SAN FRANCISCO—Unlike its predecessors, a new prognostic model suggests race and histology are important predictors of outcome in patients with peripheral T-cell lymphoma (PTCL).

Researchers analyzed nearly 9000 patients diagnosed with PTCL in the US and found evidence to suggest that patient age and race, as well as histology and disease stage can be used to predict overall survival (OS).

The group’s findings also suggested the use of radiation is associated with improved OS. And later diagnosis may be associated with favorable outcome.

Adam M. Petrich, MD, of Northwestern University in Chicago, presented this research at the 6th Annual T-cell Lymphoma Forum, which took place January 23-25. Dr Petrich was 1 of 2 speakers to receive a Young Investigator Award for his presentation.

Dr Petrich noted that at least 5 models have been used to predict outcomes in patients with newly diagnosed PTCL—the International Prognostic Index (IPI), the Prognostic Index for PTCL (PIT), the International PTCL Project model (IPTCLP), the modified Prognostic Index for T-cell Lymphoma (mPIT), and the Extranodal Natural Killer/T Cell Lymphoma (ENKTL) model.

But these models have limitations, including small patient numbers and issues with applicability. So Dr Petrich and his colleagues wanted to take a closer look at prognostic factors in PTCL, to determine which factors from previously published models remain relevant.

Patient characteristics

The researchers used data from the SEER database, which included 20 state and local registries and captured 28% of the US population. There were 8802 cases of PTCL diagnosed between 2000 and 2010.

Patients ranged in age from 20 to 85 years, and 59% were male. With regard to race, 77% of patients were white, 13% were black, 9% were classified as “other,” and 1% were of unknown race.

Forty-eight percent of patients had stage I-II disease, 31% had stage III-IV, and the stage was unknown for 21% of patients. Extranodal disease was absent in 60% of patients, present in 26%, and unknown in 14%.

Histologies were as follows:

• 38.1% of patients had PTCL-not otherwise specified (PTCL-NOS)
• 24.2% had anaplastic large-cell lymphoma (ALCL)
• 12.7% had angioimmunoblastic T-cell lymphoma (AITL)
• 9.3% had adult T-cell leukemia/lymphoma (ATLL)
• 6.9% had extranodal NK/T-cell lymphoma (ENKTL)
• 3.2% had T-cell-prolymphocytic leukemia(T-PLL)
• 2.5% had T-cell large granular lymphocytic leukemia (T-LGL)
• 1.2% had subcutaneous panniculitis-like T-cell lymphoma (SCPTCL)
• 1.1% had enteropathy-associated T-cell lymphoma (EATL)
• 0.6% had hepatosplenic T-cell lymphoma (HSTL).

Prognostic factors revealed

The researchers performed univariate and multivariate analyses to determine the importance of the aforementioned factors on OS.

“We decided, since we have a large number of patients, to use a very stringent P value,” Dr Petrich said. “Only those that are less than 0.0001 were considered significant.”

In univariate analysis, age, race, disease stage, extranodal disease, use of radiation, and histology all significantly impacted OS. But in multivariate analysis, only race, age, histology, and disease stage retained significance.

“Extranodal disease is associated with protection from overall survival, but that P value did not reach significance (P=0.009),” Dr Petrich said.

Likewise, patients diagnosed from 2009 to 2010 had better OS than patients diagnosed from 2000 to 2008, but this did not meet the significance criterion (P=0.0002).

On the other hand, OS was significantly worse for black patients compared to white patients. And compared to patients aged 20-24, those 55 years of age and older had a significantly increased risk of death.

Compared to patients with PTCL-NOS, those with EATL, ENKTL, and T-LGL all had significantly worse OS. And patients with advanced-stage disease had significantly worse OS.

The researchers also looked at the use of radiation and found that it had a significant impact on survival.

“Of course, this isn’t a pre-treatment variable, but we did add it as sort of an exploratory analysis,” Dr Petrich said. “And regardless of disease stage, [radiation] seems to be associated with improved survival. But when we include it in a multivariate analysis, it’s also highly associated with protection from 5-year mortality (P<0.0001).”

Creating, validating the prognostic model

Dr Petrich and his colleagues created a prognostic model based on some of the aforementioned factors. They assigned points according to hazard ratios (HRs).

Patients received 1 point for each of the following factors: age 55 or older (HR 1.51), black race (HR 1.43), distant-stage disease (HR 1.79), PTCL-NOS (reference), AITL (HR 1.19), ALCL (HR 0.88), and ATLL (HR 1.34).

Patients received 2 points for each of the following histologies: HSTL (HR 1.76), EATL (HR 2.32), ENKTL (HR 1.50), and T-PLL (HR couldn’t be calculated). And they received 0 points for SCPTL (HR 0.71) and T-LGL (HR 0.43).

The researchers then applied the model to the population of 8802 patients and evaluated survival. The median OS was more than 120 months for patients with a score of 0-1, 36 months for those with a score of 2, 14 months for those with a score of 3, and 9 months for those with score of 4 or 5.

“We have good discrimination of outcome based on this scoring system, with patients with the most favorable prognosis having median survival that’s out over 10 years,” Dr Petrich said.

The researchers also obtained good discrimination when they tested the model in a validation cohort of 112 patients, Dr Petrich said. He noted, however, that validating the model with a larger patient population would provide better results.

He also pointed out that this study had its limitations, such as missing data and a lack of uniformity with regard to treatment. But the research does reveal factors that are likely important prognostic indicators in PTCL.

SAN FRANCISCO—Unlike its predecessors, a new prognostic model suggests race and histology are important predictors of outcome in patients with peripheral T-cell lymphoma (PTCL).

Researchers analyzed nearly 9000 patients diagnosed with PTCL in the US and found evidence to suggest that patient age and race, as well as histology and disease stage can be used to predict overall survival (OS).

The group’s findings also suggested the use of radiation is associated with improved OS. And later diagnosis may be associated with favorable outcome.

Adam M. Petrich, MD, of Northwestern University in Chicago, presented this research at the 6th Annual T-cell Lymphoma Forum, which took place January 23-25. Dr Petrich was 1 of 2 speakers to receive a Young Investigator Award for his presentation.

Dr Petrich noted that at least 5 models have been used to predict outcomes in patients with newly diagnosed PTCL—the International Prognostic Index (IPI), the Prognostic Index for PTCL (PIT), the International PTCL Project model (IPTCLP), the modified Prognostic Index for T-cell Lymphoma (mPIT), and the Extranodal Natural Killer/T Cell Lymphoma (ENKTL) model.

But these models have limitations, including small patient numbers and issues with applicability. So Dr Petrich and his colleagues wanted to take a closer look at prognostic factors in PTCL, to determine which factors from previously published models remain relevant.

Patient characteristics

The researchers used data from the SEER database, which included 20 state and local registries and captured 28% of the US population. There were 8802 cases of PTCL diagnosed between 2000 and 2010.

Patients ranged in age from 20 to 85 years, and 59% were male. With regard to race, 77% of patients were white, 13% were black, 9% were classified as “other,” and 1% were of unknown race.

Forty-eight percent of patients had stage I-II disease, 31% had stage III-IV, and the stage was unknown for 21% of patients. Extranodal disease was absent in 60% of patients, present in 26%, and unknown in 14%.

Histologies were as follows:

• 38.1% of patients had PTCL-not otherwise specified (PTCL-NOS)
• 24.2% had anaplastic large-cell lymphoma (ALCL)
• 12.7% had angioimmunoblastic T-cell lymphoma (AITL)
• 9.3% had adult T-cell leukemia/lymphoma (ATLL)
• 6.9% had extranodal NK/T-cell lymphoma (ENKTL)
• 3.2% had T-cell-prolymphocytic leukemia(T-PLL)
• 2.5% had T-cell large granular lymphocytic leukemia (T-LGL)
• 1.2% had subcutaneous panniculitis-like T-cell lymphoma (SCPTCL)
• 1.1% had enteropathy-associated T-cell lymphoma (EATL)
• 0.6% had hepatosplenic T-cell lymphoma (HSTL).

Prognostic factors revealed

The researchers performed univariate and multivariate analyses to determine the importance of the aforementioned factors on OS.

“We decided, since we have a large number of patients, to use a very stringent P value,” Dr Petrich said. “Only those that are less than 0.0001 were considered significant.”

In univariate analysis, age, race, disease stage, extranodal disease, use of radiation, and histology all significantly impacted OS. But in multivariate analysis, only race, age, histology, and disease stage retained significance.

“Extranodal disease is associated with protection from overall survival, but that P value did not reach significance (P=0.009),” Dr Petrich said.

Likewise, patients diagnosed from 2009 to 2010 had better OS than patients diagnosed from 2000 to 2008, but this did not meet the significance criterion (P=0.0002).

On the other hand, OS was significantly worse for black patients compared to white patients. And compared to patients aged 20-24, those 55 years of age and older had a significantly increased risk of death.

Compared to patients with PTCL-NOS, those with EATL, ENKTL, and T-LGL all had significantly worse OS. And patients with advanced-stage disease had significantly worse OS.

The researchers also looked at the use of radiation and found that it had a significant impact on survival.

“Of course, this isn’t a pre-treatment variable, but we did add it as sort of an exploratory analysis,” Dr Petrich said. “And regardless of disease stage, [radiation] seems to be associated with improved survival. But when we include it in a multivariate analysis, it’s also highly associated with protection from 5-year mortality (P<0.0001).”

Creating, validating the prognostic model

Dr Petrich and his colleagues created a prognostic model based on some of the aforementioned factors. They assigned points according to hazard ratios (HRs).

