Improving survival in older AML patients

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The prognosis of AML in the elderly is very poor, with 5-year survival rates less than 10% in patients aged 65 years and older. However, in recent years, novel therapeutic approaches have been developed to focus on the older AML population. Have we begun to witness an improvement in the survival of these patients?

Dr. Jeffrey E. Lancet
A key question to ask at the outset of any discussion pertaining to improving survival in older patients with AML is how poorly do patients fare with no disease-specific therapy at all? This is important because it speaks to the issue of treatment itself (of any type) being important in the achievement of a survival benefit.

Several clinical trials and observational registration studies have made it very clear that, without treatment, the survival in AML is very short – ranging from 11-16 weeks (for patients enrolled in therapeutic trials who received best supportive care only) to only 6-8 weeks in the “real-world” setting, based upon observational studies.1,2,3,4

These data are very meaningful because older AML patients often do not receive active therapy. As recently as 2009, SEER data indicate that 50% of patients aged 65 years or older receive no treatment for AML. This trend appears to be changing, based upon data from the AMLSG in 2012-2014, in which only a minority of patients in this age range received best supportive care only for their AML.

Knowing the very poor outcomes of patients who are not treated for AML, along with a high number of patients who are not treated, we must next ask whether any treatment at all is superior to no treatment. The data appear relatively clear on this question, with two representative publications highlighting the superiority of treatment vs. no treatment. First, in the SEER registry analysis by Medeiros et al., treated patients had a median survival of 5 months, compared with 2.5 months in untreated patients, and there was an unequivocal survival advantage attributed to treatment after adjustment for covariates and propensity score matching. Treatment included both traditional induction regimens and hypomethylating agent (HMA) therapy. Similarly, a phase 3 clinical trial testing low-dose cytarabine (LDAC) vs. best supportive care demonstrated survival improvement with LDAC (odds ratio, 0.60).

Recognizing that treatment improves survival in older adults with AML and that there is an upward trend in the percent of patients who receive active therapy, we can reasonably ask next whether survival has begun to trend upward over the past several years. This, of course, is a challenging question, but one that can be at least partially addressed through analyses of registration cohorts.

SEER data regarding AML patients aged 65 and older from the 1970s to 2013 suggest modestly improved 2-year survival, from less than 10% in the 1970s to 10%-15% since the early 2000s. The Moffitt Cancer Center database of patients aged 70 years and older also indicates a strong trend toward modestly improved survival after 2005, compared with prior to 2005 (unpublished data). Although the precise reason for trending improvements in overall survival of these patients over time is not clear, it is reasonable to suggest that a greater proportion of patients who receive actual therapy for AML could explain the modest improvements being observed. Improvements in supportive care through the years could also contribute to survival improvement trends over time, though this hypothesis has not been formally tested.
 

 


Next, we should ask about the most effective currently available therapy for older adults with AML. Standard treatment options for these patients, as mentioned previously, include high-intensity (traditional induction chemotherapy) and lower-intensity (LDAC, HMAs) regimens. Unfortunately, a prospective, randomized comparison between such regimens has not been undertaken, so it is impossible to declare with any certainty as to the superiority of one approach versus another. Larger database analyses, utilizing multivariate cox regression analyses, have been performed, suggesting that HMAs and intensive therapies perform similarly, such that offering an older adult with AML frontline therapy with a lower-intensity regimen is very reasonable.5

It is quite important to address the possibility that newer therapies in AML are changing the natural history of the disease. First of all, strategies utilizing HMA therapy with 5-azacitidine or decitabine have been widely studied. Unfortunately, a clear and convincing signal of survival benefit of frontline HMA therapy, compared with conventional care regimens (most commonly LDAC) has not been demonstrated, although trends toward a very modest survival advantage favoring HMAs were observed.6,7

Interestingly, in the AZA-AML-001 study, only the subgroup of patients who were preselected to receive best supportive care achieved survival benefit from 5-azacitidine, again suggesting that treatment vs. no treatment is among the most important factors leading to survival improvement in elderly AML.

Other novel agents are coming to the forefront, with the potential to change the natural history of AML in elderly patients. CPX-351 is a liposomal product that encapsulates cytarabine and daunorubicin in a fixed and synergistic molar ratio, thereby allowing delivery of both agents to the leukemic cell in the optimal fashion for cell kill. A recently completed phase 3 trial in older adults with secondary AML demonstrated statistically significant survival improvement with CPX-351 as compared with traditional daunorubicin plus cytarabine induction. A substantial minority of patients on this trial went to allogeneic hematopoietic cell transplant during first remission, and a landmark analysis performed at the time of transplant indicated better survival among patients who had received initial therapy with CPX-351.8
 

 


These data suggest that, in selected older adults with secondary AML who are fit enough to receive induction chemotherapy, CPX-351 offers a survival advantage, even among traditionally higher-risk subgroups, including patients with adverse karyotype of above age 70 years. As such, CPX-351 (Vyxeos) received FDA approval as frontline therapy for secondary AML in 2017.

Newer targeted therapies for older adults with AML also appear to hold promise. Glasdegib, an inhibitor of SMO (part of the hedgehog signaling pathway) was recently studied in combination with LDAC versus LDAC alone in a randomized phase 2 trial in older patients considered unfit for intensive induction chemotherapy. In this trial, patients assigned to glasdegib plus LDAC had longer median and overall survival than patients treated with LDAC alone, suggesting a promising novel agent on the horizon.9

Another example of a promising and novel targeted agent for AML is venetoclax, an inhibitor of BCL-2. Encouragingly high response rates and overall survival in phase 2 trials that combined venetoclax with LDAC or HMAs have driven randomized trials to definitively ascertain a survival advantage in older patients considered unfit for intensive therapy.10,11

The question also arises as to whether therapeutic outcomes can be optimized by better selection of currently available therapies for any given. This concept requires development of a decision analysis model that can be used to accurately predict outcomes among older patients with newly diagnosed AML. At Moffitt Cancer Center, such a model is being developed using a systematic review of the literature, followed by validation in a large institutional database. To date, there is the strong initial suggestion that initial therapy selection can be optimized for best outcome, taking into account variables including ECOG performance status, Charlson Comorbidity Index, and cytogenetic risk.12
 

 


The goal of improving survival in older adults with AML remains elusive. The decision to treat (regardless of high vs. low intensity) appears critical toward achieving this goal. New therapies such as CPX-351, glasdegib, and venetoclax also hold promise in further improving survival in subgroups of older patients. Finally, development of accurate predictive models to optimize initial therapy will be of critical importance for improving survival in this very heterogeneous disease that afflicts a very heterogeneous group of patients.

Dr. Lancet is chair of the department of malignant hematology at H. Lee Moffitt Cancer Center in Tampa. He has received consulting fees from Astellas, BioSight, Celgene, Janssen R&D, and Jazz Pharmaceuticals.

References

1. Burnett AK et al. Cancer. 2007 Mar 15;109(6):1114-24.

2. Harousseau JL et al. Blood. 2009 Aug 6;114(6):1166-73.

3. Medeiros BC et al. Ann Hematol. 2015 Mar 20; 94(7):1127-38.

4. Oran B et al. Haematologica. 2012 Dec;97(12):1916-24.

5. Lancet JE et al. J Clin Oncol. 2017. doi: 10.1200/JCO.2017.35.15_suppl.7031.

6. Dombret H et al. Blood. 2015 Jul 16;126(3):291-9.

7. Kantarjian HM et al. J Clin Oncol. 2012 Jul 20;30(21):2670-7.

8. Lancet JE et al. Blood 2016 128:906.

9. Cortes JE et al. Blood 2016 128:99.

10. DiNardo CD et al. Blood 2017 130:2628.

11. Wei A et al. Blood 2017 130:890.

12. Extermann M et al. SIOG 2017.

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The prognosis of AML in the elderly is very poor, with 5-year survival rates less than 10% in patients aged 65 years and older. However, in recent years, novel therapeutic approaches have been developed to focus on the older AML population. Have we begun to witness an improvement in the survival of these patients?

Dr. Jeffrey E. Lancet
A key question to ask at the outset of any discussion pertaining to improving survival in older patients with AML is how poorly do patients fare with no disease-specific therapy at all? This is important because it speaks to the issue of treatment itself (of any type) being important in the achievement of a survival benefit.

Several clinical trials and observational registration studies have made it very clear that, without treatment, the survival in AML is very short – ranging from 11-16 weeks (for patients enrolled in therapeutic trials who received best supportive care only) to only 6-8 weeks in the “real-world” setting, based upon observational studies.1,2,3,4

These data are very meaningful because older AML patients often do not receive active therapy. As recently as 2009, SEER data indicate that 50% of patients aged 65 years or older receive no treatment for AML. This trend appears to be changing, based upon data from the AMLSG in 2012-2014, in which only a minority of patients in this age range received best supportive care only for their AML.

Knowing the very poor outcomes of patients who are not treated for AML, along with a high number of patients who are not treated, we must next ask whether any treatment at all is superior to no treatment. The data appear relatively clear on this question, with two representative publications highlighting the superiority of treatment vs. no treatment. First, in the SEER registry analysis by Medeiros et al., treated patients had a median survival of 5 months, compared with 2.5 months in untreated patients, and there was an unequivocal survival advantage attributed to treatment after adjustment for covariates and propensity score matching. Treatment included both traditional induction regimens and hypomethylating agent (HMA) therapy. Similarly, a phase 3 clinical trial testing low-dose cytarabine (LDAC) vs. best supportive care demonstrated survival improvement with LDAC (odds ratio, 0.60).

Recognizing that treatment improves survival in older adults with AML and that there is an upward trend in the percent of patients who receive active therapy, we can reasonably ask next whether survival has begun to trend upward over the past several years. This, of course, is a challenging question, but one that can be at least partially addressed through analyses of registration cohorts.

SEER data regarding AML patients aged 65 and older from the 1970s to 2013 suggest modestly improved 2-year survival, from less than 10% in the 1970s to 10%-15% since the early 2000s. The Moffitt Cancer Center database of patients aged 70 years and older also indicates a strong trend toward modestly improved survival after 2005, compared with prior to 2005 (unpublished data). Although the precise reason for trending improvements in overall survival of these patients over time is not clear, it is reasonable to suggest that a greater proportion of patients who receive actual therapy for AML could explain the modest improvements being observed. Improvements in supportive care through the years could also contribute to survival improvement trends over time, though this hypothesis has not been formally tested.
 

 


Next, we should ask about the most effective currently available therapy for older adults with AML. Standard treatment options for these patients, as mentioned previously, include high-intensity (traditional induction chemotherapy) and lower-intensity (LDAC, HMAs) regimens. Unfortunately, a prospective, randomized comparison between such regimens has not been undertaken, so it is impossible to declare with any certainty as to the superiority of one approach versus another. Larger database analyses, utilizing multivariate cox regression analyses, have been performed, suggesting that HMAs and intensive therapies perform similarly, such that offering an older adult with AML frontline therapy with a lower-intensity regimen is very reasonable.5

It is quite important to address the possibility that newer therapies in AML are changing the natural history of the disease. First of all, strategies utilizing HMA therapy with 5-azacitidine or decitabine have been widely studied. Unfortunately, a clear and convincing signal of survival benefit of frontline HMA therapy, compared with conventional care regimens (most commonly LDAC) has not been demonstrated, although trends toward a very modest survival advantage favoring HMAs were observed.6,7

Interestingly, in the AZA-AML-001 study, only the subgroup of patients who were preselected to receive best supportive care achieved survival benefit from 5-azacitidine, again suggesting that treatment vs. no treatment is among the most important factors leading to survival improvement in elderly AML.

