User login
Hemophilia B therapy granted access to PRIME program
SPK-9001, an investigational therapy intended to treat hemophilia B, has been granted access to the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) program.
The goal of the EMA’s PRIME program is to accelerate the development of therapies that may offer a major advantage over existing treatments or benefit patients with no treatment options.
Through PRIME, the EMA offers early and enhanced support to developers in order to optimize development plans and speed regulatory evaluations to potentially bring therapies to patients more quickly.
To be accepted for PRIME, a therapy must demonstrate the potential to benefit patients with unmet medical need through early clinical or nonclinical data.
About SPK-9001
SPK-9001 is a bio-engineered adeno-associated virus capsid expressing a codon-optimized, high-activity human factor IX variant enabling endogenous production of factor IX. The therapy is being developed by Spark Therapeutics and Pfizer Inc.
SPK-9001 is under investigation in a phase 1/2 trial. Results from this trial were presented at the 2016 ASH Annual Meeting.
The presentation included data on 9 patients who received a single intravenous infusion of SPK-9001 at 5 x 1011 vg/kg. The patients were followed for 52 weeks, with a long-term follow-up of 14 years.
Before their SPK-9001 infusion, the patients required anywhere from 0 to 159 factor IX infusions each year. Three patients had annualized bleeding rates (ABRs) of 0, and the remaining 6 patients had ABRs of 1, 2, 4, 10, 12, and 49.
After SPK-9001, 8 patients were able to stop receiving factor IX infusions and achieved an ABR of 0. One patient had an ABR of 2 and required on-demand factor IX therapy. (All patients stopped receiving factor IX prophylaxis).
The researchers said there were no unexpected vector or procedure-related adverse events, and none of the patients developed factor IX alloinhibitory antibodies. 
SPK-9001, an investigational therapy intended to treat hemophilia B, has been granted access to the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) program.
The goal of the EMA’s PRIME program is to accelerate the development of therapies that may offer a major advantage over existing treatments or benefit patients with no treatment options.
Through PRIME, the EMA offers early and enhanced support to developers in order to optimize development plans and speed regulatory evaluations to potentially bring therapies to patients more quickly.
To be accepted for PRIME, a therapy must demonstrate the potential to benefit patients with unmet medical need through early clinical or nonclinical data.
About SPK-9001
SPK-9001 is a bio-engineered adeno-associated virus capsid expressing a codon-optimized, high-activity human factor IX variant enabling endogenous production of factor IX. The therapy is being developed by Spark Therapeutics and Pfizer Inc.
SPK-9001 is under investigation in a phase 1/2 trial. Results from this trial were presented at the 2016 ASH Annual Meeting.
The presentation included data on 9 patients who received a single intravenous infusion of SPK-9001 at 5 x 1011 vg/kg. The patients were followed for 52 weeks, with a long-term follow-up of 14 years.
Before their SPK-9001 infusion, the patients required anywhere from 0 to 159 factor IX infusions each year. Three patients had annualized bleeding rates (ABRs) of 0, and the remaining 6 patients had ABRs of 1, 2, 4, 10, 12, and 49.
After SPK-9001, 8 patients were able to stop receiving factor IX infusions and achieved an ABR of 0. One patient had an ABR of 2 and required on-demand factor IX therapy. (All patients stopped receiving factor IX prophylaxis).
The researchers said there were no unexpected vector or procedure-related adverse events, and none of the patients developed factor IX alloinhibitory antibodies.
SPK-9001, an investigational therapy intended to treat hemophilia B, has been granted access to the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) program.
The goal of the EMA’s PRIME program is to accelerate the development of therapies that may offer a major advantage over existing treatments or benefit patients with no treatment options.
Through PRIME, the EMA offers early and enhanced support to developers in order to optimize development plans and speed regulatory evaluations to potentially bring therapies to patients more quickly.
To be accepted for PRIME, a therapy must demonstrate the potential to benefit patients with unmet medical need through early clinical or nonclinical data.
About SPK-9001
SPK-9001 is a bio-engineered adeno-associated virus capsid expressing a codon-optimized, high-activity human factor IX variant enabling endogenous production of factor IX. The therapy is being developed by Spark Therapeutics and Pfizer Inc.
SPK-9001 is under investigation in a phase 1/2 trial. Results from this trial were presented at the 2016 ASH Annual Meeting.
The presentation included data on 9 patients who received a single intravenous infusion of SPK-9001 at 5 x 1011 vg/kg. The patients were followed for 52 weeks, with a long-term follow-up of 14 years.
Before their SPK-9001 infusion, the patients required anywhere from 0 to 159 factor IX infusions each year. Three patients had annualized bleeding rates (ABRs) of 0, and the remaining 6 patients had ABRs of 1, 2, 4, 10, 12, and 49.
After SPK-9001, 8 patients were able to stop receiving factor IX infusions and achieved an ABR of 0. One patient had an ABR of 2 and required on-demand factor IX therapy. (All patients stopped receiving factor IX prophylaxis).
The researchers said there were no unexpected vector or procedure-related adverse events, and none of the patients developed factor IX alloinhibitory antibodies.
Cigarette Smoking: Modifiable Risk Factor for MS
Q) What impact does cigarette smoking have on multiple sclerosis?
The development and disease course of multiple sclerosis (MS) are influenced by a variety of factors. Some—such as genetics, environmental exposure to viruses, and place of residence at an early age—cannot be modified. There are, however, other factors that can be modified, one of which is cigarette smoking.
Between 15% and 17% of patients with MS smoke cigarettes, a rate comparable to that of the general United States population; among US veterans with MS, prevalence can reach as high as 28.5%.1-4 Factors that correlate with smoking in patients with MS include younger age, lower economic/educational background, being single, and lack of available or affordable cessation strategies.1,2,4
Studies have found that in addition to contributing to the development of diseases (eg, cardiovascular and pulmonary) and certain cancers, smoking cigarettes may put individuals at higher risk for MS.5-7 Data also show that increased duration of smoking and/or increased quantity of cigarettes smoked may exacerbate this risk.5 While the mechanisms are not well understood, there appears to be a higher prevalence of MS in male smokers and in current smokers (compared with those who have already quit).6 Other studies have also suggested an increased risk with passive exposure to cigarette smoke.6,7
Current cigarette smoking accelerates the conversion from a relapsing to a progressive form of MS.8-11 One study demonstrated that after the diagnosis of MS had been made, continued smoking increased the rate of acceleration to a progressive form by 5% per year.9 Current smokers also had a higher disability rate attributable to their MS, but smoking cessation may improve disability outcomes.9-11
Current smokers, with or without other risk factors, therefore have incentive to quit smoking to reduce risk for MS. Patients with MS who smoke should be counseled on the increased risk associated with the combination of passive smoke exposure and other genetic and environmental factors, which may increase risk for MS in first-degree family members.3
While there is no one-size-fits-all strategy for smoking cessation in patients with MS, traditional behavioral and/or medication therapies should be offered. Some factors involved in cigarette smoking are variable and difficult to address, in addition to the physical dependence on nicotine. Many patients will require interventions to address related poor health behaviors (eg, lack of exercise) and comorbid factors (eg, depression).5,7 —BW
Bryan Walker, MHS, PA-C
Department of Neurology, Division of MS and Neuroimmunology, Duke University Medical Center, Durham, North Carolina
1. Friend KB, Mernoff ST, Block P, Reeve G. Smoking rates and smoking cessation among individuals with multiple sclerosis. Disabil Rehabil. 2006;28(18):1135-1141.
2. Marrie R, Horwitz R, Cutter G, et al. High frequency of adverse health behaviors in multiple sclerosis. Mult Scler. 2009;15(1): 105-113.
3. CDC. Current cigarette smoking among adults in the United States. www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking. Accessed January 13, 2017.
4. Turner AP, Kivlahan DR, Kazis LE, Haselkorn JK. Smoking among veterans with multiple sclerosis: prevalence correlates, quit attempts, and unmet need for services. Arch Phys Med Rehabil. 2007;88(11):1394-1399.
5. Ascherio A, Munger K. Epidemiology of multiple sclerosis: from risk factors to prevention—an update. Semin Neurol. 2016; 36(2):103-114.
6. Zhang P, Wang R, Li Z, et al. The risk of smoking on multiple sclerosis: a meta-analysis based on 20,626 cases from case-control and cohort studies. PeerJ. 2016;4:e1797.
7. Hedström AK, Olsson T, Alfredsson L. Smoking is a major preventable risk factor for multiple sclerosis. Mult Scler. 2016; 22(8):1021-1026.
8. Healy BC, Ali EN, Guttmann CR, et al. Smoking and disease progression in multiple sclerosis. Arch Neurol. 2009;66(7):858-864.
9. Goldman MD, Stüve O. Smoking beyond multiple sclerosis diagnosis: a risk factor still worth modifying. JAMA Neurol. 2015;72(10):1105-1106.
10. Ramanujam R, Hedström A, Manouchehrinia A, et al. Effect of smoking cessation on multiple sclerosis prognosis. JAMA Neurol. 2015;72(10):1117-1123.
11. Ben-Zacharia A. The effect of modifiable risk factors on multiple sclerosis progression. Neurology. 2016;86(16):Supplement P1.387.
Clinician Reviews in partnership with
MS Consult is edited by Colleen J. Harris, MN, NP, MSCN, Nurse Practitioner/Manager of the Multiple Sclerosis Clinic at Foothills Medical Centre in Calgary, Alberta, Canada, and Bryan Walker, MHS, PA-C, who is in the Department of Neurology, Division of MS and Neuroimmunology, at Duke University Medical Center in Durham, North Carolina. This month’s responses were authored by Bryan Walker and Lisa Marie Fox, MSPAS, PA-C, who is in the Division of Multiple Sclerosis, Department of Neurology, at Johns Hopkins Hospital in Baltimore.
Clinician Reviews in partnership with
MS Consult is edited by Colleen J. Harris, MN, NP, MSCN, Nurse Practitioner/Manager of the Multiple Sclerosis Clinic at Foothills Medical Centre in Calgary, Alberta, Canada, and Bryan Walker, MHS, PA-C, who is in the Department of Neurology, Division of MS and Neuroimmunology, at Duke University Medical Center in Durham, North Carolina. This month’s responses were authored by Bryan Walker and Lisa Marie Fox, MSPAS, PA-C, who is in the Division of Multiple Sclerosis, Department of Neurology, at Johns Hopkins Hospital in Baltimore.
Clinician Reviews in partnership with
MS Consult is edited by Colleen J. Harris, MN, NP, MSCN, Nurse Practitioner/Manager of the Multiple Sclerosis Clinic at Foothills Medical Centre in Calgary, Alberta, Canada, and Bryan Walker, MHS, PA-C, who is in the Department of Neurology, Division of MS and Neuroimmunology, at Duke University Medical Center in Durham, North Carolina. This month’s responses were authored by Bryan Walker and Lisa Marie Fox, MSPAS, PA-C, who is in the Division of Multiple Sclerosis, Department of Neurology, at Johns Hopkins Hospital in Baltimore.
Q) What impact does cigarette smoking have on multiple sclerosis?
The development and disease course of multiple sclerosis (MS) are influenced by a variety of factors. Some—such as genetics, environmental exposure to viruses, and place of residence at an early age—cannot be modified. There are, however, other factors that can be modified, one of which is cigarette smoking.
Between 15% and 17% of patients with MS smoke cigarettes, a rate comparable to that of the general United States population; among US veterans with MS, prevalence can reach as high as 28.5%.1-4 Factors that correlate with smoking in patients with MS include younger age, lower economic/educational background, being single, and lack of available or affordable cessation strategies.1,2,4
Studies have found that in addition to contributing to the development of diseases (eg, cardiovascular and pulmonary) and certain cancers, smoking cigarettes may put individuals at higher risk for MS.5-7 Data also show that increased duration of smoking and/or increased quantity of cigarettes smoked may exacerbate this risk.5 While the mechanisms are not well understood, there appears to be a higher prevalence of MS in male smokers and in current smokers (compared with those who have already quit).6 Other studies have also suggested an increased risk with passive exposure to cigarette smoke.6,7
Current cigarette smoking accelerates the conversion from a relapsing to a progressive form of MS.8-11 One study demonstrated that after the diagnosis of MS had been made, continued smoking increased the rate of acceleration to a progressive form by 5% per year.9 Current smokers also had a higher disability rate attributable to their MS, but smoking cessation may improve disability outcomes.9-11
Current smokers, with or without other risk factors, therefore have incentive to quit smoking to reduce risk for MS. Patients with MS who smoke should be counseled on the increased risk associated with the combination of passive smoke exposure and other genetic and environmental factors, which may increase risk for MS in first-degree family members.3
While there is no one-size-fits-all strategy for smoking cessation in patients with MS, traditional behavioral and/or medication therapies should be offered. Some factors involved in cigarette smoking are variable and difficult to address, in addition to the physical dependence on nicotine. Many patients will require interventions to address related poor health behaviors (eg, lack of exercise) and comorbid factors (eg, depression).5,7 —BW
Bryan Walker, MHS, PA-C
Department of Neurology, Division of MS and Neuroimmunology, Duke University Medical Center, Durham, North Carolina
Q) What impact does cigarette smoking have on multiple sclerosis?
The development and disease course of multiple sclerosis (MS) are influenced by a variety of factors. Some—such as genetics, environmental exposure to viruses, and place of residence at an early age—cannot be modified. There are, however, other factors that can be modified, one of which is cigarette smoking.
Between 15% and 17% of patients with MS smoke cigarettes, a rate comparable to that of the general United States population; among US veterans with MS, prevalence can reach as high as 28.5%.1-4 Factors that correlate with smoking in patients with MS include younger age, lower economic/educational background, being single, and lack of available or affordable cessation strategies.1,2,4
Studies have found that in addition to contributing to the development of diseases (eg, cardiovascular and pulmonary) and certain cancers, smoking cigarettes may put individuals at higher risk for MS.5-7 Data also show that increased duration of smoking and/or increased quantity of cigarettes smoked may exacerbate this risk.5 While the mechanisms are not well understood, there appears to be a higher prevalence of MS in male smokers and in current smokers (compared with those who have already quit).6 Other studies have also suggested an increased risk with passive exposure to cigarette smoke.6,7
Current cigarette smoking accelerates the conversion from a relapsing to a progressive form of MS.8-11 One study demonstrated that after the diagnosis of MS had been made, continued smoking increased the rate of acceleration to a progressive form by 5% per year.9 Current smokers also had a higher disability rate attributable to their MS, but smoking cessation may improve disability outcomes.9-11
Current smokers, with or without other risk factors, therefore have incentive to quit smoking to reduce risk for MS. Patients with MS who smoke should be counseled on the increased risk associated with the combination of passive smoke exposure and other genetic and environmental factors, which may increase risk for MS in first-degree family members.3
While there is no one-size-fits-all strategy for smoking cessation in patients with MS, traditional behavioral and/or medication therapies should be offered. Some factors involved in cigarette smoking are variable and difficult to address, in addition to the physical dependence on nicotine. Many patients will require interventions to address related poor health behaviors (eg, lack of exercise) and comorbid factors (eg, depression).5,7 —BW
Bryan Walker, MHS, PA-C
Department of Neurology, Division of MS and Neuroimmunology, Duke University Medical Center, Durham, North Carolina
1. Friend KB, Mernoff ST, Block P, Reeve G. Smoking rates and smoking cessation among individuals with multiple sclerosis. Disabil Rehabil. 2006;28(18):1135-1141.
2. Marrie R, Horwitz R, Cutter G, et al. High frequency of adverse health behaviors in multiple sclerosis. Mult Scler. 2009;15(1): 105-113.
3. CDC. Current cigarette smoking among adults in the United States. www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking. Accessed January 13, 2017.
4. Turner AP, Kivlahan DR, Kazis LE, Haselkorn JK. Smoking among veterans with multiple sclerosis: prevalence correlates, quit attempts, and unmet need for services. Arch Phys Med Rehabil. 2007;88(11):1394-1399.
5. Ascherio A, Munger K. Epidemiology of multiple sclerosis: from risk factors to prevention—an update. Semin Neurol. 2016; 36(2):103-114.
6. Zhang P, Wang R, Li Z, et al. The risk of smoking on multiple sclerosis: a meta-analysis based on 20,626 cases from case-control and cohort studies. PeerJ. 2016;4:e1797.
7. Hedström AK, Olsson T, Alfredsson L. Smoking is a major preventable risk factor for multiple sclerosis. Mult Scler. 2016; 22(8):1021-1026.
8. Healy BC, Ali EN, Guttmann CR, et al. Smoking and disease progression in multiple sclerosis. Arch Neurol. 2009;66(7):858-864.
9. Goldman MD, Stüve O. Smoking beyond multiple sclerosis diagnosis: a risk factor still worth modifying. JAMA Neurol. 2015;72(10):1105-1106.
10. Ramanujam R, Hedström A, Manouchehrinia A, et al. Effect of smoking cessation on multiple sclerosis prognosis. JAMA Neurol. 2015;72(10):1117-1123.
11. Ben-Zacharia A. The effect of modifiable risk factors on multiple sclerosis progression. Neurology. 2016;86(16):Supplement P1.387.
1. Friend KB, Mernoff ST, Block P, Reeve G. Smoking rates and smoking cessation among individuals with multiple sclerosis. Disabil Rehabil. 2006;28(18):1135-1141.
2. Marrie R, Horwitz R, Cutter G, et al. High frequency of adverse health behaviors in multiple sclerosis. Mult Scler. 2009;15(1): 105-113.
3. CDC. Current cigarette smoking among adults in the United States. www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking. Accessed January 13, 2017.
4. Turner AP, Kivlahan DR, Kazis LE, Haselkorn JK. Smoking among veterans with multiple sclerosis: prevalence correlates, quit attempts, and unmet need for services. Arch Phys Med Rehabil. 2007;88(11):1394-1399.
5. Ascherio A, Munger K. Epidemiology of multiple sclerosis: from risk factors to prevention—an update. Semin Neurol. 2016; 36(2):103-114.
6. Zhang P, Wang R, Li Z, et al. The risk of smoking on multiple sclerosis: a meta-analysis based on 20,626 cases from case-control and cohort studies. PeerJ. 2016;4:e1797.
7. Hedström AK, Olsson T, Alfredsson L. Smoking is a major preventable risk factor for multiple sclerosis. Mult Scler. 2016; 22(8):1021-1026.
8. Healy BC, Ali EN, Guttmann CR, et al. Smoking and disease progression in multiple sclerosis. Arch Neurol. 2009;66(7):858-864.
9. Goldman MD, Stüve O. Smoking beyond multiple sclerosis diagnosis: a risk factor still worth modifying. JAMA Neurol. 2015;72(10):1105-1106.
10. Ramanujam R, Hedström A, Manouchehrinia A, et al. Effect of smoking cessation on multiple sclerosis prognosis. JAMA Neurol. 2015;72(10):1117-1123.
11. Ben-Zacharia A. The effect of modifiable risk factors on multiple sclerosis progression. Neurology. 2016;86(16):Supplement P1.387.
