PHILADELPHIA—The Society of Hospital Medicine (SHM) is pleased to announce the introduction of a dedicated billing code for hospitalists by the Centers for Medicare & Medicaid Services (CMS). This decision comes in response to concerted advocacy efforts from SHM for CMS to recognize the specialty. This is a monumental step for hospital medicine, which continues to be the fastest growing medical specialty in the United States with over 48,000 practitioners identifying as hospitalists, growing from approximately 1,000 in the mid-1990s.

“We see each day that hospitalists are driving positive change in healthcare, and this recognition by CMS affirms that hospital medicine is growing both in scope and impact,” notes Laurence Wellikson, MD, MHM, CEO of SHM. “The ability for hospital medicine practitioners to differentiate themselves from providers in other specialties will have a huge impact, particularly for upcoming value-based or pay-for-performance programs.”

Until now, hospitalists could only compare performance to that of practitioners in internal medicine or another related specialty. This new billing code will allow hospitalists to appropriately benchmark and focus improvement efforts with others in the hospital medicine specialty, facilitating more accurate comparisons and fairer assessments of hospitalist performance.

Despite varied training backgrounds, hospitalists have become focused within their own unique specialty, dedicated to providing care to hospitalized patients and working toward high-quality, patient-centered care in the hospital. They have developed institutional-based skills that differentiate them from practitioners in other specialties, such as internal and family medicine. Their specialized expertise includes improving both the efficiency and safety of care for hospitalized patients and the ability to manage and innovate in a hospital’s team-based environment.

This momentous decision coincides with the twenty-year anniversary of the coining of the term ‘hospitalist’ by Robert Wachter, MD, MHM, and Lee Goldman, MD in the New England Journal of Medicine. In recognition of this anniversary, SHM introduced a year-long celebration, the “Year of the Hospitalist,” to commemorate the specialty’s continued success and bright future.

“We have known who we are for years, and the special role that hospitalists play in the well-being of our patients, communities and health systems,” explains Brian Harte, MD, SFHM, president-elect of SHM. “The hospitalist provider code will provide Medicare and other players in the healthcare system an important new tool to better understand and acknowledge the critical role we play in the care of hospitalized patients nationwide.”

Lisa Zoks is SHM's Vice-President of Communications.

ABOUT SHM

Representing the fastest growing specialty in modern healthcare, SHM is the leading medical society for more than 48,000 hospitalists and their patients. SHM is dedicated to promoting the highest quality care for all hospitalized patients and overall excellence in the practice of hospital medicine through quality improvement, education, advocacy and research. Over the past decade, studies have shown that hospitalists can contribute to decreased patient lengths of stay, reductions in hospital costs and readmission rates, and increased patient satisfaction.

PHILADELPHIA—The Society of Hospital Medicine (SHM) is pleased to announce the introduction of a dedicated billing code for hospitalists by the Centers for Medicare & Medicaid Services (CMS). This decision comes in response to concerted advocacy efforts from SHM for CMS to recognize the specialty. This is a monumental step for hospital medicine, which continues to be the fastest growing medical specialty in the United States with over 48,000 practitioners identifying as hospitalists, growing from approximately 1,000 in the mid-1990s.

“We see each day that hospitalists are driving positive change in healthcare, and this recognition by CMS affirms that hospital medicine is growing both in scope and impact,” notes Laurence Wellikson, MD, MHM, CEO of SHM. “The ability for hospital medicine practitioners to differentiate themselves from providers in other specialties will have a huge impact, particularly for upcoming value-based or pay-for-performance programs.”

Until now, hospitalists could only compare performance to that of practitioners in internal medicine or another related specialty. This new billing code will allow hospitalists to appropriately benchmark and focus improvement efforts with others in the hospital medicine specialty, facilitating more accurate comparisons and fairer assessments of hospitalist performance.

Despite varied training backgrounds, hospitalists have become focused within their own unique specialty, dedicated to providing care to hospitalized patients and working toward high-quality, patient-centered care in the hospital. They have developed institutional-based skills that differentiate them from practitioners in other specialties, such as internal and family medicine. Their specialized expertise includes improving both the efficiency and safety of care for hospitalized patients and the ability to manage and innovate in a hospital’s team-based environment.

This momentous decision coincides with the twenty-year anniversary of the coining of the term ‘hospitalist’ by Robert Wachter, MD, MHM, and Lee Goldman, MD in the New England Journal of Medicine. In recognition of this anniversary, SHM introduced a year-long celebration, the “Year of the Hospitalist,” to commemorate the specialty’s continued success and bright future.

“We have known who we are for years, and the special role that hospitalists play in the well-being of our patients, communities and health systems,” explains Brian Harte, MD, SFHM, president-elect of SHM. “The hospitalist provider code will provide Medicare and other players in the healthcare system an important new tool to better understand and acknowledge the critical role we play in the care of hospitalized patients nationwide.”

Lisa Zoks is SHM's Vice-President of Communications.

ABOUT SHM

Representing the fastest growing specialty in modern healthcare, SHM is the leading medical society for more than 48,000 hospitalists and their patients. SHM is dedicated to promoting the highest quality care for all hospitalized patients and overall excellence in the practice of hospital medicine through quality improvement, education, advocacy and research. Over the past decade, studies have shown that hospitalists can contribute to decreased patient lengths of stay, reductions in hospital costs and readmission rates, and increased patient satisfaction.

PHILADELPHIA—The Society of Hospital Medicine (SHM) is pleased to announce the introduction of a dedicated billing code for hospitalists by the Centers for Medicare & Medicaid Services (CMS). This decision comes in response to concerted advocacy efforts from SHM for CMS to recognize the specialty. This is a monumental step for hospital medicine, which continues to be the fastest growing medical specialty in the United States with over 48,000 practitioners identifying as hospitalists, growing from approximately 1,000 in the mid-1990s.

“We see each day that hospitalists are driving positive change in healthcare, and this recognition by CMS affirms that hospital medicine is growing both in scope and impact,” notes Laurence Wellikson, MD, MHM, CEO of SHM. “The ability for hospital medicine practitioners to differentiate themselves from providers in other specialties will have a huge impact, particularly for upcoming value-based or pay-for-performance programs.”

Until now, hospitalists could only compare performance to that of practitioners in internal medicine or another related specialty. This new billing code will allow hospitalists to appropriately benchmark and focus improvement efforts with others in the hospital medicine specialty, facilitating more accurate comparisons and fairer assessments of hospitalist performance.

Despite varied training backgrounds, hospitalists have become focused within their own unique specialty, dedicated to providing care to hospitalized patients and working toward high-quality, patient-centered care in the hospital. They have developed institutional-based skills that differentiate them from practitioners in other specialties, such as internal and family medicine. Their specialized expertise includes improving both the efficiency and safety of care for hospitalized patients and the ability to manage and innovate in a hospital’s team-based environment.

This momentous decision coincides with the twenty-year anniversary of the coining of the term ‘hospitalist’ by Robert Wachter, MD, MHM, and Lee Goldman, MD in the New England Journal of Medicine. In recognition of this anniversary, SHM introduced a year-long celebration, the “Year of the Hospitalist,” to commemorate the specialty’s continued success and bright future.

“We have known who we are for years, and the special role that hospitalists play in the well-being of our patients, communities and health systems,” explains Brian Harte, MD, SFHM, president-elect of SHM. “The hospitalist provider code will provide Medicare and other players in the healthcare system an important new tool to better understand and acknowledge the critical role we play in the care of hospitalized patients nationwide.”

Lisa Zoks is SHM's Vice-President of Communications.

ABOUT SHM

Representing the fastest growing specialty in modern healthcare, SHM is the leading medical society for more than 48,000 hospitalists and their patients. SHM is dedicated to promoting the highest quality care for all hospitalized patients and overall excellence in the practice of hospital medicine through quality improvement, education, advocacy and research. Over the past decade, studies have shown that hospitalists can contribute to decreased patient lengths of stay, reductions in hospital costs and readmission rates, and increased patient satisfaction.

ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.

The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.

The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m²), and was subsequently stopped early for futility for all patients.

“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.

Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.

Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.

Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.

For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.

For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.

Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.

The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.

AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.

The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.

Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.

The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.

In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.

Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.

After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.

The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.

koakes@frontlinemedcom.com

On Twitter @karioakes

ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.

The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.