Other novel agents are coming to the forefront, with the potential to change the natural history of AML in elderly patients. CPX-351 is a liposomal product that encapsulates cytarabine and daunorubicin in a fixed and synergistic molar ratio, thereby allowing delivery of both agents to the leukemic cell in the optimal fashion for cell kill. A recently completed phase 3 trial in older adults with secondary AML demonstrated statistically significant survival improvement with CPX-351 as compared with traditional daunorubicin plus cytarabine induction. A substantial minority of patients on this trial went to allogeneic hematopoietic cell transplant during first remission, and a landmark analysis performed at the time of transplant indicated better survival among patients who had received initial therapy with CPX-351.8
 

 


These data suggest that, in selected older adults with secondary AML who are fit enough to receive induction chemotherapy, CPX-351 offers a survival advantage, even among traditionally higher-risk subgroups, including patients with adverse karyotype of above age 70 years. As such, CPX-351 (Vyxeos) received FDA approval as frontline therapy for secondary AML in 2017.

Newer targeted therapies for older adults with AML also appear to hold promise. Glasdegib, an inhibitor of SMO (part of the hedgehog signaling pathway) was recently studied in combination with LDAC versus LDAC alone in a randomized phase 2 trial in older patients considered unfit for intensive induction chemotherapy. In this trial, patients assigned to glasdegib plus LDAC had longer median and overall survival than patients treated with LDAC alone, suggesting a promising novel agent on the horizon.9

Another example of a promising and novel targeted agent for AML is venetoclax, an inhibitor of BCL-2. Encouragingly high response rates and overall survival in phase 2 trials that combined venetoclax with LDAC or HMAs have driven randomized trials to definitively ascertain a survival advantage in older patients considered unfit for intensive therapy.10,11

The question also arises as to whether therapeutic outcomes can be optimized by better selection of currently available therapies for any given. This concept requires development of a decision analysis model that can be used to accurately predict outcomes among older patients with newly diagnosed AML. At Moffitt Cancer Center, such a model is being developed using a systematic review of the literature, followed by validation in a large institutional database. To date, there is the strong initial suggestion that initial therapy selection can be optimized for best outcome, taking into account variables including ECOG performance status, Charlson Comorbidity Index, and cytogenetic risk.12
 

 


The goal of improving survival in older adults with AML remains elusive. The decision to treat (regardless of high vs. low intensity) appears critical toward achieving this goal. New therapies such as CPX-351, glasdegib, and venetoclax also hold promise in further improving survival in subgroups of older patients. Finally, development of accurate predictive models to optimize initial therapy will be of critical importance for improving survival in this very heterogeneous disease that afflicts a very heterogeneous group of patients.

Dr. Lancet is chair of the department of malignant hematology at H. Lee Moffitt Cancer Center in Tampa. He has received consulting fees from Astellas, BioSight, Celgene, Janssen R&D, and Jazz Pharmaceuticals.

References

1. Burnett AK et al. Cancer. 2007 Mar 15;109(6):1114-24.

2. Harousseau JL et al. Blood. 2009 Aug 6;114(6):1166-73.

3. Medeiros BC et al. Ann Hematol. 2015 Mar 20; 94(7):1127-38.

4. Oran B et al. Haematologica. 2012 Dec;97(12):1916-24.

5. Lancet JE et al. J Clin Oncol. 2017. doi: 10.1200/JCO.2017.35.15_suppl.7031.

6. Dombret H et al. Blood. 2015 Jul 16;126(3):291-9.

7. Kantarjian HM et al. J Clin Oncol. 2012 Jul 20;30(21):2670-7.

8. Lancet JE et al. Blood 2016 128:906.

9. Cortes JE et al. Blood 2016 128:99.

10. DiNardo CD et al. Blood 2017 130:2628.

11. Wei A et al. Blood 2017 130:890.

12. Extermann M et al. SIOG 2017.

 

The prognosis of AML in the elderly is very poor, with 5-year survival rates less than 10% in patients aged 65 years and older. However, in recent years, novel therapeutic approaches have been developed to focus on the older AML population. Have we begun to witness an improvement in the survival of these patients?

Dr. Jeffrey E. Lancet
A key question to ask at the outset of any discussion pertaining to improving survival in older patients with AML is how poorly do patients fare with no disease-specific therapy at all? This is important because it speaks to the issue of treatment itself (of any type) being important in the achievement of a survival benefit.

Several clinical trials and observational registration studies have made it very clear that, without treatment, the survival in AML is very short – ranging from 11-16 weeks (for patients enrolled in therapeutic trials who received best supportive care only) to only 6-8 weeks in the “real-world” setting, based upon observational studies.1,2,3,4

These data are very meaningful because older AML patients often do not receive active therapy. As recently as 2009, SEER data indicate that 50% of patients aged 65 years or older receive no treatment for AML. This trend appears to be changing, based upon data from the AMLSG in 2012-2014, in which only a minority of patients in this age range received best supportive care only for their AML.

Knowing the very poor outcomes of patients who are not treated for AML, along with a high number of patients who are not treated, we must next ask whether any treatment at all is superior to no treatment. The data appear relatively clear on this question, with two representative publications highlighting the superiority of treatment vs. no treatment. First, in the SEER registry analysis by Medeiros et al., treated patients had a median survival of 5 months, compared with 2.5 months in untreated patients, and there was an unequivocal survival advantage attributed to treatment after adjustment for covariates and propensity score matching. Treatment included both traditional induction regimens and hypomethylating agent (HMA) therapy. Similarly, a phase 3 clinical trial testing low-dose cytarabine (LDAC) vs. best supportive care demonstrated survival improvement with LDAC (odds ratio, 0.60).

Recognizing that treatment improves survival in older adults with AML and that there is an upward trend in the percent of patients who receive active therapy, we can reasonably ask next whether survival has begun to trend upward over the past several years. This, of course, is a challenging question, but one that can be at least partially addressed through analyses of registration cohorts.

SEER data regarding AML patients aged 65 and older from the 1970s to 2013 suggest modestly improved 2-year survival, from less than 10% in the 1970s to 10%-15% since the early 2000s. The Moffitt Cancer Center database of patients aged 70 years and older also indicates a strong trend toward modestly improved survival after 2005, compared with prior to 2005 (unpublished data). Although the precise reason for trending improvements in overall survival of these patients over time is not clear, it is reasonable to suggest that a greater proportion of patients who receive actual therapy for AML could explain the modest improvements being observed. Improvements in supportive care through the years could also contribute to survival improvement trends over time, though this hypothesis has not been formally tested.
 

 


Next, we should ask about the most effective currently available therapy for older adults with AML. Standard treatment options for these patients, as mentioned previously, include high-intensity (traditional induction chemotherapy) and lower-intensity (LDAC, HMAs) regimens. Unfortunately, a prospective, randomized comparison between such regimens has not been undertaken, so it is impossible to declare with any certainty as to the superiority of one approach versus another. Larger database analyses, utilizing multivariate cox regression analyses, have been performed, suggesting that HMAs and intensive therapies perform similarly, such that offering an older adult with AML frontline therapy with a lower-intensity regimen is very reasonable.5

It is quite important to address the possibility that newer therapies in AML are changing the natural history of the disease. First of all, strategies utilizing HMA therapy with 5-azacitidine or decitabine have been widely studied. Unfortunately, a clear and convincing signal of survival benefit of frontline HMA therapy, compared with conventional care regimens (most commonly LDAC) has not been demonstrated, although trends toward a very modest survival advantage favoring HMAs were observed.6,7

Interestingly, in the AZA-AML-001 study, only the subgroup of patients who were preselected to receive best supportive care achieved survival benefit from 5-azacitidine, again suggesting that treatment vs. no treatment is among the most important factors leading to survival improvement in elderly AML.

Other novel agents are coming to the forefront, with the potential to change the natural history of AML in elderly patients. CPX-351 is a liposomal product that encapsulates cytarabine and daunorubicin in a fixed and synergistic molar ratio, thereby allowing delivery of both agents to the leukemic cell in the optimal fashion for cell kill. A recently completed phase 3 trial in older adults with secondary AML demonstrated statistically significant survival improvement with CPX-351 as compared with traditional daunorubicin plus cytarabine induction. A substantial minority of patients on this trial went to allogeneic hematopoietic cell transplant during first remission, and a landmark analysis performed at the time of transplant indicated better survival among patients who had received initial therapy with CPX-351.8
 

 


These data suggest that, in selected older adults with secondary AML who are fit enough to receive induction chemotherapy, CPX-351 offers a survival advantage, even among traditionally higher-risk subgroups, including patients with adverse karyotype of above age 70 years. As such, CPX-351 (Vyxeos) received FDA approval as frontline therapy for secondary AML in 2017.

Newer targeted therapies for older adults with AML also appear to hold promise. Glasdegib, an inhibitor of SMO (part of the hedgehog signaling pathway) was recently studied in combination with LDAC versus LDAC alone in a randomized phase 2 trial in older patients considered unfit for intensive induction chemotherapy. In this trial, patients assigned to glasdegib plus LDAC had longer median and overall survival than patients treated with LDAC alone, suggesting a promising novel agent on the horizon.9

Another example of a promising and novel targeted agent for AML is venetoclax, an inhibitor of BCL-2. Encouragingly high response rates and overall survival in phase 2 trials that combined venetoclax with LDAC or HMAs have driven randomized trials to definitively ascertain a survival advantage in older patients considered unfit for intensive therapy.10,11

The question also arises as to whether therapeutic outcomes can be optimized by better selection of currently available therapies for any given. This concept requires development of a decision analysis model that can be used to accurately predict outcomes among older patients with newly diagnosed AML. At Moffitt Cancer Center, such a model is being developed using a systematic review of the literature, followed by validation in a large institutional database. To date, there is the strong initial suggestion that initial therapy selection can be optimized for best outcome, taking into account variables including ECOG performance status, Charlson Comorbidity Index, and cytogenetic risk.12
 

 


The goal of improving survival in older adults with AML remains elusive. The decision to treat (regardless of high vs. low intensity) appears critical toward achieving this goal. New therapies such as CPX-351, glasdegib, and venetoclax also hold promise in further improving survival in subgroups of older patients. Finally, development of accurate predictive models to optimize initial therapy will be of critical importance for improving survival in this very heterogeneous disease that afflicts a very heterogeneous group of patients.

Dr. Lancet is chair of the department of malignant hematology at H. Lee Moffitt Cancer Center in Tampa. He has received consulting fees from Astellas, BioSight, Celgene, Janssen R&D, and Jazz Pharmaceuticals.

