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Evidence inadequate to support routine thyroid screening
Current evidence is insufficient to assess the balance of benefits and harms of routinely screening nonpregnant, asymptomatic adults for thyroid dysfunction, according to a U.S. Preventive Services Task Force recommendation statement published online March 24 in the Annals of Internal Medicine.
In particular, there is not enough evidence to either support or refute the idea that such screening leads to clinically important benefits, such as reducing the incidence of cardiovascular disease and its related morbidity and mortality. Nor is there evidence that screening leads to early detection and treatment, which, in turn, improves quality of life or is beneficial for blood pressure, body mass index, bone mineral density, lipid levels, or cognitive function, said Dr. Michael L. LeFevre, chair of the task force and professor of family medicine at the University of Missouri–Columbia, and his associates.
On the other hand, the evidence concerning the harms of screening asymptomatic adults is also inadequate. It seems likely, but has not yet been proved, that screening large numbers of asymptomatic patients would result in frequent false-positive results and a “large degree” of overdiagnosis and overtreatment, given that only 3%-5% of adults have subclinical hypothyroidism and only 0.7% have subclinical hyperthyroidism. And the negative psychological effects of being labeled as chronically ill haven’t been well studied, either, the task force noted.
Regardless of this lack of evidence, it appears that many primary care providers already screen for thyroid dysfunction. Exact estimates are not available, but one brand of thyroid hormone is the most commonly prescribed drug in the country, and the number of filled prescriptions for levothyroxine rose 42% in a recent 5-year period. Given the high number of prescriptions and the low prevalence of overt thyroid dysfunction, “it is reasonable to conclude that many asymptomatic persons receive treatment. Clinicians seem to be treating more persons for thyroid dysfunction, at earlier times after initial diagnosis, and at TSH [thyroid-stimulating hormone] levels closer to normal,” Dr. LeFevre and his associates wrote (Ann. Intern. Med. 2015 March 24 [doi:10.7326/M15-0483]).
The USPSTF recommendation statement, an update of the one issued in 2004, uses a more limited definition of thyroid disease, restricting the term to denote only symptomatic “overt” hypothyroidism and hyperthyroidism (defined as persistently abnormal serum TSH and T4 levels with clearly associated clinical signs and symptoms that cannot be explained by another condition). The task force made this change to emphasize that screening can detect biochemical abnormalities as well as clinically important disease. However, “despite this change the USPSTF’s ultimate assessment is the same as in the previous recommendation,” the investigators added.
The USPSTF is an independent voluntary group of experts funded through congressional mandate by the Agency for Healthcare Research and Quality to make recommendations about the effectiveness of specific preventive care services for asymptomatic patients. Dr. LeFevre’s and his associates’ financial disclosures are available at www.uspreventiveservicestaskforce.org.
To obtain a copy of the recommendation statement, contact www.uspreventiveservicestaskforce.org.
Current evidence is insufficient to assess the balance of benefits and harms of routinely screening nonpregnant, asymptomatic adults for thyroid dysfunction, according to a U.S. Preventive Services Task Force recommendation statement published online March 24 in the Annals of Internal Medicine.
In particular, there is not enough evidence to either support or refute the idea that such screening leads to clinically important benefits, such as reducing the incidence of cardiovascular disease and its related morbidity and mortality. Nor is there evidence that screening leads to early detection and treatment, which, in turn, improves quality of life or is beneficial for blood pressure, body mass index, bone mineral density, lipid levels, or cognitive function, said Dr. Michael L. LeFevre, chair of the task force and professor of family medicine at the University of Missouri–Columbia, and his associates.
On the other hand, the evidence concerning the harms of screening asymptomatic adults is also inadequate. It seems likely, but has not yet been proved, that screening large numbers of asymptomatic patients would result in frequent false-positive results and a “large degree” of overdiagnosis and overtreatment, given that only 3%-5% of adults have subclinical hypothyroidism and only 0.7% have subclinical hyperthyroidism. And the negative psychological effects of being labeled as chronically ill haven’t been well studied, either, the task force noted.
Regardless of this lack of evidence, it appears that many primary care providers already screen for thyroid dysfunction. Exact estimates are not available, but one brand of thyroid hormone is the most commonly prescribed drug in the country, and the number of filled prescriptions for levothyroxine rose 42% in a recent 5-year period. Given the high number of prescriptions and the low prevalence of overt thyroid dysfunction, “it is reasonable to conclude that many asymptomatic persons receive treatment. Clinicians seem to be treating more persons for thyroid dysfunction, at earlier times after initial diagnosis, and at TSH [thyroid-stimulating hormone] levels closer to normal,” Dr. LeFevre and his associates wrote (Ann. Intern. Med. 2015 March 24 [doi:10.7326/M15-0483]).
The USPSTF recommendation statement, an update of the one issued in 2004, uses a more limited definition of thyroid disease, restricting the term to denote only symptomatic “overt” hypothyroidism and hyperthyroidism (defined as persistently abnormal serum TSH and T4 levels with clearly associated clinical signs and symptoms that cannot be explained by another condition). The task force made this change to emphasize that screening can detect biochemical abnormalities as well as clinically important disease. However, “despite this change the USPSTF’s ultimate assessment is the same as in the previous recommendation,” the investigators added.
The USPSTF is an independent voluntary group of experts funded through congressional mandate by the Agency for Healthcare Research and Quality to make recommendations about the effectiveness of specific preventive care services for asymptomatic patients. Dr. LeFevre’s and his associates’ financial disclosures are available at www.uspreventiveservicestaskforce.org.
To obtain a copy of the recommendation statement, contact www.uspreventiveservicestaskforce.org.
Current evidence is insufficient to assess the balance of benefits and harms of routinely screening nonpregnant, asymptomatic adults for thyroid dysfunction, according to a U.S. Preventive Services Task Force recommendation statement published online March 24 in the Annals of Internal Medicine.
In particular, there is not enough evidence to either support or refute the idea that such screening leads to clinically important benefits, such as reducing the incidence of cardiovascular disease and its related morbidity and mortality. Nor is there evidence that screening leads to early detection and treatment, which, in turn, improves quality of life or is beneficial for blood pressure, body mass index, bone mineral density, lipid levels, or cognitive function, said Dr. Michael L. LeFevre, chair of the task force and professor of family medicine at the University of Missouri–Columbia, and his associates.
On the other hand, the evidence concerning the harms of screening asymptomatic adults is also inadequate. It seems likely, but has not yet been proved, that screening large numbers of asymptomatic patients would result in frequent false-positive results and a “large degree” of overdiagnosis and overtreatment, given that only 3%-5% of adults have subclinical hypothyroidism and only 0.7% have subclinical hyperthyroidism. And the negative psychological effects of being labeled as chronically ill haven’t been well studied, either, the task force noted.
Regardless of this lack of evidence, it appears that many primary care providers already screen for thyroid dysfunction. Exact estimates are not available, but one brand of thyroid hormone is the most commonly prescribed drug in the country, and the number of filled prescriptions for levothyroxine rose 42% in a recent 5-year period. Given the high number of prescriptions and the low prevalence of overt thyroid dysfunction, “it is reasonable to conclude that many asymptomatic persons receive treatment. Clinicians seem to be treating more persons for thyroid dysfunction, at earlier times after initial diagnosis, and at TSH [thyroid-stimulating hormone] levels closer to normal,” Dr. LeFevre and his associates wrote (Ann. Intern. Med. 2015 March 24 [doi:10.7326/M15-0483]).
