LONDON – Patients with relapsing-remitting multiple sclerosis reported that their ability to walk was significantly improved following 6 months of treatment with extended-release dalfampridine – compared with patients on placebo – in a double-blind, randomized trial.

In the ENHANCE study, 43.2% of the 315 patients treated with extended-release dalfampridine (dalfampridine-ER; Ampyra) and 33.6% of the 318 who were given placebo achieved a clinically meaningful improvement of 8 or more points on the 12-item MS Walking Scale (MSWS-12) measured at week 24.

The odds ratio (OR) was 1.61, highlighting a significant difference between the two study arms (P = .006).

“This is one of the only studies to use a PRO [patient-reported outcome] as the primary outcome and to use an a priori threshold of clinical meaningfulness,” said Jeremy Hobart, MD, of Plymouth Hospitals NHS Trust (England), who reported the study’s findings at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis. This is an important, and challenging, development in MS trials, he added.

“We are all aware that walking impairments are one of the hallmarks of multiple sclerosis,” Dr. Hobart said, adding that it affects the “vast majority” of patients.

Dalfampridine-ER, which is known as prolonged-release fampridine in Europe, is the only therapy licensed to improve walking in MS, he observed. The pivotal studies that led to the drug’s approval, however, were of relatively short duration and the ENHANCE study was conducted to answer questions that have been raised about the durability of its effect on patients’ mobility.

Patients in ENHANCE received either dalfampridine-ER at a twice-daily dose of 10 mg or placebo for 24 weeks. The mean age of patients in each group was 49 and 48 years, respectively, and 59% and 57% of recruited patients in each arm were female. Patients were stratified according to their baseline Expanded Disability Status Scale (EDSS) score, with 78% and 77% in the dalfampridine-ER and placebo groups having a score of 6 or less.

Dr. Hobart noted that the mean change in MSWS-12 scores over time and an analysis of the cumulative proportion of responders at any particular threshold score on the MWSW-12 showed a clear benefit of dalfampridine-ER treatment over placebo.

The study investigators also assessed patients’ balance via the Timed Up and Go (TUG) test, with a benefit threshold set at obtaining at least a 15% or more improvement at 24 weeks. Significantly more dalfampridine-ER–treated than placebo-treated patients achieved this threshold (43.4% vs. 34.7%; OR, 1.46; P = .03).

There was a significant improvement between the two study arms on the 29-item physical scale of the Multiple Sclerosis Impact Scale (P less than .001).

However, there was no change seen in upper extremity function, with similar mean changes in the Berg Balance Scale score and the ABILHAND score at 24 weeks. The mean baseline scores for both of these measures were high, Dr. Hobart observed, which probably affected the findings. That said, patients with a baseline EDSS of 6 or higher had greater improvement in ABILHAND scores if they had received dalfampridine-ER, compared with placebo, but the difference was not statistically significant.

The safety profile was consistent with what has been seen in other trials, Dr. Hobart said, and there were no new safety concerns raised.

“The findings from ENHANCE expand and tend to ... confirm the favorable risk-benefit profile established in prior pivotal trials,” he said.

Biogen sponsored the study. Dr. Hobart disclosed receiving fees, honoraria, and research support from Biogen, Acorda, Genzyme, Global Blood Therapeutics, Merck Serono, Novartis, Tigercat, and Vanita.

LONDON – Patients with relapsing-remitting multiple sclerosis reported that their ability to walk was significantly improved following 6 months of treatment with extended-release dalfampridine – compared with patients on placebo – in a double-blind, randomized trial.

In the ENHANCE study, 43.2% of the 315 patients treated with extended-release dalfampridine (dalfampridine-ER; Ampyra) and 33.6% of the 318 who were given placebo achieved a clinically meaningful improvement of 8 or more points on the 12-item MS Walking Scale (MSWS-12) measured at week 24.

The odds ratio (OR) was 1.61, highlighting a significant difference between the two study arms (P = .006).

“This is one of the only studies to use a PRO [patient-reported outcome] as the primary outcome and to use an a priori threshold of clinical meaningfulness,” said Jeremy Hobart, MD, of Plymouth Hospitals NHS Trust (England), who reported the study’s findings at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis. This is an important, and challenging, development in MS trials, he added.

“We are all aware that walking impairments are one of the hallmarks of multiple sclerosis,” Dr. Hobart said, adding that it affects the “vast majority” of patients.

Dalfampridine-ER, which is known as prolonged-release fampridine in Europe, is the only therapy licensed to improve walking in MS, he observed. The pivotal studies that led to the drug’s approval, however, were of relatively short duration and the ENHANCE study was conducted to answer questions that have been raised about the durability of its effect on patients’ mobility.

Patients in ENHANCE received either dalfampridine-ER at a twice-daily dose of 10 mg or placebo for 24 weeks. The mean age of patients in each group was 49 and 48 years, respectively, and 59% and 57% of recruited patients in each arm were female. Patients were stratified according to their baseline Expanded Disability Status Scale (EDSS) score, with 78% and 77% in the dalfampridine-ER and placebo groups having a score of 6 or less.

Dr. Hobart noted that the mean change in MSWS-12 scores over time and an analysis of the cumulative proportion of responders at any particular threshold score on the MWSW-12 showed a clear benefit of dalfampridine-ER treatment over placebo.

The study investigators also assessed patients’ balance via the Timed Up and Go (TUG) test, with a benefit threshold set at obtaining at least a 15% or more improvement at 24 weeks. Significantly more dalfampridine-ER–treated than placebo-treated patients achieved this threshold (43.4% vs. 34.7%; OR, 1.46; P = .03).

There was a significant improvement between the two study arms on the 29-item physical scale of the Multiple Sclerosis Impact Scale (P less than .001).

However, there was no change seen in upper extremity function, with similar mean changes in the Berg Balance Scale score and the ABILHAND score at 24 weeks. The mean baseline scores for both of these measures were high, Dr. Hobart observed, which probably affected the findings. That said, patients with a baseline EDSS of 6 or higher had greater improvement in ABILHAND scores if they had received dalfampridine-ER, compared with placebo, but the difference was not statistically significant.

The safety profile was consistent with what has been seen in other trials, Dr. Hobart said, and there were no new safety concerns raised.

“The findings from ENHANCE expand and tend to ... confirm the favorable risk-benefit profile established in prior pivotal trials,” he said.

Biogen sponsored the study. Dr. Hobart disclosed receiving fees, honoraria, and research support from Biogen, Acorda, Genzyme, Global Blood Therapeutics, Merck Serono, Novartis, Tigercat, and Vanita.

LONDON – Patients with relapsing-remitting multiple sclerosis reported that their ability to walk was significantly improved following 6 months of treatment with extended-release dalfampridine – compared with patients on placebo – in a double-blind, randomized trial.

In the ENHANCE study, 43.2% of the 315 patients treated with extended-release dalfampridine (dalfampridine-ER; Ampyra) and 33.6% of the 318 who were given placebo achieved a clinically meaningful improvement of 8 or more points on the 12-item MS Walking Scale (MSWS-12) measured at week 24.

The odds ratio (OR) was 1.61, highlighting a significant difference between the two study arms (P = .006).

“This is one of the only studies to use a PRO [patient-reported outcome] as the primary outcome and to use an a priori threshold of clinical meaningfulness,” said Jeremy Hobart, MD, of Plymouth Hospitals NHS Trust (England), who reported the study’s findings at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis. This is an important, and challenging, development in MS trials, he added.

“We are all aware that walking impairments are one of the hallmarks of multiple sclerosis,” Dr. Hobart said, adding that it affects the “vast majority” of patients.

Dalfampridine-ER, which is known as prolonged-release fampridine in Europe, is the only therapy licensed to improve walking in MS, he observed. The pivotal studies that led to the drug’s approval, however, were of relatively short duration and the ENHANCE study was conducted to answer questions that have been raised about the durability of its effect on patients’ mobility.

Patients in ENHANCE received either dalfampridine-ER at a twice-daily dose of 10 mg or placebo for 24 weeks. The mean age of patients in each group was 49 and 48 years, respectively, and 59% and 57% of recruited patients in each arm were female. Patients were stratified according to their baseline Expanded Disability Status Scale (EDSS) score, with 78% and 77% in the dalfampridine-ER and placebo groups having a score of 6 or less.

Dr. Hobart noted that the mean change in MSWS-12 scores over time and an analysis of the cumulative proportion of responders at any particular threshold score on the MWSW-12 showed a clear benefit of dalfampridine-ER treatment over placebo.

The study investigators also assessed patients’ balance via the Timed Up and Go (TUG) test, with a benefit threshold set at obtaining at least a 15% or more improvement at 24 weeks. Significantly more dalfampridine-ER–treated than placebo-treated patients achieved this threshold (43.4% vs. 34.7%; OR, 1.46; P = .03).

There was a significant improvement between the two study arms on the 29-item physical scale of the Multiple Sclerosis Impact Scale (P less than .001).

However, there was no change seen in upper extremity function, with similar mean changes in the Berg Balance Scale score and the ABILHAND score at 24 weeks. The mean baseline scores for both of these measures were high, Dr. Hobart observed, which probably affected the findings. That said, patients with a baseline EDSS of 6 or higher had greater improvement in ABILHAND scores if they had received dalfampridine-ER, compared with placebo, but the difference was not statistically significant.

The safety profile was consistent with what has been seen in other trials, Dr. Hobart said, and there were no new safety concerns raised.

“The findings from ENHANCE expand and tend to ... confirm the favorable risk-benefit profile established in prior pivotal trials,” he said.

Biogen sponsored the study. Dr. Hobart disclosed receiving fees, honoraria, and research support from Biogen, Acorda, Genzyme, Global Blood Therapeutics, Merck Serono, Novartis, Tigercat, and Vanita.

As compared with the general population, hospitalists are especially prone to stress and burnout, according to an abstract published in the Journal of Hospital Medicine.

The study’s scoring showed that hospitalists started with higher levels of perceived stress than the general population of adults of similar ages. Among hospitalists who attended an average of two mindfulness sessions over five weeks, there was a statistically significant increase in mindfulness and a decrease in perceived stress.

The low number of participants, seven hospitalists, makes extrapolation difficult, but the results are suggestive.

“Even with those seven people, we did see there was a significant difference in their stress and an increase in their mindfulness, which I thought was kind of impressive just for going to only two or three sessions,” says study co-author Dennis Chang, MD, of the Icahn School of Medicine at Mount Sinai. “I think the biggest thing that I would like to see is if it actually improves how we take care of our patients, not just ourselves.”

Dr. Chang says one factor that inspired the study was a hospital survey.

