BOSTON – Results of a population-based study involving more than 8,000 adults from the Netherlands who were diabetes free at baseline has implicated low thyroid function with a 13% increased likelihood of developing type 2 diabetes, and up to 40% higher in individuals with prediabetes.

The heightened risk exists even for individuals with subclinical hypothyroidism, in whom thyroid-stimulating hormone (TSH) in the blood is still in the normal concentration range.

“These findings suggest we should consider screening people with prediabetes for low thyroid function,” Dr. Layal Chaker of Erasmus Medical Center, Rotterdam, the Netherlands, said at the annual meeting of the Endocrine Society.

Thyroid screening is recommended for patients with type 1 diabetes, since they are at increased risk of thyroid disease. An association between thyroid dysfunction in the form of hypothyroidism and type 2 diabetes has been surmised, since type 2 diabetes and hypothyroidism tend to be more prevalent in older adults, and since hypothyroidism has been linked with weight gain and reduced sensitivity to insulin.

To further study the link between thyroid function and diabetes, Dr. Chaker and her colleagues studied data from 8,452 participants aged 45 years and above (mean age 62 years, 58% female) from the Rotterdam Study, a prospective, longitudinal cohort study in the Ommoord district of Rotterdam that was undertaken to investigate the risk factors of cardiovascular, neurological, ophthalmologic, and endocrine diseases in the elderly. The cohort was considered representative of the general population in the Netherlands. All participants had blood tests to measure blood glucose, TSH, and free thyroxine (FT4). Normal blood glucose was considered to be under 5.9 mmol/L, prediabetes as over 5.9 to less than 7.0 mmol/L glucose, and diabetes as above 7.0 mmol/L.

Prediabetes and type 2 diabetes developed in 1,100 and 798 subjects, respectively, during a mean follow-up of 7.9 years. Higher TSH levels increased the risk of development of type 2 diabetes risk (hazard ratio [HR] 1.13, 95% confidence interval [CI], 1.08-1.18, per logTSH). This risk held even for subjects whose TSH levels were at the lower end of the reference range of thyroid function (HR 1.24, CI, 1.06-1.45). The risk of diabetes was reduced in subjects with FT4 levels that were elevated (HR 0.96, CI, 0.93-0.99, per pmol/L) and for those whose FT4 levels were in the reference range (HR 0.96, CI, 0.92-0.99). Low thyroid function, even within the normal range, was associated with a 1.4 times risk of progression from prediabetes to type 2 diabetes (P = .002).

“Low and, surprisingly, low-normal thyroid function are risk factors for incident diabetes, especially in individuals with prediabetes,” said Dr. Chaker.

The data point to the need to clarify whether screening for and treatment of subclinical hypothyroidism can help curb the development of diabetes, she added.

Dr. Chaker had no disclosures.

BOSTON – Results of a population-based study involving more than 8,000 adults from the Netherlands who were diabetes free at baseline has implicated low thyroid function with a 13% increased likelihood of developing type 2 diabetes, and up to 40% higher in individuals with prediabetes.

The heightened risk exists even for individuals with subclinical hypothyroidism, in whom thyroid-stimulating hormone (TSH) in the blood is still in the normal concentration range.

“These findings suggest we should consider screening people with prediabetes for low thyroid function,” Dr. Layal Chaker of Erasmus Medical Center, Rotterdam, the Netherlands, said at the annual meeting of the Endocrine Society.

Thyroid screening is recommended for patients with type 1 diabetes, since they are at increased risk of thyroid disease. An association between thyroid dysfunction in the form of hypothyroidism and type 2 diabetes has been surmised, since type 2 diabetes and hypothyroidism tend to be more prevalent in older adults, and since hypothyroidism has been linked with weight gain and reduced sensitivity to insulin.

To further study the link between thyroid function and diabetes, Dr. Chaker and her colleagues studied data from 8,452 participants aged 45 years and above (mean age 62 years, 58% female) from the Rotterdam Study, a prospective, longitudinal cohort study in the Ommoord district of Rotterdam that was undertaken to investigate the risk factors of cardiovascular, neurological, ophthalmologic, and endocrine diseases in the elderly. The cohort was considered representative of the general population in the Netherlands. All participants had blood tests to measure blood glucose, TSH, and free thyroxine (FT4). Normal blood glucose was considered to be under 5.9 mmol/L, prediabetes as over 5.9 to less than 7.0 mmol/L glucose, and diabetes as above 7.0 mmol/L.

