OBG Management

SEPTEMBER 2015

“YOUR TEENAGE PATIENT AND CONTRACEPTION: THINK 
‘LONG-ACTING’ FIRST”
DAVID R. KATTAN, MD, MPH, AND 
RONALD T. BURKMAN, MD (SEPTEMBER 2015)

What does Liletta cost 
to non-340B providers?
Drs. Kattan and Burkman state in their article: “For providers who practice in settings eligible for 340B pricing, Liletta costs $50, a fraction of the cost of alternative intrauterine devices (IUDs). The cost is slightly higher for non-340B providers but is still significantly lower than the cost of other IUDs.”

Could you provide a cost range and the source for the non-340B cost?
Sharon J. Hawthorne, MBA 
St. Louis, Missouri

Drs. Kattan and Burkman respond:
Thank you for your question and for allowing us to clarify. The manufacturer of Liletta, Actavis, offers a Patient Savings Program for private insurance patients to limit their out-of-pocket cost to $75. This program will end on December 31, 2015. Information is available at http://www.lilettacard.com.

For non-340B providers, the cost per IUD is higher, although this should be reimbursed by the patient’s insurance program. After volume discounts, the price per device is as low as $537. Without volume discounts, the price per device is $600. For more information, visit: https://www.lilettahcp.com/content/pdf/LILETTA-Quick-Reference-Guide.pdf.

Medicines360, the nonprofit partner of Actavis, states the following on its Web site (http://medicines360.org/our-mission): “Through our pharmaceutical partnerships, commercial product sales help support an affordable price to public sector clinics. This allows low income women or those without insurance the opportunity to access more healthcare choices.”

“DOES PREOPERATIVE URODYNAMICS IMPROVE OUTCOMES FOR WOMEN UNDERGOING SURGERY FOR STRESS URINARY INCONTINENCE?”
CHARLES W. NAGER, MD 
(EXAMINING THE EVIDENCE; AUGUST 2015)

Priorities for determining the etiology of incontinence
While I believe Dr. Nager’s approach accurately interprets current clinical evidence, it also reflects an inadequate paradigm. Whether or not incontinence surgery should be preceded by formal invasive urodynamic evaluation is not the question. As director of urodynamics at UConn, I understand that even the most advanced clinical urodynamics evaluation is limited in what it can measure. Nowhere in that data set is “determine the etiology of incontinence.” Therefore, the more appropriate question is: When should one consider 
urodynamic evaluation before making a diagnosis requiring therapy? The answer: By prioritizing aspects of lower urinary tract function.

As recommended by the International Continence Society, the diagnosing physician actually must conduct the urodynamic testing. This physician’s first priority is to determine if the bladder can maintain low storage pressures. History and physical examination must include an acknowledgment of potential causes, including chronic urethral obstruction or failure of autonomic/sympathetic regulation. Yes, in an otherwise healthy 45-year-old vaginally parous woman with stress urinary incontinence (SUI) symptoms, it is unlikely that storage pressures aren’t normally regulated. It takes little office visit time to reach that conclusion.

The diagnosing physician’s second priority is to determine the actual functional size of the urinary reservoir. Only the bladder can expel urine actively. Is there a bladder diverticulum or reflux into the upper tracts augmenting the reservoir? Bladder/urethral function is about volume management, yet the sphincteric mechanism is not tolerant of very high volumes, even in “normal” patients. Knowing reservoir volumes when leakage occurs and the relationship of these volumes to perceptions of “empty” and “full” is critical to determining how to respond to sphincteric insufficiency that produces SUI symptoms. I agree that an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms will have a problem here. However, if the diagnosing physician has any reason to doubt that the urinary reservoir has the same functionality as the bladder and that operational 
volumes are “normal,” then 
video­urodynamic investigation is the most direct approach. 

The third priority during evaluation is to determine how the reservoir empties. What is the source of the expulsive pressure of voiding? What is the interaction of the expulsive pressure and the urethral opening? How effectively does the bladder empty? In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem, but if the physician doesn’t consider how this patient’s bladder empties, determining how the sphincter is stressed during storage and how the patient might respond to intervention is impossible. If normal efficient voiding by detrusor pressurization cannot be assured by office evaluation, then urodynamic examination, including a pressure/flow study, is necessary. 

The last priority is to determine how the urine storage/emptying system is controlled. This is most important to the patient but least important for diagnosis. Often this can be deduced from a simple office evaluation that includes urinalysis, a voiding diary, standing stress test, possibly simple “office cystometry” (with a large Toomey syringe, a straight catheter, and saline solution), and the patient’s history. No aspect of this last priority requires invasive computerized urodynamics—unless the physician just cannot figure it out even after considering results of the first 3 steps. 

Once these evaluative priorities have been completed, a diagnosis can be considered and treatment options determined. But only then.
Phillip P. Smith, MD
Farmington, Connecticut

Dr. Nager responds:
Dr. Smith provides a very nice review of what the bladder and urethra need to do. As he points out, the most appropriate question is: When should one consider urodynamic evaluation before making a diagnosis requiring therapy? Well, when a reliable diagnosis cannot be made by history, physical examination, and simple office tests.

The literature suggests that a neurologically normal woman without prolapse and without previous incontinence surgeries can receive a reliable diagnosis without urodynamic testing. If she demonstrates SUI on office stress testing, she is not storing urine normally and urodynamics will confirm urodynamic stress incontinence 97% of the time.¹ If she voluntarily voids with a normal postvoid residual, her emptying function has been assessed and is normal.

I think Dr. Smith and I both agree that, “In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem.” We also both agree that whenever the diagnosis is unclear, or the situation is complicated, urodynamic testing is a helpful tool to assess the bladder’s storage and emptying function. I perform urodynamics regularly in my practice; it just is not necessary before surgery in a woman without prolapse and without previous incontinence surgeries who demonstrates her SUI and has a normal urinalysis and normal postvoid residual. We seem to agree on that point also.

Reference

1. Nager C, Brubaker L, Litman H, et al; Urinary Incontinence Treatment Network. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012;366(21):1987–1997.

“UPDATE ON MENOPAUSE”
ANDREW M. KAUNITZ, MD (JUNE 2015)

Should Provera still be used?
Dr. Kaunitz provided an excellent review of the Women’s Health Initiative (WHI) study and a recent testosterone trial in women in his update on hormone therapy in menopause.

After the WHI revealed differences between the estrogen-alone and estrogen–progestin study arms, implicating medroxyprogesterone acetate for increased risk of breast cancer, why is Provera still being advocated by the American College of Obstetricians and Gynecologists as a progestin safe for use in menopause?
Kathleen Norman, MD
Phoenix, Arizona

Dr. Barbieri responds:
Many insurance formularies favor the use of Provera because it is inexpensive. I try to avoid using it in my practice. Many experts do not yet diligently avoid the use of Provera; some are worried about the cost impact for patients.

For additional information on reducing the use of Provera, see my July 2014 editorial, “Hormone therapy for menopausal vasomotor symptoms,” at obgmanagement.com.

Dr. Kaunitz responds:
My preference is to use micronized oral progesterone (formulated in peanut oil) for endometrial protection in menopausal women using estrogen. I use progesterone 100 mg nightly in women taking standard-dose estrogen (estradiol patch 0.05 mg, oral estradiol 1 mg, or conjugated equine estrogen 0.625 mg). However, some patients request generic medroxyprogesterone acetate because it is so inexpensive (often $4 each month).

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

SEPTEMBER 2015

“YOUR TEENAGE PATIENT AND CONTRACEPTION: THINK 
‘LONG-ACTING’ FIRST”
DAVID R. KATTAN, MD, MPH, AND 
RONALD T. BURKMAN, MD (SEPTEMBER 2015)

What does Liletta cost 
to non-340B providers?
Drs. Kattan and Burkman state in their article: “For providers who practice in settings eligible for 340B pricing, Liletta costs $50, a fraction of the cost of alternative intrauterine devices (IUDs). The cost is slightly higher for non-340B providers but is still significantly lower than the cost of other IUDs.”

Could you provide a cost range and the source for the non-340B cost?
Sharon J. Hawthorne, MBA 
St. Louis, Missouri

Drs. Kattan and Burkman respond:
Thank you for your question and for allowing us to clarify. The manufacturer of Liletta, Actavis, offers a Patient Savings Program for private insurance patients to limit their out-of-pocket cost to $75. This program will end on December 31, 2015. Information is available at http://www.lilettacard.com.

For non-340B providers, the cost per IUD is higher, although this should be reimbursed by the patient’s insurance program. After volume discounts, the price per device is as low as $537. Without volume discounts, the price per device is $600. For more information, visit: https://www.lilettahcp.com/content/pdf/LILETTA-Quick-Reference-Guide.pdf.

