ANAHEIM, CALIF. – Before the Affordable Care Act, over 1 in 8 people under 60 years old hospitalized for acute myocardial infarction or stroke had no insurance, and it ruined most of them financially, according to an analysis presented at the American Heart Association scientific sessions.

The importance of the study is that it shows what could happen if the ACA goes away. Debate over its future is “all about pushing people off insurance.” Plans floated in early 2017 “would have increased the uninsured rate to 49 million people,” said lead investigators Rohan Khera, MD, a cardiology fellow at the University of Texas Southwestern Medical Center, Dallas.

[email protected]

ANAHEIM, CALIF. – Before the Affordable Care Act, over 1 in 8 people under 60 years old hospitalized for acute myocardial infarction or stroke had no insurance, and it ruined most of them financially, according to an analysis presented at the American Heart Association scientific sessions.

The importance of the study is that it shows what could happen if the ACA goes away. Debate over its future is “all about pushing people off insurance.” Plans floated in early 2017 “would have increased the uninsured rate to 49 million people,” said lead investigators Rohan Khera, MD, a cardiology fellow at the University of Texas Southwestern Medical Center, Dallas.

[email protected]

ANAHEIM, CALIF. – Before the Affordable Care Act, over 1 in 8 people under 60 years old hospitalized for acute myocardial infarction or stroke had no insurance, and it ruined most of them financially, according to an analysis presented at the American Heart Association scientific sessions.

The importance of the study is that it shows what could happen if the ACA goes away. Debate over its future is “all about pushing people off insurance.” Plans floated in early 2017 “would have increased the uninsured rate to 49 million people,” said lead investigators Rohan Khera, MD, a cardiology fellow at the University of Texas Southwestern Medical Center, Dallas.

[email protected]

The gut microbome may influence responses to immune checkpoint inhibitors, based on results from two studies, and one of the investigators is now gearing up for the next step - evaluating in a clinical trial whether altering the microflora will actually improve responses.

In the first study, investigators carried out a series of experiments using fecal microbiome samples from patients with metastatic melanoma embarking on therapy with a PD-1 (programmed cell death protein 1) inhibitor.

“In melanoma patients, there were differential signals in the gut microbiome of responders versus nonresponders, and I think the clincher was when we transplanted fecal samples from responders to nonresponders in germ-free mice, essentially reconstituting the microbiome and showing that it equally affected the systemic immunity and antitumor immunity when we implanted tumors, as well as response to checkpoint blockade,” lead author Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center in Houston, said in an interview.

Dr. Wargo and her colleagues first collected buccal and fecal microbiome samples from 112 patients with metastatic melanoma before they began therapy with a PD-1 inhibitor. After performing taxonomic profiling on all samples, they found that there was a clustering effect by response status in the gut microbiome, but not the oral microbiome, and because changes in the oral microbiome did not appear to be related to treatment response, they focused on the gut.

When Dr. Wargo and her colleagues studied the posttherapy microbiomes of 43 patients (30 responders and 13 nonresponders) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), they found that the responders had a significantly higher degree of alpha diversity, a measure of species diversity within a specific environment, compared with nonresponders (P less than .01). In addition, responders had a relative abundance of Ruminococcaceae, commonly occurring gut microbes that break down complex carbohydrates, the investigators reported (Science. 2017 Nov. 2. doi: 10.1126/science.aan4236).

They found that patients whose microbiomes were diverse in general, and in particular were enriched with Faecalibacterium and Clostridiales species, were more likely to respond to immunotherapy with a PD-1 inhibitor and have a longer duration of progression-free survival. In contrast, patients whose microbiomes were more enriched with Bacteroidales species were more likely to be nonresponders.

To get a better understanding of the mechanisms whereby gut bacteria may influence response to PD-1 inhibitors, they performed metagenomic analysis on samples from 14 responders and 11 nonresponders, and found that responders had micro-organisms predominantly associated with anabolic functions that may support host immunity, whereas nonresponders had microbiomes where catabolic functions were more common.

The investigators next performed immune profiling, and found that both systemic immunity and local immunity in the tumor microenvironment in responders were associated with the aforementioned favorable gut microbiome.

The researchers then transplanted feces from the human donors into germ-free mice and then injected tumor cells into the mice, and found that tumor growth was significantly reduced, and response to PD-1 inhibition was significantly enhanced, in mice who received feces from responders.

“An obvious next step is to run a clinical trial to test the hypothesis that by modulating the microbiome, you can actually enhance responses to therapy,” Dr. Wargo said. Details of the clinical trial are still being worked out, but will likely involve fecal transfers and other mechanisms for modulating the microbiome in hopes of improving responses to PD-1 inhibitors.

“It’s going to be a very biomarker-heavy trial,” she said. “We’re going to look, certainly, for changes in the microbiome, and will also do a lot of profiling in the blood, the tumor, and in the microbiome to see if there are changes that occur by modulating that microbiome. Then of course we’ll look for differences in response rates in patients as well.”
 

Bacteria also affect epithelial cancers

In a separate study, also published in Science, investigators led by Bertrand Routy, MD, of the Gustave Roussy Cancer Institute in Villejuif, France, reported that patients with non–small cell lung cancer and urothelial carcinoma who had previously used systemic antibiotics had reduced survival when treated with a PD-1 inhibitor, compared with patients who had never taken antibiotics (Science. 2017 Nov. 2 doi: 10.1126/science.aan3706).

Analysis of the gut microbiome in these patients showed that higher levels of Akkermansia muciniphila were associated with the best clinical outcomes, with the species detectable in the microbiome of 69% of patients who had partial responses to anti–PD-1 therapy, and in 58% of those with stable disease. In contrast, the bacterium was detectable in only 34% of patients who experienced disease progression.

As in the experiments by Dr. Wargo and her associates, when the French investigators first treated mice with antibiotics and then gave them oral supplements containing the bacteria, the supplements restored response to PD-1 blockade,

“We conclude from the study that the gut microbiome markedly influences the outcome of PD-1 blockade in mice and patients,” Dr. Routy and his associates wrote.

They acknowledged that the mechanism whereby a common organism such as Akkermansia muciniphila might have an immunomodulatory effect is still unknown,

“Irrespective of these remaining questions, our findings suggest that the microbiome governs the cancer-immune set point of cancer-bearing individuals and offer[s] novel avenues for manipulating the gut ecosystem to circumvent primary resistance to [immune checkpoint inhibitors],” they wrote.

The study by Dr. Wargo and her colleagues was supported by contributions to the University of Texas MD Anderson Melanoma Moon Shots program. Dr. Wargo is supported by the Binational Science Foundation, Melanoma Research Alliance, Stand Up to Cancer, and the MDACC Melanoma Moon Shots Program. The work by Dr. Routy and his associates was supported by the Goustave Roussy Cancer Institute and McGill University. Coauthors were supported by the National Cancer Institute of France and other agencies and philanthropies.

The gut microbome may influence responses to immune checkpoint inhibitors, based on results from two studies, and one of the investigators is now gearing up for the next step - evaluating in a clinical trial whether altering the microflora will actually improve responses.

In the first study, investigators carried out a series of experiments using fecal microbiome samples from patients with metastatic melanoma embarking on therapy with a PD-1 (programmed cell death protein 1) inhibitor.

“In melanoma patients, there were differential signals in the gut microbiome of responders versus nonresponders, and I think the clincher was when we transplanted fecal samples from responders to nonresponders in germ-free mice, essentially reconstituting the microbiome and showing that it equally affected the systemic immunity and antitumor immunity when we implanted tumors, as well as response to checkpoint blockade,” lead author Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center in Houston, said in an interview.

Dr. Wargo and her colleagues first collected buccal and fecal microbiome samples from 112 patients with metastatic melanoma before they began therapy with a PD-1 inhibitor. After performing taxonomic profiling on all samples, they found that there was a clustering effect by response status in the gut microbiome, but not the oral microbiome, and because changes in the oral microbiome did not appear to be related to treatment response, they focused on the gut.

