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Afinitor® (everolimus) may be a promising treatment option for patients with metastatic gastric cancer who have undergone previous treatment, according to a study published in the Journal of Clinical Oncology.

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 regulating cancer cell division and blood vessel growth. It was approved in 2009 for the treatment of selected patients with advanced renal cell (kidney) cancer.

Findings from Phase I studies have indicated that Afinitor may be effective in the treatment of advanced gastric cancer. This recent Phase II study further evaluated Afinitor’s activity among patients with previously treated advanced gastric cancer as well as its safety.

Data were collected from 53 patients with advanced gastric cancer whose disease had progressed following prior therapy. All patients received daily doses of Afinitor during the course of the study. The researchers primarily studied disease control rate (DCR)­—including complete response, partial response, and stable disease—and also evaluated progression-free survival, overall survival, and safety.

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A decrease in tumor size from the beginning of the study was observed in 45% of patients. Even though no complete or partial responses were observed, this decrease in tumor size contributed to a “promising DCR,” according to the researchers. Other outcomes included a progression-free survival of almost three months and an overall survival of approximately 10 months, both at a median follow-up of 9.6 months. Side effects (including anemia and hyponatremia, an electrolyte disturbance) were consistent with previous studies of Afinitor.

The researchers concluded that Afinitor produced a promising rate of disease control in this patient population. Further study of Afinitor in a Phase III trial is therefore warranted.

Reference: Doi T, Muro K, Boku N, et al.Multicenter Phase II study of everolimus in patients with previously treated metastatic gastric cancer. Journal of Clinical Oncology. 2010 Apr 10;28(11):1904-10.