Prediabetes and type 2 diabetes developed in 1,100 and 798 subjects, respectively, during a mean follow-up of 7.9 years. Higher TSH levels increased the risk of development of type 2 diabetes risk (hazard ratio [HR] 1.13, 95% confidence interval [CI], 1.08-1.18, per logTSH). This risk held even for subjects whose TSH levels were at the lower end of the reference range of thyroid function (HR 1.24, CI, 1.06-1.45). The risk of diabetes was reduced in subjects with FT4 levels that were elevated (HR 0.96, CI, 0.93-0.99, per pmol/L) and for those whose FT4 levels were in the reference range (HR 0.96, CI, 0.92-0.99). Low thyroid function, even within the normal range, was associated with a 1.4 times risk of progression from prediabetes to type 2 diabetes (P = .002).

“Low and, surprisingly, low-normal thyroid function are risk factors for incident diabetes, especially in individuals with prediabetes,” said Dr. Chaker.

The data point to the need to clarify whether screening for and treatment of subclinical hypothyroidism can help curb the development of diabetes, she added.

Dr. Chaker had no disclosures.

BOSTON – Results of a population-based study involving more than 8,000 adults from the Netherlands who were diabetes free at baseline has implicated low thyroid function with a 13% increased likelihood of developing type 2 diabetes, and up to 40% higher in individuals with prediabetes.

The heightened risk exists even for individuals with subclinical hypothyroidism, in whom thyroid-stimulating hormone (TSH) in the blood is still in the normal concentration range.

“These findings suggest we should consider screening people with prediabetes for low thyroid function,” Dr. Layal Chaker of Erasmus Medical Center, Rotterdam, the Netherlands, said at the annual meeting of the Endocrine Society.

Thyroid screening is recommended for patients with type 1 diabetes, since they are at increased risk of thyroid disease. An association between thyroid dysfunction in the form of hypothyroidism and type 2 diabetes has been surmised, since type 2 diabetes and hypothyroidism tend to be more prevalent in older adults, and since hypothyroidism has been linked with weight gain and reduced sensitivity to insulin.

To further study the link between thyroid function and diabetes, Dr. Chaker and her colleagues studied data from 8,452 participants aged 45 years and above (mean age 62 years, 58% female) from the Rotterdam Study, a prospective, longitudinal cohort study in the Ommoord district of Rotterdam that was undertaken to investigate the risk factors of cardiovascular, neurological, ophthalmologic, and endocrine diseases in the elderly. The cohort was considered representative of the general population in the Netherlands. All participants had blood tests to measure blood glucose, TSH, and free thyroxine (FT4). Normal blood glucose was considered to be under 5.9 mmol/L, prediabetes as over 5.9 to less than 7.0 mmol/L glucose, and diabetes as above 7.0 mmol/L.

Prediabetes and type 2 diabetes developed in 1,100 and 798 subjects, respectively, during a mean follow-up of 7.9 years. Higher TSH levels increased the risk of development of type 2 diabetes risk (hazard ratio [HR] 1.13, 95% confidence interval [CI], 1.08-1.18, per logTSH). This risk held even for subjects whose TSH levels were at the lower end of the reference range of thyroid function (HR 1.24, CI, 1.06-1.45). The risk of diabetes was reduced in subjects with FT4 levels that were elevated (HR 0.96, CI, 0.93-0.99, per pmol/L) and for those whose FT4 levels were in the reference range (HR 0.96, CI, 0.92-0.99). Low thyroid function, even within the normal range, was associated with a 1.4 times risk of progression from prediabetes to type 2 diabetes (P = .002).

“Low and, surprisingly, low-normal thyroid function are risk factors for incident diabetes, especially in individuals with prediabetes,” said Dr. Chaker.

The data point to the need to clarify whether screening for and treatment of subclinical hypothyroidism can help curb the development of diabetes, she added.

Dr. Chaker had no disclosures.

