Video

NASHVILLE, TENN. – By 2020, millennials will comprise more than a third of individuals in the workplace, and that has important implications for employment, communication, and education, according to Patrice M. Weiss, MD.

Each generation brings a unique set of experiences and expectations. Millennials – or members of “Generation Y,” who comprised 18% of the workforce in 2018 and 0% in 2008 – tend to prefer flexible work hours and communication via technology, she said during a session on navigating generational differences in the workplace during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

They, along with members of “Generation X” (generally those born between 1962 and 1981) and “Generation Z” (generally those born from 1987 on), tend to be technology savvy, whereas the “Silent Generation” (generally those born between 1925 and 1942) and older members of the “Baby Boomer Generation” (generally those born between 1943 and 1961), may prefer printed communication and phone calls, said Dr. Weiss, chief medical officer at the Carilion Clinic in Roanoke, Va.

“It’s not good, it’s not bad – it’s just the way things are changing,” she said, adding that it’s important to look at the strengths that each generation brings to the workplace.

Importantly, the generational differences also affect patient expectations and therefore should guide physician-patient interactions, she said.

In this video interview, she further discusses how generational differences should be considered in medical practice, and how clinicians can adapt to the changing expectations and different needs of patients from different generations.

“Gen Ys want to communicate with us through technology. They don’t want to pick up the phone and schedule an appointment, they want to be able to go online ... through an app and self-schedule an appointment,” she said. “And they want health care when they want it.

“We as health care providers and health care organizations, we need to meet the needs of each generation ... so what we need to do is really identify what are the needs of all the generations as patients.”

During her presentation, Dr. Weiss further noted that these generational differences present a major challenge with respect to teaching, learning, and communicating.

“Rather than becoming frustrated ... let’s hope that we can ... reach across generations, identify what their strengths are, capitalize on those, and then, as health care providers, be more user and consumer friendly to the generations, particularly the millennials [so] that they have access to us and to information.”

Dr. Weiss said she had no relevant financial disclosures.

[email protected]

NASHVILLE, TENN. – By 2020, millennials will comprise more than a third of individuals in the workplace, and that has important implications for employment, communication, and education, according to Patrice M. Weiss, MD.

Each generation brings a unique set of experiences and expectations. Millennials – or members of “Generation Y,” who comprised 18% of the workforce in 2018 and 0% in 2008 – tend to prefer flexible work hours and communication via technology, she said during a session on navigating generational differences in the workplace during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

They, along with members of “Generation X” (generally those born between 1962 and 1981) and “Generation Z” (generally those born from 1987 on), tend to be technology savvy, whereas the “Silent Generation” (generally those born between 1925 and 1942) and older members of the “Baby Boomer Generation” (generally those born between 1943 and 1961), may prefer printed communication and phone calls, said Dr. Weiss, chief medical officer at the Carilion Clinic in Roanoke, Va.

“It’s not good, it’s not bad – it’s just the way things are changing,” she said, adding that it’s important to look at the strengths that each generation brings to the workplace.

Importantly, the generational differences also affect patient expectations and therefore should guide physician-patient interactions, she said.

In this video interview, she further discusses how generational differences should be considered in medical practice, and how clinicians can adapt to the changing expectations and different needs of patients from different generations.

“Gen Ys want to communicate with us through technology. They don’t want to pick up the phone and schedule an appointment, they want to be able to go online ... through an app and self-schedule an appointment,” she said. “And they want health care when they want it.

“We as health care providers and health care organizations, we need to meet the needs of each generation ... so what we need to do is really identify what are the needs of all the generations as patients.”

During her presentation, Dr. Weiss further noted that these generational differences present a major challenge with respect to teaching, learning, and communicating.

“Rather than becoming frustrated ... let’s hope that we can ... reach across generations, identify what their strengths are, capitalize on those, and then, as health care providers, be more user and consumer friendly to the generations, particularly the millennials [so] that they have access to us and to information.”

Dr. Weiss said she had no relevant financial disclosures.

[email protected]

NASHVILLE, TENN. – By 2020, millennials will comprise more than a third of individuals in the workplace, and that has important implications for employment, communication, and education, according to Patrice M. Weiss, MD.

Each generation brings a unique set of experiences and expectations. Millennials – or members of “Generation Y,” who comprised 18% of the workforce in 2018 and 0% in 2008 – tend to prefer flexible work hours and communication via technology, she said during a session on navigating generational differences in the workplace during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

They, along with members of “Generation X” (generally those born between 1962 and 1981) and “Generation Z” (generally those born from 1987 on), tend to be technology savvy, whereas the “Silent Generation” (generally those born between 1925 and 1942) and older members of the “Baby Boomer Generation” (generally those born between 1943 and 1961), may prefer printed communication and phone calls, said Dr. Weiss, chief medical officer at the Carilion Clinic in Roanoke, Va.

“It’s not good, it’s not bad – it’s just the way things are changing,” she said, adding that it’s important to look at the strengths that each generation brings to the workplace.

Importantly, the generational differences also affect patient expectations and therefore should guide physician-patient interactions, she said.

In this video interview, she further discusses how generational differences should be considered in medical practice, and how clinicians can adapt to the changing expectations and different needs of patients from different generations.

“Gen Ys want to communicate with us through technology. They don’t want to pick up the phone and schedule an appointment, they want to be able to go online ... through an app and self-schedule an appointment,” she said. “And they want health care when they want it.

“We as health care providers and health care organizations, we need to meet the needs of each generation ... so what we need to do is really identify what are the needs of all the generations as patients.”

During her presentation, Dr. Weiss further noted that these generational differences present a major challenge with respect to teaching, learning, and communicating.

“Rather than becoming frustrated ... let’s hope that we can ... reach across generations, identify what their strengths are, capitalize on those, and then, as health care providers, be more user and consumer friendly to the generations, particularly the millennials [so] that they have access to us and to information.”

Dr. Weiss said she had no relevant financial disclosures.

[email protected]

NEWPORT BEACH, CALIF. – New research suggests patients with normal karyotype acute myeloid leukemia (NK-AML) can be divided into four risk groups associated with overall survival.

Investigators used machine learning algorithms to study the association between mutations and overall survival in 1,352 patients with NK-AML. The analysis revealed combinations of mutations that could be used to classify NK-AML patients into favorable, intermediate-1, intermediate-2, and unfavorable risk groups.

For example, patients who had NPM1 mutations but wild-type FLT3-ITD and DNMT3A, had a median overall survival of 99.1 months and could be classified as favorable risk. Conversely, patients who had NPM1, FLT3-ITD, and DNMT3A mutations, had a median overall survival of 13.4 months and could be classified as unfavorable risk.

Aziz Nazha, MD, of the Cleveland Clinic, and his colleagues conducted this research and presented the findings at the Acute Leukemia Forum of Hemedicus.

The investigators looked at genomic and clinical data from 1,352 patients with NK-AML. The patients were a median age of 55 years and had a median white blood cell count of 21.3 x 10⁹/L, a median hemoglobin of 9.1 g/dL, and a median platelet count of 61 x 10⁹/L. More than half of patients (57.3%) were male.

The patients were screened for 35 genes that are commonly mutated in AML and other myeloid malignancies. The investigators used machine learning algorithms, including random survival forest and recommender system algorithms, to study the association between mutations and overall survival in an “unbiased” way.

Dr. Nazha said there were a median of three mutations per patient sample, and “there are some competing interests between those mutations to impact the prognosis of the patient.”

The investigators used the mutations and their associations with overall survival to classify patients into the risk groups outlined in the table below.

[email protected]

NEWPORT BEACH, CALIF. – New research suggests patients with normal karyotype acute myeloid leukemia (NK-AML) can be divided into four risk groups associated with overall survival.

Investigators used machine learning algorithms to study the association between mutations and overall survival in 1,352 patients with NK-AML. The analysis revealed combinations of mutations that could be used to classify NK-AML patients into favorable, intermediate-1, intermediate-2, and unfavorable risk groups.

For example, patients who had NPM1 mutations but wild-type FLT3-ITD and DNMT3A, had a median overall survival of 99.1 months and could be classified as favorable risk. Conversely, patients who had NPM1, FLT3-ITD, and DNMT3A mutations, had a median overall survival of 13.4 months and could be classified as unfavorable risk.

Aziz Nazha, MD, of the Cleveland Clinic, and his colleagues conducted this research and presented the findings at the Acute Leukemia Forum of Hemedicus.

The investigators looked at genomic and clinical data from 1,352 patients with NK-AML. The patients were a median age of 55 years and had a median white blood cell count of 21.3 x 10⁹/L, a median hemoglobin of 9.1 g/dL, and a median platelet count of 61 x 10⁹/L. More than half of patients (57.3%) were male.

