Blood Banking

Blood donation

Photo by Marja Helander

Canadian Blood Services has made several changes to its blood donor policies in an attempt to broaden the pool of eligible donors in the country.

The agency has eliminated the upper age limit for donating blood, and donors over the age of 71 no longer need to have their physician fill out an assessment form before donating.

People with a history of most cancers are now eligible to donate blood if they have been cancer-free for 5 years.

However, this change does not apply to those with a history of hematologic malignancies.

People who have recently received most vaccines, such as a flu shot, will no longer need to wait 2 days before donating blood.

People who were born in or lived in some African countries (Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, and Nigeria) are now eligible to donate blood. According to Canadian Blood Services, HIV testing performed on blood donors can now detect HIV strains found in these countries.

Canadian Blood Services has also revised geographic deferrals affecting Western Europe based on scientific evidence that indicates the risk of variant Creutzfeldt-Jakob disease has decreased since January 2008.

People who spent 5 years or more in Western Europe since 1980 are deferred from donating blood, but Canadian Blood Services is now including an end date of 2007. People who reached the 5-year limit in Western Europe after 2007 are now eligible to donate.

“Canadian Blood Services regularly reviews the criteria used to determine if someone is eligible to donate blood, including geographic and age restrictions, based on new scientific information,” said Mindy Goldman, medical director of donor and clinical services with Canadian Blood Services.

“These restrictions are no longer necessary. We estimate that about 3000 people who try to donate each year but cannot will now be eligible to donate due to these changes.”

The complete policy changes are available at www.blood.ca/en/blood/recent-changes-donation-criteria.

Blood donation

Photo by Marja Helander

Canadian Blood Services has made several changes to its blood donor policies in an attempt to broaden the pool of eligible donors in the country.

The agency has eliminated the upper age limit for donating blood, and donors over the age of 71 no longer need to have their physician fill out an assessment form before donating.

People with a history of most cancers are now eligible to donate blood if they have been cancer-free for 5 years.

However, this change does not apply to those with a history of hematologic malignancies.

People who have recently received most vaccines, such as a flu shot, will no longer need to wait 2 days before donating blood.

People who were born in or lived in some African countries (Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, and Nigeria) are now eligible to donate blood. According to Canadian Blood Services, HIV testing performed on blood donors can now detect HIV strains found in these countries.

Canadian Blood Services has also revised geographic deferrals affecting Western Europe based on scientific evidence that indicates the risk of variant Creutzfeldt-Jakob disease has decreased since January 2008.

People who spent 5 years or more in Western Europe since 1980 are deferred from donating blood, but Canadian Blood Services is now including an end date of 2007. People who reached the 5-year limit in Western Europe after 2007 are now eligible to donate.

“Canadian Blood Services regularly reviews the criteria used to determine if someone is eligible to donate blood, including geographic and age restrictions, based on new scientific information,” said Mindy Goldman, medical director of donor and clinical services with Canadian Blood Services.

“These restrictions are no longer necessary. We estimate that about 3000 people who try to donate each year but cannot will now be eligible to donate due to these changes.”

The complete policy changes are available at www.blood.ca/en/blood/recent-changes-donation-criteria.

Blood donation

Photo by Marja Helander

Canadian Blood Services has made several changes to its blood donor policies in an attempt to broaden the pool of eligible donors in the country.

The agency has eliminated the upper age limit for donating blood, and donors over the age of 71 no longer need to have their physician fill out an assessment form before donating.

People with a history of most cancers are now eligible to donate blood if they have been cancer-free for 5 years.

However, this change does not apply to those with a history of hematologic malignancies.

People who have recently received most vaccines, such as a flu shot, will no longer need to wait 2 days before donating blood.

People who were born in or lived in some African countries (Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, and Nigeria) are now eligible to donate blood. According to Canadian Blood Services, HIV testing performed on blood donors can now detect HIV strains found in these countries.

Canadian Blood Services has also revised geographic deferrals affecting Western Europe based on scientific evidence that indicates the risk of variant Creutzfeldt-Jakob disease has decreased since January 2008.

People who spent 5 years or more in Western Europe since 1980 are deferred from donating blood, but Canadian Blood Services is now including an end date of 2007. People who reached the 5-year limit in Western Europe after 2007 are now eligible to donate.

“Canadian Blood Services regularly reviews the criteria used to determine if someone is eligible to donate blood, including geographic and age restrictions, based on new scientific information,” said Mindy Goldman, medical director of donor and clinical services with Canadian Blood Services.

“These restrictions are no longer necessary. We estimate that about 3000 people who try to donate each year but cannot will now be eligible to donate due to these changes.”

The complete policy changes are available at www.blood.ca/en/blood/recent-changes-donation-criteria.

Cancer patient receiving

chemotherapy

Photo by Rhoda Baer

Malignant and non-malignant blood disorders cost 31 European countries a total of €23 billion in 2012, according to a pair of papers published in The Lancet Haematology.

Healthcare costs accounted for €16 billion of the total costs, with €7 billion for hospital inpatient care and €4 billion for medications.

Informal care (from friends and relatives) cost €1.6 billion, productivity losses due to mortality cost €2.5 billion, and morbidity cost €3 billion.

Researchers determined these figures by analyzing data from international health organizations (WHO and EUROSTAT), as well as national ministries of health and statistical institutes.

The team estimated the economic burden of malignant and non-malignant blood disorders in 2012 for all 28 countries in the European Union (EU), as well as Iceland, Norway, and Switzerland.

The costs considered were healthcare costs (primary care, accident and emergency care, hospital inpatient and outpatient care, and drugs), informal care costs (from friends and relatives), and productivity losses (due to premature death and people being unable to work due to illness).

Malignant blood disorders

In one paper, the researchers noted that the total economic cost of blood cancers to the 31 countries studied was €12 billion in 2012. Healthcare costs measured €7.3 billion (62% of total costs), productivity losses cost €3.6 billion (30%), and informal care cost €1 billion (8%).

In the 28 EU countries, blood cancers represented 8% of the total cancer costs (€143 billion), meaning that blood cancers are the fourth most expensive type of cancer after lung (15%), breast (12%), and colorectal (10%) cancers.

When considering healthcare costs alone, blood cancers were second only to breast cancers (12% vs 13% of healthcare costs for all cancers).

In 2012, blood cancers cost, on average, €14,674 per patient in the EU (€15,126 in all 31 countries), which is almost 2 times higher than the average cost per patient across all cancers (€7929 in the EU).

The researchers said this difference may be due to the longer length of hospital stay observed for patients with blood cancers (14 days, on average, compared to 8 days across all cancers).

Another potential reason is that blood cancers are increasingly treated with complex, long-term treatments (including stem cell transplants, multi-agent chemotherapy, and radiotherapy) and diagnosed via extensive procedures.

The costs of blood cancers varied widely between the countries studied, but the reasons for this were unclear. For instance, the average healthcare costs in Finland were nearly twice as high as in Belgium (€18,014 vs €9596), despite both countries having similar national income per capita.

Non-malignant blood disorders

In the other paper, the researchers said the total economic cost of non-malignant blood disorders to the 31 countries studied was €11 billion in 2012. Healthcare costs accounted for €8 billion (75% of total costs), productivity losses for €2 billion (19%), and informal care for €618 million (6%).

Averaged across the population studied, non-malignant blood disorders represented an annual healthcare cost of €159 per 10 citizens.

“Non-malignant blood disorders cost the European economy nearly as much as all blood cancers combined,” said Jose Leal, DPhil, of the University of Oxford in the UK.

“We found wide differences in the cost of treating blood disorders in different countries, likely linked to the significant differences in the access and delivery of care for patients with blood disorders. Our findings suggest there is a need to harmonize care of blood disorders across Europe in a cost-effective way.”

Cancer patient receiving

chemotherapy

Photo by Rhoda Baer

Malignant and non-malignant blood disorders cost 31 European countries a total of €23 billion in 2012, according to a pair of papers published in The Lancet Haematology.

Healthcare costs accounted for €16 billion of the total costs, with €7 billion for hospital inpatient care and €4 billion for medications.

Informal care (from friends and relatives) cost €1.6 billion, productivity losses due to mortality cost €2.5 billion, and morbidity cost €3 billion.

Researchers determined these figures by analyzing data from international health organizations (WHO and EUROSTAT), as well as national ministries of health and statistical institutes.