“We do an annual survey of our hospitalists, and it seemed that we had, as a lot of hospital groups do, a burnout problem: People were feeling a little bit burnt out,” Dr. Chang says. “We read some articles on mindfulness, and we thought it might be interesting to see if it would help our hospital.”

Starting this Fall, Mount Sinai will offer a tailored mindfulness session for providers.

“We’re hoping we’ll see if these results really stand up,” Dr. Chang says.

He encourages hospitalists to learn more about mindfulness and to realize that small changes can have an impact.

“Even doing some breathing exercises for a couple of minutes a day can actually make a big difference,” he says. “It doesn’t take a lot of time. Maybe even going to one mindfulness session can give you some tools that you can use. It can make a huge difference in your stress levels and how you take care of patients.”

Reference

1. Chablani S, Nguyen VT, Chang D. Mindfulness for hospitalists: a pilot study investigating the effect of a mindfulness initiative on mindfulness and perceived stress among hospitalists [abstract]. J Hosp Med. 2016;11(suppl 1). Accessed September 9, 2016.

As compared with the general population, hospitalists are especially prone to stress and burnout, according to an abstract published in the Journal of Hospital Medicine.

The study’s scoring showed that hospitalists started with higher levels of perceived stress than the general population of adults of similar ages. Among hospitalists who attended an average of two mindfulness sessions over five weeks, there was a statistically significant increase in mindfulness and a decrease in perceived stress.

The low number of participants, seven hospitalists, makes extrapolation difficult, but the results are suggestive.

“Even with those seven people, we did see there was a significant difference in their stress and an increase in their mindfulness, which I thought was kind of impressive just for going to only two or three sessions,” says study co-author Dennis Chang, MD, of the Icahn School of Medicine at Mount Sinai. “I think the biggest thing that I would like to see is if it actually improves how we take care of our patients, not just ourselves.”

Dr. Chang says one factor that inspired the study was a hospital survey.

“We do an annual survey of our hospitalists, and it seemed that we had, as a lot of hospital groups do, a burnout problem: People were feeling a little bit burnt out,” Dr. Chang says. “We read some articles on mindfulness, and we thought it might be interesting to see if it would help our hospital.”

Starting this Fall, Mount Sinai will offer a tailored mindfulness session for providers.

“We’re hoping we’ll see if these results really stand up,” Dr. Chang says.

He encourages hospitalists to learn more about mindfulness and to realize that small changes can have an impact.

“Even doing some breathing exercises for a couple of minutes a day can actually make a big difference,” he says. “It doesn’t take a lot of time. Maybe even going to one mindfulness session can give you some tools that you can use. It can make a huge difference in your stress levels and how you take care of patients.”

Reference

1. Chablani S, Nguyen VT, Chang D. Mindfulness for hospitalists: a pilot study investigating the effect of a mindfulness initiative on mindfulness and perceived stress among hospitalists [abstract]. J Hosp Med. 2016;11(suppl 1). Accessed September 9, 2016.

As compared with the general population, hospitalists are especially prone to stress and burnout, according to an abstract published in the Journal of Hospital Medicine.

The study’s scoring showed that hospitalists started with higher levels of perceived stress than the general population of adults of similar ages. Among hospitalists who attended an average of two mindfulness sessions over five weeks, there was a statistically significant increase in mindfulness and a decrease in perceived stress.

The low number of participants, seven hospitalists, makes extrapolation difficult, but the results are suggestive.

“Even with those seven people, we did see there was a significant difference in their stress and an increase in their mindfulness, which I thought was kind of impressive just for going to only two or three sessions,” says study co-author Dennis Chang, MD, of the Icahn School of Medicine at Mount Sinai. “I think the biggest thing that I would like to see is if it actually improves how we take care of our patients, not just ourselves.”

Dr. Chang says one factor that inspired the study was a hospital survey.

“We do an annual survey of our hospitalists, and it seemed that we had, as a lot of hospital groups do, a burnout problem: People were feeling a little bit burnt out,” Dr. Chang says. “We read some articles on mindfulness, and we thought it might be interesting to see if it would help our hospital.”

Starting this Fall, Mount Sinai will offer a tailored mindfulness session for providers.

“We’re hoping we’ll see if these results really stand up,” Dr. Chang says.

He encourages hospitalists to learn more about mindfulness and to realize that small changes can have an impact.

“Even doing some breathing exercises for a couple of minutes a day can actually make a big difference,” he says. “It doesn’t take a lot of time. Maybe even going to one mindfulness session can give you some tools that you can use. It can make a huge difference in your stress levels and how you take care of patients.”

Reference

1. Chablani S, Nguyen VT, Chang D. Mindfulness for hospitalists: a pilot study investigating the effect of a mindfulness initiative on mindfulness and perceived stress among hospitalists [abstract]. J Hosp Med. 2016;11(suppl 1). Accessed September 9, 2016.

NEW YORK (Reuters Health) - Sustained viral response (SVR) to hepatitis C virus (HCV) treatment is associated with a reduction in liver and non-liver complications in patients with compensated cirrhosis, researchers from France report.

"The achievement of HCV eradication strikingly decreases the risks of liver-related complications, a benefit that was up to now only suggested by retrospective studies," Dr. Pierre Nahon from Hôpital Jean Verdier in Bondy, France, told Reuters Health by email.

"These benefits extend beyond liver-related complications, in particular for cardiovascular disease and MACE (major adverse cardiovascular events) as well as bacterial infection," he said. "These positive effects are translated into survival benefits, whether considering liver-related or extra-hepatic mortality."

Dr. Nahon and colleagues from 35 clinical centers in France evaluated the impact of SVR in 1,671 patients, 1,323 of whom had HCV-related compensated cirrhosis.

After a median follow-up of 58.2 months, 59.5% of patients had a negative viral load, including 668 patients (51.7%) with SVR and 119 HCV-negative patients who were still undergoing antiviral treatment.

Male gender, absence of esophageal varices, and absence of diabetes were independent predictive factors for SVR, the researchers report in Gastroenterology, online the September 15.

SVR was associated with a significantly decreased risk of hepatocellular carcinoma (HCC; hazard ratio, 0.29) and mortality among patients who had HCC at baseline.

Patients who achieved SVR were also 74% less likely to develop liver decompensation during follow-up.

Extrahepatic events - including bacterial infections and cardiovascular events - were less than half as common among patients who achieved SVR than among others, but SVR had no apparent effect on the occurrence of extrahepatic malignancies.

SVR independently predicted a lower risk of hepatic and extrahepatic complications, a finding that was confirmed by a supporting propensity-matching analysis.

SVR was a protective factor for all-cause mortality (HR, 0.27; p<0.001), as well as a predictive factor for survival without liver-related or extrahepatic deaths.

"The present report, with the advantage of a longer follow-up and by studying virological clearance at endpoint as a time-dependent covariate after interferon- or direct-acting antivirals (DAA)-based regimen, now clearly shows that achieving SVR in HCV-infected cirrhotic patients leads to an improved prognosis," the researchers conclude.

"Overall, the present data are able to specifically highlight the independent influence of SVR on the incidence of liver complications, including HCC and mortality and interestingly a positive impact on the occurrence of extrahepatic manifestations," they add.

"However," the team notes, "the achievement of SVR in DAA-treated patients is too recent to draw any definite conclusion on this point, which will require a longer follow-up of the CirVir cohort to be adequately addressed."

"Although HCV eradication is achievable in almost all patients, physicians must be aware of the persisting risk of HCC occurrence in cirrhotic patients despite viral clearance, in particular in case of associated metabolic syndrome," Dr. Nahon cautioned. "These patients must be maintained in liver cancer surveillance programs."

The study did not have commercial funding. Several authors, including Dr. Nahon, reported financial ties to Gilead Sciences and other companies selling drugs for hepatitis C.

NEW YORK (Reuters Health) - Sustained viral response (SVR) to hepatitis C virus (HCV) treatment is associated with a reduction in liver and non-liver complications in patients with compensated cirrhosis, researchers from France report.

"The achievement of HCV eradication strikingly decreases the risks of liver-related complications, a benefit that was up to now only suggested by retrospective studies," Dr. Pierre Nahon from Hôpital Jean Verdier in Bondy, France, told Reuters Health by email.

"These benefits extend beyond liver-related complications, in particular for cardiovascular disease and MACE (major adverse cardiovascular events) as well as bacterial infection," he said. "These positive effects are translated into survival benefits, whether considering liver-related or extra-hepatic mortality."

Dr. Nahon and colleagues from 35 clinical centers in France evaluated the impact of SVR in 1,671 patients, 1,323 of whom had HCV-related compensated cirrhosis.

After a median follow-up of 58.2 months, 59.5% of patients had a negative viral load, including 668 patients (51.7%) with SVR and 119 HCV-negative patients who were still undergoing antiviral treatment.

Male gender, absence of esophageal varices, and absence of diabetes were independent predictive factors for SVR, the researchers report in Gastroenterology, online the September 15.

SVR was associated with a significantly decreased risk of hepatocellular carcinoma (HCC; hazard ratio, 0.29) and mortality among patients who had HCC at baseline.

Patients who achieved SVR were also 74% less likely to develop liver decompensation during follow-up.

Extrahepatic events - including bacterial infections and cardiovascular events - were less than half as common among patients who achieved SVR than among others, but SVR had no apparent effect on the occurrence of extrahepatic malignancies.

SVR independently predicted a lower risk of hepatic and extrahepatic complications, a finding that was confirmed by a supporting propensity-matching analysis.

SVR was a protective factor for all-cause mortality (HR, 0.27; p<0.001), as well as a predictive factor for survival without liver-related or extrahepatic deaths.

"The present report, with the advantage of a longer follow-up and by studying virological clearance at endpoint as a time-dependent covariate after interferon- or direct-acting antivirals (DAA)-based regimen, now clearly shows that achieving SVR in HCV-infected cirrhotic patients leads to an improved prognosis," the researchers conclude.

"Overall, the present data are able to specifically highlight the independent influence of SVR on the incidence of liver complications, including HCC and mortality and interestingly a positive impact on the occurrence of extrahepatic manifestations," they add.

"However," the team notes, "the achievement of SVR in DAA-treated patients is too recent to draw any definite conclusion on this point, which will require a longer follow-up of the CirVir cohort to be adequately addressed."

"Although HCV eradication is achievable in almost all patients, physicians must be aware of the persisting risk of HCC occurrence in cirrhotic patients despite viral clearance, in particular in case of associated metabolic syndrome," Dr. Nahon cautioned. "These patients must be maintained in liver cancer surveillance programs."

The study did not have commercial funding. Several authors, including Dr. Nahon, reported financial ties to Gilead Sciences and other companies selling drugs for hepatitis C.

