CHICAGO – Adding daratumumab to the current two-drug standard of care for relapsed or refractory multiple myeloma dramatically improves outcomes, according to results of an interim analysis of the phase III CASTOR trial.

When added to bortezomib and dexamethasone, the anti-CD38 antibody, which has both direct and indirect antimyeloma activity, reduced the risk of progression or death by 61%, with little increase in toxicity, investigators reported in a plenary session and press briefing at the annual meeting of the American Society of Clinical Oncology.

This magnitude of benefit is “unprecedented in randomized studies that compare novel treatments for relapsed, refractory multiple myeloma,” contended lead investigator Dr. Antonio Palumbo, chief of the multiple myeloma unit at the University of Torino, Italy.

“We hope this [daratumumab combination for myeloma] will be the translation of R-CHOP for lymphoma,” he added, referring to the addition of rituximab to an established backbone regimen. “Daratumumab-DVd [bortezomib-dexamethasone] might be considered today a new standard of care for relapsed and refractory multiple myeloma.”

At present, daratumumab is approved by the Food and Drug Administration for use only after patients have received at least three other therapies, Dr. Palumbo said.

“This study will open the opportunity to have a combination approach after diagnosis, therefore, at first relapse,” he commented, while noting that sufficient evidence should be obtained before using a drug for a new indication. “It’s very important to move as fast as we can this combination into the early phases of disease, where there is the major impact, even from a cost-efficacy point of view.”

The CASTOR findings add to evidence suggesting that daratumumab is synergistic with other myeloma therapies, according to invited discussant Dr. Paul G. Richardson, the R.J. Corman Professor of Medicine, Harvard Medical School, Boston, and the clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston.

“What I think is particularly impressive is the effect on the one-prior-line-of-treatment stratum,” he said, where the reduction in risk of progression or death was 69% with the addition of daratumumab.

Findings from the POLLUX trial, soon to be presented at another meeting, show a similar benefit when daratumumab is added to lenalidomide and dexamethasone in this setting, yielding a 63% reduction in the risk of events, according to Dr. Richardson. Additionally, other anti-CD38 antibodies and immune checkpoint inhibitors are being studied in this disease.

“I would first and foremost emphasize that this is not a zero-sum game. We need all of these drugs and all of these combinations to fight this disease,” he maintained, reviewing the many options now available. “But truly, the advent of the monoclonal antibody platform in this setting has resulted in hazard ratios that are unprecedented,” he agreed.

In CASTOR, 498 patients were randomized evenly to eight cycles of bortezomib (Velcade) plus dexamethasone, either alone or with the addition of daratumumab (Darzalex) given concurrently and then as monotherapy after completion of those cycles.

In the interim analysis, conducted at a median follow-up of about 7 months, the trial met its primary endpoint of progression-free survival: the median time to an event had not been reached with the daratumumab three-drug therapy but was 7.2 months with the standard two-drug therapy (hazard ratio, 0.39; P less than .0001). The difference translated to a more than doubling of the 1-year rate of progression-free survival (60.7% vs. 26.9%).

Benefit was generally consistent across patient subgroups stratified by disease characteristics and previous treatments, although greater impact was seen among the subgroups having earlier-stage or less heavily pretreated disease.

On the basis of these interim findings, patients in the standard therapy arm were allowed to cross over to get daratumumab, according to Dr. Palumbo.

The triple regimen was also associated with a higher overall response rate (83% vs. 63%; P less than .0001) as well as deeper responses, with a doubling in rates of both very good partial response (VGPR) or better and complete response (CR) or better.

“More patients do achieve a profound cytoreduction,” Dr. Palumbo said. “The remission duration is almost [tripled] in patients with a CR or VGPR versus patients with a minimal response or partial response.”

Data for overall survival are not yet mature, but at the time of the analysis, there was also a trend toward fewer deaths with daratumumab than without it (hazard ratio, 0.77).

“Daratumumab did not significantly increase any toxicity that was already present with the combination of bortezomib and dexamethasone,” Dr. Palumbo reported.

The three-drug regimen yielded somewhat higher rates of treatment-emergent thrombocytopenia (59% vs. 44%) and sensory peripheral neuropathy (47% vs. 38%). However, “this was mainly due to the fact that the experimental arm was longer exposed to bortezomib in comparison to the control arm that had a higher proportion of early progressions,” he explained. Additionally, the increase in thrombocytopenia did not translate into increased bleeding.

Forty-five percent of patients in the daratumumab arm had an infusion-related reaction, but nearly all reactions were limited to the first infusion.

The rate of discontinuation because of treatment-emergent adverse events was 7% with daratumumab and 9% without it.

Dr. Palumbo disclosed that he has a consulting or advisory role with and receives honoraria and research funding (institutional) from Genmab, Janssen-Cilag, and Takeda. The trial was sponsored by Janssen Research & Development.

CHICAGO – Adding daratumumab to the current two-drug standard of care for relapsed or refractory multiple myeloma dramatically improves outcomes, according to results of an interim analysis of the phase III CASTOR trial.

When added to bortezomib and dexamethasone, the anti-CD38 antibody, which has both direct and indirect antimyeloma activity, reduced the risk of progression or death by 61%, with little increase in toxicity, investigators reported in a plenary session and press briefing at the annual meeting of the American Society of Clinical Oncology.

This magnitude of benefit is “unprecedented in randomized studies that compare novel treatments for relapsed, refractory multiple myeloma,” contended lead investigator Dr. Antonio Palumbo, chief of the multiple myeloma unit at the University of Torino, Italy.

“We hope this [daratumumab combination for myeloma] will be the translation of R-CHOP for lymphoma,” he added, referring to the addition of rituximab to an established backbone regimen. “Daratumumab-DVd [bortezomib-dexamethasone] might be considered today a new standard of care for relapsed and refractory multiple myeloma.”

At present, daratumumab is approved by the Food and Drug Administration for use only after patients have received at least three other therapies, Dr. Palumbo said.

“This study will open the opportunity to have a combination approach after diagnosis, therefore, at first relapse,” he commented, while noting that sufficient evidence should be obtained before using a drug for a new indication. “It’s very important to move as fast as we can this combination into the early phases of disease, where there is the major impact, even from a cost-efficacy point of view.”

The CASTOR findings add to evidence suggesting that daratumumab is synergistic with other myeloma therapies, according to invited discussant Dr. Paul G. Richardson, the R.J. Corman Professor of Medicine, Harvard Medical School, Boston, and the clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston.

“What I think is particularly impressive is the effect on the one-prior-line-of-treatment stratum,” he said, where the reduction in risk of progression or death was 69% with the addition of daratumumab.

Findings from the POLLUX trial, soon to be presented at another meeting, show a similar benefit when daratumumab is added to lenalidomide and dexamethasone in this setting, yielding a 63% reduction in the risk of events, according to Dr. Richardson. Additionally, other anti-CD38 antibodies and immune checkpoint inhibitors are being studied in this disease.

“I would first and foremost emphasize that this is not a zero-sum game. We need all of these drugs and all of these combinations to fight this disease,” he maintained, reviewing the many options now available. “But truly, the advent of the monoclonal antibody platform in this setting has resulted in hazard ratios that are unprecedented,” he agreed.

In CASTOR, 498 patients were randomized evenly to eight cycles of bortezomib (Velcade) plus dexamethasone, either alone or with the addition of daratumumab (Darzalex) given concurrently and then as monotherapy after completion of those cycles.

In the interim analysis, conducted at a median follow-up of about 7 months, the trial met its primary endpoint of progression-free survival: the median time to an event had not been reached with the daratumumab three-drug therapy but was 7.2 months with the standard two-drug therapy (hazard ratio, 0.39; P less than .0001). The difference translated to a more than doubling of the 1-year rate of progression-free survival (60.7% vs. 26.9%).

Benefit was generally consistent across patient subgroups stratified by disease characteristics and previous treatments, although greater impact was seen among the subgroups having earlier-stage or less heavily pretreated disease.

On the basis of these interim findings, patients in the standard therapy arm were allowed to cross over to get daratumumab, according to Dr. Palumbo.

The triple regimen was also associated with a higher overall response rate (83% vs. 63%; P less than .0001) as well as deeper responses, with a doubling in rates of both very good partial response (VGPR) or better and complete response (CR) or better.

“More patients do achieve a profound cytoreduction,” Dr. Palumbo said. “The remission duration is almost [tripled] in patients with a CR or VGPR versus patients with a minimal response or partial response.”

Data for overall survival are not yet mature, but at the time of the analysis, there was also a trend toward fewer deaths with daratumumab than without it (hazard ratio, 0.77).

“Daratumumab did not significantly increase any toxicity that was already present with the combination of bortezomib and dexamethasone,” Dr. Palumbo reported.

The three-drug regimen yielded somewhat higher rates of treatment-emergent thrombocytopenia (59% vs. 44%) and sensory peripheral neuropathy (47% vs. 38%). However, “this was mainly due to the fact that the experimental arm was longer exposed to bortezomib in comparison to the control arm that had a higher proportion of early progressions,” he explained. Additionally, the increase in thrombocytopenia did not translate into increased bleeding.

Forty-five percent of patients in the daratumumab arm had an infusion-related reaction, but nearly all reactions were limited to the first infusion.

The rate of discontinuation because of treatment-emergent adverse events was 7% with daratumumab and 9% without it.

Dr. Palumbo disclosed that he has a consulting or advisory role with and receives honoraria and research funding (institutional) from Genmab, Janssen-Cilag, and Takeda. The trial was sponsored by Janssen Research & Development.

CHICAGO – Adding daratumumab to the current two-drug standard of care for relapsed or refractory multiple myeloma dramatically improves outcomes, according to results of an interim analysis of the phase III CASTOR trial.

When added to bortezomib and dexamethasone, the anti-CD38 antibody, which has both direct and indirect antimyeloma activity, reduced the risk of progression or death by 61%, with little increase in toxicity, investigators reported in a plenary session and press briefing at the annual meeting of the American Society of Clinical Oncology.

This magnitude of benefit is “unprecedented in randomized studies that compare novel treatments for relapsed, refractory multiple myeloma,” contended lead investigator Dr. Antonio Palumbo, chief of the multiple myeloma unit at the University of Torino, Italy.

“We hope this [daratumumab combination for myeloma] will be the translation of R-CHOP for lymphoma,” he added, referring to the addition of rituximab to an established backbone regimen. “Daratumumab-DVd [bortezomib-dexamethasone] might be considered today a new standard of care for relapsed and refractory multiple myeloma.”

At present, daratumumab is approved by the Food and Drug Administration for use only after patients have received at least three other therapies, Dr. Palumbo said.

“This study will open the opportunity to have a combination approach after diagnosis, therefore, at first relapse,” he commented, while noting that sufficient evidence should be obtained before using a drug for a new indication. “It’s very important to move as fast as we can this combination into the early phases of disease, where there is the major impact, even from a cost-efficacy point of view.”

The CASTOR findings add to evidence suggesting that daratumumab is synergistic with other myeloma therapies, according to invited discussant Dr. Paul G. Richardson, the R.J. Corman Professor of Medicine, Harvard Medical School, Boston, and the clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston.

“What I think is particularly impressive is the effect on the one-prior-line-of-treatment stratum,” he said, where the reduction in risk of progression or death was 69% with the addition of daratumumab.

Findings from the POLLUX trial, soon to be presented at another meeting, show a similar benefit when daratumumab is added to lenalidomide and dexamethasone in this setting, yielding a 63% reduction in the risk of events, according to Dr. Richardson. Additionally, other anti-CD38 antibodies and immune checkpoint inhibitors are being studied in this disease.

“I would first and foremost emphasize that this is not a zero-sum game. We need all of these drugs and all of these combinations to fight this disease,” he maintained, reviewing the many options now available. “But truly, the advent of the monoclonal antibody platform in this setting has resulted in hazard ratios that are unprecedented,” he agreed.

In CASTOR, 498 patients were randomized evenly to eight cycles of bortezomib (Velcade) plus dexamethasone, either alone or with the addition of daratumumab (Darzalex) given concurrently and then as monotherapy after completion of those cycles.

In the interim analysis, conducted at a median follow-up of about 7 months, the trial met its primary endpoint of progression-free survival: the median time to an event had not been reached with the daratumumab three-drug therapy but was 7.2 months with the standard two-drug therapy (hazard ratio, 0.39; P less than .0001). The difference translated to a more than doubling of the 1-year rate of progression-free survival (60.7% vs. 26.9%).

Benefit was generally consistent across patient subgroups stratified by disease characteristics and previous treatments, although greater impact was seen among the subgroups having earlier-stage or less heavily pretreated disease.

On the basis of these interim findings, patients in the standard therapy arm were allowed to cross over to get daratumumab, according to Dr. Palumbo.

The triple regimen was also associated with a higher overall response rate (83% vs. 63%; P less than .0001) as well as deeper responses, with a doubling in rates of both very good partial response (VGPR) or better and complete response (CR) or better.

“More patients do achieve a profound cytoreduction,” Dr. Palumbo said. “The remission duration is almost [tripled] in patients with a CR or VGPR versus patients with a minimal response or partial response.”

Data for overall survival are not yet mature, but at the time of the analysis, there was also a trend toward fewer deaths with daratumumab than without it (hazard ratio, 0.77).