Patients received 1 point for each of the following factors: age 55 or older (HR 1.51), black race (HR 1.43), distant-stage disease (HR 1.79), PTCL-NOS (reference), AITL (HR 1.19), ALCL (HR 0.88), and ATLL (HR 1.34).

Patients received 2 points for each of the following histologies: HSTL (HR 1.76), EATL (HR 2.32), ENKTL (HR 1.50), and T-PLL (HR couldn’t be calculated). And they received 0 points for SCPTL (HR 0.71) and T-LGL (HR 0.43).

The researchers then applied the model to the population of 8802 patients and evaluated survival. The median OS was more than 120 months for patients with a score of 0-1, 36 months for those with a score of 2, 14 months for those with a score of 3, and 9 months for those with score of 4 or 5.

“We have good discrimination of outcome based on this scoring system, with patients with the most favorable prognosis having median survival that’s out over 10 years,” Dr Petrich said.

The researchers also obtained good discrimination when they tested the model in a validation cohort of 112 patients, Dr Petrich said. He noted, however, that validating the model with a larger patient population would provide better results.

He also pointed out that this study had its limitations, such as missing data and a lack of uniformity with regard to treatment. But the research does reveal factors that are likely important prognostic indicators in PTCL.

SAN FRANCISCO—Unlike its predecessors, a new prognostic model suggests race and histology are important predictors of outcome in patients with peripheral T-cell lymphoma (PTCL).

Researchers analyzed nearly 9000 patients diagnosed with PTCL in the US and found evidence to suggest that patient age and race, as well as histology and disease stage can be used to predict overall survival (OS).

The group’s findings also suggested the use of radiation is associated with improved OS. And later diagnosis may be associated with favorable outcome.

Adam M. Petrich, MD, of Northwestern University in Chicago, presented this research at the 6th Annual T-cell Lymphoma Forum, which took place January 23-25. Dr Petrich was 1 of 2 speakers to receive a Young Investigator Award for his presentation.

Dr Petrich noted that at least 5 models have been used to predict outcomes in patients with newly diagnosed PTCL—the International Prognostic Index (IPI), the Prognostic Index for PTCL (PIT), the International PTCL Project model (IPTCLP), the modified Prognostic Index for T-cell Lymphoma (mPIT), and the Extranodal Natural Killer/T Cell Lymphoma (ENKTL) model.

But these models have limitations, including small patient numbers and issues with applicability. So Dr Petrich and his colleagues wanted to take a closer look at prognostic factors in PTCL, to determine which factors from previously published models remain relevant.

Patient characteristics

The researchers used data from the SEER database, which included 20 state and local registries and captured 28% of the US population. There were 8802 cases of PTCL diagnosed between 2000 and 2010.

Patients ranged in age from 20 to 85 years, and 59% were male. With regard to race, 77% of patients were white, 13% were black, 9% were classified as “other,” and 1% were of unknown race.

Forty-eight percent of patients had stage I-II disease, 31% had stage III-IV, and the stage was unknown for 21% of patients. Extranodal disease was absent in 60% of patients, present in 26%, and unknown in 14%.

Histologies were as follows:

• 38.1% of patients had PTCL-not otherwise specified (PTCL-NOS)
• 24.2% had anaplastic large-cell lymphoma (ALCL)
• 12.7% had angioimmunoblastic T-cell lymphoma (AITL)
• 9.3% had adult T-cell leukemia/lymphoma (ATLL)
• 6.9% had extranodal NK/T-cell lymphoma (ENKTL)
• 3.2% had T-cell-prolymphocytic leukemia(T-PLL)
• 2.5% had T-cell large granular lymphocytic leukemia (T-LGL)
• 1.2% had subcutaneous panniculitis-like T-cell lymphoma (SCPTCL)
• 1.1% had enteropathy-associated T-cell lymphoma (EATL)
• 0.6% had hepatosplenic T-cell lymphoma (HSTL).

Prognostic factors revealed

The researchers performed univariate and multivariate analyses to determine the importance of the aforementioned factors on OS.

“We decided, since we have a large number of patients, to use a very stringent P value,” Dr Petrich said. “Only those that are less than 0.0001 were considered significant.”

In univariate analysis, age, race, disease stage, extranodal disease, use of radiation, and histology all significantly impacted OS. But in multivariate analysis, only race, age, histology, and disease stage retained significance.

“Extranodal disease is associated with protection from overall survival, but that P value did not reach significance (P=0.009),” Dr Petrich said.

Likewise, patients diagnosed from 2009 to 2010 had better OS than patients diagnosed from 2000 to 2008, but this did not meet the significance criterion (P=0.0002).

On the other hand, OS was significantly worse for black patients compared to white patients. And compared to patients aged 20-24, those 55 years of age and older had a significantly increased risk of death.

Compared to patients with PTCL-NOS, those with EATL, ENKTL, and T-LGL all had significantly worse OS. And patients with advanced-stage disease had significantly worse OS.

The researchers also looked at the use of radiation and found that it had a significant impact on survival.

“Of course, this isn’t a pre-treatment variable, but we did add it as sort of an exploratory analysis,” Dr Petrich said. “And regardless of disease stage, [radiation] seems to be associated with improved survival. But when we include it in a multivariate analysis, it’s also highly associated with protection from 5-year mortality (P<0.0001).”

Creating, validating the prognostic model

Dr Petrich and his colleagues created a prognostic model based on some of the aforementioned factors. They assigned points according to hazard ratios (HRs).

Patients received 1 point for each of the following factors: age 55 or older (HR 1.51), black race (HR 1.43), distant-stage disease (HR 1.79), PTCL-NOS (reference), AITL (HR 1.19), ALCL (HR 0.88), and ATLL (HR 1.34).

Patients received 2 points for each of the following histologies: HSTL (HR 1.76), EATL (HR 2.32), ENKTL (HR 1.50), and T-PLL (HR couldn’t be calculated). And they received 0 points for SCPTL (HR 0.71) and T-LGL (HR 0.43).

The researchers then applied the model to the population of 8802 patients and evaluated survival. The median OS was more than 120 months for patients with a score of 0-1, 36 months for those with a score of 2, 14 months for those with a score of 3, and 9 months for those with score of 4 or 5.

“We have good discrimination of outcome based on this scoring system, with patients with the most favorable prognosis having median survival that’s out over 10 years,” Dr Petrich said.

The researchers also obtained good discrimination when they tested the model in a validation cohort of 112 patients, Dr Petrich said. He noted, however, that validating the model with a larger patient population would provide better results.

He also pointed out that this study had its limitations, such as missing data and a lack of uniformity with regard to treatment. But the research does reveal factors that are likely important prognostic indicators in PTCL.

HSCs in the bone marrow

Scientists have long thought that hematopoietic stem cells (HSCs) are regulated similarly in males and females.

But research conducted in mice has shown that HSCs exhibit sex differences in cell-cycle regulation.

The researchers discovered that HSCs in female mice divided significantly more frequently than HSCs in male mice, and this appeared to be driven by estrogen.

Sean Morrison, PhD, of UT Southwestern Medical Center in Dallas, and his colleagues detailed these discoveries in a letter to Nature.

The research suggested that differences in HSC division depend on the ovaries and not the testes. When the investigators administered estradiol, a hormone produced mainly in the ovaries, to male and female mice, HSC division increased in both sexes.

And experiments in pregnant mice highlighted the importance of estrogen in HSC activity. Estrogen levels increased during pregnancy, which increased HSC division, HSC frequency, cellularity, and erythropoiesis in the spleen.

“Elevated estrogen levels that are sustained during pregnancy induce stem cell mobilization and red cell production in the spleen, which serves as a reserve site for additional red blood cell production,” Dr Morrison said.

He and his colleagues also found that HSCs expressed high levels of estrogen receptor-alpha. And deleting the receptor reduced HSC division in female mice but not in males.

In pregnant mice, deleting the receptor attenuated the previously observed increases in HSC division, HSC frequency, and erythropoiesis.

These results suggest estrogen acts directly on HSCs to increase their proliferation and the number of red blood cells they generate.

“If estrogen has the same effect on stem cells in humans as in mice, then this effect raises a number of possibilities that could change the way we treat people with diseases of blood cell formation,” Dr Morrison said.

“Can we promote regeneration in the blood-forming system by administering estrogen? Can we reduce the toxicity of chemotherapy to the blood-forming system by taking into account estrogen levels in female patients? Does estrogen promote the growth of some blood cancers? There are numerous clinical opportunities to pursue.”

HSCs in the bone marrow

Scientists have long thought that hematopoietic stem cells (HSCs) are regulated similarly in males and females.

But research conducted in mice has shown that HSCs exhibit sex differences in cell-cycle regulation.

The researchers discovered that HSCs in female mice divided significantly more frequently than HSCs in male mice, and this appeared to be driven by estrogen.

Sean Morrison, PhD, of UT Southwestern Medical Center in Dallas, and his colleagues detailed these discoveries in a letter to Nature.

The research suggested that differences in HSC division depend on the ovaries and not the testes. When the investigators administered estradiol, a hormone produced mainly in the ovaries, to male and female mice, HSC division increased in both sexes.

And experiments in pregnant mice highlighted the importance of estrogen in HSC activity. Estrogen levels increased during pregnancy, which increased HSC division, HSC frequency, cellularity, and erythropoiesis in the spleen.

“Elevated estrogen levels that are sustained during pregnancy induce stem cell mobilization and red cell production in the spleen, which serves as a reserve site for additional red blood cell production,” Dr Morrison said.

He and his colleagues also found that HSCs expressed high levels of estrogen receptor-alpha. And deleting the receptor reduced HSC division in female mice but not in males.