Medicines360, the nonprofit partner of Actavis, states the following on its Web site (http://medicines360.org/our-mission): “Through our pharmaceutical partnerships, commercial product sales help support an affordable price to public sector clinics. This allows low income women or those without insurance the opportunity to access more healthcare choices.”

“DOES PREOPERATIVE URODYNAMICS IMPROVE OUTCOMES FOR WOMEN UNDERGOING SURGERY FOR STRESS URINARY INCONTINENCE?”
CHARLES W. NAGER, MD 
(EXAMINING THE EVIDENCE; AUGUST 2015)

Priorities for determining the etiology of incontinence
While I believe Dr. Nager’s approach accurately interprets current clinical evidence, it also reflects an inadequate paradigm. Whether or not incontinence surgery should be preceded by formal invasive urodynamic evaluation is not the question. As director of urodynamics at UConn, I understand that even the most advanced clinical urodynamics evaluation is limited in what it can measure. Nowhere in that data set is “determine the etiology of incontinence.” Therefore, the more appropriate question is: When should one consider 
urodynamic evaluation before making a diagnosis requiring therapy? The answer: By prioritizing aspects of lower urinary tract function.

As recommended by the International Continence Society, the diagnosing physician actually must conduct the urodynamic testing. This physician’s first priority is to determine if the bladder can maintain low storage pressures. History and physical examination must include an acknowledgment of potential causes, including chronic urethral obstruction or failure of autonomic/sympathetic regulation. Yes, in an otherwise healthy 45-year-old vaginally parous woman with stress urinary incontinence (SUI) symptoms, it is unlikely that storage pressures aren’t normally regulated. It takes little office visit time to reach that conclusion.

The diagnosing physician’s second priority is to determine the actual functional size of the urinary reservoir. Only the bladder can expel urine actively. Is there a bladder diverticulum or reflux into the upper tracts augmenting the reservoir? Bladder/urethral function is about volume management, yet the sphincteric mechanism is not tolerant of very high volumes, even in “normal” patients. Knowing reservoir volumes when leakage occurs and the relationship of these volumes to perceptions of “empty” and “full” is critical to determining how to respond to sphincteric insufficiency that produces SUI symptoms. I agree that an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms will have a problem here. However, if the diagnosing physician has any reason to doubt that the urinary reservoir has the same functionality as the bladder and that operational 
volumes are “normal,” then 
video­urodynamic investigation is the most direct approach. 

The third priority during evaluation is to determine how the reservoir empties. What is the source of the expulsive pressure of voiding? What is the interaction of the expulsive pressure and the urethral opening? How effectively does the bladder empty? In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem, but if the physician doesn’t consider how this patient’s bladder empties, determining how the sphincter is stressed during storage and how the patient might respond to intervention is impossible. If normal efficient voiding by detrusor pressurization cannot be assured by office evaluation, then urodynamic examination, including a pressure/flow study, is necessary. 

The last priority is to determine how the urine storage/emptying system is controlled. This is most important to the patient but least important for diagnosis. Often this can be deduced from a simple office evaluation that includes urinalysis, a voiding diary, standing stress test, possibly simple “office cystometry” (with a large Toomey syringe, a straight catheter, and saline solution), and the patient’s history. No aspect of this last priority requires invasive computerized urodynamics—unless the physician just cannot figure it out even after considering results of the first 3 steps. 

Once these evaluative priorities have been completed, a diagnosis can be considered and treatment options determined. But only then.
Phillip P. Smith, MD
Farmington, Connecticut

Dr. Nager responds:
Dr. Smith provides a very nice review of what the bladder and urethra need to do. As he points out, the most appropriate question is: When should one consider urodynamic evaluation before making a diagnosis requiring therapy? Well, when a reliable diagnosis cannot be made by history, physical examination, and simple office tests.

The literature suggests that a neurologically normal woman without prolapse and without previous incontinence surgeries can receive a reliable diagnosis without urodynamic testing. If she demonstrates SUI on office stress testing, she is not storing urine normally and urodynamics will confirm urodynamic stress incontinence 97% of the time.¹ If she voluntarily voids with a normal postvoid residual, her emptying function has been assessed and is normal.

I think Dr. Smith and I both agree that, “In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem.” We also both agree that whenever the diagnosis is unclear, or the situation is complicated, urodynamic testing is a helpful tool to assess the bladder’s storage and emptying function. I perform urodynamics regularly in my practice; it just is not necessary before surgery in a woman without prolapse and without previous incontinence surgeries who demonstrates her SUI and has a normal urinalysis and normal postvoid residual. We seem to agree on that point also.

Reference

1. Nager C, Brubaker L, Litman H, et al; Urinary Incontinence Treatment Network. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012;366(21):1987–1997.

“UPDATE ON MENOPAUSE”
ANDREW M. KAUNITZ, MD (JUNE 2015)

Should Provera still be used?
Dr. Kaunitz provided an excellent review of the Women’s Health Initiative (WHI) study and a recent testosterone trial in women in his update on hormone therapy in menopause.

After the WHI revealed differences between the estrogen-alone and estrogen–progestin study arms, implicating medroxyprogesterone acetate for increased risk of breast cancer, why is Provera still being advocated by the American College of Obstetricians and Gynecologists as a progestin safe for use in menopause?
Kathleen Norman, MD
Phoenix, Arizona

Dr. Barbieri responds:
Many insurance formularies favor the use of Provera because it is inexpensive. I try to avoid using it in my practice. Many experts do not yet diligently avoid the use of Provera; some are worried about the cost impact for patients.

For additional information on reducing the use of Provera, see my July 2014 editorial, “Hormone therapy for menopausal vasomotor symptoms,” at obgmanagement.com.

Dr. Kaunitz responds:
My preference is to use micronized oral progesterone (formulated in peanut oil) for endometrial protection in menopausal women using estrogen. I use progesterone 100 mg nightly in women taking standard-dose estrogen (estradiol patch 0.05 mg, oral estradiol 1 mg, or conjugated equine estrogen 0.625 mg). However, some patients request generic medroxyprogesterone acetate because it is so inexpensive (often $4 each month).

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

SEPTEMBER 2015

“YOUR TEENAGE PATIENT AND CONTRACEPTION: THINK 
‘LONG-ACTING’ FIRST”
DAVID R. KATTAN, MD, MPH, AND 
RONALD T. BURKMAN, MD (SEPTEMBER 2015)

What does Liletta cost 
to non-340B providers?
Drs. Kattan and Burkman state in their article: “For providers who practice in settings eligible for 340B pricing, Liletta costs $50, a fraction of the cost of alternative intrauterine devices (IUDs). The cost is slightly higher for non-340B providers but is still significantly lower than the cost of other IUDs.”

Could you provide a cost range and the source for the non-340B cost?
Sharon J. Hawthorne, MBA 
St. Louis, Missouri

Drs. Kattan and Burkman respond:
Thank you for your question and for allowing us to clarify. The manufacturer of Liletta, Actavis, offers a Patient Savings Program for private insurance patients to limit their out-of-pocket cost to $75. This program will end on December 31, 2015. Information is available at http://www.lilettacard.com.

For non-340B providers, the cost per IUD is higher, although this should be reimbursed by the patient’s insurance program. After volume discounts, the price per device is as low as $537. Without volume discounts, the price per device is $600. For more information, visit: https://www.lilettahcp.com/content/pdf/LILETTA-Quick-Reference-Guide.pdf.

Medicines360, the nonprofit partner of Actavis, states the following on its Web site (http://medicines360.org/our-mission): “Through our pharmaceutical partnerships, commercial product sales help support an affordable price to public sector clinics. This allows low income women or those without insurance the opportunity to access more healthcare choices.”

“DOES PREOPERATIVE URODYNAMICS IMPROVE OUTCOMES FOR WOMEN UNDERGOING SURGERY FOR STRESS URINARY INCONTINENCE?”
CHARLES W. NAGER, MD 
(EXAMINING THE EVIDENCE; AUGUST 2015)

Priorities for determining the etiology of incontinence
While I believe Dr. Nager’s approach accurately interprets current clinical evidence, it also reflects an inadequate paradigm. Whether or not incontinence surgery should be preceded by formal invasive urodynamic evaluation is not the question. As director of urodynamics at UConn, I understand that even the most advanced clinical urodynamics evaluation is limited in what it can measure. Nowhere in that data set is “determine the etiology of incontinence.” Therefore, the more appropriate question is: When should one consider 
urodynamic evaluation before making a diagnosis requiring therapy? The answer: By prioritizing aspects of lower urinary tract function.

As recommended by the International Continence Society, the diagnosing physician actually must conduct the urodynamic testing. This physician’s first priority is to determine if the bladder can maintain low storage pressures. History and physical examination must include an acknowledgment of potential causes, including chronic urethral obstruction or failure of autonomic/sympathetic regulation. Yes, in an otherwise healthy 45-year-old vaginally parous woman with stress urinary incontinence (SUI) symptoms, it is unlikely that storage pressures aren’t normally regulated. It takes little office visit time to reach that conclusion.