References

1. Burnett AK et al. Cancer. 2007 Mar 15;109(6):1114-24.

2. Harousseau JL et al. Blood. 2009 Aug 6;114(6):1166-73.

3. Medeiros BC et al. Ann Hematol. 2015 Mar 20; 94(7):1127-38.

4. Oran B et al. Haematologica. 2012 Dec;97(12):1916-24.

5. Lancet JE et al. J Clin Oncol. 2017. doi: 10.1200/JCO.2017.35.15_suppl.7031.

6. Dombret H et al. Blood. 2015 Jul 16;126(3):291-9.

7. Kantarjian HM et al. J Clin Oncol. 2012 Jul 20;30(21):2670-7.

8. Lancet JE et al. Blood 2016 128:906.

9. Cortes JE et al. Blood 2016 128:99.

10. DiNardo CD et al. Blood 2017 130:2628.

11. Wei A et al. Blood 2017 130:890.

12. Extermann M et al. SIOG 2017.

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Continuous EEG Helps Detect Delayed Cerebral Ischemia

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Continuous EEG Helps Detect Delayed Cerebral Ischemia
Ann Neurol.; ePub 2018 Apr 1; Rosenthal et al.

Performing continuous EEG (cEEG) monitoring in patients who have experienced a subarachnoid hemorrhage can help predict the occurrence of delayed cerebral ischemia (DCI) according to a prospective study of 103 patients who underwent cEEG.

  • DCI is a common complication of subarachnoid hemorrhage.
  • Retrospective studies have suggested a link between cEEG and DCI but the association needed to be confirmed with a prospective evaluation.
  • Continuous EEG monitoring involved an average of 7.7 days duration, and a EEG alarm occurred in about 96% of patients with subsequent DCI but in only 19.6% of patients without the ischemic complication.
  • Among patients who had a EEG alarm, late onset epileptiform abnormalities were most likely to predict DCI.

 

Rosenthal ES, Biswal S, Zafar SF, et al. Continuous electroencephalography predicts delayed cerebral ischemia after subarachnoid hemorrhage: a prospective study of diagnostic accuracy [published online ahead of print Apr 16, 2018]. Ann Neurol. doi: 10.1002/ana.25232

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Ann Neurol.; ePub 2018 Apr 1; Rosenthal et al.
Ann Neurol.; ePub 2018 Apr 1; Rosenthal et al.

Performing continuous EEG (cEEG) monitoring in patients who have experienced a subarachnoid hemorrhage can help predict the occurrence of delayed cerebral ischemia (DCI) according to a prospective study of 103 patients who underwent cEEG.

  • DCI is a common complication of subarachnoid hemorrhage.
  • Retrospective studies have suggested a link between cEEG and DCI but the association needed to be confirmed with a prospective evaluation.
  • Continuous EEG monitoring involved an average of 7.7 days duration, and a EEG alarm occurred in about 96% of patients with subsequent DCI but in only 19.6% of patients without the ischemic complication.
  • Among patients who had a EEG alarm, late onset epileptiform abnormalities were most likely to predict DCI.

 

Rosenthal ES, Biswal S, Zafar SF, et al. Continuous electroencephalography predicts delayed cerebral ischemia after subarachnoid hemorrhage: a prospective study of diagnostic accuracy [published online ahead of print Apr 16, 2018]. Ann Neurol. doi: 10.1002/ana.25232

Performing continuous EEG (cEEG) monitoring in patients who have experienced a subarachnoid hemorrhage can help predict the occurrence of delayed cerebral ischemia (DCI) according to a prospective study of 103 patients who underwent cEEG.

  • DCI is a common complication of subarachnoid hemorrhage.
  • Retrospective studies have suggested a link between cEEG and DCI but the association needed to be confirmed with a prospective evaluation.
  • Continuous EEG monitoring involved an average of 7.7 days duration, and a EEG alarm occurred in about 96% of patients with subsequent DCI but in only 19.6% of patients without the ischemic complication.
  • Among patients who had a EEG alarm, late onset epileptiform abnormalities were most likely to predict DCI.

 

Rosenthal ES, Biswal S, Zafar SF, et al. Continuous electroencephalography predicts delayed cerebral ischemia after subarachnoid hemorrhage: a prospective study of diagnostic accuracy [published online ahead of print Apr 16, 2018]. Ann Neurol. doi: 10.1002/ana.25232

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Measuring Suboptimal Effort in Adults with Epilepsy

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Measuring Suboptimal Effort in Adults with Epilepsy
Arch Clin Neuropsychol; ePub 2018 Apr 5; Maiman et al

The commonly accepted cutoff scores for reliable digit span (RDS), a way to measure attention and working memory and assess suboptimal effort, are not appropriate for adults with epilepsy, according to a study of 63 patients with epilepsy or suspected seizures.

  • A cutoff of ≤6 or ≤7 for RDS, which is part of the Wechsler Adult Intelligence Scale, is typically used in adult clinical populations.
  • Maiman et al applied these thresholds to adult patients with epilepsy or suspected seizures, most of whom passed trial 2 of the Test for Memory Malingering with a score of 45 or above.
  • A cutoff of 6 or less on the RDS subtest yielded a specificity of 85% while 7 or less yielded 77%.
  • A secondary analysis concluded that a cutoff of 4 or less may be more appropriate for adults with epilepsy who have a low average IQ or lower.

 

Maiman M, Del Bene VA, MacAllister WS, et al. Reliable digit span: does it adequately measure suboptimal effort in an adult epilepsy population [published online ahead of print April 5, 2018]? Arch Clin Neuropsychol. doi: 10.1093/arclin/acy027

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Arch Clin Neuropsychol; ePub 2018 Apr 5; Maiman et al
Arch Clin Neuropsychol; ePub 2018 Apr 5; Maiman et al

The commonly accepted cutoff scores for reliable digit span (RDS), a way to measure attention and working memory and assess suboptimal effort, are not appropriate for adults with epilepsy, according to a study of 63 patients with epilepsy or suspected seizures.

  • A cutoff of ≤6 or ≤7 for RDS, which is part of the Wechsler Adult Intelligence Scale, is typically used in adult clinical populations.
  • Maiman et al applied these thresholds to adult patients with epilepsy or suspected seizures, most of whom passed trial 2 of the Test for Memory Malingering with a score of 45 or above.
  • A cutoff of 6 or less on the RDS subtest yielded a specificity of 85% while 7 or less yielded 77%.
  • A secondary analysis concluded that a cutoff of 4 or less may be more appropriate for adults with epilepsy who have a low average IQ or lower.

 

Maiman M, Del Bene VA, MacAllister WS, et al. Reliable digit span: does it adequately measure suboptimal effort in an adult epilepsy population [published online ahead of print April 5, 2018]? Arch Clin Neuropsychol. doi: 10.1093/arclin/acy027

The commonly accepted cutoff scores for reliable digit span (RDS), a way to measure attention and working memory and assess suboptimal effort, are not appropriate for adults with epilepsy, according to a study of 63 patients with epilepsy or suspected seizures.

  • A cutoff of ≤6 or ≤7 for RDS, which is part of the Wechsler Adult Intelligence Scale, is typically used in adult clinical populations.
  • Maiman et al applied these thresholds to adult patients with epilepsy or suspected seizures, most of whom passed trial 2 of the Test for Memory Malingering with a score of 45 or above.
  • A cutoff of 6 or less on the RDS subtest yielded a specificity of 85% while 7 or less yielded 77%.
  • A secondary analysis concluded that a cutoff of 4 or less may be more appropriate for adults with epilepsy who have a low average IQ or lower.

 

Maiman M, Del Bene VA, MacAllister WS, et al. Reliable digit span: does it adequately measure suboptimal effort in an adult epilepsy population [published online ahead of print April 5, 2018]? Arch Clin Neuropsychol. doi: 10.1093/arclin/acy027

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International travel updates

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It’s that time of year again. Many of your patients will join the 80.2 million Americans with plans for international travel this summer.

In 2016, Mexico (31.2 million) and Canada (13.9 million) were the top two destinations of U.S. residents. Based on 2016 U.S. Commerce data, an additional 35.1 million Americans headed to overseas destinations, including 9% who traveled with children. Vacation and visiting friends and relatives accounted for 55% and 27% of the reasons for all travel, respectively. Education accounted for 4% of travelers.

GOLFX/Getty Images
Europe (36%) and the Caribbean (23%) were the top overseas destinations followed by Asia (19%), Central America (8%), and South America (7%). Collectively, the Middle East, Africa, and Oceania accounted for the remaining destinations. On average, the trips were planned at least 3 months in advance. However, only 12% visited a health care provider in advance of the trip. Why the disparity? Is it the destination? Is advice only sought for travel to what is perceived as underdeveloped regions? Is it only the need for a required vaccine for entry that prompts a visit? No matter the destination, you want to make sure your patients are medically prepared and only return home with one thing: souvenirs.
 

Required versus recommended vaccines

The goal of a required vaccine is to prevent international spread of disease. The host country is protecting its citizens from visitors importing and facilitating the spread of a disease. Yellow fever and meningococcal disease are the only vaccines required for entry into any country. Entry requirements vary by country. Yellow fever may be an entry requirement for all travelers or it may be limited to those who have been in, or have had transit through, a country where yellow fever can be transmitted at least 6 days prior to the arrival at their final destination – a reminder that the sequence of the patient’s itinerary is important. In addition, just because a vaccine is not required for entry does not mean the risk for exposure and acquisition is nonexistent.

In contrast, recommended vaccines are for the protection of the individual. Travelers may be exposed to vaccine-preventable diseases that do not exist in their country (such as measles, typhoid fever, and yellow fever). They are at risk for acquisition and may return home infected, which could create the potential to spread the disease to susceptible contacts.

Most travelers comprehend required vaccines but often fail to understand the importance of receiving recommended vaccines. Lammert et al. reported that, of 24,478 persons who received pretravel advice between July 2012 and June 2014 through Global TravEpiNet, a national consortium of U.S. clinics, 97% were eligible for at least one vaccine. The majority were eligible for typhoid (n = 20,092) and hepatitis A (n = 12,990). Of patients included in the study, 25% (6,573) refused one or more vaccines. The most common reason cited for refusal was a lack of concern about the illness. Travelers visiting friends and relatives were less likely to accept all recommended vaccines, compared with those who were not visiting friends and relatives (odds ratio, 0.74) (J Trav Med. 2017 Jan. doi: 10.1093/jtm/taw075). In the United States, international travel remains the most common risk factor for acquisition of both typhoid fever and hepatitis A.

 

 

What’s new

The U.S. Advisory Committee on Immunization Practices recommends administering the hepatitis A vaccine to infants aged 6-11 months with travel to or living in developing countries and areas with high to moderate risk for hepatitis A virus transmission. Any dose received at less than 12 months of age does not count, and the administration of two age-appropriate doses should occur following this dose.