The team estimated the economic burden of malignant and non-malignant blood disorders in 2012 for all 28 countries in the European Union (EU), as well as Iceland, Norway, and Switzerland.

The costs considered were healthcare costs (primary care, accident and emergency care, hospital inpatient and outpatient care, and drugs), informal care costs (from friends and relatives), and productivity losses (due to premature death and people being unable to work due to illness).

Malignant blood disorders

In one paper, the researchers noted that the total economic cost of blood cancers to the 31 countries studied was €12 billion in 2012. Healthcare costs measured €7.3 billion (62% of total costs), productivity losses cost €3.6 billion (30%), and informal care cost €1 billion (8%).

In the 28 EU countries, blood cancers represented 8% of the total cancer costs (€143 billion), meaning that blood cancers are the fourth most expensive type of cancer after lung (15%), breast (12%), and colorectal (10%) cancers.

When considering healthcare costs alone, blood cancers were second only to breast cancers (12% vs 13% of healthcare costs for all cancers).

In 2012, blood cancers cost, on average, €14,674 per patient in the EU (€15,126 in all 31 countries), which is almost 2 times higher than the average cost per patient across all cancers (€7929 in the EU).

The researchers said this difference may be due to the longer length of hospital stay observed for patients with blood cancers (14 days, on average, compared to 8 days across all cancers).

Another potential reason is that blood cancers are increasingly treated with complex, long-term treatments (including stem cell transplants, multi-agent chemotherapy, and radiotherapy) and diagnosed via extensive procedures.

The costs of blood cancers varied widely between the countries studied, but the reasons for this were unclear. For instance, the average healthcare costs in Finland were nearly twice as high as in Belgium (€18,014 vs €9596), despite both countries having similar national income per capita.

Non-malignant blood disorders

In the other paper, the researchers said the total economic cost of non-malignant blood disorders to the 31 countries studied was €11 billion in 2012. Healthcare costs accounted for €8 billion (75% of total costs), productivity losses for €2 billion (19%), and informal care for €618 million (6%).

Averaged across the population studied, non-malignant blood disorders represented an annual healthcare cost of €159 per 10 citizens.

“Non-malignant blood disorders cost the European economy nearly as much as all blood cancers combined,” said Jose Leal, DPhil, of the University of Oxford in the UK.

“We found wide differences in the cost of treating blood disorders in different countries, likely linked to the significant differences in the access and delivery of care for patients with blood disorders. Our findings suggest there is a need to harmonize care of blood disorders across Europe in a cost-effective way.”

Cancer patient receiving

chemotherapy

Photo by Rhoda Baer

Malignant and non-malignant blood disorders cost 31 European countries a total of €23 billion in 2012, according to a pair of papers published in The Lancet Haematology.

Healthcare costs accounted for €16 billion of the total costs, with €7 billion for hospital inpatient care and €4 billion for medications.

Informal care (from friends and relatives) cost €1.6 billion, productivity losses due to mortality cost €2.5 billion, and morbidity cost €3 billion.

Researchers determined these figures by analyzing data from international health organizations (WHO and EUROSTAT), as well as national ministries of health and statistical institutes.

The team estimated the economic burden of malignant and non-malignant blood disorders in 2012 for all 28 countries in the European Union (EU), as well as Iceland, Norway, and Switzerland.

The costs considered were healthcare costs (primary care, accident and emergency care, hospital inpatient and outpatient care, and drugs), informal care costs (from friends and relatives), and productivity losses (due to premature death and people being unable to work due to illness).

Malignant blood disorders

In one paper, the researchers noted that the total economic cost of blood cancers to the 31 countries studied was €12 billion in 2012. Healthcare costs measured €7.3 billion (62% of total costs), productivity losses cost €3.6 billion (30%), and informal care cost €1 billion (8%).

In the 28 EU countries, blood cancers represented 8% of the total cancer costs (€143 billion), meaning that blood cancers are the fourth most expensive type of cancer after lung (15%), breast (12%), and colorectal (10%) cancers.

When considering healthcare costs alone, blood cancers were second only to breast cancers (12% vs 13% of healthcare costs for all cancers).

In 2012, blood cancers cost, on average, €14,674 per patient in the EU (€15,126 in all 31 countries), which is almost 2 times higher than the average cost per patient across all cancers (€7929 in the EU).

The researchers said this difference may be due to the longer length of hospital stay observed for patients with blood cancers (14 days, on average, compared to 8 days across all cancers).

Another potential reason is that blood cancers are increasingly treated with complex, long-term treatments (including stem cell transplants, multi-agent chemotherapy, and radiotherapy) and diagnosed via extensive procedures.

The costs of blood cancers varied widely between the countries studied, but the reasons for this were unclear. For instance, the average healthcare costs in Finland were nearly twice as high as in Belgium (€18,014 vs €9596), despite both countries having similar national income per capita.

Non-malignant blood disorders

In the other paper, the researchers said the total economic cost of non-malignant blood disorders to the 31 countries studied was €11 billion in 2012. Healthcare costs accounted for €8 billion (75% of total costs), productivity losses for €2 billion (19%), and informal care for €618 million (6%).

Averaged across the population studied, non-malignant blood disorders represented an annual healthcare cost of €159 per 10 citizens.

“Non-malignant blood disorders cost the European economy nearly as much as all blood cancers combined,” said Jose Leal, DPhil, of the University of Oxford in the UK.

“We found wide differences in the cost of treating blood disorders in different countries, likely linked to the significant differences in the access and delivery of care for patients with blood disorders. Our findings suggest there is a need to harmonize care of blood disorders across Europe in a cost-effective way.”

Donated blood

Photo courtesy of UAB Hospital

SAN DIEGO—Blood management guidelines can save millions of dollars and drastically reduce the waste of donated blood, according to a group of investigators.

A team at Vanderbilt University Medical Center in Nashville, Tennessee, developed blood utilization practice guidelines that resulted in $2 million in savings and a 30% reduction in blood use from 2011 to 2015.

The investigators presented these results in a poster at the 2016 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) Conference.

“The transfusion committee at Vanderbilt was interested in evaluating how we could implement evidence-based guidelines around restrictive transfusion,” said investigator Barbara J. Martin, RN.

To that end, the team first decided to change the standard practice of ordering 2 units of blood per patient. The investigators modified the medical center’s computerized provider order entry system to allow for blood ordering to be based on a specific assessment of each case, rather than a standard order of 2 units.

This change reduced red blood cell transfusions by more than 30%—from 675 units per 1000 discharges in 2011 to 432 units per 1000 discharges in 2015.

The investigators also noted that, for general and vascular surgery patients who underwent NSQIP- targeted procedures—including colectomy, proctectomy, ventral hernia, and appendectomy—between 5% and 6% were transfused with an average of 2.4 units of blood per patient in 2015.

In comparison, 11% of such patients were transfused with an average of 4.6 units of blood per patient in 2011.

“We found that, in that particular population, many of whom are transfused for acute blood loss, we still saw a significant decrease in the number of units transfused into the patient,” Martin said.

In addition to addressing blood utilization, the investigators developed guidelines to reduce waste. These guidelines state that, when more than 1 unit of blood is ordered, it must be sent in a cooler rather than the pneumatic tube. Coolers were reconfigured to optimize temperature management.

Furthermore, a specific member of the staff is tasked with “ownership” of the blood products, including returning unused product to the blood bank. Finally, individual unit wastage is reported to clinical leaders for review, and aggregate data are reported monthly.

The use of these guidelines resulted in fewer than 80 units of blood being wasted in 2015, down from 300 units in 2011.

Martin said the guidelines she and her colleagues developed could easily be implemented at other medical centers.

“Blood is a limited resource,” she noted, “and we have a responsibility as a healthcare provider to optimize the use of a resource that is difficult to get and only available through altruistic donations.”

Donated blood

Photo courtesy of UAB Hospital

SAN DIEGO—Blood management guidelines can save millions of dollars and drastically reduce the waste of donated blood, according to a group of investigators.

A team at Vanderbilt University Medical Center in Nashville, Tennessee, developed blood utilization practice guidelines that resulted in $2 million in savings and a 30% reduction in blood use from 2011 to 2015.

The investigators presented these results in a poster at the 2016 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) Conference.

“The transfusion committee at Vanderbilt was interested in evaluating how we could implement evidence-based guidelines around restrictive transfusion,” said investigator Barbara J. Martin, RN.

