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Caution crucial for stem cell transplant in scleroderma, despite potential interest
SANDESTIN, FLA. – An expert called for restraint with the use of stem cell transplantation in scleroderma at the annual Congress of Clinical Rheumatology, emphasizing that the early mortality risk shows that the patient group that should be considered for the treatment is very narrow.
Results published earlier this year found a long-term benefit for myeloablative autologous stem cell transplantation, compared with cyclophosphamide, and were highly encouraging – but only in patients with severe disease (N Engl J Med. 2018;378:35-47). This might prompt patients to express interest in the treatment, many of whom are not suitable, said Janet Pope, MD, chair of rheumatology at St. Joseph’s Health Care in London, Ont.
Because of mortality seen in the first year in the stem cell transplant group, the benefit over cyclophosphamide was seen only in subsequent years, Dr. Pope stressed.
Consideration of the approach is only appropriate for patients with early diffuse scleroderma who have a 50% mortality risk over 5 years, Dr. Pope said. Patients in the SCOT trial had a modified Rodnan Skin Score (mRSS) of 30, with an average forced vital capacity of 74%, and 73 of the 75 patients in the trial had lung involvement. Essentially, Dr. Pope said, these are patients with some organ involvement that could be lethal, but not such severe organ involvement that it requires a transplant.
“These are our sick patients,” she said.
The results published this year are even more definitive, Dr. Pope said, considering that they largely meshed with results out of Europe, published in 2014, that showed that the stem cell transplant benefit was not seen after the first year because of early mortality (JAMA. 2014 Jun 25;311[24]:2490-8). In that trial, a 10% mortality risk was seen in the first year in the transplant group, and then a benefit to transplant in the long term over cyclophosphamide.
“These are very complementary positive trials,” Dr. Pope said. “We don’t want to kill 10% of our patients who don’t have perceived high chance of mortality in the next 5 years. ... These patients are highly selected, but I think it gives our patients hope and, for some of my patients, this will be a treatment for them.”
The long-term efficacy is also encouraging in that new but less potent treatments might yield good long-term results without the early deaths, she said. “It gives an idea and hope, and it helps us to understand that maybe with immune modulation, without the nuclear blast of stem cell transplant, maybe we can do better for our patients.”
Dr. Pope reported relevant financial relationships with Actelion, Bayer, Merck, Bristol-Myers Squibb, and Roche.
SANDESTIN, FLA. – An expert called for restraint with the use of stem cell transplantation in scleroderma at the annual Congress of Clinical Rheumatology, emphasizing that the early mortality risk shows that the patient group that should be considered for the treatment is very narrow.
Results published earlier this year found a long-term benefit for myeloablative autologous stem cell transplantation, compared with cyclophosphamide, and were highly encouraging – but only in patients with severe disease (N Engl J Med. 2018;378:35-47). This might prompt patients to express interest in the treatment, many of whom are not suitable, said Janet Pope, MD, chair of rheumatology at St. Joseph’s Health Care in London, Ont.
Because of mortality seen in the first year in the stem cell transplant group, the benefit over cyclophosphamide was seen only in subsequent years, Dr. Pope stressed.
Consideration of the approach is only appropriate for patients with early diffuse scleroderma who have a 50% mortality risk over 5 years, Dr. Pope said. Patients in the SCOT trial had a modified Rodnan Skin Score (mRSS) of 30, with an average forced vital capacity of 74%, and 73 of the 75 patients in the trial had lung involvement. Essentially, Dr. Pope said, these are patients with some organ involvement that could be lethal, but not such severe organ involvement that it requires a transplant.
“These are our sick patients,” she said.
The results published this year are even more definitive, Dr. Pope said, considering that they largely meshed with results out of Europe, published in 2014, that showed that the stem cell transplant benefit was not seen after the first year because of early mortality (JAMA. 2014 Jun 25;311[24]:2490-8). In that trial, a 10% mortality risk was seen in the first year in the transplant group, and then a benefit to transplant in the long term over cyclophosphamide.
“These are very complementary positive trials,” Dr. Pope said. “We don’t want to kill 10% of our patients who don’t have perceived high chance of mortality in the next 5 years. ... These patients are highly selected, but I think it gives our patients hope and, for some of my patients, this will be a treatment for them.”
The long-term efficacy is also encouraging in that new but less potent treatments might yield good long-term results without the early deaths, she said. “It gives an idea and hope, and it helps us to understand that maybe with immune modulation, without the nuclear blast of stem cell transplant, maybe we can do better for our patients.”
Dr. Pope reported relevant financial relationships with Actelion, Bayer, Merck, Bristol-Myers Squibb, and Roche.
SANDESTIN, FLA. – An expert called for restraint with the use of stem cell transplantation in scleroderma at the annual Congress of Clinical Rheumatology, emphasizing that the early mortality risk shows that the patient group that should be considered for the treatment is very narrow.
Results published earlier this year found a long-term benefit for myeloablative autologous stem cell transplantation, compared with cyclophosphamide, and were highly encouraging – but only in patients with severe disease (N Engl J Med. 2018;378:35-47). This might prompt patients to express interest in the treatment, many of whom are not suitable, said Janet Pope, MD, chair of rheumatology at St. Joseph’s Health Care in London, Ont.
Because of mortality seen in the first year in the stem cell transplant group, the benefit over cyclophosphamide was seen only in subsequent years, Dr. Pope stressed.
Consideration of the approach is only appropriate for patients with early diffuse scleroderma who have a 50% mortality risk over 5 years, Dr. Pope said. Patients in the SCOT trial had a modified Rodnan Skin Score (mRSS) of 30, with an average forced vital capacity of 74%, and 73 of the 75 patients in the trial had lung involvement. Essentially, Dr. Pope said, these are patients with some organ involvement that could be lethal, but not such severe organ involvement that it requires a transplant.
“These are our sick patients,” she said.
The results published this year are even more definitive, Dr. Pope said, considering that they largely meshed with results out of Europe, published in 2014, that showed that the stem cell transplant benefit was not seen after the first year because of early mortality (JAMA. 2014 Jun 25;311[24]:2490-8). In that trial, a 10% mortality risk was seen in the first year in the transplant group, and then a benefit to transplant in the long term over cyclophosphamide.
“These are very complementary positive trials,” Dr. Pope said. “We don’t want to kill 10% of our patients who don’t have perceived high chance of mortality in the next 5 years. ... These patients are highly selected, but I think it gives our patients hope and, for some of my patients, this will be a treatment for them.”
The long-term efficacy is also encouraging in that new but less potent treatments might yield good long-term results without the early deaths, she said. “It gives an idea and hope, and it helps us to understand that maybe with immune modulation, without the nuclear blast of stem cell transplant, maybe we can do better for our patients.”
Dr. Pope reported relevant financial relationships with Actelion, Bayer, Merck, Bristol-Myers Squibb, and Roche.
EXPERT ANALYSIS FROM CCR 18
Keratinocyte carcinoma added no VTE risk in cohort study
Keratinocyte carcinoma patients were not at increased risk of venous thromboembolism (VTE) compared with controls in a recent population-based study of more than 700,000 insurance claims, according to investigators.
That finding suggests that clinicians should more carefully consider use of prophylactic anticoagulation in patients with squamous or basal cell carcinoma, said Shannon F. Rudy, MD, of Stanford (Calif.) University, and her coinvestigators. The report was published in JAMA Facial Plastic Surgery.
“While chemoprophylaxis is important when treating patients with an increased risk of VTE, it is equally important that such agents are not administered inappropriately because they can lead to perioperative complications,” wrote Dr. Rudy and her coauthors.
In current practice, patients with keratinocyte carcinomas (i.e., squamous cell carcinoma or basal cell carcinoma) are routinely classified at higher risk of thromboembolic events because of their diagnosis. That subsequently impacts treatment decisions regarding perioperative anticoagulation, the investigators noted.
Their population-based, retrospective analysis was based on insurance claims made between Jan. 1, 2007, and Dec. 31, 2014. The investigators identified three cohorts: 417,839 keratinocyte carcinoma patients, 314,736 controls at average risk of VTE, and 7,671 individuals considered to be at high risk of VTE because of a prior diagnosis of acute myeloid leukemia or pancreatic cancer.
In the keratinocyte carcinoma cohort, investigators found VTE risk was lower compared with the high-risk cohort in univariable analysis, multivariable analysis, and after matching patient characteristics and risk factors (odds ratio, 0.52; 95% confidence interval, 0.35-0.78; P = .001).
Compared with the control cohort, the keratinocyte carcinoma cohort had a higher risk of VTE in univariable analysis; however, the risk was lower in multivariable analysis, and not statistically different when patient characteristics and risk factors were matched (OR, 0.95; 95% CI, 0.89-1.01; P = .08).
“These results argue for careful consideration of risk assessment models, such as the Caprini score, when a surgical procedure is planned for a patient with keratinocyte carcinoma and no other risk factors for VTE in order to limit unnecessary exposure to the potential risk of VTE chemoprophylaxis,” Dr. Rudy and her coauthors wrote.
The Caprini score is a commonly used, validated, VTE risk stratification model that assigns points to specific risk factors, producing a score that can be used to decide on prophylaxis regimens, they noted.
A present or previous cancer diagnosis is worth 2 points in the Caprini system, which would put a patient at the upper end of the “low risk” category, while one additional risk factor such as planned minor surgery would indicate moderate risk.
“Recently, Caprini has begun to exclude basal cell carcinoma from this calculation, but no reference to evidence is given,” the researchers wrote.
Dr. Rudy and her coauthors had no conflicts of interest to disclose.
SOURCE: Rudy SF et al. JAMA Facial Plast Surg. 2018 May 24. doi: 10.1001/jamafacial.2018.0331.