The USPSTF recommendation statement, an update of the one issued in 2004, uses a more limited definition of thyroid disease, restricting the term to denote only symptomatic “overt” hypothyroidism and hyperthyroidism (defined as persistently abnormal serum TSH and T4 levels with clearly associated clinical signs and symptoms that cannot be explained by another condition). The task force made this change to emphasize that screening can detect biochemical abnormalities as well as clinically important disease. However, “despite this change the USPSTF’s ultimate assessment is the same as in the previous recommendation,” the investigators added.
The USPSTF is an independent voluntary group of experts funded through congressional mandate by the Agency for Healthcare Research and Quality to make recommendations about the effectiveness of specific preventive care services for asymptomatic patients. Dr. LeFevre’s and his associates’ financial disclosures are available at www.uspreventiveservicestaskforce.org.
To obtain a copy of the recommendation statement, contact www.uspreventiveservicestaskforce.org.
Key clinical point: Current evidence is insufficient to assess the balance of benefits and harms of screening nonpregnant, asymptomatic adults for thyroid dysfunction.
Major finding: Only 3%-5% of adults in the United States have subclinical hypothyroidism, and only 0.7% have subclinical hyperthyroidism.
Data source: A comprehensive review of the current evidence and a compilation of recommendations regarding the benefits and harms of screening asymptomatic adults for thyroid dysfunction.
Disclosures: The USPSTF is an independent voluntary group of experts funded through congressional mandate by the Agency for Healthcare Research and Quality to make recommendations about the effectiveness of specific preventive care services for asymptomatic patients. Dr. LeFevre’s and his associates’ financial disclosures are available at www.uspreventiveservicestaskforce.org.
VIDEO: Ask vitiligo patients about autoimmune symptoms
SAN FRANCISCO – Thyroid disease is known to be more common in patients with vitiligo, but that’s just the tip of the iceberg.
In a review of 1,098 patients, researchers at Henry Ford Hospital in Detroit found that vitiligo also travels with a host of other autoimmune diseases, including alopecia areata, Guillain-Barre syndrome, linear morphea, myasthenia gravis, discoid lupus, and Sjogren’s syndrome.
Nearly 20% of the subjects had at least one comorbid autoimmune disease. The study also confirmed previously found associations with thyroid disease, inflammatory bowel disease, pernicious anemia, and systemic lupus erythematosus.
The findings have changed the practice of investigator and dermatologist Dr. Iltefat Hamzavi, a senior staff physician at the hospital. He explained how in an interview at the annual meeting of the American Academy of Dermatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Thyroid disease is known to be more common in patients with vitiligo, but that’s just the tip of the iceberg.
In a review of 1,098 patients, researchers at Henry Ford Hospital in Detroit found that vitiligo also travels with a host of other autoimmune diseases, including alopecia areata, Guillain-Barre syndrome, linear morphea, myasthenia gravis, discoid lupus, and Sjogren’s syndrome.
Nearly 20% of the subjects had at least one comorbid autoimmune disease. The study also confirmed previously found associations with thyroid disease, inflammatory bowel disease, pernicious anemia, and systemic lupus erythematosus.
The findings have changed the practice of investigator and dermatologist Dr. Iltefat Hamzavi, a senior staff physician at the hospital. He explained how in an interview at the annual meeting of the American Academy of Dermatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Thyroid disease is known to be more common in patients with vitiligo, but that’s just the tip of the iceberg.
In a review of 1,098 patients, researchers at Henry Ford Hospital in Detroit found that vitiligo also travels with a host of other autoimmune diseases, including alopecia areata, Guillain-Barre syndrome, linear morphea, myasthenia gravis, discoid lupus, and Sjogren’s syndrome.
Nearly 20% of the subjects had at least one comorbid autoimmune disease. The study also confirmed previously found associations with thyroid disease, inflammatory bowel disease, pernicious anemia, and systemic lupus erythematosus.
The findings have changed the practice of investigator and dermatologist Dr. Iltefat Hamzavi, a senior staff physician at the hospital. He explained how in an interview at the annual meeting of the American Academy of Dermatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE AAD ANNUAL MEETING
VIDEO: Following breast cancer diagnosis, risk of thyroid cancer rises
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.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @dougbrunk
AT ENDO 2015
VIDEO: Meet Frankie and Sophie, the thyroid cancer–sniffing dogs
SAN DIEGO – Researchers at the University of Arkansas for Medical Sciences in Little Rock are teaching dogs to detect thyroid cancer from urine samples.
The dogs become alert on samples if they detect cancer, but remain passive if they don’t. The first graduate of the program, a German shepherd mix named Frankie, got it right in 30 of 34 cases, matching final surgical pathology results with a sensitivity of 86.6% and a specificity of 89.5%.
With results like those, it might not be too long before Frankie and his colleagues are providing inexpensive adjunct diagnostic services when test results are uncertain, and helping underserved areas with limited diagnostic capacity, the researchers noted.
At the Endocrine Society meeting, investigator Dr. Andrew Hinson shared clips of Frankie and another recent graduate, a border collie mix named Sophie, and explained the project’s next steps.
Frankie was rescued by principal investigator Dr. Arny Ferrando. Sophie and other dogs in the program were also rescued from local animal shelters.
More information is available at www.thefrankiefoundation.org.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN DIEGO – Researchers at the University of Arkansas for Medical Sciences in Little Rock are teaching dogs to detect thyroid cancer from urine samples.
The dogs become alert on samples if they detect cancer, but remain passive if they don’t. The first graduate of the program, a German shepherd mix named Frankie, got it right in 30 of 34 cases, matching final surgical pathology results with a sensitivity of 86.6% and a specificity of 89.5%.
With results like those, it might not be too long before Frankie and his colleagues are providing inexpensive adjunct diagnostic services when test results are uncertain, and helping underserved areas with limited diagnostic capacity, the researchers noted.
At the Endocrine Society meeting, investigator Dr. Andrew Hinson shared clips of Frankie and another recent graduate, a border collie mix named Sophie, and explained the project’s next steps.
Frankie was rescued by principal investigator Dr. Arny Ferrando. Sophie and other dogs in the program were also rescued from local animal shelters.
More information is available at www.thefrankiefoundation.org.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN DIEGO – Researchers at the University of Arkansas for Medical Sciences in Little Rock are teaching dogs to detect thyroid cancer from urine samples.
The dogs become alert on samples if they detect cancer, but remain passive if they don’t. The first graduate of the program, a German shepherd mix named Frankie, got it right in 30 of 34 cases, matching final surgical pathology results with a sensitivity of 86.6% and a specificity of 89.5%.
With results like those, it might not be too long before Frankie and his colleagues are providing inexpensive adjunct diagnostic services when test results are uncertain, and helping underserved areas with limited diagnostic capacity, the researchers noted.
At the Endocrine Society meeting, investigator Dr. Andrew Hinson shared clips of Frankie and another recent graduate, a border collie mix named Sophie, and explained the project’s next steps.