The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m²), and was subsequently stopped early for futility for all patients.

“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.

Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.

Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.

Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.

For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.

For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.

Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.

The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.

AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.

The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.

Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.

The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.

In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.

Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.

After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.

The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.

koakes@frontlinemedcom.com

On Twitter @karioakes

ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.

The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.

The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m²), and was subsequently stopped early for futility for all patients.

“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.

Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.

Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.

Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.

For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.

For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.

Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.

The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.

AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.

The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.

Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.

The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.

In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.

Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.

After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.

The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.

koakes@frontlinemedcom.com

On Twitter @karioakes

NEW ORLEANS – Treatment with fingolimod improved gait impairment in treatment-naive multiple sclerosis (MS) patients and those on a previous first-line therapy in a small, single-center study.

“Fingolimod [Gilenya] is the first disease-modifying treatment shown to improve gait impairment in MS,” commented Dr. Soledad Pérez-Sánchez of Virgen Macarena University Hospital, Seville, Spain, who presented the study as a poster at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

©solitude72/iStockphoto

The investigators also found that patients who were unsuccessfully treated with natalizumab (Tysabri) prior to fingolimod did not improve their gait during the course of the 6-month study. Natalizumab is a second-line drug in Spain, and fingolimod is a second-line therapy there as well, except in cases of aggressive onset of disease, according to the investigators.

Of 36 patients in the study, 24 were treatment-naïve/first-line patients (17 females and 7 males; mean age, 38.25 years), with the remaining 12 (9 females, 3 males; mean age, 44.25 years) having been treated with natalizumab. The mean duration of MS was 11.2 years in the naïve/first-line group and 17.9 years in patients on natalizumab prior to fingolimod. The mean Extended Disability Status Scale score in the two groups was similar at 3.79 and 3.38, respectively.

The investigators measured gait profile changes during fingolimod treatment with the Gaitrite Electronic System, which comprises an electronic pathway equipped with sensors designed to measure the timing and position of walking. The measurement parameters included velocity, ambulation time, and functional ambulation profile (FAP), the time to move unassisted through five common environmental terrains.

All patients completed the walking test prior to treatment and 3 months after treatment. At 6 months, 20 naïve/first-line patients and 11 patients previously on natalizumab completed the test. For each group of patients, the results prior to treatment and 3 months after were statistically similar. But significant differences were evident for naïve/first-line patients between the 3- and 6-month measures of velocity (89.10±31.03 to 100.70±23.75 cm/s; P = .01) and FAP (82.81±16.93 to 91.95±9.02 seconds; P = .01). These measurements trended toward significance when the values prior to treatment and 6 months after treatment were compared (P = .096, .077, and .065, in the same respective order).

Patients who had been treated with natalizumab did not display appreciable changes in velocity, ambulation time, and FAP.

“Our study shows that fingolimod improves gait impairment in naïve patients and those switched from first-line therapy. Our data are consistent with other clinical measures published so far which have pointed to better outcomes with fingolimod in naïve/first-line patients than in natalizumab-switched patients,” Dr. Pérez-Sánchez and her colleagues said.

The single-center study design and small number of patients limit any conclusions on the use of fingolimod as a gait-improving therapy in MS until further studies are completed, according to the researchers.

Funding was provided by Novartis. Dr. Pérez-Sánchez had no disclosures.

NEW ORLEANS – Treatment with fingolimod improved gait impairment in treatment-naive multiple sclerosis (MS) patients and those on a previous first-line therapy in a small, single-center study.

“Fingolimod [Gilenya] is the first disease-modifying treatment shown to improve gait impairment in MS,” commented Dr. Soledad Pérez-Sánchez of Virgen Macarena University Hospital, Seville, Spain, who presented the study as a poster at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

©solitude72/iStockphoto

The investigators also found that patients who were unsuccessfully treated with natalizumab (Tysabri) prior to fingolimod did not improve their gait during the course of the 6-month study. Natalizumab is a second-line drug in Spain, and fingolimod is a second-line therapy there as well, except in cases of aggressive onset of disease, according to the investigators.

Of 36 patients in the study, 24 were treatment-naïve/first-line patients (17 females and 7 males; mean age, 38.25 years), with the remaining 12 (9 females, 3 males; mean age, 44.25 years) having been treated with natalizumab. The mean duration of MS was 11.2 years in the naïve/first-line group and 17.9 years in patients on natalizumab prior to fingolimod. The mean Extended Disability Status Scale score in the two groups was similar at 3.79 and 3.38, respectively.

The investigators measured gait profile changes during fingolimod treatment with the Gaitrite Electronic System, which comprises an electronic pathway equipped with sensors designed to measure the timing and position of walking. The measurement parameters included velocity, ambulation time, and functional ambulation profile (FAP), the time to move unassisted through five common environmental terrains.

All patients completed the walking test prior to treatment and 3 months after treatment. At 6 months, 20 naïve/first-line patients and 11 patients previously on natalizumab completed the test. For each group of patients, the results prior to treatment and 3 months after were statistically similar. But significant differences were evident for naïve/first-line patients between the 3- and 6-month measures of velocity (89.10±31.03 to 100.70±23.75 cm/s; P = .01) and FAP (82.81±16.93 to 91.95±9.02 seconds; P = .01). These measurements trended toward significance when the values prior to treatment and 6 months after treatment were compared (P = .096, .077, and .065, in the same respective order).

Patients who had been treated with natalizumab did not display appreciable changes in velocity, ambulation time, and FAP.

“Our study shows that fingolimod improves gait impairment in naïve patients and those switched from first-line therapy. Our data are consistent with other clinical measures published so far which have pointed to better outcomes with fingolimod in naïve/first-line patients than in natalizumab-switched patients,” Dr. Pérez-Sánchez and her colleagues said.

The single-center study design and small number of patients limit any conclusions on the use of fingolimod as a gait-improving therapy in MS until further studies are completed, according to the researchers.

Funding was provided by Novartis. Dr. Pérez-Sánchez had no disclosures.

NEW ORLEANS – Treatment with fingolimod improved gait impairment in treatment-naive multiple sclerosis (MS) patients and those on a previous first-line therapy in a small, single-center study.

“Fingolimod [Gilenya] is the first disease-modifying treatment shown to improve gait impairment in MS,” commented Dr. Soledad Pérez-Sánchez of Virgen Macarena University Hospital, Seville, Spain, who presented the study as a poster at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

©solitude72/iStockphoto

The investigators also found that patients who were unsuccessfully treated with natalizumab (Tysabri) prior to fingolimod did not improve their gait during the course of the 6-month study. Natalizumab is a second-line drug in Spain, and fingolimod is a second-line therapy there as well, except in cases of aggressive onset of disease, according to the investigators.

Of 36 patients in the study, 24 were treatment-naïve/first-line patients (17 females and 7 males; mean age, 38.25 years), with the remaining 12 (9 females, 3 males; mean age, 44.25 years) having been treated with natalizumab. The mean duration of MS was 11.2 years in the naïve/first-line group and 17.9 years in patients on natalizumab prior to fingolimod. The mean Extended Disability Status Scale score in the two groups was similar at 3.79 and 3.38, respectively.

The investigators measured gait profile changes during fingolimod treatment with the Gaitrite Electronic System, which comprises an electronic pathway equipped with sensors designed to measure the timing and position of walking. The measurement parameters included velocity, ambulation time, and functional ambulation profile (FAP), the time to move unassisted through five common environmental terrains.

All patients completed the walking test prior to treatment and 3 months after treatment. At 6 months, 20 naïve/first-line patients and 11 patients previously on natalizumab completed the test. For each group of patients, the results prior to treatment and 3 months after were statistically similar. But significant differences were evident for naïve/first-line patients between the 3- and 6-month measures of velocity (89.10±31.03 to 100.70±23.75 cm/s; P = .01) and FAP (82.81±16.93 to 91.95±9.02 seconds; P = .01). These measurements trended toward significance when the values prior to treatment and 6 months after treatment were compared (P = .096, .077, and .065, in the same respective order).

Patients who had been treated with natalizumab did not display appreciable changes in velocity, ambulation time, and FAP.

“Our study shows that fingolimod improves gait impairment in naïve patients and those switched from first-line therapy. Our data are consistent with other clinical measures published so far which have pointed to better outcomes with fingolimod in naïve/first-line patients than in natalizumab-switched patients,” Dr. Pérez-Sánchez and her colleagues said.