Keratinocyte carcinoma patients were not at increased risk of venous thromboembolism (VTE) compared with controls in a recent population-based study of more than 700,000 insurance claims, according to investigators.
That finding suggests that clinicians should more carefully consider use of prophylactic anticoagulation in patients with squamous or basal cell carcinoma, said Shannon F. Rudy, MD, of Stanford (Calif.) University, and her coinvestigators. The report was published in JAMA Facial Plastic Surgery.
“While chemoprophylaxis is important when treating patients with an increased risk of VTE, it is equally important that such agents are not administered inappropriately because they can lead to perioperative complications,” wrote Dr. Rudy and her coauthors.
In current practice, patients with keratinocyte carcinomas (i.e., squamous cell carcinoma or basal cell carcinoma) are routinely classified at higher risk of thromboembolic events because of their diagnosis. That subsequently impacts treatment decisions regarding perioperative anticoagulation, the investigators noted.
Their population-based, retrospective analysis was based on insurance claims made between Jan. 1, 2007, and Dec. 31, 2014. The investigators identified three cohorts: 417,839 keratinocyte carcinoma patients, 314,736 controls at average risk of VTE, and 7,671 individuals considered to be at high risk of VTE because of a prior diagnosis of acute myeloid leukemia or pancreatic cancer.
In the keratinocyte carcinoma cohort, investigators found VTE risk was lower compared with the high-risk cohort in univariable analysis, multivariable analysis, and after matching patient characteristics and risk factors (odds ratio, 0.52; 95% confidence interval, 0.35-0.78; P = .001).
Compared with the control cohort, the keratinocyte carcinoma cohort had a higher risk of VTE in univariable analysis; however, the risk was lower in multivariable analysis, and not statistically different when patient characteristics and risk factors were matched (OR, 0.95; 95% CI, 0.89-1.01; P = .08).
“These results argue for careful consideration of risk assessment models, such as the Caprini score, when a surgical procedure is planned for a patient with keratinocyte carcinoma and no other risk factors for VTE in order to limit unnecessary exposure to the potential risk of VTE chemoprophylaxis,” Dr. Rudy and her coauthors wrote.
The Caprini score is a commonly used, validated, VTE risk stratification model that assigns points to specific risk factors, producing a score that can be used to decide on prophylaxis regimens, they noted.
A present or previous cancer diagnosis is worth 2 points in the Caprini system, which would put a patient at the upper end of the “low risk” category, while one additional risk factor such as planned minor surgery would indicate moderate risk.
“Recently, Caprini has begun to exclude basal cell carcinoma from this calculation, but no reference to evidence is given,” the researchers wrote.
Dr. Rudy and her coauthors had no conflicts of interest to disclose.
SOURCE: Rudy SF et al. JAMA Facial Plast Surg. 2018 May 24. doi: 10.1001/jamafacial.2018.0331.
Keratinocyte carcinoma patients were not at increased risk of venous thromboembolism (VTE) compared with controls in a recent population-based study of more than 700,000 insurance claims, according to investigators.
That finding suggests that clinicians should more carefully consider use of prophylactic anticoagulation in patients with squamous or basal cell carcinoma, said Shannon F. Rudy, MD, of Stanford (Calif.) University, and her coinvestigators. The report was published in JAMA Facial Plastic Surgery.
“While chemoprophylaxis is important when treating patients with an increased risk of VTE, it is equally important that such agents are not administered inappropriately because they can lead to perioperative complications,” wrote Dr. Rudy and her coauthors.
In current practice, patients with keratinocyte carcinomas (i.e., squamous cell carcinoma or basal cell carcinoma) are routinely classified at higher risk of thromboembolic events because of their diagnosis. That subsequently impacts treatment decisions regarding perioperative anticoagulation, the investigators noted.
Their population-based, retrospective analysis was based on insurance claims made between Jan. 1, 2007, and Dec. 31, 2014. The investigators identified three cohorts: 417,839 keratinocyte carcinoma patients, 314,736 controls at average risk of VTE, and 7,671 individuals considered to be at high risk of VTE because of a prior diagnosis of acute myeloid leukemia or pancreatic cancer.
In the keratinocyte carcinoma cohort, investigators found VTE risk was lower compared with the high-risk cohort in univariable analysis, multivariable analysis, and after matching patient characteristics and risk factors (odds ratio, 0.52; 95% confidence interval, 0.35-0.78; P = .001).
Compared with the control cohort, the keratinocyte carcinoma cohort had a higher risk of VTE in univariable analysis; however, the risk was lower in multivariable analysis, and not statistically different when patient characteristics and risk factors were matched (OR, 0.95; 95% CI, 0.89-1.01; P = .08).
“These results argue for careful consideration of risk assessment models, such as the Caprini score, when a surgical procedure is planned for a patient with keratinocyte carcinoma and no other risk factors for VTE in order to limit unnecessary exposure to the potential risk of VTE chemoprophylaxis,” Dr. Rudy and her coauthors wrote.
The Caprini score is a commonly used, validated, VTE risk stratification model that assigns points to specific risk factors, producing a score that can be used to decide on prophylaxis regimens, they noted.
A present or previous cancer diagnosis is worth 2 points in the Caprini system, which would put a patient at the upper end of the “low risk” category, while one additional risk factor such as planned minor surgery would indicate moderate risk.
“Recently, Caprini has begun to exclude basal cell carcinoma from this calculation, but no reference to evidence is given,” the researchers wrote.
Dr. Rudy and her coauthors had no conflicts of interest to disclose.
SOURCE: Rudy SF et al. JAMA Facial Plast Surg. 2018 May 24. doi: 10.1001/jamafacial.2018.0331.
FROM JAMA FACIAL PLASTIC SURGERY
Key clinical point: Keratinocyte patients had no increased risk of venous thromboembolism (VTE) versus controls, suggesting the need to carefully consider whether prophylactic anticoagulation is needed at the time of surgery in these patients.
Major finding: Risk of VTE in the keratinocyte carcinoma cohort was not different compared with controls after adjustment for patient characteristics and risk factors (OR, 0.95; 95% CI, 0.89-1.01; P = .08).
Study details: A population-based retrospective analysis of insurance claims made between Jan. 1, 2007, and Dec. 31, 2014, including 417,839 keratinocyte carcinoma patients, 314,736 controls, and a high-risk cohort of 7,671 individuals.
Disclosures: The authors declared no conflicts of interest.
Source: Rudy SF et al. JAMA Facial Plast Surg. 2018 May 24. doi: 10.1001/jamafacial.2018.0331.
FDA to review FLT3 agent for refractory AML
The Food and Drug Administration has granted priority review to an FMS-like tyrosine kinase 3 (FLT3)–targeting agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML).
If approved, it would be the first FLT3 inhibitor available for this indication.
The application is based on the ongoing ADMIRAL trial, a phase 3, open-label, randomized study of gilteritinib versus salvage chemotherapy. The trial is designed to enroll 369 patients with FLT3 mutations present in bone marrow or whole blood who are refractory or have relapsed on first-line therapy. The primary endpoints are overall survival and rates of complete remission and complete remission with partial hematologic recovery.
The FDA has set Nov. 29 as a target date for reaching a decision on approval of the drug.
The Food and Drug Administration has granted priority review to an FMS-like tyrosine kinase 3 (FLT3)–targeting agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML).
If approved, it would be the first FLT3 inhibitor available for this indication.
The application is based on the ongoing ADMIRAL trial, a phase 3, open-label, randomized study of gilteritinib versus salvage chemotherapy. The trial is designed to enroll 369 patients with FLT3 mutations present in bone marrow or whole blood who are refractory or have relapsed on first-line therapy. The primary endpoints are overall survival and rates of complete remission and complete remission with partial hematologic recovery.
The FDA has set Nov. 29 as a target date for reaching a decision on approval of the drug.
The Food and Drug Administration has granted priority review to an FMS-like tyrosine kinase 3 (FLT3)–targeting agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML).
If approved, it would be the first FLT3 inhibitor available for this indication.
The application is based on the ongoing ADMIRAL trial, a phase 3, open-label, randomized study of gilteritinib versus salvage chemotherapy. The trial is designed to enroll 369 patients with FLT3 mutations present in bone marrow or whole blood who are refractory or have relapsed on first-line therapy. The primary endpoints are overall survival and rates of complete remission and complete remission with partial hematologic recovery.
The FDA has set Nov. 29 as a target date for reaching a decision on approval of the drug.
ASCO 2018: Dr. Walter M. Stadler gives his top picks in prostate cancer research
The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation,
• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.
• 5002, A randomized study of finite abiraterone acetate (AA) plus leuprolide (LHRHa) versus LHRHa in biochemically recurrent nonmetastatic hormone-naïve prostate cancer (M0HNPC).
• 5004, The PROPHECY trial: Multicenter prospective trial of circulating tumor cell (CTC) AR-V7 detection in men with mCRPC receiving abiraterone (A) or enzalutamide (E).
• LBA5005, Overall survival between African American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
• 5006, Results of PROSPECT: A randomized, phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).
• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.
• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.
• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.
• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).
• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.
Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.
The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation,
• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.
• 5002, A randomized study of finite abiraterone acetate (AA) plus leuprolide (LHRHa) versus LHRHa in biochemically recurrent nonmetastatic hormone-naïve prostate cancer (M0HNPC).
• 5004, The PROPHECY trial: Multicenter prospective trial of circulating tumor cell (CTC) AR-V7 detection in men with mCRPC receiving abiraterone (A) or enzalutamide (E).
• LBA5005, Overall survival between African American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
• 5006, Results of PROSPECT: A randomized, phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).
• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.
• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.
• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.
• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).
• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.
Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.
The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation,
• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.
• 5002, A randomized study of finite abiraterone acetate (AA) plus leuprolide (LHRHa) versus LHRHa in biochemically recurrent nonmetastatic hormone-naïve prostate cancer (M0HNPC).
• 5004, The PROPHECY trial: Multicenter prospective trial of circulating tumor cell (CTC) AR-V7 detection in men with mCRPC receiving abiraterone (A) or enzalutamide (E).
• LBA5005, Overall survival between African American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
• 5006, Results of PROSPECT: A randomized, phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).
• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.
• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.
• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.
• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).
• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.
Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.
IncobotulinumtoxinA May Reduce Sialorrhea in Parkinson’s Disease
LOS ANGELES—IncobotulinumtoxinA may treat sialorrhea in Parkinson’s disease and other neurologic disorders effectively, according to a trial described at the 70th Annual Meeting of the American Academy of Neurology. The treatment effect may persist for as long as 16 weeks.
Various neurologic disorders, such as Parkinson’s disease and amyotrophic lateral sclerosis (ALS), may cause troublesome sialorrhea. Olaf Michel, PhD, Vice Chair of the Department of Otorhinolaryngology at the University Hospital Brussels, and colleagues conducted a phase III trial to investigate the safety and efficacy of incobotulinumtoxinA as a treatment for sialorrhea.
The researchers enrolled 184 participants (age 18 to 80) with chronic troublesome sialorrhea resulting from Parkinson’s disease or atypical parkinsonism, stroke, or traumatic brain injury (TBI) into the trial. They randomized participants in a double-blinded fashion to 75 U of incobotulinumtoxinA (ie, the low-dose group), 100 U of incobotulinumtoxinA (ie, the high-dose group), or placebo. The low-dose group received 15 U in each submandibular gland and 22.5, in each parotid gland. The high-dose group received 20 U in each submandibular gland and 30 U in each parotid gland. Follow-up lasted for 16 weeks after injection. The study’s primary outcomes were unstimulated salivary flow rate (uSFR) at week four, compared with baseline, and Global Impression of Change Scale (GICS) at week four.
In all, 74 participants were randomized to the low dose, 74 to the high dose, and 36 to placebo. The three groups were well balanced, but the proportion of women in the placebo group was lower than that in the treatment groups. Sialorrhea was associated with Parkinson’s disease in 70.6% of patients, atypical Parkinson syndromes in 8.7%, stroke in 17.9%, and TBI in 2.7%.
The investigators localized injection sites using anatomical landmarks in 39.2% of the low-dose group, 44.6% of the high-dose group, and 50% of the placebo group. They used ultrasound guidance to localize injection sites in 60.8% of the low-dose group, 55.4% of the high-dose group, and 50% of the placebo group.
At week four, changes in uSFR and GICS were similar in the placebo and low-dose groups. Improvements in these measures reached statistical significance in the high-dose group at week four, however. At weeks eight through 12, the improvements in uSFR and GICS in both active treatment groups were significant. Improvements in the uSFR and GICS in both dose groups were maintained at week 16, but were lower in the low-dose group than in the high-dose group. Dr. Michel and colleagues observed no relevant differences in outcomes according to the technique used to localize injection sites. They also observed no unexpected side effects.
At the end of the 16-week study, all patients entered a 48-week extension period during which they received three additional injections of dose-blinded incobotulinumtoxinA at 16-week intervals. The treatment effect stabilized and did not decline during the extension, and the investigators observed no accumulation of adverse events.
LOS ANGELES—IncobotulinumtoxinA may treat sialorrhea in Parkinson’s disease and other neurologic disorders effectively, according to a trial described at the 70th Annual Meeting of the American Academy of Neurology. The treatment effect may persist for as long as 16 weeks.
Various neurologic disorders, such as Parkinson’s disease and amyotrophic lateral sclerosis (ALS), may cause troublesome sialorrhea. Olaf Michel, PhD, Vice Chair of the Department of Otorhinolaryngology at the University Hospital Brussels, and colleagues conducted a phase III trial to investigate the safety and efficacy of incobotulinumtoxinA as a treatment for sialorrhea.
The researchers enrolled 184 participants (age 18 to 80) with chronic troublesome sialorrhea resulting from Parkinson’s disease or atypical parkinsonism, stroke, or traumatic brain injury (TBI) into the trial. They randomized participants in a double-blinded fashion to 75 U of incobotulinumtoxinA (ie, the low-dose group), 100 U of incobotulinumtoxinA (ie, the high-dose group), or placebo. The low-dose group received 15 U in each submandibular gland and 22.5, in each parotid gland. The high-dose group received 20 U in each submandibular gland and 30 U in each parotid gland. Follow-up lasted for 16 weeks after injection. The study’s primary outcomes were unstimulated salivary flow rate (uSFR) at week four, compared with baseline, and Global Impression of Change Scale (GICS) at week four.
In all, 74 participants were randomized to the low dose, 74 to the high dose, and 36 to placebo. The three groups were well balanced, but the proportion of women in the placebo group was lower than that in the treatment groups. Sialorrhea was associated with Parkinson’s disease in 70.6% of patients, atypical Parkinson syndromes in 8.7%, stroke in 17.9%, and TBI in 2.7%.
The investigators localized injection sites using anatomical landmarks in 39.2% of the low-dose group, 44.6% of the high-dose group, and 50% of the placebo group. They used ultrasound guidance to localize injection sites in 60.8% of the low-dose group, 55.4% of the high-dose group, and 50% of the placebo group.
At week four, changes in uSFR and GICS were similar in the placebo and low-dose groups. Improvements in these measures reached statistical significance in the high-dose group at week four, however. At weeks eight through 12, the improvements in uSFR and GICS in both active treatment groups were significant. Improvements in the uSFR and GICS in both dose groups were maintained at week 16, but were lower in the low-dose group than in the high-dose group. Dr. Michel and colleagues observed no relevant differences in outcomes according to the technique used to localize injection sites. They also observed no unexpected side effects.
At the end of the 16-week study, all patients entered a 48-week extension period during which they received three additional injections of dose-blinded incobotulinumtoxinA at 16-week intervals. The treatment effect stabilized and did not decline during the extension, and the investigators observed no accumulation of adverse events.
LOS ANGELES—IncobotulinumtoxinA may treat sialorrhea in Parkinson’s disease and other neurologic disorders effectively, according to a trial described at the 70th Annual Meeting of the American Academy of Neurology. The treatment effect may persist for as long as 16 weeks.
Various neurologic disorders, such as Parkinson’s disease and amyotrophic lateral sclerosis (ALS), may cause troublesome sialorrhea. Olaf Michel, PhD, Vice Chair of the Department of Otorhinolaryngology at the University Hospital Brussels, and colleagues conducted a phase III trial to investigate the safety and efficacy of incobotulinumtoxinA as a treatment for sialorrhea.
The researchers enrolled 184 participants (age 18 to 80) with chronic troublesome sialorrhea resulting from Parkinson’s disease or atypical parkinsonism, stroke, or traumatic brain injury (TBI) into the trial. They randomized participants in a double-blinded fashion to 75 U of incobotulinumtoxinA (ie, the low-dose group), 100 U of incobotulinumtoxinA (ie, the high-dose group), or placebo. The low-dose group received 15 U in each submandibular gland and 22.5, in each parotid gland. The high-dose group received 20 U in each submandibular gland and 30 U in each parotid gland. Follow-up lasted for 16 weeks after injection. The study’s primary outcomes were unstimulated salivary flow rate (uSFR) at week four, compared with baseline, and Global Impression of Change Scale (GICS) at week four.
In all, 74 participants were randomized to the low dose, 74 to the high dose, and 36 to placebo. The three groups were well balanced, but the proportion of women in the placebo group was lower than that in the treatment groups. Sialorrhea was associated with Parkinson’s disease in 70.6% of patients, atypical Parkinson syndromes in 8.7%, stroke in 17.9%, and TBI in 2.7%.
The investigators localized injection sites using anatomical landmarks in 39.2% of the low-dose group, 44.6% of the high-dose group, and 50% of the placebo group. They used ultrasound guidance to localize injection sites in 60.8% of the low-dose group, 55.4% of the high-dose group, and 50% of the placebo group.
At week four, changes in uSFR and GICS were similar in the placebo and low-dose groups. Improvements in these measures reached statistical significance in the high-dose group at week four, however. At weeks eight through 12, the improvements in uSFR and GICS in both active treatment groups were significant. Improvements in the uSFR and GICS in both dose groups were maintained at week 16, but were lower in the low-dose group than in the high-dose group. Dr. Michel and colleagues observed no relevant differences in outcomes according to the technique used to localize injection sites. They also observed no unexpected side effects.
At the end of the 16-week study, all patients entered a 48-week extension period during which they received three additional injections of dose-blinded incobotulinumtoxinA at 16-week intervals. The treatment effect stabilized and did not decline during the extension, and the investigators observed no accumulation of adverse events.
Retinal Changes Indicate Parkinson’s Disease Pathology Severity
The accumulation of phosphorylated α-synuclein in the retina may serve as a biomarker of brain pathology severity and aid in diagnosis and monitoring of Parkinson’s disease, according to data published online ahead of print May 8 in Movement Disorders.
“These data suggest that phosphorylated α-synuclein accumulates in the retina in parallel with that in the brain, including in early stages preceding development of clinical signs of parkinsonism or dementia,” said Nicolás Cuenca, PhD, Assistant Professor of Physiology, Genetics, and Microbiology at the University of Alicante in Spain, and colleagues.
Parkinson’s disease pathology is mainly characterized by the accumulation of pathologic α-synuclein deposits in the brain, but little is known about how synucleinopathy affects the retina.