Frankie was rescued by principal investigator Dr. Arny Ferrando. Sophie and other dogs in the program were also rescued from local animal shelters.
More information is available at www.thefrankiefoundation.org.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ENDO 2015
SEER: Breast cancer survivors at increased risk of thyroid cancer
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.
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.
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.
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.
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.
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.
On Twitter @dougbrunk
AT ENDO 2015
Key clinical point: The age-specific risk of thyroid cancer is higher among breast cancer survivors, compared with that of the general population.
Major finding: The 10-year risk of thyroid cancer in breast cancer survivors was highest among those aged 40 and 50 years, compared with the general population (16% and 12%, vs. 0.33% and 0.35%, respectively), and lowest among those 60 and 70 years old (0.33% and 0.27% vs. 0.05% and 0.02%).
Data source: A retrospective analysis of the National Cancer Institute’s Surveillance, Epidemiology, and End Results 9 (SEER 9) to identify individuals diagnosed with breast cancer and/or thyroid cancer between 1973 and 2011.
Disclosures: Dr. Kuo reported having no relevant financial conflicts.
Hypothyroidism less common with preemptive levothyroxine after Graves’ treatment
San Diego – Preemptive levothyroxine seems to help prevent hypothyroidism after radioactive iodine treatment for Graves’ disease, according to an interim analysis of an ongoing randomized, placebo-controlled trial at the Mayo Clinic in Rochester, Minn.
Following iodine treatment, the team is randomizing adult patients to levothyroxine 25 mcg/day or placebo at 4 weeks, then increasing the levothyroxine dose to 50 mcg/day at 6 weeks. The enrollment goal is 60 patients; the team presented results for the first 17 at the Endocrine Society annual meeting.
At 8 weeks, six of 11 (54.5%) levothyroxine patients – but four of the six (66.7%) placebo patients – had overt hypothyroidism.
Hyperthyroidism is the main concern with preemptive levothyroxine, but that hasn’t been a problem so far; in fact, the levothyroxine group has had lower rates of hyperthyroidism (18.2%) than the placebo group (33.3%). Quality of life indicators haven’t separated much; at 8 weeks, thyroid Specific Questionnaire scores were about 12 in both groups, and levothyroxine patients did slightly worse on the hypothyroid–Health Related Quality of Life survey (46 vs. 36).
Given the low numbers, you can’t put too much stock in the findings yet, but the prevention trends are moving in the right direction, said lead investigator Dr. Spyridoula Maraka, a Mayo endocrinology fellow.
“As expected, none of the analyses reached statistical significance given that the sample size is 25% of the planned population,” but “it is reassuring that initiating low-dose levothyroxine 4 weeks after [Graves’ treatment] appears safe, without an increased prevalence of hyperthyroidism. There is an encouraging trend for prevention of overt hypothyroidism .... Accordingly, we plan to continue the trial to completion,” she said.
The work is important because, in many places, the first follow-up visit after Graves’ treatment is at 2 or even 3 months. By then, the majority of patients are hypothyroid, and may even have new or worsened Graves’ orbitopathy. The hope is that pre-emptive levothyroxine will counter the problem.
The fact that more than half of the levothyroxine subjects developed hypothryroidism suggests that “maybe we need a higher dose,” Dr. Maraka said.
If nothing else, the findings argue for earlier follow-up after radioactive iodine treatment, when there’s still a chance of catching nascent hypothyroidism before symptoms set in. “Try to see your patients earlier than week 8.” Six weeks might be a good goal, Dr. Maraka said.
There were no significant baseline differences between the placebo and levothyroxine arms of the study. In both, patients were in their mid-50s, on average, with thyroids of about 30 grams; about two-thirds of patients in both arms were women.
There’s been one adverse event so far; a levothyroxine patient with a history of atrial fibrillation had heart palpitations after quitting her beta-blocker, and dropped out of the study.
Pre-emptive levothyroxine has been studied before, but only retrospectively.
Dr. Maraka has no disclosures, and there was no outside funding for the work.
San Diego – Preemptive levothyroxine seems to help prevent hypothyroidism after radioactive iodine treatment for Graves’ disease, according to an interim analysis of an ongoing randomized, placebo-controlled trial at the Mayo Clinic in Rochester, Minn.
Following iodine treatment, the team is randomizing adult patients to levothyroxine 25 mcg/day or placebo at 4 weeks, then increasing the levothyroxine dose to 50 mcg/day at 6 weeks. The enrollment goal is 60 patients; the team presented results for the first 17 at the Endocrine Society annual meeting.
At 8 weeks, six of 11 (54.5%) levothyroxine patients – but four of the six (66.7%) placebo patients – had overt hypothyroidism.
Hyperthyroidism is the main concern with preemptive levothyroxine, but that hasn’t been a problem so far; in fact, the levothyroxine group has had lower rates of hyperthyroidism (18.2%) than the placebo group (33.3%). Quality of life indicators haven’t separated much; at 8 weeks, thyroid Specific Questionnaire scores were about 12 in both groups, and levothyroxine patients did slightly worse on the hypothyroid–Health Related Quality of Life survey (46 vs. 36).
Given the low numbers, you can’t put too much stock in the findings yet, but the prevention trends are moving in the right direction, said lead investigator Dr. Spyridoula Maraka, a Mayo endocrinology fellow.
“As expected, none of the analyses reached statistical significance given that the sample size is 25% of the planned population,” but “it is reassuring that initiating low-dose levothyroxine 4 weeks after [Graves’ treatment] appears safe, without an increased prevalence of hyperthyroidism. There is an encouraging trend for prevention of overt hypothyroidism .... Accordingly, we plan to continue the trial to completion,” she said.
The work is important because, in many places, the first follow-up visit after Graves’ treatment is at 2 or even 3 months. By then, the majority of patients are hypothyroid, and may even have new or worsened Graves’ orbitopathy. The hope is that pre-emptive levothyroxine will counter the problem.
The fact that more than half of the levothyroxine subjects developed hypothryroidism suggests that “maybe we need a higher dose,” Dr. Maraka said.
If nothing else, the findings argue for earlier follow-up after radioactive iodine treatment, when there’s still a chance of catching nascent hypothyroidism before symptoms set in. “Try to see your patients earlier than week 8.” Six weeks might be a good goal, Dr. Maraka said.
There were no significant baseline differences between the placebo and levothyroxine arms of the study. In both, patients were in their mid-50s, on average, with thyroids of about 30 grams; about two-thirds of patients in both arms were women.
There’s been one adverse event so far; a levothyroxine patient with a history of atrial fibrillation had heart palpitations after quitting her beta-blocker, and dropped out of the study.
Pre-emptive levothyroxine has been studied before, but only retrospectively.
Dr. Maraka has no disclosures, and there was no outside funding for the work.
San Diego – Preemptive levothyroxine seems to help prevent hypothyroidism after radioactive iodine treatment for Graves’ disease, according to an interim analysis of an ongoing randomized, placebo-controlled trial at the Mayo Clinic in Rochester, Minn.
Following iodine treatment, the team is randomizing adult patients to levothyroxine 25 mcg/day or placebo at 4 weeks, then increasing the levothyroxine dose to 50 mcg/day at 6 weeks. The enrollment goal is 60 patients; the team presented results for the first 17 at the Endocrine Society annual meeting.
