Experts from a variety of disciplines will come together to discuss topics related to  preoperative, perioperative and postoperative care for cardiovascular surgery patients during Sunday’s full-day symposium, “Improving Systems of Care, Quality and Safety.”  

“The AATS recognizes that the delivery of high-quality, patient-centered cardiovascular care is best achieved through the use of proficient multidisciplinary teams,” said course co-chair Katherine J. Hoercher, RN, FAHA, of the Cleveland Clinic. “This symposium, with its focus on interprofessional education, is an important mechanism for developing team-based care competencies that form the underpinning of high-functioning teams.”

By bringing together faculty and learners from multiple cardiovascular surgery professions, attendees can learn how effective collaboration and utilization of standardized processes can improve outcomes in systems of care, quality and safety, Ms. Hoercher said.

“The session should provide the audience with nuts-and-bolts approaches to everyday problems through a global view of the difficulties we face in consistently delivering the highest quality medical care,” added course co-chair Glenn J.R. Whitman, MD, of The Johns Hopkins Hospital.
The morning session “will address a variety of common problems that we all face in managing cardiac surgical patients,” Dr. Whitman said. “The topics are varied and include, for example, informed consent, optimizing preoperative surgical readiness, as well as specific aspects of postoperative management such as goal-directed resuscitation and approach to the cardiac arrest patient.”

Included in the morning presentations are four talks on a team approach to minimizing transfusions, including preadmission use of epoetin; preoperative evaluation and intraoperative management; perioperative management of blood preservation; and risks, recognition and management of post cardiopulmonary bypass hemorrhage.

The afternoon portion of the symposium “will continue the morning objective and focus on specific postoperative morbidities, including hyperglycemia, perioperative myocardial infarctions and strokes,” Dr. Whitman said.

The session will conclude with presentations from five nationally-renowned speakers. Douglas R. Johnston, MD, of the Cleveland Clinic, will discuss what surgical teams can learn from fighter pilots, special ops forces and other elite performers; Peter Pronovost, MD, of Johns Hopkins Medicine, and its Armstrong Institute for Patient Safety and Quality, will discuss organizational structure and process factors for improving cardiac surgery quality and safety; Don Goldmann, MD, of the Institute for Healthcare Improvement, will provide insights on the impact of the Medicare Access and CHIP Reauthorization Act (MACRA) on the delivery of cardiovascular care; David M. Shahian, MD, of Harvard Medical School, who oversees the Society of Thoracic Surgeons’ database, will talk about meaningful outcome measures in cardiac surgery; and Alex B. Haynes, MD, of Massachusetts General Hospital, will review surgical checklists and their association with decreased morbidity and mortality.

“This session should be of interest to all AATS meeting attendees as we navigate the ever-changing landscape of health care delivery,” Ms. Hoercher said. “The information presented will be something the audience can’t easily obtain elsewhere,” added Dr. Whitman.
“I hope many of the AATS meeting attendees, both surgeons and non-surgeons, will join us at what will be an excellent educational opportunity,” Ms. Hoercher said.

Experts from a variety of disciplines will come together to discuss topics related to  preoperative, perioperative and postoperative care for cardiovascular surgery patients during Sunday’s full-day symposium, “Improving Systems of Care, Quality and Safety.”  

“The AATS recognizes that the delivery of high-quality, patient-centered cardiovascular care is best achieved through the use of proficient multidisciplinary teams,” said course co-chair Katherine J. Hoercher, RN, FAHA, of the Cleveland Clinic. “This symposium, with its focus on interprofessional education, is an important mechanism for developing team-based care competencies that form the underpinning of high-functioning teams.”

By bringing together faculty and learners from multiple cardiovascular surgery professions, attendees can learn how effective collaboration and utilization of standardized processes can improve outcomes in systems of care, quality and safety, Ms. Hoercher said.

“The session should provide the audience with nuts-and-bolts approaches to everyday problems through a global view of the difficulties we face in consistently delivering the highest quality medical care,” added course co-chair Glenn J.R. Whitman, MD, of The Johns Hopkins Hospital.
The morning session “will address a variety of common problems that we all face in managing cardiac surgical patients,” Dr. Whitman said. “The topics are varied and include, for example, informed consent, optimizing preoperative surgical readiness, as well as specific aspects of postoperative management such as goal-directed resuscitation and approach to the cardiac arrest patient.”

Included in the morning presentations are four talks on a team approach to minimizing transfusions, including preadmission use of epoetin; preoperative evaluation and intraoperative management; perioperative management of blood preservation; and risks, recognition and management of post cardiopulmonary bypass hemorrhage.

The afternoon portion of the symposium “will continue the morning objective and focus on specific postoperative morbidities, including hyperglycemia, perioperative myocardial infarctions and strokes,” Dr. Whitman said.

The session will conclude with presentations from five nationally-renowned speakers. Douglas R. Johnston, MD, of the Cleveland Clinic, will discuss what surgical teams can learn from fighter pilots, special ops forces and other elite performers; Peter Pronovost, MD, of Johns Hopkins Medicine, and its Armstrong Institute for Patient Safety and Quality, will discuss organizational structure and process factors for improving cardiac surgery quality and safety; Don Goldmann, MD, of the Institute for Healthcare Improvement, will provide insights on the impact of the Medicare Access and CHIP Reauthorization Act (MACRA) on the delivery of cardiovascular care; David M. Shahian, MD, of Harvard Medical School, who oversees the Society of Thoracic Surgeons’ database, will talk about meaningful outcome measures in cardiac surgery; and Alex B. Haynes, MD, of Massachusetts General Hospital, will review surgical checklists and their association with decreased morbidity and mortality.

“This session should be of interest to all AATS meeting attendees as we navigate the ever-changing landscape of health care delivery,” Ms. Hoercher said. “The information presented will be something the audience can’t easily obtain elsewhere,” added Dr. Whitman.
“I hope many of the AATS meeting attendees, both surgeons and non-surgeons, will join us at what will be an excellent educational opportunity,” Ms. Hoercher said.

Experts from a variety of disciplines will come together to discuss topics related to  preoperative, perioperative and postoperative care for cardiovascular surgery patients during Sunday’s full-day symposium, “Improving Systems of Care, Quality and Safety.”  

“The AATS recognizes that the delivery of high-quality, patient-centered cardiovascular care is best achieved through the use of proficient multidisciplinary teams,” said course co-chair Katherine J. Hoercher, RN, FAHA, of the Cleveland Clinic. “This symposium, with its focus on interprofessional education, is an important mechanism for developing team-based care competencies that form the underpinning of high-functioning teams.”

By bringing together faculty and learners from multiple cardiovascular surgery professions, attendees can learn how effective collaboration and utilization of standardized processes can improve outcomes in systems of care, quality and safety, Ms. Hoercher said.

“The session should provide the audience with nuts-and-bolts approaches to everyday problems through a global view of the difficulties we face in consistently delivering the highest quality medical care,” added course co-chair Glenn J.R. Whitman, MD, of The Johns Hopkins Hospital.
The morning session “will address a variety of common problems that we all face in managing cardiac surgical patients,” Dr. Whitman said. “The topics are varied and include, for example, informed consent, optimizing preoperative surgical readiness, as well as specific aspects of postoperative management such as goal-directed resuscitation and approach to the cardiac arrest patient.”