Dr. Cuenca and colleagues used immunohistochemistry to evaluate the presence of phosphorylated α-synuclein deposits in the retina of nine autopsied subjects with Parkinson’s disease, four with incidental Lewy body disease, and six controls. Eligible subjects had motor parkinsonism, Lewy body pathology, and pigmented neuron loss in the substantia nigra at autopsy. For each subject, the researchers compared the amount of retinal synucleinopathy with indicators of brain disease severity.
All subjects with Parkinson’s disease and three subjects with incidental Lewy body disease had phosphorylated α-synuclein deposits in ganglion cell perikarya, dendrites, and axons. Some of the deposits resembled brain Lewy bodies and Lewy neurites. Cells that contained phosphorylated α-synuclein had different morphologies, soma sizes (ie, from 15 µm to 30 µm), dendritic lengths (ie, from 570 µm to 1,620 µm), and receptive fields. Control subjects did not show any phosphorylated α-synuclein immunoreactivity in their retinas, however.
The Lewy-type synucleinopathy density in the retina significantly correlated with Lewy-type synucleinopathy density in the brain, with the Unified Parkinson’s disease pathology stage, and with the motor subscale of the Unifed Parkinson’s Disease Rating Scale. Confirmation of disease by autopsy partly compensated for the small number of subjects, according to the authors.
“Further investigations of the eye in Parkinson’s disease are desirable, given that ocular structures are involved in the pathology of several neurodegenerative diseases,” said Dr. Cuenca and colleagues.
—Erica Tricarico
Suggested Reading
Ortuño-Lizarán I, Beach TG, Serrano GE, et al. Phosphorylated α-synuclein in the retina is a biomarker of Parkinson’s disease pathology severity. Mov Disord. 2018 May 8 [Epub ahead of print].
Ma LJ, Xu LL, Mao CJ, et al. Progressive changes in the retinal structure of patients with Parkinson’s disease. J Parkinsons Dis. 2018;8(1):85-92.
The accumulation of phosphorylated α-synuclein in the retina may serve as a biomarker of brain pathology severity and aid in diagnosis and monitoring of Parkinson’s disease, according to data published online ahead of print May 8 in Movement Disorders.
“These data suggest that phosphorylated α-synuclein accumulates in the retina in parallel with that in the brain, including in early stages preceding development of clinical signs of parkinsonism or dementia,” said Nicolás Cuenca, PhD, Assistant Professor of Physiology, Genetics, and Microbiology at the University of Alicante in Spain, and colleagues.
Parkinson’s disease pathology is mainly characterized by the accumulation of pathologic α-synuclein deposits in the brain, but little is known about how synucleinopathy affects the retina.
Dr. Cuenca and colleagues used immunohistochemistry to evaluate the presence of phosphorylated α-synuclein deposits in the retina of nine autopsied subjects with Parkinson’s disease, four with incidental Lewy body disease, and six controls. Eligible subjects had motor parkinsonism, Lewy body pathology, and pigmented neuron loss in the substantia nigra at autopsy. For each subject, the researchers compared the amount of retinal synucleinopathy with indicators of brain disease severity.
All subjects with Parkinson’s disease and three subjects with incidental Lewy body disease had phosphorylated α-synuclein deposits in ganglion cell perikarya, dendrites, and axons. Some of the deposits resembled brain Lewy bodies and Lewy neurites. Cells that contained phosphorylated α-synuclein had different morphologies, soma sizes (ie, from 15 µm to 30 µm), dendritic lengths (ie, from 570 µm to 1,620 µm), and receptive fields. Control subjects did not show any phosphorylated α-synuclein immunoreactivity in their retinas, however.
The Lewy-type synucleinopathy density in the retina significantly correlated with Lewy-type synucleinopathy density in the brain, with the Unified Parkinson’s disease pathology stage, and with the motor subscale of the Unifed Parkinson’s Disease Rating Scale. Confirmation of disease by autopsy partly compensated for the small number of subjects, according to the authors.
“Further investigations of the eye in Parkinson’s disease are desirable, given that ocular structures are involved in the pathology of several neurodegenerative diseases,” said Dr. Cuenca and colleagues.
—Erica Tricarico
Suggested Reading
Ortuño-Lizarán I, Beach TG, Serrano GE, et al. Phosphorylated α-synuclein in the retina is a biomarker of Parkinson’s disease pathology severity. Mov Disord. 2018 May 8 [Epub ahead of print].
Ma LJ, Xu LL, Mao CJ, et al. Progressive changes in the retinal structure of patients with Parkinson’s disease. J Parkinsons Dis. 2018;8(1):85-92.
The accumulation of phosphorylated α-synuclein in the retina may serve as a biomarker of brain pathology severity and aid in diagnosis and monitoring of Parkinson’s disease, according to data published online ahead of print May 8 in Movement Disorders.
“These data suggest that phosphorylated α-synuclein accumulates in the retina in parallel with that in the brain, including in early stages preceding development of clinical signs of parkinsonism or dementia,” said Nicolás Cuenca, PhD, Assistant Professor of Physiology, Genetics, and Microbiology at the University of Alicante in Spain, and colleagues.
Parkinson’s disease pathology is mainly characterized by the accumulation of pathologic α-synuclein deposits in the brain, but little is known about how synucleinopathy affects the retina.
Dr. Cuenca and colleagues used immunohistochemistry to evaluate the presence of phosphorylated α-synuclein deposits in the retina of nine autopsied subjects with Parkinson’s disease, four with incidental Lewy body disease, and six controls. Eligible subjects had motor parkinsonism, Lewy body pathology, and pigmented neuron loss in the substantia nigra at autopsy. For each subject, the researchers compared the amount of retinal synucleinopathy with indicators of brain disease severity.
All subjects with Parkinson’s disease and three subjects with incidental Lewy body disease had phosphorylated α-synuclein deposits in ganglion cell perikarya, dendrites, and axons. Some of the deposits resembled brain Lewy bodies and Lewy neurites. Cells that contained phosphorylated α-synuclein had different morphologies, soma sizes (ie, from 15 µm to 30 µm), dendritic lengths (ie, from 570 µm to 1,620 µm), and receptive fields. Control subjects did not show any phosphorylated α-synuclein immunoreactivity in their retinas, however.
The Lewy-type synucleinopathy density in the retina significantly correlated with Lewy-type synucleinopathy density in the brain, with the Unified Parkinson’s disease pathology stage, and with the motor subscale of the Unifed Parkinson’s Disease Rating Scale. Confirmation of disease by autopsy partly compensated for the small number of subjects, according to the authors.
“Further investigations of the eye in Parkinson’s disease are desirable, given that ocular structures are involved in the pathology of several neurodegenerative diseases,” said Dr. Cuenca and colleagues.
—Erica Tricarico
Suggested Reading
Ortuño-Lizarán I, Beach TG, Serrano GE, et al. Phosphorylated α-synuclein in the retina is a biomarker of Parkinson’s disease pathology severity. Mov Disord. 2018 May 8 [Epub ahead of print].
Ma LJ, Xu LL, Mao CJ, et al. Progressive changes in the retinal structure of patients with Parkinson’s disease. J Parkinsons Dis. 2018;8(1):85-92.
How Common Are Comorbidities in Chronic Versus Episodic Migraine?
LOS ANGELES—Significantly more patients with chronic migraine versus episodic migraine report cardiovascular, respiratory, gastrointestinal, psychiatric, and sleep-related symptoms and conditions, according to research presented at the 70th Annual Meeting of the American Academy of Neurology.
Certain comorbidities, including allergies, insomnia, and neck pain, have relative frequencies in chronic migraine that are at least 10% greater than in episodic migraine. “Mechanisms explaining this association might include direct causality (eg, chronic migraine causes the comorbidity), reverse causality (eg, the condition increases chronic migraine risk), and shared genetic or environmental risk factors,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. Detection bias also may contribute to the association, they said.
Examining Relative Frequencies
Migraineurs often present with concomitant conditions that may exacerbate the disease, and many comorbidities occur more frequently in chronic migraine than in episodic migraine. To replicate and extend research on comorbid medical conditions in a systematically recruited sample of people with episodic and chronic migraine, Dr. Lipton and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, a prospective web-based survey designed to characterize self-reported headache symptoms and severity in a representative sample of people with migraine in the United States.
The CaMEO study included a comorbidities-and-endophenotypes module that asked respondents whether they ever had specific symptoms or conditions and, if present, whether they had been confirmed or diagnosed by a doctor. The investigators analyzed self-reported data for symptoms easily identified by respondents and physician-diagnosed data for conditions that required a medical diagnosis. The researchers used chi-squared analysis to compare the relative frequencies of symptoms and conditions. Percentages for female-specific conditions (eg, polycystic ovary syndrome) were calculated by comparison with female migraineurs. Dr. Lipton and colleagues presented data about respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities in one study and data about pain, psychiatric, and endocrine or neurologic comorbidities in another study.
In all, 16,763 CaMEO respondents with migraine received the comorbidities-and-endophenotypes module, and 12,810 provided valid responses. The analysis included 1,111 respondents (8.7%) with chronic migraine (ie, 15 or more headache days per month for more than three months) and 11,699 (91.3%) with episodic migraine (ie, fewer than 15 headache days per month). Compared with the episodic migraine group, the chronic migraine group had a similar mean age (41.3 vs 41.9), was more likely to be female (74.2% vs 81.5%), was more likely to be white (84.0% vs 88.7%), and had a higher mean BMI (27.7 kg/m2 vs 28.7 kg/m2). Compared with respondents with episodic migraine, respondents with chronic migraine more frequently reported allodynia, generalized anxiety disorder, and major depression and had a greater mean Migraine Disability Assessment Scale (MIDAS) score.