The diagnosing physician’s second priority is to determine the actual functional size of the urinary reservoir. Only the bladder can expel urine actively. Is there a bladder diverticulum or reflux into the upper tracts augmenting the reservoir? Bladder/urethral function is about volume management, yet the sphincteric mechanism is not tolerant of very high volumes, even in “normal” patients. Knowing reservoir volumes when leakage occurs and the relationship of these volumes to perceptions of “empty” and “full” is critical to determining how to respond to sphincteric insufficiency that produces SUI symptoms. I agree that an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms will have a problem here. However, if the diagnosing physician has any reason to doubt that the urinary reservoir has the same functionality as the bladder and that operational 
volumes are “normal,” then 
video­urodynamic investigation is the most direct approach. 

The third priority during evaluation is to determine how the reservoir empties. What is the source of the expulsive pressure of voiding? What is the interaction of the expulsive pressure and the urethral opening? How effectively does the bladder empty? In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem, but if the physician doesn’t consider how this patient’s bladder empties, determining how the sphincter is stressed during storage and how the patient might respond to intervention is impossible. If normal efficient voiding by detrusor pressurization cannot be assured by office evaluation, then urodynamic examination, including a pressure/flow study, is necessary. 

The last priority is to determine how the urine storage/emptying system is controlled. This is most important to the patient but least important for diagnosis. Often this can be deduced from a simple office evaluation that includes urinalysis, a voiding diary, standing stress test, possibly simple “office cystometry” (with a large Toomey syringe, a straight catheter, and saline solution), and the patient’s history. No aspect of this last priority requires invasive computerized urodynamics—unless the physician just cannot figure it out even after considering results of the first 3 steps. 

Once these evaluative priorities have been completed, a diagnosis can be considered and treatment options determined. But only then.
Phillip P. Smith, MD
Farmington, Connecticut

Dr. Nager responds:
Dr. Smith provides a very nice review of what the bladder and urethra need to do. As he points out, the most appropriate question is: When should one consider urodynamic evaluation before making a diagnosis requiring therapy? Well, when a reliable diagnosis cannot be made by history, physical examination, and simple office tests.

The literature suggests that a neurologically normal woman without prolapse and without previous incontinence surgeries can receive a reliable diagnosis without urodynamic testing. If she demonstrates SUI on office stress testing, she is not storing urine normally and urodynamics will confirm urodynamic stress incontinence 97% of the time.¹ If she voluntarily voids with a normal postvoid residual, her emptying function has been assessed and is normal.

I think Dr. Smith and I both agree that, “In an otherwise healthy 45-year-old vaginally parous woman with SUI symptoms, it is unlikely that there is a problem.” We also both agree that whenever the diagnosis is unclear, or the situation is complicated, urodynamic testing is a helpful tool to assess the bladder’s storage and emptying function. I perform urodynamics regularly in my practice; it just is not necessary before surgery in a woman without prolapse and without previous incontinence surgeries who demonstrates her SUI and has a normal urinalysis and normal postvoid residual. We seem to agree on that point also.

Reference

1. Nager C, Brubaker L, Litman H, et al; Urinary Incontinence Treatment Network. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012;366(21):1987–1997.

“UPDATE ON MENOPAUSE”
ANDREW M. KAUNITZ, MD (JUNE 2015)

Should Provera still be used?
Dr. Kaunitz provided an excellent review of the Women’s Health Initiative (WHI) study and a recent testosterone trial in women in his update on hormone therapy in menopause.

After the WHI revealed differences between the estrogen-alone and estrogen–progestin study arms, implicating medroxyprogesterone acetate for increased risk of breast cancer, why is Provera still being advocated by the American College of Obstetricians and Gynecologists as a progestin safe for use in menopause?
Kathleen Norman, MD
Phoenix, Arizona

Dr. Barbieri responds:
Many insurance formularies favor the use of Provera because it is inexpensive. I try to avoid using it in my practice. Many experts do not yet diligently avoid the use of Provera; some are worried about the cost impact for patients.

For additional information on reducing the use of Provera, see my July 2014 editorial, “Hormone therapy for menopausal vasomotor symptoms,” at obgmanagement.com.

Dr. Kaunitz responds:
My preference is to use micronized oral progesterone (formulated in peanut oil) for endometrial protection in menopausal women using estrogen. I use progesterone 100 mg nightly in women taking standard-dose estrogen (estradiol patch 0.05 mg, oral estradiol 1 mg, or conjugated equine estrogen 0.625 mg). However, some patients request generic medroxyprogesterone acetate because it is so inexpensive (often $4 each month).

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Read the article Get smart about dense breasts by Wendie Berg, MD, PhD, JoAnn Pushkin, and Cindy Henke-Sarmento (October 2015)

Read the article Get smart about dense breasts by Wendie Berg, MD, PhD, JoAnn Pushkin, and Cindy Henke-Sarmento (October 2015)

Read the article Get smart about dense breasts by Wendie Berg, MD, PhD, JoAnn Pushkin, and Cindy Henke-Sarmento (October 2015)

It’s a movement that shows no signs of abating. Women in 24 states, encompassing 67% of American women, now receive some level of notification after their mammogram about breast density. Individual patient advocates continue to push for notification, and states are likely to continue to draft bills. On the national level, a federal standard is being pursued through both federal legislation and federal regulation. Clinicians practicing in states with an “inform” law, either already in effect or imminent, will be tasked with engaging in new patient conversations arising from density notification. Are you ready to answer your patients’ questions?

Navigating inconsistent data and expert comments about density and discerning which patients may benefit from additional screening can create challenges in addressing a patient’s questions about the implications of her dense tissue. If you feel less than equipped to address these issues, you are not alone. A recent survey of clinicians, con-
ducted after California’s breast density notification law went into effect, showed that only 6% were comfortable answering patients’ questions relating to breast density. Seventy-five percent of respondents indicated they wanted more education on the topic.¹

For women having mammography, dense breast tissue is most important because it can mask detection of cancers, and women may want to have additional screening beyond mammography. Women with dense breasts are also at increased risk for developing breast cancer. For clinicians who are on the front lines of care for women undergoing screening, the most important action items are:

To assist you in informing patient discussions, in this article we answer some of the most frequently asked questions of 
ObGyns.

Which breasts are 
considered dense?

The American College of Radiology recommends that density be reported in 1 of 4 categories depending on the relative amounts of fat and fibroglandular tissue²:

Breasts that are either heterogeneously dense or extremely dense are considered “dense.” About 40% of women older than 
age 40 have dense breasts.³

Case study: Imaging of a cancerous breast mass in a 48-year-old woman with dense breasts

This patient has heterogeneously dense breast tissue. Standard 2D mediolateral oblique (MLO) digital mammogram (A) and MLO tomosynthesis 1-mm slice (B) reveal subtle possible distortion (arrow) in the upper right breast. On tomosynthesis, the distortion is better seen, as is the underlying irregular mass (red circle). 

Ultrasound (US) directed to the mass (C) shows an irregular hypoechoic (dark gray) mass (marked by calipers), compatible with cancer. US-guided core needle biopsy revealed grade 2 invasive ductal cancer with associated ductal carcinoma in situ. 

Axial magnetic resonance imaging of the right breast obtained after contrast injection, and after computer subtraction of nonenhanced image (D), shows irregular spiculated 
enhancing (white) mass (arrow) due to the known carcinoma.

^{Images: Courtesy Wendie Berg, MD, PhD}

Who needs more screening?

The FIGURE is a screening decision support tool representing the consensus opinion of several medical experts based on the best available scientific evidence to optimize breast cancer detection.

Do dense breasts affect 
the risk of developing 
breast cancer?

Yes. Dense breasts are a risk factor for breast cancer. According to the American Cancer 
Society’s Breast Cancer Facts & Figures 2013−2014, “The risk of breast cancer in-creases with increasing breast density; women with very high breast density have a 4- to 6-fold increased risk of breast cancer compared to women with the least dense breasts.”^4,5

There are several reasons that dense tissue increases risk. First, the glands tend to be made up of relatively actively dividing cells that can mutate and become cancerous (the more glandular tissue present, the greater the risk). Second, the local environment around the glands may produce certain growth hormones that stimulate cells to divide, and this seems to occur more in fibrous tissue than in fatty tissue.

Most women have breast density somewhere in the middle range, with their risk for breast cancer falling in between those with extremely dense breasts and those with fatty breasts.⁶ The risk for developing breast cancer is influenced by a combination of many different factors, including age, family history of cancer (particularly breast or ovarian cancer), and prior atypical breast biopsies. There currently is no reliable way to fully account for the interplay of breast density, family history, prior biopsy results, and other factors in determining overall risk. Importantly, more than half of all women who develop breast cancer have no known risk factors other than being female and aging.