Included in the morning presentations are four talks on a team approach to minimizing transfusions, including preadmission use of epoetin; preoperative evaluation and intraoperative management; perioperative management of blood preservation; and risks, recognition and management of post cardiopulmonary bypass hemorrhage.

The afternoon portion of the symposium “will continue the morning objective and focus on specific postoperative morbidities, including hyperglycemia, perioperative myocardial infarctions and strokes,” Dr. Whitman said.

The session will conclude with presentations from five nationally-renowned speakers. Douglas R. Johnston, MD, of the Cleveland Clinic, will discuss what surgical teams can learn from fighter pilots, special ops forces and other elite performers; Peter Pronovost, MD, of Johns Hopkins Medicine, and its Armstrong Institute for Patient Safety and Quality, will discuss organizational structure and process factors for improving cardiac surgery quality and safety; Don Goldmann, MD, of the Institute for Healthcare Improvement, will provide insights on the impact of the Medicare Access and CHIP Reauthorization Act (MACRA) on the delivery of cardiovascular care; David M. Shahian, MD, of Harvard Medical School, who oversees the Society of Thoracic Surgeons’ database, will talk about meaningful outcome measures in cardiac surgery; and Alex B. Haynes, MD, of Massachusetts General Hospital, will review surgical checklists and their association with decreased morbidity and mortality.

“This session should be of interest to all AATS meeting attendees as we navigate the ever-changing landscape of health care delivery,” Ms. Hoercher said. “The information presented will be something the audience can’t easily obtain elsewhere,” added Dr. Whitman.
“I hope many of the AATS meeting attendees, both surgeons and non-surgeons, will join us at what will be an excellent educational opportunity,” Ms. Hoercher said.

The American College of Cardiology/American Heart Association guidelines for preventive statin therapy would cover an estimated 9.3 million more U.S. adults than would the U.S. Preventive Services Task Force guidelines, according to a report published online April 18 in JAMA.

Most of this difference can be attributed to younger adults and those with diabetes, for whom the ACC/AHA guidelines recommend statin therapy but the USPSTF guidelines do not, said Neha J. Pagidipati, MD, of the Duke Clinical Research Institute, Durham, N.C., and her associates.

They compared the proportion of patients who would be eligible for primary prevention statin therapy according to these two sets of guidelines by applying the eligibility criteria to a sample of 3,416 participants in the nationally representative 2009-2014 National Health and Nutrition Examination Survey (NHANES). These participants were 40-75 years of age, were free of cardiovascular disease, and had triglyceride levels of 400 mg/dL or less. A total of 747 (21.5%) were taking lipid-lowering medication at the time of the survey.

If the USPSTF guidelines (JAMA. 2016 Nov 15;316[19]:1997-2007)were fully implemented in this cohort, 15.8% more of the participants would be taking statin therapy. In contrast, if the ACC/AHA guidelines (Circulation. 2014 Jun 24;129[25 Suppl 2]:S1-4) were fully implemented in this cohort, 24.3% more would be taking statins.

A total of 8.9% of the cohort would be recommended for statin therapy under the ACC/AHA guidelines but not the USPSTF guidelines. Most of this discrepancy could be attributed to the youngest adults and to those with diabetes. The ACC/AHA guidelines were much more likely to recommend statins to patients aged 40-59 years. Such patients have a relatively low 10-year risk of cardiovascular events (7.0%) but a much higher longer-term risk of 34.6% at 30 years, the investigators said.

“Given that half of all [cardiovascular] events in men and one-third in women occur before age 65 years, reliance on 10-year risk alone may miss many younger individuals who could potentially benefit from long-term statin therapy,” they noted (JAMA 2017 Apr 18. doi: 10.1001/jama.2017.3416).

Further analysis broke down which adults the ACC/AHA guidelines covered, in contrast to the USPSTF guidelines: younger male smokers, younger men with dyslipidemia, younger men with high LDL-cholesterol levels, younger women with obesity, and older men who didn’t have high LDL-cholesterol levels.

Extrapolating these findings to the general U.S. population, “there could be an estimated 17.1 million vs 26.4 million U.S. adults with a new recommendation for statin therapy, based on the USPSTF recommendations vs the ACC/AHA guideline recommendations, respectively – an estimated difference of 9.3 million individuals,” Dr. Pagidipati and her associates wrote.

“Alternative approaches to augmenting risk-based cholesterol guidelines, including those that explicitly incorporate potential benefit of therapy, should be considered,” they added.

This study was supported by the Duke Clinical Research Institute. Dr. Pagidipati reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.

The American College of Cardiology/American Heart Association guidelines for preventive statin therapy would cover an estimated 9.3 million more U.S. adults than would the U.S. Preventive Services Task Force guidelines, according to a report published online April 18 in JAMA.

Most of this difference can be attributed to younger adults and those with diabetes, for whom the ACC/AHA guidelines recommend statin therapy but the USPSTF guidelines do not, said Neha J. Pagidipati, MD, of the Duke Clinical Research Institute, Durham, N.C., and her associates.

They compared the proportion of patients who would be eligible for primary prevention statin therapy according to these two sets of guidelines by applying the eligibility criteria to a sample of 3,416 participants in the nationally representative 2009-2014 National Health and Nutrition Examination Survey (NHANES). These participants were 40-75 years of age, were free of cardiovascular disease, and had triglyceride levels of 400 mg/dL or less. A total of 747 (21.5%) were taking lipid-lowering medication at the time of the survey.

If the USPSTF guidelines (JAMA. 2016 Nov 15;316[19]:1997-2007)were fully implemented in this cohort, 15.8% more of the participants would be taking statin therapy. In contrast, if the ACC/AHA guidelines (Circulation. 2014 Jun 24;129[25 Suppl 2]:S1-4) were fully implemented in this cohort, 24.3% more would be taking statins.

A total of 8.9% of the cohort would be recommended for statin therapy under the ACC/AHA guidelines but not the USPSTF guidelines. Most of this discrepancy could be attributed to the youngest adults and to those with diabetes. The ACC/AHA guidelines were much more likely to recommend statins to patients aged 40-59 years. Such patients have a relatively low 10-year risk of cardiovascular events (7.0%) but a much higher longer-term risk of 34.6% at 30 years, the investigators said.

“Given that half of all [cardiovascular] events in men and one-third in women occur before age 65 years, reliance on 10-year risk alone may miss many younger individuals who could potentially benefit from long-term statin therapy,” they noted (JAMA 2017 Apr 18. doi: 10.1001/jama.2017.3416).

Further analysis broke down which adults the ACC/AHA guidelines covered, in contrast to the USPSTF guidelines: younger male smokers, younger men with dyslipidemia, younger men with high LDL-cholesterol levels, younger women with obesity, and older men who didn’t have high LDL-cholesterol levels.

Extrapolating these findings to the general U.S. population, “there could be an estimated 17.1 million vs 26.4 million U.S. adults with a new recommendation for statin therapy, based on the USPSTF recommendations vs the ACC/AHA guideline recommendations, respectively – an estimated difference of 9.3 million individuals,” Dr. Pagidipati and her associates wrote.

