Heidi Splete

WASHINGTON – The percentage of American teenagers reporting daily marijuana use increased significantly from 2009 to 2010, according to findings from the 2010 Monitoring the Future survey. The results were presented at a press conference Dec. 14.

"We are seeing a decrease in the number of teenagers perceiving marijuana use as harmful," said Dr. Nora D. Volkow, director of the National Institute on Drug Abuse. The survey is conducted for NIDA by the University of Michigan, Ann Arbor.

The percentage of 8th, 10th, and 12th graders reporting daily marijuana use increased from 1.0% to 1.2%, 2.8% to 3.3%, and 5.2% to 6.1%, respectively. In keeping with a gradual increase in use over the past 3 years, an increase was seen in all three grade levels measured in the survey. However, past-year and past-month reported use increased among 8th graders only.

In addition, Ecstasy appears to be gaining popularity after almost a decade of decline, said Lloyd D. Johnston, Ph.D., a research scientist at the University of Michigan and the principal investigator on the Monitoring the Future survey. In 2010, 2.4% of 8th graders and 4.7% of 10th graders reported past-year Ecstasy use, up from 1.3% and 3.7%, respectively, in the 2009 survey.

The decline in cigarette smoking appears to have stalled across all three grade levels, and nonmedical use of many prescription drugs, including OxyContin and Adderall, remained similar to last year’s levels among 12th graders.

On the positive side, past-year reports of alcohol consumption among 12th graders declined, from 43.5% to 41.2%, and binge drinking dropped from 25.2% to 23.2%, Dr. Johnston said. In addition, non-medical use of the prescription painkiller Vicodin decreased among 12th graders, he noted.

The changes in drug, cigarette, and alcohol use reflect changes in teens’ perceptions of the risks associated with these products, Dr. Volkow said. The 2010 results show a decline in the numbers of 8th graders who disapproved of marijuana use, and declines in the numbers of 10th and 12th graders who said they perceived a "great risk" of harm associated with smoking marijuana regularly. The mixed messages about the legalization of marijuana and its use as medicine might be contributing to the trend, Dr. Volkow noted.

It is important for doctors who treat teenagers to identify psychiatric problems, such as depression or anxiety, which could lead to the abuse of drugs if left untreated, Dr. Volkow said. In addition, physicians are in a unique position to help parents and teenagers understand the dangers of drugs, alcohol, and cigarette use, because they are neutral third parties, Dr. Johnston said. "I suspect that their advice would carry weight [with teens]," he said.

Monitoring the Future is an ongoing study of the opinions and beliefs of American adolescents. The 2010 survey included approximately 46,000 students in grades 8, 10, and 12. Monitoring the Future is funded by the National Institutes of Health. More detailed study results are available online.

WASHINGTON – The percentage of American teenagers reporting daily marijuana use increased significantly from 2009 to 2010, according to findings from the 2010 Monitoring the Future survey. The results were presented at a press conference Dec. 14.

"We are seeing a decrease in the number of teenagers perceiving marijuana use as harmful," said Dr. Nora D. Volkow, director of the National Institute on Drug Abuse. The survey is conducted for NIDA by the University of Michigan, Ann Arbor.

The percentage of 8th, 10th, and 12th graders reporting daily marijuana use increased from 1.0% to 1.2%, 2.8% to 3.3%, and 5.2% to 6.1%, respectively. In keeping with a gradual increase in use over the past 3 years, an increase was seen in all three grade levels measured in the survey. However, past-year and past-month reported use increased among 8th graders only.

In addition, Ecstasy appears to be gaining popularity after almost a decade of decline, said Lloyd D. Johnston, Ph.D., a research scientist at the University of Michigan and the principal investigator on the Monitoring the Future survey. In 2010, 2.4% of 8th graders and 4.7% of 10th graders reported past-year Ecstasy use, up from 1.3% and 3.7%, respectively, in the 2009 survey.

The decline in cigarette smoking appears to have stalled across all three grade levels, and nonmedical use of many prescription drugs, including OxyContin and Adderall, remained similar to last year’s levels among 12th graders.

On the positive side, past-year reports of alcohol consumption among 12th graders declined, from 43.5% to 41.2%, and binge drinking dropped from 25.2% to 23.2%, Dr. Johnston said. In addition, non-medical use of the prescription painkiller Vicodin decreased among 12th graders, he noted.

The changes in drug, cigarette, and alcohol use reflect changes in teens’ perceptions of the risks associated with these products, Dr. Volkow said. The 2010 results show a decline in the numbers of 8th graders who disapproved of marijuana use, and declines in the numbers of 10th and 12th graders who said they perceived a "great risk" of harm associated with smoking marijuana regularly. The mixed messages about the legalization of marijuana and its use as medicine might be contributing to the trend, Dr. Volkow noted.

It is important for doctors who treat teenagers to identify psychiatric problems, such as depression or anxiety, which could lead to the abuse of drugs if left untreated, Dr. Volkow said. In addition, physicians are in a unique position to help parents and teenagers understand the dangers of drugs, alcohol, and cigarette use, because they are neutral third parties, Dr. Johnston said. "I suspect that their advice would carry weight [with teens]," he said.

Monitoring the Future is an ongoing study of the opinions and beliefs of American adolescents. The 2010 survey included approximately 46,000 students in grades 8, 10, and 12. Monitoring the Future is funded by the National Institutes of Health. More detailed study results are available online.

WASHINGTON – The percentage of American teenagers reporting daily marijuana use increased significantly from 2009 to 2010, according to findings from the 2010 Monitoring the Future survey. The results were presented at a press conference Dec. 14.

"We are seeing a decrease in the number of teenagers perceiving marijuana use as harmful," said Dr. Nora D. Volkow, director of the National Institute on Drug Abuse. The survey is conducted for NIDA by the University of Michigan, Ann Arbor.

The percentage of 8th, 10th, and 12th graders reporting daily marijuana use increased from 1.0% to 1.2%, 2.8% to 3.3%, and 5.2% to 6.1%, respectively. In keeping with a gradual increase in use over the past 3 years, an increase was seen in all three grade levels measured in the survey. However, past-year and past-month reported use increased among 8th graders only.

In addition, Ecstasy appears to be gaining popularity after almost a decade of decline, said Lloyd D. Johnston, Ph.D., a research scientist at the University of Michigan and the principal investigator on the Monitoring the Future survey. In 2010, 2.4% of 8th graders and 4.7% of 10th graders reported past-year Ecstasy use, up from 1.3% and 3.7%, respectively, in the 2009 survey.

The decline in cigarette smoking appears to have stalled across all three grade levels, and nonmedical use of many prescription drugs, including OxyContin and Adderall, remained similar to last year’s levels among 12th graders.

On the positive side, past-year reports of alcohol consumption among 12th graders declined, from 43.5% to 41.2%, and binge drinking dropped from 25.2% to 23.2%, Dr. Johnston said. In addition, non-medical use of the prescription painkiller Vicodin decreased among 12th graders, he noted.

The changes in drug, cigarette, and alcohol use reflect changes in teens’ perceptions of the risks associated with these products, Dr. Volkow said. The 2010 results show a decline in the numbers of 8th graders who disapproved of marijuana use, and declines in the numbers of 10th and 12th graders who said they perceived a "great risk" of harm associated with smoking marijuana regularly. The mixed messages about the legalization of marijuana and its use as medicine might be contributing to the trend, Dr. Volkow noted.

It is important for doctors who treat teenagers to identify psychiatric problems, such as depression or anxiety, which could lead to the abuse of drugs if left untreated, Dr. Volkow said. In addition, physicians are in a unique position to help parents and teenagers understand the dangers of drugs, alcohol, and cigarette use, because they are neutral third parties, Dr. Johnston said. "I suspect that their advice would carry weight [with teens]," he said.

Monitoring the Future is an ongoing study of the opinions and beliefs of American adolescents. The 2010 survey included approximately 46,000 students in grades 8, 10, and 12. Monitoring the Future is funded by the National Institutes of Health. More detailed study results are available online.

ATLANTA – Approximately 20% of cases of chronic low back pain in younger adults seen in primary care settings might be caused by spondyloarthritis, based on data from 364 patients aged 19-45 years. The findings were presented at the annual meeting of the American College of Rheumatology.

In the cross-sectional study, 77 of 364 patients (22%) met the diagnosis of axial spondyloarthritis on examination by a rheumatologist. The average age of the patients was 36 years, 43% were male, and the average duration of chronic low back pain was 9 years.