The single-center study design and small number of patients limit any conclusions on the use of fingolimod as a gait-improving therapy in MS until further studies are completed, according to the researchers.

Funding was provided by Novartis. Dr. Pérez-Sánchez had no disclosures.

Drug release in a cancer cell

Image courtesy of PNAS

DNA origami nanostructures may be used to overcome drug resistance in acute myeloid leukemia (AML), according to preclinical research published in the journal Small.

Researchers found they could create these nanostructures in 10 minutes and load them with the anthracycline daunorubicin.

When the team introduced the structures to daunorubicin-resistant AML cells, the drug delivery vehicles entered the cells via endocytosis.

This allowed the drug to bypass defenses in the cell membrane that are effective against the free drug.

Once the nanostructures broke down, daunorubicin flooded the cells and killed them off.

Other research groups have used this delivery technique to overcome drug resistance in solid tumors, but this is the first time researchers have shown the same technique works on drug-resistant leukemia cells.

To create the DNA origami nanostructures, the researchers used the genome of a common bacteriophage and synthetic strands that were designed to fold up the bacteriophage DNA.

Although the folded-up shape performs a function, the DNA itself does not, explained Patrick Halley, a graduate student at The Ohio State University in Columbus.

“[T]he DNA capsule doesn’t do anything except hold a shape,” Halley said. “It’s just a static, rigid structure that carries things. It doesn’t encode any proteins or do anything else that we normally think of DNA as doing.”

The researchers tested the DNA origami nanostructures in AML cell lines that had developed resistance to daunorubicin. When molecules of daunorubicin enter these cells, the cells recognize the drug molecules and eject them through openings in the cell wall.

“Cancer cells have novel ways of resisting drugs, like these ‘pumps,’ and the exciting part of packaging the drug this way is that we can circumvent those defenses so that the drug accumulates in the cancer cell and causes it to die,” said John Byrd, MD, of The Ohio State University.

“Potentially, we can also tailor these structures to make them deliver drugs selectively to cancer cells and not to other parts of the body where they can cause side effects.”

In tests, the resistant AML cells effectively absorbed molecules of daunorubicin when they were hidden inside the rod-shaped nanostructures.

The researchers tracked the nanostructures inside the cells using fluorescent tags. Each structure measures about 15 nanometers wide and 100 nanometers long, and each has 4 hollow, open-ended interior compartments.

Study author Christopher Lucas, PhD, of The Ohio State University, said the design of the nanostructures maximizes the surface area available to carry the drug.

“The way daunorubicin works is it tucks into the cancer cell’s DNA and prevents it from replicating,” Dr Lucas said. “So we designed a capsule structure that would have lots of accessible DNA base-pairs for it to tuck into. When the capsule breaks down, the drug molecules are freed to flood the cell.”

The researchers said they designed the nanostructures to be strong and stable so they wouldn’t fully disintegrate and release the bulk of the drug until it was too late for the cells to eject them.

And that’s what the team observed with a fluorescence microscope. The cells drew the nanostructures into the organelles that would normally digest them (if they were food).

When the nanostructures broke down, the drug flooded the cells and caused them to disintegrate. Most cells died within the first 15 hours after consuming the nanostructures.

“DNA origami nanostructures have a lot of potential for drug delivery, not just for making effective drug delivery vehicles, but enabling new ways to study drug delivery,” said Carlos Castro, PhD, of The Ohio State University.

“For instance, we can vary the shape or mechanical stiffness of a structure very precisely and see how that affects entry into cells.”

Dr Castro said he hopes to create a streamlined and economically viable process for building DNA origami nanostructures as part of a modular drug delivery system.

Dr Byrd said the technique should work on most any form of drug-resistant cancer if further research shows it can be translated to animal models.

Drug release in a cancer cell

Image courtesy of PNAS

DNA origami nanostructures may be used to overcome drug resistance in acute myeloid leukemia (AML), according to preclinical research published in the journal Small.

Researchers found they could create these nanostructures in 10 minutes and load them with the anthracycline daunorubicin.

When the team introduced the structures to daunorubicin-resistant AML cells, the drug delivery vehicles entered the cells via endocytosis.

This allowed the drug to bypass defenses in the cell membrane that are effective against the free drug.

Once the nanostructures broke down, daunorubicin flooded the cells and killed them off.

Other research groups have used this delivery technique to overcome drug resistance in solid tumors, but this is the first time researchers have shown the same technique works on drug-resistant leukemia cells.

To create the DNA origami nanostructures, the researchers used the genome of a common bacteriophage and synthetic strands that were designed to fold up the bacteriophage DNA.

Although the folded-up shape performs a function, the DNA itself does not, explained Patrick Halley, a graduate student at The Ohio State University in Columbus.

“[T]he DNA capsule doesn’t do anything except hold a shape,” Halley said. “It’s just a static, rigid structure that carries things. It doesn’t encode any proteins or do anything else that we normally think of DNA as doing.”

The researchers tested the DNA origami nanostructures in AML cell lines that had developed resistance to daunorubicin. When molecules of daunorubicin enter these cells, the cells recognize the drug molecules and eject them through openings in the cell wall.

“Cancer cells have novel ways of resisting drugs, like these ‘pumps,’ and the exciting part of packaging the drug this way is that we can circumvent those defenses so that the drug accumulates in the cancer cell and causes it to die,” said John Byrd, MD, of The Ohio State University.

“Potentially, we can also tailor these structures to make them deliver drugs selectively to cancer cells and not to other parts of the body where they can cause side effects.”

In tests, the resistant AML cells effectively absorbed molecules of daunorubicin when they were hidden inside the rod-shaped nanostructures.

The researchers tracked the nanostructures inside the cells using fluorescent tags. Each structure measures about 15 nanometers wide and 100 nanometers long, and each has 4 hollow, open-ended interior compartments.

Study author Christopher Lucas, PhD, of The Ohio State University, said the design of the nanostructures maximizes the surface area available to carry the drug.

“The way daunorubicin works is it tucks into the cancer cell’s DNA and prevents it from replicating,” Dr Lucas said. “So we designed a capsule structure that would have lots of accessible DNA base-pairs for it to tuck into. When the capsule breaks down, the drug molecules are freed to flood the cell.”

The researchers said they designed the nanostructures to be strong and stable so they wouldn’t fully disintegrate and release the bulk of the drug until it was too late for the cells to eject them.

And that’s what the team observed with a fluorescence microscope. The cells drew the nanostructures into the organelles that would normally digest them (if they were food).

When the nanostructures broke down, the drug flooded the cells and caused them to disintegrate. Most cells died within the first 15 hours after consuming the nanostructures.

“DNA origami nanostructures have a lot of potential for drug delivery, not just for making effective drug delivery vehicles, but enabling new ways to study drug delivery,” said Carlos Castro, PhD, of The Ohio State University.

“For instance, we can vary the shape or mechanical stiffness of a structure very precisely and see how that affects entry into cells.”

Dr Castro said he hopes to create a streamlined and economically viable process for building DNA origami nanostructures as part of a modular drug delivery system.

Dr Byrd said the technique should work on most any form of drug-resistant cancer if further research shows it can be translated to animal models.

Drug release in a cancer cell

Image courtesy of PNAS

DNA origami nanostructures may be used to overcome drug resistance in acute myeloid leukemia (AML), according to preclinical research published in the journal Small.

Researchers found they could create these nanostructures in 10 minutes and load them with the anthracycline daunorubicin.

When the team introduced the structures to daunorubicin-resistant AML cells, the drug delivery vehicles entered the cells via endocytosis.

This allowed the drug to bypass defenses in the cell membrane that are effective against the free drug.

Once the nanostructures broke down, daunorubicin flooded the cells and killed them off.

Other research groups have used this delivery technique to overcome drug resistance in solid tumors, but this is the first time researchers have shown the same technique works on drug-resistant leukemia cells.

To create the DNA origami nanostructures, the researchers used the genome of a common bacteriophage and synthetic strands that were designed to fold up the bacteriophage DNA.

Although the folded-up shape performs a function, the DNA itself does not, explained Patrick Halley, a graduate student at The Ohio State University in Columbus.

“[T]he DNA capsule doesn’t do anything except hold a shape,” Halley said. “It’s just a static, rigid structure that carries things. It doesn’t encode any proteins or do anything else that we normally think of DNA as doing.”