“Alternative approaches to augmenting risk-based cholesterol guidelines, including those that explicitly incorporate potential benefit of therapy, should be considered,” they added.

This study was supported by the Duke Clinical Research Institute. Dr. Pagidipati reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.

The American College of Cardiology/American Heart Association guidelines for preventive statin therapy would cover an estimated 9.3 million more U.S. adults than would the U.S. Preventive Services Task Force guidelines, according to a report published online April 18 in JAMA.

Most of this difference can be attributed to younger adults and those with diabetes, for whom the ACC/AHA guidelines recommend statin therapy but the USPSTF guidelines do not, said Neha J. Pagidipati, MD, of the Duke Clinical Research Institute, Durham, N.C., and her associates.

They compared the proportion of patients who would be eligible for primary prevention statin therapy according to these two sets of guidelines by applying the eligibility criteria to a sample of 3,416 participants in the nationally representative 2009-2014 National Health and Nutrition Examination Survey (NHANES). These participants were 40-75 years of age, were free of cardiovascular disease, and had triglyceride levels of 400 mg/dL or less. A total of 747 (21.5%) were taking lipid-lowering medication at the time of the survey.

If the USPSTF guidelines (JAMA. 2016 Nov 15;316[19]:1997-2007)were fully implemented in this cohort, 15.8% more of the participants would be taking statin therapy. In contrast, if the ACC/AHA guidelines (Circulation. 2014 Jun 24;129[25 Suppl 2]:S1-4) were fully implemented in this cohort, 24.3% more would be taking statins.

A total of 8.9% of the cohort would be recommended for statin therapy under the ACC/AHA guidelines but not the USPSTF guidelines. Most of this discrepancy could be attributed to the youngest adults and to those with diabetes. The ACC/AHA guidelines were much more likely to recommend statins to patients aged 40-59 years. Such patients have a relatively low 10-year risk of cardiovascular events (7.0%) but a much higher longer-term risk of 34.6% at 30 years, the investigators said.

“Given that half of all [cardiovascular] events in men and one-third in women occur before age 65 years, reliance on 10-year risk alone may miss many younger individuals who could potentially benefit from long-term statin therapy,” they noted (JAMA 2017 Apr 18. doi: 10.1001/jama.2017.3416).

Further analysis broke down which adults the ACC/AHA guidelines covered, in contrast to the USPSTF guidelines: younger male smokers, younger men with dyslipidemia, younger men with high LDL-cholesterol levels, younger women with obesity, and older men who didn’t have high LDL-cholesterol levels.

Extrapolating these findings to the general U.S. population, “there could be an estimated 17.1 million vs 26.4 million U.S. adults with a new recommendation for statin therapy, based on the USPSTF recommendations vs the ACC/AHA guideline recommendations, respectively – an estimated difference of 9.3 million individuals,” Dr. Pagidipati and her associates wrote.

“Alternative approaches to augmenting risk-based cholesterol guidelines, including those that explicitly incorporate potential benefit of therapy, should be considered,” they added.

This study was supported by the Duke Clinical Research Institute. Dr. Pagidipati reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.

Video, Part 1. Femoral Attachment

1. Ultrasound is used to identify femoral and patellar attachments of medial patellofemoral ligament (MPFL).

2. MPFL is followed from patella to its attachment near adductor tubercle.

3. In-plane ultrasound guidance is used to place needle anterior and distal to tubercle.

4. Percutaneous incision is made down to needle tip. Spear is placed at needle tip for anatomical placement of socket.

5. Socket is drilled.

6. 3.0-mm suture anchor (BioComposite Knotless SutureTak; Arthrex) is placed.

7. Leading edge of torn MPFL is identified.

8. Suture passer (Labral FastPass Scorpion; Arthrex) is used to pass sutures through leading edge of torn MPFL to create horizontal mattress.

9. Sutures are tied.

10. Repair is complete.

Video, Part 2. Patellar Attachment

1. Ultrasound is used to scan patella to identify ideal or exact location of tear. In-plane ultrasound guidance is used to place spinal needle at desired socket location.

2. After spinal needle is positioned, in-line percutaneous incision is made, and needle is palpated at patella.

3. Spear is then placed at spinal needle tip for anatomical positioning of socket.

4. Socket is drilled.

5. 3.0-mm suture anchor (BioComposite Knotless SutureTak; Arthrex) is placed in socket.

6. Leading edge of torn medial patellofemoral ligament (MPFL) is identified.

7. Suture passer (Labral Past Pass Scorpion; Arthrex) is used to pass suture from anchor in horizontal mattress fashion through leading edge of torn MPFL.

8. Wire with loop (FiberSnare; Arthrex) is used as part of knotless technology to pull suture back through anchor to create knotless fixation.

9. Suture is pulled for appropriate tensioning of tissue.

10. Ultrasound is used to visualize construct to confirm that MPFL tissue abuts anchor and that repair is complete.

Video, Part 1. Femoral Attachment

1. Ultrasound is used to identify femoral and patellar attachments of medial patellofemoral ligament (MPFL).

2. MPFL is followed from patella to its attachment near adductor tubercle.

3. In-plane ultrasound guidance is used to place needle anterior and distal to tubercle.

4. Percutaneous incision is made down to needle tip. Spear is placed at needle tip for anatomical placement of socket.

5. Socket is drilled.

6. 3.0-mm suture anchor (BioComposite Knotless SutureTak; Arthrex) is placed.

7. Leading edge of torn MPFL is identified.

8. Suture passer (Labral FastPass Scorpion; Arthrex) is used to pass sutures through leading edge of torn MPFL to create horizontal mattress.

9. Sutures are tied.

10. Repair is complete.

Video, Part 2. Patellar Attachment

1. Ultrasound is used to scan patella to identify ideal or exact location of tear. In-plane ultrasound guidance is used to place spinal needle at desired socket location.

2. After spinal needle is positioned, in-line percutaneous incision is made, and needle is palpated at patella.

3. Spear is then placed at spinal needle tip for anatomical positioning of socket.

4. Socket is drilled.

5. 3.0-mm suture anchor (BioComposite Knotless SutureTak; Arthrex) is placed in socket.

6. Leading edge of torn medial patellofemoral ligament (MPFL) is identified.

7. Suture passer (Labral Past Pass Scorpion; Arthrex) is used to pass suture from anchor in horizontal mattress fashion through leading edge of torn MPFL.

8. Wire with loop (FiberSnare; Arthrex) is used as part of knotless technology to pull suture back through anchor to create knotless fixation.

9. Suture is pulled for appropriate tensioning of tissue.

10. Ultrasound is used to visualize construct to confirm that MPFL tissue abuts anchor and that repair is complete.

Video, Part 1. Femoral Attachment

1. Ultrasound is used to identify femoral and patellar attachments of medial patellofemoral ligament (MPFL).

2. MPFL is followed from patella to its attachment near adductor tubercle.

3. In-plane ultrasound guidance is used to place needle anterior and distal to tubercle.

4. Percutaneous incision is made down to needle tip. Spear is placed at needle tip for anatomical placement of socket.

5. Socket is drilled.

6. 3.0-mm suture anchor (BioComposite Knotless SutureTak; Arthrex) is placed.