Is your medical support staff “density ready?”

We’re all familiar with the adage that a picture is worth a thousand words. While the medical support personnel in your office are likely quite familiar with imaging reports and the terminology used in describing dense breasts, they may be quite unfamiliar with what a fatty versus dense breast actually looks like on a mammogram, and how cancer may display in each. Illustrated examples, as seen here, are useful for reference.

In the fatty breast (A), a small cancer (arrow) is seen easily. In a breast categorized as scattered fibroglandular density (B), a large cancer is easily seen (arrow) in the relatively fatty portion of the breast, though a small cancer could have been hidden in areas with normal glandular tissue.

In a breast categorized as heterogeneously dense (C), a 4-cm (about 1.5-inch) cancer (arrows) is hidden by the dense breast tissue. This cancer also has spread to a lymph node under the arm (curved arrow).

In an extremely dense breast (D), a cancer is seen because part of it is located in the back of the breast where there is a small amount of dark fat making it easier to see (arrow and triangle marker indicating lump). If this cancer had been located near the nipple and completely surrounded by white (dense) tissue, it probably would not have been seen on mammography.

^{Image: Courtesy of Dr. Regina Hooley and DenseBreast-info.org}

Are screening mammography outcomes different for 
women with dense versus 
fatty breasts?

Yes. Cancer is more likely to be clinically detected in the interval between mammography screens (defined as interval cancer) in women with dense breasts. Such interval cancers tend to be more aggressive and have worse outcomes. Compared with those in fatty breasts, cancers found in dense breasts more often⁷:

Does supplemental 
screening beyond mammography save lives?

Mammography is the only imaging screening modality that has been studied by multiple randomized controlled trials with mortality as an endpoint. Across those trials, mammography has been shown to reduce deaths due to breast cancer. The randomized trials that show a benefit from mammography are those in which mammography increased detection of invasive breast cancers before they spread to lymph nodes.⁸

No randomized controlled trial has yet been reported on any other imaging screening modality, but it is expected that other screening tests that increase detection of node-negative invasive breast cancers beyond mammography should further reduce breast cancer mortality.

Proving the mortality benefit of any supplemental screening modality would require a very large, very expensive randomized controlled trial with 15 to 20 years of follow-up. Given the speed of technologic developments, any results likely would be obsolete by the trial’s conclusion. What we do know is that women at high risk for breast cancer who undergo annual magnetic resonance imaging (MRI) screening are less likely to have advanced breast cancer than their counterparts who were not screened with MRI.⁹

We also know that average-risk women who are screened with ultrasonography in addition to mammography are unlikely to have palpable cancer in the interval between screens,^10,11 with the rates of such interval cancers similar to women with fatty breasts screened only with mammography. The cancers found only on MRI or ultrasound are mostly small invasive cancers (average size, approximately 1 cm) that are mostly node negative.^12,13 MRI also finds some ductal carcinoma in situ (DCIS).

These results suggest that there is a benefit to finding additional cancers with supplemental screening, though it is certainly possible that, as with mammography, some of the cancers found with supplemental screening are slow growing and may never have caused a woman harm even if left untreated.

What additional screening tests are available after a 2D mammogram for a woman with dense breasts?

Depending on the patient’s age, risk level, and breast density, additional screening tools—such as tomosynthesis (also known as 3D mammography), ultrasonography, or MRI—may be recommended in addition to mammography. Indeed, in some centers, tomosynthesis is performed alone and the radiologist also reviews computer-generated 2D mammograms.

The addition of another imaging tool after a mammogram will find more cancers than mammography alone (TABLE).¹⁴⁻¹⁷ Women at high risk for breast cancer, such as those with pathogenic BRCA mutations, and those who were treated with radiation therapy to their chest (typically for Hodgkin disease) before age 30 and at least 8 years earlier, should be referred for annual MRI in addition to mammography (see Screening Decision Support Tool FIGURE above). If tomosynthesis is performed, the added benefit of ultrasound will be lower; further study on the actual benefit of supplemental ultrasound screening after 3D mammography 
is needed.

Will insurance cover supplemental screening beyond mammography?

The answer depends on the type of screening, the patient’s insurance and risk factors, the state in which you practice, and whether or not a law is in effect requiring insurance coverage for additional screening. In Illinois, for example, a woman with dense breasts can receive a screening ultrasound without a copay or deductible if it is ordered by a physician. In Connecticut, an ultrasound copay for screening dense breasts cannot exceed $20. Generally, in other states, an ultrasound will be covered if ordered by a physician, but it is subject to the copay and deductible of an individual health plan. In New Jersey, insurance coverage is provided for additional testing if a woman has extremely dense breasts.

Regardless of state, an MRI generally will be covered by insurance (subject to copay and deductible) if the patient meets high-risk criteria. In Michigan, at least one insurance company will cover a screening MRI for normal-risk women with dense breasts at a cost that matches the copay and deductible of a screening mammogram. It is important for patients to check with their insurance carrier prior to having an MRI.

Should women with dense breasts still have mammography screening?

Yes. Mammography is the first step in screening for most women (except for those who are pregnant or breastfeeding, in which case ultrasound can be performed but is usually deferred until several months after the patient is no longer pregnant or breastfeeding). While additional screening may be recommended for women with dense breasts, and for women at high risk for developing breast cancer, there are still some cancers and precancerous changes that will show on a mammogram better than on ultrasound or MRI. Wherever possible, women with dense breasts should have digital mammography rather than film mammography, due to slightly improved cancer detection using digital mammography.¹⁸

Does tomosynthesis solve 
the problem of screening 
dense breasts?

Tomosynthesis (3D mammography) slightly improves detection of cancers compared with standard digital mammography, but some cancers will remain hidden by overlapping dense tissue. We do not yet know the benefit of annual screening tomosynthesis. Without question, women at high risk for breast cancer still should have MRI if they are able to tolerate it, even if they have had tomosynthesis.

If a patient with dense breasts undergoes screening tomosynthesis, will she also need a screening ultrasound?

Preliminary studies not yet published suggest that, for women with dense breasts, ultrasound does find another 2 to 3 invasive cancers per 1,000 women screened that are not found on tomosynthesis, but further study of this issue is needed.

If recommended for additional screening with ultrasound or MRI, will a patient need that screening every year?

Usually, yes, though age and other medical conditions will change a patient’s personal risk and benefit considerations. Therefore, screening recommendations may change from one year to the next. With technology advancements and evolving guidelines, additional screening recommendations will change in the future.

Prepare yourself and your patients will benefit

The foundation of a successful screening program involves buy-in from both patient and clinician. Patients confused as to what their density notification means may have little understanding as to what next steps should be considered. To allay confusion, your patient will be best served by being provided understandable and actionable information. Advanced preparation for these conversations about the implications of dense tissue will make for more effective patient engagement.

Acknowledgment

Much of the material within this article has been sourced from the educational Web site DenseBreast-info.org. For comprehensive lists of both patient and health care provider 
frequently asked questions, visit http://www.DenseBreast-info.org.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

It’s a movement that shows no signs of abating. Women in 24 states, encompassing 67% of American women, now receive some level of notification after their mammogram about breast density. Individual patient advocates continue to push for notification, and states are likely to continue to draft bills. On the national level, a federal standard is being pursued through both federal legislation and federal regulation. Clinicians practicing in states with an “inform” law, either already in effect or imminent, will be tasked with engaging in new patient conversations arising from density notification. Are you ready to answer your patients’ questions?

Navigating inconsistent data and expert comments about density and discerning which patients may benefit from additional screening can create challenges in addressing a patient’s questions about the implications of her dense tissue. If you feel less than equipped to address these issues, you are not alone. A recent survey of clinicians, con-
ducted after California’s breast density notification law went into effect, showed that only 6% were comfortable answering patients’ questions relating to breast density. Seventy-five percent of respondents indicated they wanted more education on the topic.¹

For women having mammography, dense breast tissue is most important because it can mask detection of cancers, and women may want to have additional screening beyond mammography. Women with dense breasts are also at increased risk for developing breast cancer. For clinicians who are on the front lines of care for women undergoing screening, the most important action items are:

To assist you in informing patient discussions, in this article we answer some of the most frequently asked questions of 
ObGyns.

Which breasts are 
considered dense?

The American College of Radiology recommends that density be reported in 1 of 4 categories depending on the relative amounts of fat and fibroglandular tissue²:

Breasts that are either heterogeneously dense or extremely dense are considered “dense.” About 40% of women older than 
age 40 have dense breasts.³

Case study: Imaging of a cancerous breast mass in a 48-year-old woman with dense breasts

This patient has heterogeneously dense breast tissue. Standard 2D mediolateral oblique (MLO) digital mammogram (A) and MLO tomosynthesis 1-mm slice (B) reveal subtle possible distortion (arrow) in the upper right breast. On tomosynthesis, the distortion is better seen, as is the underlying irregular mass (red circle). 