The researchers tested the DNA origami nanostructures in AML cell lines that had developed resistance to daunorubicin. When molecules of daunorubicin enter these cells, the cells recognize the drug molecules and eject them through openings in the cell wall.

“Cancer cells have novel ways of resisting drugs, like these ‘pumps,’ and the exciting part of packaging the drug this way is that we can circumvent those defenses so that the drug accumulates in the cancer cell and causes it to die,” said John Byrd, MD, of The Ohio State University.

“Potentially, we can also tailor these structures to make them deliver drugs selectively to cancer cells and not to other parts of the body where they can cause side effects.”

In tests, the resistant AML cells effectively absorbed molecules of daunorubicin when they were hidden inside the rod-shaped nanostructures.

The researchers tracked the nanostructures inside the cells using fluorescent tags. Each structure measures about 15 nanometers wide and 100 nanometers long, and each has 4 hollow, open-ended interior compartments.

Study author Christopher Lucas, PhD, of The Ohio State University, said the design of the nanostructures maximizes the surface area available to carry the drug.

“The way daunorubicin works is it tucks into the cancer cell’s DNA and prevents it from replicating,” Dr Lucas said. “So we designed a capsule structure that would have lots of accessible DNA base-pairs for it to tuck into. When the capsule breaks down, the drug molecules are freed to flood the cell.”

The researchers said they designed the nanostructures to be strong and stable so they wouldn’t fully disintegrate and release the bulk of the drug until it was too late for the cells to eject them.

And that’s what the team observed with a fluorescence microscope. The cells drew the nanostructures into the organelles that would normally digest them (if they were food).

When the nanostructures broke down, the drug flooded the cells and caused them to disintegrate. Most cells died within the first 15 hours after consuming the nanostructures.

“DNA origami nanostructures have a lot of potential for drug delivery, not just for making effective drug delivery vehicles, but enabling new ways to study drug delivery,” said Carlos Castro, PhD, of The Ohio State University.

“For instance, we can vary the shape or mechanical stiffness of a structure very precisely and see how that affects entry into cells.”

Dr Castro said he hopes to create a streamlined and economically viable process for building DNA origami nanostructures as part of a modular drug delivery system.

Dr Byrd said the technique should work on most any form of drug-resistant cancer if further research shows it can be translated to animal models.

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new report suggests African Americans (AAs) have significantly lower rates of most hematologic malignancies than non-Hispanic white (NHW) individuals in the US.

AAs of both sexes had significantly lower rates of leukemia, Hodgkin lymphoma (HL), and non-Hodgkin lymphoma (NHL) than NHWs, but the rate of myeloma was significantly higher among AAs.

The death rates for these malignancies followed the same patterns, with the exception of HL. There was no significant difference in HL mortality between AAs and NHWs of either sex.

These findings can be found in the report, “Cancer Statistics for African Americans, 2016,” appearing in CA: A Cancer Journal for Clinicians.

To compile this report, the researchers used data from the Surveillance, Epidemiology, and End Results program and the Centers for Disease Control and Prevention’s National Program of Cancer Registries.

Incidence

For part of the report, the researchers compared the incidence of cancers between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

Among females, the incidence of leukemia was 8.6 per 100,000 in AAs and 10.7 per 100,000 in NHWs (P<0.05). Among males, the incidence was 13.2 per 100,000 in AAs and 17.7 per 100,000 in NHWs (P<0.05).

The incidence of HL in females was 2.4 per 100,000 in AAs and 2.7 per 100,000 in NHWs (P<0.05). The incidence of HL in males was 3.2 per 100,000 in AAs and 3.4 per 100,000 in NHWs (P<0.05).

The incidence of NHL in females was 12.0 per 100,000 in AAs and 16.6 per 100,000 in NHWs (P<0.05). The incidence of NHL in males was 17.2 per 100,000 in AAs and 24.1 per 100,000 in NHWs (P<0.05).

The incidence of myeloma in females was 11.1 per 100,000 in AAs and 4.3 per 100,000 in NHWs (P<0.05). The incidence of myeloma in males was 14.8 per 100,000 in AAs and 7.0 per 100,000 in NHWs (P<0.05).

Mortality

The researchers also compared cancer mortality between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

The death rate for female leukemia patients was 4.8 per 100,000 in AAs and 5.4 per 100,000 in NHWs (P<0.05). The death rate for male leukemia patients was 8.1 per 100,000 in AAs and 9.9 per 100,000 in NHWs (P<0.05).

The death rate for female HL patients was 0.3 per 100,000 for both AAs and NHWs. The death rate for male HL patients was 0.4 per 100,000 for AAs and 0.5 per 100,000 in NHWs (not significant).

The death rate for female NHL patients was 3.6 per 100,000 in AAs and 5.0 per 100,000 in NHWs (P<0.05). The death rate for male NHL patients was 5.9 per 100,000 in AAs and 8.3 per 100,000 in NHWs (P<0.05).

The death rate for female myeloma patients was 5.4 per 100,000 in AAs and 2.4 per 100,000 in NHWs (P<0.05). The death rate for male myeloma patients was 7.8 per 100,000 in AAs and 4.0 per 100,000 in NHWs (P<0.05).

The researchers noted that the reasons for the higher rates of myeloma and myeloma death among AAs are, at present, unknown.

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new report suggests African Americans (AAs) have significantly lower rates of most hematologic malignancies than non-Hispanic white (NHW) individuals in the US.

AAs of both sexes had significantly lower rates of leukemia, Hodgkin lymphoma (HL), and non-Hodgkin lymphoma (NHL) than NHWs, but the rate of myeloma was significantly higher among AAs.

The death rates for these malignancies followed the same patterns, with the exception of HL. There was no significant difference in HL mortality between AAs and NHWs of either sex.

These findings can be found in the report, “Cancer Statistics for African Americans, 2016,” appearing in CA: A Cancer Journal for Clinicians.

To compile this report, the researchers used data from the Surveillance, Epidemiology, and End Results program and the Centers for Disease Control and Prevention’s National Program of Cancer Registries.

Incidence

For part of the report, the researchers compared the incidence of cancers between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

Among females, the incidence of leukemia was 8.6 per 100,000 in AAs and 10.7 per 100,000 in NHWs (P<0.05). Among males, the incidence was 13.2 per 100,000 in AAs and 17.7 per 100,000 in NHWs (P<0.05).

The incidence of HL in females was 2.4 per 100,000 in AAs and 2.7 per 100,000 in NHWs (P<0.05). The incidence of HL in males was 3.2 per 100,000 in AAs and 3.4 per 100,000 in NHWs (P<0.05).

The incidence of NHL in females was 12.0 per 100,000 in AAs and 16.6 per 100,000 in NHWs (P<0.05). The incidence of NHL in males was 17.2 per 100,000 in AAs and 24.1 per 100,000 in NHWs (P<0.05).

The incidence of myeloma in females was 11.1 per 100,000 in AAs and 4.3 per 100,000 in NHWs (P<0.05). The incidence of myeloma in males was 14.8 per 100,000 in AAs and 7.0 per 100,000 in NHWs (P<0.05).

Mortality

The researchers also compared cancer mortality between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

The death rate for female leukemia patients was 4.8 per 100,000 in AAs and 5.4 per 100,000 in NHWs (P<0.05). The death rate for male leukemia patients was 8.1 per 100,000 in AAs and 9.9 per 100,000 in NHWs (P<0.05).

The death rate for female HL patients was 0.3 per 100,000 for both AAs and NHWs. The death rate for male HL patients was 0.4 per 100,000 for AAs and 0.5 per 100,000 in NHWs (not significant).

The death rate for female NHL patients was 3.6 per 100,000 in AAs and 5.0 per 100,000 in NHWs (P<0.05). The death rate for male NHL patients was 5.9 per 100,000 in AAs and 8.3 per 100,000 in NHWs (P<0.05).

The death rate for female myeloma patients was 5.4 per 100,000 in AAs and 2.4 per 100,000 in NHWs (P<0.05). The death rate for male myeloma patients was 7.8 per 100,000 in AAs and 4.0 per 100,000 in NHWs (P<0.05).

The researchers noted that the reasons for the higher rates of myeloma and myeloma death among AAs are, at present, unknown.