When Dr. Wargo and her colleagues studied the posttherapy microbiomes of 43 patients (30 responders and 13 nonresponders) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), they found that the responders had a significantly higher degree of alpha diversity, a measure of species diversity within a specific environment, compared with nonresponders (P less than .01). In addition, responders had a relative abundance of Ruminococcaceae, commonly occurring gut microbes that break down complex carbohydrates, the investigators reported (Science. 2017 Nov. 2. doi: 10.1126/science.aan4236).

They found that patients whose microbiomes were diverse in general, and in particular were enriched with Faecalibacterium and Clostridiales species, were more likely to respond to immunotherapy with a PD-1 inhibitor and have a longer duration of progression-free survival. In contrast, patients whose microbiomes were more enriched with Bacteroidales species were more likely to be nonresponders.

To get a better understanding of the mechanisms whereby gut bacteria may influence response to PD-1 inhibitors, they performed metagenomic analysis on samples from 14 responders and 11 nonresponders, and found that responders had micro-organisms predominantly associated with anabolic functions that may support host immunity, whereas nonresponders had microbiomes where catabolic functions were more common.

The investigators next performed immune profiling, and found that both systemic immunity and local immunity in the tumor microenvironment in responders were associated with the aforementioned favorable gut microbiome.

The researchers then transplanted feces from the human donors into germ-free mice and then injected tumor cells into the mice, and found that tumor growth was significantly reduced, and response to PD-1 inhibition was significantly enhanced, in mice who received feces from responders.

“An obvious next step is to run a clinical trial to test the hypothesis that by modulating the microbiome, you can actually enhance responses to therapy,” Dr. Wargo said. Details of the clinical trial are still being worked out, but will likely involve fecal transfers and other mechanisms for modulating the microbiome in hopes of improving responses to PD-1 inhibitors.

“It’s going to be a very biomarker-heavy trial,” she said. “We’re going to look, certainly, for changes in the microbiome, and will also do a lot of profiling in the blood, the tumor, and in the microbiome to see if there are changes that occur by modulating that microbiome. Then of course we’ll look for differences in response rates in patients as well.”
 

Bacteria also affect epithelial cancers

In a separate study, also published in Science, investigators led by Bertrand Routy, MD, of the Gustave Roussy Cancer Institute in Villejuif, France, reported that patients with non–small cell lung cancer and urothelial carcinoma who had previously used systemic antibiotics had reduced survival when treated with a PD-1 inhibitor, compared with patients who had never taken antibiotics (Science. 2017 Nov. 2 doi: 10.1126/science.aan3706).

Analysis of the gut microbiome in these patients showed that higher levels of Akkermansia muciniphila were associated with the best clinical outcomes, with the species detectable in the microbiome of 69% of patients who had partial responses to anti–PD-1 therapy, and in 58% of those with stable disease. In contrast, the bacterium was detectable in only 34% of patients who experienced disease progression.

As in the experiments by Dr. Wargo and her associates, when the French investigators first treated mice with antibiotics and then gave them oral supplements containing the bacteria, the supplements restored response to PD-1 blockade,

“We conclude from the study that the gut microbiome markedly influences the outcome of PD-1 blockade in mice and patients,” Dr. Routy and his associates wrote.

They acknowledged that the mechanism whereby a common organism such as Akkermansia muciniphila might have an immunomodulatory effect is still unknown,

“Irrespective of these remaining questions, our findings suggest that the microbiome governs the cancer-immune set point of cancer-bearing individuals and offer[s] novel avenues for manipulating the gut ecosystem to circumvent primary resistance to [immune checkpoint inhibitors],” they wrote.

The study by Dr. Wargo and her colleagues was supported by contributions to the University of Texas MD Anderson Melanoma Moon Shots program. Dr. Wargo is supported by the Binational Science Foundation, Melanoma Research Alliance, Stand Up to Cancer, and the MDACC Melanoma Moon Shots Program. The work by Dr. Routy and his associates was supported by the Goustave Roussy Cancer Institute and McGill University. Coauthors were supported by the National Cancer Institute of France and other agencies and philanthropies.

The gut microbome may influence responses to immune checkpoint inhibitors, based on results from two studies, and one of the investigators is now gearing up for the next step - evaluating in a clinical trial whether altering the microflora will actually improve responses.

In the first study, investigators carried out a series of experiments using fecal microbiome samples from patients with metastatic melanoma embarking on therapy with a PD-1 (programmed cell death protein 1) inhibitor.

“In melanoma patients, there were differential signals in the gut microbiome of responders versus nonresponders, and I think the clincher was when we transplanted fecal samples from responders to nonresponders in germ-free mice, essentially reconstituting the microbiome and showing that it equally affected the systemic immunity and antitumor immunity when we implanted tumors, as well as response to checkpoint blockade,” lead author Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center in Houston, said in an interview.

Dr. Wargo and her colleagues first collected buccal and fecal microbiome samples from 112 patients with metastatic melanoma before they began therapy with a PD-1 inhibitor. After performing taxonomic profiling on all samples, they found that there was a clustering effect by response status in the gut microbiome, but not the oral microbiome, and because changes in the oral microbiome did not appear to be related to treatment response, they focused on the gut.

When Dr. Wargo and her colleagues studied the posttherapy microbiomes of 43 patients (30 responders and 13 nonresponders) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), they found that the responders had a significantly higher degree of alpha diversity, a measure of species diversity within a specific environment, compared with nonresponders (P less than .01). In addition, responders had a relative abundance of Ruminococcaceae, commonly occurring gut microbes that break down complex carbohydrates, the investigators reported (Science. 2017 Nov. 2. doi: 10.1126/science.aan4236).

They found that patients whose microbiomes were diverse in general, and in particular were enriched with Faecalibacterium and Clostridiales species, were more likely to respond to immunotherapy with a PD-1 inhibitor and have a longer duration of progression-free survival. In contrast, patients whose microbiomes were more enriched with Bacteroidales species were more likely to be nonresponders.

To get a better understanding of the mechanisms whereby gut bacteria may influence response to PD-1 inhibitors, they performed metagenomic analysis on samples from 14 responders and 11 nonresponders, and found that responders had micro-organisms predominantly associated with anabolic functions that may support host immunity, whereas nonresponders had microbiomes where catabolic functions were more common.

The investigators next performed immune profiling, and found that both systemic immunity and local immunity in the tumor microenvironment in responders were associated with the aforementioned favorable gut microbiome.

The researchers then transplanted feces from the human donors into germ-free mice and then injected tumor cells into the mice, and found that tumor growth was significantly reduced, and response to PD-1 inhibition was significantly enhanced, in mice who received feces from responders.

“An obvious next step is to run a clinical trial to test the hypothesis that by modulating the microbiome, you can actually enhance responses to therapy,” Dr. Wargo said. Details of the clinical trial are still being worked out, but will likely involve fecal transfers and other mechanisms for modulating the microbiome in hopes of improving responses to PD-1 inhibitors.

“It’s going to be a very biomarker-heavy trial,” she said. “We’re going to look, certainly, for changes in the microbiome, and will also do a lot of profiling in the blood, the tumor, and in the microbiome to see if there are changes that occur by modulating that microbiome. Then of course we’ll look for differences in response rates in patients as well.”
 

Bacteria also affect epithelial cancers

In a separate study, also published in Science, investigators led by Bertrand Routy, MD, of the Gustave Roussy Cancer Institute in Villejuif, France, reported that patients with non–small cell lung cancer and urothelial carcinoma who had previously used systemic antibiotics had reduced survival when treated with a PD-1 inhibitor, compared with patients who had never taken antibiotics (Science. 2017 Nov. 2 doi: 10.1126/science.aan3706).

Analysis of the gut microbiome in these patients showed that higher levels of Akkermansia muciniphila were associated with the best clinical outcomes, with the species detectable in the microbiome of 69% of patients who had partial responses to anti–PD-1 therapy, and in 58% of those with stable disease. In contrast, the bacterium was detectable in only 34% of patients who experienced disease progression.

