Breast Cancer

SAN DIEGO – Women who survive breast cancer face an increased risk of developing thyroid cancer, especially within 5 years of their breast cancer diagnosis, according to a large analysis of the National Cancer Institute’s Surveillance, Epidemiology, and End Results 9 database, covering 1973-2011.

In an interview at the meeting of the Endocrine Society, the study’s lead author, Dr. Jennifer H. Kuo, thyroid biopsy program director in the division of GI/endocrine surgery at Columbia University, New York, said that compared with patients with breast cancer alone, women who had breast cancer followed by thyroid cancer were younger on average when diagnosed with their breast cancer. They also were more likely to have had invasive ductal carcinoma, a smaller focus of cancer, and to have received radiation therapy as part of their breast cancer treatment.

Dr. Kuo concluded that recognition of the association should prompt vigilant screening for thyroid cancer among breast cancer survivors. She reported having no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – Women who survive breast cancer face an increased risk of developing thyroid cancer, especially within 5 years of their breast cancer diagnosis, according to a large analysis of the National Cancer Institute’s Surveillance, Epidemiology, and End Results 9 database, covering 1973-2011.

In an interview at the meeting of the Endocrine Society, the study’s lead author, Dr. Jennifer H. Kuo, thyroid biopsy program director in the division of GI/endocrine surgery at Columbia University, New York, said that compared with patients with breast cancer alone, women who had breast cancer followed by thyroid cancer were younger on average when diagnosed with their breast cancer. They also were more likely to have had invasive ductal carcinoma, a smaller focus of cancer, and to have received radiation therapy as part of their breast cancer treatment.

Dr. Kuo concluded that recognition of the association should prompt vigilant screening for thyroid cancer among breast cancer survivors. She reported having no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – Women who survive breast cancer face an increased risk of developing thyroid cancer, especially within 5 years of their breast cancer diagnosis, according to a large analysis of the National Cancer Institute’s Surveillance, Epidemiology, and End Results 9 database, covering 1973-2011.

In an interview at the meeting of the Endocrine Society, the study’s lead author, Dr. Jennifer H. Kuo, thyroid biopsy program director in the division of GI/endocrine surgery at Columbia University, New York, said that compared with patients with breast cancer alone, women who had breast cancer followed by thyroid cancer were younger on average when diagnosed with their breast cancer. They also were more likely to have had invasive ductal carcinoma, a smaller focus of cancer, and to have received radiation therapy as part of their breast cancer treatment.

Dr. Kuo concluded that recognition of the association should prompt vigilant screening for thyroid cancer among breast cancer survivors. She reported having no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – Breast cancer survivors face an increased risk of thyroid cancer, especially within 5 years of their breast cancer diagnosis, according to results from large retrospective analysis.

“The results of this study prompt a greater awareness of the increased risk for thyroid cancer among breast cancer survivors,” Dr. Jennifer H. Kuo said during a press briefing at the meeting of the Endocrine Society.

Doug Brunk/Frontline Medical News

Although the incidence of breast cancer has been stable in the last 2 decades, “it’s still a leading cause of cancer; it affects one in eight women in this country at some time in their lives,” said Dr. Kuo of the division of GI/endocrine surgery at Columbia University, New York. “With advancements for the treatment of breast cancer, however, survival after breast cancer has greatly improved, now reaching almost 90% at 5 years. What this means is the number of breast cancer survivors in this country is now increasing. These survivors have an 18%-30% risk of developing a second cancer. Most of these second cancers are hormonally mediated, such as ovarian and uterine cancers, but there are some studies that indicate thyroid cancer is also increased.”

To date, she said, the relationship between breast and thyroid cancer has been largely based on findings from single-center studies, which have suggested a possible increase in thyroid cancer incidence after breast cancer. To further explore this relationship, Dr. Kuo and her associates evaluated the National Cancer Institute’s Surveillance, Epidemiology, and End Results 9 (SEER 9) program to identify individuals diagnosed with breast cancer and/or thyroid cancer between 1973 and 2011. In all, they identified 704,402 patients with breast cancer only, 49,663 with thyroid cancer only, and 1,526 patients who developed thyroid cancer after breast cancer.

The 10-year risk of thyroid cancer in breast cancer survivors, compared with the general population, was highest among those aged 40 years and 50 years (16% and 12%, vs. 0.33% and 0.35%, respectively), and lowest among those 60 years and 70 years old (0.05% and 0.02% vs. 0.33% and 0.27%). Breast cancer survivors developed thyroid cancer a median of 5 years after their primary diagnosis.

Breast cancer survivors who developed thyroid cancer were younger compared with patients who had breast cancer only (a mean of 54 years vs. 61 years, respectively; P less than .001), had smaller breast cancers (a mean of 15 mm vs. 18 mm; P less than .001), a greater percentage of invasive ductal carcinoma (7.6% vs. 5.5%; P = .002), and were more likely to receive adjuvant radiation therapy (48% vs. 44%; P = .009). “This is probably reflective of the surgical treatment that these patients receive,” Dr. Kuo said.

No differences between the two cohorts were noted in terms of estrogen receptor/progesterone receptor positivity or lymph node involvement.

Because breast cancer doesn’t generally develop in younger women, breast cancer survivors in the SEER 9 database who then developed a subsequent thyroid cancer were older, compared with patients who had thyroid cancer only (a mean of 62 vs. 45 years, respectively; P less than .001). In addition, compared with patients who had thyroid cancer only, breast cancer survivors who developed thyroid cancer had smaller thyroid tumors (11 mm vs. 13 mm; P = .004) and less radioactive iodine positivity (46% vs. 37%; P less than .001). They also had a greater percentage of tall cell variant papillary thyroid cancer (.9% vs. .5%; P = .036), oxyphilic variant follicular thyroid cancer (4.3% vs. 2.6%; P less than .001), and anaplastic cancer 1.5% vs. 0.8%; P = .001).

Dr. Kuo plans to investigate if tamoxifen treatment plays a role in increasing the risk of thyroid cancer in breast cancer survivors. She reported having no relevant financial conflicts.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – Breast cancer survivors face an increased risk of thyroid cancer, especially within 5 years of their breast cancer diagnosis, according to results from large retrospective analysis.

“The results of this study prompt a greater awareness of the increased risk for thyroid cancer among breast cancer survivors,” Dr. Jennifer H. Kuo said during a press briefing at the meeting of the Endocrine Society.

Doug Brunk/Frontline Medical News

Although the incidence of breast cancer has been stable in the last 2 decades, “it’s still a leading cause of cancer; it affects one in eight women in this country at some time in their lives,” said Dr. Kuo of the division of GI/endocrine surgery at Columbia University, New York. “With advancements for the treatment of breast cancer, however, survival after breast cancer has greatly improved, now reaching almost 90% at 5 years. What this means is the number of breast cancer survivors in this country is now increasing. These survivors have an 18%-30% risk of developing a second cancer. Most of these second cancers are hormonally mediated, such as ovarian and uterine cancers, but there are some studies that indicate thyroid cancer is also increased.”

To date, she said, the relationship between breast and thyroid cancer has been largely based on findings from single-center studies, which have suggested a possible increase in thyroid cancer incidence after breast cancer. To further explore this relationship, Dr. Kuo and her associates evaluated the National Cancer Institute’s Surveillance, Epidemiology, and End Results 9 (SEER 9) program to identify individuals diagnosed with breast cancer and/or thyroid cancer between 1973 and 2011. In all, they identified 704,402 patients with breast cancer only, 49,663 with thyroid cancer only, and 1,526 patients who developed thyroid cancer after breast cancer.

The 10-year risk of thyroid cancer in breast cancer survivors, compared with the general population, was highest among those aged 40 years and 50 years (16% and 12%, vs. 0.33% and 0.35%, respectively), and lowest among those 60 years and 70 years old (0.05% and 0.02% vs. 0.33% and 0.27%). Breast cancer survivors developed thyroid cancer a median of 5 years after their primary diagnosis.

Breast cancer survivors who developed thyroid cancer were younger compared with patients who had breast cancer only (a mean of 54 years vs. 61 years, respectively; P less than .001), had smaller breast cancers (a mean of 15 mm vs. 18 mm; P less than .001), a greater percentage of invasive ductal carcinoma (7.6% vs. 5.5%; P = .002), and were more likely to receive adjuvant radiation therapy (48% vs. 44%; P = .009). “This is probably reflective of the surgical treatment that these patients receive,” Dr. Kuo said.

No differences between the two cohorts were noted in terms of estrogen receptor/progesterone receptor positivity or lymph node involvement.