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new report suggests African Americans (AAs) have significantly lower rates of most hematologic malignancies than non-Hispanic white (NHW) individuals in the US.

AAs of both sexes had significantly lower rates of leukemia, Hodgkin lymphoma (HL), and non-Hodgkin lymphoma (NHL) than NHWs, but the rate of myeloma was significantly higher among AAs.

The death rates for these malignancies followed the same patterns, with the exception of HL. There was no significant difference in HL mortality between AAs and NHWs of either sex.

These findings can be found in the report, “Cancer Statistics for African Americans, 2016,” appearing in CA: A Cancer Journal for Clinicians.

To compile this report, the researchers used data from the Surveillance, Epidemiology, and End Results program and the Centers for Disease Control and Prevention’s National Program of Cancer Registries.

Incidence

For part of the report, the researchers compared the incidence of cancers between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

Among females, the incidence of leukemia was 8.6 per 100,000 in AAs and 10.7 per 100,000 in NHWs (P<0.05). Among males, the incidence was 13.2 per 100,000 in AAs and 17.7 per 100,000 in NHWs (P<0.05).

The incidence of HL in females was 2.4 per 100,000 in AAs and 2.7 per 100,000 in NHWs (P<0.05). The incidence of HL in males was 3.2 per 100,000 in AAs and 3.4 per 100,000 in NHWs (P<0.05).

The incidence of NHL in females was 12.0 per 100,000 in AAs and 16.6 per 100,000 in NHWs (P<0.05). The incidence of NHL in males was 17.2 per 100,000 in AAs and 24.1 per 100,000 in NHWs (P<0.05).

The incidence of myeloma in females was 11.1 per 100,000 in AAs and 4.3 per 100,000 in NHWs (P<0.05). The incidence of myeloma in males was 14.8 per 100,000 in AAs and 7.0 per 100,000 in NHWs (P<0.05).

Mortality

The researchers also compared cancer mortality between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

The death rate for female leukemia patients was 4.8 per 100,000 in AAs and 5.4 per 100,000 in NHWs (P<0.05). The death rate for male leukemia patients was 8.1 per 100,000 in AAs and 9.9 per 100,000 in NHWs (P<0.05).

The death rate for female HL patients was 0.3 per 100,000 for both AAs and NHWs. The death rate for male HL patients was 0.4 per 100,000 for AAs and 0.5 per 100,000 in NHWs (not significant).

The death rate for female NHL patients was 3.6 per 100,000 in AAs and 5.0 per 100,000 in NHWs (P<0.05). The death rate for male NHL patients was 5.9 per 100,000 in AAs and 8.3 per 100,000 in NHWs (P<0.05).

The death rate for female myeloma patients was 5.4 per 100,000 in AAs and 2.4 per 100,000 in NHWs (P<0.05). The death rate for male myeloma patients was 7.8 per 100,000 in AAs and 4.0 per 100,000 in NHWs (P<0.05).

The researchers noted that the reasons for the higher rates of myeloma and myeloma death among AAs are, at present, unknown.

Excellent communication between physicians and patients is a crucial element of hospital quality, but it’s also an ongoing challenge for many institutions. One physician wondered whether letting patients read their physicians’ notes could help.

“I wanted to find new methods to improve patient understanding of their medical care plan,” says Craig Weinert, MD, MPH, medical director for adult inpatient services at the University of Minnesota Medical Center and author of “Giving Doctors’ Daily Progress Notes to Hospitalized Patients and Families to Improve Patient Experience” in the American Journal of Medical Quality. “It seemed logical to me that giving patients access to the same information that all the other members of the healthcare team were reading would improve communication. This is the overall hypothesis of the Open Notes movement.”

Another reason Dr. Weinert pursued the study: In his clinical job as an intensivist, he encounters frequent disagreements with patients’ families regarding prognosis and goals of care.

“No one has figured out how to increase the alignment of prognosis between the family and the medical team,” Dr. Weinert says. “I think having the families read the doctors’ notes, where the issues with poor-prognosis multi-organ failure are repeatedly spelled out, might help families more quickly grasp the futility of continuing care.”

During the study, hospitalized patients or family members on six wards of a university hospital received a printed copy of their medical team’s daily progress notes. Surveys afterward showed 74% to 86% of patients and family members responded favorably. Physicians were mostly satisfied, too.

“Most doctors, at the end of the study, thought that Open Notes went better than they had predicted,” Dr. Weinert says.

Complete transparency of medical records is the future of medicine, he says. It’s what patients want, “especially the younger generation.”

“Over the next 10 years,” he says, “I predict ... all [electronic medical record] vendors will have electronic portals that allow clinic and hospitalized patients access to almost everything in the EMR.”

Reference

1. Weinert C. Giving doctors’ daily progress notes to hospitalized patients and families to improve patient experience. Am J Med Qual. 2015. doi:10.1177/1062860615610424.

Excellent communication between physicians and patients is a crucial element of hospital quality, but it’s also an ongoing challenge for many institutions. One physician wondered whether letting patients read their physicians’ notes could help.

“I wanted to find new methods to improve patient understanding of their medical care plan,” says Craig Weinert, MD, MPH, medical director for adult inpatient services at the University of Minnesota Medical Center and author of “Giving Doctors’ Daily Progress Notes to Hospitalized Patients and Families to Improve Patient Experience” in the American Journal of Medical Quality. “It seemed logical to me that giving patients access to the same information that all the other members of the healthcare team were reading would improve communication. This is the overall hypothesis of the Open Notes movement.”

Another reason Dr. Weinert pursued the study: In his clinical job as an intensivist, he encounters frequent disagreements with patients’ families regarding prognosis and goals of care.

“No one has figured out how to increase the alignment of prognosis between the family and the medical team,” Dr. Weinert says. “I think having the families read the doctors’ notes, where the issues with poor-prognosis multi-organ failure are repeatedly spelled out, might help families more quickly grasp the futility of continuing care.”

During the study, hospitalized patients or family members on six wards of a university hospital received a printed copy of their medical team’s daily progress notes. Surveys afterward showed 74% to 86% of patients and family members responded favorably. Physicians were mostly satisfied, too.

“Most doctors, at the end of the study, thought that Open Notes went better than they had predicted,” Dr. Weinert says.

Complete transparency of medical records is the future of medicine, he says. It’s what patients want, “especially the younger generation.”

“Over the next 10 years,” he says, “I predict ... all [electronic medical record] vendors will have electronic portals that allow clinic and hospitalized patients access to almost everything in the EMR.”

Reference

1. Weinert C. Giving doctors’ daily progress notes to hospitalized patients and families to improve patient experience. Am J Med Qual. 2015. doi:10.1177/1062860615610424.

Excellent communication between physicians and patients is a crucial element of hospital quality, but it’s also an ongoing challenge for many institutions. One physician wondered whether letting patients read their physicians’ notes could help.

“I wanted to find new methods to improve patient understanding of their medical care plan,” says Craig Weinert, MD, MPH, medical director for adult inpatient services at the University of Minnesota Medical Center and author of “Giving Doctors’ Daily Progress Notes to Hospitalized Patients and Families to Improve Patient Experience” in the American Journal of Medical Quality. “It seemed logical to me that giving patients access to the same information that all the other members of the healthcare team were reading would improve communication. This is the overall hypothesis of the Open Notes movement.”

Another reason Dr. Weinert pursued the study: In his clinical job as an intensivist, he encounters frequent disagreements with patients’ families regarding prognosis and goals of care.

“No one has figured out how to increase the alignment of prognosis between the family and the medical team,” Dr. Weinert says. “I think having the families read the doctors’ notes, where the issues with poor-prognosis multi-organ failure are repeatedly spelled out, might help families more quickly grasp the futility of continuing care.”

During the study, hospitalized patients or family members on six wards of a university hospital received a printed copy of their medical team’s daily progress notes. Surveys afterward showed 74% to 86% of patients and family members responded favorably. Physicians were mostly satisfied, too.

“Most doctors, at the end of the study, thought that Open Notes went better than they had predicted,” Dr. Weinert says.

Complete transparency of medical records is the future of medicine, he says. It’s what patients want, “especially the younger generation.”

“Over the next 10 years,” he says, “I predict ... all [electronic medical record] vendors will have electronic portals that allow clinic and hospitalized patients access to almost everything in the EMR.”