The diagnostic techniques included a detailed patient questionnaire about inflammatory back pain, physical examination and patient history; blood tests to assess C-reactive protein levels and the presence of HLA-B27 (a gene that has been linked to spondyloarthritis); and conventional and MRI images of sacroiliac joints. Two radiologists reviewed the images for the signs of inflammation and bone lesions that might indicate axial spondyloarthritis.

Fifty-two patients were diagnosed according to MRI criteria plus one additional spondyloarthritis feature. The other 12 patients were diagnosed according to a positive HLA-B27 test plus two additional spondyloarthritis features, Dr. Angelique Weel of Maasstad Ziekenhuis, Rotterdam, the Netherlands, said at a press conference.

In addition, 24 patients (6.6%) met the criteria for ankylosing spondylitis.

The results suggest that spondyloarthritis is underdiagnosed as a cause of chronic back pain in the general population. Dr. Weel recommended that primary care physicians suspect spondyloarthritis when they see younger adults with chronic back pain, and refer these patients to a rheumatologist if they suspect an inflammatory basis for the pain.

"We also tried to make a simple questionnaire for general practitioners, so they can determine which patient with chronic low back pain should be sent to a rheumatologist to investigate possible spondyloarthritis," she noted. Possible red flags from the standardized questionnaire include the response to NSAIDs and a family history of spondyloarthritis, Dr. Weel said.

"Of course, we need to validate these data in another population, and we also have to validate our referral tool [for general physicians]," she noted.

Dr. Weel said that she had no financial conflicts to disclose.

ATLANTA – Approximately 20% of cases of chronic low back pain in younger adults seen in primary care settings might be caused by spondyloarthritis, based on data from 364 patients aged 19-45 years. The findings were presented at the annual meeting of the American College of Rheumatology.

In the cross-sectional study, 77 of 364 patients (22%) met the diagnosis of axial spondyloarthritis on examination by a rheumatologist. The average age of the patients was 36 years, 43% were male, and the average duration of chronic low back pain was 9 years.

The diagnostic techniques included a detailed patient questionnaire about inflammatory back pain, physical examination and patient history; blood tests to assess C-reactive protein levels and the presence of HLA-B27 (a gene that has been linked to spondyloarthritis); and conventional and MRI images of sacroiliac joints. Two radiologists reviewed the images for the signs of inflammation and bone lesions that might indicate axial spondyloarthritis.

Fifty-two patients were diagnosed according to MRI criteria plus one additional spondyloarthritis feature. The other 12 patients were diagnosed according to a positive HLA-B27 test plus two additional spondyloarthritis features, Dr. Angelique Weel of Maasstad Ziekenhuis, Rotterdam, the Netherlands, said at a press conference.

In addition, 24 patients (6.6%) met the criteria for ankylosing spondylitis.

The results suggest that spondyloarthritis is underdiagnosed as a cause of chronic back pain in the general population. Dr. Weel recommended that primary care physicians suspect spondyloarthritis when they see younger adults with chronic back pain, and refer these patients to a rheumatologist if they suspect an inflammatory basis for the pain.

"We also tried to make a simple questionnaire for general practitioners, so they can determine which patient with chronic low back pain should be sent to a rheumatologist to investigate possible spondyloarthritis," she noted. Possible red flags from the standardized questionnaire include the response to NSAIDs and a family history of spondyloarthritis, Dr. Weel said.

"Of course, we need to validate these data in another population, and we also have to validate our referral tool [for general physicians]," she noted.

Dr. Weel said that she had no financial conflicts to disclose.

ATLANTA – Approximately 20% of cases of chronic low back pain in younger adults seen in primary care settings might be caused by spondyloarthritis, based on data from 364 patients aged 19-45 years. The findings were presented at the annual meeting of the American College of Rheumatology.

In the cross-sectional study, 77 of 364 patients (22%) met the diagnosis of axial spondyloarthritis on examination by a rheumatologist. The average age of the patients was 36 years, 43% were male, and the average duration of chronic low back pain was 9 years.

The diagnostic techniques included a detailed patient questionnaire about inflammatory back pain, physical examination and patient history; blood tests to assess C-reactive protein levels and the presence of HLA-B27 (a gene that has been linked to spondyloarthritis); and conventional and MRI images of sacroiliac joints. Two radiologists reviewed the images for the signs of inflammation and bone lesions that might indicate axial spondyloarthritis.

Fifty-two patients were diagnosed according to MRI criteria plus one additional spondyloarthritis feature. The other 12 patients were diagnosed according to a positive HLA-B27 test plus two additional spondyloarthritis features, Dr. Angelique Weel of Maasstad Ziekenhuis, Rotterdam, the Netherlands, said at a press conference.

In addition, 24 patients (6.6%) met the criteria for ankylosing spondylitis.

The results suggest that spondyloarthritis is underdiagnosed as a cause of chronic back pain in the general population. Dr. Weel recommended that primary care physicians suspect spondyloarthritis when they see younger adults with chronic back pain, and refer these patients to a rheumatologist if they suspect an inflammatory basis for the pain.

"We also tried to make a simple questionnaire for general practitioners, so they can determine which patient with chronic low back pain should be sent to a rheumatologist to investigate possible spondyloarthritis," she noted. Possible red flags from the standardized questionnaire include the response to NSAIDs and a family history of spondyloarthritis, Dr. Weel said.

"Of course, we need to validate these data in another population, and we also have to validate our referral tool [for general physicians]," she noted.

Dr. Weel said that she had no financial conflicts to disclose.

ATLANTA – Ultrasound guidance led to a significant increase in the number of noneffusive knees with osteoarthritis that responded to corticosteroid injections, based on data from a randomized trial of 94 knees. The findings were presented at the annual meeting of the American College of Rheumatology.

The accuracy rate for knee injections in OA varies widely, said Dr. Wilmer Sibbitt, professor of rheumatology and neurology at the University of New Mexico Health Sciences Center in Albuquerque.

Injections of medication or removal of fluid from the knee joints have historically been guided by the physician’s hands-on examination of the knee, but ultrasound guidance is becoming more common as a way to improve accuracy, said Dr. Sibbitt.

"Ultrasound is being used presently for injections, and there aren’t good outcome studies to determine whether this increased accuracy provides better results, and whether it increases or reduces costs," he said in an interview.

Dr. Sibbitt and colleagues randomized adults with knee OA to receive joint injections guided by ultrasound or with the conventional palpation guidance. For the sonographically guided injections, the researchers used a one-handed reciprocating procedure device syringe that enabled them to hold the ultrasound transducer in one hand and the dual chamber syringe in the other. The injection consisted of 80 mg of triamcinolone acetonide.

The researchers evaluated patients’ pain at baseline, during the injection, 2 weeks later, and 6 months later, using an established pain rating scale.

Compared with the conventional injection group, ultrasound-guided injections yielded a 48% reduction in pain during the injection, and a 42% reduction in pain scores at follow-up. In addition, significantly more knees in the ultrasound group than in the control group responded well to the injections and significantly fewer knees in the ultrasound group than in the control group did not respond well.

The researchers also evaluated the cost-effectiveness of ultrasound-guided injections. The ultrasound-guided injection was associated with a $48 reduction in patient costs per year, and a $593 reduction in outpatient costs per year.

The study was limited by its small size, and additional research is needed to confirm the results. But the findings suggest that sonographic needle guidance improves the performance, clinical outcomes, and effectiveness of knee injections for OA patients, Dr. Sibbitt said.

Dr. Sibbitt disclosed receiving consulting fees from multiple companies including Becton Dickinson, Ferring Pharmaceuticals, Avasca Medical, and Meditech Duopross. He also disclosed stock, stock options, or bond holdings in multiple companies including Celgene, Apple, Avasca, and Java Inc. He has received research grants from the National Institutes of Health.

ATLANTA – Ultrasound guidance led to a significant increase in the number of noneffusive knees with osteoarthritis that responded to corticosteroid injections, based on data from a randomized trial of 94 knees. The findings were presented at the annual meeting of the American College of Rheumatology.

The accuracy rate for knee injections in OA varies widely, said Dr. Wilmer Sibbitt, professor of rheumatology and neurology at the University of New Mexico Health Sciences Center in Albuquerque.

Injections of medication or removal of fluid from the knee joints have historically been guided by the physician’s hands-on examination of the knee, but ultrasound guidance is becoming more common as a way to improve accuracy, said Dr. Sibbitt.