As in the experiments by Dr. Wargo and her associates, when the French investigators first treated mice with antibiotics and then gave them oral supplements containing the bacteria, the supplements restored response to PD-1 blockade,

“We conclude from the study that the gut microbiome markedly influences the outcome of PD-1 blockade in mice and patients,” Dr. Routy and his associates wrote.

They acknowledged that the mechanism whereby a common organism such as Akkermansia muciniphila might have an immunomodulatory effect is still unknown,

“Irrespective of these remaining questions, our findings suggest that the microbiome governs the cancer-immune set point of cancer-bearing individuals and offer[s] novel avenues for manipulating the gut ecosystem to circumvent primary resistance to [immune checkpoint inhibitors],” they wrote.

The study by Dr. Wargo and her colleagues was supported by contributions to the University of Texas MD Anderson Melanoma Moon Shots program. Dr. Wargo is supported by the Binational Science Foundation, Melanoma Research Alliance, Stand Up to Cancer, and the MDACC Melanoma Moon Shots Program. The work by Dr. Routy and his associates was supported by the Goustave Roussy Cancer Institute and McGill University. Coauthors were supported by the National Cancer Institute of France and other agencies and philanthropies.

LAS VEGAS – There are now vaccines for two infectious diseases that “are not purely dermatologic, but have a great impact on many patients around the world,” Kenneth J. Tomecki, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

The recent development of a vaccine to protect against malaria, with an efficacy around 40%, “is something we should all be proud of,” said Dr. Tomecki of the Cleveland Clinic. Another advance is that there is now also a vaccine for Ebola that is so effective, it is being stockpiled in African countries in preparation for future Ebola outbreaks, he added.

Dr. Tomecki had no financial conflicts to disclose.

SDEF and this news organization are owned by the same parent company.

[email protected]

LAS VEGAS – There are now vaccines for two infectious diseases that “are not purely dermatologic, but have a great impact on many patients around the world,” Kenneth J. Tomecki, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

The recent development of a vaccine to protect against malaria, with an efficacy around 40%, “is something we should all be proud of,” said Dr. Tomecki of the Cleveland Clinic. Another advance is that there is now also a vaccine for Ebola that is so effective, it is being stockpiled in African countries in preparation for future Ebola outbreaks, he added.

Dr. Tomecki had no financial conflicts to disclose.

SDEF and this news organization are owned by the same parent company.

[email protected]

LAS VEGAS – There are now vaccines for two infectious diseases that “are not purely dermatologic, but have a great impact on many patients around the world,” Kenneth J. Tomecki, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

The recent development of a vaccine to protect against malaria, with an efficacy around 40%, “is something we should all be proud of,” said Dr. Tomecki of the Cleveland Clinic. Another advance is that there is now also a vaccine for Ebola that is so effective, it is being stockpiled in African countries in preparation for future Ebola outbreaks, he added.

Dr. Tomecki had no financial conflicts to disclose.

SDEF and this news organization are owned by the same parent company.

[email protected]

Transplantation of transgenic epidermal cultures successfully created a new, functional epidermis for a boy suffering from junctional epidermolysis bullosa.

Junctional epidermolysis bullosa is a genetic disease characterized by chronic skin wounds, blisters, and erosions. The chronic wounds not only increase a patient’s risk of skin cancer, they also can cause itching, pain, limited mobility, and poor quality of life, wrote Tobias Hirsch, MD, of BG University Hospital Bergmannsheil, Bochum, Germany, and colleagues (Nature. 2017. doi: 10.1038/nature24487). There is no cure for the disease, and more than 40% of patients die prior to adolescence.

Previous studies have shown that epidermal stem cells can be used to repair a damaged epidermis, they noted. However, the technique has been criticized for being insufficient to treat the large lesions common to this disease.

The researchers described the case of a 7-year-old boy who was admitted to a children’s hospital in Germany in June 2015 with junctional epidermolysis bullosa so severe that approximately 80% of his total body surface area was affected. The patient had a genetic mutation that had resulted in blisters on much of his body since birth. Approximately 6 weeks prior to his hospital admission, he developed Staphylococcus aureus and Pseudomonas aeruginosa infections that worsened his condition. After other treatments failed, the patient’s parents consented to a combination of ex vivo cell and gene therapy, in which cultures taken from a biopsy of uninvolved skin were used to develop transgenic epidermal grafts. The grafts were applied sequentially on a dermal wound bed.

“Virtually complete epidermal regeneration was observed after 1 month,” Dr. Hirsch and associates wrote. Over 21 months, the regenerated epidermis healed and remained stable even when subjected to mechanical stress.

For follow-up, the researchers reported on 10 punch biopsies taken at 4, 8, and 21 months after the grafting procedure. “The epidermis had normal morphology and we could not detect blisters, erosions, or epidermal detachment from the underlying dermis,” they noted.

The patient has remained stable since being discharged from the hospital in February 2016, and requires no ointment or medications to maintain a healthy epidermis, they said.

“This approach would be optimal for newly diagnosed patients early in their childhood,” Dr. Hirsch and associates noted. “A bank of transduced epidermal stem cells taken at birth could be used to treat skin lesions while they develop, thus preventing, rather than restoring, the devastating clinical manifestation that arise in these patients.

The study was supported in part by several government grants from organizations including the Italian Ministry of Education and the European Research. Two of the researchers are cofounders and members of the Board of Directors of Holostem Terapie Avanzate, which met all costs of good manufacturing practice production and procedures of transgenic epidermal grafts.

[email protected]

Transplantation of transgenic epidermal cultures successfully created a new, functional epidermis for a boy suffering from junctional epidermolysis bullosa.

Junctional epidermolysis bullosa is a genetic disease characterized by chronic skin wounds, blisters, and erosions. The chronic wounds not only increase a patient’s risk of skin cancer, they also can cause itching, pain, limited mobility, and poor quality of life, wrote Tobias Hirsch, MD, of BG University Hospital Bergmannsheil, Bochum, Germany, and colleagues (Nature. 2017. doi: 10.1038/nature24487). There is no cure for the disease, and more than 40% of patients die prior to adolescence.

Previous studies have shown that epidermal stem cells can be used to repair a damaged epidermis, they noted. However, the technique has been criticized for being insufficient to treat the large lesions common to this disease.

The researchers described the case of a 7-year-old boy who was admitted to a children’s hospital in Germany in June 2015 with junctional epidermolysis bullosa so severe that approximately 80% of his total body surface area was affected. The patient had a genetic mutation that had resulted in blisters on much of his body since birth. Approximately 6 weeks prior to his hospital admission, he developed Staphylococcus aureus and Pseudomonas aeruginosa infections that worsened his condition. After other treatments failed, the patient’s parents consented to a combination of ex vivo cell and gene therapy, in which cultures taken from a biopsy of uninvolved skin were used to develop transgenic epidermal grafts. The grafts were applied sequentially on a dermal wound bed.

“Virtually complete epidermal regeneration was observed after 1 month,” Dr. Hirsch and associates wrote. Over 21 months, the regenerated epidermis healed and remained stable even when subjected to mechanical stress.

For follow-up, the researchers reported on 10 punch biopsies taken at 4, 8, and 21 months after the grafting procedure. “The epidermis had normal morphology and we could not detect blisters, erosions, or epidermal detachment from the underlying dermis,” they noted.

The patient has remained stable since being discharged from the hospital in February 2016, and requires no ointment or medications to maintain a healthy epidermis, they said.

“This approach would be optimal for newly diagnosed patients early in their childhood,” Dr. Hirsch and associates noted. “A bank of transduced epidermal stem cells taken at birth could be used to treat skin lesions while they develop, thus preventing, rather than restoring, the devastating clinical manifestation that arise in these patients.