Old but still relevant

Measles: The Advisory Committee on Immunization Practices recommends all infants aged 6-11 months receive one dose of MMR prior to international travel regardless of the destination. This should be followed by two additional countable doses. All persons at least 12 months of age and born after 1956 should receive two doses of MMR at least 28 days apart prior to international travel.

Prior to administering, determine whether your patient will travel to a yellow fever–endemic area because both are live vaccines and should be received the same day. Otherwise, administer MMR doses 28 days apart; coordination between facilities or receipt of both at one facility may be necessary.

Yellow fever vaccine: The U.S. supplies of YF-Vax by Sanofi Pasteur are not expected to be available again until the end of 2018. To provide vaccines for U.S. travelers, Stamaril – a yellow fever vaccine produced by Sanofi Pasteur in France – has been made available at more than 250 sites through an Expanded Access Investigational New Drug Program.

Since Stamaril is offered at a limited number of locations, persons with anticipated travel to a country where receipt of yellow fever vaccine is either required for entry or recommended for their protection should not wait until the last minute to obtain it. Postponing a trip or changing a destination is preferred if vaccine is not received, especially when the person is traveling to countries with an ongoing outbreak.

The vaccination does not become valid until 10 days after receipt. Infants aged at least 9 months may receive the vaccine. Since the yellow fever vaccine is a live vaccine, administration may be contraindicated in certain individuals. Exemption letters are provided for those with medical contraindication.

To locate a Stamaril site in your area: https://wwwnc.cdc.gov/travel/page/search-for-stamaril-clinics.

 

 

Current disease outbreaks

Yellow fever: Brazil

Since Dec. 2017, more than 1,100 laboratory-confirmed cases of yellow fever have been reported, including 17 reported in unvaccinated international travelers. Fatal cases also have been reported. In addition to areas in Brazil where yellow fever vaccination had been recommended prior to the recent outbreaks, the vaccine now also is recommended for people who are traveling to or living in all of Espírito Santo State, São Paulo State, and Rio de Janeiro State, as well as several cities in Bahia State. Unvaccinated travelers should avoid travel to areas where vaccination is recommended. Those previously vaccinated at 10 years ago or longer should consider a booster.

Listeria: South Africa

An ongoing outbreak has been reported since Jan. 2017. Around 1,000 people have been infected. Avoid consumption of processed meats including “Polony” (South African bologna).

Measles: Belarus, Japan, Liberia, and Taiwan

All countries have reported an increase in cases since April 2018. Measles outbreaks have been reported in an additional 13 countries since Jan. 2018, including France, Ireland, Italy, the Philippines, and the United Kingdom.

Norovirus: Canada

More than 120 cases have been linked to consumption of raw or lightly cooked oysters from western Canada.



Dr. Bonnie M. Word
So how do you assist your patients? The best thing you can do is to make sure their routine immunizations are up to date and to encourage them to seek pretravel advice 4-6 weeks prior to international travel.

For more country-specific information and up to date travel alerts, visit http://www.cdc.gov/travel.
 

Dr. Word is a pediatric infectious disease specialist and the director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures.

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It’s that time of year again. Many of your patients will join the 80.2 million Americans with plans for international travel this summer.

In 2016, Mexico (31.2 million) and Canada (13.9 million) were the top two destinations of U.S. residents. Based on 2016 U.S. Commerce data, an additional 35.1 million Americans headed to overseas destinations, including 9% who traveled with children. Vacation and visiting friends and relatives accounted for 55% and 27% of the reasons for all travel, respectively. Education accounted for 4% of travelers.

GOLFX/Getty Images
Europe (36%) and the Caribbean (23%) were the top overseas destinations followed by Asia (19%), Central America (8%), and South America (7%). Collectively, the Middle East, Africa, and Oceania accounted for the remaining destinations. On average, the trips were planned at least 3 months in advance. However, only 12% visited a health care provider in advance of the trip. Why the disparity? Is it the destination? Is advice only sought for travel to what is perceived as underdeveloped regions? Is it only the need for a required vaccine for entry that prompts a visit? No matter the destination, you want to make sure your patients are medically prepared and only return home with one thing: souvenirs.
 

Required versus recommended vaccines

The goal of a required vaccine is to prevent international spread of disease. The host country is protecting its citizens from visitors importing and facilitating the spread of a disease. Yellow fever and meningococcal disease are the only vaccines required for entry into any country. Entry requirements vary by country. Yellow fever may be an entry requirement for all travelers or it may be limited to those who have been in, or have had transit through, a country where yellow fever can be transmitted at least 6 days prior to the arrival at their final destination – a reminder that the sequence of the patient’s itinerary is important. In addition, just because a vaccine is not required for entry does not mean the risk for exposure and acquisition is nonexistent.

In contrast, recommended vaccines are for the protection of the individual. Travelers may be exposed to vaccine-preventable diseases that do not exist in their country (such as measles, typhoid fever, and yellow fever). They are at risk for acquisition and may return home infected, which could create the potential to spread the disease to susceptible contacts.

Most travelers comprehend required vaccines but often fail to understand the importance of receiving recommended vaccines. Lammert et al. reported that, of 24,478 persons who received pretravel advice between July 2012 and June 2014 through Global TravEpiNet, a national consortium of U.S. clinics, 97% were eligible for at least one vaccine. The majority were eligible for typhoid (n = 20,092) and hepatitis A (n = 12,990). Of patients included in the study, 25% (6,573) refused one or more vaccines. The most common reason cited for refusal was a lack of concern about the illness. Travelers visiting friends and relatives were less likely to accept all recommended vaccines, compared with those who were not visiting friends and relatives (odds ratio, 0.74) (J Trav Med. 2017 Jan. doi: 10.1093/jtm/taw075). In the United States, international travel remains the most common risk factor for acquisition of both typhoid fever and hepatitis A.

 

 

What’s new

The U.S. Advisory Committee on Immunization Practices recommends administering the hepatitis A vaccine to infants aged 6-11 months with travel to or living in developing countries and areas with high to moderate risk for hepatitis A virus transmission. Any dose received at less than 12 months of age does not count, and the administration of two age-appropriate doses should occur following this dose.

Old but still relevant

Measles: The Advisory Committee on Immunization Practices recommends all infants aged 6-11 months receive one dose of MMR prior to international travel regardless of the destination. This should be followed by two additional countable doses. All persons at least 12 months of age and born after 1956 should receive two doses of MMR at least 28 days apart prior to international travel.

Prior to administering, determine whether your patient will travel to a yellow fever–endemic area because both are live vaccines and should be received the same day. Otherwise, administer MMR doses 28 days apart; coordination between facilities or receipt of both at one facility may be necessary.

Yellow fever vaccine: The U.S. supplies of YF-Vax by Sanofi Pasteur are not expected to be available again until the end of 2018. To provide vaccines for U.S. travelers, Stamaril – a yellow fever vaccine produced by Sanofi Pasteur in France – has been made available at more than 250 sites through an Expanded Access Investigational New Drug Program.

Since Stamaril is offered at a limited number of locations, persons with anticipated travel to a country where receipt of yellow fever vaccine is either required for entry or recommended for their protection should not wait until the last minute to obtain it. Postponing a trip or changing a destination is preferred if vaccine is not received, especially when the person is traveling to countries with an ongoing outbreak.

The vaccination does not become valid until 10 days after receipt. Infants aged at least 9 months may receive the vaccine. Since the yellow fever vaccine is a live vaccine, administration may be contraindicated in certain individuals. Exemption letters are provided for those with medical contraindication.

To locate a Stamaril site in your area: https://wwwnc.cdc.gov/travel/page/search-for-stamaril-clinics.

 

 

Current disease outbreaks

Yellow fever: Brazil

Since Dec. 2017, more than 1,100 laboratory-confirmed cases of yellow fever have been reported, including 17 reported in unvaccinated international travelers. Fatal cases also have been reported. In addition to areas in Brazil where yellow fever vaccination had been recommended prior to the recent outbreaks, the vaccine now also is recommended for people who are traveling to or living in all of Espírito Santo State, São Paulo State, and Rio de Janeiro State, as well as several cities in Bahia State. Unvaccinated travelers should avoid travel to areas where vaccination is recommended. Those previously vaccinated at 10 years ago or longer should consider a booster.

Listeria: South Africa

An ongoing outbreak has been reported since Jan. 2017. Around 1,000 people have been infected. Avoid consumption of processed meats including “Polony” (South African bologna).

Measles: Belarus, Japan, Liberia, and Taiwan

All countries have reported an increase in cases since April 2018. Measles outbreaks have been reported in an additional 13 countries since Jan. 2018, including France, Ireland, Italy, the Philippines, and the United Kingdom.

Norovirus: Canada

More than 120 cases have been linked to consumption of raw or lightly cooked oysters from western Canada.



Dr. Bonnie M. Word
So how do you assist your patients? The best thing you can do is to make sure their routine immunizations are up to date and to encourage them to seek pretravel advice 4-6 weeks prior to international travel.

For more country-specific information and up to date travel alerts, visit http://www.cdc.gov/travel.
 

Dr. Word is a pediatric infectious disease specialist and the director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures.

It’s that time of year again. Many of your patients will join the 80.2 million Americans with plans for international travel this summer.

In 2016, Mexico (31.2 million) and Canada (13.9 million) were the top two destinations of U.S. residents. Based on 2016 U.S. Commerce data, an additional 35.1 million Americans headed to overseas destinations, including 9% who traveled with children. Vacation and visiting friends and relatives accounted for 55% and 27% of the reasons for all travel, respectively. Education accounted for 4% of travelers.

GOLFX/Getty Images
Europe (36%) and the Caribbean (23%) were the top overseas destinations followed by Asia (19%), Central America (8%), and South America (7%). Collectively, the Middle East, Africa, and Oceania accounted for the remaining destinations. On average, the trips were planned at least 3 months in advance. However, only 12% visited a health care provider in advance of the trip. Why the disparity? Is it the destination? Is advice only sought for travel to what is perceived as underdeveloped regions? Is it only the need for a required vaccine for entry that prompts a visit? No matter the destination, you want to make sure your patients are medically prepared and only return home with one thing: souvenirs.
 

Required versus recommended vaccines

The goal of a required vaccine is to prevent international spread of disease. The host country is protecting its citizens from visitors importing and facilitating the spread of a disease. Yellow fever and meningococcal disease are the only vaccines required for entry into any country. Entry requirements vary by country. Yellow fever may be an entry requirement for all travelers or it may be limited to those who have been in, or have had transit through, a country where yellow fever can be transmitted at least 6 days prior to the arrival at their final destination – a reminder that the sequence of the patient’s itinerary is important. In addition, just because a vaccine is not required for entry does not mean the risk for exposure and acquisition is nonexistent.

In contrast, recommended vaccines are for the protection of the individual. Travelers may be exposed to vaccine-preventable diseases that do not exist in their country (such as measles, typhoid fever, and yellow fever). They are at risk for acquisition and may return home infected, which could create the potential to spread the disease to susceptible contacts.