A Range of Symptoms and Conditions
Of the 31 respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 93.5%. The following five conditions or groups of conditions had relative frequencies at least 10% higher in chronic migraine than episodic migraine: allergies, hay fever, or allergic rhinitis (61.2% vs 51.2%); sinusitis or sinus infection (63.5% vs 52.7%); insomnia (50.2% vs 35.6%); vertigo, dizziness, or balance problems (29.7% vs 17.8%); and gastroesophageal reflux disease (24.4% vs 14.3%).
Of the 28 pain, psychiatric, and endocrine or neurologic comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 85.7%. The following five conditions had relative frequencies more than 10% higher in chronic migraine than in episodic migraine: chronic back pain (37.6% vs 22.5%), chronic pain (22.2% vs 7.4%), neck pain (55.3% vs 38.1%), anxiety (42.2% vs 25.7%), and depression (45.6% vs 28.1%).
The Likelihood of Medication Overuse
Of the eight endocrine or neurologic comorbidities assessed (ie, hyperhidrosis, diabetes, seizures, spasticity, underactive thyroid or thyroid medication, cervical dystonia, gout, and polycystic ovary syndrome), all but gout and polycystic ovary syndrome had significantly higher relative frequencies in chronic migraine.
When the researchers used latent class analysis to identify natural subgroups of migraine based on profiles of comorbidities and concomitant conditions, they found that a subgroup with the most comorbidities was more likely to include individuals with chronic migraine (23.1% vs 4.8%) and had greater proportions of individuals with grade IV MIDAS scores (ie, severe disability; 48.1% vs 15.1%), allodynia (67.6% vs 38.3%), medication overuse (36.4% vs 8.9%), and aura (40.1% vs 23.9%), compared with a subgroup with the fewest comorbidities
The studies were funded by Allergan.
—Jake Remaly
Suggested Reading
Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7):563-578.
LOS ANGELES—Significantly more patients with chronic migraine versus episodic migraine report cardiovascular, respiratory, gastrointestinal, psychiatric, and sleep-related symptoms and conditions, according to research presented at the 70th Annual Meeting of the American Academy of Neurology.
Certain comorbidities, including allergies, insomnia, and neck pain, have relative frequencies in chronic migraine that are at least 10% greater than in episodic migraine. “Mechanisms explaining this association might include direct causality (eg, chronic migraine causes the comorbidity), reverse causality (eg, the condition increases chronic migraine risk), and shared genetic or environmental risk factors,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. Detection bias also may contribute to the association, they said.
Examining Relative Frequencies
Migraineurs often present with concomitant conditions that may exacerbate the disease, and many comorbidities occur more frequently in chronic migraine than in episodic migraine. To replicate and extend research on comorbid medical conditions in a systematically recruited sample of people with episodic and chronic migraine, Dr. Lipton and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, a prospective web-based survey designed to characterize self-reported headache symptoms and severity in a representative sample of people with migraine in the United States.
The CaMEO study included a comorbidities-and-endophenotypes module that asked respondents whether they ever had specific symptoms or conditions and, if present, whether they had been confirmed or diagnosed by a doctor. The investigators analyzed self-reported data for symptoms easily identified by respondents and physician-diagnosed data for conditions that required a medical diagnosis. The researchers used chi-squared analysis to compare the relative frequencies of symptoms and conditions. Percentages for female-specific conditions (eg, polycystic ovary syndrome) were calculated by comparison with female migraineurs. Dr. Lipton and colleagues presented data about respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities in one study and data about pain, psychiatric, and endocrine or neurologic comorbidities in another study.
In all, 16,763 CaMEO respondents with migraine received the comorbidities-and-endophenotypes module, and 12,810 provided valid responses. The analysis included 1,111 respondents (8.7%) with chronic migraine (ie, 15 or more headache days per month for more than three months) and 11,699 (91.3%) with episodic migraine (ie, fewer than 15 headache days per month). Compared with the episodic migraine group, the chronic migraine group had a similar mean age (41.3 vs 41.9), was more likely to be female (74.2% vs 81.5%), was more likely to be white (84.0% vs 88.7%), and had a higher mean BMI (27.7 kg/m2 vs 28.7 kg/m2). Compared with respondents with episodic migraine, respondents with chronic migraine more frequently reported allodynia, generalized anxiety disorder, and major depression and had a greater mean Migraine Disability Assessment Scale (MIDAS) score.
A Range of Symptoms and Conditions
Of the 31 respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 93.5%. The following five conditions or groups of conditions had relative frequencies at least 10% higher in chronic migraine than episodic migraine: allergies, hay fever, or allergic rhinitis (61.2% vs 51.2%); sinusitis or sinus infection (63.5% vs 52.7%); insomnia (50.2% vs 35.6%); vertigo, dizziness, or balance problems (29.7% vs 17.8%); and gastroesophageal reflux disease (24.4% vs 14.3%).
Of the 28 pain, psychiatric, and endocrine or neurologic comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 85.7%. The following five conditions had relative frequencies more than 10% higher in chronic migraine than in episodic migraine: chronic back pain (37.6% vs 22.5%), chronic pain (22.2% vs 7.4%), neck pain (55.3% vs 38.1%), anxiety (42.2% vs 25.7%), and depression (45.6% vs 28.1%).
The Likelihood of Medication Overuse
Of the eight endocrine or neurologic comorbidities assessed (ie, hyperhidrosis, diabetes, seizures, spasticity, underactive thyroid or thyroid medication, cervical dystonia, gout, and polycystic ovary syndrome), all but gout and polycystic ovary syndrome had significantly higher relative frequencies in chronic migraine.
When the researchers used latent class analysis to identify natural subgroups of migraine based on profiles of comorbidities and concomitant conditions, they found that a subgroup with the most comorbidities was more likely to include individuals with chronic migraine (23.1% vs 4.8%) and had greater proportions of individuals with grade IV MIDAS scores (ie, severe disability; 48.1% vs 15.1%), allodynia (67.6% vs 38.3%), medication overuse (36.4% vs 8.9%), and aura (40.1% vs 23.9%), compared with a subgroup with the fewest comorbidities
The studies were funded by Allergan.
—Jake Remaly
Suggested Reading
Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7):563-578.
LOS ANGELES—Significantly more patients with chronic migraine versus episodic migraine report cardiovascular, respiratory, gastrointestinal, psychiatric, and sleep-related symptoms and conditions, according to research presented at the 70th Annual Meeting of the American Academy of Neurology.
Certain comorbidities, including allergies, insomnia, and neck pain, have relative frequencies in chronic migraine that are at least 10% greater than in episodic migraine. “Mechanisms explaining this association might include direct causality (eg, chronic migraine causes the comorbidity), reverse causality (eg, the condition increases chronic migraine risk), and shared genetic or environmental risk factors,” said Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in New York, and colleagues. Detection bias also may contribute to the association, they said.
Examining Relative Frequencies
Migraineurs often present with concomitant conditions that may exacerbate the disease, and many comorbidities occur more frequently in chronic migraine than in episodic migraine. To replicate and extend research on comorbid medical conditions in a systematically recruited sample of people with episodic and chronic migraine, Dr. Lipton and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, a prospective web-based survey designed to characterize self-reported headache symptoms and severity in a representative sample of people with migraine in the United States.
The CaMEO study included a comorbidities-and-endophenotypes module that asked respondents whether they ever had specific symptoms or conditions and, if present, whether they had been confirmed or diagnosed by a doctor. The investigators analyzed self-reported data for symptoms easily identified by respondents and physician-diagnosed data for conditions that required a medical diagnosis. The researchers used chi-squared analysis to compare the relative frequencies of symptoms and conditions. Percentages for female-specific conditions (eg, polycystic ovary syndrome) were calculated by comparison with female migraineurs. Dr. Lipton and colleagues presented data about respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities in one study and data about pain, psychiatric, and endocrine or neurologic comorbidities in another study.
In all, 16,763 CaMEO respondents with migraine received the comorbidities-and-endophenotypes module, and 12,810 provided valid responses. The analysis included 1,111 respondents (8.7%) with chronic migraine (ie, 15 or more headache days per month for more than three months) and 11,699 (91.3%) with episodic migraine (ie, fewer than 15 headache days per month). Compared with the episodic migraine group, the chronic migraine group had a similar mean age (41.3 vs 41.9), was more likely to be female (74.2% vs 81.5%), was more likely to be white (84.0% vs 88.7%), and had a higher mean BMI (27.7 kg/m2 vs 28.7 kg/m2). Compared with respondents with episodic migraine, respondents with chronic migraine more frequently reported allodynia, generalized anxiety disorder, and major depression and had a greater mean Migraine Disability Assessment Scale (MIDAS) score.
A Range of Symptoms and Conditions
Of the 31 respiratory, sleep disorder, cardiovascular, and gastrointestinal comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 93.5%. The following five conditions or groups of conditions had relative frequencies at least 10% higher in chronic migraine than episodic migraine: allergies, hay fever, or allergic rhinitis (61.2% vs 51.2%); sinusitis or sinus infection (63.5% vs 52.7%); insomnia (50.2% vs 35.6%); vertigo, dizziness, or balance problems (29.7% vs 17.8%); and gastroesophageal reflux disease (24.4% vs 14.3%).
Of the 28 pain, psychiatric, and endocrine or neurologic comorbidities assessed, the relative frequencies were significantly higher in chronic migraine for 85.7%. The following five conditions had relative frequencies more than 10% higher in chronic migraine than in episodic migraine: chronic back pain (37.6% vs 22.5%), chronic pain (22.2% vs 7.4%), neck pain (55.3% vs 38.1%), anxiety (42.2% vs 25.7%), and depression (45.6% vs 28.1%).
