Friday, September 30, 2011
Zometa for Early-Stage Breast Cancer: Hormones May Matter
Can Zometa (zoledronic acid) prevent recurrence in women with early-stage breast cancer? Today we'll share the latest news and research. Links may be found on the Zometa (zoledronic acid) page of our website.
A new role for Zometa
Zometa is a bisphosphonate often prescribed to prevent bone loss in women taking aromatase inhibitors for breast cancer. It's also used to treat bone metastases in women with stage IV breast cancer.
Recent studies suggest Zometa may also prevent recurrence in women with early-stage breast cancer, but the results have been inconsistent. A new study in the New England Journal of Medicine suggests the key may lie in the hormonal status of the patient.
June: Zometa benefits premenopausal women on Zoladex and hormone therapy
A June 3 study in The Lancet Oncology evaluated Zometa in premenopausal women with hormone-receptor positive, stage I or II breast cancer, who were taking Zoladex (goserelin) for ovarian supression. (Drugs.com covered the study on June 3.)
About half of the 1,803 women took Zometa plus tamoxifen or Arimidex (anastrozole). The rest took tamoxifen or Arimidex alone.
At about 5 years follow-up, more than 2 years after completion of treatment with Zometa, 8% (76/900) of the Zometa group experienced a recurrence, compared to 12% (110/903) of the tamoxifen or Arimidex alone group. There was no significant difference in overall survival. (30 deaths out of 900 women taking Zometa, 43 out of 903 not taking Zometa.)
The authors concluded that the addition of Zometa "improved disease-free survival in the patients taking anastrozole or tamoxifen." They added, "These data show persistent benefits with zoledronic acid and support its addition to adjuvant endocrine therapy in premenopausal patients with early-stage breast cancer."
September: Zometa may only benefit postmenopausal women
In a September 25 New England Journal of Medicine study, about half of the 3,360 women with early-stage breast cancer were treated with Zometa plus standard chemo and hormone therapy. The rest received standard therapy alone. Patients varied in age, menopausal and hormone-receptor status.
In contrast to the Lancet study, at 5 years follow-up, the New England Journal of Medicine study found "no improvement" in disease-free survival for women with early-stage breast cancer taking Zometa. The authors concluded that their findings, "do not support the routine use of zoledronic acid as adjuvant therapy in unselected patients with early-stage breast cancer."
However, when the study participants were evaluated by subgroup, Zometa seemed to benefit postmenopausal women. (Reuters and Medical News Today covered this aspect of the study on September 25.) Zometa improved both disease-free survival (recurrence) rates and overall survival (death) rates for the group who had undergone menopause more than 5 years earlier.
The authors concluded, "For postmenopausal women, the use of bisphosphonates remains appropriate for the prevention of treatment-induced bone loss and osteoporosis and might have beneficial effects on disease outcomes. The optimum schedule, duration, and type of bisphosphonate therapy remain unknown."
Hormonal status may be the key
How do we reconcile these two studies? One found a benefit for premenopausal patients, the other did not. The answer may lie in the hormonal status of the patients.
The New England Journal of Medicine study noted that from a hormonal perspective, the postmenopausal patients in its study were similar to the premenopausal patients in the Lancet study who were treated with Zoladex for ovarian suppression. Both groups "had low levels of reproductive hormones at study entry." The authors suggest that Zometa "operates differently according to menopausal status."
Finally, the authors note that even though chemotherapy may induce menopause in young women, complete ovarian suppression may take "many months." They conclude, "Further investigation into the possible interaction between zoledronic acid and reproductive hormones is required."
At LATESTBreastCancer.com, we'll continue to follow developments in research on Zometa for breast cancer. We'll keep you posted.
Wednesday, September 28, 2011
Help for Women with Dense Breasts: U-Systems' somo-v Automated Breast Ultrasound (ABUS)
The movement toward enhanced breast screening for women with dense breast tissue is gaining momentum. Today's blog is meant to help these women advocate for a specific supplemental
screening option: automated breast ultrasound. We'll focus on the somo-v ABUS system from U-Systems. I'll use a Q&A format.
First, how does Automated Breast Ultrasound (ABUS) differ from regular ultrasound?
Both use sound waves to detect abnormal structures in the breast that could be tumors. With plain vanilla ultrasound (hand-held ultrasound, or HHUS) either a radiologist or a highly-trained technician called a sonographer moves a kind of wand ("transducer") over the surface of the breast. Think of the wand like a flashlight. As the she moves the wand, she looks at the image on a monitor in real-time, trying to see possible tumors. Images can also be captured for later viewing. With ABUS are that a much larger transducer is configured over the breast (it isn't manually moved over the breast), automatically taking different ultrasound images from different angles. These are then processed by a computer to construct a 3-D image.
What are the main advantages of ABUS?
First, the 3-D image gives a more complete picture of the entire breast than HHUS. Second, the images can be compared from year to year, or between visits, so any changes in the breast are easier to detect. Finally, the method doesn't require a diagnostic medical sonographer to perform. The imaging is automated, similar to mammography. So you don;t have to worry about whether or not the technician might be less experienced. Most ultrasound sonographers are trained and accredited. But their level of experience can also matter with HHUS.
What systems are out there?
The main system on the market is called (and this is a mouthful...) the somo-v INSIGHT Automated Breast Ultrasound (ABUS) system. It was developed by U-Systems, a Silicon Valley company that pioneered the field. A similar competing system called the ACUSON S2000 Automated Breast Volume Scanner (ABVS) is marketed by the large German company Seimens AG.
Can Automated Breast Ultrasound be used for screening?
The simple answer is "Yes, and it increasingly is." But realize that breast ultrasound, automated or not, is usually performed as a diagnostic procedure to further characterize a suspicious mammogram or MRI result. It's also commonly used to help surgeons guide needles when they perform biopsies. Ultrasound is not traditionally used for screening to assess women with no suspicion of disease. However, given the growing concerns about mammography and women with dense breast tissue, ultrasound is increasingly used as a second, supplemental screening method for that subgroup of women. Generally, screening methods need to be more automated and require less technical skill than diagnostic methods, simply because more tests have to be performed more rapidly. This is part of the appeal of the ABUS system. But read on...
Is ABUS approved as a screening method in the US?
No. It's approved for diagnosis, but not for screening. That doesn't keep physicians from using it as a screening method. It does keep U-Systems from marketing it for screening. U-systems is conducting a very large study (20,000 women with dense breasts) in the United States to gain approval for screening. The study is looking at whether screening with mammography plus ABUS outperforms mammography alone. Here we're talking about traditional 2-D mammography and not 3-D mammography (tomosynthesis). Enrollment continues, but the company already feels the data are strong and so they submitted an application to the FDA in April 2011. They added to the data a few weeks ago. The FDA could decide any day now.
Is ABUS approved as a screening method outside the US?
Yes, in Canada and in Europe. It was approved as a screening method by the Canadian regulatory agency Health Canada just last month (Aug 2011). Here's the announcement. It was granted European Union marketing approval a year ago (Sept 2010). Here's some info on that.
Is there a way I can see how it works?
The somo-v system was recently featured on Dr. Oz. Their site has three videos of that episode, which is all about supplemental breast screening. Watch all three if you have time. If you just want to see the somo-v system, just watch part 2. Once you get there, you'll see the links to parts 1 and 3. Sorry but they're going to subject you to some commercials...
How much does it cost?
That depends on the facility providing the service, but typically about $250-300.
Will it be covered by insurance?
That also depends on the judgment and policy of the facility you use, but often it's reimbursed.
How can I find a doctor that performs ABUS in my area?
First, you might check to see if you can get access through U-Systems' clinical study. Data from the trial have already been submitted, but they might still be recruiting. Outside of the clinical trial, it might take you a lot of time to call breast centers on your own. I'd probably just call the company (1-866-364-6777). Legally, remember, they can't talk about the system for screening. So just ask where there's a system installed in your area and hold the screening questions for the facility. Let's just call it "don't ask, don't tell!"
Where can I find more information?
Go to the somo-v Automated Breast Ultrasound page on the LATESTBreastCancer.com website. There we list web links to high-quality news articles and medical journal abstracts about every new medical option.
First, how does Automated Breast Ultrasound (ABUS) differ from regular ultrasound?
Both use sound waves to detect abnormal structures in the breast that could be tumors. With plain vanilla ultrasound (hand-held ultrasound, or HHUS) either a radiologist or a highly-trained technician called a sonographer moves a kind of wand ("transducer") over the surface of the breast. Think of the wand like a flashlight. As the she moves the wand, she looks at the image on a monitor in real-time, trying to see possible tumors. Images can also be captured for later viewing. With ABUS are that a much larger transducer is configured over the breast (it isn't manually moved over the breast), automatically taking different ultrasound images from different angles. These are then processed by a computer to construct a 3-D image.
What are the main advantages of ABUS?
First, the 3-D image gives a more complete picture of the entire breast than HHUS. Second, the images can be compared from year to year, or between visits, so any changes in the breast are easier to detect. Finally, the method doesn't require a diagnostic medical sonographer to perform. The imaging is automated, similar to mammography. So you don;t have to worry about whether or not the technician might be less experienced. Most ultrasound sonographers are trained and accredited. But their level of experience can also matter with HHUS.
What systems are out there?
The main system on the market is called (and this is a mouthful...) the somo-v INSIGHT Automated Breast Ultrasound (ABUS) system. It was developed by U-Systems, a Silicon Valley company that pioneered the field. A similar competing system called the ACUSON S2000 Automated Breast Volume Scanner (ABVS) is marketed by the large German company Seimens AG.
Can Automated Breast Ultrasound be used for screening?
The simple answer is "Yes, and it increasingly is." But realize that breast ultrasound, automated or not, is usually performed as a diagnostic procedure to further characterize a suspicious mammogram or MRI result. It's also commonly used to help surgeons guide needles when they perform biopsies. Ultrasound is not traditionally used for screening to assess women with no suspicion of disease. However, given the growing concerns about mammography and women with dense breast tissue, ultrasound is increasingly used as a second, supplemental screening method for that subgroup of women. Generally, screening methods need to be more automated and require less technical skill than diagnostic methods, simply because more tests have to be performed more rapidly. This is part of the appeal of the ABUS system. But read on...
Is ABUS approved as a screening method in the US?
No. It's approved for diagnosis, but not for screening. That doesn't keep physicians from using it as a screening method. It does keep U-Systems from marketing it for screening. U-systems is conducting a very large study (20,000 women with dense breasts) in the United States to gain approval for screening. The study is looking at whether screening with mammography plus ABUS outperforms mammography alone. Here we're talking about traditional 2-D mammography and not 3-D mammography (tomosynthesis). Enrollment continues, but the company already feels the data are strong and so they submitted an application to the FDA in April 2011. They added to the data a few weeks ago. The FDA could decide any day now.
Is ABUS approved as a screening method outside the US?
Yes, in Canada and in Europe. It was approved as a screening method by the Canadian regulatory agency Health Canada just last month (Aug 2011). Here's the announcement. It was granted European Union marketing approval a year ago (Sept 2010). Here's some info on that.