PHILADELPHIA – The lack of evidence-based management strategies for the treatment of difficult inflammatory bowel disease cases, such as with Crohn’s disease, can lead to confusion for some clinicians.

Dr. Mark T. Osterman, assistant professor of medicine at the University of Pennsylvania, Philadelphia, discusses when to use antibiotics in Crohn’s disease and when to consider antibiotics in combination with draining fistulae. He also discusses available pharmacotherapies, and the value of bowel rest.

“The best treatment of all for difficult inflammatory bowel disease is aggressive and early, so that the condition doesn’t go from bad to worse,” Dr. Osterman said.

The video was recorded at this year’s meeting of Digestive Diseases: New Advances, a meeting held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – The lack of evidence-based management strategies for the treatment of difficult inflammatory bowel disease cases, such as with Crohn’s disease, can lead to confusion for some clinicians.

Dr. Mark T. Osterman, assistant professor of medicine at the University of Pennsylvania, Philadelphia, discusses when to use antibiotics in Crohn’s disease and when to consider antibiotics in combination with draining fistulae. He also discusses available pharmacotherapies, and the value of bowel rest.

“The best treatment of all for difficult inflammatory bowel disease is aggressive and early, so that the condition doesn’t go from bad to worse,” Dr. Osterman said.

The video was recorded at this year’s meeting of Digestive Diseases: New Advances, a meeting held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @whitneymcknight

PHILADELPHIA – The lack of evidence-based management strategies for the treatment of difficult inflammatory bowel disease cases, such as with Crohn’s disease, can lead to confusion for some clinicians.

Dr. Mark T. Osterman, assistant professor of medicine at the University of Pennsylvania, Philadelphia, discusses when to use antibiotics in Crohn’s disease and when to consider antibiotics in combination with draining fistulae. He also discusses available pharmacotherapies, and the value of bowel rest.

“The best treatment of all for difficult inflammatory bowel disease is aggressive and early, so that the condition doesn’t go from bad to worse,” Dr. Osterman said.

The video was recorded at this year’s meeting of Digestive Diseases: New Advances, a meeting held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy and this news organization are owned by the same company.

[email protected]

On Twitter @whitneymcknight

Adherence to positive airway pressure (PAP) therapy is a difficult patient management issue. Recent studies confirm widely varying PAP therapy adherence rates (30%-84%). Clinicians at the John D. Dingell VA Medical Center in Detroit developed a set of "super user" criteria, a 5-point method for encouraging patients to maximize adherence to PAP therapy. All 5 criteria, which are discussed in detail in this article from Federal Practitioner, must be satisfied to attain “super user” status. For more, go to: http://www.fedprac.com/the-publication/issue-single-view/how-to-make-your-patient-with-sleep-apnea-a-super-user-of-positive-airway-pressure-therapy/bbd97c064c5f91688f04b82c8b04b054/ocregister.html.

Adherence to positive airway pressure (PAP) therapy is a difficult patient management issue. Recent studies confirm widely varying PAP therapy adherence rates (30%-84%). Clinicians at the John D. Dingell VA Medical Center in Detroit developed a set of "super user" criteria, a 5-point method for encouraging patients to maximize adherence to PAP therapy. All 5 criteria, which are discussed in detail in this article from Federal Practitioner, must be satisfied to attain “super user” status. For more, go to: http://www.fedprac.com/the-publication/issue-single-view/how-to-make-your-patient-with-sleep-apnea-a-super-user-of-positive-airway-pressure-therapy/bbd97c064c5f91688f04b82c8b04b054/ocregister.html.

Adherence to positive airway pressure (PAP) therapy is a difficult patient management issue. Recent studies confirm widely varying PAP therapy adherence rates (30%-84%). Clinicians at the John D. Dingell VA Medical Center in Detroit developed a set of "super user" criteria, a 5-point method for encouraging patients to maximize adherence to PAP therapy. All 5 criteria, which are discussed in detail in this article from Federal Practitioner, must be satisfied to attain “super user” status. For more, go to: http://www.fedprac.com/the-publication/issue-single-view/how-to-make-your-patient-with-sleep-apnea-a-super-user-of-positive-airway-pressure-therapy/bbd97c064c5f91688f04b82c8b04b054/ocregister.html.