Most travelers comprehend required vaccines but often fail to understand the importance of receiving recommended vaccines. Lammert et al. reported that, of 24,478 persons who received pretravel advice between July 2012 and June 2014 through Global TravEpiNet, a national consortium of U.S. clinics, 97% were eligible for at least one vaccine. The majority were eligible for typhoid (n = 20,092) and hepatitis A (n = 12,990). Of patients included in the study, 25% (6,573) refused one or more vaccines. The most common reason cited for refusal was a lack of concern about the illness. Travelers visiting friends and relatives were less likely to accept all recommended vaccines, compared with those who were not visiting friends and relatives (odds ratio, 0.74) (J Trav Med. 2017 Jan. doi: 10.1093/jtm/taw075). In the United States, international travel remains the most common risk factor for acquisition of both typhoid fever and hepatitis A.

 

 

What’s new

The U.S. Advisory Committee on Immunization Practices recommends administering the hepatitis A vaccine to infants aged 6-11 months with travel to or living in developing countries and areas with high to moderate risk for hepatitis A virus transmission. Any dose received at less than 12 months of age does not count, and the administration of two age-appropriate doses should occur following this dose.

Old but still relevant

Measles: The Advisory Committee on Immunization Practices recommends all infants aged 6-11 months receive one dose of MMR prior to international travel regardless of the destination. This should be followed by two additional countable doses. All persons at least 12 months of age and born after 1956 should receive two doses of MMR at least 28 days apart prior to international travel.

Prior to administering, determine whether your patient will travel to a yellow fever–endemic area because both are live vaccines and should be received the same day. Otherwise, administer MMR doses 28 days apart; coordination between facilities or receipt of both at one facility may be necessary.

Yellow fever vaccine: The U.S. supplies of YF-Vax by Sanofi Pasteur are not expected to be available again until the end of 2018. To provide vaccines for U.S. travelers, Stamaril – a yellow fever vaccine produced by Sanofi Pasteur in France – has been made available at more than 250 sites through an Expanded Access Investigational New Drug Program.

Since Stamaril is offered at a limited number of locations, persons with anticipated travel to a country where receipt of yellow fever vaccine is either required for entry or recommended for their protection should not wait until the last minute to obtain it. Postponing a trip or changing a destination is preferred if vaccine is not received, especially when the person is traveling to countries with an ongoing outbreak.

The vaccination does not become valid until 10 days after receipt. Infants aged at least 9 months may receive the vaccine. Since the yellow fever vaccine is a live vaccine, administration may be contraindicated in certain individuals. Exemption letters are provided for those with medical contraindication.

To locate a Stamaril site in your area: https://wwwnc.cdc.gov/travel/page/search-for-stamaril-clinics.

 

 

Current disease outbreaks

Yellow fever: Brazil

Since Dec. 2017, more than 1,100 laboratory-confirmed cases of yellow fever have been reported, including 17 reported in unvaccinated international travelers. Fatal cases also have been reported. In addition to areas in Brazil where yellow fever vaccination had been recommended prior to the recent outbreaks, the vaccine now also is recommended for people who are traveling to or living in all of Espírito Santo State, São Paulo State, and Rio de Janeiro State, as well as several cities in Bahia State. Unvaccinated travelers should avoid travel to areas where vaccination is recommended. Those previously vaccinated at 10 years ago or longer should consider a booster.

Listeria: South Africa

An ongoing outbreak has been reported since Jan. 2017. Around 1,000 people have been infected. Avoid consumption of processed meats including “Polony” (South African bologna).

Measles: Belarus, Japan, Liberia, and Taiwan

All countries have reported an increase in cases since April 2018. Measles outbreaks have been reported in an additional 13 countries since Jan. 2018, including France, Ireland, Italy, the Philippines, and the United Kingdom.

Norovirus: Canada

More than 120 cases have been linked to consumption of raw or lightly cooked oysters from western Canada.



Dr. Bonnie M. Word
So how do you assist your patients? The best thing you can do is to make sure their routine immunizations are up to date and to encourage them to seek pretravel advice 4-6 weeks prior to international travel.

For more country-specific information and up to date travel alerts, visit http://www.cdc.gov/travel.
 

Dr. Word is a pediatric infectious disease specialist and the director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures.

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Underserved Hispanic Patients Respond Well to Epilepsy Surgery

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Epilepsy Behav; 2018 June; Smith et al

Performing epilepsy surgery on underserved Hispanic patients with intractable epilepsy relieves their depression and anxiety and improves their quality of life, according to study of 47 patients between 2008 and 2014.

  • Hispanic patients, most of whom were immigrant and Spanish speaking, were treated at a comprehensive epilepsy center in an urban public health setting.
  • They underwent presurgical and postsurgical neuropsychological evaluation and were identified retrospectively.
  • Medium to large improvements on the Beck Depression Inventory and most quality of care scales were observed postsurgery.
  • Less robust effects were also seen on the Beck Anxiety Inventory.

 

Smith JA, Armacost M, Ensign E, et al. Epilepsy surgery in the underserved Hispanic population improves depression, anxiety, and quality of life. Epilepsy Behav. 2018;83:1-6. https://doi.org/10.1016/j.yebeh.2018.03.015

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Epilepsy Behav; 2018 June; Smith et al
Epilepsy Behav; 2018 June; Smith et al

Performing epilepsy surgery on underserved Hispanic patients with intractable epilepsy relieves their depression and anxiety and improves their quality of life, according to study of 47 patients between 2008 and 2014.

  • Hispanic patients, most of whom were immigrant and Spanish speaking, were treated at a comprehensive epilepsy center in an urban public health setting.
  • They underwent presurgical and postsurgical neuropsychological evaluation and were identified retrospectively.
  • Medium to large improvements on the Beck Depression Inventory and most quality of care scales were observed postsurgery.
  • Less robust effects were also seen on the Beck Anxiety Inventory.

 

Smith JA, Armacost M, Ensign E, et al. Epilepsy surgery in the underserved Hispanic population improves depression, anxiety, and quality of life. Epilepsy Behav. 2018;83:1-6. https://doi.org/10.1016/j.yebeh.2018.03.015

Performing epilepsy surgery on underserved Hispanic patients with intractable epilepsy relieves their depression and anxiety and improves their quality of life, according to study of 47 patients between 2008 and 2014.

  • Hispanic patients, most of whom were immigrant and Spanish speaking, were treated at a comprehensive epilepsy center in an urban public health setting.
  • They underwent presurgical and postsurgical neuropsychological evaluation and were identified retrospectively.
  • Medium to large improvements on the Beck Depression Inventory and most quality of care scales were observed postsurgery.
  • Less robust effects were also seen on the Beck Anxiety Inventory.

 

Smith JA, Armacost M, Ensign E, et al. Epilepsy surgery in the underserved Hispanic population improves depression, anxiety, and quality of life. Epilepsy Behav. 2018;83:1-6. https://doi.org/10.1016/j.yebeh.2018.03.015

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Survey sheds light on consumer preferences regarding cosmetic procedures

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– The most important referral sources for cosmetic procedures are physicians and family members and friends, but there appears to be a knowledge gap as to which cosmetic providers are actually medical doctors, results from an online survey found.

“There are approximately 16 million cosmetic procedures performed in the U.S., and that number is growing rapidly,” study author Adam J. Wulkan, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “They’re performed by dermatologists, plastic surgeons, facial plastic surgeons, nurses, aestheticians, dentists, and more. Yet little is known regarding how consumers choose cosmetic procedures and providers.”

In an effort to elucidate how consumers research, self-educate, and choose cosmetic surgery procedures and providers, Dr. Wulkan and his associates used Survey Monkey to send a 20-item survey to 931 individuals in the United States. Respondents qualified for participation if they acknowledged having obtained or considered obtaining a cosmetic procedure. Of the 931 individuals polled, 323 (35%) met inclusion criteria; 84 (9%) had received a cosmetic procedure, and 239 (26%) had considered one. Nearly three-quarters of respondents (73%) were female; 22% of respondents were aged 18-29 years, 25% were aged 30-44 years, 29% were aged 45-59 years, and 24% were aged 60 years and older.

The top three sources for referral to cosmetic procedures/providers were physicians (67%), family or friends (57%), and Google searches (51%). However, fewer than half of respondents (42.5%) had a procedure performed after having a consultation. Reasons for this could be related to several factors, Dr. Wulkan said, including the cost of the procedure, fear of adverse events, or not being an appropriate candidate for treatment at the time of consultation.

 

 


The most popular cosmetic procedures were laser hair removal (28%), laser/light therapy (25%), abdominoplasty (25%), injectables (24%), and noninvasive fat reduction (24%). The survey also asked whether certain providers were medical doctors or not, and 89% of respondents thought plastic surgeons were medical doctors, and 82% thought that dermatologists were medical doctors; the respondents also thought dentists (52%), aestheticians (20%), and nurses (11%) were medical doctors. “There’s an education gap regarding which providers are medical doctors,” said Dr. Wulkan, who is a cosmetic laser and dermatology fellow at Massachusetts General Hospital, Boston. “With the growing number of nonphysician aesthetic providers, consumer education might be a valuable tool.”

Most respondents (82%) checked physician credentials prior to treatment. In addition, they were most likely to have their cosmetic procedures performed by either a plastic surgeon or by a dermatologist.

Dr. Wulkan acknowledged certain limitations of the study, including the sample size and reliability of the answers. He reported having no financial disclosures. One study coauthor had various ties to industry companies, including Allergan, Revance Therapeutics, and Cytrellis Biosystems.
 
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– The most important referral sources for cosmetic procedures are physicians and family members and friends, but there appears to be a knowledge gap as to which cosmetic providers are actually medical doctors, results from an online survey found.

“There are approximately 16 million cosmetic procedures performed in the U.S., and that number is growing rapidly,” study author Adam J. Wulkan, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “They’re performed by dermatologists, plastic surgeons, facial plastic surgeons, nurses, aestheticians, dentists, and more. Yet little is known regarding how consumers choose cosmetic procedures and providers.”

In an effort to elucidate how consumers research, self-educate, and choose cosmetic surgery procedures and providers, Dr. Wulkan and his associates used Survey Monkey to send a 20-item survey to 931 individuals in the United States. Respondents qualified for participation if they acknowledged having obtained or considered obtaining a cosmetic procedure. Of the 931 individuals polled, 323 (35%) met inclusion criteria; 84 (9%) had received a cosmetic procedure, and 239 (26%) had considered one. Nearly three-quarters of respondents (73%) were female; 22% of respondents were aged 18-29 years, 25% were aged 30-44 years, 29% were aged 45-59 years, and 24% were aged 60 years and older.

The top three sources for referral to cosmetic procedures/providers were physicians (67%), family or friends (57%), and Google searches (51%). However, fewer than half of respondents (42.5%) had a procedure performed after having a consultation. Reasons for this could be related to several factors, Dr. Wulkan said, including the cost of the procedure, fear of adverse events, or not being an appropriate candidate for treatment at the time of consultation.

