Kerri Wachter

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we’re talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I’m very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we’re talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I’m very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we’re talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I’m very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we’re talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I’m very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we’re talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I’m very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

BOSTON – Skin wrinkling and rigidity could give physicians a clue to bone mineral density, at least among early postmenopausal women, based on a study presented as a poster at the annual meeting of the Endocrine Society.

"In the women that we’re talking about, skin wrinkling and skin rigidity – features that are easily appreciable across the table when you are looking at the patient – tie in with bone mineral density as assessed by clinical gold standards, such a as dual x-ray absorptiometry," Dr. Lubna Pal said during a press conference at the meeting.

The researchers explored possible relationships between skin wrinkling/rigidity and bone mineral density (BMD) in a cohort of early menopausal women who were enrolled in the Kronos Early Estrogen Prevention Study, a longitudinal trial of menopausal hormone therapy.

The skin ancillary study to the ongoing Kronos clinical trial included 114 women who had their last menstrual period within the past 3 years. Most of the participants were white, although 30% were not. Cross-sectional baseline data were used, said Dr. Pal, who is a reproductive endocrinologist at Yale University, New Haven, Conn.

Skin wrinkles were assessed at 11 sites on the face and neck using the validated Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Participants also underwent BMD assessment by dual energy x-ray absorptiometry at the lumbar spine, left hip, and total body. The patients also underwent quantitative heel ultrasound.

Stepwise multivariable linear regression analyses explored the relationship between skin parameters and BMD. Covariates included age, body mass, race/ethnicity, age at menopause, history of smoking, multivitamins intake, and enrollment site.

The researchers found that skin wrinkle severity correlates with BMD. In particular, when wrinkles are severe, BMD is low.

"Our hypothesis, I’m very pleased to say, was substantiated by these findings," said Dr. Pal. "But we are really seeing the tip of the iceberg here. This is a tantalizing association.

"The quest for all of us really is, can we pick out markers in a cost-effective manner that may translate into overall risk detection that would prevent [fractures]?" she added.

Why look at skin wrinkles and bone density? "Well, when you look at the architecture of the skeleton and the architecture of the skin, about 90% of shared properties within tissues exist, which are the protein building blocks," Dr. Pal said.

In the skeleton, bone mineral must be deposited on some struts, and proteins provide that infrastructure, she explained. So, loss of protein in the skeleton translates into increased skeletal fragility. That structural deterioration is also seen in the skin. "As we age, the protein texture in our dermis and the deeper layers of our skin also deteriorate," Dr. Pal noted.

The women in the study are being followed longitudinally. Thus, the researchers may be able to answer questions such as whether more wrinkles are associated with a faster rate of bone loss and whether estrogen therapy has an effect on such a relationship, Dr. Pal said.

Dr. Pal and her coinvestigators reported that they have no relevant financial relationships.

Major Finding: The fracture risk for gastric bypass surgery patients was 2.3-fold greater than that for the general population.

Data Source: A retrospective study of 258 patients who underwent bariatric surgery between 1985 and 2004.

Disclosures: Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

“Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up,” Dr. Kurt Kennel said at the meeting.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

The findings are particularly important given the increasing number of severely obese individuals who are turning to bariatric surgery as a treatment option.

“We have questions about what this means in the long term,” said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1-2 years and the only issues addressed are related to surgery or weight.

“Some issues – like bone, for example – may not show the manifestations of these effects for many years and therefore we may be missing some of those effects,” said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. The REP Project connects medical records from the Mayo Clinic, local hospitals, and local private practices.

The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic. Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures. Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study. Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks. For now though, it's unclear what is driving the fracture increase in these patients.

Major Finding: The fracture risk for gastric bypass surgery patients was 2.3-fold greater than that for the general population.

Data Source: A retrospective study of 258 patients who underwent bariatric surgery between 1985 and 2004.

Disclosures: Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

“Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up,” Dr. Kurt Kennel said at the meeting.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

The findings are particularly important given the increasing number of severely obese individuals who are turning to bariatric surgery as a treatment option.

“We have questions about what this means in the long term,” said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1-2 years and the only issues addressed are related to surgery or weight.

“Some issues – like bone, for example – may not show the manifestations of these effects for many years and therefore we may be missing some of those effects,” said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. The REP Project connects medical records from the Mayo Clinic, local hospitals, and local private practices.

The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic. Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures. Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study. Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks. For now though, it's unclear what is driving the fracture increase in these patients.

Major Finding: The fracture risk for gastric bypass surgery patients was 2.3-fold greater than that for the general population.

Data Source: A retrospective study of 258 patients who underwent bariatric surgery between 1985 and 2004.

Disclosures: Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

“Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up,” Dr. Kurt Kennel said at the meeting.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

The findings are particularly important given the increasing number of severely obese individuals who are turning to bariatric surgery as a treatment option.

“We have questions about what this means in the long term,” said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1-2 years and the only issues addressed are related to surgery or weight.

“Some issues – like bone, for example – may not show the manifestations of these effects for many years and therefore we may be missing some of those effects,” said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. The REP Project connects medical records from the Mayo Clinic, local hospitals, and local private practices.

The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic. Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures. Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study. Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks. For now though, it's unclear what is driving the fracture increase in these patients.

Major Finding: More than half (60%) of women reported no pain with the vaginal-perianal method, compared with 18% with the vaginal-rectal method. The sensitivity and specificity of the vaginal-perianal method were 91% and 99%.

Data Source: A study of 200 women at least 18 years of age with an average gestational age of 35.9 weeks.

Disclosures: Dr. Trappe reported that she had no relevant financial disclosures.

WASHINGTON – Vaginal-perianal cultures for group B streptococcus may be a more comfortable option for pregnant women and have comparable accuracy to vaginal-anal cultures, a study of 200 women has shown.

“Vaginal-perianal cultures may be a reasonable, patient-preferred alternative for the recommended vaginal-rectal cultures of GBS during pregnancy,” said Dr. Karen L. Trappe of Riverside Methodist Hospital in Columbus, Ohio.

It's estimated that 10%–30% of pregnant women are colonized with GBS, which is an established cause of neonatal morbidity and mortality. In 2002, the Centers for Disease Control and Prevention advised universal prenatal screening and the American College of Obstetricians and Gynecologists published a committee opinion outlining the collection of GBS cultures between 35 and 37 weeks' gestation (Obstet. Gynecol. 2002;100:1405–12). GBS cultures are to be obtained by a swab of the lower vagina (vaginal introitus) followed by the rectum (insert swab through anal sphincter). This collection method was based on a 1977 study suggesting that the GI tract was the primary site of GBS colonization. However, vaginal-anal cultures are uncomfortable for patients.

