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FDA OKs spinal cord stimulation devices for chronic back pain
The Food and Drug Administration has expanded the indication for Abbott Laboratories’ spinal cord stimulation (SCS) devices to include treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery, the company has announced.
The new indication spans all of Abbott’s SCS devices in the United States, which include the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.
The devices feature the company’s proprietary, low-energy BurstDR stimulation waveform, a form of stimulation therapy that uses bursts of mild electrical energy without causing an abnormal tingling sensation to help disrupt pain signals before they can reach the brain, the company explained.
The expanded indication was supported by results from the DISTINCT study, which enrolled 270 adults suffering from severe, disabling chronic back pain for an average of more than 12 years and who were not eligible for surgery.
The study showed that significantly more patients who were treated with SCS achieved significant improvements in back pain, function, quality of life, and psychological status than peers treated with conservative medical management.
“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, W.Va., said in a news release.
“This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain,” Dr. Deer said.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has expanded the indication for Abbott Laboratories’ spinal cord stimulation (SCS) devices to include treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery, the company has announced.
The new indication spans all of Abbott’s SCS devices in the United States, which include the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.
The devices feature the company’s proprietary, low-energy BurstDR stimulation waveform, a form of stimulation therapy that uses bursts of mild electrical energy without causing an abnormal tingling sensation to help disrupt pain signals before they can reach the brain, the company explained.
The expanded indication was supported by results from the DISTINCT study, which enrolled 270 adults suffering from severe, disabling chronic back pain for an average of more than 12 years and who were not eligible for surgery.
The study showed that significantly more patients who were treated with SCS achieved significant improvements in back pain, function, quality of life, and psychological status than peers treated with conservative medical management.
“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, W.Va., said in a news release.
“This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain,” Dr. Deer said.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has expanded the indication for Abbott Laboratories’ spinal cord stimulation (SCS) devices to include treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery, the company has announced.
The new indication spans all of Abbott’s SCS devices in the United States, which include the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.
The devices feature the company’s proprietary, low-energy BurstDR stimulation waveform, a form of stimulation therapy that uses bursts of mild electrical energy without causing an abnormal tingling sensation to help disrupt pain signals before they can reach the brain, the company explained.
The expanded indication was supported by results from the DISTINCT study, which enrolled 270 adults suffering from severe, disabling chronic back pain for an average of more than 12 years and who were not eligible for surgery.
The study showed that significantly more patients who were treated with SCS achieved significant improvements in back pain, function, quality of life, and psychological status than peers treated with conservative medical management.
“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, W.Va., said in a news release.
“This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain,” Dr. Deer said.
A version of this article first appeared on Medscape.com.
TransCon PTH nears U.S. approval for hypoparathyroidism?
SEATTLE –
Findings from 110-week phase 2 data for the once-daily investigational parathyroid hormone (PTH) replacement drug were recently presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Overall, the drug was associated with independence from conventional calcium and active vitamin D therapy in most patients at 110 weeks, with no discontinuations due to adverse effects.
“Patients with hypoparathyroidism have low serum calcium levels and struggle with quality of life and biochemical abnormalities. The data from the TransCon PTH studies seem to show that a lot of these abnormalities can be reversed,” presenter Mishaela R. Rubin, MD, said in an interview.
Other PTH replacement therapies such as Nupara (now discontinued) and teriparatide (off-label) have been used in some patients with hypoparathyroidism.
However, “[TransCon PTH] is delivered in such a way as to have a prolonged half-life, so that’s kind of a special benefit that it has,” added Dr. Rubin of the division of endocrinology and metabolic bone disease, department of medicine, Columbia University, New York.
Asked to comment, session moderator Thanh Hoang, DO, of Walter Reed National Military Medical Center, Silver Spring, Md., said: “I think it’s a very promising medication because right now we don’t have a lot of options ... I think it would help a lot of patients.”
Approval denied, company addressing concerns
On May 1, the Food and Drug Administration issued a complete response letter, signaling denial of approval for the TransCon PTH, citing concerns related to manufacturing control of the product’s drug/device combination product, but not about the product’s safety and efficacy, according to an Ascendis statement.
The company is now working with the FDA to address these issues and is awaiting a European Union decision later this year.
The FDA did not request that the company conduct further clinical trials of TransCon PTH, which now include published 26-week phase 2 and phase 3 data along with the current longer-term phase 2 data presented at AACE.
“The company has said that they’re hopeful the issues will be addressable and that the FDA did not have any concerns about safety,” Dr. Rubin said in an interview.
Calcium normalized, bone turnover improved
Dr. Rubin presented long-term efficacy and safety data from the Phase 2 PaTH Forward trial, which involved 57 of the initial 59 participants who completed week 110 of an open-label extension of the trial.
During the first 4 weeks, patients had been randomized to TransCon PTH at fixed doses of 15 µg/day, 18 µg/day, 21 µg/day, or placebo. After week 4, all patients switched to TransCon PTH titrated to doses of 6-60 µg/day along with conventional therapy, with the goal of maintaining normocalcemia.
Participants were a mean age of 50 years, 81% were women, and 92% were White. Causes of hypoparathyroidism were neck surgery in 80%, autoimmune disease in 2%, and idiopathic disease in 19%. Disease duration was 12 years (range 1-39), and all were taking conventional therapy including calcium and active vitamin D (calcitriol or alfacaldiol).
At 110 weeks, all 57 patients were able to stop taking active vitamin D, and 53 of the 57 (93%) patients achieved independence from conventional therapy, defined as taking 0 µg/day of active vitamin D and no more than 600 mg/day of calcium (the dietary supplement dose). A total of 44 (77%) patients were not taking any calcium or active vitamin D.
“This really establishes the durability up to 2 years of keeping people off conventional therapy,” Dr. Rubin said during her presentation.
There was an initial uptick to 9.4 mg/dL in mean serum calcium, as some participants were still taking active vitamin D, but that dropped to 8.9 mg/dL by week 26. Mean 24-hour urine calcium dropped from 428 mg/day at baseline to 173 mg/day by week 26. Both serum calcium and urine calcium remained in the normal range through week 110 in all patients, at 8.6 mg/dL and 167 mg/day, respectively.
“This is a really important outcome because we know that high urine calcium in these patients sets them at risk for going on to develop nephrocalcinosis, nephrolithiasis, and ultimately, chronic kidney disease,” Dr. Rubin said.
Serum levels of two bone formation markers peaked at 12 weeks after initiation of TransCon PTH. Both trended downward thereafter through week 110 to levels approximating those of age- and sex-matched controls.
“Both markers started off low, consistent with hypoparathyroidism, but with initiation of TransCon PTH we see a robust increase in bone turnover markers, almost as if the bone is ‘waking up,’ if you will. And this is consistent with calcium being mobilized from the skeleton and going into the circulation,” Dr. Rubin explained.
Bone mineral density assessed by dual-energy x-ray absorptiometry normalized, primarily in the first 26 weeks. For lumbar spine L1-L4, mean Z-scores dropped from 1.6 to 1.0 at 26 weeks and down to 0.7 by week 100. For total hip, those values were 1.0, 0.6, and 0.4, respectively. The values approached age- and sex-matched norms, Dr. Rubin noted, to “perhaps where their skeleton would be if they hadn’t had hypoparathyroidism.”
Overall 56 of the 57 (94.9%) patients reported treatment-emergent adverse events, of which 25 (42.4%) were treatment related and none were deemed serious. There were no treatment-emergent adverse events related to hypercalcemia or hypocalcemia leading to health care visits or hospitalization, none leading to discontinuation of study drug, and none to death.
“So overall, a reassuring safety profile,” Dr. Rubin said. “We look forward to presenting the next 2 years’ worth of data to the end of the open-label extension study.”
Dr. Rubin is a paid researcher for Ascendis, which funded the study. Dr. Hoang has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE –
Findings from 110-week phase 2 data for the once-daily investigational parathyroid hormone (PTH) replacement drug were recently presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Overall, the drug was associated with independence from conventional calcium and active vitamin D therapy in most patients at 110 weeks, with no discontinuations due to adverse effects.
“Patients with hypoparathyroidism have low serum calcium levels and struggle with quality of life and biochemical abnormalities. The data from the TransCon PTH studies seem to show that a lot of these abnormalities can be reversed,” presenter Mishaela R. Rubin, MD, said in an interview.
Other PTH replacement therapies such as Nupara (now discontinued) and teriparatide (off-label) have been used in some patients with hypoparathyroidism.
However, “[TransCon PTH] is delivered in such a way as to have a prolonged half-life, so that’s kind of a special benefit that it has,” added Dr. Rubin of the division of endocrinology and metabolic bone disease, department of medicine, Columbia University, New York.
Asked to comment, session moderator Thanh Hoang, DO, of Walter Reed National Military Medical Center, Silver Spring, Md., said: “I think it’s a very promising medication because right now we don’t have a lot of options ... I think it would help a lot of patients.”
Approval denied, company addressing concerns
On May 1, the Food and Drug Administration issued a complete response letter, signaling denial of approval for the TransCon PTH, citing concerns related to manufacturing control of the product’s drug/device combination product, but not about the product’s safety and efficacy, according to an Ascendis statement.
The company is now working with the FDA to address these issues and is awaiting a European Union decision later this year.
The FDA did not request that the company conduct further clinical trials of TransCon PTH, which now include published 26-week phase 2 and phase 3 data along with the current longer-term phase 2 data presented at AACE.
“The company has said that they’re hopeful the issues will be addressable and that the FDA did not have any concerns about safety,” Dr. Rubin said in an interview.
Calcium normalized, bone turnover improved
Dr. Rubin presented long-term efficacy and safety data from the Phase 2 PaTH Forward trial, which involved 57 of the initial 59 participants who completed week 110 of an open-label extension of the trial.
During the first 4 weeks, patients had been randomized to TransCon PTH at fixed doses of 15 µg/day, 18 µg/day, 21 µg/day, or placebo. After week 4, all patients switched to TransCon PTH titrated to doses of 6-60 µg/day along with conventional therapy, with the goal of maintaining normocalcemia.
Participants were a mean age of 50 years, 81% were women, and 92% were White. Causes of hypoparathyroidism were neck surgery in 80%, autoimmune disease in 2%, and idiopathic disease in 19%. Disease duration was 12 years (range 1-39), and all were taking conventional therapy including calcium and active vitamin D (calcitriol or alfacaldiol).
At 110 weeks, all 57 patients were able to stop taking active vitamin D, and 53 of the 57 (93%) patients achieved independence from conventional therapy, defined as taking 0 µg/day of active vitamin D and no more than 600 mg/day of calcium (the dietary supplement dose). A total of 44 (77%) patients were not taking any calcium or active vitamin D.
“This really establishes the durability up to 2 years of keeping people off conventional therapy,” Dr. Rubin said during her presentation.
There was an initial uptick to 9.4 mg/dL in mean serum calcium, as some participants were still taking active vitamin D, but that dropped to 8.9 mg/dL by week 26. Mean 24-hour urine calcium dropped from 428 mg/day at baseline to 173 mg/day by week 26. Both serum calcium and urine calcium remained in the normal range through week 110 in all patients, at 8.6 mg/dL and 167 mg/day, respectively.
“This is a really important outcome because we know that high urine calcium in these patients sets them at risk for going on to develop nephrocalcinosis, nephrolithiasis, and ultimately, chronic kidney disease,” Dr. Rubin said.
Serum levels of two bone formation markers peaked at 12 weeks after initiation of TransCon PTH. Both trended downward thereafter through week 110 to levels approximating those of age- and sex-matched controls.
“Both markers started off low, consistent with hypoparathyroidism, but with initiation of TransCon PTH we see a robust increase in bone turnover markers, almost as if the bone is ‘waking up,’ if you will. And this is consistent with calcium being mobilized from the skeleton and going into the circulation,” Dr. Rubin explained.
Bone mineral density assessed by dual-energy x-ray absorptiometry normalized, primarily in the first 26 weeks. For lumbar spine L1-L4, mean Z-scores dropped from 1.6 to 1.0 at 26 weeks and down to 0.7 by week 100. For total hip, those values were 1.0, 0.6, and 0.4, respectively. The values approached age- and sex-matched norms, Dr. Rubin noted, to “perhaps where their skeleton would be if they hadn’t had hypoparathyroidism.”
Overall 56 of the 57 (94.9%) patients reported treatment-emergent adverse events, of which 25 (42.4%) were treatment related and none were deemed serious. There were no treatment-emergent adverse events related to hypercalcemia or hypocalcemia leading to health care visits or hospitalization, none leading to discontinuation of study drug, and none to death.