The patients were screened for 35 genes that are commonly mutated in AML and other myeloid malignancies. The investigators used machine learning algorithms, including random survival forest and recommender system algorithms, to study the association between mutations and overall survival in an “unbiased” way.

Dr. Nazha said there were a median of three mutations per patient sample, and “there are some competing interests between those mutations to impact the prognosis of the patient.”

The investigators used the mutations and their associations with overall survival to classify patients into the risk groups outlined in the table below.

[email protected]

NEWPORT BEACH, CALIF. – New research suggests patients with normal karyotype acute myeloid leukemia (NK-AML) can be divided into four risk groups associated with overall survival.

Investigators used machine learning algorithms to study the association between mutations and overall survival in 1,352 patients with NK-AML. The analysis revealed combinations of mutations that could be used to classify NK-AML patients into favorable, intermediate-1, intermediate-2, and unfavorable risk groups.

For example, patients who had NPM1 mutations but wild-type FLT3-ITD and DNMT3A, had a median overall survival of 99.1 months and could be classified as favorable risk. Conversely, patients who had NPM1, FLT3-ITD, and DNMT3A mutations, had a median overall survival of 13.4 months and could be classified as unfavorable risk.

Aziz Nazha, MD, of the Cleveland Clinic, and his colleagues conducted this research and presented the findings at the Acute Leukemia Forum of Hemedicus.

The investigators looked at genomic and clinical data from 1,352 patients with NK-AML. The patients were a median age of 55 years and had a median white blood cell count of 21.3 x 10⁹/L, a median hemoglobin of 9.1 g/dL, and a median platelet count of 61 x 10⁹/L. More than half of patients (57.3%) were male.

The patients were screened for 35 genes that are commonly mutated in AML and other myeloid malignancies. The investigators used machine learning algorithms, including random survival forest and recommender system algorithms, to study the association between mutations and overall survival in an “unbiased” way.

Dr. Nazha said there were a median of three mutations per patient sample, and “there are some competing interests between those mutations to impact the prognosis of the patient.”

The investigators used the mutations and their associations with overall survival to classify patients into the risk groups outlined in the table below.

[email protected]

LOS ANGELES – Recommendations on lipid management were among the highlights of this year’s annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE), Yehuda Handelsman, MD, and Paul S. Jellinger, MD, said in a video interview at the meeting.

Dr. Handelsman, medical director of the Metabolic Institute of America, in Tarzana, Calif., summarized the top take-home messages from a premeeting symposium he chaired on diabetes, cardiovascular disease (CVD), and lipid management in high-risk patients. Dr. Jellinger, professor of clinical medicine on the voluntary faculty at the University of Miami Miller School of Medicine, looked at management aspects and therapy goals based on a comparison of the lipid guideline from the American College of Cardiology and the American Heart Association with that from the AACE. Other highlights from the symposium included expert analysis of the CREDENCE trial results on canagliflozin for improving renal outcomes in patients with type 2 diabetes, advice on the management of heart failure in diabetes, and recommendations on managing hyperglycemia.

Dr. Jellinger and Dr. Handelsman, who are members of the editorial advisory board of Clinical Endocrinology News, highlighted the emergence of anabolic treatments for osteoporosis, in particular the sclerostin-neutralizing monoclonal antibody, romosozumab. The therapy was recently approved for the treatment of postmenopausal osteoporosis and is unique in that it both promotes bone formation and reduces resorption. They also noted the switch away from previous practice to now using an anabolic drug first, then going to an antiresorptive therapy, rather than the other way around.

They discussed the keynote address by social media guru, Kevin Pho, MD; a debate that centered on the merits of the American Diabetes Association’s guideline for treating diabetes versus that from the AACE; a presentation on sustained remission of type 2 diabetes with a very low calorie diet; and a report on encouraging findings with an experimental drug for Graves eye disease.
 

LOS ANGELES – Recommendations on lipid management were among the highlights of this year’s annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE), Yehuda Handelsman, MD, and Paul S. Jellinger, MD, said in a video interview at the meeting.

Dr. Handelsman, medical director of the Metabolic Institute of America, in Tarzana, Calif., summarized the top take-home messages from a premeeting symposium he chaired on diabetes, cardiovascular disease (CVD), and lipid management in high-risk patients. Dr. Jellinger, professor of clinical medicine on the voluntary faculty at the University of Miami Miller School of Medicine, looked at management aspects and therapy goals based on a comparison of the lipid guideline from the American College of Cardiology and the American Heart Association with that from the AACE. Other highlights from the symposium included expert analysis of the CREDENCE trial results on canagliflozin for improving renal outcomes in patients with type 2 diabetes, advice on the management of heart failure in diabetes, and recommendations on managing hyperglycemia.

Dr. Jellinger and Dr. Handelsman, who are members of the editorial advisory board of Clinical Endocrinology News, highlighted the emergence of anabolic treatments for osteoporosis, in particular the sclerostin-neutralizing monoclonal antibody, romosozumab. The therapy was recently approved for the treatment of postmenopausal osteoporosis and is unique in that it both promotes bone formation and reduces resorption. They also noted the switch away from previous practice to now using an anabolic drug first, then going to an antiresorptive therapy, rather than the other way around.

They discussed the keynote address by social media guru, Kevin Pho, MD; a debate that centered on the merits of the American Diabetes Association’s guideline for treating diabetes versus that from the AACE; a presentation on sustained remission of type 2 diabetes with a very low calorie diet; and a report on encouraging findings with an experimental drug for Graves eye disease.
 

LOS ANGELES – Recommendations on lipid management were among the highlights of this year’s annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE), Yehuda Handelsman, MD, and Paul S. Jellinger, MD, said in a video interview at the meeting.

Dr. Handelsman, medical director of the Metabolic Institute of America, in Tarzana, Calif., summarized the top take-home messages from a premeeting symposium he chaired on diabetes, cardiovascular disease (CVD), and lipid management in high-risk patients. Dr. Jellinger, professor of clinical medicine on the voluntary faculty at the University of Miami Miller School of Medicine, looked at management aspects and therapy goals based on a comparison of the lipid guideline from the American College of Cardiology and the American Heart Association with that from the AACE. Other highlights from the symposium included expert analysis of the CREDENCE trial results on canagliflozin for improving renal outcomes in patients with type 2 diabetes, advice on the management of heart failure in diabetes, and recommendations on managing hyperglycemia.

Dr. Jellinger and Dr. Handelsman, who are members of the editorial advisory board of Clinical Endocrinology News, highlighted the emergence of anabolic treatments for osteoporosis, in particular the sclerostin-neutralizing monoclonal antibody, romosozumab. The therapy was recently approved for the treatment of postmenopausal osteoporosis and is unique in that it both promotes bone formation and reduces resorption. They also noted the switch away from previous practice to now using an anabolic drug first, then going to an antiresorptive therapy, rather than the other way around.

They discussed the keynote address by social media guru, Kevin Pho, MD; a debate that centered on the merits of the American Diabetes Association’s guideline for treating diabetes versus that from the AACE; a presentation on sustained remission of type 2 diabetes with a very low calorie diet; and a report on encouraging findings with an experimental drug for Graves eye disease.
 

PHILADELPHIA – Adults with focal epilepsy report a range of high-disturbance symptoms and disease-related impacts on their daily lives at different disease stages, illustrating the complexity of the disease from the patient perspective, said Jacqueline French, MD, a professor at the Comprehensive Epilepsy Center at New York University.

“This underscores the need to consider these experiences, and potentially the stage of disease, when developing patient-reported outcome measures,” she said at the annual meeting of the American Academy of Neurology.

To describe the patient’s experience of living with epilepsy, including the occurrence of disease-related signs and symptoms and impact on daily life at different disease stages, Dr. French conducted qualitative, semistructured interviews with adults with focal epilepsy at the following stages: early (1 year or less since diagnosis), middle (1-5 years since diagnosis), and late (more than 5 years since diagnosis). The patients had varying seizure frequency and treatment experiences. They were asked to describe the symptoms and functional impact they had experienced related to epilepsy, and then to rate the degree to which each symptom and impact “bothered” them, using a disturbance rating scale from 0 (not at all) to 10 (extremely).