Early Interferon Treatment Delays Time to Clinically Definite MS
In patients presenting with a first clinical demyelinating event, early treatment with subcutaneous interferon beta-1a three times per week over five years prolonged the time to clinically definite multiple sclerosis (MS), compared with delayed treatment, according to research published online ahead of print December 30, 2016 in the Journal of Neurology, Neurosurgery and Psychiatry. Compared with delayed treatment, early treatment also prolonged the time to McDonald MS conversion.
Giancarlo Comi, MD, Professor of Neurology at the Scientific Institute H.S. Raffaele in Milan, and colleagues conducted REFLEXION, a preplanned extension of the REFLEX study, to compare the effect of more frequent and early dosing with that of delayed treatment. Eligible patients were between ages 18 and 50, had an Expanded Disability Status Scale (EDSS) score of 5.0 or lower, and a single clinical event suggestive of MS within 60 days of enrollment. In REFLEX, patients had been randomized to interferon beta-1a (44 μg) thrice weekly or once weekly, or placebo. Treatment lasted for 24 months or until a patient developed clinically definite MS.
In REFLEXION, patients first randomized to interferon beta-1a who had not converted to clinically definite MS continued their original dosing regimen. Patients originally receiving placebo who had not converted to clinically definite MS were switched to interferon beta-1a (44 μg thrice weekly). These patients became the delayed-treatment group. Patients who converted to clinically definite MS during REFLEX or REFLEXION received open-label interferon beta-1a 44 μg thrice weekly from then on.
EDSS scores and clinically definite MS assessments were recorded at extension baseline (ie, month 24) and every six months thereafter. The primary end point was time to conversion to clinically definite MS from first randomization to month 36. Time to clinically definite MS to month 60 was a secondary end point.
The extension study included 127 participants originally randomized to interferon beta-1a thrice weekly, 142 participants originally randomized to interferon beta-1a once weekly, and 133 patients originally randomized to placebo. At month 36, the proportion of patients who had converted to clinically definite MS was lower among patients receiving interferon thrice weekly or weekly, compared with the delayed-treatment group (25.1%, 25.7%, and 38.6%, respectively). The risk of conversion to clinically definite MS was significantly reduced for patients receiving early treatment, compared with delayed treatment. The researchers found no significant difference between the early-treatment groups.
The analysis for month 60 also found that both early-treatment groups had longer times to clinically definite MS, compared with delayed treatment. The proportion of patients who converted to clinically definite MS increased at month 60, but was still lower among participants receiving thrice-weekly or weekly interferon than among patients on delayed treatment (32.2%, 36.0%, and 40.4%, respectively). Cumulative probability of conversion was lower with thrice-weekly and weekly early treatment than with delayed treatment (39.2%, 40.7%, and 44.6%, respectively).
—Erik Greb
Suggested Reading
Comi G, De Stefano N, Freedman MS, et al. Subcutaneous interferon β-1a in the treatment of clinically isolated syndromes: 3-year and 5-year results of the phase III dosing frequency-blind multicentre REFLEXION study. J Neurol Neurosurg Psychiatry. 2016 Dec 30 [Epub ahead of print].
In patients presenting with a first clinical demyelinating event, early treatment with subcutaneous interferon beta-1a three times per week over five years prolonged the time to clinically definite multiple sclerosis (MS), compared with delayed treatment, according to research published online ahead of print December 30, 2016 in the Journal of Neurology, Neurosurgery and Psychiatry. Compared with delayed treatment, early treatment also prolonged the time to McDonald MS conversion.
Giancarlo Comi, MD, Professor of Neurology at the Scientific Institute H.S. Raffaele in Milan, and colleagues conducted REFLEXION, a preplanned extension of the REFLEX study, to compare the effect of more frequent and early dosing with that of delayed treatment. Eligible patients were between ages 18 and 50, had an Expanded Disability Status Scale (EDSS) score of 5.0 or lower, and a single clinical event suggestive of MS within 60 days of enrollment. In REFLEX, patients had been randomized to interferon beta-1a (44 μg) thrice weekly or once weekly, or placebo. Treatment lasted for 24 months or until a patient developed clinically definite MS.
In REFLEXION, patients first randomized to interferon beta-1a who had not converted to clinically definite MS continued their original dosing regimen. Patients originally receiving placebo who had not converted to clinically definite MS were switched to interferon beta-1a (44 μg thrice weekly). These patients became the delayed-treatment group. Patients who converted to clinically definite MS during REFLEX or REFLEXION received open-label interferon beta-1a 44 μg thrice weekly from then on.
EDSS scores and clinically definite MS assessments were recorded at extension baseline (ie, month 24) and every six months thereafter. The primary end point was time to conversion to clinically definite MS from first randomization to month 36. Time to clinically definite MS to month 60 was a secondary end point.
The extension study included 127 participants originally randomized to interferon beta-1a thrice weekly, 142 participants originally randomized to interferon beta-1a once weekly, and 133 patients originally randomized to placebo. At month 36, the proportion of patients who had converted to clinically definite MS was lower among patients receiving interferon thrice weekly or weekly, compared with the delayed-treatment group (25.1%, 25.7%, and 38.6%, respectively). The risk of conversion to clinically definite MS was significantly reduced for patients receiving early treatment, compared with delayed treatment. The researchers found no significant difference between the early-treatment groups.
The analysis for month 60 also found that both early-treatment groups had longer times to clinically definite MS, compared with delayed treatment. The proportion of patients who converted to clinically definite MS increased at month 60, but was still lower among participants receiving thrice-weekly or weekly interferon than among patients on delayed treatment (32.2%, 36.0%, and 40.4%, respectively). Cumulative probability of conversion was lower with thrice-weekly and weekly early treatment than with delayed treatment (39.2%, 40.7%, and 44.6%, respectively).
—Erik Greb
Suggested Reading
Comi G, De Stefano N, Freedman MS, et al. Subcutaneous interferon β-1a in the treatment of clinically isolated syndromes: 3-year and 5-year results of the phase III dosing frequency-blind multicentre REFLEXION study. J Neurol Neurosurg Psychiatry. 2016 Dec 30 [Epub ahead of print].
In patients presenting with a first clinical demyelinating event, early treatment with subcutaneous interferon beta-1a three times per week over five years prolonged the time to clinically definite multiple sclerosis (MS), compared with delayed treatment, according to research published online ahead of print December 30, 2016 in the Journal of Neurology, Neurosurgery and Psychiatry. Compared with delayed treatment, early treatment also prolonged the time to McDonald MS conversion.
Giancarlo Comi, MD, Professor of Neurology at the Scientific Institute H.S. Raffaele in Milan, and colleagues conducted REFLEXION, a preplanned extension of the REFLEX study, to compare the effect of more frequent and early dosing with that of delayed treatment. Eligible patients were between ages 18 and 50, had an Expanded Disability Status Scale (EDSS) score of 5.0 or lower, and a single clinical event suggestive of MS within 60 days of enrollment. In REFLEX, patients had been randomized to interferon beta-1a (44 μg) thrice weekly or once weekly, or placebo. Treatment lasted for 24 months or until a patient developed clinically definite MS.
In REFLEXION, patients first randomized to interferon beta-1a who had not converted to clinically definite MS continued their original dosing regimen. Patients originally receiving placebo who had not converted to clinically definite MS were switched to interferon beta-1a (44 μg thrice weekly). These patients became the delayed-treatment group. Patients who converted to clinically definite MS during REFLEX or REFLEXION received open-label interferon beta-1a 44 μg thrice weekly from then on.
EDSS scores and clinically definite MS assessments were recorded at extension baseline (ie, month 24) and every six months thereafter. The primary end point was time to conversion to clinically definite MS from first randomization to month 36. Time to clinically definite MS to month 60 was a secondary end point.
The extension study included 127 participants originally randomized to interferon beta-1a thrice weekly, 142 participants originally randomized to interferon beta-1a once weekly, and 133 patients originally randomized to placebo. At month 36, the proportion of patients who had converted to clinically definite MS was lower among patients receiving interferon thrice weekly or weekly, compared with the delayed-treatment group (25.1%, 25.7%, and 38.6%, respectively). The risk of conversion to clinically definite MS was significantly reduced for patients receiving early treatment, compared with delayed treatment. The researchers found no significant difference between the early-treatment groups.
The analysis for month 60 also found that both early-treatment groups had longer times to clinically definite MS, compared with delayed treatment. The proportion of patients who converted to clinically definite MS increased at month 60, but was still lower among participants receiving thrice-weekly or weekly interferon than among patients on delayed treatment (32.2%, 36.0%, and 40.4%, respectively). Cumulative probability of conversion was lower with thrice-weekly and weekly early treatment than with delayed treatment (39.2%, 40.7%, and 44.6%, respectively).
—Erik Greb
Suggested Reading
Comi G, De Stefano N, Freedman MS, et al. Subcutaneous interferon β-1a in the treatment of clinically isolated syndromes: 3-year and 5-year results of the phase III dosing frequency-blind multicentre REFLEXION study. J Neurol Neurosurg Psychiatry. 2016 Dec 30 [Epub ahead of print].
Posttreatment survivorship care needs of Spanish-speaking Latinas with breast cancer
After treatment, cancer patients transition to a survivorship phase, often with little information or support. Cancer survivors are at increased risk of recurrence, secondary cancers, comorbid conditions, and late treatment effects.1,2 However, many remain unaware of these risks and the options for managing them3 and face numerous unmet medical, psychosocial, and informational needs that can be addressed through survivorship care programs.4 Anxiety may increase as they lose their treatment team’s support while attempting to reestablish their lives.2 Patients need to know the long-term risks of cancer treatments, probabilities of recurrence and second cancers, effectiveness of surveillance and interventions for managing late effects and psychosocial concerns, and benefits of healthy lifestyles.2
Due to sociocultural and economic factors, Spanish-speaking Latina breast cancer survivors (SSBCS) suffer worse posttreatment health-related quality of life and more pain, fatigue, depressive symptoms, body image issues, and distress than their white counterparts.5-7 However, they are less likely to receive necessary cancer treatment, symptom management, and surveillance. For example, compared with whites, Latina breast cancer survivors receive less guideline-adherent treatment8 and follow-up care, including survivorship information.3,9 SSBCS, in particular have less access to survivorship information.10 Consequently, SSBCS are more likely to report unmet symptom management needs.11
Several breast cancer survivorship program trials have included Latinas,12,13 but their effectiveness has been demonstrated only for depressive symptoms or health worry. A comprehensive assessment of the posttreatment needs of SSBCS would provide a foundation for designing tailored survivorship interventions for this vulnerable group. This study aimed to identify the symptom management, psychosocial, and informational needs of SSBCS during the transition to survivorship from the perspectives of SSBCS and their cancer support providers and cancer physicians.
Methods
We sampled respondents within a 5-county area in Northern California to obtain multiple perspectives of the survivorship care needs of SSBCS using structured and in-depth methods: a telephone survey of SSBCS; semistructured interviews with SSBCS; semistructured interviews with cancer support providers serving SSBCS; and semistructured interviews with physicians providing cancer care for SSBCS. The study protocol was approved by the University of California San Francisco Committee on Human Research.
Sample and procedures
Structured telephone survey with SSBCS. The sample was drawn evenly from San Francisco General Hospital-University of California San Francisco primary care practices and SSBCS from a previous study who agreed to be re-contacted.14 The inclusion criteria were: completed active treatment (except adjuvant hormonal therapy) for nonmetastatic breast cancer within 10 years; living in one of the five counties; primarily Spanish-speaking; and self-identified as Latina. The exclusion criteria were: previous cancer except nonmelanoma skin cancer; terminal illness; or metastatic breast cancer. Study staff mailed potential participants a bilingual letter and information sheet, and bilingual opt-out postcard (6th grade reading level assessed by Flesch-Kincaid grade level statistic). Female bilingual-bicultural research associates conducted interviews of 20-30 minutes in Spanish after obtaining verbal consent. Participants were mailed $20. Surveys were conducted during March-November 2014.
Semistructured in-person interviews with SSBCS. Four community-based organizations (CBOs) in the targeted area providing cancer support services to Latinos agreed to recruit SSBCS for interviews. Inclusion criteria were identical to the survey. Patient navigators or support providers from CBOs contacted women by phone or in-person to invite them to an interview to assess their cancer survivorship needs. Women could choose a focus group or individual interview. With permission, names and contact information were given to study interviewers who called, explained the study, screened for eligibility, and scheduled an interview.
Recruitment was stratified by age (under or over age 50). We sampled women until saturation was achieved (no new themes emerged). Focus groups (90 minutes) were conducted at the CBOs. Individual interviews (45 minutes) were conducted in participants’ homes. Written informed consent was obtained. Participants were paid $50. Interviews were conducted during August-November, 2014, audiotaped, and transcribed.
Semistructured in-person interviews with cancer support providers and physicians. Investigators invited five cancer support providers (three patient navigators from three county hospitals, and two CBO directors of cancer psychosocial support services) and four physicians (three oncologists and one breast cancer surgeon from three county hospitals) to an in-person interview to identify SSBCS’ survivorship care needs. All agreed to participate. No further candidates were approached because saturation was achieved. We obtained written informed consent and 30-minute interviews were conducted in participants’ offices during August-October, 2014. Interviews were audiotaped and transcribed. Participants were paid $50.
Ethical approval. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.
Informed consent. Informed consent was obtained from all individual participants included in the study.
Measures
Structured telephone survey. Based on cancer survivor needs assessments,15 we assessed: physical and emotional symptoms; problems with sleep and memory/concentration; concerns about mortality, family, social isolation, intimacy, appearance; and healthy lifestyles. Items were adapted and translated into Spanish if needed, using forward/backward translation with team reconciliation. These questions used the introduction, “Now I am going to ask you if you have had any problems because of your cancer. In the past month, how much have you been bothered by …” with responses rated on a scale of 1-5 (1, Not at all; 5, A lot). For example, we asked, “In the past month, how much have you been bothered by fatigue?”
Regarding healthy lifestyles, we used the introduction, “Here are some changes women sometimes want to make after cancer. Would you like help with …?” For example, we asked, “Would you like help with getting more exercise?” We asked if they wanted help getting more exercise, eating healthier, managing stress, and doing meditation or yoga (Yes/No).
Semistructured interview guide for SSBCS. Participants were asked about their emotional and physical concerns when treatment ended, current cancer needs, symptoms or late effects, and issues related to relationships, family, employment, insurance, financial hardships, barriers to follow-up care, health behaviors, and survivorship program content. Sample questions are, “Have you had any symptoms or side effects related to your cancer or treatment?” and “What kinds of information do you feel you need now about your cancer or treatment?” A brief questionnaire assessed demographics.
Semistructured interview guide for cancer support providers and physicians. Support providers and physicians were asked about informational, psychosocial, and symptom management needs of SSBCS and recommended self-management content and formats. Sample questions are, “What kinds of information and support do you wish was available to help Spanish-speaking women take care of their health after treatment ends?” and “What do you think are the most pressing emotional needs of Spanish-speaking women after breast cancer treatment ends?” A brief questionnaire assessed demographics.
Analysis
Frequencies are reported for survey items. For questions about symptoms/concerns, we report the frequency of responding that they were bothered Somewhat/Quite a bit/A lot. For healthy lifestyles, we present the frequency answering Yes.
Verbatim semistructured interview transcripts were verified against audiotapes. Using QSR NVIVO software, transcripts were coded independently by two bilingual-bicultural investigators using a constant comparative method to generate coding categories for cancer survivorship needs.16 Coders started with themes specified by the interview guides, expanded them to represent the data, and discussed and reconciled coding discrepancies. Coding was compared by type of interview participant (survivor, support provider, or physician). Triangulation of survey and semistructured interviews occurred through team discussions to verify codes, themes, and implications for interventions.
Results
Telephone survey of SSBCS
Of the telephone survey sampling frame (N = 231), 118 individuals (51%) completed the interview, 37 (16%) were ineligible, 31 (13%) could not be reached, 22 (10%) had incorrect contact information, 19 (8%) refused to participate, and 4 (2%) were deceased. Mean age of the participants was 54.9 years (SD, 12.3); all were foreign-born, with more than half of Mexican origin; and most had less than a high-school education (Table 1). All had completed active treatment, and most (68%) were within 2 years of diagnosis.
For symptom management needs (Table 2), the most prevalent (bothersome) symptoms (reported by more than 30%, in rank order) were joint pain, sleep problems, fatigue, hot flashes, numbness/tingling of extremities, and memory. Next most prevalent (reported by 20%-30%) were vaginal dryness, dry/itchy skin, dry nose/mouth, inability to concentrate, constipation, changes in urination, and shortness of breath.
For psychosocial needs, fears of recurrence or new cancers were reported by 42%. Emotional symptoms reported by more than 30% were depression/sadness, anxieties, and feeling stressed. Next most prevalent (20%-30%) were fears, loss of interest in usual activities, and nervousness/restlessness. Social well-being concerns reported by 20%-30% of survivors were loneliness, having no one to talk to, and being a burden to their families. Body image and sexual problems reported by 20%-30% of survivors included appearance and problems being intimate with partners.
Regarding lifestyle, most of the participants said they wanted help with eating a healthier diet (74%), getting more exercise (69%), managing stress (63%), and doing yoga or meditation (55%).
Semistructured interviews
Twenty-five SSBCS completed semistructured interviews, 10 in individual interviews and 15 in one of two focus groups (one of 9 women older than 50 years; one of 6 women younger than 50). The telephone survey respondents were similar to semistructured interview respondents on all sociodemographic characteristics, but differed slightly on some clinical characteristics (Table 1). The telephone survey women had been more recently diagnosed (P < .01), were less likely to have ductal carcinoma in situ (P < .001), and more likely to have had reconstructive surgery
(P < .05).
Five cancer support providers and 4 physicians were interviewed. All support providers were Spanish-speaking Latinas with at least some college education. Cancer physicians were board certified. Two were men; two were white and two Asian; one was a breast surgeon and three were hematologists/oncologists; three spoke Spanish poorly/not at all and one spoke it fairly well.
Seven themes emerged from interviews: unmet physical symptom management needs; social support often ends when treatment ends; challenges resuming roles; sense of abandonment by health care system when treatment ends; need for formal transition from active treatment to follow-up care; fear of recurrence especially when obtaining follow-up care; and desire for information on late effects of initial treatments and side effects of hormonal treatments. We summarize results according to these themes.
Unmet physical symptom management needs. The main physical symptoms reported by survivors and physicians in interviews were arthralgia, menopausal symptoms, and neuropathy. Fatigue was reported only by survivors. Many survivors and several support providers expressed that symptoms were poorly managed and often ignored. One stated,
I have a lot of pain where I had surgery, it burns. I worry a lot about my arm because I have sacs of fluid. My doctor only says, ‘They will dissolve over the years.’ So, I don’t feel any support. (FocGrp1#6)
Survivors reported side effects of hormonal therapies, and felt that physicians downplayed these to prevent them from discontinuing medications.