7. Leading edge of torn MPFL is identified.

8. Suture passer (Labral FastPass Scorpion; Arthrex) is used to pass sutures through leading edge of torn MPFL to create horizontal mattress.

9. Sutures are tied.

10. Repair is complete.

Video, Part 2. Patellar Attachment

1. Ultrasound is used to scan patella to identify ideal or exact location of tear. In-plane ultrasound guidance is used to place spinal needle at desired socket location.

2. After spinal needle is positioned, in-line percutaneous incision is made, and needle is palpated at patella.

3. Spear is then placed at spinal needle tip for anatomical positioning of socket.

4. Socket is drilled.

5. 3.0-mm suture anchor (BioComposite Knotless SutureTak; Arthrex) is placed in socket.

6. Leading edge of torn medial patellofemoral ligament (MPFL) is identified.

7. Suture passer (Labral Past Pass Scorpion; Arthrex) is used to pass suture from anchor in horizontal mattress fashion through leading edge of torn MPFL.

8. Wire with loop (FiberSnare; Arthrex) is used as part of knotless technology to pull suture back through anchor to create knotless fixation.

9. Suture is pulled for appropriate tensioning of tissue.

10. Ultrasound is used to visualize construct to confirm that MPFL tissue abuts anchor and that repair is complete.

Boston offers its visitors an unrivaled combination of American history, culture, and entertainment. Theater and performance art make an active home in the city and its environs, and there is much to do and see during the AATS Centennial meeting this year,

Hemera/Thinkstock

In entertainment venues, on Saturday, April 29, the acclaimed Alvin Ailey Dance Company will be beforming at the Wang Theater, and Sunday, April 30, the Celebrity Series of Boston will present an evening with Broadway and television star, Kristin Chenoweth at Boston Symphony Hall; and throughout the meeting, the Boston Lyric Opera will be performing Mozaert’s “The Marriage of Figaro.”

Sports fans need not be disappointed, especially baseball fans, as Fenway Park, the home of the Boston Red Sox, will be hosting the Chicago Cubs, April 28-30, and the Baltimore Orioles, May 1-4.

SeanPavonePhoto/Thinkstock

Moodboard/Thinkstock

Boston offers its visitors an unrivaled combination of American history, culture, and entertainment. Theater and performance art make an active home in the city and its environs, and there is much to do and see during the AATS Centennial meeting this year,

Hemera/Thinkstock

In entertainment venues, on Saturday, April 29, the acclaimed Alvin Ailey Dance Company will be beforming at the Wang Theater, and Sunday, April 30, the Celebrity Series of Boston will present an evening with Broadway and television star, Kristin Chenoweth at Boston Symphony Hall; and throughout the meeting, the Boston Lyric Opera will be performing Mozaert’s “The Marriage of Figaro.”

Sports fans need not be disappointed, especially baseball fans, as Fenway Park, the home of the Boston Red Sox, will be hosting the Chicago Cubs, April 28-30, and the Baltimore Orioles, May 1-4.

SeanPavonePhoto/Thinkstock

Moodboard/Thinkstock

Boston offers its visitors an unrivaled combination of American history, culture, and entertainment. Theater and performance art make an active home in the city and its environs, and there is much to do and see during the AATS Centennial meeting this year,

Hemera/Thinkstock

In entertainment venues, on Saturday, April 29, the acclaimed Alvin Ailey Dance Company will be beforming at the Wang Theater, and Sunday, April 30, the Celebrity Series of Boston will present an evening with Broadway and television star, Kristin Chenoweth at Boston Symphony Hall; and throughout the meeting, the Boston Lyric Opera will be performing Mozaert’s “The Marriage of Figaro.”

Sports fans need not be disappointed, especially baseball fans, as Fenway Park, the home of the Boston Red Sox, will be hosting the Chicago Cubs, April 28-30, and the Baltimore Orioles, May 1-4.

SeanPavonePhoto/Thinkstock

Moodboard/Thinkstock

I was rounding on the inpatient general medicine teaching service last weekend and offered to meet my team of students and residents in the “resident library” on Saturday morning. (Although it holds the name “library,” there were no books or periodicals to be seen.) I had not been in the library for many months and was struck by a few things as I entered.

It is a dimly lit space, lined on three of the four walls with rickety desks and desktop computers all facing the walls. The walls are painted an off-white color with innumerable dings and nicks, presumably accumulated over the course of years. There was a string of garland in the shape of a Christmas tree pinned to the wall (P.S. It is March), the entire left side of which was sagging and misshapen. There were various tattered and coffee-stained papers scattered haphazardly throughout the room, including what appeared to be progress notes and test results printed from the EHR; a few worn ECGs; a telemetry strip; even a few (REALLY old, no doubt) chest x-ray films. Lining the fourth wall was a large foldable table, topped with crumbs and food scraps, a half-eaten chocolate Bundt cake, and scattered napkins and utensils, some of which appeared to be used. The one exterior-facing wall had a row of windows with crinkled blinds, some completely closed, others opened at awkward angles and seemingly stuck in place. There was a cadre of chairs in the room, none matching, all in various stages of disrepair, with one completely missing an armrest and another tucked in the corner, probably needing the addition of a handwritten sign “BRokEn.”

This library is a place where the students, interns, and residents go for a bit of a safe haven. They can take their coats off, sit down, have their own computer space, answer pages, and complain about their woes. They can bounce questions off each other, vent frustrations, find the humor in a situation, and just be themselves. So,But what struck me about their sanctuary is that it is totally and utterly depressing. And it was as if they didn’t even notice the chaos and filth laying everywhere around them. I find it impossible to believe that it does not have an effect on their mood and outlook. Although we are all social animals, and we have a real need to congregate and connect with one another, is this really the best environment to do that?

Read the full text of this blog post at hospitalleader.org.
 

Dr. Scheurer is a clinical hospitalist and the medical director of quality and safety at the Medical University of South Carolina in Charleston.

Also on The Hospital Leader…

• Should Overuse Be Considered an Adverse Event By Chris Moriates, MD
• Pulling the Welcome Mat Out from Under Our Colleagues By Brett Hendel-Paterson, MD
• The Upside of Anger By Tracy Cardin, ACNP-BC, SFHM
• Does Your Onboarding Process Really Get Folks on Board? By Leslie Flores, MH, SFHM
• A GIF Is Worth 3000 Words: Introducing #Visual Abstract for #JHMChat By Charlie Wray, DO

I was rounding on the inpatient general medicine teaching service last weekend and offered to meet my team of students and residents in the “resident library” on Saturday morning. (Although it holds the name “library,” there were no books or periodicals to be seen.) I had not been in the library for many months and was struck by a few things as I entered.