Dr. Trappe and her coinvestigators studied whether vaginal-perianal cultures were equally effective in identifying GBS and were more comfortable for patients. They included women in the study if they were at least 18 years old, were to undergo routine GBS culture, and spoke English, Spanish, or Somali. The researchers collected data from 200 patients. The average maternal age was 26 years, and the average gestational age was 35.9 weeks. In terms of ethnicity, half (49%) of patients where white, followed by black (23%), Hispanic (14%), Asian (1%), and other (13%). Although inclusion criteria were for 35–37 weeks' gestation, seven women outside of this range were enrolled – three at 34 weeks', three at 38 weeks', and one at 39 weeks' gestation.

The vaginal-perianal specimen was collected first, followed by the recommended vaginal-rectal specimen. Women were asked to rate pain on a 0–10 scale for each collection method. They also were asked if one method was more uncomfortable than the other. The overall agreement rate between the two collection methods was 96.5%. The sensitivity and specificity of the vaginal-perianal method were 91% and 99%.

“Patients also reported statistically greater pain and discomfort with the vaginal-rectal culture collection, with over two-thirds of patients reporting less discomfort with the vaginal-perianal method,” Dr. Trappe said at the meeting. More than half (60%) of women reported no pain with the vaginal-perianal method, compared with 18% with the vaginal-rectal method. “Patients indicated a preference for the vaginal-perianal collection method based on pain and discomfort surveys,” she noted.

Major Finding: More than half (60%) of women reported no pain with the vaginal-perianal method, compared with 18% with the vaginal-rectal method. The sensitivity and specificity of the vaginal-perianal method were 91% and 99%.

Data Source: A study of 200 women at least 18 years of age with an average gestational age of 35.9 weeks.

Disclosures: Dr. Trappe reported that she had no relevant financial disclosures.

WASHINGTON – Vaginal-perianal cultures for group B streptococcus may be a more comfortable option for pregnant women and have comparable accuracy to vaginal-anal cultures, a study of 200 women has shown.

“Vaginal-perianal cultures may be a reasonable, patient-preferred alternative for the recommended vaginal-rectal cultures of GBS during pregnancy,” said Dr. Karen L. Trappe of Riverside Methodist Hospital in Columbus, Ohio.

It's estimated that 10%–30% of pregnant women are colonized with GBS, which is an established cause of neonatal morbidity and mortality. In 2002, the Centers for Disease Control and Prevention advised universal prenatal screening and the American College of Obstetricians and Gynecologists published a committee opinion outlining the collection of GBS cultures between 35 and 37 weeks' gestation (Obstet. Gynecol. 2002;100:1405–12). GBS cultures are to be obtained by a swab of the lower vagina (vaginal introitus) followed by the rectum (insert swab through anal sphincter). This collection method was based on a 1977 study suggesting that the GI tract was the primary site of GBS colonization. However, vaginal-anal cultures are uncomfortable for patients.

Dr. Trappe and her coinvestigators studied whether vaginal-perianal cultures were equally effective in identifying GBS and were more comfortable for patients. They included women in the study if they were at least 18 years old, were to undergo routine GBS culture, and spoke English, Spanish, or Somali. The researchers collected data from 200 patients. The average maternal age was 26 years, and the average gestational age was 35.9 weeks. In terms of ethnicity, half (49%) of patients where white, followed by black (23%), Hispanic (14%), Asian (1%), and other (13%). Although inclusion criteria were for 35–37 weeks' gestation, seven women outside of this range were enrolled – three at 34 weeks', three at 38 weeks', and one at 39 weeks' gestation.

The vaginal-perianal specimen was collected first, followed by the recommended vaginal-rectal specimen. Women were asked to rate pain on a 0–10 scale for each collection method. They also were asked if one method was more uncomfortable than the other. The overall agreement rate between the two collection methods was 96.5%. The sensitivity and specificity of the vaginal-perianal method were 91% and 99%.

“Patients also reported statistically greater pain and discomfort with the vaginal-rectal culture collection, with over two-thirds of patients reporting less discomfort with the vaginal-perianal method,” Dr. Trappe said at the meeting. More than half (60%) of women reported no pain with the vaginal-perianal method, compared with 18% with the vaginal-rectal method. “Patients indicated a preference for the vaginal-perianal collection method based on pain and discomfort surveys,” she noted.

Major Finding: More than half (60%) of women reported no pain with the vaginal-perianal method, compared with 18% with the vaginal-rectal method. The sensitivity and specificity of the vaginal-perianal method were 91% and 99%.

Data Source: A study of 200 women at least 18 years of age with an average gestational age of 35.9 weeks.

Disclosures: Dr. Trappe reported that she had no relevant financial disclosures.

WASHINGTON – Vaginal-perianal cultures for group B streptococcus may be a more comfortable option for pregnant women and have comparable accuracy to vaginal-anal cultures, a study of 200 women has shown.

“Vaginal-perianal cultures may be a reasonable, patient-preferred alternative for the recommended vaginal-rectal cultures of GBS during pregnancy,” said Dr. Karen L. Trappe of Riverside Methodist Hospital in Columbus, Ohio.

It's estimated that 10%–30% of pregnant women are colonized with GBS, which is an established cause of neonatal morbidity and mortality. In 2002, the Centers for Disease Control and Prevention advised universal prenatal screening and the American College of Obstetricians and Gynecologists published a committee opinion outlining the collection of GBS cultures between 35 and 37 weeks' gestation (Obstet. Gynecol. 2002;100:1405–12). GBS cultures are to be obtained by a swab of the lower vagina (vaginal introitus) followed by the rectum (insert swab through anal sphincter). This collection method was based on a 1977 study suggesting that the GI tract was the primary site of GBS colonization. However, vaginal-anal cultures are uncomfortable for patients.

Dr. Trappe and her coinvestigators studied whether vaginal-perianal cultures were equally effective in identifying GBS and were more comfortable for patients. They included women in the study if they were at least 18 years old, were to undergo routine GBS culture, and spoke English, Spanish, or Somali. The researchers collected data from 200 patients. The average maternal age was 26 years, and the average gestational age was 35.9 weeks. In terms of ethnicity, half (49%) of patients where white, followed by black (23%), Hispanic (14%), Asian (1%), and other (13%). Although inclusion criteria were for 35–37 weeks' gestation, seven women outside of this range were enrolled – three at 34 weeks', three at 38 weeks', and one at 39 weeks' gestation.

The vaginal-perianal specimen was collected first, followed by the recommended vaginal-rectal specimen. Women were asked to rate pain on a 0–10 scale for each collection method. They also were asked if one method was more uncomfortable than the other. The overall agreement rate between the two collection methods was 96.5%. The sensitivity and specificity of the vaginal-perianal method were 91% and 99%.

“Patients also reported statistically greater pain and discomfort with the vaginal-rectal culture collection, with over two-thirds of patients reporting less discomfort with the vaginal-perianal method,” Dr. Trappe said at the meeting. More than half (60%) of women reported no pain with the vaginal-perianal method, compared with 18% with the vaginal-rectal method. “Patients indicated a preference for the vaginal-perianal collection method based on pain and discomfort surveys,” she noted.