Is there a way I can see how it works?
The somo-v system was recently featured on Dr. Oz. Their site has three videos of that episode, which is all about supplemental breast screening. Watch all three if you have time. If you just want to see the somo-v system, just watch part 2. Once you get there, you'll see the links to parts 1 and 3. Sorry but they're going to subject you to some commercials...
How much does it cost?
That depends on the facility providing the service, but typically about $250-300.
Will it be covered by insurance?
That also depends on the judgment and policy of the facility you use, but often it's reimbursed.
How can I find a doctor that performs ABUS in my area?
First, you might check to see if you can get access through U-Systems' clinical study. Data from the trial have already been submitted, but they might still be recruiting. Outside of the clinical trial, it might take you a lot of time to call breast centers on your own. I'd probably just call the company (1-866-364-6777). Legally, remember, they can't talk about the system for screening. So just ask where there's a system installed in your area and hold the screening questions for the facility. Let's just call it "don't ask, don't tell!"
Where can I find more information?
Go to the somo-v Automated Breast Ultrasound page on the LATESTBreastCancer.com website. There we list web links to high-quality news articles and medical journal abstracts about every new medical option.
Tuesday, September 27, 2011
Afinitor, T-DM1 and Xeloda for Metastatic Breast Cancer
Today we'll share the latest news and research on Afinitor, T-DM1 and Xeloda for metastatic breast cancer.
Afinitor plus Aromasin (phase III)
The big story this week was a phase III trial of Afinitor (everolimus) plus Aromasin (exemestane) for post-menopausal women with advanced breast cancer presented at the 2011 European Multidisciplinary Cancer Congress (EMCC). Links to the EurekAlert!, Reuters and Bloomberg articles may be found on the Afinitor page of our website.
The trial, known as BOLERO 2, involved 724 hormone-receptor positive women whose cancer had become resistant to the aromatase inhibitors Femara (letrozole) or Arimidex (anastrazole). 485 received Afinitor plus Aromasin. 239 received Aromasin alone. Progression-free survival was almost 11 months in the Afinitor group, compared to about 4 months in the Aromasin alone group.
Afinitor is also being studied in combination with other drugs for advanced breast cancer. Novartis plans to file worldwide regulatory submissions for the Afinitor/Aromasin combination by the end of 2011.
TDM-1 (phase II)
Another EMCC presentation made headlines this week. The phase II study, TDM4450g, of trastuzumab emtansine (T-DM1) as first-line therapy in women with advanced HER2 positive breast cancer was covered by Medical News Today, Bloomberg and The Telegraph (UK).
The 137 patients were treated with either T-DM1 alone or Herceptin (trastuzumab) plus Taxotere (docetaxel). The median progression-free survival was 14.2 months with T-DM1 compared to 9.2 months with Herceptin plus Taxotere. In addition, the T-DM1 group suffered fewer side effects with less hair loss and hospitalization.
Larger, phase III trials are needed before regulatory approval. Last week, The Seattle Times shared an interesting story about Jeanne Sather, a breast cancer blogger whose efforts led to a geographic expansion of a T-DM1 trial. The story may be found on our T-DM1 page.
Navelbine/Gemzar vs. Xeloda alone (phase III)
Not all research on metastatic breast cancer involves brand new drugs. Some studies experiment with combinations of existing drugs.
A September 21 phase III study from Greece in the Annals of Oncology compared Navelbine (vinorelbine) plus Gemzar (gemcitabine) to oral Xeloda (capecitabine) alone for women with metastatic breast cancer previously treated with anthracyclines and taxanes.
Progression-free survival, overall survival and overall response were similar for both groups. The authors concluded, "Given the favorable toxicity and convenience of oral administration, single-agent capecitabine is recommended for compliant patients."
At LATESTBreastCancer.com, we'll continue to follow research on treatments for metastatic breast cancer. New developments will be added to our website and database and highlighted here. Please stay tuned.
Friday, September 23, 2011
The Latest Research on Breast Reconstruction after Mastectomy
Today we'll share the latest news and research on breast reconstruction after mastectomy. Topics include the reconstruction decision, the safety of silicone and a study on two-stage implants. Links to the news items and studies below may be found on the breast implant (with expander, two-stage) page of our website.
The decision to pursue reconstruction
Women facing breast cancer have many decisions to make about treatment. If a mastectomy is selected, additional decisions about breast reconstruction are required.
Reconstruction is not for everyone. According to a September 23 article in The Atlantic, women consider many factors such as cost, convenience and lifestyle. For women who decide against reconstruction, a variety of removable prosthetic breasts are available.
For those who choose reconstruction, there are many options, including saline and silicone implants and tissue grafting procedures such as TRAM flap, DIEP free flap and Gluteal free flap procedures.
Unfortunately, not everyone may be aware of their options. The Atlantic story noted that "the data suggest that only three in seven women get the chance to learn about reconstruction before they begin cancer treatment."
Moreover, uninsured women may never be informed of their reconstruction options. In a recent study, 52% of the 54 uninsured women "knew nothing about breast reconstruction." After learning about their options, the percentage who chose reconstruction rose from 47 to 76 percent (link).
FDA update on the safety of silicone implants
For those who choose silicone breast implants, there have been some concerns about safety. Back in June, the FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants. It was big news at the time, with the Los Angeles Times, The Washington Post, MedPage Today and Medical News Today covering the story.
Essentially, the FDA reviewed the latest studies and concluded that "silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled." It found "no apparent association" between the implants and breast cancer, connective tissue disease or infertility.
Importantly, the FDA noted that 40 to 70 percent of breast reconstruction patients will need an additional surgery to modify, remove or replace the implant within the first 8 to 10 years. It recommended lifetime monitoring with periodic MRIs to detect asymptomatic ruptures.
The latest study on two-stage breast reconstruction
Breast implant reconstruction may be implemented in one or two stages. With one-stage, the implants are inserted immediately after the mastectomy. With two-stage, tissue expanders are inserted after the mastectomy, and replaced with permanent implant sometime later.
The latest study on two-stage breast reconstruction was published online in the American Cancer Society journal Cancer on September 14.
The study followed 151 women with stage II or III breast cancer for about 7 years. All received a skin-sparing mastectomy and axillary lymph node dissection with the placement of a tissue expander. All were treated with chemotherapy. About 4 weeks after chemo, tissue expanders were replaced with saline or silicone permanent implants. 8 weeks after the completion of chemo, post-mastectomy radiation was initiated.
At 7 years, local and regional control was 100%. Two women experienced chest-wall recurrence, but after 7 years. 29 patients experienced a distant metastasis. The 7-year distant metastasis-free survival rate was 81% and overall survival rate was 93%.
At 7 years, 29% underwent permanent implant removal or replacement (17.1% removal and 13.3% replacement.) The authors noted that it is "important" to consider this rate in the "context of the longevity of implants." They note,
"Breast prostheses are not permanent devices and may require revision over the life course of patients, even in women who receive implants primarily for augmentation purposes."The study was unable to identify any factors, including implant type, which predicted a risk of implant replacement or removal.
The authors noted several limitations to their study. First, surgeries to modify the implants due to complications were not considered, but could be important as they they can "impact cost and quality of life." Also, the women in the study were treated at a single cancer center, Memorial Sloan-Kettering. The results "may not be generalizable to other populations at large."
At LATESTBreastCancer.com, we'll continue to follow the research in the field of breast reconstruction. Developments will be added to our website and database and highlighted here. Please stay tuned.
Dense Breast Tissue: Supplemental Screening Methods
For women who know they have dense breast tissue, we wanted to quickly list the screening methods that are currently used to supplement standard 2-D mammography. By clicking any link below you can quickly see the most recent news and medical journal articles on each. To learn more by accessing complete lists of news and journal article links going back 2-3 years, go to LATESTBreastCancer.com and then find that screening method's page.
Breast ultrasound (US)
Ultrasound uses sound waves rather than x-rays (like mammography) to identify structures in the breast that could be tumors. Most ultrasound devices are hand-held. On our breast ultrasound page you'll find every recent news article and medical journal abstract on the use of breast ultrasound for the detection of tumors in dense breast tissue. Advantages of US are that it's relatively inexpensive (usually a few hundred dollars), widely available and doesn't cause discomfort. Hand-held ultrasound, though, requires a skilled practitioner and it will result in more false positives than mammography.
Automated breast ultrasound (ABUS)
The main advantage of automated compared to hand-held ultrasound is that enables a less labor intensive, operator-dependent workflow. The main (only?) system being marketed in the United States is the somo-v INSIGHT by U-Systems (Sunnyvale, CA). It has regulatory clearance as an adjunct to mammography and is seeing more use, particularly in Connecticut and Texas, states that recently passed dense breast tissue laws and that therefore are seeing increased demand for ultrasound screening.
3-D Mammography
Also called breast tomosynthesis and stereo digital mammography (SDM). The only FDA-approved system on the market in the United States is the Selenia Dimensions System by Hologic, Inc. (Bedford, MA). It was approved in February of this year and is becoming more available. In 3-D mammography, an x-ray imager moves around the breast, taking 15 images from different angles (standard mammography takes two images). These 15 images are then assembled using software to create the 3-D depiction. Imaging from different angles decreases the odds that a tumor will be completely hidden by dense breast tissue. I recommend the August 14th news story from the Boston Globe. The link is on LATESTBreastCancer.com's 3-D Mammography page. All links are conveniently listed in reverse chronological order.
Breast MRI
Along with breast ultrasound, breast MRI is the most commonly mentioned supplemental screening method for women with dense breast tissue. MRI uses a strong magnetic field to excite nuclear particles in breast tissue. A contrast agent chemical (gadolinium-DPA) is first injected into the bloodstream. This agent helps visualize areas containing blood vessel networks, which are suggestive of a tumor. MRI is highly sensitive but does generate a high rate of false positives. It is also very expensive ($2000-6000). The most recent news articles and medical journal articles on breast MRI can be found on our Breast MRI page. Among those are articles that discuss its use as a supplemental screening method for women at high risk, including women with dense breast tissue.
Molecular breast imaging (MBI) systems
Molecular breast imaging is "functional" imaging. It looks at metabolic activity in the breast tissue. This makes is complementary to "anatomical" imaging methods like mammography and ultrasound that look at tissue structures. MBI methods include BSGI (Breast-specific gamma imaging) and PEM (Positron emission mammography). Both generate fewer false-positives than breast MRI and so results in fewer unnecessary biopsies. They are also less expensive than MRI. BSGI and PEM are based on the same principle but use different radioactive tracer molecules and imaging systems. In both, the tracer is absorbed by cells throughout the body. Cancer cells, due to their increased rate of metabolic activity, absorb a greater amount than healthy cells and so appear as dark "hot spots" on the image. The major problem with MBI is that it results in greater exposure to radioactivity.
