by Dr. C.H. Weaver M.D. updated 2/2019

According to the results of a Phase II clinical trial, roughly 70% of patients with metastatic renal cell (kidney) cancer experienced either a reduction in detectable cancer or stable disease following treatment with Afinitor® (everolimus). These results were published in Cancer.

The kidneys are filled with tiny tubules that clean and filter the blood; this process removes waste and makes urine. Renal cell cancer (RCC) is a malignancy involving these tubules of the kidney.

Afinitor is an oral targeted therapy that works by inhibiting a protein known as the mammalian target of rapamycin (mTOR). The mTOR protein plays an important role in the growth, division, and metabolism of cancer cells. Afinitor has been approved for the treatment of patients with advanced renal cell cancer that has progressed after treatment with Sutent® (sunitinib) or Nexavar® (sorafenib).

The current study evaluated Afinitor among 37 patients with metastatic, clear cell RCC. Clear cell RCC is the most common type of RCC.

A majority of the patients had received prior systemic therapy, most commonly with interleukin-2 or interferon.

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Patients were treated with Afinitor at a dose of 10 mg per day. Treatment continued until cancer progression or the development of unacceptable side effects.

  • 14% of patients had a partial response to treatment (a reduction in detectable cancer).
  • 57% of patients had cancer that remained stable for at least six months.
  • Median survival without cancer progression was 11.2 months. Median overall survival was 22.1 months.
  • Common side effects included nausea, loss of appetite, diarrhea, stomatitis (inflammation of the mucous membranes in the mouth), pneumonitis (inflammation of the lungs), and rash.

These results provide additional evidence that Afinitor is active against metastatic RCC.

Reference: Amato RJ, Jac J, Giessinger S et al. A phase 2 study with a daily regimen of the oral mTOR inhibitor RAD001 (everolimus) in patients with metastatic clear cell renal cell cancer. Cancer [early online publication]. March 20, 2009.

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