It is a dimly lit space, lined on three of the four walls with rickety desks and desktop computers all facing the walls. The walls are painted an off-white color with innumerable dings and nicks, presumably accumulated over the course of years. There was a string of garland in the shape of a Christmas tree pinned to the wall (P.S. It is March), the entire left side of which was sagging and misshapen. There were various tattered and coffee-stained papers scattered haphazardly throughout the room, including what appeared to be progress notes and test results printed from the EHR; a few worn ECGs; a telemetry strip; even a few (REALLY old, no doubt) chest x-ray films. Lining the fourth wall was a large foldable table, topped with crumbs and food scraps, a half-eaten chocolate Bundt cake, and scattered napkins and utensils, some of which appeared to be used. The one exterior-facing wall had a row of windows with crinkled blinds, some completely closed, others opened at awkward angles and seemingly stuck in place. There was a cadre of chairs in the room, none matching, all in various stages of disrepair, with one completely missing an armrest and another tucked in the corner, probably needing the addition of a handwritten sign “BRokEn.”

This library is a place where the students, interns, and residents go for a bit of a safe haven. They can take their coats off, sit down, have their own computer space, answer pages, and complain about their woes. They can bounce questions off each other, vent frustrations, find the humor in a situation, and just be themselves. So,But what struck me about their sanctuary is that it is totally and utterly depressing. And it was as if they didn’t even notice the chaos and filth laying everywhere around them. I find it impossible to believe that it does not have an effect on their mood and outlook. Although we are all social animals, and we have a real need to congregate and connect with one another, is this really the best environment to do that?

Read the full text of this blog post at hospitalleader.org.
 

Dr. Scheurer is a clinical hospitalist and the medical director of quality and safety at the Medical University of South Carolina in Charleston.

Also on The Hospital Leader…

• Should Overuse Be Considered an Adverse Event By Chris Moriates, MD
• Pulling the Welcome Mat Out from Under Our Colleagues By Brett Hendel-Paterson, MD
• The Upside of Anger By Tracy Cardin, ACNP-BC, SFHM
• Does Your Onboarding Process Really Get Folks on Board? By Leslie Flores, MH, SFHM
• A GIF Is Worth 3000 Words: Introducing #Visual Abstract for #JHMChat By Charlie Wray, DO

I was rounding on the inpatient general medicine teaching service last weekend and offered to meet my team of students and residents in the “resident library” on Saturday morning. (Although it holds the name “library,” there were no books or periodicals to be seen.) I had not been in the library for many months and was struck by a few things as I entered.

It is a dimly lit space, lined on three of the four walls with rickety desks and desktop computers all facing the walls. The walls are painted an off-white color with innumerable dings and nicks, presumably accumulated over the course of years. There was a string of garland in the shape of a Christmas tree pinned to the wall (P.S. It is March), the entire left side of which was sagging and misshapen. There were various tattered and coffee-stained papers scattered haphazardly throughout the room, including what appeared to be progress notes and test results printed from the EHR; a few worn ECGs; a telemetry strip; even a few (REALLY old, no doubt) chest x-ray films. Lining the fourth wall was a large foldable table, topped with crumbs and food scraps, a half-eaten chocolate Bundt cake, and scattered napkins and utensils, some of which appeared to be used. The one exterior-facing wall had a row of windows with crinkled blinds, some completely closed, others opened at awkward angles and seemingly stuck in place. There was a cadre of chairs in the room, none matching, all in various stages of disrepair, with one completely missing an armrest and another tucked in the corner, probably needing the addition of a handwritten sign “BRokEn.”

This library is a place where the students, interns, and residents go for a bit of a safe haven. They can take their coats off, sit down, have their own computer space, answer pages, and complain about their woes. They can bounce questions off each other, vent frustrations, find the humor in a situation, and just be themselves. So,But what struck me about their sanctuary is that it is totally and utterly depressing. And it was as if they didn’t even notice the chaos and filth laying everywhere around them. I find it impossible to believe that it does not have an effect on their mood and outlook. Although we are all social animals, and we have a real need to congregate and connect with one another, is this really the best environment to do that?

Read the full text of this blog post at hospitalleader.org.
 

Dr. Scheurer is a clinical hospitalist and the medical director of quality and safety at the Medical University of South Carolina in Charleston.

Also on The Hospital Leader…

• Should Overuse Be Considered an Adverse Event By Chris Moriates, MD
• Pulling the Welcome Mat Out from Under Our Colleagues By Brett Hendel-Paterson, MD
• The Upside of Anger By Tracy Cardin, ACNP-BC, SFHM
• Does Your Onboarding Process Really Get Folks on Board? By Leslie Flores, MH, SFHM
• A GIF Is Worth 3000 Words: Introducing #Visual Abstract for #JHMChat By Charlie Wray, DO

President Donald Trump has signed a resolution that could strip public funding from U.S. clinics that provide abortions, including Planned Parenthood.

The April 13 action overturns a rule imposed by the Obama administration regarding how states can distribute Title X funds, money that assists low-income patients in accessing family planning and preventive health services. The Obama administration’s rule had reinforced existing law that states cannot withhold Title X funding from medical providers for reasons other than poor performance or noncompliance. In recent years, states have begun restricting participation by certain types of providers in the Title X program, such as those that provide abortions.

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

[email protected]

On Twitter @legal_med

President Donald Trump has signed a resolution that could strip public funding from U.S. clinics that provide abortions, including Planned Parenthood.

The April 13 action overturns a rule imposed by the Obama administration regarding how states can distribute Title X funds, money that assists low-income patients in accessing family planning and preventive health services. The Obama administration’s rule had reinforced existing law that states cannot withhold Title X funding from medical providers for reasons other than poor performance or noncompliance. In recent years, states have begun restricting participation by certain types of providers in the Title X program, such as those that provide abortions.

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

[email protected]

On Twitter @legal_med

President Donald Trump has signed a resolution that could strip public funding from U.S. clinics that provide abortions, including Planned Parenthood.

The April 13 action overturns a rule imposed by the Obama administration regarding how states can distribute Title X funds, money that assists low-income patients in accessing family planning and preventive health services. The Obama administration’s rule had reinforced existing law that states cannot withhold Title X funding from medical providers for reasons other than poor performance or noncompliance. In recent years, states have begun restricting participation by certain types of providers in the Title X program, such as those that provide abortions.

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0

[email protected]

On Twitter @legal_med

Arthritis aches and pains are not a normal part of aging. Nonetheless, approximately 54 million American adults who took the CDC’s National Health Survey said their doctor had diagnosed them with arthritis. That’s about 1 in 4 US adults, the majority of whom are of working age.

Related: Taking Steps to Reduce Arthritis Pain

Arthritis can make it hard to lift a cup, let alone a bag of groceries or a heavy briefcase. The percentage of adults with arthritis who have activity limitations grew from 35.9% in 2002 to 42.8% in 2014, a 20% increase independent of the aging of the population.

Research has shown that engaging in physical activity can reduce arthritis symptoms by up to 40%. But one third of adults with arthritis say they don’t engage in physical activity during leisure time. And, while they also can reduce their symptoms by participating in disease management education programs, only 1 in 10 has taken part in such programs.

Related: Lessons Learned From the RACAT Trial: A Comparison of Rheumatoid Arthritis Therapies

“It’s extremely important for primary care providers to encourage their patients with arthritis to be physically active,” says CDC epidemiologist Kamil Barbour, PhD. But Barbour adds that it’s just as important to motivate patients to attend education programs. The CDC says adults with arthritis are significantly more likely to attend an education program when a health care provider has recommended it.

