Leukemia patient

Credit: Bill Branson

Cancer deaths in children, adolescents, and young adults in the UK have fallen by 58% in the past 40 years, according to new figures from Cancer Research UK.*

Among cancer patients age 24 and under, the number of deaths each year dropped from about 1300 in the mid-1970s (1975-1977) to around 550 in more recent years (2010-2012).

And patients with leukemia have seen the steepest decline in mortality.

This is key because, according to Cancer Research UK, leukemia is the most commonly diagnosed cancer in children aged 14 and under and the sixth most commonly diagnosed cancer among 15- to 24-year-olds.

“These figures are testament to the real progress we’re making in treating children and young people with cancer,” said Pam Kearns, PhD, director of the Cancer Research UK Clinical Trials Unit in Birmingham.

“But hundreds of young people are dying from cancer each year in the UK, which means there’s still much more we need to do.”

Around 1600 children and 2200 adolescents and young adults are diagnosed with cancer every year in the UK.

And cancer remains the biggest killer of children and young people in the UK. It is the most common cause of death in children and young women aged 15 to 24 and the fourth most common cause of death in young men aged 15 to 24.

Still, the latest figures from Cancer Research UK show progress.

The mortality rate for all cancer patients ages 0 to 24 fell from 63.7 per million in 1975-1977 to 36.7 per million in 2001-2003 and then to 27.9 per million in 2010-2012. So the mortality rate has fallen 56% since 1975 and 24% in the last decade.

The average number of cancer deaths among children age 0 to 24 fell from 1325 in 1975-1977 to 681 in 2001-2003 and then to 550 in 2010-2012. That translates to a 58% decrease in deaths from 1975 and a 19% decrease in the last decade.

For leukemia patients ages 0 to 24, the mortality rate fell from 9.6 per million in 2001-2003 to 5.6 per million in 2010-2012, which translates to a 42% decrease. The annual average number of deaths dropped from 179 in 2001-2003 to 110 in 2010-2012, which translates to a 39% decrease.

“Cancer causes more deaths among children and young people than any other disease in the UK, so it’s hugely encouraging to see that death toll now falling steadily,” said Harpal Kumar, DSc, Cancer Research UK’s chief executive.

“But as the largest funder of research into children’s cancers in the UK, we will keep going until no young lives are lost to cancer.”

To that end, Cancer Research UK has launched “Cancer Research UK Kids & Teens,” an ongoing campaign to fund more research to find better treatments for young cancer patients.

“Money raised by ‘Cancer Research UK Kids & Teens’ will be restricted to research into cancers affecting children, teenagers, and young adults, enabling us to better understand these cancers and find better and kinder treatments and cures,” Dr Kumar said. “In the next 5 to 10 years, Cancer Research UK hopes to double the amount it spends on these cancers.”

*Some of the information in this article is not available on the Cancer Research UK website (and was sent to HematologyTimes upon request), but similar data and additional details are available on the organization’s Cancer Stats page.

Leukemia patient

Credit: Bill Branson

Cancer deaths in children, adolescents, and young adults in the UK have fallen by 58% in the past 40 years, according to new figures from Cancer Research UK.*

Among cancer patients age 24 and under, the number of deaths each year dropped from about 1300 in the mid-1970s (1975-1977) to around 550 in more recent years (2010-2012).

And patients with leukemia have seen the steepest decline in mortality.

This is key because, according to Cancer Research UK, leukemia is the most commonly diagnosed cancer in children aged 14 and under and the sixth most commonly diagnosed cancer among 15- to 24-year-olds.

“These figures are testament to the real progress we’re making in treating children and young people with cancer,” said Pam Kearns, PhD, director of the Cancer Research UK Clinical Trials Unit in Birmingham.

“But hundreds of young people are dying from cancer each year in the UK, which means there’s still much more we need to do.”

Around 1600 children and 2200 adolescents and young adults are diagnosed with cancer every year in the UK.

And cancer remains the biggest killer of children and young people in the UK. It is the most common cause of death in children and young women aged 15 to 24 and the fourth most common cause of death in young men aged 15 to 24.

Still, the latest figures from Cancer Research UK show progress.

The mortality rate for all cancer patients ages 0 to 24 fell from 63.7 per million in 1975-1977 to 36.7 per million in 2001-2003 and then to 27.9 per million in 2010-2012. So the mortality rate has fallen 56% since 1975 and 24% in the last decade.

The average number of cancer deaths among children age 0 to 24 fell from 1325 in 1975-1977 to 681 in 2001-2003 and then to 550 in 2010-2012. That translates to a 58% decrease in deaths from 1975 and a 19% decrease in the last decade.

For leukemia patients ages 0 to 24, the mortality rate fell from 9.6 per million in 2001-2003 to 5.6 per million in 2010-2012, which translates to a 42% decrease. The annual average number of deaths dropped from 179 in 2001-2003 to 110 in 2010-2012, which translates to a 39% decrease.

“Cancer causes more deaths among children and young people than any other disease in the UK, so it’s hugely encouraging to see that death toll now falling steadily,” said Harpal Kumar, DSc, Cancer Research UK’s chief executive.

“But as the largest funder of research into children’s cancers in the UK, we will keep going until no young lives are lost to cancer.”

To that end, Cancer Research UK has launched “Cancer Research UK Kids & Teens,” an ongoing campaign to fund more research to find better treatments for young cancer patients.

“Money raised by ‘Cancer Research UK Kids & Teens’ will be restricted to research into cancers affecting children, teenagers, and young adults, enabling us to better understand these cancers and find better and kinder treatments and cures,” Dr Kumar said. “In the next 5 to 10 years, Cancer Research UK hopes to double the amount it spends on these cancers.”

*Some of the information in this article is not available on the Cancer Research UK website (and was sent to HematologyTimes upon request), but similar data and additional details are available on the organization’s Cancer Stats page.

Leukemia patient

Credit: Bill Branson

Cancer deaths in children, adolescents, and young adults in the UK have fallen by 58% in the past 40 years, according to new figures from Cancer Research UK.*

Among cancer patients age 24 and under, the number of deaths each year dropped from about 1300 in the mid-1970s (1975-1977) to around 550 in more recent years (2010-2012).

And patients with leukemia have seen the steepest decline in mortality.

This is key because, according to Cancer Research UK, leukemia is the most commonly diagnosed cancer in children aged 14 and under and the sixth most commonly diagnosed cancer among 15- to 24-year-olds.

“These figures are testament to the real progress we’re making in treating children and young people with cancer,” said Pam Kearns, PhD, director of the Cancer Research UK Clinical Trials Unit in Birmingham.

“But hundreds of young people are dying from cancer each year in the UK, which means there’s still much more we need to do.”

Around 1600 children and 2200 adolescents and young adults are diagnosed with cancer every year in the UK.

And cancer remains the biggest killer of children and young people in the UK. It is the most common cause of death in children and young women aged 15 to 24 and the fourth most common cause of death in young men aged 15 to 24.

Still, the latest figures from Cancer Research UK show progress.

The mortality rate for all cancer patients ages 0 to 24 fell from 63.7 per million in 1975-1977 to 36.7 per million in 2001-2003 and then to 27.9 per million in 2010-2012. So the mortality rate has fallen 56% since 1975 and 24% in the last decade.

The average number of cancer deaths among children age 0 to 24 fell from 1325 in 1975-1977 to 681 in 2001-2003 and then to 550 in 2010-2012. That translates to a 58% decrease in deaths from 1975 and a 19% decrease in the last decade.

For leukemia patients ages 0 to 24, the mortality rate fell from 9.6 per million in 2001-2003 to 5.6 per million in 2010-2012, which translates to a 42% decrease. The annual average number of deaths dropped from 179 in 2001-2003 to 110 in 2010-2012, which translates to a 39% decrease.

“Cancer causes more deaths among children and young people than any other disease in the UK, so it’s hugely encouraging to see that death toll now falling steadily,” said Harpal Kumar, DSc, Cancer Research UK’s chief executive.

“But as the largest funder of research into children’s cancers in the UK, we will keep going until no young lives are lost to cancer.”

To that end, Cancer Research UK has launched “Cancer Research UK Kids & Teens,” an ongoing campaign to fund more research to find better treatments for young cancer patients.

“Money raised by ‘Cancer Research UK Kids & Teens’ will be restricted to research into cancers affecting children, teenagers, and young adults, enabling us to better understand these cancers and find better and kinder treatments and cures,” Dr Kumar said. “In the next 5 to 10 years, Cancer Research UK hopes to double the amount it spends on these cancers.”

*Some of the information in this article is not available on the Cancer Research UK website (and was sent to HematologyTimes upon request), but similar data and additional details are available on the organization’s Cancer Stats page.

Prescription medications

Credit: Steven Harbour

The European Medicines Agency (EMA) has recommended suspending a number of drugs that were approved in the European Union (EU) based on clinical studies conducted at GVK Biosciences in Hyderabad, India.

An inspection of the site suggested GVK Bio employees may have manipulated data from trials that took place there.

So the EMA compiled a list of drugs—which includes clopidogrel, dexamethasone, and tacrolimus, among others—that should be suspended.

However, the EMA said there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Bio, and patients should continue taking their medicines as prescribed.

The EMA’s opinion has been forwarded to the European Commission (EC), which will adopt a legally binding decision.

It was at the request of the EC that the EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed the drugs set to be suspended.

An inspection by the French medicines agency, Agence nationale de sécurité du médicament et des produits de santé (ANSM), in May 2014 uncovered “non-compliance with good clinical practice” at the GVK Bio site in Hyderabad.

The ANSM inspector analyzed 9 studies conducted there from 2008 to 2013 and found evidence suggesting that data from electrocardiograms (ECGs) had been manipulated. It appeared that GVK Bio employees were taking multiple ECGs of one volunteer and presenting them as ECGs of other volunteers.

The EMA said the systematic nature of these data manipulations, the extended period of time during which they took place, and the number of staff members involved casts doubt on the integrity of the way trials were performed at the Hyderabad facility and on the reliability of data generated there.

With this in mind, the CHMP looked at more than 1000 pharmaceutical forms and strengths of medicines studied at the site. For more than 300 of the medications, there was sufficient data from other sources to support the drugs’ authorization, so these will remain on the market in the EU.

For drugs that lack data from other studies, the CHMP recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs.

Whether a medicine is critical for patients will be determined by the national authorities of EU member states, depending on the situation in their country. For drugs that are considered critical, companies developing those drugs will be given 12 months to submit additional data.

The CHMP’s recommendation will be sent to the EC for a legally binding decision that will apply to all EU member states whether or not they have taken interim measures to suspend medicines.

GVK Bio responds

GVK Bio said an internal audit conducted following the ANSM inspection suggested that standard operating procedures were followed for the 9 trials analyzed. The organization also sought the opinion of 4 independent cardiologists, who said it was difficult to determine if the ECGs belong to the same volunteer or more than one person.

GVK Bio presented this information to the ANSM, but the agency concluded that the studies did not meet good clinical practice guidelines and should be rejected.

Following subsequent meetings and analyses, the EMA came to a similar conclusion—that the overall findings cast doubt on the results of trials conducted at the Hyderabad facility from 2008 to 2014.

GVK Bio said it respects the EMA’s decision, but their recommended suspension of drugs is “unprecedented and highly disproportional” for a few reasons.

First, the ANSM said the ECGs in question were not essential to demonstrate the bioequivalence of the drugs tested, and the agency’s recommendation to reject the 9 studies was a “precautionary” measure.

The ANSM also said the observations made during the inspection should not be extrapolated to other trial-related activities at the Hyderabad site or GVK Bio’s other site in Ahmedabad.

And finally, the EMA itself said there is no evidence proving that the drugs in question are ineffective or pose a risk to human health.

Prescription medications

Credit: Steven Harbour

The European Medicines Agency (EMA) has recommended suspending a number of drugs that were approved in the European Union (EU) based on clinical studies conducted at GVK Biosciences in Hyderabad, India.

An inspection of the site suggested GVK Bio employees may have manipulated data from trials that took place there.

So the EMA compiled a list of drugs—which includes clopidogrel, dexamethasone, and tacrolimus, among others—that should be suspended.

However, the EMA said there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Bio, and patients should continue taking their medicines as prescribed.

The EMA’s opinion has been forwarded to the European Commission (EC), which will adopt a legally binding decision.

It was at the request of the EC that the EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed the drugs set to be suspended.

An inspection by the French medicines agency, Agence nationale de sécurité du médicament et des produits de santé (ANSM), in May 2014 uncovered “non-compliance with good clinical practice” at the GVK Bio site in Hyderabad.