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants.

The data come from a report released by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

“Our review … continues to support the safety and effectiveness of silicone gel–filled implants when used as intended,” Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a press briefing. “We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction.”

As part of the FDA's November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA's new “Update on the Safety of Silicone Gel-Filled Breast Implants” provides a clinical update on the two silicone gel–filled breast implants available in the United States.

The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

“I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies,” said Dr. Shuren.

The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

▸ Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receive implants for breast augmentation will need them removed within 10 years. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

▸ The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

▸ The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

▸ Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

▸ Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

▸ Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

▸ Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and to Medwatch, the FDA's safety information and adverse event reporting program.

▸ Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate.

These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants.

The data come from a report released by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

“Our review … continues to support the safety and effectiveness of silicone gel–filled implants when used as intended,” Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a press briefing. “We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction.”

As part of the FDA's November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA's new “Update on the Safety of Silicone Gel-Filled Breast Implants” provides a clinical update on the two silicone gel–filled breast implants available in the United States.

The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

“I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies,” said Dr. Shuren.

The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

▸ Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receive implants for breast augmentation will need them removed within 10 years. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

▸ The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

▸ The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

▸ Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

▸ Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

▸ Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

▸ Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and to Medwatch, the FDA's safety information and adverse event reporting program.

▸ Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate.

These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

Preliminary safety data from postmarketing studies confirm that silicone gel–filled breast implants are safe and effective when used as intended, but women should fully understand the risks prior to considering the implants.

The data come from a report released by the Food and Drug Administration that updates the clinical and scientific information for silicone implants.

“Our review … continues to support the safety and effectiveness of silicone gel–filled implants when used as intended,” Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a press briefing. “We also want women to fully understand the risks and complications associated with these implants prior to considering them for breast augmentation or reconstruction.”

As part of the FDA's November 2006 approval of two silicone gel–filled breast implants (the Allergan Natrelle and the Mentor MemoryGel), each manufacturer was required to conduct postapproval studies to characterize the long-term performance and safety of the devices.

In January 2011, the agency issued a statement about a possible but small association between silicone implants and anaplastic large cell lymphoma (ALCL).

The FDA's new “Update on the Safety of Silicone Gel-Filled Breast Implants” provides a clinical update on the two silicone gel–filled breast implants available in the United States.

The updated information includes preliminary data from the postapproval studies, a summary and analysis of adverse events reported to the FDA since approval, and a review and analysis of recent clinical publications about the safety and effectiveness of silicone gel–filled breast implants.

“I do want to emphasize today [that these data are] preliminary and that there are many more years of data collection needed to complete the required 10-year studies,” said Dr. Shuren.

The report is not intended to provide a comprehensive clinical update about the safety of saline-filled breast implants.

Based on this report, according to the FDA news release, women should know the following:

▸ Breast implants are not lifetime devices. The longer a woman has silicone gel–filled breast implants, the more likely she is to experience complications. One in five patients who receive implants for breast augmentation will need them removed within 10 years. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.

▸ The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries), and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

▸ The complications that existed for women who received breast implants at the time of approval are similar to the complications observed today.

▸ Preliminary data do not indicate that silicone gel–filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer in duration than those conducted thus far.

The FDA will be holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective. For now, the agency is recommending that health care professionals and women who have silicone gel–filled breast implants do the following:

▸ Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture. Dr. Shuren noted that the first MRI should occur at 3 years post implantation and every 2 years after that.

▸ Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring, and infection.

▸ Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and to Medwatch, the FDA's safety information and adverse event reporting program.

▸ Stay in touch. If a woman has enrolled in a manufacturer-sponsored postapproval study, she should continue to participate.

These studies are the best way to collect information about the long-term rates of complications.

The agency also redesigned its website to include comprehensive information on silicone gel–filled and saline-filled breast implants.

Major Finding: The fracture risk for gastric bypass surgery patients was 2.3-fold greater than that for the general population.

Data Source: A retrospective study of 258 patients who underwent bariatric surgery between 1985 and 2004.

Disclosures: Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

“Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up,” Dr. Kurt Kennel said at the meeting.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

“We have questions about what this means in the long term,” said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1–2 years and the only issues addressed are related to surgery or weight.

“Some issues – like bone, for example – may not show the manifestations of these effects for many years and therefore we may be missing some of those effects,” said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. REP connects medical records from the Mayo Clinic, local hospitals, and local private practices. The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic.

Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures.

Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study.

Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks.

The increased rate of fractures “suggests that structural and biochemical changes in bone that are observed after bariatric surgery are clinically important.

Clinicians should discuss bone health with patients who have undergone or are considering bariatric surgery.”

Major Finding: The fracture risk for gastric bypass surgery patients was 2.3-fold greater than that for the general population.

Data Source: A retrospective study of 258 patients who underwent bariatric surgery between 1985 and 2004.

Disclosures: Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

“Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up,” Dr. Kurt Kennel said at the meeting.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

“We have questions about what this means in the long term,” said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1–2 years and the only issues addressed are related to surgery or weight.

“Some issues – like bone, for example – may not show the manifestations of these effects for many years and therefore we may be missing some of those effects,” said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. REP connects medical records from the Mayo Clinic, local hospitals, and local private practices. The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic.

Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures.

Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study.

Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks.

The increased rate of fractures “suggests that structural and biochemical changes in bone that are observed after bariatric surgery are clinically important.

Clinicians should discuss bone health with patients who have undergone or are considering bariatric surgery.”

Major Finding: The fracture risk for gastric bypass surgery patients was 2.3-fold greater than that for the general population.

Data Source: A retrospective study of 258 patients who underwent bariatric surgery between 1985 and 2004.

Disclosures: Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

“Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up,” Dr. Kurt Kennel said at the meeting.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

“We have questions about what this means in the long term,” said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1–2 years and the only issues addressed are related to surgery or weight.

“Some issues – like bone, for example – may not show the manifestations of these effects for many years and therefore we may be missing some of those effects,” said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. REP connects medical records from the Mayo Clinic, local hospitals, and local private practices. The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic.

Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures.

Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study.

Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks.

The increased rate of fractures “suggests that structural and biochemical changes in bone that are observed after bariatric surgery are clinically important.

Clinicians should discuss bone health with patients who have undergone or are considering bariatric surgery.”

Final results from the National Lung Screening Trial show a significant reduction in lung cancer mortality with the use of annual low-dose CT screening, compared with standard chest x-rays among former heavy smokers at high risk for lung cancer.

Low-dose CT screening led to a relative reduction of 20% in the rate of death from lung cancer, according to findings released online by the New England Journal of Medicine on June 29 (doi: 10.1056/NEJMoa1102873).The number needed to screen with low-dose CT to prevent one death from lung cancer was 320.