Ultrasound (US) directed to the mass (C) shows an irregular hypoechoic (dark gray) mass (marked by calipers), compatible with cancer. US-guided core needle biopsy revealed grade 2 invasive ductal cancer with associated ductal carcinoma in situ. 

Axial magnetic resonance imaging of the right breast obtained after contrast injection, and after computer subtraction of nonenhanced image (D), shows irregular spiculated 
enhancing (white) mass (arrow) due to the known carcinoma.

^{Images: Courtesy Wendie Berg, MD, PhD}

Who needs more screening?

The FIGURE is a screening decision support tool representing the consensus opinion of several medical experts based on the best available scientific evidence to optimize breast cancer detection.

Do dense breasts affect 
the risk of developing 
breast cancer?

Yes. Dense breasts are a risk factor for breast cancer. According to the American Cancer 
Society’s Breast Cancer Facts & Figures 2013−2014, “The risk of breast cancer in-creases with increasing breast density; women with very high breast density have a 4- to 6-fold increased risk of breast cancer compared to women with the least dense breasts.”^4,5

There are several reasons that dense tissue increases risk. First, the glands tend to be made up of relatively actively dividing cells that can mutate and become cancerous (the more glandular tissue present, the greater the risk). Second, the local environment around the glands may produce certain growth hormones that stimulate cells to divide, and this seems to occur more in fibrous tissue than in fatty tissue.

Most women have breast density somewhere in the middle range, with their risk for breast cancer falling in between those with extremely dense breasts and those with fatty breasts.⁶ The risk for developing breast cancer is influenced by a combination of many different factors, including age, family history of cancer (particularly breast or ovarian cancer), and prior atypical breast biopsies. There currently is no reliable way to fully account for the interplay of breast density, family history, prior biopsy results, and other factors in determining overall risk. Importantly, more than half of all women who develop breast cancer have no known risk factors other than being female and aging.

Is your medical support staff “density ready?”

We’re all familiar with the adage that a picture is worth a thousand words. While the medical support personnel in your office are likely quite familiar with imaging reports and the terminology used in describing dense breasts, they may be quite unfamiliar with what a fatty versus dense breast actually looks like on a mammogram, and how cancer may display in each. Illustrated examples, as seen here, are useful for reference.

In the fatty breast (A), a small cancer (arrow) is seen easily. In a breast categorized as scattered fibroglandular density (B), a large cancer is easily seen (arrow) in the relatively fatty portion of the breast, though a small cancer could have been hidden in areas with normal glandular tissue.

In a breast categorized as heterogeneously dense (C), a 4-cm (about 1.5-inch) cancer (arrows) is hidden by the dense breast tissue. This cancer also has spread to a lymph node under the arm (curved arrow).

In an extremely dense breast (D), a cancer is seen because part of it is located in the back of the breast where there is a small amount of dark fat making it easier to see (arrow and triangle marker indicating lump). If this cancer had been located near the nipple and completely surrounded by white (dense) tissue, it probably would not have been seen on mammography.

^{Image: Courtesy of Dr. Regina Hooley and DenseBreast-info.org}

Are screening mammography outcomes different for 
women with dense versus 
fatty breasts?

Yes. Cancer is more likely to be clinically detected in the interval between mammography screens (defined as interval cancer) in women with dense breasts. Such interval cancers tend to be more aggressive and have worse outcomes. Compared with those in fatty breasts, cancers found in dense breasts more often⁷:

Does supplemental 
screening beyond mammography save lives?

Mammography is the only imaging screening modality that has been studied by multiple randomized controlled trials with mortality as an endpoint. Across those trials, mammography has been shown to reduce deaths due to breast cancer. The randomized trials that show a benefit from mammography are those in which mammography increased detection of invasive breast cancers before they spread to lymph nodes.⁸

No randomized controlled trial has yet been reported on any other imaging screening modality, but it is expected that other screening tests that increase detection of node-negative invasive breast cancers beyond mammography should further reduce breast cancer mortality.

Proving the mortality benefit of any supplemental screening modality would require a very large, very expensive randomized controlled trial with 15 to 20 years of follow-up. Given the speed of technologic developments, any results likely would be obsolete by the trial’s conclusion. What we do know is that women at high risk for breast cancer who undergo annual magnetic resonance imaging (MRI) screening are less likely to have advanced breast cancer than their counterparts who were not screened with MRI.⁹

We also know that average-risk women who are screened with ultrasonography in addition to mammography are unlikely to have palpable cancer in the interval between screens,^10,11 with the rates of such interval cancers similar to women with fatty breasts screened only with mammography. The cancers found only on MRI or ultrasound are mostly small invasive cancers (average size, approximately 1 cm) that are mostly node negative.^12,13 MRI also finds some ductal carcinoma in situ (DCIS).

These results suggest that there is a benefit to finding additional cancers with supplemental screening, though it is certainly possible that, as with mammography, some of the cancers found with supplemental screening are slow growing and may never have caused a woman harm even if left untreated.

What additional screening tests are available after a 2D mammogram for a woman with dense breasts?

Depending on the patient’s age, risk level, and breast density, additional screening tools—such as tomosynthesis (also known as 3D mammography), ultrasonography, or MRI—may be recommended in addition to mammography. Indeed, in some centers, tomosynthesis is performed alone and the radiologist also reviews computer-generated 2D mammograms.

The addition of another imaging tool after a mammogram will find more cancers than mammography alone (TABLE).¹⁴⁻¹⁷ Women at high risk for breast cancer, such as those with pathogenic BRCA mutations, and those who were treated with radiation therapy to their chest (typically for Hodgkin disease) before age 30 and at least 8 years earlier, should be referred for annual MRI in addition to mammography (see Screening Decision Support Tool FIGURE above). If tomosynthesis is performed, the added benefit of ultrasound will be lower; further study on the actual benefit of supplemental ultrasound screening after 3D mammography 
is needed.

Will insurance cover supplemental screening beyond mammography?

The answer depends on the type of screening, the patient’s insurance and risk factors, the state in which you practice, and whether or not a law is in effect requiring insurance coverage for additional screening. In Illinois, for example, a woman with dense breasts can receive a screening ultrasound without a copay or deductible if it is ordered by a physician. In Connecticut, an ultrasound copay for screening dense breasts cannot exceed $20. Generally, in other states, an ultrasound will be covered if ordered by a physician, but it is subject to the copay and deductible of an individual health plan. In New Jersey, insurance coverage is provided for additional testing if a woman has extremely dense breasts.

Regardless of state, an MRI generally will be covered by insurance (subject to copay and deductible) if the patient meets high-risk criteria. In Michigan, at least one insurance company will cover a screening MRI for normal-risk women with dense breasts at a cost that matches the copay and deductible of a screening mammogram. It is important for patients to check with their insurance carrier prior to having an MRI.

Should women with dense breasts still have mammography screening?

Yes. Mammography is the first step in screening for most women (except for those who are pregnant or breastfeeding, in which case ultrasound can be performed but is usually deferred until several months after the patient is no longer pregnant or breastfeeding). While additional screening may be recommended for women with dense breasts, and for women at high risk for developing breast cancer, there are still some cancers and precancerous changes that will show on a mammogram better than on ultrasound or MRI. Wherever possible, women with dense breasts should have digital mammography rather than film mammography, due to slightly improved cancer detection using digital mammography.¹⁸

Does tomosynthesis solve 
the problem of screening 
dense breasts?

Tomosynthesis (3D mammography) slightly improves detection of cancers compared with standard digital mammography, but some cancers will remain hidden by overlapping dense tissue. We do not yet know the benefit of annual screening tomosynthesis. Without question, women at high risk for breast cancer still should have MRI if they are able to tolerate it, even if they have had tomosynthesis.

If a patient with dense breasts undergoes screening tomosynthesis, will she also need a screening ultrasound?

Preliminary studies not yet published suggest that, for women with dense breasts, ultrasound does find another 2 to 3 invasive cancers per 1,000 women screened that are not found on tomosynthesis, but further study of this issue is needed.

If recommended for additional screening with ultrasound or MRI, will a patient need that screening every year?

Usually, yes, though age and other medical conditions will change a patient’s personal risk and benefit considerations. Therefore, screening recommendations may change from one year to the next. With technology advancements and evolving guidelines, additional screening recommendations will change in the future.

Prepare yourself and your patients will benefit

The foundation of a successful screening program involves buy-in from both patient and clinician. Patients confused as to what their density notification means may have little understanding as to what next steps should be considered. To allay confusion, your patient will be best served by being provided understandable and actionable information. Advanced preparation for these conversations about the implications of dense tissue will make for more effective patient engagement.

