Studies challenge standards to improve treatment outcomes for patients with clotting disorders

Public release date: 8-Dec-2012
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Contact: Andrea Slesinski
aslesinski@hematology.org
614-352-5096
American Society of Hematology

(ATLANTA, December 8, 2012) Studies presented today at the 54th Annual Meeting of the American Society of Hematology (ASH) examine current treatment standards for patients with clotting disorders in an effort to improve outcomes. The studies evaluate long-held treatment standards and whether modifications in intensity and duration of therapy may offer equally effective outcomes while reducing toxicities and relapse rates.

Although significant advances have been made in delivering new and improved therapies for clotting disorders, treatment still presents challenges; patients must balance the burden of therapy and risk of treatment-related bleeding with the threat of potentially life-threatening clotting. The studies presented today examine how simple strategies in the treatment of polycythemia vera (PV) and venous thromboembolism (VTE) may be safe and help produce more effective results in patients with these disorders.

"It is important to constantly evaluate and challenge standard treatment protocols to ensure that we are utililizing the best possible strategies to treat patients with these serious disorders," said Agnes Y. Lee, MD, moderator of the press conference and Medical Director of the Thrombosis Program and Associate Professor of Medicine at the University of British Columbia and Vancouver Coastal Health in Canada. "Additionally, as we are seeing an increasing number of patients who require ongoing, long-term treatment, it is important to find new ways to improve efficacy and lower the risks of potentially life-threatening complications that accompany these aggressive therapies."

This press conference will take place on Saturday, December 8, 2012, at 2:00 p.m. EST.

A Large-Scale Trial Testing the Intensity of Cytoreductive Therapy to Prevent Cardiovascular Events in Patients with Polycythemia Vera (CYTO-PV trial) [Abstract 4]

In the first randomized clinical trial assessing the proper target hematocrit level, or percentage of red blood cells that should be maintained in patients with polycythemia vera (PV), researchers have concluded that the current recommendation to maintain a hematocrit level of less than 45 percent is associated with a lower risk of thrombosis compared with a less aggressive treatment strategy of maintaining a hematocrit level between 45 and 50 percent.

PV is a rare blood disorder that causes the bone marrow to produce too many red blood cells, making the blood much thicker.This can dramatically increase the risk of blood clots such as deep-vein thrombosis (DVT, a blood clot that forms in a vein deep in the legs) or pulmonary embolism (PE, a blood clot in the lung) and cardiovascular events such as heart attack or stroke. Because thrombosis is the most common cause of death in patients with PV, prompt diagnosis and treatment to reduce the thickness of the blood is critical.

Patients with PV usually have elevated hematocrit levels (approximately 50 to 70%, compared with less than 50% in the general population), which puts them at a higher risk of suffering heart attacks, strokes, and DVT/PE than the general population. In order to reduce this risk, a hematocrit level of less than 45 percent is recommended and initially maintained through phlebotomies. If the hematocrit level cannot be reduced through multiple phlebotomies or disease progression is documented, patients receive hydroxyurea or chemotherapy to eliminate the excess red blood cells. While these two treatment strategies have become widely accepted for PV, until recently no prospective randomized clinical trial has confirmed whether tight control of hematocrit levels below 45 percent successfully prevents or reduces blood clots in patients with PV.

In order to assess the efficacy and safety of maintaining a hematocrit level of lower than 45 percent versus a more liberal approach (keeping hematocrit levels between 45 and 50%), investigators from Italy conducted a study comparing the two strategies among 365 patients with newly diagnosed PV. Patients in Arm A were treated aggressively to maintain hematocrit levels at less than 45 percent, while the patients in Arm B were treated to maintain levels between 45 and 50 percent. The primary composite endpoint was major clots, including stroke, heart attack, transient ischemic attacks ("mini strokes"), clots in the veins in the abdomen, DVT or PE, and cardiovascular death.

The investigators observed that the risk of developing major clots was four times higher in those patients whose hematocrit levels were kept between 45 and 50 percent than in patients whose levels were kept below 45 percent. With the more intensive regimen in Arm A, 1.1 percent of the patients had a major clot versus 4.4 percent in the less aggressive regimen in Arm B. The median hematocrit levels during follow-up were 44 percent and 48 percent, respectively. Treatment with phlebotomy, anti-clotting drugs, and hydroxyurea were comparable.

