Even in this era of novel therapies for multiple myeloma, for patients with newly diagnosed disease, autologous stem cell transplant (ASCT) after chemotherapy provides benefits in terms of disease progression and extent of response, compared with chemotherapy alone. The benefit of ASCT was especially pronounced among certain groups of high-risk patients.

Novel proteasome inhibitors and immunomodulators “have dramatically increased the complete response rate and significantly extended progression-free survival and overall survival in previously untreated multiple myeloma patients,” Dr. Michele Cavo, head of the Seragnoli Institute of Hematology at the University of Bologna School of Medicine in Italy, said at a presscast in advance of the annual meeting of the American Society of Clinical Oncology.

But questions remain about how these newer agents perform, compared with high-dose melphalan (HDM) followed by ASCT, traditionally seen as the standard of care for younger and fit patients with newly diagnosed disease.

EMN02/HO95 is a large, prospective, multicenter, intergroup, randomized phase III study that addresses this question, as well as single vs. double ASCT and the use of consolidation therapy or not. The study includes patients 65 years old or younger, and the trial protocol involves induction therapy with bortezomib (Velcade)–cyclophosphamide-dexamethasone (VCD) and subsequent collection of peripheral blood stem cells.

Patients were then randomly assigned to receive bortezomib-melphalan-prednisone (VMP) or HDM as intensification therapy in centers that had a single ASCT policy. For those centers doing double (tandem) ASCT procedures, the randomization was to VMP vs. HDM + single ASCT vs. HDM + double ASCT.

Patients in each treatment arm then underwent another randomization to consolidation therapy with bortezomib-lenalidomide (Revlimid)–dexamethasone or no consolidation. All patients received lenalidomide maintenance until disease progression or toxicity. At the time of a preliminary analysis of trial data in January 2016, results from the second randomization to consolidation or no consolidation therapy were not yet complete. This first prespecified interim analysis was performed after at least 33% of the required events had occurred.

Early results show ASCT benefit

Early results on 1,266 patients (VMP, n = 512; HDM, n = 754) show that a median progression-free survival (PFS) was not yet reached after a median follow-up of 23.9 months from the first randomization (to VMP vs. HDM+ASCT), the primary endpoint of the trial.

In the overall patient population, patients achieved a significant 24% benefit in PFS when given HDM+ASCT up front (hazard ratio, 0.76 vs. VMP), and this benefit extended to certain patient subgroups, as well.

“PFS benefit with bortezomib-based ASCT was of relevance for patients at high risk of early relapse, in particular for those with revised ISS [International Staging System] stage III and high-risk cytogenetic profiles, who had a relative reduction in the risk of progression or death of 48% and 28%, respectively,” Dr. Cavo said.

Other predictors of longer PFS were ISS stage I (HR, 0.44; 95% confidence interval, 0.28-067; P less than .0001), standard risk cytogenetics (HR, 0.57; 95% CI, 0.41-0.78; P less than .0001), randomization to the HDM+ASCT arm (HR, 0.61; 95% CI, 0.45-0.82; P = .001), and less than 60% bone marrow plasma cells (HR, 0.67; 95% CI, 0.48-0.99; P = .014).

More patients receiving ASCT up front had a significantly greater reduction in tumor volume of at least 90%, as indicated by the composite of very good partial remission, complete response, and stringent complete response, which was achieved in 74.0% in the VMP arm and in 84.4% of the HDM+ASCT arm (P less than .0001).

For patients at low risk of relapse, Dr. Cavo said longer follow up will be needed to compare the different arms of the study, and future analyses will delineate the effects of consolidation or no consolidation therapy and the use of the VMP regimen, compared with single or double ASCT.

ASCO president Dr. Julie Vose said that even with effective novel agents available, older, proven approaches still retain their value. “This study demonstrated that combining the best of both worlds – initial therapy with a novel agent followed by stem cell transplant – resulted in the best patient outcomes,” she said.

Even in this era of novel therapies for multiple myeloma, for patients with newly diagnosed disease, autologous stem cell transplant (ASCT) after chemotherapy provides benefits in terms of disease progression and extent of response, compared with chemotherapy alone. The benefit of ASCT was especially pronounced among certain groups of high-risk patients.

Novel proteasome inhibitors and immunomodulators “have dramatically increased the complete response rate and significantly extended progression-free survival and overall survival in previously untreated multiple myeloma patients,” Dr. Michele Cavo, head of the Seragnoli Institute of Hematology at the University of Bologna School of Medicine in Italy, said at a presscast in advance of the annual meeting of the American Society of Clinical Oncology.

But questions remain about how these newer agents perform, compared with high-dose melphalan (HDM) followed by ASCT, traditionally seen as the standard of care for younger and fit patients with newly diagnosed disease.

EMN02/HO95 is a large, prospective, multicenter, intergroup, randomized phase III study that addresses this question, as well as single vs. double ASCT and the use of consolidation therapy or not. The study includes patients 65 years old or younger, and the trial protocol involves induction therapy with bortezomib (Velcade)–cyclophosphamide-dexamethasone (VCD) and subsequent collection of peripheral blood stem cells.

Patients were then randomly assigned to receive bortezomib-melphalan-prednisone (VMP) or HDM as intensification therapy in centers that had a single ASCT policy. For those centers doing double (tandem) ASCT procedures, the randomization was to VMP vs. HDM + single ASCT vs. HDM + double ASCT.

Patients in each treatment arm then underwent another randomization to consolidation therapy with bortezomib-lenalidomide (Revlimid)–dexamethasone or no consolidation. All patients received lenalidomide maintenance until disease progression or toxicity. At the time of a preliminary analysis of trial data in January 2016, results from the second randomization to consolidation or no consolidation therapy were not yet complete. This first prespecified interim analysis was performed after at least 33% of the required events had occurred.

Early results show ASCT benefit

Early results on 1,266 patients (VMP, n = 512; HDM, n = 754) show that a median progression-free survival (PFS) was not yet reached after a median follow-up of 23.9 months from the first randomization (to VMP vs. HDM+ASCT), the primary endpoint of the trial.

In the overall patient population, patients achieved a significant 24% benefit in PFS when given HDM+ASCT up front (hazard ratio, 0.76 vs. VMP), and this benefit extended to certain patient subgroups, as well.