Social support from family and friends often ends when treatment ends. Many survivors described a loss of support from family and friends who expected them to get back to “normal” once treatment ended. One said,
My sisters have told me to my face that there’s nothing wrong with me. So now when people ask me, I say, ‘I’m fine, thank God, I have nothing,’ even though I’m dying of pain and have all these pills to take. (Survivor#1025)
A support provider related,
The client was telling me that as she was getting closer to finishing her treatment, her husband was upset because he felt like all she was doing was focusing on the cancer. I think caregivers, family, spouses, and children out of their own sort of selfishness want this person to be well. (SuppProv#104)
A few survivors said that family bonds were strengthened after cancer and several reported lacking support because their families were in their home countries.
Challenges resuming roles, especially returning to work. Survivors, support providers, and physicians described challenges and few resources as women transition back to their normal roles. Survivors questioned their ability to return to work due to physically demanding occupations. One stated,
I would like information on how to take care of myself, how working can affect this side if I don’t take care of it. I clean houses and I need both hands. (Survivor#3012)
Survivors described how changes in memory affected daily chores and work performance. Support providers and physicians described the need for resources to aid with return to work and household responsibilities. One physician noted,
There are usually questions about how to go ahead and live their lives from that point forward. It’s a sort of reverse shock: going back to life as they know it. (Physician#004)
Support providers and physicians mentioned that women needed help with resuming intimate partner relations.
Sense of abandonment by health care system once active treatment ends. Survivors, support providers, and physicians reported a loss of support and sense of abandonment by the patients’ oncology team at the end of active treatment. One survivor stated,
Once they tell you to stop the pills, ‘You’re cured, there’s nothing wrong with you,’ the truth is that one feels, ‘Now what do I do? I have no one to help me.’ I felt very abandoned. (FocGrp1#5)
A provider said,
The support system falls apart once women complete treatment. They lose their entire support system at the medical level. They no longer have nurses checking in about symptoms and addressing anything that’s come up. They won’t have access to doctors unless they’re doing their screening. (SuppProv#101)
An oncologist, noting that this loss of support occurs when women face pressures of transitioning back to work or family obligations, commented,
So here’s a woman whose marriage is in turmoil, whose husband may even have left her during this, and now her clinic is leaving her and she’s on her own … that must be scary as hell because there’s nobody out there to support her. (Physician#002)
Need for formal transition from active treatment to follow-up care. Two themes emerged about transitioning from active treatment: transferring care from oncologists to primary care physicians (PCP); and issues of follow-up care (with oncologists or PCPs). Survivors felt lost in transitioning from specialty to primary care, or expressed apprehension seeing a PCP rather than a cancer specialist. One stated,
I have my doctor but she is not a specialist. She does what I tell her to and orders a mammogram every year. But, I don’t go to the oncologist anymore, and so I worry. With the specialists, I feel protected. (FocGrp1#5)
Physicians acknowledged the lack of a formal transition to primary care such as a survivorship care program.
Follow-up care issues were common. Physicians stressed that women needed to know how often to return for follow-up once active treatment ends and about recommended examinations and tests, especially when receiving hormonal therapy. Physicians indicated the need for patient education materials specific to patients’ treatments, for example, elevated risk of heart disease with certain chemotherapy agents. An oncologist expressed concern that PCPs are not prepared adequately about late effects and hormonal treatment side effects, and suggested providing summary notes for PCPs detailing these.
Survivors identified several barriers to follow-up care: lacking information on which symptoms merited a call to physicians; financial burden/limited health insurance; lacking appointment reminders; fear of examinations; and limited English proficiency. A survivor stated,
If you have insurance, you can make your appointment, see the doctor, and have your mammogram. I stopped taking my pills because I didn’t have insurance. I tried to get them again but they told me they would cost me a thousand dollars. (FocGrp1#5)
One oncologist suggested scheduling a follow-up appointment before patients leave treatment and calling patients who miss appointments.
Facilitators of regular follow-up care identified by survivors were physicians informing them about symptom monitoring and reporting, having a clinic contact person/navigator, being given a follow-up appointment, being assertive about one’s care, and physicians’ reinforcement of adherence to hormonal treatment and follow-up. According to support providers, a key facilitator was having a clinic contact person/navigator. Once treatment ended, support providers often served as the liaison between the patient and the physician, making them the first point of contact for symptom reporting.
Fear of recurrence especially when obtaining follow-up care. Fear of recurrence dominated survivor interviews. This fear was heightened at the time of follow-up examinations or when they experienced unusual pain. A survivor commented,
Every time I’m due for my mammogram, I can’t sleep, worrying. I lose sleep until I get the letter with my results. Then I feel at peace again. (FocGrp1#9)
Support providers discussed the need to provide reassurance to SSBCS to help them cope with fears of recurrence. Physicians expressed challenges in allaying fears of recurrence among SSBCS, requiring a lot of time when recommending follow-up mammograms.
Desire for information on late effects of treatments and side effects of hormonal therapies. All survivors expressed receiving insufficient information on potential symptoms and side effects. One stated,
Doctors only have five minutes. There has never been someone who gave me guidance like, ‘From now on you have to do this or you might get these symptoms now or in the future. (Survivor#6019)
They indicated uncertainty about what symptoms were “normal” and when symptoms merited a call to the physician. Several survivors reported being unaware that fatigue, arthralgia and neuropathy were side effects of breast cancer treatments until they reported these to physicians.
Physicians stressed the importance of women knowing about the elevated risk of future cancers, symptoms of recurrence, and seeking follow-up care if they experience symptoms that are out of the ordinary. Support providers felt that it was important to provide SSBCS with information on signs of recurrence and when to report these. However, providers expressed concern that giving women too much information might elevate their anxiety. A physician suggested,
It’s probably better to have a symptom list that’s short and relevant for the most common and catastrophic things, same thing with side effects … short to avoid overwhelming the patient. (Physician#001)
Hormonal treatments were of special concern. Survivors expressed a need for information on hormonal treatments and support providers stressed that this information is needed in simple Spanish. Several survivors indicated they stopped taking hormonal treatments due to side effects. One woman experienced severe headaches and heart palpitations, stopped taking the hormonal medication, felt better, and did not inform her physician until her next appointment. A support provider stated,
What I hear from a lot of women is that if side effects are too uncomfortable, they just stop it (hormonal treatment) without saying anything to the doctor. So more information about why they have to take it and that there is a good chance of recurrence is really important. (SuppProv#101)
Likewise, physicians indicated that SSBCS’ lack of information on hormonal treatments often resulted in nonadherence, emphasizing the need to reinforce adherence to prevent recurrence.
Conceptual framework of interventions
Based on triangulation of survey and interview results, we compiled a conceptual framework that includes needs identified, suggested components of a survivorship care intervention to address these needs, potential mediators by which such interventions could improve outcomes, and relevant outcomes (Figure). Survivorship care needs fell into four categories: symptom management, psychosocial, sense of abandonment by health care team, and healthy lifestyles. Survivorship care programs would provide skills training in symptom and stress management, and communicating with providers, family, friends, and coworkers. Mediators include increased self-efficacy, knowledge and perceived social support, ultimately leading to reduced distress (anxiety and depressive symptoms) and stress, and improved health-related quality of life.
Conclusions
Our study aimed to identify the most critical needs of SSBCS in the posttreatment survivorship phase to facilitate the design of survivorship interventions for this vulnerable group. SSBCS, cancer support providers, and cancer physicians reported substantial symptom management, psychosocial, and informational needs among this population. Results from surveys and open-ended interviews were remarkably consistent. Survivors, physicians, and support providers viewed transition out of active treatment as a time of increased psychosocial need and heightened vulnerability.
Our findings are consistent with needs assessments conducted in other breast cancer survivors. Similar to a study of rural white women with breast cancer, fear of recurrence was among the most common psychosocial concerns.17 Results of two studies that included white, African American and Latina breast cancer survivors were consistent with ours in finding that pain and fatigue were among the most persistent symptoms; in both studies, Latinas were more likely to report pain and a higher number of symptoms.7,18 The prevalence of sleep problems in our sample was identical to that reported in a sample of African American breast cancer survivors.19 Our findings of a high need for symptom management information and support, social support from family and friends, and self-management resources were similar to studies of other vulnerable breast cancer survivors.18,20
Our results suggest that it is critical for health care professionals to provide assistance with managing side effects and information to alleviate fears, and reinforce behaviors of symptom monitoring and reporting, and adherence to follow-up care and hormonal therapies. Yet this information is not being conveyed effectively and is complicated by the need to balance women’s need for information with minimizing anxiety when providing such information.
A limitation of our study is that most of our sample was Mexican origin and may not reflect experiences of Spanish-speaking Latinas of other national origin groups or outside of Northern California. Another limitation is the lack of an English-speaking comparison group, which would have permitted the identification of similarities and differences across language groups. Finally, we did not interview radiation oncologists who may have had opinions that are not represented here.
Survivorship care programs offer great promise for meeting patients’ informational and symptom management needs and improving well-being and communication with clinicians.21 Due to limited access to survivorship care information, financial hardships, and pressures from their families to resume their social roles, concerted efforts are needed to develop appropriate survivorship programs for SSBCS.22 Unique language, cultural and socioeconomic factors of Spanish-speaking Latinas require tailoring of cancer survivorship programs to best meet their needs.23 These programs need to provide psychosocial stress and symptom management assistance, simple information on recommended follow-up care, and healthy lifestyle and role reintegration strategies that account for their unique sociocultural contexts.
1. Danese MD, O’Malley C, Lindquist K, Gleeson M, Griffiths RI. An observational study of the prevalence and incidence of comorbid conditions in older women with breast cancer. Ann Oncol. 2012;23(7):1756-1765.
2. Hewitt M, Greenfield S, Stovall E, eds. From cancer patient to cancer survivor: lost in transition. Washington, DC: National Academy of Sciences; 2006.
3. Beckjord EB, Arora NK, McLaughlin W, Oakley-Girvan I, Hamilton AS, Hesse BW. Health-related information needs in a large and diverse sample of adult cancer survivors: implications for cancer care. J Cancer Surviv. 2008;2(3):179-189.
4. Hewitt ME, Bamundo A, Day R, Harvey C. Perspectives on posttreatment cancer care: qualitative research with survivors, nurses, and physicians. J Clin Oncol. 2007;25(16):2270-2273.
5. Ashing-Giwa KT, Tejero JS, Kim J, Padilla GV, Hellemann G. Examining predictive models of HRQOL in a population-based, multiethnic sample of women with breast carcinoma. Qual Life Res. 2007;16(3):413-428.
6. Clauser SB, Arora NK, Bellizzi KM, Haffer SC, Topor M, Hays RD. Disparities in HRQOL of cancer survivors and non-cancer managed care enrollees. Health Care Financ Rev. 2008;29(4):23-40.
7. Eversley R, Estrin D, Dibble S, Wardlaw L, Pedrosa M, Favila-Penney W. Posttreatment symptoms among ethnic minority breast cancer survivors. Oncol Nurs Forum. 2005;32(2):250-256.
8. Bickell NA, Wang JJ, Oluwole S, et al. Missed opportunities: racial disparities in adjuvant breast cancer treatment. J Clin Oncol. 2006;24(9):1357-1362.
9. Arora NK, Reeve BB, Hays RD, Clauser SB, Oakley-Girvan I. Assessment of quality of cancer-related follow-up care from the cancer survivor’s perspective. J Clin Oncol. 2011;29(10):1280-1289.
10. Janz NK, Mujahid MS, Hawley ST, Griggs JJ, Hamilton AS, Katz SJ. Racial/ethnic differences in adequacy of information and support for women with breast cancer. Cancer. 2008;113(5):1058-1067.
11. Yoon J, Malin JL, Tisnado DM, et al. Symptom management after breast cancer treatment: is it influenced by patient characteristics? Breast Cancer Res Treat. 2008;108(1):69-77.
12. Ashing K, Rosales M. A telephonic-based trial to reduce depressive symptoms among Latina breast cancer survivors. Psychooncology. 2014;23(5):507-515.
13. Hershman DL, Greenlee H, Awad D, et al. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013;138(3):795-806.
14. Napoles AM, Ortiz C, Santoyo-Olsson J, et al. Nuevo Amanecer: results of a randomized controlled trial of a community-based, peer-delivered stress management intervention to improve quality of life in Latinas with breast cancer. Am J Public Health. 2015;105(suppl 3):e55-63.
15. Rechis R, Reynolds KA, Beckjord EB, Nutt S, Burns RM, Schaefer JS. ‘I learned to live with it’ is not good enough: challenges reported by posttreatment cancer survivors in the Livestrong surveys. Austin, TX: Livestrong;2011.
16. Glaser BG, Strauss AL. The discovery of grounded theory: strategies for qualitative research. Hawthorne: Aldine Publishing Company; 1967.
17. Befort CA, Klemp J. Sequelae of breast cancer and the influence of menopausal status at diagnosis among rural breast cancer survivors. J Womens Health (Larchmt). 2011;20(9):1307-1313.
18. Fu OS, Crew KD, Jacobson JS, et al. Ethnicity and persistent symptom burden in breast cancer survivors. J Cancer Surviv. 2009;3(4):241-250.
19. Taylor TR, Huntley ED, Makambi K, et al. Understanding sleep disturbances in African-American breast cancer survivors: a pilot study. Psychooncology. 2012;21(8):896-902.
20. Adams N, Gisiger-Camata S, Hardy CM, Thomas TF, Jukkala A, Meneses K. Evaluating survivorship experiences and needs among rural African American breast cancer survivors. J Cancer Educ. October 24, 2015 [Epub ahead of print].
21. Blinder VS, Patil S, Thind A, et al. Return to work in low-income Latina and non-Latina white breast cancer survivors: a 3-year longitudinal study. Cancer. 2012;118(6):1664-1674.
22. Lopez-Class M, Perret-Gentil M, Kreling B, Caicedo L, Mandelblatt J, Graves KD. Quality of life among immigrant Latina breast cancer survivors: realities of culture and enhancing cancer care. J Cancer Educ. 2011;26(4):724-733.
23. Napoles-Springer AM, Ortiz C, O’Brien H, Diaz-Mendez M. Developing a culturally competent peer support intervention for Spanish-speaking Latinas with breast cancer. J Immigr Minor Health. 2009;11(4):268-280
After treatment, cancer patients transition to a survivorship phase, often with little information or support. Cancer survivors are at increased risk of recurrence, secondary cancers, comorbid conditions, and late treatment effects.1,2 However, many remain unaware of these risks and the options for managing them3 and face numerous unmet medical, psychosocial, and informational needs that can be addressed through survivorship care programs.4 Anxiety may increase as they lose their treatment team’s support while attempting to reestablish their lives.2 Patients need to know the long-term risks of cancer treatments, probabilities of recurrence and second cancers, effectiveness of surveillance and interventions for managing late effects and psychosocial concerns, and benefits of healthy lifestyles.2
Due to sociocultural and economic factors, Spanish-speaking Latina breast cancer survivors (SSBCS) suffer worse posttreatment health-related quality of life and more pain, fatigue, depressive symptoms, body image issues, and distress than their white counterparts.5-7 However, they are less likely to receive necessary cancer treatment, symptom management, and surveillance. For example, compared with whites, Latina breast cancer survivors receive less guideline-adherent treatment8 and follow-up care, including survivorship information.3,9 SSBCS, in particular have less access to survivorship information.10 Consequently, SSBCS are more likely to report unmet symptom management needs.11
Several breast cancer survivorship program trials have included Latinas,12,13 but their effectiveness has been demonstrated only for depressive symptoms or health worry. A comprehensive assessment of the posttreatment needs of SSBCS would provide a foundation for designing tailored survivorship interventions for this vulnerable group. This study aimed to identify the symptom management, psychosocial, and informational needs of SSBCS during the transition to survivorship from the perspectives of SSBCS and their cancer support providers and cancer physicians.
Methods
We sampled respondents within a 5-county area in Northern California to obtain multiple perspectives of the survivorship care needs of SSBCS using structured and in-depth methods: a telephone survey of SSBCS; semistructured interviews with SSBCS; semistructured interviews with cancer support providers serving SSBCS; and semistructured interviews with physicians providing cancer care for SSBCS. The study protocol was approved by the University of California San Francisco Committee on Human Research.
Sample and procedures
Structured telephone survey with SSBCS. The sample was drawn evenly from San Francisco General Hospital-University of California San Francisco primary care practices and SSBCS from a previous study who agreed to be re-contacted.14 The inclusion criteria were: completed active treatment (except adjuvant hormonal therapy) for nonmetastatic breast cancer within 10 years; living in one of the five counties; primarily Spanish-speaking; and self-identified as Latina. The exclusion criteria were: previous cancer except nonmelanoma skin cancer; terminal illness; or metastatic breast cancer. Study staff mailed potential participants a bilingual letter and information sheet, and bilingual opt-out postcard (6th grade reading level assessed by Flesch-Kincaid grade level statistic). Female bilingual-bicultural research associates conducted interviews of 20-30 minutes in Spanish after obtaining verbal consent. Participants were mailed $20. Surveys were conducted during March-November 2014.
Semistructured in-person interviews with SSBCS. Four community-based organizations (CBOs) in the targeted area providing cancer support services to Latinos agreed to recruit SSBCS for interviews. Inclusion criteria were identical to the survey. Patient navigators or support providers from CBOs contacted women by phone or in-person to invite them to an interview to assess their cancer survivorship needs. Women could choose a focus group or individual interview. With permission, names and contact information were given to study interviewers who called, explained the study, screened for eligibility, and scheduled an interview.
Recruitment was stratified by age (under or over age 50). We sampled women until saturation was achieved (no new themes emerged). Focus groups (90 minutes) were conducted at the CBOs. Individual interviews (45 minutes) were conducted in participants’ homes. Written informed consent was obtained. Participants were paid $50. Interviews were conducted during August-November, 2014, audiotaped, and transcribed.
Semistructured in-person interviews with cancer support providers and physicians. Investigators invited five cancer support providers (three patient navigators from three county hospitals, and two CBO directors of cancer psychosocial support services) and four physicians (three oncologists and one breast cancer surgeon from three county hospitals) to an in-person interview to identify SSBCS’ survivorship care needs. All agreed to participate. No further candidates were approached because saturation was achieved. We obtained written informed consent and 30-minute interviews were conducted in participants’ offices during August-October, 2014. Interviews were audiotaped and transcribed. Participants were paid $50.
Ethical approval. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.
Informed consent. Informed consent was obtained from all individual participants included in the study.
Measures
Structured telephone survey. Based on cancer survivor needs assessments,15 we assessed: physical and emotional symptoms; problems with sleep and memory/concentration; concerns about mortality, family, social isolation, intimacy, appearance; and healthy lifestyles. Items were adapted and translated into Spanish if needed, using forward/backward translation with team reconciliation. These questions used the introduction, “Now I am going to ask you if you have had any problems because of your cancer. In the past month, how much have you been bothered by …” with responses rated on a scale of 1-5 (1, Not at all; 5, A lot). For example, we asked, “In the past month, how much have you been bothered by fatigue?”