NEW YORK (Reuters Health) - Sustained viral response (SVR) to hepatitis C virus (HCV) treatment is associated with a reduction in liver and non-liver complications in patients with compensated cirrhosis, researchers from France report.

"The achievement of HCV eradication strikingly decreases the risks of liver-related complications, a benefit that was up to now only suggested by retrospective studies," Dr. Pierre Nahon from Hôpital Jean Verdier in Bondy, France, told Reuters Health by email.

"These benefits extend beyond liver-related complications, in particular for cardiovascular disease and MACE (major adverse cardiovascular events) as well as bacterial infection," he said. "These positive effects are translated into survival benefits, whether considering liver-related or extra-hepatic mortality."

Dr. Nahon and colleagues from 35 clinical centers in France evaluated the impact of SVR in 1,671 patients, 1,323 of whom had HCV-related compensated cirrhosis.

After a median follow-up of 58.2 months, 59.5% of patients had a negative viral load, including 668 patients (51.7%) with SVR and 119 HCV-negative patients who were still undergoing antiviral treatment.

Male gender, absence of esophageal varices, and absence of diabetes were independent predictive factors for SVR, the researchers report in Gastroenterology, online the September 15.

SVR was associated with a significantly decreased risk of hepatocellular carcinoma (HCC; hazard ratio, 0.29) and mortality among patients who had HCC at baseline.

Patients who achieved SVR were also 74% less likely to develop liver decompensation during follow-up.

Extrahepatic events - including bacterial infections and cardiovascular events - were less than half as common among patients who achieved SVR than among others, but SVR had no apparent effect on the occurrence of extrahepatic malignancies.

SVR independently predicted a lower risk of hepatic and extrahepatic complications, a finding that was confirmed by a supporting propensity-matching analysis.

SVR was a protective factor for all-cause mortality (HR, 0.27; p<0.001), as well as a predictive factor for survival without liver-related or extrahepatic deaths.

"The present report, with the advantage of a longer follow-up and by studying virological clearance at endpoint as a time-dependent covariate after interferon- or direct-acting antivirals (DAA)-based regimen, now clearly shows that achieving SVR in HCV-infected cirrhotic patients leads to an improved prognosis," the researchers conclude.

"Overall, the present data are able to specifically highlight the independent influence of SVR on the incidence of liver complications, including HCC and mortality and interestingly a positive impact on the occurrence of extrahepatic manifestations," they add.

"However," the team notes, "the achievement of SVR in DAA-treated patients is too recent to draw any definite conclusion on this point, which will require a longer follow-up of the CirVir cohort to be adequately addressed."

"Although HCV eradication is achievable in almost all patients, physicians must be aware of the persisting risk of HCC occurrence in cirrhotic patients despite viral clearance, in particular in case of associated metabolic syndrome," Dr. Nahon cautioned. "These patients must be maintained in liver cancer surveillance programs."

The study did not have commercial funding. Several authors, including Dr. Nahon, reported financial ties to Gilead Sciences and other companies selling drugs for hepatitis C.

The American Society of Clinical Oncology (ASCO) is redefining its role in cancer care. In a pair of presentations made at the Association of VA Hematology/Oncology (AVAHO) annual meeting, ASCO President Daniel F. Hayes, MD, FASCO, FACP, and Robin Zon, MD, FACP, FASCO, who chairs  ASCO’s Pathways Task Force, each outlined key initiatives that promise to push the organization of more than 40,000 oncology care providers into new areas of research and care.

Rekated: Veteran Cancer Research Highlighted in ASCO Posters and Abstracts

Pathways

Responding to the burgeoning of clinical pathways for cancer care, ASCO stepped in to develop best practices and a better process for determining appropriate pathways. Concern over the lack of consensus on quality, efficiency, and transparency in developing pathways also spurred ASCO to action.

According to Dr. Zon, clinical pathways aims to improve efficient patient care based on evidence-based practices, optimize outcomes, and reduce variations and costs. “Pathways can promote high quality care,” Dr. Zon explained, “but they must be implemented responsibly. They are here to stay.”

The ASCO task force developed 9 recommendations for clinical pathways:

1. A collaborative, national approach is necessary to remove administrative burdens.
2. The process should be transparent and consistent, including its methodology.
3. Pathways should address the full spectrum of cancer care from diagnosis to end of life.  
4. Pathways should promote the best evidence based care and be updated continuously. 
5. Patient variability and autonomy should be recognized.
6. Pathways should increase efficiency and remove preauthorizations.
7. Education, research, and access to clinical trials should be encouraged.
8. A robust certification process is essential.
9. Pathways developers should support research that examines how pathways impact patients.

Although the pathways currently have a more significant impact in private care settings, it is likely that truly evidence-based pathways can provide an important tool for oncology providers in the federal system.

TAPUR

The Targeted Agent and Profiling Utilization Registry (TAPUR) study is one of ASCO’s first forays into clinical trials and seeks to evaluate multiple the efficacy of precision medicine. Targeted therapies “should be more likely to help the patient,” asks Dr. Hayes, “but do they?” The trial is evaluating multiple molecularly guided therapies in a single master protocol with a common entry point for patients. TAPUR will include commercially available targeted drugs, but in different cancer types, ie, off label. The trial is supported by a number of pharmaceutical companies. For the trial, each tumor type-genomic variant-drug is a group with 19 patients per group. If 3 or fewer patients respond the group is stopped, but if at least 4 patients have a good overall response rate, 14 additional patients will be enrolled, with the prospect of growing further.

Related: ASCO's Chemotherapy Administration Safety Standards

Dr. Hayes also highlighted other key ASCO initiatives. The group is developing a value framework, which will provide an objective means for both patients and providers to assess the relative value for a specific patient of an intended therapy. Different patients may wish to differently weigh endpoints (overall survival [OS], progression-free survival, or response rate). The framework scores a drug based on its clinical benefits, toxicity, and cost among other factors. ASCO also is developing Cancer-LinQ, a data collection and storage system for oncology practices that consolidates data from electronic health records in a central database that can be

aggregated for research.

The American Society of Clinical Oncology (ASCO) is redefining its role in cancer care. In a pair of presentations made at the Association of VA Hematology/Oncology (AVAHO) annual meeting, ASCO President Daniel F. Hayes, MD, FASCO, FACP, and Robin Zon, MD, FACP, FASCO, who chairs  ASCO’s Pathways Task Force, each outlined key initiatives that promise to push the organization of more than 40,000 oncology care providers into new areas of research and care.

Rekated: Veteran Cancer Research Highlighted in ASCO Posters and Abstracts

Pathways

Responding to the burgeoning of clinical pathways for cancer care, ASCO stepped in to develop best practices and a better process for determining appropriate pathways. Concern over the lack of consensus on quality, efficiency, and transparency in developing pathways also spurred ASCO to action.

According to Dr. Zon, clinical pathways aims to improve efficient patient care based on evidence-based practices, optimize outcomes, and reduce variations and costs. “Pathways can promote high quality care,” Dr. Zon explained, “but they must be implemented responsibly. They are here to stay.”

The ASCO task force developed 9 recommendations for clinical pathways:

1. A collaborative, national approach is necessary to remove administrative burdens.
2. The process should be transparent and consistent, including its methodology.
3. Pathways should address the full spectrum of cancer care from diagnosis to end of life.  
4. Pathways should promote the best evidence based care and be updated continuously. 
5. Patient variability and autonomy should be recognized.
6. Pathways should increase efficiency and remove preauthorizations.
7. Education, research, and access to clinical trials should be encouraged.
8. A robust certification process is essential.
9. Pathways developers should support research that examines how pathways impact patients.

Although the pathways currently have a more significant impact in private care settings, it is likely that truly evidence-based pathways can provide an important tool for oncology providers in the federal system.

TAPUR

The Targeted Agent and Profiling Utilization Registry (TAPUR) study is one of ASCO’s first forays into clinical trials and seeks to evaluate multiple the efficacy of precision medicine. Targeted therapies “should be more likely to help the patient,” asks Dr. Hayes, “but do they?” The trial is evaluating multiple molecularly guided therapies in a single master protocol with a common entry point for patients. TAPUR will include commercially available targeted drugs, but in different cancer types, ie, off label. The trial is supported by a number of pharmaceutical companies. For the trial, each tumor type-genomic variant-drug is a group with 19 patients per group. If 3 or fewer patients respond the group is stopped, but if at least 4 patients have a good overall response rate, 14 additional patients will be enrolled, with the prospect of growing further.

Related: ASCO's Chemotherapy Administration Safety Standards

Dr. Hayes also highlighted other key ASCO initiatives. The group is developing a value framework, which will provide an objective means for both patients and providers to assess the relative value for a specific patient of an intended therapy. Different patients may wish to differently weigh endpoints (overall survival [OS], progression-free survival, or response rate). The framework scores a drug based on its clinical benefits, toxicity, and cost among other factors. ASCO also is developing Cancer-LinQ, a data collection and storage system for oncology practices that consolidates data from electronic health records in a central database that can be

aggregated for research.

The American Society of Clinical Oncology (ASCO) is redefining its role in cancer care. In a pair of presentations made at the Association of VA Hematology/Oncology (AVAHO) annual meeting, ASCO President Daniel F. Hayes, MD, FASCO, FACP, and Robin Zon, MD, FACP, FASCO, who chairs  ASCO’s Pathways Task Force, each outlined key initiatives that promise to push the organization of more than 40,000 oncology care providers into new areas of research and care.

Rekated: Veteran Cancer Research Highlighted in ASCO Posters and Abstracts

Pathways

Responding to the burgeoning of clinical pathways for cancer care, ASCO stepped in to develop best practices and a better process for determining appropriate pathways. Concern over the lack of consensus on quality, efficiency, and transparency in developing pathways also spurred ASCO to action.

According to Dr. Zon, clinical pathways aims to improve efficient patient care based on evidence-based practices, optimize outcomes, and reduce variations and costs. “Pathways can promote high quality care,” Dr. Zon explained, “but they must be implemented responsibly. They are here to stay.”

The ASCO task force developed 9 recommendations for clinical pathways:

1. A collaborative, national approach is necessary to remove administrative burdens.
2. The process should be transparent and consistent, including its methodology.
3. Pathways should address the full spectrum of cancer care from diagnosis to end of life.  
4. Pathways should promote the best evidence based care and be updated continuously. 
5. Patient variability and autonomy should be recognized.
6. Pathways should increase efficiency and remove preauthorizations.
7. Education, research, and access to clinical trials should be encouraged.
8. A robust certification process is essential.
9. Pathways developers should support research that examines how pathways impact patients.

