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1 in 3 on levothyroxine take meds that interfere with thyroid tests
, potentially compromising treatment decisions, new research shows.
“We know from previous studies that thyroid hormone use is common in older adults and that there are a multitude of medications that can interfere with thyroid function tests in different ways,” senior author Maria Papaleontiou, MD, told Medscape Medical News.
“However, to our knowledge, the extent of concurrent use of thyroid hormone and interfering medications in older adults, age 65 years and older, has not been previously explored,” added Dr. Papaleontiou, of the Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor.
The findings were presented as a poster during virtual ENDO 2021, the Endocrine Society’s annual meeting.
Commenting on the study, Thanh Duc Hoang, DO, an endocrinologist with the Walter Reed National Military Medical Center, in Bethesda, Md., said: “It is important for clinicians to be aware of various interactions and interferences of medications affecting the accuracy of thyroid function tests.”
“If patients are not able to discontinue the medications shortly before the bloodwork, the clinicians may consider ordering different thyroid tests or assays that avoid the interferences,” he told Medscape Medical News.
32% of patients taking meds that could interfere with tests
In evaluating data on 538,137 patients treated with thyroid hormones from the Corporate Data Warehouse of the Veterans Health Administration, spanning 2004-2017, first author Rachel Beeson, MD, and colleagues with the University of Michigan found most patients in the study were men (96.5%), White (77.1%), and had two or more comorbidities (62.6%).
Of this total, 170,261 (31.6%) patients treated with thyroid hormones, over a median follow-up of 56 months, were taking at least one drug that could potentially interfere with thyroid function tests.
Among the drugs with potential thyroid test interference, about 28% of patients were taking prednisone or prednisolone, 8% were taking amiodarone, and 1.42% were taking phenytoin. Other reported drugs that could potentially interfere included carbamazepine (0.91%), phenobarbital (0.15%), lithium (0.40%), and tamoxifen (0.11%).
Multivariate analysis showed that characteristics associated with those most likely to have concurrent medication use included non-Whites (OR, 1.18 vs Whites), Hispanic ethnicity (OR 1.11 vs non-Hispanic), female sex (OR 1.12 vs males), and presence of comorbidities (eg, Charlson-Deyo comorbidity score ≥ 2, OR, 2.47 vs score of 0).
Meanwhile, older patients age 85 years and over had a lower likelihood of concurrent medications interfering with thyroid tests (OR, 0.47 vs age 65-74 years).
The findings are concerning given the wide use of levothyroxine to treat hypothyroidism, which is the most widely prescribed drug in the United States.
“Our findings not only highlight the complexity of thyroid hormone management in older adults in the context of polypharmacy and multimorbidity, but they also draw attention to vulnerable groups for this practice, which included female patients, non-Whites, patients of Hispanic ethnicity, and patients with comorbidities,” Dr. Papaleontiou said.
Nature of interference possibilities varies
Medications or supplements can interfere with thyroid function tests in a variety of ways, she explained. “Some medications could lead to a decrease in the absorption of levothyroxine, others may affect how well the pill dissolves.”
In addition, certain medications can affect the circulation of thyroid hormone in the blood and how it binds with proteins, or they can lead to decreasing thyroid hormone levels due to a variety of interactions.
And in contrast, “What is even more challenging is that some medications or supplements may appear to affect thyroid function based on lab tests when in reality they don’t actually affect thyroid function and may lead to dose adjustments unnecessarily,” Dr. Papaleontiou noted.
Recommendations to counter interference
Current recommendations to try to counter the effects of polypharmacy on thyroid treatment include advising patients to take thyroid hormones on an empty stomach at least 30-60 minutes prior to eating for optimal absorption.
If the patient is taking medications known to interfere with absorption of thyroid hormones, the recommendation is to space those out by at least 4 hours.
“The big challenge in older adults is that many of them do experience polypharmacy, being at risk for multiple drug-drug interactions,” Dr. Papaleontiou said.
“Physicians and patients should be vigilant and communicate closely every time there is initiation of a new medication or supplement to consider whether there may be interference.”
The authors have reported no relevant financial relationships. Dr. Hoang has reported being a speaker for Acella Pharmaceuticals.
A version of this article first appeared on Medscape.com.
, potentially compromising treatment decisions, new research shows.
“We know from previous studies that thyroid hormone use is common in older adults and that there are a multitude of medications that can interfere with thyroid function tests in different ways,” senior author Maria Papaleontiou, MD, told Medscape Medical News.
“However, to our knowledge, the extent of concurrent use of thyroid hormone and interfering medications in older adults, age 65 years and older, has not been previously explored,” added Dr. Papaleontiou, of the Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor.
The findings were presented as a poster during virtual ENDO 2021, the Endocrine Society’s annual meeting.
Commenting on the study, Thanh Duc Hoang, DO, an endocrinologist with the Walter Reed National Military Medical Center, in Bethesda, Md., said: “It is important for clinicians to be aware of various interactions and interferences of medications affecting the accuracy of thyroid function tests.”
“If patients are not able to discontinue the medications shortly before the bloodwork, the clinicians may consider ordering different thyroid tests or assays that avoid the interferences,” he told Medscape Medical News.
32% of patients taking meds that could interfere with tests
In evaluating data on 538,137 patients treated with thyroid hormones from the Corporate Data Warehouse of the Veterans Health Administration, spanning 2004-2017, first author Rachel Beeson, MD, and colleagues with the University of Michigan found most patients in the study were men (96.5%), White (77.1%), and had two or more comorbidities (62.6%).
Of this total, 170,261 (31.6%) patients treated with thyroid hormones, over a median follow-up of 56 months, were taking at least one drug that could potentially interfere with thyroid function tests.
Among the drugs with potential thyroid test interference, about 28% of patients were taking prednisone or prednisolone, 8% were taking amiodarone, and 1.42% were taking phenytoin. Other reported drugs that could potentially interfere included carbamazepine (0.91%), phenobarbital (0.15%), lithium (0.40%), and tamoxifen (0.11%).
Multivariate analysis showed that characteristics associated with those most likely to have concurrent medication use included non-Whites (OR, 1.18 vs Whites), Hispanic ethnicity (OR 1.11 vs non-Hispanic), female sex (OR 1.12 vs males), and presence of comorbidities (eg, Charlson-Deyo comorbidity score ≥ 2, OR, 2.47 vs score of 0).
Meanwhile, older patients age 85 years and over had a lower likelihood of concurrent medications interfering with thyroid tests (OR, 0.47 vs age 65-74 years).
The findings are concerning given the wide use of levothyroxine to treat hypothyroidism, which is the most widely prescribed drug in the United States.
“Our findings not only highlight the complexity of thyroid hormone management in older adults in the context of polypharmacy and multimorbidity, but they also draw attention to vulnerable groups for this practice, which included female patients, non-Whites, patients of Hispanic ethnicity, and patients with comorbidities,” Dr. Papaleontiou said.
Nature of interference possibilities varies
Medications or supplements can interfere with thyroid function tests in a variety of ways, she explained. “Some medications could lead to a decrease in the absorption of levothyroxine, others may affect how well the pill dissolves.”
In addition, certain medications can affect the circulation of thyroid hormone in the blood and how it binds with proteins, or they can lead to decreasing thyroid hormone levels due to a variety of interactions.
And in contrast, “What is even more challenging is that some medications or supplements may appear to affect thyroid function based on lab tests when in reality they don’t actually affect thyroid function and may lead to dose adjustments unnecessarily,” Dr. Papaleontiou noted.
Recommendations to counter interference
Current recommendations to try to counter the effects of polypharmacy on thyroid treatment include advising patients to take thyroid hormones on an empty stomach at least 30-60 minutes prior to eating for optimal absorption.
If the patient is taking medications known to interfere with absorption of thyroid hormones, the recommendation is to space those out by at least 4 hours.
“The big challenge in older adults is that many of them do experience polypharmacy, being at risk for multiple drug-drug interactions,” Dr. Papaleontiou said.
“Physicians and patients should be vigilant and communicate closely every time there is initiation of a new medication or supplement to consider whether there may be interference.”
The authors have reported no relevant financial relationships. Dr. Hoang has reported being a speaker for Acella Pharmaceuticals.
A version of this article first appeared on Medscape.com.
, potentially compromising treatment decisions, new research shows.
“We know from previous studies that thyroid hormone use is common in older adults and that there are a multitude of medications that can interfere with thyroid function tests in different ways,” senior author Maria Papaleontiou, MD, told Medscape Medical News.
“However, to our knowledge, the extent of concurrent use of thyroid hormone and interfering medications in older adults, age 65 years and older, has not been previously explored,” added Dr. Papaleontiou, of the Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor.
The findings were presented as a poster during virtual ENDO 2021, the Endocrine Society’s annual meeting.
Commenting on the study, Thanh Duc Hoang, DO, an endocrinologist with the Walter Reed National Military Medical Center, in Bethesda, Md., said: “It is important for clinicians to be aware of various interactions and interferences of medications affecting the accuracy of thyroid function tests.”
“If patients are not able to discontinue the medications shortly before the bloodwork, the clinicians may consider ordering different thyroid tests or assays that avoid the interferences,” he told Medscape Medical News.
32% of patients taking meds that could interfere with tests
In evaluating data on 538,137 patients treated with thyroid hormones from the Corporate Data Warehouse of the Veterans Health Administration, spanning 2004-2017, first author Rachel Beeson, MD, and colleagues with the University of Michigan found most patients in the study were men (96.5%), White (77.1%), and had two or more comorbidities (62.6%).
Of this total, 170,261 (31.6%) patients treated with thyroid hormones, over a median follow-up of 56 months, were taking at least one drug that could potentially interfere with thyroid function tests.
Among the drugs with potential thyroid test interference, about 28% of patients were taking prednisone or prednisolone, 8% were taking amiodarone, and 1.42% were taking phenytoin. Other reported drugs that could potentially interfere included carbamazepine (0.91%), phenobarbital (0.15%), lithium (0.40%), and tamoxifen (0.11%).
Multivariate analysis showed that characteristics associated with those most likely to have concurrent medication use included non-Whites (OR, 1.18 vs Whites), Hispanic ethnicity (OR 1.11 vs non-Hispanic), female sex (OR 1.12 vs males), and presence of comorbidities (eg, Charlson-Deyo comorbidity score ≥ 2, OR, 2.47 vs score of 0).
Meanwhile, older patients age 85 years and over had a lower likelihood of concurrent medications interfering with thyroid tests (OR, 0.47 vs age 65-74 years).
The findings are concerning given the wide use of levothyroxine to treat hypothyroidism, which is the most widely prescribed drug in the United States.
“Our findings not only highlight the complexity of thyroid hormone management in older adults in the context of polypharmacy and multimorbidity, but they also draw attention to vulnerable groups for this practice, which included female patients, non-Whites, patients of Hispanic ethnicity, and patients with comorbidities,” Dr. Papaleontiou said.
Nature of interference possibilities varies
Medications or supplements can interfere with thyroid function tests in a variety of ways, she explained. “Some medications could lead to a decrease in the absorption of levothyroxine, others may affect how well the pill dissolves.”
In addition, certain medications can affect the circulation of thyroid hormone in the blood and how it binds with proteins, or they can lead to decreasing thyroid hormone levels due to a variety of interactions.
And in contrast, “What is even more challenging is that some medications or supplements may appear to affect thyroid function based on lab tests when in reality they don’t actually affect thyroid function and may lead to dose adjustments unnecessarily,” Dr. Papaleontiou noted.
Recommendations to counter interference
Current recommendations to try to counter the effects of polypharmacy on thyroid treatment include advising patients to take thyroid hormones on an empty stomach at least 30-60 minutes prior to eating for optimal absorption.
If the patient is taking medications known to interfere with absorption of thyroid hormones, the recommendation is to space those out by at least 4 hours.
“The big challenge in older adults is that many of them do experience polypharmacy, being at risk for multiple drug-drug interactions,” Dr. Papaleontiou said.
“Physicians and patients should be vigilant and communicate closely every time there is initiation of a new medication or supplement to consider whether there may be interference.”
The authors have reported no relevant financial relationships. Dr. Hoang has reported being a speaker for Acella Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Success in achondroplasia spurs testing vosoritide in more growth disorders
On the basis of the quality of sustained bone growth achieved with vosoritide in dwarfism, studies are underway or being considered for more diseases that impair bone growth, according to discussion that followed the presentation of a phase 3 trial extension study at the annual meeting of the Endocrine Society.
After 1 year on active therapy in the randomized trial and another year in the extension study, patients in the vosoritide group had sustained growth velocity while placebo group patients who crossed over to active therapy caught up, reported Ravi Savarirayan, MD, Murdoch Children’s Research Institute, University of Melbourne, Australia.
Moreover, the quality and type of bone growth, such as the improvement in body segment ratios over the second year of the study, support a durable benefit. Dr. Savarirayan said that improvements in activities of daily living are expected from this improvement in upper-to-lower body segment ratios, as well as the growth seen in the limbs.
Currently there is no approved pharmacologic therapy for achondroplasia in the United States. Growth hormone has been approved in Japan, but Dr. Savarirayan said its effects have been limited. Surgery such as limb lengthening is another option, but this approach is not uniformly effective and carries risks.
The 52-week results from the multinational phase 3 trial with vosoritide, which stimulates bone growth, were published last year in The Lancet. In that trial, 121 patients between the ages of 5 and 18 years with achondroplasia were randomized to vosoritide at a dose of 15 μg/kg once daily or placebo.