Because breast cancer doesn’t generally develop in younger women, breast cancer survivors in the SEER 9 database who then developed a subsequent thyroid cancer were older, compared with patients who had thyroid cancer only (a mean of 62 vs. 45 years, respectively; P less than .001). In addition, compared with patients who had thyroid cancer only, breast cancer survivors who developed thyroid cancer had smaller thyroid tumors (11 mm vs. 13 mm; P = .004) and less radioactive iodine positivity (46% vs. 37%; P less than .001). They also had a greater percentage of tall cell variant papillary thyroid cancer (.9% vs. .5%; P = .036), oxyphilic variant follicular thyroid cancer (4.3% vs. 2.6%; P less than .001), and anaplastic cancer 1.5% vs. 0.8%; P = .001).

Dr. Kuo plans to investigate if tamoxifen treatment plays a role in increasing the risk of thyroid cancer in breast cancer survivors. She reported having no relevant financial conflicts.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

SAN DIEGO – Breast cancer survivors face an increased risk of thyroid cancer, especially within 5 years of their breast cancer diagnosis, according to results from large retrospective analysis.

“The results of this study prompt a greater awareness of the increased risk for thyroid cancer among breast cancer survivors,” Dr. Jennifer H. Kuo said during a press briefing at the meeting of the Endocrine Society.

Doug Brunk/Frontline Medical News

Although the incidence of breast cancer has been stable in the last 2 decades, “it’s still a leading cause of cancer; it affects one in eight women in this country at some time in their lives,” said Dr. Kuo of the division of GI/endocrine surgery at Columbia University, New York. “With advancements for the treatment of breast cancer, however, survival after breast cancer has greatly improved, now reaching almost 90% at 5 years. What this means is the number of breast cancer survivors in this country is now increasing. These survivors have an 18%-30% risk of developing a second cancer. Most of these second cancers are hormonally mediated, such as ovarian and uterine cancers, but there are some studies that indicate thyroid cancer is also increased.”

To date, she said, the relationship between breast and thyroid cancer has been largely based on findings from single-center studies, which have suggested a possible increase in thyroid cancer incidence after breast cancer. To further explore this relationship, Dr. Kuo and her associates evaluated the National Cancer Institute’s Surveillance, Epidemiology, and End Results 9 (SEER 9) program to identify individuals diagnosed with breast cancer and/or thyroid cancer between 1973 and 2011. In all, they identified 704,402 patients with breast cancer only, 49,663 with thyroid cancer only, and 1,526 patients who developed thyroid cancer after breast cancer.

The 10-year risk of thyroid cancer in breast cancer survivors, compared with the general population, was highest among those aged 40 years and 50 years (16% and 12%, vs. 0.33% and 0.35%, respectively), and lowest among those 60 years and 70 years old (0.05% and 0.02% vs. 0.33% and 0.27%). Breast cancer survivors developed thyroid cancer a median of 5 years after their primary diagnosis.

Breast cancer survivors who developed thyroid cancer were younger compared with patients who had breast cancer only (a mean of 54 years vs. 61 years, respectively; P less than .001), had smaller breast cancers (a mean of 15 mm vs. 18 mm; P less than .001), a greater percentage of invasive ductal carcinoma (7.6% vs. 5.5%; P = .002), and were more likely to receive adjuvant radiation therapy (48% vs. 44%; P = .009). “This is probably reflective of the surgical treatment that these patients receive,” Dr. Kuo said.

No differences between the two cohorts were noted in terms of estrogen receptor/progesterone receptor positivity or lymph node involvement.

Because breast cancer doesn’t generally develop in younger women, breast cancer survivors in the SEER 9 database who then developed a subsequent thyroid cancer were older, compared with patients who had thyroid cancer only (a mean of 62 vs. 45 years, respectively; P less than .001). In addition, compared with patients who had thyroid cancer only, breast cancer survivors who developed thyroid cancer had smaller thyroid tumors (11 mm vs. 13 mm; P = .004) and less radioactive iodine positivity (46% vs. 37%; P less than .001). They also had a greater percentage of tall cell variant papillary thyroid cancer (.9% vs. .5%; P = .036), oxyphilic variant follicular thyroid cancer (4.3% vs. 2.6%; P less than .001), and anaplastic cancer 1.5% vs. 0.8%; P = .001).

Dr. Kuo plans to investigate if tamoxifen treatment plays a role in increasing the risk of thyroid cancer in breast cancer survivors. She reported having no relevant financial conflicts.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

A genetic assay designed to predict breast cancer metastasis and response to adjuvant chemotherapy has undergone rapid uptake, and clinicians are generally following guidelines for its use, researchers reported online in JAMA Oncology.

Overall use of the Oncotype DX 21-gene recurrence score (RS) assay rose from 1.1% in 2005 to 10.1% in 2009 (P < .001), reported Dr. Michaela Dinan of Duke University, Durham, N.C., and her associates.

©ktsimage/Thinkstock.com

“We found that use of the assay was largely restricted to the populations for which it was initially approved in 2005, namely women with estrogen receptor-positive, lymph node-negative, stage I or II breast cancer,” the investigators said (JAMA Oncol. 2015 Mar. 5 [doi:10.1001/jamaoncol.2015.43]).The RS assay has been available commercially since 2004, and the Centers for Medicare & Medicaid Services has covered it since 2006. Dr. Dinan and her associates studied records from a Surveillance, Epidemiology and End Results (SEER) data set with linked Medicare claims to understand trends in testing. The study included 70,802 patients with breast cancer, all of whom were at least 66 years old at diagnosis.

Almost 61% of patients who were tested with the RS assay met the National Comprehensive Cancer Network’s criteria for intermediate-risk disease – estrogen receptor–positive, lymph node–negative tumors measuring more than 1 cm, said the researchers. Most other tested patients had “borderline” indications for use of the assay, such as T1b or N1 disease. Significant predictors of testing included being less than 70 years old at diagnosis, having less than two comorbid conditions, and having tumors that were grade 2 or 3 or larger than 2 cm. Testing varied little geographically, and not at all by race, the investigators noted.

The RS assay is currently not required or universally recommended for all breast cancer patients who are considering adjuvant chemotherapy, so the researchers could not assess whether patients were being adequately tested, they said. They recommended analyzing other data besides that from the SEER-Medicare data set, including data on younger women, who might have distinct patterns of testing and chemotherapy use. Because some studies also indicated that the RS assay might be useful in patients with node-positive disease, the investigators also suggested examining its use in this setting and assessing how testing affects costs, chemotherapy use, and treatment outcomes.

The Agency for Healthcare Research and Quality funded the study. The authors reporting having no relevant conflicts of interest.

A genetic assay designed to predict breast cancer metastasis and response to adjuvant chemotherapy has undergone rapid uptake, and clinicians are generally following guidelines for its use, researchers reported online in JAMA Oncology.

Overall use of the Oncotype DX 21-gene recurrence score (RS) assay rose from 1.1% in 2005 to 10.1% in 2009 (P < .001), reported Dr. Michaela Dinan of Duke University, Durham, N.C., and her associates.

©ktsimage/Thinkstock.com

“We found that use of the assay was largely restricted to the populations for which it was initially approved in 2005, namely women with estrogen receptor-positive, lymph node-negative, stage I or II breast cancer,” the investigators said (JAMA Oncol. 2015 Mar. 5 [doi:10.1001/jamaoncol.2015.43]).The RS assay has been available commercially since 2004, and the Centers for Medicare & Medicaid Services has covered it since 2006. Dr. Dinan and her associates studied records from a Surveillance, Epidemiology and End Results (SEER) data set with linked Medicare claims to understand trends in testing. The study included 70,802 patients with breast cancer, all of whom were at least 66 years old at diagnosis.

Almost 61% of patients who were tested with the RS assay met the National Comprehensive Cancer Network’s criteria for intermediate-risk disease – estrogen receptor–positive, lymph node–negative tumors measuring more than 1 cm, said the researchers. Most other tested patients had “borderline” indications for use of the assay, such as T1b or N1 disease. Significant predictors of testing included being less than 70 years old at diagnosis, having less than two comorbid conditions, and having tumors that were grade 2 or 3 or larger than 2 cm. Testing varied little geographically, and not at all by race, the investigators noted.

The RS assay is currently not required or universally recommended for all breast cancer patients who are considering adjuvant chemotherapy, so the researchers could not assess whether patients were being adequately tested, they said. They recommended analyzing other data besides that from the SEER-Medicare data set, including data on younger women, who might have distinct patterns of testing and chemotherapy use. Because some studies also indicated that the RS assay might be useful in patients with node-positive disease, the investigators also suggested examining its use in this setting and assessing how testing affects costs, chemotherapy use, and treatment outcomes.