Although the pathways currently have a more significant impact in private care settings, it is likely that truly evidence-based pathways can provide an important tool for oncology providers in the federal system.

TAPUR

The Targeted Agent and Profiling Utilization Registry (TAPUR) study is one of ASCO’s first forays into clinical trials and seeks to evaluate multiple the efficacy of precision medicine. Targeted therapies “should be more likely to help the patient,” asks Dr. Hayes, “but do they?” The trial is evaluating multiple molecularly guided therapies in a single master protocol with a common entry point for patients. TAPUR will include commercially available targeted drugs, but in different cancer types, ie, off label. The trial is supported by a number of pharmaceutical companies. For the trial, each tumor type-genomic variant-drug is a group with 19 patients per group. If 3 or fewer patients respond the group is stopped, but if at least 4 patients have a good overall response rate, 14 additional patients will be enrolled, with the prospect of growing further.

Related: ASCO's Chemotherapy Administration Safety Standards

Dr. Hayes also highlighted other key ASCO initiatives. The group is developing a value framework, which will provide an objective means for both patients and providers to assess the relative value for a specific patient of an intended therapy. Different patients may wish to differently weigh endpoints (overall survival [OS], progression-free survival, or response rate). The framework scores a drug based on its clinical benefits, toxicity, and cost among other factors. ASCO also is developing Cancer-LinQ, a data collection and storage system for oncology practices that consolidates data from electronic health records in a central database that can be

aggregated for research.

Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery and the field of cardiothoracic surgery.

April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA

A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.

AATS President & Annual Meeting Chair
Thoralf M. Sundt, III

AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers

AmSECT President
Kenneth Shann

AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi

More Information

Saturday Courses 

Adult Cardiac Skills Chairs
Volkmar Falk, David Fitzgerald, Kenton Zehr

Congenital Skills Chairs
Ron Angona, David Bichell, Bohdan Maruszewski

General Thoracic Skills Chairs
Virginia Litle, Kazuhiro Yasufuku

Cardiothoracic Transplant and Mechanical Circulatory Support of Heart and Lung Failure Chairs
Matthew Bacchetta, Carmelo Milano, Rich Walczak

Surgical Ethics Forum Chairs
Bill DeBois, Martin McKneally, Robert Sade

Sunday Symposia

AATS/STS Adult Cardiac Surgery Symposium  Chairs
David Fitzgerald, Hitoshi Ognio, Vinod Thourani 

AATS/STS Congenital Heart Disease Symposium Chairs
Ron Angona, Michael Mitchell, Giovanni Stellin 

AATS/STS General Thoracic Surgery Symposium Chairs
 Seth Force, Moishe Liberman

Interprofessional Cardiothoracic Team Symposium Chairs
Steven Gottesfeld, Katherine Hoercher, Bruce Searles, Glenn Whitman

Saturday Course/Sunday Symposia Program

Share:

Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery and the field of cardiothoracic surgery.

April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA

A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.

AATS President & Annual Meeting Chair
Thoralf M. Sundt, III

AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers

AmSECT President
Kenneth Shann

AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi

More Information

Saturday Courses 

Adult Cardiac Skills Chairs
Volkmar Falk, David Fitzgerald, Kenton Zehr

Congenital Skills Chairs
Ron Angona, David Bichell, Bohdan Maruszewski

General Thoracic Skills Chairs
Virginia Litle, Kazuhiro Yasufuku

Cardiothoracic Transplant and Mechanical Circulatory Support of Heart and Lung Failure Chairs
Matthew Bacchetta, Carmelo Milano, Rich Walczak

Surgical Ethics Forum Chairs
Bill DeBois, Martin McKneally, Robert Sade

Sunday Symposia

AATS/STS Adult Cardiac Surgery Symposium  Chairs
David Fitzgerald, Hitoshi Ognio, Vinod Thourani 

AATS/STS Congenital Heart Disease Symposium Chairs
Ron Angona, Michael Mitchell, Giovanni Stellin 

AATS/STS General Thoracic Surgery Symposium Chairs
 Seth Force, Moishe Liberman

Interprofessional Cardiothoracic Team Symposium Chairs
Steven Gottesfeld, Katherine Hoercher, Bruce Searles, Glenn Whitman

Saturday Course/Sunday Symposia Program

Share:

Help us celebrate the AATS Centennial. Experience activities, events, historical artifacts and memorabilia commemorating the 100th anniversary of the American Association for Thoracic Surgery and the field of cardiothoracic surgery.

April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA

A unique aspect of this year’s meeting is our collaboration with the American Society of Extracorporeal Technology (AmSECT). During the didactic portion of the program, the two organizations will be conducting joint panel sessions of interest to all members of the team.

AATS President & Annual Meeting Chair
Thoralf M. Sundt, III

AATS Annual Meeting Co-Chairs
Robert D. Jaquiss & Bryan F. Meyers

AmSECT President
Kenneth Shann

AmSECT International Conference Co-Chairs
Emily Saulitis & Larissa M.V. Teresi

More Information

Saturday Courses 

Adult Cardiac Skills Chairs
Volkmar Falk, David Fitzgerald, Kenton Zehr

Congenital Skills Chairs
Ron Angona, David Bichell, Bohdan Maruszewski

General Thoracic Skills Chairs
Virginia Litle, Kazuhiro Yasufuku

Cardiothoracic Transplant and Mechanical Circulatory Support of Heart and Lung Failure Chairs
Matthew Bacchetta, Carmelo Milano, Rich Walczak

Surgical Ethics Forum Chairs
Bill DeBois, Martin McKneally, Robert Sade

Sunday Symposia

AATS/STS Adult Cardiac Surgery Symposium  Chairs
David Fitzgerald, Hitoshi Ognio, Vinod Thourani 

AATS/STS Congenital Heart Disease Symposium Chairs
Ron Angona, Michael Mitchell, Giovanni Stellin 

AATS/STS General Thoracic Surgery Symposium Chairs
 Seth Force, Moishe Liberman

Interprofessional Cardiothoracic Team Symposium Chairs
Steven Gottesfeld, Katherine Hoercher, Bruce Searles, Glenn Whitman

Saturday Course/Sunday Symposia Program

Share:

As more and more patients with cancer become cancer survivors, the treatment landscape is changing. Increasingly, primary care providers bear much of the burden of care, but the lack of care coordination and clinical guidelines hamper efforts to care for the growing number of survivors. A number of speakers at the recent Association of VA Hematology/Oncology (AVAHO) sought to address these challenges and report on approaches to improving the quality of care for survivors.

Related: Putting the Focus on Quality of Life in Cancer Care

The VA Survivorship Interest Group (SIG) is trying to raise awareness and facilitate the delivery of high-quality survivorship care to veterans diagnosed with cancer, according to David A. Haggstrom, MD, MAS, of the Indianapolis VA Medical Center and Indiana University School of Medicine. Through monthly meetings, SIG is  encouraging new research and promoting initiatives to develop survivorship related products and appropriate models of care delivery.

A Survivorship care plan that includes a treatment summary, and follow-up plan for a patient who has completed cancer treatment is one approach to improve care for cancer survivors. According to Haggstrom, the VA appears to be on track to meet the Commission on Care’s recommendation that ≥ 25% of eligible patients receive a survivorship care plan by the end of 2016, but more work needs to be done to get to the 2017 goal of ≥ 50%.

Related: Defining Quality Cancer Survivorship Care: Symptom Burden and Distress in Veteran Cancer Survivors. VA Puget Sound Cancer Survivorship Clinic

For example, the more than 2 million prostate cancer survivors have a number of complex problems that pose challenges to VA care providers, according to Ted A. Skolarus, MD, MPH, of the University of Michigan and VA Ann Arbor Healthcare System. Poor urinary control and sexual function can have a significant impact on quality of life for survivors. Furthermore, the lack of organized symptom assessment, clinical guidelines, and other support for patients and providers remains a challenge for providing high-quality care. Much of that burden is born by primary care providers, who are frequently uncomfortable addressing incontinence, impotence, and other psychosocial issues that are common among prostate cancer survivors.

Dr. Skolarus discussed an ongoing randomized self-management trial of veteran prostate cancer survivors, which tested self-management. Patients were assessed using an interactive voice response tool to administer a quality of life survey based on the Expanded Prostate Cancer Index Composite (EPIC), which measures urinary, sexual, bowel, and hormonal/vitality health. Patients are then provided with self-management tools that are specifically developed based on their EPIC responses. The trial is expected to close at the end of 2016.

Related: Cancer Survivorship Care

Sharon L. Bober, PhD, director of the Sexual Health Program at Dana-Farber Cancer Institute, delved in greater detail into the impact of sexual health on quality of life among cancer survivors. The majority of survivors are not prepared to deal with changes in sexual health, Dr. Bober reported, and “more than 50% have profound long lasting dysfunction.” Estimates of sexual dysfunction after cancer range from 40% to 100%, and while the issues for patients with breast or prostate cancer are more obvious, the sexual health problems are not limited to those types of cancer. Moreover, Dr. Bober argued, sexual health involves both physical and psychological aspects and proper treatment should address both.

As more and more patients with cancer become cancer survivors, the treatment landscape is changing. Increasingly, primary care providers bear much of the burden of care, but the lack of care coordination and clinical guidelines hamper efforts to care for the growing number of survivors. A number of speakers at the recent Association of VA Hematology/Oncology (AVAHO) sought to address these challenges and report on approaches to improving the quality of care for survivors.

Related: Putting the Focus on Quality of Life in Cancer Care

The VA Survivorship Interest Group (SIG) is trying to raise awareness and facilitate the delivery of high-quality survivorship care to veterans diagnosed with cancer, according to David A. Haggstrom, MD, MAS, of the Indianapolis VA Medical Center and Indiana University School of Medicine. Through monthly meetings, SIG is  encouraging new research and promoting initiatives to develop survivorship related products and appropriate models of care delivery.

A Survivorship care plan that includes a treatment summary, and follow-up plan for a patient who has completed cancer treatment is one approach to improve care for cancer survivors. According to Haggstrom, the VA appears to be on track to meet the Commission on Care’s recommendation that ≥ 25% of eligible patients receive a survivorship care plan by the end of 2016, but more work needs to be done to get to the 2017 goal of ≥ 50%.

