New Drug Dramatically Reduces Breast Cancer Risk

Welcome to Weekly Health Update


“A critical weekly review of important new research findings for health-conscious readers”




NEW DRUG DRAMATICALLY REDUCES BREAST CANCER RISK

Known risk factors for breast cancer include: (1) age greater than 60, (2) a previous personal history of breast cancer or precancerous conditions of the breast (such as atypical lobular hyperplasia, lobular carcinoma in situ, atypical ductal hyperplasia, or ductal carcinoma in situ), (3) one or more first degree relatives with breast cancer, (4) A personal history or family history of BRCA-1 or BRCA-2 hereditary breast and ovarian cancer gene mutations, (5) not having children, or having children after age 35, (6) multiple prior breast biopsies for non-cancer lumps, and (7) early-onset of menstruation, or late onset of menopause, as well as other less powerful breast cancer risk factors.

There are very few prescription medications available that significantly reduce the risk of developing cancer. However, for women who are at increased risk of developing breast cancer, the so-called SERMs (Selective Estrogen Receptor Modulators) can significantly reduce breast cancer risk. The most widely prescribed SERM is tamoxifen, which has been shown to decrease the risk of developing breast cancer, in high-risk women, by nearly 50 percent. However, while tamoxifen is commonly prescribed for women who have hormone-sensitive breast cancer (because this drug also reduces the risk of breast cancer recurrence in such cases), it is not widely prescribed for cancer prevention purposes.

There are several reasons why tamoxifen is not frequently prescribed as a breast cancer prevention medication. First of all, tamoxifen is most commonly prescribed by Oncologists, and so most primary care physicians are not comfortable enough with this medication to prescribe it. Secondly, tamoxifen has been associated with potentially serious side effects, including an increased risk of uterine cancer, blood clots in the veins and lungs, and cataracts. (Another SERM, raloxifene, does not appear to significantly increase the risk of uterine cancer, but this medication otherwise has the same potential side effects as tamoxifen.)

A new class of estrogen-blocking medications, aromatase inhibitors, is now commonly used in place of tamoxifen as hormone-blocking therapy in postmenopausal patients with breast cancer. Although aromatase inhibitors, like virtually all medications, have side effects of their own, they are not known to be associated with an increased risk of cancer or potentially life-threatening blood clots, like tamoxifen, and they appear to be even more effective in reducing the risk of breast cancer recurrence than tamoxifen and other SERMs.

Now, a newly published clinical research study, which appears in the current issue of the New England Journal of Medicine, has revealed that exemestane, an aromatase inhibitor, appears to be even more effective in preventing breast cancer than tamoxifen (as well as being safer, in terms of side effects, than tamoxifen).

This clinical research trial was a prospective, randomized, placebo-controlled, double-blinded study (which is the “gold standard” method of performing clinical research). A total of 4,560 women, ages 35 and older (the average age was 63 years), were enrolled in this clinical research study, and were secretly and randomly assigned to receive either exemestane or an identical-appearing placebo (“sugar pill”). These patient volunteers, all of whom were at increased risk of developing breast cancer, were then followed for an average of about 3 years.

By the end of the study, 11 women in the exemestane (treatment) group had developed breast cancer, while 32 women in the placebo (control) group were diagnosed with breast cancer. These findings translated into a 65 percent reduction in the risk of developing breast cancer associated with the use of exemestane in these high-risk women.

Although the prolonged use of aromatase inhibitors can lead to osteoporosis (“thinning” of the bones), there was no increase in the incidence of bone fractures or other skeletal complications noted among the women who took exemestane during the course of this research study. (Aromatase inhibitors can also cause significant bone and joint pain.) Indeed, during the course of this clinical study, there were no significant differences between the exemestane group and the placebo group in terms of side effects or complications.

Therefore, this breakthrough clinical research study showed that an aromatase inhibitor, exemestane, was more effective in preventing breast cancer in high risk women than tamoxifen and other SERMs; and unlike tamoxifen, exemestane did not appear to be associated with any significant side effects or complications following three years of treatment. Because of this clinically important combination of greater effectiveness and fewer side effects, this study’s findings are highly likely to change recommendations for the “chemoprevention” of breast cancer in women who are at an elevated risk of developing this most common of cancers in women. (One important caveat to note is that aromatase inhibitors, unlike tamoxifen and other SERMS, can only be used in postmenopausal women.)