"Ultrasound is being used presently for injections, and there aren’t good outcome studies to determine whether this increased accuracy provides better results, and whether it increases or reduces costs," he said in an interview.

Dr. Sibbitt and colleagues randomized adults with knee OA to receive joint injections guided by ultrasound or with the conventional palpation guidance. For the sonographically guided injections, the researchers used a one-handed reciprocating procedure device syringe that enabled them to hold the ultrasound transducer in one hand and the dual chamber syringe in the other. The injection consisted of 80 mg of triamcinolone acetonide.

The researchers evaluated patients’ pain at baseline, during the injection, 2 weeks later, and 6 months later, using an established pain rating scale.

Compared with the conventional injection group, ultrasound-guided injections yielded a 48% reduction in pain during the injection, and a 42% reduction in pain scores at follow-up. In addition, significantly more knees in the ultrasound group than in the control group responded well to the injections and significantly fewer knees in the ultrasound group than in the control group did not respond well.

The researchers also evaluated the cost-effectiveness of ultrasound-guided injections. The ultrasound-guided injection was associated with a $48 reduction in patient costs per year, and a $593 reduction in outpatient costs per year.

The study was limited by its small size, and additional research is needed to confirm the results. But the findings suggest that sonographic needle guidance improves the performance, clinical outcomes, and effectiveness of knee injections for OA patients, Dr. Sibbitt said.

Dr. Sibbitt disclosed receiving consulting fees from multiple companies including Becton Dickinson, Ferring Pharmaceuticals, Avasca Medical, and Meditech Duopross. He also disclosed stock, stock options, or bond holdings in multiple companies including Celgene, Apple, Avasca, and Java Inc. He has received research grants from the National Institutes of Health.

ATLANTA – Ultrasound guidance led to a significant increase in the number of noneffusive knees with osteoarthritis that responded to corticosteroid injections, based on data from a randomized trial of 94 knees. The findings were presented at the annual meeting of the American College of Rheumatology.

The accuracy rate for knee injections in OA varies widely, said Dr. Wilmer Sibbitt, professor of rheumatology and neurology at the University of New Mexico Health Sciences Center in Albuquerque.

Injections of medication or removal of fluid from the knee joints have historically been guided by the physician’s hands-on examination of the knee, but ultrasound guidance is becoming more common as a way to improve accuracy, said Dr. Sibbitt.

"Ultrasound is being used presently for injections, and there aren’t good outcome studies to determine whether this increased accuracy provides better results, and whether it increases or reduces costs," he said in an interview.

Dr. Sibbitt and colleagues randomized adults with knee OA to receive joint injections guided by ultrasound or with the conventional palpation guidance. For the sonographically guided injections, the researchers used a one-handed reciprocating procedure device syringe that enabled them to hold the ultrasound transducer in one hand and the dual chamber syringe in the other. The injection consisted of 80 mg of triamcinolone acetonide.

The researchers evaluated patients’ pain at baseline, during the injection, 2 weeks later, and 6 months later, using an established pain rating scale.

Compared with the conventional injection group, ultrasound-guided injections yielded a 48% reduction in pain during the injection, and a 42% reduction in pain scores at follow-up. In addition, significantly more knees in the ultrasound group than in the control group responded well to the injections and significantly fewer knees in the ultrasound group than in the control group did not respond well.

The researchers also evaluated the cost-effectiveness of ultrasound-guided injections. The ultrasound-guided injection was associated with a $48 reduction in patient costs per year, and a $593 reduction in outpatient costs per year.

The study was limited by its small size, and additional research is needed to confirm the results. But the findings suggest that sonographic needle guidance improves the performance, clinical outcomes, and effectiveness of knee injections for OA patients, Dr. Sibbitt said.

Dr. Sibbitt disclosed receiving consulting fees from multiple companies including Becton Dickinson, Ferring Pharmaceuticals, Avasca Medical, and Meditech Duopross. He also disclosed stock, stock options, or bond holdings in multiple companies including Celgene, Apple, Avasca, and Java Inc. He has received research grants from the National Institutes of Health.

ORLANDO – Hydroxyurea therapy was associated with an overall cumulative survival rate of 70% in children aged 3 to 18 years with sickle cell disease.

National Human Genome Research Institute

Hydroxyurea is routinely used to treat adults with sickle cell disease, but it has not been well studied in children, Dr. Clarisse Lobo of the Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti in Rio de Janeiro, Brazil, said at a press conference. Although deaths among children in the United States and Europe have decreased substantially, high mortality is still an issue in developing nations.

In a study presented Dec. 6 at the annual meeting of the American Society of Hematology, Dr. Lobo and her colleagues reviewed data from 224 children who met the criteria for hydroxyurea treatment over a 10-year period. No genotypes of sickle cell disease were excluded.

The cumulative survival rates at 10 years and 17.9 years of age were 99% and 97%, respectively, in hydroxyurea-treated children, compared with 97% and 66% in 965 untreated children (P = .027). A total of 46 deaths occurred during the study period. Only two of these occurred in hydroxyurea-treated children, and both were due to acute chest syndrome.

The treatment was significantly associated with a 68% reduction in hospitalizations, a 49% reduction in emergency department visits, and a 36% reduction in transfusions in children with sickle cell disease who were treated with hydroxyurea, compared with untreated children.

The starting dose of hydroxyurea was 15 mg/kg/day, escalated up to a maximum dose of 30 mg/kg/day. The median dose was 20 mg/kg/day, and the median treatment duration was 1.9 years.

Although the study was limited to children in Brazil, the results support the value of hydroxyurea for reducing mortality in children with sickle cell disease.

Dr. Lobo had no financial conflicts to disclose.

ORLANDO – Hydroxyurea therapy was associated with an overall cumulative survival rate of 70% in children aged 3 to 18 years with sickle cell disease.

National Human Genome Research Institute

Hydroxyurea is routinely used to treat adults with sickle cell disease, but it has not been well studied in children, Dr. Clarisse Lobo of the Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti in Rio de Janeiro, Brazil, said at a press conference. Although deaths among children in the United States and Europe have decreased substantially, high mortality is still an issue in developing nations.

In a study presented Dec. 6 at the annual meeting of the American Society of Hematology, Dr. Lobo and her colleagues reviewed data from 224 children who met the criteria for hydroxyurea treatment over a 10-year period. No genotypes of sickle cell disease were excluded.

The cumulative survival rates at 10 years and 17.9 years of age were 99% and 97%, respectively, in hydroxyurea-treated children, compared with 97% and 66% in 965 untreated children (P = .027). A total of 46 deaths occurred during the study period. Only two of these occurred in hydroxyurea-treated children, and both were due to acute chest syndrome.

The treatment was significantly associated with a 68% reduction in hospitalizations, a 49% reduction in emergency department visits, and a 36% reduction in transfusions in children with sickle cell disease who were treated with hydroxyurea, compared with untreated children.

The starting dose of hydroxyurea was 15 mg/kg/day, escalated up to a maximum dose of 30 mg/kg/day. The median dose was 20 mg/kg/day, and the median treatment duration was 1.9 years.

Although the study was limited to children in Brazil, the results support the value of hydroxyurea for reducing mortality in children with sickle cell disease.

Dr. Lobo had no financial conflicts to disclose.

ORLANDO – Hydroxyurea therapy was associated with an overall cumulative survival rate of 70% in children aged 3 to 18 years with sickle cell disease.

National Human Genome Research Institute

Hydroxyurea is routinely used to treat adults with sickle cell disease, but it has not been well studied in children, Dr. Clarisse Lobo of the Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti in Rio de Janeiro, Brazil, said at a press conference. Although deaths among children in the United States and Europe have decreased substantially, high mortality is still an issue in developing nations.

In a study presented Dec. 6 at the annual meeting of the American Society of Hematology, Dr. Lobo and her colleagues reviewed data from 224 children who met the criteria for hydroxyurea treatment over a 10-year period. No genotypes of sickle cell disease were excluded.

The cumulative survival rates at 10 years and 17.9 years of age were 99% and 97%, respectively, in hydroxyurea-treated children, compared with 97% and 66% in 965 untreated children (P = .027). A total of 46 deaths occurred during the study period. Only two of these occurred in hydroxyurea-treated children, and both were due to acute chest syndrome.

The treatment was significantly associated with a 68% reduction in hospitalizations, a 49% reduction in emergency department visits, and a 36% reduction in transfusions in children with sickle cell disease who were treated with hydroxyurea, compared with untreated children.