Because pain and depression share common neurobiological pathways and clinical manifestations, you can use similar strategies and, often, the same agents to treat both conditions when they occur together. This article from Current Psychiatry, available at http://www.currentpsychiatry.com/specialty-focus/depressive-disorders/article/chronic-pain-and-depression-treatment-of-2-culprits-in-common/6bc388cf05b07e8dc6bbc1b86f50f0bf.html, reviews different treatment options (including non-drug interventions) that can help patients with both pain and depression, as well as drug-drug interactions that can occur.

Because pain and depression share common neurobiological pathways and clinical manifestations, you can use similar strategies and, often, the same agents to treat both conditions when they occur together. This article from Current Psychiatry, available at http://www.currentpsychiatry.com/specialty-focus/depressive-disorders/article/chronic-pain-and-depression-treatment-of-2-culprits-in-common/6bc388cf05b07e8dc6bbc1b86f50f0bf.html, reviews different treatment options (including non-drug interventions) that can help patients with both pain and depression, as well as drug-drug interactions that can occur.

Because pain and depression share common neurobiological pathways and clinical manifestations, you can use similar strategies and, often, the same agents to treat both conditions when they occur together. This article from Current Psychiatry, available at http://www.currentpsychiatry.com/specialty-focus/depressive-disorders/article/chronic-pain-and-depression-treatment-of-2-culprits-in-common/6bc388cf05b07e8dc6bbc1b86f50f0bf.html, reviews different treatment options (including non-drug interventions) that can help patients with both pain and depression, as well as drug-drug interactions that can occur.

Homelessness and unstable housing situations are associated with higher rates of human immunodeficiency virus (HIV) and hepatitis C infection (HCV), according to researchers from Columbia University in New York City, McMaster University in Hamilton, Ontario, Canada, and the Ontario HIV Treatment Network in Canada. The researchers reviewed 152 studies involving 139,757 individuals who had HIV or were co-infected with HCV. The researchers found “strong evidence” that the lack of stable, secure, and adequate housing is a significant barrier to consistent and appropriate medical care, as well as the reduction of risk behaviors. For more on this research, see the Federal Practitioner article at: http://www.fedprac.com/the-publication/issue-single-view/homelessness-hiv-and-hcv/6a66b2b7db3f0299caa7aaf050129fb4/ocregister.html.

Homelessness and unstable housing situations are associated with higher rates of human immunodeficiency virus (HIV) and hepatitis C infection (HCV), according to researchers from Columbia University in New York City, McMaster University in Hamilton, Ontario, Canada, and the Ontario HIV Treatment Network in Canada. The researchers reviewed 152 studies involving 139,757 individuals who had HIV or were co-infected with HCV. The researchers found “strong evidence” that the lack of stable, secure, and adequate housing is a significant barrier to consistent and appropriate medical care, as well as the reduction of risk behaviors. For more on this research, see the Federal Practitioner article at: http://www.fedprac.com/the-publication/issue-single-view/homelessness-hiv-and-hcv/6a66b2b7db3f0299caa7aaf050129fb4/ocregister.html.

Homelessness and unstable housing situations are associated with higher rates of human immunodeficiency virus (HIV) and hepatitis C infection (HCV), according to researchers from Columbia University in New York City, McMaster University in Hamilton, Ontario, Canada, and the Ontario HIV Treatment Network in Canada. The researchers reviewed 152 studies involving 139,757 individuals who had HIV or were co-infected with HCV. The researchers found “strong evidence” that the lack of stable, secure, and adequate housing is a significant barrier to consistent and appropriate medical care, as well as the reduction of risk behaviors. For more on this research, see the Federal Practitioner article at: http://www.fedprac.com/the-publication/issue-single-view/homelessness-hiv-and-hcv/6a66b2b7db3f0299caa7aaf050129fb4/ocregister.html.

Incretin-based antidiabetic drugs didn’t raise the risk of hospitalization for heart failure, according to an international observational study involving 1.5 million patients reported online in The New England Journal of Medicine. “With 3.2 million person-years of observations, we had the statistical power to robustly assess this important drug safety issue,” the investigators said. Read more on the study at Cardiology News: http://www.ecardiologynews.com/specialty-focus/heart-failure/single-article-page/incretin-based-diabetes-drugs-dont-raise-heart-failure-risk/72ea7cb26766fc17483ad005269c5da2.html.