“Daratumumab did not significantly increase any toxicity that was already present with the combination of bortezomib and dexamethasone,” Dr. Palumbo reported.

The three-drug regimen yielded somewhat higher rates of treatment-emergent thrombocytopenia (59% vs. 44%) and sensory peripheral neuropathy (47% vs. 38%). However, “this was mainly due to the fact that the experimental arm was longer exposed to bortezomib in comparison to the control arm that had a higher proportion of early progressions,” he explained. Additionally, the increase in thrombocytopenia did not translate into increased bleeding.

Forty-five percent of patients in the daratumumab arm had an infusion-related reaction, but nearly all reactions were limited to the first infusion.

The rate of discontinuation because of treatment-emergent adverse events was 7% with daratumumab and 9% without it.

Dr. Palumbo disclosed that he has a consulting or advisory role with and receives honoraria and research funding (institutional) from Genmab, Janssen-Cilag, and Takeda. The trial was sponsored by Janssen Research & Development.

A recent treatment regimen worsened this 13-year-old Native American girl’s “acne.” Within hours of beginning the treatment (application of benzoyl peroxide–containing gel and twice-daily use of a benzoyl peroxide–based cleanser), she reported intense burning and redness in the treated areas. She stopped this regimen after a week, and her primary care provider referred her for evaluation.

The lesions have been on her face since age 2 and are not usually problematic.

The patient has a notable history of atopy, with seasonal allergies and occasional bouts of asthma. She claims to have no other health problems but does admit to being overweight for most of her life; this is an issue for most of her family members, as well. Several of her relatives developed diabetes as adults.

EXAMINATION
The patient is 5 ft tall and weighs 250 lb. She has type IV skin, consistent with her Native American heritage. The posterior aspects of both cheeks are quite red and covered with hyperkeratotic, rough, pinpoint papules. There are no comedones or pustules there or elsewhere on her body.  

No other blemishes or lesions are seen on her face, but there are hundreds of hyperkeratotic papules on her bilateral triceps. The skin in all her intertriginous (skin-on-skin) areas is quite dark and has a faintly papular, velvety appearance.

What is the diagnosis?

DISCUSSION
This girl’s facial and arm condition is keratosis pilaris (KP), an extremely common and harmless problem that affects up to 70% of newborns, though it may not fully express until age 1 or 2. Caused by an overproduction of perifollicular keratin, KP is inherited in an autosomal dominant pattern and is often seen in conjunction with atopic dermatitis and related conditions (eg, eczema, xerosis, asthma, icthyosis). KP can affect skin anywhere on the body except glabrous skin (palms and soles).

Variants of KP are also common; the one affecting this patient is keratosis pilaris rubra facei. This condition is often confused with acne, but treating it as such worsens irritation—especially in the wintertime, when humidity levels are low.

The presence of the patient’s condition from such an early age, the lack of comedones or pustules, and the discovery of more typical KP lesions on her arms all served to rule out acne and rosacea (the other item in the differential). The intertriginous hyperpigmentation represents acanthosis nigricans, reflecting her obese and (probable) prediabetic state, and is unrelated to her KP.

She will be treated with a one-week course of 2.5% hydrocortisone cream (bid application) and cessation of benzoyl peroxide–containing products. The condition should improve rapidly and become less prominent over time. Given the nature of KP, I have also found it helpful to encourage parents of affected children to research the condition online, to reinforce the information I’ve provided in the clinic.

TAKE-HOME LEARNING POINTS
• Keratosis pilaris (KP) is extremely common, affecting up to 70% of all newborns.
• Keratosis pilaris rubra facei, a common variant, affects the posterior two-thirds of the cheeks. Virtually all patients with this form will also exhibit KP on more typical areas (eg, the triceps).
• While there is no cure, moisturization helps to ease symptoms, as do other products (eg, salicylic acid–containing creams).
• KP is often mistaken for acne; unfortunately, treatment as such is counterproductive.

A recent treatment regimen worsened this 13-year-old Native American girl’s “acne.” Within hours of beginning the treatment (application of benzoyl peroxide–containing gel and twice-daily use of a benzoyl peroxide–based cleanser), she reported intense burning and redness in the treated areas. She stopped this regimen after a week, and her primary care provider referred her for evaluation.

The lesions have been on her face since age 2 and are not usually problematic.

The patient has a notable history of atopy, with seasonal allergies and occasional bouts of asthma. She claims to have no other health problems but does admit to being overweight for most of her life; this is an issue for most of her family members, as well. Several of her relatives developed diabetes as adults.

EXAMINATION
The patient is 5 ft tall and weighs 250 lb. She has type IV skin, consistent with her Native American heritage. The posterior aspects of both cheeks are quite red and covered with hyperkeratotic, rough, pinpoint papules. There are no comedones or pustules there or elsewhere on her body.  

No other blemishes or lesions are seen on her face, but there are hundreds of hyperkeratotic papules on her bilateral triceps. The skin in all her intertriginous (skin-on-skin) areas is quite dark and has a faintly papular, velvety appearance.

What is the diagnosis?

DISCUSSION
This girl’s facial and arm condition is keratosis pilaris (KP), an extremely common and harmless problem that affects up to 70% of newborns, though it may not fully express until age 1 or 2. Caused by an overproduction of perifollicular keratin, KP is inherited in an autosomal dominant pattern and is often seen in conjunction with atopic dermatitis and related conditions (eg, eczema, xerosis, asthma, icthyosis). KP can affect skin anywhere on the body except glabrous skin (palms and soles).

Variants of KP are also common; the one affecting this patient is keratosis pilaris rubra facei. This condition is often confused with acne, but treating it as such worsens irritation—especially in the wintertime, when humidity levels are low.

The presence of the patient’s condition from such an early age, the lack of comedones or pustules, and the discovery of more typical KP lesions on her arms all served to rule out acne and rosacea (the other item in the differential). The intertriginous hyperpigmentation represents acanthosis nigricans, reflecting her obese and (probable) prediabetic state, and is unrelated to her KP.

She will be treated with a one-week course of 2.5% hydrocortisone cream (bid application) and cessation of benzoyl peroxide–containing products. The condition should improve rapidly and become less prominent over time. Given the nature of KP, I have also found it helpful to encourage parents of affected children to research the condition online, to reinforce the information I’ve provided in the clinic.

TAKE-HOME LEARNING POINTS
• Keratosis pilaris (KP) is extremely common, affecting up to 70% of all newborns.
• Keratosis pilaris rubra facei, a common variant, affects the posterior two-thirds of the cheeks. Virtually all patients with this form will also exhibit KP on more typical areas (eg, the triceps).
• While there is no cure, moisturization helps to ease symptoms, as do other products (eg, salicylic acid–containing creams).
• KP is often mistaken for acne; unfortunately, treatment as such is counterproductive.

A recent treatment regimen worsened this 13-year-old Native American girl’s “acne.” Within hours of beginning the treatment (application of benzoyl peroxide–containing gel and twice-daily use of a benzoyl peroxide–based cleanser), she reported intense burning and redness in the treated areas. She stopped this regimen after a week, and her primary care provider referred her for evaluation.

The lesions have been on her face since age 2 and are not usually problematic.

The patient has a notable history of atopy, with seasonal allergies and occasional bouts of asthma. She claims to have no other health problems but does admit to being overweight for most of her life; this is an issue for most of her family members, as well. Several of her relatives developed diabetes as adults.

EXAMINATION
The patient is 5 ft tall and weighs 250 lb. She has type IV skin, consistent with her Native American heritage. The posterior aspects of both cheeks are quite red and covered with hyperkeratotic, rough, pinpoint papules. There are no comedones or pustules there or elsewhere on her body.  

No other blemishes or lesions are seen on her face, but there are hundreds of hyperkeratotic papules on her bilateral triceps. The skin in all her intertriginous (skin-on-skin) areas is quite dark and has a faintly papular, velvety appearance.

What is the diagnosis?

DISCUSSION
This girl’s facial and arm condition is keratosis pilaris (KP), an extremely common and harmless problem that affects up to 70% of newborns, though it may not fully express until age 1 or 2. Caused by an overproduction of perifollicular keratin, KP is inherited in an autosomal dominant pattern and is often seen in conjunction with atopic dermatitis and related conditions (eg, eczema, xerosis, asthma, icthyosis). KP can affect skin anywhere on the body except glabrous skin (palms and soles).

Variants of KP are also common; the one affecting this patient is keratosis pilaris rubra facei. This condition is often confused with acne, but treating it as such worsens irritation—especially in the wintertime, when humidity levels are low.

The presence of the patient’s condition from such an early age, the lack of comedones or pustules, and the discovery of more typical KP lesions on her arms all served to rule out acne and rosacea (the other item in the differential). The intertriginous hyperpigmentation represents acanthosis nigricans, reflecting her obese and (probable) prediabetic state, and is unrelated to her KP.

She will be treated with a one-week course of 2.5% hydrocortisone cream (bid application) and cessation of benzoyl peroxide–containing products. The condition should improve rapidly and become less prominent over time. Given the nature of KP, I have also found it helpful to encourage parents of affected children to research the condition online, to reinforce the information I’ve provided in the clinic.

TAKE-HOME LEARNING POINTS
• Keratosis pilaris (KP) is extremely common, affecting up to 70% of all newborns.
• Keratosis pilaris rubra facei, a common variant, affects the posterior two-thirds of the cheeks. Virtually all patients with this form will also exhibit KP on more typical areas (eg, the triceps).
• While there is no cure, moisturization helps to ease symptoms, as do other products (eg, salicylic acid–containing creams).
• KP is often mistaken for acne; unfortunately, treatment as such is counterproductive.

BALTIMORE – An “introspective” analysis connecting patient outcomes with process changes may lead to significant surgical quality improvement, according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

The case study detailed the University of Alabama at Birmingham School of Medicine’s attempt to identify the metrics used for the Society of Thoracic Surgeons lobectomy ranking, and show how the institution used root cause analysis with “lean” and process improvements to improve outcomes from Jan. 2006 until July 2014 in order to achieve a three star STS ranking.

UAB researchers found that their most common root cause analysis was failure to escalate care. The institution implemented process improvements such as increasing pulmonary rehabilitation prior to surgery, adding a respiratory therapist, eliminating (lean) non-valued steps, favoring stereotactic radiotherapy and segmentectomy instead of lobectomy for marginal patients, and using minimally invasive lobectomy. They ultimately achieved a three-star STS ranking.

Dr. Stephen D. Cassivi, professor of surgery at the Mayo Clinic in Rochester, Minn., and a discussant on the paper at AATS 2016, said in an interview that the research was important because it encourages surgeons to discuss and reevaluate quality improvement measures. He noted that early phases of surgical quality improvement was based on process measures, specifically around the idea that if surgeons were attentive to process measures, their outcome measures would improve. But over time, the emphasis on process measures has dissipated in favor of outcomes-focused analysis.

“Now that we have more robust [outcomes] data... we can examine our practices in a more thoughtful, data-driven, evidence-based way,” Dr. Cassivi said. He added that the shift from process measures to outcome measures is important in that surgeons can easily interpret and compare outcomes data across facilities. But he noted that there is a downside: If an institution’s outcome measures are not up to standard, it is sometimes difficult to determine why.

“The current way that the [outcomes] data are reported and processed is not easily interpretable into which processes we need to adapt,” Dr. Cassivi said. “There is still work that needs to be done, but [this paper] is a first step.”

Dr. Cassivi reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

BALTIMORE – An “introspective” analysis connecting patient outcomes with process changes may lead to significant surgical quality improvement, according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

The case study detailed the University of Alabama at Birmingham School of Medicine’s attempt to identify the metrics used for the Society of Thoracic Surgeons lobectomy ranking, and show how the institution used root cause analysis with “lean” and process improvements to improve outcomes from Jan. 2006 until July 2014 in order to achieve a three star STS ranking.

UAB researchers found that their most common root cause analysis was failure to escalate care. The institution implemented process improvements such as increasing pulmonary rehabilitation prior to surgery, adding a respiratory therapist, eliminating (lean) non-valued steps, favoring stereotactic radiotherapy and segmentectomy instead of lobectomy for marginal patients, and using minimally invasive lobectomy. They ultimately achieved a three-star STS ranking.

Dr. Stephen D. Cassivi, professor of surgery at the Mayo Clinic in Rochester, Minn., and a discussant on the paper at AATS 2016, said in an interview that the research was important because it encourages surgeons to discuss and reevaluate quality improvement measures. He noted that early phases of surgical quality improvement was based on process measures, specifically around the idea that if surgeons were attentive to process measures, their outcome measures would improve. But over time, the emphasis on process measures has dissipated in favor of outcomes-focused analysis.

“Now that we have more robust [outcomes] data... we can examine our practices in a more thoughtful, data-driven, evidence-based way,” Dr. Cassivi said. He added that the shift from process measures to outcome measures is important in that surgeons can easily interpret and compare outcomes data across facilities. But he noted that there is a downside: If an institution’s outcome measures are not up to standard, it is sometimes difficult to determine why.

“The current way that the [outcomes] data are reported and processed is not easily interpretable into which processes we need to adapt,” Dr. Cassivi said. “There is still work that needs to be done, but [this paper] is a first step.”