The starting dose of hydroxyurea was 15 mg/kg/day, escalated up to a maximum dose of 30 mg/kg/day. The median dose was 20 mg/kg/day, and the median treatment duration was 1.9 years.

Although the study was limited to children in Brazil, the results support the value of hydroxyurea for reducing mortality in children with sickle cell disease.

Dr. Lobo had no financial conflicts to disclose.

ORLANDO – Hydroxyurea therapy was associated with an overall cumulative survival rate of 70% in children aged 3 to 18 years with sickle cell disease.

National Human Genome Research Institute

Hydroxyurea is routinely used to treat adults with sickle cell disease, but it has not been well studied in children, Dr. Clarisse Lobo of the Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti in Rio de Janeiro, Brazil, said at a press conference. Although deaths among children in the United States and Europe have decreased substantially, high mortality is still an issue in developing nations.

In a study presented Dec. 6 at the annual meeting of the American Society of Hematology, Dr. Lobo and her colleagues reviewed data from 224 children who met the criteria for hydroxyurea treatment over a 10-year period. No genotypes of sickle cell disease were excluded.

The cumulative survival rates at 10 years and 17.9 years of age were 99% and 97%, respectively, in hydroxyurea-treated children, compared with 97% and 66% in 965 untreated children (P = .027). A total of 46 deaths occurred during the study period. Only two of these occurred in hydroxyurea-treated children, and both were due to acute chest syndrome.

The treatment was significantly associated with a 68% reduction in hospitalizations, a 49% reduction in emergency department visits, and a 36% reduction in transfusions in children with sickle cell disease who were treated with hydroxyurea, compared with untreated children.

The starting dose of hydroxyurea was 15 mg/kg/day, escalated up to a maximum dose of 30 mg/kg/day. The median dose was 20 mg/kg/day, and the median treatment duration was 1.9 years.

Although the study was limited to children in Brazil, the results support the value of hydroxyurea for reducing mortality in children with sickle cell disease.

Dr. Lobo had no financial conflicts to disclose.

ORLANDO – Hydroxyurea therapy was associated with an overall cumulative survival rate of 70% in children aged 3 to 18 years with sickle cell disease.

National Human Genome Research Institute

Hydroxyurea is routinely used to treat adults with sickle cell disease, but it has not been well studied in children, Dr. Clarisse Lobo of the Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti in Rio de Janeiro, Brazil, said at a press conference. Although deaths among children in the United States and Europe have decreased substantially, high mortality is still an issue in developing nations.

In a study presented Dec. 6 at the annual meeting of the American Society of Hematology, Dr. Lobo and her colleagues reviewed data from 224 children who met the criteria for hydroxyurea treatment over a 10-year period. No genotypes of sickle cell disease were excluded.

The cumulative survival rates at 10 years and 17.9 years of age were 99% and 97%, respectively, in hydroxyurea-treated children, compared with 97% and 66% in 965 untreated children (P = .027). A total of 46 deaths occurred during the study period. Only two of these occurred in hydroxyurea-treated children, and both were due to acute chest syndrome.

The treatment was significantly associated with a 68% reduction in hospitalizations, a 49% reduction in emergency department visits, and a 36% reduction in transfusions in children with sickle cell disease who were treated with hydroxyurea, compared with untreated children.

The starting dose of hydroxyurea was 15 mg/kg/day, escalated up to a maximum dose of 30 mg/kg/day. The median dose was 20 mg/kg/day, and the median treatment duration was 1.9 years.

Although the study was limited to children in Brazil, the results support the value of hydroxyurea for reducing mortality in children with sickle cell disease.

Dr. Lobo had no financial conflicts to disclose.

ORLANDO – Hydroxyurea therapy was associated with an overall cumulative survival rate of 70% in children aged 3 to 18 years with sickle cell disease.

National Human Genome Research Institute

Hydroxyurea is routinely used to treat adults with sickle cell disease, but it has not been well studied in children, Dr. Clarisse Lobo of the Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti in Rio de Janeiro, Brazil, said at a press conference. Although deaths among children in the United States and Europe have decreased substantially, high mortality is still an issue in developing nations.

In a study presented Dec. 6 at the annual meeting of the American Society of Hematology, Dr. Lobo and her colleagues reviewed data from 224 children who met the criteria for hydroxyurea treatment over a 10-year period. No genotypes of sickle cell disease were excluded.

The cumulative survival rates at 10 years and 17.9 years of age were 99% and 97%, respectively, in hydroxyurea-treated children, compared with 97% and 66% in 965 untreated children (P = .027). A total of 46 deaths occurred during the study period. Only two of these occurred in hydroxyurea-treated children, and both were due to acute chest syndrome.

The treatment was significantly associated with a 68% reduction in hospitalizations, a 49% reduction in emergency department visits, and a 36% reduction in transfusions in children with sickle cell disease who were treated with hydroxyurea, compared with untreated children.

The starting dose of hydroxyurea was 15 mg/kg/day, escalated up to a maximum dose of 30 mg/kg/day. The median dose was 20 mg/kg/day, and the median treatment duration was 1.9 years.

Although the study was limited to children in Brazil, the results support the value of hydroxyurea for reducing mortality in children with sickle cell disease.

Dr. Lobo had no financial conflicts to disclose.

SAN ANTONIO – Patients with both sessile serrated polyps and adenomatous polyps appeared to have a higher risk for more aggressive colorectal cancer than do those with a lesion from one pathway or the other, based on data from 433 adults gleaned from more than 17,000 baseline colonoscopies. The findings were presented at the annual meeting of the American College of Gastroenterology.

Adenomas and advanced serrated polyps (ASPs) are both precursors to colorectal cancer via different molecular pathways, said Dr. Carol Burke of the Cleveland Clinic. But the association between adenomas and ASPs (including serrated adenomas and sessile serrated polyps) is not well understood.

To determine the phenotypes in patients with different types of polyps, Dr. Burke and colleagues compared baseline polyp characteristics of individuals who were undergoing their first lifetime colonoscopies.

The researchers reviewed 17,550 colon polyp pathology reports from patients seen between April 2004 and November 2007. The final study cohort included 180 individuals with sessile serrated polyps (SSPs) only, 80 individuals with SSPs plus adenomas, and 173 with adenomas only. Individuals with incomplete exams, and those with a history of colectomy, colorectal cancer, or hereditary colorectal cancer syndrome were excluded.

The coexistent SSP/adenoma group was significantly more likely to have three or more adenomas than was the adenoma-only group (21% vs. 10%) and significantly more likely to have sessile serrated polyps measuring 10 mm or larger than was the SSP-only group (66% vs. 44%).

More adenomas in each group were located in the proximal colon than in the distal colon, although the percentages of polyps in each location were not significantly different between the SSP/adenoma group and the adenoma-only group. The size of adenomas was not significantly different between the two groups.

Pathological data showed significant differences between the SSP/adenoma group and adenoma-only group. The incidence of both tubular adenoma with high-grade dysplasia and tubulovillous adenoma with high-grade dysplasia was 3.8% in the SSP/adenoma group, compared with 0.6% and 2.3%, respectively, in the adenoma-only group. There were no significant differences in serrated polyp pathology between the SSP/adenoma group and the SSP-only group.

The results suggest that advanced serrated polyps should be considered equal in risk to adenomas in the planning of postpolypectomy surveillance, Dr. Burke said.

The average age in the SSP-only, SSP-plus-adenomas, and adenomas-only groups was 57 years, 61 years, and 58 years, respectively. The average body mass index was approximately 29 kg/m2 in all three groups, which is considered to be overweight. The proportion of women in the three groups was 42%, 44%, and 49%, respectively.

The mean age of individuals with only SSPs was significantly younger than in the other two groups, Dr. Burke noted, but the implications of this difference were not clear.

Dr. Burke said that she had no financial disclosures related to her presentation at the meeting.

SAN ANTONIO – Patients with both sessile serrated polyps and adenomatous polyps appeared to have a higher risk for more aggressive colorectal cancer than do those with a lesion from one pathway or the other, based on data from 433 adults gleaned from more than 17,000 baseline colonoscopies. The findings were presented at the annual meeting of the American College of Gastroenterology.

Adenomas and advanced serrated polyps (ASPs) are both precursors to colorectal cancer via different molecular pathways, said Dr. Carol Burke of the Cleveland Clinic. But the association between adenomas and ASPs (including serrated adenomas and sessile serrated polyps) is not well understood.

To determine the phenotypes in patients with different types of polyps, Dr. Burke and colleagues compared baseline polyp characteristics of individuals who were undergoing their first lifetime colonoscopies.