Relative to those in the placebo arm, which did not experience any change in growth, the median growth at the end of 52 weeks was 1.75 cm/year greater (6.71 vs. 3.99 cm).
After crossover, placebo patients catch up
In the extension study, the placebo patients were crossed over to the active therapy and both groups were followed for an additional 52 weeks. Over this period, velocity declined modestly in those in the group initially randomized to vosoritide but climbed steeply in the placebo group so that rates after 1 year were nearly identical (5.57 vs. 5.65 cm, respectively).
“The results suggest this medication may well have a durable effect,” said Dr. Savarirayan, who believes that the benefit is derived from stimulation of the growth plates. Based on the very similar efficacy observed in the placebo group once switched to active therapy, the response to vosoritide appears to be predictable.
Of the 60 patients initially randomized to vosoritide, 58 entered the extension. Of the patients who did not remain in the study, two left due to discomfort from injection-site reactions. All 61 patients initially assigned to placebo crossed over.
“We did not see any evidence of tachyphylaxis in the randomized study or in the extension,” Dr. Savarirayan said.
Although two more patients initiated on vosoritide discontinued treatment before the end of 2 years, there were no new adverse events observed. Rather, injection-site pain, which self-resolved in all patients, appears to be the most significant side effect.
“In children, the daily subcutaneous injections can be an issue,” Dr. Savarirayan acknowledged.
Injection site reactions most common adverse event
In a detailed evaluation of safety in a previously published dose-finding phase 2 study, injection-site reactions were also the most common of treatment-related adverse events, but there were no episodes of anaphylaxis or other grade 3 or higher hypersensitivity reactions (N Engl J Med. 2019 Jul 4;381:25-35).
Prior to clinical trials, continuous infusion of endogenous C-type natriuretic peptide demonstrated an ability to stimulate long-bone growth in experimental studies. Vosoritide, a recombinant analogue of C-type natriuretic peptide, appears to provide the same activity but offers a longer half-life.
Based on the benefits observed in achondroplasia, other applications are now being explored.
“When you evaluate the quality of the bone growth associated with vosoritide, it is normal,” said Melita Irving, MD, a consultant in clinical genetics at the Guy’s and St .Thomas’ NHS Trust, London. Dr. Irving has been involved in other research initiatives with this therapy and she cited a variety of evidence that has supported healthy bone development, including favorable changes in markers of bone growth such as type 10 collagen.
As a result, vosoritide, which is now under review by the U.S. Food and Drug Administration for treatment of dwarfism, is being pursued for several other diseases that result in abnormal bone growth, such as hypochondroplasia. Not least, clinical studies in idiopathic short stature have reached “early stages,” Dr. Irving said.
Dr. Savarirayan and Dr. Irving report no relevant conflicts of interest.
On the basis of the quality of sustained bone growth achieved with vosoritide in dwarfism, studies are underway or being considered for more diseases that impair bone growth, according to discussion that followed the presentation of a phase 3 trial extension study at the annual meeting of the Endocrine Society.
After 1 year on active therapy in the randomized trial and another year in the extension study, patients in the vosoritide group had sustained growth velocity while placebo group patients who crossed over to active therapy caught up, reported Ravi Savarirayan, MD, Murdoch Children’s Research Institute, University of Melbourne, Australia.
Moreover, the quality and type of bone growth, such as the improvement in body segment ratios over the second year of the study, support a durable benefit. Dr. Savarirayan said that improvements in activities of daily living are expected from this improvement in upper-to-lower body segment ratios, as well as the growth seen in the limbs.
Currently there is no approved pharmacologic therapy for achondroplasia in the United States. Growth hormone has been approved in Japan, but Dr. Savarirayan said its effects have been limited. Surgery such as limb lengthening is another option, but this approach is not uniformly effective and carries risks.
The 52-week results from the multinational phase 3 trial with vosoritide, which stimulates bone growth, were published last year in The Lancet. In that trial, 121 patients between the ages of 5 and 18 years with achondroplasia were randomized to vosoritide at a dose of 15 μg/kg once daily or placebo.
Relative to those in the placebo arm, which did not experience any change in growth, the median growth at the end of 52 weeks was 1.75 cm/year greater (6.71 vs. 3.99 cm).
After crossover, placebo patients catch up
In the extension study, the placebo patients were crossed over to the active therapy and both groups were followed for an additional 52 weeks. Over this period, velocity declined modestly in those in the group initially randomized to vosoritide but climbed steeply in the placebo group so that rates after 1 year were nearly identical (5.57 vs. 5.65 cm, respectively).
“The results suggest this medication may well have a durable effect,” said Dr. Savarirayan, who believes that the benefit is derived from stimulation of the growth plates. Based on the very similar efficacy observed in the placebo group once switched to active therapy, the response to vosoritide appears to be predictable.
Of the 60 patients initially randomized to vosoritide, 58 entered the extension. Of the patients who did not remain in the study, two left due to discomfort from injection-site reactions. All 61 patients initially assigned to placebo crossed over.
“We did not see any evidence of tachyphylaxis in the randomized study or in the extension,” Dr. Savarirayan said.
Although two more patients initiated on vosoritide discontinued treatment before the end of 2 years, there were no new adverse events observed. Rather, injection-site pain, which self-resolved in all patients, appears to be the most significant side effect.
“In children, the daily subcutaneous injections can be an issue,” Dr. Savarirayan acknowledged.
Injection site reactions most common adverse event
In a detailed evaluation of safety in a previously published dose-finding phase 2 study, injection-site reactions were also the most common of treatment-related adverse events, but there were no episodes of anaphylaxis or other grade 3 or higher hypersensitivity reactions (N Engl J Med. 2019 Jul 4;381:25-35).
Prior to clinical trials, continuous infusion of endogenous C-type natriuretic peptide demonstrated an ability to stimulate long-bone growth in experimental studies. Vosoritide, a recombinant analogue of C-type natriuretic peptide, appears to provide the same activity but offers a longer half-life.
Based on the benefits observed in achondroplasia, other applications are now being explored.
“When you evaluate the quality of the bone growth associated with vosoritide, it is normal,” said Melita Irving, MD, a consultant in clinical genetics at the Guy’s and St .Thomas’ NHS Trust, London. Dr. Irving has been involved in other research initiatives with this therapy and she cited a variety of evidence that has supported healthy bone development, including favorable changes in markers of bone growth such as type 10 collagen.
As a result, vosoritide, which is now under review by the U.S. Food and Drug Administration for treatment of dwarfism, is being pursued for several other diseases that result in abnormal bone growth, such as hypochondroplasia. Not least, clinical studies in idiopathic short stature have reached “early stages,” Dr. Irving said.
Dr. Savarirayan and Dr. Irving report no relevant conflicts of interest.
On the basis of the quality of sustained bone growth achieved with vosoritide in dwarfism, studies are underway or being considered for more diseases that impair bone growth, according to discussion that followed the presentation of a phase 3 trial extension study at the annual meeting of the Endocrine Society.
After 1 year on active therapy in the randomized trial and another year in the extension study, patients in the vosoritide group had sustained growth velocity while placebo group patients who crossed over to active therapy caught up, reported Ravi Savarirayan, MD, Murdoch Children’s Research Institute, University of Melbourne, Australia.
Moreover, the quality and type of bone growth, such as the improvement in body segment ratios over the second year of the study, support a durable benefit. Dr. Savarirayan said that improvements in activities of daily living are expected from this improvement in upper-to-lower body segment ratios, as well as the growth seen in the limbs.
Currently there is no approved pharmacologic therapy for achondroplasia in the United States. Growth hormone has been approved in Japan, but Dr. Savarirayan said its effects have been limited. Surgery such as limb lengthening is another option, but this approach is not uniformly effective and carries risks.
The 52-week results from the multinational phase 3 trial with vosoritide, which stimulates bone growth, were published last year in The Lancet. In that trial, 121 patients between the ages of 5 and 18 years with achondroplasia were randomized to vosoritide at a dose of 15 μg/kg once daily or placebo.
Relative to those in the placebo arm, which did not experience any change in growth, the median growth at the end of 52 weeks was 1.75 cm/year greater (6.71 vs. 3.99 cm).
After crossover, placebo patients catch up
In the extension study, the placebo patients were crossed over to the active therapy and both groups were followed for an additional 52 weeks. Over this period, velocity declined modestly in those in the group initially randomized to vosoritide but climbed steeply in the placebo group so that rates after 1 year were nearly identical (5.57 vs. 5.65 cm, respectively).
“The results suggest this medication may well have a durable effect,” said Dr. Savarirayan, who believes that the benefit is derived from stimulation of the growth plates. Based on the very similar efficacy observed in the placebo group once switched to active therapy, the response to vosoritide appears to be predictable.
Of the 60 patients initially randomized to vosoritide, 58 entered the extension. Of the patients who did not remain in the study, two left due to discomfort from injection-site reactions. All 61 patients initially assigned to placebo crossed over.
“We did not see any evidence of tachyphylaxis in the randomized study or in the extension,” Dr. Savarirayan said.
Although two more patients initiated on vosoritide discontinued treatment before the end of 2 years, there were no new adverse events observed. Rather, injection-site pain, which self-resolved in all patients, appears to be the most significant side effect.
“In children, the daily subcutaneous injections can be an issue,” Dr. Savarirayan acknowledged.
Injection site reactions most common adverse event
In a detailed evaluation of safety in a previously published dose-finding phase 2 study, injection-site reactions were also the most common of treatment-related adverse events, but there were no episodes of anaphylaxis or other grade 3 or higher hypersensitivity reactions (N Engl J Med. 2019 Jul 4;381:25-35).
Prior to clinical trials, continuous infusion of endogenous C-type natriuretic peptide demonstrated an ability to stimulate long-bone growth in experimental studies. Vosoritide, a recombinant analogue of C-type natriuretic peptide, appears to provide the same activity but offers a longer half-life.
Based on the benefits observed in achondroplasia, other applications are now being explored.
“When you evaluate the quality of the bone growth associated with vosoritide, it is normal,” said Melita Irving, MD, a consultant in clinical genetics at the Guy’s and St .Thomas’ NHS Trust, London. Dr. Irving has been involved in other research initiatives with this therapy and she cited a variety of evidence that has supported healthy bone development, including favorable changes in markers of bone growth such as type 10 collagen.
As a result, vosoritide, which is now under review by the U.S. Food and Drug Administration for treatment of dwarfism, is being pursued for several other diseases that result in abnormal bone growth, such as hypochondroplasia. Not least, clinical studies in idiopathic short stature have reached “early stages,” Dr. Irving said.
Dr. Savarirayan and Dr. Irving report no relevant conflicts of interest.
FROM ENDO 2021
Imaging alternative to AVS could boost detection of primary aldosteronism
A noninvasive imaging method for identifying whether the source of a patient’s primary aldosteronism is from unilateral or bilateral adrenal adenomas worked as well as the standard method, invasive adrenal vein sampling, in a head-to-head comparison with 143 patients.
This noninvasive alternative, which also does not require the substantial technical expertise that AVS demands, should make assessment of adenoma laterality in patients with primary aldosteronism (PA) much more widely available and accessible, predicted Dr. Wu, a researcher at Queen Mary University of London.
“It will allow more places to do this, and I think it will definitely allow more patients to be diagnosed” with PA from a unilateral source. AVS “is a real bottleneck,” she said. “We hope metomidate, or molecular imaging using other selective radiotracers, will enable many more patients to be diagnosed and appropriately managed.” Creating new diagnostic options for patients with PA and potentially increasing the number of these patients who are surgical candidates “is the aim of this study.”
Patients with PA develop a curable form of hypertension if their excess aldosterone can be neutralized with a mineralocorticoid receptor antagonist (MRA), or even more definitively by surgical removal of the adrenal aldosteronoma generating the hormonal excess as long as the adenoma is unilateral. Conventional imaging of the adrenals with CT or MRI has proven unreliable for identifying adrenal nodules noninvasively, which has made the invasive and technically challenging standard option of AVS the only game in town.
But some endocrinologists caution that the results from this one study do not suffice to make 11C-metomidate-based PET-CT imaging a widely used alternative.
‘This is a first step.’
“This study is a first step. It will take lots more data for endocrinologists to buy into a scan over AVS,” commented David A. D’Alessio, MD, professor and chief of the division of endocrinology and metabolism at Duke University in Durham, N.C.
But Dr. D’Alessio also acknowledged the clear benefits from a safe and effective alternative to AVS.
“A reliable, less invasive, and less technical means of lateralizing excess aldosterone production would increase the number of people [with a unilateral PA source] going to surgery. The reality is that, if you are not a patient at the Mayo Clinic . . .or the National Institutes of Health, then AVS is a bit of crap shoot” that is very operator and institution dependent for its accuracy, Dr. D’Alessio said in an interview.
Metomidate specifically binds to key enzymes of the adrenal corticosteroid biosynthetic pathway, making it a precise targeting agent for a radioactive tag as documented almost a decade ago. One limitation is that this radiotracer labeling of metomidate has a 20-minute half life, which means it must be produced on site, thereby making the technology out of reach for locations that can’t set up this capability.
MATCHing imaging against AVS
To test the clinical utility of metomidate-based PET-CT directly against AVS, Dr. Wu and her associates enrolled 143 adults with confirmed PA and hypertension at two centers in London and one in Cambridge, England. The MATCH study cohort averaged 53 years of age; two-thirds were men, 58% were White, and 30% were Black. Their median blood pressure was 147/91 mm Hg, and they were maintained on a median of two antihypertensive drugs.