Although preliminary study results were announced in November 2010, the article by the National Lung Screening Trial (NLST) research team marks the first time that the results appear in a peer-reviewed journal. Acknowledging that the earlier announcement has led to calls for lung cancer screening, the authors urge rigorous analysis of cost-effectiveness before public policy recommendations are made.

"The reduction in lung-cancer mortality must be weighed against the harms from positive screening results and overdiagnosis, as well as the costs," they wrote.

In the study, 53,454 men and women aged 55-74 years – who were current or former smokers with a smoking history of at least 30 pack-years – were recruited at 33 U.S. medical centers. A total of 26,722 participants were randomized to receive three annual screens with low-dose helical CT; 26,732 were randomized to three annual screens using chest x-ray. The two groups were virtually identical in demographics and smoking history.

In all three screening rounds, positive screening tests were substantially more common in the low-dose CT group than in the radiography group (27.3% vs. 9.2% in the first round; 27.9% vs. 6.2% in the second; and 16.8% vs. 5% in the third). All told, 39.1% of the CT group and 16% of the radiography group had at least one positive result.

The percentage of screening tests that identified a clinically significant abnormality -- other than an abnormality suspicious for lung cancer – also was more than three times as high in the low-dose CT group as in the radiography group (7.5% vs. 2.1%).

More than 90% of positive screenings in the first round of the study led to a diagnostic evaluation, though the follow-up rates were lower in the later rounds. Diagnostic evaluation most often consisted of additional imaging with invasive procedures being performed infrequently.

Across the three screenings, most of the positive results were false positives – 96.4% in the CT group and 94.5% in the radiography group. Of the total number of low-dose CT screening tests, 24.2% were classified as positive and 23.4% had false-positive results; of the total number of radiographic screening tests, 6.9% were classified as positive and 6.5% were false-positive results.

In all, 1,060 lung cancers were diagnosed in the low-dose CT group (645/100,000 person-years) vs. 941 in the radiography group (572/100,000 person-years). Of these cancers, 649 in the low-dose CT group were diagnosed after a positive screening test and 44 were diagnosed after a negative screening test. In the radiography group, 279 cancers were diagnosed after a positive screening test and 137 were diagnosed after a negative screening test.

In both groups, the remaining cases were among participants who missed screening or were diagnosed after their trial screening phase was over

Analysis of lung cancer-specific mortality showed that in the CT group 356 lung cancer deaths occurred after 144,103 person-years; in the radiography group 443 lung cancer deaths occurred after 143,368 person-years. This corresponded to 247 and 309 lung cancer deaths, respectively, per 100,000 person-years in the CT and radiography groups.

There were 1,877 and 2,000 deaths from all causes in the CT and radiography groups, respectively, "representing a significant reduction with low-dose CT screening of 6.7% ... in the rate of death from any cause," the investigators wrote. While lung cancer accounted for 24.1% of all the deaths in the trial, 60.3% of the excess deaths in the radiography group were due to lung cancer.

The authors concluded that "although some agencies and organizations are contemplating the establishment of lung-cancer screening recommendations on the basis of the findings of the NLST, the current NLST data alone are, in our opinion, insufficient to fully inform such important decisions."

They noted that "The observation that low-dose CT screening can reduce the rate of death from lung cancer has generated many questions." Among these they listed: Will populations with different risk profiles benefit from screening? Could less frequent screening programs be equally effective? Would the use of different criteria for a positive screening result translate to similar benefit? For how long should people be screened?

In an accompanying editorial, Dr. Harold C. Sox, professor of medicine at the Dartmouth Institute in Hanover, N. H., agreed with the investigators’ reservations. In particular, the cost effectiveness of low-dose CT screening for lung cancer must be analyzed, he said: "Policy makers should wait for cost-effectiveness analyses to determine the amount of overdiagnosis in the NLST, and, perhaps identification of biologic markers of cancers that do not progress."

In addition, "it may be possible to define subgroups of smokers who are at higher or lower risk for lung cancer and tailor the screening strategy accordingly," he said. "The findings of the NLST regarding lung-cancer mortality signal the beginning of the end of one era of research on lung-cancer screening and the start of another. The focus will shift to informing the difficult patient-centered and policy decisions that are yet to come."

Dr. Sox also noted that "overdiagnosis is a problem because predicting which early-stage cancers will not progress is in an early stage of development, so that everyone with screen-detected cancer receives treatment that some do not need," he wrote in an accompanying editorial (doi: 10.1056/NEJME1103776).

All but two of the NLST study authors reported that they have no relevant financial relationships. Jonathan D. Clap reported having financial interest in Human Genome Sciences. Constantine Gatsonis, Ph.D., is a consultant for Wilex AG, Mela Sciences, and Endocyte Inc., has received speaker fees from Bayer Health and payment for education development by the Radiologic Society of North America. He also has invested in the Vanguard Health Fund. Dr. Sox had no conflicts.

Final results from the National Lung Screening Trial show a significant reduction in lung cancer mortality with the use of annual low-dose CT screening, compared with standard chest x-rays among former heavy smokers at high risk for lung cancer.

Low-dose CT screening led to a relative reduction of 20% in the rate of death from lung cancer, according to findings released online by the New England Journal of Medicine on June 29 (doi: 10.1056/NEJMoa1102873).The number needed to screen with low-dose CT to prevent one death from lung cancer was 320.

Although preliminary study results were announced in November 2010, the article by the National Lung Screening Trial (NLST) research team marks the first time that the results appear in a peer-reviewed journal. Acknowledging that the earlier announcement has led to calls for lung cancer screening, the authors urge rigorous analysis of cost-effectiveness before public policy recommendations are made.

"The reduction in lung-cancer mortality must be weighed against the harms from positive screening results and overdiagnosis, as well as the costs," they wrote.

In the study, 53,454 men and women aged 55-74 years – who were current or former smokers with a smoking history of at least 30 pack-years – were recruited at 33 U.S. medical centers. A total of 26,722 participants were randomized to receive three annual screens with low-dose helical CT; 26,732 were randomized to three annual screens using chest x-ray. The two groups were virtually identical in demographics and smoking history.

In all three screening rounds, positive screening tests were substantially more common in the low-dose CT group than in the radiography group (27.3% vs. 9.2% in the first round; 27.9% vs. 6.2% in the second; and 16.8% vs. 5% in the third). All told, 39.1% of the CT group and 16% of the radiography group had at least one positive result.

The percentage of screening tests that identified a clinically significant abnormality -- other than an abnormality suspicious for lung cancer – also was more than three times as high in the low-dose CT group as in the radiography group (7.5% vs. 2.1%).

More than 90% of positive screenings in the first round of the study led to a diagnostic evaluation, though the follow-up rates were lower in the later rounds. Diagnostic evaluation most often consisted of additional imaging with invasive procedures being performed infrequently.