The ANSM inspector analyzed 9 studies conducted there from 2008 to 2013 and found evidence suggesting that data from electrocardiograms (ECGs) had been manipulated. It appeared that GVK Bio employees were taking multiple ECGs of one volunteer and presenting them as ECGs of other volunteers.

The EMA said the systematic nature of these data manipulations, the extended period of time during which they took place, and the number of staff members involved casts doubt on the integrity of the way trials were performed at the Hyderabad facility and on the reliability of data generated there.

With this in mind, the CHMP looked at more than 1000 pharmaceutical forms and strengths of medicines studied at the site. For more than 300 of the medications, there was sufficient data from other sources to support the drugs’ authorization, so these will remain on the market in the EU.

For drugs that lack data from other studies, the CHMP recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs.

Whether a medicine is critical for patients will be determined by the national authorities of EU member states, depending on the situation in their country. For drugs that are considered critical, companies developing those drugs will be given 12 months to submit additional data.

The CHMP’s recommendation will be sent to the EC for a legally binding decision that will apply to all EU member states whether or not they have taken interim measures to suspend medicines.

GVK Bio responds

GVK Bio said an internal audit conducted following the ANSM inspection suggested that standard operating procedures were followed for the 9 trials analyzed. The organization also sought the opinion of 4 independent cardiologists, who said it was difficult to determine if the ECGs belong to the same volunteer or more than one person.

GVK Bio presented this information to the ANSM, but the agency concluded that the studies did not meet good clinical practice guidelines and should be rejected.

Following subsequent meetings and analyses, the EMA came to a similar conclusion—that the overall findings cast doubt on the results of trials conducted at the Hyderabad facility from 2008 to 2014.

GVK Bio said it respects the EMA’s decision, but their recommended suspension of drugs is “unprecedented and highly disproportional” for a few reasons.

First, the ANSM said the ECGs in question were not essential to demonstrate the bioequivalence of the drugs tested, and the agency’s recommendation to reject the 9 studies was a “precautionary” measure.

The ANSM also said the observations made during the inspection should not be extrapolated to other trial-related activities at the Hyderabad site or GVK Bio’s other site in Ahmedabad.

And finally, the EMA itself said there is no evidence proving that the drugs in question are ineffective or pose a risk to human health.

Prescription medications

Credit: Steven Harbour

The European Medicines Agency (EMA) has recommended suspending a number of drugs that were approved in the European Union (EU) based on clinical studies conducted at GVK Biosciences in Hyderabad, India.

An inspection of the site suggested GVK Bio employees may have manipulated data from trials that took place there.

So the EMA compiled a list of drugs—which includes clopidogrel, dexamethasone, and tacrolimus, among others—that should be suspended.

However, the EMA said there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Bio, and patients should continue taking their medicines as prescribed.

The EMA’s opinion has been forwarded to the European Commission (EC), which will adopt a legally binding decision.

It was at the request of the EC that the EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed the drugs set to be suspended.

An inspection by the French medicines agency, Agence nationale de sécurité du médicament et des produits de santé (ANSM), in May 2014 uncovered “non-compliance with good clinical practice” at the GVK Bio site in Hyderabad.

The ANSM inspector analyzed 9 studies conducted there from 2008 to 2013 and found evidence suggesting that data from electrocardiograms (ECGs) had been manipulated. It appeared that GVK Bio employees were taking multiple ECGs of one volunteer and presenting them as ECGs of other volunteers.

The EMA said the systematic nature of these data manipulations, the extended period of time during which they took place, and the number of staff members involved casts doubt on the integrity of the way trials were performed at the Hyderabad facility and on the reliability of data generated there.

With this in mind, the CHMP looked at more than 1000 pharmaceutical forms and strengths of medicines studied at the site. For more than 300 of the medications, there was sufficient data from other sources to support the drugs’ authorization, so these will remain on the market in the EU.

For drugs that lack data from other studies, the CHMP recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs.

Whether a medicine is critical for patients will be determined by the national authorities of EU member states, depending on the situation in their country. For drugs that are considered critical, companies developing those drugs will be given 12 months to submit additional data.

The CHMP’s recommendation will be sent to the EC for a legally binding decision that will apply to all EU member states whether or not they have taken interim measures to suspend medicines.

GVK Bio responds

GVK Bio said an internal audit conducted following the ANSM inspection suggested that standard operating procedures were followed for the 9 trials analyzed. The organization also sought the opinion of 4 independent cardiologists, who said it was difficult to determine if the ECGs belong to the same volunteer or more than one person.

GVK Bio presented this information to the ANSM, but the agency concluded that the studies did not meet good clinical practice guidelines and should be rejected.

Following subsequent meetings and analyses, the EMA came to a similar conclusion—that the overall findings cast doubt on the results of trials conducted at the Hyderabad facility from 2008 to 2014.

GVK Bio said it respects the EMA’s decision, but their recommended suspension of drugs is “unprecedented and highly disproportional” for a few reasons.

First, the ANSM said the ECGs in question were not essential to demonstrate the bioequivalence of the drugs tested, and the agency’s recommendation to reject the 9 studies was a “precautionary” measure.

The ANSM also said the observations made during the inspection should not be extrapolated to other trial-related activities at the Hyderabad site or GVK Bio’s other site in Ahmedabad.

And finally, the EMA itself said there is no evidence proving that the drugs in question are ineffective or pose a risk to human health.

CORONADO, CALIF. – Results from a new meta-analysis suggest that glossectomy significantly improves sleep outcomes when performed as part of a multi-level surgery for adults with obstructive sleep apnea.

However, “there is insufficient evidence to analyze the role of glossectomy as a stand-alone procedure for the treatment of sleep apnea,” lead study author Dr. Alexander W. Murphey said in an interview in advance of The Triological Society’s Combined Sections meeting, where the work was presented. “The lack of available data for glossectomy as a single treatment was disappointing, and points to the need for further studies in this population.”

Glossectomy for OSA was first reported in 1991 as a salvage surgery after uvulopalatopharyngoplasty, said Dr. Murphey, who is completing a clinical research fellowship in the department of otolaryngology-head and neck surgery at Medical University of South Carolina, Charleston, under the mentoring of Dr. Marion B. Gillespie and Dr. Shaun A. Nguyen. Since that time, “many modifications have been made regarding technique and instrumentation with recent focus on minimally invasive techniques aimed at maximizing tissue reduction while limiting the inherent morbidity associated with glossectomy,” he said. “The aim of our study was to review and analyze all of the available literature on partial glossectomy for OSA in one study. Overall, there is a significant lack of research into glossectomy, and what literature is available include small, case-series that analyze glossectomy as part of complex, multi-level surgeries. This study represents the first large scale meta-analysis on the role of glossectomy, and attempts to determine the role of glossectomy both as part of multi-level surgery, and as a single, stand-alone sleep apnea treatment.”

Dr. Murphey used the PubMed-NCBI literature database to identify studies with 10 or more patients and reported preoperative and postoperative apnea-hypopnea index (AHI) scores. The primary endpoint was change in AHI while secondary endpoints included predefined surgical success rates, and changes in additional reported sleep outcomes such as Epworth Sleep Scores (ESS), Lowest Oxygen Saturation (LSAT), and snoring visual analog scale (VAS). The researchers reported results from 15 articles with 442 patients treated with three glossectomy techniques (midline glossectomy, lingualplasty, and submucosal minimally invasive lingual excision (SMILE). In pooled analyses that compared baseline vs. post-surgery, investigators observed significant reductions in AHI (from 48 to 20); ESS (from 12 to 5), and VAS (from 9 to 3; all with a P of less than .0001). In addition, they observed a significant increase in LSAT (from 77% to 84%; P less than .0001), according to the findings, presented at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

Surgical success, which was defined as an AHI less than 20 and a greater than 50% reduction in AHI, was achieved in 56% of cases, while complications occurred in 18% of patients. Only 24 patients (5%) were treated with glossectomy as sole therapy for OSA. Among these 24 patients, significant reductions occurred in AHI (from 42 to 25; P=.0345) and ESS (from 12 to 7; P less than .0001).

Dr. Murphey acknowledged certain limitations of the analysis, including “a lack of quality research involving glossectomy, with the majority of available published data drawn from small, case-series without control arms,” he said. “Additionally, studies varied in surgical approach, inclusion criteria, and accompanying procedures in multi-level treatment. This makes it extremely difficult to truly compare treatments.”

The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – Results from a new meta-analysis suggest that glossectomy significantly improves sleep outcomes when performed as part of a multi-level surgery for adults with obstructive sleep apnea.

However, “there is insufficient evidence to analyze the role of glossectomy as a stand-alone procedure for the treatment of sleep apnea,” lead study author Dr. Alexander W. Murphey said in an interview in advance of The Triological Society’s Combined Sections meeting, where the work was presented. “The lack of available data for glossectomy as a single treatment was disappointing, and points to the need for further studies in this population.”

Glossectomy for OSA was first reported in 1991 as a salvage surgery after uvulopalatopharyngoplasty, said Dr. Murphey, who is completing a clinical research fellowship in the department of otolaryngology-head and neck surgery at Medical University of South Carolina, Charleston, under the mentoring of Dr. Marion B. Gillespie and Dr. Shaun A. Nguyen. Since that time, “many modifications have been made regarding technique and instrumentation with recent focus on minimally invasive techniques aimed at maximizing tissue reduction while limiting the inherent morbidity associated with glossectomy,” he said. “The aim of our study was to review and analyze all of the available literature on partial glossectomy for OSA in one study. Overall, there is a significant lack of research into glossectomy, and what literature is available include small, case-series that analyze glossectomy as part of complex, multi-level surgeries. This study represents the first large scale meta-analysis on the role of glossectomy, and attempts to determine the role of glossectomy both as part of multi-level surgery, and as a single, stand-alone sleep apnea treatment.”

Dr. Murphey used the PubMed-NCBI literature database to identify studies with 10 or more patients and reported preoperative and postoperative apnea-hypopnea index (AHI) scores. The primary endpoint was change in AHI while secondary endpoints included predefined surgical success rates, and changes in additional reported sleep outcomes such as Epworth Sleep Scores (ESS), Lowest Oxygen Saturation (LSAT), and snoring visual analog scale (VAS). The researchers reported results from 15 articles with 442 patients treated with three glossectomy techniques (midline glossectomy, lingualplasty, and submucosal minimally invasive lingual excision (SMILE). In pooled analyses that compared baseline vs. post-surgery, investigators observed significant reductions in AHI (from 48 to 20); ESS (from 12 to 5), and VAS (from 9 to 3; all with a P of less than .0001). In addition, they observed a significant increase in LSAT (from 77% to 84%; P less than .0001), according to the findings, presented at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

Surgical success, which was defined as an AHI less than 20 and a greater than 50% reduction in AHI, was achieved in 56% of cases, while complications occurred in 18% of patients. Only 24 patients (5%) were treated with glossectomy as sole therapy for OSA. Among these 24 patients, significant reductions occurred in AHI (from 42 to 25; P=.0345) and ESS (from 12 to 7; P less than .0001).

Dr. Murphey acknowledged certain limitations of the analysis, including “a lack of quality research involving glossectomy, with the majority of available published data drawn from small, case-series without control arms,” he said. “Additionally, studies varied in surgical approach, inclusion criteria, and accompanying procedures in multi-level treatment. This makes it extremely difficult to truly compare treatments.”

The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – Results from a new meta-analysis suggest that glossectomy significantly improves sleep outcomes when performed as part of a multi-level surgery for adults with obstructive sleep apnea.

However, “there is insufficient evidence to analyze the role of glossectomy as a stand-alone procedure for the treatment of sleep apnea,” lead study author Dr. Alexander W. Murphey said in an interview in advance of The Triological Society’s Combined Sections meeting, where the work was presented. “The lack of available data for glossectomy as a single treatment was disappointing, and points to the need for further studies in this population.”

Glossectomy for OSA was first reported in 1991 as a salvage surgery after uvulopalatopharyngoplasty, said Dr. Murphey, who is completing a clinical research fellowship in the department of otolaryngology-head and neck surgery at Medical University of South Carolina, Charleston, under the mentoring of Dr. Marion B. Gillespie and Dr. Shaun A. Nguyen. Since that time, “many modifications have been made regarding technique and instrumentation with recent focus on minimally invasive techniques aimed at maximizing tissue reduction while limiting the inherent morbidity associated with glossectomy,” he said. “The aim of our study was to review and analyze all of the available literature on partial glossectomy for OSA in one study. Overall, there is a significant lack of research into glossectomy, and what literature is available include small, case-series that analyze glossectomy as part of complex, multi-level surgeries. This study represents the first large scale meta-analysis on the role of glossectomy, and attempts to determine the role of glossectomy both as part of multi-level surgery, and as a single, stand-alone sleep apnea treatment.”