 

 


The most popular cosmetic procedures were laser hair removal (28%), laser/light therapy (25%), abdominoplasty (25%), injectables (24%), and noninvasive fat reduction (24%). The survey also asked whether certain providers were medical doctors or not, and 89% of respondents thought plastic surgeons were medical doctors, and 82% thought that dermatologists were medical doctors; the respondents also thought dentists (52%), aestheticians (20%), and nurses (11%) were medical doctors. “There’s an education gap regarding which providers are medical doctors,” said Dr. Wulkan, who is a cosmetic laser and dermatology fellow at Massachusetts General Hospital, Boston. “With the growing number of nonphysician aesthetic providers, consumer education might be a valuable tool.”

Most respondents (82%) checked physician credentials prior to treatment. In addition, they were most likely to have their cosmetic procedures performed by either a plastic surgeon or by a dermatologist.

Dr. Wulkan acknowledged certain limitations of the study, including the sample size and reliability of the answers. He reported having no financial disclosures. One study coauthor had various ties to industry companies, including Allergan, Revance Therapeutics, and Cytrellis Biosystems.
 

 

– The most important referral sources for cosmetic procedures are physicians and family members and friends, but there appears to be a knowledge gap as to which cosmetic providers are actually medical doctors, results from an online survey found.

“There are approximately 16 million cosmetic procedures performed in the U.S., and that number is growing rapidly,” study author Adam J. Wulkan, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “They’re performed by dermatologists, plastic surgeons, facial plastic surgeons, nurses, aestheticians, dentists, and more. Yet little is known regarding how consumers choose cosmetic procedures and providers.”

In an effort to elucidate how consumers research, self-educate, and choose cosmetic surgery procedures and providers, Dr. Wulkan and his associates used Survey Monkey to send a 20-item survey to 931 individuals in the United States. Respondents qualified for participation if they acknowledged having obtained or considered obtaining a cosmetic procedure. Of the 931 individuals polled, 323 (35%) met inclusion criteria; 84 (9%) had received a cosmetic procedure, and 239 (26%) had considered one. Nearly three-quarters of respondents (73%) were female; 22% of respondents were aged 18-29 years, 25% were aged 30-44 years, 29% were aged 45-59 years, and 24% were aged 60 years and older.

The top three sources for referral to cosmetic procedures/providers were physicians (67%), family or friends (57%), and Google searches (51%). However, fewer than half of respondents (42.5%) had a procedure performed after having a consultation. Reasons for this could be related to several factors, Dr. Wulkan said, including the cost of the procedure, fear of adverse events, or not being an appropriate candidate for treatment at the time of consultation.

 

 


The most popular cosmetic procedures were laser hair removal (28%), laser/light therapy (25%), abdominoplasty (25%), injectables (24%), and noninvasive fat reduction (24%). The survey also asked whether certain providers were medical doctors or not, and 89% of respondents thought plastic surgeons were medical doctors, and 82% thought that dermatologists were medical doctors; the respondents also thought dentists (52%), aestheticians (20%), and nurses (11%) were medical doctors. “There’s an education gap regarding which providers are medical doctors,” said Dr. Wulkan, who is a cosmetic laser and dermatology fellow at Massachusetts General Hospital, Boston. “With the growing number of nonphysician aesthetic providers, consumer education might be a valuable tool.”

Most respondents (82%) checked physician credentials prior to treatment. In addition, they were most likely to have their cosmetic procedures performed by either a plastic surgeon or by a dermatologist.

Dr. Wulkan acknowledged certain limitations of the study, including the sample size and reliability of the answers. He reported having no financial disclosures. One study coauthor had various ties to industry companies, including Allergan, Revance Therapeutics, and Cytrellis Biosystems.
 
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REPORTING FROM ASLMS 2018

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Key clinical point: An education gap exists regarding which cosmetic surgery providers are medical doctors.


Major finding: Physicians were the top source of referral to cosmetic procedures/providers, yet only 82% of consumers believe that dermatologists are medical doctors.


Study details: Responses from 323 consumers who completed a 20-item online survey about cosmetic surgery procedures and providers.


Disclosures: Dr. Wulkan reported having no financial disclosures. One study coauthor had various ties to industry companies, including Allergan, Revance, and Cytrellis.

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New cases of Merkel cell carcinoma increased 95% between 2000 and 2013

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FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

The number of new cases per year of Merkel cell carcinoma (MCC) increased by 95% during 2000-2013, according to a review of Surveillance, Epidemiology, and End Results (SEER) data.

There were 652 cases of MCC in the SEER-18 registry in 2013, up from the 334 cases captured by the database in 2000.

This increase exceeded the 56.5% increase seen with melanoma over the same time period, the investigators wrote in the Journal of the American Academy of Dermatology.

The total number of incident MCC cases in the United States in 2013 was calculated as 2,488 cases/year by using SEER-derived incidence rates combined with U.S. Census population data. The MCC incidence rate rose precipitously with age, increasing 10-fold between ages 40-44 years (0.1 cases/100,000 person-years) and ages 60-64 years (0.9 cases/100,000 person-years).

Given the aging of the population and an assumption that the incidence rates within any given age group will remain stable, the annual incidence of Merkel cell carcinoma in the United States will increase to 3,284 cases/year in 2025, Kelly G. Paulson, MD, PhD, of the Fred Hutchinson Cancer Research Center, Seattle, and her colleagues projected.

“The incidence of MCC is increasing and will likely continue to rise as the Baby Boomer population enters the higher-risk age groups for MCC,” Dr. Paulson and colleagues said. ”Because of its high propensity for spread, the need for adjuvant radiation in many cases, and the clear role for early immunotherapy in the metastatic setting, both early detection and optimal management will be critical for improved outcomes,” they concluded.

SOURCE: Paulson KG et al. J Am Acad Derm. 2018 Mar;78(3):457-463.

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FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

The number of new cases per year of Merkel cell carcinoma (MCC) increased by 95% during 2000-2013, according to a review of Surveillance, Epidemiology, and End Results (SEER) data.

There were 652 cases of MCC in the SEER-18 registry in 2013, up from the 334 cases captured by the database in 2000.

This increase exceeded the 56.5% increase seen with melanoma over the same time period, the investigators wrote in the Journal of the American Academy of Dermatology.

The total number of incident MCC cases in the United States in 2013 was calculated as 2,488 cases/year by using SEER-derived incidence rates combined with U.S. Census population data. The MCC incidence rate rose precipitously with age, increasing 10-fold between ages 40-44 years (0.1 cases/100,000 person-years) and ages 60-64 years (0.9 cases/100,000 person-years).

Given the aging of the population and an assumption that the incidence rates within any given age group will remain stable, the annual incidence of Merkel cell carcinoma in the United States will increase to 3,284 cases/year in 2025, Kelly G. Paulson, MD, PhD, of the Fred Hutchinson Cancer Research Center, Seattle, and her colleagues projected.

“The incidence of MCC is increasing and will likely continue to rise as the Baby Boomer population enters the higher-risk age groups for MCC,” Dr. Paulson and colleagues said. ”Because of its high propensity for spread, the need for adjuvant radiation in many cases, and the clear role for early immunotherapy in the metastatic setting, both early detection and optimal management will be critical for improved outcomes,” they concluded.

SOURCE: Paulson KG et al. J Am Acad Derm. 2018 Mar;78(3):457-463.

 

FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

The number of new cases per year of Merkel cell carcinoma (MCC) increased by 95% during 2000-2013, according to a review of Surveillance, Epidemiology, and End Results (SEER) data.

There were 652 cases of MCC in the SEER-18 registry in 2013, up from the 334 cases captured by the database in 2000.

This increase exceeded the 56.5% increase seen with melanoma over the same time period, the investigators wrote in the Journal of the American Academy of Dermatology.

The total number of incident MCC cases in the United States in 2013 was calculated as 2,488 cases/year by using SEER-derived incidence rates combined with U.S. Census population data. The MCC incidence rate rose precipitously with age, increasing 10-fold between ages 40-44 years (0.1 cases/100,000 person-years) and ages 60-64 years (0.9 cases/100,000 person-years).

Given the aging of the population and an assumption that the incidence rates within any given age group will remain stable, the annual incidence of Merkel cell carcinoma in the United States will increase to 3,284 cases/year in 2025, Kelly G. Paulson, MD, PhD, of the Fred Hutchinson Cancer Research Center, Seattle, and her colleagues projected.

“The incidence of MCC is increasing and will likely continue to rise as the Baby Boomer population enters the higher-risk age groups for MCC,” Dr. Paulson and colleagues said. ”Because of its high propensity for spread, the need for adjuvant radiation in many cases, and the clear role for early immunotherapy in the metastatic setting, both early detection and optimal management will be critical for improved outcomes,” they concluded.

SOURCE: Paulson KG et al. J Am Acad Derm. 2018 Mar;78(3):457-463.

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Key clinical point: The incidence of Merkel cell carcinoma (MCC) is expected to continue at a brisk increase.

Major finding: During 2000-2013, the rate of new U.S. MCC cases increased by 95% to 2,488 diagnoses/year.

Study details: Incidence and future projections were calculated by combining registry data from the SEER-18 Database and U.S. Census data.

Disclosures: The study was funded by grants from the National Institutes of Health, the Prostate Cancer Foundation, the University of Washington MCC Patient Gift Fund, and the Bloom endowment at University of Washington in Seattle. One coauthor disclosed support from EMD Serono, Pfizer, and Bristol-Meyers Squibb. All other authors had no conflicts of interest.

Source: Paulson KG et al. J Am Acad Derm. 2018 Mar;78(3): 457-63.

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VIDEO: Assessing consumer knowledge about cosmetic procedures

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– Most people rely on physicians, family, and friends to obtain relevant information about cosmetic procedures, but a knowledge gap exists regarding which cosmetic providers are medical doctors.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Those are two key findings from a national survey that set out to assess how consumers research, educate themselves, and choose cosmetic procedures and providers. At the annual conference of the American Society for Laser Medicine and Surgery, study author Adam J. Wulkan, MD, discussed results from the 20-item survey, which was based on responses from 323 people who have obtained or have considered obtaining a cosmetic procedure such as laser hair removal.

Dr. Wulkan is a dermatologist at Massachusetts General Hospital, Boston. He reported having no financial disclosures. Study coauthor Mathew Avram, MD, serves on the medical advisory board of Sciton and on the scientific advisory boards of Sienna Biopharmaceuticals, Cytrellis, and Allergan. He also is consultant for Merz Aesthetics, Allergan, Soliton, Invasix, and Revance, and has intellectual property with Cytrellis. He also holds stock options with Cytrellis, Invasix, and Zalea.

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– Most people rely on physicians, family, and friends to obtain relevant information about cosmetic procedures, but a knowledge gap exists regarding which cosmetic providers are medical doctors.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Those are two key findings from a national survey that set out to assess how consumers research, educate themselves, and choose cosmetic procedures and providers. At the annual conference of the American Society for Laser Medicine and Surgery, study author Adam J. Wulkan, MD, discussed results from the 20-item survey, which was based on responses from 323 people who have obtained or have considered obtaining a cosmetic procedure such as laser hair removal.