Across the three screenings, most of the positive results were false positives – 96.4% in the CT group and 94.5% in the radiography group. Of the total number of low-dose CT screening tests, 24.2% were classified as positive and 23.4% had false-positive results; of the total number of radiographic screening tests, 6.9% were classified as positive and 6.5% were false-positive results.

In all, 1,060 lung cancers were diagnosed in the low-dose CT group (645/100,000 person-years) vs. 941 in the radiography group (572/100,000 person-years). Of these cancers, 649 in the low-dose CT group were diagnosed after a positive screening test and 44 were diagnosed after a negative screening test. In the radiography group, 279 cancers were diagnosed after a positive screening test and 137 were diagnosed after a negative screening test.

In both groups, the remaining cases were among participants who missed screening or were diagnosed after their trial screening phase was over

Analysis of lung cancer-specific mortality showed that in the CT group 356 lung cancer deaths occurred after 144,103 person-years; in the radiography group 443 lung cancer deaths occurred after 143,368 person-years. This corresponded to 247 and 309 lung cancer deaths, respectively, per 100,000 person-years in the CT and radiography groups.

There were 1,877 and 2,000 deaths from all causes in the CT and radiography groups, respectively, "representing a significant reduction with low-dose CT screening of 6.7% ... in the rate of death from any cause," the investigators wrote. While lung cancer accounted for 24.1% of all the deaths in the trial, 60.3% of the excess deaths in the radiography group were due to lung cancer.

The authors concluded that "although some agencies and organizations are contemplating the establishment of lung-cancer screening recommendations on the basis of the findings of the NLST, the current NLST data alone are, in our opinion, insufficient to fully inform such important decisions."

They noted that "The observation that low-dose CT screening can reduce the rate of death from lung cancer has generated many questions." Among these they listed: Will populations with different risk profiles benefit from screening? Could less frequent screening programs be equally effective? Would the use of different criteria for a positive screening result translate to similar benefit? For how long should people be screened?

In an accompanying editorial, Dr. Harold C. Sox, professor of medicine at the Dartmouth Institute in Hanover, N. H., agreed with the investigators’ reservations. In particular, the cost effectiveness of low-dose CT screening for lung cancer must be analyzed, he said: "Policy makers should wait for cost-effectiveness analyses to determine the amount of overdiagnosis in the NLST, and, perhaps identification of biologic markers of cancers that do not progress."

In addition, "it may be possible to define subgroups of smokers who are at higher or lower risk for lung cancer and tailor the screening strategy accordingly," he said. "The findings of the NLST regarding lung-cancer mortality signal the beginning of the end of one era of research on lung-cancer screening and the start of another. The focus will shift to informing the difficult patient-centered and policy decisions that are yet to come."

Dr. Sox also noted that "overdiagnosis is a problem because predicting which early-stage cancers will not progress is in an early stage of development, so that everyone with screen-detected cancer receives treatment that some do not need," he wrote in an accompanying editorial (doi: 10.1056/NEJME1103776).

All but two of the NLST study authors reported that they have no relevant financial relationships. Jonathan D. Clap reported having financial interest in Human Genome Sciences. Constantine Gatsonis, Ph.D., is a consultant for Wilex AG, Mela Sciences, and Endocyte Inc., has received speaker fees from Bayer Health and payment for education development by the Radiologic Society of North America. He also has invested in the Vanguard Health Fund. Dr. Sox had no conflicts.

Final results from the National Lung Screening Trial show a significant reduction in lung cancer mortality with the use of annual low-dose CT screening, compared with standard chest x-rays among former heavy smokers at high risk for lung cancer.

Low-dose CT screening led to a relative reduction of 20% in the rate of death from lung cancer, according to findings released online by the New England Journal of Medicine on June 29 (doi: 10.1056/NEJMoa1102873).The number needed to screen with low-dose CT to prevent one death from lung cancer was 320.

Although preliminary study results were announced in November 2010, the article by the National Lung Screening Trial (NLST) research team marks the first time that the results appear in a peer-reviewed journal. Acknowledging that the earlier announcement has led to calls for lung cancer screening, the authors urge rigorous analysis of cost-effectiveness before public policy recommendations are made.

"The reduction in lung-cancer mortality must be weighed against the harms from positive screening results and overdiagnosis, as well as the costs," they wrote.

In the study, 53,454 men and women aged 55-74 years – who were current or former smokers with a smoking history of at least 30 pack-years – were recruited at 33 U.S. medical centers. A total of 26,722 participants were randomized to receive three annual screens with low-dose helical CT; 26,732 were randomized to three annual screens using chest x-ray. The two groups were virtually identical in demographics and smoking history.

In all three screening rounds, positive screening tests were substantially more common in the low-dose CT group than in the radiography group (27.3% vs. 9.2% in the first round; 27.9% vs. 6.2% in the second; and 16.8% vs. 5% in the third). All told, 39.1% of the CT group and 16% of the radiography group had at least one positive result.

The percentage of screening tests that identified a clinically significant abnormality -- other than an abnormality suspicious for lung cancer – also was more than three times as high in the low-dose CT group as in the radiography group (7.5% vs. 2.1%).

More than 90% of positive screenings in the first round of the study led to a diagnostic evaluation, though the follow-up rates were lower in the later rounds. Diagnostic evaluation most often consisted of additional imaging with invasive procedures being performed infrequently.

Across the three screenings, most of the positive results were false positives – 96.4% in the CT group and 94.5% in the radiography group. Of the total number of low-dose CT screening tests, 24.2% were classified as positive and 23.4% had false-positive results; of the total number of radiographic screening tests, 6.9% were classified as positive and 6.5% were false-positive results.

In all, 1,060 lung cancers were diagnosed in the low-dose CT group (645/100,000 person-years) vs. 941 in the radiography group (572/100,000 person-years). Of these cancers, 649 in the low-dose CT group were diagnosed after a positive screening test and 44 were diagnosed after a negative screening test. In the radiography group, 279 cancers were diagnosed after a positive screening test and 137 were diagnosed after a negative screening test.

In both groups, the remaining cases were among participants who missed screening or were diagnosed after their trial screening phase was over

Analysis of lung cancer-specific mortality showed that in the CT group 356 lung cancer deaths occurred after 144,103 person-years; in the radiography group 443 lung cancer deaths occurred after 143,368 person-years. This corresponded to 247 and 309 lung cancer deaths, respectively, per 100,000 person-years in the CT and radiography groups.

There were 1,877 and 2,000 deaths from all causes in the CT and radiography groups, respectively, "representing a significant reduction with low-dose CT screening of 6.7% ... in the rate of death from any cause," the investigators wrote. While lung cancer accounted for 24.1% of all the deaths in the trial, 60.3% of the excess deaths in the radiography group were due to lung cancer.

The authors concluded that "although some agencies and organizations are contemplating the establishment of lung-cancer screening recommendations on the basis of the findings of the NLST, the current NLST data alone are, in our opinion, insufficient to fully inform such important decisions."