The study was supported in part by several government grants from organizations including the Italian Ministry of Education and the European Research. Two of the researchers are cofounders and members of the Board of Directors of Holostem Terapie Avanzate, which met all costs of good manufacturing practice production and procedures of transgenic epidermal grafts.

[email protected]

Transplantation of transgenic epidermal cultures successfully created a new, functional epidermis for a boy suffering from junctional epidermolysis bullosa.

Junctional epidermolysis bullosa is a genetic disease characterized by chronic skin wounds, blisters, and erosions. The chronic wounds not only increase a patient’s risk of skin cancer, they also can cause itching, pain, limited mobility, and poor quality of life, wrote Tobias Hirsch, MD, of BG University Hospital Bergmannsheil, Bochum, Germany, and colleagues (Nature. 2017. doi: 10.1038/nature24487). There is no cure for the disease, and more than 40% of patients die prior to adolescence.

Previous studies have shown that epidermal stem cells can be used to repair a damaged epidermis, they noted. However, the technique has been criticized for being insufficient to treat the large lesions common to this disease.

The researchers described the case of a 7-year-old boy who was admitted to a children’s hospital in Germany in June 2015 with junctional epidermolysis bullosa so severe that approximately 80% of his total body surface area was affected. The patient had a genetic mutation that had resulted in blisters on much of his body since birth. Approximately 6 weeks prior to his hospital admission, he developed Staphylococcus aureus and Pseudomonas aeruginosa infections that worsened his condition. After other treatments failed, the patient’s parents consented to a combination of ex vivo cell and gene therapy, in which cultures taken from a biopsy of uninvolved skin were used to develop transgenic epidermal grafts. The grafts were applied sequentially on a dermal wound bed.

“Virtually complete epidermal regeneration was observed after 1 month,” Dr. Hirsch and associates wrote. Over 21 months, the regenerated epidermis healed and remained stable even when subjected to mechanical stress.

For follow-up, the researchers reported on 10 punch biopsies taken at 4, 8, and 21 months after the grafting procedure. “The epidermis had normal morphology and we could not detect blisters, erosions, or epidermal detachment from the underlying dermis,” they noted.

The patient has remained stable since being discharged from the hospital in February 2016, and requires no ointment or medications to maintain a healthy epidermis, they said.

“This approach would be optimal for newly diagnosed patients early in their childhood,” Dr. Hirsch and associates noted. “A bank of transduced epidermal stem cells taken at birth could be used to treat skin lesions while they develop, thus preventing, rather than restoring, the devastating clinical manifestation that arise in these patients.

The study was supported in part by several government grants from organizations including the Italian Ministry of Education and the European Research. Two of the researchers are cofounders and members of the Board of Directors of Holostem Terapie Avanzate, which met all costs of good manufacturing practice production and procedures of transgenic epidermal grafts.

[email protected]

LAS VEGAS – Currently, there are available treatments that are effective in contouring the body, Christopher B. Zachary, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Some devices can help patients looking for reductions of trouble spots, such as around the abdomen, and are safe and effective, said Dr. Zachary of the University of California, Irvine. However, they are not a realistic option for obese or overweight patients, he added.

In addition, other treatments can be combined with body sculpting devices to optimize results, particularly when removing fat in the submental area, he noted.

Dr. Zachary disclosed relationships with Solta, Zeltiq, Sciton, DUSA, Zimmer, Cutera, Alma, and Amway.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Currently, there are available treatments that are effective in contouring the body, Christopher B. Zachary, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Some devices can help patients looking for reductions of trouble spots, such as around the abdomen, and are safe and effective, said Dr. Zachary of the University of California, Irvine. However, they are not a realistic option for obese or overweight patients, he added.

In addition, other treatments can be combined with body sculpting devices to optimize results, particularly when removing fat in the submental area, he noted.

Dr. Zachary disclosed relationships with Solta, Zeltiq, Sciton, DUSA, Zimmer, Cutera, Alma, and Amway.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Currently, there are available treatments that are effective in contouring the body, Christopher B. Zachary, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

Some devices can help patients looking for reductions of trouble spots, such as around the abdomen, and are safe and effective, said Dr. Zachary of the University of California, Irvine. However, they are not a realistic option for obese or overweight patients, he added.

In addition, other treatments can be combined with body sculpting devices to optimize results, particularly when removing fat in the submental area, he noted.

Dr. Zachary disclosed relationships with Solta, Zeltiq, Sciton, DUSA, Zimmer, Cutera, Alma, and Amway.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – For those starting to use toxins and fillers, “my first advice is to get a good education,” Christopher B. Zachary, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“Know … how to evaluate your patient, know where the problems are, know what the danger zones are, understand your anatomy,” advised Dr. Zachary of the University of California, Irvine.

“In general, the upper face is an easier place to start,” when learning to work with toxins , he noted. Procedures on the upper face, such as the treatment for crow’s feet or a brow lift, can be “a home run,” while the lower face is much more complicated, he said in the video interview.

Dr. Zachary disclosed relationships with companies including Solta, Zeltiq, Sciton, DUSA, Zimmer, Cutera, Alma, and Amway.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – For those starting to use toxins and fillers, “my first advice is to get a good education,” Christopher B. Zachary, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“Know … how to evaluate your patient, know where the problems are, know what the danger zones are, understand your anatomy,” advised Dr. Zachary of the University of California, Irvine.

“In general, the upper face is an easier place to start,” when learning to work with toxins , he noted. Procedures on the upper face, such as the treatment for crow’s feet or a brow lift, can be “a home run,” while the lower face is much more complicated, he said in the video interview.

Dr. Zachary disclosed relationships with companies including Solta, Zeltiq, Sciton, DUSA, Zimmer, Cutera, Alma, and Amway.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – For those starting to use toxins and fillers, “my first advice is to get a good education,” Christopher B. Zachary, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“Know … how to evaluate your patient, know where the problems are, know what the danger zones are, understand your anatomy,” advised Dr. Zachary of the University of California, Irvine.

“In general, the upper face is an easier place to start,” when learning to work with toxins , he noted. Procedures on the upper face, such as the treatment for crow’s feet or a brow lift, can be “a home run,” while the lower face is much more complicated, he said in the video interview.

Dr. Zachary disclosed relationships with companies including Solta, Zeltiq, Sciton, DUSA, Zimmer, Cutera, Alma, and Amway.

SDEF and this news organization are owned by the same parent company.

ANAHEIM, CALIF. – Thirty million Americans became hypertensive overnight on Nov. 13 with the introduction of new high blood pressure guidelines from the American College of Cardiology and American Heart Association.

That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, a change that jumps the U.S. adult prevalence of hypertension from roughly 32% to 46%. Nearly half of all U.S. adults now have hypertension, bringing the total national hypertensive population to a staggering 103 million.

Goal is to transform care

But the new guidelines (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.005) for preventing, detecting, evaluating, and managing adult hypertension do lots more than just shake up the epidemiology of high blood pressure. With 106 total recommendations, the guidelines seek to transform every aspect of blood pressure in American medical practice, starting with how it’s measured and stretching to redefine applications of medical systems to try to ensure that every person with a blood pressure that truly falls outside the redefined limits gets a comprehensive package of interventions.

Mitchel L. Zoler/Frontline Medical News

One goal for all adults

“The systolic blood pressure goal for older people has gone from 140 mm Hg to 150 mm Hg and now to 130 mm Hg in the space of 2-3 years,” commented Dr. Appel, professor of epidemiology at Johns Hopkins University in Baltimore and not involved in the guideline-writing process.

In fact, the guidelines simplified the treatment goal all around, to less than 130/80 mm Hg for patients with diabetes, those with chronic kidney disease, and the elderly; that goal remains the same for all adults.

“It will be clearer and easier now that everyone should be less than 130/80 mm Hg. You won’t need to remember a second target,” said Sandra J. Taler, MD, a nephrologist and professor of medicine at the Mayo Clinic in Rochester, Minn., and a member of the guidelines task force.

