinoma, RCC

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Everolimus in the management of metastatic renal cell carcinoma: an evidence-based review of its place in therapy

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