They noted that "The observation that low-dose CT screening can reduce the rate of death from lung cancer has generated many questions." Among these they listed: Will populations with different risk profiles benefit from screening? Could less frequent screening programs be equally effective? Would the use of different criteria for a positive screening result translate to similar benefit? For how long should people be screened?

In an accompanying editorial, Dr. Harold C. Sox, professor of medicine at the Dartmouth Institute in Hanover, N. H., agreed with the investigators’ reservations. In particular, the cost effectiveness of low-dose CT screening for lung cancer must be analyzed, he said: "Policy makers should wait for cost-effectiveness analyses to determine the amount of overdiagnosis in the NLST, and, perhaps identification of biologic markers of cancers that do not progress."

In addition, "it may be possible to define subgroups of smokers who are at higher or lower risk for lung cancer and tailor the screening strategy accordingly," he said. "The findings of the NLST regarding lung-cancer mortality signal the beginning of the end of one era of research on lung-cancer screening and the start of another. The focus will shift to informing the difficult patient-centered and policy decisions that are yet to come."

Dr. Sox also noted that "overdiagnosis is a problem because predicting which early-stage cancers will not progress is in an early stage of development, so that everyone with screen-detected cancer receives treatment that some do not need," he wrote in an accompanying editorial (doi: 10.1056/NEJME1103776).

All but two of the NLST study authors reported that they have no relevant financial relationships. Jonathan D. Clap reported having financial interest in Human Genome Sciences. Constantine Gatsonis, Ph.D., is a consultant for Wilex AG, Mela Sciences, and Endocyte Inc., has received speaker fees from Bayer Health and payment for education development by the Radiologic Society of North America. He also has invested in the Vanguard Health Fund. Dr. Sox had no conflicts.

Final results from the National Lung Screening Trial show a significant reduction in lung cancer mortality with the use of annual low-dose CT screening, compared with standard chest x-rays among former heavy smokers at high risk for lung cancer.

Low-dose CT screening led to a relative reduction of 20% in the rate of death from lung cancer, according to findings released online by the New England Journal of Medicine on June 29 (doi: 10.1056/NEJMoa1102873).The number needed to screen with low-dose CT to prevent one death from lung cancer was 320.

Although preliminary study results were announced in November 2010, the article by the National Lung Screening Trial (NLST) research team marks the first time that the results appear in a peer-reviewed journal. Acknowledging that the earlier announcement has led to calls for lung cancer screening, the authors urge rigorous analysis of cost-effectiveness before public policy recommendations are made.

"The reduction in lung-cancer mortality must be weighed against the harms from positive screening results and overdiagnosis, as well as the costs," they wrote.

In the study, 53,454 men and women aged 55-74 years – who were current or former smokers with a smoking history of at least 30 pack-years – were recruited at 33 U.S. medical centers. A total of 26,722 participants were randomized to receive three annual screens with low-dose helical CT; 26,732 were randomized to three annual screens using chest x-ray. The two groups were virtually identical in demographics and smoking history.

In all three screening rounds, positive screening tests were substantially more common in the low-dose CT group than in the radiography group (27.3% vs. 9.2% in the first round; 27.9% vs. 6.2% in the second; and 16.8% vs. 5% in the third). All told, 39.1% of the CT group and 16% of the radiography group had at least one positive result.

The percentage of screening tests that identified a clinically significant abnormality -- other than an abnormality suspicious for lung cancer – also was more than three times as high in the low-dose CT group as in the radiography group (7.5% vs. 2.1%).

More than 90% of positive screenings in the first round of the study led to a diagnostic evaluation, though the follow-up rates were lower in the later rounds. Diagnostic evaluation most often consisted of additional imaging with invasive procedures being performed infrequently.

Across the three screenings, most of the positive results were false positives – 96.4% in the CT group and 94.5% in the radiography group. Of the total number of low-dose CT screening tests, 24.2% were classified as positive and 23.4% had false-positive results; of the total number of radiographic screening tests, 6.9% were classified as positive and 6.5% were false-positive results.

In all, 1,060 lung cancers were diagnosed in the low-dose CT group (645/100,000 person-years) vs. 941 in the radiography group (572/100,000 person-years). Of these cancers, 649 in the low-dose CT group were diagnosed after a positive screening test and 44 were diagnosed after a negative screening test. In the radiography group, 279 cancers were diagnosed after a positive screening test and 137 were diagnosed after a negative screening test.

In both groups, the remaining cases were among participants who missed screening or were diagnosed after their trial screening phase was over

Analysis of lung cancer-specific mortality showed that in the CT group 356 lung cancer deaths occurred after 144,103 person-years; in the radiography group 443 lung cancer deaths occurred after 143,368 person-years. This corresponded to 247 and 309 lung cancer deaths, respectively, per 100,000 person-years in the CT and radiography groups.

There were 1,877 and 2,000 deaths from all causes in the CT and radiography groups, respectively, "representing a significant reduction with low-dose CT screening of 6.7% ... in the rate of death from any cause," the investigators wrote. While lung cancer accounted for 24.1% of all the deaths in the trial, 60.3% of the excess deaths in the radiography group were due to lung cancer.

The authors concluded that "although some agencies and organizations are contemplating the establishment of lung-cancer screening recommendations on the basis of the findings of the NLST, the current NLST data alone are, in our opinion, insufficient to fully inform such important decisions."

They noted that "The observation that low-dose CT screening can reduce the rate of death from lung cancer has generated many questions." Among these they listed: Will populations with different risk profiles benefit from screening? Could less frequent screening programs be equally effective? Would the use of different criteria for a positive screening result translate to similar benefit? For how long should people be screened?

In an accompanying editorial, Dr. Harold C. Sox, professor of medicine at the Dartmouth Institute in Hanover, N. H., agreed with the investigators’ reservations. In particular, the cost effectiveness of low-dose CT screening for lung cancer must be analyzed, he said: "Policy makers should wait for cost-effectiveness analyses to determine the amount of overdiagnosis in the NLST, and, perhaps identification of biologic markers of cancers that do not progress."

In addition, "it may be possible to define subgroups of smokers who are at higher or lower risk for lung cancer and tailor the screening strategy accordingly," he said. "The findings of the NLST regarding lung-cancer mortality signal the beginning of the end of one era of research on lung-cancer screening and the start of another. The focus will shift to informing the difficult patient-centered and policy decisions that are yet to come."

Dr. Sox also noted that "overdiagnosis is a problem because predicting which early-stage cancers will not progress is in an early stage of development, so that everyone with screen-detected cancer receives treatment that some do not need," he wrote in an accompanying editorial (doi: 10.1056/NEJME1103776).