The researchers reviewed 17,550 colon polyp pathology reports from patients seen between April 2004 and November 2007. The final study cohort included 180 individuals with sessile serrated polyps (SSPs) only, 80 individuals with SSPs plus adenomas, and 173 with adenomas only. Individuals with incomplete exams, and those with a history of colectomy, colorectal cancer, or hereditary colorectal cancer syndrome were excluded.

The coexistent SSP/adenoma group was significantly more likely to have three or more adenomas than was the adenoma-only group (21% vs. 10%) and significantly more likely to have sessile serrated polyps measuring 10 mm or larger than was the SSP-only group (66% vs. 44%).

More adenomas in each group were located in the proximal colon than in the distal colon, although the percentages of polyps in each location were not significantly different between the SSP/adenoma group and the adenoma-only group. The size of adenomas was not significantly different between the two groups.

Pathological data showed significant differences between the SSP/adenoma group and adenoma-only group. The incidence of both tubular adenoma with high-grade dysplasia and tubulovillous adenoma with high-grade dysplasia was 3.8% in the SSP/adenoma group, compared with 0.6% and 2.3%, respectively, in the adenoma-only group. There were no significant differences in serrated polyp pathology between the SSP/adenoma group and the SSP-only group.

The results suggest that advanced serrated polyps should be considered equal in risk to adenomas in the planning of postpolypectomy surveillance, Dr. Burke said.

The average age in the SSP-only, SSP-plus-adenomas, and adenomas-only groups was 57 years, 61 years, and 58 years, respectively. The average body mass index was approximately 29 kg/m2 in all three groups, which is considered to be overweight. The proportion of women in the three groups was 42%, 44%, and 49%, respectively.

The mean age of individuals with only SSPs was significantly younger than in the other two groups, Dr. Burke noted, but the implications of this difference were not clear.

Dr. Burke said that she had no financial disclosures related to her presentation at the meeting.

SAN ANTONIO – Patients with both sessile serrated polyps and adenomatous polyps appeared to have a higher risk for more aggressive colorectal cancer than do those with a lesion from one pathway or the other, based on data from 433 adults gleaned from more than 17,000 baseline colonoscopies. The findings were presented at the annual meeting of the American College of Gastroenterology.

Adenomas and advanced serrated polyps (ASPs) are both precursors to colorectal cancer via different molecular pathways, said Dr. Carol Burke of the Cleveland Clinic. But the association between adenomas and ASPs (including serrated adenomas and sessile serrated polyps) is not well understood.

To determine the phenotypes in patients with different types of polyps, Dr. Burke and colleagues compared baseline polyp characteristics of individuals who were undergoing their first lifetime colonoscopies.

The researchers reviewed 17,550 colon polyp pathology reports from patients seen between April 2004 and November 2007. The final study cohort included 180 individuals with sessile serrated polyps (SSPs) only, 80 individuals with SSPs plus adenomas, and 173 with adenomas only. Individuals with incomplete exams, and those with a history of colectomy, colorectal cancer, or hereditary colorectal cancer syndrome were excluded.

The coexistent SSP/adenoma group was significantly more likely to have three or more adenomas than was the adenoma-only group (21% vs. 10%) and significantly more likely to have sessile serrated polyps measuring 10 mm or larger than was the SSP-only group (66% vs. 44%).

More adenomas in each group were located in the proximal colon than in the distal colon, although the percentages of polyps in each location were not significantly different between the SSP/adenoma group and the adenoma-only group. The size of adenomas was not significantly different between the two groups.

Pathological data showed significant differences between the SSP/adenoma group and adenoma-only group. The incidence of both tubular adenoma with high-grade dysplasia and tubulovillous adenoma with high-grade dysplasia was 3.8% in the SSP/adenoma group, compared with 0.6% and 2.3%, respectively, in the adenoma-only group. There were no significant differences in serrated polyp pathology between the SSP/adenoma group and the SSP-only group.

The results suggest that advanced serrated polyps should be considered equal in risk to adenomas in the planning of postpolypectomy surveillance, Dr. Burke said.

The average age in the SSP-only, SSP-plus-adenomas, and adenomas-only groups was 57 years, 61 years, and 58 years, respectively. The average body mass index was approximately 29 kg/m2 in all three groups, which is considered to be overweight. The proportion of women in the three groups was 42%, 44%, and 49%, respectively.

The mean age of individuals with only SSPs was significantly younger than in the other two groups, Dr. Burke noted, but the implications of this difference were not clear.

Dr. Burke said that she had no financial disclosures related to her presentation at the meeting.

SAN ANTONIO – Patients with both sessile serrated polyps and adenomatous polyps appeared to have a higher risk for more aggressive colorectal cancer than do those with a lesion from one pathway or the other, based on data from 433 adults gleaned from more than 17,000 baseline colonoscopies. The findings were presented at the annual meeting of the American College of Gastroenterology.

Adenomas and advanced serrated polyps (ASPs) are both precursors to colorectal cancer via different molecular pathways, said Dr. Carol Burke of the Cleveland Clinic. But the association between adenomas and ASPs (including serrated adenomas and sessile serrated polyps) is not well understood.

To determine the phenotypes in patients with different types of polyps, Dr. Burke and colleagues compared baseline polyp characteristics of individuals who were undergoing their first lifetime colonoscopies.

The researchers reviewed 17,550 colon polyp pathology reports from patients seen between April 2004 and November 2007. The final study cohort included 180 individuals with sessile serrated polyps (SSPs) only, 80 individuals with SSPs plus adenomas, and 173 with adenomas only. Individuals with incomplete exams, and those with a history of colectomy, colorectal cancer, or hereditary colorectal cancer syndrome were excluded.

The coexistent SSP/adenoma group was significantly more likely to have three or more adenomas than was the adenoma-only group (21% vs. 10%) and significantly more likely to have sessile serrated polyps measuring 10 mm or larger than was the SSP-only group (66% vs. 44%).

More adenomas in each group were located in the proximal colon than in the distal colon, although the percentages of polyps in each location were not significantly different between the SSP/adenoma group and the adenoma-only group. The size of adenomas was not significantly different between the two groups.

Pathological data showed significant differences between the SSP/adenoma group and adenoma-only group. The incidence of both tubular adenoma with high-grade dysplasia and tubulovillous adenoma with high-grade dysplasia was 3.8% in the SSP/adenoma group, compared with 0.6% and 2.3%, respectively, in the adenoma-only group. There were no significant differences in serrated polyp pathology between the SSP/adenoma group and the SSP-only group.

The results suggest that advanced serrated polyps should be considered equal in risk to adenomas in the planning of postpolypectomy surveillance, Dr. Burke said.

The average age in the SSP-only, SSP-plus-adenomas, and adenomas-only groups was 57 years, 61 years, and 58 years, respectively. The average body mass index was approximately 29 kg/m2 in all three groups, which is considered to be overweight. The proportion of women in the three groups was 42%, 44%, and 49%, respectively.

The mean age of individuals with only SSPs was significantly younger than in the other two groups, Dr. Burke noted, but the implications of this difference were not clear.

Dr. Burke said that she had no financial disclosures related to her presentation at the meeting.

SAN ANTONIO – Patients with both sessile serrated polyps and adenomatous polyps appeared to have a higher risk for more aggressive colorectal cancer than do those with a lesion from one pathway or the other, based on data from 433 adults gleaned from more than 17,000 baseline colonoscopies. The findings were presented at the annual meeting of the American College of Gastroenterology.

Adenomas and advanced serrated polyps (ASPs) are both precursors to colorectal cancer via different molecular pathways, said Dr. Carol Burke of the Cleveland Clinic. But the association between adenomas and ASPs (including serrated adenomas and sessile serrated polyps) is not well understood.

To determine the phenotypes in patients with different types of polyps, Dr. Burke and colleagues compared baseline polyp characteristics of individuals who were undergoing their first lifetime colonoscopies.

The researchers reviewed 17,550 colon polyp pathology reports from patients seen between April 2004 and November 2007. The final study cohort included 180 individuals with sessile serrated polyps (SSPs) only, 80 individuals with SSPs plus adenomas, and 173 with adenomas only. Individuals with incomplete exams, and those with a history of colectomy, colorectal cancer, or hereditary colorectal cancer syndrome were excluded.

The coexistent SSP/adenoma group was significantly more likely to have three or more adenomas than was the adenoma-only group (21% vs. 10%) and significantly more likely to have sessile serrated polyps measuring 10 mm or larger than was the SSP-only group (66% vs. 44%).