Regarding healthy lifestyles, we used the introduction, “Here are some changes women sometimes want to make after cancer. Would you like help with …?” For example, we asked, “Would you like help with getting more exercise?” We asked if they wanted help getting more exercise, eating healthier, managing stress, and doing meditation or yoga (Yes/No).
Semistructured interview guide for SSBCS. Participants were asked about their emotional and physical concerns when treatment ended, current cancer needs, symptoms or late effects, and issues related to relationships, family, employment, insurance, financial hardships, barriers to follow-up care, health behaviors, and survivorship program content. Sample questions are, “Have you had any symptoms or side effects related to your cancer or treatment?” and “What kinds of information do you feel you need now about your cancer or treatment?” A brief questionnaire assessed demographics.
Semistructured interview guide for cancer support providers and physicians. Support providers and physicians were asked about informational, psychosocial, and symptom management needs of SSBCS and recommended self-management content and formats. Sample questions are, “What kinds of information and support do you wish was available to help Spanish-speaking women take care of their health after treatment ends?” and “What do you think are the most pressing emotional needs of Spanish-speaking women after breast cancer treatment ends?” A brief questionnaire assessed demographics.
Analysis
Frequencies are reported for survey items. For questions about symptoms/concerns, we report the frequency of responding that they were bothered Somewhat/Quite a bit/A lot. For healthy lifestyles, we present the frequency answering Yes.
Verbatim semistructured interview transcripts were verified against audiotapes. Using QSR NVIVO software, transcripts were coded independently by two bilingual-bicultural investigators using a constant comparative method to generate coding categories for cancer survivorship needs.16 Coders started with themes specified by the interview guides, expanded them to represent the data, and discussed and reconciled coding discrepancies. Coding was compared by type of interview participant (survivor, support provider, or physician). Triangulation of survey and semistructured interviews occurred through team discussions to verify codes, themes, and implications for interventions.
Results
Telephone survey of SSBCS
Of the telephone survey sampling frame (N = 231), 118 individuals (51%) completed the interview, 37 (16%) were ineligible, 31 (13%) could not be reached, 22 (10%) had incorrect contact information, 19 (8%) refused to participate, and 4 (2%) were deceased. Mean age of the participants was 54.9 years (SD, 12.3); all were foreign-born, with more than half of Mexican origin; and most had less than a high-school education (Table 1). All had completed active treatment, and most (68%) were within 2 years of diagnosis.
For symptom management needs (Table 2), the most prevalent (bothersome) symptoms (reported by more than 30%, in rank order) were joint pain, sleep problems, fatigue, hot flashes, numbness/tingling of extremities, and memory. Next most prevalent (reported by 20%-30%) were vaginal dryness, dry/itchy skin, dry nose/mouth, inability to concentrate, constipation, changes in urination, and shortness of breath.
For psychosocial needs, fears of recurrence or new cancers were reported by 42%. Emotional symptoms reported by more than 30% were depression/sadness, anxieties, and feeling stressed. Next most prevalent (20%-30%) were fears, loss of interest in usual activities, and nervousness/restlessness. Social well-being concerns reported by 20%-30% of survivors were loneliness, having no one to talk to, and being a burden to their families. Body image and sexual problems reported by 20%-30% of survivors included appearance and problems being intimate with partners.
Regarding lifestyle, most of the participants said they wanted help with eating a healthier diet (74%), getting more exercise (69%), managing stress (63%), and doing yoga or meditation (55%).
Semistructured interviews
Twenty-five SSBCS completed semistructured interviews, 10 in individual interviews and 15 in one of two focus groups (one of 9 women older than 50 years; one of 6 women younger than 50). The telephone survey respondents were similar to semistructured interview respondents on all sociodemographic characteristics, but differed slightly on some clinical characteristics (Table 1). The telephone survey women had been more recently diagnosed (P < .01), were less likely to have ductal carcinoma in situ (P < .001), and more likely to have had reconstructive surgery
(P < .05).
Five cancer support providers and 4 physicians were interviewed. All support providers were Spanish-speaking Latinas with at least some college education. Cancer physicians were board certified. Two were men; two were white and two Asian; one was a breast surgeon and three were hematologists/oncologists; three spoke Spanish poorly/not at all and one spoke it fairly well.
Seven themes emerged from interviews: unmet physical symptom management needs; social support often ends when treatment ends; challenges resuming roles; sense of abandonment by health care system when treatment ends; need for formal transition from active treatment to follow-up care; fear of recurrence especially when obtaining follow-up care; and desire for information on late effects of initial treatments and side effects of hormonal treatments. We summarize results according to these themes.
Unmet physical symptom management needs. The main physical symptoms reported by survivors and physicians in interviews were arthralgia, menopausal symptoms, and neuropathy. Fatigue was reported only by survivors. Many survivors and several support providers expressed that symptoms were poorly managed and often ignored. One stated,
I have a lot of pain where I had surgery, it burns. I worry a lot about my arm because I have sacs of fluid. My doctor only says, ‘They will dissolve over the years.’ So, I don’t feel any support. (FocGrp1#6)
Survivors reported side effects of hormonal therapies, and felt that physicians downplayed these to prevent them from discontinuing medications.
Social support from family and friends often ends when treatment ends. Many survivors described a loss of support from family and friends who expected them to get back to “normal” once treatment ended. One said,
My sisters have told me to my face that there’s nothing wrong with me. So now when people ask me, I say, ‘I’m fine, thank God, I have nothing,’ even though I’m dying of pain and have all these pills to take. (Survivor#1025)
A support provider related,
The client was telling me that as she was getting closer to finishing her treatment, her husband was upset because he felt like all she was doing was focusing on the cancer. I think caregivers, family, spouses, and children out of their own sort of selfishness want this person to be well. (SuppProv#104)
A few survivors said that family bonds were strengthened after cancer and several reported lacking support because their families were in their home countries.
Challenges resuming roles, especially returning to work. Survivors, support providers, and physicians described challenges and few resources as women transition back to their normal roles. Survivors questioned their ability to return to work due to physically demanding occupations. One stated,
I would like information on how to take care of myself, how working can affect this side if I don’t take care of it. I clean houses and I need both hands. (Survivor#3012)
Survivors described how changes in memory affected daily chores and work performance. Support providers and physicians described the need for resources to aid with return to work and household responsibilities. One physician noted,
There are usually questions about how to go ahead and live their lives from that point forward. It’s a sort of reverse shock: going back to life as they know it. (Physician#004)
Support providers and physicians mentioned that women needed help with resuming intimate partner relations.
Sense of abandonment by health care system once active treatment ends. Survivors, support providers, and physicians reported a loss of support and sense of abandonment by the patients’ oncology team at the end of active treatment. One survivor stated,
Once they tell you to stop the pills, ‘You’re cured, there’s nothing wrong with you,’ the truth is that one feels, ‘Now what do I do? I have no one to help me.’ I felt very abandoned. (FocGrp1#5)
A provider said,
The support system falls apart once women complete treatment. They lose their entire support system at the medical level. They no longer have nurses checking in about symptoms and addressing anything that’s come up. They won’t have access to doctors unless they’re doing their screening. (SuppProv#101)
An oncologist, noting that this loss of support occurs when women face pressures of transitioning back to work or family obligations, commented,
So here’s a woman whose marriage is in turmoil, whose husband may even have left her during this, and now her clinic is leaving her and she’s on her own … that must be scary as hell because there’s nobody out there to support her. (Physician#002)
Need for formal transition from active treatment to follow-up care. Two themes emerged about transitioning from active treatment: transferring care from oncologists to primary care physicians (PCP); and issues of follow-up care (with oncologists or PCPs). Survivors felt lost in transitioning from specialty to primary care, or expressed apprehension seeing a PCP rather than a cancer specialist. One stated,
I have my doctor but she is not a specialist. She does what I tell her to and orders a mammogram every year. But, I don’t go to the oncologist anymore, and so I worry. With the specialists, I feel protected. (FocGrp1#5)
Physicians acknowledged the lack of a formal transition to primary care such as a survivorship care program.
Follow-up care issues were common. Physicians stressed that women needed to know how often to return for follow-up once active treatment ends and about recommended examinations and tests, especially when receiving hormonal therapy. Physicians indicated the need for patient education materials specific to patients’ treatments, for example, elevated risk of heart disease with certain chemotherapy agents. An oncologist expressed concern that PCPs are not prepared adequately about late effects and hormonal treatment side effects, and suggested providing summary notes for PCPs detailing these.
Survivors identified several barriers to follow-up care: lacking information on which symptoms merited a call to physicians; financial burden/limited health insurance; lacking appointment reminders; fear of examinations; and limited English proficiency. A survivor stated,
If you have insurance, you can make your appointment, see the doctor, and have your mammogram. I stopped taking my pills because I didn’t have insurance. I tried to get them again but they told me they would cost me a thousand dollars. (FocGrp1#5)
One oncologist suggested scheduling a follow-up appointment before patients leave treatment and calling patients who miss appointments.
Facilitators of regular follow-up care identified by survivors were physicians informing them about symptom monitoring and reporting, having a clinic contact person/navigator, being given a follow-up appointment, being assertive about one’s care, and physicians’ reinforcement of adherence to hormonal treatment and follow-up. According to support providers, a key facilitator was having a clinic contact person/navigator. Once treatment ended, support providers often served as the liaison between the patient and the physician, making them the first point of contact for symptom reporting.
Fear of recurrence especially when obtaining follow-up care. Fear of recurrence dominated survivor interviews. This fear was heightened at the time of follow-up examinations or when they experienced unusual pain. A survivor commented,
Every time I’m due for my mammogram, I can’t sleep, worrying. I lose sleep until I get the letter with my results. Then I feel at peace again. (FocGrp1#9)
Support providers discussed the need to provide reassurance to SSBCS to help them cope with fears of recurrence. Physicians expressed challenges in allaying fears of recurrence among SSBCS, requiring a lot of time when recommending follow-up mammograms.
Desire for information on late effects of treatments and side effects of hormonal therapies. All survivors expressed receiving insufficient information on potential symptoms and side effects. One stated,
Doctors only have five minutes. There has never been someone who gave me guidance like, ‘From now on you have to do this or you might get these symptoms now or in the future. (Survivor#6019)
They indicated uncertainty about what symptoms were “normal” and when symptoms merited a call to the physician. Several survivors reported being unaware that fatigue, arthralgia and neuropathy were side effects of breast cancer treatments until they reported these to physicians.
Physicians stressed the importance of women knowing about the elevated risk of future cancers, symptoms of recurrence, and seeking follow-up care if they experience symptoms that are out of the ordinary. Support providers felt that it was important to provide SSBCS with information on signs of recurrence and when to report these. However, providers expressed concern that giving women too much information might elevate their anxiety. A physician suggested,
It’s probably better to have a symptom list that’s short and relevant for the most common and catastrophic things, same thing with side effects … short to avoid overwhelming the patient. (Physician#001)
Hormonal treatments were of special concern. Survivors expressed a need for information on hormonal treatments and support providers stressed that this information is needed in simple Spanish. Several survivors indicated they stopped taking hormonal treatments due to side effects. One woman experienced severe headaches and heart palpitations, stopped taking the hormonal medication, felt better, and did not inform her physician until her next appointment. A support provider stated,
What I hear from a lot of women is that if side effects are too uncomfortable, they just stop it (hormonal treatment) without saying anything to the doctor. So more information about why they have to take it and that there is a good chance of recurrence is really important. (SuppProv#101)
Likewise, physicians indicated that SSBCS’ lack of information on hormonal treatments often resulted in nonadherence, emphasizing the need to reinforce adherence to prevent recurrence.
Conceptual framework of interventions
Based on triangulation of survey and interview results, we compiled a conceptual framework that includes needs identified, suggested components of a survivorship care intervention to address these needs, potential mediators by which such interventions could improve outcomes, and relevant outcomes (Figure). Survivorship care needs fell into four categories: symptom management, psychosocial, sense of abandonment by health care team, and healthy lifestyles. Survivorship care programs would provide skills training in symptom and stress management, and communicating with providers, family, friends, and coworkers. Mediators include increased self-efficacy, knowledge and perceived social support, ultimately leading to reduced distress (anxiety and depressive symptoms) and stress, and improved health-related quality of life.
Conclusions
Our study aimed to identify the most critical needs of SSBCS in the posttreatment survivorship phase to facilitate the design of survivorship interventions for this vulnerable group. SSBCS, cancer support providers, and cancer physicians reported substantial symptom management, psychosocial, and informational needs among this population. Results from surveys and open-ended interviews were remarkably consistent. Survivors, physicians, and support providers viewed transition out of active treatment as a time of increased psychosocial need and heightened vulnerability.
Our findings are consistent with needs assessments conducted in other breast cancer survivors. Similar to a study of rural white women with breast cancer, fear of recurrence was among the most common psychosocial concerns.17 Results of two studies that included white, African American and Latina breast cancer survivors were consistent with ours in finding that pain and fatigue were among the most persistent symptoms; in both studies, Latinas were more likely to report pain and a higher number of symptoms.7,18 The prevalence of sleep problems in our sample was identical to that reported in a sample of African American breast cancer survivors.19 Our findings of a high need for symptom management information and support, social support from family and friends, and self-management resources were similar to studies of other vulnerable breast cancer survivors.18,20
Our results suggest that it is critical for health care professionals to provide assistance with managing side effects and information to alleviate fears, and reinforce behaviors of symptom monitoring and reporting, and adherence to follow-up care and hormonal therapies. Yet this information is not being conveyed effectively and is complicated by the need to balance women’s need for information with minimizing anxiety when providing such information.
A limitation of our study is that most of our sample was Mexican origin and may not reflect experiences of Spanish-speaking Latinas of other national origin groups or outside of Northern California. Another limitation is the lack of an English-speaking comparison group, which would have permitted the identification of similarities and differences across language groups. Finally, we did not interview radiation oncologists who may have had opinions that are not represented here.
Survivorship care programs offer great promise for meeting patients’ informational and symptom management needs and improving well-being and communication with clinicians.21 Due to limited access to survivorship care information, financial hardships, and pressures from their families to resume their social roles, concerted efforts are needed to develop appropriate survivorship programs for SSBCS.22 Unique language, cultural and socioeconomic factors of Spanish-speaking Latinas require tailoring of cancer survivorship programs to best meet their needs.23 These programs need to provide psychosocial stress and symptom management assistance, simple information on recommended follow-up care, and healthy lifestyle and role reintegration strategies that account for their unique sociocultural contexts.
After treatment, cancer patients transition to a survivorship phase, often with little information or support. Cancer survivors are at increased risk of recurrence, secondary cancers, comorbid conditions, and late treatment effects.1,2 However, many remain unaware of these risks and the options for managing them3 and face numerous unmet medical, psychosocial, and informational needs that can be addressed through survivorship care programs.4 Anxiety may increase as they lose their treatment team’s support while attempting to reestablish their lives.2 Patients need to know the long-term risks of cancer treatments, probabilities of recurrence and second cancers, effectiveness of surveillance and interventions for managing late effects and psychosocial concerns, and benefits of healthy lifestyles.2
Due to sociocultural and economic factors, Spanish-speaking Latina breast cancer survivors (SSBCS) suffer worse posttreatment health-related quality of life and more pain, fatigue, depressive symptoms, body image issues, and distress than their white counterparts.5-7 However, they are less likely to receive necessary cancer treatment, symptom management, and surveillance. For example, compared with whites, Latina breast cancer survivors receive less guideline-adherent treatment8 and follow-up care, including survivorship information.3,9 SSBCS, in particular have less access to survivorship information.10 Consequently, SSBCS are more likely to report unmet symptom management needs.11
Several breast cancer survivorship program trials have included Latinas,12,13 but their effectiveness has been demonstrated only for depressive symptoms or health worry. A comprehensive assessment of the posttreatment needs of SSBCS would provide a foundation for designing tailored survivorship interventions for this vulnerable group. This study aimed to identify the symptom management, psychosocial, and informational needs of SSBCS during the transition to survivorship from the perspectives of SSBCS and their cancer support providers and cancer physicians.
Methods
We sampled respondents within a 5-county area in Northern California to obtain multiple perspectives of the survivorship care needs of SSBCS using structured and in-depth methods: a telephone survey of SSBCS; semistructured interviews with SSBCS; semistructured interviews with cancer support providers serving SSBCS; and semistructured interviews with physicians providing cancer care for SSBCS. The study protocol was approved by the University of California San Francisco Committee on Human Research.
Sample and procedures
Structured telephone survey with SSBCS. The sample was drawn evenly from San Francisco General Hospital-University of California San Francisco primary care practices and SSBCS from a previous study who agreed to be re-contacted.14 The inclusion criteria were: completed active treatment (except adjuvant hormonal therapy) for nonmetastatic breast cancer within 10 years; living in one of the five counties; primarily Spanish-speaking; and self-identified as Latina. The exclusion criteria were: previous cancer except nonmelanoma skin cancer; terminal illness; or metastatic breast cancer. Study staff mailed potential participants a bilingual letter and information sheet, and bilingual opt-out postcard (6th grade reading level assessed by Flesch-Kincaid grade level statistic). Female bilingual-bicultural research associates conducted interviews of 20-30 minutes in Spanish after obtaining verbal consent. Participants were mailed $20. Surveys were conducted during March-November 2014.
Semistructured in-person interviews with SSBCS. Four community-based organizations (CBOs) in the targeted area providing cancer support services to Latinos agreed to recruit SSBCS for interviews. Inclusion criteria were identical to the survey. Patient navigators or support providers from CBOs contacted women by phone or in-person to invite them to an interview to assess their cancer survivorship needs. Women could choose a focus group or individual interview. With permission, names and contact information were given to study interviewers who called, explained the study, screened for eligibility, and scheduled an interview.
Recruitment was stratified by age (under or over age 50). We sampled women until saturation was achieved (no new themes emerged). Focus groups (90 minutes) were conducted at the CBOs. Individual interviews (45 minutes) were conducted in participants’ homes. Written informed consent was obtained. Participants were paid $50. Interviews were conducted during August-November, 2014, audiotaped, and transcribed.
Semistructured in-person interviews with cancer support providers and physicians. Investigators invited five cancer support providers (three patient navigators from three county hospitals, and two CBO directors of cancer psychosocial support services) and four physicians (three oncologists and one breast cancer surgeon from three county hospitals) to an in-person interview to identify SSBCS’ survivorship care needs. All agreed to participate. No further candidates were approached because saturation was achieved. We obtained written informed consent and 30-minute interviews were conducted in participants’ offices during August-October, 2014. Interviews were audiotaped and transcribed. Participants were paid $50.
Ethical approval. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.
Informed consent. Informed consent was obtained from all individual participants included in the study.
Measures
Structured telephone survey. Based on cancer survivor needs assessments,15 we assessed: physical and emotional symptoms; problems with sleep and memory/concentration; concerns about mortality, family, social isolation, intimacy, appearance; and healthy lifestyles. Items were adapted and translated into Spanish if needed, using forward/backward translation with team reconciliation. These questions used the introduction, “Now I am going to ask you if you have had any problems because of your cancer. In the past month, how much have you been bothered by …” with responses rated on a scale of 1-5 (1, Not at all; 5, A lot). For example, we asked, “In the past month, how much have you been bothered by fatigue?”