Breast ultrasound (US)
Ultrasound uses sound waves rather than x-rays (like mammography) to identify structures in the breast that could be tumors. Most ultrasound devices are hand-held. On our breast ultrasound page you'll find every recent news article and medical journal abstract on the use of breast ultrasound for the detection of tumors in dense breast tissue. Advantages of US are that it's relatively inexpensive (usually a few hundred dollars), widely available and doesn't cause discomfort. Hand-held ultrasound, though, requires a skilled practitioner and it will result in more false positives than mammography.
Automated breast ultrasound (ABUS)
The main advantage of automated compared to hand-held ultrasound is that enables a less labor intensive, operator-dependent workflow. The main (only?) system being marketed in the United States is the somo-v INSIGHT by U-Systems (Sunnyvale, CA). It has regulatory clearance as an adjunct to mammography and is seeing more use, particularly in Connecticut and Texas, states that recently passed dense breast tissue laws and that therefore are seeing increased demand for ultrasound screening.
3-D Mammography
Also called breast tomosynthesis and stereo digital mammography (SDM). The only FDA-approved system on the market in the United States is the Selenia Dimensions System by Hologic, Inc. (Bedford, MA). It was approved in February of this year and is becoming more available. In 3-D mammography, an x-ray imager moves around the breast, taking 15 images from different angles (standard mammography takes two images). These 15 images are then assembled using software to create the 3-D depiction. Imaging from different angles decreases the odds that a tumor will be completely hidden by dense breast tissue. I recommend the August 14th news story from the Boston Globe. The link is on LATESTBreastCancer.com's 3-D Mammography page. All links are conveniently listed in reverse chronological order.
Breast MRI
Along with breast ultrasound, breast MRI is the most commonly mentioned supplemental screening method for women with dense breast tissue. MRI uses a strong magnetic field to excite nuclear particles in breast tissue. A contrast agent chemical (gadolinium-DPA) is first injected into the bloodstream. This agent helps visualize areas containing blood vessel networks, which are suggestive of a tumor. MRI is highly sensitive but does generate a high rate of false positives. It is also very expensive ($2000-6000). The most recent news articles and medical journal articles on breast MRI can be found on our Breast MRI page. Among those are articles that discuss its use as a supplemental screening method for women at high risk, including women with dense breast tissue.
Molecular breast imaging (MBI) systems
Molecular breast imaging is "functional" imaging. It looks at metabolic activity in the breast tissue. This makes is complementary to "anatomical" imaging methods like mammography and ultrasound that look at tissue structures. MBI methods include BSGI (Breast-specific gamma imaging) and PEM (Positron emission mammography). Both generate fewer false-positives than breast MRI and so results in fewer unnecessary biopsies. They are also less expensive than MRI. BSGI and PEM are based on the same principle but use different radioactive tracer molecules and imaging systems. In both, the tracer is absorbed by cells throughout the body. Cancer cells, due to their increased rate of metabolic activity, absorb a greater amount than healthy cells and so appear as dark "hot spots" on the image. The major problem with MBI is that it results in greater exposure to radioactivity.
Labels:
3-d mammography,
abus,
breast tomosynthesis,
breast-specific gamma imaging,
bsgi,
dense breasts,
hologic,
mri,
pem,
positron emission mammography,
screening,
selenia dimensions,
somo-v,
u-systems
Wednesday, September 21, 2011
The Latest Research on CYP2D6 Variations for Women on Tamoxifen
Do CYP2D6 variations matter for women on tamoxifen? Variations may affect how women metabolize tamoxifen, but do they make a difference in breast cancer recurrence or prevention? Recent studies suggest maybe not. Today we'll share the latest news and research on how CYP2D6 variations affect women on tamoxifen.
Background from the Dr. Susan Love Research Foundation
An overview from the Dr. Susan Love Research Foundation provides a nice background to the issue. Essentially, a gene called cytochrome P450 2D6 generates an enzyme called CYP2D6. Variations in the gene affect the enzyme production and affect how well a woman metabolizes, or processes tamoxifen. Some women process it better than others.
A 2007 study suggested that women with a certain variation were almost twice as likely to have their cancer recur. Subsequently, some specialists started recommending CYP2D6 testing before starting tamoxifen.
Later studies, however, found that variations in CYP2D6 made no difference in breast cancer recurrence. Dr. Love's website notes that more studies are needed to resolve the inconsistency in the research.
The Latest Research
Dr. Love's website was updated in January 2011. What has happened since then? Studies on CYP2D6 and tamoxifen continue to trickle in. Today we'll share the latest research. Links to all of the studies discussed below may be found on the CYP2D6 testing page of our website.
CYP2D6 variations when tamoxifen is prescribed for prevention
Tamoxifen is sometimes prescribed to prevent breast cancer in women at high-risk. An August 31 study in Clinical Cancer Research found that CYP2D6 variations made no difference in whether or not tamoxifen or Evista (raloxifene) were effective when taken to prevent breast cancer.
CYP2D6 variations when tamoxifen is prescribed to prevent recurrence.
Tamoxifen is also prescribed to prevent recurrence in women treated for breast cancer. Since January 2011, three studies have suggested that CYP2D6 variations make no difference in breast cancer recurrence rates for women on tamoxifen.
A January 15 study in the Journal of the National Cancer Institute from Denmark found, "The association between CYP2D6 inhibition and recurrence in tamoxifen-treated patients is likely null or small."
In a March 25 study in Breast Cancer Research and Treatment from Korea, CYP2D6 variations were not associated with clinical outcomes, such as recurrence, in early-stage breast cancer patients treated with tamoxifen.
Most recently, an August 5 MD Anderson study in Cancer found "no significant effect of CYP2D6 genotype on risk of recurrence in breast cancer patients who received adjuvant tamoxifen therapy."
Current Recommendations
Due to the current state of research, the 2011 National Comprehensive Cancer Network (NCCN) Guidelines do recommend CY2D6 testing for evaluating treatment with tamoxifen. (See March 21 OncLive.com article.)
In Europe, according to the 2011 St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer, "The Panel was almost unanimous in rejecting CYP2D6 testing to dictate choice of endocrine therapy type." In the UK, a cost/benefit analysis in the September issue of Health Technology Assessment concluded that CYP2D6 testing could not be recommended at this time due to the rapidly evolving research and limited and conflicting data.
At LATESTBreastCancer.com, we'll continue to follow the research in CYP2D6 testing and tamoxifen. We'll add any developments to our website and database and highlight them in this blog. Please stay tuned.
Background from the Dr. Susan Love Research Foundation
An overview from the Dr. Susan Love Research Foundation provides a nice background to the issue. Essentially, a gene called cytochrome P450 2D6 generates an enzyme called CYP2D6. Variations in the gene affect the enzyme production and affect how well a woman metabolizes, or processes tamoxifen. Some women process it better than others.
A 2007 study suggested that women with a certain variation were almost twice as likely to have their cancer recur. Subsequently, some specialists started recommending CYP2D6 testing before starting tamoxifen.
Later studies, however, found that variations in CYP2D6 made no difference in breast cancer recurrence. Dr. Love's website notes that more studies are needed to resolve the inconsistency in the research.
The Latest Research
Dr. Love's website was updated in January 2011. What has happened since then? Studies on CYP2D6 and tamoxifen continue to trickle in. Today we'll share the latest research. Links to all of the studies discussed below may be found on the CYP2D6 testing page of our website.
CYP2D6 variations when tamoxifen is prescribed for prevention
Tamoxifen is sometimes prescribed to prevent breast cancer in women at high-risk. An August 31 study in Clinical Cancer Research found that CYP2D6 variations made no difference in whether or not tamoxifen or Evista (raloxifene) were effective when taken to prevent breast cancer.
CYP2D6 variations when tamoxifen is prescribed to prevent recurrence.
Tamoxifen is also prescribed to prevent recurrence in women treated for breast cancer. Since January 2011, three studies have suggested that CYP2D6 variations make no difference in breast cancer recurrence rates for women on tamoxifen.
A January 15 study in the Journal of the National Cancer Institute from Denmark found, "The association between CYP2D6 inhibition and recurrence in tamoxifen-treated patients is likely null or small."
In a March 25 study in Breast Cancer Research and Treatment from Korea, CYP2D6 variations were not associated with clinical outcomes, such as recurrence, in early-stage breast cancer patients treated with tamoxifen.
Most recently, an August 5 MD Anderson study in Cancer found "no significant effect of CYP2D6 genotype on risk of recurrence in breast cancer patients who received adjuvant tamoxifen therapy."
Current Recommendations
Due to the current state of research, the 2011 National Comprehensive Cancer Network (NCCN) Guidelines do recommend CY2D6 testing for evaluating treatment with tamoxifen. (See March 21 OncLive.com article.)
In Europe, according to the 2011 St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer, "The Panel was almost unanimous in rejecting CYP2D6 testing to dictate choice of endocrine therapy type." In the UK, a cost/benefit analysis in the September issue of Health Technology Assessment concluded that CYP2D6 testing could not be recommended at this time due to the rapidly evolving research and limited and conflicting data.
At LATESTBreastCancer.com, we'll continue to follow the research in CYP2D6 testing and tamoxifen. We'll add any developments to our website and database and highlight them in this blog. Please stay tuned.
The Golden State's Dense Breast Tissue Bill: An Argument In Favor
Today I'll continue the discussion on California's dense breast tissue bill, SB 791, sponsored by Joe Simitian of Latest Medical's hometown of Palo Alto. The bill is similar to bills recently passed in Connecticut and Texas. Basically, it would require physicians to notify patients with highly dense breasts about their breast density and the possibility that they may require additional imaging services like ultrasound or MRI. The California Medical Association (CMA) and many physicians oppose the bill. Patients and patient advocates tend to support it.
As the founder of a company focused on empowering cancer patients with information, I support the bill. To
me, nothing justifies withholding potentially life-saving information from
patients.
The simple, central issue is
that today most women are not being informed about a serious health risk: dense
breast tissue. According to a recent poll, 95 percent of women ages 40+ don’t
know their breast density and close to 90 percent don’t know it increases the
risk of developing breast cancer. Yet the medical community has known
about this issue for over a decade.
What are the arguments against the bill? I’ll use the CMA as a proxy for the opposition. In their press release, the CMA states that
there isn't yet clarity on what "dense breasts" means, nor on what should be done clinically with the information. But
"clarity" is a vague term. In fact, there's well over a decade of
research about the risks associated with dense breast tissue and on the
value of supplemental screening. It’s common sense that imaging the
breast using different, proven methods will increase the likelihood of finding an
abnormality. But we don't have to rely on common sense. Recent
studies published in high quality medical journals come to the same
conclusion.
In fact, as an argument
against the bill, the CMA's press release says that breast density is already
reported to physicians in mammography reports. Isn't this an admission
that there is a workable way to measure breast density and that the information
has clinical relevance?
One can concede that the
measurement of breast density is an ongoing area of research. And one can
concede that the value of different supplemental screening methods is still
being quantified. The CMA's policy statement says that, "the science is still
out on this matter." Yes, science is never finished. It's always still out on every matter.