Acknowledgment

Much of the material within this article has been sourced from the educational Web site DenseBreast-info.org. For comprehensive lists of both patient and health care provider 
frequently asked questions, visit http://www.DenseBreast-info.org.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

It’s a movement that shows no signs of abating. Women in 24 states, encompassing 67% of American women, now receive some level of notification after their mammogram about breast density. Individual patient advocates continue to push for notification, and states are likely to continue to draft bills. On the national level, a federal standard is being pursued through both federal legislation and federal regulation. Clinicians practicing in states with an “inform” law, either already in effect or imminent, will be tasked with engaging in new patient conversations arising from density notification. Are you ready to answer your patients’ questions?

Navigating inconsistent data and expert comments about density and discerning which patients may benefit from additional screening can create challenges in addressing a patient’s questions about the implications of her dense tissue. If you feel less than equipped to address these issues, you are not alone. A recent survey of clinicians, con-
ducted after California’s breast density notification law went into effect, showed that only 6% were comfortable answering patients’ questions relating to breast density. Seventy-five percent of respondents indicated they wanted more education on the topic.¹

For women having mammography, dense breast tissue is most important because it can mask detection of cancers, and women may want to have additional screening beyond mammography. Women with dense breasts are also at increased risk for developing breast cancer. For clinicians who are on the front lines of care for women undergoing screening, the most important action items are:

To assist you in informing patient discussions, in this article we answer some of the most frequently asked questions of 
ObGyns.

Which breasts are 
considered dense?

The American College of Radiology recommends that density be reported in 1 of 4 categories depending on the relative amounts of fat and fibroglandular tissue²:

Breasts that are either heterogeneously dense or extremely dense are considered “dense.” About 40% of women older than 
age 40 have dense breasts.³

Case study: Imaging of a cancerous breast mass in a 48-year-old woman with dense breasts

This patient has heterogeneously dense breast tissue. Standard 2D mediolateral oblique (MLO) digital mammogram (A) and MLO tomosynthesis 1-mm slice (B) reveal subtle possible distortion (arrow) in the upper right breast. On tomosynthesis, the distortion is better seen, as is the underlying irregular mass (red circle). 

Ultrasound (US) directed to the mass (C) shows an irregular hypoechoic (dark gray) mass (marked by calipers), compatible with cancer. US-guided core needle biopsy revealed grade 2 invasive ductal cancer with associated ductal carcinoma in situ. 

Axial magnetic resonance imaging of the right breast obtained after contrast injection, and after computer subtraction of nonenhanced image (D), shows irregular spiculated 
enhancing (white) mass (arrow) due to the known carcinoma.

^{Images: Courtesy Wendie Berg, MD, PhD}

Who needs more screening?

The FIGURE is a screening decision support tool representing the consensus opinion of several medical experts based on the best available scientific evidence to optimize breast cancer detection.

Do dense breasts affect 
the risk of developing 
breast cancer?

Yes. Dense breasts are a risk factor for breast cancer. According to the American Cancer 
Society’s Breast Cancer Facts & Figures 2013−2014, “The risk of breast cancer in-creases with increasing breast density; women with very high breast density have a 4- to 6-fold increased risk of breast cancer compared to women with the least dense breasts.”^4,5

There are several reasons that dense tissue increases risk. First, the glands tend to be made up of relatively actively dividing cells that can mutate and become cancerous (the more glandular tissue present, the greater the risk). Second, the local environment around the glands may produce certain growth hormones that stimulate cells to divide, and this seems to occur more in fibrous tissue than in fatty tissue.

Most women have breast density somewhere in the middle range, with their risk for breast cancer falling in between those with extremely dense breasts and those with fatty breasts.⁶ The risk for developing breast cancer is influenced by a combination of many different factors, including age, family history of cancer (particularly breast or ovarian cancer), and prior atypical breast biopsies. There currently is no reliable way to fully account for the interplay of breast density, family history, prior biopsy results, and other factors in determining overall risk. Importantly, more than half of all women who develop breast cancer have no known risk factors other than being female and aging.

Is your medical support staff “density ready?”

We’re all familiar with the adage that a picture is worth a thousand words. While the medical support personnel in your office are likely quite familiar with imaging reports and the terminology used in describing dense breasts, they may be quite unfamiliar with what a fatty versus dense breast actually looks like on a mammogram, and how cancer may display in each. Illustrated examples, as seen here, are useful for reference.

In the fatty breast (A), a small cancer (arrow) is seen easily. In a breast categorized as scattered fibroglandular density (B), a large cancer is easily seen (arrow) in the relatively fatty portion of the breast, though a small cancer could have been hidden in areas with normal glandular tissue.

In a breast categorized as heterogeneously dense (C), a 4-cm (about 1.5-inch) cancer (arrows) is hidden by the dense breast tissue. This cancer also has spread to a lymph node under the arm (curved arrow).

In an extremely dense breast (D), a cancer is seen because part of it is located in the back of the breast where there is a small amount of dark fat making it easier to see (arrow and triangle marker indicating lump). If this cancer had been located near the nipple and completely surrounded by white (dense) tissue, it probably would not have been seen on mammography.

^{Image: Courtesy of Dr. Regina Hooley and DenseBreast-info.org}

Are screening mammography outcomes different for 
women with dense versus 
fatty breasts?

Yes. Cancer is more likely to be clinically detected in the interval between mammography screens (defined as interval cancer) in women with dense breasts. Such interval cancers tend to be more aggressive and have worse outcomes. Compared with those in fatty breasts, cancers found in dense breasts more often⁷:

Does supplemental 
screening beyond mammography save lives?

Mammography is the only imaging screening modality that has been studied by multiple randomized controlled trials with mortality as an endpoint. Across those trials, mammography has been shown to reduce deaths due to breast cancer. The randomized trials that show a benefit from mammography are those in which mammography increased detection of invasive breast cancers before they spread to lymph nodes.⁸

No randomized controlled trial has yet been reported on any other imaging screening modality, but it is expected that other screening tests that increase detection of node-negative invasive breast cancers beyond mammography should further reduce breast cancer mortality.

Proving the mortality benefit of any supplemental screening modality would require a very large, very expensive randomized controlled trial with 15 to 20 years of follow-up. Given the speed of technologic developments, any results likely would be obsolete by the trial’s conclusion. What we do know is that women at high risk for breast cancer who undergo annual magnetic resonance imaging (MRI) screening are less likely to have advanced breast cancer than their counterparts who were not screened with MRI.⁹

We also know that average-risk women who are screened with ultrasonography in addition to mammography are unlikely to have palpable cancer in the interval between screens,^10,11 with the rates of such interval cancers similar to women with fatty breasts screened only with mammography. The cancers found only on MRI or ultrasound are mostly small invasive cancers (average size, approximately 1 cm) that are mostly node negative.^12,13 MRI also finds some ductal carcinoma in situ (DCIS).

These results suggest that there is a benefit to finding additional cancers with supplemental screening, though it is certainly possible that, as with mammography, some of the cancers found with supplemental screening are slow growing and may never have caused a woman harm even if left untreated.

What additional screening tests are available after a 2D mammogram for a woman with dense breasts?

Depending on the patient’s age, risk level, and breast density, additional screening tools—such as tomosynthesis (also known as 3D mammography), ultrasonography, or MRI—may be recommended in addition to mammography. Indeed, in some centers, tomosynthesis is performed alone and the radiologist also reviews computer-generated 2D mammograms.

The addition of another imaging tool after a mammogram will find more cancers than mammography alone (TABLE).¹⁴⁻¹⁷ Women at high risk for breast cancer, such as those with pathogenic BRCA mutations, and those who were treated with radiation therapy to their chest (typically for Hodgkin disease) before age 30 and at least 8 years earlier, should be referred for annual MRI in addition to mammography (see Screening Decision Support Tool FIGURE above). If tomosynthesis is performed, the added benefit of ultrasound will be lower; further study on the actual benefit of supplemental ultrasound screening after 3D mammography 
is needed.

Will insurance cover supplemental screening beyond mammography?

The answer depends on the type of screening, the patient’s insurance and risk factors, the state in which you practice, and whether or not a law is in effect requiring insurance coverage for additional screening. In Illinois, for example, a woman with dense breasts can receive a screening ultrasound without a copay or deductible if it is ordered by a physician. In Connecticut, an ultrasound copay for screening dense breasts cannot exceed $20. Generally, in other states, an ultrasound will be covered if ordered by a physician, but it is subject to the copay and deductible of an individual health plan. In New Jersey, insurance coverage is provided for additional testing if a woman has extremely dense breasts.

Regardless of state, an MRI generally will be covered by insurance (subject to copay and deductible) if the patient meets high-risk criteria. In Michigan, at least one insurance company will cover a screening MRI for normal-risk women with dense breasts at a cost that matches the copay and deductible of a screening mammogram. It is important for patients to check with their insurance carrier prior to having an MRI.