More adenomas in each group were located in the proximal colon than in the distal colon, although the percentages of polyps in each location were not significantly different between the SSP/adenoma group and the adenoma-only group. The size of adenomas was not significantly different between the two groups.

Pathological data showed significant differences between the SSP/adenoma group and adenoma-only group. The incidence of both tubular adenoma with high-grade dysplasia and tubulovillous adenoma with high-grade dysplasia was 3.8% in the SSP/adenoma group, compared with 0.6% and 2.3%, respectively, in the adenoma-only group. There were no significant differences in serrated polyp pathology between the SSP/adenoma group and the SSP-only group.

The results suggest that advanced serrated polyps should be considered equal in risk to adenomas in the planning of postpolypectomy surveillance, Dr. Burke said.

The average age in the SSP-only, SSP-plus-adenomas, and adenomas-only groups was 57 years, 61 years, and 58 years, respectively. The average body mass index was approximately 29 kg/m2 in all three groups, which is considered to be overweight. The proportion of women in the three groups was 42%, 44%, and 49%, respectively.

The mean age of individuals with only SSPs was significantly younger than in the other two groups, Dr. Burke noted, but the implications of this difference were not clear.

Dr. Burke said that she had no financial disclosures related to her presentation at the meeting.

SAN ANTONIO – Patients with both sessile serrated polyps and adenomatous polyps appeared to have a higher risk for more aggressive colorectal cancer than do those with a lesion from one pathway or the other, based on data from 433 adults gleaned from more than 17,000 baseline colonoscopies. The findings were presented at the annual meeting of the American College of Gastroenterology.

Adenomas and advanced serrated polyps (ASPs) are both precursors to colorectal cancer via different molecular pathways, said Dr. Carol Burke of the Cleveland Clinic. But the association between adenomas and ASPs (including serrated adenomas and sessile serrated polyps) is not well understood.

To determine the phenotypes in patients with different types of polyps, Dr. Burke and colleagues compared baseline polyp characteristics of individuals who were undergoing their first lifetime colonoscopies.

The researchers reviewed 17,550 colon polyp pathology reports from patients seen between April 2004 and November 2007. The final study cohort included 180 individuals with sessile serrated polyps (SSPs) only, 80 individuals with SSPs plus adenomas, and 173 with adenomas only. Individuals with incomplete exams, and those with a history of colectomy, colorectal cancer, or hereditary colorectal cancer syndrome were excluded.

The coexistent SSP/adenoma group was significantly more likely to have three or more adenomas than was the adenoma-only group (21% vs. 10%) and significantly more likely to have sessile serrated polyps measuring 10 mm or larger than was the SSP-only group (66% vs. 44%).

More adenomas in each group were located in the proximal colon than in the distal colon, although the percentages of polyps in each location were not significantly different between the SSP/adenoma group and the adenoma-only group. The size of adenomas was not significantly different between the two groups.

Pathological data showed significant differences between the SSP/adenoma group and adenoma-only group. The incidence of both tubular adenoma with high-grade dysplasia and tubulovillous adenoma with high-grade dysplasia was 3.8% in the SSP/adenoma group, compared with 0.6% and 2.3%, respectively, in the adenoma-only group. There were no significant differences in serrated polyp pathology between the SSP/adenoma group and the SSP-only group.

The results suggest that advanced serrated polyps should be considered equal in risk to adenomas in the planning of postpolypectomy surveillance, Dr. Burke said.

The average age in the SSP-only, SSP-plus-adenomas, and adenomas-only groups was 57 years, 61 years, and 58 years, respectively. The average body mass index was approximately 29 kg/m2 in all three groups, which is considered to be overweight. The proportion of women in the three groups was 42%, 44%, and 49%, respectively.

The mean age of individuals with only SSPs was significantly younger than in the other two groups, Dr. Burke noted, but the implications of this difference were not clear.

Dr. Burke said that she had no financial disclosures related to her presentation at the meeting.

ORLANDO – Patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia who took 400 mg of nilotinib twice daily had an overall survival rate of 97% after 3 years, investigators reported Dec. 6 at the annual meeting of the American Society of Hematology.

Nilotinib was approved by the Food and Drug Administration in June 2010 as a first-line therapy for newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase after the drug demonstrated higher and faster molecular response rates than imatinib. The current study was conducted by Dr. Gianantonio Rosti of the University of Bologna (Italy) and associates to confirm that the efficacy of nilotinib is durable over a 3-year period, the time during which most failures on imatinib occur.

The investigators enrolled 73 patients with newly diagnosed Ph+ CML in a phase II open-label, multicenter clinical trial. The patients ranged in age from 18 to 83 years, with a median age of 51 years. All patients received 400 mg of nilotinib two times per day, Dr. Rosti said at a press briefing in advance of his presentation at the meeting.

The study’s primary end point was a complete cytogenetic response rate at 12 months, meaning that no cells containing a Philadelphia chromosome were found in the patient’s bone marrow. The complete cytogenetic response rate was 78% at 3 months and 96% at 6, 12, and 18 months. Within 12 months, all patients had achieved a complete cytogenetic response at least once.

The progression-free survival and failure-free survival rates were 97% after 3 years, and the event-free survival rate was 91% after a median follow-up of 36 months.

The study is ongoing, and the current median follow-up time is longer than 3 years (30-40 months), Dr. Rosti said. Patient responses remained stable, and only one patient progressed to alternative lengthening of telomeres–-associated promyelocytic leukemia, Dr. Rosti said. A total of 97% of patients obtained a major molecular response. In addition, 70% obtained a complete molecular response, and 25% of these patients are stable, he said.

Dr. Rosti said he has received research funding from Novartis. He has also served as a consultant and on the speakers bureau and board of directors or advisory committee for the company. He has received honoraria and served on the speakers bureau for Bristol-Myers Squibb, and on the speakers bureau for Roche.

ORLANDO – Patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia who took 400 mg of nilotinib twice daily had an overall survival rate of 97% after 3 years, investigators reported Dec. 6 at the annual meeting of the American Society of Hematology.

Nilotinib was approved by the Food and Drug Administration in June 2010 as a first-line therapy for newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase after the drug demonstrated higher and faster molecular response rates than imatinib. The current study was conducted by Dr. Gianantonio Rosti of the University of Bologna (Italy) and associates to confirm that the efficacy of nilotinib is durable over a 3-year period, the time during which most failures on imatinib occur.

The investigators enrolled 73 patients with newly diagnosed Ph+ CML in a phase II open-label, multicenter clinical trial. The patients ranged in age from 18 to 83 years, with a median age of 51 years. All patients received 400 mg of nilotinib two times per day, Dr. Rosti said at a press briefing in advance of his presentation at the meeting.

The study’s primary end point was a complete cytogenetic response rate at 12 months, meaning that no cells containing a Philadelphia chromosome were found in the patient’s bone marrow. The complete cytogenetic response rate was 78% at 3 months and 96% at 6, 12, and 18 months. Within 12 months, all patients had achieved a complete cytogenetic response at least once.

The progression-free survival and failure-free survival rates were 97% after 3 years, and the event-free survival rate was 91% after a median follow-up of 36 months.

The study is ongoing, and the current median follow-up time is longer than 3 years (30-40 months), Dr. Rosti said. Patient responses remained stable, and only one patient progressed to alternative lengthening of telomeres–-associated promyelocytic leukemia, Dr. Rosti said. A total of 97% of patients obtained a major molecular response. In addition, 70% obtained a complete molecular response, and 25% of these patients are stable, he said.

Dr. Rosti said he has received research funding from Novartis. He has also served as a consultant and on the speakers bureau and board of directors or advisory committee for the company. He has received honoraria and served on the speakers bureau for Bristol-Myers Squibb, and on the speakers bureau for Roche.

ORLANDO – Patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia who took 400 mg of nilotinib twice daily had an overall survival rate of 97% after 3 years, investigators reported Dec. 6 at the annual meeting of the American Society of Hematology.

Nilotinib was approved by the Food and Drug Administration in June 2010 as a first-line therapy for newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase after the drug demonstrated higher and faster molecular response rates than imatinib. The current study was conducted by Dr. Gianantonio Rosti of the University of Bologna (Italy) and associates to confirm that the efficacy of nilotinib is durable over a 3-year period, the time during which most failures on imatinib occur.