Dr. Murphey used the PubMed-NCBI literature database to identify studies with 10 or more patients and reported preoperative and postoperative apnea-hypopnea index (AHI) scores. The primary endpoint was change in AHI while secondary endpoints included predefined surgical success rates, and changes in additional reported sleep outcomes such as Epworth Sleep Scores (ESS), Lowest Oxygen Saturation (LSAT), and snoring visual analog scale (VAS). The researchers reported results from 15 articles with 442 patients treated with three glossectomy techniques (midline glossectomy, lingualplasty, and submucosal minimally invasive lingual excision (SMILE). In pooled analyses that compared baseline vs. post-surgery, investigators observed significant reductions in AHI (from 48 to 20); ESS (from 12 to 5), and VAS (from 9 to 3; all with a P of less than .0001). In addition, they observed a significant increase in LSAT (from 77% to 84%; P less than .0001), according to the findings, presented at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

Surgical success, which was defined as an AHI less than 20 and a greater than 50% reduction in AHI, was achieved in 56% of cases, while complications occurred in 18% of patients. Only 24 patients (5%) were treated with glossectomy as sole therapy for OSA. Among these 24 patients, significant reductions occurred in AHI (from 42 to 25; P=.0345) and ESS (from 12 to 7; P less than .0001).

Dr. Murphey acknowledged certain limitations of the analysis, including “a lack of quality research involving glossectomy, with the majority of available published data drawn from small, case-series without control arms,” he said. “Additionally, studies varied in surgical approach, inclusion criteria, and accompanying procedures in multi-level treatment. This makes it extremely difficult to truly compare treatments.”

The researchers reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

All vascular surgeons want to be good doctors and to take the best possible care of their patients. They, therefore, train diligently and strive to keep up with new developments by reading vascular journals and attending cutting edge vascular meetings. They seek to optimize their judgment, communicate well and honestly with patients, perform their procedures with care, and follow their patients closely.

However, doing all these things does not ensure ascendancy in the profession. There are other factors which go into being a successful vascular surgeon. Many of these are not taught in medical school or residency training, and failure to recognize their importance can derail an otherwise prominent career. It is, therefore, important to highlight some of these factors which can be pitfalls to even the best trained and most committed vascular surgeon.

Vascular surgeons exist in a professionally competitive environment. We compete for patients with several other specialists including interventional cardiologists, interventional radiologists, and some general and cardiac surgeons as well as other lesser competitors.

All are hungry for patients and all consider themselves expert in all or some of the things we do. We also face competition from other vascular surgeons, few of whom feel busy enough to turn away patients. Therefore, it is important that vascular surgeons consider the competitive landscape when they are choosing a location or institution in which to practice. Is there an empty niche for the particular skills one brings to the area or the institution, and will other physicians in the area recognize those skills? Even then they must compete effectively not only by providing superior care but also by engaging in appropriate public relations and marketing of their assets.

Recognizing the importance of professional relationships with nonphysicians and other physicians outside our specialty and cultivating these relationships are other keys to success. The need for good relationships with referring physicians is obvious. Not so obvious is the need to have good relationships with hospital administrators who control essential resources, with other specialists like anesthesiologists and intensivists who can optimize the care our patients receive, with industry representatives, and even with other vascular surgeons. To make these relationships work to our advantage it is crucial to make them mutually beneficial. People are much more inclined to be helpful if what they are doing also helps them. Mutual self-interest can even improve interactions with competitors.

It is also important to avoid making enemies. This is particularly hard to do in the competitive environment in which we work. It is even harder to do in the present health care setting in which others who we do not control are unreasonable or incompetent. This is particularly true with those in positions of administrative authority like hospital executives or operating room supervisors. Making enemies of these individuals can be disastrous since they often control resources that determine our destiny. Keeping such individuals supportive or at least neutral, despite their possible serious flaws, is worth the sometimes painful effort required.

One must also be aware that nothing elicits hostility like success. If a young vascular surgeon/specialist has introduced a new technique or is particularly charming and hard-working and therefore has a booming practice, rest assured that his or her competitors – or even non-competitors – will be covertly or overtly hostile and take every opportunity to damage or bring down the successful individual. It does not matter that the hostility is unjustified and based on jealousy. It can still be unfairly damaging. All should realize that jealousy and greed are among the most powerful motivators of human behavior.

In view of all these considerations, it is apparent that all vascular surgeons, especially talented and successful ones, will at various times in their careers face battles. All cannot be fought. So one has to decide which ones should be avoided and which ones to engage in. Battles to fight should be picked carefully because they will consume energy and leave scars, no matter the outcome.

Most battles are best avoided unless victory is certain. Multiple simultaneous battles should be avoided. Battles in which one faces numerous opponents at the same time should also be shunned. Ideally in unavoidable conflicts, one should have as many allies as possible, although the loyalty of allies cannot always be counted on. Self-interest will determine the loyalty of presumed allies.

Never underestimate enemies, or overestimate allies. If the outcome of a battle is uncertain or to be determined by a board or other group, know how that group will vote before taking on the fight. Always remember the role of jealousy and greed in determining human behavior in battle. Defeated opponents do not forget and are forever dangerous.

Time is a vascular surgeon’s most important asset. Anything that one can do to enlist others to protect or expand this time is helpful. To this end, loyal nurses, physician’s assistants, or nonprofessional associates are invaluable. Their loyalty, which must be reciprocated, can be earned by recognizing their contributions and rewarding them intellectually and financially. This mutual loyalty is essential to success in practice and in the inevitable conflicts that will occur.

All these concepts and many others are not covered in medical school or residency training. Yet all are important in a vascular surgery career, whether it be in a practice or academic setting. Human nature is a constant and its elements may often work against one’s success. Being aware of some of these often noxious and little discussed elements will hopefully enable vascular surgeons to cope with them better and ultimately survive in what can be a difficult environment.

Dr. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular 
Specialist do not necessarily reflect those of the Society or publisher.

All vascular surgeons want to be good doctors and to take the best possible care of their patients. They, therefore, train diligently and strive to keep up with new developments by reading vascular journals and attending cutting edge vascular meetings. They seek to optimize their judgment, communicate well and honestly with patients, perform their procedures with care, and follow their patients closely.

However, doing all these things does not ensure ascendancy in the profession. There are other factors which go into being a successful vascular surgeon. Many of these are not taught in medical school or residency training, and failure to recognize their importance can derail an otherwise prominent career. It is, therefore, important to highlight some of these factors which can be pitfalls to even the best trained and most committed vascular surgeon.

Vascular surgeons exist in a professionally competitive environment. We compete for patients with several other specialists including interventional cardiologists, interventional radiologists, and some general and cardiac surgeons as well as other lesser competitors.

All are hungry for patients and all consider themselves expert in all or some of the things we do. We also face competition from other vascular surgeons, few of whom feel busy enough to turn away patients. Therefore, it is important that vascular surgeons consider the competitive landscape when they are choosing a location or institution in which to practice. Is there an empty niche for the particular skills one brings to the area or the institution, and will other physicians in the area recognize those skills? Even then they must compete effectively not only by providing superior care but also by engaging in appropriate public relations and marketing of their assets.

Recognizing the importance of professional relationships with nonphysicians and other physicians outside our specialty and cultivating these relationships are other keys to success. The need for good relationships with referring physicians is obvious. Not so obvious is the need to have good relationships with hospital administrators who control essential resources, with other specialists like anesthesiologists and intensivists who can optimize the care our patients receive, with industry representatives, and even with other vascular surgeons. To make these relationships work to our advantage it is crucial to make them mutually beneficial. People are much more inclined to be helpful if what they are doing also helps them. Mutual self-interest can even improve interactions with competitors.

It is also important to avoid making enemies. This is particularly hard to do in the competitive environment in which we work. It is even harder to do in the present health care setting in which others who we do not control are unreasonable or incompetent. This is particularly true with those in positions of administrative authority like hospital executives or operating room supervisors. Making enemies of these individuals can be disastrous since they often control resources that determine our destiny. Keeping such individuals supportive or at least neutral, despite their possible serious flaws, is worth the sometimes painful effort required.

One must also be aware that nothing elicits hostility like success. If a young vascular surgeon/specialist has introduced a new technique or is particularly charming and hard-working and therefore has a booming practice, rest assured that his or her competitors – or even non-competitors – will be covertly or overtly hostile and take every opportunity to damage or bring down the successful individual. It does not matter that the hostility is unjustified and based on jealousy. It can still be unfairly damaging. All should realize that jealousy and greed are among the most powerful motivators of human behavior.

In view of all these considerations, it is apparent that all vascular surgeons, especially talented and successful ones, will at various times in their careers face battles. All cannot be fought. So one has to decide which ones should be avoided and which ones to engage in. Battles to fight should be picked carefully because they will consume energy and leave scars, no matter the outcome.

Most battles are best avoided unless victory is certain. Multiple simultaneous battles should be avoided. Battles in which one faces numerous opponents at the same time should also be shunned. Ideally in unavoidable conflicts, one should have as many allies as possible, although the loyalty of allies cannot always be counted on. Self-interest will determine the loyalty of presumed allies.

Never underestimate enemies, or overestimate allies. If the outcome of a battle is uncertain or to be determined by a board or other group, know how that group will vote before taking on the fight. Always remember the role of jealousy and greed in determining human behavior in battle. Defeated opponents do not forget and are forever dangerous.

Time is a vascular surgeon’s most important asset. Anything that one can do to enlist others to protect or expand this time is helpful. To this end, loyal nurses, physician’s assistants, or nonprofessional associates are invaluable. Their loyalty, which must be reciprocated, can be earned by recognizing their contributions and rewarding them intellectually and financially. This mutual loyalty is essential to success in practice and in the inevitable conflicts that will occur.

All these concepts and many others are not covered in medical school or residency training. Yet all are important in a vascular surgery career, whether it be in a practice or academic setting. Human nature is a constant and its elements may often work against one’s success. Being aware of some of these often noxious and little discussed elements will hopefully enable vascular surgeons to cope with them better and ultimately survive in what can be a difficult environment.

Dr. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular 
Specialist do not necessarily reflect those of the Society or publisher.

All vascular surgeons want to be good doctors and to take the best possible care of their patients. They, therefore, train diligently and strive to keep up with new developments by reading vascular journals and attending cutting edge vascular meetings. They seek to optimize their judgment, communicate well and honestly with patients, perform their procedures with care, and follow their patients closely.

However, doing all these things does not ensure ascendancy in the profession. There are other factors which go into being a successful vascular surgeon. Many of these are not taught in medical school or residency training, and failure to recognize their importance can derail an otherwise prominent career. It is, therefore, important to highlight some of these factors which can be pitfalls to even the best trained and most committed vascular surgeon.

Vascular surgeons exist in a professionally competitive environment. We compete for patients with several other specialists including interventional cardiologists, interventional radiologists, and some general and cardiac surgeons as well as other lesser competitors.

All are hungry for patients and all consider themselves expert in all or some of the things we do. We also face competition from other vascular surgeons, few of whom feel busy enough to turn away patients. Therefore, it is important that vascular surgeons consider the competitive landscape when they are choosing a location or institution in which to practice. Is there an empty niche for the particular skills one brings to the area or the institution, and will other physicians in the area recognize those skills? Even then they must compete effectively not only by providing superior care but also by engaging in appropriate public relations and marketing of their assets.

Recognizing the importance of professional relationships with nonphysicians and other physicians outside our specialty and cultivating these relationships are other keys to success. The need for good relationships with referring physicians is obvious. Not so obvious is the need to have good relationships with hospital administrators who control essential resources, with other specialists like anesthesiologists and intensivists who can optimize the care our patients receive, with industry representatives, and even with other vascular surgeons. To make these relationships work to our advantage it is crucial to make them mutually beneficial. People are much more inclined to be helpful if what they are doing also helps them. Mutual self-interest can even improve interactions with competitors.

It is also important to avoid making enemies. This is particularly hard to do in the competitive environment in which we work. It is even harder to do in the present health care setting in which others who we do not control are unreasonable or incompetent. This is particularly true with those in positions of administrative authority like hospital executives or operating room supervisors. Making enemies of these individuals can be disastrous since they often control resources that determine our destiny. Keeping such individuals supportive or at least neutral, despite their possible serious flaws, is worth the sometimes painful effort required.