The Likelihood of Medication Overuse
Of the eight endocrine or neurologic comorbidities assessed (ie, hyperhidrosis, diabetes, seizures, spasticity, underactive thyroid or thyroid medication, cervical dystonia, gout, and polycystic ovary syndrome), all but gout and polycystic ovary syndrome had significantly higher relative frequencies in chronic migraine.
When the researchers used latent class analysis to identify natural subgroups of migraine based on profiles of comorbidities and concomitant conditions, they found that a subgroup with the most comorbidities was more likely to include individuals with chronic migraine (23.1% vs 4.8%) and had greater proportions of individuals with grade IV MIDAS scores (ie, severe disability; 48.1% vs 15.1%), allodynia (67.6% vs 38.3%), medication overuse (36.4% vs 8.9%), and aura (40.1% vs 23.9%), compared with a subgroup with the fewest comorbidities
The studies were funded by Allergan.
—Jake Remaly
Suggested Reading
Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7):563-578.
Interim Results Show Efficacy for a Novel MS Drug
LOS ANGELES—Preliminary results for annualized relapse rate and MRI parameters support ALKS 8700 (also known as BIIB098) as an oral treatment for patients with relapsing-remitting multiple sclerosis (MS), said Richard A. Leigh-Pemberton, MD, and colleagues, who presented interim phase III findings at the 70th Annual Meeting of the American Academy of Neurology. Dr. Leigh-Pemberton is Senior Medical Director at Alkermes in Waltham, Massachusetts.
ALKS 8700 is a prodrug of monomethyl fumarate, which is the active metabolite of dimethyl fumarate. It is being developed as an oral disease-modifying therapy for relapsing forms of MS and is designed to treat the disease in a manner similar to that of dimethyl fumarate, but with the potential for improved gastrointestinal tolerability. Two phase III studies are ongoing—EVOLVE-MS-1, an open-label study evaluating the long-term safety and tolerability of ALKS 8700 (462 mg twice daily) over 96 weeks, and EVOLVE-MS-2, a five-week, randomized, double-blind study evaluating the gastrointestinal tolerability of ALKS 8700 (462 mg twice daily) and dimethyl fumarate (240 mg twice daily).
Interim exploratory results on relapse rates and one-year MRI end points from the ongoing EVOLVE-MS-1 study were reported.
Approximately 900 patients will be enrolled in EVOLVE-MS-1. Main inclusion criteria include patients ages 18 to 65 with a confirmed diagnosis of relapsing-remitting MS according to the 2010 revised McDonald criteria, an Expanded Disability Status Scale (EDSS) score of 6 or lower, and no evidence of relapse within 30 days prior to starting the study drug. Main exclusion criteria include a diagnosis of progressive forms of MS, pregnancy or breastfeeding, history of other clinically significant medical condition, any clinically significant abnormal laboratory test at screening, and an absolute lymphocyte count less than 0.9 × 103/µL.
As of the January 12, 2018, data cutoff for this interim analysis, 528 de novo patients (those who had not participated in any prior study of ALKS 8700) had enrolled in EVOLVE-MS-1, and 374 had completed a one-year MRI assessment. Mean age was approximately 41, and about 70% were female. Median follow-up was 0.93 patient years for the de novo patients, and annualized relapse
This study was sponsored by Alkermes and Biogen.
—Glenn S. Williams
LOS ANGELES—Preliminary results for annualized relapse rate and MRI parameters support ALKS 8700 (also known as BIIB098) as an oral treatment for patients with relapsing-remitting multiple sclerosis (MS), said Richard A. Leigh-Pemberton, MD, and colleagues, who presented interim phase III findings at the 70th Annual Meeting of the American Academy of Neurology. Dr. Leigh-Pemberton is Senior Medical Director at Alkermes in Waltham, Massachusetts.
ALKS 8700 is a prodrug of monomethyl fumarate, which is the active metabolite of dimethyl fumarate. It is being developed as an oral disease-modifying therapy for relapsing forms of MS and is designed to treat the disease in a manner similar to that of dimethyl fumarate, but with the potential for improved gastrointestinal tolerability. Two phase III studies are ongoing—EVOLVE-MS-1, an open-label study evaluating the long-term safety and tolerability of ALKS 8700 (462 mg twice daily) over 96 weeks, and EVOLVE-MS-2, a five-week, randomized, double-blind study evaluating the gastrointestinal tolerability of ALKS 8700 (462 mg twice daily) and dimethyl fumarate (240 mg twice daily).
Interim exploratory results on relapse rates and one-year MRI end points from the ongoing EVOLVE-MS-1 study were reported.
Approximately 900 patients will be enrolled in EVOLVE-MS-1. Main inclusion criteria include patients ages 18 to 65 with a confirmed diagnosis of relapsing-remitting MS according to the 2010 revised McDonald criteria, an Expanded Disability Status Scale (EDSS) score of 6 or lower, and no evidence of relapse within 30 days prior to starting the study drug. Main exclusion criteria include a diagnosis of progressive forms of MS, pregnancy or breastfeeding, history of other clinically significant medical condition, any clinically significant abnormal laboratory test at screening, and an absolute lymphocyte count less than 0.9 × 103/µL.
As of the January 12, 2018, data cutoff for this interim analysis, 528 de novo patients (those who had not participated in any prior study of ALKS 8700) had enrolled in EVOLVE-MS-1, and 374 had completed a one-year MRI assessment. Mean age was approximately 41, and about 70% were female. Median follow-up was 0.93 patient years for the de novo patients, and annualized relapse
This study was sponsored by Alkermes and Biogen.
—Glenn S. Williams
LOS ANGELES—Preliminary results for annualized relapse rate and MRI parameters support ALKS 8700 (also known as BIIB098) as an oral treatment for patients with relapsing-remitting multiple sclerosis (MS), said Richard A. Leigh-Pemberton, MD, and colleagues, who presented interim phase III findings at the 70th Annual Meeting of the American Academy of Neurology. Dr. Leigh-Pemberton is Senior Medical Director at Alkermes in Waltham, Massachusetts.
ALKS 8700 is a prodrug of monomethyl fumarate, which is the active metabolite of dimethyl fumarate. It is being developed as an oral disease-modifying therapy for relapsing forms of MS and is designed to treat the disease in a manner similar to that of dimethyl fumarate, but with the potential for improved gastrointestinal tolerability. Two phase III studies are ongoing—EVOLVE-MS-1, an open-label study evaluating the long-term safety and tolerability of ALKS 8700 (462 mg twice daily) over 96 weeks, and EVOLVE-MS-2, a five-week, randomized, double-blind study evaluating the gastrointestinal tolerability of ALKS 8700 (462 mg twice daily) and dimethyl fumarate (240 mg twice daily).
Interim exploratory results on relapse rates and one-year MRI end points from the ongoing EVOLVE-MS-1 study were reported.
Approximately 900 patients will be enrolled in EVOLVE-MS-1. Main inclusion criteria include patients ages 18 to 65 with a confirmed diagnosis of relapsing-remitting MS according to the 2010 revised McDonald criteria, an Expanded Disability Status Scale (EDSS) score of 6 or lower, and no evidence of relapse within 30 days prior to starting the study drug. Main exclusion criteria include a diagnosis of progressive forms of MS, pregnancy or breastfeeding, history of other clinically significant medical condition, any clinically significant abnormal laboratory test at screening, and an absolute lymphocyte count less than 0.9 × 103/µL.
As of the January 12, 2018, data cutoff for this interim analysis, 528 de novo patients (those who had not participated in any prior study of ALKS 8700) had enrolled in EVOLVE-MS-1, and 374 had completed a one-year MRI assessment. Mean age was approximately 41, and about 70% were female. Median follow-up was 0.93 patient years for the de novo patients, and annualized relapse
This study was sponsored by Alkermes and Biogen.
—Glenn S. Williams
Product Update: FUJIFILM; Freemie, Preventeza, and C-Panty
NEW VISUALIZATION SYSTEMS FROM FUJIFILM
FUJIFILM New Development, USA, has introduced 2 visualization systems for minimally invasive surgery. Using proprietary technology, the Ultra-Slim Video Laparoscope System (EL-580FN) delivers enhanced image resolution, color fidelity, and display quality, says FUJIFILM. The product features include “Chip on the Tip” high-definition digital imaging processing, less fogging, autoclave sterilization reprocessing, and a low profile, lightweight ergonomic handle. The 3.8-mm-diameter distal end was designed to improve workflow, reduce physician fatigue, and potentially reduce the size of incisions. The accompanying Digital Video Processor System is used for endoscopic procedures with automatic light control, an anti-blur function for motion images, and digital zoom.
FUJIFILM reports that the Full High Definition Surgical Visualization System is designed for a wide variety of surgical applications and offers edge enhancement, automatic gain control, dynamic contrast function, selective color enhancement, smoke reduction, and grid removal features. It includes a portfolio of rigid scopes, cameras, and video processing systems.
FOR MORE INFORMATION, VISIT: http://www.fujifilmusa.com
FREEMIE BREAST MILK COLLECTION SYSTEM
Freemie® offers a hands-free breast-milk collection system with the Freemie Liberty Mobile Hands Free Breast Pump System and Next Generation Freemie Closed System Collection Cups.
The concealable pump has a rechargeable battery and hospital-power suction for single or double pumping. Programmable memory buttons allow the mother to preset or adjust speed and suction functions. Tubing lengths can be changed so that the pump can be placed on a desk, worn with a detachable belt clip, or carried in a bag.
Freemie says the cups are lower-profile and more compact than other pump system cups, and when placed on the breast under the mother’s bra, can be easily removed so that milk can be transferred to storage. Each cup, with a 25 mm or 28 mm funnel and valve, holds 8 oz of milk.