Incretin-based antidiabetic drugs didn’t raise the risk of hospitalization for heart failure, according to an international observational study involving 1.5 million patients reported online in The New England Journal of Medicine. “With 3.2 million person-years of observations, we had the statistical power to robustly assess this important drug safety issue,” the investigators said. Read more on the study at Cardiology News: http://www.ecardiologynews.com/specialty-focus/heart-failure/single-article-page/incretin-based-diabetes-drugs-dont-raise-heart-failure-risk/72ea7cb26766fc17483ad005269c5da2.html.

Incretin-based antidiabetic drugs didn’t raise the risk of hospitalization for heart failure, according to an international observational study involving 1.5 million patients reported online in The New England Journal of Medicine. “With 3.2 million person-years of observations, we had the statistical power to robustly assess this important drug safety issue,” the investigators said. Read more on the study at Cardiology News: http://www.ecardiologynews.com/specialty-focus/heart-failure/single-article-page/incretin-based-diabetes-drugs-dont-raise-heart-failure-risk/72ea7cb26766fc17483ad005269c5da2.html.

The prevalence of type 1 diabetes in people younger than age 20 increased by 23% from 2001 to 2009, and the disease now affects as many as 1.25 million Americans. This case from Clinician Reviews provides a brief overview of the diagnosis and management considerations required for successful care of these patients. The article is available at: http://www.clinicianreviews.com/the-publication/issue-single-view/the-challenges-of-type-1-diabetes-a-case-based-review/a5a6fab4483946a829d60880ec2e3a74.html.

The prevalence of type 1 diabetes in people younger than age 20 increased by 23% from 2001 to 2009, and the disease now affects as many as 1.25 million Americans. This case from Clinician Reviews provides a brief overview of the diagnosis and management considerations required for successful care of these patients. The article is available at: http://www.clinicianreviews.com/the-publication/issue-single-view/the-challenges-of-type-1-diabetes-a-case-based-review/a5a6fab4483946a829d60880ec2e3a74.html.

The prevalence of type 1 diabetes in people younger than age 20 increased by 23% from 2001 to 2009, and the disease now affects as many as 1.25 million Americans. This case from Clinician Reviews provides a brief overview of the diagnosis and management considerations required for successful care of these patients. The article is available at: http://www.clinicianreviews.com/the-publication/issue-single-view/the-challenges-of-type-1-diabetes-a-case-based-review/a5a6fab4483946a829d60880ec2e3a74.html.

This patient handout from the American Thoracic Society doesn’t just list the signs and symptoms of chronic obstructive pulmonary disease (COPD); it also explains what is causing the symptoms and steps to take to get better control over them. The handout, available at http://www.thoracic.org/patients/patient-resources/resources/signs-symptoms-of-COPD.pdf, discusses symptoms such as fatigue, shortness of breath, and coughing, as well as the point at which patients should reach out to their health care providers.

This patient handout from the American Thoracic Society doesn’t just list the signs and symptoms of chronic obstructive pulmonary disease (COPD); it also explains what is causing the symptoms and steps to take to get better control over them. The handout, available at http://www.thoracic.org/patients/patient-resources/resources/signs-symptoms-of-COPD.pdf, discusses symptoms such as fatigue, shortness of breath, and coughing, as well as the point at which patients should reach out to their health care providers.

This patient handout from the American Thoracic Society doesn’t just list the signs and symptoms of chronic obstructive pulmonary disease (COPD); it also explains what is causing the symptoms and steps to take to get better control over them. The handout, available at http://www.thoracic.org/patients/patient-resources/resources/signs-symptoms-of-COPD.pdf, discusses symptoms such as fatigue, shortness of breath, and coughing, as well as the point at which patients should reach out to their health care providers.