One must also be aware that nothing elicits hostility like success. If a young vascular surgeon/specialist has introduced a new technique or is particularly charming and hard-working and therefore has a booming practice, rest assured that his or her competitors – or even non-competitors – will be covertly or overtly hostile and take every opportunity to damage or bring down the successful individual. It does not matter that the hostility is unjustified and based on jealousy. It can still be unfairly damaging. All should realize that jealousy and greed are among the most powerful motivators of human behavior.

In view of all these considerations, it is apparent that all vascular surgeons, especially talented and successful ones, will at various times in their careers face battles. All cannot be fought. So one has to decide which ones should be avoided and which ones to engage in. Battles to fight should be picked carefully because they will consume energy and leave scars, no matter the outcome.

Most battles are best avoided unless victory is certain. Multiple simultaneous battles should be avoided. Battles in which one faces numerous opponents at the same time should also be shunned. Ideally in unavoidable conflicts, one should have as many allies as possible, although the loyalty of allies cannot always be counted on. Self-interest will determine the loyalty of presumed allies.

Never underestimate enemies, or overestimate allies. If the outcome of a battle is uncertain or to be determined by a board or other group, know how that group will vote before taking on the fight. Always remember the role of jealousy and greed in determining human behavior in battle. Defeated opponents do not forget and are forever dangerous.

Time is a vascular surgeon’s most important asset. Anything that one can do to enlist others to protect or expand this time is helpful. To this end, loyal nurses, physician’s assistants, or nonprofessional associates are invaluable. Their loyalty, which must be reciprocated, can be earned by recognizing their contributions and rewarding them intellectually and financially. This mutual loyalty is essential to success in practice and in the inevitable conflicts that will occur.

All these concepts and many others are not covered in medical school or residency training. Yet all are important in a vascular surgery career, whether it be in a practice or academic setting. Human nature is a constant and its elements may often work against one’s success. Being aware of some of these often noxious and little discussed elements will hopefully enable vascular surgeons to cope with them better and ultimately survive in what can be a difficult environment.

Dr. Veith is professor of surgery at New York University Medical Center and the Cleveland Clinic and an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular 
Specialist do not necessarily reflect those of the Society or publisher.

Team performing surgery

Credit: Piotr Bodzek

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval for the antiplatelet agent cangrelor (Kengrexal) and a hemostatic sealant powder to be marketed as Raplixa (formerly known as Fibrocaps).

Cangrelor is an intravenous antiplatelet agent that provides immediate and reversible P2Y12 inhibition. It is intended to prevent thrombosis in the acute care setting.

The sealant powder is a ready-to-use, biologically active, powdered fibrin sealant that provides hemostasis in a range of bleeding settings. It is intended for use in patients undergoing surgery.

Neither product has been approved for commercial use in any market, and both are under review by the US Food and Drug Administration as well as the European Medicines Agency/European Commission.

The European Commission generally follows CHMP recommendations for marketing authorizations and delivers its final decision within 3 months of the CHMP recommendation. Decisions are applicable to all 28 member states of the European Union, plus Iceland, Norway, and Liechtenstein.

About cangrelor

Cangrelor is intended to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, particularly in patients undergoing percutaneous coronary intervention (PCI).

The CHMP is recommending cangrelor for European marketing authorization based on results from the CHAMPION PHOENIX trial, which was funded by the drug’s developer, The Medicines Company.

This phase 3, randomized, double-blind trial was a comparison of cangrelor and oral clopidogrel in 11,145 patients undergoing PCI.

In the initial analysis of the trial data, researchers found that cangrelor reduced the overall odds of complications from stenting procedures—including death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis—compared to clopidogrel.

However, cangrelor also increased the risk of major and minor bleeding, as well as transient dyspnea.

Results of a second analysis suggested cangrelor can reduce the risk of stent thrombosis alone in patients undergoing PCI, when compared to clopidogrel. Cangrelor was an independent predictor of freedom from stent thrombosis at 30 days after PCI.

About Raplixa 

This sealant powder is a mixture of 2 essential blood clotting proteins, fibrinogen and thrombin, formulated as a dry powder for topical use. It is intended to aid hemostasis during surgery.

The CHMP is recommending Raplixa (formerly Fibrocaps) for European marketing authorization based on results of the phase 3 FINISH-3 trial, which was funded by ProFibrix, Inc., the company that was developing the product at the time. (The Medicines Company recently purchased all the outstanding equity of ProFibrix.)

In this randomized, single-blind, controlled trial, researchers compared Raplixa administered with a gelatin sponge to the gelatin sponge alone as a hemostat for surgical bleeding in 4 indications: spinal, hepatic, vascular, and soft tissue dissection.

Raplixa significantly reduced the median time to hemostasis and the restricted mean time to hemostasis, compared with the gelatin sponge alone, for all 4 indications. Raplixa also significantly increased the probability of hemostasis at 3- and 5-minute time points.

The incidence of adverse events was generally similar between the treatment arms. However, non-neutralizing, anti-thrombin antibodies were slightly more common in the sponge-alone arm.

Team performing surgery

Credit: Piotr Bodzek

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval for the antiplatelet agent cangrelor (Kengrexal) and a hemostatic sealant powder to be marketed as Raplixa (formerly known as Fibrocaps).

Cangrelor is an intravenous antiplatelet agent that provides immediate and reversible P2Y12 inhibition. It is intended to prevent thrombosis in the acute care setting.

The sealant powder is a ready-to-use, biologically active, powdered fibrin sealant that provides hemostasis in a range of bleeding settings. It is intended for use in patients undergoing surgery.

Neither product has been approved for commercial use in any market, and both are under review by the US Food and Drug Administration as well as the European Medicines Agency/European Commission.

The European Commission generally follows CHMP recommendations for marketing authorizations and delivers its final decision within 3 months of the CHMP recommendation. Decisions are applicable to all 28 member states of the European Union, plus Iceland, Norway, and Liechtenstein.

About cangrelor

Cangrelor is intended to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, particularly in patients undergoing percutaneous coronary intervention (PCI).

The CHMP is recommending cangrelor for European marketing authorization based on results from the CHAMPION PHOENIX trial, which was funded by the drug’s developer, The Medicines Company.

This phase 3, randomized, double-blind trial was a comparison of cangrelor and oral clopidogrel in 11,145 patients undergoing PCI.

In the initial analysis of the trial data, researchers found that cangrelor reduced the overall odds of complications from stenting procedures—including death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis—compared to clopidogrel.

However, cangrelor also increased the risk of major and minor bleeding, as well as transient dyspnea.

Results of a second analysis suggested cangrelor can reduce the risk of stent thrombosis alone in patients undergoing PCI, when compared to clopidogrel. Cangrelor was an independent predictor of freedom from stent thrombosis at 30 days after PCI.

About Raplixa 

This sealant powder is a mixture of 2 essential blood clotting proteins, fibrinogen and thrombin, formulated as a dry powder for topical use. It is intended to aid hemostasis during surgery.

The CHMP is recommending Raplixa (formerly Fibrocaps) for European marketing authorization based on results of the phase 3 FINISH-3 trial, which was funded by ProFibrix, Inc., the company that was developing the product at the time. (The Medicines Company recently purchased all the outstanding equity of ProFibrix.)

In this randomized, single-blind, controlled trial, researchers compared Raplixa administered with a gelatin sponge to the gelatin sponge alone as a hemostat for surgical bleeding in 4 indications: spinal, hepatic, vascular, and soft tissue dissection.

Raplixa significantly reduced the median time to hemostasis and the restricted mean time to hemostasis, compared with the gelatin sponge alone, for all 4 indications. Raplixa also significantly increased the probability of hemostasis at 3- and 5-minute time points.

The incidence of adverse events was generally similar between the treatment arms. However, non-neutralizing, anti-thrombin antibodies were slightly more common in the sponge-alone arm.

Team performing surgery

Credit: Piotr Bodzek

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval for the antiplatelet agent cangrelor (Kengrexal) and a hemostatic sealant powder to be marketed as Raplixa (formerly known as Fibrocaps).

Cangrelor is an intravenous antiplatelet agent that provides immediate and reversible P2Y12 inhibition. It is intended to prevent thrombosis in the acute care setting.

The sealant powder is a ready-to-use, biologically active, powdered fibrin sealant that provides hemostasis in a range of bleeding settings. It is intended for use in patients undergoing surgery.

Neither product has been approved for commercial use in any market, and both are under review by the US Food and Drug Administration as well as the European Medicines Agency/European Commission.

The European Commission generally follows CHMP recommendations for marketing authorizations and delivers its final decision within 3 months of the CHMP recommendation. Decisions are applicable to all 28 member states of the European Union, plus Iceland, Norway, and Liechtenstein.

About cangrelor

Cangrelor is intended to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, particularly in patients undergoing percutaneous coronary intervention (PCI).

The CHMP is recommending cangrelor for European marketing authorization based on results from the CHAMPION PHOENIX trial, which was funded by the drug’s developer, The Medicines Company.

This phase 3, randomized, double-blind trial was a comparison of cangrelor and oral clopidogrel in 11,145 patients undergoing PCI.

In the initial analysis of the trial data, researchers found that cangrelor reduced the overall odds of complications from stenting procedures—including death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis—compared to clopidogrel.

However, cangrelor also increased the risk of major and minor bleeding, as well as transient dyspnea.

Results of a second analysis suggested cangrelor can reduce the risk of stent thrombosis alone in patients undergoing PCI, when compared to clopidogrel. Cangrelor was an independent predictor of freedom from stent thrombosis at 30 days after PCI.

About Raplixa 

This sealant powder is a mixture of 2 essential blood clotting proteins, fibrinogen and thrombin, formulated as a dry powder for topical use. It is intended to aid hemostasis during surgery.

The CHMP is recommending Raplixa (formerly Fibrocaps) for European marketing authorization based on results of the phase 3 FINISH-3 trial, which was funded by ProFibrix, Inc., the company that was developing the product at the time. (The Medicines Company recently purchased all the outstanding equity of ProFibrix.)

In this randomized, single-blind, controlled trial, researchers compared Raplixa administered with a gelatin sponge to the gelatin sponge alone as a hemostat for surgical bleeding in 4 indications: spinal, hepatic, vascular, and soft tissue dissection.

Raplixa significantly reduced the median time to hemostasis and the restricted mean time to hemostasis, compared with the gelatin sponge alone, for all 4 indications. Raplixa also significantly increased the probability of hemostasis at 3- and 5-minute time points.

The incidence of adverse events was generally similar between the treatment arms. However, non-neutralizing, anti-thrombin antibodies were slightly more common in the sponge-alone arm.

Hydroxyurea

Credit: Zak Hubbard

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending the approval of ruxolitinib (Jakavi) to

treat adults with polycythemia vera (PV) who are resistant to or cannot tolerate hydroxyurea.

The European Commission generally follows the CHMP’s advice and delivers its final decision within 3 months of the CHMP recommendation.

If approved, ruxolitinib would be the first targeted treatment option for PV patients in Europe.

The European Commission’s decision will be applicable to all 28 member states of the European Union, plus Iceland, Norway, and Liechtenstein.

About ruxolitinib

Ruxolitinib is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. It was approved by the European Commission in August 2012 to treat adults with primary myelofibrosis (MF), post-PV MF, or post-essential thrombocythemia MF. The drug is approved to treat MF in more than 70 countries.

Novartis licensed ruxolitinib from Incyte Corporation (which markets the drug as Jakafi in the US) for development and commercialization outside the US. Ruxolitinib is approved in the US to treat patients with MF and those with PV.

Ruxolitinib in PV: The RESPONSE trial

The CHMP’s recommendation to approve ruxolitinib for PV was based on results from the phase 3 RESPONSE trial, which was funded by Incyte.

The trial included 222 patients who had PV for at least 24 weeks. All patients had an inadequate response to or could not tolerate hydroxyurea, had undergone a phlebotomy, and had an enlarged spleen.

They were randomized to receive ruxolitinib starting at 10 mg twice daily or best available therapy (BAT) as determined by the investigator. The ruxolitinib dose was adjusted as needed.

The study was designed to measure the reduced need for phlebotomy beginning at week 8 and continuing through week 32, in addition to at least a 35% reduction in spleen volume at week 32.

Twenty-one percent of ruxolitinib-treated patients met this endpoint, compared to 1% of patients who received BAT.

Ruxolitinib was generally well-tolerated, but 3.6% of patients discontinued treatment due to adverse events, compared to 1.8% of patients on BAT.