Should women with dense breasts still have mammography screening?

Yes. Mammography is the first step in screening for most women (except for those who are pregnant or breastfeeding, in which case ultrasound can be performed but is usually deferred until several months after the patient is no longer pregnant or breastfeeding). While additional screening may be recommended for women with dense breasts, and for women at high risk for developing breast cancer, there are still some cancers and precancerous changes that will show on a mammogram better than on ultrasound or MRI. Wherever possible, women with dense breasts should have digital mammography rather than film mammography, due to slightly improved cancer detection using digital mammography.¹⁸

Does tomosynthesis solve 
the problem of screening 
dense breasts?

Tomosynthesis (3D mammography) slightly improves detection of cancers compared with standard digital mammography, but some cancers will remain hidden by overlapping dense tissue. We do not yet know the benefit of annual screening tomosynthesis. Without question, women at high risk for breast cancer still should have MRI if they are able to tolerate it, even if they have had tomosynthesis.

If a patient with dense breasts undergoes screening tomosynthesis, will she also need a screening ultrasound?

Preliminary studies not yet published suggest that, for women with dense breasts, ultrasound does find another 2 to 3 invasive cancers per 1,000 women screened that are not found on tomosynthesis, but further study of this issue is needed.

If recommended for additional screening with ultrasound or MRI, will a patient need that screening every year?

Usually, yes, though age and other medical conditions will change a patient’s personal risk and benefit considerations. Therefore, screening recommendations may change from one year to the next. With technology advancements and evolving guidelines, additional screening recommendations will change in the future.

Prepare yourself and your patients will benefit

The foundation of a successful screening program involves buy-in from both patient and clinician. Patients confused as to what their density notification means may have little understanding as to what next steps should be considered. To allay confusion, your patient will be best served by being provided understandable and actionable information. Advanced preparation for these conversations about the implications of dense tissue will make for more effective patient engagement.

Acknowledgment

Much of the material within this article has been sourced from the educational Web site DenseBreast-info.org. For comprehensive lists of both patient and health care provider 
frequently asked questions, visit http://www.DenseBreast-info.org.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As the proportion of the elderly in the US population continues to increase, with life expectancy trending upward, we can expect to see more gynecologic cancers in our patients.^1,2 At present, the most effective approach to these cancers commonly includes aggressive surgical resection with chemotherapy and, in some cases, radiation. It remains unclear whether elderly patients should be managed the same as younger patients, with minimal data to guide physicians. Some evidence suggests an increased risk of surgical complications in 
older adults.³

To optimize surgical care in our elderly patients, we need to understand the risks of perioperative mortality and morbidity in this population. For example, the current standard of care for advanced epithelial ovarian cancer is aggressive cytoreductive surgery followed by adjuvant chemotherapy,⁴ although neoadjuvant chemotherapy is gaining utility and popularity in certain circumstances. During pretreatment counseling, it is imperative that we communicate patient-specific outcomes so that patients and their families can make educated decisions in line with their goals. What should we know about age-dependent outcomes when counseling our patients?

To optimize surgical care in this population, we also need to develop and use new methods of surgical decision making. Although some data suggest that age is an independent risk factor for postoperative complications, not all elderly patients are the same in terms of comorbidities and functional status. In order to truly assess risks, we need to identify additional preoperative risk factors. Are there accurate scoring tools or predictors of outcomes available to help us assess the risks of postoperative mortality and morbidity?

In this article, we highlight recent developments in surgical treatment of the elderly, focusing on:

• postoperative mortality and morbidity in patients older than 80 years
• adjuncts to preoperative assessment for oncogeriatric surgical patients.

Risks rise sharply in older patients undergoing treatment for ovarian Ca

Moore KN, Reid MS, Fong DN, et al. Ovarian cancer in the octogenarian: does the paradigm of aggressive cytoreductive surgery and chemotherapy still apply? 
Gynecol Oncol. 2008;110(2):133–139.

Mahdi H, Wiechert A, Lockhart D, Rose PG. Impact of age on 30-day mortality and morbidity in patients undergoing surgery for ovarian cancer. Int J Gynecol 
Cancer. 2015;25(7):1216–1223.

The cornerstone of optimal survival from certain gynecologic cancers, such as advanced ovarian cancer, is aggressive debulking surgery. However, older adults are classically under-represented in clinical trials that guide this standard of care.

To determine whether patients aged 80 years or older respond differently from younger patients to conventional ovarian cancer management, Moore and colleagues retrospectively reviewed their institutional experience. They found that postoperative mortality increased from 5.4% in patients aged 80 to 84 years to 9.1% in those aged 85 to 89 and 14.4% in those older than 90. The rates for younger patients were 0.6% for patients younger than 60 years, 2.8% for those aged 60 to 69 years, and 2.5% for those aged 70 to 
79 years (P<.001).

Notably, 13% of patients aged 80 years or older who underwent primary surgery died during their primary hospitalization. Of those who survived, 50% were discharged to skilled nursing facilities. Of patients who underwent cytoreductive surgery, 13% were unable to undergo any intended adjuvant therapy, and only 57% completed more than 3 cycles of chemotherapy, either due to demise or toxicities. Two-month survival for patients 80 years or older was comparable between patients who underwent primary surgery and those who had primary chemotherapy (20% and 26%, respectively).

With a similar objective, Mahdi and colleagues identified 2,087 patients with ovarian cancer who underwent surgery. After adjusting for confounders with multivariable analyses, they found that octogenarians whose initial management was surgery were 9 times more likely than younger patients to die and 70% more likely to develop complications within 30 days. Among patients who underwent neoadjuvant chemotherapy, there were no significant differences between older and younger patients in 30-day postoperative mortality or morbidity.

When evaluating elderly patients for surgery, the use of multiple risk-assessment strategies may improve accuracy

Huisman MG, Audisio RA, Ugolini G, et al. Screening for predictors of adverse outcome in onco-geriatric surgical patients: a multicenter prospective cohort study. Eur J Surg Oncol. 2015;41(7):844–851.

Uppal S, Igwe E, Rice L, Spencer R, Rose SL. Frailty index predicts severe complications in gynecologic oncology patients. Gynecol Oncol. 2015;137(1):98–101.

The National Comprehensive Cancer 
Network recommends that clinicians determine baseline life expectancy for older adults with cancer to aid in management decision making. The use of tools such as www.eprognosis.com, developed to determine anticipated life expectancy independent of cancer, can prove useful in determining a patient’s risk of dying or suffering from their cancer before dying of another cause.⁵

When it comes to the determination of risk related to a patient’s cancer diagnosis and selection of potential management options, many argue that the subgroup of elderly patients is not homogenous and that the use of age alone to guide management decisions may be unfair. Preoperative evaluation ideally should incorporate a global assessment of predictive risk factors.

Three assessment tools are 
especially useful

Huisman and colleagues set out to identify accurate preoperative assessment methods in elderly patients undergoing oncologic surgery. They prospectively recruited 328 patients aged 70 years or older and evaluated patients preoperatively using 11 well-known geriatric screening tools. They compared these evaluations with outcomes to determine which tools best predict the occurrence of major postoperative complications. They found the strongest correlation with outcomes when combining gender and type of surgery with the following 3 assessment tools:

• Timed Up and Go (TUG)—a walking test to measure functional status
• American Society of Anesthesiologists scale—a scoring system that quantifies preoperative physical status and estimates anesthetic risk
• Nutritional Risk Screening—an assessment of nutritional risk based on recent weight loss, overall condition, and reduction of food intake.

All 3 are simple and short screening tools. When used together, they can provide clinicians with accurate risk estimations.

The findings of Huisman and colleagues reinforce the importance of a global assessment of the patient’s comorbidities, functional status, and nutritional status when determining candidacy for oncologic surgery.

Functional index predicts need 
for postoperative ICU care 
and risk of death

Uppal and colleagues set out to quantify the predictive value of the modified Functional Index (mFI) in assessing the need for postoperative critical care support and/or the risk of death within 30 days after gynecologic cancer surgery. The mFI can be calculated by adding 1 point for each variable listed in the TABLE, with a score of 4 or higher representing a high-frailty cohort.

Of 6,551 patients who underwent gynecologic surgery, 188 were admitted to the intensive care unit (ICU) or died within 
30 days after surgery. The mFI was calculated, with multivariate analyses of additional variables. An mFI score of 3 or higher was predictive of the need for critical care support and the risk of 30-day mortality and was associated with a significantly higher number of complications (P<.001).

Predictors significant for postoperative critical care support or death were:

• preoperative albumin level less than 3 g/dL (odds ratio [OR] = 6.5)
• operative time (OR = 1.003 per minute of increase)
• nonlaparoscopic surgery (OR = 3.3)
• mFI score, with a score of 0 serving as the reference (OR for a score of 1 = 1.26; score of 2 = 1.9; score of 3 = 2.33; and score of 4 or higher = 12.5).