“Some people may be upset that we changed the rules on them. They had normal blood pressure yesterday, and today it’s high. But it’s a good awakening, especially for using lifestyle interventions,” Dr. Taler said in an interview.
 

Preferred intervention: Lifestyle, not drugs

Lifestyle optimization is repeatedly cited as the cornerstone of intervention for everyone, including those with elevated blood pressure with a systolic pressure of 120-129 mm Hg, and as the only endorsed intervention for patients with hypertension of 130-139 mm Hg but below a 10% risk for a cardiovascular disease event during the next 10 years on the American College of Cardiology’s online risk calculator. The guidelines list six lifestyle goals: weight loss, following a DASH diet, reducing sodium, enhancing potassium, 90-150 min/wk of physical activity, and moderate alcohol intake.

Mitchel L. Zoler/Frontline Medical News

Team-based care essential

The guidelines also put unprecedented emphasis on using a team-based management approach, which means having nurses, nurse practitioners, pharmacists, dietitians, and other clinicians, allowing for more frequent and focused care. Dr. Whelton and others cited in particular the VA Health System and Kaiser-Permanente as operating team-based and system-driven blood pressure management programs that have resulted in control rates for more than 90% of hypertensive patients. The team-based approach is also a key in the Target:BP program that the American Heart Association and American Medical Association founded. Target:BP will be instrumental in promoting implementation of the new guidelines, Dr. Carey said. Another systems recommendation is that every patient with hypertension should have a “clear, detailed, and current evidence-based plan of care.”

“Using nurse practitioners, physician assistants, and pharmacists has been shown to improve blood pressure levels,” and health systems that use this approach have had “great success,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago and not part of the guidelines task force. Some systems have used this approach to achieve high levels of blood pressure control. Now that financial penalties and incentives from payers also exist to push for higher levels of blood pressure control, the alignment of financial and health incentives should result in big changes, Dr. Lloyd-Jones predicted in a video interview.

[email protected]

On Twitter @mitchelzoler

ANAHEIM, CALIF. – Thirty million Americans became hypertensive overnight on Nov. 13 with the introduction of new high blood pressure guidelines from the American College of Cardiology and American Heart Association.

That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, a change that jumps the U.S. adult prevalence of hypertension from roughly 32% to 46%. Nearly half of all U.S. adults now have hypertension, bringing the total national hypertensive population to a staggering 103 million.

Goal is to transform care

But the new guidelines (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.005) for preventing, detecting, evaluating, and managing adult hypertension do lots more than just shake up the epidemiology of high blood pressure. With 106 total recommendations, the guidelines seek to transform every aspect of blood pressure in American medical practice, starting with how it’s measured and stretching to redefine applications of medical systems to try to ensure that every person with a blood pressure that truly falls outside the redefined limits gets a comprehensive package of interventions.

Mitchel L. Zoler/Frontline Medical News

One goal for all adults

“The systolic blood pressure goal for older people has gone from 140 mm Hg to 150 mm Hg and now to 130 mm Hg in the space of 2-3 years,” commented Dr. Appel, professor of epidemiology at Johns Hopkins University in Baltimore and not involved in the guideline-writing process.

In fact, the guidelines simplified the treatment goal all around, to less than 130/80 mm Hg for patients with diabetes, those with chronic kidney disease, and the elderly; that goal remains the same for all adults.

“It will be clearer and easier now that everyone should be less than 130/80 mm Hg. You won’t need to remember a second target,” said Sandra J. Taler, MD, a nephrologist and professor of medicine at the Mayo Clinic in Rochester, Minn., and a member of the guidelines task force.

“Some people may be upset that we changed the rules on them. They had normal blood pressure yesterday, and today it’s high. But it’s a good awakening, especially for using lifestyle interventions,” Dr. Taler said in an interview.
 

Preferred intervention: Lifestyle, not drugs

Lifestyle optimization is repeatedly cited as the cornerstone of intervention for everyone, including those with elevated blood pressure with a systolic pressure of 120-129 mm Hg, and as the only endorsed intervention for patients with hypertension of 130-139 mm Hg but below a 10% risk for a cardiovascular disease event during the next 10 years on the American College of Cardiology’s online risk calculator. The guidelines list six lifestyle goals: weight loss, following a DASH diet, reducing sodium, enhancing potassium, 90-150 min/wk of physical activity, and moderate alcohol intake.

Mitchel L. Zoler/Frontline Medical News

Team-based care essential

The guidelines also put unprecedented emphasis on using a team-based management approach, which means having nurses, nurse practitioners, pharmacists, dietitians, and other clinicians, allowing for more frequent and focused care. Dr. Whelton and others cited in particular the VA Health System and Kaiser-Permanente as operating team-based and system-driven blood pressure management programs that have resulted in control rates for more than 90% of hypertensive patients. The team-based approach is also a key in the Target:BP program that the American Heart Association and American Medical Association founded. Target:BP will be instrumental in promoting implementation of the new guidelines, Dr. Carey said. Another systems recommendation is that every patient with hypertension should have a “clear, detailed, and current evidence-based plan of care.”

“Using nurse practitioners, physician assistants, and pharmacists has been shown to improve blood pressure levels,” and health systems that use this approach have had “great success,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago and not part of the guidelines task force. Some systems have used this approach to achieve high levels of blood pressure control. Now that financial penalties and incentives from payers also exist to push for higher levels of blood pressure control, the alignment of financial and health incentives should result in big changes, Dr. Lloyd-Jones predicted in a video interview.

[email protected]

On Twitter @mitchelzoler

ANAHEIM, CALIF. – Thirty million Americans became hypertensive overnight on Nov. 13 with the introduction of new high blood pressure guidelines from the American College of Cardiology and American Heart Association.

That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, a change that jumps the U.S. adult prevalence of hypertension from roughly 32% to 46%. Nearly half of all U.S. adults now have hypertension, bringing the total national hypertensive population to a staggering 103 million.

Goal is to transform care

But the new guidelines (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.005) for preventing, detecting, evaluating, and managing adult hypertension do lots more than just shake up the epidemiology of high blood pressure. With 106 total recommendations, the guidelines seek to transform every aspect of blood pressure in American medical practice, starting with how it’s measured and stretching to redefine applications of medical systems to try to ensure that every person with a blood pressure that truly falls outside the redefined limits gets a comprehensive package of interventions.

Mitchel L. Zoler/Frontline Medical News

One goal for all adults

“The systolic blood pressure goal for older people has gone from 140 mm Hg to 150 mm Hg and now to 130 mm Hg in the space of 2-3 years,” commented Dr. Appel, professor of epidemiology at Johns Hopkins University in Baltimore and not involved in the guideline-writing process.

In fact, the guidelines simplified the treatment goal all around, to less than 130/80 mm Hg for patients with diabetes, those with chronic kidney disease, and the elderly; that goal remains the same for all adults.

“It will be clearer and easier now that everyone should be less than 130/80 mm Hg. You won’t need to remember a second target,” said Sandra J. Taler, MD, a nephrologist and professor of medicine at the Mayo Clinic in Rochester, Minn., and a member of the guidelines task force.

“Some people may be upset that we changed the rules on them. They had normal blood pressure yesterday, and today it’s high. But it’s a good awakening, especially for using lifestyle interventions,” Dr. Taler said in an interview.
 

Preferred intervention: Lifestyle, not drugs

Lifestyle optimization is repeatedly cited as the cornerstone of intervention for everyone, including those with elevated blood pressure with a systolic pressure of 120-129 mm Hg, and as the only endorsed intervention for patients with hypertension of 130-139 mm Hg but below a 10% risk for a cardiovascular disease event during the next 10 years on the American College of Cardiology’s online risk calculator. The guidelines list six lifestyle goals: weight loss, following a DASH diet, reducing sodium, enhancing potassium, 90-150 min/wk of physical activity, and moderate alcohol intake.