To that end, the team first decided to change the standard practice of ordering 2 units of blood per patient. The investigators modified the medical center’s computerized provider order entry system to allow for blood ordering to be based on a specific assessment of each case, rather than a standard order of 2 units.

This change reduced red blood cell transfusions by more than 30%—from 675 units per 1000 discharges in 2011 to 432 units per 1000 discharges in 2015.

The investigators also noted that, for general and vascular surgery patients who underwent NSQIP- targeted procedures—including colectomy, proctectomy, ventral hernia, and appendectomy—between 5% and 6% were transfused with an average of 2.4 units of blood per patient in 2015.

In comparison, 11% of such patients were transfused with an average of 4.6 units of blood per patient in 2011.

“We found that, in that particular population, many of whom are transfused for acute blood loss, we still saw a significant decrease in the number of units transfused into the patient,” Martin said.

In addition to addressing blood utilization, the investigators developed guidelines to reduce waste. These guidelines state that, when more than 1 unit of blood is ordered, it must be sent in a cooler rather than the pneumatic tube. Coolers were reconfigured to optimize temperature management.

Furthermore, a specific member of the staff is tasked with “ownership” of the blood products, including returning unused product to the blood bank. Finally, individual unit wastage is reported to clinical leaders for review, and aggregate data are reported monthly.

The use of these guidelines resulted in fewer than 80 units of blood being wasted in 2015, down from 300 units in 2011.

Martin said the guidelines she and her colleagues developed could easily be implemented at other medical centers.

“Blood is a limited resource,” she noted, “and we have a responsibility as a healthcare provider to optimize the use of a resource that is difficult to get and only available through altruistic donations.”

Donated blood

Photo courtesy of UAB Hospital

SAN DIEGO—Blood management guidelines can save millions of dollars and drastically reduce the waste of donated blood, according to a group of investigators.

A team at Vanderbilt University Medical Center in Nashville, Tennessee, developed blood utilization practice guidelines that resulted in $2 million in savings and a 30% reduction in blood use from 2011 to 2015.

The investigators presented these results in a poster at the 2016 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) Conference.

“The transfusion committee at Vanderbilt was interested in evaluating how we could implement evidence-based guidelines around restrictive transfusion,” said investigator Barbara J. Martin, RN.

To that end, the team first decided to change the standard practice of ordering 2 units of blood per patient. The investigators modified the medical center’s computerized provider order entry system to allow for blood ordering to be based on a specific assessment of each case, rather than a standard order of 2 units.

This change reduced red blood cell transfusions by more than 30%—from 675 units per 1000 discharges in 2011 to 432 units per 1000 discharges in 2015.

The investigators also noted that, for general and vascular surgery patients who underwent NSQIP- targeted procedures—including colectomy, proctectomy, ventral hernia, and appendectomy—between 5% and 6% were transfused with an average of 2.4 units of blood per patient in 2015.

In comparison, 11% of such patients were transfused with an average of 4.6 units of blood per patient in 2011.

“We found that, in that particular population, many of whom are transfused for acute blood loss, we still saw a significant decrease in the number of units transfused into the patient,” Martin said.

In addition to addressing blood utilization, the investigators developed guidelines to reduce waste. These guidelines state that, when more than 1 unit of blood is ordered, it must be sent in a cooler rather than the pneumatic tube. Coolers were reconfigured to optimize temperature management.

Furthermore, a specific member of the staff is tasked with “ownership” of the blood products, including returning unused product to the blood bank. Finally, individual unit wastage is reported to clinical leaders for review, and aggregate data are reported monthly.

The use of these guidelines resulted in fewer than 80 units of blood being wasted in 2015, down from 300 units in 2011.

Martin said the guidelines she and her colleagues developed could easily be implemented at other medical centers.

“Blood is a limited resource,” she noted, “and we have a responsibility as a healthcare provider to optimize the use of a resource that is difficult to get and only available through altruistic donations.”

Woman on a scale

A study of more than 400 women suggests that losing weight can reduce levels of cancer-promoting proteins in the blood.

Overweight or obese women who lost weight over a 12-month period—through diet alone or both diet and exercise—significantly lowered their levels of proteins that play a role in angiogenesis.

Researchers say this finding suggests that losing weight might help reduce the risk of developing certain cancers.

“We know that being overweight and having a sedentary lifestyle is associated with an increase in risk for developing certain types of cancer,” said Catherine Duggan, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, Washington.

“However, we don’t know exactly why. We wanted to investigate how levels of some biomarkers associated with angiogenesis were altered when overweight, sedentary, postmenopausal women enrolled in a research study lost weight and/or became physically active over the course of a year.”

Dr Duggan and her colleagues described this investigation in Cancer Research.

The team studied 439 women who were postmenopausal and overweight or obese but were otherwise healthy and ranged in age from 50 to 75.

The women were randomized to 1 of 4 study arms:

• A diet arm, in which women restricted their calorie intake to no more than 2000 kcal per day that included less than 30% of fat calories
• An aerobic exercise arm, in which women performed 45 minutes of moderate to vigorous exercise 5 days a week
• A combined diet and exercise arm
• A control arm.

The researchers collected blood samples at baseline and at 12 months, measuring levels of the angiogenesis-related proteins VEGF, PAI-1, and PEDF.

They also measured weight loss at 12 months and found that women in all 3 intervention arms had a significantly higher mean weight loss than women in the control arm.

The mean weight loss was 0.8% of body weight for women in the control arm, 2.4% for women in the exercise arm (P=0.03), 8.5% for women in the diet arm (P<0.001), and 10.8% for women in the diet and exercise arm (P<0.001).

Compared with women in the control arm, those in the diet-only arm and the diet and exercise arm had significantly lower levels of the angiogenesis-related proteins at 12 months. However, such effects were not apparent among women in the exercise-only arm.

Specifically, women in the diet and exercise arm had a significantly greater reduction in PAI-1 at 12 months than women in the control arm (-19.3% and +3.48%, respectively, P<0.0001).

Women in the diet-only arm and the diet and exercise arm had significantly greater reductions in PEDF than controls (-9.20%, -9.90%, and +0.18%, respectively, both P<0.0001).

And women in the diet-only arm (-8.25%, P=0.0005) and the diet and exercise arm (-9.98%, P<0.0001) had significantly greater reductions in VEGF than controls (-1.21%).

The researchers also observed a linear trend in the reductions. So the more weight loss the women experienced, the greater the reduction in angiogenesis-related protein levels.

“Our study shows that weight loss is a safe and effective method of improving the angiogenic profile in healthy individuals,” Dr Duggan said. “We were surprised by the magnitude of change in these biomarkers with weight loss.”

“While we can’t say for certain that reducing the circulating levels of angiogenic factors through weight loss would impact the growth of tumors, it is possible that they might be associated with a less favorable milieu for tumor growth and proliferation.”

Dr Duggan and her colleagues said limitations of this study include the fact that the researchers only measured 3 angiogenic factors and did not measure them in adipose or other tissues.

Woman on a scale

A study of more than 400 women suggests that losing weight can reduce levels of cancer-promoting proteins in the blood.

Overweight or obese women who lost weight over a 12-month period—through diet alone or both diet and exercise—significantly lowered their levels of proteins that play a role in angiogenesis.

Researchers say this finding suggests that losing weight might help reduce the risk of developing certain cancers.

“We know that being overweight and having a sedentary lifestyle is associated with an increase in risk for developing certain types of cancer,” said Catherine Duggan, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, Washington.

“However, we don’t know exactly why. We wanted to investigate how levels of some biomarkers associated with angiogenesis were altered when overweight, sedentary, postmenopausal women enrolled in a research study lost weight and/or became physically active over the course of a year.”

Dr Duggan and her colleagues described this investigation in Cancer Research.

The team studied 439 women who were postmenopausal and overweight or obese but were otherwise healthy and ranged in age from 50 to 75.

The women were randomized to 1 of 4 study arms:

• A diet arm, in which women restricted their calorie intake to no more than 2000 kcal per day that included less than 30% of fat calories
• An aerobic exercise arm, in which women performed 45 minutes of moderate to vigorous exercise 5 days a week
• A combined diet and exercise arm
• A control arm.

The researchers collected blood samples at baseline and at 12 months, measuring levels of the angiogenesis-related proteins VEGF, PAI-1, and PEDF.

They also measured weight loss at 12 months and found that women in all 3 intervention arms had a significantly higher mean weight loss than women in the control arm.