Arthritis aches and pains are not a normal part of aging. Nonetheless, approximately 54 million American adults who took the CDC’s National Health Survey said their doctor had diagnosed them with arthritis. That’s about 1 in 4 US adults, the majority of whom are of working age.

Related: Taking Steps to Reduce Arthritis Pain

Arthritis can make it hard to lift a cup, let alone a bag of groceries or a heavy briefcase. The percentage of adults with arthritis who have activity limitations grew from 35.9% in 2002 to 42.8% in 2014, a 20% increase independent of the aging of the population.

Research has shown that engaging in physical activity can reduce arthritis symptoms by up to 40%. But one third of adults with arthritis say they don’t engage in physical activity during leisure time. And, while they also can reduce their symptoms by participating in disease management education programs, only 1 in 10 has taken part in such programs.

Related: Lessons Learned From the RACAT Trial: A Comparison of Rheumatoid Arthritis Therapies

“It’s extremely important for primary care providers to encourage their patients with arthritis to be physically active,” says CDC epidemiologist Kamil Barbour, PhD. But Barbour adds that it’s just as important to motivate patients to attend education programs. The CDC says adults with arthritis are significantly more likely to attend an education program when a health care provider has recommended it.

Arthritis aches and pains are not a normal part of aging. Nonetheless, approximately 54 million American adults who took the CDC’s National Health Survey said their doctor had diagnosed them with arthritis. That’s about 1 in 4 US adults, the majority of whom are of working age.

Related: Taking Steps to Reduce Arthritis Pain

Arthritis can make it hard to lift a cup, let alone a bag of groceries or a heavy briefcase. The percentage of adults with arthritis who have activity limitations grew from 35.9% in 2002 to 42.8% in 2014, a 20% increase independent of the aging of the population.

Research has shown that engaging in physical activity can reduce arthritis symptoms by up to 40%. But one third of adults with arthritis say they don’t engage in physical activity during leisure time. And, while they also can reduce their symptoms by participating in disease management education programs, only 1 in 10 has taken part in such programs.

Related: Lessons Learned From the RACAT Trial: A Comparison of Rheumatoid Arthritis Therapies

“It’s extremely important for primary care providers to encourage their patients with arthritis to be physically active,” says CDC epidemiologist Kamil Barbour, PhD. But Barbour adds that it’s just as important to motivate patients to attend education programs. The CDC says adults with arthritis are significantly more likely to attend an education program when a health care provider has recommended it.

Image from NIAID

Researchers say they have developed biodegradable nanoparticles that can be used to genetically reprogram T cells while they are still in the body.

The nanoparticles were able to program T cells with genes encoding leukemia-specific chimeric antigen receptors (CARs).

The resulting CAR T cells were able to eliminate leukemia or slow the progression of disease in a mouse model of B-cell acute lymphoblastic leukemia (B-ALL).

Researchers reported these results in Nature Nanotechnology.

“Our technology is the first that we know of to quickly program tumor-recognizing capabilities into T cells without extracting them for laboratory manipulation,” said Matthias Stephan, MD, PhD, of Fred Hutchinson Cancer Research Center in Seattle, Washington.

“The reprogrammed cells begin to work within 24 to 48 hours and continue to produce these receptors for weeks. This suggests that our technology has the potential to allow the immune system to quickly mount a strong enough response to destroy cancerous cells before the disease becomes fatal.”

Dr Stephan and his colleagues designed their nanoparticles to carry genes that encode for CARs intended to target and eliminate B-ALL. The nanoparticles are coated with ligands that make them seek out and bind to T cells.

When a nanoparticle binds to a T cell, the cell engulfs the particle. The nanoparticle then travels to the cell’s nucleus and dissolves.

The CAR genes integrate into chromosomes housed in the nucleus, making it possible for the T cells to begin decoding the new genes and producing CARs within 1 or 2 days.

Once they determined their CAR-carrying nanoparticles reprogrammed a noticeable percentage of T cells, the researchers tested the T cells’ efficacy in a mouse model of B-ALL.

The team infused the nanoparticles into 10 mice and found the treatment eradicated tumors in 7 of the animals. The other 3 mice “showed substantial regression” of leukemia, the researchers said.

On average, mice that received CAR-carrying nanoparticles had a 58-day improvement in survival compared to control mice.

Mice that received the nanoparticles also had “dramatically reduced” B-cell numbers in their spleens. The researchers noted that this is consistent with the reversible B-cell aplasia observed in patients who receive conventional CD19 CAR T-cell therapy.

Dr Stephan and his colleagues also tested conventional CAR T-cell therapy in the B-ALL mouse model. The mice received cyclophosphamide followed by CAR T cells created ex vivo.

These mice had significantly better survival than controls, but their survival was comparable to that of the mice that received the CAR-carrying nanoparticles.

Although these nanoparticles are several steps away from the clinic, Dr Stephan said he imagines a future in which nanoparticles transform cell-based immunotherapies into easily administered, off-the-shelf treatments that are available anywhere.

“I’ve never had cancer, but if I did get a cancer diagnosis, I would want to start treatment right away,” Dr Stephan said. “I want to make cellular immunotherapy a treatment option the day of diagnosis and have it able to be done in an outpatient setting near where people live.”

Image from NIAID

Researchers say they have developed biodegradable nanoparticles that can be used to genetically reprogram T cells while they are still in the body.

The nanoparticles were able to program T cells with genes encoding leukemia-specific chimeric antigen receptors (CARs).

The resulting CAR T cells were able to eliminate leukemia or slow the progression of disease in a mouse model of B-cell acute lymphoblastic leukemia (B-ALL).

Researchers reported these results in Nature Nanotechnology.

“Our technology is the first that we know of to quickly program tumor-recognizing capabilities into T cells without extracting them for laboratory manipulation,” said Matthias Stephan, MD, PhD, of Fred Hutchinson Cancer Research Center in Seattle, Washington.

“The reprogrammed cells begin to work within 24 to 48 hours and continue to produce these receptors for weeks. This suggests that our technology has the potential to allow the immune system to quickly mount a strong enough response to destroy cancerous cells before the disease becomes fatal.”

Dr Stephan and his colleagues designed their nanoparticles to carry genes that encode for CARs intended to target and eliminate B-ALL. The nanoparticles are coated with ligands that make them seek out and bind to T cells.

When a nanoparticle binds to a T cell, the cell engulfs the particle. The nanoparticle then travels to the cell’s nucleus and dissolves.

The CAR genes integrate into chromosomes housed in the nucleus, making it possible for the T cells to begin decoding the new genes and producing CARs within 1 or 2 days.

Once they determined their CAR-carrying nanoparticles reprogrammed a noticeable percentage of T cells, the researchers tested the T cells’ efficacy in a mouse model of B-ALL.

The team infused the nanoparticles into 10 mice and found the treatment eradicated tumors in 7 of the animals. The other 3 mice “showed substantial regression” of leukemia, the researchers said.

On average, mice that received CAR-carrying nanoparticles had a 58-day improvement in survival compared to control mice.

Mice that received the nanoparticles also had “dramatically reduced” B-cell numbers in their spleens. The researchers noted that this is consistent with the reversible B-cell aplasia observed in patients who receive conventional CD19 CAR T-cell therapy.