A total of 62 patients who were aged 18-60 years (mean age, 37 years; 73% female) were interviewed. In all, 19 of the patients had early-stage disease, 17 had middle-stage, and 26 had late-stage disease. Symptoms reported with the highest frequency and highest average disturbance (AD) ratings across all cohorts included twitching/tremors (80% of patients; AD, 5.3), confusion (78%; AD, 7.8), difficulty talking (75%; AD, 8.1), impaired/loss of consciousness (70%; AD, 6.8), stiffening (65%; AD, 5.4), déjà vu (62%; AD, 5.1), difficulty remembering (60%; AD, 8.5), and dizziness/light-headedness (58%; AD, 6.4).

The high-frequency/high-disturbance daily impact of epilepsy included the inability to drive (74%; AD, 7.1), limited ability to work and/or go to school (61%; AD, 6.7), limitations on leisure and social activities (58%; AD, 6.3), and memory loss (47%; AD, 8.4).

Dr French noted that, although disease experiences were similar among the cohorts, some heterogeneity across patient subgroups was observed.

Eisai sponsored the study.

[email protected]

PHILADELPHIA – Adults with focal epilepsy report a range of high-disturbance symptoms and disease-related impacts on their daily lives at different disease stages, illustrating the complexity of the disease from the patient perspective, said Jacqueline French, MD, a professor at the Comprehensive Epilepsy Center at New York University.

“This underscores the need to consider these experiences, and potentially the stage of disease, when developing patient-reported outcome measures,” she said at the annual meeting of the American Academy of Neurology.

To describe the patient’s experience of living with epilepsy, including the occurrence of disease-related signs and symptoms and impact on daily life at different disease stages, Dr. French conducted qualitative, semistructured interviews with adults with focal epilepsy at the following stages: early (1 year or less since diagnosis), middle (1-5 years since diagnosis), and late (more than 5 years since diagnosis). The patients had varying seizure frequency and treatment experiences. They were asked to describe the symptoms and functional impact they had experienced related to epilepsy, and then to rate the degree to which each symptom and impact “bothered” them, using a disturbance rating scale from 0 (not at all) to 10 (extremely).

A total of 62 patients who were aged 18-60 years (mean age, 37 years; 73% female) were interviewed. In all, 19 of the patients had early-stage disease, 17 had middle-stage, and 26 had late-stage disease. Symptoms reported with the highest frequency and highest average disturbance (AD) ratings across all cohorts included twitching/tremors (80% of patients; AD, 5.3), confusion (78%; AD, 7.8), difficulty talking (75%; AD, 8.1), impaired/loss of consciousness (70%; AD, 6.8), stiffening (65%; AD, 5.4), déjà vu (62%; AD, 5.1), difficulty remembering (60%; AD, 8.5), and dizziness/light-headedness (58%; AD, 6.4).

The high-frequency/high-disturbance daily impact of epilepsy included the inability to drive (74%; AD, 7.1), limited ability to work and/or go to school (61%; AD, 6.7), limitations on leisure and social activities (58%; AD, 6.3), and memory loss (47%; AD, 8.4).

Dr French noted that, although disease experiences were similar among the cohorts, some heterogeneity across patient subgroups was observed.

Eisai sponsored the study.

[email protected]

PHILADELPHIA – Adults with focal epilepsy report a range of high-disturbance symptoms and disease-related impacts on their daily lives at different disease stages, illustrating the complexity of the disease from the patient perspective, said Jacqueline French, MD, a professor at the Comprehensive Epilepsy Center at New York University.

“This underscores the need to consider these experiences, and potentially the stage of disease, when developing patient-reported outcome measures,” she said at the annual meeting of the American Academy of Neurology.

To describe the patient’s experience of living with epilepsy, including the occurrence of disease-related signs and symptoms and impact on daily life at different disease stages, Dr. French conducted qualitative, semistructured interviews with adults with focal epilepsy at the following stages: early (1 year or less since diagnosis), middle (1-5 years since diagnosis), and late (more than 5 years since diagnosis). The patients had varying seizure frequency and treatment experiences. They were asked to describe the symptoms and functional impact they had experienced related to epilepsy, and then to rate the degree to which each symptom and impact “bothered” them, using a disturbance rating scale from 0 (not at all) to 10 (extremely).

A total of 62 patients who were aged 18-60 years (mean age, 37 years; 73% female) were interviewed. In all, 19 of the patients had early-stage disease, 17 had middle-stage, and 26 had late-stage disease. Symptoms reported with the highest frequency and highest average disturbance (AD) ratings across all cohorts included twitching/tremors (80% of patients; AD, 5.3), confusion (78%; AD, 7.8), difficulty talking (75%; AD, 8.1), impaired/loss of consciousness (70%; AD, 6.8), stiffening (65%; AD, 5.4), déjà vu (62%; AD, 5.1), difficulty remembering (60%; AD, 8.5), and dizziness/light-headedness (58%; AD, 6.4).

The high-frequency/high-disturbance daily impact of epilepsy included the inability to drive (74%; AD, 7.1), limited ability to work and/or go to school (61%; AD, 6.7), limitations on leisure and social activities (58%; AD, 6.3), and memory loss (47%; AD, 8.4).

Dr French noted that, although disease experiences were similar among the cohorts, some heterogeneity across patient subgroups was observed.

Eisai sponsored the study.

[email protected]

PHILADELPHIA – Physical activity is associated with slower cognitive decline in de novo patients with Parkinson’s disease, according to Sneha Mantri, MD, of Duke University in Durham, N.C., and colleagues, who presented the results of their study at the annual meeting of the American Academy of Neurology.

Physical activity is an important component of the management of Parkinson’s disease and is shown to mitigate cognitive decline among patients with moderate disease, said Dr. Mantri and colleagues. “Exercise levels in de novo and early disease may influence risk of future cognitive decline; early disease also presents an opportunity for early intervention and possible disease modification,” Dr. Mantri said.

Physical activity levels in early disease are known to be low, but the effects of activity on cognition are currently unclear. To assess the relationship between physical activity and cognition, Dr. Mantri and colleagues examined patients with Parkinson’s disease who were enrolled in the prospective Parkinson’s Progression Markers Initiative (PPMI) cohort. At annual study visits, participants completed the Physical Activity Scale for the Elderly (PASE), a validated self-reported questionnaire assessing household, leisure, and work activities over the previous 7 days. The researchers used a linear mixed-effects model to compare rates of change in the Montreal Cognitive Assessment (MoCA) according to PASE scores; covariates included age, sex, Unified Parkinson’s Disease Rating Scale (UPDRS) part III score, and baseline MoCA.

A total of 379 patients completed at least one PASE questionnaire over the course of the study. PASE scores in this cohort have been previously described (Mantri S et al. J Park Dis. 2018;8[1]:107-11). Although overall rates of cognitive decline are known to be modest in this early cohort, PASE over time has a significant effect on MoCA during follow-up (P = 0.02) which suggest that higher levels of activity throughout disease are associated with better cognitive performance.
 

Dr. Mantri had nothing to disclose. Among her coauthors, Dr. Tropea received personal compensation from Genzyme and Medtronics and research support from Sanofi. Dr. Morley had nothing to disclose.

[email protected]

SOURCE: Mantri S et al. AAN 2019, Abstract P2.8-021.

PHILADELPHIA – Physical activity is associated with slower cognitive decline in de novo patients with Parkinson’s disease, according to Sneha Mantri, MD, of Duke University in Durham, N.C., and colleagues, who presented the results of their study at the annual meeting of the American Academy of Neurology.

Physical activity is an important component of the management of Parkinson’s disease and is shown to mitigate cognitive decline among patients with moderate disease, said Dr. Mantri and colleagues. “Exercise levels in de novo and early disease may influence risk of future cognitive decline; early disease also presents an opportunity for early intervention and possible disease modification,” Dr. Mantri said.

Physical activity levels in early disease are known to be low, but the effects of activity on cognition are currently unclear. To assess the relationship between physical activity and cognition, Dr. Mantri and colleagues examined patients with Parkinson’s disease who were enrolled in the prospective Parkinson’s Progression Markers Initiative (PPMI) cohort. At annual study visits, participants completed the Physical Activity Scale for the Elderly (PASE), a validated self-reported questionnaire assessing household, leisure, and work activities over the previous 7 days. The researchers used a linear mixed-effects model to compare rates of change in the Montreal Cognitive Assessment (MoCA) according to PASE scores; covariates included age, sex, Unified Parkinson’s Disease Rating Scale (UPDRS) part III score, and baseline MoCA.

A total of 379 patients completed at least one PASE questionnaire over the course of the study. PASE scores in this cohort have been previously described (Mantri S et al. J Park Dis. 2018;8[1]:107-11). Although overall rates of cognitive decline are known to be modest in this early cohort, PASE over time has a significant effect on MoCA during follow-up (P = 0.02) which suggest that higher levels of activity throughout disease are associated with better cognitive performance.
 