Dr. Cassivi reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

BALTIMORE – An “introspective” analysis connecting patient outcomes with process changes may lead to significant surgical quality improvement, according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

The case study detailed the University of Alabama at Birmingham School of Medicine’s attempt to identify the metrics used for the Society of Thoracic Surgeons lobectomy ranking, and show how the institution used root cause analysis with “lean” and process improvements to improve outcomes from Jan. 2006 until July 2014 in order to achieve a three star STS ranking.

UAB researchers found that their most common root cause analysis was failure to escalate care. The institution implemented process improvements such as increasing pulmonary rehabilitation prior to surgery, adding a respiratory therapist, eliminating (lean) non-valued steps, favoring stereotactic radiotherapy and segmentectomy instead of lobectomy for marginal patients, and using minimally invasive lobectomy. They ultimately achieved a three-star STS ranking.

Dr. Stephen D. Cassivi, professor of surgery at the Mayo Clinic in Rochester, Minn., and a discussant on the paper at AATS 2016, said in an interview that the research was important because it encourages surgeons to discuss and reevaluate quality improvement measures. He noted that early phases of surgical quality improvement was based on process measures, specifically around the idea that if surgeons were attentive to process measures, their outcome measures would improve. But over time, the emphasis on process measures has dissipated in favor of outcomes-focused analysis.

“Now that we have more robust [outcomes] data... we can examine our practices in a more thoughtful, data-driven, evidence-based way,” Dr. Cassivi said. He added that the shift from process measures to outcome measures is important in that surgeons can easily interpret and compare outcomes data across facilities. But he noted that there is a downside: If an institution’s outcome measures are not up to standard, it is sometimes difficult to determine why.

“The current way that the [outcomes] data are reported and processed is not easily interpretable into which processes we need to adapt,” Dr. Cassivi said. “There is still work that needs to be done, but [this paper] is a first step.”

Dr. Cassivi reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

The hemodynamic characteristics of precapillary pulmonary hypertension differ from those typically thought of as defining the disease, suggests a study published in Chest.

A pulmonary hypertension patient’s diagnostic category is used to select which patients will or won’t receive pulmonary arterial hypertension (PAH)-targeted therapies, such as treprostinil. Currently, patients with a mean pulmonary arterial wedge pressure (mPAWP) less than or equal to 15 mm Hg are classified as having precapillary pulmonary hypertension, which includes PAH; and patients with a mPAWP above 15 mm Hg are classified as having postcapillary pulmonary hypertension. Current recommendations advise against treating patients with postcapillary hypertension with PAH-targeted therapies.

First author Dr. Christian Gerges of the division of cardiology, Vienna General Hospital, Medical University of Vienna and colleagues hypothesized that a precapillary hemodynamic profile is characterized by a mPAWP that is lower than the currently accepted 15 mm Hg, an elevated diastolic pulmonary vascular pressure gradient (DPG), “and a beneficial response to PAH-targeted therapies.”

The study identified an mPAWP less than 12 mm Hg and a DPG greater than or equal to 7 mm Hg as the best hemodynamic discriminators between idiopathic PAH and postcapillary pulmonary hypertension.

This study also found that patients with a mPAWP less than 12 mm Hg combined with a diastolic pulmonary vascular pressure gradient (DPG) greater than 20 mm Hg are likely to have a significant response to PAH-targeted-therapy.

The researchers analyzed hemodynamic data from a retrospective cohort of 4,363 stable patients who underwent a first diagnostic right heart catheterization at the Medical University of Vienna between May 1996 and June 2006. Of these patients, 3,524 (81%) also received a left heart catheterization. Additionally, the researchers analyzed deidentified individual data for 541 patients from four randomized placebo-controlled trials and 437 patients from one open-label trial of treprostinil in PAH. These trials all had similar inclusion criteria and data collection processes (Chest. 2016 Apr;149[4]:1061-73. doi: 10.1378/chest.15-0928).

Funding was provided by educational grants from Bayer and United Therapeutics Corporation. All but two coauthors had no disclosures; the remaining authors disclosed numerous ties to industry sources.*

*Correction, 6/14/16: An earlier version of this article misstated the investigators' conflicts of interest.

The hemodynamic characteristics of precapillary pulmonary hypertension differ from those typically thought of as defining the disease, suggests a study published in Chest.

A pulmonary hypertension patient’s diagnostic category is used to select which patients will or won’t receive pulmonary arterial hypertension (PAH)-targeted therapies, such as treprostinil. Currently, patients with a mean pulmonary arterial wedge pressure (mPAWP) less than or equal to 15 mm Hg are classified as having precapillary pulmonary hypertension, which includes PAH; and patients with a mPAWP above 15 mm Hg are classified as having postcapillary pulmonary hypertension. Current recommendations advise against treating patients with postcapillary hypertension with PAH-targeted therapies.

First author Dr. Christian Gerges of the division of cardiology, Vienna General Hospital, Medical University of Vienna and colleagues hypothesized that a precapillary hemodynamic profile is characterized by a mPAWP that is lower than the currently accepted 15 mm Hg, an elevated diastolic pulmonary vascular pressure gradient (DPG), “and a beneficial response to PAH-targeted therapies.”

The study identified an mPAWP less than 12 mm Hg and a DPG greater than or equal to 7 mm Hg as the best hemodynamic discriminators between idiopathic PAH and postcapillary pulmonary hypertension.

This study also found that patients with a mPAWP less than 12 mm Hg combined with a diastolic pulmonary vascular pressure gradient (DPG) greater than 20 mm Hg are likely to have a significant response to PAH-targeted-therapy.

The researchers analyzed hemodynamic data from a retrospective cohort of 4,363 stable patients who underwent a first diagnostic right heart catheterization at the Medical University of Vienna between May 1996 and June 2006. Of these patients, 3,524 (81%) also received a left heart catheterization. Additionally, the researchers analyzed deidentified individual data for 541 patients from four randomized placebo-controlled trials and 437 patients from one open-label trial of treprostinil in PAH. These trials all had similar inclusion criteria and data collection processes (Chest. 2016 Apr;149[4]:1061-73. doi: 10.1378/chest.15-0928).

Funding was provided by educational grants from Bayer and United Therapeutics Corporation. All but two coauthors had no disclosures; the remaining authors disclosed numerous ties to industry sources.*

*Correction, 6/14/16: An earlier version of this article misstated the investigators' conflicts of interest.

The hemodynamic characteristics of precapillary pulmonary hypertension differ from those typically thought of as defining the disease, suggests a study published in Chest.

A pulmonary hypertension patient’s diagnostic category is used to select which patients will or won’t receive pulmonary arterial hypertension (PAH)-targeted therapies, such as treprostinil. Currently, patients with a mean pulmonary arterial wedge pressure (mPAWP) less than or equal to 15 mm Hg are classified as having precapillary pulmonary hypertension, which includes PAH; and patients with a mPAWP above 15 mm Hg are classified as having postcapillary pulmonary hypertension. Current recommendations advise against treating patients with postcapillary hypertension with PAH-targeted therapies.

First author Dr. Christian Gerges of the division of cardiology, Vienna General Hospital, Medical University of Vienna and colleagues hypothesized that a precapillary hemodynamic profile is characterized by a mPAWP that is lower than the currently accepted 15 mm Hg, an elevated diastolic pulmonary vascular pressure gradient (DPG), “and a beneficial response to PAH-targeted therapies.”

The study identified an mPAWP less than 12 mm Hg and a DPG greater than or equal to 7 mm Hg as the best hemodynamic discriminators between idiopathic PAH and postcapillary pulmonary hypertension.

This study also found that patients with a mPAWP less than 12 mm Hg combined with a diastolic pulmonary vascular pressure gradient (DPG) greater than 20 mm Hg are likely to have a significant response to PAH-targeted-therapy.

The researchers analyzed hemodynamic data from a retrospective cohort of 4,363 stable patients who underwent a first diagnostic right heart catheterization at the Medical University of Vienna between May 1996 and June 2006. Of these patients, 3,524 (81%) also received a left heart catheterization. Additionally, the researchers analyzed deidentified individual data for 541 patients from four randomized placebo-controlled trials and 437 patients from one open-label trial of treprostinil in PAH. These trials all had similar inclusion criteria and data collection processes (Chest. 2016 Apr;149[4]:1061-73. doi: 10.1378/chest.15-0928).

Funding was provided by educational grants from Bayer and United Therapeutics Corporation. All but two coauthors had no disclosures; the remaining authors disclosed numerous ties to industry sources.*

*Correction, 6/14/16: An earlier version of this article misstated the investigators' conflicts of interest.

At the 2016 American Society of Clinical Oncology in Chicago, Illinois, researchers from the VA submitted new abstracts on more than 20 different research projects focused on veteran’s oncology care. The researchers conducted studies with the scope of veteran diagnosis, treatment, and quality of care. The abstracts were presented at the annual ASCO meeting during poster sessions and online.

General Oncology

The Impact of a Veterans Administration NURSE Disease Management Program: the Oncology Aspect

Author(s): George Anthony Dawson,  et al.

Background: In an effort to decrease time to diagnosis and/or treatment intervention in newly diagnosed veteran cancer patients, Hudson Valley administrators chose the disease case management team model as a potential useful solution to enhance and / or expedite health care delivery. This disease management program began in 2008. The team consists of 3 registered nurses who work under the auspices of the quality management division rather than a specific oncology clinic. This report will show the clinical impact of Hudson Valley VA’s disease management team.

To read the full abstract click here: http://meetinglibrary.asco.org/content/161764-176

Implementation of a Nurse Communication Strategy to Improve Perception of Nurse-Patient Communication at the Bedside on an Inpatient Oncology Unit

Author(s): Lyn Cain Zehner, et al.

Background: Patients spend more time with nurses when in the hospital than with any other health care professional. Patient experience scores have been used as a measure of quality patient outcomes. The Hospital Consumer Assessment of Healthcare Providers and Systems Survey (HCAHPS) score communication with nurses, correlates with improvements in 4 other dimensions: pain, communication about medications, responsiveness of staff, and overall rating. As patient experience scores are tied to Medicare reimbursement, nurses have an impact on reimbursement. The nurse communication scores on the inpatient 29 bed oncology unit reflected an opportunity for improvement. The purpose of this project was to develop a communication strategy that staff would implement at the bedside. The goal was to achieve an improvement in the HCAHPS Communication with Nurses question.

To read the full abstract click here: http://meetinglibrary.asco.org/content/166250-176

Modified Ketogenic Diet in Advanced Malignancies–Final Results of a Safety and Feasibility Trial Within the Veterans Affairs Healthcare System

Author(s): Jocelyn Tan-Shalaby, et al.

Final report of a safety and feasibility trial within the Pittsburgh Veteran Affairs HealthCare System- Modified Ketogenic Diet in Advanced Cancer.
Background: Malignant cells have dysfunctional mitochondria, which limit their ability to use energy from fatty acids and ketones. Preclinical animal studies using a ketogenic diet in cancer show encouraging results. The authors tested safety and feasibility of the modified ketogenic diet in a veteran population of advanced cancer patients across a variety of solid tumors.

To read the full abstract click here: http://meetinglibrary.asco.org/content/170081-176

[Click through for : Prostate Cancer, Liver, Radiation Oncology, Lung Cancer, Colorectal, HIV and Cancer, Palliative Care, Esophageal]

Prostate Cancer

Improving Risk Stratification Among Veterans With Newly Diagnosed, Clinically Low-Risk Prostate Cancer Using the 17-Gene Genomic Prostate Score Assay.

Author(s): Julie Ann Lynch, et al.

Background: Active surveillance (AS) is a recommended treatment option for low risk prostate cancer (PCa). Studies have shown high rates of AS in the VA yet treatment variation exists between VAMCs, likely due to concern about missing aggressive disease. The 17-gene Genomic Prostate Score (GPS) has been validated to predict likelihood of favorable pathology in men with low risk PCa. This study compares treatment patterns before and after introduction of the GPS to determine if the assay assists in risk-stratification. Men with PCa who met National Comprehensive Cancer Network criteria for very low, low, or intermediate risk PCa were eligible. Chart review of men across 6 VAMCs established baseline treatment in untested patients in 2013-2014. In 2015, Veterans at the same VAMCs were offered the assay in a prospective study. Treatment recommendations and treatment implemented were captured.

To read the full abstract click here: http://meetinglibrary.asco.org/content/170703-176

Trends in Utilization of Novel Oral Therapeutic Agents for Men With Metastatic Castrate-Resistant Prostate Cancer Within the United States Veteran’s Affairs Health System.

Author(s): Elizabeth Henry, et al.

Background: Therapeutic options for men with metastatic castrate resistant prostate cancer (mCRPC) have expanded significantly over the past 5 years with several new agents demonstrating improved survival, including two oral agents. Abiraterone acetate, a CYP-17 androgen synthesis inhibitor, obtained initial FDA approval in 2011 for post-docetaxel (D) use, and gained expanded approval in 2012 for pre-D use. Enzalutamide, an androgen receptor signaling inhibitor, also gained FDA approval in 2012 (post-D) and indication was expanded in 2014 (pre-D). Due to the relatively recent approvals of these agents, there is limited data on rates of uptake and prescribing patterns for patients with mCRPC.

To read the full abstract click here: http://meetinglibrary.asco.org/content/157970-172

Liver

A Comparison of Liver Cancer Patients Receiving Palliative Care at Two Veteran Affairs Medical Centers.