In pregnant mice, deleting the receptor attenuated the previously observed increases in HSC division, HSC frequency, and erythropoiesis.

These results suggest estrogen acts directly on HSCs to increase their proliferation and the number of red blood cells they generate.

“If estrogen has the same effect on stem cells in humans as in mice, then this effect raises a number of possibilities that could change the way we treat people with diseases of blood cell formation,” Dr Morrison said.

“Can we promote regeneration in the blood-forming system by administering estrogen? Can we reduce the toxicity of chemotherapy to the blood-forming system by taking into account estrogen levels in female patients? Does estrogen promote the growth of some blood cancers? There are numerous clinical opportunities to pursue.”

HSCs in the bone marrow

Scientists have long thought that hematopoietic stem cells (HSCs) are regulated similarly in males and females.

But research conducted in mice has shown that HSCs exhibit sex differences in cell-cycle regulation.

The researchers discovered that HSCs in female mice divided significantly more frequently than HSCs in male mice, and this appeared to be driven by estrogen.

Sean Morrison, PhD, of UT Southwestern Medical Center in Dallas, and his colleagues detailed these discoveries in a letter to Nature.

The research suggested that differences in HSC division depend on the ovaries and not the testes. When the investigators administered estradiol, a hormone produced mainly in the ovaries, to male and female mice, HSC division increased in both sexes.

And experiments in pregnant mice highlighted the importance of estrogen in HSC activity. Estrogen levels increased during pregnancy, which increased HSC division, HSC frequency, cellularity, and erythropoiesis in the spleen.

“Elevated estrogen levels that are sustained during pregnancy induce stem cell mobilization and red cell production in the spleen, which serves as a reserve site for additional red blood cell production,” Dr Morrison said.

He and his colleagues also found that HSCs expressed high levels of estrogen receptor-alpha. And deleting the receptor reduced HSC division in female mice but not in males.

In pregnant mice, deleting the receptor attenuated the previously observed increases in HSC division, HSC frequency, and erythropoiesis.

These results suggest estrogen acts directly on HSCs to increase their proliferation and the number of red blood cells they generate.

“If estrogen has the same effect on stem cells in humans as in mice, then this effect raises a number of possibilities that could change the way we treat people with diseases of blood cell formation,” Dr Morrison said.

“Can we promote regeneration in the blood-forming system by administering estrogen? Can we reduce the toxicity of chemotherapy to the blood-forming system by taking into account estrogen levels in female patients? Does estrogen promote the growth of some blood cancers? There are numerous clinical opportunities to pursue.”

Cancer patient

Credit: Bill Branson

Childhood cancer patients are no more likely than their healthy peers to develop post-traumatic stress disorder (PTSD), according to research published in the Journal of Clinical Oncology.

“A cancer diagnosis is a highly significant and challenging event, but this study highlights the impressive capacity of children to adjust to changes in their lives and, in most cases, do just fine or even thrive emotionally as a result,” said study author Sean Phipps, PhD, of St Jude Children’s Research Hospital in Memphis.

PTSD is a treatable anxiety disorder that can develop following terrifying events that result in real or potential physical harm. The diagnosis is based on patient reports of certain symptoms, including persistent frightening thoughts, flashbacks, numbness, detachment, and sleep disturbances.

For this study, researchers used 3 established PTSD screening methods on 255 pediatric cancer patients (aged 8 to 17 at diagnosis) and 101 of their healthy, demographically matched peers.

This included a symptom check list and a structured diagnostic interview about the event in a child’s life he or she identified as the most traumatic. The researchers also interviewed parents about PTSD symptoms in themselves and their children.

Based on self-reported symptoms, 2.8% of cancer patients (n=7) met the criteria for a diagnosis of PTSD, either when the study was conducted or in the past.

The PTSD was cancer-related in 2 of these patients. In the other 5 patients, the disorder was linked to a drive-by shooting, Hurricane Katrina, or other stressful events.

By diagnostic interview, 0.4% of the cancer patients met PTSD criteria. According to parents’ reports, 1.6% of the cancer patients met criteria for current PTSD, and 5.9% met lifetime criteria.

These rates of PTSD were not significantly different from the rates reported in the healthy control subjects (all P values were greater than 0.1).

Unlike many previous studies of PTSD in cancer patients, researchers initially refrained from asking patients specifically about their diagnosis. Investigators wanted to avoid suggesting to patients that their cancer diagnoses were traumatic.

“We know such suggestions, called ‘focusing illusions,’ prime individuals to think about their cancer experience as traumatic and leaves them prone to exaggerating its impact in subjective reports,” Dr Phipps said.

Cancer patient

Credit: Bill Branson

Childhood cancer patients are no more likely than their healthy peers to develop post-traumatic stress disorder (PTSD), according to research published in the Journal of Clinical Oncology.

“A cancer diagnosis is a highly significant and challenging event, but this study highlights the impressive capacity of children to adjust to changes in their lives and, in most cases, do just fine or even thrive emotionally as a result,” said study author Sean Phipps, PhD, of St Jude Children’s Research Hospital in Memphis.

PTSD is a treatable anxiety disorder that can develop following terrifying events that result in real or potential physical harm. The diagnosis is based on patient reports of certain symptoms, including persistent frightening thoughts, flashbacks, numbness, detachment, and sleep disturbances.

For this study, researchers used 3 established PTSD screening methods on 255 pediatric cancer patients (aged 8 to 17 at diagnosis) and 101 of their healthy, demographically matched peers.

This included a symptom check list and a structured diagnostic interview about the event in a child’s life he or she identified as the most traumatic. The researchers also interviewed parents about PTSD symptoms in themselves and their children.

Based on self-reported symptoms, 2.8% of cancer patients (n=7) met the criteria for a diagnosis of PTSD, either when the study was conducted or in the past.

The PTSD was cancer-related in 2 of these patients. In the other 5 patients, the disorder was linked to a drive-by shooting, Hurricane Katrina, or other stressful events.

By diagnostic interview, 0.4% of the cancer patients met PTSD criteria. According to parents’ reports, 1.6% of the cancer patients met criteria for current PTSD, and 5.9% met lifetime criteria.

These rates of PTSD were not significantly different from the rates reported in the healthy control subjects (all P values were greater than 0.1).

Unlike many previous studies of PTSD in cancer patients, researchers initially refrained from asking patients specifically about their diagnosis. Investigators wanted to avoid suggesting to patients that their cancer diagnoses were traumatic.

“We know such suggestions, called ‘focusing illusions,’ prime individuals to think about their cancer experience as traumatic and leaves them prone to exaggerating its impact in subjective reports,” Dr Phipps said.

Cancer patient

Credit: Bill Branson

Childhood cancer patients are no more likely than their healthy peers to develop post-traumatic stress disorder (PTSD), according to research published in the Journal of Clinical Oncology.

“A cancer diagnosis is a highly significant and challenging event, but this study highlights the impressive capacity of children to adjust to changes in their lives and, in most cases, do just fine or even thrive emotionally as a result,” said study author Sean Phipps, PhD, of St Jude Children’s Research Hospital in Memphis.

PTSD is a treatable anxiety disorder that can develop following terrifying events that result in real or potential physical harm. The diagnosis is based on patient reports of certain symptoms, including persistent frightening thoughts, flashbacks, numbness, detachment, and sleep disturbances.

For this study, researchers used 3 established PTSD screening methods on 255 pediatric cancer patients (aged 8 to 17 at diagnosis) and 101 of their healthy, demographically matched peers.

This included a symptom check list and a structured diagnostic interview about the event in a child’s life he or she identified as the most traumatic. The researchers also interviewed parents about PTSD symptoms in themselves and their children.

Based on self-reported symptoms, 2.8% of cancer patients (n=7) met the criteria for a diagnosis of PTSD, either when the study was conducted or in the past.

The PTSD was cancer-related in 2 of these patients. In the other 5 patients, the disorder was linked to a drive-by shooting, Hurricane Katrina, or other stressful events.

By diagnostic interview, 0.4% of the cancer patients met PTSD criteria. According to parents’ reports, 1.6% of the cancer patients met criteria for current PTSD, and 5.9% met lifetime criteria.

These rates of PTSD were not significantly different from the rates reported in the healthy control subjects (all P values were greater than 0.1).

Unlike many previous studies of PTSD in cancer patients, researchers initially refrained from asking patients specifically about their diagnosis. Investigators wanted to avoid suggesting to patients that their cancer diagnoses were traumatic.

“We know such suggestions, called ‘focusing illusions,’ prime individuals to think about their cancer experience as traumatic and leaves them prone to exaggerating its impact in subjective reports,” Dr Phipps said.

Doctor consults with a family

Credit: Rhoda Baer

Previous research has indicated that requiring conflict of interest (COI) disclosures may lead advisers to give more biased advice.

However, virtually all of the prior studies questioned the effectiveness of COI disclosures that advisers were unable to avoid.

With a new study, researchers examined situations in which advisers have the ability to avoid COIs—such as doctors who can decide whether to accept gifts or payments from pharmaceutical companies.

And the results showed that when COIs can be avoided, disclosure successfully deters advisers from accepting COIs, so they have nothing to disclose except the absence of conflicts.

The research was published in Psychological Science.

“Prior research has cast doubt as to the effectiveness of disclosure for managing conflicts of interest, particularly when consumers have the burden of interpreting and reacting to the information,” said study author Sunita Sah, PhD, MB ChB, of Georgetown University in Washington, DC.

“Our findings suggest that disclosure can become a successful intervention to managing some conflicts of interest if it motivates professionals or providers to avoid such conflicts.”

For this study, the researchers conducted 3 experiments to determine how COIs influence advisers. In the first experiment, 97 adviser–advisee pairs participated in an online game with Amazon.com gift cards at stake.