There was no difference in the safety profile between the regimens. Six patients in Arm A and one patient in Arm B developed myelofibrosis, a blood disorder that causes the bone marrow to be replaced by scar tissue. Researchers observed no statistical difference in the frequency of acute leukemias that occurred in three patients in Arm A and one patient in Arm B.

"These data validate the notion that it is important to keep hematocrit levels below 45 percent for this population of patients who are at a high risk of developing clotting complications," said Tiziano Barbui, MD, lead author and Professor of Hematology and Scientific Director of the Research Foundation at Ospedali Riuniti di Bergamo in Italy. "The results from our study will be especially important in the development of new drugs for polycythemia vera, as we look to maintain these levels more effectively and with minimal complications."

Dr. Barbui will present this study during the Plenary Scientific Session on Sunday, December 9 at 3:05 p.m. EST at the Georgia World Congress Center in Hall B5, Level 1, Building B.

Two Doses of Apixaban for the Extended Treatment of Venous Thromboembolism [LBA 1]

Center for Disease Control and Prevention, "Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE): Data & Statistics," http://www.cdc.gov/NCBDDD/dvt/data.html (Accessed November 2012).

Dr. Agnelli will present this study during the Late-Breaking Abstracts session on Tuesday, December11, at 7:30 a.m. EST at the Georgia World Congress Center in Hall B5, Level 1, Building B.

###

American Society of Hematology 54th Annual Meeting

The study authors and moderator will be available for interviews after the press conference or by telephone. Additional press briefings will take place throughout the meeting on new targeted treatment for chronic lymphocytic leukemia (CLL) and hard-to-treat blood disorders, efforts to reduce toxicity and improve survival for blood cancer therapy, and advances in stem cell technology and transplant strategies. For the complete annual meeting program and abstracts, visit www.hematology.org/2012abstracts. Follow ASH on Twitter (use the hashtag #ASH12 when posting tweets about the meeting) and on Facebook at www.facebook.com/AmericanSocietyofHematology for the most up-to-date information about the 2012 ASH Annual Meeting.

The American Society of Hematology (ASH) (www.hematology.org) is the world's largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. For more than 50 years, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology. The official journal of ASH is Blood (www.bloodjournal.org), the most cited peer-reviewed publication in the field, which is available weekly in print and online.

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AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.

Public release date: 8-Dec-2012
[ | E-mail | Share ]

Contact: Andrea Slesinski
aslesinski@hematology.org
614-352-5096
American Society of Hematology

(ATLANTA, December 8, 2012) Studies presented today at the 54th Annual Meeting of the American Society of Hematology (ASH) examine current treatment standards for patients with clotting disorders in an effort to improve outcomes. The studies evaluate long-held treatment standards and whether modifications in intensity and duration of therapy may offer equally effective outcomes while reducing toxicities and relapse rates.

Although significant advances have been made in delivering new and improved therapies for clotting disorders, treatment still presents challenges; patients must balance the burden of therapy and risk of treatment-related bleeding with the threat of potentially life-threatening clotting. The studies presented today examine how simple strategies in the treatment of polycythemia vera (PV) and venous thromboembolism (VTE) may be safe and help produce more effective results in patients with these disorders.

"It is important to constantly evaluate and challenge standard treatment protocols to ensure that we are utililizing the best possible strategies to treat patients with these serious disorders," said Agnes Y. Lee, MD, moderator of the press conference and Medical Director of the Thrombosis Program and Associate Professor of Medicine at the University of British Columbia and Vancouver Coastal Health in Canada. "Additionally, as we are seeing an increasing number of patients who require ongoing, long-term treatment, it is important to find new ways to improve efficacy and lower the risks of potentially life-threatening complications that accompany these aggressive therapies."

This press conference will take place on Saturday, December 8, 2012, at 2:00 p.m. EST.

A Large-Scale Trial Testing the Intensity of Cytoreductive Therapy to Prevent Cardiovascular Events in Patients with Polycythemia Vera (CYTO-PV trial) [Abstract 4]

In the first randomized clinical trial assessing the proper target hematocrit level, or percentage of red blood cells that should be maintained in patients with polycythemia vera (PV), researchers have concluded that the current recommendation to maintain a hematocrit level of less than 45 percent is associated with a lower risk of thrombosis compared with a less aggressive treatment strategy of maintaining a hematocrit level between 45 and 50 percent.