The Agency for Healthcare Research and Quality funded the study. The authors reporting having no relevant conflicts of interest.

A genetic assay designed to predict breast cancer metastasis and response to adjuvant chemotherapy has undergone rapid uptake, and clinicians are generally following guidelines for its use, researchers reported online in JAMA Oncology.

Overall use of the Oncotype DX 21-gene recurrence score (RS) assay rose from 1.1% in 2005 to 10.1% in 2009 (P < .001), reported Dr. Michaela Dinan of Duke University, Durham, N.C., and her associates.

©ktsimage/Thinkstock.com

“We found that use of the assay was largely restricted to the populations for which it was initially approved in 2005, namely women with estrogen receptor-positive, lymph node-negative, stage I or II breast cancer,” the investigators said (JAMA Oncol. 2015 Mar. 5 [doi:10.1001/jamaoncol.2015.43]).The RS assay has been available commercially since 2004, and the Centers for Medicare & Medicaid Services has covered it since 2006. Dr. Dinan and her associates studied records from a Surveillance, Epidemiology and End Results (SEER) data set with linked Medicare claims to understand trends in testing. The study included 70,802 patients with breast cancer, all of whom were at least 66 years old at diagnosis.

Almost 61% of patients who were tested with the RS assay met the National Comprehensive Cancer Network’s criteria for intermediate-risk disease – estrogen receptor–positive, lymph node–negative tumors measuring more than 1 cm, said the researchers. Most other tested patients had “borderline” indications for use of the assay, such as T1b or N1 disease. Significant predictors of testing included being less than 70 years old at diagnosis, having less than two comorbid conditions, and having tumors that were grade 2 or 3 or larger than 2 cm. Testing varied little geographically, and not at all by race, the investigators noted.

The RS assay is currently not required or universally recommended for all breast cancer patients who are considering adjuvant chemotherapy, so the researchers could not assess whether patients were being adequately tested, they said. They recommended analyzing other data besides that from the SEER-Medicare data set, including data on younger women, who might have distinct patterns of testing and chemotherapy use. Because some studies also indicated that the RS assay might be useful in patients with node-positive disease, the investigators also suggested examining its use in this setting and assessing how testing affects costs, chemotherapy use, and treatment outcomes.

The Agency for Healthcare Research and Quality funded the study. The authors reporting having no relevant conflicts of interest.

Screening mammography in women with dense breasts (ie, containing more than 50% fibroglandular tissue) is challenging for two reasons:

Because nearly half of women in the United States undergoing screening mammography have dense breasts, it is vital that we provide them with accurate and useful counseling.

The challenge of managing women with dense breasts has become complicated by the fact that 21 states have passed laws requiring that women with dense breasts be informed through scripted messages of the decreased sensitivity of screening and increased risk of cancer and advised to
discuss with their provider whether additional testing (eg, with supplemental ultrasound) should be ordered. These laws may be well-intentioned, but they are problematic.

Although there are data documenting increased cancer detection with screening ultrasonography, there are no data currently available demonstrating that this increased detection adds value by improving important outcomes like disease-specific mortality. Further, the value proposition (improved outcomes/cost) of screening ultrasonography is unknown.

In this article, Sprague and colleagues attempt to fill this void by assessing the potential benefits, harms, and cost-effectivenessof supplemental ultrasonography following a negative screening mammogram for women with dense breasts.

Through the use of validated micro-simulation modeling, they calculate that the routine use of supplemental ultrasonography in women with dense breasts might result in 0.36 fewer deaths per 1,000 women screened. Compare this to 6 fewer deaths per 1,000 women undergoing screening mammography.

Moreover, the specificity of supplemental ultrasonography in this setting is poor, with 94% of recommended biopsies yielding benign findings (ie, positive predictive value of 6%).²

What this evidence means for practice
At present, there is little evidence that routine supplemental ultrasonography improves important outcomes such as disease-specific mortality at a rational cost. However, there may be hope on the horizon: Emerging data suggest that digital tomosynthesis as a primary screening modality may improve both specificity and sensitivity, compared with mammography, in women with dense breasts.

Initial experience with tomosynthesis demonstrates both fewer callbacks and improved cancer detection in women, compared with screening mammography.^3,4 However, the value proposition of this new technology will ultimately depend on a careful analysis of its effect on mortality and cost.
–Mark D. Pearlman, MD

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.

Screening mammography in women with dense breasts (ie, containing more than 50% fibroglandular tissue) is challenging for two reasons:

Because nearly half of women in the United States undergoing screening mammography have dense breasts, it is vital that we provide them with accurate and useful counseling.

The challenge of managing women with dense breasts has become complicated by the fact that 21 states have passed laws requiring that women with dense breasts be informed through scripted messages of the decreased sensitivity of screening and increased risk of cancer and advised to
discuss with their provider whether additional testing (eg, with supplemental ultrasound) should be ordered. These laws may be well-intentioned, but they are problematic.

Although there are data documenting increased cancer detection with screening ultrasonography, there are no data currently available demonstrating that this increased detection adds value by improving important outcomes like disease-specific mortality. Further, the value proposition (improved outcomes/cost) of screening ultrasonography is unknown.

In this article, Sprague and colleagues attempt to fill this void by assessing the potential benefits, harms, and cost-effectivenessof supplemental ultrasonography following a negative screening mammogram for women with dense breasts.

Through the use of validated micro-simulation modeling, they calculate that the routine use of supplemental ultrasonography in women with dense breasts might result in 0.36 fewer deaths per 1,000 women screened. Compare this to 6 fewer deaths per 1,000 women undergoing screening mammography.

Moreover, the specificity of supplemental ultrasonography in this setting is poor, with 94% of recommended biopsies yielding benign findings (ie, positive predictive value of 6%).²

What this evidence means for practice
At present, there is little evidence that routine supplemental ultrasonography improves important outcomes such as disease-specific mortality at a rational cost. However, there may be hope on the horizon: Emerging data suggest that digital tomosynthesis as a primary screening modality may improve both specificity and sensitivity, compared with mammography, in women with dense breasts.

Initial experience with tomosynthesis demonstrates both fewer callbacks and improved cancer detection in women, compared with screening mammography.^3,4 However, the value proposition of this new technology will ultimately depend on a careful analysis of its effect on mortality and cost.
–Mark D. Pearlman, MD

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.

Screening mammography in women with dense breasts (ie, containing more than 50% fibroglandular tissue) is challenging for two reasons:

Because nearly half of women in the United States undergoing screening mammography have dense breasts, it is vital that we provide them with accurate and useful counseling.

The challenge of managing women with dense breasts has become complicated by the fact that 21 states have passed laws requiring that women with dense breasts be informed through scripted messages of the decreased sensitivity of screening and increased risk of cancer and advised to
discuss with their provider whether additional testing (eg, with supplemental ultrasound) should be ordered. These laws may be well-intentioned, but they are problematic.

Although there are data documenting increased cancer detection with screening ultrasonography, there are no data currently available demonstrating that this increased detection adds value by improving important outcomes like disease-specific mortality. Further, the value proposition (improved outcomes/cost) of screening ultrasonography is unknown.

In this article, Sprague and colleagues attempt to fill this void by assessing the potential benefits, harms, and cost-effectivenessof supplemental ultrasonography following a negative screening mammogram for women with dense breasts.

Through the use of validated micro-simulation modeling, they calculate that the routine use of supplemental ultrasonography in women with dense breasts might result in 0.36 fewer deaths per 1,000 women screened. Compare this to 6 fewer deaths per 1,000 women undergoing screening mammography.

Moreover, the specificity of supplemental ultrasonography in this setting is poor, with 94% of recommended biopsies yielding benign findings (ie, positive predictive value of 6%).²

What this evidence means for practice
At present, there is little evidence that routine supplemental ultrasonography improves important outcomes such as disease-specific mortality at a rational cost. However, there may be hope on the horizon: Emerging data suggest that digital tomosynthesis as a primary screening modality may improve both specificity and sensitivity, compared with mammography, in women with dense breasts.

Initial experience with tomosynthesis demonstrates both fewer callbacks and improved cancer detection in women, compared with screening mammography.^3,4 However, the value proposition of this new technology will ultimately depend on a careful analysis of its effect on mortality and cost.
–Mark D. Pearlman, MD

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.

