Afinitor and Nexavar or Votrient

Everolimus has been approved by the US Food and Drug Administration (FDA) as the first oral, daily therapy (5 mg and 10 mg tablets) to treat advanced kidney cancer after failure of treatment with sunitinib or sorafenib. The NCCN lists it for both first and second line therapy. The approach of tailoring treatment with this drug in combination with other biologicals based on molecular profiles is potentially promising but it is not supported by the literature.

Afinitor is in several combination trials. One of them is Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer.Another active trial is: Sorafenib and RAD001 Renal Cell Carcinoma. The objective of the phase I part of the study is to determine the maximum tolerated dose and dose limiting toxicities of the combination of RAD001 and sorafenib in patients with untreated metastatic kidney cancer. Phase II part of the study will determine safety, response rate,progression free survival and time to disease progression in kidney cancer patients.

I had not been able to find any published studies of the combination of Votrient and Afinitor. I found one study: Pazopanib and Everolimus in Patients With Advanced Solid Tumors and Previously Treated Kidney Cancer, NCT01184326. This research study is evaluating the combination of pazopanib and everolimus in patients that have a malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective, or metastatic or locally advanced unresectable kidney cancer. In this research study the investigators are testing the safety of the combination of pazopanib and everolimus as well as to find the appropriate dose to use for further studies.

Afinitor, Prescribing Information

P. Cen, A. Daleiden, G. Doshi, R. Amato; A phase I study of everolimus plus sorafenib in patients with metastatic renal cell carcinoma (mRCC). J Clin Oncol 27, 2009 (suppl; abstr e16056)

nccn.org, kidney cancer 2012

 

Comments

[Jeff]

Thanks for this great article. I really appreciate you sharing it.