The investigators enrolled 73 patients with newly diagnosed Ph+ CML in a phase II open-label, multicenter clinical trial. The patients ranged in age from 18 to 83 years, with a median age of 51 years. All patients received 400 mg of nilotinib two times per day, Dr. Rosti said at a press briefing in advance of his presentation at the meeting.

The study’s primary end point was a complete cytogenetic response rate at 12 months, meaning that no cells containing a Philadelphia chromosome were found in the patient’s bone marrow. The complete cytogenetic response rate was 78% at 3 months and 96% at 6, 12, and 18 months. Within 12 months, all patients had achieved a complete cytogenetic response at least once.

The progression-free survival and failure-free survival rates were 97% after 3 years, and the event-free survival rate was 91% after a median follow-up of 36 months.

The study is ongoing, and the current median follow-up time is longer than 3 years (30-40 months), Dr. Rosti said. Patient responses remained stable, and only one patient progressed to alternative lengthening of telomeres–-associated promyelocytic leukemia, Dr. Rosti said. A total of 97% of patients obtained a major molecular response. In addition, 70% obtained a complete molecular response, and 25% of these patients are stable, he said.

Dr. Rosti said he has received research funding from Novartis. He has also served as a consultant and on the speakers bureau and board of directors or advisory committee for the company. He has received honoraria and served on the speakers bureau for Bristol-Myers Squibb, and on the speakers bureau for Roche.

ORLANDO – Brentuximab vedotin, an investigational agent, was associated with complete remission in 34% of patients whose Hodgkin’s lymphoma recurred after autologous stem cell transplantation, according to the results of a phase II trial involving 102 patients.

"The antibody component of the drug allows for the selective delivery of the chemotherapeutic agent directly into the Hodgkin’s lymphoma cells," Dr. Robert Chen said at a press conference held in conjunction with the annual meeting of the American Society of Hematology.

"The overall response rate was 75%," with a median duration of 29 weeks, said Dr. Chen of City of Hope National Medical Center in Duarte, Calif. "Overall, 94% of the patients achieved any kind of tumor reduction," he said.

Dr. Chen and colleagues conducted the single-arm, multicenter study to evaluate the safety and efficacy of brentuximab vedotin, an antibody-drug conjugate, in patients with relapsed or refractory Hodgkin’s lymphoma following autologous stem cell transplants. In general, the prognosis for this patient population is poor, with a median survival time of 2.4 years, Dr. Chen noted.

The patients received 1.8 mg/kg of brentuximab vedotin every 3 weeks in the form of a 30-minute intravenous infusion. Patients had up to 16 treatment cycles.

The most common side effect was peripheral neuropathy, reported by 43% of the patients. However, approximately two-thirds of these patients had resolution of the peripheral neuropathy after treatment completion. The side effect profile is manageable, compared with other combination chemotherapy regimens, Dr. Chen said. Other commonly reported side effects included fatigue, nausea, and upper respiratory tract infections.

The patients ranged in age from 15 to 77 years, with a median age of 31 years, and 53% were women. The patients had received an average of 3.5 previous chemotherapy treatments in addition to autologous stem cell transplantation. The average length of treatment was 27 weeks (nine cycles), and patients were followed every 12 weeks.

A total of 96 of 102 patients (94%) achieved some degree of tumor reduction, and the estimated 12-month overall survival was 88%.

The results of this phase II study will be submitted to the Food and Drug Administration early in 2011, Dr. Chen said. Two additional trials are underway to evaluate brentuximab vedotin’s effectiveness in newly diagnosed Hodgkin’s lymphoma patients and as maintenance therapy.

"Once a patient fails a transplant, the prognosis is generally poor, said Dr. Ginna G. Laport, an associate professor of medicine at Stanford (Calif.) University. Dr. Laport served as the press conference moderator and several of her patients participated in the study. Brentuximab vedotin represents "a big breakthrough for this population," she said. "I think this is a very exciting drug."

Dr. Chen and his colleagues received research funding from the study sponsor, Seattle Genetics.

ORLANDO – Brentuximab vedotin, an investigational agent, was associated with complete remission in 34% of patients whose Hodgkin’s lymphoma recurred after autologous stem cell transplantation, according to the results of a phase II trial involving 102 patients.

"The antibody component of the drug allows for the selective delivery of the chemotherapeutic agent directly into the Hodgkin’s lymphoma cells," Dr. Robert Chen said at a press conference held in conjunction with the annual meeting of the American Society of Hematology.

"The overall response rate was 75%," with a median duration of 29 weeks, said Dr. Chen of City of Hope National Medical Center in Duarte, Calif. "Overall, 94% of the patients achieved any kind of tumor reduction," he said.

Dr. Chen and colleagues conducted the single-arm, multicenter study to evaluate the safety and efficacy of brentuximab vedotin, an antibody-drug conjugate, in patients with relapsed or refractory Hodgkin’s lymphoma following autologous stem cell transplants. In general, the prognosis for this patient population is poor, with a median survival time of 2.4 years, Dr. Chen noted.

The patients received 1.8 mg/kg of brentuximab vedotin every 3 weeks in the form of a 30-minute intravenous infusion. Patients had up to 16 treatment cycles.

The most common side effect was peripheral neuropathy, reported by 43% of the patients. However, approximately two-thirds of these patients had resolution of the peripheral neuropathy after treatment completion. The side effect profile is manageable, compared with other combination chemotherapy regimens, Dr. Chen said. Other commonly reported side effects included fatigue, nausea, and upper respiratory tract infections.

The patients ranged in age from 15 to 77 years, with a median age of 31 years, and 53% were women. The patients had received an average of 3.5 previous chemotherapy treatments in addition to autologous stem cell transplantation. The average length of treatment was 27 weeks (nine cycles), and patients were followed every 12 weeks.

A total of 96 of 102 patients (94%) achieved some degree of tumor reduction, and the estimated 12-month overall survival was 88%.

The results of this phase II study will be submitted to the Food and Drug Administration early in 2011, Dr. Chen said. Two additional trials are underway to evaluate brentuximab vedotin’s effectiveness in newly diagnosed Hodgkin’s lymphoma patients and as maintenance therapy.

"Once a patient fails a transplant, the prognosis is generally poor, said Dr. Ginna G. Laport, an associate professor of medicine at Stanford (Calif.) University. Dr. Laport served as the press conference moderator and several of her patients participated in the study. Brentuximab vedotin represents "a big breakthrough for this population," she said. "I think this is a very exciting drug."

Dr. Chen and his colleagues received research funding from the study sponsor, Seattle Genetics.

ORLANDO – Brentuximab vedotin, an investigational agent, was associated with complete remission in 34% of patients whose Hodgkin’s lymphoma recurred after autologous stem cell transplantation, according to the results of a phase II trial involving 102 patients.

"The antibody component of the drug allows for the selective delivery of the chemotherapeutic agent directly into the Hodgkin’s lymphoma cells," Dr. Robert Chen said at a press conference held in conjunction with the annual meeting of the American Society of Hematology.

"The overall response rate was 75%," with a median duration of 29 weeks, said Dr. Chen of City of Hope National Medical Center in Duarte, Calif. "Overall, 94% of the patients achieved any kind of tumor reduction," he said.

Dr. Chen and colleagues conducted the single-arm, multicenter study to evaluate the safety and efficacy of brentuximab vedotin, an antibody-drug conjugate, in patients with relapsed or refractory Hodgkin’s lymphoma following autologous stem cell transplants. In general, the prognosis for this patient population is poor, with a median survival time of 2.4 years, Dr. Chen noted.

The patients received 1.8 mg/kg of brentuximab vedotin every 3 weeks in the form of a 30-minute intravenous infusion. Patients had up to 16 treatment cycles.

The most common side effect was peripheral neuropathy, reported by 43% of the patients. However, approximately two-thirds of these patients had resolution of the peripheral neuropathy after treatment completion. The side effect profile is manageable, compared with other combination chemotherapy regimens, Dr. Chen said. Other commonly reported side effects included fatigue, nausea, and upper respiratory tract infections.

The patients ranged in age from 15 to 77 years, with a median age of 31 years, and 53% were women. The patients had received an average of 3.5 previous chemotherapy treatments in addition to autologous stem cell transplantation. The average length of treatment was 27 weeks (nine cycles), and patients were followed every 12 weeks.

A total of 96 of 102 patients (94%) achieved some degree of tumor reduction, and the estimated 12-month overall survival was 88%.