Newly diagnosed native valve infectious endocarditis is not in and of itself an indication for anticoagulation. What’s less clear, however, is how one should proceed when a patient has a preexisting or coexisting indication for anticoagulation such as atrial fibrillation, deep vein thrombosis, pulmonary embolism, or a mechanical prosthetic heart valve. Recommendations for anticoagulation in patients with infectious endocarditis are summarized in this evidence-based review article from Cleveland Clinic Journal of Medicine: http://www.ccjm.org/current-issue/issue-single-view/can-patients-with-infectious-endocarditis-be-safely-anticoagulated/dbe0163aac4657c558cd476fcb1e815d.html.

Newly diagnosed native valve infectious endocarditis is not in and of itself an indication for anticoagulation. What’s less clear, however, is how one should proceed when a patient has a preexisting or coexisting indication for anticoagulation such as atrial fibrillation, deep vein thrombosis, pulmonary embolism, or a mechanical prosthetic heart valve. Recommendations for anticoagulation in patients with infectious endocarditis are summarized in this evidence-based review article from Cleveland Clinic Journal of Medicine: http://www.ccjm.org/current-issue/issue-single-view/can-patients-with-infectious-endocarditis-be-safely-anticoagulated/dbe0163aac4657c558cd476fcb1e815d.html.

Newly diagnosed native valve infectious endocarditis is not in and of itself an indication for anticoagulation. What’s less clear, however, is how one should proceed when a patient has a preexisting or coexisting indication for anticoagulation such as atrial fibrillation, deep vein thrombosis, pulmonary embolism, or a mechanical prosthetic heart valve. Recommendations for anticoagulation in patients with infectious endocarditis are summarized in this evidence-based review article from Cleveland Clinic Journal of Medicine: http://www.ccjm.org/current-issue/issue-single-view/can-patients-with-infectious-endocarditis-be-safely-anticoagulated/dbe0163aac4657c558cd476fcb1e815d.html.

Oncologists should take an individualized approach when making decisions about adjuvant endocrine therapies for premenopausal hormone receptor–positive, HER2-negative early breast cancer, suggests an analysis of a pair of randomized phase III trials published online in the Journal of Clinical Oncology.

Investigators led by Meredith M. Regan, Sc.D., of Dana-Farber Cancer Institute in Boston, analyzed data from the TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) trials of adjuvant endocrine therapies, comprising a total of nearly 5,000 women.

Results suggested that the absolute improvement in the 5-year breast cancer–free interval rate with exemestane plus ovarian function suppression (OFS) versus tamoxifen with or without OFS ranged from less than 1% in women with a lowest recurrence risk based on clinicopathologic factors to 10%-15% in women with a highest risk.

“TEXT and SOFT demonstrated that premenopausal women with hormone receptor–positive disease benefit, on average, from exemestane plus OFS versus tamoxifen with or without OFS. However, individualized treatment decisions should weigh the benefits against the adverse effects and costs of these therapy options,” the investigators wrote.

“In the absence of predictive biomarkers, consideration of a patient’s prognosis, as illustrated by STEPP [Subpopulation Treatment Effect Pattern Plot] analysis of a composite measure of recurrence risk in the TEXT and SOFT populations, is integral to this decision making,” they added.

In the SOFT trial, women were randomized to 5 years of tamoxifen alone (as an active comparator), tamoxifen plus OFS, or exemestane (Aromasin) plus OFS. In the TEXT trial, women were randomized to 5 years of exemestane plus OFS or of tamoxifen plus OFS.

Dr. Regan and colleagues based their analyses on a total of 4,891 women. They assessed each patient’s composite recurrence risk from a Cox model that included a set of conventional clinicopathologic factors: age, nodal status, tumor size and grade, and estrogen receptor, progesterone receptor, and Ki-67 expression levels. And they used STEPP methodology to assess the impact of endocrine therapy across groups having different risk.

The median duration of follow-up was 5.6 years in the SOFT trial and 6 years in the TEXT trial. Results showed that the 5-year breast cancer–free interval rate was 90.8% for the study cohort as a whole. But it ranged considerably from 98.6% for patients with composite risk in the lowest quartile to 77.5% for patients with composite risk in the highest quartiles, the investigators reported (J Clin Oncol. 2016. doi: 10.1200/JCO.2015.64.3171).