At 8 weeks, six of 11 (54.5%) levothyroxine patients – but four of the six (66.7%) placebo patients – had overt hypothyroidism.
Hyperthyroidism is the main concern with preemptive levothyroxine, but that hasn’t been a problem so far; in fact, the levothyroxine group has had lower rates of hyperthyroidism (18.2%) than the placebo group (33.3%). Quality of life indicators haven’t separated much; at 8 weeks, thyroid Specific Questionnaire scores were about 12 in both groups, and levothyroxine patients did slightly worse on the hypothyroid–Health Related Quality of Life survey (46 vs. 36).
Given the low numbers, you can’t put too much stock in the findings yet, but the prevention trends are moving in the right direction, said lead investigator Dr. Spyridoula Maraka, a Mayo endocrinology fellow.
“As expected, none of the analyses reached statistical significance given that the sample size is 25% of the planned population,” but “it is reassuring that initiating low-dose levothyroxine 4 weeks after [Graves’ treatment] appears safe, without an increased prevalence of hyperthyroidism. There is an encouraging trend for prevention of overt hypothyroidism .... Accordingly, we plan to continue the trial to completion,” she said.
The work is important because, in many places, the first follow-up visit after Graves’ treatment is at 2 or even 3 months. By then, the majority of patients are hypothyroid, and may even have new or worsened Graves’ orbitopathy. The hope is that pre-emptive levothyroxine will counter the problem.
The fact that more than half of the levothyroxine subjects developed hypothryroidism suggests that “maybe we need a higher dose,” Dr. Maraka said.
If nothing else, the findings argue for earlier follow-up after radioactive iodine treatment, when there’s still a chance of catching nascent hypothyroidism before symptoms set in. “Try to see your patients earlier than week 8.” Six weeks might be a good goal, Dr. Maraka said.
There were no significant baseline differences between the placebo and levothyroxine arms of the study. In both, patients were in their mid-50s, on average, with thyroids of about 30 grams; about two-thirds of patients in both arms were women.
There’s been one adverse event so far; a levothyroxine patient with a history of atrial fibrillation had heart palpitations after quitting her beta-blocker, and dropped out of the study.
Pre-emptive levothyroxine has been studied before, but only retrospectively.
Dr. Maraka has no disclosures, and there was no outside funding for the work.
AT ENDO 2015
Key clinical point: Don’t wait 8 weeks to see Graves’ patients after radioactive iodine treatment.
Major finding: Eight weeks following radioactive iodine treatment for Graves’ disease, 54.5% of patients started preemptively on levothyroxine at 4 weeks had overt hypothyroidism, versus 66.7% of placebo patients.
Data source: First 17 patients of a randomized, controlled clinical trial at the Mayo Clinic in Rochester, Minn.
Disclosures: There was no outside funding for the work, and the lead investigator has no disclosures.
Most thyroid nodules have favorable prognosis
During 5 years of follow-up, cancer arose in only 0.3% of thyroid nodules that were cytologically and sonographically benign at baseline, according to a large prospective study published online March 3 in JAMA.
Furthermore, only two of the five nodules that became cancerous had grown beforehand, reported Dr. Cosimo Durante of the Sapienza University of Rome and his associates. “These data suggest that the American Thyroid Association’s recommendation for indication for repeat cytology should be revised. Clinical and sonographic findings should probably play larger roles in the decision-making process,” the researchers said (JAMA 2015;313:926-35).
Advances in diagnostic imaging have increased the detection of thyroid nodules, the great majority of which are found to be benign. For such nodules, the ATA recommends repeating thyroid ultrasonography at 6-18 months and then every 3-5 years thereafter, as long as nodules do not significantly grow (defined as at least a 20% increase in two nodule diameters, with a minimum increase of at least 2 mm [Thyroid 2009;19:1167-214]). But little is known about rate, extent, or predictors of nodule growth, the researchers noted. Therefore, they performed annual thyroid ultrasound examinations on 992 patients who had one to four asymptomatic subcentimeter thyroid modules that were cytologically or sonographically benign at baseline.
After 5 years of follow-up, just 15.4% of patients had experienced significant nodule growth according to the ATA definition, the researchers reported. Average growth was 4.9 mm, and 9.3% of patients developed new nodules, of which one was found to be cancerous. Growth was least likely when a patient’s largest nodule measured 7.5 mm or less and was significantly more likely when patients had multiple nodules instead of one; had baseline nodule volume greater than 0.2 mL; were up to 45 years old, compared with at least 60 years of age; and were male, the investigators said.
Among older patients, having a body mass index of 28.6 kg/m2 more than doubled the odds of nodule growth, in keeping with recent reports linking obesity and insulin resistance with nodular thyroid disease, they added.
The findings suggest that repeat thyroid ultrasonography could be safely extended to 12 months for initial follow-up and to every 5 years thereafter for most patients, as long as nodule size remained stable, Dr. Durante and his associates said. “This approach should be suitable for about 85% of patients, whose risk of disease progression is low. Closer surveillance may be appropriate for nodules occurring in younger patients or older overweight individuals with multiple nodules, large nodules (greater than 7.5 mm), or both,” they added.
The Umberto Di Mario Foundation, Banca d’Italia, and the Italian Thyroid Cancer Observatory Foundation funded the study. The authors reported having no conflicts of interest.
Thyroid nodules are pervasive, whereas thyroid cancer is not. The findings from Durante et al represent an important step in improving the efficiency and mitigating the expense of follow-up for the vast majority of thyroid nodules that are either cytologically or sonographically benign.
These prospective data provide reassurance about the validity of a benign cytology result obtained by ultrasound-guided fine-needle aspiration and confirm a very low false-negative rate, at 1.1%. The practice of routine sonographic surveillance with repeat fine-needle aspiration for growth, as recommended by published guidelines, is not the most efficient strategy to detect the very small number of missed cancers among previously sampled cytologically benign nodules. The one-size-fits-all approach simply does not work. Instead, surveillance strategies should be individualized based on a nodule’s sonographic appearance.
Many nodules detected on ultrasound are small (less than 1 cm) and not sonographically suspicious. In the study by Durante et al, only one cancer was diagnosed during follow-up among the 852 sonographically benign nodules that were smaller than 1 cm. Of note, the trigger for fine-needle aspiration for this nodule was development of hypoechogenicity and irregular margins, not growth.
Although 69% of nodules [in the study] remained stable in size, size increase was not a harbinger of malignancy, especially if the nodule had no sonographically suspicious features.
Anne R. Cappola, M.D., Sc.M., and Susan J. Mandel, M.D., M.P.H., are with the University of Pennsylvania, Philadelphia. Dr. Cappola is also an associate editor of JAMA. These comments are based on their accompanying editorial (JAMA 2015 March 3 [doi:10.1001/jama.2015.0836]).
Thyroid nodules are pervasive, whereas thyroid cancer is not. The findings from Durante et al represent an important step in improving the efficiency and mitigating the expense of follow-up for the vast majority of thyroid nodules that are either cytologically or sonographically benign.