“PFS benefit with bortezomib-based ASCT was of relevance for patients at high risk of early relapse, in particular for those with revised ISS [International Staging System] stage III and high-risk cytogenetic profiles, who had a relative reduction in the risk of progression or death of 48% and 28%, respectively,” Dr. Cavo said.

Other predictors of longer PFS were ISS stage I (HR, 0.44; 95% confidence interval, 0.28-067; P less than .0001), standard risk cytogenetics (HR, 0.57; 95% CI, 0.41-0.78; P less than .0001), randomization to the HDM+ASCT arm (HR, 0.61; 95% CI, 0.45-0.82; P = .001), and less than 60% bone marrow plasma cells (HR, 0.67; 95% CI, 0.48-0.99; P = .014).

More patients receiving ASCT up front had a significantly greater reduction in tumor volume of at least 90%, as indicated by the composite of very good partial remission, complete response, and stringent complete response, which was achieved in 74.0% in the VMP arm and in 84.4% of the HDM+ASCT arm (P less than .0001).

For patients at low risk of relapse, Dr. Cavo said longer follow up will be needed to compare the different arms of the study, and future analyses will delineate the effects of consolidation or no consolidation therapy and the use of the VMP regimen, compared with single or double ASCT.

ASCO president Dr. Julie Vose said that even with effective novel agents available, older, proven approaches still retain their value. “This study demonstrated that combining the best of both worlds – initial therapy with a novel agent followed by stem cell transplant – resulted in the best patient outcomes,” she said.

Even in this era of novel therapies for multiple myeloma, for patients with newly diagnosed disease, autologous stem cell transplant (ASCT) after chemotherapy provides benefits in terms of disease progression and extent of response, compared with chemotherapy alone. The benefit of ASCT was especially pronounced among certain groups of high-risk patients.

Novel proteasome inhibitors and immunomodulators “have dramatically increased the complete response rate and significantly extended progression-free survival and overall survival in previously untreated multiple myeloma patients,” Dr. Michele Cavo, head of the Seragnoli Institute of Hematology at the University of Bologna School of Medicine in Italy, said at a presscast in advance of the annual meeting of the American Society of Clinical Oncology.

But questions remain about how these newer agents perform, compared with high-dose melphalan (HDM) followed by ASCT, traditionally seen as the standard of care for younger and fit patients with newly diagnosed disease.

EMN02/HO95 is a large, prospective, multicenter, intergroup, randomized phase III study that addresses this question, as well as single vs. double ASCT and the use of consolidation therapy or not. The study includes patients 65 years old or younger, and the trial protocol involves induction therapy with bortezomib (Velcade)–cyclophosphamide-dexamethasone (VCD) and subsequent collection of peripheral blood stem cells.

Patients were then randomly assigned to receive bortezomib-melphalan-prednisone (VMP) or HDM as intensification therapy in centers that had a single ASCT policy. For those centers doing double (tandem) ASCT procedures, the randomization was to VMP vs. HDM + single ASCT vs. HDM + double ASCT.

Patients in each treatment arm then underwent another randomization to consolidation therapy with bortezomib-lenalidomide (Revlimid)–dexamethasone or no consolidation. All patients received lenalidomide maintenance until disease progression or toxicity. At the time of a preliminary analysis of trial data in January 2016, results from the second randomization to consolidation or no consolidation therapy were not yet complete. This first prespecified interim analysis was performed after at least 33% of the required events had occurred.

Early results show ASCT benefit

Early results on 1,266 patients (VMP, n = 512; HDM, n = 754) show that a median progression-free survival (PFS) was not yet reached after a median follow-up of 23.9 months from the first randomization (to VMP vs. HDM+ASCT), the primary endpoint of the trial.

In the overall patient population, patients achieved a significant 24% benefit in PFS when given HDM+ASCT up front (hazard ratio, 0.76 vs. VMP), and this benefit extended to certain patient subgroups, as well.

“PFS benefit with bortezomib-based ASCT was of relevance for patients at high risk of early relapse, in particular for those with revised ISS [International Staging System] stage III and high-risk cytogenetic profiles, who had a relative reduction in the risk of progression or death of 48% and 28%, respectively,” Dr. Cavo said.

Other predictors of longer PFS were ISS stage I (HR, 0.44; 95% confidence interval, 0.28-067; P less than .0001), standard risk cytogenetics (HR, 0.57; 95% CI, 0.41-0.78; P less than .0001), randomization to the HDM+ASCT arm (HR, 0.61; 95% CI, 0.45-0.82; P = .001), and less than 60% bone marrow plasma cells (HR, 0.67; 95% CI, 0.48-0.99; P = .014).

More patients receiving ASCT up front had a significantly greater reduction in tumor volume of at least 90%, as indicated by the composite of very good partial remission, complete response, and stringent complete response, which was achieved in 74.0% in the VMP arm and in 84.4% of the HDM+ASCT arm (P less than .0001).

For patients at low risk of relapse, Dr. Cavo said longer follow up will be needed to compare the different arms of the study, and future analyses will delineate the effects of consolidation or no consolidation therapy and the use of the VMP regimen, compared with single or double ASCT.

ASCO president Dr. Julie Vose said that even with effective novel agents available, older, proven approaches still retain their value. “This study demonstrated that combining the best of both worlds – initial therapy with a novel agent followed by stem cell transplant – resulted in the best patient outcomes,” she said.

ATLANTA – A new smartphone application aimed at providing psychoeducation to patients with bipolar disorder was well received and showed promise for improving outcomes in a feasibility study, according to Dr. Eduard Vieta.

Early results of the study showed that adherence was quite high, with retention at 76% among 49 patients with bipolar disorder who tested the SIMPle app (Self Monitoring and Psychoeducation in Bipolar Patients with a Smartphone Application), Dr. Vieta said at the annual meeting of the American Psychiatric Association.

The app, currently available for free for Android and iPhones, is an interactive educational program that includes weekly and daily tests, with alerts for patients to take medications or see their doctor.

The patients in the study were representative of generally stable bipolar disorder patients in a real-world setting, as the app ideally would be used by those who are “in near remission or at least not acutely ill,” said Dr. Vieta of the University of Barcelona.