Advisers informed the advisees regarding the number of filled dots on a grid. The estimators were paid based on their accuracy, but advisers had a conflict. They were paid more if advisees gave an estimate that was higher than the true value.

The set up—with advisees only seeing a small subset of the complete grid—was designed to simulate a situation in which a consumer receives advice from a better-informed but conflicted professional. The results replicated previous research and showed that disclosure led advisers to give higher (and more biased) recommendations than nondisclosure.

In the second experiment, the researchers again randomly assigned pairs of advisees and advisers to conditions in which the conflict was either disclosed or not disclosed.

There was, however, an important change from the first study. Advisers were given a choice of whether to accept or reject the COI.

Without disclosure, a majority of advisers (63%) chose the incentives that created a COI. But with disclosure, a minority (33%) accepted the conflict.

Advice was higher (and more biased) for those who chose incentives with conflicts than for those who did not, and advisers in the disclosure condition gave significantly less biased advice than those in the nondisclosure condition.

Finally, in a study with 248 participants, the researchers added a third condition to the second experiment: voluntary disclosure. In this third condition, advisers decided both whether to choose incentives that entailed a conflict and whether to disclose if they had a conflict.

Similar to mandatory disclosure, voluntary disclosure led advisers to avoid COIs and then disclose their freedom from conflicts to advisees.

“Disclosure doesn’t seem to be much good when conflicts are unavoidable, but it does seem to help when advisers have a choice about whether to subject themselves to conflicts,” said study author George Loewenstein, PhD, of Carnegie Mellon University in Pittsburgh.

“A nice feature of disclosure is that it is, in effect, ‘self-calibrating.’ Doctors, for example, are unlikely to find it worth it to accept small gifts such as pens or calendars if the gifts are going to be disclosed. Although larger gifts would be more tempting, doctors are likely to be deterred from accepting them because disclosure of large gifts would be more damaging to their reputations.”

Doctor consults with a family

Credit: Rhoda Baer

Previous research has indicated that requiring conflict of interest (COI) disclosures may lead advisers to give more biased advice.

However, virtually all of the prior studies questioned the effectiveness of COI disclosures that advisers were unable to avoid.

With a new study, researchers examined situations in which advisers have the ability to avoid COIs—such as doctors who can decide whether to accept gifts or payments from pharmaceutical companies.

And the results showed that when COIs can be avoided, disclosure successfully deters advisers from accepting COIs, so they have nothing to disclose except the absence of conflicts.

The research was published in Psychological Science.

“Prior research has cast doubt as to the effectiveness of disclosure for managing conflicts of interest, particularly when consumers have the burden of interpreting and reacting to the information,” said study author Sunita Sah, PhD, MB ChB, of Georgetown University in Washington, DC.

“Our findings suggest that disclosure can become a successful intervention to managing some conflicts of interest if it motivates professionals or providers to avoid such conflicts.”

For this study, the researchers conducted 3 experiments to determine how COIs influence advisers. In the first experiment, 97 adviser–advisee pairs participated in an online game with Amazon.com gift cards at stake.

Advisers informed the advisees regarding the number of filled dots on a grid. The estimators were paid based on their accuracy, but advisers had a conflict. They were paid more if advisees gave an estimate that was higher than the true value.

The set up—with advisees only seeing a small subset of the complete grid—was designed to simulate a situation in which a consumer receives advice from a better-informed but conflicted professional. The results replicated previous research and showed that disclosure led advisers to give higher (and more biased) recommendations than nondisclosure.

In the second experiment, the researchers again randomly assigned pairs of advisees and advisers to conditions in which the conflict was either disclosed or not disclosed.

There was, however, an important change from the first study. Advisers were given a choice of whether to accept or reject the COI.

Without disclosure, a majority of advisers (63%) chose the incentives that created a COI. But with disclosure, a minority (33%) accepted the conflict.

Advice was higher (and more biased) for those who chose incentives with conflicts than for those who did not, and advisers in the disclosure condition gave significantly less biased advice than those in the nondisclosure condition.

Finally, in a study with 248 participants, the researchers added a third condition to the second experiment: voluntary disclosure. In this third condition, advisers decided both whether to choose incentives that entailed a conflict and whether to disclose if they had a conflict.

Similar to mandatory disclosure, voluntary disclosure led advisers to avoid COIs and then disclose their freedom from conflicts to advisees.

“Disclosure doesn’t seem to be much good when conflicts are unavoidable, but it does seem to help when advisers have a choice about whether to subject themselves to conflicts,” said study author George Loewenstein, PhD, of Carnegie Mellon University in Pittsburgh.

“A nice feature of disclosure is that it is, in effect, ‘self-calibrating.’ Doctors, for example, are unlikely to find it worth it to accept small gifts such as pens or calendars if the gifts are going to be disclosed. Although larger gifts would be more tempting, doctors are likely to be deterred from accepting them because disclosure of large gifts would be more damaging to their reputations.”

Doctor consults with a family

Credit: Rhoda Baer

Previous research has indicated that requiring conflict of interest (COI) disclosures may lead advisers to give more biased advice.

However, virtually all of the prior studies questioned the effectiveness of COI disclosures that advisers were unable to avoid.

With a new study, researchers examined situations in which advisers have the ability to avoid COIs—such as doctors who can decide whether to accept gifts or payments from pharmaceutical companies.

And the results showed that when COIs can be avoided, disclosure successfully deters advisers from accepting COIs, so they have nothing to disclose except the absence of conflicts.

The research was published in Psychological Science.

“Prior research has cast doubt as to the effectiveness of disclosure for managing conflicts of interest, particularly when consumers have the burden of interpreting and reacting to the information,” said study author Sunita Sah, PhD, MB ChB, of Georgetown University in Washington, DC.

“Our findings suggest that disclosure can become a successful intervention to managing some conflicts of interest if it motivates professionals or providers to avoid such conflicts.”

For this study, the researchers conducted 3 experiments to determine how COIs influence advisers. In the first experiment, 97 adviser–advisee pairs participated in an online game with Amazon.com gift cards at stake.

Advisers informed the advisees regarding the number of filled dots on a grid. The estimators were paid based on their accuracy, but advisers had a conflict. They were paid more if advisees gave an estimate that was higher than the true value.

The set up—with advisees only seeing a small subset of the complete grid—was designed to simulate a situation in which a consumer receives advice from a better-informed but conflicted professional. The results replicated previous research and showed that disclosure led advisers to give higher (and more biased) recommendations than nondisclosure.

In the second experiment, the researchers again randomly assigned pairs of advisees and advisers to conditions in which the conflict was either disclosed or not disclosed.

There was, however, an important change from the first study. Advisers were given a choice of whether to accept or reject the COI.

Without disclosure, a majority of advisers (63%) chose the incentives that created a COI. But with disclosure, a minority (33%) accepted the conflict.

Advice was higher (and more biased) for those who chose incentives with conflicts than for those who did not, and advisers in the disclosure condition gave significantly less biased advice than those in the nondisclosure condition.

Finally, in a study with 248 participants, the researchers added a third condition to the second experiment: voluntary disclosure. In this third condition, advisers decided both whether to choose incentives that entailed a conflict and whether to disclose if they had a conflict.

Similar to mandatory disclosure, voluntary disclosure led advisers to avoid COIs and then disclose their freedom from conflicts to advisees.

“Disclosure doesn’t seem to be much good when conflicts are unavoidable, but it does seem to help when advisers have a choice about whether to subject themselves to conflicts,” said study author George Loewenstein, PhD, of Carnegie Mellon University in Pittsburgh.

“A nice feature of disclosure is that it is, in effect, ‘self-calibrating.’ Doctors, for example, are unlikely to find it worth it to accept small gifts such as pens or calendars if the gifts are going to be disclosed. Although larger gifts would be more tempting, doctors are likely to be deterred from accepting them because disclosure of large gifts would be more damaging to their reputations.”

Since FDA approval of endovascular aneurysm repair in 1999, the management of abdominal aortic aneurysms has transformed. Only 5.2% of AAAs were repaired by EVAR in 2000 compared to 74% in 2010. While the volume of AAA cases has remained constant at about 45,000 cases annually, the increase in EVAR has led to a 34% drop in open AAA cases. This national decline in open AAA cases is paralleled by a 33% decline in open AAA cases completed by vascular trainees since 2001, as reported in national Accreditation Council for Graduate Medical Education case logs.

In conjunction with this decrease in open AAA repair volume, trainees are reporting low confidence in independently performing open aneurysm cases, with nearly 40% of 2014 graduating vascular trainees having expressed low confidence in their ability on a 3-point Likert scale (1 – not confident, 2 – somewhat confident, 3 – very confident).

Over the past decade, we have also seen a threefold increase in adjudicated cases against vascular surgeons due to complications arising from open AAA cases, along with an increase in litigation against vascular surgeons who have been in practice for fewer than 3 years.

Open AAA surgery volume will continue to decrease as branched and fenestrated technology improves, and as expanded utilization in patients with complex anatomy occurs with the next generation of endografts.

By 2020, based on prediction models, vascular trainees will complete only five open aneurysm cases during their training, This raises serious questions about how we will educate the next generation of vascular surgeons to safely and effectively manage patients who can be treated only by open repair.

Since FDA approval of endovascular aneurysm repair in 1999, the management of abdominal aortic aneurysms has transformed. Only 5.2% of AAAs were repaired by EVAR in 2000 compared to 74% in 2010. While the volume of AAA cases has remained constant at about 45,000 cases annually, the increase in EVAR has led to a 34% drop in open AAA cases. This national decline in open AAA cases is paralleled by a 33% decline in open AAA cases completed by vascular trainees since 2001, as reported in national Accreditation Council for Graduate Medical Education case logs.

