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.
4 comments:
Jody,
Thank you for such an informative, excellent posting. I'm livid that the drug is so darn expensive; it's just not fair.
Beth,
It's awful that we have to think about the cost when something that has proven beneficial has been demonstrated. This is especially true in the case of hormone positive breast cancers, which represent about 75% of all the cases.
In fact between the two big trial advances announced this year - there was clear progress in both hormone positive and HER2+ cancers with Genetech's new Pertuzumab. This will (just a guess) be more than Everolimus but I haven't seen a cost announced on that one yet, only guesses.
Thanks for reading,
Jody
Thanks for sharing information about Bolero. It is worth to know about.
Nice sharing and keep posting.
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