More than 20 states have enacted so-called breast density notification laws, but the impact has varied. And part of the problem, experts say, is that ob.gyns. don’t have enough information to advise patients about their secondary screening options.

“If primary care clinicians can’t answer the patients’ questions adequately, then this law could potentially negatively impact patients,” said Dr. Kathleen Khong, a radiologist at the University of California, Davis, who has been researching the impact of California’s notification law, which went into effect in 2013.

Connecticut became the first state to enact a breast density notification law in 2009, requiring that all patients be given information about their breast density on their mammography report. For women with dense breasts, the law mandated specific language on the report stating that patients “might benefit from supplementary screening tests, which can include a breast ultrasound screening or a breast MRI examination.”

Since then, another 20 states have enacted similar laws. And patient advocates are pushing Congress to set a minimum federal standard for notifying patients about their breast density.

But as more states adopt notification mandates, researchers have found that the implementation is often uneven, in part because ob.gyns. and other women’s health care providers don’t know how to counsel patients about the pros and cons of further imaging.

For instance, in Connecticut, some practices refer 100% of women with dense breasts for whole-breast ultrasound screening, while other practices refer none. And only 45% of Connecticut women who were referred for follow-up ultrasonography activity received it, according to Dr. Priscilla Slanetz, a radiologist at Beth Israel Deaconess Medical Center in Boston, and her colleagues (N. Engl. J. Med. 2015;372:593-5).

Dr. Slanetz and her colleagues were looking at the implementation in Connecticut because their home state of Massachusetts is considering a breast density notification of its own.

“It became very clear to myself and my two colleagues that although we’re very aware of breast density, our primary care providers in particular really have no knowledge about it,” Dr. Slanetz said.

Dr. Sharon Mass, an ob.gyn. in Morristown, N.J., agrees, adding that education is a challenge because of a lack of consistent evidence to help guide physicians as they encounter questions from their patients.

While about half of women have dense breasts, the existing notification laws don’t account for the fact that some women have heterogenously dense breasts, while others have extremely dense breasts, Dr. Mass said.

The need for more education is echoed in a recent study led by Dr. Khong at the University of California, Davis. According to a survey of 77 physicians in the UC Davis Medical Center following the implementation of a notification law in April 2013, roughly half (49%) reported no knowledge of the legislation and 32% noted an increase in patient levels of concern about breast density. About 50% of women receiving mammograms receive the notification about dense breasts, according to the UC Davis researchers.

The survey found that 55% of respondents were “somewhat comfortable” and 12% were “not comfortable” with breast density questions from their patients. Three-quarters of survey respondents said they wanted more education about the breast density law and its implications for primary care.

But even education is going to be a challenge, said Dr. Khong.

“Breast density is a very complicated and controversial topic and there is no straight answer for every patient,” Dr. Khong said, adding that there is no prospective study that spells out what specific type of imaging is appropriate for women with varying degrees of breast density.

“So even if we teach primary care physicians, we can’t give them a black and white answer for every patient,” she said. “It is very difficult. It is very case by case.”

Dr. Mass added that because of the case-by-case nature, the American Congress of Obstetricians and Gynecologists has “actually been opposed to every single one of these initiatives in every state because there is not the support at the grassroots level or the physician level to understand what to do with this information.”

Dr. Khong said that UC Davis is working to address these issues by surveying other academic medical centers and ultimately developing an education plan for primary care physicians, which could range from educational conferences to brochures or PowerPoint sources for self-learning, to a dynamic algorithm that will help guide clinicians to the appropriate kinds of supplemental screening.

The New Jersey section of ACOG has developed a brochure for physicians aimed at helping them address patient concerns around breast density and further screening based on their state’s law. But “on a national level, [clear guidance] does not exist at all and [it] is a huge deficit,” Dr. Mass said.

Dr. Slanetz agreed that screening can be a highly patient-specific decision, and the notification laws create an opportunity for an in-depth discussion.

“This whole movement, I think, is wonderful because it really does open a discussion with our patients about the strength and limitations of these different imaging tools we have,” Dr. Slanetz said. It “opens the door for primary care providers to really individualize how we best screen patients because there are a lot of patients out there, whether or not they have dense breast tissue, that might actually qualify for high-risk screening.”

But Dr. Slanetz cautioned against laws that recommend a specific kind of screening. If the law calls for a specific test and there is no insurance mandate to cover it, “you are going to create potential disparities in access to appropriate care, having women who are of lower socioeconomic status not being able to take advantage of the additional screening,” she said.

gtwachtman@frontlinemedcom.com

More than 20 states have enacted so-called breast density notification laws, but the impact has varied. And part of the problem, experts say, is that ob.gyns. don’t have enough information to advise patients about their secondary screening options.

“If primary care clinicians can’t answer the patients’ questions adequately, then this law could potentially negatively impact patients,” said Dr. Kathleen Khong, a radiologist at the University of California, Davis, who has been researching the impact of California’s notification law, which went into effect in 2013.

Connecticut became the first state to enact a breast density notification law in 2009, requiring that all patients be given information about their breast density on their mammography report. For women with dense breasts, the law mandated specific language on the report stating that patients “might benefit from supplementary screening tests, which can include a breast ultrasound screening or a breast MRI examination.”

Since then, another 20 states have enacted similar laws. And patient advocates are pushing Congress to set a minimum federal standard for notifying patients about their breast density.

But as more states adopt notification mandates, researchers have found that the implementation is often uneven, in part because ob.gyns. and other women’s health care providers don’t know how to counsel patients about the pros and cons of further imaging.

For instance, in Connecticut, some practices refer 100% of women with dense breasts for whole-breast ultrasound screening, while other practices refer none. And only 45% of Connecticut women who were referred for follow-up ultrasonography activity received it, according to Dr. Priscilla Slanetz, a radiologist at Beth Israel Deaconess Medical Center in Boston, and her colleagues (N. Engl. J. Med. 2015;372:593-5).

Dr. Slanetz and her colleagues were looking at the implementation in Connecticut because their home state of Massachusetts is considering a breast density notification of its own.

“It became very clear to myself and my two colleagues that although we’re very aware of breast density, our primary care providers in particular really have no knowledge about it,” Dr. Slanetz said.

Dr. Sharon Mass, an ob.gyn. in Morristown, N.J., agrees, adding that education is a challenge because of a lack of consistent evidence to help guide physicians as they encounter questions from their patients.

While about half of women have dense breasts, the existing notification laws don’t account for the fact that some women have heterogenously dense breasts, while others have extremely dense breasts, Dr. Mass said.

The need for more education is echoed in a recent study led by Dr. Khong at the University of California, Davis. According to a survey of 77 physicians in the UC Davis Medical Center following the implementation of a notification law in April 2013, roughly half (49%) reported no knowledge of the legislation and 32% noted an increase in patient levels of concern about breast density. About 50% of women receiving mammograms receive the notification about dense breasts, according to the UC Davis researchers.

The survey found that 55% of respondents were “somewhat comfortable” and 12% were “not comfortable” with breast density questions from their patients. Three-quarters of survey respondents said they wanted more education about the breast density law and its implications for primary care.

But even education is going to be a challenge, said Dr. Khong.

“Breast density is a very complicated and controversial topic and there is no straight answer for every patient,” Dr. Khong said, adding that there is no prospective study that spells out what specific type of imaging is appropriate for women with varying degrees of breast density.

“So even if we teach primary care physicians, we can’t give them a black and white answer for every patient,” she said. “It is very difficult. It is very case by case.”

Dr. Mass added that because of the case-by-case nature, the American Congress of Obstetricians and Gynecologists has “actually been opposed to every single one of these initiatives in every state because there is not the support at the grassroots level or the physician level to understand what to do with this information.”

Dr. Khong said that UC Davis is working to address these issues by surveying other academic medical centers and ultimately developing an education plan for primary care physicians, which could range from educational conferences to brochures or PowerPoint sources for self-learning, to a dynamic algorithm that will help guide clinicians to the appropriate kinds of supplemental screening.

The New Jersey section of ACOG has developed a brochure for physicians aimed at helping them address patient concerns around breast density and further screening based on their state’s law. But “on a national level, [clear guidance] does not exist at all and [it] is a huge deficit,” Dr. Mass said.

Dr. Slanetz agreed that screening can be a highly patient-specific decision, and the notification laws create an opportunity for an in-depth discussion.

“This whole movement, I think, is wonderful because it really does open a discussion with our patients about the strength and limitations of these different imaging tools we have,” Dr. Slanetz said. It “opens the door for primary care providers to really individualize how we best screen patients because there are a lot of patients out there, whether or not they have dense breast tissue, that might actually qualify for high-risk screening.”