“People like the app and did follow the daily and weekly tests, which is a good sign,” he said, noting that satisfaction was high, and good correlation between test scores and mood changes suggested that the app is reliable for monitoring mood changes.

There were 10 suicide alerts during the study that were quickly addressed because messages were received immediately, he said.

The latest version of the app includes simpler navigation, rewards for fulfilling the daily and weekly testing, and medication reminders.

Dr. Vieta and his colleagues at the University of Barcelona previously have demonstrated the value of psychoeducation among patients with bipolar disorder. They developed a successful psychoeducation program in the late 1990s, which led to a trial published in 2003 and development of a training manual in 2006 that has been translated into numerous languages.

The program and trial showed that adding psychoeducation to medication in patients with bipolar disorder improves outcomes in terms of relapse and hospitalizations: the rate of relapses in the study was reduced by nearly 80%, Dr. Vieta said.

Providing such education, however, which has become a standard of care, is limited by the need for personnel training and by staffing and financial resource constraints.

“We wanted something nonstigmatizing but also linked to the clinical care team. … Clearly, we would like to make this intervention more widely available without compromising quality,” Dr. Vieta said, describing the impetus for the SIMPle app.

A phase II, randomized controlled study of the app is now underway, he said, adding that “this is really quite exciting. … There is huge potential for things we can do with this app.”

Dr. Vieta is a consultant or adviser for several pharmaceutical companies. He also has received research grants, honoraria, or consulting fees from numerous entities.

[email protected]

ATLANTA – A new smartphone application aimed at providing psychoeducation to patients with bipolar disorder was well received and showed promise for improving outcomes in a feasibility study, according to Dr. Eduard Vieta.

Early results of the study showed that adherence was quite high, with retention at 76% among 49 patients with bipolar disorder who tested the SIMPle app (Self Monitoring and Psychoeducation in Bipolar Patients with a Smartphone Application), Dr. Vieta said at the annual meeting of the American Psychiatric Association.

The app, currently available for free for Android and iPhones, is an interactive educational program that includes weekly and daily tests, with alerts for patients to take medications or see their doctor.

The patients in the study were representative of generally stable bipolar disorder patients in a real-world setting, as the app ideally would be used by those who are “in near remission or at least not acutely ill,” said Dr. Vieta of the University of Barcelona.

“People like the app and did follow the daily and weekly tests, which is a good sign,” he said, noting that satisfaction was high, and good correlation between test scores and mood changes suggested that the app is reliable for monitoring mood changes.

There were 10 suicide alerts during the study that were quickly addressed because messages were received immediately, he said.

The latest version of the app includes simpler navigation, rewards for fulfilling the daily and weekly testing, and medication reminders.

Dr. Vieta and his colleagues at the University of Barcelona previously have demonstrated the value of psychoeducation among patients with bipolar disorder. They developed a successful psychoeducation program in the late 1990s, which led to a trial published in 2003 and development of a training manual in 2006 that has been translated into numerous languages.

The program and trial showed that adding psychoeducation to medication in patients with bipolar disorder improves outcomes in terms of relapse and hospitalizations: the rate of relapses in the study was reduced by nearly 80%, Dr. Vieta said.

Providing such education, however, which has become a standard of care, is limited by the need for personnel training and by staffing and financial resource constraints.

“We wanted something nonstigmatizing but also linked to the clinical care team. … Clearly, we would like to make this intervention more widely available without compromising quality,” Dr. Vieta said, describing the impetus for the SIMPle app.

A phase II, randomized controlled study of the app is now underway, he said, adding that “this is really quite exciting. … There is huge potential for things we can do with this app.”

Dr. Vieta is a consultant or adviser for several pharmaceutical companies. He also has received research grants, honoraria, or consulting fees from numerous entities.

[email protected]

ATLANTA – A new smartphone application aimed at providing psychoeducation to patients with bipolar disorder was well received and showed promise for improving outcomes in a feasibility study, according to Dr. Eduard Vieta.

Early results of the study showed that adherence was quite high, with retention at 76% among 49 patients with bipolar disorder who tested the SIMPle app (Self Monitoring and Psychoeducation in Bipolar Patients with a Smartphone Application), Dr. Vieta said at the annual meeting of the American Psychiatric Association.

The app, currently available for free for Android and iPhones, is an interactive educational program that includes weekly and daily tests, with alerts for patients to take medications or see their doctor.

The patients in the study were representative of generally stable bipolar disorder patients in a real-world setting, as the app ideally would be used by those who are “in near remission or at least not acutely ill,” said Dr. Vieta of the University of Barcelona.

“People like the app and did follow the daily and weekly tests, which is a good sign,” he said, noting that satisfaction was high, and good correlation between test scores and mood changes suggested that the app is reliable for monitoring mood changes.

There were 10 suicide alerts during the study that were quickly addressed because messages were received immediately, he said.

The latest version of the app includes simpler navigation, rewards for fulfilling the daily and weekly testing, and medication reminders.

Dr. Vieta and his colleagues at the University of Barcelona previously have demonstrated the value of psychoeducation among patients with bipolar disorder. They developed a successful psychoeducation program in the late 1990s, which led to a trial published in 2003 and development of a training manual in 2006 that has been translated into numerous languages.

The program and trial showed that adding psychoeducation to medication in patients with bipolar disorder improves outcomes in terms of relapse and hospitalizations: the rate of relapses in the study was reduced by nearly 80%, Dr. Vieta said.

Providing such education, however, which has become a standard of care, is limited by the need for personnel training and by staffing and financial resource constraints.

“We wanted something nonstigmatizing but also linked to the clinical care team. … Clearly, we would like to make this intervention more widely available without compromising quality,” Dr. Vieta said, describing the impetus for the SIMPle app.

A phase II, randomized controlled study of the app is now underway, he said, adding that “this is really quite exciting. … There is huge potential for things we can do with this app.”

Dr. Vieta is a consultant or adviser for several pharmaceutical companies. He also has received research grants, honoraria, or consulting fees from numerous entities.

[email protected]

SAN DIEGO – Statin use, but not aspirin use, showed a protective effect against pancreatic ductal adenocarcinoma in a large prospective case-control study.

