Last Friday, the U.S. Food and Drug Administration approved Novartis Pharmaceuticals’ drug Afinitor in combination with Aromasin to treat the relapse or progression of cancer after treatment in postmenopausal women.

“This is the first approval from the class of drugs known as mTOR inhibitors for the treatment of postmenopausal women with advanced hormone-receptor positive breast cancer,” stated Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Women with hormone-receptor positive, HER2-negative breast cancer may take the combination after treatment with Femara or Arimidex.

Breast cancer is the second leading cause of cancer-related death among women, according to the FDA’s website. About 226,870 new cases of invasive breast cancer will be diagnosed in women in 2012, according to the American Cancer Society. Though the numbers have decreased since 1990 due to early detection, improved treatment and advanced screenings, the American Cancer Society reports that about 39,510 women will die from the disease this year.

Common symptoms that occur with breast cancer

According to the U.S. National Library of Medicine, symptoms of early breast cancer are difficult to detect, but as the cancer grows, a woman may experience:

• a lump in the breast or in the armpit. The lump usually does not cause pain, but is hard to the touch;
• a change in how the breast or nipple appears or feels, including a difference in size, shape or redness;
• bloody, clear, yellow and/or green fluid leaking from the nipple.

The site also reports symptoms of a more advanced stage of breast cancer:

• pain or discomfort in the bones or in the breasts;
• skin ulcers;
• increased swelling of the arm closest to the cancer;
• Decreased weight.

The Clinical Trial

In the study, 724 postmenopausal women with HER2-negative breast cancer were given Afinitor combined with Aromasin, or a placebo in combination with Aromasin, after treatment with Femara or Arimidex.  The women continued their treatment until the cancer progressed or the side effects grew to be intolerable.

According to the FDA press release, this study was conducted to determine how long patients lived without their cancer progressing.  Results showed that patients who took the combination of Afinitor and Aromasin experienced a 4.6-month improvement time to cancer progression or death compared to those who were assigned the placebo-Aromasin combination.

Side effects

According to the FDA press release, patients reported the following side effects during the Afinitor study:

• ulcers of the mouth
• infections
• rash
• fatigue
• diarrhea
• decrease in appetite

Patients over age 65 should be monitored more often because they are likely to suffer serious side effects.