FOR MORE INFORMATION, VISIT: http://www.freemie.com
PREVENTEZA: EMERGENCY CONTRACEPTIVE
Combe, Inc, the maker of Vagisil®, has launched Preventeza™ (levonorgestrel tablet, 1.5 mg), an emergency contraceptive for the prevention of pregnancy if unprotected sex or failed birth control occurs.
Available online or over-the-counter as a single tablet, Preventeza is a proven option to help women prevent pregnancy before it starts by using a higher dose of levonorgestrel than most birth control pills. It must be used within 72 hours of unprotected intercourse, and is not intended to be used as regular birth control. Combe says that Preventeza works mainly by stopping the release of an egg from the ovary and may also prevent fertilization of an egg or prevent a fertilized egg from implanting in the uterus. Combe also says that levonorgestrel 1.5 mg will not work if the woman is already pregnant and will not affect an existing pregnancy.
FOR MORE INFORMATION, VISIT: https://www.vagisil.com/products/preventeza-emergency-contraceptive
UPSPRING’S C-PANTY FOR POSTCESAREAN RECOVERY
UpSpring® says that its patented C-Panty® undergarment provides medical-grade compression and speeds recovery after cesarean delivery. C-Panty helps to reduce swelling and discomfort, supports weakened muscles, and reduces the incision bulge without hooks, straps, or Velcro that might irritate the incision area.
C-Panty’s medical-grade silicone panel suppresses the formation of excess or improperly formed collagen, which can contribute to scarring, says UpSpring. The silicone may help reduce itchiness, and can lessen the chance of infection at the incision area. The silicone is durable, washable, and integrated into the panty, eliminating the need for scar gel or scar gel pads.
The C-Panty can be worn immediately after birth and for up to 12 months. If worn when the incision is not healed, the silicone panel should be covered with a panty liner or pad. Once the incision has healed, the covering can be discontinued.
FOR MORE INFORMATION, VISIT: https://www.upspringbaby.com/cpanty
NEW VISUALIZATION SYSTEMS FROM FUJIFILM
FUJIFILM New Development, USA, has introduced 2 visualization systems for minimally invasive surgery. Using proprietary technology, the Ultra-Slim Video Laparoscope System (EL-580FN) delivers enhanced image resolution, color fidelity, and display quality, says FUJIFILM. The product features include “Chip on the Tip” high-definition digital imaging processing, less fogging, autoclave sterilization reprocessing, and a low profile, lightweight ergonomic handle. The 3.8-mm-diameter distal end was designed to improve workflow, reduce physician fatigue, and potentially reduce the size of incisions. The accompanying Digital Video Processor System is used for endoscopic procedures with automatic light control, an anti-blur function for motion images, and digital zoom.
FUJIFILM reports that the Full High Definition Surgical Visualization System is designed for a wide variety of surgical applications and offers edge enhancement, automatic gain control, dynamic contrast function, selective color enhancement, smoke reduction, and grid removal features. It includes a portfolio of rigid scopes, cameras, and video processing systems.
FOR MORE INFORMATION, VISIT: http://www.fujifilmusa.com
FREEMIE BREAST MILK COLLECTION SYSTEM
Freemie® offers a hands-free breast-milk collection system with the Freemie Liberty Mobile Hands Free Breast Pump System and Next Generation Freemie Closed System Collection Cups.
The concealable pump has a rechargeable battery and hospital-power suction for single or double pumping. Programmable memory buttons allow the mother to preset or adjust speed and suction functions. Tubing lengths can be changed so that the pump can be placed on a desk, worn with a detachable belt clip, or carried in a bag.
Freemie says the cups are lower-profile and more compact than other pump system cups, and when placed on the breast under the mother’s bra, can be easily removed so that milk can be transferred to storage. Each cup, with a 25 mm or 28 mm funnel and valve, holds 8 oz of milk.
FOR MORE INFORMATION, VISIT: http://www.freemie.com
PREVENTEZA: EMERGENCY CONTRACEPTIVE
Combe, Inc, the maker of Vagisil®, has launched Preventeza™ (levonorgestrel tablet, 1.5 mg), an emergency contraceptive for the prevention of pregnancy if unprotected sex or failed birth control occurs.
Available online or over-the-counter as a single tablet, Preventeza is a proven option to help women prevent pregnancy before it starts by using a higher dose of levonorgestrel than most birth control pills. It must be used within 72 hours of unprotected intercourse, and is not intended to be used as regular birth control. Combe says that Preventeza works mainly by stopping the release of an egg from the ovary and may also prevent fertilization of an egg or prevent a fertilized egg from implanting in the uterus. Combe also says that levonorgestrel 1.5 mg will not work if the woman is already pregnant and will not affect an existing pregnancy.
FOR MORE INFORMATION, VISIT: https://www.vagisil.com/products/preventeza-emergency-contraceptive
UPSPRING’S C-PANTY FOR POSTCESAREAN RECOVERY
UpSpring® says that its patented C-Panty® undergarment provides medical-grade compression and speeds recovery after cesarean delivery. C-Panty helps to reduce swelling and discomfort, supports weakened muscles, and reduces the incision bulge without hooks, straps, or Velcro that might irritate the incision area.
C-Panty’s medical-grade silicone panel suppresses the formation of excess or improperly formed collagen, which can contribute to scarring, says UpSpring. The silicone may help reduce itchiness, and can lessen the chance of infection at the incision area. The silicone is durable, washable, and integrated into the panty, eliminating the need for scar gel or scar gel pads.
The C-Panty can be worn immediately after birth and for up to 12 months. If worn when the incision is not healed, the silicone panel should be covered with a panty liner or pad. Once the incision has healed, the covering can be discontinued.
FOR MORE INFORMATION, VISIT: https://www.upspringbaby.com/cpanty
NEW VISUALIZATION SYSTEMS FROM FUJIFILM
FUJIFILM New Development, USA, has introduced 2 visualization systems for minimally invasive surgery. Using proprietary technology, the Ultra-Slim Video Laparoscope System (EL-580FN) delivers enhanced image resolution, color fidelity, and display quality, says FUJIFILM. The product features include “Chip on the Tip” high-definition digital imaging processing, less fogging, autoclave sterilization reprocessing, and a low profile, lightweight ergonomic handle. The 3.8-mm-diameter distal end was designed to improve workflow, reduce physician fatigue, and potentially reduce the size of incisions. The accompanying Digital Video Processor System is used for endoscopic procedures with automatic light control, an anti-blur function for motion images, and digital zoom.
FUJIFILM reports that the Full High Definition Surgical Visualization System is designed for a wide variety of surgical applications and offers edge enhancement, automatic gain control, dynamic contrast function, selective color enhancement, smoke reduction, and grid removal features. It includes a portfolio of rigid scopes, cameras, and video processing systems.
FOR MORE INFORMATION, VISIT: http://www.fujifilmusa.com
FREEMIE BREAST MILK COLLECTION SYSTEM
Freemie® offers a hands-free breast-milk collection system with the Freemie Liberty Mobile Hands Free Breast Pump System and Next Generation Freemie Closed System Collection Cups.
The concealable pump has a rechargeable battery and hospital-power suction for single or double pumping. Programmable memory buttons allow the mother to preset or adjust speed and suction functions. Tubing lengths can be changed so that the pump can be placed on a desk, worn with a detachable belt clip, or carried in a bag.
Freemie says the cups are lower-profile and more compact than other pump system cups, and when placed on the breast under the mother’s bra, can be easily removed so that milk can be transferred to storage. Each cup, with a 25 mm or 28 mm funnel and valve, holds 8 oz of milk.
FOR MORE INFORMATION, VISIT: http://www.freemie.com
PREVENTEZA: EMERGENCY CONTRACEPTIVE
Combe, Inc, the maker of Vagisil®, has launched Preventeza™ (levonorgestrel tablet, 1.5 mg), an emergency contraceptive for the prevention of pregnancy if unprotected sex or failed birth control occurs.
Available online or over-the-counter as a single tablet, Preventeza is a proven option to help women prevent pregnancy before it starts by using a higher dose of levonorgestrel than most birth control pills. It must be used within 72 hours of unprotected intercourse, and is not intended to be used as regular birth control. Combe says that Preventeza works mainly by stopping the release of an egg from the ovary and may also prevent fertilization of an egg or prevent a fertilized egg from implanting in the uterus. Combe also says that levonorgestrel 1.5 mg will not work if the woman is already pregnant and will not affect an existing pregnancy.
FOR MORE INFORMATION, VISIT: https://www.vagisil.com/products/preventeza-emergency-contraceptive
UPSPRING’S C-PANTY FOR POSTCESAREAN RECOVERY
UpSpring® says that its patented C-Panty® undergarment provides medical-grade compression and speeds recovery after cesarean delivery. C-Panty helps to reduce swelling and discomfort, supports weakened muscles, and reduces the incision bulge without hooks, straps, or Velcro that might irritate the incision area.
C-Panty’s medical-grade silicone panel suppresses the formation of excess or improperly formed collagen, which can contribute to scarring, says UpSpring. The silicone may help reduce itchiness, and can lessen the chance of infection at the incision area. The silicone is durable, washable, and integrated into the panty, eliminating the need for scar gel or scar gel pads.
The C-Panty can be worn immediately after birth and for up to 12 months. If worn when the incision is not healed, the silicone panel should be covered with a panty liner or pad. Once the incision has healed, the covering can be discontinued.
FOR MORE INFORMATION, VISIT: https://www.upspringbaby.com/cpanty
Endometrial cancer survivors may need long-term cardiovascular monitoring
Endometrial cancer survivors are at increased long-term risk for a number of adverse cardiovascular outcomes, results of a large, population-based study suggest.