 

For a comprehensive guide to living an evidence-based cancer prevention lifestyle, order your copy of my new book, A Cancer Prevention Guide for the Human Race.  For the price of a cheeseburger, fries, and a shake, you can purchase this landmark new book, in both paperback and e-book formats, and begin living an evidence-based cancer prevention lifestyle today!

For a groundbreaking overview of cancer risks, and evidence-based strategies to reduce your risk of developing cancer, order your copy of my new book, A Cancer Prevention Guide for the Human Race,” from Amazon, Barnes & Noble, Books-A-Million, Vroman’s Bookstore, and other fine bookstores!

On Thanksgiving Day, 2010, A Cancer Prevention Guide for the Human Race was ranked #6 among all cancer-related books on the Amazon.com “Top 100 Bestseller’s List” for Kindle e-books! On Christmas Day, 2010, A Cancer Prevention Guide for the Human Race was the #1 book on the Amazon.comTop 100 New Book Releases in Cancer” list!


Disclaimer:  As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity



Dr. Wascher is an oncologic surgeon, professor of surgery, cancer researcher, oncology consultant, and a widely published author



For a different perspective on Dr. Wascher, please click on the following YouTube link:

Texas Blues Jam



I and the staff of Weekly Health Update would again like to take this opportunity to thank the more than 100,000 health-conscious people, from around the world, who visit this premier global health information website every month. (More than 1.2 million health-conscious people visited Weekly Health Update in 2010!) As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can.





Bookmark and Share



 

 

Post to Twitter

Non-Compliance with Hormonal Therapy for Breast Cancer and Risk of Death

 

Welcome to Weekly Health Update


“A critical weekly review of important new research findings for health-conscious readers”


NON-COMPLIANCE WITH HORMONAL THERAPY FOR BREAST CANCER AND RISK OF DEATH

The management of breast cancer today bears little resemblance to the way that we managed this most common cancer among women when I entered medical school in the early 1980s.  Back then, both early-stage and advanced breast cancers were managed with a standard “one-size-fits-all” approach that included removal of the entire breast (mastectomy) and most of the lymph nodes in the armpit area (axillary lymph node dissection).  Twenty-five years ago, most women with breast cancer also received chemotherapy, while “hormonal therapy” for many premenopausal women with breast cancer consisted of the surgical removal of both ovaries (oopherectomy). 

In 2010, 85 to 90 percent of women are eligible to undergo breast-conserving surgery (“lumpectomy”).  Radical removal of the armpit lymph nodes has also become unnecessary for the majority of women with newly diagnosed breast cancer, as approximately two-thirds of women will be found to have normal armpit lymph nodes using a high-tech lymph node mapping procedure known as sentinel lymph node biopsy.  (Sentinel lymph node biopsy is associated with one-tenth the incidence of the risks associated with more radical lymph node dissections.)  Using a recently validated genetic test (Oncotype DX), many women with early-stage, favorable breast cancers can also safely choose to avoid chemotherapy, based upon the results of individualized “molecular” testing of their breast tumors. 

Instead of undergoing surgery to remove their ovaries, premenopausal women with hormone-sensitive breast cancers can now opt to take one of several different hormone-blocking medications (selective estrogen receptor modulators, or “SERMs”) for 5 years, to further reduce their risk of developing either a recurrence of their breast cancer or a new breast cancer.  For postmenopausal women with hormone-sensitive cancers, a different class of hormone blocking medications, the aromatase inhibitors (“AIs”), are often prescribed, also for 5 years.  These medications have been shown to reduce the risk of both recurrent breast cancer and new breast cancers by as much as 50 percent, and so they have become powerful clinical tools in our breast cancer prevention and treatment armamentarium.  However, as with almost all medications, SERMs and AIs are associated with some rather significant side effects.  In the case of SERMs, these side effects can include bone pain, hot flashes, nausea, mood swings, decreased libido, and constipation, among others.  Tamoxifen, the most commonly prescribed SERM, is also associated with a small but significant increase in the risk of uterine cancer.  (Raloxifene, the newest SERM to be approved for breast cancer prevention and treatment, appears not to significantly increase the risk of uterine cancer.)  Both of these SERMS are also associated with an increased risk of blood clots in the body, as well.  On the other hand, in addition to their potent ability to reduce the risk of both recurrent and new breast cancers, tamoxifen and raloxifene also decrease the risk of osteoporosis and osteoporosis-related bone fractures.