“There also appears to be no chemoenhancing effect from combining the two drugs,” Dr. Livia Archibugi of Hospital Sant’Andrea in Rome, Italy, said at the annual Digestive Disease Week. The study also confirmed known risk factors for pancreatic cancer, “supporting the genuineness of our population,” she and her associates said.

Louise Koenig/Frontline Medical News

This is the first epidemiologic study to look at both aspirin and statins in relationship to pancreatic cancer. Both types of drugs have shown anticarcinogenic effects in laboratory and epidemiologic studies, Dr. Archibugi noted. For example, aspirin blocks mTOR, NF-kappa B and Wnt signaling, which inhibits carcinogenesis and angiogenesis and promotes apoptosis and DNA mismatch repair. A recent meta-analysis, found a 23% lower risk of pancreatic cancer among aspirin users than nonusers, but the study did not assess concurrent statin use.

Statins, for their part, are both immunomodulatory and anti-inflammatory, and inhibit angiogenesis at low doses, said Dr. Archibugi. However, studies have yielded mixed results about whether they reduce the risk of pancreatic cancer, she noted.

Therefore, between 2005 and 2016, she and her colleagues used questionnaires to study environmental exposures and the family and individual health histories of 408 consecutive patients with pancreatic ductal adenocarcinoma and 816 age- and sex-matched controls. The controls were gastroenterology patients at the same hospital and did not have chronic obstructive pulmonary disease, cirrhosis, chronic kidney failure, acute bleeding, inflammatory bowel disease, or a history of cancer in the past 5 years. The study was large enough to have an 80% power to detect an odds ratio of 0.65 for the relationship between incident pancreatic cancer and either aspirin or statin exposure, and an odds ratio of 0.5 for dual exposure, Dr. Archibugi noted.

Reported statin use was significantly more common among controls (24%) than cases (18%; P = .03), and controls were more likely than cases to report taking either low-dose (less than 20 mg) or high-dose (greater than 20 mg) statins, the investigators found. Proportionally more controls also reported at least a 5-year history of statin use. After controlling for age, sex, and known risk factors, only statin use was significantly associated with incident pancreatic cancer in the multivariate analysis (OR, 0.59; 95% confidence interval, 0.42-0.85; P = .004). The protective effect of statins held up in subgroups stratified by gender, age, and statin type, Dr. Archibugi said.

In contrast, statistically similar proportions of cases (19%) and controls (23%) reported using aspirin, and although aspirin use was inversely linked to incident pancreatic cancer in the univariate analysis, the effect lost significance in the multivariable analysis (OR, 0.78; 95% CI, 0.54-1.11). Moreover, patients who took both aspirin and statins were no less likely to develop pancreatic cancer than those who took only statins.

Like all case-control studies, recall bias could have affected the associations, she noted. However, the same analyses correlated pancreatic cancer with several known risk factors, including smoking (OR, 1.8), heavy drinking (OR, 1.7), diabetes (OR, 1.8), chronic pancreatitis (OR, 14.3), and first-degree family history of pancreatic cancer (OR, 3.1).

Dr. Archibugi and her associates had no disclosures.

SAN DIEGO – Statin use, but not aspirin use, showed a protective effect against pancreatic ductal adenocarcinoma in a large prospective case-control study.

“There also appears to be no chemoenhancing effect from combining the two drugs,” Dr. Livia Archibugi of Hospital Sant’Andrea in Rome, Italy, said at the annual Digestive Disease Week. The study also confirmed known risk factors for pancreatic cancer, “supporting the genuineness of our population,” she and her associates said.

Louise Koenig/Frontline Medical News

This is the first epidemiologic study to look at both aspirin and statins in relationship to pancreatic cancer. Both types of drugs have shown anticarcinogenic effects in laboratory and epidemiologic studies, Dr. Archibugi noted. For example, aspirin blocks mTOR, NF-kappa B and Wnt signaling, which inhibits carcinogenesis and angiogenesis and promotes apoptosis and DNA mismatch repair. A recent meta-analysis, found a 23% lower risk of pancreatic cancer among aspirin users than nonusers, but the study did not assess concurrent statin use.

Statins, for their part, are both immunomodulatory and anti-inflammatory, and inhibit angiogenesis at low doses, said Dr. Archibugi. However, studies have yielded mixed results about whether they reduce the risk of pancreatic cancer, she noted.

Therefore, between 2005 and 2016, she and her colleagues used questionnaires to study environmental exposures and the family and individual health histories of 408 consecutive patients with pancreatic ductal adenocarcinoma and 816 age- and sex-matched controls. The controls were gastroenterology patients at the same hospital and did not have chronic obstructive pulmonary disease, cirrhosis, chronic kidney failure, acute bleeding, inflammatory bowel disease, or a history of cancer in the past 5 years. The study was large enough to have an 80% power to detect an odds ratio of 0.65 for the relationship between incident pancreatic cancer and either aspirin or statin exposure, and an odds ratio of 0.5 for dual exposure, Dr. Archibugi noted.

Reported statin use was significantly more common among controls (24%) than cases (18%; P = .03), and controls were more likely than cases to report taking either low-dose (less than 20 mg) or high-dose (greater than 20 mg) statins, the investigators found. Proportionally more controls also reported at least a 5-year history of statin use. After controlling for age, sex, and known risk factors, only statin use was significantly associated with incident pancreatic cancer in the multivariate analysis (OR, 0.59; 95% confidence interval, 0.42-0.85; P = .004). The protective effect of statins held up in subgroups stratified by gender, age, and statin type, Dr. Archibugi said.

In contrast, statistically similar proportions of cases (19%) and controls (23%) reported using aspirin, and although aspirin use was inversely linked to incident pancreatic cancer in the univariate analysis, the effect lost significance in the multivariable analysis (OR, 0.78; 95% CI, 0.54-1.11). Moreover, patients who took both aspirin and statins were no less likely to develop pancreatic cancer than those who took only statins.

Like all case-control studies, recall bias could have affected the associations, she noted. However, the same analyses correlated pancreatic cancer with several known risk factors, including smoking (OR, 1.8), heavy drinking (OR, 1.7), diabetes (OR, 1.8), chronic pancreatitis (OR, 14.3), and first-degree family history of pancreatic cancer (OR, 3.1).