Author(s): Sarah Lee, Zhen Wang, et al.

Background: Liver cancer is a leading cause of death. Lack of data exists on palliative care in this group, and care varies by location. The authors aim to determine if there are differences in palliative care for liver cancer patients by VA site.

To read the full abstract click here: http://meetinglibrary.asco.org/content/171726-176

[Click through for :  Radiation Oncology, Lung Cancer, Colorectal, HIV and Cancer, Palliative Care, Esophageal]

Radiation Oncology

A Cross-Sectional View of Radiation Dose Fractionation Schemes Used for Treating Painful Bone Metastases (PBM) Within Veterans Health Administration’s Radiation Oncology Centers.

Author(s): George Anthony Dawson, et al.

Background: The use of single fraction radiotherapy in the treatment of PBM in the United States is now gaining clinical acceptance, especially at large institutional levels. In this cross-sectional report, the authors report the varying dose fractionation schemes used to treat PBM by VHA radiation oncology centers.

To read the full abstract click here: http://meetinglibrary.asco.org/content/161496-176

Will Academic and Community Physicians Engage and Share Knowledge in an Online Physician Social Network? Lessons from the Radiation Oncology Community.

Author(s): Nadine Housri, et al.

Background: The exponential growth of medical knowledge has made it increasingly difficult for clinicians to make sense of new information and recognize how to incorporate new research results into clinical practice. The authors sought to determine whether a social question and answer website designed to connect academic and community physicians would consistently engage radiation oncologists to share evidence based information and clinical insights with each other.

To read the full abstract click here: http://meetinglibrary.asco.org/content/171497-176

Lung Cancer

Non–Small Cell Lung Cancer in Veterans: Disparities in Prevalence and Survival Among Different Histologic Subtypes.

Author(s): Hussein Assi, Efstratios Koutroumpakis, et al.

Background: Since the 1980s, adenocarcinoma (AC) of the lung has become more common than squamous cell carcinoma (SCC). Given the differences in smoking patterns, it is unclear if the same holds true among veterans. In this study, the authors compare the distribution of lung AC and SCC in the veterans’ population to that in the general population. They also looked at the survival of patients with different histologies in the VA population.

To read the full abstract click here: http://meetinglibrary.asco.org/content/167505-176

VA Oncologists’ Attitudes and Behaviors Regarding Genomic-Based Targeted Therapy for the Management of Advanced Lung Cancer.

Author(s): Jennifer Arney, et al.

Background: Genomic-based targeted therapy (GBTT) has emerged as a treatment option for patients with advanced lung cancer. Clinical practice guidelines of the National Comprehensive Cancer Network and the American Society of Clinical Oncology recommend testing all metastatic adenocarcinomas for EGFR mutation, and use of EGFR-TKIs (erlotinib) as first-line therapy for advanced adenocarcinoma lung cancer patients with EGFR mutation positive. Little is known about how oncologists utilize genomic testing and GBTT in a clinical setting. Drawing from the Cabana and colleagues theoretical framework on providers’ adherence to guidelines, this study aims to elicit provider and facility-level barriers and facilitators to using GBTT in VA healthcare delivery system.

To read the full abstract click here: http://meetinglibrary.asco.org/content/166517-176

[Click through for: Colorectal, HIV and Cancer, Palliative Care, Esophageal]

Colorectal

Survival Advantage for Hepatectomy With or Without Hemicolectomy in Colorectal Liver Metastases.

Author(s): Dalia A. Mobarek, et al.

Background: Surgical resection of colorectal liver metastases offers the greatest chance of long-term survival. The authors aimed to study survival in patients presenting with hepatic metastasis at the outset and rates of surgical intervention in the VHA.

To read the full abstract click here: http://meetinglibrary.asco.org/content/171640-176

Colorectal Liver Metastases Management in the Veterans Health Administration: Geographic Disparity.

Author(s): Dalia A. Mobarek, et al.

Background: Multidisciplinary management including surgical resection of colorectal liver metastases offers the greatest chance of long-term survival. The authors aimed to study surgical intervention types, rates and factors affecting the decision making in the VHA.

To read the full abstract click here: http://meetinglibrary.asco.org/content/160233-173

HIV and Cancer

Gleason Grade in HIV+ Versus Uninfected Prostate Cancer Patients in the Veterans Aging Cohort Study.

Author(s): Roxanne Jimmy Wadia, et al.

Background: Little is known about how the biology of prostate cancer in HIV+ men compares to that of uninfected men. The purpose of this study was to compare the Gleason grade (GL) of prostate adenocarcinoma (PrCA) in HIV+ vs uninfected patients in the combination antiretroviral therapy (ART) era (1997-present).

To read the full abstract click here: http://meetinglibrary.asco.org/content/162980-176

Disparities in AIDS-Related Kaposi Sarcoma Incidence and Survival.

Author(s): Firas El Chaer, et al.

Background: With advances in combined antiretroviral therapy (ART), Kaposi’s sarcoma (KS) incidence has decreased over the past decade. Geographical and racial disparities may contribute to variation in the incidence and outcomes of multiple cancers in the U.S., including KS. Using the Surveillance, Epidemiology, and End Results (SEER) database, the authors analyzed KS incidence and survival by race and geographical region in the ART era.

To read the full abstract click here: http://meetinglibrary.asco.org/content/168953-176

[Click through for : Palliative Care, Esophageal]

Palliative Care

Palliative Care Interventions and EOL Care Outcomes for Hepatocellular Patients (pts) at 2 VA Medical Centers.

Author(s): Zhen Wang, et al.

Background: Palliative care interventions and its effect on EOL outcomes for liver cancer pts have not been described. The authors investigated the association between palliative care intervention and EOL care outcomes.

To read the full abstract click here: http://meetinglibrary.asco.org/content/167081-176

Esophageal

Characteristics of Esophageal Carcinoma in a Veteran Population.

Author(s): Theresa Ratajczak, et al.

Background: Esophageal cancer is projected to increase by approximately 35% through 2025 in the U.S. The authors investigated the characteristics of esophageal carcinoma in a veteran population.

To read the full abstract click here: http://meetinglibrary.asco.org/content/162712-176

At the 2016 American Society of Clinical Oncology in Chicago, Illinois, researchers from the VA submitted new abstracts on more than 20 different research projects focused on veteran’s oncology care. The researchers conducted studies with the scope of veteran diagnosis, treatment, and quality of care. The abstracts were presented at the annual ASCO meeting during poster sessions and online.

General Oncology

The Impact of a Veterans Administration NURSE Disease Management Program: the Oncology Aspect

Author(s): George Anthony Dawson,  et al.

Background: In an effort to decrease time to diagnosis and/or treatment intervention in newly diagnosed veteran cancer patients, Hudson Valley administrators chose the disease case management team model as a potential useful solution to enhance and / or expedite health care delivery. This disease management program began in 2008. The team consists of 3 registered nurses who work under the auspices of the quality management division rather than a specific oncology clinic. This report will show the clinical impact of Hudson Valley VA’s disease management team.

To read the full abstract click here: http://meetinglibrary.asco.org/content/161764-176

Implementation of a Nurse Communication Strategy to Improve Perception of Nurse-Patient Communication at the Bedside on an Inpatient Oncology Unit

Author(s): Lyn Cain Zehner, et al.

Background: Patients spend more time with nurses when in the hospital than with any other health care professional. Patient experience scores have been used as a measure of quality patient outcomes. The Hospital Consumer Assessment of Healthcare Providers and Systems Survey (HCAHPS) score communication with nurses, correlates with improvements in 4 other dimensions: pain, communication about medications, responsiveness of staff, and overall rating. As patient experience scores are tied to Medicare reimbursement, nurses have an impact on reimbursement. The nurse communication scores on the inpatient 29 bed oncology unit reflected an opportunity for improvement. The purpose of this project was to develop a communication strategy that staff would implement at the bedside. The goal was to achieve an improvement in the HCAHPS Communication with Nurses question.

To read the full abstract click here: http://meetinglibrary.asco.org/content/166250-176

Modified Ketogenic Diet in Advanced Malignancies–Final Results of a Safety and Feasibility Trial Within the Veterans Affairs Healthcare System

Author(s): Jocelyn Tan-Shalaby, et al.

Final report of a safety and feasibility trial within the Pittsburgh Veteran Affairs HealthCare System- Modified Ketogenic Diet in Advanced Cancer.
Background: Malignant cells have dysfunctional mitochondria, which limit their ability to use energy from fatty acids and ketones. Preclinical animal studies using a ketogenic diet in cancer show encouraging results. The authors tested safety and feasibility of the modified ketogenic diet in a veteran population of advanced cancer patients across a variety of solid tumors.

To read the full abstract click here: http://meetinglibrary.asco.org/content/170081-176

[Click through for : Prostate Cancer, Liver, Radiation Oncology, Lung Cancer, Colorectal, HIV and Cancer, Palliative Care, Esophageal]

Prostate Cancer

Improving Risk Stratification Among Veterans With Newly Diagnosed, Clinically Low-Risk Prostate Cancer Using the 17-Gene Genomic Prostate Score Assay.

Author(s): Julie Ann Lynch, et al.

Background: Active surveillance (AS) is a recommended treatment option for low risk prostate cancer (PCa). Studies have shown high rates of AS in the VA yet treatment variation exists between VAMCs, likely due to concern about missing aggressive disease. The 17-gene Genomic Prostate Score (GPS) has been validated to predict likelihood of favorable pathology in men with low risk PCa. This study compares treatment patterns before and after introduction of the GPS to determine if the assay assists in risk-stratification. Men with PCa who met National Comprehensive Cancer Network criteria for very low, low, or intermediate risk PCa were eligible. Chart review of men across 6 VAMCs established baseline treatment in untested patients in 2013-2014. In 2015, Veterans at the same VAMCs were offered the assay in a prospective study. Treatment recommendations and treatment implemented were captured.

To read the full abstract click here: http://meetinglibrary.asco.org/content/170703-176

Trends in Utilization of Novel Oral Therapeutic Agents for Men With Metastatic Castrate-Resistant Prostate Cancer Within the United States Veteran’s Affairs Health System.

Author(s): Elizabeth Henry, et al.

Background: Therapeutic options for men with metastatic castrate resistant prostate cancer (mCRPC) have expanded significantly over the past 5 years with several new agents demonstrating improved survival, including two oral agents. Abiraterone acetate, a CYP-17 androgen synthesis inhibitor, obtained initial FDA approval in 2011 for post-docetaxel (D) use, and gained expanded approval in 2012 for pre-D use. Enzalutamide, an androgen receptor signaling inhibitor, also gained FDA approval in 2012 (post-D) and indication was expanded in 2014 (pre-D). Due to the relatively recent approvals of these agents, there is limited data on rates of uptake and prescribing patterns for patients with mCRPC.

To read the full abstract click here: http://meetinglibrary.asco.org/content/157970-172

Liver

A Comparison of Liver Cancer Patients Receiving Palliative Care at Two Veteran Affairs Medical Centers.

Author(s): Sarah Lee, Zhen Wang, et al.

Background: Liver cancer is a leading cause of death. Lack of data exists on palliative care in this group, and care varies by location. The authors aim to determine if there are differences in palliative care for liver cancer patients by VA site.

To read the full abstract click here: http://meetinglibrary.asco.org/content/171726-176

[Click through for :  Radiation Oncology, Lung Cancer, Colorectal, HIV and Cancer, Palliative Care, Esophageal]

Radiation Oncology

A Cross-Sectional View of Radiation Dose Fractionation Schemes Used for Treating Painful Bone Metastases (PBM) Within Veterans Health Administration’s Radiation Oncology Centers.

Author(s): George Anthony Dawson, et al.

Background: The use of single fraction radiotherapy in the treatment of PBM in the United States is now gaining clinical acceptance, especially at large institutional levels. In this cross-sectional report, the authors report the varying dose fractionation schemes used to treat PBM by VHA radiation oncology centers.

To read the full abstract click here: http://meetinglibrary.asco.org/content/161496-176

Will Academic and Community Physicians Engage and Share Knowledge in an Online Physician Social Network? Lessons from the Radiation Oncology Community.

Author(s): Nadine Housri, et al.

Background: The exponential growth of medical knowledge has made it increasingly difficult for clinicians to make sense of new information and recognize how to incorporate new research results into clinical practice. The authors sought to determine whether a social question and answer website designed to connect academic and community physicians would consistently engage radiation oncologists to share evidence based information and clinical insights with each other.

To read the full abstract click here: http://meetinglibrary.asco.org/content/171497-176

Lung Cancer

Non–Small Cell Lung Cancer in Veterans: Disparities in Prevalence and Survival Among Different Histologic Subtypes.

Author(s): Hussein Assi, Efstratios Koutroumpakis, et al.

Background: Since the 1980s, adenocarcinoma (AC) of the lung has become more common than squamous cell carcinoma (SCC). Given the differences in smoking patterns, it is unclear if the same holds true among veterans. In this study, the authors compare the distribution of lung AC and SCC in the veterans’ population to that in the general population. They also looked at the survival of patients with different histologies in the VA population.

To read the full abstract click here: http://meetinglibrary.asco.org/content/167505-176

VA Oncologists’ Attitudes and Behaviors Regarding Genomic-Based Targeted Therapy for the Management of Advanced Lung Cancer.

