In a nutshell
This study examined the long-term safety of everolimus (Afinitor). Everolimus treatment was found to be safe, with adverse (negative) events that were managed by reducing treatment dosage, or breaking treatment for several weeks.
Some background
Everolimus is a therapy that slows cancer cell growth and increases cell death. In a previous study, everolimus used in combination with exemestane (Aromasin; a therapy that blocks the activity of estrogen hormones) safely and effectively reduced the risk of disease progression by 57% compared to a placebo (substance with no effect on the body). The long-term safety of this treatment, however, was not reported.
Methods & findings
The current study examined the long-term safety of everolimus, as well as the time course of negative effects experienced.
720 post-menopausal women with hormone receptor positive (HR+) breast cancer were included in this study. 482 patients were treated with everolimus and exemestane (group 1). 238 patients were treated with a placebo and exemestane (group 2). Patients were followed for an average of 18 months. 100% of group 1 patients and 91% of group 2 patients experienced adverse (negative) effects.
Stomatitis (inflammation of the oral cavity) was experienced by 67% of group 1 and 12% of group 2. For group 1 patients, one third of the instances of stomatitis were reported in the first two weeks of treatment.
Pneumonitis (inflammation of the lungs) was reported by 20% in group 1, and by less than 1% in group 2. One quarter of the instances of pneumonitis among group 1 patients were reported in the first 12 weeks of treatment.
Hyperglycemia (low blood sugar levels) developed in 16% of patients in group 1, and in 3% of patients in group 2. Serious hypoglycemia was reported in 6% of group 1, and 1% of group 2 patients.
Patients in group 1 also reported increased rates of fatigue compared to group 2.
Treatment breaks or dose reductions were needed in 62% of group 1 patients and in 12% of group 2 patients. 44% of the group 1 patients resumed the full dose after break. 76% of the adverse events leading to dose interruption or reduction resolved within 2 weeks.
The bottom line
This study concluded that everolimus has an acceptable long-term safety profile, and that negative effects can be managed by dose reduction or a break from treatment.
The fine print
This study was funded by Novartis, the manufacturer of everolimus.
Published By :
Annals of oncology
Date :
Mar 11, 2014