Even after adjustment for potentially confounding factors, the cohort of 2,648 endometrial cancer survivors in this retrospective study had a “high burden” of cardiovascular events compared with 10,503 age-matched women, according to the investigators.
That finding highlights a need for increased monitoring and risk management for cardiovascular disease in endometrial cancer survivors, potentially for up to 10 years, according to Sean Soisson, a PhD student in the division of public health at the University of Utah, Salt Lake City, and his coinvestigators.
The study, published in the Journal of the National Cancer Institute, is not the first to find associations between endometrial cancer and long-term cardiovascular outcomes. However, many of the previous studies had small sample sizes, relied on patient-reported outcomes, or lacked a comparison group, according to investigators.
The study was based on data from the Surveillance, Epidemiology, and End Results (SEER) Utah Cancer Registry for women diagnosed between 1997 and 2012 with an invasive first primary endometrial cancer. The investigators identified cardiovascular disease diagnoses in those patients based on review of electronic medical records and ambulatory surgery and inpatient data.
Endometrial cancer survivors had elevated risks for hypertension, heart disease, and blood vessel diseases at 1-5 years after diagnosis, and for some diseases, the risk persisted at 5-10 years after diagnosis, the investigators found.
Survivors were about 50% more likely to be diagnosed with cardiac dysrhythmias compared with the general population both at 1-5 years (hazard ratio, 1.55; 99% confidence interval, 1.23-1.97) and 5-10 years (HR, 1.41; 99% CI, 1.06-1.88) after diagnosis, according to reported data.
There was a twofold increase in risk of phlebitis, thrombophlebitis, and thromboembolism for survivors (HR, 2.07, 99% CI, 1.57-2.72), and risk remained elevated in the 5- to 10-year time frame (HR, 1.53; 99% CI, 1.08-2.17), data show.
Similar increases in risk were reported for other cardiovascular diseases at 1-5 years, and in some cases also at 5-10 years. Cerebrovascular disease was the only major category where no increased risk was found among endometrial cancer survivors, the investigators said.
Type of cancer treatment also may have influenced risk. Among patients who had endometrial cancer, radiation therapy and chemotherapy both increased risk for cardiovascular disorders versus surgery. Advanced age and obesity may have increased risk, the investigators added.
“Studies that examine risk for long-term cardiovascular outcomes among endometrial cancer survivors are becoming increasingly more critical because of the high overall survival rate among individuals diagnosed with endometrial cancer, the large number of endometrial cancer survivors, the projected increase in the number of endometrial cancer diagnoses, the introduction of more complex therapies, and the high mortality due to cardiovascular disease among endometrial cancer survivors,” the authors wrote.
The National Cancer Institute and other organizations supported the study. The authors had no conflicts of interest to disclose.
SOURCE: Soisson S, et al. J Natl Cancer Inst. 2018 May 8. doi: 10.1093/jnci/djy070.
Endometrial cancer survivors are at increased long-term risk for a number of adverse cardiovascular outcomes, results of a large, population-based study suggest.
Even after adjustment for potentially confounding factors, the cohort of 2,648 endometrial cancer survivors in this retrospective study had a “high burden” of cardiovascular events compared with 10,503 age-matched women, according to the investigators.
That finding highlights a need for increased monitoring and risk management for cardiovascular disease in endometrial cancer survivors, potentially for up to 10 years, according to Sean Soisson, a PhD student in the division of public health at the University of Utah, Salt Lake City, and his coinvestigators.
The study, published in the Journal of the National Cancer Institute, is not the first to find associations between endometrial cancer and long-term cardiovascular outcomes. However, many of the previous studies had small sample sizes, relied on patient-reported outcomes, or lacked a comparison group, according to investigators.
The study was based on data from the Surveillance, Epidemiology, and End Results (SEER) Utah Cancer Registry for women diagnosed between 1997 and 2012 with an invasive first primary endometrial cancer. The investigators identified cardiovascular disease diagnoses in those patients based on review of electronic medical records and ambulatory surgery and inpatient data.
Endometrial cancer survivors had elevated risks for hypertension, heart disease, and blood vessel diseases at 1-5 years after diagnosis, and for some diseases, the risk persisted at 5-10 years after diagnosis, the investigators found.
Survivors were about 50% more likely to be diagnosed with cardiac dysrhythmias compared with the general population both at 1-5 years (hazard ratio, 1.55; 99% confidence interval, 1.23-1.97) and 5-10 years (HR, 1.41; 99% CI, 1.06-1.88) after diagnosis, according to reported data.
There was a twofold increase in risk of phlebitis, thrombophlebitis, and thromboembolism for survivors (HR, 2.07, 99% CI, 1.57-2.72), and risk remained elevated in the 5- to 10-year time frame (HR, 1.53; 99% CI, 1.08-2.17), data show.
Similar increases in risk were reported for other cardiovascular diseases at 1-5 years, and in some cases also at 5-10 years. Cerebrovascular disease was the only major category where no increased risk was found among endometrial cancer survivors, the investigators said.
Type of cancer treatment also may have influenced risk. Among patients who had endometrial cancer, radiation therapy and chemotherapy both increased risk for cardiovascular disorders versus surgery. Advanced age and obesity may have increased risk, the investigators added.
“Studies that examine risk for long-term cardiovascular outcomes among endometrial cancer survivors are becoming increasingly more critical because of the high overall survival rate among individuals diagnosed with endometrial cancer, the large number of endometrial cancer survivors, the projected increase in the number of endometrial cancer diagnoses, the introduction of more complex therapies, and the high mortality due to cardiovascular disease among endometrial cancer survivors,” the authors wrote.
The National Cancer Institute and other organizations supported the study. The authors had no conflicts of interest to disclose.
SOURCE: Soisson S, et al. J Natl Cancer Inst. 2018 May 8. doi: 10.1093/jnci/djy070.
Endometrial cancer survivors are at increased long-term risk for a number of adverse cardiovascular outcomes, results of a large, population-based study suggest.
Even after adjustment for potentially confounding factors, the cohort of 2,648 endometrial cancer survivors in this retrospective study had a “high burden” of cardiovascular events compared with 10,503 age-matched women, according to the investigators.
That finding highlights a need for increased monitoring and risk management for cardiovascular disease in endometrial cancer survivors, potentially for up to 10 years, according to Sean Soisson, a PhD student in the division of public health at the University of Utah, Salt Lake City, and his coinvestigators.
The study, published in the Journal of the National Cancer Institute, is not the first to find associations between endometrial cancer and long-term cardiovascular outcomes. However, many of the previous studies had small sample sizes, relied on patient-reported outcomes, or lacked a comparison group, according to investigators.
The study was based on data from the Surveillance, Epidemiology, and End Results (SEER) Utah Cancer Registry for women diagnosed between 1997 and 2012 with an invasive first primary endometrial cancer. The investigators identified cardiovascular disease diagnoses in those patients based on review of electronic medical records and ambulatory surgery and inpatient data.
Endometrial cancer survivors had elevated risks for hypertension, heart disease, and blood vessel diseases at 1-5 years after diagnosis, and for some diseases, the risk persisted at 5-10 years after diagnosis, the investigators found.
Survivors were about 50% more likely to be diagnosed with cardiac dysrhythmias compared with the general population both at 1-5 years (hazard ratio, 1.55; 99% confidence interval, 1.23-1.97) and 5-10 years (HR, 1.41; 99% CI, 1.06-1.88) after diagnosis, according to reported data.
There was a twofold increase in risk of phlebitis, thrombophlebitis, and thromboembolism for survivors (HR, 2.07, 99% CI, 1.57-2.72), and risk remained elevated in the 5- to 10-year time frame (HR, 1.53; 99% CI, 1.08-2.17), data show.
Similar increases in risk were reported for other cardiovascular diseases at 1-5 years, and in some cases also at 5-10 years. Cerebrovascular disease was the only major category where no increased risk was found among endometrial cancer survivors, the investigators said.
Type of cancer treatment also may have influenced risk. Among patients who had endometrial cancer, radiation therapy and chemotherapy both increased risk for cardiovascular disorders versus surgery. Advanced age and obesity may have increased risk, the investigators added.
“Studies that examine risk for long-term cardiovascular outcomes among endometrial cancer survivors are becoming increasingly more critical because of the high overall survival rate among individuals diagnosed with endometrial cancer, the large number of endometrial cancer survivors, the projected increase in the number of endometrial cancer diagnoses, the introduction of more complex therapies, and the high mortality due to cardiovascular disease among endometrial cancer survivors,” the authors wrote.
The National Cancer Institute and other organizations supported the study. The authors had no conflicts of interest to disclose.
SOURCE: Soisson S, et al. J Natl Cancer Inst. 2018 May 8. doi: 10.1093/jnci/djy070.
FROM THE JOURNAL OF THE NATIONAL CANCER INSTITUTE
Key clinical point: Endometrial cancer survivors may require increased monitoring for cardiovascular disease up to 10 years after diagnosis.
Major finding: Survivors were at increased risk of phlebitis, thrombophlebitis, and thromboembolism (HR, 2.07), cardiac dysrhythmias (HR, 1.55), and other cardiovascular diseases at 1-5 years after diagnosis, with some risks persisting in the 5- to 10-year evaluation time frame.
Study details: A retrospective, population-based cohort study of 2,648 endometrial cancer survivors diagnosed between 1997 and 2012 and 10,503 age-matched controls.
Disclosures: The National Cancer Institute and other organizations supported the study. The authors had no conflicts of interest to disclose.
Source: Soisson S et al. J Natl Cancer Inst. 2018 May 8. doi: 10.1093/jnci/djy070.