These prospective data provide reassurance about the validity of a benign cytology result obtained by ultrasound-guided fine-needle aspiration and confirm a very low false-negative rate, at 1.1%. The practice of routine sonographic surveillance with repeat fine-needle aspiration for growth, as recommended by published guidelines, is not the most efficient strategy to detect the very small number of missed cancers among previously sampled cytologically benign nodules. The one-size-fits-all approach simply does not work. Instead, surveillance strategies should be individualized based on a nodule’s sonographic appearance.
Many nodules detected on ultrasound are small (less than 1 cm) and not sonographically suspicious. In the study by Durante et al, only one cancer was diagnosed during follow-up among the 852 sonographically benign nodules that were smaller than 1 cm. Of note, the trigger for fine-needle aspiration for this nodule was development of hypoechogenicity and irregular margins, not growth.
Although 69% of nodules [in the study] remained stable in size, size increase was not a harbinger of malignancy, especially if the nodule had no sonographically suspicious features.
Anne R. Cappola, M.D., Sc.M., and Susan J. Mandel, M.D., M.P.H., are with the University of Pennsylvania, Philadelphia. Dr. Cappola is also an associate editor of JAMA. These comments are based on their accompanying editorial (JAMA 2015 March 3 [doi:10.1001/jama.2015.0836]).
Thyroid nodules are pervasive, whereas thyroid cancer is not. The findings from Durante et al represent an important step in improving the efficiency and mitigating the expense of follow-up for the vast majority of thyroid nodules that are either cytologically or sonographically benign.
These prospective data provide reassurance about the validity of a benign cytology result obtained by ultrasound-guided fine-needle aspiration and confirm a very low false-negative rate, at 1.1%. The practice of routine sonographic surveillance with repeat fine-needle aspiration for growth, as recommended by published guidelines, is not the most efficient strategy to detect the very small number of missed cancers among previously sampled cytologically benign nodules. The one-size-fits-all approach simply does not work. Instead, surveillance strategies should be individualized based on a nodule’s sonographic appearance.
Many nodules detected on ultrasound are small (less than 1 cm) and not sonographically suspicious. In the study by Durante et al, only one cancer was diagnosed during follow-up among the 852 sonographically benign nodules that were smaller than 1 cm. Of note, the trigger for fine-needle aspiration for this nodule was development of hypoechogenicity and irregular margins, not growth.
Although 69% of nodules [in the study] remained stable in size, size increase was not a harbinger of malignancy, especially if the nodule had no sonographically suspicious features.
Anne R. Cappola, M.D., Sc.M., and Susan J. Mandel, M.D., M.P.H., are with the University of Pennsylvania, Philadelphia. Dr. Cappola is also an associate editor of JAMA. These comments are based on their accompanying editorial (JAMA 2015 March 3 [doi:10.1001/jama.2015.0836]).
During 5 years of follow-up, cancer arose in only 0.3% of thyroid nodules that were cytologically and sonographically benign at baseline, according to a large prospective study published online March 3 in JAMA.
Furthermore, only two of the five nodules that became cancerous had grown beforehand, reported Dr. Cosimo Durante of the Sapienza University of Rome and his associates. “These data suggest that the American Thyroid Association’s recommendation for indication for repeat cytology should be revised. Clinical and sonographic findings should probably play larger roles in the decision-making process,” the researchers said (JAMA 2015;313:926-35).
Advances in diagnostic imaging have increased the detection of thyroid nodules, the great majority of which are found to be benign. For such nodules, the ATA recommends repeating thyroid ultrasonography at 6-18 months and then every 3-5 years thereafter, as long as nodules do not significantly grow (defined as at least a 20% increase in two nodule diameters, with a minimum increase of at least 2 mm [Thyroid 2009;19:1167-214]). But little is known about rate, extent, or predictors of nodule growth, the researchers noted. Therefore, they performed annual thyroid ultrasound examinations on 992 patients who had one to four asymptomatic subcentimeter thyroid modules that were cytologically or sonographically benign at baseline.
After 5 years of follow-up, just 15.4% of patients had experienced significant nodule growth according to the ATA definition, the researchers reported. Average growth was 4.9 mm, and 9.3% of patients developed new nodules, of which one was found to be cancerous. Growth was least likely when a patient’s largest nodule measured 7.5 mm or less and was significantly more likely when patients had multiple nodules instead of one; had baseline nodule volume greater than 0.2 mL; were up to 45 years old, compared with at least 60 years of age; and were male, the investigators said.
Among older patients, having a body mass index of 28.6 kg/m2 more than doubled the odds of nodule growth, in keeping with recent reports linking obesity and insulin resistance with nodular thyroid disease, they added.
The findings suggest that repeat thyroid ultrasonography could be safely extended to 12 months for initial follow-up and to every 5 years thereafter for most patients, as long as nodule size remained stable, Dr. Durante and his associates said. “This approach should be suitable for about 85% of patients, whose risk of disease progression is low. Closer surveillance may be appropriate for nodules occurring in younger patients or older overweight individuals with multiple nodules, large nodules (greater than 7.5 mm), or both,” they added.
The Umberto Di Mario Foundation, Banca d’Italia, and the Italian Thyroid Cancer Observatory Foundation funded the study. The authors reported having no conflicts of interest.
During 5 years of follow-up, cancer arose in only 0.3% of thyroid nodules that were cytologically and sonographically benign at baseline, according to a large prospective study published online March 3 in JAMA.
Furthermore, only two of the five nodules that became cancerous had grown beforehand, reported Dr. Cosimo Durante of the Sapienza University of Rome and his associates. “These data suggest that the American Thyroid Association’s recommendation for indication for repeat cytology should be revised. Clinical and sonographic findings should probably play larger roles in the decision-making process,” the researchers said (JAMA 2015;313:926-35).
Advances in diagnostic imaging have increased the detection of thyroid nodules, the great majority of which are found to be benign. For such nodules, the ATA recommends repeating thyroid ultrasonography at 6-18 months and then every 3-5 years thereafter, as long as nodules do not significantly grow (defined as at least a 20% increase in two nodule diameters, with a minimum increase of at least 2 mm [Thyroid 2009;19:1167-214]). But little is known about rate, extent, or predictors of nodule growth, the researchers noted. Therefore, they performed annual thyroid ultrasound examinations on 992 patients who had one to four asymptomatic subcentimeter thyroid modules that were cytologically or sonographically benign at baseline.
After 5 years of follow-up, just 15.4% of patients had experienced significant nodule growth according to the ATA definition, the researchers reported. Average growth was 4.9 mm, and 9.3% of patients developed new nodules, of which one was found to be cancerous. Growth was least likely when a patient’s largest nodule measured 7.5 mm or less and was significantly more likely when patients had multiple nodules instead of one; had baseline nodule volume greater than 0.2 mL; were up to 45 years old, compared with at least 60 years of age; and were male, the investigators said.
Among older patients, having a body mass index of 28.6 kg/m2 more than doubled the odds of nodule growth, in keeping with recent reports linking obesity and insulin resistance with nodular thyroid disease, they added.
The findings suggest that repeat thyroid ultrasonography could be safely extended to 12 months for initial follow-up and to every 5 years thereafter for most patients, as long as nodule size remained stable, Dr. Durante and his associates said. “This approach should be suitable for about 85% of patients, whose risk of disease progression is low. Closer surveillance may be appropriate for nodules occurring in younger patients or older overweight individuals with multiple nodules, large nodules (greater than 7.5 mm), or both,” they added.