The mean weight loss was 0.8% of body weight for women in the control arm, 2.4% for women in the exercise arm (P=0.03), 8.5% for women in the diet arm (P<0.001), and 10.8% for women in the diet and exercise arm (P<0.001).

Compared with women in the control arm, those in the diet-only arm and the diet and exercise arm had significantly lower levels of the angiogenesis-related proteins at 12 months. However, such effects were not apparent among women in the exercise-only arm.

Specifically, women in the diet and exercise arm had a significantly greater reduction in PAI-1 at 12 months than women in the control arm (-19.3% and +3.48%, respectively, P<0.0001).

Women in the diet-only arm and the diet and exercise arm had significantly greater reductions in PEDF than controls (-9.20%, -9.90%, and +0.18%, respectively, both P<0.0001).

And women in the diet-only arm (-8.25%, P=0.0005) and the diet and exercise arm (-9.98%, P<0.0001) had significantly greater reductions in VEGF than controls (-1.21%).

The researchers also observed a linear trend in the reductions. So the more weight loss the women experienced, the greater the reduction in angiogenesis-related protein levels.

“Our study shows that weight loss is a safe and effective method of improving the angiogenic profile in healthy individuals,” Dr Duggan said. “We were surprised by the magnitude of change in these biomarkers with weight loss.”

“While we can’t say for certain that reducing the circulating levels of angiogenic factors through weight loss would impact the growth of tumors, it is possible that they might be associated with a less favorable milieu for tumor growth and proliferation.”

Dr Duggan and her colleagues said limitations of this study include the fact that the researchers only measured 3 angiogenic factors and did not measure them in adipose or other tissues.

Woman on a scale

A study of more than 400 women suggests that losing weight can reduce levels of cancer-promoting proteins in the blood.

Overweight or obese women who lost weight over a 12-month period—through diet alone or both diet and exercise—significantly lowered their levels of proteins that play a role in angiogenesis.

Researchers say this finding suggests that losing weight might help reduce the risk of developing certain cancers.

“We know that being overweight and having a sedentary lifestyle is associated with an increase in risk for developing certain types of cancer,” said Catherine Duggan, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, Washington.

“However, we don’t know exactly why. We wanted to investigate how levels of some biomarkers associated with angiogenesis were altered when overweight, sedentary, postmenopausal women enrolled in a research study lost weight and/or became physically active over the course of a year.”

Dr Duggan and her colleagues described this investigation in Cancer Research.

The team studied 439 women who were postmenopausal and overweight or obese but were otherwise healthy and ranged in age from 50 to 75.

The women were randomized to 1 of 4 study arms:

• A diet arm, in which women restricted their calorie intake to no more than 2000 kcal per day that included less than 30% of fat calories
• An aerobic exercise arm, in which women performed 45 minutes of moderate to vigorous exercise 5 days a week
• A combined diet and exercise arm
• A control arm.

The researchers collected blood samples at baseline and at 12 months, measuring levels of the angiogenesis-related proteins VEGF, PAI-1, and PEDF.

They also measured weight loss at 12 months and found that women in all 3 intervention arms had a significantly higher mean weight loss than women in the control arm.

The mean weight loss was 0.8% of body weight for women in the control arm, 2.4% for women in the exercise arm (P=0.03), 8.5% for women in the diet arm (P<0.001), and 10.8% for women in the diet and exercise arm (P<0.001).

Compared with women in the control arm, those in the diet-only arm and the diet and exercise arm had significantly lower levels of the angiogenesis-related proteins at 12 months. However, such effects were not apparent among women in the exercise-only arm.

Specifically, women in the diet and exercise arm had a significantly greater reduction in PAI-1 at 12 months than women in the control arm (-19.3% and +3.48%, respectively, P<0.0001).

Women in the diet-only arm and the diet and exercise arm had significantly greater reductions in PEDF than controls (-9.20%, -9.90%, and +0.18%, respectively, both P<0.0001).

And women in the diet-only arm (-8.25%, P=0.0005) and the diet and exercise arm (-9.98%, P<0.0001) had significantly greater reductions in VEGF than controls (-1.21%).

The researchers also observed a linear trend in the reductions. So the more weight loss the women experienced, the greater the reduction in angiogenesis-related protein levels.

“Our study shows that weight loss is a safe and effective method of improving the angiogenic profile in healthy individuals,” Dr Duggan said. “We were surprised by the magnitude of change in these biomarkers with weight loss.”

“While we can’t say for certain that reducing the circulating levels of angiogenic factors through weight loss would impact the growth of tumors, it is possible that they might be associated with a less favorable milieu for tumor growth and proliferation.”

Dr Duggan and her colleagues said limitations of this study include the fact that the researchers only measured 3 angiogenic factors and did not measure them in adipose or other tissues.

Blood for transfusion
Photo by Elise Amendola

A large study has revealed an unexpected association between blood donor characteristics and transfusion recipients’ outcomes.

It is the first study to suggest that red blood cell (RBC) transfusions from younger donors or female donors may increase the risk of death in recipients.

“We need further research to confirm these findings and to look at possible biological mechanisms,” said Michaël Chassé, MD, PhD, of Université Laval in Quebec, Canada.

“One possibility is that components in the blood of younger donors or female donors may affect the immune system of the transfusion recipient.”

For this study, Dr Chassé and his colleagues linked 30,503 patients who received a transfusion at The Ottawa Hospital between October 2006 and December 2013 with their respective blood donors (80,755 donors in total).

The average age of the recipients was 66.2 years. They were followed for an average of 2.3 years, with a maximum follow-up time of 7.2 years.

The researchers found that recipients of RBCs from female donors had an 8% increased risk of death from any cause per unit transfused, when compared with recipients of RBCs from male donors. The adjusted hazard ratio (aHR) was 1.08 (95% CI, 1.06-1.09; P<0.001).

A similar increased risk of death was observed for recipients of RBCs from younger donors. When compared to recipients of RBCs from donors ages 40 to 49.9, the risk of death was higher for recipients of RBCs from donors ages 17 to 19.9 (aHR=1.08; 95% CI, 1.06-1.10; P<0.001) and recipients of RBCs from donors ages 20 to 29.9 (aHR=1.06; 95% CI, 1.04-1.09; P<0.001).

“Though our research suggests that we should investigate what’s behind the associations that we found, there is no definitive evidence yet that proves that one type of blood is better or worse for patients,” said Jason Acker, PhD, of Canadian Blood Services in Edmonton, Alberta.

“This study opens up new areas of investigation where we can really dig into the biological explanations and understand true cause and effect.”

The study was published in JAMA Internal Medicine.

Blood for transfusion
Photo by Elise Amendola

A large study has revealed an unexpected association between blood donor characteristics and transfusion recipients’ outcomes.

It is the first study to suggest that red blood cell (RBC) transfusions from younger donors or female donors may increase the risk of death in recipients.

“We need further research to confirm these findings and to look at possible biological mechanisms,” said Michaël Chassé, MD, PhD, of Université Laval in Quebec, Canada.

“One possibility is that components in the blood of younger donors or female donors may affect the immune system of the transfusion recipient.”

For this study, Dr Chassé and his colleagues linked 30,503 patients who received a transfusion at The Ottawa Hospital between October 2006 and December 2013 with their respective blood donors (80,755 donors in total).

The average age of the recipients was 66.2 years. They were followed for an average of 2.3 years, with a maximum follow-up time of 7.2 years.

The researchers found that recipients of RBCs from female donors had an 8% increased risk of death from any cause per unit transfused, when compared with recipients of RBCs from male donors. The adjusted hazard ratio (aHR) was 1.08 (95% CI, 1.06-1.09; P<0.001).

A similar increased risk of death was observed for recipients of RBCs from younger donors. When compared to recipients of RBCs from donors ages 40 to 49.9, the risk of death was higher for recipients of RBCs from donors ages 17 to 19.9 (aHR=1.08; 95% CI, 1.06-1.10; P<0.001) and recipients of RBCs from donors ages 20 to 29.9 (aHR=1.06; 95% CI, 1.04-1.09; P<0.001).

“Though our research suggests that we should investigate what’s behind the associations that we found, there is no definitive evidence yet that proves that one type of blood is better or worse for patients,” said Jason Acker, PhD, of Canadian Blood Services in Edmonton, Alberta.

“This study opens up new areas of investigation where we can really dig into the biological explanations and understand true cause and effect.”

The study was published in JAMA Internal Medicine.