“So overall, a reassuring safety profile,” Dr. Rubin said. “We look forward to presenting the next 2 years’ worth of data to the end of the open-label extension study.”
Dr. Rubin is a paid researcher for Ascendis, which funded the study. Dr. Hoang has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE –
Findings from 110-week phase 2 data for the once-daily investigational parathyroid hormone (PTH) replacement drug were recently presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Overall, the drug was associated with independence from conventional calcium and active vitamin D therapy in most patients at 110 weeks, with no discontinuations due to adverse effects.
“Patients with hypoparathyroidism have low serum calcium levels and struggle with quality of life and biochemical abnormalities. The data from the TransCon PTH studies seem to show that a lot of these abnormalities can be reversed,” presenter Mishaela R. Rubin, MD, said in an interview.
Other PTH replacement therapies such as Nupara (now discontinued) and teriparatide (off-label) have been used in some patients with hypoparathyroidism.
However, “[TransCon PTH] is delivered in such a way as to have a prolonged half-life, so that’s kind of a special benefit that it has,” added Dr. Rubin of the division of endocrinology and metabolic bone disease, department of medicine, Columbia University, New York.
Asked to comment, session moderator Thanh Hoang, DO, of Walter Reed National Military Medical Center, Silver Spring, Md., said: “I think it’s a very promising medication because right now we don’t have a lot of options ... I think it would help a lot of patients.”
Approval denied, company addressing concerns
On May 1, the Food and Drug Administration issued a complete response letter, signaling denial of approval for the TransCon PTH, citing concerns related to manufacturing control of the product’s drug/device combination product, but not about the product’s safety and efficacy, according to an Ascendis statement.
The company is now working with the FDA to address these issues and is awaiting a European Union decision later this year.
The FDA did not request that the company conduct further clinical trials of TransCon PTH, which now include published 26-week phase 2 and phase 3 data along with the current longer-term phase 2 data presented at AACE.
“The company has said that they’re hopeful the issues will be addressable and that the FDA did not have any concerns about safety,” Dr. Rubin said in an interview.
Calcium normalized, bone turnover improved
Dr. Rubin presented long-term efficacy and safety data from the Phase 2 PaTH Forward trial, which involved 57 of the initial 59 participants who completed week 110 of an open-label extension of the trial.
During the first 4 weeks, patients had been randomized to TransCon PTH at fixed doses of 15 µg/day, 18 µg/day, 21 µg/day, or placebo. After week 4, all patients switched to TransCon PTH titrated to doses of 6-60 µg/day along with conventional therapy, with the goal of maintaining normocalcemia.
Participants were a mean age of 50 years, 81% were women, and 92% were White. Causes of hypoparathyroidism were neck surgery in 80%, autoimmune disease in 2%, and idiopathic disease in 19%. Disease duration was 12 years (range 1-39), and all were taking conventional therapy including calcium and active vitamin D (calcitriol or alfacaldiol).
At 110 weeks, all 57 patients were able to stop taking active vitamin D, and 53 of the 57 (93%) patients achieved independence from conventional therapy, defined as taking 0 µg/day of active vitamin D and no more than 600 mg/day of calcium (the dietary supplement dose). A total of 44 (77%) patients were not taking any calcium or active vitamin D.
“This really establishes the durability up to 2 years of keeping people off conventional therapy,” Dr. Rubin said during her presentation.
There was an initial uptick to 9.4 mg/dL in mean serum calcium, as some participants were still taking active vitamin D, but that dropped to 8.9 mg/dL by week 26. Mean 24-hour urine calcium dropped from 428 mg/day at baseline to 173 mg/day by week 26. Both serum calcium and urine calcium remained in the normal range through week 110 in all patients, at 8.6 mg/dL and 167 mg/day, respectively.
“This is a really important outcome because we know that high urine calcium in these patients sets them at risk for going on to develop nephrocalcinosis, nephrolithiasis, and ultimately, chronic kidney disease,” Dr. Rubin said.
Serum levels of two bone formation markers peaked at 12 weeks after initiation of TransCon PTH. Both trended downward thereafter through week 110 to levels approximating those of age- and sex-matched controls.
“Both markers started off low, consistent with hypoparathyroidism, but with initiation of TransCon PTH we see a robust increase in bone turnover markers, almost as if the bone is ‘waking up,’ if you will. And this is consistent with calcium being mobilized from the skeleton and going into the circulation,” Dr. Rubin explained.
Bone mineral density assessed by dual-energy x-ray absorptiometry normalized, primarily in the first 26 weeks. For lumbar spine L1-L4, mean Z-scores dropped from 1.6 to 1.0 at 26 weeks and down to 0.7 by week 100. For total hip, those values were 1.0, 0.6, and 0.4, respectively. The values approached age- and sex-matched norms, Dr. Rubin noted, to “perhaps where their skeleton would be if they hadn’t had hypoparathyroidism.”
Overall 56 of the 57 (94.9%) patients reported treatment-emergent adverse events, of which 25 (42.4%) were treatment related and none were deemed serious. There were no treatment-emergent adverse events related to hypercalcemia or hypocalcemia leading to health care visits or hospitalization, none leading to discontinuation of study drug, and none to death.
“So overall, a reassuring safety profile,” Dr. Rubin said. “We look forward to presenting the next 2 years’ worth of data to the end of the open-label extension study.”
Dr. Rubin is a paid researcher for Ascendis, which funded the study. Dr. Hoang has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT AACE 2023
Redo-TAVR in U.S. database yields good news: Outcomes rival first intervention
Data support redo if needed.
Even after 3 years of follow-up, redo transcatheter aortic valve replacement (TAVR) performs about as well as the first procedure, whether compared for hard endpoints, such as death and stroke, or for softer endpoints, such as function and quality of life, new registry data suggest.
reported Rajendra Makkar, MD, associate director, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.
The results were presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
Data for this analysis were drawn from 348,338 TAVR procedures with the Edwards balloon-expandable valves in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Replacement Registry.
Of these, 1,216 were redo procedures. In 475 of the cases, the redo was performed in a patient whose first procedure was with an Edwards device. In the remaining 741 cases, the Edwards device replaced a different prosthetic heart valve. The median time to the redo from the first procedure was 26 months.
For the analysis, the redo-TAVRs were compared with native TAVR patients through 1:1 propensity matching employing 35 covariates, such as age, body mass index (BMI), baseline comorbidities, prior cardiovascular procedures, valve size, and Society of Thoracic Surgeons risk score.
Low death and stroke rates following TAVR redos
The rates of all-cause death or stroke within hospital (4.7% vs. 3.9%; P = .32) and at 30 days (6.1% vs. 5.9%; P = .77) were numerically but not statistically higher in the redo group.
At 1 year, the rates of death (17.3% vs. 17.7%; P = .961) and stroke (3.3% vs. 3.5%; P = .982) were numerically but not significantly lower among those who underwent a redo procedure.
The secondary endpoints told the same story. The one exception was the higher aortic valve reintervention rate (0.61% vs. 0.09%; P = .03) at 30 days in the redo group. This did reach statistical significance, but Dr. Makkar pointed out rates were very low regardless. The rates climbed in both groups by 1 year (1.09% vs. 0.21%; P = .01).
No other secondary endpoints differed significantly at 30 days or at 1 year. Even though some were numerically higher after redo at 1 year, such as major vascular complications (1.25 vs. 1.60; P = .51), others were lower, such as new-start dialysis (1.62 vs. 0.98; P = .26). All-cause readmission rates at 1 year were nearly identical (32.56% vs. 32.23%; P = .82).
Consistent with the comparable outcomes on the hard endpoints, major and similar improvements were seen in both the redo and the propensity-matched native TAVR patients on the Kansas City Cardiomyopathy Questionnaire Overall Summary. The slight advantage for the redo group was not significant at 30 days, but the degree of improvement was greater after the redo than after native TAVR at 1 year (15% vs. 10%; P = .03).
“You bring good news,” said Alain G. Cribier, MD, director of cardiology, Charles Nicolle Hospital, University of Rouen, France. Widely regarded as the father of TAVR for his first-in-human series in 2002, Dr. Cribier said that there are several reassuring take-home messages from this study.
“First, these data tell us that the redo rate is extremely low,” he said, noting that the registry data suggests a risk well below 1%. “Second, we are seeing from this data that there are no more complications [than TAVR in a native valve] if you need to do this.”
Redo patients are generally sicker
The propensity matching was designed to eliminate baseline differences for the outcome comparisons, but Dr. Makkar did point out that redo-TAVR patients were sicker than the native TAVR patients. For example, when compared prior to propensity matching, the STS score was higher (8.3 vs. 5.2; P < .01), more patients had atrial fibrillation (47.9% vs. 36.2%; P < .01), and more patients had a prior stroke (15.0% vs. 10.7%; P < .01).
The registry only has follow-up out to 1 year, but participating patients were matched to a claims database to capture outcomes out to 3 years. Mortality rates at long-term follow-up were not significantly different for redo vs. native TAVR (42.2% vs. 40.3% respectively; P = .98); for the entire dataset or when compared in subgroups defined by Edwards valve redo of an Edwards valve (P = .909) or an Edwards valve redo of a non-Edwards device (P = .871).
Whether an early redo, defined as 12 months after the index TAVR procedure, or a late redo, the rate of mortality ranged from approximately 16% to 18% with no significant difference between redo and native TAVR.
A moderator for the late-breaking trials session where these data were presented, Darren Mylotte, MD, a consultant in cardiology for the Galway University Hospitals, Ireland, challenged Dr. Makkar about the potential for selection bias. He said redo patients might be the ones that interventionalists feel confident about helping, making this comparison unrepresentative.
“I think that the selection bias is likely to cut both ways,” Dr. Makkar replied. For many patients with a failed TAVR, he explained that clinicians might think, “There is nothing to be done for this patient except to try a redo.”
Dr. Makkar reports financial relationships with Abbott, Cordis, Edwards Lifesciences, and Medtronic. Dr. Cribier reports a financial relationship with Edwards Lifesciences. Dr. Mylotte reports no potential conflicts of interest.
Data support redo if needed.
Data support redo if needed.
Even after 3 years of follow-up, redo transcatheter aortic valve replacement (TAVR) performs about as well as the first procedure, whether compared for hard endpoints, such as death and stroke, or for softer endpoints, such as function and quality of life, new registry data suggest.
reported Rajendra Makkar, MD, associate director, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.
The results were presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
Data for this analysis were drawn from 348,338 TAVR procedures with the Edwards balloon-expandable valves in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Replacement Registry.
Of these, 1,216 were redo procedures. In 475 of the cases, the redo was performed in a patient whose first procedure was with an Edwards device. In the remaining 741 cases, the Edwards device replaced a different prosthetic heart valve. The median time to the redo from the first procedure was 26 months.
For the analysis, the redo-TAVRs were compared with native TAVR patients through 1:1 propensity matching employing 35 covariates, such as age, body mass index (BMI), baseline comorbidities, prior cardiovascular procedures, valve size, and Society of Thoracic Surgeons risk score.
Low death and stroke rates following TAVR redos
The rates of all-cause death or stroke within hospital (4.7% vs. 3.9%; P = .32) and at 30 days (6.1% vs. 5.9%; P = .77) were numerically but not statistically higher in the redo group.
At 1 year, the rates of death (17.3% vs. 17.7%; P = .961) and stroke (3.3% vs. 3.5%; P = .982) were numerically but not significantly lower among those who underwent a redo procedure.
The secondary endpoints told the same story. The one exception was the higher aortic valve reintervention rate (0.61% vs. 0.09%; P = .03) at 30 days in the redo group. This did reach statistical significance, but Dr. Makkar pointed out rates were very low regardless. The rates climbed in both groups by 1 year (1.09% vs. 0.21%; P = .01).
No other secondary endpoints differed significantly at 30 days or at 1 year. Even though some were numerically higher after redo at 1 year, such as major vascular complications (1.25 vs. 1.60; P = .51), others were lower, such as new-start dialysis (1.62 vs. 0.98; P = .26). All-cause readmission rates at 1 year were nearly identical (32.56% vs. 32.23%; P = .82).
Consistent with the comparable outcomes on the hard endpoints, major and similar improvements were seen in both the redo and the propensity-matched native TAVR patients on the Kansas City Cardiomyopathy Questionnaire Overall Summary. The slight advantage for the redo group was not significant at 30 days, but the degree of improvement was greater after the redo than after native TAVR at 1 year (15% vs. 10%; P = .03).
“You bring good news,” said Alain G. Cribier, MD, director of cardiology, Charles Nicolle Hospital, University of Rouen, France. Widely regarded as the father of TAVR for his first-in-human series in 2002, Dr. Cribier said that there are several reassuring take-home messages from this study.