The Umberto Di Mario Foundation, Banca d’Italia, and the Italian Thyroid Cancer Observatory Foundation funded the study. The authors reported having no conflicts of interest.
FROM JAMA
Key clinical point: The vast majority of thyroid nodules found to be benign at baseline remained so 5 years later.
Major finding: Cancer arose in only 0.3% of nodules in 5 years of follow-up.
Data source: Prospective, multicenter, observational study of 992 patients with 1,567 asymptomatic thyroid nodules.
Disclosures: The Umberto Di Mario Foundation, Banca d’Italia, and the Italian Thyroid Cancer Observatory Foundation funded the study. The authors reported having no conflicts of interest.
Lenvima gets the FDA’s nod for differentiated thyroid cancer
The Food and Drug Administration has approved the kinase inhibitor lenvatinib (Lenvima) for the treatment of differentiated thyroid cancer, the agency announced Feb. 13. The drug is approved for use in patients in whom disease progressed despite receiving radioactive iodine therapy.
A trial of 392 patients with progressive, radioactive iodine–refractory differentiated thyroid cancer (DTC) found a median progression-free survival time of 18.3 months in participants treated with Lenvima, compared with a median of 3.6 months in those who received a placebo, the FDA said in a statement. In addition, 65% of lenvatinib-treated patients saw a reduction in tumor size, compared with just 2% of patients who received placebo.
DTC is the most common type of thyroid cancer. The National Cancer Institute has estimated that nearly 63,000 Americans were diagnosed with thyroid cancer, and nearly 1,900 died from the disease in 2014, the FDA said.
Lenvatinib was approved early upon expedited review under the FDA’s priority review program, which allows for the accelerated evaluation of promising drugs that would significantly benefit patients with serious illness.
Common side effects from the drug included hypertension, fatigue, diarrhea, joint and muscle pain, decreased appetite, weight loss, and nausea, among others.
Lenvatinib is marketed by Eisai, based in Woodcliff Lake, N.J.
The Food and Drug Administration has approved the kinase inhibitor lenvatinib (Lenvima) for the treatment of differentiated thyroid cancer, the agency announced Feb. 13. The drug is approved for use in patients in whom disease progressed despite receiving radioactive iodine therapy.
A trial of 392 patients with progressive, radioactive iodine–refractory differentiated thyroid cancer (DTC) found a median progression-free survival time of 18.3 months in participants treated with Lenvima, compared with a median of 3.6 months in those who received a placebo, the FDA said in a statement. In addition, 65% of lenvatinib-treated patients saw a reduction in tumor size, compared with just 2% of patients who received placebo.
DTC is the most common type of thyroid cancer. The National Cancer Institute has estimated that nearly 63,000 Americans were diagnosed with thyroid cancer, and nearly 1,900 died from the disease in 2014, the FDA said.
Lenvatinib was approved early upon expedited review under the FDA’s priority review program, which allows for the accelerated evaluation of promising drugs that would significantly benefit patients with serious illness.
Common side effects from the drug included hypertension, fatigue, diarrhea, joint and muscle pain, decreased appetite, weight loss, and nausea, among others.
Lenvatinib is marketed by Eisai, based in Woodcliff Lake, N.J.
The Food and Drug Administration has approved the kinase inhibitor lenvatinib (Lenvima) for the treatment of differentiated thyroid cancer, the agency announced Feb. 13. The drug is approved for use in patients in whom disease progressed despite receiving radioactive iodine therapy.
A trial of 392 patients with progressive, radioactive iodine–refractory differentiated thyroid cancer (DTC) found a median progression-free survival time of 18.3 months in participants treated with Lenvima, compared with a median of 3.6 months in those who received a placebo, the FDA said in a statement. In addition, 65% of lenvatinib-treated patients saw a reduction in tumor size, compared with just 2% of patients who received placebo.
DTC is the most common type of thyroid cancer. The National Cancer Institute has estimated that nearly 63,000 Americans were diagnosed with thyroid cancer, and nearly 1,900 died from the disease in 2014, the FDA said.
Lenvatinib was approved early upon expedited review under the FDA’s priority review program, which allows for the accelerated evaluation of promising drugs that would significantly benefit patients with serious illness.
Common side effects from the drug included hypertension, fatigue, diarrhea, joint and muscle pain, decreased appetite, weight loss, and nausea, among others.
Lenvatinib is marketed by Eisai, based in Woodcliff Lake, N.J.
Study aims to determine prognostic factors for subset of thyroid cancer patients
CORONADO, CALIF. – In patients with radioactive iodine–refractory differentiated thyroid cancer, those with target lesions less than 1.5 cm in size appeared to derive less benefit from sorafenib in terms of progression-free survival, results from an international study showed.
In addition, papillary histology was a positive predictive factor and a predictive factor for benefit from sorafenib.
“Patients with radioactive iodine–refractory differentiated thyroid cancer have a poor prognosis, and there is a lack of effective treatments,” Dr. Martin Schlumberger said at the annual meeting of the American Thyroid Association. “The median survival for this subset is estimated to be 2.5-5 years.”
Sorafenib was approved by the Food and Drug Administration in November 2013 for the treatment of radioactive iodine–refractory differentiated thyroid cancer based on results from the randomized, controlled, double-blind phase III DECISION trial (Lancet 2014;384:319-28). Investigators found that the use of sorafenib extended median progression-free survival by 5 months, compared with placebo (10.8 vs 5.8 months; P < .0001). The purpose of the current analysis was to determine which demographic baseline or disease-related characteristics are prognostic for better outcomes in this patient population. To do so, Dr. Schlumberger of the department of nuclear medicine and endocrine oncology at Gustave Roussy, Villejuif, France, and his associates performed multivariate Cox proportional hazards models adjusted for treatment effect.
He reported findings from 417 patients. Of these, 210 were randomized to receive placebo and 207 were randomized to receive sorafenib. Variables found to be prognostic factors for progression-free survival in placebo patients, and in all patients when adjusted for sorafenib treatment, included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia vs. Europe and North America. Subgroup analyses of patients in the sorafenib arm revealed that the following baseline or disease-related variables were predictive of progression-free survival: papillary histology, tumor size of at least 1.5 cm, and having only lung metastases.
In a post-hoc exploratory analysis of progression-free survival by thyroid cancer symptoms among all 417 patients at study entry, the researchers found that both symptomatic and asymptomatic patients had improved progression-free survival following treatment with sorafenib.
On the basis of these findings, radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm “appear to have a good prognosis and may be candidates for a ‘watch and wait’ approach before initiating treatment with sorafenib,” Dr. Schlumberger concluded.
Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
On Twitter @dougbrunk
CORONADO, CALIF. – In patients with radioactive iodine–refractory differentiated thyroid cancer, those with target lesions less than 1.5 cm in size appeared to derive less benefit from sorafenib in terms of progression-free survival, results from an international study showed.
In addition, papillary histology was a positive predictive factor and a predictive factor for benefit from sorafenib.