Reference

1. Weinert C. Giving doctors’ daily progress notes to hospitalized patients and families to improve patient experience. Am J Med Qual. 2015. doi:10.1177/1062860615610424.

(Reuters Health) - Elderly patients hospitalized for cancer surgery are more likely to have complications afterward compared to the middle-aged, particularly when they have several other health problems, a U.S. study suggests.

Overall, almost one in 10 adults age 55 and older had at least one post-operative issue like delirium, dehydration, falls, fractures, pressure ulcers or unusual weight loss, the study of nearly 1 million cancer surgery patients found.

These setbacks were even more common when patients were at least 65 years old, had two or more other serious health problems in addition to malignancies, or had surgeries for tumors of the digestive system or nearby organs.

But the odds were worst for people over 75 - about 46 percent of them had at least one complication, compared with 22 percent of adults aged 55 to 64.

"With the population aging, it's becoming increasingly important to consider not only the survival benefits of cancer surgery but the impact on functionality, vitality and quality of life," said lead study author Dr. Hung-Jui Tan, a researcher in urologic oncology at the University of California, Los Angeles.

While the events studied here are specific to the initial hospitalization, they can carry potential long-term ramifications," Tan added by email.

To see how age influences the risk of post-operative complications, Tan and colleagues reviewed hospital admission records for a nationwide sample of 940,000 adults age 55 and older who had cancer surgery from 2009 to 2011.

Compared with patients who were under age 65, those who were 65 to 74 years old were 23 percent more likely to have complications, while the over-75 group had 66 percent higher odds, researchers report in the Journal of Clinical Oncology.

Complications were most likely when patients were having surgery for cancers of the bladder, ovary, colon, rectum, pancreas or stomach.

After suffering post-operative setbacks, patients were also more likely to have further complications during their hospital stay, to remain in the hospital longer and to have more costly care. They were also more likely to die in the hospital and less likely to be discharged to home.

One limitation of the study is its reliance on administrative claims data, which is designed for billing purposes and might not always reflect the nuances of patients' medical conditions, the authors note. In addition, it's possible that some complications may have resulted from conditions patients had before they arrived at the hospital for cancer surgery.

The study can't prove that advanced age directly causes post-operative problems. But the findings suggest doctors and patients should consider these potential risks when deciding the best course of treatment, Tan said.

Patients should also understand that not all complications are equally devastating to quality of life. Dehydration and weight loss, for example, are nutritional problems that might be treated with fluids, noted Dr. Siri Rostoft, a geriatric medicine researcher at Oslo University Hospital in Norway.

"Cancer is often a lethal disease if left untreated that causes conditions such as bleeding, obstruction of the intestines, and pain," Rostoft, who wasn't involved in the study, said by email. "Not treating patients may be worse for their quality of life than operating."

Still, the findings add to a growing body of data on post-operative complications that may help doctors and patients decide if the potential benefits of surgery outweigh the possible risks, Dr. Steven Cunningham, a researcher at Saint Agnes Hospital and Cancer Institute in Baltimore who wasn't involved in the study, said by email.

Complications in the study were more likely at non-teaching hospitals and facilities that did fewer cancer surgeries, a factor that patients should also consider when they have a choice about where to go for surgery, noted Dr. Kwok-Leung Cheung, a researcher at the University of Nottingham in the U.K. and member of the surgical task force for the International Society of Geriatric Oncology.

Knowing when not to operate also matters, Cheung, who wasn't involved in the study, added by email.

"The surgeon should seriously consider the intensity of surgery, which has been identified as one of the important factors with post operative problems," Cheung added. "The use of minimally invasive techniques including laparoscopic and robotic surgery should be considered wherever appropriate."

(Reuters Health) - Elderly patients hospitalized for cancer surgery are more likely to have complications afterward compared to the middle-aged, particularly when they have several other health problems, a U.S. study suggests.

Overall, almost one in 10 adults age 55 and older had at least one post-operative issue like delirium, dehydration, falls, fractures, pressure ulcers or unusual weight loss, the study of nearly 1 million cancer surgery patients found.

These setbacks were even more common when patients were at least 65 years old, had two or more other serious health problems in addition to malignancies, or had surgeries for tumors of the digestive system or nearby organs.

But the odds were worst for people over 75 - about 46 percent of them had at least one complication, compared with 22 percent of adults aged 55 to 64.

"With the population aging, it's becoming increasingly important to consider not only the survival benefits of cancer surgery but the impact on functionality, vitality and quality of life," said lead study author Dr. Hung-Jui Tan, a researcher in urologic oncology at the University of California, Los Angeles.

While the events studied here are specific to the initial hospitalization, they can carry potential long-term ramifications," Tan added by email.

To see how age influences the risk of post-operative complications, Tan and colleagues reviewed hospital admission records for a nationwide sample of 940,000 adults age 55 and older who had cancer surgery from 2009 to 2011.

Compared with patients who were under age 65, those who were 65 to 74 years old were 23 percent more likely to have complications, while the over-75 group had 66 percent higher odds, researchers report in the Journal of Clinical Oncology.

Complications were most likely when patients were having surgery for cancers of the bladder, ovary, colon, rectum, pancreas or stomach.

After suffering post-operative setbacks, patients were also more likely to have further complications during their hospital stay, to remain in the hospital longer and to have more costly care. They were also more likely to die in the hospital and less likely to be discharged to home.

One limitation of the study is its reliance on administrative claims data, which is designed for billing purposes and might not always reflect the nuances of patients' medical conditions, the authors note. In addition, it's possible that some complications may have resulted from conditions patients had before they arrived at the hospital for cancer surgery.

The study can't prove that advanced age directly causes post-operative problems. But the findings suggest doctors and patients should consider these potential risks when deciding the best course of treatment, Tan said.

Patients should also understand that not all complications are equally devastating to quality of life. Dehydration and weight loss, for example, are nutritional problems that might be treated with fluids, noted Dr. Siri Rostoft, a geriatric medicine researcher at Oslo University Hospital in Norway.

"Cancer is often a lethal disease if left untreated that causes conditions such as bleeding, obstruction of the intestines, and pain," Rostoft, who wasn't involved in the study, said by email. "Not treating patients may be worse for their quality of life than operating."

Still, the findings add to a growing body of data on post-operative complications that may help doctors and patients decide if the potential benefits of surgery outweigh the possible risks, Dr. Steven Cunningham, a researcher at Saint Agnes Hospital and Cancer Institute in Baltimore who wasn't involved in the study, said by email.

Complications in the study were more likely at non-teaching hospitals and facilities that did fewer cancer surgeries, a factor that patients should also consider when they have a choice about where to go for surgery, noted Dr. Kwok-Leung Cheung, a researcher at the University of Nottingham in the U.K. and member of the surgical task force for the International Society of Geriatric Oncology.

Knowing when not to operate also matters, Cheung, who wasn't involved in the study, added by email.

"The surgeon should seriously consider the intensity of surgery, which has been identified as one of the important factors with post operative problems," Cheung added. "The use of minimally invasive techniques including laparoscopic and robotic surgery should be considered wherever appropriate."

(Reuters Health) - Elderly patients hospitalized for cancer surgery are more likely to have complications afterward compared to the middle-aged, particularly when they have several other health problems, a U.S. study suggests.

Overall, almost one in 10 adults age 55 and older had at least one post-operative issue like delirium, dehydration, falls, fractures, pressure ulcers or unusual weight loss, the study of nearly 1 million cancer surgery patients found.

These setbacks were even more common when patients were at least 65 years old, had two or more other serious health problems in addition to malignancies, or had surgeries for tumors of the digestive system or nearby organs.

But the odds were worst for people over 75 - about 46 percent of them had at least one complication, compared with 22 percent of adults aged 55 to 64.

"With the population aging, it's becoming increasingly important to consider not only the survival benefits of cancer surgery but the impact on functionality, vitality and quality of life," said lead study author Dr. Hung-Jui Tan, a researcher in urologic oncology at the University of California, Los Angeles.

While the events studied here are specific to the initial hospitalization, they can carry potential long-term ramifications," Tan added by email.

To see how age influences the risk of post-operative complications, Tan and colleagues reviewed hospital admission records for a nationwide sample of 940,000 adults age 55 and older who had cancer surgery from 2009 to 2011.