“First, these data tell us that the redo rate is extremely low,” he said, noting that the registry data suggests a risk well below 1%. “Second, we are seeing from this data that there are no more complications [than TAVR in a native valve] if you need to do this.”
Redo patients are generally sicker
The propensity matching was designed to eliminate baseline differences for the outcome comparisons, but Dr. Makkar did point out that redo-TAVR patients were sicker than the native TAVR patients. For example, when compared prior to propensity matching, the STS score was higher (8.3 vs. 5.2; P < .01), more patients had atrial fibrillation (47.9% vs. 36.2%; P < .01), and more patients had a prior stroke (15.0% vs. 10.7%; P < .01).
The registry only has follow-up out to 1 year, but participating patients were matched to a claims database to capture outcomes out to 3 years. Mortality rates at long-term follow-up were not significantly different for redo vs. native TAVR (42.2% vs. 40.3% respectively; P = .98); for the entire dataset or when compared in subgroups defined by Edwards valve redo of an Edwards valve (P = .909) or an Edwards valve redo of a non-Edwards device (P = .871).
Whether an early redo, defined as 12 months after the index TAVR procedure, or a late redo, the rate of mortality ranged from approximately 16% to 18% with no significant difference between redo and native TAVR.
A moderator for the late-breaking trials session where these data were presented, Darren Mylotte, MD, a consultant in cardiology for the Galway University Hospitals, Ireland, challenged Dr. Makkar about the potential for selection bias. He said redo patients might be the ones that interventionalists feel confident about helping, making this comparison unrepresentative.
“I think that the selection bias is likely to cut both ways,” Dr. Makkar replied. For many patients with a failed TAVR, he explained that clinicians might think, “There is nothing to be done for this patient except to try a redo.”
Dr. Makkar reports financial relationships with Abbott, Cordis, Edwards Lifesciences, and Medtronic. Dr. Cribier reports a financial relationship with Edwards Lifesciences. Dr. Mylotte reports no potential conflicts of interest.
Even after 3 years of follow-up, redo transcatheter aortic valve replacement (TAVR) performs about as well as the first procedure, whether compared for hard endpoints, such as death and stroke, or for softer endpoints, such as function and quality of life, new registry data suggest.
reported Rajendra Makkar, MD, associate director, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.
The results were presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.
Data for this analysis were drawn from 348,338 TAVR procedures with the Edwards balloon-expandable valves in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Replacement Registry.
Of these, 1,216 were redo procedures. In 475 of the cases, the redo was performed in a patient whose first procedure was with an Edwards device. In the remaining 741 cases, the Edwards device replaced a different prosthetic heart valve. The median time to the redo from the first procedure was 26 months.
For the analysis, the redo-TAVRs were compared with native TAVR patients through 1:1 propensity matching employing 35 covariates, such as age, body mass index (BMI), baseline comorbidities, prior cardiovascular procedures, valve size, and Society of Thoracic Surgeons risk score.
Low death and stroke rates following TAVR redos
The rates of all-cause death or stroke within hospital (4.7% vs. 3.9%; P = .32) and at 30 days (6.1% vs. 5.9%; P = .77) were numerically but not statistically higher in the redo group.
At 1 year, the rates of death (17.3% vs. 17.7%; P = .961) and stroke (3.3% vs. 3.5%; P = .982) were numerically but not significantly lower among those who underwent a redo procedure.
The secondary endpoints told the same story. The one exception was the higher aortic valve reintervention rate (0.61% vs. 0.09%; P = .03) at 30 days in the redo group. This did reach statistical significance, but Dr. Makkar pointed out rates were very low regardless. The rates climbed in both groups by 1 year (1.09% vs. 0.21%; P = .01).
No other secondary endpoints differed significantly at 30 days or at 1 year. Even though some were numerically higher after redo at 1 year, such as major vascular complications (1.25 vs. 1.60; P = .51), others were lower, such as new-start dialysis (1.62 vs. 0.98; P = .26). All-cause readmission rates at 1 year were nearly identical (32.56% vs. 32.23%; P = .82).
Consistent with the comparable outcomes on the hard endpoints, major and similar improvements were seen in both the redo and the propensity-matched native TAVR patients on the Kansas City Cardiomyopathy Questionnaire Overall Summary. The slight advantage for the redo group was not significant at 30 days, but the degree of improvement was greater after the redo than after native TAVR at 1 year (15% vs. 10%; P = .03).
“You bring good news,” said Alain G. Cribier, MD, director of cardiology, Charles Nicolle Hospital, University of Rouen, France. Widely regarded as the father of TAVR for his first-in-human series in 2002, Dr. Cribier said that there are several reassuring take-home messages from this study.
“First, these data tell us that the redo rate is extremely low,” he said, noting that the registry data suggests a risk well below 1%. “Second, we are seeing from this data that there are no more complications [than TAVR in a native valve] if you need to do this.”
Redo patients are generally sicker
The propensity matching was designed to eliminate baseline differences for the outcome comparisons, but Dr. Makkar did point out that redo-TAVR patients were sicker than the native TAVR patients. For example, when compared prior to propensity matching, the STS score was higher (8.3 vs. 5.2; P < .01), more patients had atrial fibrillation (47.9% vs. 36.2%; P < .01), and more patients had a prior stroke (15.0% vs. 10.7%; P < .01).
The registry only has follow-up out to 1 year, but participating patients were matched to a claims database to capture outcomes out to 3 years. Mortality rates at long-term follow-up were not significantly different for redo vs. native TAVR (42.2% vs. 40.3% respectively; P = .98); for the entire dataset or when compared in subgroups defined by Edwards valve redo of an Edwards valve (P = .909) or an Edwards valve redo of a non-Edwards device (P = .871).
Whether an early redo, defined as 12 months after the index TAVR procedure, or a late redo, the rate of mortality ranged from approximately 16% to 18% with no significant difference between redo and native TAVR.
A moderator for the late-breaking trials session where these data were presented, Darren Mylotte, MD, a consultant in cardiology for the Galway University Hospitals, Ireland, challenged Dr. Makkar about the potential for selection bias. He said redo patients might be the ones that interventionalists feel confident about helping, making this comparison unrepresentative.
“I think that the selection bias is likely to cut both ways,” Dr. Makkar replied. For many patients with a failed TAVR, he explained that clinicians might think, “There is nothing to be done for this patient except to try a redo.”
Dr. Makkar reports financial relationships with Abbott, Cordis, Edwards Lifesciences, and Medtronic. Dr. Cribier reports a financial relationship with Edwards Lifesciences. Dr. Mylotte reports no potential conflicts of interest.
FROM EUROPCR 2023
Docs fervently hope federal ban on noncompete clauses goes through
The Federal Trade Commission’s proposed regulation that would ban noncompete agreements across the country seems like potential good news for doctors. Of course, many hospitals and employers are against it. As a result, the FTC’s sweeping proposal has tongues wagging on both sides of the issue.
Many physicians are thrilled that they may soon have more control over their career and not be stuck in jobs where they feel frustrated, underpaid, or blocked in their progress.
As of 2018, as many as 45% of primary care physicians had inked such agreements with their employers.
Typically, the agreements prevent physicians from practicing medicine with a new employer for a defined period within a specific geographic area. No matter how attractive an alternate offer of employment might be, doctors are bound by the agreements to say no if the offer exists in that defined area and time period.
The period for public comment on the proposed regulation ended on April 19, and there is currently no set date for a decision.
In a Medscape poll of 558 physicians, more than 9 out of 10 respondents said that they were either currently bound by a noncompete clause or that they had been bound by one in the past that had forced them to temporarily stop working, commute long distances, move to a different area, or switch fields.
The new proposal would make it illegal for an employer, such as a hospital or large group, to enter a noncompete with a worker; maintain a noncompete with a worker; or represent to a worker, under certain circumstances, that the worker is subject to a noncompete.
It also would not only ban future noncompete agreements but also retroactively invalidate existing ones. The FTC reasons that noncompete clauses could potentially increase worker earnings as well as lower health care costs by billions of dollars. If the ruling were to move forward, it would represent part of President Biden’s “worker-forward” priorities, focusing on how competition can be a good thing for employees. The President billed the FTC’s announcement as a “huge win for workers.”
In its statements on the proposed ban, the FTC claimed that it could lower consumer prices across the board by as much as $150 billion per year and return nearly $300 million to workers each year.
However, even if passed, the draft rule would keep in place nonsolicitation rules that many health care organizations have put into place. That means that, if a physician leaves an employer, he or she cannot reach out to former patients and colleagues to bring them along or invite them to switch to him or her in the new job.
Within that clause, however, the FTC has specified that if such nonsolicitation agreement has the “equivalent effect” of a noncompete, the agency would deem it such. That means, even if that rule stays, it could be contested and may be interpreted as violating the noncompete law. So there’s value in reading all the fine print should the ban move forward.
Could the ban bring potential downsides?
Most physicians view the potential to break free of a noncompete agreement as a victory. Peter Glennon, an employment litigation attorney with The Glennon Law Firm in Rochester, N.Y., says not so fast. “If you ask anyone if they’d prefer a noncompete agreement, of course they’re going to say no,” he said in an interview. “It sounds like a restriction, one that can hold you back.”
Mr. Glennon believes that there are actually upsides to physician noncompetes. For instance, many noncompetes come with sign-on bonuses that could potentially disappear without the agreements. There’s also the fact that when some physicians sign a noncompete agreement, they then receive pro bono training and continuing education along with marketing and promotion of their skills. Without signing a noncompete, employers may be less incentivized to provide all those benefits to their physician employers.
Those benefits – and the noncompetes – also vary by specialty, Mr. Glennon said. “In 2021, Washington, DC, banned noncompetes for doctors making less than $250,000. So, most generalists there can walk across the street and get a new job. For specialists like cardiologists or neurosurgeons, however, advanced training and marketing benefits matter, so many of them don’t want to lose noncompetes.”
Still, most physicians hope that the FTC’s ban takes hold. Manan Shah, MD, founder, and chief medical officer at Wyndly, an allergy relief startup practice, is one of them.
“Initially, it might disincentivize hospital systems from helping new physicians build up their name and practice because they might be concerned about a physician leaving and starting anew,” he said. “But in the long term, hospitals require physicians to bring their patients to them for care, so the best hospitals will always compete for the best physicians and support them as they build up their practice.”
Dr. Shah views noncompetes as overly prohibitive to physicians. “Right now, if a physician starts a job at a large hospital system and realizes they want to switch jobs, the noncompete distances are so wide they often have to move cities to continue practicing,” he said. “Picking up and starting over in a new city isn’t an option for everyone and can be especially difficult for someone with a family.”
Where Mr. Glennon argued that a physician leaving a team-based practice might harm patients, Shah takes a different perspective. “Imagine you have a doctor whom you trust and have been working with,” he said. “If something changes at their hospital and they decide to move, you literally have to find a new doctor instead of just being able to see them at another location down the street.”
Another potential burden of the noncompete agreements is that they could possibly squelch doctor’s desires to hang up their own shingle. According to Dr. Shah, the agreements make it so that if a physician wants to work independently, it’s nearly impossible to fly solo. “This is frustrating because independent practices have been shown to be more cost effective and allow patients to build better relationships with their doctors,” he claimed.
A 2016 study from Annals of Family Medicine supports that claim, at least for small general practices. Another study appearing in JAMA concurred. It does point out, however, that the cost equation is nuanced and that benefits of larger systems include more resilience to economic downturns and can provide more specialized care.
Will nonprofit hospitals be subject to this noncompete ban?
Further complicating the noncompete ban issue is how it might impact nonprofit institutions versus their for-profit peers. Most hospitals structured as nonprofits would be exempt from the rule because the FTC Act provides that it can enforce against “persons, partnerships, or corporations,” which are further defined as entities “organized to carry on business for their own profit or that of their members.”
The fallout from this, said Dr. Shah, is that it “would disproportionately affect health care providers, since many hospital systems are nonprofits. This is disconcerting because we know that many nonprofit systems make large profits anyway and can offer executive teams’ lucrative packages, while the nurses, assistants, and physicians providing the care are generally not well compensated.”
So far, about nine states plus Washington, D.C., have already put noncompete bans in place, and they may serve as a harbinger of things to come should the federal ban go into effect. Each varies in its specifics. Some, like Indiana, outright ban them, whereas others limit them based on variables like income and industry. “We’re seeing these states responding to local market conditions,” said Darryl Drevna, senior director of regulatory affairs at the American Medical Group Association. “Health care is a hyperlocal market. Depending on the situation, the bans adapt and respond specific to those states.”
Should the federal ban take hold, however, it will supersede whatever rules the individual states have in place.