In the SOFT population, patients who remained premenopausal after neoadjuvant or adjuvant chemotherapy had an absolute improvement of 5% or more in the 5-year breast cancer–free interval rate with exemestane plus OFS, compared with tamoxifen plus OFS or tamoxifen alone. The difference was 10%-15% for the subset at intermediate to high risk for recurrence.

In addition, a benefit of tamoxifen plus OFS over tamoxifen alone was evident in patients having the highest composite risk.

Among patients who were not given chemotherapy, who on average had the lowest composite recurrence risk, the 5-year breast cancer–free interval rate was excellent regardless of the endocrine therapy received.

In the TEXT trial population, the benefit of exemestane plus OFS over tamoxifen plus OFS in 5-year breast cancer–free interval rate ranged from 5% to 15%. Again, the patients who were not given chemotherapy, who had the lowest composite recurrence risk, fared well regardless of which endocrine therapy they received.

These findings should help guide clinical decisions in premenopausal women with hormone receptor–positive, HER2-negative breast cancer, both at the extremes of risk and in the scenario of intermediate risk, where factors such as patient preference, tolerance, and cost play a greater role, according to the investigators.

“Further follow-up of TEXT and SOFT patients is essential to guide patient care,” they concluded.

Oncologists should take an individualized approach when making decisions about adjuvant endocrine therapies for premenopausal hormone receptor–positive, HER2-negative early breast cancer, suggests an analysis of a pair of randomized phase III trials published online in the Journal of Clinical Oncology.

Investigators led by Meredith M. Regan, Sc.D., of Dana-Farber Cancer Institute in Boston, analyzed data from the TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) trials of adjuvant endocrine therapies, comprising a total of nearly 5,000 women.

Results suggested that the absolute improvement in the 5-year breast cancer–free interval rate with exemestane plus ovarian function suppression (OFS) versus tamoxifen with or without OFS ranged from less than 1% in women with a lowest recurrence risk based on clinicopathologic factors to 10%-15% in women with a highest risk.

“TEXT and SOFT demonstrated that premenopausal women with hormone receptor–positive disease benefit, on average, from exemestane plus OFS versus tamoxifen with or without OFS. However, individualized treatment decisions should weigh the benefits against the adverse effects and costs of these therapy options,” the investigators wrote.

“In the absence of predictive biomarkers, consideration of a patient’s prognosis, as illustrated by STEPP [Subpopulation Treatment Effect Pattern Plot] analysis of a composite measure of recurrence risk in the TEXT and SOFT populations, is integral to this decision making,” they added.

In the SOFT trial, women were randomized to 5 years of tamoxifen alone (as an active comparator), tamoxifen plus OFS, or exemestane (Aromasin) plus OFS. In the TEXT trial, women were randomized to 5 years of exemestane plus OFS or of tamoxifen plus OFS.

Dr. Regan and colleagues based their analyses on a total of 4,891 women. They assessed each patient’s composite recurrence risk from a Cox model that included a set of conventional clinicopathologic factors: age, nodal status, tumor size and grade, and estrogen receptor, progesterone receptor, and Ki-67 expression levels. And they used STEPP methodology to assess the impact of endocrine therapy across groups having different risk.

The median duration of follow-up was 5.6 years in the SOFT trial and 6 years in the TEXT trial. Results showed that the 5-year breast cancer–free interval rate was 90.8% for the study cohort as a whole. But it ranged considerably from 98.6% for patients with composite risk in the lowest quartile to 77.5% for patients with composite risk in the highest quartiles, the investigators reported (J Clin Oncol. 2016. doi: 10.1200/JCO.2015.64.3171).

In the SOFT population, patients who remained premenopausal after neoadjuvant or adjuvant chemotherapy had an absolute improvement of 5% or more in the 5-year breast cancer–free interval rate with exemestane plus OFS, compared with tamoxifen plus OFS or tamoxifen alone. The difference was 10%-15% for the subset at intermediate to high risk for recurrence.

In addition, a benefit of tamoxifen plus OFS over tamoxifen alone was evident in patients having the highest composite risk.

Among patients who were not given chemotherapy, who on average had the lowest composite recurrence risk, the 5-year breast cancer–free interval rate was excellent regardless of the endocrine therapy received.

