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Everolimus is also known as Afinitor. On March 30, 2009, the FDA approved Everolimus for the treatment of patients with advanced kidney cancer after failure of treatment with Sunitinib or Sorafenib. Whereas Temsirolimus requires weekly intravenous administration, Everolimus is administered orally, providing a distinct advantage for patients. The dosage is 10mg of Everolimus every day, during a 28-day cycle, without interruption. Afinitor can be taken with or without food.
In 2008, the effectiveness and safety of Everolimus were evaluated in an international, multicenter, randomized, double-blind trial comparing Everolimus to placebo. In this study 416 patients with metastatic kidney cancer who had previously failed treatment with Sunitinib or Sorafenib were randomized to receive Everolimus. Prior therapy with Bevacizumab, Interleukin-2, or Interferon-α was also permitted. Everolimus resulted in a statistically significant improvement in progression-free survival (4.0 vs 1.9 mo; p < 0.0001). ). The treatment effect was similar across prognostic scores and prior treatment status. These results confirmed the activity of Everolimus in second- or third-line therapy, |
Adverse Effects:
The most common adverse reactions (incidence ≥30 percent) were stomatitis, infections, asthenia, fatigue, cough, and diarrhea. The most common grade 3/4 adverse reactions (incidence ≥ 3 percent) were infections, dyspnea, fatigue, stomatitis, dehydration, pneumonitis, abdominal pain, and asthenia. The most common laboratory abnormalities were anemia, hypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and increased creatinine (incidence ≥50 percent).
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