Some opponents of the federal ban proposal question its authority to begin with, however, Mr. Glennon included. “Many people believe the FTC is overstepping,” he said. “Some people believe that Section 5 of the FTC Act does not give it the authority to police labor markets.”
Mr. Drevna noted that the FTC has taken an aggressive stance, one that will ultimately wind up in the courts. “How it works out is anyone’s guess,” he said. “Ideally, the FTC will consider the comments and concerns of groups like AMGA and realize that states are best suited to regulate in this area.”
In general, the ban’s supporters are employees/physicians; those who oppose it are their employers. Joining the AMGA in speaking out against the noncompete ban is the American Hospital Association, whereas the American College of Emergency Physicians has come out largely in support of the ban.
Still, doctors like Dr. Shah remain hopeful. “I am optimistic that perhaps my colleagues will not continue to be stuck in overrestrictive noncompetes, but I am also realistic,” he said. “Hospital systems are already coming out strongly against this and they have deep pockets, so I won’t be surprised if it does not come to pass.”
A version of this article first appeared on Medscape.com.
The Federal Trade Commission’s proposed regulation that would ban noncompete agreements across the country seems like potential good news for doctors. Of course, many hospitals and employers are against it. As a result, the FTC’s sweeping proposal has tongues wagging on both sides of the issue.
Many physicians are thrilled that they may soon have more control over their career and not be stuck in jobs where they feel frustrated, underpaid, or blocked in their progress.
As of 2018, as many as 45% of primary care physicians had inked such agreements with their employers.
Typically, the agreements prevent physicians from practicing medicine with a new employer for a defined period within a specific geographic area. No matter how attractive an alternate offer of employment might be, doctors are bound by the agreements to say no if the offer exists in that defined area and time period.
The period for public comment on the proposed regulation ended on April 19, and there is currently no set date for a decision.
In a Medscape poll of 558 physicians, more than 9 out of 10 respondents said that they were either currently bound by a noncompete clause or that they had been bound by one in the past that had forced them to temporarily stop working, commute long distances, move to a different area, or switch fields.
The new proposal would make it illegal for an employer, such as a hospital or large group, to enter a noncompete with a worker; maintain a noncompete with a worker; or represent to a worker, under certain circumstances, that the worker is subject to a noncompete.
It also would not only ban future noncompete agreements but also retroactively invalidate existing ones. The FTC reasons that noncompete clauses could potentially increase worker earnings as well as lower health care costs by billions of dollars. If the ruling were to move forward, it would represent part of President Biden’s “worker-forward” priorities, focusing on how competition can be a good thing for employees. The President billed the FTC’s announcement as a “huge win for workers.”
In its statements on the proposed ban, the FTC claimed that it could lower consumer prices across the board by as much as $150 billion per year and return nearly $300 million to workers each year.
However, even if passed, the draft rule would keep in place nonsolicitation rules that many health care organizations have put into place. That means that, if a physician leaves an employer, he or she cannot reach out to former patients and colleagues to bring them along or invite them to switch to him or her in the new job.
Within that clause, however, the FTC has specified that if such nonsolicitation agreement has the “equivalent effect” of a noncompete, the agency would deem it such. That means, even if that rule stays, it could be contested and may be interpreted as violating the noncompete law. So there’s value in reading all the fine print should the ban move forward.
Could the ban bring potential downsides?
Most physicians view the potential to break free of a noncompete agreement as a victory. Peter Glennon, an employment litigation attorney with The Glennon Law Firm in Rochester, N.Y., says not so fast. “If you ask anyone if they’d prefer a noncompete agreement, of course they’re going to say no,” he said in an interview. “It sounds like a restriction, one that can hold you back.”
Mr. Glennon believes that there are actually upsides to physician noncompetes. For instance, many noncompetes come with sign-on bonuses that could potentially disappear without the agreements. There’s also the fact that when some physicians sign a noncompete agreement, they then receive pro bono training and continuing education along with marketing and promotion of their skills. Without signing a noncompete, employers may be less incentivized to provide all those benefits to their physician employers.
Those benefits – and the noncompetes – also vary by specialty, Mr. Glennon said. “In 2021, Washington, DC, banned noncompetes for doctors making less than $250,000. So, most generalists there can walk across the street and get a new job. For specialists like cardiologists or neurosurgeons, however, advanced training and marketing benefits matter, so many of them don’t want to lose noncompetes.”
Still, most physicians hope that the FTC’s ban takes hold. Manan Shah, MD, founder, and chief medical officer at Wyndly, an allergy relief startup practice, is one of them.
“Initially, it might disincentivize hospital systems from helping new physicians build up their name and practice because they might be concerned about a physician leaving and starting anew,” he said. “But in the long term, hospitals require physicians to bring their patients to them for care, so the best hospitals will always compete for the best physicians and support them as they build up their practice.”
Dr. Shah views noncompetes as overly prohibitive to physicians. “Right now, if a physician starts a job at a large hospital system and realizes they want to switch jobs, the noncompete distances are so wide they often have to move cities to continue practicing,” he said. “Picking up and starting over in a new city isn’t an option for everyone and can be especially difficult for someone with a family.”
Where Mr. Glennon argued that a physician leaving a team-based practice might harm patients, Shah takes a different perspective. “Imagine you have a doctor whom you trust and have been working with,” he said. “If something changes at their hospital and they decide to move, you literally have to find a new doctor instead of just being able to see them at another location down the street.”
Another potential burden of the noncompete agreements is that they could possibly squelch doctor’s desires to hang up their own shingle. According to Dr. Shah, the agreements make it so that if a physician wants to work independently, it’s nearly impossible to fly solo. “This is frustrating because independent practices have been shown to be more cost effective and allow patients to build better relationships with their doctors,” he claimed.
A 2016 study from Annals of Family Medicine supports that claim, at least for small general practices. Another study appearing in JAMA concurred. It does point out, however, that the cost equation is nuanced and that benefits of larger systems include more resilience to economic downturns and can provide more specialized care.
Will nonprofit hospitals be subject to this noncompete ban?
Further complicating the noncompete ban issue is how it might impact nonprofit institutions versus their for-profit peers. Most hospitals structured as nonprofits would be exempt from the rule because the FTC Act provides that it can enforce against “persons, partnerships, or corporations,” which are further defined as entities “organized to carry on business for their own profit or that of their members.”
The fallout from this, said Dr. Shah, is that it “would disproportionately affect health care providers, since many hospital systems are nonprofits. This is disconcerting because we know that many nonprofit systems make large profits anyway and can offer executive teams’ lucrative packages, while the nurses, assistants, and physicians providing the care are generally not well compensated.”
So far, about nine states plus Washington, D.C., have already put noncompete bans in place, and they may serve as a harbinger of things to come should the federal ban go into effect. Each varies in its specifics. Some, like Indiana, outright ban them, whereas others limit them based on variables like income and industry. “We’re seeing these states responding to local market conditions,” said Darryl Drevna, senior director of regulatory affairs at the American Medical Group Association. “Health care is a hyperlocal market. Depending on the situation, the bans adapt and respond specific to those states.”
Should the federal ban take hold, however, it will supersede whatever rules the individual states have in place.
Some opponents of the federal ban proposal question its authority to begin with, however, Mr. Glennon included. “Many people believe the FTC is overstepping,” he said. “Some people believe that Section 5 of the FTC Act does not give it the authority to police labor markets.”
Mr. Drevna noted that the FTC has taken an aggressive stance, one that will ultimately wind up in the courts. “How it works out is anyone’s guess,” he said. “Ideally, the FTC will consider the comments and concerns of groups like AMGA and realize that states are best suited to regulate in this area.”
In general, the ban’s supporters are employees/physicians; those who oppose it are their employers. Joining the AMGA in speaking out against the noncompete ban is the American Hospital Association, whereas the American College of Emergency Physicians has come out largely in support of the ban.
Still, doctors like Dr. Shah remain hopeful. “I am optimistic that perhaps my colleagues will not continue to be stuck in overrestrictive noncompetes, but I am also realistic,” he said. “Hospital systems are already coming out strongly against this and they have deep pockets, so I won’t be surprised if it does not come to pass.”
A version of this article first appeared on Medscape.com.
The Federal Trade Commission’s proposed regulation that would ban noncompete agreements across the country seems like potential good news for doctors. Of course, many hospitals and employers are against it. As a result, the FTC’s sweeping proposal has tongues wagging on both sides of the issue.
Many physicians are thrilled that they may soon have more control over their career and not be stuck in jobs where they feel frustrated, underpaid, or blocked in their progress.
As of 2018, as many as 45% of primary care physicians had inked such agreements with their employers.
Typically, the agreements prevent physicians from practicing medicine with a new employer for a defined period within a specific geographic area. No matter how attractive an alternate offer of employment might be, doctors are bound by the agreements to say no if the offer exists in that defined area and time period.
The period for public comment on the proposed regulation ended on April 19, and there is currently no set date for a decision.
In a Medscape poll of 558 physicians, more than 9 out of 10 respondents said that they were either currently bound by a noncompete clause or that they had been bound by one in the past that had forced them to temporarily stop working, commute long distances, move to a different area, or switch fields.
The new proposal would make it illegal for an employer, such as a hospital or large group, to enter a noncompete with a worker; maintain a noncompete with a worker; or represent to a worker, under certain circumstances, that the worker is subject to a noncompete.
It also would not only ban future noncompete agreements but also retroactively invalidate existing ones. The FTC reasons that noncompete clauses could potentially increase worker earnings as well as lower health care costs by billions of dollars. If the ruling were to move forward, it would represent part of President Biden’s “worker-forward” priorities, focusing on how competition can be a good thing for employees. The President billed the FTC’s announcement as a “huge win for workers.”
In its statements on the proposed ban, the FTC claimed that it could lower consumer prices across the board by as much as $150 billion per year and return nearly $300 million to workers each year.
However, even if passed, the draft rule would keep in place nonsolicitation rules that many health care organizations have put into place. That means that, if a physician leaves an employer, he or she cannot reach out to former patients and colleagues to bring them along or invite them to switch to him or her in the new job.
Within that clause, however, the FTC has specified that if such nonsolicitation agreement has the “equivalent effect” of a noncompete, the agency would deem it such. That means, even if that rule stays, it could be contested and may be interpreted as violating the noncompete law. So there’s value in reading all the fine print should the ban move forward.
Could the ban bring potential downsides?
Most physicians view the potential to break free of a noncompete agreement as a victory. Peter Glennon, an employment litigation attorney with The Glennon Law Firm in Rochester, N.Y., says not so fast. “If you ask anyone if they’d prefer a noncompete agreement, of course they’re going to say no,” he said in an interview. “It sounds like a restriction, one that can hold you back.”
Mr. Glennon believes that there are actually upsides to physician noncompetes. For instance, many noncompetes come with sign-on bonuses that could potentially disappear without the agreements. There’s also the fact that when some physicians sign a noncompete agreement, they then receive pro bono training and continuing education along with marketing and promotion of their skills. Without signing a noncompete, employers may be less incentivized to provide all those benefits to their physician employers.
Those benefits – and the noncompetes – also vary by specialty, Mr. Glennon said. “In 2021, Washington, DC, banned noncompetes for doctors making less than $250,000. So, most generalists there can walk across the street and get a new job. For specialists like cardiologists or neurosurgeons, however, advanced training and marketing benefits matter, so many of them don’t want to lose noncompetes.”
Still, most physicians hope that the FTC’s ban takes hold. Manan Shah, MD, founder, and chief medical officer at Wyndly, an allergy relief startup practice, is one of them.
“Initially, it might disincentivize hospital systems from helping new physicians build up their name and practice because they might be concerned about a physician leaving and starting anew,” he said. “But in the long term, hospitals require physicians to bring their patients to them for care, so the best hospitals will always compete for the best physicians and support them as they build up their practice.”
Dr. Shah views noncompetes as overly prohibitive to physicians. “Right now, if a physician starts a job at a large hospital system and realizes they want to switch jobs, the noncompete distances are so wide they often have to move cities to continue practicing,” he said. “Picking up and starting over in a new city isn’t an option for everyone and can be especially difficult for someone with a family.”
Where Mr. Glennon argued that a physician leaving a team-based practice might harm patients, Shah takes a different perspective. “Imagine you have a doctor whom you trust and have been working with,” he said. “If something changes at their hospital and they decide to move, you literally have to find a new doctor instead of just being able to see them at another location down the street.”
Another potential burden of the noncompete agreements is that they could possibly squelch doctor’s desires to hang up their own shingle. According to Dr. Shah, the agreements make it so that if a physician wants to work independently, it’s nearly impossible to fly solo. “This is frustrating because independent practices have been shown to be more cost effective and allow patients to build better relationships with their doctors,” he claimed.