Blood for transfusion
Photo by Elise Amendola

A large study has revealed an unexpected association between blood donor characteristics and transfusion recipients’ outcomes.

It is the first study to suggest that red blood cell (RBC) transfusions from younger donors or female donors may increase the risk of death in recipients.

“We need further research to confirm these findings and to look at possible biological mechanisms,” said Michaël Chassé, MD, PhD, of Université Laval in Quebec, Canada.

“One possibility is that components in the blood of younger donors or female donors may affect the immune system of the transfusion recipient.”

For this study, Dr Chassé and his colleagues linked 30,503 patients who received a transfusion at The Ottawa Hospital between October 2006 and December 2013 with their respective blood donors (80,755 donors in total).

The average age of the recipients was 66.2 years. They were followed for an average of 2.3 years, with a maximum follow-up time of 7.2 years.

The researchers found that recipients of RBCs from female donors had an 8% increased risk of death from any cause per unit transfused, when compared with recipients of RBCs from male donors. The adjusted hazard ratio (aHR) was 1.08 (95% CI, 1.06-1.09; P<0.001).

A similar increased risk of death was observed for recipients of RBCs from younger donors. When compared to recipients of RBCs from donors ages 40 to 49.9, the risk of death was higher for recipients of RBCs from donors ages 17 to 19.9 (aHR=1.08; 95% CI, 1.06-1.10; P<0.001) and recipients of RBCs from donors ages 20 to 29.9 (aHR=1.06; 95% CI, 1.04-1.09; P<0.001).

“Though our research suggests that we should investigate what’s behind the associations that we found, there is no definitive evidence yet that proves that one type of blood is better or worse for patients,” said Jason Acker, PhD, of Canadian Blood Services in Edmonton, Alberta.

“This study opens up new areas of investigation where we can really dig into the biological explanations and understand true cause and effect.”

The study was published in JAMA Internal Medicine.

Blood for transfusion

Photo by Elise Amendola

Results of a large, retrospective study suggest that neurological diseases are not transmitted via blood transfusion.

Previous studies have shown that such diseases can be induced in healthy laboratory animals through the injection of diseased brain tissue from humans.

This has caused concern that neurological diseases might be transmitted from human to human via blood transfusions.

However, a study published in Annals of Internal Medicine suggests such transmission does not occur.

“The results are unusually clear for such a complicated subject as this,” said study author Gustaf Edgren, PhD, of Karolinska Institutet in Stockholm, Sweden.

“We’ve been working with this question for a long time now and have found no indication that these diseases can be transmitted via transfusions.”

Dr Edgren and his colleagues conducted this study by analyzing data from 1,465,845 patients who received blood transfusions in Sweden or Denmark between 1968 and 2012.

The team used multivariable Cox regression models (taking into account sex, age, place of residence, blood group, number of transfusions, and time since first transfusion) to estimate hazard ratios for dementia of any type, Alzheimer’s disease, and Parkinson’s disease in patients who received transfusions from donors who were later diagnosed with any of these diseases, compared to patients who received blood from healthy donors.

In all, 2.9% of patients received a transfusion from a donor diagnosed with one of the aforementioned neurological diseases. And there was no evidence of disease transmission via transfusion.

The hazard ratio for dementia in transfusion recipients whose donors were diagnosed with dementia, compared to recipients of blood from healthy donors, was 1.04 (95% CI, 0.99 to 1.09).

The hazard ratios for Alzheimer’s disease and Parkinson’s disease were 0.99 (95% CI, 0.85 to 1.15) and 0.94 (95% CI, 0.78 to 1.14), respectively.

“Blood transfusions are extremely safe in the Western world today, but, even so, we are working continuously and proactively on identifying any overlooked risks,” Dr Edgren said.

“The Swedish-Danish database that we have built up and used in many similar studies clearly demonstrates the value of our vast health registries. This kind of study would have simply been extremely difficult anywhere else in the world.”

Blood for transfusion

Photo by Elise Amendola

Results of a large, retrospective study suggest that neurological diseases are not transmitted via blood transfusion.

Previous studies have shown that such diseases can be induced in healthy laboratory animals through the injection of diseased brain tissue from humans.

This has caused concern that neurological diseases might be transmitted from human to human via blood transfusions.

However, a study published in Annals of Internal Medicine suggests such transmission does not occur.

“The results are unusually clear for such a complicated subject as this,” said study author Gustaf Edgren, PhD, of Karolinska Institutet in Stockholm, Sweden.

“We’ve been working with this question for a long time now and have found no indication that these diseases can be transmitted via transfusions.”

Dr Edgren and his colleagues conducted this study by analyzing data from 1,465,845 patients who received blood transfusions in Sweden or Denmark between 1968 and 2012.

The team used multivariable Cox regression models (taking into account sex, age, place of residence, blood group, number of transfusions, and time since first transfusion) to estimate hazard ratios for dementia of any type, Alzheimer’s disease, and Parkinson’s disease in patients who received transfusions from donors who were later diagnosed with any of these diseases, compared to patients who received blood from healthy donors.

In all, 2.9% of patients received a transfusion from a donor diagnosed with one of the aforementioned neurological diseases. And there was no evidence of disease transmission via transfusion.

The hazard ratio for dementia in transfusion recipients whose donors were diagnosed with dementia, compared to recipients of blood from healthy donors, was 1.04 (95% CI, 0.99 to 1.09).

The hazard ratios for Alzheimer’s disease and Parkinson’s disease were 0.99 (95% CI, 0.85 to 1.15) and 0.94 (95% CI, 0.78 to 1.14), respectively.

“Blood transfusions are extremely safe in the Western world today, but, even so, we are working continuously and proactively on identifying any overlooked risks,” Dr Edgren said.

“The Swedish-Danish database that we have built up and used in many similar studies clearly demonstrates the value of our vast health registries. This kind of study would have simply been extremely difficult anywhere else in the world.”

Blood for transfusion

Photo by Elise Amendola

Results of a large, retrospective study suggest that neurological diseases are not transmitted via blood transfusion.

Previous studies have shown that such diseases can be induced in healthy laboratory animals through the injection of diseased brain tissue from humans.

This has caused concern that neurological diseases might be transmitted from human to human via blood transfusions.

However, a study published in Annals of Internal Medicine suggests such transmission does not occur.

“The results are unusually clear for such a complicated subject as this,” said study author Gustaf Edgren, PhD, of Karolinska Institutet in Stockholm, Sweden.

“We’ve been working with this question for a long time now and have found no indication that these diseases can be transmitted via transfusions.”

Dr Edgren and his colleagues conducted this study by analyzing data from 1,465,845 patients who received blood transfusions in Sweden or Denmark between 1968 and 2012.

The team used multivariable Cox regression models (taking into account sex, age, place of residence, blood group, number of transfusions, and time since first transfusion) to estimate hazard ratios for dementia of any type, Alzheimer’s disease, and Parkinson’s disease in patients who received transfusions from donors who were later diagnosed with any of these diseases, compared to patients who received blood from healthy donors.

In all, 2.9% of patients received a transfusion from a donor diagnosed with one of the aforementioned neurological diseases. And there was no evidence of disease transmission via transfusion.

The hazard ratio for dementia in transfusion recipients whose donors were diagnosed with dementia, compared to recipients of blood from healthy donors, was 1.04 (95% CI, 0.99 to 1.09).

The hazard ratios for Alzheimer’s disease and Parkinson’s disease were 0.99 (95% CI, 0.85 to 1.15) and 0.94 (95% CI, 0.78 to 1.14), respectively.

“Blood transfusions are extremely safe in the Western world today, but, even so, we are working continuously and proactively on identifying any overlooked risks,” Dr Edgren said.

“The Swedish-Danish database that we have built up and used in many similar studies clearly demonstrates the value of our vast health registries. This kind of study would have simply been extremely difficult anywhere else in the world.”

Uwe Platzbecker, MD

COPENHAGEN—Results from a pair of phase 2 trials suggest luspatercept can produce erythroid responses and enable transfusion independence in patients with lower-risk myelodysplastic syndromes (MDS).

In a 3-month base study, 51% of patients treated with luspatercept had an erythroid response, and 35% achieved transfusion independence.

In an ongoing extension study, 81% of luspatercept-treated patients have had an erythroid response, and 50% have achieved transfusion independence.

The majority of adverse events in both trials were grade 1 and 2.