Author(s): Jennifer Arney, et al.

Background: Genomic-based targeted therapy (GBTT) has emerged as a treatment option for patients with advanced lung cancer. Clinical practice guidelines of the National Comprehensive Cancer Network and the American Society of Clinical Oncology recommend testing all metastatic adenocarcinomas for EGFR mutation, and use of EGFR-TKIs (erlotinib) as first-line therapy for advanced adenocarcinoma lung cancer patients with EGFR mutation positive. Little is known about how oncologists utilize genomic testing and GBTT in a clinical setting. Drawing from the Cabana and colleagues theoretical framework on providers’ adherence to guidelines, this study aims to elicit provider and facility-level barriers and facilitators to using GBTT in VA healthcare delivery system.

To read the full abstract click here: http://meetinglibrary.asco.org/content/166517-176

[Click through for: Colorectal, HIV and Cancer, Palliative Care, Esophageal]

Colorectal

Survival Advantage for Hepatectomy With or Without Hemicolectomy in Colorectal Liver Metastases.

Author(s): Dalia A. Mobarek, et al.

Background: Surgical resection of colorectal liver metastases offers the greatest chance of long-term survival. The authors aimed to study survival in patients presenting with hepatic metastasis at the outset and rates of surgical intervention in the VHA.

To read the full abstract click here: http://meetinglibrary.asco.org/content/171640-176

Colorectal Liver Metastases Management in the Veterans Health Administration: Geographic Disparity.

Author(s): Dalia A. Mobarek, et al.

Background: Multidisciplinary management including surgical resection of colorectal liver metastases offers the greatest chance of long-term survival. The authors aimed to study surgical intervention types, rates and factors affecting the decision making in the VHA.

To read the full abstract click here: http://meetinglibrary.asco.org/content/160233-173

HIV and Cancer

Gleason Grade in HIV+ Versus Uninfected Prostate Cancer Patients in the Veterans Aging Cohort Study.

Author(s): Roxanne Jimmy Wadia, et al.

Background: Little is known about how the biology of prostate cancer in HIV+ men compares to that of uninfected men. The purpose of this study was to compare the Gleason grade (GL) of prostate adenocarcinoma (PrCA) in HIV+ vs uninfected patients in the combination antiretroviral therapy (ART) era (1997-present).

To read the full abstract click here: http://meetinglibrary.asco.org/content/162980-176

Disparities in AIDS-Related Kaposi Sarcoma Incidence and Survival.

Author(s): Firas El Chaer, et al.

Background: With advances in combined antiretroviral therapy (ART), Kaposi’s sarcoma (KS) incidence has decreased over the past decade. Geographical and racial disparities may contribute to variation in the incidence and outcomes of multiple cancers in the U.S., including KS. Using the Surveillance, Epidemiology, and End Results (SEER) database, the authors analyzed KS incidence and survival by race and geographical region in the ART era.

To read the full abstract click here: http://meetinglibrary.asco.org/content/168953-176

[Click through for : Palliative Care, Esophageal]

Palliative Care

Palliative Care Interventions and EOL Care Outcomes for Hepatocellular Patients (pts) at 2 VA Medical Centers.

Author(s): Zhen Wang, et al.

Background: Palliative care interventions and its effect on EOL outcomes for liver cancer pts have not been described. The authors investigated the association between palliative care intervention and EOL care outcomes.

To read the full abstract click here: http://meetinglibrary.asco.org/content/167081-176

Esophageal

Characteristics of Esophageal Carcinoma in a Veteran Population.

Author(s): Theresa Ratajczak, et al.

Background: Esophageal cancer is projected to increase by approximately 35% through 2025 in the U.S. The authors investigated the characteristics of esophageal carcinoma in a veteran population.

To read the full abstract click here: http://meetinglibrary.asco.org/content/162712-176

At the 2016 American Society of Clinical Oncology in Chicago, Illinois, researchers from the VA submitted new abstracts on more than 20 different research projects focused on veteran’s oncology care. The researchers conducted studies with the scope of veteran diagnosis, treatment, and quality of care. The abstracts were presented at the annual ASCO meeting during poster sessions and online.

General Oncology

The Impact of a Veterans Administration NURSE Disease Management Program: the Oncology Aspect

Author(s): George Anthony Dawson,  et al.

Background: In an effort to decrease time to diagnosis and/or treatment intervention in newly diagnosed veteran cancer patients, Hudson Valley administrators chose the disease case management team model as a potential useful solution to enhance and / or expedite health care delivery. This disease management program began in 2008. The team consists of 3 registered nurses who work under the auspices of the quality management division rather than a specific oncology clinic. This report will show the clinical impact of Hudson Valley VA’s disease management team.

To read the full abstract click here: http://meetinglibrary.asco.org/content/161764-176

Implementation of a Nurse Communication Strategy to Improve Perception of Nurse-Patient Communication at the Bedside on an Inpatient Oncology Unit

Author(s): Lyn Cain Zehner, et al.

Background: Patients spend more time with nurses when in the hospital than with any other health care professional. Patient experience scores have been used as a measure of quality patient outcomes. The Hospital Consumer Assessment of Healthcare Providers and Systems Survey (HCAHPS) score communication with nurses, correlates with improvements in 4 other dimensions: pain, communication about medications, responsiveness of staff, and overall rating. As patient experience scores are tied to Medicare reimbursement, nurses have an impact on reimbursement. The nurse communication scores on the inpatient 29 bed oncology unit reflected an opportunity for improvement. The purpose of this project was to develop a communication strategy that staff would implement at the bedside. The goal was to achieve an improvement in the HCAHPS Communication with Nurses question.

To read the full abstract click here: http://meetinglibrary.asco.org/content/166250-176

Modified Ketogenic Diet in Advanced Malignancies–Final Results of a Safety and Feasibility Trial Within the Veterans Affairs Healthcare System

Author(s): Jocelyn Tan-Shalaby, et al.

Final report of a safety and feasibility trial within the Pittsburgh Veteran Affairs HealthCare System- Modified Ketogenic Diet in Advanced Cancer.
Background: Malignant cells have dysfunctional mitochondria, which limit their ability to use energy from fatty acids and ketones. Preclinical animal studies using a ketogenic diet in cancer show encouraging results. The authors tested safety and feasibility of the modified ketogenic diet in a veteran population of advanced cancer patients across a variety of solid tumors.

To read the full abstract click here: http://meetinglibrary.asco.org/content/170081-176

[Click through for : Prostate Cancer, Liver, Radiation Oncology, Lung Cancer, Colorectal, HIV and Cancer, Palliative Care, Esophageal]

Prostate Cancer

Improving Risk Stratification Among Veterans With Newly Diagnosed, Clinically Low-Risk Prostate Cancer Using the 17-Gene Genomic Prostate Score Assay.

Author(s): Julie Ann Lynch, et al.

Background: Active surveillance (AS) is a recommended treatment option for low risk prostate cancer (PCa). Studies have shown high rates of AS in the VA yet treatment variation exists between VAMCs, likely due to concern about missing aggressive disease. The 17-gene Genomic Prostate Score (GPS) has been validated to predict likelihood of favorable pathology in men with low risk PCa. This study compares treatment patterns before and after introduction of the GPS to determine if the assay assists in risk-stratification. Men with PCa who met National Comprehensive Cancer Network criteria for very low, low, or intermediate risk PCa were eligible. Chart review of men across 6 VAMCs established baseline treatment in untested patients in 2013-2014. In 2015, Veterans at the same VAMCs were offered the assay in a prospective study. Treatment recommendations and treatment implemented were captured.

To read the full abstract click here: http://meetinglibrary.asco.org/content/170703-176

Trends in Utilization of Novel Oral Therapeutic Agents for Men With Metastatic Castrate-Resistant Prostate Cancer Within the United States Veteran’s Affairs Health System.

Author(s): Elizabeth Henry, et al.

Background: Therapeutic options for men with metastatic castrate resistant prostate cancer (mCRPC) have expanded significantly over the past 5 years with several new agents demonstrating improved survival, including two oral agents. Abiraterone acetate, a CYP-17 androgen synthesis inhibitor, obtained initial FDA approval in 2011 for post-docetaxel (D) use, and gained expanded approval in 2012 for pre-D use. Enzalutamide, an androgen receptor signaling inhibitor, also gained FDA approval in 2012 (post-D) and indication was expanded in 2014 (pre-D). Due to the relatively recent approvals of these agents, there is limited data on rates of uptake and prescribing patterns for patients with mCRPC.

To read the full abstract click here: http://meetinglibrary.asco.org/content/157970-172

Liver

A Comparison of Liver Cancer Patients Receiving Palliative Care at Two Veteran Affairs Medical Centers.

Author(s): Sarah Lee, Zhen Wang, et al.

Background: Liver cancer is a leading cause of death. Lack of data exists on palliative care in this group, and care varies by location. The authors aim to determine if there are differences in palliative care for liver cancer patients by VA site.

To read the full abstract click here: http://meetinglibrary.asco.org/content/171726-176

[Click through for :  Radiation Oncology, Lung Cancer, Colorectal, HIV and Cancer, Palliative Care, Esophageal]

Radiation Oncology

A Cross-Sectional View of Radiation Dose Fractionation Schemes Used for Treating Painful Bone Metastases (PBM) Within Veterans Health Administration’s Radiation Oncology Centers.

Author(s): George Anthony Dawson, et al.

Background: The use of single fraction radiotherapy in the treatment of PBM in the United States is now gaining clinical acceptance, especially at large institutional levels. In this cross-sectional report, the authors report the varying dose fractionation schemes used to treat PBM by VHA radiation oncology centers.

To read the full abstract click here: http://meetinglibrary.asco.org/content/161496-176

Will Academic and Community Physicians Engage and Share Knowledge in an Online Physician Social Network? Lessons from the Radiation Oncology Community.

Author(s): Nadine Housri, et al.

Background: The exponential growth of medical knowledge has made it increasingly difficult for clinicians to make sense of new information and recognize how to incorporate new research results into clinical practice. The authors sought to determine whether a social question and answer website designed to connect academic and community physicians would consistently engage radiation oncologists to share evidence based information and clinical insights with each other.

To read the full abstract click here: http://meetinglibrary.asco.org/content/171497-176

Lung Cancer

Non–Small Cell Lung Cancer in Veterans: Disparities in Prevalence and Survival Among Different Histologic Subtypes.

Author(s): Hussein Assi, Efstratios Koutroumpakis, et al.

Background: Since the 1980s, adenocarcinoma (AC) of the lung has become more common than squamous cell carcinoma (SCC). Given the differences in smoking patterns, it is unclear if the same holds true among veterans. In this study, the authors compare the distribution of lung AC and SCC in the veterans’ population to that in the general population. They also looked at the survival of patients with different histologies in the VA population.

To read the full abstract click here: http://meetinglibrary.asco.org/content/167505-176

VA Oncologists’ Attitudes and Behaviors Regarding Genomic-Based Targeted Therapy for the Management of Advanced Lung Cancer.

Author(s): Jennifer Arney, et al.

Background: Genomic-based targeted therapy (GBTT) has emerged as a treatment option for patients with advanced lung cancer. Clinical practice guidelines of the National Comprehensive Cancer Network and the American Society of Clinical Oncology recommend testing all metastatic adenocarcinomas for EGFR mutation, and use of EGFR-TKIs (erlotinib) as first-line therapy for advanced adenocarcinoma lung cancer patients with EGFR mutation positive. Little is known about how oncologists utilize genomic testing and GBTT in a clinical setting. Drawing from the Cabana and colleagues theoretical framework on providers’ adherence to guidelines, this study aims to elicit provider and facility-level barriers and facilitators to using GBTT in VA healthcare delivery system.

To read the full abstract click here: http://meetinglibrary.asco.org/content/166517-176

[Click through for: Colorectal, HIV and Cancer, Palliative Care, Esophageal]

Colorectal

Survival Advantage for Hepatectomy With or Without Hemicolectomy in Colorectal Liver Metastases.

Author(s): Dalia A. Mobarek, et al.

Background: Surgical resection of colorectal liver metastases offers the greatest chance of long-term survival. The authors aimed to study survival in patients presenting with hepatic metastasis at the outset and rates of surgical intervention in the VHA.

To read the full abstract click here: http://meetinglibrary.asco.org/content/171640-176

Colorectal Liver Metastases Management in the Veterans Health Administration: Geographic Disparity.

Author(s): Dalia A. Mobarek, et al.

Background: Multidisciplinary management including surgical resection of colorectal liver metastases offers the greatest chance of long-term survival. The authors aimed to study surgical intervention types, rates and factors affecting the decision making in the VHA.

To read the full abstract click here: http://meetinglibrary.asco.org/content/160233-173

HIV and Cancer

Gleason Grade in HIV+ Versus Uninfected Prostate Cancer Patients in the Veterans Aging Cohort Study.

Author(s): Roxanne Jimmy Wadia, et al.

Background: Little is known about how the biology of prostate cancer in HIV+ men compares to that of uninfected men. The purpose of this study was to compare the Gleason grade (GL) of prostate adenocarcinoma (PrCA) in HIV+ vs uninfected patients in the combination antiretroviral therapy (ART) era (1997-present).

To read the full abstract click here: http://meetinglibrary.asco.org/content/162980-176

Disparities in AIDS-Related Kaposi Sarcoma Incidence and Survival.