A 2016 study from Annals of Family Medicine supports that claim, at least for small general practices. Another study appearing in JAMA concurred. It does point out, however, that the cost equation is nuanced and that benefits of larger systems include more resilience to economic downturns and can provide more specialized care.
Will nonprofit hospitals be subject to this noncompete ban?
Further complicating the noncompete ban issue is how it might impact nonprofit institutions versus their for-profit peers. Most hospitals structured as nonprofits would be exempt from the rule because the FTC Act provides that it can enforce against “persons, partnerships, or corporations,” which are further defined as entities “organized to carry on business for their own profit or that of their members.”
The fallout from this, said Dr. Shah, is that it “would disproportionately affect health care providers, since many hospital systems are nonprofits. This is disconcerting because we know that many nonprofit systems make large profits anyway and can offer executive teams’ lucrative packages, while the nurses, assistants, and physicians providing the care are generally not well compensated.”
So far, about nine states plus Washington, D.C., have already put noncompete bans in place, and they may serve as a harbinger of things to come should the federal ban go into effect. Each varies in its specifics. Some, like Indiana, outright ban them, whereas others limit them based on variables like income and industry. “We’re seeing these states responding to local market conditions,” said Darryl Drevna, senior director of regulatory affairs at the American Medical Group Association. “Health care is a hyperlocal market. Depending on the situation, the bans adapt and respond specific to those states.”
Should the federal ban take hold, however, it will supersede whatever rules the individual states have in place.
Some opponents of the federal ban proposal question its authority to begin with, however, Mr. Glennon included. “Many people believe the FTC is overstepping,” he said. “Some people believe that Section 5 of the FTC Act does not give it the authority to police labor markets.”
Mr. Drevna noted that the FTC has taken an aggressive stance, one that will ultimately wind up in the courts. “How it works out is anyone’s guess,” he said. “Ideally, the FTC will consider the comments and concerns of groups like AMGA and realize that states are best suited to regulate in this area.”
In general, the ban’s supporters are employees/physicians; those who oppose it are their employers. Joining the AMGA in speaking out against the noncompete ban is the American Hospital Association, whereas the American College of Emergency Physicians has come out largely in support of the ban.
Still, doctors like Dr. Shah remain hopeful. “I am optimistic that perhaps my colleagues will not continue to be stuck in overrestrictive noncompetes, but I am also realistic,” he said. “Hospital systems are already coming out strongly against this and they have deep pockets, so I won’t be surprised if it does not come to pass.”
A version of this article first appeared on Medscape.com.
Immunotherapy plus chemo improves quality of life in NSCLC
In the trial, patients who received the PD-1 inhibitor plus platinum-doublet chemotherapy in the first-line setting reported significant improvements in pain symptoms and delay in time to deterioration, as well as improvements in disease-related symptoms, such as dyspnea, constipation, nausea, and vomiting.
Overall, “the findings support the concept that the superior efficacy and favorable safety profile of cemiplimab plus chemotherapy translate to better patient-reported outcomes compared with chemotherapy alone in patients with advanced non–small cell lung cancer, “ corresponding author Tamta Makharadze, MD, of LTD High Technology Hospital Med Center in Batumi, Georgia, said in a press release.
The delays reported in time to definitive clinically meaningful deterioration “are particularly pertinent, given the anticipated continued improvements in cancer survivorship among patients with advanced NSCLC,” the authors explained.
The research was published online May 8 in Cancer.
Quality of life is especially important for patients with advanced NSCLC, for whom the benefits of improved survival must be weighed against the potential drawbacks of treatment toxicities, which can severely impact quality of life, the authors noted.
In the initial multinational phase 3 EMPOWER-Lung 3 trial, Dr. Makharadze and colleagues randomly assigned 466 patients with stage IIIB, IIIC, or stage IV NSCLC to receive either 350 mg of cemiplimab (Libtayo, Regeneron Pharmaceuticals) every 3 weeks along with investigator’s choice of platinum‐doublet chemotherapy or placebo plus chemotherapy. Investigator’s choice of chemotherapy was either paclitaxel plus carboplatin or cisplatin, pemetrexed plus carboplatin, or cisplatin.
The researchers found that the addition of cemiplimab to chemotherapy was associated with a significant, almost 9-month improvement in overall survival. While the trial also highlighted significant improvements in quality of life, functioning, and most symptoms with cemiplimab in comparison with placebo, the current study provides more details on these patient-reported quality-of-life outcomes.
In the latest analysis, Dr. Makharadze and colleagues evaluated data on the 312 patients in the cemiplimab arm and the 154 in the placebo arm. The median age of the patients was 63 years, and most (83.9%) were men.
Patients in the cemiplimab arm reported significant improvements in pain symptoms from baseline, as measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life–Core 30 (QLQ‐C30) score (–4.98; P = .004).
Patients who were treated with cemiplimab also reported a significant delay in time to definitive clinically meaningful deterioration (hazard ratio [HR], 0.39; P < .0001).
Significant delays in the time to deterioration in other functioning and symptom scales favored the cemiplimab group, including dyspnea (HR, 0.54), nausea/vomiting (HR, 0.39), and constipation (HR, 0.48).
The cemiplimab group also reported significantly delayed time to deterioration in physical (HR, 0.62) and emotional functioning (HR, 0.52) compared with the placebo arm as well as significant overall improvements from baseline in global health status/quality of life scores.
No significant improvements in patient-reported outcomes favoring the placebo group were observed on any quality-of-life metric evaluated using the symptom scales.
As for study limitations, the authors said that although about 86% of patients in both arms completed at least one question at baseline and post baseline, “the results may have overrepresented the patients who did well in both treatment arms because patients who progressed no longer completed the questionnaires.”
Nevertheless, the results “show that the favorable efficacy achieved with cemiplimab plus chemotherapy over placebo plus chemotherapy is accompanied by significant overall improvement in pain and significant delay in [time to definitive clinically meaningful deterioration] in multiple patient‐reported cancer‐related and lung cancer–specific functions and symptoms,” the authors concluded.
The study was sponsored by Regeneron Pharmaceuticals and Sanofi.
A version of this article originally appeared on Medscape.com.
In the trial, patients who received the PD-1 inhibitor plus platinum-doublet chemotherapy in the first-line setting reported significant improvements in pain symptoms and delay in time to deterioration, as well as improvements in disease-related symptoms, such as dyspnea, constipation, nausea, and vomiting.
Overall, “the findings support the concept that the superior efficacy and favorable safety profile of cemiplimab plus chemotherapy translate to better patient-reported outcomes compared with chemotherapy alone in patients with advanced non–small cell lung cancer, “ corresponding author Tamta Makharadze, MD, of LTD High Technology Hospital Med Center in Batumi, Georgia, said in a press release.
The delays reported in time to definitive clinically meaningful deterioration “are particularly pertinent, given the anticipated continued improvements in cancer survivorship among patients with advanced NSCLC,” the authors explained.
The research was published online May 8 in Cancer.
Quality of life is especially important for patients with advanced NSCLC, for whom the benefits of improved survival must be weighed against the potential drawbacks of treatment toxicities, which can severely impact quality of life, the authors noted.
In the initial multinational phase 3 EMPOWER-Lung 3 trial, Dr. Makharadze and colleagues randomly assigned 466 patients with stage IIIB, IIIC, or stage IV NSCLC to receive either 350 mg of cemiplimab (Libtayo, Regeneron Pharmaceuticals) every 3 weeks along with investigator’s choice of platinum‐doublet chemotherapy or placebo plus chemotherapy. Investigator’s choice of chemotherapy was either paclitaxel plus carboplatin or cisplatin, pemetrexed plus carboplatin, or cisplatin.
The researchers found that the addition of cemiplimab to chemotherapy was associated with a significant, almost 9-month improvement in overall survival. While the trial also highlighted significant improvements in quality of life, functioning, and most symptoms with cemiplimab in comparison with placebo, the current study provides more details on these patient-reported quality-of-life outcomes.
In the latest analysis, Dr. Makharadze and colleagues evaluated data on the 312 patients in the cemiplimab arm and the 154 in the placebo arm. The median age of the patients was 63 years, and most (83.9%) were men.
Patients in the cemiplimab arm reported significant improvements in pain symptoms from baseline, as measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life–Core 30 (QLQ‐C30) score (–4.98; P = .004).
Patients who were treated with cemiplimab also reported a significant delay in time to definitive clinically meaningful deterioration (hazard ratio [HR], 0.39; P < .0001).
Significant delays in the time to deterioration in other functioning and symptom scales favored the cemiplimab group, including dyspnea (HR, 0.54), nausea/vomiting (HR, 0.39), and constipation (HR, 0.48).
The cemiplimab group also reported significantly delayed time to deterioration in physical (HR, 0.62) and emotional functioning (HR, 0.52) compared with the placebo arm as well as significant overall improvements from baseline in global health status/quality of life scores.
No significant improvements in patient-reported outcomes favoring the placebo group were observed on any quality-of-life metric evaluated using the symptom scales.
As for study limitations, the authors said that although about 86% of patients in both arms completed at least one question at baseline and post baseline, “the results may have overrepresented the patients who did well in both treatment arms because patients who progressed no longer completed the questionnaires.”
Nevertheless, the results “show that the favorable efficacy achieved with cemiplimab plus chemotherapy over placebo plus chemotherapy is accompanied by significant overall improvement in pain and significant delay in [time to definitive clinically meaningful deterioration] in multiple patient‐reported cancer‐related and lung cancer–specific functions and symptoms,” the authors concluded.
The study was sponsored by Regeneron Pharmaceuticals and Sanofi.
A version of this article originally appeared on Medscape.com.
In the trial, patients who received the PD-1 inhibitor plus platinum-doublet chemotherapy in the first-line setting reported significant improvements in pain symptoms and delay in time to deterioration, as well as improvements in disease-related symptoms, such as dyspnea, constipation, nausea, and vomiting.
Overall, “the findings support the concept that the superior efficacy and favorable safety profile of cemiplimab plus chemotherapy translate to better patient-reported outcomes compared with chemotherapy alone in patients with advanced non–small cell lung cancer, “ corresponding author Tamta Makharadze, MD, of LTD High Technology Hospital Med Center in Batumi, Georgia, said in a press release.
The delays reported in time to definitive clinically meaningful deterioration “are particularly pertinent, given the anticipated continued improvements in cancer survivorship among patients with advanced NSCLC,” the authors explained.
The research was published online May 8 in Cancer.
Quality of life is especially important for patients with advanced NSCLC, for whom the benefits of improved survival must be weighed against the potential drawbacks of treatment toxicities, which can severely impact quality of life, the authors noted.
In the initial multinational phase 3 EMPOWER-Lung 3 trial, Dr. Makharadze and colleagues randomly assigned 466 patients with stage IIIB, IIIC, or stage IV NSCLC to receive either 350 mg of cemiplimab (Libtayo, Regeneron Pharmaceuticals) every 3 weeks along with investigator’s choice of platinum‐doublet chemotherapy or placebo plus chemotherapy. Investigator’s choice of chemotherapy was either paclitaxel plus carboplatin or cisplatin, pemetrexed plus carboplatin, or cisplatin.
The researchers found that the addition of cemiplimab to chemotherapy was associated with a significant, almost 9-month improvement in overall survival. While the trial also highlighted significant improvements in quality of life, functioning, and most symptoms with cemiplimab in comparison with placebo, the current study provides more details on these patient-reported quality-of-life outcomes.
In the latest analysis, Dr. Makharadze and colleagues evaluated data on the 312 patients in the cemiplimab arm and the 154 in the placebo arm. The median age of the patients was 63 years, and most (83.9%) were men.
Patients in the cemiplimab arm reported significant improvements in pain symptoms from baseline, as measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life–Core 30 (QLQ‐C30) score (–4.98; P = .004).
Patients who were treated with cemiplimab also reported a significant delay in time to definitive clinically meaningful deterioration (hazard ratio [HR], 0.39; P < .0001).
Significant delays in the time to deterioration in other functioning and symptom scales favored the cemiplimab group, including dyspnea (HR, 0.54), nausea/vomiting (HR, 0.39), and constipation (HR, 0.48).
The cemiplimab group also reported significantly delayed time to deterioration in physical (HR, 0.62) and emotional functioning (HR, 0.52) compared with the placebo arm as well as significant overall improvements from baseline in global health status/quality of life scores.
No significant improvements in patient-reported outcomes favoring the placebo group were observed on any quality-of-life metric evaluated using the symptom scales.
As for study limitations, the authors said that although about 86% of patients in both arms completed at least one question at baseline and post baseline, “the results may have overrepresented the patients who did well in both treatment arms because patients who progressed no longer completed the questionnaires.”