The researchers assessed every patient with both the imaging method and AVS, performed in random order and blindly scored. They then began each patient on a 1-month regimen with an MRA (usually spironolactone but eplerenone [Inspra] was also an option) to test the responsiveness of each patient’s hypertension to this drug class and to gauge their likely response to adrenalectomy. After the MRA test, the researchers assessed the lateralization tests and determined that 78 patients were appropriate candidates for unilateral adrenalectomy while the remaining 65 patients were not and continued on the MRA regimen. They recommended surgery if patients were clear positives by AVS, by PET-CT imaging, or both.
The study had four primary outcomes to assess the ability of the two diagnostic methods to predict the success of surgery based on four increasingly stringent postsurgical criteria calculated in hierarchical sequence: Partial or complete biochemical success, complete biochemical success, partial or complete clinical success (partial meaning any significant reduction in blood pressure), or complete clinical success (systolic pressure reduced to less than 135 mm Hg). Only one of the 78 patients treated with surgery failed to achieve at least a partial biochemical response.
For each of the four metrics, 11C-metomidate PET-CT produced point estimates of diagnostic accuracy that consistently edged out AVS. While these advantages were not large enough to meet the prespecified threshold for proving superiority, they comfortably showed the noninferiority of this imaging method compared with AVS.
For example, the PET-CT method had 43.6% accuracy for predicting a clinical cure, compared with 39.7% accuracy for AVS. For complete biochemical cure, imaging had 68.8% accuracy, compared with 62.3% for AVS, Dr. Wu reported.
Another notable finding from the study was how strongly a robust blood pressure response to spironolactone predicted the clinical outcome from surgery. Patients whose systolic blood pressure fell below 135 mm Hg on MRA treatment had a nearly 18-fold higher rate of achieving a complete clinical cure following surgery compared with patients who did not have as dramatic a blood pressure response to MRA treatment.
Woefully low rates of PA assessment
But regardless of the success that PET-CT imaging has for identifying surgical candidates, the first step is to identify patients with PA, a diagnosis that’s woefully underperformed worldwide. One example: A separate report at ENDO 2021 retrospectively reviewed nearly 12,000 patients with hypertension and an indication of PA, such as treatment-resistant hypertension or early-onset hypertension, and managed at either of two university outpatient clinics in Michigan during 2010-2019. The report documented that 3% underwent PA assessment.
Diagnosis of patients with PA “is a major problem,” noted Dr. D’Alessio. “I think of PA as an underdiagnosed and undertreated condition, with a huge impact on morbidity and mortality. Any advance in this area is likely to be useful.” But, he added, “I’m dubious whether this [new imaging approach] will increase diagnosis of PA.” What’s needed is “getting more primary care physicians to do more screening” for PA among their patients with hypertension and a suggestion of a PA cause.
“Surgical cures are glamorous, but medical management is also very effective, and we have good, inexpensive drugs to do this,” the MRAs, Dr. D’Alessio said.
The study received no commercial funding. Dr. Wu and her coauthors had no disclosures. Dr. D’Alessio has been a speaker on behalf of Novo Nordisk, a consultant to Intarcia and Lilly, and has received research funding from Lilly and Merck.
A noninvasive imaging method for identifying whether the source of a patient’s primary aldosteronism is from unilateral or bilateral adrenal adenomas worked as well as the standard method, invasive adrenal vein sampling, in a head-to-head comparison with 143 patients.
This noninvasive alternative, which also does not require the substantial technical expertise that AVS demands, should make assessment of adenoma laterality in patients with primary aldosteronism (PA) much more widely available and accessible, predicted Dr. Wu, a researcher at Queen Mary University of London.
“It will allow more places to do this, and I think it will definitely allow more patients to be diagnosed” with PA from a unilateral source. AVS “is a real bottleneck,” she said. “We hope metomidate, or molecular imaging using other selective radiotracers, will enable many more patients to be diagnosed and appropriately managed.” Creating new diagnostic options for patients with PA and potentially increasing the number of these patients who are surgical candidates “is the aim of this study.”
Patients with PA develop a curable form of hypertension if their excess aldosterone can be neutralized with a mineralocorticoid receptor antagonist (MRA), or even more definitively by surgical removal of the adrenal aldosteronoma generating the hormonal excess as long as the adenoma is unilateral. Conventional imaging of the adrenals with CT or MRI has proven unreliable for identifying adrenal nodules noninvasively, which has made the invasive and technically challenging standard option of AVS the only game in town.
But some endocrinologists caution that the results from this one study do not suffice to make 11C-metomidate-based PET-CT imaging a widely used alternative.
‘This is a first step.’
“This study is a first step. It will take lots more data for endocrinologists to buy into a scan over AVS,” commented David A. D’Alessio, MD, professor and chief of the division of endocrinology and metabolism at Duke University in Durham, N.C.
But Dr. D’Alessio also acknowledged the clear benefits from a safe and effective alternative to AVS.
“A reliable, less invasive, and less technical means of lateralizing excess aldosterone production would increase the number of people [with a unilateral PA source] going to surgery. The reality is that, if you are not a patient at the Mayo Clinic . . .or the National Institutes of Health, then AVS is a bit of crap shoot” that is very operator and institution dependent for its accuracy, Dr. D’Alessio said in an interview.
Metomidate specifically binds to key enzymes of the adrenal corticosteroid biosynthetic pathway, making it a precise targeting agent for a radioactive tag as documented almost a decade ago. One limitation is that this radiotracer labeling of metomidate has a 20-minute half life, which means it must be produced on site, thereby making the technology out of reach for locations that can’t set up this capability.
MATCHing imaging against AVS
To test the clinical utility of metomidate-based PET-CT directly against AVS, Dr. Wu and her associates enrolled 143 adults with confirmed PA and hypertension at two centers in London and one in Cambridge, England. The MATCH study cohort averaged 53 years of age; two-thirds were men, 58% were White, and 30% were Black. Their median blood pressure was 147/91 mm Hg, and they were maintained on a median of two antihypertensive drugs.
The researchers assessed every patient with both the imaging method and AVS, performed in random order and blindly scored. They then began each patient on a 1-month regimen with an MRA (usually spironolactone but eplerenone [Inspra] was also an option) to test the responsiveness of each patient’s hypertension to this drug class and to gauge their likely response to adrenalectomy. After the MRA test, the researchers assessed the lateralization tests and determined that 78 patients were appropriate candidates for unilateral adrenalectomy while the remaining 65 patients were not and continued on the MRA regimen. They recommended surgery if patients were clear positives by AVS, by PET-CT imaging, or both.
The study had four primary outcomes to assess the ability of the two diagnostic methods to predict the success of surgery based on four increasingly stringent postsurgical criteria calculated in hierarchical sequence: Partial or complete biochemical success, complete biochemical success, partial or complete clinical success (partial meaning any significant reduction in blood pressure), or complete clinical success (systolic pressure reduced to less than 135 mm Hg). Only one of the 78 patients treated with surgery failed to achieve at least a partial biochemical response.
For each of the four metrics, 11C-metomidate PET-CT produced point estimates of diagnostic accuracy that consistently edged out AVS. While these advantages were not large enough to meet the prespecified threshold for proving superiority, they comfortably showed the noninferiority of this imaging method compared with AVS.
For example, the PET-CT method had 43.6% accuracy for predicting a clinical cure, compared with 39.7% accuracy for AVS. For complete biochemical cure, imaging had 68.8% accuracy, compared with 62.3% for AVS, Dr. Wu reported.
Another notable finding from the study was how strongly a robust blood pressure response to spironolactone predicted the clinical outcome from surgery. Patients whose systolic blood pressure fell below 135 mm Hg on MRA treatment had a nearly 18-fold higher rate of achieving a complete clinical cure following surgery compared with patients who did not have as dramatic a blood pressure response to MRA treatment.
Woefully low rates of PA assessment
But regardless of the success that PET-CT imaging has for identifying surgical candidates, the first step is to identify patients with PA, a diagnosis that’s woefully underperformed worldwide. One example: A separate report at ENDO 2021 retrospectively reviewed nearly 12,000 patients with hypertension and an indication of PA, such as treatment-resistant hypertension or early-onset hypertension, and managed at either of two university outpatient clinics in Michigan during 2010-2019. The report documented that 3% underwent PA assessment.
Diagnosis of patients with PA “is a major problem,” noted Dr. D’Alessio. “I think of PA as an underdiagnosed and undertreated condition, with a huge impact on morbidity and mortality. Any advance in this area is likely to be useful.” But, he added, “I’m dubious whether this [new imaging approach] will increase diagnosis of PA.” What’s needed is “getting more primary care physicians to do more screening” for PA among their patients with hypertension and a suggestion of a PA cause.
“Surgical cures are glamorous, but medical management is also very effective, and we have good, inexpensive drugs to do this,” the MRAs, Dr. D’Alessio said.
The study received no commercial funding. Dr. Wu and her coauthors had no disclosures. Dr. D’Alessio has been a speaker on behalf of Novo Nordisk, a consultant to Intarcia and Lilly, and has received research funding from Lilly and Merck.
A noninvasive imaging method for identifying whether the source of a patient’s primary aldosteronism is from unilateral or bilateral adrenal adenomas worked as well as the standard method, invasive adrenal vein sampling, in a head-to-head comparison with 143 patients.
This noninvasive alternative, which also does not require the substantial technical expertise that AVS demands, should make assessment of adenoma laterality in patients with primary aldosteronism (PA) much more widely available and accessible, predicted Dr. Wu, a researcher at Queen Mary University of London.
“It will allow more places to do this, and I think it will definitely allow more patients to be diagnosed” with PA from a unilateral source. AVS “is a real bottleneck,” she said. “We hope metomidate, or molecular imaging using other selective radiotracers, will enable many more patients to be diagnosed and appropriately managed.” Creating new diagnostic options for patients with PA and potentially increasing the number of these patients who are surgical candidates “is the aim of this study.”
Patients with PA develop a curable form of hypertension if their excess aldosterone can be neutralized with a mineralocorticoid receptor antagonist (MRA), or even more definitively by surgical removal of the adrenal aldosteronoma generating the hormonal excess as long as the adenoma is unilateral. Conventional imaging of the adrenals with CT or MRI has proven unreliable for identifying adrenal nodules noninvasively, which has made the invasive and technically challenging standard option of AVS the only game in town.
But some endocrinologists caution that the results from this one study do not suffice to make 11C-metomidate-based PET-CT imaging a widely used alternative.
‘This is a first step.’
“This study is a first step. It will take lots more data for endocrinologists to buy into a scan over AVS,” commented David A. D’Alessio, MD, professor and chief of the division of endocrinology and metabolism at Duke University in Durham, N.C.
But Dr. D’Alessio also acknowledged the clear benefits from a safe and effective alternative to AVS.
“A reliable, less invasive, and less technical means of lateralizing excess aldosterone production would increase the number of people [with a unilateral PA source] going to surgery. The reality is that, if you are not a patient at the Mayo Clinic . . .or the National Institutes of Health, then AVS is a bit of crap shoot” that is very operator and institution dependent for its accuracy, Dr. D’Alessio said in an interview.
Metomidate specifically binds to key enzymes of the adrenal corticosteroid biosynthetic pathway, making it a precise targeting agent for a radioactive tag as documented almost a decade ago. One limitation is that this radiotracer labeling of metomidate has a 20-minute half life, which means it must be produced on site, thereby making the technology out of reach for locations that can’t set up this capability.
MATCHing imaging against AVS
To test the clinical utility of metomidate-based PET-CT directly against AVS, Dr. Wu and her associates enrolled 143 adults with confirmed PA and hypertension at two centers in London and one in Cambridge, England. The MATCH study cohort averaged 53 years of age; two-thirds were men, 58% were White, and 30% were Black. Their median blood pressure was 147/91 mm Hg, and they were maintained on a median of two antihypertensive drugs.
The researchers assessed every patient with both the imaging method and AVS, performed in random order and blindly scored. They then began each patient on a 1-month regimen with an MRA (usually spironolactone but eplerenone [Inspra] was also an option) to test the responsiveness of each patient’s hypertension to this drug class and to gauge their likely response to adrenalectomy. After the MRA test, the researchers assessed the lateralization tests and determined that 78 patients were appropriate candidates for unilateral adrenalectomy while the remaining 65 patients were not and continued on the MRA regimen. They recommended surgery if patients were clear positives by AVS, by PET-CT imaging, or both.
The study had four primary outcomes to assess the ability of the two diagnostic methods to predict the success of surgery based on four increasingly stringent postsurgical criteria calculated in hierarchical sequence: Partial or complete biochemical success, complete biochemical success, partial or complete clinical success (partial meaning any significant reduction in blood pressure), or complete clinical success (systolic pressure reduced to less than 135 mm Hg). Only one of the 78 patients treated with surgery failed to achieve at least a partial biochemical response.
For each of the four metrics, 11C-metomidate PET-CT produced point estimates of diagnostic accuracy that consistently edged out AVS. While these advantages were not large enough to meet the prespecified threshold for proving superiority, they comfortably showed the noninferiority of this imaging method compared with AVS.
For example, the PET-CT method had 43.6% accuracy for predicting a clinical cure, compared with 39.7% accuracy for AVS. For complete biochemical cure, imaging had 68.8% accuracy, compared with 62.3% for AVS, Dr. Wu reported.
Another notable finding from the study was how strongly a robust blood pressure response to spironolactone predicted the clinical outcome from surgery. Patients whose systolic blood pressure fell below 135 mm Hg on MRA treatment had a nearly 18-fold higher rate of achieving a complete clinical cure following surgery compared with patients who did not have as dramatic a blood pressure response to MRA treatment.