Another CMA argument
cites the bill's impact on patients (they'll be scared) and
physicians (they'll face practical and legal problems).
Possibly. But these are secondary issues--consequences of communicating
the facts. The truth can't be sacrificed for the sake of convenience. The
priority must be patients' health, not shielding them from worry or
protecting physicians.
Finally, one can argue that what's needed is better cost-benefit data regarding supplemental screening of women with dense breast tissue. But the bill doesn't involve changes to reimbursement.
Maybe it should. But right now it's only about communicating information. Once they're informed, women can do their own cost-benefit analysis with their doctor. They can weigh in their other risk factors, their anxiety level about developing breast
cancer, their level of concern about a possible unnecessary biopsy, and their
ability to pay for supplemental screening if it isn't covered.
This is a decision that
women need to have the opportunity to make. The bill ensures that they will.
Without the notice that the bill requires, we know that many women with very dense breasts who aren't aware of this issue will be at risk while we wait years for the
results of more definitive randomized controlled trials. SB 971 is important for the simple reason that people have the right to make decisions about their health based on the
best available information.
Tomorrow I'll go into what I view as another reason why it's important to empower patients with this kind of
information.
Monday, September 19, 2011
Breast Cancer News Weekly Wrap-Up (Sept. 12 to 18)
Today we'll wrap-up last week's breast cancer news. Topics include hot flashes, fatigue, mammography and environmental BPAs. Links to the news and research below may be found on the treatment pages of the LATESTBreastCancer.com website.
Effexor and Catapres effective for hot flashes
Some breast cancer treatments may induce menopause and cause unpleasant side effects such as hot flashes. A September 12 study in the Journal of Clinical Oncology compared Effexor (venlafaxine) to Catapres (clonidine) to a placebo for the treatment of hot flashes in breast cancer patients.
Both Effexor and Catapres were found to be effective in the management of hot flashes. Effexor resulted in a more immediate reduction in hot flashes, but at week 12, hot flashes were lower in the Catapres group. Reports of nausea, constipation and appetite loss were higher in the Effexor group.
A September 12 Family Practice News report on the study included a commentary which noted that the small size of the study was its "main weakness." In the end, only 35 patients took Effexor, 28 Catapres and 17 the placebo. A larger study would be needed to "reliably identify suspected differences between the study arms." Also, the study authors noted that the duration of the study may have been too short to adequately assess side effects.
Nonetheless, in the Family Practice News story, study authors said the "more rapid reduction in hot flashes suggests that venlafaxine is to be preferred over clonidine." They advised 37.5 mg daily in the first week, increasing to 75 mg "if greater efficacy is desired."
Fatigue after treatment associated with pain and depression
Last week EurekAlert! and the UPI covered a study from Spain on fatigue in breast cancer survivors. The study found that patients most affected by fatigue also suffered "episodes of depression, body image deterioration, neck and shoulder pain, and limited arm movement, possibly due to the surgical intervention," such as breast conserving surgery (lumpectomy) and mastectomy.
The lead author noted that these findings should "motivate" patient support programs to provide resources to improve psychological states and pain to improve fatigue.
Higher mammography rates associated with higher mastectomy rates
One of the goals of screening mammography is to detect breast cancer earlier to allow more women to undergo breast conserving surgery (lumpectomy) instead of mastectomy. A recent study in Norway found the opposite to be true.
The study compared breast surgery rates before and after the implementation of a breast screening program and rates between those invited for screening and those not. Screening was associated with an increase in all breast surgery (lumpectomy plus mastectomy) and an increase in mastectomy rates.
A September 13 story in US News and World Report/HealthDay noted that the study did not investigate why mastectomy rates climbed. Possible reasons include overdiagnosis (detecting and treating tumors that might never have posed a risk), poor access to radiation centers (making mastectomy a safer option), improved breast reconstruction techniques (making mastectomy a less "dreadful" choice) and patient decision to undergo more aggressive treatment due to recurrence fears.
BPA may interfere with tamoxifen
There may be another reason to avoid bisphenol-A (BPA). BPAs, which are used to make plastics, have been associated with a variety of health concerns. According to recent study in cells, BPA may not only increase the risk of developing breast cancer, may also interfere with tamoxifen therapy. (Link to the study.)
On September 13, the San Francisco Chronicle covered the study. In the lab, when non-cancerous cells from high-risk patients were exposed to BPA, they started to behave like cancer cells. When these BPA-exposed cells were exposed to tamoxifen, they continued to grow. "The study found that healthy cells exposed to BPA and methylparaben started figuring out ways to bypass drugs like tamoxifen."
Avoiding BPA may not be easy. According to Dr. William Goodson, lead study author, ""It's used so much. We kind of swim in it." Still, efforts to ban BPAs are underway. A current bill (AB1319) on the governor's desk would ban BPA in sippy cups and baby bottles in California.
At LATESTBreastCancer.com, we'll continue to follow the latest breast cancer news and research. You may access links to news articles, medical journal abstracts and FDA information on every breast cancer test and treatment option on our website anytime.
Effexor and Catapres effective for hot flashes
Some breast cancer treatments may induce menopause and cause unpleasant side effects such as hot flashes. A September 12 study in the Journal of Clinical Oncology compared Effexor (venlafaxine) to Catapres (clonidine) to a placebo for the treatment of hot flashes in breast cancer patients.
Both Effexor and Catapres were found to be effective in the management of hot flashes. Effexor resulted in a more immediate reduction in hot flashes, but at week 12, hot flashes were lower in the Catapres group. Reports of nausea, constipation and appetite loss were higher in the Effexor group.
A September 12 Family Practice News report on the study included a commentary which noted that the small size of the study was its "main weakness." In the end, only 35 patients took Effexor, 28 Catapres and 17 the placebo. A larger study would be needed to "reliably identify suspected differences between the study arms." Also, the study authors noted that the duration of the study may have been too short to adequately assess side effects.
Nonetheless, in the Family Practice News story, study authors said the "more rapid reduction in hot flashes suggests that venlafaxine is to be preferred over clonidine." They advised 37.5 mg daily in the first week, increasing to 75 mg "if greater efficacy is desired."
Fatigue after treatment associated with pain and depression
Last week EurekAlert! and the UPI covered a study from Spain on fatigue in breast cancer survivors. The study found that patients most affected by fatigue also suffered "episodes of depression, body image deterioration, neck and shoulder pain, and limited arm movement, possibly due to the surgical intervention," such as breast conserving surgery (lumpectomy) and mastectomy.
The lead author noted that these findings should "motivate" patient support programs to provide resources to improve psychological states and pain to improve fatigue.
Higher mammography rates associated with higher mastectomy rates
One of the goals of screening mammography is to detect breast cancer earlier to allow more women to undergo breast conserving surgery (lumpectomy) instead of mastectomy. A recent study in Norway found the opposite to be true.
The study compared breast surgery rates before and after the implementation of a breast screening program and rates between those invited for screening and those not. Screening was associated with an increase in all breast surgery (lumpectomy plus mastectomy) and an increase in mastectomy rates.
A September 13 story in US News and World Report/HealthDay noted that the study did not investigate why mastectomy rates climbed. Possible reasons include overdiagnosis (detecting and treating tumors that might never have posed a risk), poor access to radiation centers (making mastectomy a safer option), improved breast reconstruction techniques (making mastectomy a less "dreadful" choice) and patient decision to undergo more aggressive treatment due to recurrence fears.
BPA may interfere with tamoxifen
There may be another reason to avoid bisphenol-A (BPA). BPAs, which are used to make plastics, have been associated with a variety of health concerns. According to recent study in cells, BPA may not only increase the risk of developing breast cancer, may also interfere with tamoxifen therapy. (Link to the study.)
On September 13, the San Francisco Chronicle covered the study. In the lab, when non-cancerous cells from high-risk patients were exposed to BPA, they started to behave like cancer cells. When these BPA-exposed cells were exposed to tamoxifen, they continued to grow. "The study found that healthy cells exposed to BPA and methylparaben started figuring out ways to bypass drugs like tamoxifen."
Avoiding BPA may not be easy. According to Dr. William Goodson, lead study author, ""It's used so much. We kind of swim in it." Still, efforts to ban BPAs are underway. A current bill (AB1319) on the governor's desk would ban BPA in sippy cups and baby bottles in California.
At LATESTBreastCancer.com, we'll continue to follow the latest breast cancer news and research. You may access links to news articles, medical journal abstracts and FDA information on every breast cancer test and treatment option on our website anytime.
Friday, September 16, 2011
Breast Cancer News for BRCA 1/2 Mutation Carriers
BRCA 1/2 gene mutation carriers have been in the news lately. Today we'll share the latest headlines and the studies behind them.
ABC News: "Women Develop BRCA-Related Cancer Earlier Than Their Moms, Study Says"
This was the big story of the week. ABC News, US News and World Report, the Los Angeles Times and Medical News Today all ran stories. (Links may be found on the BRCAnalysis page of our website. From the home page, click the "Treatments" tab and search for "BRCAnalysis" in the box on the top right.)
The headlines stemmed from an MD Anderson study published in Cancer on September 12. According to the study, breast and ovarian cancers appear to be diagnosed at earlier ages in later generations. A statistical model revealed that for BRCA mutation carriers, breast cancer would be diagnosed almost 8 years earlier than in the generation before.
Currently, BRCA mutation carriers are advised to start screening by 25. In the Los Angeles Times, the authors said their findings may support earlier screenings for future generations.
Medical News Today: "BRCA1 Gene Mutation Associated With Neoadjuvant Chemotherapy"
Another BRCA study from MD Anderson made news this month. This one revealed some good news for BRCA 1 carriers.
Last week, Medical News Today and US News and World Report covered a Journal of Clinical Oncology study which found that carriers of the BRCA 1 mutation had a better response to chemotherapy before surgery, known as neoadjuvant chemotherapy.
In the study, 46% of the BRCA 1 carriers achieved a pathological complete response (pCR), meaning the tumor disappeared in response to treatment. Only 13% of the BRCA 2 carriers and 22% of the non-BRCA carriers achieved pCR.
However, after about 3 years, BRCA status made no significant difference in survival. But, BRCA 1 carriers who achieved a pCR had better 5 year relapse-free and overall survival rates than BRCA 1 carriers who did not.
In the media stories, lead author, Dr. Banu Arun noted,
Next week, we'll share the latest breast cancer news and research on hot flashes and fatigue after treatment. Until then, you may explore all the latest news and research on any breast cancer test or treatment option at our LATESTBreastCancer.com website anytime.
ABC News: "Women Develop BRCA-Related Cancer Earlier Than Their Moms, Study Says"
This was the big story of the week. ABC News, US News and World Report, the Los Angeles Times and Medical News Today all ran stories. (Links may be found on the BRCAnalysis page of our website. From the home page, click the "Treatments" tab and search for "BRCAnalysis" in the box on the top right.)
The headlines stemmed from an MD Anderson study published in Cancer on September 12. According to the study, breast and ovarian cancers appear to be diagnosed at earlier ages in later generations. A statistical model revealed that for BRCA mutation carriers, breast cancer would be diagnosed almost 8 years earlier than in the generation before.