In conjunction with this decrease in open AAA repair volume, trainees are reporting low confidence in independently performing open aneurysm cases, with nearly 40% of 2014 graduating vascular trainees having expressed low confidence in their ability on a 3-point Likert scale (1 – not confident, 2 – somewhat confident, 3 – very confident).

Over the past decade, we have also seen a threefold increase in adjudicated cases against vascular surgeons due to complications arising from open AAA cases, along with an increase in litigation against vascular surgeons who have been in practice for fewer than 3 years.

Open AAA surgery volume will continue to decrease as branched and fenestrated technology improves, and as expanded utilization in patients with complex anatomy occurs with the next generation of endografts.

By 2020, based on prediction models, vascular trainees will complete only five open aneurysm cases during their training, This raises serious questions about how we will educate the next generation of vascular surgeons to safely and effectively manage patients who can be treated only by open repair.

Since FDA approval of endovascular aneurysm repair in 1999, the management of abdominal aortic aneurysms has transformed. Only 5.2% of AAAs were repaired by EVAR in 2000 compared to 74% in 2010. While the volume of AAA cases has remained constant at about 45,000 cases annually, the increase in EVAR has led to a 34% drop in open AAA cases. This national decline in open AAA cases is paralleled by a 33% decline in open AAA cases completed by vascular trainees since 2001, as reported in national Accreditation Council for Graduate Medical Education case logs.

In conjunction with this decrease in open AAA repair volume, trainees are reporting low confidence in independently performing open aneurysm cases, with nearly 40% of 2014 graduating vascular trainees having expressed low confidence in their ability on a 3-point Likert scale (1 – not confident, 2 – somewhat confident, 3 – very confident).

Over the past decade, we have also seen a threefold increase in adjudicated cases against vascular surgeons due to complications arising from open AAA cases, along with an increase in litigation against vascular surgeons who have been in practice for fewer than 3 years.

Open AAA surgery volume will continue to decrease as branched and fenestrated technology improves, and as expanded utilization in patients with complex anatomy occurs with the next generation of endografts.

By 2020, based on prediction models, vascular trainees will complete only five open aneurysm cases during their training, This raises serious questions about how we will educate the next generation of vascular surgeons to safely and effectively manage patients who can be treated only by open repair.

For elderly patients with carotid disease, carotid endarterectomy carries a lower risk of perioperative stroke or transient ischemic attack, the same risk of perioperative MI, and a slightly higher risk of perioperative death compared with carotid artery stenting, according to a meta-analysis.

However, the individual elderly patient’s vascular anatomy plays a crucial role in determining perioperative risk, as does his or her overall health and clinical profile.

"The results of [our] analysis suggest that careful consideration of a constellation of clinical and anatomic factors is required before an appropriate treatment of carotid disease in elderly patients is selected. The cardiovascular disease burden and general health of the individual patient should be meticulously evaluated before interventional instead of optimal medical treatment is applied," said Dr. George A. Antoniou of the department of vascular surgery, Hellenic Red Cross Hospital, Athens, and his associates.

Which treatment is the most appropriate for elderly patients with carotid disease is still much debated. Dr. Antoniou and his colleagues performed a comprehensive review of the medical literature since 1986 and a meta-analysis of 44 articles that directly compared outcomes in elderly patients with those of younger patients after carotid endarterectomy (39 studies) or carotid stenting (18 articles).

"Elderly" was defined as older than 80 years in most of these studies, and as older than 75 years in many, but there was great variability among the studies, and some even considered "older than 65 years" to be elderly.

Overall, the meta-analysis included 269,596 endarterectomies in elderly patients against 243,089 in younger patients, and 38,751 carotid stenting procedures in elderly patients against 36,450 in younger patients.

For endarterectomy, the rate of perioperative stroke was not significantly different between elderly (0.9%) and younger (1.2%) patients, nor was the rate of TIA (1.9% vs 1.8%, respectively). However, perioperative mortality was significantly higher in elderly (0.5%) than in younger (0.4%) patients.

In contrast, for carotid stenting, the rate of perioperative stroke was significantly higher for elderly patients (2.4%) than for younger patients (1.7%), as was the rate of TIA (3.6% vs 2.1%). And mortality was not significantly different between elderly patients (0.6%) and younger patients (0.7%), the researchers wrote (JAMA Surg. 2013 Oct. 23 [doi:10.1001/jamasurg.2013.4135]).

Both procedures were associated with an increased rate of perioperative MI in elderly patients, compared with younger patients. These rates were 2.2% in elderly patients, compared with 1.4% in younger patients undergoing endarterectomy; and 2.3% in elderly patients, compared with 1.5% in younger patients undergoing carotid stenting.

These findings remained robust in sensitivity analyses.

"It seems that endarterectomy is associated with improved neurologic outcomes compared with carotid stenting in elderly patients, at the expense of increased perioperative mortality." However, the small increase in mortality seen with endarterectomy – one-tenth of 1% – may not be clinically significant, Dr. Antoniou and his associates said.

Moreover, neurologic risk is closely tied to vascular anatomy. Elderly patients tend to have more unfavorable anatomy than do younger patients, but should be assessed on an individual basis. Unfavorable traits include heavily calcified and tortuous supra-aortic branches, as well as adverse morphology of the aortic arch such as elongation, distortion, and stenosis.

Manipulating the stenting instruments through such features may in itself raise the risk of neurologic sequelae. It also makes the procedure more technically difficult, which increases the risk of endothelial trauma, thrombus dislodgment, and thromboembolic events.

"In addition, elderly patients with significant extracranial atherosclerotic disease are likely to have a compromised cerebrovascular reserve, which makes them more susceptible to ischemic events from cerebral microembolization," the researchers said.

They reported having no conflicts.

For elderly patients with carotid disease, carotid endarterectomy carries a lower risk of perioperative stroke or transient ischemic attack, the same risk of perioperative MI, and a slightly higher risk of perioperative death compared with carotid artery stenting, according to a meta-analysis.

However, the individual elderly patient’s vascular anatomy plays a crucial role in determining perioperative risk, as does his or her overall health and clinical profile.

"The results of [our] analysis suggest that careful consideration of a constellation of clinical and anatomic factors is required before an appropriate treatment of carotid disease in elderly patients is selected. The cardiovascular disease burden and general health of the individual patient should be meticulously evaluated before interventional instead of optimal medical treatment is applied," said Dr. George A. Antoniou of the department of vascular surgery, Hellenic Red Cross Hospital, Athens, and his associates.

Which treatment is the most appropriate for elderly patients with carotid disease is still much debated. Dr. Antoniou and his colleagues performed a comprehensive review of the medical literature since 1986 and a meta-analysis of 44 articles that directly compared outcomes in elderly patients with those of younger patients after carotid endarterectomy (39 studies) or carotid stenting (18 articles).

"Elderly" was defined as older than 80 years in most of these studies, and as older than 75 years in many, but there was great variability among the studies, and some even considered "older than 65 years" to be elderly.

Overall, the meta-analysis included 269,596 endarterectomies in elderly patients against 243,089 in younger patients, and 38,751 carotid stenting procedures in elderly patients against 36,450 in younger patients.

For endarterectomy, the rate of perioperative stroke was not significantly different between elderly (0.9%) and younger (1.2%) patients, nor was the rate of TIA (1.9% vs 1.8%, respectively). However, perioperative mortality was significantly higher in elderly (0.5%) than in younger (0.4%) patients.

In contrast, for carotid stenting, the rate of perioperative stroke was significantly higher for elderly patients (2.4%) than for younger patients (1.7%), as was the rate of TIA (3.6% vs 2.1%). And mortality was not significantly different between elderly patients (0.6%) and younger patients (0.7%), the researchers wrote (JAMA Surg. 2013 Oct. 23 [doi:10.1001/jamasurg.2013.4135]).

Both procedures were associated with an increased rate of perioperative MI in elderly patients, compared with younger patients. These rates were 2.2% in elderly patients, compared with 1.4% in younger patients undergoing endarterectomy; and 2.3% in elderly patients, compared with 1.5% in younger patients undergoing carotid stenting.

These findings remained robust in sensitivity analyses.

"It seems that endarterectomy is associated with improved neurologic outcomes compared with carotid stenting in elderly patients, at the expense of increased perioperative mortality." However, the small increase in mortality seen with endarterectomy – one-tenth of 1% – may not be clinically significant, Dr. Antoniou and his associates said.

Moreover, neurologic risk is closely tied to vascular anatomy. Elderly patients tend to have more unfavorable anatomy than do younger patients, but should be assessed on an individual basis. Unfavorable traits include heavily calcified and tortuous supra-aortic branches, as well as adverse morphology of the aortic arch such as elongation, distortion, and stenosis.

Manipulating the stenting instruments through such features may in itself raise the risk of neurologic sequelae. It also makes the procedure more technically difficult, which increases the risk of endothelial trauma, thrombus dislodgment, and thromboembolic events.

"In addition, elderly patients with significant extracranial atherosclerotic disease are likely to have a compromised cerebrovascular reserve, which makes them more susceptible to ischemic events from cerebral microembolization," the researchers said.

They reported having no conflicts.

For elderly patients with carotid disease, carotid endarterectomy carries a lower risk of perioperative stroke or transient ischemic attack, the same risk of perioperative MI, and a slightly higher risk of perioperative death compared with carotid artery stenting, according to a meta-analysis.

However, the individual elderly patient’s vascular anatomy plays a crucial role in determining perioperative risk, as does his or her overall health and clinical profile.