Dr Stephan and his colleagues also tested conventional CAR T-cell therapy in the B-ALL mouse model. The mice received cyclophosphamide followed by CAR T cells created ex vivo.

These mice had significantly better survival than controls, but their survival was comparable to that of the mice that received the CAR-carrying nanoparticles.

Although these nanoparticles are several steps away from the clinic, Dr Stephan said he imagines a future in which nanoparticles transform cell-based immunotherapies into easily administered, off-the-shelf treatments that are available anywhere.

“I’ve never had cancer, but if I did get a cancer diagnosis, I would want to start treatment right away,” Dr Stephan said. “I want to make cellular immunotherapy a treatment option the day of diagnosis and have it able to be done in an outpatient setting near where people live.”

Image from NIAID

Researchers say they have developed biodegradable nanoparticles that can be used to genetically reprogram T cells while they are still in the body.

The nanoparticles were able to program T cells with genes encoding leukemia-specific chimeric antigen receptors (CARs).

The resulting CAR T cells were able to eliminate leukemia or slow the progression of disease in a mouse model of B-cell acute lymphoblastic leukemia (B-ALL).

Researchers reported these results in Nature Nanotechnology.

“Our technology is the first that we know of to quickly program tumor-recognizing capabilities into T cells without extracting them for laboratory manipulation,” said Matthias Stephan, MD, PhD, of Fred Hutchinson Cancer Research Center in Seattle, Washington.

“The reprogrammed cells begin to work within 24 to 48 hours and continue to produce these receptors for weeks. This suggests that our technology has the potential to allow the immune system to quickly mount a strong enough response to destroy cancerous cells before the disease becomes fatal.”

Dr Stephan and his colleagues designed their nanoparticles to carry genes that encode for CARs intended to target and eliminate B-ALL. The nanoparticles are coated with ligands that make them seek out and bind to T cells.

When a nanoparticle binds to a T cell, the cell engulfs the particle. The nanoparticle then travels to the cell’s nucleus and dissolves.

The CAR genes integrate into chromosomes housed in the nucleus, making it possible for the T cells to begin decoding the new genes and producing CARs within 1 or 2 days.

Once they determined their CAR-carrying nanoparticles reprogrammed a noticeable percentage of T cells, the researchers tested the T cells’ efficacy in a mouse model of B-ALL.

The team infused the nanoparticles into 10 mice and found the treatment eradicated tumors in 7 of the animals. The other 3 mice “showed substantial regression” of leukemia, the researchers said.

On average, mice that received CAR-carrying nanoparticles had a 58-day improvement in survival compared to control mice.

Mice that received the nanoparticles also had “dramatically reduced” B-cell numbers in their spleens. The researchers noted that this is consistent with the reversible B-cell aplasia observed in patients who receive conventional CD19 CAR T-cell therapy.

Dr Stephan and his colleagues also tested conventional CAR T-cell therapy in the B-ALL mouse model. The mice received cyclophosphamide followed by CAR T cells created ex vivo.

These mice had significantly better survival than controls, but their survival was comparable to that of the mice that received the CAR-carrying nanoparticles.

Although these nanoparticles are several steps away from the clinic, Dr Stephan said he imagines a future in which nanoparticles transform cell-based immunotherapies into easily administered, off-the-shelf treatments that are available anywhere.

“I’ve never had cancer, but if I did get a cancer diagnosis, I would want to start treatment right away,” Dr Stephan said. “I want to make cellular immunotherapy a treatment option the day of diagnosis and have it able to be done in an outpatient setting near where people live.”

The drug is now approved for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone to treat MM patients who have received at least 1 prior therapy.

Health Canada granted daratumumab priority review for this indication due to a high unmet medical need in patients with MM.

When a drug is granted priority review, Health Canada aims to complete its review of the drug within 180 days from the time an application is submitted.

Health Canada grants priority review to products intended for the treatment, prevention, or diagnosis of serious, life-threatening, or severely debilitating diseases or conditions.

About daratumumab

Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, which is highly expressed on the surface of MM cells.

The drug is being developed by Janssen Biotech, Inc. under an exclusive worldwide license from Genmab.

Daratumumab received conditional approval in Canada last year.

In June 2016, Health Canada issued a Notice of Compliance with Conditions approving daratumumab for MM patients who had received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or patients who are refractory to both a proteasome inhibitor and an immunomodulatory agent.

Phase 3 trial data

Health Canada’s expanded approval for daratumumab is based on data from the phase 3 POLLUX and CASTOR trials.

In the POLLUX trial, researchers compared treatment with lenalidomide and dexamethasone to treatment with daratumumab, lenalidomide, and dexamethasone in patients with relapsed or refractory MM.

Patients who received daratumumab in combination had a significantly higher response rate and longer progression-free survival than patients who received the 2-drug combination.

However, treatment with daratumumab was associated with infusion-related reactions and a higher incidence of neutropenia.

Results from this trial were published in NEJM in October 2016.

In the CASTOR trial, researchers compared treatment with bortezomib and dexamethasone to treatment with daratumumab, bortezomib, and dexamethasone in patients with previously treated MM.

Patients who received the 3-drug combination had a higher response rate, longer progression-free survival, and a higher incidence of grade 3/4 adverse events than those who received the 2-drug combination.

Results from this trial were published in NEJM in August 2016.

The drug is now approved for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone to treat MM patients who have received at least 1 prior therapy.

Health Canada granted daratumumab priority review for this indication due to a high unmet medical need in patients with MM.

When a drug is granted priority review, Health Canada aims to complete its review of the drug within 180 days from the time an application is submitted.

Health Canada grants priority review to products intended for the treatment, prevention, or diagnosis of serious, life-threatening, or severely debilitating diseases or conditions.

About daratumumab

Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, which is highly expressed on the surface of MM cells.

The drug is being developed by Janssen Biotech, Inc. under an exclusive worldwide license from Genmab.

Daratumumab received conditional approval in Canada last year.

In June 2016, Health Canada issued a Notice of Compliance with Conditions approving daratumumab for MM patients who had received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or patients who are refractory to both a proteasome inhibitor and an immunomodulatory agent.

Phase 3 trial data

Health Canada’s expanded approval for daratumumab is based on data from the phase 3 POLLUX and CASTOR trials.

In the POLLUX trial, researchers compared treatment with lenalidomide and dexamethasone to treatment with daratumumab, lenalidomide, and dexamethasone in patients with relapsed or refractory MM.

Patients who received daratumumab in combination had a significantly higher response rate and longer progression-free survival than patients who received the 2-drug combination.

However, treatment with daratumumab was associated with infusion-related reactions and a higher incidence of neutropenia.

Results from this trial were published in NEJM in October 2016.

In the CASTOR trial, researchers compared treatment with bortezomib and dexamethasone to treatment with daratumumab, bortezomib, and dexamethasone in patients with previously treated MM.

Patients who received the 3-drug combination had a higher response rate, longer progression-free survival, and a higher incidence of grade 3/4 adverse events than those who received the 2-drug combination.

Results from this trial were published in NEJM in August 2016.

The drug is now approved for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone to treat MM patients who have received at least 1 prior therapy.

Health Canada granted daratumumab priority review for this indication due to a high unmet medical need in patients with MM.