Uwe Platzbecker, MD, of the University Hospital in Dresden, Germany, presented these results at the 21st Congress of the European Hematology Association (abstract S131*). The studies were sponsored by Acceleron Pharma, Inc.

Luspatercept (formerly ACE-536) is a modified activin receptor type IIB fusion protein that increases red blood cell (RBC) levels by targeting molecules in the TGF-β superfamily. Acceleron and Celgene are developing luspatercept to treat anemia in patients with rare blood disorders.

The phase 2 base study was a dose-escalation trial in which MDS patients received luspatercept for 3 months. In the ongoing extension study, patients from the base study are receiving luspatercept for an additional 24 months.

In both studies, patients with high transfusion burden (≥4 RBC units/8 weeks) and those with low transfusion burden (<4 RBC units/8 weeks) received luspatercept once every 3 weeks.

Base study

This study included 58 patients with a median age of 71.5 (range, 27-90). Their median time since diagnosis was 2.4 years (range, 0-14). Seventeen percent of patients had prior lenalidomide treatment, and 66% had previously received erythropoiesis-stimulating agents (ESAs).

In patients with low transfusion burden (n=19), the median hemoglobin at baseline was 8.7 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=39), the median number of RBC units transfused per 8 weeks was 6 (range, 4-18).

Patients received luspatercept subcutaneously every 3 weeks for up to 5 doses. The study included 7 dose-escalation cohorts (n=27, 0.125 to 1.75 mg/kg) and an expansion cohort (n=31, 1.0 to 1.75 mg/kg).

The primary outcome measure was the proportion of patients who had an erythroid response. In non-transfusion-dependent patients, an erythroid response was defined as a hemoglobin increase of at least 1.5 g/dL from baseline for at least 14 days.

In transfusion-dependent patients, an erythroid response was defined as a reduction of at least 4 RBC units transfused or a reduction of at least 50% of RBC units transfused compared to pretreatment.

Fifty-one percent (25/49) of patients treated at the higher dose levels had an erythroid response. And 35% (14/40) of transfused patients treated at the higher dose levels were transfusion independent for at least 8 weeks.

Extension study

This study includes 32 patients with a median age of 71.5 (range, 29-90). Their median time since diagnosis was 2.9 years (range, 0-14). Nineteen percent of patients had prior lenalidomide treatment, and 59% had previously received ESAs.

In patients with low transfusion burden (n=13), the median hemoglobin at baseline was 8.5 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=19), the median number of RBC units transfused per 8 weeks was 6 (range, 4-14).

In this ongoing study, patients are receiving luspatercept (1.0 to 1.75 mg/kg) subcutaneously every 3 weeks for an additional 24 months.

At last follow-up (March 4, 2016), 81% (26/32) of patients had an erythroid response. And 50% (11/22) of patients who were transfused prior to study initiation achieved transfusion independence for at least 8 weeks (range, 9-80+ weeks).

Dr Platzbecker noted that, in both studies, erythroid responses were observed whether or not patients previously received ESAs and regardless of patients’ baseline erythropoietin levels.

Safety

There were three grade 3 adverse events that were possibly or probably related to luspatercept—an increase in blast cell count, myalgia, and worsening of general condition.

Adverse events that were possibly or probably related to luspatercept and occurred in at least 2 patients were fatigue (7%, n=4), bone pain (5%, n=3), diarrhea (5%, n=3), myalgia (5%, n=3), headache (3%, n=2), hypertension (3%, n=2), and injection site erythema (3%, n=2).

Dr Platzbecker said luspatercept was generally safe and well-tolerated in these studies. And the results of these trials supported the initiation of a phase 3 study (MEDALIST, NCT02631070) in patients with lower-risk MDS.

*Data in the abstract differ from data presented at the meeting.

Uwe Platzbecker, MD

COPENHAGEN—Results from a pair of phase 2 trials suggest luspatercept can produce erythroid responses and enable transfusion independence in patients with lower-risk myelodysplastic syndromes (MDS).

In a 3-month base study, 51% of patients treated with luspatercept had an erythroid response, and 35% achieved transfusion independence.

In an ongoing extension study, 81% of luspatercept-treated patients have had an erythroid response, and 50% have achieved transfusion independence.

The majority of adverse events in both trials were grade 1 and 2.

Uwe Platzbecker, MD, of the University Hospital in Dresden, Germany, presented these results at the 21st Congress of the European Hematology Association (abstract S131*). The studies were sponsored by Acceleron Pharma, Inc.

Luspatercept (formerly ACE-536) is a modified activin receptor type IIB fusion protein that increases red blood cell (RBC) levels by targeting molecules in the TGF-β superfamily. Acceleron and Celgene are developing luspatercept to treat anemia in patients with rare blood disorders.

The phase 2 base study was a dose-escalation trial in which MDS patients received luspatercept for 3 months. In the ongoing extension study, patients from the base study are receiving luspatercept for an additional 24 months.

In both studies, patients with high transfusion burden (≥4 RBC units/8 weeks) and those with low transfusion burden (<4 RBC units/8 weeks) received luspatercept once every 3 weeks.

Base study

This study included 58 patients with a median age of 71.5 (range, 27-90). Their median time since diagnosis was 2.4 years (range, 0-14). Seventeen percent of patients had prior lenalidomide treatment, and 66% had previously received erythropoiesis-stimulating agents (ESAs).

In patients with low transfusion burden (n=19), the median hemoglobin at baseline was 8.7 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=39), the median number of RBC units transfused per 8 weeks was 6 (range, 4-18).

Patients received luspatercept subcutaneously every 3 weeks for up to 5 doses. The study included 7 dose-escalation cohorts (n=27, 0.125 to 1.75 mg/kg) and an expansion cohort (n=31, 1.0 to 1.75 mg/kg).

The primary outcome measure was the proportion of patients who had an erythroid response. In non-transfusion-dependent patients, an erythroid response was defined as a hemoglobin increase of at least 1.5 g/dL from baseline for at least 14 days.

In transfusion-dependent patients, an erythroid response was defined as a reduction of at least 4 RBC units transfused or a reduction of at least 50% of RBC units transfused compared to pretreatment.

Fifty-one percent (25/49) of patients treated at the higher dose levels had an erythroid response. And 35% (14/40) of transfused patients treated at the higher dose levels were transfusion independent for at least 8 weeks.

Extension study

This study includes 32 patients with a median age of 71.5 (range, 29-90). Their median time since diagnosis was 2.9 years (range, 0-14). Nineteen percent of patients had prior lenalidomide treatment, and 59% had previously received ESAs.

In patients with low transfusion burden (n=13), the median hemoglobin at baseline was 8.5 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=19), the median number of RBC units transfused per 8 weeks was 6 (range, 4-14).

In this ongoing study, patients are receiving luspatercept (1.0 to 1.75 mg/kg) subcutaneously every 3 weeks for an additional 24 months.

At last follow-up (March 4, 2016), 81% (26/32) of patients had an erythroid response. And 50% (11/22) of patients who were transfused prior to study initiation achieved transfusion independence for at least 8 weeks (range, 9-80+ weeks).

Dr Platzbecker noted that, in both studies, erythroid responses were observed whether or not patients previously received ESAs and regardless of patients’ baseline erythropoietin levels.

Safety

There were three grade 3 adverse events that were possibly or probably related to luspatercept—an increase in blast cell count, myalgia, and worsening of general condition.

Adverse events that were possibly or probably related to luspatercept and occurred in at least 2 patients were fatigue (7%, n=4), bone pain (5%, n=3), diarrhea (5%, n=3), myalgia (5%, n=3), headache (3%, n=2), hypertension (3%, n=2), and injection site erythema (3%, n=2).

Dr Platzbecker said luspatercept was generally safe and well-tolerated in these studies. And the results of these trials supported the initiation of a phase 3 study (MEDALIST, NCT02631070) in patients with lower-risk MDS.

*Data in the abstract differ from data presented at the meeting.

Uwe Platzbecker, MD

COPENHAGEN—Results from a pair of phase 2 trials suggest luspatercept can produce erythroid responses and enable transfusion independence in patients with lower-risk myelodysplastic syndromes (MDS).

In a 3-month base study, 51% of patients treated with luspatercept had an erythroid response, and 35% achieved transfusion independence.

In an ongoing extension study, 81% of luspatercept-treated patients have had an erythroid response, and 50% have achieved transfusion independence.

The majority of adverse events in both trials were grade 1 and 2.