Dr. Archibugi and her associates had no disclosures.

SAN DIEGO – Statin use, but not aspirin use, showed a protective effect against pancreatic ductal adenocarcinoma in a large prospective case-control study.

“There also appears to be no chemoenhancing effect from combining the two drugs,” Dr. Livia Archibugi of Hospital Sant’Andrea in Rome, Italy, said at the annual Digestive Disease Week. The study also confirmed known risk factors for pancreatic cancer, “supporting the genuineness of our population,” she and her associates said.

Louise Koenig/Frontline Medical News

This is the first epidemiologic study to look at both aspirin and statins in relationship to pancreatic cancer. Both types of drugs have shown anticarcinogenic effects in laboratory and epidemiologic studies, Dr. Archibugi noted. For example, aspirin blocks mTOR, NF-kappa B and Wnt signaling, which inhibits carcinogenesis and angiogenesis and promotes apoptosis and DNA mismatch repair. A recent meta-analysis, found a 23% lower risk of pancreatic cancer among aspirin users than nonusers, but the study did not assess concurrent statin use.

Statins, for their part, are both immunomodulatory and anti-inflammatory, and inhibit angiogenesis at low doses, said Dr. Archibugi. However, studies have yielded mixed results about whether they reduce the risk of pancreatic cancer, she noted.

Therefore, between 2005 and 2016, she and her colleagues used questionnaires to study environmental exposures and the family and individual health histories of 408 consecutive patients with pancreatic ductal adenocarcinoma and 816 age- and sex-matched controls. The controls were gastroenterology patients at the same hospital and did not have chronic obstructive pulmonary disease, cirrhosis, chronic kidney failure, acute bleeding, inflammatory bowel disease, or a history of cancer in the past 5 years. The study was large enough to have an 80% power to detect an odds ratio of 0.65 for the relationship between incident pancreatic cancer and either aspirin or statin exposure, and an odds ratio of 0.5 for dual exposure, Dr. Archibugi noted.

Reported statin use was significantly more common among controls (24%) than cases (18%; P = .03), and controls were more likely than cases to report taking either low-dose (less than 20 mg) or high-dose (greater than 20 mg) statins, the investigators found. Proportionally more controls also reported at least a 5-year history of statin use. After controlling for age, sex, and known risk factors, only statin use was significantly associated with incident pancreatic cancer in the multivariate analysis (OR, 0.59; 95% confidence interval, 0.42-0.85; P = .004). The protective effect of statins held up in subgroups stratified by gender, age, and statin type, Dr. Archibugi said.

In contrast, statistically similar proportions of cases (19%) and controls (23%) reported using aspirin, and although aspirin use was inversely linked to incident pancreatic cancer in the univariate analysis, the effect lost significance in the multivariable analysis (OR, 0.78; 95% CI, 0.54-1.11). Moreover, patients who took both aspirin and statins were no less likely to develop pancreatic cancer than those who took only statins.

Like all case-control studies, recall bias could have affected the associations, she noted. However, the same analyses correlated pancreatic cancer with several known risk factors, including smoking (OR, 1.8), heavy drinking (OR, 1.7), diabetes (OR, 1.8), chronic pancreatitis (OR, 14.3), and first-degree family history of pancreatic cancer (OR, 3.1).

Dr. Archibugi and her associates had no disclosures.

• New options for acne treatment
• Expert critiques isotretinoin controversies
• Busting atopic dermatitis therapy myths
• Promising new topicals for treating eczema
• Cut simple carbs to clear acne
• Two conditions raise suspicion for pediatric psoriasis
• Ask teens with acne about whey protein

Faculty
Lawrence F. Eichenfield, M.D.
Chief of pediatric and adolescent dermatology
Rady Children’s Hospital—San Diego
Professor of medicine and pediatrics
University of California, San Diego
Director, Rady Children’s Hospital/UCSD’s Eczema and Inflammatory Skin Disease Center

Andrew Krakowski, M.D.
Board-certified dermatologist and pediatric dermatologist with a clinical research focus on acne, eczema, and the application of lasers/photomedicine in children
Chief medical officer for DermOne, LLC
West Conshohocken, Pa.

Disclosures: Dr. Eichenfield has served as an investigator and/or consultant for Anacor Pharmaceuticals, Otsuka Pharmaceuticals, and Regeneron Pharmaceuticals. Dr. Krakowski said he had no relevant financial disclosures.

©Copyright 2016, by Frontline Medical Communications Inc. All rights reserved.

• New options for acne treatment
• Expert critiques isotretinoin controversies
• Busting atopic dermatitis therapy myths
• Promising new topicals for treating eczema
• Cut simple carbs to clear acne
• Two conditions raise suspicion for pediatric psoriasis
• Ask teens with acne about whey protein

Faculty
Lawrence F. Eichenfield, M.D.
Chief of pediatric and adolescent dermatology
Rady Children’s Hospital—San Diego
Professor of medicine and pediatrics
University of California, San Diego
Director, Rady Children’s Hospital/UCSD’s Eczema and Inflammatory Skin Disease Center

Andrew Krakowski, M.D.
Board-certified dermatologist and pediatric dermatologist with a clinical research focus on acne, eczema, and the application of lasers/photomedicine in children
Chief medical officer for DermOne, LLC
West Conshohocken, Pa.

Disclosures: Dr. Eichenfield has served as an investigator and/or consultant for Anacor Pharmaceuticals, Otsuka Pharmaceuticals, and Regeneron Pharmaceuticals. Dr. Krakowski said he had no relevant financial disclosures.

©Copyright 2016, by Frontline Medical Communications Inc. All rights reserved.

• New options for acne treatment
• Expert critiques isotretinoin controversies
• Busting atopic dermatitis therapy myths
• Promising new topicals for treating eczema
• Cut simple carbs to clear acne
• Two conditions raise suspicion for pediatric psoriasis
• Ask teens with acne about whey protein

Faculty
Lawrence F. Eichenfield, M.D.
Chief of pediatric and adolescent dermatology
Rady Children’s Hospital—San Diego
Professor of medicine and pediatrics
University of California, San Diego
Director, Rady Children’s Hospital/UCSD’s Eczema and Inflammatory Skin Disease Center

Andrew Krakowski, M.D.
Board-certified dermatologist and pediatric dermatologist with a clinical research focus on acne, eczema, and the application of lasers/photomedicine in children
Chief medical officer for DermOne, LLC
West Conshohocken, Pa.