Nevertheless, the results “show that the favorable efficacy achieved with cemiplimab plus chemotherapy over placebo plus chemotherapy is accompanied by significant overall improvement in pain and significant delay in [time to definitive clinically meaningful deterioration] in multiple patient‐reported cancer‐related and lung cancer–specific functions and symptoms,” the authors concluded.
The study was sponsored by Regeneron Pharmaceuticals and Sanofi.
A version of this article originally appeared on Medscape.com.
FROM CANCER
How BMI over time impacts GI cancer risk
according to new data from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial.
The researchers found that being overweight or obese in early and middle adulthood was associated with an increased risk for colorectal cancer (CRC) and noncolorectal GI cancers. Maintaining or increasing BMI over time among overweight or obese individuals was also associated with an increased GI cancer risk.
Aspirin use did not significantly modify these associations, suggesting that aspirin may not be as effective for cancer prevention among overweight or obese individuals.
The results provide “relatively consistent messaging that overweight or obesity from early to later adulthood as well as BMI increases throughout adulthood were associated with increased risk of GI cancers, especially CRC,” the authors of an editorial accompanying the study wrote.
These “important findings highlight the unmet need to identify the critical time window linking adiposity and GI cancer,” said editorialists Mengyao Shi, MBBS, MPD, and Yin Cao, ScD, MPH, of Washington University in St. Louis.
The analysis was published online in JAMA Network Open.
A growing body of evidence has revealed a strong association between obesity and GI cancers, with chronic inflammation being a likely cause. As rates of overweight and obesity continue to grow, better understanding of the association between obesity and cancer has become increasingly important.
In the analysis, Holli A. Loomans-Kropp, PhD, MPH, with Ohio State University, Columbus, and Asad Umar, PhD, DVM, with the National Cancer Institute, Rockville, Md., explored associations between BMI in early adulthood (age 20), middle adulthood (age 50) and later adulthood (age 55 and over) and GI cancer risk in 135,161 adults from the PLCO Cancer Screening Trial.
BMI was determined using self-reported height and weight at each age time point. The median age at enrollment was 62 years, and 50% of participants were women. Overweight BMI was 25.0-29.9 kg/m2 and obese BMI was 30 or higher.
During as many as 21 years of follow-up, 2,803 individuals developed CRC and 2,285 developed non-CRC GI cancers (esophageal, liver, gastric, and pancreatic).
Overweight BMI in early, middle, and later adulthood was associated with an increased risk of CRC (hazard ratio, 1.23 for early and middle years; HR, 1.21 for later years). Obese BMI in middle and later adulthood was also associated with increased risk of CRC (HR, 1.55 and 1.39, respectively).
The authors observed similar associations between BMI in middle and later adulthood and overall GI and non-CRC GI risk.
“When modeled continuously, we observed 2%-4% increased risk of both CRC and noncolorectal GI cancer with each 1-unit increase in BMI across all time points,” the researchers said.
Their data also suggest that BMI over time may be associated with GI cancer risk. Adults who exhibited no change in overweight or obese BMIs between early and later adulthood and those who exhibited increases in BMI from underweight or normal in early adulthood to overweight or obese BMI in later adulthood had a significantly higher risk for CRC and noncolorectal GI cancer.
Among frequent aspirin users, those with overweight or obese BMIs in early, middle, and later adulthood still had an increased risk for CRC and noncolorectal GI cancer (hazard ratios, 1.44, 1.45, and 1.43, respectively).
The finding that regular weekly aspirin use did not modify GI cancer risk suggests that obesity may alter the cancer-preventive effect of aspirin, the researchers suggested. Individuals with obesity may need to increase aspirin frequency or dosage to see an effect, but upping the dose comes with its own risks, including GI bleeding.
Overall, until now, most epidemiologic studies have examined BMI at one time point, “missing the opportunity to delineate the contribution of adiposity throughout the life course,” Dr. Shi and Dr. Cao wrote.
“As we continue to investigate precision-based interventions to intercept the link between obesity and cancer, it is imperative to reiterate the importance of maintaining a healthy weight and lifestyle from an early age and incorporate it widely into cancer prevention strategies at all levels with immediate implementation,” the editorialists concluded.
This study was supported in part by funds from Ohio State University and the NIH. The study authors reported no relevant financial relationships. Dr. Cao has received personal fees from Geneoscopy for consulting.
A version of this article originally appeared on Medscape.com.
according to new data from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial.
The researchers found that being overweight or obese in early and middle adulthood was associated with an increased risk for colorectal cancer (CRC) and noncolorectal GI cancers. Maintaining or increasing BMI over time among overweight or obese individuals was also associated with an increased GI cancer risk.
Aspirin use did not significantly modify these associations, suggesting that aspirin may not be as effective for cancer prevention among overweight or obese individuals.
The results provide “relatively consistent messaging that overweight or obesity from early to later adulthood as well as BMI increases throughout adulthood were associated with increased risk of GI cancers, especially CRC,” the authors of an editorial accompanying the study wrote.
These “important findings highlight the unmet need to identify the critical time window linking adiposity and GI cancer,” said editorialists Mengyao Shi, MBBS, MPD, and Yin Cao, ScD, MPH, of Washington University in St. Louis.
The analysis was published online in JAMA Network Open.
A growing body of evidence has revealed a strong association between obesity and GI cancers, with chronic inflammation being a likely cause. As rates of overweight and obesity continue to grow, better understanding of the association between obesity and cancer has become increasingly important.
In the analysis, Holli A. Loomans-Kropp, PhD, MPH, with Ohio State University, Columbus, and Asad Umar, PhD, DVM, with the National Cancer Institute, Rockville, Md., explored associations between BMI in early adulthood (age 20), middle adulthood (age 50) and later adulthood (age 55 and over) and GI cancer risk in 135,161 adults from the PLCO Cancer Screening Trial.
BMI was determined using self-reported height and weight at each age time point. The median age at enrollment was 62 years, and 50% of participants were women. Overweight BMI was 25.0-29.9 kg/m2 and obese BMI was 30 or higher.
During as many as 21 years of follow-up, 2,803 individuals developed CRC and 2,285 developed non-CRC GI cancers (esophageal, liver, gastric, and pancreatic).
Overweight BMI in early, middle, and later adulthood was associated with an increased risk of CRC (hazard ratio, 1.23 for early and middle years; HR, 1.21 for later years). Obese BMI in middle and later adulthood was also associated with increased risk of CRC (HR, 1.55 and 1.39, respectively).
The authors observed similar associations between BMI in middle and later adulthood and overall GI and non-CRC GI risk.
“When modeled continuously, we observed 2%-4% increased risk of both CRC and noncolorectal GI cancer with each 1-unit increase in BMI across all time points,” the researchers said.
Their data also suggest that BMI over time may be associated with GI cancer risk. Adults who exhibited no change in overweight or obese BMIs between early and later adulthood and those who exhibited increases in BMI from underweight or normal in early adulthood to overweight or obese BMI in later adulthood had a significantly higher risk for CRC and noncolorectal GI cancer.
Among frequent aspirin users, those with overweight or obese BMIs in early, middle, and later adulthood still had an increased risk for CRC and noncolorectal GI cancer (hazard ratios, 1.44, 1.45, and 1.43, respectively).
The finding that regular weekly aspirin use did not modify GI cancer risk suggests that obesity may alter the cancer-preventive effect of aspirin, the researchers suggested. Individuals with obesity may need to increase aspirin frequency or dosage to see an effect, but upping the dose comes with its own risks, including GI bleeding.
Overall, until now, most epidemiologic studies have examined BMI at one time point, “missing the opportunity to delineate the contribution of adiposity throughout the life course,” Dr. Shi and Dr. Cao wrote.
“As we continue to investigate precision-based interventions to intercept the link between obesity and cancer, it is imperative to reiterate the importance of maintaining a healthy weight and lifestyle from an early age and incorporate it widely into cancer prevention strategies at all levels with immediate implementation,” the editorialists concluded.
This study was supported in part by funds from Ohio State University and the NIH. The study authors reported no relevant financial relationships. Dr. Cao has received personal fees from Geneoscopy for consulting.
A version of this article originally appeared on Medscape.com.
according to new data from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial.
The researchers found that being overweight or obese in early and middle adulthood was associated with an increased risk for colorectal cancer (CRC) and noncolorectal GI cancers. Maintaining or increasing BMI over time among overweight or obese individuals was also associated with an increased GI cancer risk.
Aspirin use did not significantly modify these associations, suggesting that aspirin may not be as effective for cancer prevention among overweight or obese individuals.
The results provide “relatively consistent messaging that overweight or obesity from early to later adulthood as well as BMI increases throughout adulthood were associated with increased risk of GI cancers, especially CRC,” the authors of an editorial accompanying the study wrote.
These “important findings highlight the unmet need to identify the critical time window linking adiposity and GI cancer,” said editorialists Mengyao Shi, MBBS, MPD, and Yin Cao, ScD, MPH, of Washington University in St. Louis.
The analysis was published online in JAMA Network Open.
A growing body of evidence has revealed a strong association between obesity and GI cancers, with chronic inflammation being a likely cause. As rates of overweight and obesity continue to grow, better understanding of the association between obesity and cancer has become increasingly important.
In the analysis, Holli A. Loomans-Kropp, PhD, MPH, with Ohio State University, Columbus, and Asad Umar, PhD, DVM, with the National Cancer Institute, Rockville, Md., explored associations between BMI in early adulthood (age 20), middle adulthood (age 50) and later adulthood (age 55 and over) and GI cancer risk in 135,161 adults from the PLCO Cancer Screening Trial.
BMI was determined using self-reported height and weight at each age time point. The median age at enrollment was 62 years, and 50% of participants were women. Overweight BMI was 25.0-29.9 kg/m2 and obese BMI was 30 or higher.
During as many as 21 years of follow-up, 2,803 individuals developed CRC and 2,285 developed non-CRC GI cancers (esophageal, liver, gastric, and pancreatic).
Overweight BMI in early, middle, and later adulthood was associated with an increased risk of CRC (hazard ratio, 1.23 for early and middle years; HR, 1.21 for later years). Obese BMI in middle and later adulthood was also associated with increased risk of CRC (HR, 1.55 and 1.39, respectively).
The authors observed similar associations between BMI in middle and later adulthood and overall GI and non-CRC GI risk.
“When modeled continuously, we observed 2%-4% increased risk of both CRC and noncolorectal GI cancer with each 1-unit increase in BMI across all time points,” the researchers said.
Their data also suggest that BMI over time may be associated with GI cancer risk. Adults who exhibited no change in overweight or obese BMIs between early and later adulthood and those who exhibited increases in BMI from underweight or normal in early adulthood to overweight or obese BMI in later adulthood had a significantly higher risk for CRC and noncolorectal GI cancer.
Among frequent aspirin users, those with overweight or obese BMIs in early, middle, and later adulthood still had an increased risk for CRC and noncolorectal GI cancer (hazard ratios, 1.44, 1.45, and 1.43, respectively).
The finding that regular weekly aspirin use did not modify GI cancer risk suggests that obesity may alter the cancer-preventive effect of aspirin, the researchers suggested. Individuals with obesity may need to increase aspirin frequency or dosage to see an effect, but upping the dose comes with its own risks, including GI bleeding.
Overall, until now, most epidemiologic studies have examined BMI at one time point, “missing the opportunity to delineate the contribution of adiposity throughout the life course,” Dr. Shi and Dr. Cao wrote.
“As we continue to investigate precision-based interventions to intercept the link between obesity and cancer, it is imperative to reiterate the importance of maintaining a healthy weight and lifestyle from an early age and incorporate it widely into cancer prevention strategies at all levels with immediate implementation,” the editorialists concluded.
This study was supported in part by funds from Ohio State University and the NIH. The study authors reported no relevant financial relationships. Dr. Cao has received personal fees from Geneoscopy for consulting.
A version of this article originally appeared on Medscape.com.
FROM JAMA NETWORK OPEN
AHA urges action against racial inequities in stroke care
Stroke is a “disease of disparities,” with racial and ethnic inequities in incidence, prevalence, treatment, and outcomes, and research is needed to identify structural or “upstream” interventions to address the problem, the American Heart Association says in a new scientific statement.
including Black, Hispanic, and Indigenous peoples,” writing group chair Amytis Towfighi, MD, professor of neurology, University of Southern California, Los Angeles, says in a news release.
“While research has historically focused on describing these inequities, it is critical to develop and test interventions to address them,” Dr. Towfighi adds.
The scientific statement was published online in the journal Stroke.
It follows a 2020 AHA presidential advisory that declared structural racism a fundamental driver of poor health and early death from heart disease and stroke.