Woefully low rates of PA assessment
But regardless of the success that PET-CT imaging has for identifying surgical candidates, the first step is to identify patients with PA, a diagnosis that’s woefully underperformed worldwide. One example: A separate report at ENDO 2021 retrospectively reviewed nearly 12,000 patients with hypertension and an indication of PA, such as treatment-resistant hypertension or early-onset hypertension, and managed at either of two university outpatient clinics in Michigan during 2010-2019. The report documented that 3% underwent PA assessment.
Diagnosis of patients with PA “is a major problem,” noted Dr. D’Alessio. “I think of PA as an underdiagnosed and undertreated condition, with a huge impact on morbidity and mortality. Any advance in this area is likely to be useful.” But, he added, “I’m dubious whether this [new imaging approach] will increase diagnosis of PA.” What’s needed is “getting more primary care physicians to do more screening” for PA among their patients with hypertension and a suggestion of a PA cause.
“Surgical cures are glamorous, but medical management is also very effective, and we have good, inexpensive drugs to do this,” the MRAs, Dr. D’Alessio said.
The study received no commercial funding. Dr. Wu and her coauthors had no disclosures. Dr. D’Alessio has been a speaker on behalf of Novo Nordisk, a consultant to Intarcia and Lilly, and has received research funding from Lilly and Merck.
FROM ENDO 2021
Delaying surgery didn’t impact survival in early-stage cervical cancer
in the National Cancer Database.
The 5-year overall survival rate was 85.7% among women who had radical hysterectomy and lymphadenectomy within 4 weeks of diagnosis, 86.6% among those who had the same surgery 4-8 weeks after diagnosis, and 89.6% among those who had surgery 8-12 weeks after diagnosis (P = .12).
“For patients with clinical stage I cervical carcinoma undergoing radical hysterectomy, we found no evidence of a detrimental effect of waiting time (up to 12 weeks from diagnosis) on overall survival,” the study investigators reported in a poster at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer.
The investigators looked at the issue of surgical wait times because of surgery delays due to the COVID-19 pandemic, according to investigator Dimitrios Nasioudis, MD, of the University of Pennsylvania in Philadelphia.
“We wanted to see if there was a real impact in the survival of patients,” Dr. Nasioudis said in an interview. He added that “many times, there is a question of when to perform surgery,” especially when patients need medical optimization.
Dr. Nasioudis called the findings “reassuring” and said “waiting up to 3 or 4 months is reasonable.”
Still, the investigators plan to validate the results with more granular patient-level institutional data, he said. Given the limits of the database, there was no information on tumor relapse or cause of death and no central pathology review.
Study details
The study included 4,782 patients who underwent primary radical hysterectomy with lymphadenectomy. Patients had clinical stage I adenocarcinoma, squamous, or adenosquamous carcinoma of the cervix, with no history of another tumor or other cervical surgery.
The median time to surgery was 34 days across the study population. Patients were divided into three groups according to the timing of their surgery:
- Group 1 included 1,823 (38.1%) patients who had surgery less than 4 weeks from diagnosis.
- Group 2 included 2,207 (46.2%) patients who had surgery 4-8 weeks from diagnosis.
- Group 3 included 752 (15.7%) patients who had surgery 8-12 weeks from diagnosis.
Patients in group 1 had a higher rate of positive lymph nodes, compared with patients in groups 2 and 3 (18.4%, 15.6%, and 14.7%, respectively; P = .014). Patients in group 1 also had a higher incidence of lymphovascular space invasion (42.1%, 38.1%, and 33%; P = .007) and a higher rate of positive surgical margins (6.3%, 5.2%, and 3.9%; P = .047).
Group 1 patients “had more aggressive features,” which could explain why they had surgery within a month, Dr. Nasioudis said.
Patients in groups 3 and 2 were more likely to have government insurance, compared with patients in group 1 (35.6%, 31.6%, and 24.6%, respectively P < .001). Group 3 patients were more likely than those in groups 2 and 1 to have comorbidities (14.2%, 11.6%, and 10.5%; P = .29).
However, there were no survival differences between groups in a multivariate analysis controlling for confounders, which included tumor size, histology and extension, status of lymph nodes, receipt of radiotherapy, patient age, insurance, race, and comorbidities. Furthermore, in a stratified analysis based on tumor extent, the timing of surgery had no impact on survival.
Dr. Nasioudis said he suspects access to care was an issue for some women, and there were likely delays for medical optimization.
Access to gynecologic oncology services at the University of Pennsylvania is “pretty easy,” he said, so delays are usually related to medical optimization, but that’s not always the case in underserved areas of the United States.
There was no funding for this study, and the investigators didn’t have any disclosures.
in the National Cancer Database.
The 5-year overall survival rate was 85.7% among women who had radical hysterectomy and lymphadenectomy within 4 weeks of diagnosis, 86.6% among those who had the same surgery 4-8 weeks after diagnosis, and 89.6% among those who had surgery 8-12 weeks after diagnosis (P = .12).
“For patients with clinical stage I cervical carcinoma undergoing radical hysterectomy, we found no evidence of a detrimental effect of waiting time (up to 12 weeks from diagnosis) on overall survival,” the study investigators reported in a poster at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer.
The investigators looked at the issue of surgical wait times because of surgery delays due to the COVID-19 pandemic, according to investigator Dimitrios Nasioudis, MD, of the University of Pennsylvania in Philadelphia.
“We wanted to see if there was a real impact in the survival of patients,” Dr. Nasioudis said in an interview. He added that “many times, there is a question of when to perform surgery,” especially when patients need medical optimization.
Dr. Nasioudis called the findings “reassuring” and said “waiting up to 3 or 4 months is reasonable.”
Still, the investigators plan to validate the results with more granular patient-level institutional data, he said. Given the limits of the database, there was no information on tumor relapse or cause of death and no central pathology review.
Study details
The study included 4,782 patients who underwent primary radical hysterectomy with lymphadenectomy. Patients had clinical stage I adenocarcinoma, squamous, or adenosquamous carcinoma of the cervix, with no history of another tumor or other cervical surgery.
The median time to surgery was 34 days across the study population. Patients were divided into three groups according to the timing of their surgery:
- Group 1 included 1,823 (38.1%) patients who had surgery less than 4 weeks from diagnosis.
- Group 2 included 2,207 (46.2%) patients who had surgery 4-8 weeks from diagnosis.
- Group 3 included 752 (15.7%) patients who had surgery 8-12 weeks from diagnosis.
Patients in group 1 had a higher rate of positive lymph nodes, compared with patients in groups 2 and 3 (18.4%, 15.6%, and 14.7%, respectively; P = .014). Patients in group 1 also had a higher incidence of lymphovascular space invasion (42.1%, 38.1%, and 33%; P = .007) and a higher rate of positive surgical margins (6.3%, 5.2%, and 3.9%; P = .047).
Group 1 patients “had more aggressive features,” which could explain why they had surgery within a month, Dr. Nasioudis said.
Patients in groups 3 and 2 were more likely to have government insurance, compared with patients in group 1 (35.6%, 31.6%, and 24.6%, respectively P < .001). Group 3 patients were more likely than those in groups 2 and 1 to have comorbidities (14.2%, 11.6%, and 10.5%; P = .29).
However, there were no survival differences between groups in a multivariate analysis controlling for confounders, which included tumor size, histology and extension, status of lymph nodes, receipt of radiotherapy, patient age, insurance, race, and comorbidities. Furthermore, in a stratified analysis based on tumor extent, the timing of surgery had no impact on survival.
Dr. Nasioudis said he suspects access to care was an issue for some women, and there were likely delays for medical optimization.
Access to gynecologic oncology services at the University of Pennsylvania is “pretty easy,” he said, so delays are usually related to medical optimization, but that’s not always the case in underserved areas of the United States.
There was no funding for this study, and the investigators didn’t have any disclosures.
in the National Cancer Database.
The 5-year overall survival rate was 85.7% among women who had radical hysterectomy and lymphadenectomy within 4 weeks of diagnosis, 86.6% among those who had the same surgery 4-8 weeks after diagnosis, and 89.6% among those who had surgery 8-12 weeks after diagnosis (P = .12).
“For patients with clinical stage I cervical carcinoma undergoing radical hysterectomy, we found no evidence of a detrimental effect of waiting time (up to 12 weeks from diagnosis) on overall survival,” the study investigators reported in a poster at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer.
The investigators looked at the issue of surgical wait times because of surgery delays due to the COVID-19 pandemic, according to investigator Dimitrios Nasioudis, MD, of the University of Pennsylvania in Philadelphia.
“We wanted to see if there was a real impact in the survival of patients,” Dr. Nasioudis said in an interview. He added that “many times, there is a question of when to perform surgery,” especially when patients need medical optimization.
Dr. Nasioudis called the findings “reassuring” and said “waiting up to 3 or 4 months is reasonable.”
Still, the investigators plan to validate the results with more granular patient-level institutional data, he said. Given the limits of the database, there was no information on tumor relapse or cause of death and no central pathology review.
Study details
The study included 4,782 patients who underwent primary radical hysterectomy with lymphadenectomy. Patients had clinical stage I adenocarcinoma, squamous, or adenosquamous carcinoma of the cervix, with no history of another tumor or other cervical surgery.
The median time to surgery was 34 days across the study population. Patients were divided into three groups according to the timing of their surgery:
- Group 1 included 1,823 (38.1%) patients who had surgery less than 4 weeks from diagnosis.
- Group 2 included 2,207 (46.2%) patients who had surgery 4-8 weeks from diagnosis.
- Group 3 included 752 (15.7%) patients who had surgery 8-12 weeks from diagnosis.
Patients in group 1 had a higher rate of positive lymph nodes, compared with patients in groups 2 and 3 (18.4%, 15.6%, and 14.7%, respectively; P = .014). Patients in group 1 also had a higher incidence of lymphovascular space invasion (42.1%, 38.1%, and 33%; P = .007) and a higher rate of positive surgical margins (6.3%, 5.2%, and 3.9%; P = .047).
Group 1 patients “had more aggressive features,” which could explain why they had surgery within a month, Dr. Nasioudis said.
Patients in groups 3 and 2 were more likely to have government insurance, compared with patients in group 1 (35.6%, 31.6%, and 24.6%, respectively P < .001). Group 3 patients were more likely than those in groups 2 and 1 to have comorbidities (14.2%, 11.6%, and 10.5%; P = .29).
However, there were no survival differences between groups in a multivariate analysis controlling for confounders, which included tumor size, histology and extension, status of lymph nodes, receipt of radiotherapy, patient age, insurance, race, and comorbidities. Furthermore, in a stratified analysis based on tumor extent, the timing of surgery had no impact on survival.
Dr. Nasioudis said he suspects access to care was an issue for some women, and there were likely delays for medical optimization.
Access to gynecologic oncology services at the University of Pennsylvania is “pretty easy,” he said, so delays are usually related to medical optimization, but that’s not always the case in underserved areas of the United States.
There was no funding for this study, and the investigators didn’t have any disclosures.
FROM SGO 2021
Rucaparib extends PFS in BRCA-mutated ovarian cancer, with an exception
Investigator-assessed PFS in both an intention-to-treat (ITT) analysis and an efficacy analysis that excluded patients with BRCA reversion mutations was 7.4 months in the rucaparib arm, compared with 5.7 months in patients who received either platinum-based chemotherapy or weekly paclitaxel.
Among the 23 patients with BRCA reversion mutations, however, investigator-assessed PFS was 2.9 months with rucaparib and 5.5 months with chemotherapy.
Overall survival data were not mature at the time of data cutoff in September 2020.
“Although the numbers are very small, the results suggest that presence of a BRCA reversion mutation may predict a reduced benefit from rucaparib,” said Rebecca Kristeleit, MBChB, PhD, of Guy’s and St. Thomas’ NHS Foundation Trust in London.
She presented the findings from ARIEL4 at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 11479).
Invited discussant Ursula Matulonis, MD, of the Dana-Farber Cancer Institute in Boston, commented that the “BRCA reversion mutation data from ARIEL4 is intriguing. Strategies to overcome and better understand this type of resistance mechanism are needed.”
Study rationale and details
Rucaparib is approved as monotherapy for patients with BRCA-mutated, relapsed ovarian cancer who have received at least two prior lines of platinum-based chemotherapy. The approval was based on results of two phase 1/2 studies. ARIEL4 is a phase 3 confirmatory study, designed in consultation with both the U.S. Food and Drug Administration and the European Medicines Agency.
Women with relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer with deleterious germline or somatic BRCA mutations were eligible for enrollment in ARIEL4. The patients had to have received at least two lines of chemotherapy, including at least one platinum-based regimen, with no prior PARP inhibitor or single-agent paclitaxel treatment.
Overall, 95% of patients had epithelial ovarian cancer, 3% had fallopian tube cancer, and 2% had primary peritoneal cancer. About 90% of cancers were serous in histology. Most patients (84%) had germline BRCA mutations, 16% had somatic mutations, and the status was unknown in the remaining patients.
Patients were randomized on a 2:1 basis to receive rucaparib at 600 mg twice daily (n = 233) or chemotherapy (n = 116), stratified by platinum sensitivity status. Patients assigned to chemotherapy whose disease was considered platinum resistant or partially platinum sensitive were assigned to weekly paclitaxel. Patients with fully platinum-sensitive disease were assigned to platinum-based single-agent or doublet chemotherapy. Treatment cycles were 28 days.