Regarding healthy lifestyles, we used the introduction, “Here are some changes women sometimes want to make after cancer. Would you like help with …?” For example, we asked, “Would you like help with getting more exercise?” We asked if they wanted help getting more exercise, eating healthier, managing stress, and doing meditation or yoga (Yes/No).
Semistructured interview guide for SSBCS. Participants were asked about their emotional and physical concerns when treatment ended, current cancer needs, symptoms or late effects, and issues related to relationships, family, employment, insurance, financial hardships, barriers to follow-up care, health behaviors, and survivorship program content. Sample questions are, “Have you had any symptoms or side effects related to your cancer or treatment?” and “What kinds of information do you feel you need now about your cancer or treatment?” A brief questionnaire assessed demographics.
Semistructured interview guide for cancer support providers and physicians. Support providers and physicians were asked about informational, psychosocial, and symptom management needs of SSBCS and recommended self-management content and formats. Sample questions are, “What kinds of information and support do you wish was available to help Spanish-speaking women take care of their health after treatment ends?” and “What do you think are the most pressing emotional needs of Spanish-speaking women after breast cancer treatment ends?” A brief questionnaire assessed demographics.
Analysis
Frequencies are reported for survey items. For questions about symptoms/concerns, we report the frequency of responding that they were bothered Somewhat/Quite a bit/A lot. For healthy lifestyles, we present the frequency answering Yes.
Verbatim semistructured interview transcripts were verified against audiotapes. Using QSR NVIVO software, transcripts were coded independently by two bilingual-bicultural investigators using a constant comparative method to generate coding categories for cancer survivorship needs.16 Coders started with themes specified by the interview guides, expanded them to represent the data, and discussed and reconciled coding discrepancies. Coding was compared by type of interview participant (survivor, support provider, or physician). Triangulation of survey and semistructured interviews occurred through team discussions to verify codes, themes, and implications for interventions.
Results
Telephone survey of SSBCS
Of the telephone survey sampling frame (N = 231), 118 individuals (51%) completed the interview, 37 (16%) were ineligible, 31 (13%) could not be reached, 22 (10%) had incorrect contact information, 19 (8%) refused to participate, and 4 (2%) were deceased. Mean age of the participants was 54.9 years (SD, 12.3); all were foreign-born, with more than half of Mexican origin; and most had less than a high-school education (Table 1). All had completed active treatment, and most (68%) were within 2 years of diagnosis.
For symptom management needs (Table 2), the most prevalent (bothersome) symptoms (reported by more than 30%, in rank order) were joint pain, sleep problems, fatigue, hot flashes, numbness/tingling of extremities, and memory. Next most prevalent (reported by 20%-30%) were vaginal dryness, dry/itchy skin, dry nose/mouth, inability to concentrate, constipation, changes in urination, and shortness of breath.
For psychosocial needs, fears of recurrence or new cancers were reported by 42%. Emotional symptoms reported by more than 30% were depression/sadness, anxieties, and feeling stressed. Next most prevalent (20%-30%) were fears, loss of interest in usual activities, and nervousness/restlessness. Social well-being concerns reported by 20%-30% of survivors were loneliness, having no one to talk to, and being a burden to their families. Body image and sexual problems reported by 20%-30% of survivors included appearance and problems being intimate with partners.
Regarding lifestyle, most of the participants said they wanted help with eating a healthier diet (74%), getting more exercise (69%), managing stress (63%), and doing yoga or meditation (55%).
Semistructured interviews
Twenty-five SSBCS completed semistructured interviews, 10 in individual interviews and 15 in one of two focus groups (one of 9 women older than 50 years; one of 6 women younger than 50). The telephone survey respondents were similar to semistructured interview respondents on all sociodemographic characteristics, but differed slightly on some clinical characteristics (Table 1). The telephone survey women had been more recently diagnosed (P < .01), were less likely to have ductal carcinoma in situ (P < .001), and more likely to have had reconstructive surgery
(P < .05).
Five cancer support providers and 4 physicians were interviewed. All support providers were Spanish-speaking Latinas with at least some college education. Cancer physicians were board certified. Two were men; two were white and two Asian; one was a breast surgeon and three were hematologists/oncologists; three spoke Spanish poorly/not at all and one spoke it fairly well.
Seven themes emerged from interviews: unmet physical symptom management needs; social support often ends when treatment ends; challenges resuming roles; sense of abandonment by health care system when treatment ends; need for formal transition from active treatment to follow-up care; fear of recurrence especially when obtaining follow-up care; and desire for information on late effects of initial treatments and side effects of hormonal treatments. We summarize results according to these themes.
Unmet physical symptom management needs. The main physical symptoms reported by survivors and physicians in interviews were arthralgia, menopausal symptoms, and neuropathy. Fatigue was reported only by survivors. Many survivors and several support providers expressed that symptoms were poorly managed and often ignored. One stated,
I have a lot of pain where I had surgery, it burns. I worry a lot about my arm because I have sacs of fluid. My doctor only says, ‘They will dissolve over the years.’ So, I don’t feel any support. (FocGrp1#6)
Survivors reported side effects of hormonal therapies, and felt that physicians downplayed these to prevent them from discontinuing medications.
Social support from family and friends often ends when treatment ends. Many survivors described a loss of support from family and friends who expected them to get back to “normal” once treatment ended. One said,
My sisters have told me to my face that there’s nothing wrong with me. So now when people ask me, I say, ‘I’m fine, thank God, I have nothing,’ even though I’m dying of pain and have all these pills to take. (Survivor#1025)
A support provider related,
The client was telling me that as she was getting closer to finishing her treatment, her husband was upset because he felt like all she was doing was focusing on the cancer. I think caregivers, family, spouses, and children out of their own sort of selfishness want this person to be well. (SuppProv#104)
A few survivors said that family bonds were strengthened after cancer and several reported lacking support because their families were in their home countries.
Challenges resuming roles, especially returning to work. Survivors, support providers, and physicians described challenges and few resources as women transition back to their normal roles. Survivors questioned their ability to return to work due to physically demanding occupations. One stated,
I would like information on how to take care of myself, how working can affect this side if I don’t take care of it. I clean houses and I need both hands. (Survivor#3012)
Survivors described how changes in memory affected daily chores and work performance. Support providers and physicians described the need for resources to aid with return to work and household responsibilities. One physician noted,
There are usually questions about how to go ahead and live their lives from that point forward. It’s a sort of reverse shock: going back to life as they know it. (Physician#004)
Support providers and physicians mentioned that women needed help with resuming intimate partner relations.
Sense of abandonment by health care system once active treatment ends. Survivors, support providers, and physicians reported a loss of support and sense of abandonment by the patients’ oncology team at the end of active treatment. One survivor stated,
Once they tell you to stop the pills, ‘You’re cured, there’s nothing wrong with you,’ the truth is that one feels, ‘Now what do I do? I have no one to help me.’ I felt very abandoned. (FocGrp1#5)
A provider said,
The support system falls apart once women complete treatment. They lose their entire support system at the medical level. They no longer have nurses checking in about symptoms and addressing anything that’s come up. They won’t have access to doctors unless they’re doing their screening. (SuppProv#101)
An oncologist, noting that this loss of support occurs when women face pressures of transitioning back to work or family obligations, commented,
So here’s a woman whose marriage is in turmoil, whose husband may even have left her during this, and now her clinic is leaving her and she’s on her own … that must be scary as hell because there’s nobody out there to support her. (Physician#002)
Need for formal transition from active treatment to follow-up care. Two themes emerged about transitioning from active treatment: transferring care from oncologists to primary care physicians (PCP); and issues of follow-up care (with oncologists or PCPs). Survivors felt lost in transitioning from specialty to primary care, or expressed apprehension seeing a PCP rather than a cancer specialist. One stated,
I have my doctor but she is not a specialist. She does what I tell her to and orders a mammogram every year. But, I don’t go to the oncologist anymore, and so I worry. With the specialists, I feel protected. (FocGrp1#5)
Physicians acknowledged the lack of a formal transition to primary care such as a survivorship care program.
Follow-up care issues were common. Physicians stressed that women needed to know how often to return for follow-up once active treatment ends and about recommended examinations and tests, especially when receiving hormonal therapy. Physicians indicated the need for patient education materials specific to patients’ treatments, for example, elevated risk of heart disease with certain chemotherapy agents. An oncologist expressed concern that PCPs are not prepared adequately about late effects and hormonal treatment side effects, and suggested providing summary notes for PCPs detailing these.
Survivors identified several barriers to follow-up care: lacking information on which symptoms merited a call to physicians; financial burden/limited health insurance; lacking appointment reminders; fear of examinations; and limited English proficiency. A survivor stated,
If you have insurance, you can make your appointment, see the doctor, and have your mammogram. I stopped taking my pills because I didn’t have insurance. I tried to get them again but they told me they would cost me a thousand dollars. (FocGrp1#5)
One oncologist suggested scheduling a follow-up appointment before patients leave treatment and calling patients who miss appointments.
Facilitators of regular follow-up care identified by survivors were physicians informing them about symptom monitoring and reporting, having a clinic contact person/navigator, being given a follow-up appointment, being assertive about one’s care, and physicians’ reinforcement of adherence to hormonal treatment and follow-up. According to support providers, a key facilitator was having a clinic contact person/navigator. Once treatment ended, support providers often served as the liaison between the patient and the physician, making them the first point of contact for symptom reporting.
Fear of recurrence especially when obtaining follow-up care. Fear of recurrence dominated survivor interviews. This fear was heightened at the time of follow-up examinations or when they experienced unusual pain. A survivor commented,
Every time I’m due for my mammogram, I can’t sleep, worrying. I lose sleep until I get the letter with my results. Then I feel at peace again. (FocGrp1#9)
Support providers discussed the need to provide reassurance to SSBCS to help them cope with fears of recurrence. Physicians expressed challenges in allaying fears of recurrence among SSBCS, requiring a lot of time when recommending follow-up mammograms.
Desire for information on late effects of treatments and side effects of hormonal therapies. All survivors expressed receiving insufficient information on potential symptoms and side effects. One stated,
Doctors only have five minutes. There has never been someone who gave me guidance like, ‘From now on you have to do this or you might get these symptoms now or in the future. (Survivor#6019)
They indicated uncertainty about what symptoms were “normal” and when symptoms merited a call to the physician. Several survivors reported being unaware that fatigue, arthralgia and neuropathy were side effects of breast cancer treatments until they reported these to physicians.
Physicians stressed the importance of women knowing about the elevated risk of future cancers, symptoms of recurrence, and seeking follow-up care if they experience symptoms that are out of the ordinary. Support providers felt that it was important to provide SSBCS with information on signs of recurrence and when to report these. However, providers expressed concern that giving women too much information might elevate their anxiety. A physician suggested,
It’s probably better to have a symptom list that’s short and relevant for the most common and catastrophic things, same thing with side effects … short to avoid overwhelming the patient. (Physician#001)
Hormonal treatments were of special concern. Survivors expressed a need for information on hormonal treatments and support providers stressed that this information is needed in simple Spanish. Several survivors indicated they stopped taking hormonal treatments due to side effects. One woman experienced severe headaches and heart palpitations, stopped taking the hormonal medication, felt better, and did not inform her physician until her next appointment. A support provider stated,
What I hear from a lot of women is that if side effects are too uncomfortable, they just stop it (hormonal treatment) without saying anything to the doctor. So more information about why they have to take it and that there is a good chance of recurrence is really important. (SuppProv#101)
Likewise, physicians indicated that SSBCS’ lack of information on hormonal treatments often resulted in nonadherence, emphasizing the need to reinforce adherence to prevent recurrence.
Conceptual framework of interventions
Based on triangulation of survey and interview results, we compiled a conceptual framework that includes needs identified, suggested components of a survivorship care intervention to address these needs, potential mediators by which such interventions could improve outcomes, and relevant outcomes (Figure). Survivorship care needs fell into four categories: symptom management, psychosocial, sense of abandonment by health care team, and healthy lifestyles. Survivorship care programs would provide skills training in symptom and stress management, and communicating with providers, family, friends, and coworkers. Mediators include increased self-efficacy, knowledge and perceived social support, ultimately leading to reduced distress (anxiety and depressive symptoms) and stress, and improved health-related quality of life.
Conclusions
Our study aimed to identify the most critical needs of SSBCS in the posttreatment survivorship phase to facilitate the design of survivorship interventions for this vulnerable group. SSBCS, cancer support providers, and cancer physicians reported substantial symptom management, psychosocial, and informational needs among this population. Results from surveys and open-ended interviews were remarkably consistent. Survivors, physicians, and support providers viewed transition out of active treatment as a time of increased psychosocial need and heightened vulnerability.
Our findings are consistent with needs assessments conducted in other breast cancer survivors. Similar to a study of rural white women with breast cancer, fear of recurrence was among the most common psychosocial concerns.17 Results of two studies that included white, African American and Latina breast cancer survivors were consistent with ours in finding that pain and fatigue were among the most persistent symptoms; in both studies, Latinas were more likely to report pain and a higher number of symptoms.7,18 The prevalence of sleep problems in our sample was identical to that reported in a sample of African American breast cancer survivors.19 Our findings of a high need for symptom management information and support, social support from family and friends, and self-management resources were similar to studies of other vulnerable breast cancer survivors.18,20
Our results suggest that it is critical for health care professionals to provide assistance with managing side effects and information to alleviate fears, and reinforce behaviors of symptom monitoring and reporting, and adherence to follow-up care and hormonal therapies. Yet this information is not being conveyed effectively and is complicated by the need to balance women’s need for information with minimizing anxiety when providing such information.
A limitation of our study is that most of our sample was Mexican origin and may not reflect experiences of Spanish-speaking Latinas of other national origin groups or outside of Northern California. Another limitation is the lack of an English-speaking comparison group, which would have permitted the identification of similarities and differences across language groups. Finally, we did not interview radiation oncologists who may have had opinions that are not represented here.
Survivorship care programs offer great promise for meeting patients’ informational and symptom management needs and improving well-being and communication with clinicians.21 Due to limited access to survivorship care information, financial hardships, and pressures from their families to resume their social roles, concerted efforts are needed to develop appropriate survivorship programs for SSBCS.22 Unique language, cultural and socioeconomic factors of Spanish-speaking Latinas require tailoring of cancer survivorship programs to best meet their needs.23 These programs need to provide psychosocial stress and symptom management assistance, simple information on recommended follow-up care, and healthy lifestyle and role reintegration strategies that account for their unique sociocultural contexts.
1. Danese MD, O’Malley C, Lindquist K, Gleeson M, Griffiths RI. An observational study of the prevalence and incidence of comorbid conditions in older women with breast cancer. Ann Oncol. 2012;23(7):1756-1765.
2. Hewitt M, Greenfield S, Stovall E, eds. From cancer patient to cancer survivor: lost in transition. Washington, DC: National Academy of Sciences; 2006.
3. Beckjord EB, Arora NK, McLaughlin W, Oakley-Girvan I, Hamilton AS, Hesse BW. Health-related information needs in a large and diverse sample of adult cancer survivors: implications for cancer care. J Cancer Surviv. 2008;2(3):179-189.
4. Hewitt ME, Bamundo A, Day R, Harvey C. Perspectives on posttreatment cancer care: qualitative research with survivors, nurses, and physicians. J Clin Oncol. 2007;25(16):2270-2273.
5. Ashing-Giwa KT, Tejero JS, Kim J, Padilla GV, Hellemann G. Examining predictive models of HRQOL in a population-based, multiethnic sample of women with breast carcinoma. Qual Life Res. 2007;16(3):413-428.
6. Clauser SB, Arora NK, Bellizzi KM, Haffer SC, Topor M, Hays RD. Disparities in HRQOL of cancer survivors and non-cancer managed care enrollees. Health Care Financ Rev. 2008;29(4):23-40.
7. Eversley R, Estrin D, Dibble S, Wardlaw L, Pedrosa M, Favila-Penney W. Posttreatment symptoms among ethnic minority breast cancer survivors. Oncol Nurs Forum. 2005;32(2):250-256.
8. Bickell NA, Wang JJ, Oluwole S, et al. Missed opportunities: racial disparities in adjuvant breast cancer treatment. J Clin Oncol. 2006;24(9):1357-1362.
9. Arora NK, Reeve BB, Hays RD, Clauser SB, Oakley-Girvan I. Assessment of quality of cancer-related follow-up care from the cancer survivor’s perspective. J Clin Oncol. 2011;29(10):1280-1289.
10. Janz NK, Mujahid MS, Hawley ST, Griggs JJ, Hamilton AS, Katz SJ. Racial/ethnic differences in adequacy of information and support for women with breast cancer. Cancer. 2008;113(5):1058-1067.
11. Yoon J, Malin JL, Tisnado DM, et al. Symptom management after breast cancer treatment: is it influenced by patient characteristics? Breast Cancer Res Treat. 2008;108(1):69-77.
12. Ashing K, Rosales M. A telephonic-based trial to reduce depressive symptoms among Latina breast cancer survivors. Psychooncology. 2014;23(5):507-515.
13. Hershman DL, Greenlee H, Awad D, et al. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013;138(3):795-806.
14. Napoles AM, Ortiz C, Santoyo-Olsson J, et al. Nuevo Amanecer: results of a randomized controlled trial of a community-based, peer-delivered stress management intervention to improve quality of life in Latinas with breast cancer. Am J Public Health. 2015;105(suppl 3):e55-63.
15. Rechis R, Reynolds KA, Beckjord EB, Nutt S, Burns RM, Schaefer JS. ‘I learned to live with it’ is not good enough: challenges reported by posttreatment cancer survivors in the Livestrong surveys. Austin, TX: Livestrong;2011.
16. Glaser BG, Strauss AL. The discovery of grounded theory: strategies for qualitative research. Hawthorne: Aldine Publishing Company; 1967.
17. Befort CA, Klemp J. Sequelae of breast cancer and the influence of menopausal status at diagnosis among rural breast cancer survivors. J Womens Health (Larchmt). 2011;20(9):1307-1313.
18. Fu OS, Crew KD, Jacobson JS, et al. Ethnicity and persistent symptom burden in breast cancer survivors. J Cancer Surviv. 2009;3(4):241-250.
19. Taylor TR, Huntley ED, Makambi K, et al. Understanding sleep disturbances in African-American breast cancer survivors: a pilot study. Psychooncology. 2012;21(8):896-902.
20. Adams N, Gisiger-Camata S, Hardy CM, Thomas TF, Jukkala A, Meneses K. Evaluating survivorship experiences and needs among rural African American breast cancer survivors. J Cancer Educ. October 24, 2015 [Epub ahead of print].
21. Blinder VS, Patil S, Thind A, et al. Return to work in low-income Latina and non-Latina white breast cancer survivors: a 3-year longitudinal study. Cancer. 2012;118(6):1664-1674.