But Dr. Slanetz cautioned against laws that recommend a specific kind of screening. If the law calls for a specific test and there is no insurance mandate to cover it, “you are going to create potential disparities in access to appropriate care, having women who are of lower socioeconomic status not being able to take advantage of the additional screening,” she said.

gtwachtman@frontlinemedcom.com

More than 20 states have enacted so-called breast density notification laws, but the impact has varied. And part of the problem, experts say, is that ob.gyns. don’t have enough information to advise patients about their secondary screening options.

“If primary care clinicians can’t answer the patients’ questions adequately, then this law could potentially negatively impact patients,” said Dr. Kathleen Khong, a radiologist at the University of California, Davis, who has been researching the impact of California’s notification law, which went into effect in 2013.

Connecticut became the first state to enact a breast density notification law in 2009, requiring that all patients be given information about their breast density on their mammography report. For women with dense breasts, the law mandated specific language on the report stating that patients “might benefit from supplementary screening tests, which can include a breast ultrasound screening or a breast MRI examination.”

Since then, another 20 states have enacted similar laws. And patient advocates are pushing Congress to set a minimum federal standard for notifying patients about their breast density.

But as more states adopt notification mandates, researchers have found that the implementation is often uneven, in part because ob.gyns. and other women’s health care providers don’t know how to counsel patients about the pros and cons of further imaging.

For instance, in Connecticut, some practices refer 100% of women with dense breasts for whole-breast ultrasound screening, while other practices refer none. And only 45% of Connecticut women who were referred for follow-up ultrasonography activity received it, according to Dr. Priscilla Slanetz, a radiologist at Beth Israel Deaconess Medical Center in Boston, and her colleagues (N. Engl. J. Med. 2015;372:593-5).

Dr. Slanetz and her colleagues were looking at the implementation in Connecticut because their home state of Massachusetts is considering a breast density notification of its own.

“It became very clear to myself and my two colleagues that although we’re very aware of breast density, our primary care providers in particular really have no knowledge about it,” Dr. Slanetz said.

Dr. Sharon Mass, an ob.gyn. in Morristown, N.J., agrees, adding that education is a challenge because of a lack of consistent evidence to help guide physicians as they encounter questions from their patients.

While about half of women have dense breasts, the existing notification laws don’t account for the fact that some women have heterogenously dense breasts, while others have extremely dense breasts, Dr. Mass said.

The need for more education is echoed in a recent study led by Dr. Khong at the University of California, Davis. According to a survey of 77 physicians in the UC Davis Medical Center following the implementation of a notification law in April 2013, roughly half (49%) reported no knowledge of the legislation and 32% noted an increase in patient levels of concern about breast density. About 50% of women receiving mammograms receive the notification about dense breasts, according to the UC Davis researchers.

The survey found that 55% of respondents were “somewhat comfortable” and 12% were “not comfortable” with breast density questions from their patients. Three-quarters of survey respondents said they wanted more education about the breast density law and its implications for primary care.

But even education is going to be a challenge, said Dr. Khong.

“Breast density is a very complicated and controversial topic and there is no straight answer for every patient,” Dr. Khong said, adding that there is no prospective study that spells out what specific type of imaging is appropriate for women with varying degrees of breast density.

“So even if we teach primary care physicians, we can’t give them a black and white answer for every patient,” she said. “It is very difficult. It is very case by case.”

Dr. Mass added that because of the case-by-case nature, the American Congress of Obstetricians and Gynecologists has “actually been opposed to every single one of these initiatives in every state because there is not the support at the grassroots level or the physician level to understand what to do with this information.”

Dr. Khong said that UC Davis is working to address these issues by surveying other academic medical centers and ultimately developing an education plan for primary care physicians, which could range from educational conferences to brochures or PowerPoint sources for self-learning, to a dynamic algorithm that will help guide clinicians to the appropriate kinds of supplemental screening.

The New Jersey section of ACOG has developed a brochure for physicians aimed at helping them address patient concerns around breast density and further screening based on their state’s law. But “on a national level, [clear guidance] does not exist at all and [it] is a huge deficit,” Dr. Mass said.

Dr. Slanetz agreed that screening can be a highly patient-specific decision, and the notification laws create an opportunity for an in-depth discussion.

“This whole movement, I think, is wonderful because it really does open a discussion with our patients about the strength and limitations of these different imaging tools we have,” Dr. Slanetz said. It “opens the door for primary care providers to really individualize how we best screen patients because there are a lot of patients out there, whether or not they have dense breast tissue, that might actually qualify for high-risk screening.”

But Dr. Slanetz cautioned against laws that recommend a specific kind of screening. If the law calls for a specific test and there is no insurance mandate to cover it, “you are going to create potential disparities in access to appropriate care, having women who are of lower socioeconomic status not being able to take advantage of the additional screening,” she said.

gtwachtman@frontlinemedcom.com

A 1-year course of trastuzumab emtansine was found to be well tolerated and safe for patients with HER2-positive early breast cancer who had undergone anthracycline-based chemotherapy in an industry-sponsored open-label phase II clinical trial.

The investigators described this as the first study to assess trastuzumab emtansine (T-DM1), a conjugate of the monoclonal antibody trastuzumab and the cytotoxic agent emtansine, in patients with early-stage rather than metastatic disease. They found that the conjugate agent was better tolerated than has been reported for trastuzumab alone in numerous studies, suggesting that it may become a less toxic alternative to the conventional chemotherapy-plus-trastuzumab approach for breast cancer.

“If validated in phase III studies, the favorable tolerability of T-DM1 may allow use of targeted cytotoxic therapy for a longer duration (e.g., 1 year) than is feasible with conventional cytotoxic agents,” wrote Dr. Ian E. Krop of breast oncology, Dana-Farber Cancer Institute, Boston, and his associates (J. Clin. Oncol 2015 Feb. 23 [doi:10.1200/JCO.2014.58.7782]).

Three randomized phase III trials are now underway – NCT01772472 (KATHERINE),NCT01966471, and NCT02131064 – to confirm and extend the results of their study.

T-DM1 delivers the emtansine directly to tumor cells that overexpress HER2, inhibiting microtubule function and leading to cell death. In patients with metastatic breast cancer, the conjugate produces fewer adverse effects typically associated with chemotherapy, such as hair loss and neutropenia, presumably because it spares cells other than tumor cells. However, trastuzumab can be associated with cardiotoxicity, particularly in patients who also receive anthracycline-based regimens.

To assess the safety and tolerability of T-DM1 in early-stage breast cancer, Dr. Krop and his associates examined it in this single-arm trial involving 153 patients with HER2-positive early breast cancer whose left ventricular ejection fraction was 55% or greater at baseline. The patients were treated at 35 sites during a 1-year period and followed for a median of 25 months (range, 0.2-29.0 months).

They received four cycles of (neo)adjuvant doxorubicin plus cyclophosphamide or three to four cycles of fluorouracil plus epirubicin plus cyclophosphamide, then were given four cycles of T-DM1. They could then opt to receive three to four cycles of docetaxel, with or without trastuzumab, at their physician’s discretion. Sequential or concurrent radiotherapy could then be provided, and T-DM1 was resumed for a planned year of treatment.

Of the 148 patients who received at least 1 cycle of T-DM1, 122 (82%) completed the planned duration of therapy – a median of 14 cycles. “Only 17.6% of patients who initiated treatment with T-DM1 did not complete the planned therapy duration,” the investigators wrote, adding that by comparison, 31% of patients in a joint analysis of the NSABP and NCCTG trials discontinued trastuzumab alone before completing 1 year of treatment .

None of the study participants developed a cardiac event or symptomatic heart failure. By comparison, previous trials of adjuvant trastuzumab alone showed 2%-4% rates of CHF after anthracycline-based chemotherapy.

In this study, 2.7% of patients had asymptomatic declines in LVEF. By comparison, rates of LVEF decline ranged from 7% to 34% in previous trials of single-agent trastuzumab. Of the four women in this study who had LVEF decreases, one discontinued T-DM1 when her LVEF dipped to 45%; it subsequently recovered to baseline level.

Other adverse events included nausea (38% of patients) and headache (37%). The most common adverse events of grade 3 and above were thrombocytopenia (8.1%), increased ALT (7.4%), and increased AST (7.4%).