The most common hematologic adverse events associated with ruxolitinib were anemia and thrombocytopenia. The most common non-hematologic events were headache, diarrhea, fatigue, dizziness, constipation, and shingles.

Hydroxyurea

Credit: Zak Hubbard

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending the approval of ruxolitinib (Jakavi) to

treat adults with polycythemia vera (PV) who are resistant to or cannot tolerate hydroxyurea.

The European Commission generally follows the CHMP’s advice and delivers its final decision within 3 months of the CHMP recommendation.

If approved, ruxolitinib would be the first targeted treatment option for PV patients in Europe.

The European Commission’s decision will be applicable to all 28 member states of the European Union, plus Iceland, Norway, and Liechtenstein.

About ruxolitinib

Ruxolitinib is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. It was approved by the European Commission in August 2012 to treat adults with primary myelofibrosis (MF), post-PV MF, or post-essential thrombocythemia MF. The drug is approved to treat MF in more than 70 countries.

Novartis licensed ruxolitinib from Incyte Corporation (which markets the drug as Jakafi in the US) for development and commercialization outside the US. Ruxolitinib is approved in the US to treat patients with MF and those with PV.

Ruxolitinib in PV: The RESPONSE trial

The CHMP’s recommendation to approve ruxolitinib for PV was based on results from the phase 3 RESPONSE trial, which was funded by Incyte.

The trial included 222 patients who had PV for at least 24 weeks. All patients had an inadequate response to or could not tolerate hydroxyurea, had undergone a phlebotomy, and had an enlarged spleen.

They were randomized to receive ruxolitinib starting at 10 mg twice daily or best available therapy (BAT) as determined by the investigator. The ruxolitinib dose was adjusted as needed.

The study was designed to measure the reduced need for phlebotomy beginning at week 8 and continuing through week 32, in addition to at least a 35% reduction in spleen volume at week 32.

Twenty-one percent of ruxolitinib-treated patients met this endpoint, compared to 1% of patients who received BAT.

Ruxolitinib was generally well-tolerated, but 3.6% of patients discontinued treatment due to adverse events, compared to 1.8% of patients on BAT.

The most common hematologic adverse events associated with ruxolitinib were anemia and thrombocytopenia. The most common non-hematologic events were headache, diarrhea, fatigue, dizziness, constipation, and shingles.

Hydroxyurea

Credit: Zak Hubbard

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending the approval of ruxolitinib (Jakavi) to

treat adults with polycythemia vera (PV) who are resistant to or cannot tolerate hydroxyurea.

The European Commission generally follows the CHMP’s advice and delivers its final decision within 3 months of the CHMP recommendation.

If approved, ruxolitinib would be the first targeted treatment option for PV patients in Europe.

The European Commission’s decision will be applicable to all 28 member states of the European Union, plus Iceland, Norway, and Liechtenstein.

About ruxolitinib

Ruxolitinib is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. It was approved by the European Commission in August 2012 to treat adults with primary myelofibrosis (MF), post-PV MF, or post-essential thrombocythemia MF. The drug is approved to treat MF in more than 70 countries.

Novartis licensed ruxolitinib from Incyte Corporation (which markets the drug as Jakafi in the US) for development and commercialization outside the US. Ruxolitinib is approved in the US to treat patients with MF and those with PV.

Ruxolitinib in PV: The RESPONSE trial

The CHMP’s recommendation to approve ruxolitinib for PV was based on results from the phase 3 RESPONSE trial, which was funded by Incyte.

The trial included 222 patients who had PV for at least 24 weeks. All patients had an inadequate response to or could not tolerate hydroxyurea, had undergone a phlebotomy, and had an enlarged spleen.

They were randomized to receive ruxolitinib starting at 10 mg twice daily or best available therapy (BAT) as determined by the investigator. The ruxolitinib dose was adjusted as needed.

The study was designed to measure the reduced need for phlebotomy beginning at week 8 and continuing through week 32, in addition to at least a 35% reduction in spleen volume at week 32.

Twenty-one percent of ruxolitinib-treated patients met this endpoint, compared to 1% of patients who received BAT.

Ruxolitinib was generally well-tolerated, but 3.6% of patients discontinued treatment due to adverse events, compared to 1.8% of patients on BAT.

The most common hematologic adverse events associated with ruxolitinib were anemia and thrombocytopenia. The most common non-hematologic events were headache, diarrhea, fatigue, dizziness, constipation, and shingles.

Shortly after passage of the $1.1 trillion “Cromnibus,” the House and Senate concluded their legislative business for the 113th Congress and adjourned. Many issues of importance to surgeons and our patients remain unresolved and are expected to be high on the legislative agenda of the 114th Congress in the first quarter of 2015.

Returning as Members of Congress in January will be two physicians whose campaigns were assisted by the active participation of SurgeonsPAC. They are Dr. Ami Bera, an emergency physician from the 7th District of California (Sacramento area) and Dr. Dan Benishek, a general surgeon and fellow of the American College of Surgeons from the 1st District of Michigan (Upper Peninsula). Both Dr. Bera and Dr. Benishek have served as champions for the cause of the legislative agenda supported by the College.

One of the ways by which SurgeonsPAC participated in the re-election campaign of both Members is known as an independent expenditure (IE). The Code of Federal Regulations defines and independent expenditure as an expenditure for a communication that expressly advocates for “the election or defeat of a clearly identified candidate that is not made in cooperation, consultation, or concert with, or at the request or suggestion of, a candidate, a candidate’s authorized committee, or their agents, or a political party committee or its agents.” [11 CFR 100.16(a)]

In August, the Board of Directors of SurgeonsPAC unanimously voted to direct staff of the Division of Advocacy and Health Policy to develop recommendations for independent expenditures for a bipartisan slate of candidates who had a record of being supportive of the College’s legislative agenda and whose election was enough at risk that an independent expenditure by the College would potentially be of significant benefit for their race. In October, the PAC Board considered those recommendations and voted to support the expenditure of $100,000 each for IEs for Dr. Bera, a Democrat, and Dr. Benishek, a Republican. Both have been champions on issues such as repeal and replacement of the Sustainable Growth Rate (SGR), medical liability reform, and repeal of the 96-hour rule.

For Dr. Bera, the SurgeonsPAC dollars were utilized for a radio and direct mail campaign that was part of a larger effort in which other physician political action committees participated similarly. For Dr. Benishek, a television ad was produced and run through local cable providers.

On election night, Dr. Benishek was declared the winner, receiving 52.1% of the vote compared with his opponent’s 45.3%. As one of four fellows of the American College of Surgeons in Congress, we look forward to continuing to work with “Dr. Dan” and his excellent staff in his upcoming third term.

Dr. Bera’s race was much closer, as he actually trailed his opponent when election night closed with 49.8% of the vote. Subsequently, with the counting and inclusion of the mail-in ballots specifically targeted by the physician community’s IE effort, Dr. Bera overtook his opponent’s slim margin. Two weeks later, on 19 Nov. 2014, the Associated Press called the election for Dr. Bera, whose 1,400-vote lead at that time was felt to be substantial enough to preclude his opponent making up the difference with the remaining 4,300 provisional ballots that had yet to be counted. Dr. Bera’s CA-7 district race proved to be the most expensive in the nation with an estimated $19.6 million in total expenditures. Despite representing only 0.51% of that total, SurgeonsPAC’s contribution, in the collective with that of other physician organizations, no doubt played a significant role in returning a physician to Congress to continue to champion our causes.

In my opinion, these examples of careful candidate selection and subsequent support of Drs. Benishek and Bera exemplify the importance of a strong political action committee. The ultimate goal of SurgeonsPAC is the election to Congress and retention in Congress of those who support our policy positions and legislative agenda. Though SurgeonsPAC is one of nine physician PACs that can be accurately labeled as “million dollar” (per election cycle) PACs, our relative size and, thus, the number of candidates like Drs. Bera and Benishek we could support would be much greater if the Fellow participation rate more closely resembled that of our colleagues in other physician organizations. However, year after year, only 3%-4% of Fellows contribute, as compared with participation rates of 10%-25% in those physician PACs larger than SurgeonsPAC.

Recently, all Fellows received an e-mail from Dr. Andrew Warshaw, founding SurgeonsPAC Board Chairman and current President of the ACS, urging Fellows to make a $25 donation to SurgeonsPAC. Those wishing to learn more about the critical role SurgeonsPAC plays in our advocacy efforts can log on to www.surgeonspac.org.

Until next month...

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.

Shortly after passage of the $1.1 trillion “Cromnibus,” the House and Senate concluded their legislative business for the 113th Congress and adjourned. Many issues of importance to surgeons and our patients remain unresolved and are expected to be high on the legislative agenda of the 114th Congress in the first quarter of 2015.

Returning as Members of Congress in January will be two physicians whose campaigns were assisted by the active participation of SurgeonsPAC. They are Dr. Ami Bera, an emergency physician from the 7th District of California (Sacramento area) and Dr. Dan Benishek, a general surgeon and fellow of the American College of Surgeons from the 1st District of Michigan (Upper Peninsula). Both Dr. Bera and Dr. Benishek have served as champions for the cause of the legislative agenda supported by the College.

One of the ways by which SurgeonsPAC participated in the re-election campaign of both Members is known as an independent expenditure (IE). The Code of Federal Regulations defines and independent expenditure as an expenditure for a communication that expressly advocates for “the election or defeat of a clearly identified candidate that is not made in cooperation, consultation, or concert with, or at the request or suggestion of, a candidate, a candidate’s authorized committee, or their agents, or a political party committee or its agents.” [11 CFR 100.16(a)]

In August, the Board of Directors of SurgeonsPAC unanimously voted to direct staff of the Division of Advocacy and Health Policy to develop recommendations for independent expenditures for a bipartisan slate of candidates who had a record of being supportive of the College’s legislative agenda and whose election was enough at risk that an independent expenditure by the College would potentially be of significant benefit for their race. In October, the PAC Board considered those recommendations and voted to support the expenditure of $100,000 each for IEs for Dr. Bera, a Democrat, and Dr. Benishek, a Republican. Both have been champions on issues such as repeal and replacement of the Sustainable Growth Rate (SGR), medical liability reform, and repeal of the 96-hour rule.

For Dr. Bera, the SurgeonsPAC dollars were utilized for a radio and direct mail campaign that was part of a larger effort in which other physician political action committees participated similarly. For Dr. Benishek, a television ad was produced and run through local cable providers.

On election night, Dr. Benishek was declared the winner, receiving 52.1% of the vote compared with his opponent’s 45.3%. As one of four fellows of the American College of Surgeons in Congress, we look forward to continuing to work with “Dr. Dan” and his excellent staff in his upcoming third term.

Dr. Bera’s race was much closer, as he actually trailed his opponent when election night closed with 49.8% of the vote. Subsequently, with the counting and inclusion of the mail-in ballots specifically targeted by the physician community’s IE effort, Dr. Bera overtook his opponent’s slim margin. Two weeks later, on 19 Nov. 2014, the Associated Press called the election for Dr. Bera, whose 1,400-vote lead at that time was felt to be substantial enough to preclude his opponent making up the difference with the remaining 4,300 provisional ballots that had yet to be counted. Dr. Bera’s CA-7 district race proved to be the most expensive in the nation with an estimated $19.6 million in total expenditures. Despite representing only 0.51% of that total, SurgeonsPAC’s contribution, in the collective with that of other physician organizations, no doubt played a significant role in returning a physician to Congress to continue to champion our causes.

In my opinion, these examples of careful candidate selection and subsequent support of Drs. Benishek and Bera exemplify the importance of a strong political action committee. The ultimate goal of SurgeonsPAC is the election to Congress and retention in Congress of those who support our policy positions and legislative agenda. Though SurgeonsPAC is one of nine physician PACs that can be accurately labeled as “million dollar” (per election cycle) PACs, our relative size and, thus, the number of candidates like Drs. Bera and Benishek we could support would be much greater if the Fellow participation rate more closely resembled that of our colleagues in other physician organizations. However, year after year, only 3%-4% of Fellows contribute, as compared with participation rates of 10%-25% in those physician PACs larger than SurgeonsPAC.

Recently, all Fellows received an e-mail from Dr. Andrew Warshaw, founding SurgeonsPAC Board Chairman and current President of the ACS, urging Fellows to make a $25 donation to SurgeonsPAC. Those wishing to learn more about the critical role SurgeonsPAC plays in our advocacy efforts can log on to www.surgeonspac.org.

Until next month...

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.