Compared with patients who were under age 65, those who were 65 to 74 years old were 23 percent more likely to have complications, while the over-75 group had 66 percent higher odds, researchers report in the Journal of Clinical Oncology.

Complications were most likely when patients were having surgery for cancers of the bladder, ovary, colon, rectum, pancreas or stomach.

After suffering post-operative setbacks, patients were also more likely to have further complications during their hospital stay, to remain in the hospital longer and to have more costly care. They were also more likely to die in the hospital and less likely to be discharged to home.

One limitation of the study is its reliance on administrative claims data, which is designed for billing purposes and might not always reflect the nuances of patients' medical conditions, the authors note. In addition, it's possible that some complications may have resulted from conditions patients had before they arrived at the hospital for cancer surgery.

The study can't prove that advanced age directly causes post-operative problems. But the findings suggest doctors and patients should consider these potential risks when deciding the best course of treatment, Tan said.

Patients should also understand that not all complications are equally devastating to quality of life. Dehydration and weight loss, for example, are nutritional problems that might be treated with fluids, noted Dr. Siri Rostoft, a geriatric medicine researcher at Oslo University Hospital in Norway.

"Cancer is often a lethal disease if left untreated that causes conditions such as bleeding, obstruction of the intestines, and pain," Rostoft, who wasn't involved in the study, said by email. "Not treating patients may be worse for their quality of life than operating."

Still, the findings add to a growing body of data on post-operative complications that may help doctors and patients decide if the potential benefits of surgery outweigh the possible risks, Dr. Steven Cunningham, a researcher at Saint Agnes Hospital and Cancer Institute in Baltimore who wasn't involved in the study, said by email.

Complications in the study were more likely at non-teaching hospitals and facilities that did fewer cancer surgeries, a factor that patients should also consider when they have a choice about where to go for surgery, noted Dr. Kwok-Leung Cheung, a researcher at the University of Nottingham in the U.K. and member of the surgical task force for the International Society of Geriatric Oncology.

Knowing when not to operate also matters, Cheung, who wasn't involved in the study, added by email.

"The surgeon should seriously consider the intensity of surgery, which has been identified as one of the important factors with post operative problems," Cheung added. "The use of minimally invasive techniques including laparoscopic and robotic surgery should be considered wherever appropriate."

Genetically modified zebrafish

New research suggests T-cell acute lymphoblastic leukemia (T-ALL) cells use the tricarboxylic acid (TCA) cycle to support their growth and survival.

Investigators say the findings could aid the development of therapeutics that can kill T-ALL cells by targeting an enzyme that exists in the TCA cycle—dihydrolipoamide S-succinyltransferase (DLST).

The team described this research in the journal Leukemia.

“Researchers have wrongly assumed that cancer cells do not use the TCA cycle to support their growth,” said study author Hui Feng, MD, PhD, of Boston University Medical Center in Massachusetts.

“Our new findings provide solid evidence that these cancer cells depend on the TCA cycle for their survival. Additionally, we demonstrated the importance of DLST in T-cell leukemia development and have identified a targetable enzyme for T-cell leukemia treatment.”

For this study, the investigators set out to examine the mechanisms underlying MYC-mediated tumorigenesis in T-ALL.

They used a zebrafish model of MYC-induced T-ALL to screen for genes that contribute to disease onset. The results suggested the TCA-cycle enzyme DLST is an important contributor to T-ALL development.

And experiments showed that heterozygous inactivation of DLST significantly delayed disease onset in the zebrafish, apparently without affecting the development of the fish.

Further analysis revealed that inhibiting the activity of DLST could effectively kill human T-ALL cells. Specifically, RNAi knockdown of DLST decreased cell viability and induced apoptosis in human T-ALL cell

lines.

The investigators found that knockdown of DLST disrupted the TCA cycle in the human T-ALL cells. But adding succinate, the downstream TCA-cycle intermediate, to the cells rescued defects in cell viability caused by DLST knockdown.

The investigators said the therapeutic benefit of DLST inhibition may extend to cancers other than T-ALL as well.

Genetically modified zebrafish

New research suggests T-cell acute lymphoblastic leukemia (T-ALL) cells use the tricarboxylic acid (TCA) cycle to support their growth and survival.

Investigators say the findings could aid the development of therapeutics that can kill T-ALL cells by targeting an enzyme that exists in the TCA cycle—dihydrolipoamide S-succinyltransferase (DLST).

The team described this research in the journal Leukemia.

“Researchers have wrongly assumed that cancer cells do not use the TCA cycle to support their growth,” said study author Hui Feng, MD, PhD, of Boston University Medical Center in Massachusetts.

“Our new findings provide solid evidence that these cancer cells depend on the TCA cycle for their survival. Additionally, we demonstrated the importance of DLST in T-cell leukemia development and have identified a targetable enzyme for T-cell leukemia treatment.”

For this study, the investigators set out to examine the mechanisms underlying MYC-mediated tumorigenesis in T-ALL.

They used a zebrafish model of MYC-induced T-ALL to screen for genes that contribute to disease onset. The results suggested the TCA-cycle enzyme DLST is an important contributor to T-ALL development.

And experiments showed that heterozygous inactivation of DLST significantly delayed disease onset in the zebrafish, apparently without affecting the development of the fish.

Further analysis revealed that inhibiting the activity of DLST could effectively kill human T-ALL cells. Specifically, RNAi knockdown of DLST decreased cell viability and induced apoptosis in human T-ALL cell

lines.

The investigators found that knockdown of DLST disrupted the TCA cycle in the human T-ALL cells. But adding succinate, the downstream TCA-cycle intermediate, to the cells rescued defects in cell viability caused by DLST knockdown.

The investigators said the therapeutic benefit of DLST inhibition may extend to cancers other than T-ALL as well.

Genetically modified zebrafish

New research suggests T-cell acute lymphoblastic leukemia (T-ALL) cells use the tricarboxylic acid (TCA) cycle to support their growth and survival.

Investigators say the findings could aid the development of therapeutics that can kill T-ALL cells by targeting an enzyme that exists in the TCA cycle—dihydrolipoamide S-succinyltransferase (DLST).

The team described this research in the journal Leukemia.

“Researchers have wrongly assumed that cancer cells do not use the TCA cycle to support their growth,” said study author Hui Feng, MD, PhD, of Boston University Medical Center in Massachusetts.

“Our new findings provide solid evidence that these cancer cells depend on the TCA cycle for their survival. Additionally, we demonstrated the importance of DLST in T-cell leukemia development and have identified a targetable enzyme for T-cell leukemia treatment.”

For this study, the investigators set out to examine the mechanisms underlying MYC-mediated tumorigenesis in T-ALL.

They used a zebrafish model of MYC-induced T-ALL to screen for genes that contribute to disease onset. The results suggested the TCA-cycle enzyme DLST is an important contributor to T-ALL development.

And experiments showed that heterozygous inactivation of DLST significantly delayed disease onset in the zebrafish, apparently without affecting the development of the fish.

Further analysis revealed that inhibiting the activity of DLST could effectively kill human T-ALL cells. Specifically, RNAi knockdown of DLST decreased cell viability and induced apoptosis in human T-ALL cell

lines.

The investigators found that knockdown of DLST disrupted the TCA cycle in the human T-ALL cells. But adding succinate, the downstream TCA-cycle intermediate, to the cells rescued defects in cell viability caused by DLST knockdown.

The investigators said the therapeutic benefit of DLST inhibition may extend to cancers other than T-ALL as well.

Micrograph showing CLL

The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) is recommending orphan designation for the second-generation BTK inhibitor acalabrutinib (ACP-196) for 3 indications.

The COMP is recommending the drug receive orphan designation as a treatment for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma, and Waldenström’s macroglobulinemia.

The COMP adopts an opinion on orphan drug designation, and that opinion is submitted to the European Commission (EC) for endorsement.

To be granted orphan designation by the EC, a medicine must be intended for the treatment, prevention, or diagnosis of a disease that is life-threatening and has a prevalence of up to 5 in 10,000 in the European Union. Additionally, the medicine must aim to provide significant benefit to those affected by the condition.

Orphan designation provides companies with development and market exclusivity incentives for designated compounds and medicines.

About acalabrutinib

Acalabrutinib is under development by AstraZeneca and Acerta Pharma BV. The drug is currently being evaluated in trials of patients with CLL/SLL, mantle cell lymphoma, Waldentröm’s macroglobulinemia, and a range of other hematologic malignancies and solid tumor cancers.