Uwe Platzbecker, MD, of the University Hospital in Dresden, Germany, presented these results at the 21st Congress of the European Hematology Association (abstract S131*). The studies were sponsored by Acceleron Pharma, Inc.

Luspatercept (formerly ACE-536) is a modified activin receptor type IIB fusion protein that increases red blood cell (RBC) levels by targeting molecules in the TGF-β superfamily. Acceleron and Celgene are developing luspatercept to treat anemia in patients with rare blood disorders.

The phase 2 base study was a dose-escalation trial in which MDS patients received luspatercept for 3 months. In the ongoing extension study, patients from the base study are receiving luspatercept for an additional 24 months.

In both studies, patients with high transfusion burden (≥4 RBC units/8 weeks) and those with low transfusion burden (<4 RBC units/8 weeks) received luspatercept once every 3 weeks.

Base study

This study included 58 patients with a median age of 71.5 (range, 27-90). Their median time since diagnosis was 2.4 years (range, 0-14). Seventeen percent of patients had prior lenalidomide treatment, and 66% had previously received erythropoiesis-stimulating agents (ESAs).

In patients with low transfusion burden (n=19), the median hemoglobin at baseline was 8.7 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=39), the median number of RBC units transfused per 8 weeks was 6 (range, 4-18).

Patients received luspatercept subcutaneously every 3 weeks for up to 5 doses. The study included 7 dose-escalation cohorts (n=27, 0.125 to 1.75 mg/kg) and an expansion cohort (n=31, 1.0 to 1.75 mg/kg).

The primary outcome measure was the proportion of patients who had an erythroid response. In non-transfusion-dependent patients, an erythroid response was defined as a hemoglobin increase of at least 1.5 g/dL from baseline for at least 14 days.

In transfusion-dependent patients, an erythroid response was defined as a reduction of at least 4 RBC units transfused or a reduction of at least 50% of RBC units transfused compared to pretreatment.

Fifty-one percent (25/49) of patients treated at the higher dose levels had an erythroid response. And 35% (14/40) of transfused patients treated at the higher dose levels were transfusion independent for at least 8 weeks.

Extension study

This study includes 32 patients with a median age of 71.5 (range, 29-90). Their median time since diagnosis was 2.9 years (range, 0-14). Nineteen percent of patients had prior lenalidomide treatment, and 59% had previously received ESAs.

In patients with low transfusion burden (n=13), the median hemoglobin at baseline was 8.5 g/dL (range, 6.4-10.1). In patients with high transfusion burden (n=19), the median number of RBC units transfused per 8 weeks was 6 (range, 4-14).

In this ongoing study, patients are receiving luspatercept (1.0 to 1.75 mg/kg) subcutaneously every 3 weeks for an additional 24 months.

At last follow-up (March 4, 2016), 81% (26/32) of patients had an erythroid response. And 50% (11/22) of patients who were transfused prior to study initiation achieved transfusion independence for at least 8 weeks (range, 9-80+ weeks).

Dr Platzbecker noted that, in both studies, erythroid responses were observed whether or not patients previously received ESAs and regardless of patients’ baseline erythropoietin levels.

Safety

There were three grade 3 adverse events that were possibly or probably related to luspatercept—an increase in blast cell count, myalgia, and worsening of general condition.

Adverse events that were possibly or probably related to luspatercept and occurred in at least 2 patients were fatigue (7%, n=4), bone pain (5%, n=3), diarrhea (5%, n=3), myalgia (5%, n=3), headache (3%, n=2), hypertension (3%, n=2), and injection site erythema (3%, n=2).

Dr Platzbecker said luspatercept was generally safe and well-tolerated in these studies. And the results of these trials supported the initiation of a phase 3 study (MEDALIST, NCT02631070) in patients with lower-risk MDS.

*Data in the abstract differ from data presented at the meeting.

Blood collection

Photo by Charles Haymond

Haemonetics Corporation is recalling all lots of the Leukotrap RC System with RC2D Filter (re-order numbers 129-62 and 129-63) distributed since April 14, 2016.

The company says using these lots of the blood collection system may result in a higher-than-expected level of leukocytes in transfused blood.

Earlier this month, Haemonetics recalled 3 lots of the Leukotrap RC System with RC2D Filter due to reports of higher-than-expected residual white blood cells.

Since then, the company has received additional reports related to other lots.

Blood products that have been processed with the lots distributed since April 14, 2016, should not be re-filtered and should be labeled as non-leukoreduced, unless individual units have been tested and found suitable to be labeled as leukoreduced.

Continued use of these lots will require customers to verify that each unit labeled as leukoreduced was tested and meets standards for residual white blood cells acceptable to the US Food and Drug Administration.

Customers who want to return unused product to Haemonetics should contact their local customer service representative.

Blood collection

Photo by Charles Haymond

Haemonetics Corporation is recalling all lots of the Leukotrap RC System with RC2D Filter (re-order numbers 129-62 and 129-63) distributed since April 14, 2016.

The company says using these lots of the blood collection system may result in a higher-than-expected level of leukocytes in transfused blood.

Earlier this month, Haemonetics recalled 3 lots of the Leukotrap RC System with RC2D Filter due to reports of higher-than-expected residual white blood cells.

Since then, the company has received additional reports related to other lots.

Blood products that have been processed with the lots distributed since April 14, 2016, should not be re-filtered and should be labeled as non-leukoreduced, unless individual units have been tested and found suitable to be labeled as leukoreduced.

Continued use of these lots will require customers to verify that each unit labeled as leukoreduced was tested and meets standards for residual white blood cells acceptable to the US Food and Drug Administration.

Customers who want to return unused product to Haemonetics should contact their local customer service representative.

Blood collection

Photo by Charles Haymond

Haemonetics Corporation is recalling all lots of the Leukotrap RC System with RC2D Filter (re-order numbers 129-62 and 129-63) distributed since April 14, 2016.

The company says using these lots of the blood collection system may result in a higher-than-expected level of leukocytes in transfused blood.

Earlier this month, Haemonetics recalled 3 lots of the Leukotrap RC System with RC2D Filter due to reports of higher-than-expected residual white blood cells.

Since then, the company has received additional reports related to other lots.

Blood products that have been processed with the lots distributed since April 14, 2016, should not be re-filtered and should be labeled as non-leukoreduced, unless individual units have been tested and found suitable to be labeled as leukoreduced.

Continued use of these lots will require customers to verify that each unit labeled as leukoreduced was tested and meets standards for residual white blood cells acceptable to the US Food and Drug Administration.

Customers who want to return unused product to Haemonetics should contact their local customer service representative.

Donated blood

Photo courtesy of UAB Hospital

The US Food and Drug Administration (FDA) has approved the use of a new assay to screen donated blood for the Zika virus.

The Procleix Zika Virus Assay is approved for use under an investigational new drug study protocol.

Blood banks can use the test to screen donated blood for the Zika virus in potentially endemic areas of the southern US. Testing may be extended to other areas of the US if the Zika virus continues to spread.

The Procleix Zika Virus Assay, which was co-developed by Hologic, Inc. and Grifols, is designed to run on the Procleix Panther System, an automated, nucleic acid technology blood screening platform. The system has received regulatory approvals in countries around the world and is currently in development for the US market.

“The American Red Cross is pleased to participate in the Procleix Zika Virus Assay investigational study, which will allow us to begin blood donor testing for Zika virus early this summer in areas most likely to have local mosquito transmission of the virus,” said Susan Stramer, PhD, vice-president of scientific affairs at the American Red Cross.

The FDA previously authorized use of another test, the cobas® Zika test (developed by Roche), to screen blood donations for Zika virus. The cobas Zika test can be used under an investigational new drug study protocol for screening donated blood in areas with active, mosquito-borne transmission of the Zika virus.

Donated blood

Photo courtesy of UAB Hospital

The US Food and Drug Administration (FDA) has approved the use of a new assay to screen donated blood for the Zika virus.

The Procleix Zika Virus Assay is approved for use under an investigational new drug study protocol.

Blood banks can use the test to screen donated blood for the Zika virus in potentially endemic areas of the southern US. Testing may be extended to other areas of the US if the Zika virus continues to spread.

The Procleix Zika Virus Assay, which was co-developed by Hologic, Inc. and Grifols, is designed to run on the Procleix Panther System, an automated, nucleic acid technology blood screening platform. The system has received regulatory approvals in countries around the world and is currently in development for the US market.