"The results of [our] analysis suggest that careful consideration of a constellation of clinical and anatomic factors is required before an appropriate treatment of carotid disease in elderly patients is selected. The cardiovascular disease burden and general health of the individual patient should be meticulously evaluated before interventional instead of optimal medical treatment is applied," said Dr. George A. Antoniou of the department of vascular surgery, Hellenic Red Cross Hospital, Athens, and his associates.

Which treatment is the most appropriate for elderly patients with carotid disease is still much debated. Dr. Antoniou and his colleagues performed a comprehensive review of the medical literature since 1986 and a meta-analysis of 44 articles that directly compared outcomes in elderly patients with those of younger patients after carotid endarterectomy (39 studies) or carotid stenting (18 articles).

"Elderly" was defined as older than 80 years in most of these studies, and as older than 75 years in many, but there was great variability among the studies, and some even considered "older than 65 years" to be elderly.

Overall, the meta-analysis included 269,596 endarterectomies in elderly patients against 243,089 in younger patients, and 38,751 carotid stenting procedures in elderly patients against 36,450 in younger patients.

For endarterectomy, the rate of perioperative stroke was not significantly different between elderly (0.9%) and younger (1.2%) patients, nor was the rate of TIA (1.9% vs 1.8%, respectively). However, perioperative mortality was significantly higher in elderly (0.5%) than in younger (0.4%) patients.

In contrast, for carotid stenting, the rate of perioperative stroke was significantly higher for elderly patients (2.4%) than for younger patients (1.7%), as was the rate of TIA (3.6% vs 2.1%). And mortality was not significantly different between elderly patients (0.6%) and younger patients (0.7%), the researchers wrote (JAMA Surg. 2013 Oct. 23 [doi:10.1001/jamasurg.2013.4135]).

Both procedures were associated with an increased rate of perioperative MI in elderly patients, compared with younger patients. These rates were 2.2% in elderly patients, compared with 1.4% in younger patients undergoing endarterectomy; and 2.3% in elderly patients, compared with 1.5% in younger patients undergoing carotid stenting.

These findings remained robust in sensitivity analyses.

"It seems that endarterectomy is associated with improved neurologic outcomes compared with carotid stenting in elderly patients, at the expense of increased perioperative mortality." However, the small increase in mortality seen with endarterectomy – one-tenth of 1% – may not be clinically significant, Dr. Antoniou and his associates said.

Moreover, neurologic risk is closely tied to vascular anatomy. Elderly patients tend to have more unfavorable anatomy than do younger patients, but should be assessed on an individual basis. Unfavorable traits include heavily calcified and tortuous supra-aortic branches, as well as adverse morphology of the aortic arch such as elongation, distortion, and stenosis.

Manipulating the stenting instruments through such features may in itself raise the risk of neurologic sequelae. It also makes the procedure more technically difficult, which increases the risk of endothelial trauma, thrombus dislodgment, and thromboembolic events.

"In addition, elderly patients with significant extracranial atherosclerotic disease are likely to have a compromised cerebrovascular reserve, which makes them more susceptible to ischemic events from cerebral microembolization," the researchers said.

They reported having no conflicts.

Prescription bottles

Credit: Steven Harbour

The phase 3 RESONATE study has been stopped early due to positive results in patients receiving ibrutinib.

In this trial, researchers compared the BTK inhibitor ibrutinib to the CD20-directed antibody ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The study has ended early because 2 key endpoints were met—namely, ibrutinib significantly improved progression-free and overall survival rates.

The RESONATE study enrolled 391 patients with relapsed or refractory CLL or SLL with measurable nodal disease who were not eligible for treatment with purine-analog-based therapy. Patients had received at least 1 prior therapy.

The researchers randomized patients to receive 420 mg of ibrutinib orally once daily or intravenous doses of ofatumumab over the course of 24 weeks until disease progression or unacceptable toxicity.

At the planned interim analysis, ibrutinib had significantly improved progression-free survival (the primary endpoint) and overall survival (a secondary endpoint).

And the safety profile of ibrutinib was acceptable, according to the companies developing the drug (Pharmacyclics, Inc. and Janssen Research and Development, LLC).

Based on these results, an independent data monitoring committee recommended that patients in the ofatumumab arm be given access to ibrutinib.

Pharmacyclics has informed the US Food and Drug Administration of this recommendation, and Janssen has informed the European Medicines Agency. Both companies are in talks with the health authorities to define the next regulatory steps.

Pharmacyclics has said detailed data from the RESONATE study will be presented at an upcoming oncology conference.

Ibrutinib was recently approved by the US Food and Drug Administration to treat mantle cell lymphoma.

Prescription bottles

Credit: Steven Harbour

The phase 3 RESONATE study has been stopped early due to positive results in patients receiving ibrutinib.

In this trial, researchers compared the BTK inhibitor ibrutinib to the CD20-directed antibody ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The study has ended early because 2 key endpoints were met—namely, ibrutinib significantly improved progression-free and overall survival rates.

The RESONATE study enrolled 391 patients with relapsed or refractory CLL or SLL with measurable nodal disease who were not eligible for treatment with purine-analog-based therapy. Patients had received at least 1 prior therapy.

The researchers randomized patients to receive 420 mg of ibrutinib orally once daily or intravenous doses of ofatumumab over the course of 24 weeks until disease progression or unacceptable toxicity.

At the planned interim analysis, ibrutinib had significantly improved progression-free survival (the primary endpoint) and overall survival (a secondary endpoint).

And the safety profile of ibrutinib was acceptable, according to the companies developing the drug (Pharmacyclics, Inc. and Janssen Research and Development, LLC).

Based on these results, an independent data monitoring committee recommended that patients in the ofatumumab arm be given access to ibrutinib.

Pharmacyclics has informed the US Food and Drug Administration of this recommendation, and Janssen has informed the European Medicines Agency. Both companies are in talks with the health authorities to define the next regulatory steps.

Pharmacyclics has said detailed data from the RESONATE study will be presented at an upcoming oncology conference.

Ibrutinib was recently approved by the US Food and Drug Administration to treat mantle cell lymphoma.

Prescription bottles

Credit: Steven Harbour

The phase 3 RESONATE study has been stopped early due to positive results in patients receiving ibrutinib.

In this trial, researchers compared the BTK inhibitor ibrutinib to the CD20-directed antibody ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The study has ended early because 2 key endpoints were met—namely, ibrutinib significantly improved progression-free and overall survival rates.

The RESONATE study enrolled 391 patients with relapsed or refractory CLL or SLL with measurable nodal disease who were not eligible for treatment with purine-analog-based therapy. Patients had received at least 1 prior therapy.

The researchers randomized patients to receive 420 mg of ibrutinib orally once daily or intravenous doses of ofatumumab over the course of 24 weeks until disease progression or unacceptable toxicity.

At the planned interim analysis, ibrutinib had significantly improved progression-free survival (the primary endpoint) and overall survival (a secondary endpoint).

And the safety profile of ibrutinib was acceptable, according to the companies developing the drug (Pharmacyclics, Inc. and Janssen Research and Development, LLC).

Based on these results, an independent data monitoring committee recommended that patients in the ofatumumab arm be given access to ibrutinib.

Pharmacyclics has informed the US Food and Drug Administration of this recommendation, and Janssen has informed the European Medicines Agency. Both companies are in talks with the health authorities to define the next regulatory steps.

Pharmacyclics has said detailed data from the RESONATE study will be presented at an upcoming oncology conference.

Ibrutinib was recently approved by the US Food and Drug Administration to treat mantle cell lymphoma.

Stem cells for transplant

Credit: Chad McNeeley

A music therapy intervention can help adolescents and young adults (AYAs) cope with cancer and its treatment, according to research published in the journal Cancer.

The intervention consisted of writing song lyrics and producing music videos.

It helped AYA cancer patients communicate their feelings about their disease and its treatment, hematopoietic stem cell transplant (HSCT).

The program also had positive effects on patients’ social integration and family environment.

About the intervention

The therapeutic music video (TMV) intervention was designed to improve resilience in AYA cancer patients undergoing HSCT. Resilience is the process of positively adjusting to stressors.

“Adolescents and young adults who are resilient have the ability to rise above their illness, gain a sense of mastery and confidence in how they have dealt with their cancer, and demonstrate a desire to reach out and help others,” said study author Joan Haase, PhD, RN, of the Indiana University School of Nursing.

Dr Haase and her colleagues wanted to use the TMV intervention to help AYAs explore and express thoughts and emotions about their disease and treatment that might otherwise go unspoken.

The patients did this by writing song lyrics and producing videos with the help of a board-certified music therapist. As they moved through phases of the intervention—making sound recordings, collecting video images, and storyboarding—patients had opportunities to involve family, friends, and healthcare providers in their project.

Results of the study

To test the intervention, Dr Haase and her colleagues enrolled 113 cancer patients (aged 11 to 24 years) who were undergoing HSCT.

The patients were randomized to the TMV intervention group or a control group that received audiobooks. All patients completed 6 sessions over 3 weeks.

After the intervention, the TMV group reported significantly better courageous coping. And at 100 days after HSCT, the TMV group reported significantly better social integration and family environments.

Parents reported that the videos gave them insight into their children’s cancer experiences. However, parents needed help to initiate and sustain conversations about messages shared through their children’s videos.

The investigators said these findings provide evidence supporting the use of a music-based intervention delivered by a music therapist to help AYAs cope with high-risk, high-intensity cancer treatments.

“The availability of music therapy services from a board-certified music therapist in the United States has become more widespread, and, through studies like this one, we hope to see increased availability and access to this important allied health service,” said study author Sheri L. Robb, PhD, also of the Indiana University School of Nursing.