Currently, BRCA mutation carriers are advised to start screening by 25. In the Los Angeles Times, the authors said their findings may support earlier screenings for future generations.
Medical News Today: "BRCA1 Gene Mutation Associated With Neoadjuvant Chemotherapy"
Another BRCA study from MD Anderson made news this month. This one revealed some good news for BRCA 1 carriers.
Last week, Medical News Today and US News and World Report covered a Journal of Clinical Oncology study which found that carriers of the BRCA 1 mutation had a better response to chemotherapy before surgery, known as neoadjuvant chemotherapy.
In the study, 46% of the BRCA 1 carriers achieved a pathological complete response (pCR), meaning the tumor disappeared in response to treatment. Only 13% of the BRCA 2 carriers and 22% of the non-BRCA carriers achieved pCR.
However, after about 3 years, BRCA status made no significant difference in survival. But, BRCA 1 carriers who achieved a pCR had better 5 year relapse-free and overall survival rates than BRCA 1 carriers who did not.
In the media stories, lead author, Dr. Banu Arun noted,
"This new insight tempts us to speculate that the presence of the BRCA1 mutation determines how some women will respond to neoadjuvant chemotherapy. However, we need future prospective studies with larger cohorts and longer-term follow up to validate these findings and determine optimum treatment."
Next week, we'll share the latest breast cancer news and research on hot flashes and fatigue after treatment. Until then, you may explore all the latest news and research on any breast cancer test or treatment option at our LATESTBreastCancer.com website anytime.
Wednesday, September 14, 2011
Herceptin for Small, Early-Stage Breast Cancer: Does Tumor Size Matter?
When it comes to Herceptin for HER2 positive breast cancer, does tumor size matter? What if the tumor is very small? Should Herceptin still be considered? Today we'll share the latest research on Herceptin (trastuzumab) for women with small, node-negative, HER2 positive breast cancer.
Clinical Breast Cancer: HER2 positive breast cancer has a higher risk of recurrence than other breast cancers
A July 15 Clinical Breast Cancer study from MD Anderson compared the risk of recurrence for women with different breast cancer subtypes. All of the women had small (less than 2cm), node-negative breast cancer. None were treated with chemotherapy or Herceptin.
The study found that women with HER2 positive breast cancer had a greater risk of recurrence than women with hormone-receptor positive breast cancer. Triple-negative breast cancer also had a greater risk than hormone-receptor positive breast cancer, but the difference was not as high as with the HER2 group.
Cancer (6/16): Herceptin plus chemotherapy beneficial for tumors 2cm or less
A June 16 study in Cancer from the Memorial Sloan-Kettering Cancer Center compared recurrence rates for women treated with and without Herceptin plus chemotherapy for small (2cm or less), node-negative, HER2 positive breast cancer. Based on their comparison, the authors concluded, "Women with small, node-negative, HER2+ primary breast cancers likely derive significant benefit from adjuvant trastuzumab with chemotherapy."
Cancer (9/1): Herceptin reduces recurrence after lumpectomy for tumors 5cm or less
A September 1 study in Cancer from the Memorial Sloan-Kettering Cancer Center compared localregional recurrence rates (LRR) for women treated with or without Herceptin after lumpectomy (breast conserving surgery) and radiation. All women had node-negative, HER2 positive breast cancer measuring 5cm or less.
According to the conclusion, "Even among women with lower risk breast cancer, the relatively high locoregional failure rates associated with positive HER2 status could be reduced markedly with adjuvant trastuzumab chemotherapy." Within 3 years, there was a 10% recurrence rate for women not treated with Herceptin compared to a 1% rate with Herceptin.
Internal Medicine News: Uncertainty for tumors less than 1cm
An August 16 Internal Medicine News article discussed the uncertainty about Herceptin for women with very small (less than 1cm), node-negative, HER2 positive breast cancer.
Although studies such as the July 15 Clinical Breast Cancer study above suggest a higher risk of recurrence for small, HER2 positive breast cancer, an American Society of Clinical Oncology (ASCO) presentation suggested that for women with very small tumors (1cm or less), the risk of recurrence may be so low that the benefit of Herceptin may not be worth the risk of cardiovascular disease.
Nonetheless, Dr. Gabriel Hortobagyi from MD Anderson was quoted to say he discusses Herceptin and chemotherapy with anyone with HER2 positive breast cancer, regardless of tumor size.
For more on Herceptin for HER2 positive breast cancer, including two-years worth of news, research and overviews, please visit the Hercetpin (trastuzumab) page of our website. From the home page of our site, click the "Treatments" tab and search for "Herceptin" in the box in the top right corner.
Clinical Breast Cancer: HER2 positive breast cancer has a higher risk of recurrence than other breast cancers
A July 15 Clinical Breast Cancer study from MD Anderson compared the risk of recurrence for women with different breast cancer subtypes. All of the women had small (less than 2cm), node-negative breast cancer. None were treated with chemotherapy or Herceptin.
The study found that women with HER2 positive breast cancer had a greater risk of recurrence than women with hormone-receptor positive breast cancer. Triple-negative breast cancer also had a greater risk than hormone-receptor positive breast cancer, but the difference was not as high as with the HER2 group.
Cancer (6/16): Herceptin plus chemotherapy beneficial for tumors 2cm or less
A June 16 study in Cancer from the Memorial Sloan-Kettering Cancer Center compared recurrence rates for women treated with and without Herceptin plus chemotherapy for small (2cm or less), node-negative, HER2 positive breast cancer. Based on their comparison, the authors concluded, "Women with small, node-negative, HER2+ primary breast cancers likely derive significant benefit from adjuvant trastuzumab with chemotherapy."
Cancer (9/1): Herceptin reduces recurrence after lumpectomy for tumors 5cm or less
A September 1 study in Cancer from the Memorial Sloan-Kettering Cancer Center compared localregional recurrence rates (LRR) for women treated with or without Herceptin after lumpectomy (breast conserving surgery) and radiation. All women had node-negative, HER2 positive breast cancer measuring 5cm or less.
According to the conclusion, "Even among women with lower risk breast cancer, the relatively high locoregional failure rates associated with positive HER2 status could be reduced markedly with adjuvant trastuzumab chemotherapy." Within 3 years, there was a 10% recurrence rate for women not treated with Herceptin compared to a 1% rate with Herceptin.
Internal Medicine News: Uncertainty for tumors less than 1cm
An August 16 Internal Medicine News article discussed the uncertainty about Herceptin for women with very small (less than 1cm), node-negative, HER2 positive breast cancer.
Although studies such as the July 15 Clinical Breast Cancer study above suggest a higher risk of recurrence for small, HER2 positive breast cancer, an American Society of Clinical Oncology (ASCO) presentation suggested that for women with very small tumors (1cm or less), the risk of recurrence may be so low that the benefit of Herceptin may not be worth the risk of cardiovascular disease.
Nonetheless, Dr. Gabriel Hortobagyi from MD Anderson was quoted to say he discusses Herceptin and chemotherapy with anyone with HER2 positive breast cancer, regardless of tumor size.
For more on Herceptin for HER2 positive breast cancer, including two-years worth of news, research and overviews, please visit the Hercetpin (trastuzumab) page of our website. From the home page of our site, click the "Treatments" tab and search for "Herceptin" in the box in the top right corner.
Tuesday, September 13, 2011
The Golden State's Dense Breast Tissue Bill: First, Some Facts
Yesterday, SB 791 (California's dense breast tissue bill) passed the State Legislature and will now go to Governor Jerry Brown (1). The bill is sponsored by State Senator Joe Simitian (D-Palo Alto). It's similar to bills passed in Connecticut and, more recently, Texas.
This bill is extremely important in and of itself. But I also find the fight around the bill really interesting. It highlights some not-so-flattering aspects of our nation's healthcare system as well as the extreme importance of being a well informed, proactive patient in the era of more personalized cancer care.
More on that tomorrow. First, today, let's lay a foundation and focus on the basic facts of the case.
The bill: SB 791 would require that, following a mammogram, women with dense breast tissue be informed by the radiology lab that: 1) they do, in fact, have dense breast tissue, 2) that dense breast tissue makes mammography a less effective screening method, and 3) that they may want to discuss the value of additional screening with their doctor.
What is dense breast tissue? It is not a disease or condition. Women's breasts differ with regard to their fat content. Breasts composed of less fat and more glandular and connective tissue are denser. Denser tissue shows up darker (whiter) on a mammogram, potentially obscuring abnormalities that could be cancer, which also appear white. Here's a good link if you want to see this. A mammogram result will include a score for breast tissue density of between 1 ("almost entirely fatty") to 4 ("extremely dense tissue present").
How much less effective is mammography in women with very dense breast tissue? An often cited 2002 study of 11,000 women out of Columbia-Presbyterian Medical Center in NYC found that while mammography detected 98% of cancer in women with fatty breasts, it found only 48% in women with the densest breasts (2). There are plenty more studies on this.
But there's another troubling aspect to dense breast tissue. It doesn't just hide tumors, it's also a strong risk factor for breast cancer. In fact, it seems that having very dense breasts is a stronger risk factor than family history. So it's a double-whammy.
The association between breast density and increased breast cancer risk was actually first reported over 30 years ago. Since then there have been many confirming studies. The best estimate is that breast density in the highest quartile represents a 4-6 times higher risk of breast cancer. That means that the 25% of women with the densest breasts have about a five times higher than average risk of getting breast cancer. The paper I'm citing comes out of Germany and was published in 2009 (3). It also states that this magnitude of risk "is only topped by age and BRCA1/2 mutation."
Despite all this, a 2010 Harris Interactive poll found that 95% of women don't know their breast density. And 90% don't know that it substantially increases cancer risk. (Sorry, can only find secondary references to thee poll.) It seems clear that there's a communication problem here. And that's what SB 791 is trying to correct.
So why is the mighty California Medical Association (and several other big medical organizations) opposing the bill? They explain their position in a press release from June 2011. But I find the CMA's position and arguments unconvincing.
I also think that the communication problem that gave rise to the legislation is due to larger shortcomings of our healthcare system. Women with dense breast tissue should be cognizant of these shortcomings. And so should breast cancer patients as they navigate different aspects of their treatment in the emerging era of personalized medicine.
I'll write about that tomorrow. After that, I'll highlight some newer screening technologies featured on our main website that might be able to make a real difference for women with dense breasts.
(1) "Governor Jerry Brown...whose aura smiles and never frowns." Couldn't resist. Any time I hear the governor's name those words flow automatically. Evidence of a misspent youth. Be the first to post the reference as a comment and I'll send you a token $5 Starbuck's card.
(2) Radiology. 2002 Oct;225(1):165-75. (PubMed ID 12355001)
(3) Breast Care (Basel). 2009;4(2):89-92. Epub 2009 Apr 24.(PubMed ID 20847885)
This bill is extremely important in and of itself. But I also find the fight around the bill really interesting. It highlights some not-so-flattering aspects of our nation's healthcare system as well as the extreme importance of being a well informed, proactive patient in the era of more personalized cancer care.