22. Lopez-Class M, Perret-Gentil M, Kreling B, Caicedo L, Mandelblatt J, Graves KD. Quality of life among immigrant Latina breast cancer survivors: realities of culture and enhancing cancer care. J Cancer Educ. 2011;26(4):724-733.
23. Napoles-Springer AM, Ortiz C, O’Brien H, Diaz-Mendez M. Developing a culturally competent peer support intervention for Spanish-speaking Latinas with breast cancer. J Immigr Minor Health. 2009;11(4):268-280
1. Danese MD, O’Malley C, Lindquist K, Gleeson M, Griffiths RI. An observational study of the prevalence and incidence of comorbid conditions in older women with breast cancer. Ann Oncol. 2012;23(7):1756-1765.
2. Hewitt M, Greenfield S, Stovall E, eds. From cancer patient to cancer survivor: lost in transition. Washington, DC: National Academy of Sciences; 2006.
3. Beckjord EB, Arora NK, McLaughlin W, Oakley-Girvan I, Hamilton AS, Hesse BW. Health-related information needs in a large and diverse sample of adult cancer survivors: implications for cancer care. J Cancer Surviv. 2008;2(3):179-189.
4. Hewitt ME, Bamundo A, Day R, Harvey C. Perspectives on posttreatment cancer care: qualitative research with survivors, nurses, and physicians. J Clin Oncol. 2007;25(16):2270-2273.
5. Ashing-Giwa KT, Tejero JS, Kim J, Padilla GV, Hellemann G. Examining predictive models of HRQOL in a population-based, multiethnic sample of women with breast carcinoma. Qual Life Res. 2007;16(3):413-428.
6. Clauser SB, Arora NK, Bellizzi KM, Haffer SC, Topor M, Hays RD. Disparities in HRQOL of cancer survivors and non-cancer managed care enrollees. Health Care Financ Rev. 2008;29(4):23-40.
7. Eversley R, Estrin D, Dibble S, Wardlaw L, Pedrosa M, Favila-Penney W. Posttreatment symptoms among ethnic minority breast cancer survivors. Oncol Nurs Forum. 2005;32(2):250-256.
8. Bickell NA, Wang JJ, Oluwole S, et al. Missed opportunities: racial disparities in adjuvant breast cancer treatment. J Clin Oncol. 2006;24(9):1357-1362.
9. Arora NK, Reeve BB, Hays RD, Clauser SB, Oakley-Girvan I. Assessment of quality of cancer-related follow-up care from the cancer survivor’s perspective. J Clin Oncol. 2011;29(10):1280-1289.
10. Janz NK, Mujahid MS, Hawley ST, Griggs JJ, Hamilton AS, Katz SJ. Racial/ethnic differences in adequacy of information and support for women with breast cancer. Cancer. 2008;113(5):1058-1067.
11. Yoon J, Malin JL, Tisnado DM, et al. Symptom management after breast cancer treatment: is it influenced by patient characteristics? Breast Cancer Res Treat. 2008;108(1):69-77.
12. Ashing K, Rosales M. A telephonic-based trial to reduce depressive symptoms among Latina breast cancer survivors. Psychooncology. 2014;23(5):507-515.
13. Hershman DL, Greenlee H, Awad D, et al. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013;138(3):795-806.
14. Napoles AM, Ortiz C, Santoyo-Olsson J, et al. Nuevo Amanecer: results of a randomized controlled trial of a community-based, peer-delivered stress management intervention to improve quality of life in Latinas with breast cancer. Am J Public Health. 2015;105(suppl 3):e55-63.
15. Rechis R, Reynolds KA, Beckjord EB, Nutt S, Burns RM, Schaefer JS. ‘I learned to live with it’ is not good enough: challenges reported by posttreatment cancer survivors in the Livestrong surveys. Austin, TX: Livestrong;2011.
16. Glaser BG, Strauss AL. The discovery of grounded theory: strategies for qualitative research. Hawthorne: Aldine Publishing Company; 1967.
17. Befort CA, Klemp J. Sequelae of breast cancer and the influence of menopausal status at diagnosis among rural breast cancer survivors. J Womens Health (Larchmt). 2011;20(9):1307-1313.
18. Fu OS, Crew KD, Jacobson JS, et al. Ethnicity and persistent symptom burden in breast cancer survivors. J Cancer Surviv. 2009;3(4):241-250.
19. Taylor TR, Huntley ED, Makambi K, et al. Understanding sleep disturbances in African-American breast cancer survivors: a pilot study. Psychooncology. 2012;21(8):896-902.
20. Adams N, Gisiger-Camata S, Hardy CM, Thomas TF, Jukkala A, Meneses K. Evaluating survivorship experiences and needs among rural African American breast cancer survivors. J Cancer Educ. October 24, 2015 [Epub ahead of print].
21. Blinder VS, Patil S, Thind A, et al. Return to work in low-income Latina and non-Latina white breast cancer survivors: a 3-year longitudinal study. Cancer. 2012;118(6):1664-1674.
22. Lopez-Class M, Perret-Gentil M, Kreling B, Caicedo L, Mandelblatt J, Graves KD. Quality of life among immigrant Latina breast cancer survivors: realities of culture and enhancing cancer care. J Cancer Educ. 2011;26(4):724-733.
23. Napoles-Springer AM, Ortiz C, O’Brien H, Diaz-Mendez M. Developing a culturally competent peer support intervention for Spanish-speaking Latinas with breast cancer. J Immigr Minor Health. 2009;11(4):268-280
Colorectal tumors: ESD passes long-term test
Endoscopic submucosal dissection (ESD) of superficial colorectal tumors has a favorable long-term outcome, with 94.6% overall survival and 100% disease-specific survival at a median 79 months of follow-up, reported Kenjiro Shigita, MD, of the department of gastroenterology and metabolism, Hiroshima (Japan) University Hospital, and his associates.
The technique is more complicated than endoscopic mucosal resection, but continued advances in the technology and increasingly available training have made it safer than it was, Dr. Shigita and associates wrote (Gastrointest Endosc. 2017. doi: 10.1016/j.gie.2016.07.044). 
The study “shows what is possible with an aggressive endoscopic approach,” Dr. Allen added.
Dr. Shigita and associates analyzed data from 222 patients (224 tumors) at their institution for a minimum of 5 years, or until death (median 79 months). Overall survival was 94.6%, and disease-specific survival was 100%.
Patients received follow-up colonoscopy at 1 year if they had a histologic complete resection, defined as horizontal margin negative and vertical margin negative. Those with a histologic positive margin underwent additional colonoscopies at 6 months and 1 year following the ESD procedure.
The en bloc resection rate was 89.7% (201/224), the histologic complete resection rate was 85.7% (192/224), and the R0 resection rate was 83.0% (186/224). R0 was defined as histologic complete resection and no risk of lymph node metastasis as determined by histologic examination.
Delayed bleeding occurred in 6.3% of cases (14/224) and perforation in 5.4% (12/224). All of the adverse events were successfully managed during the procedure.
In 201 tumors, no further surgical resection was performed. In this sample, the local recurrence rate was 1.5%, and none were metastatic. Of these procedures, 179 were en bloc, while 22 were piecemeal. Only one of the en bloc procedures had a recurrence (0.6%), compared with two of the piecemeal procedures (9.1%, P = .038), the authors wrote.
Dr. Allen noted the importance of management and follow-up care of patients. “The authors were careful in deciding which patients needed traditional surgery in addition to endoscopic resection. Also there was careful follow-up with endoscopic surveillance to be sure resection was complete,” he said.
The study is limited by the fact that it is retrospective and was performed at a single center, and the authors stressed the importance of surveillance. “The possibility of local recurrence should be taken into account after piecemeal resection or histologic incomplete resection, and the likelihood of metachronous tumors should be considered,” the authors wrote.
The study is intriguing and warrants further investigation. “This approach should be carefully evaluated with U.S.-based studies and advanced endoscopic training offered,” Dr. Allen said.
Endoscopic submucosal dissection (ESD) of superficial colorectal tumors has a favorable long-term outcome, with 94.6% overall survival and 100% disease-specific survival at a median 79 months of follow-up, reported Kenjiro Shigita, MD, of the department of gastroenterology and metabolism, Hiroshima (Japan) University Hospital, and his associates.
The technique is more complicated than endoscopic mucosal resection, but continued advances in the technology and increasingly available training have made it safer than it was, Dr. Shigita and associates wrote (Gastrointest Endosc. 2017. doi: 10.1016/j.gie.2016.07.044).
The study “shows what is possible with an aggressive endoscopic approach,” Dr. Allen added.
Dr. Shigita and associates analyzed data from 222 patients (224 tumors) at their institution for a minimum of 5 years, or until death (median 79 months). Overall survival was 94.6%, and disease-specific survival was 100%.
Patients received follow-up colonoscopy at 1 year if they had a histologic complete resection, defined as horizontal margin negative and vertical margin negative. Those with a histologic positive margin underwent additional colonoscopies at 6 months and 1 year following the ESD procedure.
The en bloc resection rate was 89.7% (201/224), the histologic complete resection rate was 85.7% (192/224), and the R0 resection rate was 83.0% (186/224). R0 was defined as histologic complete resection and no risk of lymph node metastasis as determined by histologic examination.
Delayed bleeding occurred in 6.3% of cases (14/224) and perforation in 5.4% (12/224). All of the adverse events were successfully managed during the procedure.
In 201 tumors, no further surgical resection was performed. In this sample, the local recurrence rate was 1.5%, and none were metastatic. Of these procedures, 179 were en bloc, while 22 were piecemeal. Only one of the en bloc procedures had a recurrence (0.6%), compared with two of the piecemeal procedures (9.1%, P = .038), the authors wrote.
Dr. Allen noted the importance of management and follow-up care of patients. “The authors were careful in deciding which patients needed traditional surgery in addition to endoscopic resection. Also there was careful follow-up with endoscopic surveillance to be sure resection was complete,” he said.
The study is limited by the fact that it is retrospective and was performed at a single center, and the authors stressed the importance of surveillance. “The possibility of local recurrence should be taken into account after piecemeal resection or histologic incomplete resection, and the likelihood of metachronous tumors should be considered,” the authors wrote.
The study is intriguing and warrants further investigation. “This approach should be carefully evaluated with U.S.-based studies and advanced endoscopic training offered,” Dr. Allen said.
Endoscopic submucosal dissection (ESD) of superficial colorectal tumors has a favorable long-term outcome, with 94.6% overall survival and 100% disease-specific survival at a median 79 months of follow-up, reported Kenjiro Shigita, MD, of the department of gastroenterology and metabolism, Hiroshima (Japan) University Hospital, and his associates.
The technique is more complicated than endoscopic mucosal resection, but continued advances in the technology and increasingly available training have made it safer than it was, Dr. Shigita and associates wrote (Gastrointest Endosc. 2017. doi: 10.1016/j.gie.2016.07.044).
The study “shows what is possible with an aggressive endoscopic approach,” Dr. Allen added.
Dr. Shigita and associates analyzed data from 222 patients (224 tumors) at their institution for a minimum of 5 years, or until death (median 79 months). Overall survival was 94.6%, and disease-specific survival was 100%.
Patients received follow-up colonoscopy at 1 year if they had a histologic complete resection, defined as horizontal margin negative and vertical margin negative. Those with a histologic positive margin underwent additional colonoscopies at 6 months and 1 year following the ESD procedure.
The en bloc resection rate was 89.7% (201/224), the histologic complete resection rate was 85.7% (192/224), and the R0 resection rate was 83.0% (186/224). R0 was defined as histologic complete resection and no risk of lymph node metastasis as determined by histologic examination.
Delayed bleeding occurred in 6.3% of cases (14/224) and perforation in 5.4% (12/224). All of the adverse events were successfully managed during the procedure.
In 201 tumors, no further surgical resection was performed. In this sample, the local recurrence rate was 1.5%, and none were metastatic. Of these procedures, 179 were en bloc, while 22 were piecemeal. Only one of the en bloc procedures had a recurrence (0.6%), compared with two of the piecemeal procedures (9.1%, P = .038), the authors wrote.
Dr. Allen noted the importance of management and follow-up care of patients. “The authors were careful in deciding which patients needed traditional surgery in addition to endoscopic resection. Also there was careful follow-up with endoscopic surveillance to be sure resection was complete,” he said.
The study is limited by the fact that it is retrospective and was performed at a single center, and the authors stressed the importance of surveillance. “The possibility of local recurrence should be taken into account after piecemeal resection or histologic incomplete resection, and the likelihood of metachronous tumors should be considered,” the authors wrote.
The study is intriguing and warrants further investigation. “This approach should be carefully evaluated with U.S.-based studies and advanced endoscopic training offered,” Dr. Allen said.
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point: Endoscopic submucosal dissection is safe and effective when done by well-trained endoscopists.
Major finding: After 5 or more years, disease-specific survival was 100%.
Data source: Retrospective study of 222 patients at a single center.
Disclosures: The study was funded by the Japan Agency for Medical Research and Development. The authors of the study reported having no financial disclosures. Dr Allen reported having no financial disclosures.
David Hafler, MD
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Barrett’s esophagus: Cancer risk is highest in first year after diagnosis
The highest risk of diagnosis with esophageal adenocarcinoma occurs in the first month after diagnosis with Barrett’s esophagus (BE).
Further, the risk of this type of esophageal cancer is lower than previously believed after that first year, according to a study of 7,932 Swedish residents who were diagnosed with BE from 2006 to 2013.
Esophageal adenocarcinoma (EA) is the most common type of esophageal cancer in the United States, and more than half of patients present with late-stage disease. “The connection between BE and EA is well known, and risk factors for both conditions remain vastly the same, including male sex, age over 50 years, central obesity, and symptomatic GERD [gastroesophageal reflux disease],” Dr. Holmberg said in an interview.
“In order to reduce mortality from esophageal cancer through surveillance and early treatment, we need to improve on BE screening programs,” he said. He also noted that, of all EA cases in Sweden, where screening for BE itself is not recommended in national guidelines, an “astonishing” 97% were diagnosed in patients with previously unknown BE.
Screening programs urge regular endoscopic surveillance in nondysplastic BE patients, but Dr. Holmberg said that their cost-effectiveness is questionable. Complicating matters, there has been conflicting research about the risk of EA that these patients actually face.
As the new study notes, patients with BE were previously thought to face a 30-125 times greater relative risk of EA than the general population did and a mean annual risk of 0.5%. But, recent studies in Europe and the U.S. have suggested that the risk is lower, with an estimated annual risk range of 0.12%-0.18%.
Dr. Holmberg said he and his colleagues launched the new study to better understand the risk in the first year after BE diagnosis.
The researchers used the Swedish National Patient Register to track 7,932 Swedish residents who were diagnosed with BE from 2006 to 2013. About two-thirds were male, and the median age at BE diagnosis was 66 years.
The findings appear in the European Journal of Cancer (2017;75:41-6). Of the patients with BE, 89 new cases of EA were diagnosed 62% of the time within a year of BE diagnosis.
Over a median follow-up of 2.13 person-years, the overall incidence of EA in the patients with BE was 1.47 (95% CI, 0.91-2.02) per 1,000 person-years. That is the equivalent of an annual risk of 0.15%.
The highest incidence rate by far was in the period of 7 to 30 days after diagnosis at 15.53 (95% CI, 4.77-26.29). The incident rates varied from 1.44 to 4.10 (95% CI, 0.00-7.38) for other periods (31-100 days, 101 days to 6 months, over 6 months to 1 year, over 1 year to 3 years, over 3 years to end of follow-up).
How should physicians interpret the study findings and look forward? “Nondysplastic BE represents almost 80% of all BE,” Dr. Holmberg said, but “nondiscriminatory long-term surveillance in nondysplastic BE is not cost-efficient.”
However, while this is “the group with the least risk of EA development, it still generates a large chunk of all EA cases. It is likely that future management of nondysplastic BE will include more risk factors than just degree of dysplasia.”
He added that “individuals with multiple risk factors, such as Caucasian males, age over 50 years, obesity, symptomatic reflux, and with long-segment nondysplastic BE would likely benefit more from more frequent surveillance or even prophylactic treatment with radio-frequency ablation compared to individuals without those risk factors.”
The study was funded by the Swedish Cancer Society and the Swedish Research Council. The authors report no relevant disclosures.
The highest risk of diagnosis with esophageal adenocarcinoma occurs in the first month after diagnosis with Barrett’s esophagus (BE).
Further, the risk of this type of esophageal cancer is lower than previously believed after that first year, according to a study of 7,932 Swedish residents who were diagnosed with BE from 2006 to 2013.
Esophageal adenocarcinoma (EA) is the most common type of esophageal cancer in the United States, and more than half of patients present with late-stage disease. “The connection between BE and EA is well known, and risk factors for both conditions remain vastly the same, including male sex, age over 50 years, central obesity, and symptomatic GERD [gastroesophageal reflux disease],” Dr. Holmberg said in an interview.
“In order to reduce mortality from esophageal cancer through surveillance and early treatment, we need to improve on BE screening programs,” he said. He also noted that, of all EA cases in Sweden, where screening for BE itself is not recommended in national guidelines, an “astonishing” 97% were diagnosed in patients with previously unknown BE.
Screening programs urge regular endoscopic surveillance in nondysplastic BE patients, but Dr. Holmberg said that their cost-effectiveness is questionable. Complicating matters, there has been conflicting research about the risk of EA that these patients actually face.
As the new study notes, patients with BE were previously thought to face a 30-125 times greater relative risk of EA than the general population did and a mean annual risk of 0.5%. But, recent studies in Europe and the U.S. have suggested that the risk is lower, with an estimated annual risk range of 0.12%-0.18%.
Dr. Holmberg said he and his colleagues launched the new study to better understand the risk in the first year after BE diagnosis.
The researchers used the Swedish National Patient Register to track 7,932 Swedish residents who were diagnosed with BE from 2006 to 2013. About two-thirds were male, and the median age at BE diagnosis was 66 years.
The findings appear in the European Journal of Cancer (2017;75:41-6). Of the patients with BE, 89 new cases of EA were diagnosed 62% of the time within a year of BE diagnosis.
Over a median follow-up of 2.13 person-years, the overall incidence of EA in the patients with BE was 1.47 (95% CI, 0.91-2.02) per 1,000 person-years. That is the equivalent of an annual risk of 0.15%.
The highest incidence rate by far was in the period of 7 to 30 days after diagnosis at 15.53 (95% CI, 4.77-26.29). The incident rates varied from 1.44 to 4.10 (95% CI, 0.00-7.38) for other periods (31-100 days, 101 days to 6 months, over 6 months to 1 year, over 1 year to 3 years, over 3 years to end of follow-up).
How should physicians interpret the study findings and look forward? “Nondysplastic BE represents almost 80% of all BE,” Dr. Holmberg said, but “nondiscriminatory long-term surveillance in nondysplastic BE is not cost-efficient.”
However, while this is “the group with the least risk of EA development, it still generates a large chunk of all EA cases. It is likely that future management of nondysplastic BE will include more risk factors than just degree of dysplasia.”