Dr. Towfighi and colleagues reviewed the literature on interventions to address racial and ethnic inequities to identify gaps and areas for future research.
They note that various interventions have shown promise in reducing inequities across the stroke continuum of care.
For example, data suggest that careful attention to stroke preparedness among patients, caregivers, and emergency medical services can reduce inequities in getting people suspected of having a stroke to the emergency department quickly, with delivery of prompt treatment.
However, insufficient research attention has been paid to reducing inequities in rehabilitation, recovery, and social reintegration, the writing group says.
In addition, most studies have addressed patient-level factors, such as medication adherence, health literacy, and health behaviors, but not upstream social factors such as structural racism, housing, income, food security, and access to care, which also affect stroke incidence, care, and outcomes.
“Combating the effects of systemic racism will involve upstream interventions, including policy changes, place-based interventions, and engaging with the health care systems that serve predominantly historically disenfranchised populations and the communities they serve, understanding the barriers, and collaboratively developing solutions to address barriers,” the writing group says.
Further research is needed across the stroke continuum of care to tackle racial and ethnic inequities in stroke care and improve outcomes, they say.
“It’s critical for historically disenfranchised communities to participate in research so that researchers may collaborate in addressing the communities’ needs and concerns,” Bernadette Boden-Albala, DrPH, MPH, vice chair of the writing group, says in the news release.
“Opportunities include working with community stakeholder groups and community organizations to advocate for partnerships with hospitals, academic medical centers, local colleges and universities; or joining community advisory boards and volunteering with the American Heart Association,” Dr. Boden-Albala adds.
Dr. Towfighi encourages health care professionals to “think outside the ‘stroke box.’ Sustainable, effective interventions to address inequities will likely require collaboration with patients, their communities, policymakers, and other sectors.”
The scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular and Stroke Nursing, the Council on Cardiovascular Radiology and Intervention, the Council on Clinical Cardiology, the Council on Hypertension, the Council on the Kidney in Cardiovascular Disease, and the Council on Peripheral Vascular Disease.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
Stroke is a “disease of disparities,” with racial and ethnic inequities in incidence, prevalence, treatment, and outcomes, and research is needed to identify structural or “upstream” interventions to address the problem, the American Heart Association says in a new scientific statement.
including Black, Hispanic, and Indigenous peoples,” writing group chair Amytis Towfighi, MD, professor of neurology, University of Southern California, Los Angeles, says in a news release.
“While research has historically focused on describing these inequities, it is critical to develop and test interventions to address them,” Dr. Towfighi adds.
The scientific statement was published online in the journal Stroke.
It follows a 2020 AHA presidential advisory that declared structural racism a fundamental driver of poor health and early death from heart disease and stroke.
Dr. Towfighi and colleagues reviewed the literature on interventions to address racial and ethnic inequities to identify gaps and areas for future research.
They note that various interventions have shown promise in reducing inequities across the stroke continuum of care.
For example, data suggest that careful attention to stroke preparedness among patients, caregivers, and emergency medical services can reduce inequities in getting people suspected of having a stroke to the emergency department quickly, with delivery of prompt treatment.
However, insufficient research attention has been paid to reducing inequities in rehabilitation, recovery, and social reintegration, the writing group says.
In addition, most studies have addressed patient-level factors, such as medication adherence, health literacy, and health behaviors, but not upstream social factors such as structural racism, housing, income, food security, and access to care, which also affect stroke incidence, care, and outcomes.
“Combating the effects of systemic racism will involve upstream interventions, including policy changes, place-based interventions, and engaging with the health care systems that serve predominantly historically disenfranchised populations and the communities they serve, understanding the barriers, and collaboratively developing solutions to address barriers,” the writing group says.
Further research is needed across the stroke continuum of care to tackle racial and ethnic inequities in stroke care and improve outcomes, they say.
“It’s critical for historically disenfranchised communities to participate in research so that researchers may collaborate in addressing the communities’ needs and concerns,” Bernadette Boden-Albala, DrPH, MPH, vice chair of the writing group, says in the news release.
“Opportunities include working with community stakeholder groups and community organizations to advocate for partnerships with hospitals, academic medical centers, local colleges and universities; or joining community advisory boards and volunteering with the American Heart Association,” Dr. Boden-Albala adds.
Dr. Towfighi encourages health care professionals to “think outside the ‘stroke box.’ Sustainable, effective interventions to address inequities will likely require collaboration with patients, their communities, policymakers, and other sectors.”
The scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular and Stroke Nursing, the Council on Cardiovascular Radiology and Intervention, the Council on Clinical Cardiology, the Council on Hypertension, the Council on the Kidney in Cardiovascular Disease, and the Council on Peripheral Vascular Disease.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
Stroke is a “disease of disparities,” with racial and ethnic inequities in incidence, prevalence, treatment, and outcomes, and research is needed to identify structural or “upstream” interventions to address the problem, the American Heart Association says in a new scientific statement.
including Black, Hispanic, and Indigenous peoples,” writing group chair Amytis Towfighi, MD, professor of neurology, University of Southern California, Los Angeles, says in a news release.
“While research has historically focused on describing these inequities, it is critical to develop and test interventions to address them,” Dr. Towfighi adds.
The scientific statement was published online in the journal Stroke.
It follows a 2020 AHA presidential advisory that declared structural racism a fundamental driver of poor health and early death from heart disease and stroke.
Dr. Towfighi and colleagues reviewed the literature on interventions to address racial and ethnic inequities to identify gaps and areas for future research.
They note that various interventions have shown promise in reducing inequities across the stroke continuum of care.
For example, data suggest that careful attention to stroke preparedness among patients, caregivers, and emergency medical services can reduce inequities in getting people suspected of having a stroke to the emergency department quickly, with delivery of prompt treatment.
However, insufficient research attention has been paid to reducing inequities in rehabilitation, recovery, and social reintegration, the writing group says.
In addition, most studies have addressed patient-level factors, such as medication adherence, health literacy, and health behaviors, but not upstream social factors such as structural racism, housing, income, food security, and access to care, which also affect stroke incidence, care, and outcomes.
“Combating the effects of systemic racism will involve upstream interventions, including policy changes, place-based interventions, and engaging with the health care systems that serve predominantly historically disenfranchised populations and the communities they serve, understanding the barriers, and collaboratively developing solutions to address barriers,” the writing group says.
Further research is needed across the stroke continuum of care to tackle racial and ethnic inequities in stroke care and improve outcomes, they say.
“It’s critical for historically disenfranchised communities to participate in research so that researchers may collaborate in addressing the communities’ needs and concerns,” Bernadette Boden-Albala, DrPH, MPH, vice chair of the writing group, says in the news release.
“Opportunities include working with community stakeholder groups and community organizations to advocate for partnerships with hospitals, academic medical centers, local colleges and universities; or joining community advisory boards and volunteering with the American Heart Association,” Dr. Boden-Albala adds.
Dr. Towfighi encourages health care professionals to “think outside the ‘stroke box.’ Sustainable, effective interventions to address inequities will likely require collaboration with patients, their communities, policymakers, and other sectors.”
The scientific statement was prepared by the volunteer writing group on behalf of the AHA Stroke Council, the Council on Cardiovascular and Stroke Nursing, the Council on Cardiovascular Radiology and Intervention, the Council on Clinical Cardiology, the Council on Hypertension, the Council on the Kidney in Cardiovascular Disease, and the Council on Peripheral Vascular Disease.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
FROM STROKE
Genomic assay changes minds on HER2+ BC treatment
The prospective pilot study is small, and the researchers didn’t report on how the patients fared, according to a poster presented at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Plus, the test itself hasn’t been analyzed prospectively. But the study’s lead author, Olga Martínez-Sáez, MD, PhD, said in an interview that the 56% number is significant.
“We consider this percentage to be clinically very relevant,” said Dr. Martínez-Sáez, an oncologist at Hospital Clinic of Barcelona and the University of Barcelona. “HER2DX can change practice.”
Also in an interview, Kent Hoskins, MD, associate chief of hematology/oncology at University of Illinois at Chicago, described HER2DX as a next-generation genomic test that builds on assays developed 2 decades ago to help identify patients who would benefit – or not – from adjuvant chemotherapy.
Dr. Hoskins, who isn’t connected to the new study but has studied genomic tests for breast cancer, said the HER2DX test seeks to provide guidance to oncologists about which of several treatments are most effective in treating patients with HER2+ breast cancer.
“The overall trend in the HER2+ space is escalating therapy, and the cure rates have improved quite substantially,” he said. “But do they all need that much therapy? That’s the clinical question that this assay is addressing.”
The assay examines clinical features and the expression of 4 gene signatures, Dr. Martínez-Sáez said. It provides a risk score estimating the likelihood of recurrence plus a score that estimates the likelihood of achieving pathological complete response (pCR) with trastuzumab-based neoadjuvant therapy and an ERBB2 mRNA score.
In a retrospective 2022 study published in eBioMedicine, researchers reported that the assay “predicts response following neoadjuvant letrozole in combination with dual HER2 blockade with trastuzumab and pertuzumab in early-stage HER2-positive/hormone receptor–positive breast cancer.”
In the 2022 study, researchers wrote that assay results and other scores “might help better tailor systemic therapy in this context and identify candidates for avoiding chemotherapy, a therapy associated with short- and long-term toxicities and impact in quality of life.”
For the new study, a decision-impact analysis, researchers tracked 89 patients with HER2+ breast cancer (median age = 53 years, range 30-79, and 52% postmenopausal), the poster says. Most had T1-2 tumors (87%), negative nodes (64%), grade 2 (56%) or 3 (41%) tumors, and ductal histology (87%). And most were hormone receptor positive (65%). Seventy-eight percent of patients received neoadjuvant therapy (NAT), and 22% underwent upfront surgery.
In 56% of cases, oncologists changed their treatment decisions after getting the results of the HER2DX assays. In 59% of these cases, oncologists de-escalated therapy; in 41%, they escalated therapy, opting for more intense chemotherapy 65% of the time, according to the poster.
Clinician confidence in their decisions improved in 67% of cases, the researchers reported in their poster. Among 56 patients treated with neoadjuvant therapy who could be evaluated, “HER2DX pCR score was significantly associated with pCR (81% in pCR-medium/high and 32% in pCR-low; odds ratio=9.3, P = 0.001) independently of the rest of variables.”
Dr. Hoskins said the new report suggests that the assay can change treatment decisions, although he cautioned that “this study does not in itself establish its place in standard of care.” Large, prospective, randomized research is still needed, he said.
Dr. Martínez-Sáez said, in an interview, that the HER2DX assay should cost about as much as genomic assays for other breast cancer subtypes. These kinds of tests have cost several thousand dollars each in recent years.
What’s next? The decision impact study is ongoing. As for research into the assay itself, “prospective clinical trials are planned to demonstrate its clinical utility to de-escalate and guide therapy,” Dr. Martínez-Sáez said.
No funding is reported. Reveal Genomics is the developer of the HER2DX assay. Dr. Martinez- Saez reports financial relationships with Novartis, Eisai, Roche, and Reveal Genomics. Other study authors report multiple disclosures. Dr. Hoskins discloses non-financial research support from Agendia, which makes the MammaPrint early-breast-cancer assay.
The prospective pilot study is small, and the researchers didn’t report on how the patients fared, according to a poster presented at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Plus, the test itself hasn’t been analyzed prospectively. But the study’s lead author, Olga Martínez-Sáez, MD, PhD, said in an interview that the 56% number is significant.
“We consider this percentage to be clinically very relevant,” said Dr. Martínez-Sáez, an oncologist at Hospital Clinic of Barcelona and the University of Barcelona. “HER2DX can change practice.”
Also in an interview, Kent Hoskins, MD, associate chief of hematology/oncology at University of Illinois at Chicago, described HER2DX as a next-generation genomic test that builds on assays developed 2 decades ago to help identify patients who would benefit – or not – from adjuvant chemotherapy.
Dr. Hoskins, who isn’t connected to the new study but has studied genomic tests for breast cancer, said the HER2DX test seeks to provide guidance to oncologists about which of several treatments are most effective in treating patients with HER2+ breast cancer.
“The overall trend in the HER2+ space is escalating therapy, and the cure rates have improved quite substantially,” he said. “But do they all need that much therapy? That’s the clinical question that this assay is addressing.”
The assay examines clinical features and the expression of 4 gene signatures, Dr. Martínez-Sáez said. It provides a risk score estimating the likelihood of recurrence plus a score that estimates the likelihood of achieving pathological complete response (pCR) with trastuzumab-based neoadjuvant therapy and an ERBB2 mRNA score.