T-DM1 is marketed by Genentech as Kadcyla.Genentech supported the study. Dr. Krop is an employee of Vertex Pharmaceuticals and has received funding from Genentech. His associates reported ties to numerous industry sources

A 1-year course of trastuzumab emtansine was found to be well tolerated and safe for patients with HER2-positive early breast cancer who had undergone anthracycline-based chemotherapy in an industry-sponsored open-label phase II clinical trial.

The investigators described this as the first study to assess trastuzumab emtansine (T-DM1), a conjugate of the monoclonal antibody trastuzumab and the cytotoxic agent emtansine, in patients with early-stage rather than metastatic disease. They found that the conjugate agent was better tolerated than has been reported for trastuzumab alone in numerous studies, suggesting that it may become a less toxic alternative to the conventional chemotherapy-plus-trastuzumab approach for breast cancer.

“If validated in phase III studies, the favorable tolerability of T-DM1 may allow use of targeted cytotoxic therapy for a longer duration (e.g., 1 year) than is feasible with conventional cytotoxic agents,” wrote Dr. Ian E. Krop of breast oncology, Dana-Farber Cancer Institute, Boston, and his associates (J. Clin. Oncol 2015 Feb. 23 [doi:10.1200/JCO.2014.58.7782]).

Three randomized phase III trials are now underway – NCT01772472 (KATHERINE),NCT01966471, and NCT02131064 – to confirm and extend the results of their study.

T-DM1 delivers the emtansine directly to tumor cells that overexpress HER2, inhibiting microtubule function and leading to cell death. In patients with metastatic breast cancer, the conjugate produces fewer adverse effects typically associated with chemotherapy, such as hair loss and neutropenia, presumably because it spares cells other than tumor cells. However, trastuzumab can be associated with cardiotoxicity, particularly in patients who also receive anthracycline-based regimens.

To assess the safety and tolerability of T-DM1 in early-stage breast cancer, Dr. Krop and his associates examined it in this single-arm trial involving 153 patients with HER2-positive early breast cancer whose left ventricular ejection fraction was 55% or greater at baseline. The patients were treated at 35 sites during a 1-year period and followed for a median of 25 months (range, 0.2-29.0 months).

They received four cycles of (neo)adjuvant doxorubicin plus cyclophosphamide or three to four cycles of fluorouracil plus epirubicin plus cyclophosphamide, then were given four cycles of T-DM1. They could then opt to receive three to four cycles of docetaxel, with or without trastuzumab, at their physician’s discretion. Sequential or concurrent radiotherapy could then be provided, and T-DM1 was resumed for a planned year of treatment.

Of the 148 patients who received at least 1 cycle of T-DM1, 122 (82%) completed the planned duration of therapy – a median of 14 cycles. “Only 17.6% of patients who initiated treatment with T-DM1 did not complete the planned therapy duration,” the investigators wrote, adding that by comparison, 31% of patients in a joint analysis of the NSABP and NCCTG trials discontinued trastuzumab alone before completing 1 year of treatment .

None of the study participants developed a cardiac event or symptomatic heart failure. By comparison, previous trials of adjuvant trastuzumab alone showed 2%-4% rates of CHF after anthracycline-based chemotherapy.

In this study, 2.7% of patients had asymptomatic declines in LVEF. By comparison, rates of LVEF decline ranged from 7% to 34% in previous trials of single-agent trastuzumab. Of the four women in this study who had LVEF decreases, one discontinued T-DM1 when her LVEF dipped to 45%; it subsequently recovered to baseline level.

Other adverse events included nausea (38% of patients) and headache (37%). The most common adverse events of grade 3 and above were thrombocytopenia (8.1%), increased ALT (7.4%), and increased AST (7.4%).

T-DM1 is marketed by Genentech as Kadcyla.Genentech supported the study. Dr. Krop is an employee of Vertex Pharmaceuticals and has received funding from Genentech. His associates reported ties to numerous industry sources

A 1-year course of trastuzumab emtansine was found to be well tolerated and safe for patients with HER2-positive early breast cancer who had undergone anthracycline-based chemotherapy in an industry-sponsored open-label phase II clinical trial.

The investigators described this as the first study to assess trastuzumab emtansine (T-DM1), a conjugate of the monoclonal antibody trastuzumab and the cytotoxic agent emtansine, in patients with early-stage rather than metastatic disease. They found that the conjugate agent was better tolerated than has been reported for trastuzumab alone in numerous studies, suggesting that it may become a less toxic alternative to the conventional chemotherapy-plus-trastuzumab approach for breast cancer.

“If validated in phase III studies, the favorable tolerability of T-DM1 may allow use of targeted cytotoxic therapy for a longer duration (e.g., 1 year) than is feasible with conventional cytotoxic agents,” wrote Dr. Ian E. Krop of breast oncology, Dana-Farber Cancer Institute, Boston, and his associates (J. Clin. Oncol 2015 Feb. 23 [doi:10.1200/JCO.2014.58.7782]).

Three randomized phase III trials are now underway – NCT01772472 (KATHERINE),NCT01966471, and NCT02131064 – to confirm and extend the results of their study.

T-DM1 delivers the emtansine directly to tumor cells that overexpress HER2, inhibiting microtubule function and leading to cell death. In patients with metastatic breast cancer, the conjugate produces fewer adverse effects typically associated with chemotherapy, such as hair loss and neutropenia, presumably because it spares cells other than tumor cells. However, trastuzumab can be associated with cardiotoxicity, particularly in patients who also receive anthracycline-based regimens.

To assess the safety and tolerability of T-DM1 in early-stage breast cancer, Dr. Krop and his associates examined it in this single-arm trial involving 153 patients with HER2-positive early breast cancer whose left ventricular ejection fraction was 55% or greater at baseline. The patients were treated at 35 sites during a 1-year period and followed for a median of 25 months (range, 0.2-29.0 months).

They received four cycles of (neo)adjuvant doxorubicin plus cyclophosphamide or three to four cycles of fluorouracil plus epirubicin plus cyclophosphamide, then were given four cycles of T-DM1. They could then opt to receive three to four cycles of docetaxel, with or without trastuzumab, at their physician’s discretion. Sequential or concurrent radiotherapy could then be provided, and T-DM1 was resumed for a planned year of treatment.

Of the 148 patients who received at least 1 cycle of T-DM1, 122 (82%) completed the planned duration of therapy – a median of 14 cycles. “Only 17.6% of patients who initiated treatment with T-DM1 did not complete the planned therapy duration,” the investigators wrote, adding that by comparison, 31% of patients in a joint analysis of the NSABP and NCCTG trials discontinued trastuzumab alone before completing 1 year of treatment .

None of the study participants developed a cardiac event or symptomatic heart failure. By comparison, previous trials of adjuvant trastuzumab alone showed 2%-4% rates of CHF after anthracycline-based chemotherapy.

In this study, 2.7% of patients had asymptomatic declines in LVEF. By comparison, rates of LVEF decline ranged from 7% to 34% in previous trials of single-agent trastuzumab. Of the four women in this study who had LVEF decreases, one discontinued T-DM1 when her LVEF dipped to 45%; it subsequently recovered to baseline level.

Other adverse events included nausea (38% of patients) and headache (37%). The most common adverse events of grade 3 and above were thrombocytopenia (8.1%), increased ALT (7.4%), and increased AST (7.4%).

T-DM1 is marketed by Genentech as Kadcyla.Genentech supported the study. Dr. Krop is an employee of Vertex Pharmaceuticals and has received funding from Genentech. His associates reported ties to numerous industry sources

Survival rates overall for cancer patients are higher now than 20 years ago, though younger patients are faring significantly better than older ones for many types of cancer, according to investigators.

The findings were published online Feb. 19 in JAMA Oncology.

Furthermore, racial disparities in survival persist for most cancer sites, wrote Chenjie Zeng and associates at Vanderbilt University, Nashville, Tenn.

Using data from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program, the researchers calculated survival rates for just over a million patients diagnosed with cancer of the colon or rectum, breast, prostate, lung, liver, pancreas or ovary over the time span from 1990 to 2009. Survival rates were obtained for each cancer site; results were grouped in 5-year cohorts by diagnosis date, and further broken down by race, sex, and age group (20-49, 50-64, 65-74, and 75-85 years at time of diagnosis).

©xrender/Thinkstock

Hazard ratios for cancer-specific death were obtained by comparing all later 5-year cohorts to the 1990-1994 group. Adjusted HRs for patients aged 50-64 years diagnosed with cancer in 2005-2009 compared with those diagnosed in 1990-1994 were 0.57 for colon or rectal cancer, 0.48 for breast cancer, 0.61 for liver cancer, and 0.32 for prostate cancer. By contrast, the oldest patients (aged 75-85 years) had HRs of 0.88, 0.88, 0.76, and 0.65, respectively, for these cancer sites. Age-related findings were less pronounced for lung and pancreatic cancers, Ms. Zeng and associates said (JAMA Oncology 2015 Feb. 19 [doi:10.1001/jamaoncol.2014.161]).