More on that tomorrow. First, today, let's lay a foundation and focus on the basic facts of the case.
The bill: SB 791 would require that, following a mammogram, women with dense breast tissue be informed by the radiology lab that: 1) they do, in fact, have dense breast tissue, 2) that dense breast tissue makes mammography a less effective screening method, and 3) that they may want to discuss the value of additional screening with their doctor.
What is dense breast tissue? It is not a disease or condition. Women's breasts differ with regard to their fat content. Breasts composed of less fat and more glandular and connective tissue are denser. Denser tissue shows up darker (whiter) on a mammogram, potentially obscuring abnormalities that could be cancer, which also appear white. Here's a good link if you want to see this. A mammogram result will include a score for breast tissue density of between 1 ("almost entirely fatty") to 4 ("extremely dense tissue present").
How much less effective is mammography in women with very dense breast tissue? An often cited 2002 study of 11,000 women out of Columbia-Presbyterian Medical Center in NYC found that while mammography detected 98% of cancer in women with fatty breasts, it found only 48% in women with the densest breasts (2). There are plenty more studies on this.
But there's another troubling aspect to dense breast tissue. It doesn't just hide tumors, it's also a strong risk factor for breast cancer. In fact, it seems that having very dense breasts is a stronger risk factor than family history. So it's a double-whammy.
The association between breast density and increased breast cancer risk was actually first reported over 30 years ago. Since then there have been many confirming studies. The best estimate is that breast density in the highest quartile represents a 4-6 times higher risk of breast cancer. That means that the 25% of women with the densest breasts have about a five times higher than average risk of getting breast cancer. The paper I'm citing comes out of Germany and was published in 2009 (3). It also states that this magnitude of risk "is only topped by age and BRCA1/2 mutation."
Despite all this, a 2010 Harris Interactive poll found that 95% of women don't know their breast density. And 90% don't know that it substantially increases cancer risk. (Sorry, can only find secondary references to thee poll.) It seems clear that there's a communication problem here. And that's what SB 791 is trying to correct.
So why is the mighty California Medical Association (and several other big medical organizations) opposing the bill? They explain their position in a press release from June 2011. But I find the CMA's position and arguments unconvincing.
I also think that the communication problem that gave rise to the legislation is due to larger shortcomings of our healthcare system. Women with dense breast tissue should be cognizant of these shortcomings. And so should breast cancer patients as they navigate different aspects of their treatment in the emerging era of personalized medicine.
I'll write about that tomorrow. After that, I'll highlight some newer screening technologies featured on our main website that might be able to make a real difference for women with dense breasts.
(1) "Governor Jerry Brown...whose aura smiles and never frowns." Couldn't resist. Any time I hear the governor's name those words flow automatically. Evidence of a misspent youth. Be the first to post the reference as a comment and I'll send you a token $5 Starbuck's card.
(2) Radiology. 2002 Oct;225(1):165-75. (PubMed ID 12355001)
(3) Breast Care (Basel). 2009;4(2):89-92. Epub 2009 Apr 24.(PubMed ID 20847885)
Labels:
Breast Cancer Detection Bill,
breast cancer risk,
california medical association,
dense breast tissue,
Governor Jerry Brown,
SB 173,
SB 791,
Senator Joe Simitian
Location:
Palo Alto, CA, USA
Radiation Therapy for Breast Cancer: Three New Studies
What's new in breast cancer radiation therapy news? Last week we added three studies on radiation to the LATESTBreastCancer.com database and website. Topics include postmastectomy radiation, radiation of the axilla and heart related side-effects.
Radiation after mastectomy reduces recurrence rates in women with large breast tumors
An August 20 study from MD Anderson in the International Journal of Radiation Oncology, Biology Physics examined recurrence rates of 162 patients with clinically T3N0 tumors who were treated with neoadjuvant (before surgery) chemotherapy and mastectomy. 'T3' means the tumors were larger than 5 cm. 'N0' means there was no lymph node involvement. (For some of the patients, pathological evaluation later revealed lymph node involvement.)
The study revealed that women who also received postmastectomy radiation were less likely to experience a local-regional recurrence (LRR) than those who did not receive radiation. Postmastectomy radiation reduced recurrence rates in women with and without lymph node involvement. Accordingly, the authors suggested that postmastectomy radiation be considered for women with T3N0 breast cancer.
Whole breast radiation is sufficient to prevent lymph node recurrence after sentinel lymph node procedure
An August 31 study in Cancer from the Memorial Sloan-Kettering Cancer Center evaluated the effectiveness of whole breast irradiation in preventing lymph node recurrence in 326 women with positive sentinel lymph nodes (SLNs) who did not undergo axillary lymph node dissection. Instead of removing all lymph nodes in the axilla area, only the sentinel lymph nodes were removed. 93% received some sort of radiation therapy.
After 4 years, 3 of the 326 women experienced a lymph node recurrence. Two of them received radiation in the standard supine (face-up) position. One did not receive radiation at all. There was no lymph node recurrence among the 66 who received radiation in the prone (face-down) position.
The authors concluded that regional control was high (99% at 4 years) in women with low-volume sentinel lymph node disease, "regardless of whether the axilla was irradiated." They noted,
An August 30 study in Cancer Epidemiology, Biomarkers & Prevention evaluated the risk of cardiovascular disease in 806 women over 65 with early stage breast cancer.
As a group, radiotherapy was not associated with a greater risk of cardiovascular disease. However, among women who received radiation, those who were treated for cancer of the left breast had a significantly increased risk of cardiovascular disease compared to those with right-side breast cancer.
The authors concluded that laterality (the side of treatment) "is critical to understanding the effect of" radiotherapy on cardiovascular disease. "As some irradiation to the heart is unavoidable, . . . continued effort is required to minimize such exposures, especially in older women with left-sided tumors."
To see all the latest news and research on radiation therapy for breast cancer, please visit the LATESTBreastCancer.com website. Click on the "Treatments" tab and search for "radiation" or "postmastectomy".
Radiation after mastectomy reduces recurrence rates in women with large breast tumors
An August 20 study from MD Anderson in the International Journal of Radiation Oncology, Biology Physics examined recurrence rates of 162 patients with clinically T3N0 tumors who were treated with neoadjuvant (before surgery) chemotherapy and mastectomy. 'T3' means the tumors were larger than 5 cm. 'N0' means there was no lymph node involvement. (For some of the patients, pathological evaluation later revealed lymph node involvement.)
The study revealed that women who also received postmastectomy radiation were less likely to experience a local-regional recurrence (LRR) than those who did not receive radiation. Postmastectomy radiation reduced recurrence rates in women with and without lymph node involvement. Accordingly, the authors suggested that postmastectomy radiation be considered for women with T3N0 breast cancer.
Whole breast radiation is sufficient to prevent lymph node recurrence after sentinel lymph node procedure
An August 31 study in Cancer from the Memorial Sloan-Kettering Cancer Center evaluated the effectiveness of whole breast irradiation in preventing lymph node recurrence in 326 women with positive sentinel lymph nodes (SLNs) who did not undergo axillary lymph node dissection. Instead of removing all lymph nodes in the axilla area, only the sentinel lymph nodes were removed. 93% received some sort of radiation therapy.
After 4 years, 3 of the 326 women experienced a lymph node recurrence. Two of them received radiation in the standard supine (face-up) position. One did not receive radiation at all. There was no lymph node recurrence among the 66 who received radiation in the prone (face-down) position.
The authors concluded that regional control was high (99% at 4 years) in women with low-volume sentinel lymph node disease, "regardless of whether the axilla was irradiated." They noted,
"Whole-breast radiation alone, including in the prone position, is sufficient treatment after breast-conserving surgery for select patients with tumor-containing SLNs who omit axillary dissection."Risk of cardiovascular disease after radiation is greater in older women with left-side breast cancer
An August 30 study in Cancer Epidemiology, Biomarkers & Prevention evaluated the risk of cardiovascular disease in 806 women over 65 with early stage breast cancer.
As a group, radiotherapy was not associated with a greater risk of cardiovascular disease. However, among women who received radiation, those who were treated for cancer of the left breast had a significantly increased risk of cardiovascular disease compared to those with right-side breast cancer.
The authors concluded that laterality (the side of treatment) "is critical to understanding the effect of" radiotherapy on cardiovascular disease. "As some irradiation to the heart is unavoidable, . . . continued effort is required to minimize such exposures, especially in older women with left-sided tumors."
To see all the latest news and research on radiation therapy for breast cancer, please visit the LATESTBreastCancer.com website. Click on the "Treatments" tab and search for "radiation" or "postmastectomy".
Monday, September 12, 2011
More Media Headlines from Breast Cancer Symposium 2011
This weekend, there were a few more headlines from the 2011 Breast Cancer Symposium in San Francisco. Topics include accelerated partial breast irradiation, neoadjuvant (before surgery) chemotherapy and NKTR-102, a drug in development for metastatic breast cancer.
HemOnc Today: "Control rates similar after partial irradiation across various subtypes in early-stage breast cancer"
On September 9, HemOncToday.com shared a study which found excellent 5-year local control rates among women with a variety of breast cancer molecular subtypes treated with accelerated partial breast irradiation (APBI). APBI reduces treatment time from over 6 weeks to just five days.
Until now, most trials of APBI included only women with more favorable cancer subtypes. Dr. Robert R. Kuske was quoted to say, "I'm very glad to see this study being published, which shows that even younger women with aggressive breast cancer may have a 5-day alternative to the 6.5 weeks." He hoped that "hesitant physicians will now open the floodgates and will put these patients onto clinical trials in these subtypes."
MD Anderson: "Chemotherapy is as Effective Before Breast Cancer Surgery as After"
A study from MD Anderson compared local-regional recurrence (LRR) rates of women treated with chemotherapy before and after breast conserving surgery (lumpectomy).
5 and 10-year LRR rates were "excellent" for both groups. When age and tumor characteristics were factored in, "survival rates were essentially the same for both groups of women."
Dr. Elizabeth Ann Mittendorf, lead study author concluded,
Medical News Today: "Positive Results From Phase 2 Clinical Study Of NKTR-102 In Metastatic Breast Cancer Presented In Oral Session At The ASCO 2011 Symposium"
Nektar Therapeutics announced positive phase 2 study results of NKTR-102 for metastatic breast cancer. The study showed promising progression-free survival and overall survival, even for women with a poor prognosis or who have been "heavily pretreated" with anthracylines/taxanes and/or Xeloda (capecitabine).
NKTR-102 was also "very well-tolerated," with minimal alopecia (hair loss), neuropathy (nerve damage) and neutropenia (low white blood cell count). The most common grade-3 toxicity was diarrhea, which typically occured after 3 months of therapy.
A phase 3 trial known as BEACON (BrEAst Cancer Outcomes with NKTR-102) is expected to begin in December 2011.
Tomorrow we'll share the latest research radiation therapy for breast cancer. Please stay tuned.