“Patients with radioactive iodine–refractory differentiated thyroid cancer have a poor prognosis, and there is a lack of effective treatments,” Dr. Martin Schlumberger said at the annual meeting of the American Thyroid Association. “The median survival for this subset is estimated to be 2.5-5 years.”
Sorafenib was approved by the Food and Drug Administration in November 2013 for the treatment of radioactive iodine–refractory differentiated thyroid cancer based on results from the randomized, controlled, double-blind phase III DECISION trial (Lancet 2014;384:319-28). Investigators found that the use of sorafenib extended median progression-free survival by 5 months, compared with placebo (10.8 vs 5.8 months; P < .0001). The purpose of the current analysis was to determine which demographic baseline or disease-related characteristics are prognostic for better outcomes in this patient population. To do so, Dr. Schlumberger of the department of nuclear medicine and endocrine oncology at Gustave Roussy, Villejuif, France, and his associates performed multivariate Cox proportional hazards models adjusted for treatment effect.
He reported findings from 417 patients. Of these, 210 were randomized to receive placebo and 207 were randomized to receive sorafenib. Variables found to be prognostic factors for progression-free survival in placebo patients, and in all patients when adjusted for sorafenib treatment, included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia vs. Europe and North America. Subgroup analyses of patients in the sorafenib arm revealed that the following baseline or disease-related variables were predictive of progression-free survival: papillary histology, tumor size of at least 1.5 cm, and having only lung metastases.
In a post-hoc exploratory analysis of progression-free survival by thyroid cancer symptoms among all 417 patients at study entry, the researchers found that both symptomatic and asymptomatic patients had improved progression-free survival following treatment with sorafenib.
On the basis of these findings, radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm “appear to have a good prognosis and may be candidates for a ‘watch and wait’ approach before initiating treatment with sorafenib,” Dr. Schlumberger concluded.
Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
On Twitter @dougbrunk
CORONADO, CALIF. – In patients with radioactive iodine–refractory differentiated thyroid cancer, those with target lesions less than 1.5 cm in size appeared to derive less benefit from sorafenib in terms of progression-free survival, results from an international study showed.
In addition, papillary histology was a positive predictive factor and a predictive factor for benefit from sorafenib.
“Patients with radioactive iodine–refractory differentiated thyroid cancer have a poor prognosis, and there is a lack of effective treatments,” Dr. Martin Schlumberger said at the annual meeting of the American Thyroid Association. “The median survival for this subset is estimated to be 2.5-5 years.”
Sorafenib was approved by the Food and Drug Administration in November 2013 for the treatment of radioactive iodine–refractory differentiated thyroid cancer based on results from the randomized, controlled, double-blind phase III DECISION trial (Lancet 2014;384:319-28). Investigators found that the use of sorafenib extended median progression-free survival by 5 months, compared with placebo (10.8 vs 5.8 months; P < .0001). The purpose of the current analysis was to determine which demographic baseline or disease-related characteristics are prognostic for better outcomes in this patient population. To do so, Dr. Schlumberger of the department of nuclear medicine and endocrine oncology at Gustave Roussy, Villejuif, France, and his associates performed multivariate Cox proportional hazards models adjusted for treatment effect.
He reported findings from 417 patients. Of these, 210 were randomized to receive placebo and 207 were randomized to receive sorafenib. Variables found to be prognostic factors for progression-free survival in placebo patients, and in all patients when adjusted for sorafenib treatment, included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia vs. Europe and North America. Subgroup analyses of patients in the sorafenib arm revealed that the following baseline or disease-related variables were predictive of progression-free survival: papillary histology, tumor size of at least 1.5 cm, and having only lung metastases.
In a post-hoc exploratory analysis of progression-free survival by thyroid cancer symptoms among all 417 patients at study entry, the researchers found that both symptomatic and asymptomatic patients had improved progression-free survival following treatment with sorafenib.
On the basis of these findings, radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm “appear to have a good prognosis and may be candidates for a ‘watch and wait’ approach before initiating treatment with sorafenib,” Dr. Schlumberger concluded.
Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
On Twitter @dougbrunk
AT THE ATA ANNUAL MEETING
Key clinical point: Radioactive iodine–refractory differentiated thyroid cancer patients with no progressive disease and a tumor size of less than 1.5 cm may be candidates for a “watch and wait” approach before initiating treatment with sorafenib.
Major finding: Baseline or disease-related variables found to be prognostic factors for progression-free survival in placebo patients and in all patients when adjusted for sorafenib treatment included papillary histology, lower targeted tumor size, baseline thyroglobulin less than 486 ng/mL, lower number of lesions, and residing in Asia versus Europe and North America.
Data source: An analysis of 417 patients from the randomized, controlled, double-blind, phase III DECISION trial.
Disclosures: Dr. Schlumberger is an adviser to AstraZeneca, Bayer, Eisai, Exelixis, and Genzyme. He has also received research support from Genzyme and Bayer.
Robotic thyroidectomy outcomes better in high-volume centers
CORONADO, CALIF. – Robotic thyroid surgery performed at the highest-volume center had a lower complication rate and shorter hospital stays than did the other hospitals in the study, results from a study of national data showed.
The Food and Drug Administration suspended its approval of robotic thyroidectomy in October 2011, citing risks and lack of adequate safety and outcomes research. The researchers observed a drop in the number of robotic thyroidectomies performed in the United States after the FDA issued its restriction in 2011. “That move appears to have made a pretty large impact on the projected growth of this procedure,” Dr. Hinson said at the annual meeting of the American Thyroid Association.
In Korea, where the procedure gained recognition in the early 2000s, “a lot of people cite cultural factors, such as aversion to neck scars, lean body habitus, and low body mass index make the procedure more feasible, so it’s a very popular approach there,” said Dr. Hinson, a research fellow at the University of Arkansas for Medical Sciences, Little Rock. In addition, until recently, there were financial incentives to do thyroid surgery with robotic assistance in the Korean health care system. “That said, in the United States, the cultural forces are distinct, our patients are larger and heavier on average, and most patients don’t have a strong aversion to a neck scar. The procedure is paid the same with or without the robot, but takes on average three times as long with the robot. Surgeons have such great results with open techniques that it’s very hard to make an argument that robotic surgery improves outcomes that much.”
In what is believed to be the largest study of its kind in the United States, Dr. Hinson and his associates evaluated data from the University HealthSystem Consortium (UHC) and an additional academic center which did not participate in the UHC discharge database. The study included 484 patients who underwent robotic thyroidectomy in the United States between 2009 and 2013. Data were compiled from discharge summaries at 110 university medical centers and another 140 of their affiliated hospitals. The researchers collected data on age, gender, race, insurance, comorbidities, complications, discharge status, length of stay, and ICU admission.
Dr. Hinson and his associates found that, compared with outpatients, inpatients had significantly greater numbers of comorbidities and complications. The most common comorbidity was hypertension (12 cases), followed by chronic pulmonary disease (8 cases) and diabetes with complications and comorbidities (6 cases). The median hospital length of stay was 1 day for inpatients, and 57% of outpatients stayed overnight. In addition, 8% of inpatients required an ICU stay, while 99% of outpatients and 97% of inpatients were discharged to home. The highest-volume institution in the data set performed most of the outpatient cases and had a lower rate of complications. “That makes sense,” Dr. Hinson said. “If you’re proficient, you’re more likely to have learned how to avoid complications.