Dr. Wulkan is a dermatologist at Massachusetts General Hospital, Boston. He reported having no financial disclosures. Study coauthor Mathew Avram, MD, serves on the medical advisory board of Sciton and on the scientific advisory boards of Sienna Biopharmaceuticals, Cytrellis, and Allergan. He also is consultant for Merz Aesthetics, Allergan, Soliton, Invasix, and Revance, and has intellectual property with Cytrellis. He also holds stock options with Cytrellis, Invasix, and Zalea.

 

– Most people rely on physicians, family, and friends to obtain relevant information about cosmetic procedures, but a knowledge gap exists regarding which cosmetic providers are medical doctors.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Those are two key findings from a national survey that set out to assess how consumers research, educate themselves, and choose cosmetic procedures and providers. At the annual conference of the American Society for Laser Medicine and Surgery, study author Adam J. Wulkan, MD, discussed results from the 20-item survey, which was based on responses from 323 people who have obtained or have considered obtaining a cosmetic procedure such as laser hair removal.

Dr. Wulkan is a dermatologist at Massachusetts General Hospital, Boston. He reported having no financial disclosures. Study coauthor Mathew Avram, MD, serves on the medical advisory board of Sciton and on the scientific advisory boards of Sienna Biopharmaceuticals, Cytrellis, and Allergan. He also is consultant for Merz Aesthetics, Allergan, Soliton, Invasix, and Revance, and has intellectual property with Cytrellis. He also holds stock options with Cytrellis, Invasix, and Zalea.

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Alternate 2:1 sunitinib schedule showed safety gains in renal cell carcinoma

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For adults with metastatic, treatment-naive renal clear cell carcinoma, an alternate (2 weeks on, 1 week off) oral sunitinib schedule might be more tolerable than the approved 4:2 schedule, according to the results of a single-arm, multicenter, phase 2 trial.

After a median follow-up of 17 months, 25% of 59 patients had experienced grade 3 fatigue, hand-foot syndrome, or diarrhea, 37% had required dose reductions, and only 10% had stopped treatment because of toxicity. Rates of treatment discontinuation and dose reduction compared favorably with those seen with the 4:2 schedule in the pivotal COMPARZ (Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma) trial (37% and 51%, respectively), reported Eric Jonasch, MD, of the University of Texas MD Anderson Cancer Center, Houston, and his associates in the Journal of Clinical Oncology.

Sunitinib, a multitargeted receptor tyrosine kinase inhibitor, is standard first-line therapy for metastatic clear cell renal cell carcinoma. But side effects impede treatment, and moderate to severe diarrhea, fatigue, and hand-foot syndrome are especially hard to manage without dose-reducing or interrupting therapy. These and other toxicities tend to peak during the second half of the Food and Drug Administration–approved 4-week treatment cycle, the investigators noted. Building on retrospective studies that have reported less toxicity with an alternate 2:1 schedule, they powered their trial to test whether this schedule would produce grade 3 or worse diarrhea, fatigue, or hand-foot syndrome in no more than 15% of patients.

Despite missing this endpoint, “the initial 2:1 schedule and subsequent schedule and dose alterations ensured that 90% [of patients] could continue treatment and avoid protracted high-grade toxicities,” the investigators said. Sunitinib showed “robust” efficacy – a 57% overall response rate and 13.7-month median progression-free survival – even though most patients were intermediate risk (67%) or poor risk (10%), they added. The nonrandomized data support using the alternate 2:1 schedule to maintain quality of life and extend treatment duration, they concluded.

Pfizer makes sunitinib and funded the study. Dr. Jonasch disclosed research funding, travel reimbursement, and an advisory relationship with Pfizer.
 

SOURCE: Jonasch E et al. J Clin Oncol. 2018 Apr 11. doi: 10.1200/JCO.2017.77.1485.

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For adults with metastatic, treatment-naive renal clear cell carcinoma, an alternate (2 weeks on, 1 week off) oral sunitinib schedule might be more tolerable than the approved 4:2 schedule, according to the results of a single-arm, multicenter, phase 2 trial.

After a median follow-up of 17 months, 25% of 59 patients had experienced grade 3 fatigue, hand-foot syndrome, or diarrhea, 37% had required dose reductions, and only 10% had stopped treatment because of toxicity. Rates of treatment discontinuation and dose reduction compared favorably with those seen with the 4:2 schedule in the pivotal COMPARZ (Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma) trial (37% and 51%, respectively), reported Eric Jonasch, MD, of the University of Texas MD Anderson Cancer Center, Houston, and his associates in the Journal of Clinical Oncology.

Sunitinib, a multitargeted receptor tyrosine kinase inhibitor, is standard first-line therapy for metastatic clear cell renal cell carcinoma. But side effects impede treatment, and moderate to severe diarrhea, fatigue, and hand-foot syndrome are especially hard to manage without dose-reducing or interrupting therapy. These and other toxicities tend to peak during the second half of the Food and Drug Administration–approved 4-week treatment cycle, the investigators noted. Building on retrospective studies that have reported less toxicity with an alternate 2:1 schedule, they powered their trial to test whether this schedule would produce grade 3 or worse diarrhea, fatigue, or hand-foot syndrome in no more than 15% of patients.

Despite missing this endpoint, “the initial 2:1 schedule and subsequent schedule and dose alterations ensured that 90% [of patients] could continue treatment and avoid protracted high-grade toxicities,” the investigators said. Sunitinib showed “robust” efficacy – a 57% overall response rate and 13.7-month median progression-free survival – even though most patients were intermediate risk (67%) or poor risk (10%), they added. The nonrandomized data support using the alternate 2:1 schedule to maintain quality of life and extend treatment duration, they concluded.

Pfizer makes sunitinib and funded the study. Dr. Jonasch disclosed research funding, travel reimbursement, and an advisory relationship with Pfizer.
 

SOURCE: Jonasch E et al. J Clin Oncol. 2018 Apr 11. doi: 10.1200/JCO.2017.77.1485.

 

For adults with metastatic, treatment-naive renal clear cell carcinoma, an alternate (2 weeks on, 1 week off) oral sunitinib schedule might be more tolerable than the approved 4:2 schedule, according to the results of a single-arm, multicenter, phase 2 trial.

After a median follow-up of 17 months, 25% of 59 patients had experienced grade 3 fatigue, hand-foot syndrome, or diarrhea, 37% had required dose reductions, and only 10% had stopped treatment because of toxicity. Rates of treatment discontinuation and dose reduction compared favorably with those seen with the 4:2 schedule in the pivotal COMPARZ (Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma) trial (37% and 51%, respectively), reported Eric Jonasch, MD, of the University of Texas MD Anderson Cancer Center, Houston, and his associates in the Journal of Clinical Oncology.

Sunitinib, a multitargeted receptor tyrosine kinase inhibitor, is standard first-line therapy for metastatic clear cell renal cell carcinoma. But side effects impede treatment, and moderate to severe diarrhea, fatigue, and hand-foot syndrome are especially hard to manage without dose-reducing or interrupting therapy. These and other toxicities tend to peak during the second half of the Food and Drug Administration–approved 4-week treatment cycle, the investigators noted. Building on retrospective studies that have reported less toxicity with an alternate 2:1 schedule, they powered their trial to test whether this schedule would produce grade 3 or worse diarrhea, fatigue, or hand-foot syndrome in no more than 15% of patients.

Despite missing this endpoint, “the initial 2:1 schedule and subsequent schedule and dose alterations ensured that 90% [of patients] could continue treatment and avoid protracted high-grade toxicities,” the investigators said. Sunitinib showed “robust” efficacy – a 57% overall response rate and 13.7-month median progression-free survival – even though most patients were intermediate risk (67%) or poor risk (10%), they added. The nonrandomized data support using the alternate 2:1 schedule to maintain quality of life and extend treatment duration, they concluded.

Pfizer makes sunitinib and funded the study. Dr. Jonasch disclosed research funding, travel reimbursement, and an advisory relationship with Pfizer.
 

SOURCE: Jonasch E et al. J Clin Oncol. 2018 Apr 11. doi: 10.1200/JCO.2017.77.1485.

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Key clinical point: For patients with metastatic, treatment-naive clear cell renal cell carcinoma, an alternate (2 weeks on, 1 week off) sunitinib schedule may be more tolerable than the FDA-approved 4:2 schedule.

Major finding: After a median follow-up of 17 months, 25% of patients had grade 3 fatigue, hand-foot syndrome, or diarrhea, 37% needed dose reductions, and 10% stopped treatment because of toxicities.

Study details: Single-arm, multicenter phase 2 study of 59 patients initiating oral sunitinib (50 mg daily) on a 2:1 schedule.

Disclosures: Pfizer makes sunitinib and funded the study. Dr. Jonasch disclosed research funding, travel reimbursement, and an advisory relationship with Pfizer.

Source: Jonasch E et al. J Clin Oncol. 2018 Apr 11. doi: 10.1200/JCO.2017.77.1485 .

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Metabolic syndrome scoring system predicts CVD in type 2 diabetes

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A scoring system that addresses severity of metabolic syndrome successfully predicted risk for future coronary heart disease in individuals with type 2 diabetes; the system identified the association independent of hemoglobin A1c levels, according to work presented at the annual meeting of the Endocrine Society.

The findings may point toward an additional surveillance tool for coronary heart disease (CHD) in patients who have type 2 diabetes, according to Mark D. DeBoer, MD, and his coauthors, who had not previously applied the metabolic syndrome severity scoring system to individuals with diabetes.

Bruce Jancin/MDedge News
Dr. Mark D. DeBoer

When broken down by quartile, increasing severity of metabolic syndrome for individuals with type 2 diabetes was associated with an increased risk of future cardiovascular disease, even when blood glucose levels were not included in calculation of metabolic syndrome (P less than .001 with glucose levels and P = .001 without glucose levels).

Dr. DeBoer, of the department of pediatrics and the Child Health Research Center at the University of Virginia, Charlottesville, and his coinvestigators, had previously developed the continuous scoring system for metabolic syndrome. The system incorporates the components that form the diagnostic criteria for metabolic syndrome – waist circumference, systolic blood pressure, and levels of HDL cholesterol, triglycerides, and blood glucose.

However, rather than using cutoffs for a dichotomous score of 0 or 1 for each criterion, the investigators developed sex- and race/ethnicity-specific scores of severity. This approach may identify metabolic dysregulation that would not be apparent if measures of several different criteria were just short of missing the cutoff, for example.

“These scores are standardized like z scores such that 2.0 is two standard deviations above the mean,” wrote Dr. DeBoer and his colleagues. Thus, the scores are dubbed “MetS z scores;” a free online calculator is available.

In developing the model, the investigators performed single-factor confirmatory factor analyses using data from 6,870 adults from the National Health and Nutrition Examination Survey cohort, developing scores specific for non-Hispanic whites, non-Hispanic blacks, and Hispanics.

 

 


In the present work, MetS z scores were applied to data from the Atherosclerosis Risk in Communities (ARIC) study, which followed 8,660 participants aged 45-64 years for 12 years, with adjudicated follow-up for cardiovascular incidents up to 20 years. Only participants with no baseline CHD and with complete metabolic syndrome risk factor data were included.