All but two of the NLST study authors reported that they have no relevant financial relationships. Jonathan D. Clap reported having financial interest in Human Genome Sciences. Constantine Gatsonis, Ph.D., is a consultant for Wilex AG, Mela Sciences, and Endocyte Inc., has received speaker fees from Bayer Health and payment for education development by the Radiologic Society of North America. He also has invested in the Vanguard Health Fund. Dr. Sox had no conflicts.

Final results from the National Lung Screening Trial show a significant reduction in lung cancer mortality with the use of annual low-dose CT screening, compared with standard chest x-rays among former heavy smokers at high risk for lung cancer.

Low-dose CT screening led to a relative reduction of 20% in the rate of death from lung cancer, according to findings released online by the New England Journal of Medicine on June 29 (doi: 10.1056/NEJMoa1102873).The number needed to screen with low-dose CT to prevent one death from lung cancer was 320.

Although preliminary study results were announced in November 2010, the article by the National Lung Screening Trial (NLST) research team marks the first time that the results appear in a peer-reviewed journal. Acknowledging that the earlier announcement has led to calls for lung cancer screening, the authors urge rigorous analysis of cost-effectiveness before public policy recommendations are made.

"The reduction in lung-cancer mortality must be weighed against the harms from positive screening results and overdiagnosis, as well as the costs," they wrote.

In the study, 53,454 men and women aged 55-74 years – who were current or former smokers with a smoking history of at least 30 pack-years – were recruited at 33 U.S. medical centers. A total of 26,722 participants were randomized to receive three annual screens with low-dose helical CT; 26,732 were randomized to three annual screens using chest x-ray. The two groups were virtually identical in demographics and smoking history.

In all three screening rounds, positive screening tests were substantially more common in the low-dose CT group than in the radiography group (27.3% vs. 9.2% in the first round; 27.9% vs. 6.2% in the second; and 16.8% vs. 5% in the third). All told, 39.1% of the CT group and 16% of the radiography group had at least one positive result.

The percentage of screening tests that identified a clinically significant abnormality -- other than an abnormality suspicious for lung cancer – also was more than three times as high in the low-dose CT group as in the radiography group (7.5% vs. 2.1%).

More than 90% of positive screenings in the first round of the study led to a diagnostic evaluation, though the follow-up rates were lower in the later rounds. Diagnostic evaluation most often consisted of additional imaging with invasive procedures being performed infrequently.

Across the three screenings, most of the positive results were false positives – 96.4% in the CT group and 94.5% in the radiography group. Of the total number of low-dose CT screening tests, 24.2% were classified as positive and 23.4% had false-positive results; of the total number of radiographic screening tests, 6.9% were classified as positive and 6.5% were false-positive results.

In all, 1,060 lung cancers were diagnosed in the low-dose CT group (645/100,000 person-years) vs. 941 in the radiography group (572/100,000 person-years). Of these cancers, 649 in the low-dose CT group were diagnosed after a positive screening test and 44 were diagnosed after a negative screening test. In the radiography group, 279 cancers were diagnosed after a positive screening test and 137 were diagnosed after a negative screening test.

In both groups, the remaining cases were among participants who missed screening or were diagnosed after their trial screening phase was over

Analysis of lung cancer-specific mortality showed that in the CT group 356 lung cancer deaths occurred after 144,103 person-years; in the radiography group 443 lung cancer deaths occurred after 143,368 person-years. This corresponded to 247 and 309 lung cancer deaths, respectively, per 100,000 person-years in the CT and radiography groups.

There were 1,877 and 2,000 deaths from all causes in the CT and radiography groups, respectively, "representing a significant reduction with low-dose CT screening of 6.7% ... in the rate of death from any cause," the investigators wrote. While lung cancer accounted for 24.1% of all the deaths in the trial, 60.3% of the excess deaths in the radiography group were due to lung cancer.

The authors concluded that "although some agencies and organizations are contemplating the establishment of lung-cancer screening recommendations on the basis of the findings of the NLST, the current NLST data alone are, in our opinion, insufficient to fully inform such important decisions."

They noted that "The observation that low-dose CT screening can reduce the rate of death from lung cancer has generated many questions." Among these they listed: Will populations with different risk profiles benefit from screening? Could less frequent screening programs be equally effective? Would the use of different criteria for a positive screening result translate to similar benefit? For how long should people be screened?

In an accompanying editorial, Dr. Harold C. Sox, professor of medicine at the Dartmouth Institute in Hanover, N. H., agreed with the investigators’ reservations. In particular, the cost effectiveness of low-dose CT screening for lung cancer must be analyzed, he said: "Policy makers should wait for cost-effectiveness analyses to determine the amount of overdiagnosis in the NLST, and, perhaps identification of biologic markers of cancers that do not progress."

In addition, "it may be possible to define subgroups of smokers who are at higher or lower risk for lung cancer and tailor the screening strategy accordingly," he said. "The findings of the NLST regarding lung-cancer mortality signal the beginning of the end of one era of research on lung-cancer screening and the start of another. The focus will shift to informing the difficult patient-centered and policy decisions that are yet to come."

Dr. Sox also noted that "overdiagnosis is a problem because predicting which early-stage cancers will not progress is in an early stage of development, so that everyone with screen-detected cancer receives treatment that some do not need," he wrote in an accompanying editorial (doi: 10.1056/NEJME1103776).

All but two of the NLST study authors reported that they have no relevant financial relationships. Jonathan D. Clap reported having financial interest in Human Genome Sciences. Constantine Gatsonis, Ph.D., is a consultant for Wilex AG, Mela Sciences, and Endocyte Inc., has received speaker fees from Bayer Health and payment for education development by the Radiologic Society of North America. He also has invested in the Vanguard Health Fund. Dr. Sox had no conflicts.

Final results from the National Lung Screening Trial show a significant reduction in lung cancer mortality with the use of annual low-dose CT screening, compared with standard chest x-rays among former heavy smokers at high risk for lung cancer.

Low-dose CT screening led to a relative reduction of 20% in the rate of death from lung cancer, according to findings released online by the New England Journal of Medicine on June 29 (doi: 10.1056/NEJMoa1102873).The number needed to screen with low-dose CT to prevent one death from lung cancer was 320.

Although preliminary study results were announced in November 2010, the article by the National Lung Screening Trial (NLST) research team marks the first time that the results appear in a peer-reviewed journal. Acknowledging that the earlier announcement has led to calls for lung cancer screening, the authors urge rigorous analysis of cost-effectiveness before public policy recommendations are made.

"The reduction in lung-cancer mortality must be weighed against the harms from positive screening results and overdiagnosis, as well as the costs," they wrote.

In the study, 53,454 men and women aged 55-74 years – who were current or former smokers with a smoking history of at least 30 pack-years – were recruited at 33 U.S. medical centers. A total of 26,722 participants were randomized to receive three annual screens with low-dose helical CT; 26,732 were randomized to three annual screens using chest x-ray. The two groups were virtually identical in demographics and smoking history.