Dr. Mantri had nothing to disclose. Among her coauthors, Dr. Tropea received personal compensation from Genzyme and Medtronics and research support from Sanofi. Dr. Morley had nothing to disclose.

[email protected]

SOURCE: Mantri S et al. AAN 2019, Abstract P2.8-021.

PHILADELPHIA – Physical activity is associated with slower cognitive decline in de novo patients with Parkinson’s disease, according to Sneha Mantri, MD, of Duke University in Durham, N.C., and colleagues, who presented the results of their study at the annual meeting of the American Academy of Neurology.

Physical activity is an important component of the management of Parkinson’s disease and is shown to mitigate cognitive decline among patients with moderate disease, said Dr. Mantri and colleagues. “Exercise levels in de novo and early disease may influence risk of future cognitive decline; early disease also presents an opportunity for early intervention and possible disease modification,” Dr. Mantri said.

Physical activity levels in early disease are known to be low, but the effects of activity on cognition are currently unclear. To assess the relationship between physical activity and cognition, Dr. Mantri and colleagues examined patients with Parkinson’s disease who were enrolled in the prospective Parkinson’s Progression Markers Initiative (PPMI) cohort. At annual study visits, participants completed the Physical Activity Scale for the Elderly (PASE), a validated self-reported questionnaire assessing household, leisure, and work activities over the previous 7 days. The researchers used a linear mixed-effects model to compare rates of change in the Montreal Cognitive Assessment (MoCA) according to PASE scores; covariates included age, sex, Unified Parkinson’s Disease Rating Scale (UPDRS) part III score, and baseline MoCA.

A total of 379 patients completed at least one PASE questionnaire over the course of the study. PASE scores in this cohort have been previously described (Mantri S et al. J Park Dis. 2018;8[1]:107-11). Although overall rates of cognitive decline are known to be modest in this early cohort, PASE over time has a significant effect on MoCA during follow-up (P = 0.02) which suggest that higher levels of activity throughout disease are associated with better cognitive performance.
 

Dr. Mantri had nothing to disclose. Among her coauthors, Dr. Tropea received personal compensation from Genzyme and Medtronics and research support from Sanofi. Dr. Morley had nothing to disclose.

[email protected]

SOURCE: Mantri S et al. AAN 2019, Abstract P2.8-021.

LOS ANGELES – The venerable insulin pump is being repurposed: A Detroit-area endocrinology team reports successfully using insulin pumps to deliver hydrocortisone to patients with adrenal insufficiency who have fared poorly on oral medications.

“We’ve seen amazing results,” said endocrinologist Opada Alzohaili, MD, MBA, of Wayne State University, Detroit, coauthor of a study released at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

Dr. Alzohaili said he and his colleagues developed the approach to manage patients who are “so sick that they go to the hospital 10-12 times a year.” Oral medication just did not control their disorder.

“Most of the time, we end up way overdosing them [on oral medication] just to prevent them from going to the hospital in adrenal crisis,” he said in an interview.

LOS ANGELES – The venerable insulin pump is being repurposed: A Detroit-area endocrinology team reports successfully using insulin pumps to deliver hydrocortisone to patients with adrenal insufficiency who have fared poorly on oral medications.

“We’ve seen amazing results,” said endocrinologist Opada Alzohaili, MD, MBA, of Wayne State University, Detroit, coauthor of a study released at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

Dr. Alzohaili said he and his colleagues developed the approach to manage patients who are “so sick that they go to the hospital 10-12 times a year.” Oral medication just did not control their disorder.

“Most of the time, we end up way overdosing them [on oral medication] just to prevent them from going to the hospital in adrenal crisis,” he said in an interview.

LOS ANGELES – The venerable insulin pump is being repurposed: A Detroit-area endocrinology team reports successfully using insulin pumps to deliver hydrocortisone to patients with adrenal insufficiency who have fared poorly on oral medications.

“We’ve seen amazing results,” said endocrinologist Opada Alzohaili, MD, MBA, of Wayne State University, Detroit, coauthor of a study released at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists.

Dr. Alzohaili said he and his colleagues developed the approach to manage patients who are “so sick that they go to the hospital 10-12 times a year.” Oral medication just did not control their disorder.

“Most of the time, we end up way overdosing them [on oral medication] just to prevent them from going to the hospital in adrenal crisis,” he said in an interview.

NASHVILLE, TENN. – All women should be assessed for cardiovascular disease in the antepartum and postpartum periods using a specific toolkit algorithm, according to new comprehensive guidance from the American College of Obstetricians and Gynecologists.

The toolkit algorithm is called the California Improving Health Care Response to Cardiovascular Disease in Pregnancy and Postpartum Toolkit. It was developed by the Cardiovascular Disease in Pregnancy Postpartum Task Force to serve as a resource for obstetrics, primary care and emergency medicine providers who provide prenatal care or interact with women during the postpartum period. It incldues an overview of clinical assessment and comprehensive management strategies for cardiovascular disease based on risk factors and presenting symptoms.

The guidance also calls for all pregnant and postpartum women with known or suspected CVD to undergo further evaluation by a “Pregnancy Heart Team that includes a cardiologist and maternal–fetal medicine subspecialist, or both, and other subspecialists as necessary.” The guidance was issued in Practice Bulletin 212, Pregnancy and Heart Disease, which is published in the May edition of Obstetrics & Gynecology (Obstet Gynecol. 2019 May;133[5]:e320-e356).


In all, 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period are included in the guidance.

ACOG president Lisa Hollier, MD, convened the task force that developed this guidance to address cardiac contributors to maternal mortality, she said during a press briefing at the ACOG annual clinical and scientific meeting.

“When I began my presidency a year ago, my goal was to bring together a multidisciplinary group of clinicians ... to create clinical guidance that would make a difference in the lives of women," said Dr. Hollier, who is also a professor of obstetrics and gynecology at Baylor College of Medicine, Houston. 

Jovanmandic/Getty Images

[email protected]

SOURCE: Hollier L et al., Obstet Gynecol. 2019 May;133[5]:e320-56.

NASHVILLE, TENN. – All women should be assessed for cardiovascular disease in the antepartum and postpartum periods using a specific toolkit algorithm, according to new comprehensive guidance from the American College of Obstetricians and Gynecologists.

The toolkit algorithm is called the California Improving Health Care Response to Cardiovascular Disease in Pregnancy and Postpartum Toolkit. It was developed by the Cardiovascular Disease in Pregnancy Postpartum Task Force to serve as a resource for obstetrics, primary care and emergency medicine providers who provide prenatal care or interact with women during the postpartum period. It incldues an overview of clinical assessment and comprehensive management strategies for cardiovascular disease based on risk factors and presenting symptoms.

The guidance also calls for all pregnant and postpartum women with known or suspected CVD to undergo further evaluation by a “Pregnancy Heart Team that includes a cardiologist and maternal–fetal medicine subspecialist, or both, and other subspecialists as necessary.” The guidance was issued in Practice Bulletin 212, Pregnancy and Heart Disease, which is published in the May edition of Obstetrics & Gynecology (Obstet Gynecol. 2019 May;133[5]:e320-e356).


In all, 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period are included in the guidance.

ACOG president Lisa Hollier, MD, convened the task force that developed this guidance to address cardiac contributors to maternal mortality, she said during a press briefing at the ACOG annual clinical and scientific meeting.

“When I began my presidency a year ago, my goal was to bring together a multidisciplinary group of clinicians ... to create clinical guidance that would make a difference in the lives of women," said Dr. Hollier, who is also a professor of obstetrics and gynecology at Baylor College of Medicine, Houston. 

Jovanmandic/Getty Images

[email protected]

SOURCE: Hollier L et al., Obstet Gynecol. 2019 May;133[5]:e320-56.

NASHVILLE, TENN. – All women should be assessed for cardiovascular disease in the antepartum and postpartum periods using a specific toolkit algorithm, according to new comprehensive guidance from the American College of Obstetricians and Gynecologists.

The toolkit algorithm is called the California Improving Health Care Response to Cardiovascular Disease in Pregnancy and Postpartum Toolkit. It was developed by the Cardiovascular Disease in Pregnancy Postpartum Task Force to serve as a resource for obstetrics, primary care and emergency medicine providers who provide prenatal care or interact with women during the postpartum period. It incldues an overview of clinical assessment and comprehensive management strategies for cardiovascular disease based on risk factors and presenting symptoms.