On radiologically confirmed disease progression or unacceptable toxicity, patients assigned to chemotherapy had the option to cross over to the rucaparib arm. The follow-up portion of the study began 28 days after the last treatment dose, with visits every 8 weeks thereafter.
Baseline characteristics in the ITT population were similar between arms. There were 13 patients in the rucaparib arm and 10 in the chemotherapy arm who had BRCA reversion mutations and were excluded from the efficacy population.
Efficacy and safety
Investigator-assessed PFS in the efficacy population was a median of 7.4 months with rucaparib and 5.7 months with chemotherapy, translating to a hazard ratio (HR) of 0.64 (P = .001). In the ITT population, the respective median PFS intervals were identical, although with a slightly less favorable HR of 0.67 (P = .002). In the 23 patients with BRCA reversion mutations, the median PFS was worse with rucaparib, at 2.9 months, compared with 5.5 months for chemotherapy. This translated to a HR of 2.77, although the 95% confidence interval was wide and crossed 1, likely due to the small sample size.
Among patients who had measurable disease at baseline, the overall response rate in the efficacy population was 40.3% with rucaparib and 32.3% with chemotherapy, a difference that was not statistically significant (P = .13). The overall response data were similar in the ITT population (37.9% and 30.2%, respectively).
In the efficacy population, the duration of response was significantly longer in the rucaparib arm, at a median of 9.4 months versus 7.2 months (HR, 0.59; 95% CI, 0.36-0.98). The respective median response durations were identical in the ITT population, but the HR was 0.56 (95% CI, 0.34-0.93).
In both the efficacy and ITT populations, global health status was virtually identical and unchanged from baseline in both treatment arms through cycle 7.
Treatment-emergent adverse events (TEAEs) were more frequent with rucaparib. The most common TEAEs in the rucaparib and chemotherapy arms, respectively, were anemia/decreased hemoglobin (53.9% and 31.9%), nausea (53.4% and 31.9%), asthenia/fatigue (49.6% and 44.2%), ALT/AST increase (34.5% and 11.5%), and vomiting (34.1% and 16.8%).
In all, 8.2% of patients in the rucaparib arm and 12.4% of those in the chemotherapy arm discontinued therapy due to TEAEs.
Four patients in the rucaparib arm developed myelodysplastic syndrome or acute myeloid leukemia – one during treatment and three during follow-up. There were no cases of myelodysplastic syndrome or acute myeloid leukemia in patients who received chemotherapy.
“Data from ARIEL4 fits the paradigm that single-agent activity of PARP inhibitors in BRCA-mutated, recurrent ovarian cancer may be comparable to chemotherapy, and may, at times, be superior, depending on the study population, trial design, and treatment for control patients,” Dr. Matulonis said.
The study was funded by Clovis Oncology. Dr. Kristeleit disclosed relationships with Clovis, Roche, and Tesaro. Dr. Matulonis disclosed relationships with Novartis, Merck, and Immunogen.
Investigator-assessed PFS in both an intention-to-treat (ITT) analysis and an efficacy analysis that excluded patients with BRCA reversion mutations was 7.4 months in the rucaparib arm, compared with 5.7 months in patients who received either platinum-based chemotherapy or weekly paclitaxel.
Among the 23 patients with BRCA reversion mutations, however, investigator-assessed PFS was 2.9 months with rucaparib and 5.5 months with chemotherapy.
Overall survival data were not mature at the time of data cutoff in September 2020.
“Although the numbers are very small, the results suggest that presence of a BRCA reversion mutation may predict a reduced benefit from rucaparib,” said Rebecca Kristeleit, MBChB, PhD, of Guy’s and St. Thomas’ NHS Foundation Trust in London.
She presented the findings from ARIEL4 at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 11479).
Invited discussant Ursula Matulonis, MD, of the Dana-Farber Cancer Institute in Boston, commented that the “BRCA reversion mutation data from ARIEL4 is intriguing. Strategies to overcome and better understand this type of resistance mechanism are needed.”
Study rationale and details
Rucaparib is approved as monotherapy for patients with BRCA-mutated, relapsed ovarian cancer who have received at least two prior lines of platinum-based chemotherapy. The approval was based on results of two phase 1/2 studies. ARIEL4 is a phase 3 confirmatory study, designed in consultation with both the U.S. Food and Drug Administration and the European Medicines Agency.
Women with relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer with deleterious germline or somatic BRCA mutations were eligible for enrollment in ARIEL4. The patients had to have received at least two lines of chemotherapy, including at least one platinum-based regimen, with no prior PARP inhibitor or single-agent paclitaxel treatment.
Overall, 95% of patients had epithelial ovarian cancer, 3% had fallopian tube cancer, and 2% had primary peritoneal cancer. About 90% of cancers were serous in histology. Most patients (84%) had germline BRCA mutations, 16% had somatic mutations, and the status was unknown in the remaining patients.
Patients were randomized on a 2:1 basis to receive rucaparib at 600 mg twice daily (n = 233) or chemotherapy (n = 116), stratified by platinum sensitivity status. Patients assigned to chemotherapy whose disease was considered platinum resistant or partially platinum sensitive were assigned to weekly paclitaxel. Patients with fully platinum-sensitive disease were assigned to platinum-based single-agent or doublet chemotherapy. Treatment cycles were 28 days.
On radiologically confirmed disease progression or unacceptable toxicity, patients assigned to chemotherapy had the option to cross over to the rucaparib arm. The follow-up portion of the study began 28 days after the last treatment dose, with visits every 8 weeks thereafter.
Baseline characteristics in the ITT population were similar between arms. There were 13 patients in the rucaparib arm and 10 in the chemotherapy arm who had BRCA reversion mutations and were excluded from the efficacy population.
Efficacy and safety
Investigator-assessed PFS in the efficacy population was a median of 7.4 months with rucaparib and 5.7 months with chemotherapy, translating to a hazard ratio (HR) of 0.64 (P = .001). In the ITT population, the respective median PFS intervals were identical, although with a slightly less favorable HR of 0.67 (P = .002). In the 23 patients with BRCA reversion mutations, the median PFS was worse with rucaparib, at 2.9 months, compared with 5.5 months for chemotherapy. This translated to a HR of 2.77, although the 95% confidence interval was wide and crossed 1, likely due to the small sample size.
Among patients who had measurable disease at baseline, the overall response rate in the efficacy population was 40.3% with rucaparib and 32.3% with chemotherapy, a difference that was not statistically significant (P = .13). The overall response data were similar in the ITT population (37.9% and 30.2%, respectively).
In the efficacy population, the duration of response was significantly longer in the rucaparib arm, at a median of 9.4 months versus 7.2 months (HR, 0.59; 95% CI, 0.36-0.98). The respective median response durations were identical in the ITT population, but the HR was 0.56 (95% CI, 0.34-0.93).
In both the efficacy and ITT populations, global health status was virtually identical and unchanged from baseline in both treatment arms through cycle 7.
Treatment-emergent adverse events (TEAEs) were more frequent with rucaparib. The most common TEAEs in the rucaparib and chemotherapy arms, respectively, were anemia/decreased hemoglobin (53.9% and 31.9%), nausea (53.4% and 31.9%), asthenia/fatigue (49.6% and 44.2%), ALT/AST increase (34.5% and 11.5%), and vomiting (34.1% and 16.8%).
In all, 8.2% of patients in the rucaparib arm and 12.4% of those in the chemotherapy arm discontinued therapy due to TEAEs.
Four patients in the rucaparib arm developed myelodysplastic syndrome or acute myeloid leukemia – one during treatment and three during follow-up. There were no cases of myelodysplastic syndrome or acute myeloid leukemia in patients who received chemotherapy.
“Data from ARIEL4 fits the paradigm that single-agent activity of PARP inhibitors in BRCA-mutated, recurrent ovarian cancer may be comparable to chemotherapy, and may, at times, be superior, depending on the study population, trial design, and treatment for control patients,” Dr. Matulonis said.
The study was funded by Clovis Oncology. Dr. Kristeleit disclosed relationships with Clovis, Roche, and Tesaro. Dr. Matulonis disclosed relationships with Novartis, Merck, and Immunogen.
Investigator-assessed PFS in both an intention-to-treat (ITT) analysis and an efficacy analysis that excluded patients with BRCA reversion mutations was 7.4 months in the rucaparib arm, compared with 5.7 months in patients who received either platinum-based chemotherapy or weekly paclitaxel.
Among the 23 patients with BRCA reversion mutations, however, investigator-assessed PFS was 2.9 months with rucaparib and 5.5 months with chemotherapy.
Overall survival data were not mature at the time of data cutoff in September 2020.
“Although the numbers are very small, the results suggest that presence of a BRCA reversion mutation may predict a reduced benefit from rucaparib,” said Rebecca Kristeleit, MBChB, PhD, of Guy’s and St. Thomas’ NHS Foundation Trust in London.
She presented the findings from ARIEL4 at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 11479).
Invited discussant Ursula Matulonis, MD, of the Dana-Farber Cancer Institute in Boston, commented that the “BRCA reversion mutation data from ARIEL4 is intriguing. Strategies to overcome and better understand this type of resistance mechanism are needed.”
Study rationale and details
Rucaparib is approved as monotherapy for patients with BRCA-mutated, relapsed ovarian cancer who have received at least two prior lines of platinum-based chemotherapy. The approval was based on results of two phase 1/2 studies. ARIEL4 is a phase 3 confirmatory study, designed in consultation with both the U.S. Food and Drug Administration and the European Medicines Agency.
Women with relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer with deleterious germline or somatic BRCA mutations were eligible for enrollment in ARIEL4. The patients had to have received at least two lines of chemotherapy, including at least one platinum-based regimen, with no prior PARP inhibitor or single-agent paclitaxel treatment.
Overall, 95% of patients had epithelial ovarian cancer, 3% had fallopian tube cancer, and 2% had primary peritoneal cancer. About 90% of cancers were serous in histology. Most patients (84%) had germline BRCA mutations, 16% had somatic mutations, and the status was unknown in the remaining patients.
Patients were randomized on a 2:1 basis to receive rucaparib at 600 mg twice daily (n = 233) or chemotherapy (n = 116), stratified by platinum sensitivity status. Patients assigned to chemotherapy whose disease was considered platinum resistant or partially platinum sensitive were assigned to weekly paclitaxel. Patients with fully platinum-sensitive disease were assigned to platinum-based single-agent or doublet chemotherapy. Treatment cycles were 28 days.
On radiologically confirmed disease progression or unacceptable toxicity, patients assigned to chemotherapy had the option to cross over to the rucaparib arm. The follow-up portion of the study began 28 days after the last treatment dose, with visits every 8 weeks thereafter.
Baseline characteristics in the ITT population were similar between arms. There were 13 patients in the rucaparib arm and 10 in the chemotherapy arm who had BRCA reversion mutations and were excluded from the efficacy population.
Efficacy and safety
Investigator-assessed PFS in the efficacy population was a median of 7.4 months with rucaparib and 5.7 months with chemotherapy, translating to a hazard ratio (HR) of 0.64 (P = .001). In the ITT population, the respective median PFS intervals were identical, although with a slightly less favorable HR of 0.67 (P = .002). In the 23 patients with BRCA reversion mutations, the median PFS was worse with rucaparib, at 2.9 months, compared with 5.5 months for chemotherapy. This translated to a HR of 2.77, although the 95% confidence interval was wide and crossed 1, likely due to the small sample size.
Among patients who had measurable disease at baseline, the overall response rate in the efficacy population was 40.3% with rucaparib and 32.3% with chemotherapy, a difference that was not statistically significant (P = .13). The overall response data were similar in the ITT population (37.9% and 30.2%, respectively).
In the efficacy population, the duration of response was significantly longer in the rucaparib arm, at a median of 9.4 months versus 7.2 months (HR, 0.59; 95% CI, 0.36-0.98). The respective median response durations were identical in the ITT population, but the HR was 0.56 (95% CI, 0.34-0.93).
In both the efficacy and ITT populations, global health status was virtually identical and unchanged from baseline in both treatment arms through cycle 7.
Treatment-emergent adverse events (TEAEs) were more frequent with rucaparib. The most common TEAEs in the rucaparib and chemotherapy arms, respectively, were anemia/decreased hemoglobin (53.9% and 31.9%), nausea (53.4% and 31.9%), asthenia/fatigue (49.6% and 44.2%), ALT/AST increase (34.5% and 11.5%), and vomiting (34.1% and 16.8%).
In all, 8.2% of patients in the rucaparib arm and 12.4% of those in the chemotherapy arm discontinued therapy due to TEAEs.
Four patients in the rucaparib arm developed myelodysplastic syndrome or acute myeloid leukemia – one during treatment and three during follow-up. There were no cases of myelodysplastic syndrome or acute myeloid leukemia in patients who received chemotherapy.
“Data from ARIEL4 fits the paradigm that single-agent activity of PARP inhibitors in BRCA-mutated, recurrent ovarian cancer may be comparable to chemotherapy, and may, at times, be superior, depending on the study population, trial design, and treatment for control patients,” Dr. Matulonis said.
The study was funded by Clovis Oncology. Dr. Kristeleit disclosed relationships with Clovis, Roche, and Tesaro. Dr. Matulonis disclosed relationships with Novartis, Merck, and Immunogen.
FROM SGO 2021
‘Reassuring’ data on COVID-19 vaccines in pregnancy
Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.
More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.
“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.
Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.
The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).
“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”
The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”
By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”
Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.
Analyzing surveillance data
To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).
The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.
At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.
Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.
Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.
The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.
Rates of outcomes “of interest” were no higher among these women than in the general population. 
In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”
Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.
Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.
“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.
The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”
Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.