PV is a rare blood disorder that causes the bone marrow to produce too many red blood cells, making the blood much thicker.This can dramatically increase the risk of blood clots such as deep-vein thrombosis (DVT, a blood clot that forms in a vein deep in the legs) or pulmonary embolism (PE, a blood clot in the lung) and cardiovascular events such as heart attack or stroke. Because thrombosis is the most common cause of death in patients with PV, prompt diagnosis and treatment to reduce the thickness of the blood is critical.

Patients with PV usually have elevated hematocrit levels (approximately 50 to 70%, compared with less than 50% in the general population), which puts them at a higher risk of suffering heart attacks, strokes, and DVT/PE than the general population. In order to reduce this risk, a hematocrit level of less than 45 percent is recommended and initially maintained through phlebotomies. If the hematocrit level cannot be reduced through multiple phlebotomies or disease progression is documented, patients receive hydroxyurea or chemotherapy to eliminate the excess red blood cells. While these two treatment strategies have become widely accepted for PV, until recently no prospective randomized clinical trial has confirmed whether tight control of hematocrit levels below 45 percent successfully prevents or reduces blood clots in patients with PV.

In order to assess the efficacy and safety of maintaining a hematocrit level of lower than 45 percent versus a more liberal approach (keeping hematocrit levels between 45 and 50%), investigators from Italy conducted a study comparing the two strategies among 365 patients with newly diagnosed PV. Patients in Arm A were treated aggressively to maintain hematocrit levels at less than 45 percent, while the patients in Arm B were treated to maintain levels between 45 and 50 percent. The primary composite endpoint was major clots, including stroke, heart attack, transient ischemic attacks ("mini strokes"), clots in the veins in the abdomen, DVT or PE, and cardiovascular death.

The investigators observed that the risk of developing major clots was four times higher in those patients whose hematocrit levels were kept between 45 and 50 percent than in patients whose levels were kept below 45 percent. With the more intensive regimen in Arm A, 1.1 percent of the patients had a major clot versus 4.4 percent in the less aggressive regimen in Arm B. The median hematocrit levels during follow-up were 44 percent and 48 percent, respectively. Treatment with phlebotomy, anti-clotting drugs, and hydroxyurea were comparable.

There was no difference in the safety profile between the regimens. Six patients in Arm A and one patient in Arm B developed myelofibrosis, a blood disorder that causes the bone marrow to be replaced by scar tissue. Researchers observed no statistical difference in the frequency of acute leukemias that occurred in three patients in Arm A and one patient in Arm B.

"These data validate the notion that it is important to keep hematocrit levels below 45 percent for this population of patients who are at a high risk of developing clotting complications," said Tiziano Barbui, MD, lead author and Professor of Hematology and Scientific Director of the Research Foundation at Ospedali Riuniti di Bergamo in Italy. "The results from our study will be especially important in the development of new drugs for polycythemia vera, as we look to maintain these levels more effectively and with minimal complications."

Dr. Barbui will present this study during the Plenary Scientific Session on Sunday, December 9 at 3:05 p.m. EST at the Georgia World Congress Center in Hall B5, Level 1, Building B.

Two Doses of Apixaban for the Extended Treatment of Venous Thromboembolism [LBA 1]

Center for Disease Control and Prevention, "Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE): Data & Statistics," http://www.cdc.gov/NCBDDD/dvt/data.html (Accessed November 2012).

Dr. Agnelli will present this study during the Late-Breaking Abstracts session on Tuesday, December11, at 7:30 a.m. EST at the Georgia World Congress Center in Hall B5, Level 1, Building B.

###

American Society of Hematology 54th Annual Meeting

The study authors and moderator will be available for interviews after the press conference or by telephone. Additional press briefings will take place throughout the meeting on new targeted treatment for chronic lymphocytic leukemia (CLL) and hard-to-treat blood disorders, efforts to reduce toxicity and improve survival for blood cancer therapy, and advances in stem cell technology and transplant strategies. For the complete annual meeting program and abstracts, visit www.hematology.org/2012abstracts. Follow ASH on Twitter (use the hashtag #ASH12 when posting tweets about the meeting) and on Facebook at www.facebook.com/AmericanSocietyofHematology for the most up-to-date information about the 2012 ASH Annual Meeting.

The American Society of Hematology (ASH) (www.hematology.org) is the world's largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. For more than 50 years, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology. The official journal of ASH is Blood (www.bloodjournal.org), the most cited peer-reviewed publication in the field, which is available weekly in print and online.

---

[ | E-mail | Share ]

?

AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.

Source: http://www.eurekalert.org/pub_releases/2012-12/asoh-scs120712.php

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