Mitchel L. Zoler/Frontline Medical News

Team-based care essential

The guidelines also put unprecedented emphasis on using a team-based management approach, which means having nurses, nurse practitioners, pharmacists, dietitians, and other clinicians, allowing for more frequent and focused care. Dr. Whelton and others cited in particular the VA Health System and Kaiser-Permanente as operating team-based and system-driven blood pressure management programs that have resulted in control rates for more than 90% of hypertensive patients. The team-based approach is also a key in the Target:BP program that the American Heart Association and American Medical Association founded. Target:BP will be instrumental in promoting implementation of the new guidelines, Dr. Carey said. Another systems recommendation is that every patient with hypertension should have a “clear, detailed, and current evidence-based plan of care.”

“Using nurse practitioners, physician assistants, and pharmacists has been shown to improve blood pressure levels,” and health systems that use this approach have had “great success,” commented Donald M. Lloyd-Jones, MD, professor and chairman of preventive medicine at Northwestern University in Chicago and not part of the guidelines task force. Some systems have used this approach to achieve high levels of blood pressure control. Now that financial penalties and incentives from payers also exist to push for higher levels of blood pressure control, the alignment of financial and health incentives should result in big changes, Dr. Lloyd-Jones predicted in a video interview.

[email protected]

On Twitter @mitchelzoler

The Food and Drug Administration has approved dasatinib for children with Philadelphia chromosome–positive (Ph+) chronic phase chronic myeloid leukemia (CML).

The tyrosine kinase inhibitor was approved for the treatment of newly diagnosed adult patients with chronic phase Ph+ CML in 2010.

[email protected]

On Twitter @nikolaideslaura

The Food and Drug Administration has approved dasatinib for children with Philadelphia chromosome–positive (Ph+) chronic phase chronic myeloid leukemia (CML).

The tyrosine kinase inhibitor was approved for the treatment of newly diagnosed adult patients with chronic phase Ph+ CML in 2010.

[email protected]

On Twitter @nikolaideslaura

The Food and Drug Administration has approved dasatinib for children with Philadelphia chromosome–positive (Ph+) chronic phase chronic myeloid leukemia (CML).

The tyrosine kinase inhibitor was approved for the treatment of newly diagnosed adult patients with chronic phase Ph+ CML in 2010.

[email protected]

On Twitter @nikolaideslaura

PHILADELPHIA – Is it time to think about “the better mammogram” as the new standard of care? Can nuclear medicine provide a cost-effective workaround for imaging of women with dense breasts? According to two leading breast imaging researchers, it may be time to revisit current screening practices to take best advantage of today’s imaging technology.

“Digital breast tomosynthesis is the new kid on the block for screening,” said Emily F. Conant, MD, professor of radiology and chief of breast imaging at the University of Pennsylvania, Philadelphia. “It’s becoming the new standard of care in mammography,” she said, speaking during a plenary session at the annual meeting of the North American Menopause Society.

Digital breast tomosynthesis (DBT) can involve simultaneous acquisition of a conventional 2D mammogram along with a series of images to create a 3D image. Another protocol, which delivers a lower radiation dose, produces a “synthetic” 2D reconstruction of 3D mammography.*

Courtesy Dr. Deborah J. Rhodes

Molecular breast imaging

Another imaging modality uses nuclear medicine to capture the physiologic changes that accompany cancer. Molecular breast imaging (MBI), or scintimammography, can help “unveil the reservoir of hidden cancers in dense breasts,” said Deborah J. Rhodes, MD, professor of medicine at the Mayo Clinic, Rochester, Minn.

Dr. Rhodes – along with Michael O’Connor, PhD, Connie Hruska, PhD, Katie Hunt, MD, and Amy Conners, MD, her collaborators at the Mayo Clinic – uses a specialized array of gamma cameras to detect uptake of an injected radionuclide that’s preferentially avid for tumor tissue. This technique can unmask smaller tumors not seen on mammogram because it’s not impeded by having to “see” through dense breast tissue.

The radiation dose for an MBI study is a bit more than for DBT, but less than a coronary calcium score scan. The cost is about one-tenth that of breast magnetic resonance imaging (MRI), and interpretation is relatively straightforward, said Dr. Rhodes, who also presented data at the North American Menopause Society plenary.

“The traditional measure of mammography’s performance inflates its effectiveness,” especially in dense breast tissue, said Dr. Rhodes. “What is the sensitivity of mammography in the dense breast? It depends on what you measure it against.”

When cancers detected by MRI or MBI are added, the sensitivity of mammography drops from the 86.9% reported by the Breast Cancer Surveillance Consortium to 21%-31%, according to several published studies.

In one study, Dr. Rhodes and her Mayo colleagues found that the diagnostic yield per 1,000 patients with dense breasts by mammogram alone was 1.9 cancers. When MBI was added, that figure jumped to 8.8 cancers per 1,000 patients, an incremental gain of 363%.

“Tumor size matters profoundly,” she added. “If a tumor is detected above 2 cm, long-term survival drops below 50%.”

That contrasts with the better-than-80% long-term survival rate seen for those with sub-centimeter tumors, even in node-positive disease. “Only a third of tumors are detected when they are less than 1 cm” with regular screening mammography, Dr. Rhodes said.

However, in 2016 the U.S. Preventive Services Task Force concluded that the current evidence was insufficient to assess whether adjunctive screening for breast cancer using breast ultrasonography, MRI, DBT, or other methods should be used in women with dense breasts. The USPSTF noted that there weren’t studies that addressed the effect of supplemental screening on breast cancer morbidity or mortality.

The problem is that it can take 20 years or more to demonstrate mortality reduction, meaning that “no other imaging modality can compete” with mammography when this yardstick is used, Dr. Rhodes said. “This insistence on a mortality endpoint before we change practice” is impeding progress in screening, she said.

The American College of Obstetricians and Gynecologists “does not recommend adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.” However, the organization “strongly supports additional research to identify more effective screening methods” that will improve outcomes and minimize false positives in women with dense breasts.

Though DBT is becoming more widely available, MBI is still primarily used in research centers. Both Dr. Conant and Dr. Rhodes acknowledged that since these techniques are not required to be covered by insurance, payment – and patient access – may vary. Both physicians said their home institutions have worked hard to keep costs down for their studies.

Dr. Conant is consultant or advisory board member for Hologic. Dr. Rhodes reported having no conflicts of interest.

*Correction, 11/15/2017: An earlier version of this story misstated the synthetic mammography protocol.

[email protected]

On Twitter @karioakes

PHILADELPHIA – Is it time to think about “the better mammogram” as the new standard of care? Can nuclear medicine provide a cost-effective workaround for imaging of women with dense breasts? According to two leading breast imaging researchers, it may be time to revisit current screening practices to take best advantage of today’s imaging technology.

“Digital breast tomosynthesis is the new kid on the block for screening,” said Emily F. Conant, MD, professor of radiology and chief of breast imaging at the University of Pennsylvania, Philadelphia. “It’s becoming the new standard of care in mammography,” she said, speaking during a plenary session at the annual meeting of the North American Menopause Society.

Digital breast tomosynthesis (DBT) can involve simultaneous acquisition of a conventional 2D mammogram along with a series of images to create a 3D image. Another protocol, which delivers a lower radiation dose, produces a “synthetic” 2D reconstruction of 3D mammography.*

Courtesy Dr. Deborah J. Rhodes

Molecular breast imaging

Another imaging modality uses nuclear medicine to capture the physiologic changes that accompany cancer. Molecular breast imaging (MBI), or scintimammography, can help “unveil the reservoir of hidden cancers in dense breasts,” said Deborah J. Rhodes, MD, professor of medicine at the Mayo Clinic, Rochester, Minn.

Dr. Rhodes – along with Michael O’Connor, PhD, Connie Hruska, PhD, Katie Hunt, MD, and Amy Conners, MD, her collaborators at the Mayo Clinic – uses a specialized array of gamma cameras to detect uptake of an injected radionuclide that’s preferentially avid for tumor tissue. This technique can unmask smaller tumors not seen on mammogram because it’s not impeded by having to “see” through dense breast tissue.