Author(s): Firas El Chaer, et al.

Background: With advances in combined antiretroviral therapy (ART), Kaposi’s sarcoma (KS) incidence has decreased over the past decade. Geographical and racial disparities may contribute to variation in the incidence and outcomes of multiple cancers in the U.S., including KS. Using the Surveillance, Epidemiology, and End Results (SEER) database, the authors analyzed KS incidence and survival by race and geographical region in the ART era.

To read the full abstract click here: http://meetinglibrary.asco.org/content/168953-176

[Click through for : Palliative Care, Esophageal]

Palliative Care

Palliative Care Interventions and EOL Care Outcomes for Hepatocellular Patients (pts) at 2 VA Medical Centers.

Author(s): Zhen Wang, et al.

Background: Palliative care interventions and its effect on EOL outcomes for liver cancer pts have not been described. The authors investigated the association between palliative care intervention and EOL care outcomes.

To read the full abstract click here: http://meetinglibrary.asco.org/content/167081-176

Esophageal

Characteristics of Esophageal Carcinoma in a Veteran Population.

Author(s): Theresa Ratajczak, et al.

Background: Esophageal cancer is projected to increase by approximately 35% through 2025 in the U.S. The authors investigated the characteristics of esophageal carcinoma in a veteran population.

To read the full abstract click here: http://meetinglibrary.asco.org/content/162712-176

Non-neutralizing, factor VIII–specific IgG antibodies can contribute significantly to reductions in factor VIII half-life in patients with hemophilia A, according to a study published online in Blood.

Screening for factor VIII–specific IgG may aid in tailoring factor VIII prophylactic regimens for hemophilia A patients, said Christoph J. Hofbauer, Ph.D., of the biopharmaceutical company Baxalta in Vienna, and his associates at the Medical University of Vienna.

The researchers examined the effect of factor VIII–specific IgG antibodies on factor VIII half-life in 42 adult patients with hemophilia A without inhibitors. Patients ranged in age from 18-61 years, and 37 of them had severe disease. Of the cohort, 31 received recombinant factor VIII concentrates and 11 received plasma-derived factor VIII concentrates (Blood. 2016 May 23 [Epub ahead of print])

In the initial antibody screen, 15 patients tested positive for factor VIII–binding IgG with titers of at least 1:20. Factor VIII–specific antibodies were found at titers of at least 1:40 in 9 of the 15 subjects. Most had low- to moderate-affinity IgG1 and IgG3 antibodies. One patient with high-affinity IgG4 antibodies went on to develop low titers of factor VIII inhibitors.

Patients with factor VIII–specific antibodies had a shorter factor VIII half-life (median 7.8 hours) than did patients without antibodies (median 10.4 hours).

Dr. Hofbauer is employed by Baxalta, which makes a variety of antihemophilic factors.

[email protected]

On Twitter @maryjodales

Non-neutralizing, factor VIII–specific IgG antibodies can contribute significantly to reductions in factor VIII half-life in patients with hemophilia A, according to a study published online in Blood.

Screening for factor VIII–specific IgG may aid in tailoring factor VIII prophylactic regimens for hemophilia A patients, said Christoph J. Hofbauer, Ph.D., of the biopharmaceutical company Baxalta in Vienna, and his associates at the Medical University of Vienna.

The researchers examined the effect of factor VIII–specific IgG antibodies on factor VIII half-life in 42 adult patients with hemophilia A without inhibitors. Patients ranged in age from 18-61 years, and 37 of them had severe disease. Of the cohort, 31 received recombinant factor VIII concentrates and 11 received plasma-derived factor VIII concentrates (Blood. 2016 May 23 [Epub ahead of print])

In the initial antibody screen, 15 patients tested positive for factor VIII–binding IgG with titers of at least 1:20. Factor VIII–specific antibodies were found at titers of at least 1:40 in 9 of the 15 subjects. Most had low- to moderate-affinity IgG1 and IgG3 antibodies. One patient with high-affinity IgG4 antibodies went on to develop low titers of factor VIII inhibitors.

Patients with factor VIII–specific antibodies had a shorter factor VIII half-life (median 7.8 hours) than did patients without antibodies (median 10.4 hours).

Dr. Hofbauer is employed by Baxalta, which makes a variety of antihemophilic factors.

[email protected]

On Twitter @maryjodales

Non-neutralizing, factor VIII–specific IgG antibodies can contribute significantly to reductions in factor VIII half-life in patients with hemophilia A, according to a study published online in Blood.

Screening for factor VIII–specific IgG may aid in tailoring factor VIII prophylactic regimens for hemophilia A patients, said Christoph J. Hofbauer, Ph.D., of the biopharmaceutical company Baxalta in Vienna, and his associates at the Medical University of Vienna.

The researchers examined the effect of factor VIII–specific IgG antibodies on factor VIII half-life in 42 adult patients with hemophilia A without inhibitors. Patients ranged in age from 18-61 years, and 37 of them had severe disease. Of the cohort, 31 received recombinant factor VIII concentrates and 11 received plasma-derived factor VIII concentrates (Blood. 2016 May 23 [Epub ahead of print])

In the initial antibody screen, 15 patients tested positive for factor VIII–binding IgG with titers of at least 1:20. Factor VIII–specific antibodies were found at titers of at least 1:40 in 9 of the 15 subjects. Most had low- to moderate-affinity IgG1 and IgG3 antibodies. One patient with high-affinity IgG4 antibodies went on to develop low titers of factor VIII inhibitors.

Patients with factor VIII–specific antibodies had a shorter factor VIII half-life (median 7.8 hours) than did patients without antibodies (median 10.4 hours).

Dr. Hofbauer is employed by Baxalta, which makes a variety of antihemophilic factors.

[email protected]

On Twitter @maryjodales

BALTIMORE – Surgeons’ adherence to select quality measures when treating stage IIIA non–small-cell lung cancer patients led to improved patient survival, according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

Researchers at Washington University in St. Louis identified 10,323 patients who received surgery for Stage IIIA NSCLC in the National Cancer Data Base from 2006 to 2010, and chose four quality measures that should have been met by surgeons: delivery of neoadjuvant multiagent chemotherapy (with or without radiation therapy); performing a lobectomy or greater resection; obtaining more than 10 lymph nodes, and achieving an R0 resection.

The researchers said 12.8% of patients met all four quality measures. Kaplan-Meier analysis demonstrated improved overall median survival by number of quality measures obtained: 0 quality measures, 12.7 months; 1 quality measure, 25.0 months; 2 quality measures, 31.4 months; 3 quality measures, 36.6 months; and 4 quality measures, 43.5 months.

In an interview, Dr. Mark S. Allen, professor of surgery at the Mayo Clinic in Rochester, Minn., and a discussant on the paper at AATS 2016, said the most striking result of the study was that such a low percentage of patients had all four quality measures performed for stage IIIA cancer. He called that finding “disappointing.”

“In general, [the study] shows there is still some work to be done to improve the quality when we operate on stage IIIA patients,” Dr. Allen said. “I’m not sure we do the greatest job of staging them clinically. When they are staged properly they probably do need preoperative chemotherapy, and I’m not sure we do that all the time.” He added that surgeon education about quality outcomes was critical to process improvement and patient outcomes.

Dr. Allen reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

BALTIMORE – Surgeons’ adherence to select quality measures when treating stage IIIA non–small-cell lung cancer patients led to improved patient survival, according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

Researchers at Washington University in St. Louis identified 10,323 patients who received surgery for Stage IIIA NSCLC in the National Cancer Data Base from 2006 to 2010, and chose four quality measures that should have been met by surgeons: delivery of neoadjuvant multiagent chemotherapy (with or without radiation therapy); performing a lobectomy or greater resection; obtaining more than 10 lymph nodes, and achieving an R0 resection.

The researchers said 12.8% of patients met all four quality measures. Kaplan-Meier analysis demonstrated improved overall median survival by number of quality measures obtained: 0 quality measures, 12.7 months; 1 quality measure, 25.0 months; 2 quality measures, 31.4 months; 3 quality measures, 36.6 months; and 4 quality measures, 43.5 months.

In an interview, Dr. Mark S. Allen, professor of surgery at the Mayo Clinic in Rochester, Minn., and a discussant on the paper at AATS 2016, said the most striking result of the study was that such a low percentage of patients had all four quality measures performed for stage IIIA cancer. He called that finding “disappointing.”

“In general, [the study] shows there is still some work to be done to improve the quality when we operate on stage IIIA patients,” Dr. Allen said. “I’m not sure we do the greatest job of staging them clinically. When they are staged properly they probably do need preoperative chemotherapy, and I’m not sure we do that all the time.” He added that surgeon education about quality outcomes was critical to process improvement and patient outcomes.

Dr. Allen reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

BALTIMORE – Surgeons’ adherence to select quality measures when treating stage IIIA non–small-cell lung cancer patients led to improved patient survival, according to a study presented at the 2016 annual meeting of the American Association for Thoracic Surgery.

Researchers at Washington University in St. Louis identified 10,323 patients who received surgery for Stage IIIA NSCLC in the National Cancer Data Base from 2006 to 2010, and chose four quality measures that should have been met by surgeons: delivery of neoadjuvant multiagent chemotherapy (with or without radiation therapy); performing a lobectomy or greater resection; obtaining more than 10 lymph nodes, and achieving an R0 resection.

The researchers said 12.8% of patients met all four quality measures. Kaplan-Meier analysis demonstrated improved overall median survival by number of quality measures obtained: 0 quality measures, 12.7 months; 1 quality measure, 25.0 months; 2 quality measures, 31.4 months; 3 quality measures, 36.6 months; and 4 quality measures, 43.5 months.

In an interview, Dr. Mark S. Allen, professor of surgery at the Mayo Clinic in Rochester, Minn., and a discussant on the paper at AATS 2016, said the most striking result of the study was that such a low percentage of patients had all four quality measures performed for stage IIIA cancer. He called that finding “disappointing.”

“In general, [the study] shows there is still some work to be done to improve the quality when we operate on stage IIIA patients,” Dr. Allen said. “I’m not sure we do the greatest job of staging them clinically. When they are staged properly they probably do need preoperative chemotherapy, and I’m not sure we do that all the time.” He added that surgeon education about quality outcomes was critical to process improvement and patient outcomes.

Dr. Allen reported no relevant financial disclosures.

[email protected]

On Twitter @richpizzi

ORLANDO – Old notions about transgender and transsexual individuals are changing, driven by the emergence of transgender identity, scientific evidence, political activism in those communities, and the gay and lesbian rights movement, as well as patients demanding to be part of the decision-making process.

The terminology has evolved as well. What was called transsexualism in the DSM-III in 1980 became gender identity disorder in the DSM-IV (1994; 2000), and in the current DSM-5 is gender dysphoria. Terminology is still in flux with the possibility that terminology may evolve to “gender incongruence.”

The umbrella term “transgender” now covers transsexual, crossdressing, bigender, drag queen/king, female/male impersonator, and gender queer, and probably more, according to Eli Coleman, Ph.D., professor and director of the program in human sexuality at the University of Minnesota, Minneapolis. “Probably the most proper term you hear now is ‘trans,’ ” he said during a session on transgender medicine at the annual meeting of the American Association of Clinical Endocrinologists.

The DSM-5 criteria for gender dysphoria include a marked incongruence between one’s experienced/expressed gender and the assigned gender for at least 6 months with at least two of the following: an incongruence between one’s felt gender identity and one’s primary and secondary sex characteristics, a strong desire to be rid of one’s gender, a strong desire for the primary and/or secondary sex characteristics of the other gender, a strong desire to be of the other gender (or an alternative gender from the assigned one), a strong desire to be treated as such, and a strong conviction that one has the typical feeling and reactions of the other gender. Dr. Coleman said a further criterion of the DSM-5 is that “the condition is associated with clinically significant distress or impairment in social, occupational, or other areas of functioning.”

A new view of trans

There is now an awareness of a spectrum of gender identity and an affirmation of the right of individuals to express that identity as they would like. Many treatment options exist, and it is up to the individual to decide which way and how far they want to go. Dr. Coleman quoted the late Virginia Prince, a transvestite and a pioneering transgender activist: “If you get on a train in Los Angeles bound for New York, you don’t have to go all the way to New York. If you want, you can get off in Chicago.” So even if a person wants to undergo medical transitioning, hormone therapy does not necessarily have to be followed by sex-reassignment surgery.

Dr. Coleman is past president of the World Professional Association for Transgender Health (WPATH, www.wpath.org), which has published “Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People,” Version 7, a set of guidelines for health care providers. The guidelines are designed help patients achieve comfort with their gendered selves, maximize their overall health and psychological well-being, and achieve self-fulfillment. If untreated or undertreated, gender dysphoria is associated with increased morbidity and mortality, according to WPATH. Hormone treatment may reduce gender dysphoria symptoms by reducing the characteristics of the original sex and inducing ones of the opposite sex. Hormones can be used before or after sex-reassignment surgery, or on their own for patients not seeking surgery who “want [to] … get off in Chicago,” Dr. Coleman said.