HemOnc Today: "Control rates similar after partial irradiation across various subtypes in early-stage breast cancer"
On September 9, HemOncToday.com shared a study which found excellent 5-year local control rates among women with a variety of breast cancer molecular subtypes treated with accelerated partial breast irradiation (APBI). APBI reduces treatment time from over 6 weeks to just five days.
Until now, most trials of APBI included only women with more favorable cancer subtypes. Dr. Robert R. Kuske was quoted to say, "I'm very glad to see this study being published, which shows that even younger women with aggressive breast cancer may have a 5-day alternative to the 6.5 weeks." He hoped that "hesitant physicians will now open the floodgates and will put these patients onto clinical trials in these subtypes."
MD Anderson: "Chemotherapy is as Effective Before Breast Cancer Surgery as After"
A study from MD Anderson compared local-regional recurrence (LRR) rates of women treated with chemotherapy before and after breast conserving surgery (lumpectomy).
5 and 10-year LRR rates were "excellent" for both groups. When age and tumor characteristics were factored in, "survival rates were essentially the same for both groups of women."
Dr. Elizabeth Ann Mittendorf, lead study author concluded,
“This study shows that women appropriately selected for BCT, even some women with Stage 3 breast cancer, can have excellent rates of local-regional control,” Mittendorf said. “The most important thing is putting all the factors together to determine who can most benefit from this approach.”
Medical News Today: "Positive Results From Phase 2 Clinical Study Of NKTR-102 In Metastatic Breast Cancer Presented In Oral Session At The ASCO 2011 Symposium"
Nektar Therapeutics announced positive phase 2 study results of NKTR-102 for metastatic breast cancer. The study showed promising progression-free survival and overall survival, even for women with a poor prognosis or who have been "heavily pretreated" with anthracylines/taxanes and/or Xeloda (capecitabine).
NKTR-102 was also "very well-tolerated," with minimal alopecia (hair loss), neuropathy (nerve damage) and neutropenia (low white blood cell count). The most common grade-3 toxicity was diarrhea, which typically occured after 3 months of therapy.
A phase 3 trial known as BEACON (BrEAst Cancer Outcomes with NKTR-102) is expected to begin in December 2011.
Tomorrow we'll share the latest research radiation therapy for breast cancer. Please stay tuned.
Thursday, September 8, 2011
Media Headlines from the 2011 Breast Cancer Symposium
Breast Cancer Symposium 2011 is underway in San Francisco this week. Today we'll share the media coverage of some of the presentations.
Medical News Today: "Young Women With Early Breast Cancer Have Similar Survival With Breast Conservation, Mastectomy"
More young women under 40 with breast cancer are choosing mastectomy over breast conserving surgery (lumpectomy), in part because of concerns about recurrence. Two presentations suggest that there is no survival difference between women treated with a mastectomy and those treated with a lumpectomy plus radiation.
US News and World Report wrote about both studies. The first, presented a few days ahead of the Symposium, evaluated medical records of 628 women aged 21 to 40. Local recurrence and survival rates were similar for women treated with mastectomy and women treated with lumpectomy.
According to Medical News Today, the second study reviewed the records of nearly 15,000 women under 40 with breast cancer. Overall survival was similar between women treated with mastectomy and those treated with lumpectomy plus radiation. When women were matched with others with similar cancer characteristics, such as tumor size and lymph node involvement, there was no difference in overall survival.
HemOnc Today: "New tool may help predict breast-cancer-associated lymphedema"
On September 8, HemOnc Today shared a Brazilian study of a model to predict lymphedema before axillary lymph node dissection. The statistical model "demonstrated more than 70% accuracy for predicting the 5-year risk for developing lymphedema after lymph node removal during breast cancer surgery."
Dr. Jose Bevilacqua, a study author, noted that the model used "readily available clinical factors," such as age, BMI and number of chemotherapy cycles, for a "quick and easy estimation of individual risks of developing lymphedema after axillary lymph node surgery in women with breast cancer."
Drugs.com: "Syndax Pharmaceutical's Positive Phase 2 Data Supports Potential for Entinostat in Advanced Breast Cancer"
On September 6, Drugs.com printed a press release from Syndax about a positive phase 2 study of entinostat for advanced breast cancer.
For post-menopausal women with estrogen-receptor positive metastatic breast cancer, entinostat plus Aromasin (exemestane) improved progression-free survival and overall survival compared to placebo plus Aromasin.
A phase 3 trial is planned for early 2012.
US News and World Report: "Annual Breast Exams, Mammograms Still Key to Detecting Breast Cancer"
There's more fuel in the screening mammography debate. On September 6, US News and World Report/HealthDay covered a study from Michigan which reviewed breast cancer detection and treatment records from almost 6,000 women with breast cancer.
Overall, breast cancer detected by palpitation (feel) tended to be later-stage and more likely to be treated with a mastectomy and chemotherapy compared to breast cancer detected by mammography.
For women under 50, 48% of breast cancers were detected by mammography and 46% by palpitation. Dr. Andrew Seidman, an official of the American Society of Clinical Oncology (ASCO), said, "Undoubtedly, this area will continue to remain an area of controversy for some, but certainly women in this age group would be well-served to know about this data."
Not every study we add to the LATESTBreastCancer.com website and database makes media headlines. Next week, we'll highlight some new research which is under the media radar. Please stay tuned.
Medical News Today: "Young Women With Early Breast Cancer Have Similar Survival With Breast Conservation, Mastectomy"
More young women under 40 with breast cancer are choosing mastectomy over breast conserving surgery (lumpectomy), in part because of concerns about recurrence. Two presentations suggest that there is no survival difference between women treated with a mastectomy and those treated with a lumpectomy plus radiation.
US News and World Report wrote about both studies. The first, presented a few days ahead of the Symposium, evaluated medical records of 628 women aged 21 to 40. Local recurrence and survival rates were similar for women treated with mastectomy and women treated with lumpectomy.
According to Medical News Today, the second study reviewed the records of nearly 15,000 women under 40 with breast cancer. Overall survival was similar between women treated with mastectomy and those treated with lumpectomy plus radiation. When women were matched with others with similar cancer characteristics, such as tumor size and lymph node involvement, there was no difference in overall survival.
HemOnc Today: "New tool may help predict breast-cancer-associated lymphedema"
On September 8, HemOnc Today shared a Brazilian study of a model to predict lymphedema before axillary lymph node dissection. The statistical model "demonstrated more than 70% accuracy for predicting the 5-year risk for developing lymphedema after lymph node removal during breast cancer surgery."
Dr. Jose Bevilacqua, a study author, noted that the model used "readily available clinical factors," such as age, BMI and number of chemotherapy cycles, for a "quick and easy estimation of individual risks of developing lymphedema after axillary lymph node surgery in women with breast cancer."
Drugs.com: "Syndax Pharmaceutical's Positive Phase 2 Data Supports Potential for Entinostat in Advanced Breast Cancer"
On September 6, Drugs.com printed a press release from Syndax about a positive phase 2 study of entinostat for advanced breast cancer.
For post-menopausal women with estrogen-receptor positive metastatic breast cancer, entinostat plus Aromasin (exemestane) improved progression-free survival and overall survival compared to placebo plus Aromasin.
A phase 3 trial is planned for early 2012.
US News and World Report: "Annual Breast Exams, Mammograms Still Key to Detecting Breast Cancer"
There's more fuel in the screening mammography debate. On September 6, US News and World Report/HealthDay covered a study from Michigan which reviewed breast cancer detection and treatment records from almost 6,000 women with breast cancer.
Overall, breast cancer detected by palpitation (feel) tended to be later-stage and more likely to be treated with a mastectomy and chemotherapy compared to breast cancer detected by mammography.
For women under 50, 48% of breast cancers were detected by mammography and 46% by palpitation. Dr. Andrew Seidman, an official of the American Society of Clinical Oncology (ASCO), said, "Undoubtedly, this area will continue to remain an area of controversy for some, but certainly women in this age group would be well-served to know about this data."
Not every study we add to the LATESTBreastCancer.com website and database makes media headlines. Next week, we'll highlight some new research which is under the media radar. Please stay tuned.
Wednesday, September 7, 2011
Soy Vey! Is Soy Safe for Breast Cancer Survivors or Not?
Is soy safe for breast cancer survivors? Traditionally, caution was advised. Then, a big study in April suggested that survivors needn't worry about soy consumption. Now, a new study raises concerns again. Today we'll share the latest research on soy for breast cancer survivors.
Links to all of the studies, news stories and overviews discussed below may be found on the soy page of the LATESTBreastCancer.com website. If the link does not take you directly to the soy page, please click the "Treatments" tab, then search for "soy" in the search box in the top right corner.
A little biology
The issue for breast cancer survivors involves the isoflavones in soy. Isoflavones are phytoestrogens, or an estrogen-like compounds found in plants. They act like weak estrogens and are able to bind to estrogen receptors in cells. For women with estrogen receptor positive breast cancer, there is some concern about the estrogen-like behavior of isoflavones in soy.
April 2011 study: Dietary soy is safe after breast cancer
An April 5 presentation to the American Association for Cancer Research caused quite a media stir, with headlines in the Los Angeles Times ("Soy: Breast cancer survivors can eat soy foods without risk, study finds") and Consumer Reports Health ("No need to avoid soy after breast cancer").
The study analyzed soy consumption data from 18,000 breast cancer survivors in China and America followed for an average of more than 9 years. According to the study conclusion, "Soy food consumption was not associated with an increased risk of mortality or cancer recurrence among breast cancer survivors."
On the positive side, this data represented a large number of women over a long period of time. On the other hand, the study has not yet been published in a medical journal or subject to critical peer review. Also, the study conclusions relate to dietary soy not soy supplements.
August 2011 study: Soy supplements may affect aromatase inhibitor activity
An August 10 study from The Netherlands published in Toxicology examined the effects of the soy isoflavone genistein on estrogen dependent breast cancer cells. In the study, genistein induced tumor cell growth and increased aromatase expression and activity. The data suggested that soy-based supplements "might affect the efficacy of breast cancer treatment with aromatase inhibitors." The authors caution,
The North American Menopause Society (NAMS) issued a comprehensive report on soy isoflavones for menopausal symptoms (link to full report). It provides a thorough review of the biology of soy and the recent research on hot flashes, breast safety and bone health. With respect to use after a breast cancer diagnosis, the report notes,
NAMS is not alone in recommending caution when using soy after breast cancer. The National Institutes of Health National Center for Complementary and Alternative Medicine webpage on soy notes,
Links to all of the studies, news stories and overviews discussed below may be found on the soy page of the LATESTBreastCancer.com website. If the link does not take you directly to the soy page, please click the "Treatments" tab, then search for "soy" in the search box in the top right corner.
A little biology
The issue for breast cancer survivors involves the isoflavones in soy. Isoflavones are phytoestrogens, or an estrogen-like compounds found in plants. They act like weak estrogens and are able to bind to estrogen receptors in cells. For women with estrogen receptor positive breast cancer, there is some concern about the estrogen-like behavior of isoflavones in soy.