Data from a phase 1/2 trial of acalabrutinib in CLL were presented at the 2015 ASH Annual Meeting and simultaneously published in NEJM.

The researchers reported on 61 patients with relapsed CLL who had a median age of 62 (range, 44-84) and a median of 3 prior therapies (range, 1-13).

Patients enrolled in the phase 1 portion of the study received escalating doses of acalabrutinib, with a maximum dose of 400 mg once daily. Patients involved in the phase 2 portion of the study were treated with a 100 mg dose twice daily.

At a median follow-up of 14.3 months (range, 0.5 to 20), 53 patients were still receiving treatment.

The most common adverse events of all grades (occurring in at least 20% of patients) were headache (43%), diarrhea (39%), increased weight (26%), pyrexia (23%), upper respiratory tract infection (23%), fatigue (21%), peripheral edema (21%), hypertension (20%), and nausea (20%).

Grade 3/4 adverse events included diarrhea (2%), increased weight (2%), pyrexia (3%), fatigue (3%), hypertension (7%), and arthralgia (2%).

The overall response rate among the 60 evaluable patients was 95%. This included partial responses in 85% of patients and partial responses with lymphocytosis in 10%. The rate of stable disease was 5%.

The researchers noted that responses occurred in all dosing cohorts, and the response rate increased over time.

Micrograph showing CLL

The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) is recommending orphan designation for the second-generation BTK inhibitor acalabrutinib (ACP-196) for 3 indications.

The COMP is recommending the drug receive orphan designation as a treatment for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma, and Waldenström’s macroglobulinemia.

The COMP adopts an opinion on orphan drug designation, and that opinion is submitted to the European Commission (EC) for endorsement.

To be granted orphan designation by the EC, a medicine must be intended for the treatment, prevention, or diagnosis of a disease that is life-threatening and has a prevalence of up to 5 in 10,000 in the European Union. Additionally, the medicine must aim to provide significant benefit to those affected by the condition.

Orphan designation provides companies with development and market exclusivity incentives for designated compounds and medicines.

About acalabrutinib

Acalabrutinib is under development by AstraZeneca and Acerta Pharma BV. The drug is currently being evaluated in trials of patients with CLL/SLL, mantle cell lymphoma, Waldentröm’s macroglobulinemia, and a range of other hematologic malignancies and solid tumor cancers.

Data from a phase 1/2 trial of acalabrutinib in CLL were presented at the 2015 ASH Annual Meeting and simultaneously published in NEJM.

The researchers reported on 61 patients with relapsed CLL who had a median age of 62 (range, 44-84) and a median of 3 prior therapies (range, 1-13).

Patients enrolled in the phase 1 portion of the study received escalating doses of acalabrutinib, with a maximum dose of 400 mg once daily. Patients involved in the phase 2 portion of the study were treated with a 100 mg dose twice daily.

At a median follow-up of 14.3 months (range, 0.5 to 20), 53 patients were still receiving treatment.

The most common adverse events of all grades (occurring in at least 20% of patients) were headache (43%), diarrhea (39%), increased weight (26%), pyrexia (23%), upper respiratory tract infection (23%), fatigue (21%), peripheral edema (21%), hypertension (20%), and nausea (20%).

Grade 3/4 adverse events included diarrhea (2%), increased weight (2%), pyrexia (3%), fatigue (3%), hypertension (7%), and arthralgia (2%).

The overall response rate among the 60 evaluable patients was 95%. This included partial responses in 85% of patients and partial responses with lymphocytosis in 10%. The rate of stable disease was 5%.

The researchers noted that responses occurred in all dosing cohorts, and the response rate increased over time.

Micrograph showing CLL

The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) is recommending orphan designation for the second-generation BTK inhibitor acalabrutinib (ACP-196) for 3 indications.

The COMP is recommending the drug receive orphan designation as a treatment for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma, and Waldenström’s macroglobulinemia.

The COMP adopts an opinion on orphan drug designation, and that opinion is submitted to the European Commission (EC) for endorsement.

To be granted orphan designation by the EC, a medicine must be intended for the treatment, prevention, or diagnosis of a disease that is life-threatening and has a prevalence of up to 5 in 10,000 in the European Union. Additionally, the medicine must aim to provide significant benefit to those affected by the condition.

Orphan designation provides companies with development and market exclusivity incentives for designated compounds and medicines.

About acalabrutinib

Acalabrutinib is under development by AstraZeneca and Acerta Pharma BV. The drug is currently being evaluated in trials of patients with CLL/SLL, mantle cell lymphoma, Waldentröm’s macroglobulinemia, and a range of other hematologic malignancies and solid tumor cancers.

Data from a phase 1/2 trial of acalabrutinib in CLL were presented at the 2015 ASH Annual Meeting and simultaneously published in NEJM.

The researchers reported on 61 patients with relapsed CLL who had a median age of 62 (range, 44-84) and a median of 3 prior therapies (range, 1-13).

Patients enrolled in the phase 1 portion of the study received escalating doses of acalabrutinib, with a maximum dose of 400 mg once daily. Patients involved in the phase 2 portion of the study were treated with a 100 mg dose twice daily.

At a median follow-up of 14.3 months (range, 0.5 to 20), 53 patients were still receiving treatment.

The most common adverse events of all grades (occurring in at least 20% of patients) were headache (43%), diarrhea (39%), increased weight (26%), pyrexia (23%), upper respiratory tract infection (23%), fatigue (21%), peripheral edema (21%), hypertension (20%), and nausea (20%).

Grade 3/4 adverse events included diarrhea (2%), increased weight (2%), pyrexia (3%), fatigue (3%), hypertension (7%), and arthralgia (2%).

The overall response rate among the 60 evaluable patients was 95%. This included partial responses in 85% of patients and partial responses with lymphocytosis in 10%. The rate of stable disease was 5%.

The researchers noted that responses occurred in all dosing cohorts, and the response rate increased over time.

NEW ORLEANS – The visual system is relevant and accessible for the study of multiple sclerosis and can aid in the measurement of neuronal and axonal injury.

Capturing primary neuronal loss in the afferent visual pathway was among the topics addressed during a session focused on novel methods for measuring disease progression in MS at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

In this video interview at the meeting, session chair Dr. Fiona Costello of the University of Calgary, Alta., discussed the presentation on the visual pathway, as well as presentations on the use of microRNA biomarkers and the use of MRI as an outcome measure in progressive MS.

“The gestalt is that the field is moving in a new direction; the field is looking for not only a better understanding of what causes disability in MS, but also more reliable, objective, accessible means of capturing the same thing that is relevant and meaningful to patients and their caretakers,” she said.

sworcester@frontlinemedcom.com

NEW ORLEANS – The visual system is relevant and accessible for the study of multiple sclerosis and can aid in the measurement of neuronal and axonal injury.

Capturing primary neuronal loss in the afferent visual pathway was among the topics addressed during a session focused on novel methods for measuring disease progression in MS at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

In this video interview at the meeting, session chair Dr. Fiona Costello of the University of Calgary, Alta., discussed the presentation on the visual pathway, as well as presentations on the use of microRNA biomarkers and the use of MRI as an outcome measure in progressive MS.

“The gestalt is that the field is moving in a new direction; the field is looking for not only a better understanding of what causes disability in MS, but also more reliable, objective, accessible means of capturing the same thing that is relevant and meaningful to patients and their caretakers,” she said.

sworcester@frontlinemedcom.com

NEW ORLEANS – The visual system is relevant and accessible for the study of multiple sclerosis and can aid in the measurement of neuronal and axonal injury.

Capturing primary neuronal loss in the afferent visual pathway was among the topics addressed during a session focused on novel methods for measuring disease progression in MS at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

In this video interview at the meeting, session chair Dr. Fiona Costello of the University of Calgary, Alta., discussed the presentation on the visual pathway, as well as presentations on the use of microRNA biomarkers and the use of MRI as an outcome measure in progressive MS.

“The gestalt is that the field is moving in a new direction; the field is looking for not only a better understanding of what causes disability in MS, but also more reliable, objective, accessible means of capturing the same thing that is relevant and meaningful to patients and their caretakers,” she said.

sworcester@frontlinemedcom.com