When a drug is granted priority review, Health Canada aims to complete its review of the drug within 180 days from the time an application is submitted.

Health Canada grants priority review to products intended for the treatment, prevention, or diagnosis of serious, life-threatening, or severely debilitating diseases or conditions.

About daratumumab

Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, which is highly expressed on the surface of MM cells.

The drug is being developed by Janssen Biotech, Inc. under an exclusive worldwide license from Genmab.

Daratumumab received conditional approval in Canada last year.

In June 2016, Health Canada issued a Notice of Compliance with Conditions approving daratumumab for MM patients who had received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or patients who are refractory to both a proteasome inhibitor and an immunomodulatory agent.

Phase 3 trial data

Health Canada’s expanded approval for daratumumab is based on data from the phase 3 POLLUX and CASTOR trials.

In the POLLUX trial, researchers compared treatment with lenalidomide and dexamethasone to treatment with daratumumab, lenalidomide, and dexamethasone in patients with relapsed or refractory MM.

Patients who received daratumumab in combination had a significantly higher response rate and longer progression-free survival than patients who received the 2-drug combination.

However, treatment with daratumumab was associated with infusion-related reactions and a higher incidence of neutropenia.

Results from this trial were published in NEJM in October 2016.

In the CASTOR trial, researchers compared treatment with bortezomib and dexamethasone to treatment with daratumumab, bortezomib, and dexamethasone in patients with previously treated MM.

Patients who received the 3-drug combination had a higher response rate, longer progression-free survival, and a higher incidence of grade 3/4 adverse events than those who received the 2-drug combination.

Results from this trial were published in NEJM in August 2016.

Photo by Rhoda Baer

A dual kinase inhibitor is active against a range of hematologic malignancies, according to preclinical research.

Investigators found that ASN002, a SYK/JAK inhibitor, exhibited “potent” antiproliferative activity in leukemia, lymphoma, and myeloma cell lines.

ASN002 also inhibited tumor growth in mouse models of these malignancies and proved active against ibrutinib-resistant diffuse large B-cell lymphoma (DLBCL).

The investigators presented these results at the AACR Annual Meeting 2017 (abstract 4204).

The work was conducted by employees of Asana BioSciences, the company developing ASN002.

The investigators tested ASN002 in 178 cell lines and found the drug exhibited “strong antiproliferative activity” in a range of hematologic cancer cell lines, including:

• Leukemia—HEL31, HL60, Jurkat, MOLM-13, and MOLM-16
• Lymphoma—KARPAS-299, OCI-LY10, OCI-LY-19, Pfeiffer, Raji, Ramos, SU-DHL-1, SU-DHL-6, and SU-DHL-10
• Myeloma—H929, JJN3, OPM2, and U266.

In addition, ASN002 was active against ibrutinib-resistant clones derived from the DLBCL cell line SU-DHL-6.

In a SU-DHL-6 xenograft model, the combination of ASN002 and ibrutinib was more effective than either compound alone.

The investigators also found that ASN002 alone demonstrated “strong tumor growth inhibition” in mouse models of DLBCL (Pfeiffer and SU-DHL-6), myeloma (H929), and erythroleukemia (HEL).

The team pointed out that ASN002 is currently under investigation in a phase 1/2 study of patients with B-cell lymphomas (DLBCL, mantle cell lymphoma, and follicular lymphoma) as well as solid tumors.

The investigators said that, to date, ASN002 has been well tolerated and has shown encouraging early evidence of clinical activity and symptomatic benefit in the lymphoma patients.

Photo by Rhoda Baer

A dual kinase inhibitor is active against a range of hematologic malignancies, according to preclinical research.

Investigators found that ASN002, a SYK/JAK inhibitor, exhibited “potent” antiproliferative activity in leukemia, lymphoma, and myeloma cell lines.

ASN002 also inhibited tumor growth in mouse models of these malignancies and proved active against ibrutinib-resistant diffuse large B-cell lymphoma (DLBCL).

The investigators presented these results at the AACR Annual Meeting 2017 (abstract 4204).

The work was conducted by employees of Asana BioSciences, the company developing ASN002.

The investigators tested ASN002 in 178 cell lines and found the drug exhibited “strong antiproliferative activity” in a range of hematologic cancer cell lines, including:

• Leukemia—HEL31, HL60, Jurkat, MOLM-13, and MOLM-16
• Lymphoma—KARPAS-299, OCI-LY10, OCI-LY-19, Pfeiffer, Raji, Ramos, SU-DHL-1, SU-DHL-6, and SU-DHL-10
• Myeloma—H929, JJN3, OPM2, and U266.

In addition, ASN002 was active against ibrutinib-resistant clones derived from the DLBCL cell line SU-DHL-6.

In a SU-DHL-6 xenograft model, the combination of ASN002 and ibrutinib was more effective than either compound alone.

The investigators also found that ASN002 alone demonstrated “strong tumor growth inhibition” in mouse models of DLBCL (Pfeiffer and SU-DHL-6), myeloma (H929), and erythroleukemia (HEL).

The team pointed out that ASN002 is currently under investigation in a phase 1/2 study of patients with B-cell lymphomas (DLBCL, mantle cell lymphoma, and follicular lymphoma) as well as solid tumors.

The investigators said that, to date, ASN002 has been well tolerated and has shown encouraging early evidence of clinical activity and symptomatic benefit in the lymphoma patients.

Photo by Rhoda Baer

A dual kinase inhibitor is active against a range of hematologic malignancies, according to preclinical research.

Investigators found that ASN002, a SYK/JAK inhibitor, exhibited “potent” antiproliferative activity in leukemia, lymphoma, and myeloma cell lines.

ASN002 also inhibited tumor growth in mouse models of these malignancies and proved active against ibrutinib-resistant diffuse large B-cell lymphoma (DLBCL).

The investigators presented these results at the AACR Annual Meeting 2017 (abstract 4204).

The work was conducted by employees of Asana BioSciences, the company developing ASN002.

The investigators tested ASN002 in 178 cell lines and found the drug exhibited “strong antiproliferative activity” in a range of hematologic cancer cell lines, including:

• Leukemia—HEL31, HL60, Jurkat, MOLM-13, and MOLM-16
• Lymphoma—KARPAS-299, OCI-LY10, OCI-LY-19, Pfeiffer, Raji, Ramos, SU-DHL-1, SU-DHL-6, and SU-DHL-10
• Myeloma—H929, JJN3, OPM2, and U266.

In addition, ASN002 was active against ibrutinib-resistant clones derived from the DLBCL cell line SU-DHL-6.

In a SU-DHL-6 xenograft model, the combination of ASN002 and ibrutinib was more effective than either compound alone.

The investigators also found that ASN002 alone demonstrated “strong tumor growth inhibition” in mouse models of DLBCL (Pfeiffer and SU-DHL-6), myeloma (H929), and erythroleukemia (HEL).

The team pointed out that ASN002 is currently under investigation in a phase 1/2 study of patients with B-cell lymphomas (DLBCL, mantle cell lymphoma, and follicular lymphoma) as well as solid tumors.

The investigators said that, to date, ASN002 has been well tolerated and has shown encouraging early evidence of clinical activity and symptomatic benefit in the lymphoma patients.