When they combined the mFI and albumin scores—both readily available in the preoperative setting—Uppal and colleagues were able to develop an algorithm to determine patients who were at “low risk” versus “high risk” for ICU admission and/or death postoperatively (FIGURE).

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Bottom line

Older patients are more commonly affected by multiple medical comorbidities, as well as functional, cognitive, and nutritional deficiencies, which contribute to their increased risk of morbidity and mortality after surgery. The elderly experience greater morbidity with noncardiac surgery in general.

Clearly, the decision to operate on an elderly patient should be approached with caution, and a critical assessment of the patient’s risk factors should be performed to inform counseling about the patient’s management options. Future randomized prospective data will help us better understand the relationship between age and surgical outcomes.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As the proportion of the elderly in the US population continues to increase, with life expectancy trending upward, we can expect to see more gynecologic cancers in our patients.^1,2 At present, the most effective approach to these cancers commonly includes aggressive surgical resection with chemotherapy and, in some cases, radiation. It remains unclear whether elderly patients should be managed the same as younger patients, with minimal data to guide physicians. Some evidence suggests an increased risk of surgical complications in 
older adults.³

To optimize surgical care in our elderly patients, we need to understand the risks of perioperative mortality and morbidity in this population. For example, the current standard of care for advanced epithelial ovarian cancer is aggressive cytoreductive surgery followed by adjuvant chemotherapy,⁴ although neoadjuvant chemotherapy is gaining utility and popularity in certain circumstances. During pretreatment counseling, it is imperative that we communicate patient-specific outcomes so that patients and their families can make educated decisions in line with their goals. What should we know about age-dependent outcomes when counseling our patients?

To optimize surgical care in this population, we also need to develop and use new methods of surgical decision making. Although some data suggest that age is an independent risk factor for postoperative complications, not all elderly patients are the same in terms of comorbidities and functional status. In order to truly assess risks, we need to identify additional preoperative risk factors. Are there accurate scoring tools or predictors of outcomes available to help us assess the risks of postoperative mortality and morbidity?

In this article, we highlight recent developments in surgical treatment of the elderly, focusing on:

• postoperative mortality and morbidity in patients older than 80 years
• adjuncts to preoperative assessment for oncogeriatric surgical patients.

Risks rise sharply in older patients undergoing treatment for ovarian Ca

Moore KN, Reid MS, Fong DN, et al. Ovarian cancer in the octogenarian: does the paradigm of aggressive cytoreductive surgery and chemotherapy still apply? 
Gynecol Oncol. 2008;110(2):133–139.

Mahdi H, Wiechert A, Lockhart D, Rose PG. Impact of age on 30-day mortality and morbidity in patients undergoing surgery for ovarian cancer. Int J Gynecol 
Cancer. 2015;25(7):1216–1223.

The cornerstone of optimal survival from certain gynecologic cancers, such as advanced ovarian cancer, is aggressive debulking surgery. However, older adults are classically under-represented in clinical trials that guide this standard of care.

To determine whether patients aged 80 years or older respond differently from younger patients to conventional ovarian cancer management, Moore and colleagues retrospectively reviewed their institutional experience. They found that postoperative mortality increased from 5.4% in patients aged 80 to 84 years to 9.1% in those aged 85 to 89 and 14.4% in those older than 90. The rates for younger patients were 0.6% for patients younger than 60 years, 2.8% for those aged 60 to 69 years, and 2.5% for those aged 70 to 
79 years (P<.001).

Notably, 13% of patients aged 80 years or older who underwent primary surgery died during their primary hospitalization. Of those who survived, 50% were discharged to skilled nursing facilities. Of patients who underwent cytoreductive surgery, 13% were unable to undergo any intended adjuvant therapy, and only 57% completed more than 3 cycles of chemotherapy, either due to demise or toxicities. Two-month survival for patients 80 years or older was comparable between patients who underwent primary surgery and those who had primary chemotherapy (20% and 26%, respectively).

With a similar objective, Mahdi and colleagues identified 2,087 patients with ovarian cancer who underwent surgery. After adjusting for confounders with multivariable analyses, they found that octogenarians whose initial management was surgery were 9 times more likely than younger patients to die and 70% more likely to develop complications within 30 days. Among patients who underwent neoadjuvant chemotherapy, there were no significant differences between older and younger patients in 30-day postoperative mortality or morbidity.

When evaluating elderly patients for surgery, the use of multiple risk-assessment strategies may improve accuracy

Huisman MG, Audisio RA, Ugolini G, et al. Screening for predictors of adverse outcome in onco-geriatric surgical patients: a multicenter prospective cohort study. Eur J Surg Oncol. 2015;41(7):844–851.

Uppal S, Igwe E, Rice L, Spencer R, Rose SL. Frailty index predicts severe complications in gynecologic oncology patients. Gynecol Oncol. 2015;137(1):98–101.

The National Comprehensive Cancer 
Network recommends that clinicians determine baseline life expectancy for older adults with cancer to aid in management decision making. The use of tools such as www.eprognosis.com, developed to determine anticipated life expectancy independent of cancer, can prove useful in determining a patient’s risk of dying or suffering from their cancer before dying of another cause.⁵

When it comes to the determination of risk related to a patient’s cancer diagnosis and selection of potential management options, many argue that the subgroup of elderly patients is not homogenous and that the use of age alone to guide management decisions may be unfair. Preoperative evaluation ideally should incorporate a global assessment of predictive risk factors.

Three assessment tools are 
especially useful

Huisman and colleagues set out to identify accurate preoperative assessment methods in elderly patients undergoing oncologic surgery. They prospectively recruited 328 patients aged 70 years or older and evaluated patients preoperatively using 11 well-known geriatric screening tools. They compared these evaluations with outcomes to determine which tools best predict the occurrence of major postoperative complications. They found the strongest correlation with outcomes when combining gender and type of surgery with the following 3 assessment tools:

• Timed Up and Go (TUG)—a walking test to measure functional status
• American Society of Anesthesiologists scale—a scoring system that quantifies preoperative physical status and estimates anesthetic risk
• Nutritional Risk Screening—an assessment of nutritional risk based on recent weight loss, overall condition, and reduction of food intake.

All 3 are simple and short screening tools. When used together, they can provide clinicians with accurate risk estimations.

The findings of Huisman and colleagues reinforce the importance of a global assessment of the patient’s comorbidities, functional status, and nutritional status when determining candidacy for oncologic surgery.

Functional index predicts need 
for postoperative ICU care 
and risk of death

Uppal and colleagues set out to quantify the predictive value of the modified Functional Index (mFI) in assessing the need for postoperative critical care support and/or the risk of death within 30 days after gynecologic cancer surgery. The mFI can be calculated by adding 1 point for each variable listed in the TABLE, with a score of 4 or higher representing a high-frailty cohort.

Of 6,551 patients who underwent gynecologic surgery, 188 were admitted to the intensive care unit (ICU) or died within 
30 days after surgery. The mFI was calculated, with multivariate analyses of additional variables. An mFI score of 3 or higher was predictive of the need for critical care support and the risk of 30-day mortality and was associated with a significantly higher number of complications (P<.001).

Predictors significant for postoperative critical care support or death were:

• preoperative albumin level less than 3 g/dL (odds ratio [OR] = 6.5)
• operative time (OR = 1.003 per minute of increase)
• nonlaparoscopic surgery (OR = 3.3)
• mFI score, with a score of 0 serving as the reference (OR for a score of 1 = 1.26; score of 2 = 1.9; score of 3 = 2.33; and score of 4 or higher = 12.5).

When they combined the mFI and albumin scores—both readily available in the preoperative setting—Uppal and colleagues were able to develop an algorithm to determine patients who were at “low risk” versus “high risk” for ICU admission and/or death postoperatively (FIGURE).

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Bottom line

Older patients are more commonly affected by multiple medical comorbidities, as well as functional, cognitive, and nutritional deficiencies, which contribute to their increased risk of morbidity and mortality after surgery. The elderly experience greater morbidity with noncardiac surgery in general.

Clearly, the decision to operate on an elderly patient should be approached with caution, and a critical assessment of the patient’s risk factors should be performed to inform counseling about the patient’s management options. Future randomized prospective data will help us better understand the relationship between age and surgical outcomes.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As the proportion of the elderly in the US population continues to increase, with life expectancy trending upward, we can expect to see more gynecologic cancers in our patients.^1,2 At present, the most effective approach to these cancers commonly includes aggressive surgical resection with chemotherapy and, in some cases, radiation. It remains unclear whether elderly patients should be managed the same as younger patients, with minimal data to guide physicians. Some evidence suggests an increased risk of surgical complications in 
older adults.³