African Americans had a greater increase in prostate cancer survival than did whites or Asians; ovarian cancer survival, however, was reduced for African Americans but improved among whites over the study period. Overall survival rates were poorer for all cancer sites for African Americans when compared to whites, with racial disparities in screening and care a potential factor.

Some of the age-related survival differences may be attributed to younger patients’ being able to take greater advantage of newer therapies, since the largest age-related survival gap occurred for cancer sites with greater treatment advances (breast, colorectal, and prostate cancers), Ms. Zeng and associates said.

Study limitations included inability to exclude potential confounders such as socioeconomic status, lifestyle choices, and comorbidities, as well as oversampling of urban and foreign-born individuals in the study population, the researchers noted.

Survival rates overall for cancer patients are higher now than 20 years ago, though younger patients are faring significantly better than older ones for many types of cancer, according to investigators.

The findings were published online Feb. 19 in JAMA Oncology.

Furthermore, racial disparities in survival persist for most cancer sites, wrote Chenjie Zeng and associates at Vanderbilt University, Nashville, Tenn.

Using data from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program, the researchers calculated survival rates for just over a million patients diagnosed with cancer of the colon or rectum, breast, prostate, lung, liver, pancreas or ovary over the time span from 1990 to 2009. Survival rates were obtained for each cancer site; results were grouped in 5-year cohorts by diagnosis date, and further broken down by race, sex, and age group (20-49, 50-64, 65-74, and 75-85 years at time of diagnosis).

©xrender/Thinkstock

Hazard ratios for cancer-specific death were obtained by comparing all later 5-year cohorts to the 1990-1994 group. Adjusted HRs for patients aged 50-64 years diagnosed with cancer in 2005-2009 compared with those diagnosed in 1990-1994 were 0.57 for colon or rectal cancer, 0.48 for breast cancer, 0.61 for liver cancer, and 0.32 for prostate cancer. By contrast, the oldest patients (aged 75-85 years) had HRs of 0.88, 0.88, 0.76, and 0.65, respectively, for these cancer sites. Age-related findings were less pronounced for lung and pancreatic cancers, Ms. Zeng and associates said (JAMA Oncology 2015 Feb. 19 [doi:10.1001/jamaoncol.2014.161]).

African Americans had a greater increase in prostate cancer survival than did whites or Asians; ovarian cancer survival, however, was reduced for African Americans but improved among whites over the study period. Overall survival rates were poorer for all cancer sites for African Americans when compared to whites, with racial disparities in screening and care a potential factor.

Some of the age-related survival differences may be attributed to younger patients’ being able to take greater advantage of newer therapies, since the largest age-related survival gap occurred for cancer sites with greater treatment advances (breast, colorectal, and prostate cancers), Ms. Zeng and associates said.

Study limitations included inability to exclude potential confounders such as socioeconomic status, lifestyle choices, and comorbidities, as well as oversampling of urban and foreign-born individuals in the study population, the researchers noted.

Survival rates overall for cancer patients are higher now than 20 years ago, though younger patients are faring significantly better than older ones for many types of cancer, according to investigators.

The findings were published online Feb. 19 in JAMA Oncology.

Furthermore, racial disparities in survival persist for most cancer sites, wrote Chenjie Zeng and associates at Vanderbilt University, Nashville, Tenn.

Using data from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program, the researchers calculated survival rates for just over a million patients diagnosed with cancer of the colon or rectum, breast, prostate, lung, liver, pancreas or ovary over the time span from 1990 to 2009. Survival rates were obtained for each cancer site; results were grouped in 5-year cohorts by diagnosis date, and further broken down by race, sex, and age group (20-49, 50-64, 65-74, and 75-85 years at time of diagnosis).

©xrender/Thinkstock

Hazard ratios for cancer-specific death were obtained by comparing all later 5-year cohorts to the 1990-1994 group. Adjusted HRs for patients aged 50-64 years diagnosed with cancer in 2005-2009 compared with those diagnosed in 1990-1994 were 0.57 for colon or rectal cancer, 0.48 for breast cancer, 0.61 for liver cancer, and 0.32 for prostate cancer. By contrast, the oldest patients (aged 75-85 years) had HRs of 0.88, 0.88, 0.76, and 0.65, respectively, for these cancer sites. Age-related findings were less pronounced for lung and pancreatic cancers, Ms. Zeng and associates said (JAMA Oncology 2015 Feb. 19 [doi:10.1001/jamaoncol.2014.161]).

African Americans had a greater increase in prostate cancer survival than did whites or Asians; ovarian cancer survival, however, was reduced for African Americans but improved among whites over the study period. Overall survival rates were poorer for all cancer sites for African Americans when compared to whites, with racial disparities in screening and care a potential factor.

Some of the age-related survival differences may be attributed to younger patients’ being able to take greater advantage of newer therapies, since the largest age-related survival gap occurred for cancer sites with greater treatment advances (breast, colorectal, and prostate cancers), Ms. Zeng and associates said.

Study limitations included inability to exclude potential confounders such as socioeconomic status, lifestyle choices, and comorbidities, as well as oversampling of urban and foreign-born individuals in the study population, the researchers noted.

Adding pertuzumab to trastuzumab and docetaxel for treatment of HER2-positive metastatic breast cancer was more effective than adding a placebo to trastuzumab plus chemotherapy, according to Dr. Sandra M. Swain and her associates.

The median overall survival rate for the pertuzumab combination group was 56.5 months, while median survival time in the placebo group was 40.8 months. Median progression-free survival increased by 6.3 months, and the median duration of response was increased by 7.7 months. No significant difference in adverse events was found between the two groups.

While the results were promising, most of the deaths in the study were from breast cancer, indicating that better treatments are still needed. It is also “not clear whether hormonal therapy plus pertuzumab and trastuzumab is more effective than hormonal therapy plus trastuzumab alone in patients,” the investigators said.

Find the full study in the New England Journal of Medicine 2015;372:724-34 (doi:10.1056/NEJMoa1413513).

Adding pertuzumab to trastuzumab and docetaxel for treatment of HER2-positive metastatic breast cancer was more effective than adding a placebo to trastuzumab plus chemotherapy, according to Dr. Sandra M. Swain and her associates.

The median overall survival rate for the pertuzumab combination group was 56.5 months, while median survival time in the placebo group was 40.8 months. Median progression-free survival increased by 6.3 months, and the median duration of response was increased by 7.7 months. No significant difference in adverse events was found between the two groups.

While the results were promising, most of the deaths in the study were from breast cancer, indicating that better treatments are still needed. It is also “not clear whether hormonal therapy plus pertuzumab and trastuzumab is more effective than hormonal therapy plus trastuzumab alone in patients,” the investigators said.

Find the full study in the New England Journal of Medicine 2015;372:724-34 (doi:10.1056/NEJMoa1413513).

Adding pertuzumab to trastuzumab and docetaxel for treatment of HER2-positive metastatic breast cancer was more effective than adding a placebo to trastuzumab plus chemotherapy, according to Dr. Sandra M. Swain and her associates.

The median overall survival rate for the pertuzumab combination group was 56.5 months, while median survival time in the placebo group was 40.8 months. Median progression-free survival increased by 6.3 months, and the median duration of response was increased by 7.7 months. No significant difference in adverse events was found between the two groups.

While the results were promising, most of the deaths in the study were from breast cancer, indicating that better treatments are still needed. It is also “not clear whether hormonal therapy plus pertuzumab and trastuzumab is more effective than hormonal therapy plus trastuzumab alone in patients,” the investigators said.

Find the full study in the New England Journal of Medicine 2015;372:724-34 (doi:10.1056/NEJMoa1413513).

Background Clinical trials are valuable in advancing cancer care through the investigation of ways in which to better prevent, detect and diagnose, and/or treat cancer. Recruitment of adults into clinical trials has historically been low.

Objective To survey adult cancer patients who reside in New York state to better understand their participation in and attitudes about clinical trials.

Methods From January 2012-April 2013, we conducted a one-time survey about clinical trials in 8 cancer-treatment or cancer-patient support organizations in the state. Surveys were offered in person and online to adults with a past or current cancer diagnosis. Analysis was limited to adults who resided in the state and provided a self-reported status of previous participation in clinical trials.

