Lenvatinib with or Without Everolimus in Patients with Metastatic Renal Cell Carcinoma After Immune Checkpoint Inhibitors and Vascular Endothelial Growth Factor Receptor‐Tyrosine Kinase Inhibitor Therapies
Introduction Lenvatinib (Len) plus everolimus (Eve) is an approved therapy for metastatic renal cell carcinoma (mRCC) after first‐line vascular endothelial growth factor receptor‐tyrosine kinase inhibitors (VEGFR‐TKIs), but limited data exist on the efficacy of Len ± Eve after progression on immune...
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Published in | The oncologist (Dayton, Ohio) Vol. 26; no. 6; pp. 476 - 482 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Hoboken, USA
John Wiley & Sons, Inc
01.06.2021
Oxford University Press |
Subjects | |
Online Access | Get full text |
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Summary: | Introduction
Lenvatinib (Len) plus everolimus (Eve) is an approved therapy for metastatic renal cell carcinoma (mRCC) after first‐line vascular endothelial growth factor receptor‐tyrosine kinase inhibitors (VEGFR‐TKIs), but limited data exist on the efficacy of Len ± Eve after progression on immune checkpoint inhibitors (ICIs) and VEGFR‐TKIs.
Methods
We retrospectively reviewed the records of patients with mRCC at our institution who were treated with Len ± Eve after ICI and VEGFR‐TKI. A blinded radiologist assessed objective response as defined by RECIST version 1.1. Descriptive statistics and the Kaplan‐Meier method were used.
Results
Fifty‐five patients were included in the analysis. Of these patients, 81.8% had clear‐cell histology (ccRCC), and 76.4% had International Metastatic RCC Database Consortium intermediate‐risk disease. Median number of prior therapies was four (range, 2–10); all patients had prior ICIs and VEGFR‐TKIs, and 80% were previously treated with ICI and at least two VEGFR‐TKIs, including cabozantinib. One patient (1.8%) achieved a complete response, and 11 patients (20.0%) achieved a partial response, for an overall response rate (ORR) of 21.8%; 35 patients (63.6%) achieved stable disease. In all patients, median progression‐free survival (PFS) was 6.2 months (95% confidence interval [CI], 4.8–9.4) and median overall survival (OS) was 12.1 months (95% CI, 8.8–16.0). In patients with ccRCC, ORR was 24.4%, PFS was 7.1 months (95% CI, 5.0–10.5), and OS was 11.7 months (95% CI, 7.9–16.1). 50.9% of patients required dose reductions and 7.3% discontinued treatment because of toxicity.
Conclusion
Len ± Eve demonstrated meaningful clinical activity and tolerability in heavily pretreated patients with mRCC after disease progression with prior ICIs and VEGFR‐TKIs.
Implications for Practice
As the therapeutic landscape for patients with metastatic renal cell carcinoma continues to evolve, this single‐center, retrospective review highlights the real‐world efficacy of lenvatinib with or without everolimus in heavily pretreated patients. This article supports the use of lenvatinib with or without everolimus as a viable salvage strategy for patients whose disease progresses after treatment with immune checkpoint inhibitors and vascular endothelial growth factor receptor‐tyrosine kinase inhibitor therapies, including cabozantinib.
This article reports on the efficacy and safety of lenvatinib alone or in combination with everolimus in patients with clear‐cell and non–clear‐cell metastatic renal cell carcinoma who previously received immune checkpoint inhibitor and VEGFR‐TKI therapies. |
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Bibliography: | commercialreprints@wiley.com . Disclosures of potential conflicts of interest may be found at the end of this article No part of this article may be reproduced, stored, or transmitted in any form or for any means without the prior permission in writing from the copyright holder. For information on purchasing reprints contact Disclosures of potential conflicts of interest may be found at the end of this article. No part of this article may be reproduced, stored, or transmitted in any form or for any means without the prior permission in writing from the copyright holder. For information on purchasing reprints contact commercialreprints@wiley.com. |
ISSN: | 1083-7159 1549-490X |
DOI: | 10.1002/onco.13770 |