Related: Defining Quality Cancer Survivorship Care: Symptom Burden and Distress in Veteran Cancer Survivors. VA Puget Sound Cancer Survivorship Clinic

For example, the more than 2 million prostate cancer survivors have a number of complex problems that pose challenges to VA care providers, according to Ted A. Skolarus, MD, MPH, of the University of Michigan and VA Ann Arbor Healthcare System. Poor urinary control and sexual function can have a significant impact on quality of life for survivors. Furthermore, the lack of organized symptom assessment, clinical guidelines, and other support for patients and providers remains a challenge for providing high-quality care. Much of that burden is born by primary care providers, who are frequently uncomfortable addressing incontinence, impotence, and other psychosocial issues that are common among prostate cancer survivors.

Dr. Skolarus discussed an ongoing randomized self-management trial of veteran prostate cancer survivors, which tested self-management. Patients were assessed using an interactive voice response tool to administer a quality of life survey based on the Expanded Prostate Cancer Index Composite (EPIC), which measures urinary, sexual, bowel, and hormonal/vitality health. Patients are then provided with self-management tools that are specifically developed based on their EPIC responses. The trial is expected to close at the end of 2016.

Related: Cancer Survivorship Care

Sharon L. Bober, PhD, director of the Sexual Health Program at Dana-Farber Cancer Institute, delved in greater detail into the impact of sexual health on quality of life among cancer survivors. The majority of survivors are not prepared to deal with changes in sexual health, Dr. Bober reported, and “more than 50% have profound long lasting dysfunction.” Estimates of sexual dysfunction after cancer range from 40% to 100%, and while the issues for patients with breast or prostate cancer are more obvious, the sexual health problems are not limited to those types of cancer. Moreover, Dr. Bober argued, sexual health involves both physical and psychological aspects and proper treatment should address both.

As more and more patients with cancer become cancer survivors, the treatment landscape is changing. Increasingly, primary care providers bear much of the burden of care, but the lack of care coordination and clinical guidelines hamper efforts to care for the growing number of survivors. A number of speakers at the recent Association of VA Hematology/Oncology (AVAHO) sought to address these challenges and report on approaches to improving the quality of care for survivors.

Related: Putting the Focus on Quality of Life in Cancer Care

The VA Survivorship Interest Group (SIG) is trying to raise awareness and facilitate the delivery of high-quality survivorship care to veterans diagnosed with cancer, according to David A. Haggstrom, MD, MAS, of the Indianapolis VA Medical Center and Indiana University School of Medicine. Through monthly meetings, SIG is  encouraging new research and promoting initiatives to develop survivorship related products and appropriate models of care delivery.

A Survivorship care plan that includes a treatment summary, and follow-up plan for a patient who has completed cancer treatment is one approach to improve care for cancer survivors. According to Haggstrom, the VA appears to be on track to meet the Commission on Care’s recommendation that ≥ 25% of eligible patients receive a survivorship care plan by the end of 2016, but more work needs to be done to get to the 2017 goal of ≥ 50%.

Related: Defining Quality Cancer Survivorship Care: Symptom Burden and Distress in Veteran Cancer Survivors. VA Puget Sound Cancer Survivorship Clinic

For example, the more than 2 million prostate cancer survivors have a number of complex problems that pose challenges to VA care providers, according to Ted A. Skolarus, MD, MPH, of the University of Michigan and VA Ann Arbor Healthcare System. Poor urinary control and sexual function can have a significant impact on quality of life for survivors. Furthermore, the lack of organized symptom assessment, clinical guidelines, and other support for patients and providers remains a challenge for providing high-quality care. Much of that burden is born by primary care providers, who are frequently uncomfortable addressing incontinence, impotence, and other psychosocial issues that are common among prostate cancer survivors.

Dr. Skolarus discussed an ongoing randomized self-management trial of veteran prostate cancer survivors, which tested self-management. Patients were assessed using an interactive voice response tool to administer a quality of life survey based on the Expanded Prostate Cancer Index Composite (EPIC), which measures urinary, sexual, bowel, and hormonal/vitality health. Patients are then provided with self-management tools that are specifically developed based on their EPIC responses. The trial is expected to close at the end of 2016.

Related: Cancer Survivorship Care

Sharon L. Bober, PhD, director of the Sexual Health Program at Dana-Farber Cancer Institute, delved in greater detail into the impact of sexual health on quality of life among cancer survivors. The majority of survivors are not prepared to deal with changes in sexual health, Dr. Bober reported, and “more than 50% have profound long lasting dysfunction.” Estimates of sexual dysfunction after cancer range from 40% to 100%, and while the issues for patients with breast or prostate cancer are more obvious, the sexual health problems are not limited to those types of cancer. Moreover, Dr. Bober argued, sexual health involves both physical and psychological aspects and proper treatment should address both.

Man using a computer

The Lymphoma Association has launched Lymphoma TrialsLink, an online information service that can help lymphoma patients in the UK find clinical trials that might be right for them.

Lymphoma TrialsLink pulls information from different clinical trials databases and puts it in one place.

Lymphoma TrialsLink also provides information about different types of clinical trials and interviews with clinicians and patients who have participated in trials.

The service is available via the Lymphoma Association website: www.lymphomas.org.uk/TrialsLink.

At Lymphoma TrialsLink, patients can search by their type of lymphoma and geographical location to find easy-to-understand information about trials.

At present, treatment trials (phases 1/2 and 2/3), non-drug and non-treatment trials, and cross-tumoral trials that are currently recruiting participants in the UK are available on the Lymphoma TrialsLink website. Information on phase 1, phase 4, and invitation-only trials will be introduced in 2017.

Trial information, which is searchable by type of lymphoma and location, is sourced from a number of databases, including Cancer Research UK trials, UK clinical trials gateway, clinicaltrials.gov, and the NCRI Lymphoma Clinical Studies Group.

The data is verified by the coordinating trial center to ensure that closing dates and trial centers are up-to-date. The content on Lymphoma TrialsLink will be updated monthly.

“Clinical trials are essential for investigating drugs for the treatment of lymphatic cancer and improving survivorship rates,” said Jonathan Pearce, Lymphoma Association chief executive.

“Clinical trials aren’t right for everyone, but we want people to feel empowered to make an informed decision. Lymphoma TrialsLink will mean that lymphoma patients who aren’t currently aware of clinical trials will have the opportunity to find out more about relevant trials and make the best possible decisions about their healthcare.”

A recent Lymphoma Association survey of more than 3000 lymphoma patients* revealed that 78% were not given the option of participating in a clinical trial. Of those who were, the majority joined a trial.

“Lymphoma is the UK’s fifth most common cancer, yet it is neither well-known nor easily understood,” Pearce noted. “We are committed to supporting clinical research to help improve knowledge of lymphoma, to drive advances in treatments, and to deliver better outcomes for people affected by lymphoma.”

Lymphoma TrialsLink is funded by voluntary donations from Lymphoma Association supporters who responded to a fundraising appeal earlier this year.

*A quality health survey commissioned in 2016 by the Lymphoma Association. The full results of the survey are expected to be published soon.

Man using a computer

The Lymphoma Association has launched Lymphoma TrialsLink, an online information service that can help lymphoma patients in the UK find clinical trials that might be right for them.

Lymphoma TrialsLink pulls information from different clinical trials databases and puts it in one place.

Lymphoma TrialsLink also provides information about different types of clinical trials and interviews with clinicians and patients who have participated in trials.

The service is available via the Lymphoma Association website: www.lymphomas.org.uk/TrialsLink.

At Lymphoma TrialsLink, patients can search by their type of lymphoma and geographical location to find easy-to-understand information about trials.

At present, treatment trials (phases 1/2 and 2/3), non-drug and non-treatment trials, and cross-tumoral trials that are currently recruiting participants in the UK are available on the Lymphoma TrialsLink website. Information on phase 1, phase 4, and invitation-only trials will be introduced in 2017.

Trial information, which is searchable by type of lymphoma and location, is sourced from a number of databases, including Cancer Research UK trials, UK clinical trials gateway, clinicaltrials.gov, and the NCRI Lymphoma Clinical Studies Group.

The data is verified by the coordinating trial center to ensure that closing dates and trial centers are up-to-date. The content on Lymphoma TrialsLink will be updated monthly.

“Clinical trials are essential for investigating drugs for the treatment of lymphatic cancer and improving survivorship rates,” said Jonathan Pearce, Lymphoma Association chief executive.

“Clinical trials aren’t right for everyone, but we want people to feel empowered to make an informed decision. Lymphoma TrialsLink will mean that lymphoma patients who aren’t currently aware of clinical trials will have the opportunity to find out more about relevant trials and make the best possible decisions about their healthcare.”

A recent Lymphoma Association survey of more than 3000 lymphoma patients* revealed that 78% were not given the option of participating in a clinical trial. Of those who were, the majority joined a trial.

“Lymphoma is the UK’s fifth most common cancer, yet it is neither well-known nor easily understood,” Pearce noted. “We are committed to supporting clinical research to help improve knowledge of lymphoma, to drive advances in treatments, and to deliver better outcomes for people affected by lymphoma.”

Lymphoma TrialsLink is funded by voluntary donations from Lymphoma Association supporters who responded to a fundraising appeal earlier this year.

*A quality health survey commissioned in 2016 by the Lymphoma Association. The full results of the survey are expected to be published soon.

Man using a computer

The Lymphoma Association has launched Lymphoma TrialsLink, an online information service that can help lymphoma patients in the UK find clinical trials that might be right for them.

Lymphoma TrialsLink pulls information from different clinical trials databases and puts it in one place.

Lymphoma TrialsLink also provides information about different types of clinical trials and interviews with clinicians and patients who have participated in trials.

The service is available via the Lymphoma Association website: www.lymphomas.org.uk/TrialsLink.

At Lymphoma TrialsLink, patients can search by their type of lymphoma and geographical location to find easy-to-understand information about trials.

At present, treatment trials (phases 1/2 and 2/3), non-drug and non-treatment trials, and cross-tumoral trials that are currently recruiting participants in the UK are available on the Lymphoma TrialsLink website. Information on phase 1, phase 4, and invitation-only trials will be introduced in 2017.

Trial information, which is searchable by type of lymphoma and location, is sourced from a number of databases, including Cancer Research UK trials, UK clinical trials gateway, clinicaltrials.gov, and the NCRI Lymphoma Clinical Studies Group.

The data is verified by the coordinating trial center to ensure that closing dates and trial centers are up-to-date. The content on Lymphoma TrialsLink will be updated monthly.

“Clinical trials are essential for investigating drugs for the treatment of lymphatic cancer and improving survivorship rates,” said Jonathan Pearce, Lymphoma Association chief executive.

“Clinical trials aren’t right for everyone, but we want people to feel empowered to make an informed decision. Lymphoma TrialsLink will mean that lymphoma patients who aren’t currently aware of clinical trials will have the opportunity to find out more about relevant trials and make the best possible decisions about their healthcare.”