AIs are also associated with significant side effects in some patients, including hot flashes, bone and joint pain, mood changes, rash, headache, insomnia, and a small but significant increase in the risk of osteoporosis and osteoporosis-related bone fractures, among other symptoms and complications.

In view of the side effects profiles of SERMs and AIs, it is not surprising that patient compliance with these medications is an ongoing problem in the management of breast cancer (and, especially, among premenopausal women).  A newly published clinical research study in the journal Breast Cancer Research & Treatment reveals just how serious the issue of patient compliance with hormonal therapy is among breast cancer patients, as well as the significant impact of such noncompliance on the subsequent risk of death.

In this clinical study, performed by my Northern California Kaiser Permanente colleagues, 8,769 women diagnosed with hormone-sensitive breast cancer between 1996 and 2007 were evaluated.  One of the most powerful clinical assets of Kaiser Permanente is its comprehensive electronic health records system (“Health Connect”), which allows any Kaiser Permanente health care provider to access any individual patient’s detailed medical history, including diagnoses, past and current treatments (including surgeries and medications), lab results, radiology results, and other important clinical information.  This rich source of clinical information not only improves the quality and efficiency of care provided to patients, but it also serves as a powerful tool to conduct meaningful clinical research on large numbers of patients in an effort to further improve the delivery of high-quality health care.  (Indeed, Kaiser Permanente’s computerized medical records system is often held up as an example of what the future of electronic medical records should look like in the United States.)

The results of this study revealed the true potential costs of noncompliance with hormonal therapy among patients diagnosed with relatively early-stage hormone-sensitive breast cancers.  Among the nearly 9,000 women who filled at least an initial prescription for their breast cancer hormonal therapy medications, 31 percent subsequently discontinued their SERMs or AIs, and an additional 28 percent continued with hormonal therapy, but were not fully compliant in taking their SERMs or AIs.  (This combined 59 percent incidence of overall noncompliance is consistent with the 50 to 60 percent incidence of noncompliance with hormonal therapy that has been identified in previous clinical research studies.)

During an average follow-up period of 4.4 years, 831 of these 8,769 patients died.  Based upon the observed survival data collected in this study, the women who were compliant with their SERMs or AIs had a statistically predicted 10-year survival rate of 81 percent, while the women who prematurely discontinued their hormonal therapy had a predicted 10-year survival rate of 74 percent.  (The women who continued with their hormonal therapy, but who were not compliant with their daily doses, were projected to have an intermediate 10-year survival rate of 78 percent.) 

In the final analysis of their data, the authors of this study found that early discontinuation of hormonal therapy or continuing with hormonal therapy in a noncompliant manner were associated with a significant reduction in survival among patients with hormone-sensitive breast cancers.

The results of this study say two important things, in my mind.  The first is that SERMs and AIs significantly reduce the risk of death in patients with hormone-sensitive breast cancer (as has already clearly been shown by multiple prospective, randomized, blinded, placebo-controlled clinical research studies).  As with all medications, discontinuing hormonal therapies prematurely, or taking these important breast cancer medications in a haphazard manner, deprives breast cancer patients of the full potential benefits of SERMs and AIs.  The second important observation to be derived from this study is that we need to continue to search for new hormonal therapies with improved side effect profiles, to encourage better patient compliance with this important aspect of breast cancer prevention and treatment.

If you are a breast cancer survivor who has been prescribed hormonal therapy (or a woman who is at very high risk of developing breast cancer, and who been prescribed a SERM or AI for breast cancer prevention purposes), then you should make every effort to work together with your Oncologist to help you to remain compliant with your SERM or AI prescription, including the aggressive management of any unpleasant treatment side effects that you might be experiencing.

 

To learn more about an evidence-based approach to breast cancer prevention, watch for the publication of my new landmark book, “A Cancer Prevention Guide for the Human Race,” in September of this year.



 

Disclaimer: As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity


Dr. Wascher is an oncologic surgeon, a professor of surgery, a cancer researcher, an oncology consultant, and a widely published author



For a different perspective on Dr. Wascher, please click on the following YouTube link: 

 

Texas Blues Jam



I and the staff of Weekly Health Update would again like to take this opportunity to thank the more than 100,000 health-conscious people, from around the world, who visit our premier global health information website every month.  As always, we enjoy receiving your stimulating feedback and questions, and I will continue to try and personally answer as many of your inquiries as I possibly can.



 

Bookmark and Share



 

Post to Twitter

Better Tag Cloud