The radiation dose for an MBI study is a bit more than for DBT, but less than a coronary calcium score scan. The cost is about one-tenth that of breast magnetic resonance imaging (MRI), and interpretation is relatively straightforward, said Dr. Rhodes, who also presented data at the North American Menopause Society plenary.

“The traditional measure of mammography’s performance inflates its effectiveness,” especially in dense breast tissue, said Dr. Rhodes. “What is the sensitivity of mammography in the dense breast? It depends on what you measure it against.”

When cancers detected by MRI or MBI are added, the sensitivity of mammography drops from the 86.9% reported by the Breast Cancer Surveillance Consortium to 21%-31%, according to several published studies.

In one study, Dr. Rhodes and her Mayo colleagues found that the diagnostic yield per 1,000 patients with dense breasts by mammogram alone was 1.9 cancers. When MBI was added, that figure jumped to 8.8 cancers per 1,000 patients, an incremental gain of 363%.

“Tumor size matters profoundly,” she added. “If a tumor is detected above 2 cm, long-term survival drops below 50%.”

That contrasts with the better-than-80% long-term survival rate seen for those with sub-centimeter tumors, even in node-positive disease. “Only a third of tumors are detected when they are less than 1 cm” with regular screening mammography, Dr. Rhodes said.

However, in 2016 the U.S. Preventive Services Task Force concluded that the current evidence was insufficient to assess whether adjunctive screening for breast cancer using breast ultrasonography, MRI, DBT, or other methods should be used in women with dense breasts. The USPSTF noted that there weren’t studies that addressed the effect of supplemental screening on breast cancer morbidity or mortality.

The problem is that it can take 20 years or more to demonstrate mortality reduction, meaning that “no other imaging modality can compete” with mammography when this yardstick is used, Dr. Rhodes said. “This insistence on a mortality endpoint before we change practice” is impeding progress in screening, she said.

The American College of Obstetricians and Gynecologists “does not recommend adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.” However, the organization “strongly supports additional research to identify more effective screening methods” that will improve outcomes and minimize false positives in women with dense breasts.

Though DBT is becoming more widely available, MBI is still primarily used in research centers. Both Dr. Conant and Dr. Rhodes acknowledged that since these techniques are not required to be covered by insurance, payment – and patient access – may vary. Both physicians said their home institutions have worked hard to keep costs down for their studies.

Dr. Conant is consultant or advisory board member for Hologic. Dr. Rhodes reported having no conflicts of interest.

*Correction, 11/15/2017: An earlier version of this story misstated the synthetic mammography protocol.

[email protected]

On Twitter @karioakes

PHILADELPHIA – Is it time to think about “the better mammogram” as the new standard of care? Can nuclear medicine provide a cost-effective workaround for imaging of women with dense breasts? According to two leading breast imaging researchers, it may be time to revisit current screening practices to take best advantage of today’s imaging technology.

“Digital breast tomosynthesis is the new kid on the block for screening,” said Emily F. Conant, MD, professor of radiology and chief of breast imaging at the University of Pennsylvania, Philadelphia. “It’s becoming the new standard of care in mammography,” she said, speaking during a plenary session at the annual meeting of the North American Menopause Society.

Digital breast tomosynthesis (DBT) can involve simultaneous acquisition of a conventional 2D mammogram along with a series of images to create a 3D image. Another protocol, which delivers a lower radiation dose, produces a “synthetic” 2D reconstruction of 3D mammography.*

Courtesy Dr. Deborah J. Rhodes

Molecular breast imaging

Another imaging modality uses nuclear medicine to capture the physiologic changes that accompany cancer. Molecular breast imaging (MBI), or scintimammography, can help “unveil the reservoir of hidden cancers in dense breasts,” said Deborah J. Rhodes, MD, professor of medicine at the Mayo Clinic, Rochester, Minn.

Dr. Rhodes – along with Michael O’Connor, PhD, Connie Hruska, PhD, Katie Hunt, MD, and Amy Conners, MD, her collaborators at the Mayo Clinic – uses a specialized array of gamma cameras to detect uptake of an injected radionuclide that’s preferentially avid for tumor tissue. This technique can unmask smaller tumors not seen on mammogram because it’s not impeded by having to “see” through dense breast tissue.

The radiation dose for an MBI study is a bit more than for DBT, but less than a coronary calcium score scan. The cost is about one-tenth that of breast magnetic resonance imaging (MRI), and interpretation is relatively straightforward, said Dr. Rhodes, who also presented data at the North American Menopause Society plenary.

“The traditional measure of mammography’s performance inflates its effectiveness,” especially in dense breast tissue, said Dr. Rhodes. “What is the sensitivity of mammography in the dense breast? It depends on what you measure it against.”

When cancers detected by MRI or MBI are added, the sensitivity of mammography drops from the 86.9% reported by the Breast Cancer Surveillance Consortium to 21%-31%, according to several published studies.

In one study, Dr. Rhodes and her Mayo colleagues found that the diagnostic yield per 1,000 patients with dense breasts by mammogram alone was 1.9 cancers. When MBI was added, that figure jumped to 8.8 cancers per 1,000 patients, an incremental gain of 363%.

“Tumor size matters profoundly,” she added. “If a tumor is detected above 2 cm, long-term survival drops below 50%.”

That contrasts with the better-than-80% long-term survival rate seen for those with sub-centimeter tumors, even in node-positive disease. “Only a third of tumors are detected when they are less than 1 cm” with regular screening mammography, Dr. Rhodes said.

However, in 2016 the U.S. Preventive Services Task Force concluded that the current evidence was insufficient to assess whether adjunctive screening for breast cancer using breast ultrasonography, MRI, DBT, or other methods should be used in women with dense breasts. The USPSTF noted that there weren’t studies that addressed the effect of supplemental screening on breast cancer morbidity or mortality.

The problem is that it can take 20 years or more to demonstrate mortality reduction, meaning that “no other imaging modality can compete” with mammography when this yardstick is used, Dr. Rhodes said. “This insistence on a mortality endpoint before we change practice” is impeding progress in screening, she said.

The American College of Obstetricians and Gynecologists “does not recommend adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.” However, the organization “strongly supports additional research to identify more effective screening methods” that will improve outcomes and minimize false positives in women with dense breasts.

Though DBT is becoming more widely available, MBI is still primarily used in research centers. Both Dr. Conant and Dr. Rhodes acknowledged that since these techniques are not required to be covered by insurance, payment – and patient access – may vary. Both physicians said their home institutions have worked hard to keep costs down for their studies.

Dr. Conant is consultant or advisory board member for Hologic. Dr. Rhodes reported having no conflicts of interest.

*Correction, 11/15/2017: An earlier version of this story misstated the synthetic mammography protocol.

[email protected]

On Twitter @karioakes

SAN DIEGO – Statin therapy wasn’t effective against a rising rate of hepatic steatosis in HIV patients, and may increase nonalcoholic fatty liver disease (NAFLD) risk, according to a small study.

The findings are contrary to the limited data currently available, which suggest statins can have a beneficial effect on hepatic steatosis, according to the study’s investigators.

NAFLD is one of the leading causes of mortality and morbidity in people living with HIV, said Vanessa El Kamari, MD, of Case Western Reserve University, Cleveland, and rates are continuing to increase. With a lack of therapeutic interventions for NAFLD in patients with HIV, finding effective treatments is a major concern for providers.

Dr. El Kamari and her colleagues conducted a secondary analysis of the SATURN-HIV trial, a randomized, placebo-controlled trial of 147 patients with HIV who were on stable antiretroviral therapy (ART) with LDL cholesterol levels at or below 130 mg/dL. Patients were either treated with 10 mg rosuvastatin or placebo.