The results of this phase II study will be submitted to the Food and Drug Administration early in 2011, Dr. Chen said. Two additional trials are underway to evaluate brentuximab vedotin’s effectiveness in newly diagnosed Hodgkin’s lymphoma patients and as maintenance therapy.

"Once a patient fails a transplant, the prognosis is generally poor, said Dr. Ginna G. Laport, an associate professor of medicine at Stanford (Calif.) University. Dr. Laport served as the press conference moderator and several of her patients participated in the study. Brentuximab vedotin represents "a big breakthrough for this population," she said. "I think this is a very exciting drug."

Dr. Chen and his colleagues received research funding from the study sponsor, Seattle Genetics.

ORLANDO – Oral apixaban reduced the incidence of major venous thromboembolism after joint replacement surgery by approximately half compared with enoxaparin, with no increased risk of bleeding, investigators have reported.

Of approximately 7,000 patients who underwent thromboprophylaxis after surgery, major VTE occurred in 0.68% of those who had received apixaban, compared with 1.50% who had been given enoxaparin. This was a statistically significant difference, study investigator Gary E. Raskob, Ph.D., said in a press conference at the annual meeting of the American Society of Hematology.

Prevention of major venous thromboembolism (VTE) is "a significant issue in health care in the United States," where the number of knee and hip replacements is expected to increase, said Dr. Raskob, dean of the College of Public Health at the University of Oklahoma Health Sciences Center in Oklahoma City.

Previous studies have demonstrated the potential for an increased risk of bleeding with new anticoagulants. To provide more precise estimates of the incidence of major VTE and safety outcomes, the investigators combined data from two phase III, randomized, double-blind clinical trials of patients who had undergone knee (ADVANCE-2 study) or hip replacement (ADVANCE-3). A total of 8,464 were randomized to receive apixaban, a novel orally administered factor Xa inhibitor (4,236 patients), or enoxaparin (4,228 patients).

Efficacy results related to VTE were based on 3,394 patients in each group. Major VTE occurred in 23 patients in the apixaban group (0.68%), compared with 51 patients in the enoxaparin group (1.50%).

Bleeding results were based on 4,174 apixaban patients and 4,228 enoxaparin patients. Major bleeding occurred in 31 patients in the apixaban group and 32 in the enoxaparin group (0.74% vs. 0.77%). Major bleeding at the surgical site occurred in 26 in the apixaban group and 27 in the enoxaparin group. Overall, major or clinically relevant nonmajor bleeding occurred in 182 apixaban patients and 206 enoxaparin patients (4.4% vs. 4.9%).

The patients received 2.5 mg of apixaban twice daily or 40 mg of enoxaparin once daily. Apixaban was started 12-24 hours after wound closure, and enoxaparin was started approximately 12 hours before surgery and resumed 12-24 hours after wound closure. Both medications were continued for 10-14 days in the knee replacement group and 32-38 days in the hip replacement group. Patients were followed up at 30 days and 60 days after their last doses of either study medication.

Myocardial infarction or stroke occurred in 13 apixaban patients and 10 enoxaparin patients during the course of the study and follow-up period.

Dr. Raskob has served as a consultant or member of the board of directors or advisory committee for multiple companies, including Bristol-Meyers Squibb, Pfizer, Bayer, Johnson & Johnson, Sanofi Aventis, and Daiichi Sankyo.

ORLANDO – Oral apixaban reduced the incidence of major venous thromboembolism after joint replacement surgery by approximately half compared with enoxaparin, with no increased risk of bleeding, investigators have reported.

Of approximately 7,000 patients who underwent thromboprophylaxis after surgery, major VTE occurred in 0.68% of those who had received apixaban, compared with 1.50% who had been given enoxaparin. This was a statistically significant difference, study investigator Gary E. Raskob, Ph.D., said in a press conference at the annual meeting of the American Society of Hematology.

Prevention of major venous thromboembolism (VTE) is "a significant issue in health care in the United States," where the number of knee and hip replacements is expected to increase, said Dr. Raskob, dean of the College of Public Health at the University of Oklahoma Health Sciences Center in Oklahoma City.

Previous studies have demonstrated the potential for an increased risk of bleeding with new anticoagulants. To provide more precise estimates of the incidence of major VTE and safety outcomes, the investigators combined data from two phase III, randomized, double-blind clinical trials of patients who had undergone knee (ADVANCE-2 study) or hip replacement (ADVANCE-3). A total of 8,464 were randomized to receive apixaban, a novel orally administered factor Xa inhibitor (4,236 patients), or enoxaparin (4,228 patients).

Efficacy results related to VTE were based on 3,394 patients in each group. Major VTE occurred in 23 patients in the apixaban group (0.68%), compared with 51 patients in the enoxaparin group (1.50%).

Bleeding results were based on 4,174 apixaban patients and 4,228 enoxaparin patients. Major bleeding occurred in 31 patients in the apixaban group and 32 in the enoxaparin group (0.74% vs. 0.77%). Major bleeding at the surgical site occurred in 26 in the apixaban group and 27 in the enoxaparin group. Overall, major or clinically relevant nonmajor bleeding occurred in 182 apixaban patients and 206 enoxaparin patients (4.4% vs. 4.9%).

The patients received 2.5 mg of apixaban twice daily or 40 mg of enoxaparin once daily. Apixaban was started 12-24 hours after wound closure, and enoxaparin was started approximately 12 hours before surgery and resumed 12-24 hours after wound closure. Both medications were continued for 10-14 days in the knee replacement group and 32-38 days in the hip replacement group. Patients were followed up at 30 days and 60 days after their last doses of either study medication.

Myocardial infarction or stroke occurred in 13 apixaban patients and 10 enoxaparin patients during the course of the study and follow-up period.

Dr. Raskob has served as a consultant or member of the board of directors or advisory committee for multiple companies, including Bristol-Meyers Squibb, Pfizer, Bayer, Johnson & Johnson, Sanofi Aventis, and Daiichi Sankyo.

ORLANDO – Oral apixaban reduced the incidence of major venous thromboembolism after joint replacement surgery by approximately half compared with enoxaparin, with no increased risk of bleeding, investigators have reported.

Of approximately 7,000 patients who underwent thromboprophylaxis after surgery, major VTE occurred in 0.68% of those who had received apixaban, compared with 1.50% who had been given enoxaparin. This was a statistically significant difference, study investigator Gary E. Raskob, Ph.D., said in a press conference at the annual meeting of the American Society of Hematology.

Prevention of major venous thromboembolism (VTE) is "a significant issue in health care in the United States," where the number of knee and hip replacements is expected to increase, said Dr. Raskob, dean of the College of Public Health at the University of Oklahoma Health Sciences Center in Oklahoma City.

Previous studies have demonstrated the potential for an increased risk of bleeding with new anticoagulants. To provide more precise estimates of the incidence of major VTE and safety outcomes, the investigators combined data from two phase III, randomized, double-blind clinical trials of patients who had undergone knee (ADVANCE-2 study) or hip replacement (ADVANCE-3). A total of 8,464 were randomized to receive apixaban, a novel orally administered factor Xa inhibitor (4,236 patients), or enoxaparin (4,228 patients).

Efficacy results related to VTE were based on 3,394 patients in each group. Major VTE occurred in 23 patients in the apixaban group (0.68%), compared with 51 patients in the enoxaparin group (1.50%).

Bleeding results were based on 4,174 apixaban patients and 4,228 enoxaparin patients. Major bleeding occurred in 31 patients in the apixaban group and 32 in the enoxaparin group (0.74% vs. 0.77%). Major bleeding at the surgical site occurred in 26 in the apixaban group and 27 in the enoxaparin group. Overall, major or clinically relevant nonmajor bleeding occurred in 182 apixaban patients and 206 enoxaparin patients (4.4% vs. 4.9%).

The patients received 2.5 mg of apixaban twice daily or 40 mg of enoxaparin once daily. Apixaban was started 12-24 hours after wound closure, and enoxaparin was started approximately 12 hours before surgery and resumed 12-24 hours after wound closure. Both medications were continued for 10-14 days in the knee replacement group and 32-38 days in the hip replacement group. Patients were followed up at 30 days and 60 days after their last doses of either study medication.

Myocardial infarction or stroke occurred in 13 apixaban patients and 10 enoxaparin patients during the course of the study and follow-up period.

Dr. Raskob has served as a consultant or member of the board of directors or advisory committee for multiple companies, including Bristol-Meyers Squibb, Pfizer, Bayer, Johnson & Johnson, Sanofi Aventis, and Daiichi Sankyo.