Gender nonconformity is not pathological

“Gender nonconformity is not pathological, yet gender dysphoria is a specific distress that can be alleviated through medically necessary treatment,” Dr. Coleman said. “Gender dysphoria may be classified as a mental disorder [but] not necessarily a lifetime diagnosis.” It is the stress of the dysphoria that may be diagnosable and treated, but being gender nonconforming in itself is not the target of treatment. He said mental health professionals therefore have an important role in addressing the negative effects of stigma and helping the individuals become comfortable with a form of gender expression that suits them. This role requires a mental health professional who is skilled in this area.

Treatments to try to change gender identity and expression to become congruent with the sex assigned at birth have failed in the past and are no longer considered ethical, he said. Dr. Coleman suggested that intervening with medical treatments early to suppress puberty and then offering feminizing or masculinizing hormone therapy at the appropriate time may be the best course of action to avoid or alleviate gender dysphoria. He said studies have shown that sex-reassignment surgery can provide “an undeniable effect” on outcomes such as “subjective well-being, cosmesis, and sexual function.”

He recommended that health care professionals become familiar with transgender health care issues, examine their own attitudes and beliefs about these issues, seek out educational opportunities, and get to know and consult with experts in transgender health care. But that is not enough.

“You’ll never understand the condition if you just listen to your patients in the office,” he said. “You’ve got to get into a car and talk to somebody or have coffee with them and really get to know them outside of the office.” That includes meeting with transgender people several years after they have transitioned, who can give insights into the process that are not apparent from just seeing patients in the office in the midst of their gender dysphoria.

The knowledge gained must also be imbued in the health care professional’s staff as well. “You’ve got to have the right attitudes, but you’ve got to train your whole staff about this … that [patients] cannot be treated badly at all,” he said.

ORLANDO – Old notions about transgender and transsexual individuals are changing, driven by the emergence of transgender identity, scientific evidence, political activism in those communities, and the gay and lesbian rights movement, as well as patients demanding to be part of the decision-making process.

The terminology has evolved as well. What was called transsexualism in the DSM-III in 1980 became gender identity disorder in the DSM-IV (1994; 2000), and in the current DSM-5 is gender dysphoria. Terminology is still in flux with the possibility that terminology may evolve to “gender incongruence.”

The umbrella term “transgender” now covers transsexual, crossdressing, bigender, drag queen/king, female/male impersonator, and gender queer, and probably more, according to Eli Coleman, Ph.D., professor and director of the program in human sexuality at the University of Minnesota, Minneapolis. “Probably the most proper term you hear now is ‘trans,’ ” he said during a session on transgender medicine at the annual meeting of the American Association of Clinical Endocrinologists.

The DSM-5 criteria for gender dysphoria include a marked incongruence between one’s experienced/expressed gender and the assigned gender for at least 6 months with at least two of the following: an incongruence between one’s felt gender identity and one’s primary and secondary sex characteristics, a strong desire to be rid of one’s gender, a strong desire for the primary and/or secondary sex characteristics of the other gender, a strong desire to be of the other gender (or an alternative gender from the assigned one), a strong desire to be treated as such, and a strong conviction that one has the typical feeling and reactions of the other gender. Dr. Coleman said a further criterion of the DSM-5 is that “the condition is associated with clinically significant distress or impairment in social, occupational, or other areas of functioning.”

A new view of trans

There is now an awareness of a spectrum of gender identity and an affirmation of the right of individuals to express that identity as they would like. Many treatment options exist, and it is up to the individual to decide which way and how far they want to go. Dr. Coleman quoted the late Virginia Prince, a transvestite and a pioneering transgender activist: “If you get on a train in Los Angeles bound for New York, you don’t have to go all the way to New York. If you want, you can get off in Chicago.” So even if a person wants to undergo medical transitioning, hormone therapy does not necessarily have to be followed by sex-reassignment surgery.

Dr. Coleman is past president of the World Professional Association for Transgender Health (WPATH, www.wpath.org), which has published “Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People,” Version 7, a set of guidelines for health care providers. The guidelines are designed help patients achieve comfort with their gendered selves, maximize their overall health and psychological well-being, and achieve self-fulfillment. If untreated or undertreated, gender dysphoria is associated with increased morbidity and mortality, according to WPATH. Hormone treatment may reduce gender dysphoria symptoms by reducing the characteristics of the original sex and inducing ones of the opposite sex. Hormones can be used before or after sex-reassignment surgery, or on their own for patients not seeking surgery who “want [to] … get off in Chicago,” Dr. Coleman said.

Gender nonconformity is not pathological

“Gender nonconformity is not pathological, yet gender dysphoria is a specific distress that can be alleviated through medically necessary treatment,” Dr. Coleman said. “Gender dysphoria may be classified as a mental disorder [but] not necessarily a lifetime diagnosis.” It is the stress of the dysphoria that may be diagnosable and treated, but being gender nonconforming in itself is not the target of treatment. He said mental health professionals therefore have an important role in addressing the negative effects of stigma and helping the individuals become comfortable with a form of gender expression that suits them. This role requires a mental health professional who is skilled in this area.

Treatments to try to change gender identity and expression to become congruent with the sex assigned at birth have failed in the past and are no longer considered ethical, he said. Dr. Coleman suggested that intervening with medical treatments early to suppress puberty and then offering feminizing or masculinizing hormone therapy at the appropriate time may be the best course of action to avoid or alleviate gender dysphoria. He said studies have shown that sex-reassignment surgery can provide “an undeniable effect” on outcomes such as “subjective well-being, cosmesis, and sexual function.”

He recommended that health care professionals become familiar with transgender health care issues, examine their own attitudes and beliefs about these issues, seek out educational opportunities, and get to know and consult with experts in transgender health care. But that is not enough.

“You’ll never understand the condition if you just listen to your patients in the office,” he said. “You’ve got to get into a car and talk to somebody or have coffee with them and really get to know them outside of the office.” That includes meeting with transgender people several years after they have transitioned, who can give insights into the process that are not apparent from just seeing patients in the office in the midst of their gender dysphoria.

The knowledge gained must also be imbued in the health care professional’s staff as well. “You’ve got to have the right attitudes, but you’ve got to train your whole staff about this … that [patients] cannot be treated badly at all,” he said.

ORLANDO – Old notions about transgender and transsexual individuals are changing, driven by the emergence of transgender identity, scientific evidence, political activism in those communities, and the gay and lesbian rights movement, as well as patients demanding to be part of the decision-making process.

The terminology has evolved as well. What was called transsexualism in the DSM-III in 1980 became gender identity disorder in the DSM-IV (1994; 2000), and in the current DSM-5 is gender dysphoria. Terminology is still in flux with the possibility that terminology may evolve to “gender incongruence.”

The umbrella term “transgender” now covers transsexual, crossdressing, bigender, drag queen/king, female/male impersonator, and gender queer, and probably more, according to Eli Coleman, Ph.D., professor and director of the program in human sexuality at the University of Minnesota, Minneapolis. “Probably the most proper term you hear now is ‘trans,’ ” he said during a session on transgender medicine at the annual meeting of the American Association of Clinical Endocrinologists.

The DSM-5 criteria for gender dysphoria include a marked incongruence between one’s experienced/expressed gender and the assigned gender for at least 6 months with at least two of the following: an incongruence between one’s felt gender identity and one’s primary and secondary sex characteristics, a strong desire to be rid of one’s gender, a strong desire for the primary and/or secondary sex characteristics of the other gender, a strong desire to be of the other gender (or an alternative gender from the assigned one), a strong desire to be treated as such, and a strong conviction that one has the typical feeling and reactions of the other gender. Dr. Coleman said a further criterion of the DSM-5 is that “the condition is associated with clinically significant distress or impairment in social, occupational, or other areas of functioning.”

A new view of trans

There is now an awareness of a spectrum of gender identity and an affirmation of the right of individuals to express that identity as they would like. Many treatment options exist, and it is up to the individual to decide which way and how far they want to go. Dr. Coleman quoted the late Virginia Prince, a transvestite and a pioneering transgender activist: “If you get on a train in Los Angeles bound for New York, you don’t have to go all the way to New York. If you want, you can get off in Chicago.” So even if a person wants to undergo medical transitioning, hormone therapy does not necessarily have to be followed by sex-reassignment surgery.

Dr. Coleman is past president of the World Professional Association for Transgender Health (WPATH, www.wpath.org), which has published “Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People,” Version 7, a set of guidelines for health care providers. The guidelines are designed help patients achieve comfort with their gendered selves, maximize their overall health and psychological well-being, and achieve self-fulfillment. If untreated or undertreated, gender dysphoria is associated with increased morbidity and mortality, according to WPATH. Hormone treatment may reduce gender dysphoria symptoms by reducing the characteristics of the original sex and inducing ones of the opposite sex. Hormones can be used before or after sex-reassignment surgery, or on their own for patients not seeking surgery who “want [to] … get off in Chicago,” Dr. Coleman said.

Gender nonconformity is not pathological

“Gender nonconformity is not pathological, yet gender dysphoria is a specific distress that can be alleviated through medically necessary treatment,” Dr. Coleman said. “Gender dysphoria may be classified as a mental disorder [but] not necessarily a lifetime diagnosis.” It is the stress of the dysphoria that may be diagnosable and treated, but being gender nonconforming in itself is not the target of treatment. He said mental health professionals therefore have an important role in addressing the negative effects of stigma and helping the individuals become comfortable with a form of gender expression that suits them. This role requires a mental health professional who is skilled in this area.

Treatments to try to change gender identity and expression to become congruent with the sex assigned at birth have failed in the past and are no longer considered ethical, he said. Dr. Coleman suggested that intervening with medical treatments early to suppress puberty and then offering feminizing or masculinizing hormone therapy at the appropriate time may be the best course of action to avoid or alleviate gender dysphoria. He said studies have shown that sex-reassignment surgery can provide “an undeniable effect” on outcomes such as “subjective well-being, cosmesis, and sexual function.”

He recommended that health care professionals become familiar with transgender health care issues, examine their own attitudes and beliefs about these issues, seek out educational opportunities, and get to know and consult with experts in transgender health care. But that is not enough.

“You’ll never understand the condition if you just listen to your patients in the office,” he said. “You’ve got to get into a car and talk to somebody or have coffee with them and really get to know them outside of the office.” That includes meeting with transgender people several years after they have transitioned, who can give insights into the process that are not apparent from just seeing patients in the office in the midst of their gender dysphoria.

The knowledge gained must also be imbued in the health care professional’s staff as well. “You’ve got to have the right attitudes, but you’ve got to train your whole staff about this … that [patients] cannot be treated badly at all,” he said.

LONDON – Long-term treatment with the interleukin 17A inhibitor secukinumab showed suggestive evidence of inhibiting structural progression of spinal disease in 168 patients with ankylosing spondylitis, the first time any evidence for an effect like this has been seen with a biologic drug or any other agent used to treat ankylosing spondylitis.

However, the effect occurred in uncontrolled, 2-year open-label treatment of patients originally enrolled in one of the secukinumab pivotal trials, and the analysis did not include comparison against a historical control group, caveats that demand confirmation of this effect in additional studies, Dr. Jürgen Braun said at the European Congress of Rheumatology.

Mitchel L. Zoler/Frontline Medical News

In a second, unrelated study, the oral Janus kinase inhibitor tofacitinib showed promising efficacy for controlling clinical symptoms in patients with active ankylosing spondylitis (AS) during 12 weeks of treatment in a placebo-controlled, dose-ranging phase II study.

The open-label secukinumab extension study involved patients who had been enrolled in the MEASURE 1 study, one of the pivotal trials that had established secukinumab as safe and effective for improving the clinical status of patients with active AS. The primary endpoint of MEASURE 1 had been the percentage of patients achieving at least a 20% improvement in their Assessment of Spondyloarthritis international Society (ASAS20) response after 16 weeks of treatment (New Engl J Med. 2015 Dec 24;373[26]:2534-48).

Based in part on these data the Food and Drug Administration approved secukinumab (Cosentyx) for the treatment of ankylosing spondylitis in January 2016. The new data reported by Dr. Braun assessed the level of spinal pathology in a subgroup of the MEASURE 1 patients when measured by radiography using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) at baseline and after 104 weeks on secukinumab treatment.

Patients in MEASURE 1 who began on active treatment received 10 mg/kg intravenous secukinumab for 4 weeks, followed by subcutaneous dosages of either 75 mg or 150 mg every 4 weeks for 104 weeks. His analysis also included some patients who entered MEASURE 1 in the placebo group and then switched to open-label, subcutaneous secukinumab treatment after 16 or 24 weeks on placebo.

Analysis of 168 patients who started on intravenous secukinumab and later received any subcutaneous secukinumab treatment out to 104 weeks showed an average increase in mSASSS of 0.30 after 104 weeks when compared against their baseline scores, reported Dr. Braun, professor and medical director of the Ruhr Rheumatology Center of the University of Bochum, Germany.

Among an additional 89 patients who began in the placebo group and then switched to subcutaneous secukinumab, the average change in mSASSS from baseline to 104 weeks was 0.54. By comparison, Dr. Braun noted that AS patients treated with a tumor necrosis factor inhibitor have shown 2-year progression in their mSASSS of about 0.8-0.9, and AS patients not treated with an active biologic drug have shown 2-year mSASSS progression of about 1.0.

A second analysis of the data reported by Dr. Braun showed that among the 168 patients treated for the full 104 weeks with secukinumab about 80% showed no mSASSS progression, but about 20% did have some level of detectable mSASSS progression.