Vaccination could benefit infants
In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.
“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”
Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.
Dr. Shimabukuro has reported no relevant financial relationships.
Lindsay Kalter contributed to the reporting for this story.
A version of this article first appeared on Medscape.com.
Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.
More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.
“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.
Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.
The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).
“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”
The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”
By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”
Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.
Analyzing surveillance data
To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).
The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.
At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.
Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.
Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.
The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.
Rates of outcomes “of interest” were no higher among these women than in the general population.
In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”
Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.
Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.
“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.
The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”
Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.
Vaccination could benefit infants
In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.
“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”
Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.
Dr. Shimabukuro has reported no relevant financial relationships.
Lindsay Kalter contributed to the reporting for this story.
A version of this article first appeared on Medscape.com.
Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.
More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.
“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.
Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.
The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).
“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”
The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”
By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”
Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.
Analyzing surveillance data
To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).
The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.
At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.
Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.
Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.
The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.
Rates of outcomes “of interest” were no higher among these women than in the general population.
In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”
Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.
Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.
“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.
The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”
Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.
Vaccination could benefit infants
In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.
“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”
Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.
Dr. Shimabukuro has reported no relevant financial relationships.
Lindsay Kalter contributed to the reporting for this story.
A version of this article first appeared on Medscape.com.
Most breast cancer screening centers not following guidelines
, say researchers reporting on a new analysis.
They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.
This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.
The new analysis was published online in JAMA Internal Medicine.
This may be doing “more harm than good,” warn the authors of an accompanying editorial.
“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.
“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.
“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.
The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.
The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.
The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.
One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.
In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.
“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.
“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.
Details of the analysis
The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.
They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.
Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.
A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.
The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.
Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, say researchers reporting on a new analysis.
They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.
This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.
The new analysis was published online in JAMA Internal Medicine.
This may be doing “more harm than good,” warn the authors of an accompanying editorial.
“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.
“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.
“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.
The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.
The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.
The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.
One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.
In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.
“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.
“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.
Details of the analysis
The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.
They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.
Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.
A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.
The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.
Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, say researchers reporting on a new analysis.
They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.
This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.
The new analysis was published online in JAMA Internal Medicine.
This may be doing “more harm than good,” warn the authors of an accompanying editorial.
“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.
“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.
“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.
The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.
The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.
The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.
One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.
In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.
“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.
“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.
Details of the analysis
The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.
They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.
Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.
A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.
The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.
Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
When to not go with your gut: Modern approaches to abdominal wall pain
Abdominal pain is a commonly seen presenting concern in gastroenterology clinics. Establishing a diagnosis effectively and efficiently can be challenging given the broad differential. Abdominal wall pain is an often-overlooked diagnosis but accounts for up to 30% of cases of chronic abdominal pain1 and up to 10% of patients with chronic idiopathic abdominal pain seen in gastroenterology practices.2 Trigger point injection in the office can be both diagnostic and therapeutic.
The prevalence of chronic abdominal wall pain is highest in the fifth and sixth decades, and it is four times more likely to occur in women than in men. Common comorbid conditions include obesity, gastroesophageal reflux disease, irritable bowel syndrome, and fibromyalgia.3 Abdominal wall pain is often sharp or burning due to somatic innervation of the abdominal wall supplied by the anterior branches of thoracic intercostal nerves (T7 to T11). Abdominal wall pain may originate from entrapment of these nerves.2 Potential causes of entrapment include disruption of insulating fat, localized edema and distension, and scar tissue or fibrosis from prior surgical procedures.3 Symptoms are typically exacerbated with any actions or activities that engage the abdominal wall such as twisting or turning, and pain often improves with rest.
The classic physical exam finding for abdominal wall pain is a positive Carnett sign. This is determined via palpation of the point of maximal tenderness. First, this is done with a single finger while the patient’s abdominal wall is relaxed. The same point is then palpated again while the patient engages their abdominal muscles, most commonly while the patient to performs a “sit up” or lifts their legs off the exam table. Exacerbation of pain with these maneuvers indicates a positive test and suggests the abdominal wall as the underlying etiology.
While performing the maneuver for determining Carnett sign is a simple test in the traditional office visit, the COVID-19 pandemic has led to a burgeoning proportion of telehealth visits, limiting the physician’s ability to perform a direct physical exam. Fortunately, the maneuvers required when testing for Carnett sign are simple enough that a clinician can guide a patient step-by-step on how to perform the test. Ideally, if a family member or friend is available to serve as the clinician’s hands, the test can be performed with ease while directly visualizing proper technique. Sample videos of how the test is performed are readily available on the Internet for patients to view (the authors suggest screening the video yourself before providing a link to patients). The sensitivity and specificity of Carnett sign are very high (>70%) and even better when there is no apparent hernia.1
Management
Trigger point injections with local anesthetic can be both diagnostic and therapeutic in patients with abdominal wall pain. An immediate reduction of pain by at least 50% with injection at the site of maximal tenderness strongly supports the diagnosis of abdominal wall pain.1 Patients should first be thoroughly counseled on potential side effects of local corticosteroid injection to include risk of infection, bleeding, pain, skin hypopigmentation, or thinning and fat atrophy. Repeat injections are rarely needed, and any additional injection should be performed after at least 3 months. Additional adjunct therapies include nonsteroidal anti-inflammatory medications, topical therapies such as lidocaine, and neuroleptic agents such as gabapentin.4 One previously described trigger point injection technique, involves a mix of triamcinolone and lidocaine injected at the point of maximal tenderness.5 This technique is easy to perform in clinic and has minimal risks.
Conclusion
Abdominal wall pain is a common, yet often-overlooked, condition that can be diagnosed with a good clinical history and physical exam. A simple in-office trigger point injection can confirm the diagnosis and offer durable relief for most patients. A shift to virtual medicine does not need to a barrier to diagnosis, particularly in the attentive patient.
Dr. Park is a fellow in the gastroenterology service in the Department of Internal Medicine at Naval Medical Center San Diego and an assistant professor in the department of medicine of the Uniformed Services University in Bethesda, Md. Dr. Singla is a gastroenterologist at Capital Digestive Care in Silver Spring, Md., and an associate professor in the department of medicine at the Uniformed Services University. The authors have no conflicts of interest.
References
1. Glissen Brown JR et al. J Clin Gastroenterol. 2016;50(10):828-35.
2. Srinivasan R, Greenbaum DS. Am J Gastroenterol. 2002;97(4):824-30.
3. Kambox AK et al. Mayo Clin Proc. 2019;94(1):139-44.
4. Scheltinga MR, Roumen RM. Hernia. 2018;22(3):507-16.
5. Singla M, Laczek JT. Am J Gastroenterol. 2020 May;115(5):645-7.
Abdominal pain is a commonly seen presenting concern in gastroenterology clinics. Establishing a diagnosis effectively and efficiently can be challenging given the broad differential. Abdominal wall pain is an often-overlooked diagnosis but accounts for up to 30% of cases of chronic abdominal pain1 and up to 10% of patients with chronic idiopathic abdominal pain seen in gastroenterology practices.2 Trigger point injection in the office can be both diagnostic and therapeutic.
The prevalence of chronic abdominal wall pain is highest in the fifth and sixth decades, and it is four times more likely to occur in women than in men. Common comorbid conditions include obesity, gastroesophageal reflux disease, irritable bowel syndrome, and fibromyalgia.3 Abdominal wall pain is often sharp or burning due to somatic innervation of the abdominal wall supplied by the anterior branches of thoracic intercostal nerves (T7 to T11). Abdominal wall pain may originate from entrapment of these nerves.2 Potential causes of entrapment include disruption of insulating fat, localized edema and distension, and scar tissue or fibrosis from prior surgical procedures.3 Symptoms are typically exacerbated with any actions or activities that engage the abdominal wall such as twisting or turning, and pain often improves with rest.
The classic physical exam finding for abdominal wall pain is a positive Carnett sign. This is determined via palpation of the point of maximal tenderness. First, this is done with a single finger while the patient’s abdominal wall is relaxed. The same point is then palpated again while the patient engages their abdominal muscles, most commonly while the patient to performs a “sit up” or lifts their legs off the exam table. Exacerbation of pain with these maneuvers indicates a positive test and suggests the abdominal wall as the underlying etiology.
While performing the maneuver for determining Carnett sign is a simple test in the traditional office visit, the COVID-19 pandemic has led to a burgeoning proportion of telehealth visits, limiting the physician’s ability to perform a direct physical exam. Fortunately, the maneuvers required when testing for Carnett sign are simple enough that a clinician can guide a patient step-by-step on how to perform the test. Ideally, if a family member or friend is available to serve as the clinician’s hands, the test can be performed with ease while directly visualizing proper technique. Sample videos of how the test is performed are readily available on the Internet for patients to view (the authors suggest screening the video yourself before providing a link to patients). The sensitivity and specificity of Carnett sign are very high (>70%) and even better when there is no apparent hernia.1
Management
Trigger point injections with local anesthetic can be both diagnostic and therapeutic in patients with abdominal wall pain. An immediate reduction of pain by at least 50% with injection at the site of maximal tenderness strongly supports the diagnosis of abdominal wall pain.1 Patients should first be thoroughly counseled on potential side effects of local corticosteroid injection to include risk of infection, bleeding, pain, skin hypopigmentation, or thinning and fat atrophy. Repeat injections are rarely needed, and any additional injection should be performed after at least 3 months. Additional adjunct therapies include nonsteroidal anti-inflammatory medications, topical therapies such as lidocaine, and neuroleptic agents such as gabapentin.4 One previously described trigger point injection technique, involves a mix of triamcinolone and lidocaine injected at the point of maximal tenderness.5 This technique is easy to perform in clinic and has minimal risks.
Conclusion
Abdominal wall pain is a common, yet often-overlooked, condition that can be diagnosed with a good clinical history and physical exam. A simple in-office trigger point injection can confirm the diagnosis and offer durable relief for most patients. A shift to virtual medicine does not need to a barrier to diagnosis, particularly in the attentive patient.
Dr. Park is a fellow in the gastroenterology service in the Department of Internal Medicine at Naval Medical Center San Diego and an assistant professor in the department of medicine of the Uniformed Services University in Bethesda, Md. Dr. Singla is a gastroenterologist at Capital Digestive Care in Silver Spring, Md., and an associate professor in the department of medicine at the Uniformed Services University. The authors have no conflicts of interest.
References
1. Glissen Brown JR et al. J Clin Gastroenterol. 2016;50(10):828-35.
2. Srinivasan R, Greenbaum DS. Am J Gastroenterol. 2002;97(4):824-30.
3. Kambox AK et al. Mayo Clin Proc. 2019;94(1):139-44.
4. Scheltinga MR, Roumen RM. Hernia. 2018;22(3):507-16.
5. Singla M, Laczek JT. Am J Gastroenterol. 2020 May;115(5):645-7.
Abdominal pain is a commonly seen presenting concern in gastroenterology clinics. Establishing a diagnosis effectively and efficiently can be challenging given the broad differential. Abdominal wall pain is an often-overlooked diagnosis but accounts for up to 30% of cases of chronic abdominal pain1 and up to 10% of patients with chronic idiopathic abdominal pain seen in gastroenterology practices.2 Trigger point injection in the office can be both diagnostic and therapeutic.
The prevalence of chronic abdominal wall pain is highest in the fifth and sixth decades, and it is four times more likely to occur in women than in men. Common comorbid conditions include obesity, gastroesophageal reflux disease, irritable bowel syndrome, and fibromyalgia.3 Abdominal wall pain is often sharp or burning due to somatic innervation of the abdominal wall supplied by the anterior branches of thoracic intercostal nerves (T7 to T11). Abdominal wall pain may originate from entrapment of these nerves.2 Potential causes of entrapment include disruption of insulating fat, localized edema and distension, and scar tissue or fibrosis from prior surgical procedures.3 Symptoms are typically exacerbated with any actions or activities that engage the abdominal wall such as twisting or turning, and pain often improves with rest.
The classic physical exam finding for abdominal wall pain is a positive Carnett sign. This is determined via palpation of the point of maximal tenderness. First, this is done with a single finger while the patient’s abdominal wall is relaxed. The same point is then palpated again while the patient engages their abdominal muscles, most commonly while the patient to performs a “sit up” or lifts their legs off the exam table. Exacerbation of pain with these maneuvers indicates a positive test and suggests the abdominal wall as the underlying etiology.
While performing the maneuver for determining Carnett sign is a simple test in the traditional office visit, the COVID-19 pandemic has led to a burgeoning proportion of telehealth visits, limiting the physician’s ability to perform a direct physical exam. Fortunately, the maneuvers required when testing for Carnett sign are simple enough that a clinician can guide a patient step-by-step on how to perform the test. Ideally, if a family member or friend is available to serve as the clinician’s hands, the test can be performed with ease while directly visualizing proper technique. Sample videos of how the test is performed are readily available on the Internet for patients to view (the authors suggest screening the video yourself before providing a link to patients). The sensitivity and specificity of Carnett sign are very high (>70%) and even better when there is no apparent hernia.1
Management
Trigger point injections with local anesthetic can be both diagnostic and therapeutic in patients with abdominal wall pain. An immediate reduction of pain by at least 50% with injection at the site of maximal tenderness strongly supports the diagnosis of abdominal wall pain.1 Patients should first be thoroughly counseled on potential side effects of local corticosteroid injection to include risk of infection, bleeding, pain, skin hypopigmentation, or thinning and fat atrophy. Repeat injections are rarely needed, and any additional injection should be performed after at least 3 months. Additional adjunct therapies include nonsteroidal anti-inflammatory medications, topical therapies such as lidocaine, and neuroleptic agents such as gabapentin.4 One previously described trigger point injection technique, involves a mix of triamcinolone and lidocaine injected at the point of maximal tenderness.5 This technique is easy to perform in clinic and has minimal risks.