In all three screening rounds, positive screening tests were substantially more common in the low-dose CT group than in the radiography group (27.3% vs. 9.2% in the first round; 27.9% vs. 6.2% in the second; and 16.8% vs. 5% in the third). All told, 39.1% of the CT group and 16% of the radiography group had at least one positive result.

The percentage of screening tests that identified a clinically significant abnormality -- other than an abnormality suspicious for lung cancer – also was more than three times as high in the low-dose CT group as in the radiography group (7.5% vs. 2.1%).

More than 90% of positive screenings in the first round of the study led to a diagnostic evaluation, though the follow-up rates were lower in the later rounds. Diagnostic evaluation most often consisted of additional imaging with invasive procedures being performed infrequently.

Across the three screenings, most of the positive results were false positives – 96.4% in the CT group and 94.5% in the radiography group. Of the total number of low-dose CT screening tests, 24.2% were classified as positive and 23.4% had false-positive results; of the total number of radiographic screening tests, 6.9% were classified as positive and 6.5% were false-positive results.

In all, 1,060 lung cancers were diagnosed in the low-dose CT group (645/100,000 person-years) vs. 941 in the radiography group (572/100,000 person-years). Of these cancers, 649 in the low-dose CT group were diagnosed after a positive screening test and 44 were diagnosed after a negative screening test. In the radiography group, 279 cancers were diagnosed after a positive screening test and 137 were diagnosed after a negative screening test.

In both groups, the remaining cases were among participants who missed screening or were diagnosed after their trial screening phase was over

Analysis of lung cancer-specific mortality showed that in the CT group 356 lung cancer deaths occurred after 144,103 person-years; in the radiography group 443 lung cancer deaths occurred after 143,368 person-years. This corresponded to 247 and 309 lung cancer deaths, respectively, per 100,000 person-years in the CT and radiography groups.

There were 1,877 and 2,000 deaths from all causes in the CT and radiography groups, respectively, "representing a significant reduction with low-dose CT screening of 6.7% ... in the rate of death from any cause," the investigators wrote. While lung cancer accounted for 24.1% of all the deaths in the trial, 60.3% of the excess deaths in the radiography group were due to lung cancer.

The authors concluded that "although some agencies and organizations are contemplating the establishment of lung-cancer screening recommendations on the basis of the findings of the NLST, the current NLST data alone are, in our opinion, insufficient to fully inform such important decisions."

They noted that "The observation that low-dose CT screening can reduce the rate of death from lung cancer has generated many questions." Among these they listed: Will populations with different risk profiles benefit from screening? Could less frequent screening programs be equally effective? Would the use of different criteria for a positive screening result translate to similar benefit? For how long should people be screened?

In an accompanying editorial, Dr. Harold C. Sox, professor of medicine at the Dartmouth Institute in Hanover, N. H., agreed with the investigators’ reservations. In particular, the cost effectiveness of low-dose CT screening for lung cancer must be analyzed, he said: "Policy makers should wait for cost-effectiveness analyses to determine the amount of overdiagnosis in the NLST, and, perhaps identification of biologic markers of cancers that do not progress."

In addition, "it may be possible to define subgroups of smokers who are at higher or lower risk for lung cancer and tailor the screening strategy accordingly," he said. "The findings of the NLST regarding lung-cancer mortality signal the beginning of the end of one era of research on lung-cancer screening and the start of another. The focus will shift to informing the difficult patient-centered and policy decisions that are yet to come."

Dr. Sox also noted that "overdiagnosis is a problem because predicting which early-stage cancers will not progress is in an early stage of development, so that everyone with screen-detected cancer receives treatment that some do not need," he wrote in an accompanying editorial (doi: 10.1056/NEJME1103776).

All but two of the NLST study authors reported that they have no relevant financial relationships. Jonathan D. Clap reported having financial interest in Human Genome Sciences. Constantine Gatsonis, Ph.D., is a consultant for Wilex AG, Mela Sciences, and Endocyte Inc., has received speaker fees from Bayer Health and payment for education development by the Radiologic Society of North America. He also has invested in the Vanguard Health Fund. Dr. Sox had no conflicts.

The Food and Drug Administration has approved LaVív, a product offering a novel approach to treating moderate to severe nasolabial folds in adults through autologous cell therapy.

The patented technology includes an advanced process that uses a patient's own fibroblasts to treat smile lines. The cells are cultured, and then injected into the patient.

The FDA approved the Fibrocell Sciences' Biologics License Application for its lead product, LaVív (azficel-T) this month (June 2011). In clinical trials, the product was well tolerated. The majority of adverse events were injection-site reactions that were generally mild to moderate in intensity and resolved within 1 week.

LaVív is expected to be available through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians are trained, the number of cities served will expand as well, according to a company statement.

Small fibroblast samples are taken from behind the patient's ear and sent to Fibrocell's laboratory. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment. The recommended course of LaVív administration is a series of three treatments, typically 3-6 weeks apart.

Additional information about LaVív is available at www.mylaviv.com.

The Food and Drug Administration has approved LaVív, a product offering a novel approach to treating moderate to severe nasolabial folds in adults through autologous cell therapy.

The patented technology includes an advanced process that uses a patient's own fibroblasts to treat smile lines. The cells are cultured, and then injected into the patient.

The FDA approved the Fibrocell Sciences' Biologics License Application for its lead product, LaVív (azficel-T) this month (June 2011). In clinical trials, the product was well tolerated. The majority of adverse events were injection-site reactions that were generally mild to moderate in intensity and resolved within 1 week.

LaVív is expected to be available through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians are trained, the number of cities served will expand as well, according to a company statement.

Small fibroblast samples are taken from behind the patient's ear and sent to Fibrocell's laboratory. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment. The recommended course of LaVív administration is a series of three treatments, typically 3-6 weeks apart.

Additional information about LaVív is available at www.mylaviv.com.

The Food and Drug Administration has approved LaVív, a product offering a novel approach to treating moderate to severe nasolabial folds in adults through autologous cell therapy.

The patented technology includes an advanced process that uses a patient's own fibroblasts to treat smile lines. The cells are cultured, and then injected into the patient.

The FDA approved the Fibrocell Sciences' Biologics License Application for its lead product, LaVív (azficel-T) this month (June 2011). In clinical trials, the product was well tolerated. The majority of adverse events were injection-site reactions that were generally mild to moderate in intensity and resolved within 1 week.

LaVív is expected to be available through trained clinical investigators in select metropolitan areas. As manufacturing capacity is increased and more physicians are trained, the number of cities served will expand as well, according to a company statement.

Small fibroblast samples are taken from behind the patient's ear and sent to Fibrocell's laboratory. Over a period of approximately 90 days, hundreds of millions of fibroblasts are cultured and then frozen until needed for treatment. The recommended course of LaVív administration is a series of three treatments, typically 3-6 weeks apart.

Additional information about LaVív is available at www.mylaviv.com.