Disclosures: Dr. Eichenfield has served as an investigator and/or consultant for Anacor Pharmaceuticals, Otsuka Pharmaceuticals, and Regeneron Pharmaceuticals. Dr. Krakowski said he had no relevant financial disclosures.

©Copyright 2016, by Frontline Medical Communications Inc. All rights reserved.

October 20-22, 2016
Radisson Blu Aqua Hotel
Chicago, IL

Course Directors
David H. Adams
Steven F. Bolling
Robert O. Bonow
Howard C. Herrmann

Nurse Planner
Michele Mistovich

Course Overview
The American College of Cardiology and the American Association for Thoracic Surgery are again partnering to bring together cardiologists and surgeons in a cooperative, case-based course to address the rapid advances in the treatment of valvular heart disease (VHD).

Focusing on interactivity and practical decision-making, this unique conference will engage participants in discussions, debates and potential controversies using real-world cases. Its renowned faculty will include experts on the cutting edge of clinically relevant VHD data.

The interdisciplinary course emphasizes clinical decision-making with medical, surgical and interventional options for patient care, taking into account that constantly changing management tools can impact the surgical team. There will be breakout sessions for cardiologists, cardiac surgeons, nurses and physician assistants designed to help specialists manage their unique challenges from a team perspective.

Target Audience
Cardiologists, interventional cardiologists, cardiothoracic surgeons, internists, nurses, physician assistants and health care professionals involved in VHD evaluation, diagnosis and/or management.

More Information 

Registration/Housing 

October 20-22, 2016
Radisson Blu Aqua Hotel
Chicago, IL

Course Directors
David H. Adams
Steven F. Bolling
Robert O. Bonow
Howard C. Herrmann

Nurse Planner
Michele Mistovich

Course Overview
The American College of Cardiology and the American Association for Thoracic Surgery are again partnering to bring together cardiologists and surgeons in a cooperative, case-based course to address the rapid advances in the treatment of valvular heart disease (VHD).

Focusing on interactivity and practical decision-making, this unique conference will engage participants in discussions, debates and potential controversies using real-world cases. Its renowned faculty will include experts on the cutting edge of clinically relevant VHD data.

The interdisciplinary course emphasizes clinical decision-making with medical, surgical and interventional options for patient care, taking into account that constantly changing management tools can impact the surgical team. There will be breakout sessions for cardiologists, cardiac surgeons, nurses and physician assistants designed to help specialists manage their unique challenges from a team perspective.

Target Audience
Cardiologists, interventional cardiologists, cardiothoracic surgeons, internists, nurses, physician assistants and health care professionals involved in VHD evaluation, diagnosis and/or management.

More Information 

Registration/Housing 

October 20-22, 2016
Radisson Blu Aqua Hotel
Chicago, IL

Course Directors
David H. Adams
Steven F. Bolling
Robert O. Bonow
Howard C. Herrmann

Nurse Planner
Michele Mistovich

Course Overview
The American College of Cardiology and the American Association for Thoracic Surgery are again partnering to bring together cardiologists and surgeons in a cooperative, case-based course to address the rapid advances in the treatment of valvular heart disease (VHD).

Focusing on interactivity and practical decision-making, this unique conference will engage participants in discussions, debates and potential controversies using real-world cases. Its renowned faculty will include experts on the cutting edge of clinically relevant VHD data.

The interdisciplinary course emphasizes clinical decision-making with medical, surgical and interventional options for patient care, taking into account that constantly changing management tools can impact the surgical team. There will be breakout sessions for cardiologists, cardiac surgeons, nurses and physician assistants designed to help specialists manage their unique challenges from a team perspective.

Target Audience
Cardiologists, interventional cardiologists, cardiothoracic surgeons, internists, nurses, physician assistants and health care professionals involved in VHD evaluation, diagnosis and/or management.

More Information 

Registration/Housing 

Click here to read the supplement

Click here to read the supplement

Click here to read the supplement

View Preliminary Program & Register

October 28-29, 2016
Westin Boston Waterfront Hotel
Boston, MA, USA

Program Directors
G. Alexander Patterson
David J. Sugarbaker

Program Committee
Thomas A. D’Amico
Shaf Keshavjee
James D. Luketich
Bryan F. Meyers
Scott J. Swanson

Overview
Currently practicing surgeons will be able to improve patient outcomes by enriching their knowledge and technical skills in the definition, diagnosis and resolution of thoracic surgical difficulties and post-operative complications. Expert faculty will provide state-of-the-art solutions to challenges in the field. Attendees will augment their overall understanding of thoracic diseases, upgrade their competency and ability to formulate new clinical strategies, and enhance their diagnosis and surgical treatment of thoracic diseases.

Information

Registration 

View Preliminary Program & Register

October 28-29, 2016
Westin Boston Waterfront Hotel
Boston, MA, USA

Program Directors
G. Alexander Patterson
David J. Sugarbaker

Program Committee
Thomas A. D’Amico
Shaf Keshavjee
James D. Luketich
Bryan F. Meyers
Scott J. Swanson

Overview
Currently practicing surgeons will be able to improve patient outcomes by enriching their knowledge and technical skills in the definition, diagnosis and resolution of thoracic surgical difficulties and post-operative complications. Expert faculty will provide state-of-the-art solutions to challenges in the field. Attendees will augment their overall understanding of thoracic diseases, upgrade their competency and ability to formulate new clinical strategies, and enhance their diagnosis and surgical treatment of thoracic diseases.