Conclusion
Abdominal wall pain is a common, yet often-overlooked, condition that can be diagnosed with a good clinical history and physical exam. A simple in-office trigger point injection can confirm the diagnosis and offer durable relief for most patients. A shift to virtual medicine does not need to a barrier to diagnosis, particularly in the attentive patient.
Dr. Park is a fellow in the gastroenterology service in the Department of Internal Medicine at Naval Medical Center San Diego and an assistant professor in the department of medicine of the Uniformed Services University in Bethesda, Md. Dr. Singla is a gastroenterologist at Capital Digestive Care in Silver Spring, Md., and an associate professor in the department of medicine at the Uniformed Services University. The authors have no conflicts of interest.
References
1. Glissen Brown JR et al. J Clin Gastroenterol. 2016;50(10):828-35.
2. Srinivasan R, Greenbaum DS. Am J Gastroenterol. 2002;97(4):824-30.
3. Kambox AK et al. Mayo Clin Proc. 2019;94(1):139-44.
4. Scheltinga MR, Roumen RM. Hernia. 2018;22(3):507-16.
5. Singla M, Laczek JT. Am J Gastroenterol. 2020 May;115(5):645-7.
Advocating in a pandemic: A fellow’s perspective on AGA Advocacy Day
Gastroenterology fellowship is an exercise in balance. You are learning your way around different parts of the gastrointestinal tract, both cerebrally and anatomically. You are continuously taking care of patients, in the hospital and in the clinic. You attend all kinds of conferences, didactics, and webinars. And though the hours are long, the work is worth seeing a smile from even one patient for whom you have made a tangible difference in health care. Though these moments are priceless, how often they happen is often limited by access to care, health care disparities, and systemic injustice. Fighting for each one of our patients and their health is difficult for even the most seasoned physician. Training during the middle of a pandemic has brought health care disparities to the forefront; delays in colorectal cancer screening and postponements of nonurgent procedures will have downstream impacts. It was with these thoughts in mind that I decided to participate in AGA (American Gastroenterological Association) Advocacy Day in September 2020 as a gastroenterology fellow.
After close to 20 years of in-person Advocacy Days, the AGA decided to take its advocacy efforts to a virtual platform in the fall of 2020. The country remained in the throes of the worst pandemic it had seen in over a century, and social distancing efforts necessitated a different venue than previous years. This year’s online platform was designed to let individuals involved in gastroenterology health care join each other and discuss policies germane to our patients and our profession.
I have to confess that I did not have significant legislative experience, and I signed up for the virtual Advocacy Day with a sense of slight trepidation. Would I be prepared to talk to experts in the field? What did I know about health care policy on the granular level? How could I get across my message cogently and successfully? All I really knew was that I wanted to get engaged with a group of gastroenterologists early on in my career who were not only vociferous advocates for their patients at the bedside, but who were also able to actively support policy changes that would bring about systemic change.
As it turned out, I had nothing to worry about. This advocacy experience was designed for gastroenterology clinical providers to be able to talk intelligently about topics they knew well – research funding, colonoscopy costs, and different levels of therapy for patients with inflammatory bowel disease, among others. To provide an overview of public policy issues, the AGA prepared a legislative briefing book that allowed us to take a deep dive into these topics. I remember reviewing the issue briefs in detail, understanding that I did not need to be an expert but that familiarity with the issues would be a key component of having a successful meeting. I also completed an online advocacy training module that gave me insight into how and why I could advocate for my profession as a future gastroenterologist. Based on our congressional district and state, we were divided into groups of congressional advocates who would speak to specific congressional staff members. During our meetings, we had legislative staff available to help us navigate the finer points of public policy. Each member of my group chose a topic that was personally relevant to them. Throughout our sessions, we shared personal stories, dove in and out of virtual meeting rooms, and made sure we were clear in what we were advocating for.
As a second-year gastroenterology fellow working at the National Institutes of Health, I chose to focus on digestive diseases research funding for the research community. I talked to the congressional staff members about a patient I had seen earlier that year. He was a man in his mid-30s who was diagnosed with hepatitis C more than 10 years ago and was told, at the time of his diagnosis, that there were no good treatments for him. He had resigned himself to that fact until I saw him in my office and spoke to him about the remarkable advances in liver disease treatment that were made over the past few years. I talked to him about how Hepatitis C was a disease that could now be cured – the relief on his face was clear and only reaffirmed in me the understanding that research in digestive diseases has improved the health of our nation’s population through sustained research efforts in gastrointestinal cancers and other life-altering illnesses.
So what did I take away from this adventure in advocacy? Our role as gastroenterologists can go beyond treating one patient in one office in one hospital system at a time. We can effect change by addressing policies that we know are hurting our patients and their health. The learning curve is made much easier under the excellence of the AGA advocacy staff, who takes the time to gather resources and educate us on the specifics of relevant legislative policies, as well as of the congressional members with whom we are speaking. Our advice was sought after because, after years of training, we were the experts in this field. I was proud to have joined this grassroots network of engaged members to speak to our lawmakers. I can only imagine, in the years to come, how wonderful it would be to do this in person in our nation’s capital.
Dr. Asif is a gastroenterology fellow working with the University of Maryland and National Institutes of Health. He has no conflicts of interest to disclose.
Gastroenterology fellowship is an exercise in balance. You are learning your way around different parts of the gastrointestinal tract, both cerebrally and anatomically. You are continuously taking care of patients, in the hospital and in the clinic. You attend all kinds of conferences, didactics, and webinars. And though the hours are long, the work is worth seeing a smile from even one patient for whom you have made a tangible difference in health care. Though these moments are priceless, how often they happen is often limited by access to care, health care disparities, and systemic injustice. Fighting for each one of our patients and their health is difficult for even the most seasoned physician. Training during the middle of a pandemic has brought health care disparities to the forefront; delays in colorectal cancer screening and postponements of nonurgent procedures will have downstream impacts. It was with these thoughts in mind that I decided to participate in AGA (American Gastroenterological Association) Advocacy Day in September 2020 as a gastroenterology fellow.
After close to 20 years of in-person Advocacy Days, the AGA decided to take its advocacy efforts to a virtual platform in the fall of 2020. The country remained in the throes of the worst pandemic it had seen in over a century, and social distancing efforts necessitated a different venue than previous years. This year’s online platform was designed to let individuals involved in gastroenterology health care join each other and discuss policies germane to our patients and our profession.
I have to confess that I did not have significant legislative experience, and I signed up for the virtual Advocacy Day with a sense of slight trepidation. Would I be prepared to talk to experts in the field? What did I know about health care policy on the granular level? How could I get across my message cogently and successfully? All I really knew was that I wanted to get engaged with a group of gastroenterologists early on in my career who were not only vociferous advocates for their patients at the bedside, but who were also able to actively support policy changes that would bring about systemic change.
As it turned out, I had nothing to worry about. This advocacy experience was designed for gastroenterology clinical providers to be able to talk intelligently about topics they knew well – research funding, colonoscopy costs, and different levels of therapy for patients with inflammatory bowel disease, among others. To provide an overview of public policy issues, the AGA prepared a legislative briefing book that allowed us to take a deep dive into these topics. I remember reviewing the issue briefs in detail, understanding that I did not need to be an expert but that familiarity with the issues would be a key component of having a successful meeting. I also completed an online advocacy training module that gave me insight into how and why I could advocate for my profession as a future gastroenterologist. Based on our congressional district and state, we were divided into groups of congressional advocates who would speak to specific congressional staff members. During our meetings, we had legislative staff available to help us navigate the finer points of public policy. Each member of my group chose a topic that was personally relevant to them. Throughout our sessions, we shared personal stories, dove in and out of virtual meeting rooms, and made sure we were clear in what we were advocating for.
As a second-year gastroenterology fellow working at the National Institutes of Health, I chose to focus on digestive diseases research funding for the research community. I talked to the congressional staff members about a patient I had seen earlier that year. He was a man in his mid-30s who was diagnosed with hepatitis C more than 10 years ago and was told, at the time of his diagnosis, that there were no good treatments for him. He had resigned himself to that fact until I saw him in my office and spoke to him about the remarkable advances in liver disease treatment that were made over the past few years. I talked to him about how Hepatitis C was a disease that could now be cured – the relief on his face was clear and only reaffirmed in me the understanding that research in digestive diseases has improved the health of our nation’s population through sustained research efforts in gastrointestinal cancers and other life-altering illnesses.
So what did I take away from this adventure in advocacy? Our role as gastroenterologists can go beyond treating one patient in one office in one hospital system at a time. We can effect change by addressing policies that we know are hurting our patients and their health. The learning curve is made much easier under the excellence of the AGA advocacy staff, who takes the time to gather resources and educate us on the specifics of relevant legislative policies, as well as of the congressional members with whom we are speaking. Our advice was sought after because, after years of training, we were the experts in this field. I was proud to have joined this grassroots network of engaged members to speak to our lawmakers. I can only imagine, in the years to come, how wonderful it would be to do this in person in our nation’s capital.
Dr. Asif is a gastroenterology fellow working with the University of Maryland and National Institutes of Health. He has no conflicts of interest to disclose.
Gastroenterology fellowship is an exercise in balance. You are learning your way around different parts of the gastrointestinal tract, both cerebrally and anatomically. You are continuously taking care of patients, in the hospital and in the clinic. You attend all kinds of conferences, didactics, and webinars. And though the hours are long, the work is worth seeing a smile from even one patient for whom you have made a tangible difference in health care. Though these moments are priceless, how often they happen is often limited by access to care, health care disparities, and systemic injustice. Fighting for each one of our patients and their health is difficult for even the most seasoned physician. Training during the middle of a pandemic has brought health care disparities to the forefront; delays in colorectal cancer screening and postponements of nonurgent procedures will have downstream impacts. It was with these thoughts in mind that I decided to participate in AGA (American Gastroenterological Association) Advocacy Day in September 2020 as a gastroenterology fellow.
After close to 20 years of in-person Advocacy Days, the AGA decided to take its advocacy efforts to a virtual platform in the fall of 2020. The country remained in the throes of the worst pandemic it had seen in over a century, and social distancing efforts necessitated a different venue than previous years. This year’s online platform was designed to let individuals involved in gastroenterology health care join each other and discuss policies germane to our patients and our profession.
I have to confess that I did not have significant legislative experience, and I signed up for the virtual Advocacy Day with a sense of slight trepidation. Would I be prepared to talk to experts in the field? What did I know about health care policy on the granular level? How could I get across my message cogently and successfully? All I really knew was that I wanted to get engaged with a group of gastroenterologists early on in my career who were not only vociferous advocates for their patients at the bedside, but who were also able to actively support policy changes that would bring about systemic change.
As it turned out, I had nothing to worry about. This advocacy experience was designed for gastroenterology clinical providers to be able to talk intelligently about topics they knew well – research funding, colonoscopy costs, and different levels of therapy for patients with inflammatory bowel disease, among others. To provide an overview of public policy issues, the AGA prepared a legislative briefing book that allowed us to take a deep dive into these topics. I remember reviewing the issue briefs in detail, understanding that I did not need to be an expert but that familiarity with the issues would be a key component of having a successful meeting. I also completed an online advocacy training module that gave me insight into how and why I could advocate for my profession as a future gastroenterologist. Based on our congressional district and state, we were divided into groups of congressional advocates who would speak to specific congressional staff members. During our meetings, we had legislative staff available to help us navigate the finer points of public policy. Each member of my group chose a topic that was personally relevant to them. Throughout our sessions, we shared personal stories, dove in and out of virtual meeting rooms, and made sure we were clear in what we were advocating for.
As a second-year gastroenterology fellow working at the National Institutes of Health, I chose to focus on digestive diseases research funding for the research community. I talked to the congressional staff members about a patient I had seen earlier that year. He was a man in his mid-30s who was diagnosed with hepatitis C more than 10 years ago and was told, at the time of his diagnosis, that there were no good treatments for him. He had resigned himself to that fact until I saw him in my office and spoke to him about the remarkable advances in liver disease treatment that were made over the past few years. I talked to him about how Hepatitis C was a disease that could now be cured – the relief on his face was clear and only reaffirmed in me the understanding that research in digestive diseases has improved the health of our nation’s population through sustained research efforts in gastrointestinal cancers and other life-altering illnesses.
So what did I take away from this adventure in advocacy? Our role as gastroenterologists can go beyond treating one patient in one office in one hospital system at a time. We can effect change by addressing policies that we know are hurting our patients and their health. The learning curve is made much easier under the excellence of the AGA advocacy staff, who takes the time to gather resources and educate us on the specifics of relevant legislative policies, as well as of the congressional members with whom we are speaking. Our advice was sought after because, after years of training, we were the experts in this field. I was proud to have joined this grassroots network of engaged members to speak to our lawmakers. I can only imagine, in the years to come, how wonderful it would be to do this in person in our nation’s capital.
Dr. Asif is a gastroenterology fellow working with the University of Maryland and National Institutes of Health. He has no conflicts of interest to disclose.
Financial toxicity linked to survival time in head and neck cancer
Worries about out-of-pocket costs of treatment they are receiving – so-called “financial toxicity” – may harm outcomes for patients with cancer, new research suggests.
The study found that patients with head and neck cancer who were worried about their finances had approximately double the risk of dying when compared to patients without such worries.
