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Modeling Spontaneous Metastatic Renal Cell Carcinoma (mRCC) in Mice Following Nephrectomy
Published on: April 29, 2014
Everolimus in renal cell carcinoma
1International Biomedical Communications, Frederick, MD, USA. Dr.Yanni.Wang@gmail.com
Abstract:
Everolimus (also known as RAD-001; Afinitor®) is an orally active inhibitor of the intracellular protein kinase mammalian target of rapamycin. The U.S. Food and Drug Administration and the European Medicines Agency recently approved everolimus for the treatment of advanced renal cell carcinoma (RCC) on the basis of the results of a randomized phase III clinical trial. In the trial, 10 mg daily everolimus was effective and well tolerated by patients with advanced RCC, whose disease had progressed while under the treatment with sunitinib and/or sorafenib. Everolimus treatment led to 36% of 6-month progression-free survival (PFS) rate and 31% of 3-month PFS rate. Most of the adverse events were mild to moderate (grade 1-2) in severity. The most frequent grade 3-4 adverse events were stomatitis, fatigue, pneumonitis and infections. Clinical trials on everolimus in combination with sunitinib, sorafenib, imatinib and vatalanib for the treatment of RCC are ongoing.
Insights
Everolimus (RAD-001) is an effective treatment for advanced renal cell carcinoma (RCC) that has progressed on other therapies. This oral medication demonstrated good tolerability and improved progression-free survival rates in patients with advanced RCC.
Area of Science:
- Oncology
- Pharmacology
Background:
- Advanced renal cell carcinoma (RCC) presents a significant therapeutic challenge.
- Prior treatments like sunitinib and sorafenib may not be effective for all patients.
- Mammalian target of rapamycin (mTOR) pathway inhibitors offer a novel therapeutic approach.
Purpose of the Study:
- To evaluate the efficacy and safety of everolimus in patients with advanced RCC.
- To determine the progression-free survival (PFS) rates associated with everolimus treatment.
- To identify the most common adverse events in patients receiving everolimus.
Main Methods:
- A randomized phase III clinical trial was conducted.
- Patients received 10 mg of everolimus daily.
- Disease progression was assessed based on predefined criteria.
Main Results:
- Everolimus demonstrated a 36% 6-month PFS rate and a 31% 3-month PFS rate.
- The treatment was generally well-tolerated, with most adverse events being mild to moderate.
- Frequent grade 3-4 adverse events included stomatitis, fatigue, pneumonitis, and infections.
Conclusions:
- Everolimus is an effective and well-tolerated treatment option for advanced RCC patients progressing on prior therapies.
- The drug offers a meaningful improvement in progression-free survival.
- Ongoing trials are exploring combination therapies involving everolimus for RCC treatment.
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