A recent Lymphoma Association survey of more than 3000 lymphoma patients* revealed that 78% were not given the option of participating in a clinical trial. Of those who were, the majority joined a trial.

“Lymphoma is the UK’s fifth most common cancer, yet it is neither well-known nor easily understood,” Pearce noted. “We are committed to supporting clinical research to help improve knowledge of lymphoma, to drive advances in treatments, and to deliver better outcomes for people affected by lymphoma.”

Lymphoma TrialsLink is funded by voluntary donations from Lymphoma Association supporters who responded to a fundraising appeal earlier this year.

*A quality health survey commissioned in 2016 by the Lymphoma Association. The full results of the survey are expected to be published soon.

Elena Fidarova, MD

Photo courtesy of ASTRO

BOSTON—A new study suggests that roughly half of cancer patients in developing countries need radiation therapy (RT) to treat their disease, but many of these patients do not have access to it.

Examining 9 developing countries, investigators found that between 18% and 82% of patients who can benefit from RT do not receive the treatment.

These findings were presented at ASTRO’s 58th Annual Meeting (abstract 82).

“Access to radiation therapy remains limited in low-and middle-income countries,” said study investigator Elena Fidarova, MD, of the International Atomic Energy Agency in Vienna, Austria.

“In Ghana and the Philippines, for example, about 8 in 10 cancer patients who need radiation therapy will not receive needed treatment.”

Dr Fidarova and her colleagues conducted this study to assess levels of optimal and actual RT utilization (RTU) and calculate unmet RT need in 9 developing countries—Costa Rica, Ghana, Malaysia, the Philippines, Romania, Serbia, Slovenia, Tunisia, and Uruguay.

The investigators determined the optimal and actual RTU rates for each country. The optimal RTU rate is the proportion of all newly diagnosed cancer patients who have an indication for RT at least once in their lifetime.

An indication for RT was defined as a clinical scenario for which RT is recommended as the treatment of choice because there is evidence of its superiority to alternative modalities and/or no treatment (eg, better survival, local control, or quality of life profiles).

In clinical situations where RT was equivalent to other treatment options, all comparable modalities were included in the model, and a subsequent sensitivity analysis was conducted to determine the proportion of these patients for whom RT was indicated.

Results

The median optimal RTU for all countries was 52%. Optimal RTU rates ranged from a low of 47% for Costa Rica to a high of 56% for Tunisia. Differences in optimal RTU rates are attributable to varying incidence rates of cancer types in each country.

The median actual RTU rate was roughly half of optimal utilization, suggesting that nearly half of cancer patients across these 9 countries combined may not be receiving adequate care for their disease.

The median actual RTU rate was 28%. The lowest rates of utilization were in Ghana (9%) and the Philippines (10.3%), while the highest utilization rates were in Tunisia (46%) and Uruguay (37%).

Actual RTU rates were lower than optimal RTU rates for all 9 countries, with the smallest difference in Tunisia and the widest gap in Ghana—at nearly 43 percentage points.

The median level of unmet need was 47% for all countries combined.

Ghana and the Philippines had the highest levels of unmet need, at 82.3% and 80.5%, respectively. Costa Rica and Tunisia had the lowest levels of unmet need, at 25.5% and 18%, respectively.

The unmet need was especially high in countries with limited resources and a large population. The number of teletherapy machines per 1000 cancer cases ranged from a high of 1.3 in Tunisia to a low of 0.19 in Ghana.

The strong correlation between the actual RTU rates and the number of teletherapy machines per 1000 cancer cases/year in each country confirms that, although other access factors may be at play, the availability of RT machines is an important factor in RT utilization.

“Differences between optimal and actual RTU rates and the high percentage of unmet RT need likely stem from a number of complex reasons, although inadequate capacity for radiation therapy is the most obvious factor,” Dr Fidarova said.

“As obstacles in access to existing RT services—such as inadequate referral patterns, affordability of treatment, and geographical distribution of centers—differ by country, so does the ideal mix of solutions.”

Elena Fidarova, MD

Photo courtesy of ASTRO

BOSTON—A new study suggests that roughly half of cancer patients in developing countries need radiation therapy (RT) to treat their disease, but many of these patients do not have access to it.

Examining 9 developing countries, investigators found that between 18% and 82% of patients who can benefit from RT do not receive the treatment.

These findings were presented at ASTRO’s 58th Annual Meeting (abstract 82).

“Access to radiation therapy remains limited in low-and middle-income countries,” said study investigator Elena Fidarova, MD, of the International Atomic Energy Agency in Vienna, Austria.

“In Ghana and the Philippines, for example, about 8 in 10 cancer patients who need radiation therapy will not receive needed treatment.”

Dr Fidarova and her colleagues conducted this study to assess levels of optimal and actual RT utilization (RTU) and calculate unmet RT need in 9 developing countries—Costa Rica, Ghana, Malaysia, the Philippines, Romania, Serbia, Slovenia, Tunisia, and Uruguay.

The investigators determined the optimal and actual RTU rates for each country. The optimal RTU rate is the proportion of all newly diagnosed cancer patients who have an indication for RT at least once in their lifetime.

An indication for RT was defined as a clinical scenario for which RT is recommended as the treatment of choice because there is evidence of its superiority to alternative modalities and/or no treatment (eg, better survival, local control, or quality of life profiles).

In clinical situations where RT was equivalent to other treatment options, all comparable modalities were included in the model, and a subsequent sensitivity analysis was conducted to determine the proportion of these patients for whom RT was indicated.

Results

The median optimal RTU for all countries was 52%. Optimal RTU rates ranged from a low of 47% for Costa Rica to a high of 56% for Tunisia. Differences in optimal RTU rates are attributable to varying incidence rates of cancer types in each country.

The median actual RTU rate was roughly half of optimal utilization, suggesting that nearly half of cancer patients across these 9 countries combined may not be receiving adequate care for their disease.

The median actual RTU rate was 28%. The lowest rates of utilization were in Ghana (9%) and the Philippines (10.3%), while the highest utilization rates were in Tunisia (46%) and Uruguay (37%).

Actual RTU rates were lower than optimal RTU rates for all 9 countries, with the smallest difference in Tunisia and the widest gap in Ghana—at nearly 43 percentage points.

The median level of unmet need was 47% for all countries combined.

Ghana and the Philippines had the highest levels of unmet need, at 82.3% and 80.5%, respectively. Costa Rica and Tunisia had the lowest levels of unmet need, at 25.5% and 18%, respectively.

The unmet need was especially high in countries with limited resources and a large population. The number of teletherapy machines per 1000 cancer cases ranged from a high of 1.3 in Tunisia to a low of 0.19 in Ghana.

The strong correlation between the actual RTU rates and the number of teletherapy machines per 1000 cancer cases/year in each country confirms that, although other access factors may be at play, the availability of RT machines is an important factor in RT utilization.

“Differences between optimal and actual RTU rates and the high percentage of unmet RT need likely stem from a number of complex reasons, although inadequate capacity for radiation therapy is the most obvious factor,” Dr Fidarova said.

“As obstacles in access to existing RT services—such as inadequate referral patterns, affordability of treatment, and geographical distribution of centers—differ by country, so does the ideal mix of solutions.”

Elena Fidarova, MD

Photo courtesy of ASTRO

BOSTON—A new study suggests that roughly half of cancer patients in developing countries need radiation therapy (RT) to treat their disease, but many of these patients do not have access to it.

Examining 9 developing countries, investigators found that between 18% and 82% of patients who can benefit from RT do not receive the treatment.

These findings were presented at ASTRO’s 58th Annual Meeting (abstract 82).

“Access to radiation therapy remains limited in low-and middle-income countries,” said study investigator Elena Fidarova, MD, of the International Atomic Energy Agency in Vienna, Austria.

“In Ghana and the Philippines, for example, about 8 in 10 cancer patients who need radiation therapy will not receive needed treatment.”

Dr Fidarova and her colleagues conducted this study to assess levels of optimal and actual RT utilization (RTU) and calculate unmet RT need in 9 developing countries—Costa Rica, Ghana, Malaysia, the Philippines, Romania, Serbia, Slovenia, Tunisia, and Uruguay.

The investigators determined the optimal and actual RTU rates for each country. The optimal RTU rate is the proportion of all newly diagnosed cancer patients who have an indication for RT at least once in their lifetime.

An indication for RT was defined as a clinical scenario for which RT is recommended as the treatment of choice because there is evidence of its superiority to alternative modalities and/or no treatment (eg, better survival, local control, or quality of life profiles).

In clinical situations where RT was equivalent to other treatment options, all comparable modalities were included in the model, and a subsequent sensitivity analysis was conducted to determine the proportion of these patients for whom RT was indicated.

Results

The median optimal RTU for all countries was 52%. Optimal RTU rates ranged from a low of 47% for Costa Rica to a high of 56% for Tunisia. Differences in optimal RTU rates are attributable to varying incidence rates of cancer types in each country.

The median actual RTU rate was roughly half of optimal utilization, suggesting that nearly half of cancer patients across these 9 countries combined may not be receiving adequate care for their disease.

The median actual RTU rate was 28%. The lowest rates of utilization were in Ghana (9%) and the Philippines (10.3%), while the highest utilization rates were in Tunisia (46%) and Uruguay (37%).

Actual RTU rates were lower than optimal RTU rates for all 9 countries, with the smallest difference in Tunisia and the widest gap in Ghana—at nearly 43 percentage points.

The median level of unmet need was 47% for all countries combined.

Ghana and the Philippines had the highest levels of unmet need, at 82.3% and 80.5%, respectively. Costa Rica and Tunisia had the lowest levels of unmet need, at 25.5% and 18%, respectively.

The unmet need was especially high in countries with limited resources and a large population. The number of teletherapy machines per 1000 cancer cases ranged from a high of 1.3 in Tunisia to a low of 0.19 in Ghana.

The strong correlation between the actual RTU rates and the number of teletherapy machines per 1000 cancer cases/year in each country confirms that, although other access factors may be at play, the availability of RT machines is an important factor in RT utilization.

“Differences between optimal and actual RTU rates and the high percentage of unmet RT need likely stem from a number of complex reasons, although inadequate capacity for radiation therapy is the most obvious factor,” Dr Fidarova said.

“As obstacles in access to existing RT services—such as inadequate referral patterns, affordability of treatment, and geographical distribution of centers—differ by country, so does the ideal mix of solutions.”

Micrograph showing MF

The National Comprehensive Cancer Network (NCCN) has published new clinical practice guidelines for myeloproliferative neoplasms (MPNs).