The findings were published in Oral Oncology.
“This is the first time that financial worry was shown to impact survival,” senior author Anurag Singh, MD, of Roswell Park Cancer Center, Buffalo, N.Y., told this news organization.
“The association we found was very strong and very concerning,” he said. “If you are worried about your finances, your risk of dying is roughly double.”
Dr. Singh emphasized that the risk of dying was not related to missing treatment due to financial concerns. Although it has been reported that as many as a quarter of all patients with cancer choose not to fill a prescription because of cost, this was not the case for the current study population.
“Our patients all finished on time and did not skip treatments,” Dr. Singh said.
Dr. Singh suggests these results could be extrapolated to the larger cancer population, as many cancer types require long treatments, expensive targeted agents, and surgery. “It is possible, and we are studying it in lung, breast, and prostate cancer patients,” he said.
The problem of financial toxicity has been widely reported. However, few solutions have emerged, especially those that can be implemented immediately. Dr. Singh said his institution has begun a referral program and plans to publish on this soon.
“We have been utilizing financial counselors for our head and neck patients for more than 3 years,” he said. “This has stabilized the amount of financial worry during the course of treatment – meaning it didn’t get worse while the patient was undergoing treatment.”
Financial worries linked to worse outcomes
In the article, Dr. Singh and colleagues explained that they studied patients with head and neck cancer because medical and out-of-pocket expenses are higher for this type of tumor compared with other malignancies.
Previous studies have shown that patients with head and neck cancer are at risk for worsening quality of life due to financial toxicity, and one study showed that more than two out of three such patients relied on cost-coping strategies, such as selling personal assets or taking credit card loans (J Onc Pract. 2017;13:e310-8).
For their study, Dr. Singh and colleagues conducted a retrospective review of 284 patients treated at Roswell Park Comprehensive Cancer Center with definitive or postoperative radiation therapy between 2013 and 2017. The median age of patients was 61 years, and more than three-quarters were men (77.5%).
Of this group, 204 patients (71.8%) received definitive radiation, and 80 patients (28.2%) were treated with adjuvant radiation. Chemotherapy was used for 237 patients (83.5%), usually cisplatin. The median follow-up was 39.9 months.
At baseline, 41 (14.4%) patients reported a high level of financial difficulties, and the rate of relapse was higher among these patients.
In the group of patients with financial difficulties, 14 of 41 (33%) patients had a relapse (7 distant, 7 local). Subsequent treatments included none (n = 6, 42.9%), systemic therapy (n = 5, 35.7%), and surgery (n = 3, 21.4%). Three patients (21.4%) received immunotherapy at some point during treatment.
Among patients who reported low financial difficulty at baseline, 50 of 243 patients (20.6%) had a relapse (34 distant, 16 local). Subsequent treatments included none (n = 15, 30%), systemic therapy (n = 25, 50%), and surgery (n = 10, 20%). Fourteen patients (28%) received immunotherapy at some point during treatment.
The researchers noted there was no significant association between financial difficulties and receipt of additional treatments (P = .36) or immunotherapy (P = .62).
However, on multivariable analysis, they found a significant association between financial difficulties and worse overall survival (hazard ratio [HR], 1.75; P = .03) and cancer-specific survival (HR, 2.28; P = .003).
When the team narrowed their focus to 66 patients matched with well-balanced baseline characteristics, the significant association was even more pronounced. A high level of financial difficulties remained associated with worse overall survival (HR, 2.72; P = .04) and cancer-specific survival (HR, 3.75; P = .02).
The team noted that an earlier study (J Clin Oncol. 2016;34:980-6) found a higher risk of death among patients with cancer who filed for bankruptcy than among those who hadn’t. The adjusted mortality among cancer patients who filed for bankruptcy was nearly double (HR, 1.79; 95% confidence interval, 1.64-1.96). Colorectal, prostate, and thyroid cancers had the highest hazard ratios.
The hazard ratios for overall survival in the overall and matched-pair populations in the current study (1.75 and 2.72) are consistent with the overall cohort hazard ratio of 1.79 reported in the 2016 study, according to Dr. Singh and colleagues.
“If confirmed in other cohorts, this would suggest that relatively mild financial toxicity at baseline may have the same impact on mortality as an extreme consequence like post-therapy bankruptcy,” Dr. Singh and colleagues wrote.
Their study was supported by the National Cancer Institute Cancer Center. The authors declared no disclosures.
A version of this article first appeared on Medscape.com.
Worries about out-of-pocket costs of treatment they are receiving – so-called “financial toxicity” – may harm outcomes for patients with cancer, new research suggests.
The study found that patients with head and neck cancer who were worried about their finances had approximately double the risk of dying when compared to patients without such worries.
The findings were published in Oral Oncology.
“This is the first time that financial worry was shown to impact survival,” senior author Anurag Singh, MD, of Roswell Park Cancer Center, Buffalo, N.Y., told this news organization.
“The association we found was very strong and very concerning,” he said. “If you are worried about your finances, your risk of dying is roughly double.”
Dr. Singh emphasized that the risk of dying was not related to missing treatment due to financial concerns. Although it has been reported that as many as a quarter of all patients with cancer choose not to fill a prescription because of cost, this was not the case for the current study population.
“Our patients all finished on time and did not skip treatments,” Dr. Singh said.
Dr. Singh suggests these results could be extrapolated to the larger cancer population, as many cancer types require long treatments, expensive targeted agents, and surgery. “It is possible, and we are studying it in lung, breast, and prostate cancer patients,” he said.
The problem of financial toxicity has been widely reported. However, few solutions have emerged, especially those that can be implemented immediately. Dr. Singh said his institution has begun a referral program and plans to publish on this soon.
“We have been utilizing financial counselors for our head and neck patients for more than 3 years,” he said. “This has stabilized the amount of financial worry during the course of treatment – meaning it didn’t get worse while the patient was undergoing treatment.”
Financial worries linked to worse outcomes
In the article, Dr. Singh and colleagues explained that they studied patients with head and neck cancer because medical and out-of-pocket expenses are higher for this type of tumor compared with other malignancies.
Previous studies have shown that patients with head and neck cancer are at risk for worsening quality of life due to financial toxicity, and one study showed that more than two out of three such patients relied on cost-coping strategies, such as selling personal assets or taking credit card loans (J Onc Pract. 2017;13:e310-8).
For their study, Dr. Singh and colleagues conducted a retrospective review of 284 patients treated at Roswell Park Comprehensive Cancer Center with definitive or postoperative radiation therapy between 2013 and 2017. The median age of patients was 61 years, and more than three-quarters were men (77.5%).
Of this group, 204 patients (71.8%) received definitive radiation, and 80 patients (28.2%) were treated with adjuvant radiation. Chemotherapy was used for 237 patients (83.5%), usually cisplatin. The median follow-up was 39.9 months.
At baseline, 41 (14.4%) patients reported a high level of financial difficulties, and the rate of relapse was higher among these patients.
In the group of patients with financial difficulties, 14 of 41 (33%) patients had a relapse (7 distant, 7 local). Subsequent treatments included none (n = 6, 42.9%), systemic therapy (n = 5, 35.7%), and surgery (n = 3, 21.4%). Three patients (21.4%) received immunotherapy at some point during treatment.
Among patients who reported low financial difficulty at baseline, 50 of 243 patients (20.6%) had a relapse (34 distant, 16 local). Subsequent treatments included none (n = 15, 30%), systemic therapy (n = 25, 50%), and surgery (n = 10, 20%). Fourteen patients (28%) received immunotherapy at some point during treatment.
The researchers noted there was no significant association between financial difficulties and receipt of additional treatments (P = .36) or immunotherapy (P = .62).
However, on multivariable analysis, they found a significant association between financial difficulties and worse overall survival (hazard ratio [HR], 1.75; P = .03) and cancer-specific survival (HR, 2.28; P = .003).
When the team narrowed their focus to 66 patients matched with well-balanced baseline characteristics, the significant association was even more pronounced. A high level of financial difficulties remained associated with worse overall survival (HR, 2.72; P = .04) and cancer-specific survival (HR, 3.75; P = .02).
The team noted that an earlier study (J Clin Oncol. 2016;34:980-6) found a higher risk of death among patients with cancer who filed for bankruptcy than among those who hadn’t. The adjusted mortality among cancer patients who filed for bankruptcy was nearly double (HR, 1.79; 95% confidence interval, 1.64-1.96). Colorectal, prostate, and thyroid cancers had the highest hazard ratios.
The hazard ratios for overall survival in the overall and matched-pair populations in the current study (1.75 and 2.72) are consistent with the overall cohort hazard ratio of 1.79 reported in the 2016 study, according to Dr. Singh and colleagues.
“If confirmed in other cohorts, this would suggest that relatively mild financial toxicity at baseline may have the same impact on mortality as an extreme consequence like post-therapy bankruptcy,” Dr. Singh and colleagues wrote.
Their study was supported by the National Cancer Institute Cancer Center. The authors declared no disclosures.
A version of this article first appeared on Medscape.com.
Worries about out-of-pocket costs of treatment they are receiving – so-called “financial toxicity” – may harm outcomes for patients with cancer, new research suggests.
The study found that patients with head and neck cancer who were worried about their finances had approximately double the risk of dying when compared to patients without such worries.
The findings were published in Oral Oncology.
“This is the first time that financial worry was shown to impact survival,” senior author Anurag Singh, MD, of Roswell Park Cancer Center, Buffalo, N.Y., told this news organization.
“The association we found was very strong and very concerning,” he said. “If you are worried about your finances, your risk of dying is roughly double.”
Dr. Singh emphasized that the risk of dying was not related to missing treatment due to financial concerns. Although it has been reported that as many as a quarter of all patients with cancer choose not to fill a prescription because of cost, this was not the case for the current study population.
“Our patients all finished on time and did not skip treatments,” Dr. Singh said.
Dr. Singh suggests these results could be extrapolated to the larger cancer population, as many cancer types require long treatments, expensive targeted agents, and surgery. “It is possible, and we are studying it in lung, breast, and prostate cancer patients,” he said.
The problem of financial toxicity has been widely reported. However, few solutions have emerged, especially those that can be implemented immediately. Dr. Singh said his institution has begun a referral program and plans to publish on this soon.
“We have been utilizing financial counselors for our head and neck patients for more than 3 years,” he said. “This has stabilized the amount of financial worry during the course of treatment – meaning it didn’t get worse while the patient was undergoing treatment.”
Financial worries linked to worse outcomes
In the article, Dr. Singh and colleagues explained that they studied patients with head and neck cancer because medical and out-of-pocket expenses are higher for this type of tumor compared with other malignancies.
Previous studies have shown that patients with head and neck cancer are at risk for worsening quality of life due to financial toxicity, and one study showed that more than two out of three such patients relied on cost-coping strategies, such as selling personal assets or taking credit card loans (J Onc Pract. 2017;13:e310-8).
For their study, Dr. Singh and colleagues conducted a retrospective review of 284 patients treated at Roswell Park Comprehensive Cancer Center with definitive or postoperative radiation therapy between 2013 and 2017. The median age of patients was 61 years, and more than three-quarters were men (77.5%).
Of this group, 204 patients (71.8%) received definitive radiation, and 80 patients (28.2%) were treated with adjuvant radiation. Chemotherapy was used for 237 patients (83.5%), usually cisplatin. The median follow-up was 39.9 months.
At baseline, 41 (14.4%) patients reported a high level of financial difficulties, and the rate of relapse was higher among these patients.
In the group of patients with financial difficulties, 14 of 41 (33%) patients had a relapse (7 distant, 7 local). Subsequent treatments included none (n = 6, 42.9%), systemic therapy (n = 5, 35.7%), and surgery (n = 3, 21.4%). Three patients (21.4%) received immunotherapy at some point during treatment.
Among patients who reported low financial difficulty at baseline, 50 of 243 patients (20.6%) had a relapse (34 distant, 16 local). Subsequent treatments included none (n = 15, 30%), systemic therapy (n = 25, 50%), and surgery (n = 10, 20%). Fourteen patients (28%) received immunotherapy at some point during treatment.
The researchers noted there was no significant association between financial difficulties and receipt of additional treatments (P = .36) or immunotherapy (P = .62).
However, on multivariable analysis, they found a significant association between financial difficulties and worse overall survival (hazard ratio [HR], 1.75; P = .03) and cancer-specific survival (HR, 2.28; P = .003).
When the team narrowed their focus to 66 patients matched with well-balanced baseline characteristics, the significant association was even more pronounced. A high level of financial difficulties remained associated with worse overall survival (HR, 2.72; P = .04) and cancer-specific survival (HR, 3.75; P = .02).
The team noted that an earlier study (J Clin Oncol. 2016;34:980-6) found a higher risk of death among patients with cancer who filed for bankruptcy than among those who hadn’t. The adjusted mortality among cancer patients who filed for bankruptcy was nearly double (HR, 1.79; 95% confidence interval, 1.64-1.96). Colorectal, prostate, and thyroid cancers had the highest hazard ratios.
The hazard ratios for overall survival in the overall and matched-pair populations in the current study (1.75 and 2.72) are consistent with the overall cohort hazard ratio of 1.79 reported in the 2016 study, according to Dr. Singh and colleagues.
“If confirmed in other cohorts, this would suggest that relatively mild financial toxicity at baseline may have the same impact on mortality as an extreme consequence like post-therapy bankruptcy,” Dr. Singh and colleagues wrote.
Their study was supported by the National Cancer Institute Cancer Center. The authors declared no disclosures.
A version of this article first appeared on Medscape.com.