Shortly after passage of the $1.1 trillion “Cromnibus,” the House and Senate concluded their legislative business for the 113th Congress and adjourned. Many issues of importance to surgeons and our patients remain unresolved and are expected to be high on the legislative agenda of the 114th Congress in the first quarter of 2015.

Returning as Members of Congress in January will be two physicians whose campaigns were assisted by the active participation of SurgeonsPAC. They are Dr. Ami Bera, an emergency physician from the 7th District of California (Sacramento area) and Dr. Dan Benishek, a general surgeon and fellow of the American College of Surgeons from the 1st District of Michigan (Upper Peninsula). Both Dr. Bera and Dr. Benishek have served as champions for the cause of the legislative agenda supported by the College.

One of the ways by which SurgeonsPAC participated in the re-election campaign of both Members is known as an independent expenditure (IE). The Code of Federal Regulations defines and independent expenditure as an expenditure for a communication that expressly advocates for “the election or defeat of a clearly identified candidate that is not made in cooperation, consultation, or concert with, or at the request or suggestion of, a candidate, a candidate’s authorized committee, or their agents, or a political party committee or its agents.” [11 CFR 100.16(a)]

In August, the Board of Directors of SurgeonsPAC unanimously voted to direct staff of the Division of Advocacy and Health Policy to develop recommendations for independent expenditures for a bipartisan slate of candidates who had a record of being supportive of the College’s legislative agenda and whose election was enough at risk that an independent expenditure by the College would potentially be of significant benefit for their race. In October, the PAC Board considered those recommendations and voted to support the expenditure of $100,000 each for IEs for Dr. Bera, a Democrat, and Dr. Benishek, a Republican. Both have been champions on issues such as repeal and replacement of the Sustainable Growth Rate (SGR), medical liability reform, and repeal of the 96-hour rule.

For Dr. Bera, the SurgeonsPAC dollars were utilized for a radio and direct mail campaign that was part of a larger effort in which other physician political action committees participated similarly. For Dr. Benishek, a television ad was produced and run through local cable providers.

On election night, Dr. Benishek was declared the winner, receiving 52.1% of the vote compared with his opponent’s 45.3%. As one of four fellows of the American College of Surgeons in Congress, we look forward to continuing to work with “Dr. Dan” and his excellent staff in his upcoming third term.

Dr. Bera’s race was much closer, as he actually trailed his opponent when election night closed with 49.8% of the vote. Subsequently, with the counting and inclusion of the mail-in ballots specifically targeted by the physician community’s IE effort, Dr. Bera overtook his opponent’s slim margin. Two weeks later, on 19 Nov. 2014, the Associated Press called the election for Dr. Bera, whose 1,400-vote lead at that time was felt to be substantial enough to preclude his opponent making up the difference with the remaining 4,300 provisional ballots that had yet to be counted. Dr. Bera’s CA-7 district race proved to be the most expensive in the nation with an estimated $19.6 million in total expenditures. Despite representing only 0.51% of that total, SurgeonsPAC’s contribution, in the collective with that of other physician organizations, no doubt played a significant role in returning a physician to Congress to continue to champion our causes.

In my opinion, these examples of careful candidate selection and subsequent support of Drs. Benishek and Bera exemplify the importance of a strong political action committee. The ultimate goal of SurgeonsPAC is the election to Congress and retention in Congress of those who support our policy positions and legislative agenda. Though SurgeonsPAC is one of nine physician PACs that can be accurately labeled as “million dollar” (per election cycle) PACs, our relative size and, thus, the number of candidates like Drs. Bera and Benishek we could support would be much greater if the Fellow participation rate more closely resembled that of our colleagues in other physician organizations. However, year after year, only 3%-4% of Fellows contribute, as compared with participation rates of 10%-25% in those physician PACs larger than SurgeonsPAC.

Recently, all Fellows received an e-mail from Dr. Andrew Warshaw, founding SurgeonsPAC Board Chairman and current President of the ACS, urging Fellows to make a $25 donation to SurgeonsPAC. Those wishing to learn more about the critical role SurgeonsPAC plays in our advocacy efforts can log on to www.surgeonspac.org.

Until next month...

Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.

Rural surgeons who provide cancer care face a particular set of challenges. Rural patients tend to be older, sicker, less educated and economically disadvantaged. Rural areas have a higher prevalence of chronic diseases including heart disease and cancer. Rural patients present with more advanced cancers than their urban counterparts. Specific rural regions (i.e., Appalachia) have documented higher cancer incidences and mortality rates.

In addition, there are several barriers to providing cancer care for rural populations. These include poor access to health care services and specialists; geographic barriers preventing access to providers, services, and technology; minimal transportation options for either cancer screening or treatment; limited knowledge of cancer and low participation in screening and other healthy practices; prohibitive costs of screening and cancer treatment; and, in some cases, suboptimal care provided to cancer patients (J. Am. Coll. Surg. 2014;219:814-8; Gosschalk, A. and Carozza, S., “Cancer in rural areas: A literature review,” Rural Healthy People 2010, Vol. 2 [College Station: The Texas A&M University System Health Science Center, 2003]).

Several examples of suboptimal care for rural cancer patients have appeared in professional journals and meetings and in the lay press. Examples of rural cancer care inadequacies include lower use of needle biopsy and sentinel lymph node biopsy techniques for breast cancer patients (Am. J. Surg. 2014;208:382-90; Am. J. Surg. 2013;206:674-81; ACS Surgery News, “Use of minimally invasive biopsy lags in Texas,” February 2013, p. 15); significantly lower rates of radiation treatment in breast lumpectomy patients (USA Today, Nov. 18, 2012); lower rates of adequate lymph node dissection, appropriate chemotherapy, and higher death rates in colon cancer patients (Chow, C.J., ACS Clinical Congress Presentation 2012); higher mastectomy rates and later-stage cancers in breast cancer patients (Jethwa, K., AACR Annual Conference Presentation 2013); higher likelihood of discharge to a skilled nursing facility instead of home in colon cancer patients; and the list goes on and on. These articles all come from academic centers through database studies. It is rare indeed to see data collected and published by the rural centers and providers actually caring for rural cancer patients.

My personal bias is that rural surgeons provide very competent, compassionate, high quality care that allows the cancer patient to remain close to their homes and support systems. This opinion has been reinforced by my involvement with the ACS Advisory Council on Rural Surgery, the rural listserve /ACS Rural Community and through my interaction with surgeons across the country at ACS Chapter meetings and at the Congress.

A study done by Finlayson (Med. Care 1999;37:204-9) documented that nearly 100% of rural patients preferred to receive their care locally, especially if the quality of care was the same as the larger distant hospital. In fact, nearly half of the patients polled would choose to remain local even if the mortality rate at the local hospital was double that of a hospital requiring the patient to travel for care. More recent papers however suggest that patients may be bypassing their local hospitals for care because of concerns about the quality of care provided locally (J. Rural Health 1999;10:70-9; J. Rural Health 2007;23:17-24).

A 2013 ASCO presentation documented that General Surgeons perform a majority of cancer surgeries in the United States (Stizenberg, K.; SSO 66th Annual Cancer Symposium; Abstract 75, March 8, 2013). Only 303 (< 8%) counties in the United States even have a surgical oncologist. A 2014 ASCO presentation estimated a 43% increase in inpatient oncology procedures and a 25% increase in outpatient procedures between 2002 and 2020. By 2025 the total demand for oncology care will rise by 43% (ASCO, “The state of cancer care 2014,” J. Oncol. Prac. 2014;10:119-42). Another study (ACS Surgery News, “Surgeon supply to drop 18% by 2028,” January 2013, p. 1) has estimated that, with predicted future surgeon shortages, general surgeons will be called upon to perform 25% of cases now done by other surgical specialists. General surgeons, both rural and urban, are clearly providing the bulk of cancer care to patients and this trend is on the rise in coming years.

Rural surgeons have certain barriers that prevent them from measuring, documenting, and publicizing the specifics of the care provided to their patients. These surgeons often are in single or small group practices and manage their own businesses. They have no office or hospital staff dedicated to quality endeavors. Financial and time constraints prevent them from being champions of quality care in their communities. Additionally, small numbers of specific cases can result in high statistical complication and mortality rates even if these events happen infrequently. This inability to collect data and assess the quality of care provided can lead to patient outmigration and even “tiering” by third-party payers that forces patients away from their hometown hospitals and providers using financial disincentives.

Rural surgeons can and must now take the lead in collecting, assessing, and reporting data about the care they provide for their communities. This process can be in the form of standardized programs like ACS Rural National Surgical Quality Improvement Program (NSQIP), Surgical Care Improvement Project (SCIP), or Commission on Cancer (CoC) accreditation involvement. Smaller institutions with a single surgeon may not have the financial and staff resources to formally participate but each surgeon can assess what makes up the majority of his or her caseload, whether that is endoscopy or breast or colon cases, and find national benchmarks that can easily be measured. Every endoscopy department can collect data on cecal intubation rates, withdrawal times, adequacy of preps, adenoma detection rates, and appropriate follow-up intervals. Individual surgeons can pick and chose specific benchmarks from NSQIP, Commission on Cancer, National Accreditation Program for Breast Centers (NAPBC), or ACS Committee on Trauma standards documents and use these to evaluate the care they provide. Easy examples might include number of lymph nodes harvested at colon cancer surgery, percentage of breast cancer patients diagnosed with needle biopsy, and percentage treated with conservative surgery and appropriate postop radiation and or chemotherapy, or the percentage of melanoma patients treated per National Comprehensive Cancer Network guidelines. Other ways for institutions to document quality might be to partner with their tertiary referral center for CoC accreditation or just to participate in cancer conferences by videoconferencing. The Commission on Cancer has designated CoC Liason Program Chairs in each state that are available to aid in setting up these types of programs.

It is time for rural surgeons to partner with their hospitals and communities to carry out needs assessments and think of ways to fill those needs. An example might be to work with primary care providers to develop aggressive colon, breast, or lung cancer screening programs in communities with high numbers of late-stage cases. Transparency of the data collected and the care provided in the form of “Quality Reports to the Community” can improve local referral patterns, improve the financial viability of the local hospital, and prove to the community that quality care is being rendered. Pooling the data from a large base of rural surgeons could serve to disprove the academic community notion that rural patients receive suboptimal cancer care.

Dr. Sarap is a practicing general surgeon in Cambridge, Ohio. He is a member of the Advisory Council on Rural Surgery and has been appointed the Commission on Cancer Liaison Program Chair for Ohio.

Rural surgeons who provide cancer care face a particular set of challenges. Rural patients tend to be older, sicker, less educated and economically disadvantaged. Rural areas have a higher prevalence of chronic diseases including heart disease and cancer. Rural patients present with more advanced cancers than their urban counterparts. Specific rural regions (i.e., Appalachia) have documented higher cancer incidences and mortality rates.

In addition, there are several barriers to providing cancer care for rural populations. These include poor access to health care services and specialists; geographic barriers preventing access to providers, services, and technology; minimal transportation options for either cancer screening or treatment; limited knowledge of cancer and low participation in screening and other healthy practices; prohibitive costs of screening and cancer treatment; and, in some cases, suboptimal care provided to cancer patients (J. Am. Coll. Surg. 2014;219:814-8; Gosschalk, A. and Carozza, S., “Cancer in rural areas: A literature review,” Rural Healthy People 2010, Vol. 2 [College Station: The Texas A&M University System Health Science Center, 2003]).

Several examples of suboptimal care for rural cancer patients have appeared in professional journals and meetings and in the lay press. Examples of rural cancer care inadequacies include lower use of needle biopsy and sentinel lymph node biopsy techniques for breast cancer patients (Am. J. Surg. 2014;208:382-90; Am. J. Surg. 2013;206:674-81; ACS Surgery News, “Use of minimally invasive biopsy lags in Texas,” February 2013, p. 15); significantly lower rates of radiation treatment in breast lumpectomy patients (USA Today, Nov. 18, 2012); lower rates of adequate lymph node dissection, appropriate chemotherapy, and higher death rates in colon cancer patients (Chow, C.J., ACS Clinical Congress Presentation 2012); higher mastectomy rates and later-stage cancers in breast cancer patients (Jethwa, K., AACR Annual Conference Presentation 2013); higher likelihood of discharge to a skilled nursing facility instead of home in colon cancer patients; and the list goes on and on. These articles all come from academic centers through database studies. It is rare indeed to see data collected and published by the rural centers and providers actually caring for rural cancer patients.

My personal bias is that rural surgeons provide very competent, compassionate, high quality care that allows the cancer patient to remain close to their homes and support systems. This opinion has been reinforced by my involvement with the ACS Advisory Council on Rural Surgery, the rural listserve /ACS Rural Community and through my interaction with surgeons across the country at ACS Chapter meetings and at the Congress.