The phase II study of tofacitinib (Xeljanz) randomized 208 patients with active AS to either tofacitinib at daily dosages of 2 mg bid, 5 mg bid, 10 mg bid, or placebo. The study’s primary endpoint was their ASAS20 response after 12 weeks that underwent a Bayesian Emax model analysis to estimate incremental efficacy when compared against placebo.

The primary efficacy analysis showed the greatest EmaxASAS20 response among patients treated with 5 mg bid daily, 63%, which was about 23% above the placebo level, reportedDr. Désirée van der Heijde, professor of rheumatology at the Leiden University Medical Center, The Netherlands. The absolute ASAS20 response rate of the 52 patients randomized to this tofacitinib dosage was about 81%, about 40% higher than the response rate seen in the 51 patients in the placebo arm.

All dosages of tofacitinib tested were well tolerated, with safety data similar to what has previously been shown for tofacitinib, a drug that has Food and Drug Administration approval for treating rheumatoid arthritis.

[email protected]

On Twitter @mitchelzoler

LONDON – Long-term treatment with the interleukin 17A inhibitor secukinumab showed suggestive evidence of inhibiting structural progression of spinal disease in 168 patients with ankylosing spondylitis, the first time any evidence for an effect like this has been seen with a biologic drug or any other agent used to treat ankylosing spondylitis.

However, the effect occurred in uncontrolled, 2-year open-label treatment of patients originally enrolled in one of the secukinumab pivotal trials, and the analysis did not include comparison against a historical control group, caveats that demand confirmation of this effect in additional studies, Dr. Jürgen Braun said at the European Congress of Rheumatology.

Mitchel L. Zoler/Frontline Medical News

In a second, unrelated study, the oral Janus kinase inhibitor tofacitinib showed promising efficacy for controlling clinical symptoms in patients with active ankylosing spondylitis (AS) during 12 weeks of treatment in a placebo-controlled, dose-ranging phase II study.

The open-label secukinumab extension study involved patients who had been enrolled in the MEASURE 1 study, one of the pivotal trials that had established secukinumab as safe and effective for improving the clinical status of patients with active AS. The primary endpoint of MEASURE 1 had been the percentage of patients achieving at least a 20% improvement in their Assessment of Spondyloarthritis international Society (ASAS20) response after 16 weeks of treatment (New Engl J Med. 2015 Dec 24;373[26]:2534-48).

Based in part on these data the Food and Drug Administration approved secukinumab (Cosentyx) for the treatment of ankylosing spondylitis in January 2016. The new data reported by Dr. Braun assessed the level of spinal pathology in a subgroup of the MEASURE 1 patients when measured by radiography using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) at baseline and after 104 weeks on secukinumab treatment.

Patients in MEASURE 1 who began on active treatment received 10 mg/kg intravenous secukinumab for 4 weeks, followed by subcutaneous dosages of either 75 mg or 150 mg every 4 weeks for 104 weeks. His analysis also included some patients who entered MEASURE 1 in the placebo group and then switched to open-label, subcutaneous secukinumab treatment after 16 or 24 weeks on placebo.

Analysis of 168 patients who started on intravenous secukinumab and later received any subcutaneous secukinumab treatment out to 104 weeks showed an average increase in mSASSS of 0.30 after 104 weeks when compared against their baseline scores, reported Dr. Braun, professor and medical director of the Ruhr Rheumatology Center of the University of Bochum, Germany.

Among an additional 89 patients who began in the placebo group and then switched to subcutaneous secukinumab, the average change in mSASSS from baseline to 104 weeks was 0.54. By comparison, Dr. Braun noted that AS patients treated with a tumor necrosis factor inhibitor have shown 2-year progression in their mSASSS of about 0.8-0.9, and AS patients not treated with an active biologic drug have shown 2-year mSASSS progression of about 1.0.

A second analysis of the data reported by Dr. Braun showed that among the 168 patients treated for the full 104 weeks with secukinumab about 80% showed no mSASSS progression, but about 20% did have some level of detectable mSASSS progression.

The phase II study of tofacitinib (Xeljanz) randomized 208 patients with active AS to either tofacitinib at daily dosages of 2 mg bid, 5 mg bid, 10 mg bid, or placebo. The study’s primary endpoint was their ASAS20 response after 12 weeks that underwent a Bayesian Emax model analysis to estimate incremental efficacy when compared against placebo.

The primary efficacy analysis showed the greatest EmaxASAS20 response among patients treated with 5 mg bid daily, 63%, which was about 23% above the placebo level, reportedDr. Désirée van der Heijde, professor of rheumatology at the Leiden University Medical Center, The Netherlands. The absolute ASAS20 response rate of the 52 patients randomized to this tofacitinib dosage was about 81%, about 40% higher than the response rate seen in the 51 patients in the placebo arm.

All dosages of tofacitinib tested were well tolerated, with safety data similar to what has previously been shown for tofacitinib, a drug that has Food and Drug Administration approval for treating rheumatoid arthritis.

[email protected]

On Twitter @mitchelzoler

LONDON – Long-term treatment with the interleukin 17A inhibitor secukinumab showed suggestive evidence of inhibiting structural progression of spinal disease in 168 patients with ankylosing spondylitis, the first time any evidence for an effect like this has been seen with a biologic drug or any other agent used to treat ankylosing spondylitis.

However, the effect occurred in uncontrolled, 2-year open-label treatment of patients originally enrolled in one of the secukinumab pivotal trials, and the analysis did not include comparison against a historical control group, caveats that demand confirmation of this effect in additional studies, Dr. Jürgen Braun said at the European Congress of Rheumatology.

Mitchel L. Zoler/Frontline Medical News

In a second, unrelated study, the oral Janus kinase inhibitor tofacitinib showed promising efficacy for controlling clinical symptoms in patients with active ankylosing spondylitis (AS) during 12 weeks of treatment in a placebo-controlled, dose-ranging phase II study.

The open-label secukinumab extension study involved patients who had been enrolled in the MEASURE 1 study, one of the pivotal trials that had established secukinumab as safe and effective for improving the clinical status of patients with active AS. The primary endpoint of MEASURE 1 had been the percentage of patients achieving at least a 20% improvement in their Assessment of Spondyloarthritis international Society (ASAS20) response after 16 weeks of treatment (New Engl J Med. 2015 Dec 24;373[26]:2534-48).

Based in part on these data the Food and Drug Administration approved secukinumab (Cosentyx) for the treatment of ankylosing spondylitis in January 2016. The new data reported by Dr. Braun assessed the level of spinal pathology in a subgroup of the MEASURE 1 patients when measured by radiography using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) at baseline and after 104 weeks on secukinumab treatment.

Patients in MEASURE 1 who began on active treatment received 10 mg/kg intravenous secukinumab for 4 weeks, followed by subcutaneous dosages of either 75 mg or 150 mg every 4 weeks for 104 weeks. His analysis also included some patients who entered MEASURE 1 in the placebo group and then switched to open-label, subcutaneous secukinumab treatment after 16 or 24 weeks on placebo.

Analysis of 168 patients who started on intravenous secukinumab and later received any subcutaneous secukinumab treatment out to 104 weeks showed an average increase in mSASSS of 0.30 after 104 weeks when compared against their baseline scores, reported Dr. Braun, professor and medical director of the Ruhr Rheumatology Center of the University of Bochum, Germany.

Among an additional 89 patients who began in the placebo group and then switched to subcutaneous secukinumab, the average change in mSASSS from baseline to 104 weeks was 0.54. By comparison, Dr. Braun noted that AS patients treated with a tumor necrosis factor inhibitor have shown 2-year progression in their mSASSS of about 0.8-0.9, and AS patients not treated with an active biologic drug have shown 2-year mSASSS progression of about 1.0.

A second analysis of the data reported by Dr. Braun showed that among the 168 patients treated for the full 104 weeks with secukinumab about 80% showed no mSASSS progression, but about 20% did have some level of detectable mSASSS progression.

The phase II study of tofacitinib (Xeljanz) randomized 208 patients with active AS to either tofacitinib at daily dosages of 2 mg bid, 5 mg bid, 10 mg bid, or placebo. The study’s primary endpoint was their ASAS20 response after 12 weeks that underwent a Bayesian Emax model analysis to estimate incremental efficacy when compared against placebo.

The primary efficacy analysis showed the greatest EmaxASAS20 response among patients treated with 5 mg bid daily, 63%, which was about 23% above the placebo level, reportedDr. Désirée van der Heijde, professor of rheumatology at the Leiden University Medical Center, The Netherlands. The absolute ASAS20 response rate of the 52 patients randomized to this tofacitinib dosage was about 81%, about 40% higher than the response rate seen in the 51 patients in the placebo arm.

All dosages of tofacitinib tested were well tolerated, with safety data similar to what has previously been shown for tofacitinib, a drug that has Food and Drug Administration approval for treating rheumatoid arthritis.

[email protected]

On Twitter @mitchelzoler

The FP diagnosed flat warts based on their typical appearance and location. Flat warts are frequently found on the face and neck and can easily be spread when men shave their beards or women shave their legs. Flat warts can also occur on the face of young children.

The FP suggested cryotherapy for the largest warts and prescribed topical imiquimod (3 times per week) for home use. The FP suggested that the patient wait 2 weeks before starting the imiquimod to allow the cryotherapy to do its work and for any blistering or irritation to subside. A follow-up appointment was set for 6 weeks.

At the follow-up visit, there was little improvement and the patient wanted to try an alternative therapy. The risks and benefits of Candida antigen intralesional injection were discussed and the patient decided to proceed with this approach. Intralesional injections with Candida antigen induce a localized, cell-mediated, and human papillomavirus (HPV)-specific response that may target the injected wart as well as more distant warts. This method has moderate effectiveness (60% cure rates) for treatment of recalcitrant warts. The Candida antigen must be diluted before use, and 0.1 to 0.3 mL should be injected into the largest warts using a 30-gauge needle (up to 1 mL per treatment). Warn patients to expect itching in the area, burning, or peeling, and repeat the procedure every 4 weeks with up to 3 treatments or until warts are gone.

For this patient, the Candida antigen was diluted with normal saline (0.25 mL of generic Candida antigen with 0.75 mL of normal saline). The mixture was injected with a 30-gauge needle into approximately 10 of the largest flat warts. One month later, all of the flat warts were gone.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux, EJ. Flat warts. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:755-758.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

The FP diagnosed flat warts based on their typical appearance and location. Flat warts are frequently found on the face and neck and can easily be spread when men shave their beards or women shave their legs. Flat warts can also occur on the face of young children.

The FP suggested cryotherapy for the largest warts and prescribed topical imiquimod (3 times per week) for home use. The FP suggested that the patient wait 2 weeks before starting the imiquimod to allow the cryotherapy to do its work and for any blistering or irritation to subside. A follow-up appointment was set for 6 weeks.

At the follow-up visit, there was little improvement and the patient wanted to try an alternative therapy. The risks and benefits of Candida antigen intralesional injection were discussed and the patient decided to proceed with this approach. Intralesional injections with Candida antigen induce a localized, cell-mediated, and human papillomavirus (HPV)-specific response that may target the injected wart as well as more distant warts. This method has moderate effectiveness (60% cure rates) for treatment of recalcitrant warts. The Candida antigen must be diluted before use, and 0.1 to 0.3 mL should be injected into the largest warts using a 30-gauge needle (up to 1 mL per treatment). Warn patients to expect itching in the area, burning, or peeling, and repeat the procedure every 4 weeks with up to 3 treatments or until warts are gone.

For this patient, the Candida antigen was diluted with normal saline (0.25 mL of generic Candida antigen with 0.75 mL of normal saline). The mixture was injected with a 30-gauge needle into approximately 10 of the largest flat warts. One month later, all of the flat warts were gone.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux, EJ. Flat warts. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:755-758.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

The FP diagnosed flat warts based on their typical appearance and location. Flat warts are frequently found on the face and neck and can easily be spread when men shave their beards or women shave their legs. Flat warts can also occur on the face of young children.

The FP suggested cryotherapy for the largest warts and prescribed topical imiquimod (3 times per week) for home use. The FP suggested that the patient wait 2 weeks before starting the imiquimod to allow the cryotherapy to do its work and for any blistering or irritation to subside. A follow-up appointment was set for 6 weeks.

At the follow-up visit, there was little improvement and the patient wanted to try an alternative therapy. The risks and benefits of Candida antigen intralesional injection were discussed and the patient decided to proceed with this approach. Intralesional injections with Candida antigen induce a localized, cell-mediated, and human papillomavirus (HPV)-specific response that may target the injected wart as well as more distant warts. This method has moderate effectiveness (60% cure rates) for treatment of recalcitrant warts. The Candida antigen must be diluted before use, and 0.1 to 0.3 mL should be injected into the largest warts using a 30-gauge needle (up to 1 mL per treatment). Warn patients to expect itching in the area, burning, or peeling, and repeat the procedure every 4 weeks with up to 3 treatments or until warts are gone.

For this patient, the Candida antigen was diluted with normal saline (0.25 mL of generic Candida antigen with 0.75 mL of normal saline). The mixture was injected with a 30-gauge needle into approximately 10 of the largest flat warts. One month later, all of the flat warts were gone.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux, EJ. Flat warts. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:755-758.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com