The current guidelines focus on the management of patients with myelofibrosis (MF), but NCCN said recommendations for managing essential thrombocythemia (ET) and polycythemia vera (PV) will be included in subsequent versions of the NCCN guidelines for MPNs.

The new guidelines provide recommendations on the workup and diagnosis of primary MF, post-ET MF, and post-PV MF.

The document also includes recommendations for managing MF-associated anemia, supportive care options, and treatment recommendations according to a patient’s risk group.

Treatment of low-risk MF

The guidelines recommend that patients with low-risk, asymptomatic MF be observed or enrolled in a clinical trial. They should be monitored for progression every 3 to 6 months.

Patients with low-risk, symptomatic MF should receive ruxolitinib or interferons or be enrolled on a clinical trial. They should be monitored for progression every 3 to 6 months.

If patients respond to treatment, they should continue to receive it. If they do not respond or lose their response, they should receive ruxolitinib or interferons or be enrolled on a clinical trial. If these patients progress, they should be treated according to their risk category.

Intermediate-1-risk MF

Patients with intermediate-1-risk MF should be assessed for symptom burden and observed if asymptomatic. If symptomatic, they should receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic hematopoietic stem cell transplant (HSCT).

Patients should be monitored for response and progression every 3 to 6 months. If they respond to treatment, they should continue to receive it.

If patients do not respond or lose their response, they should be observed, receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic HSCT. If these patients progress, they should be treated according to their risk category.

Intermediate-2- or high-risk MF

Patients who are transplant candidates should receive allogeneic HSCT.

Patients who are ineligible for transplant should be assessed for symptom burden. Those with a platelet count of 50,000 or lower should be considered for a clinical trial.

Those with higher platelet counts should receive ruxolitinib or be enrolled on a clinical trial. They should be monitored for response or progression every 3 to 6 months.

If these patients respond to treatment, they should continue on that treatment. If they do not respond or lose their response, the patients should be monitored for progression.

If they progress and are candidates for transplant, these patients should receive hypomethylating agents or chemotherapy to induce remission, followed by HSCT.

If the patients progress and are ineligible for transplant, they should be enrolled on a clinical trial or receive hypomethylating agents or chemotherapy.

For patients who are ineligible for transplant and only have symptomatic anemia, they should receive treatment to manage that anemia. The guidelines list a range of treatment options.

“The management of MPNs has been variable in the past and largely driven by review articles and individual opinions,” said Ruben A. Mesa, MD, chair of the NCCN Guidelines Panel for MPN.

“The NCCN Guidelines Panel for MPN hopes these inaugural guidelines will help leverage the evidence base in MPN care for clear, well-informed treatment guidelines to hopefully improve quality of care and provide better outcomes for patients with MPN.”

Dr Mesa is scheduled to present the new NCCN guidelines during the NCCN 11th Annual Congress: Hematologic Malignancies™ on September 30, in a session titled, “Myeloprofilerative Neoplasms and Myelofibrosis: Evolving Management.”

Micrograph showing MF

The National Comprehensive Cancer Network (NCCN) has published new clinical practice guidelines for myeloproliferative neoplasms (MPNs).

The current guidelines focus on the management of patients with myelofibrosis (MF), but NCCN said recommendations for managing essential thrombocythemia (ET) and polycythemia vera (PV) will be included in subsequent versions of the NCCN guidelines for MPNs.

The new guidelines provide recommendations on the workup and diagnosis of primary MF, post-ET MF, and post-PV MF.

The document also includes recommendations for managing MF-associated anemia, supportive care options, and treatment recommendations according to a patient’s risk group.

Treatment of low-risk MF

The guidelines recommend that patients with low-risk, asymptomatic MF be observed or enrolled in a clinical trial. They should be monitored for progression every 3 to 6 months.

Patients with low-risk, symptomatic MF should receive ruxolitinib or interferons or be enrolled on a clinical trial. They should be monitored for progression every 3 to 6 months.

If patients respond to treatment, they should continue to receive it. If they do not respond or lose their response, they should receive ruxolitinib or interferons or be enrolled on a clinical trial. If these patients progress, they should be treated according to their risk category.

Intermediate-1-risk MF

Patients with intermediate-1-risk MF should be assessed for symptom burden and observed if asymptomatic. If symptomatic, they should receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic hematopoietic stem cell transplant (HSCT).

Patients should be monitored for response and progression every 3 to 6 months. If they respond to treatment, they should continue to receive it.

If patients do not respond or lose their response, they should be observed, receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic HSCT. If these patients progress, they should be treated according to their risk category.

Intermediate-2- or high-risk MF

Patients who are transplant candidates should receive allogeneic HSCT.

Patients who are ineligible for transplant should be assessed for symptom burden. Those with a platelet count of 50,000 or lower should be considered for a clinical trial.

Those with higher platelet counts should receive ruxolitinib or be enrolled on a clinical trial. They should be monitored for response or progression every 3 to 6 months.

If these patients respond to treatment, they should continue on that treatment. If they do not respond or lose their response, the patients should be monitored for progression.

If they progress and are candidates for transplant, these patients should receive hypomethylating agents or chemotherapy to induce remission, followed by HSCT.

If the patients progress and are ineligible for transplant, they should be enrolled on a clinical trial or receive hypomethylating agents or chemotherapy.

For patients who are ineligible for transplant and only have symptomatic anemia, they should receive treatment to manage that anemia. The guidelines list a range of treatment options.

“The management of MPNs has been variable in the past and largely driven by review articles and individual opinions,” said Ruben A. Mesa, MD, chair of the NCCN Guidelines Panel for MPN.

“The NCCN Guidelines Panel for MPN hopes these inaugural guidelines will help leverage the evidence base in MPN care for clear, well-informed treatment guidelines to hopefully improve quality of care and provide better outcomes for patients with MPN.”

Dr Mesa is scheduled to present the new NCCN guidelines during the NCCN 11th Annual Congress: Hematologic Malignancies™ on September 30, in a session titled, “Myeloprofilerative Neoplasms and Myelofibrosis: Evolving Management.”

Micrograph showing MF

The National Comprehensive Cancer Network (NCCN) has published new clinical practice guidelines for myeloproliferative neoplasms (MPNs).

The current guidelines focus on the management of patients with myelofibrosis (MF), but NCCN said recommendations for managing essential thrombocythemia (ET) and polycythemia vera (PV) will be included in subsequent versions of the NCCN guidelines for MPNs.

The new guidelines provide recommendations on the workup and diagnosis of primary MF, post-ET MF, and post-PV MF.

The document also includes recommendations for managing MF-associated anemia, supportive care options, and treatment recommendations according to a patient’s risk group.

Treatment of low-risk MF

The guidelines recommend that patients with low-risk, asymptomatic MF be observed or enrolled in a clinical trial. They should be monitored for progression every 3 to 6 months.

Patients with low-risk, symptomatic MF should receive ruxolitinib or interferons or be enrolled on a clinical trial. They should be monitored for progression every 3 to 6 months.

If patients respond to treatment, they should continue to receive it. If they do not respond or lose their response, they should receive ruxolitinib or interferons or be enrolled on a clinical trial. If these patients progress, they should be treated according to their risk category.

Intermediate-1-risk MF

Patients with intermediate-1-risk MF should be assessed for symptom burden and observed if asymptomatic. If symptomatic, they should receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic hematopoietic stem cell transplant (HSCT).

Patients should be monitored for response and progression every 3 to 6 months. If they respond to treatment, they should continue to receive it.

If patients do not respond or lose their response, they should be observed, receive ruxolitinib, be enrolled on a clinical trial, or undergo allogeneic HSCT. If these patients progress, they should be treated according to their risk category.

Intermediate-2- or high-risk MF

Patients who are transplant candidates should receive allogeneic HSCT.

Patients who are ineligible for transplant should be assessed for symptom burden. Those with a platelet count of 50,000 or lower should be considered for a clinical trial.

Those with higher platelet counts should receive ruxolitinib or be enrolled on a clinical trial. They should be monitored for response or progression every 3 to 6 months.

If these patients respond to treatment, they should continue on that treatment. If they do not respond or lose their response, the patients should be monitored for progression.

If they progress and are candidates for transplant, these patients should receive hypomethylating agents or chemotherapy to induce remission, followed by HSCT.

If the patients progress and are ineligible for transplant, they should be enrolled on a clinical trial or receive hypomethylating agents or chemotherapy.

For patients who are ineligible for transplant and only have symptomatic anemia, they should receive treatment to manage that anemia. The guidelines list a range of treatment options.

“The management of MPNs has been variable in the past and largely driven by review articles and individual opinions,” said Ruben A. Mesa, MD, chair of the NCCN Guidelines Panel for MPN.

“The NCCN Guidelines Panel for MPN hopes these inaugural guidelines will help leverage the evidence base in MPN care for clear, well-informed treatment guidelines to hopefully improve quality of care and provide better outcomes for patients with MPN.”

Dr Mesa is scheduled to present the new NCCN guidelines during the NCCN 11th Annual Congress: Hematologic Malignancies™ on September 30, in a session titled, “Myeloprofilerative Neoplasms and Myelofibrosis: Evolving Management.”

Blood samples

Photo by Graham Colm

The US Office of Special Counsel (OSC) has called for further review of allegations made about the Trioplex assay, a test used to detect Zika and other viruses.

A whistleblower recently alleged that the Centers for Disease Control and Prevention (CDC) has been using and promoting the Trioplex assay even though this test is nearly 40% less effective for Zika virus detection than another test, the Singleplex assay.

The CDC conducted an investigation that suggested this claim is not accurate, but the OSC has recommended additional review of the issue. (The OSC is an independent federal investigative and prosecutorial agency.)

Allegations

The allegations about the Trioplex assay were made by Robert Lanciotti, PhD, a CDC microbiologist based in Fort Collins, Colorado.

Dr Lanciotti conducted a study in which the Trioplex assay—which tests for Zika, dengue, and chikungunya—missed 39% of Zika infections detected by the Singleplex assay, which only tests for Zika.

Dr Lanciotti also raised concerns that the CDC’s Emergency Operations Center (EOC) withheld from public health laboratories information about the sensitivity differences between the Trioplex and Singleplex assays.

He said the CDC may have given laboratories the mistaken impression that Trioplex was a better test.

The Singleplex assay was made by Dr Lanciotti’s lab, while the Trioplex assay was developed at the CDC’s dengue branch lab in Puerto Rico.

Investigation

The OSC referred Dr Lanciotti’s claims to the Department of Health and Human Services (HHS) for investigation on July 1, 2016.

HHS Secretary Sylvia Mathews Burwell directed Steve Monroe, PhD, associate director for laboratory science and safety at the CDC, to conduct the investigation. The investigative team did not include employees who worked in EOC or in the zoonotic infectious diseases branch of the CDC.