A study done by Finlayson (Med. Care 1999;37:204-9) documented that nearly 100% of rural patients preferred to receive their care locally, especially if the quality of care was the same as the larger distant hospital. In fact, nearly half of the patients polled would choose to remain local even if the mortality rate at the local hospital was double that of a hospital requiring the patient to travel for care. More recent papers however suggest that patients may be bypassing their local hospitals for care because of concerns about the quality of care provided locally (J. Rural Health 1999;10:70-9; J. Rural Health 2007;23:17-24).

A 2013 ASCO presentation documented that General Surgeons perform a majority of cancer surgeries in the United States (Stizenberg, K.; SSO 66th Annual Cancer Symposium; Abstract 75, March 8, 2013). Only 303 (< 8%) counties in the United States even have a surgical oncologist. A 2014 ASCO presentation estimated a 43% increase in inpatient oncology procedures and a 25% increase in outpatient procedures between 2002 and 2020. By 2025 the total demand for oncology care will rise by 43% (ASCO, “The state of cancer care 2014,” J. Oncol. Prac. 2014;10:119-42). Another study (ACS Surgery News, “Surgeon supply to drop 18% by 2028,” January 2013, p. 1) has estimated that, with predicted future surgeon shortages, general surgeons will be called upon to perform 25% of cases now done by other surgical specialists. General surgeons, both rural and urban, are clearly providing the bulk of cancer care to patients and this trend is on the rise in coming years.

Rural surgeons have certain barriers that prevent them from measuring, documenting, and publicizing the specifics of the care provided to their patients. These surgeons often are in single or small group practices and manage their own businesses. They have no office or hospital staff dedicated to quality endeavors. Financial and time constraints prevent them from being champions of quality care in their communities. Additionally, small numbers of specific cases can result in high statistical complication and mortality rates even if these events happen infrequently. This inability to collect data and assess the quality of care provided can lead to patient outmigration and even “tiering” by third-party payers that forces patients away from their hometown hospitals and providers using financial disincentives.

Rural surgeons can and must now take the lead in collecting, assessing, and reporting data about the care they provide for their communities. This process can be in the form of standardized programs like ACS Rural National Surgical Quality Improvement Program (NSQIP), Surgical Care Improvement Project (SCIP), or Commission on Cancer (CoC) accreditation involvement. Smaller institutions with a single surgeon may not have the financial and staff resources to formally participate but each surgeon can assess what makes up the majority of his or her caseload, whether that is endoscopy or breast or colon cases, and find national benchmarks that can easily be measured. Every endoscopy department can collect data on cecal intubation rates, withdrawal times, adequacy of preps, adenoma detection rates, and appropriate follow-up intervals. Individual surgeons can pick and chose specific benchmarks from NSQIP, Commission on Cancer, National Accreditation Program for Breast Centers (NAPBC), or ACS Committee on Trauma standards documents and use these to evaluate the care they provide. Easy examples might include number of lymph nodes harvested at colon cancer surgery, percentage of breast cancer patients diagnosed with needle biopsy, and percentage treated with conservative surgery and appropriate postop radiation and or chemotherapy, or the percentage of melanoma patients treated per National Comprehensive Cancer Network guidelines. Other ways for institutions to document quality might be to partner with their tertiary referral center for CoC accreditation or just to participate in cancer conferences by videoconferencing. The Commission on Cancer has designated CoC Liason Program Chairs in each state that are available to aid in setting up these types of programs.

It is time for rural surgeons to partner with their hospitals and communities to carry out needs assessments and think of ways to fill those needs. An example might be to work with primary care providers to develop aggressive colon, breast, or lung cancer screening programs in communities with high numbers of late-stage cases. Transparency of the data collected and the care provided in the form of “Quality Reports to the Community” can improve local referral patterns, improve the financial viability of the local hospital, and prove to the community that quality care is being rendered. Pooling the data from a large base of rural surgeons could serve to disprove the academic community notion that rural patients receive suboptimal cancer care.

Dr. Sarap is a practicing general surgeon in Cambridge, Ohio. He is a member of the Advisory Council on Rural Surgery and has been appointed the Commission on Cancer Liaison Program Chair for Ohio.

Rural surgeons who provide cancer care face a particular set of challenges. Rural patients tend to be older, sicker, less educated and economically disadvantaged. Rural areas have a higher prevalence of chronic diseases including heart disease and cancer. Rural patients present with more advanced cancers than their urban counterparts. Specific rural regions (i.e., Appalachia) have documented higher cancer incidences and mortality rates.

In addition, there are several barriers to providing cancer care for rural populations. These include poor access to health care services and specialists; geographic barriers preventing access to providers, services, and technology; minimal transportation options for either cancer screening or treatment; limited knowledge of cancer and low participation in screening and other healthy practices; prohibitive costs of screening and cancer treatment; and, in some cases, suboptimal care provided to cancer patients (J. Am. Coll. Surg. 2014;219:814-8; Gosschalk, A. and Carozza, S., “Cancer in rural areas: A literature review,” Rural Healthy People 2010, Vol. 2 [College Station: The Texas A&M University System Health Science Center, 2003]).

Several examples of suboptimal care for rural cancer patients have appeared in professional journals and meetings and in the lay press. Examples of rural cancer care inadequacies include lower use of needle biopsy and sentinel lymph node biopsy techniques for breast cancer patients (Am. J. Surg. 2014;208:382-90; Am. J. Surg. 2013;206:674-81; ACS Surgery News, “Use of minimally invasive biopsy lags in Texas,” February 2013, p. 15); significantly lower rates of radiation treatment in breast lumpectomy patients (USA Today, Nov. 18, 2012); lower rates of adequate lymph node dissection, appropriate chemotherapy, and higher death rates in colon cancer patients (Chow, C.J., ACS Clinical Congress Presentation 2012); higher mastectomy rates and later-stage cancers in breast cancer patients (Jethwa, K., AACR Annual Conference Presentation 2013); higher likelihood of discharge to a skilled nursing facility instead of home in colon cancer patients; and the list goes on and on. These articles all come from academic centers through database studies. It is rare indeed to see data collected and published by the rural centers and providers actually caring for rural cancer patients.

My personal bias is that rural surgeons provide very competent, compassionate, high quality care that allows the cancer patient to remain close to their homes and support systems. This opinion has been reinforced by my involvement with the ACS Advisory Council on Rural Surgery, the rural listserve /ACS Rural Community and through my interaction with surgeons across the country at ACS Chapter meetings and at the Congress.

A study done by Finlayson (Med. Care 1999;37:204-9) documented that nearly 100% of rural patients preferred to receive their care locally, especially if the quality of care was the same as the larger distant hospital. In fact, nearly half of the patients polled would choose to remain local even if the mortality rate at the local hospital was double that of a hospital requiring the patient to travel for care. More recent papers however suggest that patients may be bypassing their local hospitals for care because of concerns about the quality of care provided locally (J. Rural Health 1999;10:70-9; J. Rural Health 2007;23:17-24).

A 2013 ASCO presentation documented that General Surgeons perform a majority of cancer surgeries in the United States (Stizenberg, K.; SSO 66th Annual Cancer Symposium; Abstract 75, March 8, 2013). Only 303 (< 8%) counties in the United States even have a surgical oncologist. A 2014 ASCO presentation estimated a 43% increase in inpatient oncology procedures and a 25% increase in outpatient procedures between 2002 and 2020. By 2025 the total demand for oncology care will rise by 43% (ASCO, “The state of cancer care 2014,” J. Oncol. Prac. 2014;10:119-42). Another study (ACS Surgery News, “Surgeon supply to drop 18% by 2028,” January 2013, p. 1) has estimated that, with predicted future surgeon shortages, general surgeons will be called upon to perform 25% of cases now done by other surgical specialists. General surgeons, both rural and urban, are clearly providing the bulk of cancer care to patients and this trend is on the rise in coming years.

Rural surgeons have certain barriers that prevent them from measuring, documenting, and publicizing the specifics of the care provided to their patients. These surgeons often are in single or small group practices and manage their own businesses. They have no office or hospital staff dedicated to quality endeavors. Financial and time constraints prevent them from being champions of quality care in their communities. Additionally, small numbers of specific cases can result in high statistical complication and mortality rates even if these events happen infrequently. This inability to collect data and assess the quality of care provided can lead to patient outmigration and even “tiering” by third-party payers that forces patients away from their hometown hospitals and providers using financial disincentives.

Rural surgeons can and must now take the lead in collecting, assessing, and reporting data about the care they provide for their communities. This process can be in the form of standardized programs like ACS Rural National Surgical Quality Improvement Program (NSQIP), Surgical Care Improvement Project (SCIP), or Commission on Cancer (CoC) accreditation involvement. Smaller institutions with a single surgeon may not have the financial and staff resources to formally participate but each surgeon can assess what makes up the majority of his or her caseload, whether that is endoscopy or breast or colon cases, and find national benchmarks that can easily be measured. Every endoscopy department can collect data on cecal intubation rates, withdrawal times, adequacy of preps, adenoma detection rates, and appropriate follow-up intervals. Individual surgeons can pick and chose specific benchmarks from NSQIP, Commission on Cancer, National Accreditation Program for Breast Centers (NAPBC), or ACS Committee on Trauma standards documents and use these to evaluate the care they provide. Easy examples might include number of lymph nodes harvested at colon cancer surgery, percentage of breast cancer patients diagnosed with needle biopsy, and percentage treated with conservative surgery and appropriate postop radiation and or chemotherapy, or the percentage of melanoma patients treated per National Comprehensive Cancer Network guidelines. Other ways for institutions to document quality might be to partner with their tertiary referral center for CoC accreditation or just to participate in cancer conferences by videoconferencing. The Commission on Cancer has designated CoC Liason Program Chairs in each state that are available to aid in setting up these types of programs.

It is time for rural surgeons to partner with their hospitals and communities to carry out needs assessments and think of ways to fill those needs. An example might be to work with primary care providers to develop aggressive colon, breast, or lung cancer screening programs in communities with high numbers of late-stage cases. Transparency of the data collected and the care provided in the form of “Quality Reports to the Community” can improve local referral patterns, improve the financial viability of the local hospital, and prove to the community that quality care is being rendered. Pooling the data from a large base of rural surgeons could serve to disprove the academic community notion that rural patients receive suboptimal cancer care.

Dr. Sarap is a practicing general surgeon in Cambridge, Ohio. He is a member of the Advisory Council on Rural Surgery and has been appointed the Commission on Cancer Liaison Program Chair for Ohio.

The surgery chief resident texted me: “Patient in ED with peritonitis. Incarcerated hernia.”

I came to the ED; should be easy I thought. See the patient, have a short conversation since the chief resident would have done all the preop. Of course, things are rarely that simple.

First, she was a Jehovah’s Witness on warfarin with an INR of 4. More significantly, she had end-stage COPD. I reviewed her CT scan and labs and went to see her and could tell without any conversation she needed an operation. I needed more information, but not about her belly pain or when it started or whether she had peritonitis on exam. I needed to know how far she could walk, how much oxygen was she on at home, how much was she sleeping, how much weight had she lost, and could she leave the house.

It took 30 minutes to determine her functional status, whether she would survive the postoperative ICU care, whether she would come off the ventilator, and would she want a tracheostomy. It took another 15 minutes to discuss blood product use. Her husband was present, and I left them to decide what they wanted within the context of her goals for her life. She accepted some blood products, underwent surgery, and did well. She came off the ventilator quickly postop and returned home from the hospital. Although she did well, we had a plan for the ventilator and her goals of care defined should she have done poorly.

He was 72, had stage IV lung cancer, and was too weak for chemotherapy. Now he had free air and peritonitis. The referring institution called me and said he was too much for their surgeons. I suggested perhaps they needed to have “the talk” prior to transport. They were unwilling to do so and sent him by helicopter because he was hypotensive. He clearly needed an operation by all surgical standards. But I wanted to wait for his family and talk with them before taking him to the OR; he was in no condition for any component of informed consent.

The family arrived 30 minutes later. His wife, the daughters who had been helping to take care of him, and two more relatives that had just arrived in town. His wife was clear: The man was sleeping all the time, losing weight, barely eating a couple of bites, unsteady on his feet, and confused when he was awake. I discussed options: The surgeon part of me wanted to “fix the hole,” the ICU doc in me knew he would die in the ICU on a ventilator, and the palliative medicine part of me knew hospice was his best option. I told the family he needed surgery but would likely not leave the hospital alive. I recommended hospice.