He added that “individuals with multiple risk factors, such as Caucasian males, age over 50 years, obesity, symptomatic reflux, and with long-segment nondysplastic BE would likely benefit more from more frequent surveillance or even prophylactic treatment with radio-frequency ablation compared to individuals without those risk factors.”
The study was funded by the Swedish Cancer Society and the Swedish Research Council. The authors report no relevant disclosures.
The highest risk of diagnosis with esophageal adenocarcinoma occurs in the first month after diagnosis with Barrett’s esophagus (BE).
Further, the risk of this type of esophageal cancer is lower than previously believed after that first year, according to a study of 7,932 Swedish residents who were diagnosed with BE from 2006 to 2013.
Esophageal adenocarcinoma (EA) is the most common type of esophageal cancer in the United States, and more than half of patients present with late-stage disease. “The connection between BE and EA is well known, and risk factors for both conditions remain vastly the same, including male sex, age over 50 years, central obesity, and symptomatic GERD [gastroesophageal reflux disease],” Dr. Holmberg said in an interview.
“In order to reduce mortality from esophageal cancer through surveillance and early treatment, we need to improve on BE screening programs,” he said. He also noted that, of all EA cases in Sweden, where screening for BE itself is not recommended in national guidelines, an “astonishing” 97% were diagnosed in patients with previously unknown BE.
Screening programs urge regular endoscopic surveillance in nondysplastic BE patients, but Dr. Holmberg said that their cost-effectiveness is questionable. Complicating matters, there has been conflicting research about the risk of EA that these patients actually face.
As the new study notes, patients with BE were previously thought to face a 30-125 times greater relative risk of EA than the general population did and a mean annual risk of 0.5%. But, recent studies in Europe and the U.S. have suggested that the risk is lower, with an estimated annual risk range of 0.12%-0.18%.
Dr. Holmberg said he and his colleagues launched the new study to better understand the risk in the first year after BE diagnosis.
The researchers used the Swedish National Patient Register to track 7,932 Swedish residents who were diagnosed with BE from 2006 to 2013. About two-thirds were male, and the median age at BE diagnosis was 66 years.
The findings appear in the European Journal of Cancer (2017;75:41-6). Of the patients with BE, 89 new cases of EA were diagnosed 62% of the time within a year of BE diagnosis.
Over a median follow-up of 2.13 person-years, the overall incidence of EA in the patients with BE was 1.47 (95% CI, 0.91-2.02) per 1,000 person-years. That is the equivalent of an annual risk of 0.15%.
The highest incidence rate by far was in the period of 7 to 30 days after diagnosis at 15.53 (95% CI, 4.77-26.29). The incident rates varied from 1.44 to 4.10 (95% CI, 0.00-7.38) for other periods (31-100 days, 101 days to 6 months, over 6 months to 1 year, over 1 year to 3 years, over 3 years to end of follow-up).
How should physicians interpret the study findings and look forward? “Nondysplastic BE represents almost 80% of all BE,” Dr. Holmberg said, but “nondiscriminatory long-term surveillance in nondysplastic BE is not cost-efficient.”
However, while this is “the group with the least risk of EA development, it still generates a large chunk of all EA cases. It is likely that future management of nondysplastic BE will include more risk factors than just degree of dysplasia.”
He added that “individuals with multiple risk factors, such as Caucasian males, age over 50 years, obesity, symptomatic reflux, and with long-segment nondysplastic BE would likely benefit more from more frequent surveillance or even prophylactic treatment with radio-frequency ablation compared to individuals without those risk factors.”
The study was funded by the Swedish Cancer Society and the Swedish Research Council. The authors report no relevant disclosures.
FROM THE EUROPEAN JOURNAL OF CANCER
Key clinical point: While their overall risk over the short term is low, patients with Barrett’s esophagus are especially likely to be diagnosed with esophageal adenocarcinoma in the first weeks after Barrett’s diagnosis.
Major finding: Over a median of 2.13 person-years, the annual risk of esophageal adenocarcinoma diagnosis was 0.15% in patients with Barrett’s esophagus, but the incidence rate was especially high (15.53; 95% confidence interval, 4.77-26.29) from 7 to 30 days after Barrett’s diagnosis, compared with rates of 1.44-4.10 (95% CI, 0.00-7.38) for later periods.
Data source: A population-centered analysis of 7,932 Swedish residents diagnosed with Barrett’s esophagus from 2006 to 2013.
Disclosures: The study was funded by the Swedish Cancer Society and the Swedish Research Council. The authors report no relevant disclosures.
Miami Breast Cancer Symposium to explore treatment controversies
FROM MBCC (FRONTLINE MEDICAL NEWS) – Oncology Practice will be on site this coming week at the Miami Breast Cancer Symposium in Miami Beach, reporting on the latest in multidisciplinary management of breast cancer patients. Sessions will highlight updates in systemic therapy, immunology and immunotherapy, and overcoming therapeutic resistance, as well as explore treatment controversies, such as omitting anthracyclines, extended-field radiation therapy, and who should be receiving extended hormonal therapy. The symposium, hosted by Physicians’ Education Resource, begins Thursday, March 9. Our team will provide daily coverage of the following presentations and more:
Overcoming Resistance to HER2 Targeted Therapy
Mark D. Pegram, MD
Overcoming Resistance to Endocrine Ablative Therapy
William J. Gradishar, MD
Medical Crossfire: Is Extended Field Radiation Therapy Ready for Prime Time?
Lawrence J. Solin, MD, & Thomas A. Buchholz, MD
Raising the Therapeutic Index for HER2+ Targeted Therapy: Can We Safely Omit
Anthracyclines?
Sara Hurvitz, MD
Update on Neoadjuvant Treatment Strategies in HER2+ Breast Cancer
Debu Tripathy, MD
Update on PARP Inhibitors in Breast Cancer
Kimberly L. Blackwell, MD
Update on Immunology and Immunotherapy in Breast Cancer
Elizabeth Mittendorf, MD, PhD
Medical Crossfire: Is Extended Hormonal Therapy Required for Everyone?
William J. Gradishar, MD, & Sara Hurvitz, MD
FROM MBCC (FRONTLINE MEDICAL NEWS) – Oncology Practice will be on site this coming week at the Miami Breast Cancer Symposium in Miami Beach, reporting on the latest in multidisciplinary management of breast cancer patients. Sessions will highlight updates in systemic therapy, immunology and immunotherapy, and overcoming therapeutic resistance, as well as explore treatment controversies, such as omitting anthracyclines, extended-field radiation therapy, and who should be receiving extended hormonal therapy. The symposium, hosted by Physicians’ Education Resource, begins Thursday, March 9. Our team will provide daily coverage of the following presentations and more:
Overcoming Resistance to HER2 Targeted Therapy
Mark D. Pegram, MD
Overcoming Resistance to Endocrine Ablative Therapy
William J. Gradishar, MD
Medical Crossfire: Is Extended Field Radiation Therapy Ready for Prime Time?
Lawrence J. Solin, MD, & Thomas A. Buchholz, MD
Raising the Therapeutic Index for HER2+ Targeted Therapy: Can We Safely Omit
Anthracyclines?
Sara Hurvitz, MD
Update on Neoadjuvant Treatment Strategies in HER2+ Breast Cancer
Debu Tripathy, MD
Update on PARP Inhibitors in Breast Cancer
Kimberly L. Blackwell, MD
Update on Immunology and Immunotherapy in Breast Cancer
Elizabeth Mittendorf, MD, PhD
Medical Crossfire: Is Extended Hormonal Therapy Required for Everyone?
William J. Gradishar, MD, & Sara Hurvitz, MD
FROM MBCC (FRONTLINE MEDICAL NEWS) – Oncology Practice will be on site this coming week at the Miami Breast Cancer Symposium in Miami Beach, reporting on the latest in multidisciplinary management of breast cancer patients. Sessions will highlight updates in systemic therapy, immunology and immunotherapy, and overcoming therapeutic resistance, as well as explore treatment controversies, such as omitting anthracyclines, extended-field radiation therapy, and who should be receiving extended hormonal therapy. The symposium, hosted by Physicians’ Education Resource, begins Thursday, March 9. Our team will provide daily coverage of the following presentations and more:
Overcoming Resistance to HER2 Targeted Therapy
Mark D. Pegram, MD
Overcoming Resistance to Endocrine Ablative Therapy
William J. Gradishar, MD
Medical Crossfire: Is Extended Field Radiation Therapy Ready for Prime Time?
Lawrence J. Solin, MD, & Thomas A. Buchholz, MD
Raising the Therapeutic Index for HER2+ Targeted Therapy: Can We Safely Omit
Anthracyclines?
Sara Hurvitz, MD
Update on Neoadjuvant Treatment Strategies in HER2+ Breast Cancer
Debu Tripathy, MD
Update on PARP Inhibitors in Breast Cancer
Kimberly L. Blackwell, MD
Update on Immunology and Immunotherapy in Breast Cancer
Elizabeth Mittendorf, MD, PhD
Medical Crossfire: Is Extended Hormonal Therapy Required for Everyone?
William J. Gradishar, MD, & Sara Hurvitz, MD
Voclosporin linked to threefold increase in lupus nephritis remission
Treatment with the investigational calcineurin inhibitor voclosporin is associated with a significant, threefold-higher rate of complete remission for lupus nephritis, compared with the current standard of care, according to 48-week data from the AURA-LV (Aurinia Urinary Protein Reduction Active–Lupus With Voclosporin) study.
In a company release, manufacturer Aurinia Pharmaceuticals presented the results of the international phase IIb controlled trial involving 265 patients with active lupus nephritis from 20 countries, which they say has now met its primary and secondary endpoints.
After 48 weeks, 49% of patients in the low-dose group and 40% in the high-dose group had achieved complete remission, compared with 24% in the control group (P less than .001 for low-dose vs. control; P = .026 for high-dose vs. control). This represented a threefold-higher remission rate for the low-dose group (odds ratio, 3.21) and a twofold-higher rate for the high-dose group (OR, 2.1), compared with controls.
Complete remission was defined as a composite endpoint that included urine protein/creatinine ratio of 0.5 mg/mg or less; normal, stable renal function; presence of sustained, low dose steroids; and no administration of rescue medications.
Partial remission – defined as at least a 50% reduction in urine protein/creatinine ratio with no concomitant use of rescue medication – was seen in 68% of patients in the low-dose voclosporin group, 72% of patients in the high-dose group, and 48% of patients in the control arm (P = .007 for low-dose vs. control; P = .002 for high-dose vs. control).
Investigators said there were no unexpected safety signals from voclosporin, but there were three deaths and one malignancy reported in the control arm after the study treatment period ended.
Brad Rovin, MD, of Ohio State University in Columbus said in the company’s statement that current treatments for this severe complication of systemic lupus erythematosus are toxic, and complete renal response rates are low.
“The AURA trial’s long-term results convincingly demonstrate that the addition of voclosporin to standard of care treatment is superior to standard of care alone,” Dr. Rovin said. “This is an impressive renal response rate, and these results may shift the treatment paradigm of lupus nephritis.”
Aurinia’s chief medical officer, Neil Solomons, MD, said in the release that the results provide the company with confidence that they can now execute a successful phase III program.
The 24-week results of the study – in which all primary and the 24-week secondary endpoints were also met – were released in November 2016.
Treatment with the investigational calcineurin inhibitor voclosporin is associated with a significant, threefold-higher rate of complete remission for lupus nephritis, compared with the current standard of care, according to 48-week data from the AURA-LV (Aurinia Urinary Protein Reduction Active–Lupus With Voclosporin) study.
In a company release, manufacturer Aurinia Pharmaceuticals presented the results of the international phase IIb controlled trial involving 265 patients with active lupus nephritis from 20 countries, which they say has now met its primary and secondary endpoints.
After 48 weeks, 49% of patients in the low-dose group and 40% in the high-dose group had achieved complete remission, compared with 24% in the control group (P less than .001 for low-dose vs. control; P = .026 for high-dose vs. control). This represented a threefold-higher remission rate for the low-dose group (odds ratio, 3.21) and a twofold-higher rate for the high-dose group (OR, 2.1), compared with controls.
Complete remission was defined as a composite endpoint that included urine protein/creatinine ratio of 0.5 mg/mg or less; normal, stable renal function; presence of sustained, low dose steroids; and no administration of rescue medications.
Partial remission – defined as at least a 50% reduction in urine protein/creatinine ratio with no concomitant use of rescue medication – was seen in 68% of patients in the low-dose voclosporin group, 72% of patients in the high-dose group, and 48% of patients in the control arm (P = .007 for low-dose vs. control; P = .002 for high-dose vs. control).
Investigators said there were no unexpected safety signals from voclosporin, but there were three deaths and one malignancy reported in the control arm after the study treatment period ended.
Brad Rovin, MD, of Ohio State University in Columbus said in the company’s statement that current treatments for this severe complication of systemic lupus erythematosus are toxic, and complete renal response rates are low.
“The AURA trial’s long-term results convincingly demonstrate that the addition of voclosporin to standard of care treatment is superior to standard of care alone,” Dr. Rovin said. “This is an impressive renal response rate, and these results may shift the treatment paradigm of lupus nephritis.”
Aurinia’s chief medical officer, Neil Solomons, MD, said in the release that the results provide the company with confidence that they can now execute a successful phase III program.
The 24-week results of the study – in which all primary and the 24-week secondary endpoints were also met – were released in November 2016.
Treatment with the investigational calcineurin inhibitor voclosporin is associated with a significant, threefold-higher rate of complete remission for lupus nephritis, compared with the current standard of care, according to 48-week data from the AURA-LV (Aurinia Urinary Protein Reduction Active–Lupus With Voclosporin) study.
In a company release, manufacturer Aurinia Pharmaceuticals presented the results of the international phase IIb controlled trial involving 265 patients with active lupus nephritis from 20 countries, which they say has now met its primary and secondary endpoints.
After 48 weeks, 49% of patients in the low-dose group and 40% in the high-dose group had achieved complete remission, compared with 24% in the control group (P less than .001 for low-dose vs. control; P = .026 for high-dose vs. control). This represented a threefold-higher remission rate for the low-dose group (odds ratio, 3.21) and a twofold-higher rate for the high-dose group (OR, 2.1), compared with controls.
Complete remission was defined as a composite endpoint that included urine protein/creatinine ratio of 0.5 mg/mg or less; normal, stable renal function; presence of sustained, low dose steroids; and no administration of rescue medications.
Partial remission – defined as at least a 50% reduction in urine protein/creatinine ratio with no concomitant use of rescue medication – was seen in 68% of patients in the low-dose voclosporin group, 72% of patients in the high-dose group, and 48% of patients in the control arm (P = .007 for low-dose vs. control; P = .002 for high-dose vs. control).
Investigators said there were no unexpected safety signals from voclosporin, but there were three deaths and one malignancy reported in the control arm after the study treatment period ended.
Brad Rovin, MD, of Ohio State University in Columbus said in the company’s statement that current treatments for this severe complication of systemic lupus erythematosus are toxic, and complete renal response rates are low.
“The AURA trial’s long-term results convincingly demonstrate that the addition of voclosporin to standard of care treatment is superior to standard of care alone,” Dr. Rovin said. “This is an impressive renal response rate, and these results may shift the treatment paradigm of lupus nephritis.”
Aurinia’s chief medical officer, Neil Solomons, MD, said in the release that the results provide the company with confidence that they can now execute a successful phase III program.
The 24-week results of the study – in which all primary and the 24-week secondary endpoints were also met – were released in November 2016.
Key clinical point:
Major finding: Nearly half of patients treated with the lower dose of investigational calcineurin inhibitor voclosporin achieved complete remission compared to one-quarter of patients in the control group.
Data source: The AURA-LV phase IIb controlled study involving 265 patients with active lupus nephritis.
Disclosures: The results were presented in a company release from manufacturer Aurinia Pharmaceuticals.
Neuropsychiatric Strategies May Benefit Patients With Refractory Epilepsy
HOUSTON—Treating psychiatric symptoms in patients with refractory epilepsy is likely to improve the overall course of the disease, as well as patients’ quality of life, according to an overview provided at the 70th Annual Meeting of the American Epilepsy Society.
Epilepsy “is not necessarily a neurologic disease with psychiatric comorbidity. Maybe there is something in the interface … that is really our target,” he said.
Epilepsy and psychiatry have considerable symptom overlap, Dr. Salpekar noted. For example, someone with a seizure focus in the amygdala might have an aura of anxiety or overwhelming fear that resembles the early stages of a panic attack.
Neurologists should aim to treat seizures and psychiatric symptoms. “Think about psychiatric symptoms as clues that we have not treated the entire disease yet,” Dr. Salpekar said. “We want to use our anticonvulsants to treat the entire disease, and maybe that will lead to improved seizure control.”
A Bidirectional Relationship
Understanding the bidirectional relationship between neuropsychiatric disorders and epilepsy is key to treatment. “Not only are you more likely to be depressed if you have epilepsy, but you are more likely to have epilepsy or develop seizures if you are depressed,” Dr. Salpekar said. This finding represents “a paradigm shift … in how we interpret what this illness could be.”
In addition, ADHD increases the likelihood of seizures, and one study found that 28% of children with ADHD who underwent polysomnography had centrotemporal spikes. Other research suggests that patients with epilepsy may have structural changes and cognitive symptoms prior to their first identified seizures.
Antiepileptic drugs (AEDs) effectively treat psychiatric symptoms, including impulsivity, rage outbursts, and mood lability. “In the psychiatric world, we depend upon these [drugs] all the time,” Dr. Salpekar said. “Maybe there are relationships between seizure control and behavior control that are more clear-cut than we have thought.”
Treatment Options
Dr. Salpekar and colleagues in 2006 conducted a review of patients with epilepsy and comorbid bipolar spectrum disorder. They reviewed cases to see whether treatment with AEDs improved bipolar symptoms, such as mood lability, impulsivity, rage outbursts, and extreme irritability, as well as seizures. They found that carbamazepine, divalproex sodium, lamotrigine, and oxcarbazepine monotherapies were associated with better psychiatric symptom ratings, compared with other monotherapies. In many cases, the drugs appeared to treat epilepsy and mood disorder simultaneously. The findings suggest that AEDs can “bridge the gap between epilepsy or seizure counts and psychiatric symptoms” and that neurologists should “aim for broad-spectrum treatment,” he said.
Psychiatric symptoms sometimes may be related to AEDs. If an AED causes depressive symptoms or irritability, neurologists should try to remove it. In addition, benzodiazepine withdrawal may cause depression, and this effect may occur in certain patients due to their metabolism. “If someone is a fast metabolizer, and they are taking b.i.d. clonazepam, what happens if it wears off?” In those cases, behavior problems may occur late in the afternoon when serum drug concentrations are lowest.
Many GABAergic drugs have been reported to improve anxiety. Gabapentin also has been reported to improve social phobia and chronic pain. Potential negative effects of GABAergic drugs include depression, sedation, mood lability, and hyperactivity.
Among antiglutamatergic drugs, lamotrigine may be the best evidence-based option for improving mood or depression. Lamotrigine, however, may promote mania in patients with a propensity for bipolar spectrum disorder.