“One of our team’s next steps is to disseminate findings, train professional music therapists on this intervention, and then conduct an implementation study to examine how the intervention may change as it moves into the standard care setting and whether, in the presence of these changes, patient benefits are maintained.”

Stem cells for transplant

Credit: Chad McNeeley

A music therapy intervention can help adolescents and young adults (AYAs) cope with cancer and its treatment, according to research published in the journal Cancer.

The intervention consisted of writing song lyrics and producing music videos.

It helped AYA cancer patients communicate their feelings about their disease and its treatment, hematopoietic stem cell transplant (HSCT).

The program also had positive effects on patients’ social integration and family environment.

About the intervention

The therapeutic music video (TMV) intervention was designed to improve resilience in AYA cancer patients undergoing HSCT. Resilience is the process of positively adjusting to stressors.

“Adolescents and young adults who are resilient have the ability to rise above their illness, gain a sense of mastery and confidence in how they have dealt with their cancer, and demonstrate a desire to reach out and help others,” said study author Joan Haase, PhD, RN, of the Indiana University School of Nursing.

Dr Haase and her colleagues wanted to use the TMV intervention to help AYAs explore and express thoughts and emotions about their disease and treatment that might otherwise go unspoken.

The patients did this by writing song lyrics and producing videos with the help of a board-certified music therapist. As they moved through phases of the intervention—making sound recordings, collecting video images, and storyboarding—patients had opportunities to involve family, friends, and healthcare providers in their project.

Results of the study

To test the intervention, Dr Haase and her colleagues enrolled 113 cancer patients (aged 11 to 24 years) who were undergoing HSCT.

The patients were randomized to the TMV intervention group or a control group that received audiobooks. All patients completed 6 sessions over 3 weeks.

After the intervention, the TMV group reported significantly better courageous coping. And at 100 days after HSCT, the TMV group reported significantly better social integration and family environments.

Parents reported that the videos gave them insight into their children’s cancer experiences. However, parents needed help to initiate and sustain conversations about messages shared through their children’s videos.

The investigators said these findings provide evidence supporting the use of a music-based intervention delivered by a music therapist to help AYAs cope with high-risk, high-intensity cancer treatments.

“The availability of music therapy services from a board-certified music therapist in the United States has become more widespread, and, through studies like this one, we hope to see increased availability and access to this important allied health service,” said study author Sheri L. Robb, PhD, also of the Indiana University School of Nursing.

“One of our team’s next steps is to disseminate findings, train professional music therapists on this intervention, and then conduct an implementation study to examine how the intervention may change as it moves into the standard care setting and whether, in the presence of these changes, patient benefits are maintained.”

Stem cells for transplant

Credit: Chad McNeeley

A music therapy intervention can help adolescents and young adults (AYAs) cope with cancer and its treatment, according to research published in the journal Cancer.

The intervention consisted of writing song lyrics and producing music videos.

It helped AYA cancer patients communicate their feelings about their disease and its treatment, hematopoietic stem cell transplant (HSCT).

The program also had positive effects on patients’ social integration and family environment.

About the intervention

The therapeutic music video (TMV) intervention was designed to improve resilience in AYA cancer patients undergoing HSCT. Resilience is the process of positively adjusting to stressors.

“Adolescents and young adults who are resilient have the ability to rise above their illness, gain a sense of mastery and confidence in how they have dealt with their cancer, and demonstrate a desire to reach out and help others,” said study author Joan Haase, PhD, RN, of the Indiana University School of Nursing.

Dr Haase and her colleagues wanted to use the TMV intervention to help AYAs explore and express thoughts and emotions about their disease and treatment that might otherwise go unspoken.

The patients did this by writing song lyrics and producing videos with the help of a board-certified music therapist. As they moved through phases of the intervention—making sound recordings, collecting video images, and storyboarding—patients had opportunities to involve family, friends, and healthcare providers in their project.

Results of the study

To test the intervention, Dr Haase and her colleagues enrolled 113 cancer patients (aged 11 to 24 years) who were undergoing HSCT.

The patients were randomized to the TMV intervention group or a control group that received audiobooks. All patients completed 6 sessions over 3 weeks.

After the intervention, the TMV group reported significantly better courageous coping. And at 100 days after HSCT, the TMV group reported significantly better social integration and family environments.

Parents reported that the videos gave them insight into their children’s cancer experiences. However, parents needed help to initiate and sustain conversations about messages shared through their children’s videos.

The investigators said these findings provide evidence supporting the use of a music-based intervention delivered by a music therapist to help AYAs cope with high-risk, high-intensity cancer treatments.

“The availability of music therapy services from a board-certified music therapist in the United States has become more widespread, and, through studies like this one, we hope to see increased availability and access to this important allied health service,” said study author Sheri L. Robb, PhD, also of the Indiana University School of Nursing.

“One of our team’s next steps is to disseminate findings, train professional music therapists on this intervention, and then conduct an implementation study to examine how the intervention may change as it moves into the standard care setting and whether, in the presence of these changes, patient benefits are maintained.”

This is the third report from Gutman and colleagues on the outcomes of a double-blind, multicenter, randomized, controlled trial of vaginal prolapse repair using synthetic mesh versus native-tissue colpopexy in women with significant vaginal prolapse.

The trial involved 33 women who underwent mesh repair and 32 who underwent repair without mesh. (The mesh-free repair consisted primarily of uterosacral suspension and concurrent colporrhaphy.) It was halted when it reached a predetermined threshold for discontinuation, which was a mesh erosion rate of 15% or more.

Investigators found no difference in long-term cure rates between the mesh and no-mesh groups, regardless of the definition of cure (ie, anatomic, symptomatic, or combined). Nor was there a difference in the overall recurrence rate.

Summary of earlier reports
Three-month outcomes. The first report from this trial described 3-month objective treatment outcomes, with success described as prolapse no greater than stage 1.¹ It found a high erosion rate (15.6%) for vaginal mesh, with no differences between groups in overall subjective or objective cure rates, with an overall recurrence rate of 59.4% (19 cases) in the mesh group versus 70.4% (24 cases) in the no-mesh group (P = .28), with recurrence defined as prolapse beyond stage 1 in any compartment. Investigators also observed potential benefit in the mesh group in the anterior vaginal wall at point Ba at a median of 9.7 months after surgery.

Related Article: Stop using synthetic mesh for routine repair of pelvic organ prolapse Cheryl B. Iglesia, MD (Stop/Start, April 2013)

One-year outcomes. The second report described 1-year objective and functional outcomes in all participants of the trial.² It found comparable objective and subjective cure rates between groups but a higher reoperation rate for mesh repairs. Prolapse recurred in the anterior department in 46.9% of women in the mesh group versus 60.6% in the no-mesh group (P = .40).

Subjective quality-of-life assessments continued to reflect significant improvement in symptoms from baseline. Vaginal bulging was relieved in 96.2% of women in the mesh group, compared with 90.9% in the no-mesh group (P = .62).

More women in the mesh group required reoperation for recurrent prolapse or mesh exposure (5 in the mesh group vs 0 in the no-mesh group; P = .017).

Strengths and limitations of the trial
Gutman and colleagues are to be congratulated for continuing to monitor longer-term outcomes of vaginal prolapse repairs augmented with synthetic mesh, as data are sorely needed on both early complications and those more remote from surgery. However, it is regrettable that continued attrition in this trial led to minimal power to compare outcomes between groups.

Cure rates were assessed three ways: anatomically, by virtue of symptoms, and by a combination of the two measures. Participants had documentation of at least 2-year anatomic outcomes and 3-year subjective outcomes using validated measures. 

Forty-one (63%) of the original 65 women in the trial had anatomic outcomes (20 in the mesh group vs 21 in the no-mesh group), and 51 (78%) of the original 65 women had evaluable subjective outcomes (25 in the mesh group vs 26 in the no-mesh group).

Women who underwent reoperation for recurrent prolapse were removed from any outcomes analysis and considered to have failed composite outcomes measures (anatomic and subjective assessment and whether reoperation or a pessary was required for recurrent prolapse).

The length of follow-up was similar between groups (median, 3 years; interquartile range, 2.97–3.15), and both groups demonstrated significant anatomic and subjective improvement from baseline.

No difference was observed between groups in the original primary anatomic outcome, which was a POP-Q stage no greater than 1 (45% in the mesh group vs 43% in the no-mesh group; P >.99). Nor was there a difference between groups in any other anatomic outcome, including POP-Q point Ba (median, –1.5 for mesh [range, –2.5, 1.0] vs –0.5 [range, –3.0, 4.0] for the no-mesh group; P = .21) and bulge symptoms (92% for the mesh group vs 81% for the no-mesh group; relative risk, 1.4; 95% confidence interval, 0.91–1.42).

Despite small numbers and markedly reduced comparative validity (readily acknowledged by the investigators), these longer-term outcomes were assessed by examiners blinded to treatment and using validated objective and subjective outcome measures.

The only other randomized trial of mesh versus native-tissue repair with 3-year outcomes had a much larger sample size and follow-up but addressed only anterior-compartment prolapse.³

What this evidence means for practice
The 3-year data presented by Gutman and colleagues should be viewed with caution, owing to the trial’s reduced sample size and power. However, they may be useful in designing future trials.
In the meantime, given the limited longer-term outcomes data available at present, I would recommend continued individualized use of mesh versus native-tissue repair in women presenting with prolapse, including educating patients about the risks and benefits of both approaches. It also is important that outcomes be followed in all of our patients in a robust, unbiased fashion. The new American Urogynecologic Society Pelvic Floor Disorders Registry provides the opportunity for this.
Holly E. Richter, PhD, MD

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected]

This is the third report from Gutman and colleagues on the outcomes of a double-blind, multicenter, randomized, controlled trial of vaginal prolapse repair using synthetic mesh versus native-tissue colpopexy in women with significant vaginal prolapse.