Dr. DeBoer and his collaborators compared MetS z scores for patients who were never diagnosed with diabetes, those who had diabetes at baseline, and those who had an incident diagnosis of type 2 diabetes at the second, third, or fourth ARIC study visit. They found that individuals who entered ARIC with diabetes had the highest z scores, while those with incident type 2 diabetes had higher baseline scores, compared with those who never had a diabetes diagnosis. The difference in z scores was lowest for white men, while black men and women “exhibited increased scores after diagnosis, suggesting inadequate treatment,” wrote Dr. DeBoer and his colleagues.

The investigators also looked for an association between MetS z scores and the primary outcome measure, time to incident CHD, calculating the z score both with and without the inclusion of glucose levels.

Dr. DeBoer and his colleagues analyzed the association between MetS z score and CHD for patients with and without type 2 diabetes. They found metabolic syndrome severity as assessed by MetS z score was independently associated with increased risk for CHD in participants with diabetes (P = .001).

 

 


“We additionally assessed whether the [metabolic syndrome] z score predicted future CHD following adjustment for HbA1c and when using a similar score derived without glucose as a component,” wrote Dr. DeBoer and his collaborators.

When metabolic syndrome severity as assessed by z score was broken into quartiles, “increasing MetS severity (by quartile) increased the risk of future CVD [cardiovascular disease], both using the traditional 5-component MetS z score and the no-glucose score,” wrote Dr. DeBoer and his colleagues. “This continuous MetS severity z score confers risk for future CHD among individuals with type 2 diabetes, both with the traditional MetS score and a score without glucose. These findings were independent of HbA1c and may relate to risk associated with the pathophysiologic processes underlying MetS.”

The investigators plan to integrate an automated metabolic syndrome severity score calculator into the electronic medical record “to identify and track risk in individuals over time and identify those who may benefit from increased intervention,” wrote Dr. DeBoer and his collaborators.

The National Institutes of Health funded the study. Dr. DeBoer reported no relevant conflicts of interest.

SOURCE: DeBoer MD et al. ENDO 2018, Abstract SAT-015.

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A scoring system that addresses severity of metabolic syndrome successfully predicted risk for future coronary heart disease in individuals with type 2 diabetes; the system identified the association independent of hemoglobin A1c levels, according to work presented at the annual meeting of the Endocrine Society.

The findings may point toward an additional surveillance tool for coronary heart disease (CHD) in patients who have type 2 diabetes, according to Mark D. DeBoer, MD, and his coauthors, who had not previously applied the metabolic syndrome severity scoring system to individuals with diabetes.

Bruce Jancin/MDedge News
Dr. Mark D. DeBoer

When broken down by quartile, increasing severity of metabolic syndrome for individuals with type 2 diabetes was associated with an increased risk of future cardiovascular disease, even when blood glucose levels were not included in calculation of metabolic syndrome (P less than .001 with glucose levels and P = .001 without glucose levels).

Dr. DeBoer, of the department of pediatrics and the Child Health Research Center at the University of Virginia, Charlottesville, and his coinvestigators, had previously developed the continuous scoring system for metabolic syndrome. The system incorporates the components that form the diagnostic criteria for metabolic syndrome – waist circumference, systolic blood pressure, and levels of HDL cholesterol, triglycerides, and blood glucose.

However, rather than using cutoffs for a dichotomous score of 0 or 1 for each criterion, the investigators developed sex- and race/ethnicity-specific scores of severity. This approach may identify metabolic dysregulation that would not be apparent if measures of several different criteria were just short of missing the cutoff, for example.

“These scores are standardized like z scores such that 2.0 is two standard deviations above the mean,” wrote Dr. DeBoer and his colleagues. Thus, the scores are dubbed “MetS z scores;” a free online calculator is available.

In developing the model, the investigators performed single-factor confirmatory factor analyses using data from 6,870 adults from the National Health and Nutrition Examination Survey cohort, developing scores specific for non-Hispanic whites, non-Hispanic blacks, and Hispanics.

 

 


In the present work, MetS z scores were applied to data from the Atherosclerosis Risk in Communities (ARIC) study, which followed 8,660 participants aged 45-64 years for 12 years, with adjudicated follow-up for cardiovascular incidents up to 20 years. Only participants with no baseline CHD and with complete metabolic syndrome risk factor data were included.

Dr. DeBoer and his collaborators compared MetS z scores for patients who were never diagnosed with diabetes, those who had diabetes at baseline, and those who had an incident diagnosis of type 2 diabetes at the second, third, or fourth ARIC study visit. They found that individuals who entered ARIC with diabetes had the highest z scores, while those with incident type 2 diabetes had higher baseline scores, compared with those who never had a diabetes diagnosis. The difference in z scores was lowest for white men, while black men and women “exhibited increased scores after diagnosis, suggesting inadequate treatment,” wrote Dr. DeBoer and his colleagues.

The investigators also looked for an association between MetS z scores and the primary outcome measure, time to incident CHD, calculating the z score both with and without the inclusion of glucose levels.

Dr. DeBoer and his colleagues analyzed the association between MetS z score and CHD for patients with and without type 2 diabetes. They found metabolic syndrome severity as assessed by MetS z score was independently associated with increased risk for CHD in participants with diabetes (P = .001).

 

 


“We additionally assessed whether the [metabolic syndrome] z score predicted future CHD following adjustment for HbA1c and when using a similar score derived without glucose as a component,” wrote Dr. DeBoer and his collaborators.

When metabolic syndrome severity as assessed by z score was broken into quartiles, “increasing MetS severity (by quartile) increased the risk of future CVD [cardiovascular disease], both using the traditional 5-component MetS z score and the no-glucose score,” wrote Dr. DeBoer and his colleagues. “This continuous MetS severity z score confers risk for future CHD among individuals with type 2 diabetes, both with the traditional MetS score and a score without glucose. These findings were independent of HbA1c and may relate to risk associated with the pathophysiologic processes underlying MetS.”

The investigators plan to integrate an automated metabolic syndrome severity score calculator into the electronic medical record “to identify and track risk in individuals over time and identify those who may benefit from increased intervention,” wrote Dr. DeBoer and his collaborators.

The National Institutes of Health funded the study. Dr. DeBoer reported no relevant conflicts of interest.

SOURCE: DeBoer MD et al. ENDO 2018, Abstract SAT-015.

 

A scoring system that addresses severity of metabolic syndrome successfully predicted risk for future coronary heart disease in individuals with type 2 diabetes; the system identified the association independent of hemoglobin A1c levels, according to work presented at the annual meeting of the Endocrine Society.

The findings may point toward an additional surveillance tool for coronary heart disease (CHD) in patients who have type 2 diabetes, according to Mark D. DeBoer, MD, and his coauthors, who had not previously applied the metabolic syndrome severity scoring system to individuals with diabetes.

Bruce Jancin/MDedge News
Dr. Mark D. DeBoer

When broken down by quartile, increasing severity of metabolic syndrome for individuals with type 2 diabetes was associated with an increased risk of future cardiovascular disease, even when blood glucose levels were not included in calculation of metabolic syndrome (P less than .001 with glucose levels and P = .001 without glucose levels).

Dr. DeBoer, of the department of pediatrics and the Child Health Research Center at the University of Virginia, Charlottesville, and his coinvestigators, had previously developed the continuous scoring system for metabolic syndrome. The system incorporates the components that form the diagnostic criteria for metabolic syndrome – waist circumference, systolic blood pressure, and levels of HDL cholesterol, triglycerides, and blood glucose.

However, rather than using cutoffs for a dichotomous score of 0 or 1 for each criterion, the investigators developed sex- and race/ethnicity-specific scores of severity. This approach may identify metabolic dysregulation that would not be apparent if measures of several different criteria were just short of missing the cutoff, for example.

“These scores are standardized like z scores such that 2.0 is two standard deviations above the mean,” wrote Dr. DeBoer and his colleagues. Thus, the scores are dubbed “MetS z scores;” a free online calculator is available.

In developing the model, the investigators performed single-factor confirmatory factor analyses using data from 6,870 adults from the National Health and Nutrition Examination Survey cohort, developing scores specific for non-Hispanic whites, non-Hispanic blacks, and Hispanics.

 

 


In the present work, MetS z scores were applied to data from the Atherosclerosis Risk in Communities (ARIC) study, which followed 8,660 participants aged 45-64 years for 12 years, with adjudicated follow-up for cardiovascular incidents up to 20 years. Only participants with no baseline CHD and with complete metabolic syndrome risk factor data were included.

Dr. DeBoer and his collaborators compared MetS z scores for patients who were never diagnosed with diabetes, those who had diabetes at baseline, and those who had an incident diagnosis of type 2 diabetes at the second, third, or fourth ARIC study visit. They found that individuals who entered ARIC with diabetes had the highest z scores, while those with incident type 2 diabetes had higher baseline scores, compared with those who never had a diabetes diagnosis. The difference in z scores was lowest for white men, while black men and women “exhibited increased scores after diagnosis, suggesting inadequate treatment,” wrote Dr. DeBoer and his colleagues.

The investigators also looked for an association between MetS z scores and the primary outcome measure, time to incident CHD, calculating the z score both with and without the inclusion of glucose levels.

Dr. DeBoer and his colleagues analyzed the association between MetS z score and CHD for patients with and without type 2 diabetes. They found metabolic syndrome severity as assessed by MetS z score was independently associated with increased risk for CHD in participants with diabetes (P = .001).

 

 


“We additionally assessed whether the [metabolic syndrome] z score predicted future CHD following adjustment for HbA1c and when using a similar score derived without glucose as a component,” wrote Dr. DeBoer and his collaborators.

When metabolic syndrome severity as assessed by z score was broken into quartiles, “increasing MetS severity (by quartile) increased the risk of future CVD [cardiovascular disease], both using the traditional 5-component MetS z score and the no-glucose score,” wrote Dr. DeBoer and his colleagues. “This continuous MetS severity z score confers risk for future CHD among individuals with type 2 diabetes, both with the traditional MetS score and a score without glucose. These findings were independent of HbA1c and may relate to risk associated with the pathophysiologic processes underlying MetS.”

The investigators plan to integrate an automated metabolic syndrome severity score calculator into the electronic medical record “to identify and track risk in individuals over time and identify those who may benefit from increased intervention,” wrote Dr. DeBoer and his collaborators.

The National Institutes of Health funded the study. Dr. DeBoer reported no relevant conflicts of interest.

SOURCE: DeBoer MD et al. ENDO 2018, Abstract SAT-015.

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Key clinical point: Increasing metabolic syndrome severity was associated with increased risk for cardiovascular disease.

Major finding: Risk for future cardiovascular disease was upped with higher scores, even when glucose wasn’t considered (P = .001).

Study details: A retrospective analysis of Atherosclerosis Risk in Communities study data on 1,419 patients with and 7,241 patients without diabetes.

Disclosures: The National Institutes of Health sponsored the study. Dr. DeBoer reported no relevant conflicts of interest.

Source: DeBoer MD et al. ENDO 2018, Abstract SAT-015.

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