“The American Red Cross is pleased to participate in the Procleix Zika Virus Assay investigational study, which will allow us to begin blood donor testing for Zika virus early this summer in areas most likely to have local mosquito transmission of the virus,” said Susan Stramer, PhD, vice-president of scientific affairs at the American Red Cross.

The FDA previously authorized use of another test, the cobas® Zika test (developed by Roche), to screen blood donations for Zika virus. The cobas Zika test can be used under an investigational new drug study protocol for screening donated blood in areas with active, mosquito-borne transmission of the Zika virus.

Donated blood

Photo courtesy of UAB Hospital

The US Food and Drug Administration (FDA) has approved the use of a new assay to screen donated blood for the Zika virus.

The Procleix Zika Virus Assay is approved for use under an investigational new drug study protocol.

Blood banks can use the test to screen donated blood for the Zika virus in potentially endemic areas of the southern US. Testing may be extended to other areas of the US if the Zika virus continues to spread.

The Procleix Zika Virus Assay, which was co-developed by Hologic, Inc. and Grifols, is designed to run on the Procleix Panther System, an automated, nucleic acid technology blood screening platform. The system has received regulatory approvals in countries around the world and is currently in development for the US market.

“The American Red Cross is pleased to participate in the Procleix Zika Virus Assay investigational study, which will allow us to begin blood donor testing for Zika virus early this summer in areas most likely to have local mosquito transmission of the virus,” said Susan Stramer, PhD, vice-president of scientific affairs at the American Red Cross.

The FDA previously authorized use of another test, the cobas® Zika test (developed by Roche), to screen blood donations for Zika virus. The cobas Zika test can be used under an investigational new drug study protocol for screening donated blood in areas with active, mosquito-borne transmission of the Zika virus.

Blood donation

Photo by Marja Helander

Health Canada has decided to change its policy regarding blood donations from men who have sex with men (MSM).

The policy has been that MSMs can only donate blood if they have abstained from sexual contact with another man for a period of 5 years. As of August 15, that period will be shortened to 1 year.

The change is a result of proposals from Canada’s blood operators, Canadian Blood Services and Héma-Québec.

These proposals included scientific data indicating that decreasing the deferral period for MSMs would not affect the safety of the blood supply.

The change brings Canada in line with several other countries that have implemented a 1-year deferral period for MSM blood donors, including the US, Australia, New Zealand, England, Scotland, and France.

Health Canada said the country’s blood system continues to have rigorous scientific and screening processes in place to protect the safety of Canadians.

Canadian Blood Services and Héma-Québec will continue to screen all donations for HIV and other infections. As an extra precaution, Health Canada and the blood operators will monitor donations from new donors to see if there is an increase in HIV or other infection rates.

According to Health Canada, there has not been a single HIV infection from blood transfusion in Canada in 25 years.

However, the frequency of HIV infection remains higher among MSMs (10%) than among heterosexuals or lesbians (less than 1% for both). And it was because of this that Canada implemented the 5-year deferral period for MSM blood donors. Prior to the implementation of that policy, MSMs were completely barred from donating blood in Canada.

“It has been demonstrated that implementing a 5-year temporary exclusion in 2013 had no impact on the safety of the transfusion system,” said Marc Germain, vice-president of medical affairs at Héma-Québec.

“As a result of recent data concerning transfusion safety, the exclusion policy applied to men who have had sex with another man could be reviewed. [The new 1-year deferral period] is scientifically justified and will not endanger the very high level of safety of blood products.”

“This is an exciting, incremental step forward in updating our blood donation criteria based on the latest scientific evidence,” said Graham Sher, chief executive officer of Canadian Blood Services.

“Canadian Blood Services is dedicated to being as minimally restrictive as possible while also maintaining the safety of the blood supply.”

Canadian Blood Services said it is exploring the possibility of moving toward behavior-based screening of blood donors. The organization is working with researchers, the LGBTQ community, patient groups, and other stakeholders to determine how best to gather the scientific evidence required to determine future changes to donor eligibility criteria.

Blood donation

Photo by Marja Helander

Health Canada has decided to change its policy regarding blood donations from men who have sex with men (MSM).

The policy has been that MSMs can only donate blood if they have abstained from sexual contact with another man for a period of 5 years. As of August 15, that period will be shortened to 1 year.

The change is a result of proposals from Canada’s blood operators, Canadian Blood Services and Héma-Québec.

These proposals included scientific data indicating that decreasing the deferral period for MSMs would not affect the safety of the blood supply.

The change brings Canada in line with several other countries that have implemented a 1-year deferral period for MSM blood donors, including the US, Australia, New Zealand, England, Scotland, and France.

Health Canada said the country’s blood system continues to have rigorous scientific and screening processes in place to protect the safety of Canadians.

Canadian Blood Services and Héma-Québec will continue to screen all donations for HIV and other infections. As an extra precaution, Health Canada and the blood operators will monitor donations from new donors to see if there is an increase in HIV or other infection rates.

According to Health Canada, there has not been a single HIV infection from blood transfusion in Canada in 25 years.

However, the frequency of HIV infection remains higher among MSMs (10%) than among heterosexuals or lesbians (less than 1% for both). And it was because of this that Canada implemented the 5-year deferral period for MSM blood donors. Prior to the implementation of that policy, MSMs were completely barred from donating blood in Canada.

“It has been demonstrated that implementing a 5-year temporary exclusion in 2013 had no impact on the safety of the transfusion system,” said Marc Germain, vice-president of medical affairs at Héma-Québec.

“As a result of recent data concerning transfusion safety, the exclusion policy applied to men who have had sex with another man could be reviewed. [The new 1-year deferral period] is scientifically justified and will not endanger the very high level of safety of blood products.”

“This is an exciting, incremental step forward in updating our blood donation criteria based on the latest scientific evidence,” said Graham Sher, chief executive officer of Canadian Blood Services.

“Canadian Blood Services is dedicated to being as minimally restrictive as possible while also maintaining the safety of the blood supply.”

Canadian Blood Services said it is exploring the possibility of moving toward behavior-based screening of blood donors. The organization is working with researchers, the LGBTQ community, patient groups, and other stakeholders to determine how best to gather the scientific evidence required to determine future changes to donor eligibility criteria.

Blood donation

Photo by Marja Helander

Health Canada has decided to change its policy regarding blood donations from men who have sex with men (MSM).

The policy has been that MSMs can only donate blood if they have abstained from sexual contact with another man for a period of 5 years. As of August 15, that period will be shortened to 1 year.

The change is a result of proposals from Canada’s blood operators, Canadian Blood Services and Héma-Québec.

These proposals included scientific data indicating that decreasing the deferral period for MSMs would not affect the safety of the blood supply.

The change brings Canada in line with several other countries that have implemented a 1-year deferral period for MSM blood donors, including the US, Australia, New Zealand, England, Scotland, and France.

Health Canada said the country’s blood system continues to have rigorous scientific and screening processes in place to protect the safety of Canadians.

Canadian Blood Services and Héma-Québec will continue to screen all donations for HIV and other infections. As an extra precaution, Health Canada and the blood operators will monitor donations from new donors to see if there is an increase in HIV or other infection rates.

According to Health Canada, there has not been a single HIV infection from blood transfusion in Canada in 25 years.

However, the frequency of HIV infection remains higher among MSMs (10%) than among heterosexuals or lesbians (less than 1% for both). And it was because of this that Canada implemented the 5-year deferral period for MSM blood donors. Prior to the implementation of that policy, MSMs were completely barred from donating blood in Canada.

“It has been demonstrated that implementing a 5-year temporary exclusion in 2013 had no impact on the safety of the transfusion system,” said Marc Germain, vice-president of medical affairs at Héma-Québec.

“As a result of recent data concerning transfusion safety, the exclusion policy applied to men who have had sex with another man could be reviewed. [The new 1-year deferral period] is scientifically justified and will not endanger the very high level of safety of blood products.”

“This is an exciting, incremental step forward in updating our blood donation criteria based on the latest scientific evidence,” said Graham Sher, chief executive officer of Canadian Blood Services.

“Canadian Blood Services is dedicated to being as minimally restrictive as possible while also maintaining the safety of the blood supply.”

Canadian Blood Services said it is exploring the possibility of moving toward behavior-based screening of blood donors. The organization is working with researchers, the LGBTQ community, patient groups, and other stakeholders to determine how best to gather the scientific evidence required to determine future changes to donor eligibility criteria.