For certain women with metastatic breast cancer, a bolero is no longer a fashion accessory but great news about a potentially life-prolonging cancer treatment.
Results of the international BOLERO-2 trial (Breast Cancer Trials of Oral Everolimus) released yesterday at the San Antonio Breast Cancer Symposium and discussed in a press briefing this morning show that the combination of everolimus (Afinitor/Novaris) and exemestane (Aromisin/Pfizer) represents a “new standard of care” in women with hormone resistant, metastatic breast cancer. These women, whose cancer is fueled by the estrogen, have disease that has advanced despite previous treatment with endocrine and/or chemotherapy.
This is good news from a number of angles:
1) Both are oral medications.
2) The new strategy delivers a “smart bomb” that specifically interrupts the molecular pathways involved in drug resistance. It continues the evolution in treatment that digs deeper into the biological mechanisms of the cell with each new generation of medications.
3) The everolimus/exemestane combination kept the cancer at bay for a median of 7.4 months compared to the 3.2 months for those who took exemestane alone with “modest addition of toxicity.” Those side effects, higher in the group with the drug combination, include shortness of breath, hyperglycemia, mouth sores and fatigue.
On the American Cancer Society Blog Len Lichtenfeld, M.D. wrote, “This study suggests that researchers could indeed produce remarkable results by rationally designing a treatment approach based on science where the hormone resistance was turned off and allowed a different hormone therapy to effectively treat the disease.”
Rational design. Elegant design. You hear these phrases attached to the larger and more significant trials. It’s the same principle as garbage in, garbage out. BOLERO-2 was expected to be successful because it expanded naturally from one finding to the next.
A drawback will be the cost. In this excellent article by AP’s Marilyn Marchione a one-month supply of Novartis AG’s Afinitor, originally developed as an anti-rejection agent for organ transplants, is listed at $11,000 per month. Another article in the Boston Globe listed the price as $7,000 per month.
You can listen to Gabriel Hortobagyi, M.D., director of the Multidiscliplinary Breast Cancer Research Program at the University of Texas MD Anderson Cancer Center, and lead investigator, discuss the trial here: http://www.onclive.com/conference-coverage/sabcs-2011/Dr-Hortobagyi-Discusses-the-BOLERO-2-Everolimus-Trial
This trial was funded by Novartis.