Information

Registration 

View Preliminary Program & Register

October 28-29, 2016
Westin Boston Waterfront Hotel
Boston, MA, USA

Program Directors
G. Alexander Patterson
David J. Sugarbaker

Program Committee
Thomas A. D’Amico
Shaf Keshavjee
James D. Luketich
Bryan F. Meyers
Scott J. Swanson

Overview
Currently practicing surgeons will be able to improve patient outcomes by enriching their knowledge and technical skills in the definition, diagnosis and resolution of thoracic surgical difficulties and post-operative complications. Expert faculty will provide state-of-the-art solutions to challenges in the field. Attendees will augment their overall understanding of thoracic diseases, upgrade their competency and ability to formulate new clinical strategies, and enhance their diagnosis and surgical treatment of thoracic diseases.

Information

Registration 

SAN DIEGO – A colonoscopy capsule that requires no bowel preparation safely detected pedunculated and sessile polyps as small as 7 mm in a feasibility study of 54 volunteers.

The capsule scans the colon with very-low-dose X-rays, and the images are converted to high-resolution three-dimensional reconstructions that physicians can review remotely in about 10 minutes, said Dr. Nadir Arber of the Integrated Cancer Prevention Center at Tel Aviv Sourasky Medical Center. “All 54 capsules were excreted naturally, without discomfort or side effects,” he reported at the annual Digestive Disease Week.

Amy Karon

Bowel preparation is the most common reason for skipping a colonoscopy, and poor preparation leads to missed adenomas on conventional screens, Dr. Arber noted. “A colorectal cancer screening method that would generate structural data of the colon, without cathartic cleansing or diet restrictions, would offer an attractive alternative for many patients,” he said.

This capsule is no larger than others that have been approved, but it uses low-dose X-rays to circumvent the need for bowel preparation. Patients swallow the capsules and go about their day while wearing tracking patches on their lower backs that transmit (nonionizing) radiofrequency data to a localization system. This system determines when a capsule has reached the colon. At this point, the capsule is activated and begins emitting X-rays, but only when it is moving, Dr. Arber said. Because the capsule usually is not moving, radiation exposure is minimized. Also, an axis-positioning system reconciles the location of the capsule with the colonic wall to prevent movement artifacts.

The 54 volunteers in the study were 45-75 years old. The capsules took an average of 66 hours to move through the entire alimentary tract, with a standard deviation of 37 hours. If swallowed before the first meal of the day, the transit time averaged 51 hours, with a standard deviation of 25 hours. The total radiation dose per procedure averaged 0.03 mSv (standard deviation, 0.0007 mSv), which is equivalent to one dental or chest X-ray, Dr. Arber said.

Examples of reconstructed lesions included a 12 × 4 mm flat sessile polyp, a double-headed polyp with heads measuring 7 and 15 mm, and a 25-mm polyp in the sigmoid colon. “In humans, 7-mm polyps are well within the detection capability of the system,” he said.

He and his associates are planning multicenter studies to compare adenoma detection by the capsule with traditional colonoscopy. Reconstructing long pedunculated polyps might be difficult because of image distortion, Dr. Arber acknowledged.

He reported that his spouse or partner has received consulting fees from Check-Cap Ltd., the maker of the capsule.

SAN DIEGO – A colonoscopy capsule that requires no bowel preparation safely detected pedunculated and sessile polyps as small as 7 mm in a feasibility study of 54 volunteers.

The capsule scans the colon with very-low-dose X-rays, and the images are converted to high-resolution three-dimensional reconstructions that physicians can review remotely in about 10 minutes, said Dr. Nadir Arber of the Integrated Cancer Prevention Center at Tel Aviv Sourasky Medical Center. “All 54 capsules were excreted naturally, without discomfort or side effects,” he reported at the annual Digestive Disease Week.

Amy Karon

Bowel preparation is the most common reason for skipping a colonoscopy, and poor preparation leads to missed adenomas on conventional screens, Dr. Arber noted. “A colorectal cancer screening method that would generate structural data of the colon, without cathartic cleansing or diet restrictions, would offer an attractive alternative for many patients,” he said.

This capsule is no larger than others that have been approved, but it uses low-dose X-rays to circumvent the need for bowel preparation. Patients swallow the capsules and go about their day while wearing tracking patches on their lower backs that transmit (nonionizing) radiofrequency data to a localization system. This system determines when a capsule has reached the colon. At this point, the capsule is activated and begins emitting X-rays, but only when it is moving, Dr. Arber said. Because the capsule usually is not moving, radiation exposure is minimized. Also, an axis-positioning system reconciles the location of the capsule with the colonic wall to prevent movement artifacts.

The 54 volunteers in the study were 45-75 years old. The capsules took an average of 66 hours to move through the entire alimentary tract, with a standard deviation of 37 hours. If swallowed before the first meal of the day, the transit time averaged 51 hours, with a standard deviation of 25 hours. The total radiation dose per procedure averaged 0.03 mSv (standard deviation, 0.0007 mSv), which is equivalent to one dental or chest X-ray, Dr. Arber said.

Examples of reconstructed lesions included a 12 × 4 mm flat sessile polyp, a double-headed polyp with heads measuring 7 and 15 mm, and a 25-mm polyp in the sigmoid colon. “In humans, 7-mm polyps are well within the detection capability of the system,” he said.

He and his associates are planning multicenter studies to compare adenoma detection by the capsule with traditional colonoscopy. Reconstructing long pedunculated polyps might be difficult because of image distortion, Dr. Arber acknowledged.

He reported that his spouse or partner has received consulting fees from Check-Cap Ltd., the maker of the capsule.

SAN DIEGO – A colonoscopy capsule that requires no bowel preparation safely detected pedunculated and sessile polyps as small as 7 mm in a feasibility study of 54 volunteers.

The capsule scans the colon with very-low-dose X-rays, and the images are converted to high-resolution three-dimensional reconstructions that physicians can review remotely in about 10 minutes, said Dr. Nadir Arber of the Integrated Cancer Prevention Center at Tel Aviv Sourasky Medical Center. “All 54 capsules were excreted naturally, without discomfort or side effects,” he reported at the annual Digestive Disease Week.

Amy Karon

Bowel preparation is the most common reason for skipping a colonoscopy, and poor preparation leads to missed adenomas on conventional screens, Dr. Arber noted. “A colorectal cancer screening method that would generate structural data of the colon, without cathartic cleansing or diet restrictions, would offer an attractive alternative for many patients,” he said.