In the TEXT trial population, the benefit of exemestane plus OFS over tamoxifen plus OFS in 5-year breast cancer–free interval rate ranged from 5% to 15%. Again, the patients who were not given chemotherapy, who had the lowest composite recurrence risk, fared well regardless of which endocrine therapy they received.

These findings should help guide clinical decisions in premenopausal women with hormone receptor–positive, HER2-negative breast cancer, both at the extremes of risk and in the scenario of intermediate risk, where factors such as patient preference, tolerance, and cost play a greater role, according to the investigators.

“Further follow-up of TEXT and SOFT patients is essential to guide patient care,” they concluded.

Oncologists should take an individualized approach when making decisions about adjuvant endocrine therapies for premenopausal hormone receptor–positive, HER2-negative early breast cancer, suggests an analysis of a pair of randomized phase III trials published online in the Journal of Clinical Oncology.

Investigators led by Meredith M. Regan, Sc.D., of Dana-Farber Cancer Institute in Boston, analyzed data from the TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) trials of adjuvant endocrine therapies, comprising a total of nearly 5,000 women.

Results suggested that the absolute improvement in the 5-year breast cancer–free interval rate with exemestane plus ovarian function suppression (OFS) versus tamoxifen with or without OFS ranged from less than 1% in women with a lowest recurrence risk based on clinicopathologic factors to 10%-15% in women with a highest risk.

“TEXT and SOFT demonstrated that premenopausal women with hormone receptor–positive disease benefit, on average, from exemestane plus OFS versus tamoxifen with or without OFS. However, individualized treatment decisions should weigh the benefits against the adverse effects and costs of these therapy options,” the investigators wrote.

“In the absence of predictive biomarkers, consideration of a patient’s prognosis, as illustrated by STEPP [Subpopulation Treatment Effect Pattern Plot] analysis of a composite measure of recurrence risk in the TEXT and SOFT populations, is integral to this decision making,” they added.

In the SOFT trial, women were randomized to 5 years of tamoxifen alone (as an active comparator), tamoxifen plus OFS, or exemestane (Aromasin) plus OFS. In the TEXT trial, women were randomized to 5 years of exemestane plus OFS or of tamoxifen plus OFS.

Dr. Regan and colleagues based their analyses on a total of 4,891 women. They assessed each patient’s composite recurrence risk from a Cox model that included a set of conventional clinicopathologic factors: age, nodal status, tumor size and grade, and estrogen receptor, progesterone receptor, and Ki-67 expression levels. And they used STEPP methodology to assess the impact of endocrine therapy across groups having different risk.

The median duration of follow-up was 5.6 years in the SOFT trial and 6 years in the TEXT trial. Results showed that the 5-year breast cancer–free interval rate was 90.8% for the study cohort as a whole. But it ranged considerably from 98.6% for patients with composite risk in the lowest quartile to 77.5% for patients with composite risk in the highest quartiles, the investigators reported (J Clin Oncol. 2016. doi: 10.1200/JCO.2015.64.3171).

In the SOFT population, patients who remained premenopausal after neoadjuvant or adjuvant chemotherapy had an absolute improvement of 5% or more in the 5-year breast cancer–free interval rate with exemestane plus OFS, compared with tamoxifen plus OFS or tamoxifen alone. The difference was 10%-15% for the subset at intermediate to high risk for recurrence.

In addition, a benefit of tamoxifen plus OFS over tamoxifen alone was evident in patients having the highest composite risk.

Among patients who were not given chemotherapy, who on average had the lowest composite recurrence risk, the 5-year breast cancer–free interval rate was excellent regardless of the endocrine therapy received.

In the TEXT trial population, the benefit of exemestane plus OFS over tamoxifen plus OFS in 5-year breast cancer–free interval rate ranged from 5% to 15%. Again, the patients who were not given chemotherapy, who had the lowest composite recurrence risk, fared well regardless of which endocrine therapy they received.

These findings should help guide clinical decisions in premenopausal women with hormone receptor–positive, HER2-negative breast cancer, both at the extremes of risk and in the scenario of intermediate risk, where factors such as patient preference, tolerance, and cost play a greater role, according to the investigators.

“Further follow-up of TEXT and SOFT patients is essential to guide patient care,” they concluded.