The guidance also calls for all pregnant and postpartum women with known or suspected CVD to undergo further evaluation by a “Pregnancy Heart Team that includes a cardiologist and maternal–fetal medicine subspecialist, or both, and other subspecialists as necessary.” The guidance was issued in Practice Bulletin 212, Pregnancy and Heart Disease, which is published in the May edition of Obstetrics & Gynecology (Obstet Gynecol. 2019 May;133[5]:e320-e356).


In all, 27 specific recommendations and conclusions relating to screening, diagnosis, and management of CVD for women during the prepregnancy period through the postpartum period are included in the guidance.

ACOG president Lisa Hollier, MD, convened the task force that developed this guidance to address cardiac contributors to maternal mortality, she said during a press briefing at the ACOG annual clinical and scientific meeting.

“When I began my presidency a year ago, my goal was to bring together a multidisciplinary group of clinicians ... to create clinical guidance that would make a difference in the lives of women," said Dr. Hollier, who is also a professor of obstetrics and gynecology at Baylor College of Medicine, Houston. 

Jovanmandic/Getty Images

[email protected]

SOURCE: Hollier L et al., Obstet Gynecol. 2019 May;133[5]:e320-56.

NEWPORT BEACH, CALIF. – The combination of oral rigosertib and azacitidine is proceeding to a phase 3 trial in patients with myelodysplastic syndromes (MDS), but it isn’t clear if the combination will continue to be developed for acute myeloid leukemia (AML).

In a phase 1/2 trial, oral rigosertib plus azacitidine produced a 90% response rate in higher-risk MDS patients who were naive to hypomethylating agents (HMAs), a 54% response rate in higher-risk MDS patients who had failed HMA therapy, and a 50% response rate in patients with AML.

Genitourinary toxicities were initially a concern in this trial, but researchers found ways to mitigate the risk of these toxicities, according to Richard Woodman, MD, chief medical officer and senior vice president of research and development at Onconova Therapeutics, the company developing rigosertib.

Dr. Woodman and his colleagues presented results from the phase 1/2 trial in two posters at the Acute Leukemia Forum of Hemedicus.

Results in AML

The researchers reported phase 1 results in 17 patients with AML. Eleven patients had AML, according to investigator assessment, and six patients had refractory anemia with excess blasts in transformation, according to French American British criteria, as well as least 20% excess blasts at baseline.

The median age of the patients was 73 years, and 53% were men. Two patients had received no prior therapies, six patients had relapsed disease, and nine were refractory to their last therapy.

Patients received oral rigosertib at escalating doses twice daily on days 1-21 of a 28-day cycle. The recommended phase 2 dose was 840 mg daily (560 mg in the morning and 280 mg in the afternoon), but there were two expansion cohorts in which patients received 1,120 mg daily (560 mg twice a day or 840 mg in the morning and 280 mg in the afternoon). The patients also received azacitidine at 75 mg/m² per day subcutaneously or intravenously for 7 days starting on day 8.

Patients received a median of three treatment cycles. Fifteen of the 17 patients (88%) discontinued treatment, most because of progressive disease (n = 5), toxicity (n = 4), or death (n = 3).

Twelve patients were evaluable for response, and six (50%) responded. One patient achieved a morphologic complete remission (CR), three achieved a morphologic leukemia-free state, and two had a partial response.

The most common treatment-emergent adverse events (TEAEs) were fatigue (53%), diarrhea (53%), nausea (53%), constipation (47%), back pain (41%), pyrexia (41%), and pneumonia (35%). Grade 3 or higher TEAEs included pneumonia (35%) and anemia (24%).

These results haven’t provided a clear way forward for oral rigosertib and azacitidine in AML. Dr. Woodman said the researchers will have to review past studies and evaluate how AML patients (with at least 20% blasts) have responded to intravenous rigosertib, consult experts in the field, and then decide how they will move forward with oral rigosertib and azacitidine in AML.

Results in MDS

Dr. Woodman and his colleagues presented data on 74 patients with higher-risk MDS. The median age was 69 years, and 59% were men. Most patients were high risk (n = 23) or very high risk (n = 33), according to the Revised International Prognostic Scoring System.

The patients received oral rigosertib at a dose of 840 mg/day or higher on days 1-21 of a 28-day cycle. They also received azacitidine at 75 mg/m² per day subcutaneously or intravenously for 7 days starting on day 8.

The median duration of treatment was 7.8 months in patients who were HMA naive and 4.9 months in patients who failed HMA therapy. The most common reasons for treatment discontinuation in the HMA-naive patients were toxicity (n = 8), progression (n = 7), and patient request (n = 7). The most common reasons for discontinuation in patients who had failed HMA therapy were progression (n = 12), toxicity (n = 5), and investigator decision (n = 4).

In total, 55 patients were evaluable for response, 26 who had failed HMA therapy and 29 who were HMA naive.

“The best responses, not surprisingly, were in patients that were HMA naive,” Dr. Woodman said.

In the HMA-naive patients, the overall response rate was 90%. Ten patients had a CR, five had a marrow CR with hematologic improvement, three had hematologic improvement alone, eight had a marrow CR alone, and three patients had stable disease. None of the patients progressed.

In the patients who had failed HMA therapy, the overall response rate was 54%. One patient achieved a CR, one had a partial response, five had a marrow CR with hematologic improvement, two had hematologic improvement alone, five had a marrow CR alone, seven had stable disease, and five progressed.

The median duration of response was 10.8 months in patients who failed HMA therapy and 12.2 months in the HMA-naive patients.

The most common TEAEs in the entire MDS cohort were hematuria (45%), constipation (43%), diarrhea (42%), fatigue (42%), dysuria (38%), pyrexia (36%), nausea (35%), neutropenia (31%), and thrombocytopenia (30%).

Grade 3 or higher TEAEs were neutropenia (27%), thrombocytopenia (26%), hematuria (9%), dysuria (9%), diarrhea (5%), fatigue (4%), and pyrexia (1%).

Dr. Woodman said patients who were most likely to be at risk for genitourinary toxicities (hematuria and dysuria) were those who weren’t well hydrated, took rigosertib at night, and didn’t void their bladders before bedtime. He said the researchers’ hypothesis is that there is some local bladder irritation in that setting.

However, the researchers found ways to mitigate the risk of genitourinary toxicities, including:

• Requiring the second dose of rigosertib to be taken in the afternoon rather than evening (about 3 p.m.).
• Asking patients to consume at least 2 liters of fluid per day.
• Having patients empty their bladders before bedtime.
• Assessing urine pH roughly 2 hours after the morning dose of rigosertib and prescribing sodium bicarbonate if the pH is less than 7.5.

Dr. Woodman said the phase 2 results in MDS patients have prompted the development of a phase 3 trial in which researchers will compare oral rigosertib plus azacitidine to azacitidine plus placebo.

Dr. Woodman is employed by Onconova Therapeutics, which sponsored the phase 1/2 trial. The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – The combination of oral rigosertib and azacitidine is proceeding to a phase 3 trial in patients with myelodysplastic syndromes (MDS), but it isn’t clear if the combination will continue to be developed for acute myeloid leukemia (AML).

In a phase 1/2 trial, oral rigosertib plus azacitidine produced a 90% response rate in higher-risk MDS patients who were naive to hypomethylating agents (HMAs), a 54% response rate in higher-risk MDS patients who had failed HMA therapy, and a 50% response rate in patients with AML.

Genitourinary toxicities were initially a concern in this trial, but researchers found ways to mitigate the risk of these toxicities, according to Richard Woodman, MD, chief medical officer and senior vice president of research and development at Onconova Therapeutics, the company developing rigosertib.

Dr. Woodman and his colleagues presented results from the phase 1/2 trial in two posters at the Acute Leukemia Forum of Hemedicus.

Results in AML

The researchers reported phase 1 results in 17 patients with AML. Eleven patients had AML, according to investigator assessment, and six patients had refractory anemia with excess blasts in transformation, according to French American British criteria, as well as least 20% excess blasts at baseline.

The median age of the patients was 73 years, and 53% were men. Two patients had received no prior therapies, six patients had relapsed disease, and nine were refractory to their last therapy.

Patients received oral rigosertib at escalating doses twice daily on days 1-21 of a 28-day cycle. The recommended phase 2 dose was 840 mg daily (560 mg in the morning and 280 mg in the afternoon), but there were two expansion cohorts in which patients received 1,120 mg daily (560 mg twice a day or 840 mg in the morning and 280 mg in the afternoon). The patients also received azacitidine at 75 mg/m² per day subcutaneously or intravenously for 7 days starting on day 8.

Patients received a median of three treatment cycles. Fifteen of the 17 patients (88%) discontinued treatment, most because of progressive disease (n = 5), toxicity (n = 4), or death (n = 3).