Among drugs with other mechanisms of action, carbamazepine is known to be a mood stabilizer, and eslicarbazepine may have the same effect. Levetiracetam may cause irritability, but the drug also may improve mood in some cases. “There are positives and negatives with any of our AEDs,” Dr. Salpekar said.
An Important Question to Ask Patients
Patients with severe refractory epilepsy often have depression, and treating depression may improve their quality of life dramatically. “When all else fails, at the very least, we want to identify if depression is present because we can do something about that most of the time,” Dr. Salpekar said.
Many depression screening tools are available, but the important thing is to broach the subject. “I would encourage all of you to ask one question of your patients. Just say, ‘Are you depressed?’ That might be all you have to do.”
Depression may be more common in patients with temporal lobe foci, and evidence suggests that adults with left foci have an increased likelihood of depression. Waxman and Geschwind observed that patients with temporal lobe epilepsy may have an increased preoccupation with philosophical, moral, or religious issues, which also can be characteristic of manic episodes, Dr. Salpekar said.
Dr. Salpekar and colleagues conducted a study of children with medically refractory epilepsy who presented for surgical evaluation to assess whether psychiatric symptoms differed according to seizure focus. Researchers reviewed case records for 40 patients. Patients with suspected temporal lobe foci had more behavioral problems and were more likely to have a diagnosis of depression, compared with children with extratemporal foci. This finding “lends some credence to our idea that temporal lobe foci are worse … in terms of depression,” he said.
Treating Depression
Neurologists can follow practical steps to address depression. First, determine whether symptoms are attributable to drug side effects. Then, address lifestyle factors, including sleep, exercise, and diet, and consider social stressors, such as family members or employers who do not appreciate the patient’s cognitive or physical limitations. Neurologists should identify targets that help measure whether treatment is working and consider whether low doses of adjunctive AEDs may help treat psychiatric symptoms. Finally, neurologists may consider prescribing an antidepressant. “If you are going to use an antidepressant, get comfortable, skilled, and knowledgeable about using one of them,” he said.
Studies have provided data regarding the use of antidepressants in patients with epilepsy. In an observational pediatric study, 36 patients who received fluoxetine or sertraline improved clinically, whereas two patients who received fluoxetine or sertraline had worsened seizures. Studies also have provided evidence for the use of citalopram and sertraline in adults with epilepsy. Other studies regarding the treatment of depression in epilepsy are ongoing.
Selective serotonin reuptake inhibitors (SSRIs) entail a low risk of lowering seizure threshold, as do certain antipsychotics (eg, haloperidol, risperidone, and aripiprazole). Methylphenidate is considered safe and is widely used for children with epilepsy and comorbid ADHD.
Nonmedical treatment also can benefit patients. Social skills groups, overnight camps, and cognitive behavioral therapy may be effective options. Vocational support also is important. “Meaningful activity can … tip the balance into more functionality,” he said. “Think about seizure control and behavior control as partners,” Dr. Salpekar concluded. “Think about treating both of these types of targets as working together to improve the entire illness.”
—Jake Remaly
Suggested Reading
Hermann BP, Dabbs K, Becker T, et al. Brain development in children with new onset epilepsy: a prospective controlled cohort investigation. Epilepsia. 2010;51(10):2038-2046.
Hesdorffer DC, Hauser WA, Olafsson E, et al. Depression and suicide attempt as risk factors for incident unprovoked seizures. Ann Neurol. 2006;59(1):35-41.
Salpekar JA. Mood disorders in epilepsy. Focus. 2016;14(4):465-472.
Salpekar JA, Berl MM, Havens K, et al. Psychiatric symptoms in children prior to epilepsy surgery differ according to suspected seizure focus. Epilepsia. 2013;54(6):1074-1082.
Salpekar JA, Conry JA, Doss W, et al. Clinical experience with anticonvulsant medication in pediatric epilepsy and comorbid bipolar spectrum disorder. Epilepsy Behav. 2006;9(2):327-334.
Silvestri R, Gagliano A, Calarese T, et al. Ictal and interictal EEG abnormalities in ADHD children recorded over night by video-polysomnography. Epilepsy Res. 2007;75(2-3):130-137.
Waxman SG, Geschwind N. The interictal behavior syndrome of temporal lobe epilepsy. Arch Gen Psychiatry. 1975;32(12):1580-1586.
HOUSTON—Treating psychiatric symptoms in patients with refractory epilepsy is likely to improve the overall course of the disease, as well as patients’ quality of life, according to an overview provided at the 70th Annual Meeting of the American Epilepsy Society.
Epilepsy “is not necessarily a neurologic disease with psychiatric comorbidity. Maybe there is something in the interface … that is really our target,” he said.
Epilepsy and psychiatry have considerable symptom overlap, Dr. Salpekar noted. For example, someone with a seizure focus in the amygdala might have an aura of anxiety or overwhelming fear that resembles the early stages of a panic attack.
Neurologists should aim to treat seizures and psychiatric symptoms. “Think about psychiatric symptoms as clues that we have not treated the entire disease yet,” Dr. Salpekar said. “We want to use our anticonvulsants to treat the entire disease, and maybe that will lead to improved seizure control.”
A Bidirectional Relationship
Understanding the bidirectional relationship between neuropsychiatric disorders and epilepsy is key to treatment. “Not only are you more likely to be depressed if you have epilepsy, but you are more likely to have epilepsy or develop seizures if you are depressed,” Dr. Salpekar said. This finding represents “a paradigm shift … in how we interpret what this illness could be.”
In addition, ADHD increases the likelihood of seizures, and one study found that 28% of children with ADHD who underwent polysomnography had centrotemporal spikes. Other research suggests that patients with epilepsy may have structural changes and cognitive symptoms prior to their first identified seizures.
Antiepileptic drugs (AEDs) effectively treat psychiatric symptoms, including impulsivity, rage outbursts, and mood lability. “In the psychiatric world, we depend upon these [drugs] all the time,” Dr. Salpekar said. “Maybe there are relationships between seizure control and behavior control that are more clear-cut than we have thought.”
Treatment Options
Dr. Salpekar and colleagues in 2006 conducted a review of patients with epilepsy and comorbid bipolar spectrum disorder. They reviewed cases to see whether treatment with AEDs improved bipolar symptoms, such as mood lability, impulsivity, rage outbursts, and extreme irritability, as well as seizures. They found that carbamazepine, divalproex sodium, lamotrigine, and oxcarbazepine monotherapies were associated with better psychiatric symptom ratings, compared with other monotherapies. In many cases, the drugs appeared to treat epilepsy and mood disorder simultaneously. The findings suggest that AEDs can “bridge the gap between epilepsy or seizure counts and psychiatric symptoms” and that neurologists should “aim for broad-spectrum treatment,” he said.
Psychiatric symptoms sometimes may be related to AEDs. If an AED causes depressive symptoms or irritability, neurologists should try to remove it. In addition, benzodiazepine withdrawal may cause depression, and this effect may occur in certain patients due to their metabolism. “If someone is a fast metabolizer, and they are taking b.i.d. clonazepam, what happens if it wears off?” In those cases, behavior problems may occur late in the afternoon when serum drug concentrations are lowest.
Many GABAergic drugs have been reported to improve anxiety. Gabapentin also has been reported to improve social phobia and chronic pain. Potential negative effects of GABAergic drugs include depression, sedation, mood lability, and hyperactivity.
Among antiglutamatergic drugs, lamotrigine may be the best evidence-based option for improving mood or depression. Lamotrigine, however, may promote mania in patients with a propensity for bipolar spectrum disorder.
Among drugs with other mechanisms of action, carbamazepine is known to be a mood stabilizer, and eslicarbazepine may have the same effect. Levetiracetam may cause irritability, but the drug also may improve mood in some cases. “There are positives and negatives with any of our AEDs,” Dr. Salpekar said.
An Important Question to Ask Patients
Patients with severe refractory epilepsy often have depression, and treating depression may improve their quality of life dramatically. “When all else fails, at the very least, we want to identify if depression is present because we can do something about that most of the time,” Dr. Salpekar said.
Many depression screening tools are available, but the important thing is to broach the subject. “I would encourage all of you to ask one question of your patients. Just say, ‘Are you depressed?’ That might be all you have to do.”
Depression may be more common in patients with temporal lobe foci, and evidence suggests that adults with left foci have an increased likelihood of depression. Waxman and Geschwind observed that patients with temporal lobe epilepsy may have an increased preoccupation with philosophical, moral, or religious issues, which also can be characteristic of manic episodes, Dr. Salpekar said.
Dr. Salpekar and colleagues conducted a study of children with medically refractory epilepsy who presented for surgical evaluation to assess whether psychiatric symptoms differed according to seizure focus. Researchers reviewed case records for 40 patients. Patients with suspected temporal lobe foci had more behavioral problems and were more likely to have a diagnosis of depression, compared with children with extratemporal foci. This finding “lends some credence to our idea that temporal lobe foci are worse … in terms of depression,” he said.
Treating Depression
Neurologists can follow practical steps to address depression. First, determine whether symptoms are attributable to drug side effects. Then, address lifestyle factors, including sleep, exercise, and diet, and consider social stressors, such as family members or employers who do not appreciate the patient’s cognitive or physical limitations. Neurologists should identify targets that help measure whether treatment is working and consider whether low doses of adjunctive AEDs may help treat psychiatric symptoms. Finally, neurologists may consider prescribing an antidepressant. “If you are going to use an antidepressant, get comfortable, skilled, and knowledgeable about using one of them,” he said.
Studies have provided data regarding the use of antidepressants in patients with epilepsy. In an observational pediatric study, 36 patients who received fluoxetine or sertraline improved clinically, whereas two patients who received fluoxetine or sertraline had worsened seizures. Studies also have provided evidence for the use of citalopram and sertraline in adults with epilepsy. Other studies regarding the treatment of depression in epilepsy are ongoing.
Selective serotonin reuptake inhibitors (SSRIs) entail a low risk of lowering seizure threshold, as do certain antipsychotics (eg, haloperidol, risperidone, and aripiprazole). Methylphenidate is considered safe and is widely used for children with epilepsy and comorbid ADHD.
Nonmedical treatment also can benefit patients. Social skills groups, overnight camps, and cognitive behavioral therapy may be effective options. Vocational support also is important. “Meaningful activity can … tip the balance into more functionality,” he said. “Think about seizure control and behavior control as partners,” Dr. Salpekar concluded. “Think about treating both of these types of targets as working together to improve the entire illness.”
—Jake Remaly
Suggested Reading
Hermann BP, Dabbs K, Becker T, et al. Brain development in children with new onset epilepsy: a prospective controlled cohort investigation. Epilepsia. 2010;51(10):2038-2046.
Hesdorffer DC, Hauser WA, Olafsson E, et al. Depression and suicide attempt as risk factors for incident unprovoked seizures. Ann Neurol. 2006;59(1):35-41.
Salpekar JA. Mood disorders in epilepsy. Focus. 2016;14(4):465-472.
Salpekar JA, Berl MM, Havens K, et al. Psychiatric symptoms in children prior to epilepsy surgery differ according to suspected seizure focus. Epilepsia. 2013;54(6):1074-1082.
Salpekar JA, Conry JA, Doss W, et al. Clinical experience with anticonvulsant medication in pediatric epilepsy and comorbid bipolar spectrum disorder. Epilepsy Behav. 2006;9(2):327-334.
Silvestri R, Gagliano A, Calarese T, et al. Ictal and interictal EEG abnormalities in ADHD children recorded over night by video-polysomnography. Epilepsy Res. 2007;75(2-3):130-137.
Waxman SG, Geschwind N. The interictal behavior syndrome of temporal lobe epilepsy. Arch Gen Psychiatry. 1975;32(12):1580-1586.
HOUSTON—Treating psychiatric symptoms in patients with refractory epilepsy is likely to improve the overall course of the disease, as well as patients’ quality of life, according to an overview provided at the 70th Annual Meeting of the American Epilepsy Society.
Epilepsy “is not necessarily a neurologic disease with psychiatric comorbidity. Maybe there is something in the interface … that is really our target,” he said.
Epilepsy and psychiatry have considerable symptom overlap, Dr. Salpekar noted. For example, someone with a seizure focus in the amygdala might have an aura of anxiety or overwhelming fear that resembles the early stages of a panic attack.
Neurologists should aim to treat seizures and psychiatric symptoms. “Think about psychiatric symptoms as clues that we have not treated the entire disease yet,” Dr. Salpekar said. “We want to use our anticonvulsants to treat the entire disease, and maybe that will lead to improved seizure control.”
A Bidirectional Relationship
Understanding the bidirectional relationship between neuropsychiatric disorders and epilepsy is key to treatment. “Not only are you more likely to be depressed if you have epilepsy, but you are more likely to have epilepsy or develop seizures if you are depressed,” Dr. Salpekar said. This finding represents “a paradigm shift … in how we interpret what this illness could be.”
In addition, ADHD increases the likelihood of seizures, and one study found that 28% of children with ADHD who underwent polysomnography had centrotemporal spikes. Other research suggests that patients with epilepsy may have structural changes and cognitive symptoms prior to their first identified seizures.
Antiepileptic drugs (AEDs) effectively treat psychiatric symptoms, including impulsivity, rage outbursts, and mood lability. “In the psychiatric world, we depend upon these [drugs] all the time,” Dr. Salpekar said. “Maybe there are relationships between seizure control and behavior control that are more clear-cut than we have thought.”
Treatment Options
Dr. Salpekar and colleagues in 2006 conducted a review of patients with epilepsy and comorbid bipolar spectrum disorder. They reviewed cases to see whether treatment with AEDs improved bipolar symptoms, such as mood lability, impulsivity, rage outbursts, and extreme irritability, as well as seizures. They found that carbamazepine, divalproex sodium, lamotrigine, and oxcarbazepine monotherapies were associated with better psychiatric symptom ratings, compared with other monotherapies. In many cases, the drugs appeared to treat epilepsy and mood disorder simultaneously. The findings suggest that AEDs can “bridge the gap between epilepsy or seizure counts and psychiatric symptoms” and that neurologists should “aim for broad-spectrum treatment,” he said.
Psychiatric symptoms sometimes may be related to AEDs. If an AED causes depressive symptoms or irritability, neurologists should try to remove it. In addition, benzodiazepine withdrawal may cause depression, and this effect may occur in certain patients due to their metabolism. “If someone is a fast metabolizer, and they are taking b.i.d. clonazepam, what happens if it wears off?” In those cases, behavior problems may occur late in the afternoon when serum drug concentrations are lowest.
Many GABAergic drugs have been reported to improve anxiety. Gabapentin also has been reported to improve social phobia and chronic pain. Potential negative effects of GABAergic drugs include depression, sedation, mood lability, and hyperactivity.
Among antiglutamatergic drugs, lamotrigine may be the best evidence-based option for improving mood or depression. Lamotrigine, however, may promote mania in patients with a propensity for bipolar spectrum disorder.
Among drugs with other mechanisms of action, carbamazepine is known to be a mood stabilizer, and eslicarbazepine may have the same effect. Levetiracetam may cause irritability, but the drug also may improve mood in some cases. “There are positives and negatives with any of our AEDs,” Dr. Salpekar said.
An Important Question to Ask Patients
Patients with severe refractory epilepsy often have depression, and treating depression may improve their quality of life dramatically. “When all else fails, at the very least, we want to identify if depression is present because we can do something about that most of the time,” Dr. Salpekar said.
Many depression screening tools are available, but the important thing is to broach the subject. “I would encourage all of you to ask one question of your patients. Just say, ‘Are you depressed?’ That might be all you have to do.”
Depression may be more common in patients with temporal lobe foci, and evidence suggests that adults with left foci have an increased likelihood of depression. Waxman and Geschwind observed that patients with temporal lobe epilepsy may have an increased preoccupation with philosophical, moral, or religious issues, which also can be characteristic of manic episodes, Dr. Salpekar said.
Dr. Salpekar and colleagues conducted a study of children with medically refractory epilepsy who presented for surgical evaluation to assess whether psychiatric symptoms differed according to seizure focus. Researchers reviewed case records for 40 patients. Patients with suspected temporal lobe foci had more behavioral problems and were more likely to have a diagnosis of depression, compared with children with extratemporal foci. This finding “lends some credence to our idea that temporal lobe foci are worse … in terms of depression,” he said.
Treating Depression
Neurologists can follow practical steps to address depression. First, determine whether symptoms are attributable to drug side effects. Then, address lifestyle factors, including sleep, exercise, and diet, and consider social stressors, such as family members or employers who do not appreciate the patient’s cognitive or physical limitations. Neurologists should identify targets that help measure whether treatment is working and consider whether low doses of adjunctive AEDs may help treat psychiatric symptoms. Finally, neurologists may consider prescribing an antidepressant. “If you are going to use an antidepressant, get comfortable, skilled, and knowledgeable about using one of them,” he said.
Studies have provided data regarding the use of antidepressants in patients with epilepsy. In an observational pediatric study, 36 patients who received fluoxetine or sertraline improved clinically, whereas two patients who received fluoxetine or sertraline had worsened seizures. Studies also have provided evidence for the use of citalopram and sertraline in adults with epilepsy. Other studies regarding the treatment of depression in epilepsy are ongoing.
Selective serotonin reuptake inhibitors (SSRIs) entail a low risk of lowering seizure threshold, as do certain antipsychotics (eg, haloperidol, risperidone, and aripiprazole). Methylphenidate is considered safe and is widely used for children with epilepsy and comorbid ADHD.
Nonmedical treatment also can benefit patients. Social skills groups, overnight camps, and cognitive behavioral therapy may be effective options. Vocational support also is important. “Meaningful activity can … tip the balance into more functionality,” he said. “Think about seizure control and behavior control as partners,” Dr. Salpekar concluded. “Think about treating both of these types of targets as working together to improve the entire illness.”
—Jake Remaly
Suggested Reading
Hermann BP, Dabbs K, Becker T, et al. Brain development in children with new onset epilepsy: a prospective controlled cohort investigation. Epilepsia. 2010;51(10):2038-2046.
Hesdorffer DC, Hauser WA, Olafsson E, et al. Depression and suicide attempt as risk factors for incident unprovoked seizures. Ann Neurol. 2006;59(1):35-41.
Salpekar JA. Mood disorders in epilepsy. Focus. 2016;14(4):465-472.
Salpekar JA, Berl MM, Havens K, et al. Psychiatric symptoms in children prior to epilepsy surgery differ according to suspected seizure focus. Epilepsia. 2013;54(6):1074-1082.
Salpekar JA, Conry JA, Doss W, et al. Clinical experience with anticonvulsant medication in pediatric epilepsy and comorbid bipolar spectrum disorder. Epilepsy Behav. 2006;9(2):327-334.
Silvestri R, Gagliano A, Calarese T, et al. Ictal and interictal EEG abnormalities in ADHD children recorded over night by video-polysomnography. Epilepsy Res. 2007;75(2-3):130-137.
Waxman SG, Geschwind N. The interictal behavior syndrome of temporal lobe epilepsy. Arch Gen Psychiatry. 1975;32(12):1580-1586.