Results Of the 1,832 participants who completed the survey, 1,475 were included in the analysis. Our sample represented all regions of the state. Most of the respondents (68.1%) had never participated in a clinical trial. Almost 32% said they had never received information about research studies. Most (84%) felt that patients should be asked to participate in clinical trials, but fewer (70%) were willing to be approached about participation.

Limitations The sample is predominantly white and female and overrepresents breast and hematologic cancers.

Conclusions Increased outreach coupled with a team approach to educate and enroll patients in clinical trials may be the necessary first steps to increase participation in trials and ensure a diverse sample of participants.

Click on the PDF icon at the top of this introduction to read the full article.

Background Clinical trials are valuable in advancing cancer care through the investigation of ways in which to better prevent, detect and diagnose, and/or treat cancer. Recruitment of adults into clinical trials has historically been low.

Objective To survey adult cancer patients who reside in New York state to better understand their participation in and attitudes about clinical trials.

Methods From January 2012-April 2013, we conducted a one-time survey about clinical trials in 8 cancer-treatment or cancer-patient support organizations in the state. Surveys were offered in person and online to adults with a past or current cancer diagnosis. Analysis was limited to adults who resided in the state and provided a self-reported status of previous participation in clinical trials.

Results Of the 1,832 participants who completed the survey, 1,475 were included in the analysis. Our sample represented all regions of the state. Most of the respondents (68.1%) had never participated in a clinical trial. Almost 32% said they had never received information about research studies. Most (84%) felt that patients should be asked to participate in clinical trials, but fewer (70%) were willing to be approached about participation.

Limitations The sample is predominantly white and female and overrepresents breast and hematologic cancers.

Conclusions Increased outreach coupled with a team approach to educate and enroll patients in clinical trials may be the necessary first steps to increase participation in trials and ensure a diverse sample of participants.

Click on the PDF icon at the top of this introduction to read the full article.

Background Clinical trials are valuable in advancing cancer care through the investigation of ways in which to better prevent, detect and diagnose, and/or treat cancer. Recruitment of adults into clinical trials has historically been low.

Objective To survey adult cancer patients who reside in New York state to better understand their participation in and attitudes about clinical trials.

Methods From January 2012-April 2013, we conducted a one-time survey about clinical trials in 8 cancer-treatment or cancer-patient support organizations in the state. Surveys were offered in person and online to adults with a past or current cancer diagnosis. Analysis was limited to adults who resided in the state and provided a self-reported status of previous participation in clinical trials.

Results Of the 1,832 participants who completed the survey, 1,475 were included in the analysis. Our sample represented all regions of the state. Most of the respondents (68.1%) had never participated in a clinical trial. Almost 32% said they had never received information about research studies. Most (84%) felt that patients should be asked to participate in clinical trials, but fewer (70%) were willing to be approached about participation.

Limitations The sample is predominantly white and female and overrepresents breast and hematologic cancers.

Conclusions Increased outreach coupled with a team approach to educate and enroll patients in clinical trials may be the necessary first steps to increase participation in trials and ensure a diverse sample of participants.

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Background Breast and colon cancer screening in rural community clinics is underused.

Objective To evaluate the effectiveness and cost-effectiveness of alternative interventions designed to promote simultaneous screening for breast and colon cancer in community clinics.

Methods A 3-arm, quasi-experimental evaluation was conducted during May 2008-August 2011 in 8 federally qualified health clinics in predominately rural Louisiana. Baseline screening rates reported by the clinics was <10% for breast cancer (using mammography) and 1%- 2% for colon cancer (using the fecal occult blood test [FOBT]). 744 women aged 50 years or older who were eligible for routine mammography and an FOBT were recruited. The combined screening efforts included: enhanced care; health literacy-informed education (education alone), or health literacy-informed education with nurse support (nurse support).

Results Postintervention screening rates for completing both tests were 28.1% with enhanced care, 23.7% with education alone, and 38.7% with nurse support. After adjusting for age, race, and literacy, patients who received nurse support were 2.21 times more likely to complete both screenings than were those who received the education alone (95% confidence interval [CI], 1.12-4.38; P = .023). The incremental cost per additional woman completing both screenings was $3,987 for education with nurse support over education alone, and $5,987 over enhanced care.

Limitations There were differences between the 3 arms in sociodemographic characteristics, literacy, and previous screening history. Not all variables that were significantly different between arms were adjusted for, therefore adjustments for key variables (age, race, literacy) were made in statistical analyses. Other limitations related generalizability of results.

Conclusions Although joint breast and colon cancer screening rates were increased substantially over existing baseline rates in all 3 arms, the completion rate for both tests was modest. Nurse support and telephone follow-up were most effective. However, it is not likely to be cost effective or affordable in clinics with limited resources.

Funding National Cancer Institute (R01-CA115869-05), supported in part by 1 U54 GM104940 from the National Institute of General Medical Sciences of the National Institutes of Health. 

Background Breast and colon cancer screening in rural community clinics is underused.

Objective To evaluate the effectiveness and cost-effectiveness of alternative interventions designed to promote simultaneous screening for breast and colon cancer in community clinics.

Methods A 3-arm, quasi-experimental evaluation was conducted during May 2008-August 2011 in 8 federally qualified health clinics in predominately rural Louisiana. Baseline screening rates reported by the clinics was <10% for breast cancer (using mammography) and 1%- 2% for colon cancer (using the fecal occult blood test [FOBT]). 744 women aged 50 years or older who were eligible for routine mammography and an FOBT were recruited. The combined screening efforts included: enhanced care; health literacy-informed education (education alone), or health literacy-informed education with nurse support (nurse support).

Results Postintervention screening rates for completing both tests were 28.1% with enhanced care, 23.7% with education alone, and 38.7% with nurse support. After adjusting for age, race, and literacy, patients who received nurse support were 2.21 times more likely to complete both screenings than were those who received the education alone (95% confidence interval [CI], 1.12-4.38; P = .023). The incremental cost per additional woman completing both screenings was $3,987 for education with nurse support over education alone, and $5,987 over enhanced care.

Limitations There were differences between the 3 arms in sociodemographic characteristics, literacy, and previous screening history. Not all variables that were significantly different between arms were adjusted for, therefore adjustments for key variables (age, race, literacy) were made in statistical analyses. Other limitations related generalizability of results.

Conclusions Although joint breast and colon cancer screening rates were increased substantially over existing baseline rates in all 3 arms, the completion rate for both tests was modest. Nurse support and telephone follow-up were most effective. However, it is not likely to be cost effective or affordable in clinics with limited resources.

Funding National Cancer Institute (R01-CA115869-05), supported in part by 1 U54 GM104940 from the National Institute of General Medical Sciences of the National Institutes of Health. 

Background Breast and colon cancer screening in rural community clinics is underused.

Objective To evaluate the effectiveness and cost-effectiveness of alternative interventions designed to promote simultaneous screening for breast and colon cancer in community clinics.

Methods A 3-arm, quasi-experimental evaluation was conducted during May 2008-August 2011 in 8 federally qualified health clinics in predominately rural Louisiana. Baseline screening rates reported by the clinics was <10% for breast cancer (using mammography) and 1%- 2% for colon cancer (using the fecal occult blood test [FOBT]). 744 women aged 50 years or older who were eligible for routine mammography and an FOBT were recruited. The combined screening efforts included: enhanced care; health literacy-informed education (education alone), or health literacy-informed education with nurse support (nurse support).

Results Postintervention screening rates for completing both tests were 28.1% with enhanced care, 23.7% with education alone, and 38.7% with nurse support. After adjusting for age, race, and literacy, patients who received nurse support were 2.21 times more likely to complete both screenings than were those who received the education alone (95% confidence interval [CI], 1.12-4.38; P = .023). The incremental cost per additional woman completing both screenings was $3,987 for education with nurse support over education alone, and $5,987 over enhanced care.

Limitations There were differences between the 3 arms in sociodemographic characteristics, literacy, and previous screening history. Not all variables that were significantly different between arms were adjusted for, therefore adjustments for key variables (age, race, literacy) were made in statistical analyses. Other limitations related generalizability of results.

Conclusions Although joint breast and colon cancer screening rates were increased substantially over existing baseline rates in all 3 arms, the completion rate for both tests was modest. Nurse support and telephone follow-up were most effective. However, it is not likely to be cost effective or affordable in clinics with limited resources.

Funding National Cancer Institute (R01-CA115869-05), supported in part by 1 U54 GM104940 from the National Institute of General Medical Sciences of the National Institutes of Health.