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Everolimus

In Advanced Renal Cell Carcinoma

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Abstract

  • ▲ Everolimus is an orally administered, targeted therapy indicated for the treatment of advanced renal cell carcinoma. It inhibits the mammalian target of rapamycin, an integral component of multiple pathways involved in cell growth and proliferation.

  • ▲ Median progression-free survival was significantly longer with everolimus 10 mg once daily than with placebo in both second interim (4.0 vs 1.9 months) and updated (4.9 vs 1.9 months) analyses of a randomized, double-blind, placebo-controlled, multicentre, phase III trial in patients with metastatic renal cell carcinoma that had progressed while receiving sunitinib and/or sorafenib treatment.

  • ▲ At the second interim analysis, median overall survival was 8.8 months for placebo recipients; at this analysis, overall survival had not yet been reached for everolimus recipients.

  • ▲ With regard to objective response at the second interim analysis, 64% of everolimus and 32% of placebo recipients had either a partial response (1% and 0%) or stable disease (63% and 32%).

  • ▲ The tolerability profile of everolimus was largely manageable in the phase III trial, with most treatment-related adverse events being of grade 1 or 2 severity.

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Acknowledgements and Disclosures

The manuscript was reviewed by: D. Cho, Division of Hematology and Oncology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA; I. Davis, Ludwig Institute for Cancer Research, Melbourne, Victoria, Australia.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Karly P. Garnock-Jones.

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Garnock-Jones, K.P., Keating, G.M. Everolimus. Drugs 69, 2115–2124 (2009). https://doi.org/10.2165/11203770-000000000-00000

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  • DOI: https://doi.org/10.2165/11203770-000000000-00000

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