The wife was thoughtful and looked at her daughters and said, “We need to send him to hospice.” The wife and daughters were the easiest family I have spoken with in a long time. She was clear about whet he wanted and how much he had declined in the past few months. We were able to get him to inpatient hospice from the ED.

Surgery has changed, at least in my practice. Oh, what would I give for a healthy 17-year-old with appendicitis who gets better within hours of the operating room and my conversation with the family that takes 10 seconds. Instead, I take care of the very old and the very sick and the very chronically ill. My conversations are not “you need surgery;” that is done by the chief resident. My conversations are “tell me your functional status and what do you want if/when things go poorly.” Much more complicated and much less fun. The surgeon wants to fix the hole. I can fix the hole. But have I really helped the patient and his or her family? Although it takes me longer and involves more of my emotions and skills, it really is better for the patients and their families to have “the talk.”

Next time you see a patient who is chronically ill, please have the conversation about functional status and goals of care, before you operate. Or transfer. Perhaps then we can save the patient a helicopter ride to hospice.

Dr. Toevs is a trauma critical care surgeon at Allegheny General Hospital in Pittsburgh. She has a master’s degree in bioethics and board certification in hospice and palliative medicine.

The surgery chief resident texted me: “Patient in ED with peritonitis. Incarcerated hernia.”

I came to the ED; should be easy I thought. See the patient, have a short conversation since the chief resident would have done all the preop. Of course, things are rarely that simple.

First, she was a Jehovah’s Witness on warfarin with an INR of 4. More significantly, she had end-stage COPD. I reviewed her CT scan and labs and went to see her and could tell without any conversation she needed an operation. I needed more information, but not about her belly pain or when it started or whether she had peritonitis on exam. I needed to know how far she could walk, how much oxygen was she on at home, how much was she sleeping, how much weight had she lost, and could she leave the house.

It took 30 minutes to determine her functional status, whether she would survive the postoperative ICU care, whether she would come off the ventilator, and would she want a tracheostomy. It took another 15 minutes to discuss blood product use. Her husband was present, and I left them to decide what they wanted within the context of her goals for her life. She accepted some blood products, underwent surgery, and did well. She came off the ventilator quickly postop and returned home from the hospital. Although she did well, we had a plan for the ventilator and her goals of care defined should she have done poorly.

He was 72, had stage IV lung cancer, and was too weak for chemotherapy. Now he had free air and peritonitis. The referring institution called me and said he was too much for their surgeons. I suggested perhaps they needed to have “the talk” prior to transport. They were unwilling to do so and sent him by helicopter because he was hypotensive. He clearly needed an operation by all surgical standards. But I wanted to wait for his family and talk with them before taking him to the OR; he was in no condition for any component of informed consent.

The family arrived 30 minutes later. His wife, the daughters who had been helping to take care of him, and two more relatives that had just arrived in town. His wife was clear: The man was sleeping all the time, losing weight, barely eating a couple of bites, unsteady on his feet, and confused when he was awake. I discussed options: The surgeon part of me wanted to “fix the hole,” the ICU doc in me knew he would die in the ICU on a ventilator, and the palliative medicine part of me knew hospice was his best option. I told the family he needed surgery but would likely not leave the hospital alive. I recommended hospice.

The wife was thoughtful and looked at her daughters and said, “We need to send him to hospice.” The wife and daughters were the easiest family I have spoken with in a long time. She was clear about whet he wanted and how much he had declined in the past few months. We were able to get him to inpatient hospice from the ED.

Surgery has changed, at least in my practice. Oh, what would I give for a healthy 17-year-old with appendicitis who gets better within hours of the operating room and my conversation with the family that takes 10 seconds. Instead, I take care of the very old and the very sick and the very chronically ill. My conversations are not “you need surgery;” that is done by the chief resident. My conversations are “tell me your functional status and what do you want if/when things go poorly.” Much more complicated and much less fun. The surgeon wants to fix the hole. I can fix the hole. But have I really helped the patient and his or her family? Although it takes me longer and involves more of my emotions and skills, it really is better for the patients and their families to have “the talk.”

Next time you see a patient who is chronically ill, please have the conversation about functional status and goals of care, before you operate. Or transfer. Perhaps then we can save the patient a helicopter ride to hospice.

Dr. Toevs is a trauma critical care surgeon at Allegheny General Hospital in Pittsburgh. She has a master’s degree in bioethics and board certification in hospice and palliative medicine.

The surgery chief resident texted me: “Patient in ED with peritonitis. Incarcerated hernia.”

I came to the ED; should be easy I thought. See the patient, have a short conversation since the chief resident would have done all the preop. Of course, things are rarely that simple.

First, she was a Jehovah’s Witness on warfarin with an INR of 4. More significantly, she had end-stage COPD. I reviewed her CT scan and labs and went to see her and could tell without any conversation she needed an operation. I needed more information, but not about her belly pain or when it started or whether she had peritonitis on exam. I needed to know how far she could walk, how much oxygen was she on at home, how much was she sleeping, how much weight had she lost, and could she leave the house.

It took 30 minutes to determine her functional status, whether she would survive the postoperative ICU care, whether she would come off the ventilator, and would she want a tracheostomy. It took another 15 minutes to discuss blood product use. Her husband was present, and I left them to decide what they wanted within the context of her goals for her life. She accepted some blood products, underwent surgery, and did well. She came off the ventilator quickly postop and returned home from the hospital. Although she did well, we had a plan for the ventilator and her goals of care defined should she have done poorly.

He was 72, had stage IV lung cancer, and was too weak for chemotherapy. Now he had free air and peritonitis. The referring institution called me and said he was too much for their surgeons. I suggested perhaps they needed to have “the talk” prior to transport. They were unwilling to do so and sent him by helicopter because he was hypotensive. He clearly needed an operation by all surgical standards. But I wanted to wait for his family and talk with them before taking him to the OR; he was in no condition for any component of informed consent.

The family arrived 30 minutes later. His wife, the daughters who had been helping to take care of him, and two more relatives that had just arrived in town. His wife was clear: The man was sleeping all the time, losing weight, barely eating a couple of bites, unsteady on his feet, and confused when he was awake. I discussed options: The surgeon part of me wanted to “fix the hole,” the ICU doc in me knew he would die in the ICU on a ventilator, and the palliative medicine part of me knew hospice was his best option. I told the family he needed surgery but would likely not leave the hospital alive. I recommended hospice.

The wife was thoughtful and looked at her daughters and said, “We need to send him to hospice.” The wife and daughters were the easiest family I have spoken with in a long time. She was clear about whet he wanted and how much he had declined in the past few months. We were able to get him to inpatient hospice from the ED.

Surgery has changed, at least in my practice. Oh, what would I give for a healthy 17-year-old with appendicitis who gets better within hours of the operating room and my conversation with the family that takes 10 seconds. Instead, I take care of the very old and the very sick and the very chronically ill. My conversations are not “you need surgery;” that is done by the chief resident. My conversations are “tell me your functional status and what do you want if/when things go poorly.” Much more complicated and much less fun. The surgeon wants to fix the hole. I can fix the hole. But have I really helped the patient and his or her family? Although it takes me longer and involves more of my emotions and skills, it really is better for the patients and their families to have “the talk.”

Next time you see a patient who is chronically ill, please have the conversation about functional status and goals of care, before you operate. Or transfer. Perhaps then we can save the patient a helicopter ride to hospice.

Dr. Toevs is a trauma critical care surgeon at Allegheny General Hospital in Pittsburgh. She has a master’s degree in bioethics and board certification in hospice and palliative medicine.

Following the introduction of noninvasive prenatal testing (NIPT) at the Maine Medical Center in Portland, the number of invasive prenatal diagnostic procedures decreased.

In a retrospective study, Joseph R. Wax, MD, and colleagues gathered statistics on the rates of genetic counseling, invasive prenatal diagnosis, and trisomy 21 detection among women who were at increased risk for aneuploidy. These rates were compared before and after the availability of NIPT.

The study included 1,046 women who underwent NIPT between June 1, 2012, and February 1, 2013, as well as 1,464 women who would have been eligible for NIPT if it had been available between December 1, 2010, and November 30, 2011. All women were aged 35 years or older and had ultrasound findings suggestive of increased risk of aneuploidy, a positive aneuploidy screen, prior trisomic fetus, or parental balanced translocation with increased risk for trisomy 13 or 21. One laboratory performed NIPT after patients received genetic counseling. The two groups were compared by maternal demographics, aneuploidy risk factors, rates of genetic counseling, invasive diagnostic procedures, and trisomy 21 detection.¹

Results of the study
A total of 33 fetuses with trisomy 21 were identified by positive aneuploidy screening. After the introduction of NIPT, genetic counseling for aneuploidy risk increased (adjusted odds ratio [aOR], 1.77; P <.0001). However, the overall use of invasive diagnostic testing (aOR, 0.42; P <.0001), including amniocentesis (aOR, 0.37, P <.0001), decreased, although the prenatal diagnosis of trisomy 21 remained similar (88% vs 100%; P = .86).¹

Dr. Wax and colleagues concluded that, “NIPT in clinical practice uses more genetic counseling resources but requires significantly fewer invasive procedures to maintain the detection rates of trisomy 21.”¹

Following the introduction of noninvasive prenatal testing (NIPT) at the Maine Medical Center in Portland, the number of invasive prenatal diagnostic procedures decreased.

In a retrospective study, Joseph R. Wax, MD, and colleagues gathered statistics on the rates of genetic counseling, invasive prenatal diagnosis, and trisomy 21 detection among women who were at increased risk for aneuploidy. These rates were compared before and after the availability of NIPT.

The study included 1,046 women who underwent NIPT between June 1, 2012, and February 1, 2013, as well as 1,464 women who would have been eligible for NIPT if it had been available between December 1, 2010, and November 30, 2011. All women were aged 35 years or older and had ultrasound findings suggestive of increased risk of aneuploidy, a positive aneuploidy screen, prior trisomic fetus, or parental balanced translocation with increased risk for trisomy 13 or 21. One laboratory performed NIPT after patients received genetic counseling. The two groups were compared by maternal demographics, aneuploidy risk factors, rates of genetic counseling, invasive diagnostic procedures, and trisomy 21 detection.¹

Results of the study
A total of 33 fetuses with trisomy 21 were identified by positive aneuploidy screening. After the introduction of NIPT, genetic counseling for aneuploidy risk increased (adjusted odds ratio [aOR], 1.77; P <.0001). However, the overall use of invasive diagnostic testing (aOR, 0.42; P <.0001), including amniocentesis (aOR, 0.37, P <.0001), decreased, although the prenatal diagnosis of trisomy 21 remained similar (88% vs 100%; P = .86).¹

Dr. Wax and colleagues concluded that, “NIPT in clinical practice uses more genetic counseling resources but requires significantly fewer invasive procedures to maintain the detection rates of trisomy 21.”¹

Following the introduction of noninvasive prenatal testing (NIPT) at the Maine Medical Center in Portland, the number of invasive prenatal diagnostic procedures decreased.

In a retrospective study, Joseph R. Wax, MD, and colleagues gathered statistics on the rates of genetic counseling, invasive prenatal diagnosis, and trisomy 21 detection among women who were at increased risk for aneuploidy. These rates were compared before and after the availability of NIPT.

The study included 1,046 women who underwent NIPT between June 1, 2012, and February 1, 2013, as well as 1,464 women who would have been eligible for NIPT if it had been available between December 1, 2010, and November 30, 2011. All women were aged 35 years or older and had ultrasound findings suggestive of increased risk of aneuploidy, a positive aneuploidy screen, prior trisomic fetus, or parental balanced translocation with increased risk for trisomy 13 or 21. One laboratory performed NIPT after patients received genetic counseling. The two groups were compared by maternal demographics, aneuploidy risk factors, rates of genetic counseling, invasive diagnostic procedures, and trisomy 21 detection.¹

Results of the study
A total of 33 fetuses with trisomy 21 were identified by positive aneuploidy screening. After the introduction of NIPT, genetic counseling for aneuploidy risk increased (adjusted odds ratio [aOR], 1.77; P <.0001). However, the overall use of invasive diagnostic testing (aOR, 0.42; P <.0001), including amniocentesis (aOR, 0.37, P <.0001), decreased, although the prenatal diagnosis of trisomy 21 remained similar (88% vs 100%; P = .86).¹

Dr. Wax and colleagues concluded that, “NIPT in clinical practice uses more genetic counseling resources but requires significantly fewer invasive procedures to maintain the detection rates of trisomy 21.”¹