This capsule is no larger than others that have been approved, but it uses low-dose X-rays to circumvent the need for bowel preparation. Patients swallow the capsules and go about their day while wearing tracking patches on their lower backs that transmit (nonionizing) radiofrequency data to a localization system. This system determines when a capsule has reached the colon. At this point, the capsule is activated and begins emitting X-rays, but only when it is moving, Dr. Arber said. Because the capsule usually is not moving, radiation exposure is minimized. Also, an axis-positioning system reconciles the location of the capsule with the colonic wall to prevent movement artifacts.

The 54 volunteers in the study were 45-75 years old. The capsules took an average of 66 hours to move through the entire alimentary tract, with a standard deviation of 37 hours. If swallowed before the first meal of the day, the transit time averaged 51 hours, with a standard deviation of 25 hours. The total radiation dose per procedure averaged 0.03 mSv (standard deviation, 0.0007 mSv), which is equivalent to one dental or chest X-ray, Dr. Arber said.

Examples of reconstructed lesions included a 12 × 4 mm flat sessile polyp, a double-headed polyp with heads measuring 7 and 15 mm, and a 25-mm polyp in the sigmoid colon. “In humans, 7-mm polyps are well within the detection capability of the system,” he said.

He and his associates are planning multicenter studies to compare adenoma detection by the capsule with traditional colonoscopy. Reconstructing long pedunculated polyps might be difficult because of image distortion, Dr. Arber acknowledged.

He reported that his spouse or partner has received consulting fees from Check-Cap Ltd., the maker of the capsule.

October 20-22, 2016
Hyatt Regency O’Hare
Chicago, IL

Program Directors
David H. Harpole, Jr.
Marco A. Zenati

This course will provide an intensive and interactive training program for cardiothoracic surgeons across all subspecialties to acquire the critical skills required in effective clinical trial design and implementation. This course is particularly suited to help professionals who are considering applying for clinical trial funding to better understand the complex nature of preparing and submitting clinical trial proposals.

Invited faculty includes currently funded clinical trial leading investigators and experts in the field of biostatistics and health sciences research. The program will offer a process in which the clinical trial protocol development can be streamlined. Interactive features will include hands-on focus groups and mock study sessions.

Register Today! Space available for only 40 participants.

Registration/Housing/Preliminary Program 

October 20-22, 2016
Hyatt Regency O’Hare
Chicago, IL

Program Directors
David H. Harpole, Jr.
Marco A. Zenati

This course will provide an intensive and interactive training program for cardiothoracic surgeons across all subspecialties to acquire the critical skills required in effective clinical trial design and implementation. This course is particularly suited to help professionals who are considering applying for clinical trial funding to better understand the complex nature of preparing and submitting clinical trial proposals.

Invited faculty includes currently funded clinical trial leading investigators and experts in the field of biostatistics and health sciences research. The program will offer a process in which the clinical trial protocol development can be streamlined. Interactive features will include hands-on focus groups and mock study sessions.

Register Today! Space available for only 40 participants.

Registration/Housing/Preliminary Program 

October 20-22, 2016
Hyatt Regency O’Hare
Chicago, IL

Program Directors
David H. Harpole, Jr.
Marco A. Zenati

This course will provide an intensive and interactive training program for cardiothoracic surgeons across all subspecialties to acquire the critical skills required in effective clinical trial design and implementation. This course is particularly suited to help professionals who are considering applying for clinical trial funding to better understand the complex nature of preparing and submitting clinical trial proposals.

Invited faculty includes currently funded clinical trial leading investigators and experts in the field of biostatistics and health sciences research. The program will offer a process in which the clinical trial protocol development can be streamlined. Interactive features will include hands-on focus groups and mock study sessions.

Register Today! Space available for only 40 participants.

Registration/Housing/Preliminary Program 

June 24-25, 2016
Renaissance Boston Waterfront Hotel
Boston, MA

Co-Directors
Thoralf M. Sundt, III
Steven Yule

Program Committee
David J. Bunnell (APACVS)
David C. Fitzgerald (AMSECT)
Jake Jaquiss
M. Blair Marshall
Shannon Pengel
Kenneth Shann (AMSECT)
Marco Zenati

Patient Safety is essential for successful surgical care — in cardiothoracic surgery — and all disciplines. In the more than 10 years since the Institute of Medicine made patient safety a priority, little progress has been made in changing culture and practice on the front lines.

This two-day course — including team training and simulation experiences — will make a difference, offering surgical team members practical safety behaviors for improving patient outcomes.

View Preliminary Program 

Special Benefits for Team Registration!

Registration 

Housing 

Housing Closes June 2nd. 

June 24-25, 2016
Renaissance Boston Waterfront Hotel
Boston, MA

Co-Directors
Thoralf M. Sundt, III
Steven Yule

Program Committee
David J. Bunnell (APACVS)
David C. Fitzgerald (AMSECT)
Jake Jaquiss
M. Blair Marshall
Shannon Pengel
Kenneth Shann (AMSECT)
Marco Zenati

Patient Safety is essential for successful surgical care — in cardiothoracic surgery — and all disciplines. In the more than 10 years since the Institute of Medicine made patient safety a priority, little progress has been made in changing culture and practice on the front lines.

This two-day course — including team training and simulation experiences — will make a difference, offering surgical team members practical safety behaviors for improving patient outcomes.

View Preliminary Program 

Special Benefits for Team Registration!

Registration 

Housing 

Housing Closes June 2nd. 

June 24-25, 2016
Renaissance Boston Waterfront Hotel
Boston, MA

Co-Directors
Thoralf M. Sundt, III
Steven Yule

Program Committee
David J. Bunnell (APACVS)
David C. Fitzgerald (AMSECT)
Jake Jaquiss
M. Blair Marshall
Shannon Pengel
Kenneth Shann (AMSECT)
Marco Zenati

Patient Safety is essential for successful surgical care — in cardiothoracic surgery — and all disciplines. In the more than 10 years since the Institute of Medicine made patient safety a priority, little progress has been made in changing culture and practice on the front lines.

This two-day course — including team training and simulation experiences — will make a difference, offering surgical team members practical safety behaviors for improving patient outcomes.

View Preliminary Program 

Special Benefits for Team Registration!

Registration 

Housing 

Housing Closes June 2nd.