April 2011 study: Dietary soy is safe after breast cancer
An April 5 presentation to the American Association for Cancer Research caused quite a media stir, with headlines in the Los Angeles Times ("Soy: Breast cancer survivors can eat soy foods without risk, study finds") and Consumer Reports Health ("No need to avoid soy after breast cancer").
The study analyzed soy consumption data from 18,000 breast cancer survivors in China and America followed for an average of more than 9 years. According to the study conclusion, "Soy food consumption was not associated with an increased risk of mortality or cancer recurrence among breast cancer survivors."
On the positive side, this data represented a large number of women over a long period of time. On the other hand, the study has not yet been published in a medical journal or subject to critical peer review. Also, the study conclusions relate to dietary soy not soy supplements.
August 2011 study: Soy supplements may affect aromatase inhibitor activity
An August 10 study from The Netherlands published in Toxicology examined the effects of the soy isoflavone genistein on estrogen dependent breast cancer cells. In the study, genistein induced tumor cell growth and increased aromatase expression and activity. The data suggested that soy-based supplements "might affect the efficacy of breast cancer treatment with aromatase inhibitors." The authors caution,
Considering the high number of breast cancer patients using soy supplements to treat menopausal symptoms, the increasing risk for adverse interactions with breast cancer treatment is of major concern and should be considered with care.NAMS 2011 Isoflavones Report: More studies are needed
The North American Menopause Society (NAMS) issued a comprehensive report on soy isoflavones for menopausal symptoms (link to full report). It provides a thorough review of the biology of soy and the recent research on hot flashes, breast safety and bone health. With respect to use after a breast cancer diagnosis, the report notes,
Specific recommendations regarding soy or isoflavoneInterestingly, the report discusses human studies from both China and the United States which support the safety of soy after breast cancer. (p. 740) Nevertheless, it does not recommend soy due to safety concerns in cells and animals.
consumption by breast cancer survivors cannot be made at
this time; studies in human subjects indicate a null or
protective effect, whereas cell culture and rodent studies
indicate potential for risk. Further studies are needed. (p. 739)
NAMS is not alone in recommending caution when using soy after breast cancer. The National Institutes of Health National Center for Complementary and Alternative Medicine webpage on soy notes,
Soy's possible role in breast cancer risk is uncertain. Until more is known about soy's effect on estrogen levels, women who have or who are at increased risk of developing breast cancer or other hormone-sensitive conditions (such as ovarian or uterine cancer) should be particularly careful about using soy and should discuss it with their health care providers.The American Cancer Society publishes a similar warning,
The isoflavones in soy have weak estrogen-like activity, and it is unclear how they might affect the growth of estrogen receptor-positive breast cancers. Some researchers suggest they may act as anti-estrogens and reduce cancer growth, while others suggest their estrogen-like activity could cause cancer to grow faster. Until this issue is resolved, many oncologists recommend that people taking tamoxifen or aromatase inhibitors and people with estrogen-sensitive breast tumors should avoid adding large amounts of soy, including soy supplements or isoflavones, to their diets.At LATESTBreastCancer.com, we'll continue to follow and share the latest research on soy for breast cancer survivors. Any new developments will be added to the LATESTBreastCancer.com website and highlighted here. Please stay tuned.
Thursday, September 1, 2011
Breast Cancer News Weekly Wrap-Up (Aug. 28 to Sept. 1)
What's new in breast cancer news? Today we'll share the week's headlines and the studies behind them.
US News and World Report: "Some Older Breast Cancer Patients Can Skip Hormone Therapy: Study"
This headline sounds encouraging. For hormone receptor positive breast cancer, hormonal therapy is typically prescribed for five years and associated with unpleasant side effects. Who wouldn't want to skip it?
However, there is some fine print. (Links to the US News and World Report/HealthDay story, the underlying study and related Memo to the Media may be found on the Arimidex (anastrozole) page of our website.)
The August 31 Journal of the National Cancer Institute (JNCI) study evaluated mortality (death) rates for women in Denmark with early-stage, node-negative, hormone-receptor positive breast cancer. Women over 60, with small tumors (up to 10mm), who received no hormonal therapy or chemotherapy were not at an increased risk of death compared with women the same age in the general population.
In an accompanying editorial, the authors noted that even if there is no benefit in terms of mortality, hormonal therapy reduces the risk of recurrence in the same or opposite breast, and many "will continue to take it for that reason." (See the JNCI Memo to the Media under the News tab.)
For women in this subset, this study is another factor to be considered in the decision on whether to take hormonal therapy. According to the Memo to the Media, "patient preferences regarding risks and benefits play a critical role" in the decision. In US News and World Report, Dr. Jennifer Griggs, a study co-author, suggested a three month trial of hormone therapy to gauge side effects before deciding whether to continue.
Reuters: "New breast cancer gene may help predict risk"
The gene at issue, known as CHEK2, is not really new. The CHEK2 genetic test is available, but not generally offered. Instead, BRCA 1/2 genetic tests are typically used to assess hereditary risk. (More on the test and links to the study and story below may be found on the CHEK 2 gene testing page of our website.)
The August 29 Journal of Clinical Oncology study from Poland estimated breast cancer risk in women with CHEK2 mutations and family histories of breast cancer. Baseline lifetime risk was assumed to be 6%. Women with a CHEK2 mutation and no family history had an estimated lifetime risk of 20%. Risk increased with family history. A second-degree relative with breast cancer raised the risk to 28%, one first-degree relative to 34% and both a first- and second-degree relative to 44%.
An August 29 story in Reuters noted that the study may not be "ready for prime time yet." According to Reuters, Dr. James P. Evans, editor-in-chief of Genetics in Medicine, called the study a "nice start," but said it would be "premature" to recommend CHEK2 testing for everyone with a family history now. Dr. Diana Petitti, of Arizona State University in Phoenix, said the study is "an important breakthrough," but more research is needed, noting that "this is a field where replication is critical."
One of the concerns is that the Polish women in the study may be different than Americans. In America, the lifetime risk of breast cancer is about 12% (1 in 8). According to the study authors, that number is only about 6 percent in Poland.
ScienceDaily.com: "Breast Cancer Risk Drops When Diet Includes Walnuts, Researchers Find"
A recent study in Nutrition and Cancer found that walnut consumption reduced breast cancer risk in mice. Study leader Elaine Hardman, Ph.D was quoted in ScienceDaily.com to say, "The results of this study indicate that increased consumption of walnut could be part of a healthy diet and reduce risk for cancer in future generations." (Link on the the Fruits, Vegetables and Nuts page of our website.)
Animals studies such as this one are often interesting, but the applicability in humans has not yet been proven in human trials.
Toronto Sun: "Smoking after menopause could increase risk for breast cancer: Study"
This week, the Toronto Sun, US News and World Report/HealthDay and WebMD covered an August 10 study in The Journal of Endocrinology and Metabolism which found higher androgen and estrogen levels in smokers.
According to the study, because hormone levels dropped with smoking cessation, "hormone related disease risks could potentially be modified by changing smoking habits."
Next week, we'll share the latest research on soy for breast cancer survivors. Until then, all the latest news and research on any breast cancer test or treatment option may be found on the treatment pages of the LATESTBreastCancer.com website.
US News and World Report: "Some Older Breast Cancer Patients Can Skip Hormone Therapy: Study"
This headline sounds encouraging. For hormone receptor positive breast cancer, hormonal therapy is typically prescribed for five years and associated with unpleasant side effects. Who wouldn't want to skip it?
However, there is some fine print. (Links to the US News and World Report/HealthDay story, the underlying study and related Memo to the Media may be found on the Arimidex (anastrozole) page of our website.)
The August 31 Journal of the National Cancer Institute (JNCI) study evaluated mortality (death) rates for women in Denmark with early-stage, node-negative, hormone-receptor positive breast cancer. Women over 60, with small tumors (up to 10mm), who received no hormonal therapy or chemotherapy were not at an increased risk of death compared with women the same age in the general population.
In an accompanying editorial, the authors noted that even if there is no benefit in terms of mortality, hormonal therapy reduces the risk of recurrence in the same or opposite breast, and many "will continue to take it for that reason." (See the JNCI Memo to the Media under the News tab.)
For women in this subset, this study is another factor to be considered in the decision on whether to take hormonal therapy. According to the Memo to the Media, "patient preferences regarding risks and benefits play a critical role" in the decision. In US News and World Report, Dr. Jennifer Griggs, a study co-author, suggested a three month trial of hormone therapy to gauge side effects before deciding whether to continue.
Reuters: "New breast cancer gene may help predict risk"
The gene at issue, known as CHEK2, is not really new. The CHEK2 genetic test is available, but not generally offered. Instead, BRCA 1/2 genetic tests are typically used to assess hereditary risk. (More on the test and links to the study and story below may be found on the CHEK 2 gene testing page of our website.)
The August 29 Journal of Clinical Oncology study from Poland estimated breast cancer risk in women with CHEK2 mutations and family histories of breast cancer. Baseline lifetime risk was assumed to be 6%. Women with a CHEK2 mutation and no family history had an estimated lifetime risk of 20%. Risk increased with family history. A second-degree relative with breast cancer raised the risk to 28%, one first-degree relative to 34% and both a first- and second-degree relative to 44%.
An August 29 story in Reuters noted that the study may not be "ready for prime time yet." According to Reuters, Dr. James P. Evans, editor-in-chief of Genetics in Medicine, called the study a "nice start," but said it would be "premature" to recommend CHEK2 testing for everyone with a family history now. Dr. Diana Petitti, of Arizona State University in Phoenix, said the study is "an important breakthrough," but more research is needed, noting that "this is a field where replication is critical."
One of the concerns is that the Polish women in the study may be different than Americans. In America, the lifetime risk of breast cancer is about 12% (1 in 8). According to the study authors, that number is only about 6 percent in Poland.
ScienceDaily.com: "Breast Cancer Risk Drops When Diet Includes Walnuts, Researchers Find"
A recent study in Nutrition and Cancer found that walnut consumption reduced breast cancer risk in mice. Study leader Elaine Hardman, Ph.D was quoted in ScienceDaily.com to say, "The results of this study indicate that increased consumption of walnut could be part of a healthy diet and reduce risk for cancer in future generations." (Link on the the Fruits, Vegetables and Nuts page of our website.)
Animals studies such as this one are often interesting, but the applicability in humans has not yet been proven in human trials.
Toronto Sun: "Smoking after menopause could increase risk for breast cancer: Study"
This week, the Toronto Sun, US News and World Report/HealthDay and WebMD covered an August 10 study in The Journal of Endocrinology and Metabolism which found higher androgen and estrogen levels in smokers.
According to the study, because hormone levels dropped with smoking cessation, "hormone related disease risks could potentially be modified by changing smoking habits."
Next week, we'll share the latest research on soy for breast cancer survivors. Until then, all the latest news and research on any breast cancer test or treatment option may be found on the treatment pages of the LATESTBreastCancer.com website.
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