Twelve patients were evaluable for response, and six (50%) responded. One patient achieved a morphologic complete remission (CR), three achieved a morphologic leukemia-free state, and two had a partial response.

The most common treatment-emergent adverse events (TEAEs) were fatigue (53%), diarrhea (53%), nausea (53%), constipation (47%), back pain (41%), pyrexia (41%), and pneumonia (35%). Grade 3 or higher TEAEs included pneumonia (35%) and anemia (24%).

These results haven’t provided a clear way forward for oral rigosertib and azacitidine in AML. Dr. Woodman said the researchers will have to review past studies and evaluate how AML patients (with at least 20% blasts) have responded to intravenous rigosertib, consult experts in the field, and then decide how they will move forward with oral rigosertib and azacitidine in AML.

Results in MDS

Dr. Woodman and his colleagues presented data on 74 patients with higher-risk MDS. The median age was 69 years, and 59% were men. Most patients were high risk (n = 23) or very high risk (n = 33), according to the Revised International Prognostic Scoring System.

The patients received oral rigosertib at a dose of 840 mg/day or higher on days 1-21 of a 28-day cycle. They also received azacitidine at 75 mg/m² per day subcutaneously or intravenously for 7 days starting on day 8.

The median duration of treatment was 7.8 months in patients who were HMA naive and 4.9 months in patients who failed HMA therapy. The most common reasons for treatment discontinuation in the HMA-naive patients were toxicity (n = 8), progression (n = 7), and patient request (n = 7). The most common reasons for discontinuation in patients who had failed HMA therapy were progression (n = 12), toxicity (n = 5), and investigator decision (n = 4).

In total, 55 patients were evaluable for response, 26 who had failed HMA therapy and 29 who were HMA naive.

“The best responses, not surprisingly, were in patients that were HMA naive,” Dr. Woodman said.

In the HMA-naive patients, the overall response rate was 90%. Ten patients had a CR, five had a marrow CR with hematologic improvement, three had hematologic improvement alone, eight had a marrow CR alone, and three patients had stable disease. None of the patients progressed.

In the patients who had failed HMA therapy, the overall response rate was 54%. One patient achieved a CR, one had a partial response, five had a marrow CR with hematologic improvement, two had hematologic improvement alone, five had a marrow CR alone, seven had stable disease, and five progressed.

The median duration of response was 10.8 months in patients who failed HMA therapy and 12.2 months in the HMA-naive patients.

The most common TEAEs in the entire MDS cohort were hematuria (45%), constipation (43%), diarrhea (42%), fatigue (42%), dysuria (38%), pyrexia (36%), nausea (35%), neutropenia (31%), and thrombocytopenia (30%).

Grade 3 or higher TEAEs were neutropenia (27%), thrombocytopenia (26%), hematuria (9%), dysuria (9%), diarrhea (5%), fatigue (4%), and pyrexia (1%).

Dr. Woodman said patients who were most likely to be at risk for genitourinary toxicities (hematuria and dysuria) were those who weren’t well hydrated, took rigosertib at night, and didn’t void their bladders before bedtime. He said the researchers’ hypothesis is that there is some local bladder irritation in that setting.

However, the researchers found ways to mitigate the risk of genitourinary toxicities, including:

• Requiring the second dose of rigosertib to be taken in the afternoon rather than evening (about 3 p.m.).
• Asking patients to consume at least 2 liters of fluid per day.
• Having patients empty their bladders before bedtime.
• Assessing urine pH roughly 2 hours after the morning dose of rigosertib and prescribing sodium bicarbonate if the pH is less than 7.5.

Dr. Woodman said the phase 2 results in MDS patients have prompted the development of a phase 3 trial in which researchers will compare oral rigosertib plus azacitidine to azacitidine plus placebo.

Dr. Woodman is employed by Onconova Therapeutics, which sponsored the phase 1/2 trial. The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – The combination of oral rigosertib and azacitidine is proceeding to a phase 3 trial in patients with myelodysplastic syndromes (MDS), but it isn’t clear if the combination will continue to be developed for acute myeloid leukemia (AML).

In a phase 1/2 trial, oral rigosertib plus azacitidine produced a 90% response rate in higher-risk MDS patients who were naive to hypomethylating agents (HMAs), a 54% response rate in higher-risk MDS patients who had failed HMA therapy, and a 50% response rate in patients with AML.

Genitourinary toxicities were initially a concern in this trial, but researchers found ways to mitigate the risk of these toxicities, according to Richard Woodman, MD, chief medical officer and senior vice president of research and development at Onconova Therapeutics, the company developing rigosertib.

Dr. Woodman and his colleagues presented results from the phase 1/2 trial in two posters at the Acute Leukemia Forum of Hemedicus.

Results in AML

The researchers reported phase 1 results in 17 patients with AML. Eleven patients had AML, according to investigator assessment, and six patients had refractory anemia with excess blasts in transformation, according to French American British criteria, as well as least 20% excess blasts at baseline.

The median age of the patients was 73 years, and 53% were men. Two patients had received no prior therapies, six patients had relapsed disease, and nine were refractory to their last therapy.

Patients received oral rigosertib at escalating doses twice daily on days 1-21 of a 28-day cycle. The recommended phase 2 dose was 840 mg daily (560 mg in the morning and 280 mg in the afternoon), but there were two expansion cohorts in which patients received 1,120 mg daily (560 mg twice a day or 840 mg in the morning and 280 mg in the afternoon). The patients also received azacitidine at 75 mg/m² per day subcutaneously or intravenously for 7 days starting on day 8.

Patients received a median of three treatment cycles. Fifteen of the 17 patients (88%) discontinued treatment, most because of progressive disease (n = 5), toxicity (n = 4), or death (n = 3).

Twelve patients were evaluable for response, and six (50%) responded. One patient achieved a morphologic complete remission (CR), three achieved a morphologic leukemia-free state, and two had a partial response.

The most common treatment-emergent adverse events (TEAEs) were fatigue (53%), diarrhea (53%), nausea (53%), constipation (47%), back pain (41%), pyrexia (41%), and pneumonia (35%). Grade 3 or higher TEAEs included pneumonia (35%) and anemia (24%).

These results haven’t provided a clear way forward for oral rigosertib and azacitidine in AML. Dr. Woodman said the researchers will have to review past studies and evaluate how AML patients (with at least 20% blasts) have responded to intravenous rigosertib, consult experts in the field, and then decide how they will move forward with oral rigosertib and azacitidine in AML.

Results in MDS

Dr. Woodman and his colleagues presented data on 74 patients with higher-risk MDS. The median age was 69 years, and 59% were men. Most patients were high risk (n = 23) or very high risk (n = 33), according to the Revised International Prognostic Scoring System.

The patients received oral rigosertib at a dose of 840 mg/day or higher on days 1-21 of a 28-day cycle. They also received azacitidine at 75 mg/m² per day subcutaneously or intravenously for 7 days starting on day 8.

The median duration of treatment was 7.8 months in patients who were HMA naive and 4.9 months in patients who failed HMA therapy. The most common reasons for treatment discontinuation in the HMA-naive patients were toxicity (n = 8), progression (n = 7), and patient request (n = 7). The most common reasons for discontinuation in patients who had failed HMA therapy were progression (n = 12), toxicity (n = 5), and investigator decision (n = 4).

In total, 55 patients were evaluable for response, 26 who had failed HMA therapy and 29 who were HMA naive.

“The best responses, not surprisingly, were in patients that were HMA naive,” Dr. Woodman said.

In the HMA-naive patients, the overall response rate was 90%. Ten patients had a CR, five had a marrow CR with hematologic improvement, three had hematologic improvement alone, eight had a marrow CR alone, and three patients had stable disease. None of the patients progressed.

In the patients who had failed HMA therapy, the overall response rate was 54%. One patient achieved a CR, one had a partial response, five had a marrow CR with hematologic improvement, two had hematologic improvement alone, five had a marrow CR alone, seven had stable disease, and five progressed.

The median duration of response was 10.8 months in patients who failed HMA therapy and 12.2 months in the HMA-naive patients.

The most common TEAEs in the entire MDS cohort were hematuria (45%), constipation (43%), diarrhea (42%), fatigue (42%), dysuria (38%), pyrexia (36%), nausea (35%), neutropenia (31%), and thrombocytopenia (30%).

Grade 3 or higher TEAEs were neutropenia (27%), thrombocytopenia (26%), hematuria (9%), dysuria (9%), diarrhea (5%), fatigue (4%), and pyrexia (1%).