The CDC said its investigation did not substantiate Dr Lanciotti’s claims. Investigators said they were unable to reach a “statistically valid conclusion about the relative performance” of the tests.

The CDC’s report pointed to a study conducted by its dengue branch in Puerto Rico that “found no difference in sensitivity” between the assays. The Trioplex assay was developed at this lab.

The report also said the CDC acted reasonably when it withheld information about the sensitivity differences between the Trioplex and Singleplex assays because there was conflicting data from different  labs. The investigators said releasing that data could have created “considerable confusion during an ongoing emergency response.”

The CDC also noted that, in late August, the agency made changes intended to improve the sensitivity of the Trioplex assay, such as increasing sample volumes and allowing whole blood as a specimen type.

Response

Dr Lanciotti took issue with several points in the CDC’s report. Perhaps most importantly, he said “there was clearly enough data to warrant a ‘pause’ in the recommendation of the Trioplex until an extensive comparison could be performed.”

He referenced a multicenter study conducted independently by the Blood Systems Research Institute in San Francisco, California, which demonstrated the Trioplex assay’s lower sensitivity.

Dr Lanciotti added that the method used by this institution to assess the tests is “the most accurate method to evaluate the clinical sensitivity . . . of individual assays.”

Reassignment

Prior to disclosing his concerns to the OSC, Dr Lanciotti voiced the concerns internally and in an email to state public health officials in April 2016.

In May, he was reassigned to a non‐supervisory position within his lab. After the reassignment, Dr Lanciotti filed a whistleblower retaliation claim alleging that his diminished duties, from lab chief to a non‐supervisory position, was in reprisal for his disclosures.

After an investigation, the OSC secured an agreement from the CDC to reinstate Dr Lanciotti as chief of his lab.

OSC assessment

In a letter to President Barack Obama, Carolyn Lerner, head of the OSC, said the CDC “conducted a thorough investigation into Dr Lanciotti’s allegations, and its findings appear reasonable.”

On the other hand, Dr Lanciotti has raised “serious concerns” about the CDC’s findings.

“As the agency contemplates additional improvements or changes to the Zika testing protocol, I encourage CDC to review Dr Lanciotti’s comments, respond to each of his concerns, and utilize his expertise as the agency works to ensure it is implementing the most effective testing methods in response to this public health emergency,” Lerner said.

“I also encourage the CDC to promote scientific debate within its labs. Whistleblowers should be encouraged to speak out on matters of public concern.”

Blood samples

Photo by Graham Colm

The US Office of Special Counsel (OSC) has called for further review of allegations made about the Trioplex assay, a test used to detect Zika and other viruses.

A whistleblower recently alleged that the Centers for Disease Control and Prevention (CDC) has been using and promoting the Trioplex assay even though this test is nearly 40% less effective for Zika virus detection than another test, the Singleplex assay.

The CDC conducted an investigation that suggested this claim is not accurate, but the OSC has recommended additional review of the issue. (The OSC is an independent federal investigative and prosecutorial agency.)

Allegations

The allegations about the Trioplex assay were made by Robert Lanciotti, PhD, a CDC microbiologist based in Fort Collins, Colorado.

Dr Lanciotti conducted a study in which the Trioplex assay—which tests for Zika, dengue, and chikungunya—missed 39% of Zika infections detected by the Singleplex assay, which only tests for Zika.

Dr Lanciotti also raised concerns that the CDC’s Emergency Operations Center (EOC) withheld from public health laboratories information about the sensitivity differences between the Trioplex and Singleplex assays.

He said the CDC may have given laboratories the mistaken impression that Trioplex was a better test.

The Singleplex assay was made by Dr Lanciotti’s lab, while the Trioplex assay was developed at the CDC’s dengue branch lab in Puerto Rico.

Investigation

The OSC referred Dr Lanciotti’s claims to the Department of Health and Human Services (HHS) for investigation on July 1, 2016.

HHS Secretary Sylvia Mathews Burwell directed Steve Monroe, PhD, associate director for laboratory science and safety at the CDC, to conduct the investigation. The investigative team did not include employees who worked in EOC or in the zoonotic infectious diseases branch of the CDC.

The CDC said its investigation did not substantiate Dr Lanciotti’s claims. Investigators said they were unable to reach a “statistically valid conclusion about the relative performance” of the tests.

The CDC’s report pointed to a study conducted by its dengue branch in Puerto Rico that “found no difference in sensitivity” between the assays. The Trioplex assay was developed at this lab.

The report also said the CDC acted reasonably when it withheld information about the sensitivity differences between the Trioplex and Singleplex assays because there was conflicting data from different  labs. The investigators said releasing that data could have created “considerable confusion during an ongoing emergency response.”

The CDC also noted that, in late August, the agency made changes intended to improve the sensitivity of the Trioplex assay, such as increasing sample volumes and allowing whole blood as a specimen type.

Response

Dr Lanciotti took issue with several points in the CDC’s report. Perhaps most importantly, he said “there was clearly enough data to warrant a ‘pause’ in the recommendation of the Trioplex until an extensive comparison could be performed.”

He referenced a multicenter study conducted independently by the Blood Systems Research Institute in San Francisco, California, which demonstrated the Trioplex assay’s lower sensitivity.

Dr Lanciotti added that the method used by this institution to assess the tests is “the most accurate method to evaluate the clinical sensitivity . . . of individual assays.”

Reassignment

Prior to disclosing his concerns to the OSC, Dr Lanciotti voiced the concerns internally and in an email to state public health officials in April 2016.

In May, he was reassigned to a non‐supervisory position within his lab. After the reassignment, Dr Lanciotti filed a whistleblower retaliation claim alleging that his diminished duties, from lab chief to a non‐supervisory position, was in reprisal for his disclosures.

After an investigation, the OSC secured an agreement from the CDC to reinstate Dr Lanciotti as chief of his lab.

OSC assessment

In a letter to President Barack Obama, Carolyn Lerner, head of the OSC, said the CDC “conducted a thorough investigation into Dr Lanciotti’s allegations, and its findings appear reasonable.”

On the other hand, Dr Lanciotti has raised “serious concerns” about the CDC’s findings.

“As the agency contemplates additional improvements or changes to the Zika testing protocol, I encourage CDC to review Dr Lanciotti’s comments, respond to each of his concerns, and utilize his expertise as the agency works to ensure it is implementing the most effective testing methods in response to this public health emergency,” Lerner said.

“I also encourage the CDC to promote scientific debate within its labs. Whistleblowers should be encouraged to speak out on matters of public concern.”

Blood samples

Photo by Graham Colm

The US Office of Special Counsel (OSC) has called for further review of allegations made about the Trioplex assay, a test used to detect Zika and other viruses.

A whistleblower recently alleged that the Centers for Disease Control and Prevention (CDC) has been using and promoting the Trioplex assay even though this test is nearly 40% less effective for Zika virus detection than another test, the Singleplex assay.

The CDC conducted an investigation that suggested this claim is not accurate, but the OSC has recommended additional review of the issue. (The OSC is an independent federal investigative and prosecutorial agency.)

Allegations

The allegations about the Trioplex assay were made by Robert Lanciotti, PhD, a CDC microbiologist based in Fort Collins, Colorado.

Dr Lanciotti conducted a study in which the Trioplex assay—which tests for Zika, dengue, and chikungunya—missed 39% of Zika infections detected by the Singleplex assay, which only tests for Zika.

Dr Lanciotti also raised concerns that the CDC’s Emergency Operations Center (EOC) withheld from public health laboratories information about the sensitivity differences between the Trioplex and Singleplex assays.

He said the CDC may have given laboratories the mistaken impression that Trioplex was a better test.

The Singleplex assay was made by Dr Lanciotti’s lab, while the Trioplex assay was developed at the CDC’s dengue branch lab in Puerto Rico.

Investigation

The OSC referred Dr Lanciotti’s claims to the Department of Health and Human Services (HHS) for investigation on July 1, 2016.

HHS Secretary Sylvia Mathews Burwell directed Steve Monroe, PhD, associate director for laboratory science and safety at the CDC, to conduct the investigation. The investigative team did not include employees who worked in EOC or in the zoonotic infectious diseases branch of the CDC.

The CDC said its investigation did not substantiate Dr Lanciotti’s claims. Investigators said they were unable to reach a “statistically valid conclusion about the relative performance” of the tests.

The CDC’s report pointed to a study conducted by its dengue branch in Puerto Rico that “found no difference in sensitivity” between the assays. The Trioplex assay was developed at this lab.

The report also said the CDC acted reasonably when it withheld information about the sensitivity differences between the Trioplex and Singleplex assays because there was conflicting data from different  labs. The investigators said releasing that data could have created “considerable confusion during an ongoing emergency response.”

The CDC also noted that, in late August, the agency made changes intended to improve the sensitivity of the Trioplex assay, such as increasing sample volumes and allowing whole blood as a specimen type.

Response

Dr Lanciotti took issue with several points in the CDC’s report. Perhaps most importantly, he said “there was clearly enough data to warrant a ‘pause’ in the recommendation of the Trioplex until an extensive comparison could be performed.”

He referenced a multicenter study conducted independently by the Blood Systems Research Institute in San Francisco, California, which demonstrated the Trioplex assay’s lower sensitivity.

Dr Lanciotti added that the method used by this institution to assess the tests is “the most accurate method to evaluate the clinical sensitivity . . . of individual assays.”

Reassignment

Prior to disclosing his concerns to the OSC, Dr Lanciotti voiced the concerns internally and in an email to state public health officials in April 2016.

In May, he was reassigned to a non‐supervisory position within his lab. After the reassignment, Dr Lanciotti filed a whistleblower retaliation claim alleging that his diminished duties, from lab chief to a non‐supervisory position, was in reprisal for his disclosures.

After an investigation, the OSC secured an agreement from the CDC to reinstate Dr Lanciotti as chief of his lab.

OSC assessment

In a letter to President Barack Obama, Carolyn Lerner, head of the OSC, said the CDC “conducted a thorough investigation into Dr Lanciotti’s allegations, and its findings appear reasonable.”

On the other hand, Dr Lanciotti has raised “serious concerns” about the CDC’s findings.

“As the agency contemplates additional improvements or changes to the Zika testing protocol, I encourage CDC to review Dr Lanciotti’s comments, respond to each of his concerns, and utilize his expertise as the agency works to ensure it is implementing the most effective testing methods in response to this public health emergency,” Lerner said.

“I also encourage the CDC to promote scientific debate within its labs. Whistleblowers should be encouraged to speak out on matters of public concern.”