“The approach to the neck has largely been unchanged over the last 100 years,” he said. While several other surgical fields have found highly successful and popular niches for endoscopic and/or robotic technology, the uses for these services has been largely limited in head and neck surgery. The da Vinci system was largely created with abdominal surgery in mind. As surgical techniques and robotic technology develop, systemic applications for this technology, previously unrecognized, may emerge. A lot of academic centers were/are hopeful that robotic thyroid surgery may provide the gateway for advancement of such techniques in the head and neck region.”
He reported having no financial disclosures.
On Twitter @dougbrunk
CORONADO, CALIF. – Robotic thyroid surgery performed at the highest-volume center had a lower complication rate and shorter hospital stays than did the other hospitals in the study, results from a study of national data showed.
The Food and Drug Administration suspended its approval of robotic thyroidectomy in October 2011, citing risks and lack of adequate safety and outcomes research. The researchers observed a drop in the number of robotic thyroidectomies performed in the United States after the FDA issued its restriction in 2011. “That move appears to have made a pretty large impact on the projected growth of this procedure,” Dr. Hinson said at the annual meeting of the American Thyroid Association.
In Korea, where the procedure gained recognition in the early 2000s, “a lot of people cite cultural factors, such as aversion to neck scars, lean body habitus, and low body mass index make the procedure more feasible, so it’s a very popular approach there,” said Dr. Hinson, a research fellow at the University of Arkansas for Medical Sciences, Little Rock. In addition, until recently, there were financial incentives to do thyroid surgery with robotic assistance in the Korean health care system. “That said, in the United States, the cultural forces are distinct, our patients are larger and heavier on average, and most patients don’t have a strong aversion to a neck scar. The procedure is paid the same with or without the robot, but takes on average three times as long with the robot. Surgeons have such great results with open techniques that it’s very hard to make an argument that robotic surgery improves outcomes that much.”
In what is believed to be the largest study of its kind in the United States, Dr. Hinson and his associates evaluated data from the University HealthSystem Consortium (UHC) and an additional academic center which did not participate in the UHC discharge database. The study included 484 patients who underwent robotic thyroidectomy in the United States between 2009 and 2013. Data were compiled from discharge summaries at 110 university medical centers and another 140 of their affiliated hospitals. The researchers collected data on age, gender, race, insurance, comorbidities, complications, discharge status, length of stay, and ICU admission.
Dr. Hinson and his associates found that, compared with outpatients, inpatients had significantly greater numbers of comorbidities and complications. The most common comorbidity was hypertension (12 cases), followed by chronic pulmonary disease (8 cases) and diabetes with complications and comorbidities (6 cases). The median hospital length of stay was 1 day for inpatients, and 57% of outpatients stayed overnight. In addition, 8% of inpatients required an ICU stay, while 99% of outpatients and 97% of inpatients were discharged to home. The highest-volume institution in the data set performed most of the outpatient cases and had a lower rate of complications. “That makes sense,” Dr. Hinson said. “If you’re proficient, you’re more likely to have learned how to avoid complications.
“The approach to the neck has largely been unchanged over the last 100 years,” he said. While several other surgical fields have found highly successful and popular niches for endoscopic and/or robotic technology, the uses for these services has been largely limited in head and neck surgery. The da Vinci system was largely created with abdominal surgery in mind. As surgical techniques and robotic technology develop, systemic applications for this technology, previously unrecognized, may emerge. A lot of academic centers were/are hopeful that robotic thyroid surgery may provide the gateway for advancement of such techniques in the head and neck region.”
He reported having no financial disclosures.
On Twitter @dougbrunk
CORONADO, CALIF. – Robotic thyroid surgery performed at the highest-volume center had a lower complication rate and shorter hospital stays than did the other hospitals in the study, results from a study of national data showed.
The Food and Drug Administration suspended its approval of robotic thyroidectomy in October 2011, citing risks and lack of adequate safety and outcomes research. The researchers observed a drop in the number of robotic thyroidectomies performed in the United States after the FDA issued its restriction in 2011. “That move appears to have made a pretty large impact on the projected growth of this procedure,” Dr. Hinson said at the annual meeting of the American Thyroid Association.
In Korea, where the procedure gained recognition in the early 2000s, “a lot of people cite cultural factors, such as aversion to neck scars, lean body habitus, and low body mass index make the procedure more feasible, so it’s a very popular approach there,” said Dr. Hinson, a research fellow at the University of Arkansas for Medical Sciences, Little Rock. In addition, until recently, there were financial incentives to do thyroid surgery with robotic assistance in the Korean health care system. “That said, in the United States, the cultural forces are distinct, our patients are larger and heavier on average, and most patients don’t have a strong aversion to a neck scar. The procedure is paid the same with or without the robot, but takes on average three times as long with the robot. Surgeons have such great results with open techniques that it’s very hard to make an argument that robotic surgery improves outcomes that much.”
In what is believed to be the largest study of its kind in the United States, Dr. Hinson and his associates evaluated data from the University HealthSystem Consortium (UHC) and an additional academic center which did not participate in the UHC discharge database. The study included 484 patients who underwent robotic thyroidectomy in the United States between 2009 and 2013. Data were compiled from discharge summaries at 110 university medical centers and another 140 of their affiliated hospitals. The researchers collected data on age, gender, race, insurance, comorbidities, complications, discharge status, length of stay, and ICU admission.
Dr. Hinson and his associates found that, compared with outpatients, inpatients had significantly greater numbers of comorbidities and complications. The most common comorbidity was hypertension (12 cases), followed by chronic pulmonary disease (8 cases) and diabetes with complications and comorbidities (6 cases). The median hospital length of stay was 1 day for inpatients, and 57% of outpatients stayed overnight. In addition, 8% of inpatients required an ICU stay, while 99% of outpatients and 97% of inpatients were discharged to home. The highest-volume institution in the data set performed most of the outpatient cases and had a lower rate of complications. “That makes sense,” Dr. Hinson said. “If you’re proficient, you’re more likely to have learned how to avoid complications.
“The approach to the neck has largely been unchanged over the last 100 years,” he said. While several other surgical fields have found highly successful and popular niches for endoscopic and/or robotic technology, the uses for these services has been largely limited in head and neck surgery. The da Vinci system was largely created with abdominal surgery in mind. As surgical techniques and robotic technology develop, systemic applications for this technology, previously unrecognized, may emerge. A lot of academic centers were/are hopeful that robotic thyroid surgery may provide the gateway for advancement of such techniques in the head and neck region.”
He reported having no financial disclosures.
On Twitter @dougbrunk
AT THE ATA ANNUAL MEETING
Key clinical point: Robotic thyroid surgery performed by higher-volume surgeons is associated with lower complications and shorter hospital stays.
Major finding: Compared with outpatients, inpatients had a significantly greater number of comorbidities (P < .001) and complications (P =.005). In addition, the highest-volume institution in the data set performed most of the outpatient cases and had a lower rate of complications.
Data source: A study of 484 patients from the University HealthSystem Consortium who underwent robotic thyroidectomy in the United States between 2009 and 2013.
Disclosures:Dr. Hinson reported having no financial disclosures.