Dr. Woodman said patients who were most likely to be at risk for genitourinary toxicities (hematuria and dysuria) were those who weren’t well hydrated, took rigosertib at night, and didn’t void their bladders before bedtime. He said the researchers’ hypothesis is that there is some local bladder irritation in that setting.

However, the researchers found ways to mitigate the risk of genitourinary toxicities, including:

• Requiring the second dose of rigosertib to be taken in the afternoon rather than evening (about 3 p.m.).
• Asking patients to consume at least 2 liters of fluid per day.
• Having patients empty their bladders before bedtime.
• Assessing urine pH roughly 2 hours after the morning dose of rigosertib and prescribing sodium bicarbonate if the pH is less than 7.5.

Dr. Woodman said the phase 2 results in MDS patients have prompted the development of a phase 3 trial in which researchers will compare oral rigosertib plus azacitidine to azacitidine plus placebo.

Dr. Woodman is employed by Onconova Therapeutics, which sponsored the phase 1/2 trial. The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – Researchers say they’ve found an association between the percentage of cytogenetically abnormal cells at allogeneic stem cell transplant (ASCT) and posttransplant outcomes in patients with myelodysplastic syndromes (MDS).

Patients who had more than 60% cytogenetically abnormal cells at ASCT had significantly inferior overall survival (OS) and relapse-free survival (RFS), compared to patients with fewer abnormal cells.

Dipenkumar Modi, MD, of Barbara Ann Karmanos Cancer Institute at Wayne State University in Detroit, and his colleagues conducted this research and presented the results at the Acute Leukemia Forum of Hemedicus.

The researchers studied 109 adult MDS patients who underwent ASCT from January 2000 through December 2016. The patients were divided into three groups based on the percentage of cytogenetically abnormal cells at ASCT:

• Group 1 had less than 30% (n = 22)
• Group 2 had 30%-60% (n = 23)
• Group 3 had greater than 60% (n = 64).

Baseline characteristics were largely similar between the groups. However, patients in group 3 were significantly more likely than those in groups 1 and 2 to have del(5q) and monosomy 5+7 (P = .048).

Patients in group 1 had a significantly higher percentage of bone marrow transplants (as opposed to peripheral blood stem cell transplants) than patients in groups 2 and 3 (P = .039). And patients in group 1 had significantly fewer blasts at ASCT than patients in groups 2 and 3 (P = .011).

The researchers found no significant between-group differences in relapse and nonrelapse mortality, but there were significant differences in OS and RFS.

Patients in group 3 had inferior RFS compared to patients in group 1, which was the reference group. The hazard ratio (HR) was 2.503 (P = .013) in a univariable analysis and 2.196 (P = .049) in a multivariable analysis.

Group 3 also had inferior OS compared to group 1. The hazard ratio was 2.589 (P = .021) in a univariable analysis and 2.478 (P = .040) in a multivariable analysis.

There was no significant difference in RFS or OS between groups 1 and 2. The HR for RFS in group 2 was 1.879 (P = .148) in a univariable analysis and 1.365 (P = .506) in a multivariable analysis. The HR for OS was 1.997 (P = .155) and 1.413 (P = .511), respectively.

Dr. Modi said these results suggest patients with greater than 60% cytogenetically abnormal cells at ASCT should be monitored more closely after transplant, and their immunosuppressive medication should be tapered as soon as possible.

Dr. Modi and his colleagues reported having no conflicts of interest relevant to this research.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – Researchers say they’ve found an association between the percentage of cytogenetically abnormal cells at allogeneic stem cell transplant (ASCT) and posttransplant outcomes in patients with myelodysplastic syndromes (MDS).

Patients who had more than 60% cytogenetically abnormal cells at ASCT had significantly inferior overall survival (OS) and relapse-free survival (RFS), compared to patients with fewer abnormal cells.

Dipenkumar Modi, MD, of Barbara Ann Karmanos Cancer Institute at Wayne State University in Detroit, and his colleagues conducted this research and presented the results at the Acute Leukemia Forum of Hemedicus.

The researchers studied 109 adult MDS patients who underwent ASCT from January 2000 through December 2016. The patients were divided into three groups based on the percentage of cytogenetically abnormal cells at ASCT:

• Group 1 had less than 30% (n = 22)
• Group 2 had 30%-60% (n = 23)
• Group 3 had greater than 60% (n = 64).

Baseline characteristics were largely similar between the groups. However, patients in group 3 were significantly more likely than those in groups 1 and 2 to have del(5q) and monosomy 5+7 (P = .048).

Patients in group 1 had a significantly higher percentage of bone marrow transplants (as opposed to peripheral blood stem cell transplants) than patients in groups 2 and 3 (P = .039). And patients in group 1 had significantly fewer blasts at ASCT than patients in groups 2 and 3 (P = .011).

The researchers found no significant between-group differences in relapse and nonrelapse mortality, but there were significant differences in OS and RFS.

Patients in group 3 had inferior RFS compared to patients in group 1, which was the reference group. The hazard ratio (HR) was 2.503 (P = .013) in a univariable analysis and 2.196 (P = .049) in a multivariable analysis.

Group 3 also had inferior OS compared to group 1. The hazard ratio was 2.589 (P = .021) in a univariable analysis and 2.478 (P = .040) in a multivariable analysis.

There was no significant difference in RFS or OS between groups 1 and 2. The HR for RFS in group 2 was 1.879 (P = .148) in a univariable analysis and 1.365 (P = .506) in a multivariable analysis. The HR for OS was 1.997 (P = .155) and 1.413 (P = .511), respectively.

Dr. Modi said these results suggest patients with greater than 60% cytogenetically abnormal cells at ASCT should be monitored more closely after transplant, and their immunosuppressive medication should be tapered as soon as possible.

Dr. Modi and his colleagues reported having no conflicts of interest relevant to this research.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – Researchers say they’ve found an association between the percentage of cytogenetically abnormal cells at allogeneic stem cell transplant (ASCT) and posttransplant outcomes in patients with myelodysplastic syndromes (MDS).

Patients who had more than 60% cytogenetically abnormal cells at ASCT had significantly inferior overall survival (OS) and relapse-free survival (RFS), compared to patients with fewer abnormal cells.

Dipenkumar Modi, MD, of Barbara Ann Karmanos Cancer Institute at Wayne State University in Detroit, and his colleagues conducted this research and presented the results at the Acute Leukemia Forum of Hemedicus.

The researchers studied 109 adult MDS patients who underwent ASCT from January 2000 through December 2016. The patients were divided into three groups based on the percentage of cytogenetically abnormal cells at ASCT:

• Group 1 had less than 30% (n = 22)
• Group 2 had 30%-60% (n = 23)
• Group 3 had greater than 60% (n = 64).

Baseline characteristics were largely similar between the groups. However, patients in group 3 were significantly more likely than those in groups 1 and 2 to have del(5q) and monosomy 5+7 (P = .048).

Patients in group 1 had a significantly higher percentage of bone marrow transplants (as opposed to peripheral blood stem cell transplants) than patients in groups 2 and 3 (P = .039). And patients in group 1 had significantly fewer blasts at ASCT than patients in groups 2 and 3 (P = .011).

The researchers found no significant between-group differences in relapse and nonrelapse mortality, but there were significant differences in OS and RFS.

Patients in group 3 had inferior RFS compared to patients in group 1, which was the reference group. The hazard ratio (HR) was 2.503 (P = .013) in a univariable analysis and 2.196 (P = .049) in a multivariable analysis.

Group 3 also had inferior OS compared to group 1. The hazard ratio was 2.589 (P = .021) in a univariable analysis and 2.478 (P = .040) in a multivariable analysis.

There was no significant difference in RFS or OS between groups 1 and 2. The HR for RFS in group 2 was 1.879 (P = .148) in a univariable analysis and 1.365 (P = .506) in a multivariable analysis. The HR for OS was 1.997 (P = .155) and 1.413 (P = .511), respectively.

Dr. Modi said these results suggest patients with greater than 60% cytogenetically abnormal cells at ASCT should be monitored more closely after transplant, and their immunosuppressive medication should be tapered as soon as possible.

Dr. Modi and his colleagues reported having no conflicts of interest relevant to this research.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

LOS ANGELES – In patients with end-stage renal disease, women older than 50 years have a significantly higher mortality, compared with their male counterparts, results from an analysis of national data showed.

“The racial and ethnic disparities in the prevalence, treatment, risks, and outcomes of [hypertension] in patients with CKD [chronic kidney disease], are well recognized,” the study’s senior author, Ricardo Correa, MD, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “Whites have better control of blood pressure, compared with Hispanics or African Americans with CKD, for example. On the other hand, gender differences in the outcome of blood pressure control and mortality across the different CKD stages have been very poorly studied, with conflicting results.”