Patients in the treatment and placebo arms were an average age of 45 years, most patients were male (81% and 76%, respectively), and a majority was African American (69% and 67%, respectively). The two groups reported average CD4+ counts of 644 and 636, respectively.

Investigators used validated scores to determine hepatic steatosis in patients, although researchers acknowledged that liver biopsy is the gold standard for hepatic steatosis measurement.

“We understand liver fat score has its limitation,” said Dr. El Kamari in a question and answer session following the presentation at an annual scientific meeting on infectious diseases. “Further studies are needed in this area in order to detect, in noninvasive ways, hepatic steatosis.”

Liver fat scores (LFS) were measured on entry, at week 48, and week 96.

After 96 weeks, investigators saw significant increases in LFS in both the placebo and rosuvastatin groups (P = .01 and P less than .01, respectively). Progression from nonsteatosis at baseline to steatosis over 96 weeks was greater in patients given rosuvastatin than in those given placebo (odds ratio, 4.3; P = .03).

Studying predictors for LFS changes, a trend toward insignificance among the randomization group led investigators to the conclusion that statin may have negatively affected the liver fat score of patients over the 96-week time period.

The study researchers identified 92 patients who did not have hepatic steatosis at baseline to study how statins influenced the development of hepatic steatosis.

Of the 13 patients who developed steatosis during the trial period, 10 were part of the rosuvastatin group, while only 3 were from the placebo group.

Increases in LFS were associated with increases in insulin resistance, detected presence of HIV-1 RNA, and higher interferon-inducible proteins, according to Dr. El Kamari.

While increased homeostatic assessment of insulin resistance was associated with increased hepatic homeostasis, Dr. El Kamari was not able to determine if statins that are not associated with insulin resistance will have different outcomes.

The investigators cautioned that the findings may not be generalizable to the entire HIV population due to the overwhelming majority of African American patients with increased inflammation, as well as the study patients’ LDL cholesterol levels of less than or equal to 130 mg/dL.

The National Institutes of Health funded the study. Dr. El Kamari had no disclosures.

[email protected]

On Twitter @eaztweets

SAN DIEGO – Statin therapy wasn’t effective against a rising rate of hepatic steatosis in HIV patients, and may increase nonalcoholic fatty liver disease (NAFLD) risk, according to a small study.

The findings are contrary to the limited data currently available, which suggest statins can have a beneficial effect on hepatic steatosis, according to the study’s investigators.

NAFLD is one of the leading causes of mortality and morbidity in people living with HIV, said Vanessa El Kamari, MD, of Case Western Reserve University, Cleveland, and rates are continuing to increase. With a lack of therapeutic interventions for NAFLD in patients with HIV, finding effective treatments is a major concern for providers.

Dr. El Kamari and her colleagues conducted a secondary analysis of the SATURN-HIV trial, a randomized, placebo-controlled trial of 147 patients with HIV who were on stable antiretroviral therapy (ART) with LDL cholesterol levels at or below 130 mg/dL. Patients were either treated with 10 mg rosuvastatin or placebo.

Patients in the treatment and placebo arms were an average age of 45 years, most patients were male (81% and 76%, respectively), and a majority was African American (69% and 67%, respectively). The two groups reported average CD4+ counts of 644 and 636, respectively.

Investigators used validated scores to determine hepatic steatosis in patients, although researchers acknowledged that liver biopsy is the gold standard for hepatic steatosis measurement.

“We understand liver fat score has its limitation,” said Dr. El Kamari in a question and answer session following the presentation at an annual scientific meeting on infectious diseases. “Further studies are needed in this area in order to detect, in noninvasive ways, hepatic steatosis.”

Liver fat scores (LFS) were measured on entry, at week 48, and week 96.

After 96 weeks, investigators saw significant increases in LFS in both the placebo and rosuvastatin groups (P = .01 and P less than .01, respectively). Progression from nonsteatosis at baseline to steatosis over 96 weeks was greater in patients given rosuvastatin than in those given placebo (odds ratio, 4.3; P = .03).

Studying predictors for LFS changes, a trend toward insignificance among the randomization group led investigators to the conclusion that statin may have negatively affected the liver fat score of patients over the 96-week time period.

The study researchers identified 92 patients who did not have hepatic steatosis at baseline to study how statins influenced the development of hepatic steatosis.

Of the 13 patients who developed steatosis during the trial period, 10 were part of the rosuvastatin group, while only 3 were from the placebo group.

Increases in LFS were associated with increases in insulin resistance, detected presence of HIV-1 RNA, and higher interferon-inducible proteins, according to Dr. El Kamari.

While increased homeostatic assessment of insulin resistance was associated with increased hepatic homeostasis, Dr. El Kamari was not able to determine if statins that are not associated with insulin resistance will have different outcomes.

The investigators cautioned that the findings may not be generalizable to the entire HIV population due to the overwhelming majority of African American patients with increased inflammation, as well as the study patients’ LDL cholesterol levels of less than or equal to 130 mg/dL.

The National Institutes of Health funded the study. Dr. El Kamari had no disclosures.

[email protected]

On Twitter @eaztweets

SAN DIEGO – Statin therapy wasn’t effective against a rising rate of hepatic steatosis in HIV patients, and may increase nonalcoholic fatty liver disease (NAFLD) risk, according to a small study.

The findings are contrary to the limited data currently available, which suggest statins can have a beneficial effect on hepatic steatosis, according to the study’s investigators.

NAFLD is one of the leading causes of mortality and morbidity in people living with HIV, said Vanessa El Kamari, MD, of Case Western Reserve University, Cleveland, and rates are continuing to increase. With a lack of therapeutic interventions for NAFLD in patients with HIV, finding effective treatments is a major concern for providers.

Dr. El Kamari and her colleagues conducted a secondary analysis of the SATURN-HIV trial, a randomized, placebo-controlled trial of 147 patients with HIV who were on stable antiretroviral therapy (ART) with LDL cholesterol levels at or below 130 mg/dL. Patients were either treated with 10 mg rosuvastatin or placebo.

Patients in the treatment and placebo arms were an average age of 45 years, most patients were male (81% and 76%, respectively), and a majority was African American (69% and 67%, respectively). The two groups reported average CD4+ counts of 644 and 636, respectively.

Investigators used validated scores to determine hepatic steatosis in patients, although researchers acknowledged that liver biopsy is the gold standard for hepatic steatosis measurement.

“We understand liver fat score has its limitation,” said Dr. El Kamari in a question and answer session following the presentation at an annual scientific meeting on infectious diseases. “Further studies are needed in this area in order to detect, in noninvasive ways, hepatic steatosis.”

Liver fat scores (LFS) were measured on entry, at week 48, and week 96.

After 96 weeks, investigators saw significant increases in LFS in both the placebo and rosuvastatin groups (P = .01 and P less than .01, respectively). Progression from nonsteatosis at baseline to steatosis over 96 weeks was greater in patients given rosuvastatin than in those given placebo (odds ratio, 4.3; P = .03).

Studying predictors for LFS changes, a trend toward insignificance among the randomization group led investigators to the conclusion that statin may have negatively affected the liver fat score of patients over the 96-week time period.

The study researchers identified 92 patients who did not have hepatic steatosis at baseline to study how statins influenced the development of hepatic steatosis.

Of the 13 patients who developed steatosis during the trial period, 10 were part of the rosuvastatin group, while only 3 were from the placebo group.

Increases in LFS were associated with increases in insulin resistance, detected presence of HIV-1 RNA, and higher interferon-inducible proteins, according to Dr. El Kamari.

While increased homeostatic assessment of insulin resistance was associated with increased hepatic homeostasis, Dr. El Kamari was not able to determine if statins that are not associated with insulin resistance will have different outcomes.

The investigators cautioned that the findings may not be generalizable to the entire HIV population due to the overwhelming majority of African American patients with increased inflammation, as well as the study patients’ LDL cholesterol levels of less than or equal to 130 mg/dL.

The National Institutes of Health funded the study. Dr. El Kamari had no disclosures.

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