The trial involved 33 women who underwent mesh repair and 32 who underwent repair without mesh. (The mesh-free repair consisted primarily of uterosacral suspension and concurrent colporrhaphy.) It was halted when it reached a predetermined threshold for discontinuation, which was a mesh erosion rate of 15% or more.

Investigators found no difference in long-term cure rates between the mesh and no-mesh groups, regardless of the definition of cure (ie, anatomic, symptomatic, or combined). Nor was there a difference in the overall recurrence rate.

Summary of earlier reports
Three-month outcomes. The first report from this trial described 3-month objective treatment outcomes, with success described as prolapse no greater than stage 1.¹ It found a high erosion rate (15.6%) for vaginal mesh, with no differences between groups in overall subjective or objective cure rates, with an overall recurrence rate of 59.4% (19 cases) in the mesh group versus 70.4% (24 cases) in the no-mesh group (P = .28), with recurrence defined as prolapse beyond stage 1 in any compartment. Investigators also observed potential benefit in the mesh group in the anterior vaginal wall at point Ba at a median of 9.7 months after surgery.

Related Article: Stop using synthetic mesh for routine repair of pelvic organ prolapse Cheryl B. Iglesia, MD (Stop/Start, April 2013)

One-year outcomes. The second report described 1-year objective and functional outcomes in all participants of the trial.² It found comparable objective and subjective cure rates between groups but a higher reoperation rate for mesh repairs. Prolapse recurred in the anterior department in 46.9% of women in the mesh group versus 60.6% in the no-mesh group (P = .40).

Subjective quality-of-life assessments continued to reflect significant improvement in symptoms from baseline. Vaginal bulging was relieved in 96.2% of women in the mesh group, compared with 90.9% in the no-mesh group (P = .62).

More women in the mesh group required reoperation for recurrent prolapse or mesh exposure (5 in the mesh group vs 0 in the no-mesh group; P = .017).

Strengths and limitations of the trial
Gutman and colleagues are to be congratulated for continuing to monitor longer-term outcomes of vaginal prolapse repairs augmented with synthetic mesh, as data are sorely needed on both early complications and those more remote from surgery. However, it is regrettable that continued attrition in this trial led to minimal power to compare outcomes between groups.

Cure rates were assessed three ways: anatomically, by virtue of symptoms, and by a combination of the two measures. Participants had documentation of at least 2-year anatomic outcomes and 3-year subjective outcomes using validated measures. 

Forty-one (63%) of the original 65 women in the trial had anatomic outcomes (20 in the mesh group vs 21 in the no-mesh group), and 51 (78%) of the original 65 women had evaluable subjective outcomes (25 in the mesh group vs 26 in the no-mesh group).

Women who underwent reoperation for recurrent prolapse were removed from any outcomes analysis and considered to have failed composite outcomes measures (anatomic and subjective assessment and whether reoperation or a pessary was required for recurrent prolapse).

The length of follow-up was similar between groups (median, 3 years; interquartile range, 2.97–3.15), and both groups demonstrated significant anatomic and subjective improvement from baseline.

No difference was observed between groups in the original primary anatomic outcome, which was a POP-Q stage no greater than 1 (45% in the mesh group vs 43% in the no-mesh group; P >.99). Nor was there a difference between groups in any other anatomic outcome, including POP-Q point Ba (median, –1.5 for mesh [range, –2.5, 1.0] vs –0.5 [range, –3.0, 4.0] for the no-mesh group; P = .21) and bulge symptoms (92% for the mesh group vs 81% for the no-mesh group; relative risk, 1.4; 95% confidence interval, 0.91–1.42).

Despite small numbers and markedly reduced comparative validity (readily acknowledged by the investigators), these longer-term outcomes were assessed by examiners blinded to treatment and using validated objective and subjective outcome measures.

The only other randomized trial of mesh versus native-tissue repair with 3-year outcomes had a much larger sample size and follow-up but addressed only anterior-compartment prolapse.³

What this evidence means for practice
The 3-year data presented by Gutman and colleagues should be viewed with caution, owing to the trial’s reduced sample size and power. However, they may be useful in designing future trials.
In the meantime, given the limited longer-term outcomes data available at present, I would recommend continued individualized use of mesh versus native-tissue repair in women presenting with prolapse, including educating patients about the risks and benefits of both approaches. It also is important that outcomes be followed in all of our patients in a robust, unbiased fashion. The new American Urogynecologic Society Pelvic Floor Disorders Registry provides the opportunity for this.
Holly E. Richter, PhD, MD

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected]

This is the third report from Gutman and colleagues on the outcomes of a double-blind, multicenter, randomized, controlled trial of vaginal prolapse repair using synthetic mesh versus native-tissue colpopexy in women with significant vaginal prolapse.

The trial involved 33 women who underwent mesh repair and 32 who underwent repair without mesh. (The mesh-free repair consisted primarily of uterosacral suspension and concurrent colporrhaphy.) It was halted when it reached a predetermined threshold for discontinuation, which was a mesh erosion rate of 15% or more.

Investigators found no difference in long-term cure rates between the mesh and no-mesh groups, regardless of the definition of cure (ie, anatomic, symptomatic, or combined). Nor was there a difference in the overall recurrence rate.

Summary of earlier reports
Three-month outcomes. The first report from this trial described 3-month objective treatment outcomes, with success described as prolapse no greater than stage 1.¹ It found a high erosion rate (15.6%) for vaginal mesh, with no differences between groups in overall subjective or objective cure rates, with an overall recurrence rate of 59.4% (19 cases) in the mesh group versus 70.4% (24 cases) in the no-mesh group (P = .28), with recurrence defined as prolapse beyond stage 1 in any compartment. Investigators also observed potential benefit in the mesh group in the anterior vaginal wall at point Ba at a median of 9.7 months after surgery.

Related Article: Stop using synthetic mesh for routine repair of pelvic organ prolapse Cheryl B. Iglesia, MD (Stop/Start, April 2013)

One-year outcomes. The second report described 1-year objective and functional outcomes in all participants of the trial.² It found comparable objective and subjective cure rates between groups but a higher reoperation rate for mesh repairs. Prolapse recurred in the anterior department in 46.9% of women in the mesh group versus 60.6% in the no-mesh group (P = .40).

Subjective quality-of-life assessments continued to reflect significant improvement in symptoms from baseline. Vaginal bulging was relieved in 96.2% of women in the mesh group, compared with 90.9% in the no-mesh group (P = .62).

More women in the mesh group required reoperation for recurrent prolapse or mesh exposure (5 in the mesh group vs 0 in the no-mesh group; P = .017).

Strengths and limitations of the trial
Gutman and colleagues are to be congratulated for continuing to monitor longer-term outcomes of vaginal prolapse repairs augmented with synthetic mesh, as data are sorely needed on both early complications and those more remote from surgery. However, it is regrettable that continued attrition in this trial led to minimal power to compare outcomes between groups.

Cure rates were assessed three ways: anatomically, by virtue of symptoms, and by a combination of the two measures. Participants had documentation of at least 2-year anatomic outcomes and 3-year subjective outcomes using validated measures. 

Forty-one (63%) of the original 65 women in the trial had anatomic outcomes (20 in the mesh group vs 21 in the no-mesh group), and 51 (78%) of the original 65 women had evaluable subjective outcomes (25 in the mesh group vs 26 in the no-mesh group).

Women who underwent reoperation for recurrent prolapse were removed from any outcomes analysis and considered to have failed composite outcomes measures (anatomic and subjective assessment and whether reoperation or a pessary was required for recurrent prolapse).

The length of follow-up was similar between groups (median, 3 years; interquartile range, 2.97–3.15), and both groups demonstrated significant anatomic and subjective improvement from baseline.

No difference was observed between groups in the original primary anatomic outcome, which was a POP-Q stage no greater than 1 (45% in the mesh group vs 43% in the no-mesh group; P >.99). Nor was there a difference between groups in any other anatomic outcome, including POP-Q point Ba (median, –1.5 for mesh [range, –2.5, 1.0] vs –0.5 [range, –3.0, 4.0] for the no-mesh group; P = .21) and bulge symptoms (92% for the mesh group vs 81% for the no-mesh group; relative risk, 1.4; 95% confidence interval, 0.91–1.42).

Despite small numbers and markedly reduced comparative validity (readily acknowledged by the investigators), these longer-term outcomes were assessed by examiners blinded to treatment and using validated objective and subjective outcome measures.

The only other randomized trial of mesh versus native-tissue repair with 3-year outcomes had a much larger sample size and follow-up but addressed only anterior-compartment prolapse.³

What this evidence means for practice
The 3-year data presented by Gutman and colleagues should be viewed with caution, owing to the trial’s reduced sample size and power. However, they may be useful in designing future trials.
In the meantime, given the limited longer-term outcomes data available at present, I would recommend continued individualized use of mesh versus native-tissue repair in women presenting with prolapse, including educating patients about the risks and benefits of both approaches. It also is important that outcomes be followed in all of our patients in a robust, unbiased fashion. The new American Urogynecologic Society Pelvic Floor Disorders Registry provides the opportunity for this.
Holly E. Richter, PhD, MD

WE WANT TO HEAR FROM YOU!
Drop us a line and let us know what you think about current articles, which topics you'd like to see covered in future issues, and what challenges you face in daily practice. Tell us what you think by emailing us at: [email protected]