The importance of gender difference has been mostly the focus in cardiovascular diseases, he continued, with compelling data revealing a higher incidence in men than in women of similar age, and a menopause-associated increase in cardiovascular disease in women.

“Whether the same can be said for hypertension, remains to be elucidated,” said Dr. Correa, an endocrinologist who directs the diabetes and metabolism fellowship at the University of Arizona in Phoenix.

In what he said is the first study of its kind, Dr. Correa and his colleagues set out to determine if gender in the U.S. population and menopausal age affect the inpatient survival rate in hypertensive patients across different stages of CKD. They drew from the 2005-2012 National Inpatient Sample to identify 2,121,750 hospitalized hypertensive patients and compared a number of factors between men and women, including crude mortality and mortality per CKD stage, menopausal age, length of stay, and total hospital charges.

Of the 2,121,750 patients, 1,092,931 (52%) were men and 1,028,819 (48%) were women; their mean age was 65 years. Among women, 32% had stage 3 CKD, 15% had stage 4 disease, 3% had stage 5 CKD, and 54% had end-stage renal disease (ESRD). Among men, 33% had stage 3 CKD, 13% had stage 4 disease, 3% had stage 5 CKD, and 51% had ESRD. The researchers observed that in-hospital crude mortality was significantly higher for men, compared with a matched group of women at CKD stages 3 and 4 (3.09% vs. 3.29% for CDK 3; P less than .0001 and 4.05% vs. 4.36% for CDK 4; P = .0004), yet was nonsignificant among those with ESRD (4.68% vs. 4.83%; P = .45).

“One could hypothesize that cardiac remodeling in hemodialysis women may be different than that in hemodialysis men to the extent that it affects mortality,” Dr. Correa said. “However, it is unclear if the survival benefit for dialysis men is owing to the possibility of a selection bias or not. Dialysis women may not be receiving equal access to cardiovascular procedures or surgical interventions (arteriovenous fistula, for example) or women may not be offered adequate hemodialysis to the same extent as men are. Further investigations regarding sex-based differences in dialysis treatment are required.”

He acknowledged certain limitations of the study, including its observational design. “We lacked detailed information regarding the cause of death, dialysis efficiency, types of dialysis accesses, and left ventricular hypertrophy measurements. We did not account for transitions between different hemodialysis modalities [and] we do not have information about distances or traveling time to dialysis units.”

The study’s first author was Kelvin Tran, MD. The researchers reported having no financial disclosures.

[email protected]

LOS ANGELES – In patients with end-stage renal disease, women older than 50 years have a significantly higher mortality, compared with their male counterparts, results from an analysis of national data showed.

“The racial and ethnic disparities in the prevalence, treatment, risks, and outcomes of [hypertension] in patients with CKD [chronic kidney disease], are well recognized,” the study’s senior author, Ricardo Correa, MD, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “Whites have better control of blood pressure, compared with Hispanics or African Americans with CKD, for example. On the other hand, gender differences in the outcome of blood pressure control and mortality across the different CKD stages have been very poorly studied, with conflicting results.”

The importance of gender difference has been mostly the focus in cardiovascular diseases, he continued, with compelling data revealing a higher incidence in men than in women of similar age, and a menopause-associated increase in cardiovascular disease in women.

“Whether the same can be said for hypertension, remains to be elucidated,” said Dr. Correa, an endocrinologist who directs the diabetes and metabolism fellowship at the University of Arizona in Phoenix.

In what he said is the first study of its kind, Dr. Correa and his colleagues set out to determine if gender in the U.S. population and menopausal age affect the inpatient survival rate in hypertensive patients across different stages of CKD. They drew from the 2005-2012 National Inpatient Sample to identify 2,121,750 hospitalized hypertensive patients and compared a number of factors between men and women, including crude mortality and mortality per CKD stage, menopausal age, length of stay, and total hospital charges.

Of the 2,121,750 patients, 1,092,931 (52%) were men and 1,028,819 (48%) were women; their mean age was 65 years. Among women, 32% had stage 3 CKD, 15% had stage 4 disease, 3% had stage 5 CKD, and 54% had end-stage renal disease (ESRD). Among men, 33% had stage 3 CKD, 13% had stage 4 disease, 3% had stage 5 CKD, and 51% had ESRD. The researchers observed that in-hospital crude mortality was significantly higher for men, compared with a matched group of women at CKD stages 3 and 4 (3.09% vs. 3.29% for CDK 3; P less than .0001 and 4.05% vs. 4.36% for CDK 4; P = .0004), yet was nonsignificant among those with ESRD (4.68% vs. 4.83%; P = .45).

“One could hypothesize that cardiac remodeling in hemodialysis women may be different than that in hemodialysis men to the extent that it affects mortality,” Dr. Correa said. “However, it is unclear if the survival benefit for dialysis men is owing to the possibility of a selection bias or not. Dialysis women may not be receiving equal access to cardiovascular procedures or surgical interventions (arteriovenous fistula, for example) or women may not be offered adequate hemodialysis to the same extent as men are. Further investigations regarding sex-based differences in dialysis treatment are required.”

He acknowledged certain limitations of the study, including its observational design. “We lacked detailed information regarding the cause of death, dialysis efficiency, types of dialysis accesses, and left ventricular hypertrophy measurements. We did not account for transitions between different hemodialysis modalities [and] we do not have information about distances or traveling time to dialysis units.”

The study’s first author was Kelvin Tran, MD. The researchers reported having no financial disclosures.

[email protected]

LOS ANGELES – In patients with end-stage renal disease, women older than 50 years have a significantly higher mortality, compared with their male counterparts, results from an analysis of national data showed.

“The racial and ethnic disparities in the prevalence, treatment, risks, and outcomes of [hypertension] in patients with CKD [chronic kidney disease], are well recognized,” the study’s senior author, Ricardo Correa, MD, said in an interview in advance of the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “Whites have better control of blood pressure, compared with Hispanics or African Americans with CKD, for example. On the other hand, gender differences in the outcome of blood pressure control and mortality across the different CKD stages have been very poorly studied, with conflicting results.”

The importance of gender difference has been mostly the focus in cardiovascular diseases, he continued, with compelling data revealing a higher incidence in men than in women of similar age, and a menopause-associated increase in cardiovascular disease in women.

“Whether the same can be said for hypertension, remains to be elucidated,” said Dr. Correa, an endocrinologist who directs the diabetes and metabolism fellowship at the University of Arizona in Phoenix.

In what he said is the first study of its kind, Dr. Correa and his colleagues set out to determine if gender in the U.S. population and menopausal age affect the inpatient survival rate in hypertensive patients across different stages of CKD. They drew from the 2005-2012 National Inpatient Sample to identify 2,121,750 hospitalized hypertensive patients and compared a number of factors between men and women, including crude mortality and mortality per CKD stage, menopausal age, length of stay, and total hospital charges.

Of the 2,121,750 patients, 1,092,931 (52%) were men and 1,028,819 (48%) were women; their mean age was 65 years. Among women, 32% had stage 3 CKD, 15% had stage 4 disease, 3% had stage 5 CKD, and 54% had end-stage renal disease (ESRD). Among men, 33% had stage 3 CKD, 13% had stage 4 disease, 3% had stage 5 CKD, and 51% had ESRD. The researchers observed that in-hospital crude mortality was significantly higher for men, compared with a matched group of women at CKD stages 3 and 4 (3.09% vs. 3.29% for CDK 3; P less than .0001 and 4.05% vs. 4.36% for CDK 4; P = .0004), yet was nonsignificant among those with ESRD (4.68% vs. 4.83%; P = .45).

“One could hypothesize that cardiac remodeling in hemodialysis women may be different than that in hemodialysis men to the extent that it affects mortality,” Dr. Correa said. “However, it is unclear if the survival benefit for dialysis men is owing to the possibility of a selection bias or not. Dialysis women may not be receiving equal access to cardiovascular procedures or surgical interventions (arteriovenous fistula, for example) or women may not be offered adequate hemodialysis to the same extent as men are. Further investigations regarding sex-based differences in dialysis treatment are required.”

He acknowledged certain limitations of the study, including its observational design. “We lacked detailed information regarding the cause of death, dialysis efficiency, types of dialysis accesses, and left ventricular hypertrophy measurements. We did not account for transitions between different hemodialysis modalities [and] we do not have information about distances or traveling time to dialysis units.”

The study’s first author was Kelvin Tran, MD. The researchers reported having no financial disclosures.

[email protected]