In a retrospective 2022 study published in eBioMedicine, researchers reported that the assay “predicts response following neoadjuvant letrozole in combination with dual HER2 blockade with trastuzumab and pertuzumab in early-stage HER2-positive/hormone receptor–positive breast cancer.”
In the 2022 study, researchers wrote that assay results and other scores “might help better tailor systemic therapy in this context and identify candidates for avoiding chemotherapy, a therapy associated with short- and long-term toxicities and impact in quality of life.”
For the new study, a decision-impact analysis, researchers tracked 89 patients with HER2+ breast cancer (median age = 53 years, range 30-79, and 52% postmenopausal), the poster says. Most had T1-2 tumors (87%), negative nodes (64%), grade 2 (56%) or 3 (41%) tumors, and ductal histology (87%). And most were hormone receptor positive (65%). Seventy-eight percent of patients received neoadjuvant therapy (NAT), and 22% underwent upfront surgery.
In 56% of cases, oncologists changed their treatment decisions after getting the results of the HER2DX assays. In 59% of these cases, oncologists de-escalated therapy; in 41%, they escalated therapy, opting for more intense chemotherapy 65% of the time, according to the poster.
Clinician confidence in their decisions improved in 67% of cases, the researchers reported in their poster. Among 56 patients treated with neoadjuvant therapy who could be evaluated, “HER2DX pCR score was significantly associated with pCR (81% in pCR-medium/high and 32% in pCR-low; odds ratio=9.3, P = 0.001) independently of the rest of variables.”
Dr. Hoskins said the new report suggests that the assay can change treatment decisions, although he cautioned that “this study does not in itself establish its place in standard of care.” Large, prospective, randomized research is still needed, he said.
Dr. Martínez-Sáez said, in an interview, that the HER2DX assay should cost about as much as genomic assays for other breast cancer subtypes. These kinds of tests have cost several thousand dollars each in recent years.
What’s next? The decision impact study is ongoing. As for research into the assay itself, “prospective clinical trials are planned to demonstrate its clinical utility to de-escalate and guide therapy,” Dr. Martínez-Sáez said.
No funding is reported. Reveal Genomics is the developer of the HER2DX assay. Dr. Martinez- Saez reports financial relationships with Novartis, Eisai, Roche, and Reveal Genomics. Other study authors report multiple disclosures. Dr. Hoskins discloses non-financial research support from Agendia, which makes the MammaPrint early-breast-cancer assay.
The prospective pilot study is small, and the researchers didn’t report on how the patients fared, according to a poster presented at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Plus, the test itself hasn’t been analyzed prospectively. But the study’s lead author, Olga Martínez-Sáez, MD, PhD, said in an interview that the 56% number is significant.
“We consider this percentage to be clinically very relevant,” said Dr. Martínez-Sáez, an oncologist at Hospital Clinic of Barcelona and the University of Barcelona. “HER2DX can change practice.”
Also in an interview, Kent Hoskins, MD, associate chief of hematology/oncology at University of Illinois at Chicago, described HER2DX as a next-generation genomic test that builds on assays developed 2 decades ago to help identify patients who would benefit – or not – from adjuvant chemotherapy.
Dr. Hoskins, who isn’t connected to the new study but has studied genomic tests for breast cancer, said the HER2DX test seeks to provide guidance to oncologists about which of several treatments are most effective in treating patients with HER2+ breast cancer.
“The overall trend in the HER2+ space is escalating therapy, and the cure rates have improved quite substantially,” he said. “But do they all need that much therapy? That’s the clinical question that this assay is addressing.”
The assay examines clinical features and the expression of 4 gene signatures, Dr. Martínez-Sáez said. It provides a risk score estimating the likelihood of recurrence plus a score that estimates the likelihood of achieving pathological complete response (pCR) with trastuzumab-based neoadjuvant therapy and an ERBB2 mRNA score.
In a retrospective 2022 study published in eBioMedicine, researchers reported that the assay “predicts response following neoadjuvant letrozole in combination with dual HER2 blockade with trastuzumab and pertuzumab in early-stage HER2-positive/hormone receptor–positive breast cancer.”
In the 2022 study, researchers wrote that assay results and other scores “might help better tailor systemic therapy in this context and identify candidates for avoiding chemotherapy, a therapy associated with short- and long-term toxicities and impact in quality of life.”
For the new study, a decision-impact analysis, researchers tracked 89 patients with HER2+ breast cancer (median age = 53 years, range 30-79, and 52% postmenopausal), the poster says. Most had T1-2 tumors (87%), negative nodes (64%), grade 2 (56%) or 3 (41%) tumors, and ductal histology (87%). And most were hormone receptor positive (65%). Seventy-eight percent of patients received neoadjuvant therapy (NAT), and 22% underwent upfront surgery.
In 56% of cases, oncologists changed their treatment decisions after getting the results of the HER2DX assays. In 59% of these cases, oncologists de-escalated therapy; in 41%, they escalated therapy, opting for more intense chemotherapy 65% of the time, according to the poster.
Clinician confidence in their decisions improved in 67% of cases, the researchers reported in their poster. Among 56 patients treated with neoadjuvant therapy who could be evaluated, “HER2DX pCR score was significantly associated with pCR (81% in pCR-medium/high and 32% in pCR-low; odds ratio=9.3, P = 0.001) independently of the rest of variables.”
Dr. Hoskins said the new report suggests that the assay can change treatment decisions, although he cautioned that “this study does not in itself establish its place in standard of care.” Large, prospective, randomized research is still needed, he said.
Dr. Martínez-Sáez said, in an interview, that the HER2DX assay should cost about as much as genomic assays for other breast cancer subtypes. These kinds of tests have cost several thousand dollars each in recent years.
What’s next? The decision impact study is ongoing. As for research into the assay itself, “prospective clinical trials are planned to demonstrate its clinical utility to de-escalate and guide therapy,” Dr. Martínez-Sáez said.
No funding is reported. Reveal Genomics is the developer of the HER2DX assay. Dr. Martinez- Saez reports financial relationships with Novartis, Eisai, Roche, and Reveal Genomics. Other study authors report multiple disclosures. Dr. Hoskins discloses non-financial research support from Agendia, which makes the MammaPrint early-breast-cancer assay.
FROM ESMO BREAST CANCER 2023
DLBCL: Major new treatment breakthroughs
Significant breakthroughs have come in just the past few weeks and months, through the use of CAR T-cell and immunotherapies and with the approval in April by the Food and Drug Administration of polatuzumab for frontline DLBCL.
“Until the publishing of data from the POLARIX study (NCT03274492), which led to the approval of polatuzumab vedotin plus rituximab-cyclophosphamide, doxorubicin, and prednisone (pola + R-CHP), we had not had a breakthrough in frontline DLBCL therapies since the addition of rituximab 22 years ago,” said Dr. Charalambos Andreadis, MD, of the University of California at San Francisco’s Helen Diller Family Comprehensive Cancer Center.
“Pola + R-CHP is an improvement over the standard-of-care treatment, R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone), giving treatment naive patients an increase in PFS without an increase in side effects,” Dr. Andreadis said.
R-CHP-polatuzumab was approved only for patients with an International Prognostic Indices score between 2 and 5, leaving patients with IPI scores of 0 or 1 with the frontline standard of care (SoC) treatment of R-CHOP, which has a cure rate of between 60% and 70%.
“The highest likelihood of relapse is in the first year following treatment. After 2 years in remission, patients’ chance of relapsing is the same as the general populations’ chance of getting DLBCL for the first time. This is why even a slight increase in the progression-free survival rate with the addition of pola is so significant,” Dr. Andreadis noted.
Historically, patients with relapsed or refractory (RR) DLBCL who did not respond to R-CHOP or who experienced disease relapse less than a year after primary intervention were treated with alternative chemotherapy regimens, often followed by autologous stem cell transplants (ASCT). Randomized control studies have shown that CAR T-cell therapies yield higher success rates than chemotherapy and ASCT, leading to the SoC in RR patients being CAR-T cell therapy directly following failed primary treatment.
“There are many new CAR T-cell platforms in development, as well as novel combination strategies that aim to target critical genetic pathways,” Kieron Dunleavy, MD, professor of medicine at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital, said in an interview. “While access to CAR T-cell therapies is becoming easier and more feasible in many centers, fast access continues to be an issue for many patients, often depending on geography and socioeconomic factors.”
Asked about the latest breakthroughs in treating DLBCL, Dr. Dunleavy said, “A significant proportion of patients with relapsed or refractory DLBCL do not have easy access to CAR T-cell therapies, so this needs to be addressed and improved. Sometimes the rapidity of clinical progression in DLBCL can make these therapies challenging to deliver, considering logistical issues like apheresis and insurance approvals, which are frequently complex. This highlights the need for alternative and ‘easier to deliver’ CAR-T cells and our continued prioritization of developing alternative effective agents for DLBCL.
“Currently, commercially approved CAR T-cells in DLBCL target the CD-19 marker on lymphoma cells but CAR T-cells targeting other and more than one antigen as well as alternative anti CD19 agents like loncastuximab and tafasitamab are similarly FDA approved and available for patients,” Dr. Dunleavy concluded.
Dr. Dunleavy is affiliated with the MedStar Georgetown Lymphoma group, where Rep. Raskin publicly announced that he had completed 4 months of chemotherapy treatment for DLBCL. On April 27, in an open letter to the U.S. public, he wrote that he rang the bell at MedStar to mark his preliminary diagnosis of being “in remission,” with a “90% prognosis of no relapse.”
Interviewed about the latest advances in treating DLBCL, Jason Westin, MD, associate professor of lymphoma and myeloma at the MD Anderson Cancer Center in Houston, said that even with improvements in overall survival possible with CAR T-cell therapies, “usually, a clinical trial should be considered strongly, as it is often the best option for patients, both in a newly diagnosed or in a relapsed setting, as they allow access to tomorrow’s breakthrough therapies today.”
Dr. Westin cited the example of bispecific T-cell engagers (BITE) as a promising therapy that is available to patients in clinical trials. These agents bind to one side to the lymphoma cell, but they also have a binding arm for T-cells, so they activate a patient’s own immune cells to kill lymphoma cells, in some cases offering a cure when CAR T-cell therapy has failed.
The first BITE to be approved, mosunetuzumab, is authorized only for the treatment of follicular lymphoma. However, data from a recent clinical study indicated that the agent yields complete responses in 24% of heavily pretreated patients with RR DLBCL.
Another BITE, glofitamab, was approved in Canada in March 2023 for use in RR DLBCL. Based on its high efficacy, it soon may be approved elsewhere.
Dr. Andreadis noted, “We are finally at a point where for both treatment naive and RR DLBCL patients, there are several promising options on the horizon that don’t involve ASCT. Furthermore, these breakthroughs reinforce each other, as there are studies in which therapies like BITE are being brought to the front line and pola to RR cases.”
The growing field of new frontline and RR DLBCL therapies lend credence to the optimism of specialists who treat DLBCL – and to the sanguine note that Congressman Raskin struck in published comments about his treatment for DLBCL.
Dr. Andreadis reported ties with BMS, Novartis, Roche, Genmab, Merck, Gilead, AbbVie, and J&J. Dr. Dunleavy disclosed relationships with ONO Pharmaceuticals, Kymera, Merck, Genentech, AstraZeneca, Amgen, ADC Therapeutics, MorphoSys and Incyte, Kite/Gilead, Cellectar. Dr. Westin reported ties with Kite/Gilead, BMS, Novartis, Genentech, AstraZeneca, Morphosys/Incyte, ADC Therapeutics, Kymera, Nurix, and MonteRosa.
Significant breakthroughs have come in just the past few weeks and months, through the use of CAR T-cell and immunotherapies and with the approval in April by the Food and Drug Administration of polatuzumab for frontline DLBCL.
“Until the publishing of data from the POLARIX study (NCT03274492), which led to the approval of polatuzumab vedotin plus rituximab-cyclophosphamide, doxorubicin, and prednisone (pola + R-CHP), we had not had a breakthrough in frontline DLBCL therapies since the addition of rituximab 22 years ago,” said Dr. Charalambos Andreadis, MD, of the University of California at San Francisco’s Helen Diller Family Comprehensive Cancer Center.
“Pola + R-CHP is an improvement over the standard-of-care treatment, R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone), giving treatment naive patients an increase in PFS without an increase in side effects,” Dr. Andreadis said.
R-CHP-polatuzumab was approved only for patients with an International Prognostic Indices score between 2 and 5, leaving patients with IPI scores of 0 or 1 with the frontline standard of care (SoC) treatment of R-CHOP, which has a cure rate of between 60% and 70%.
“The highest likelihood of relapse is in the first year following treatment. After 2 years in remission, patients’ chance of relapsing is the same as the general populations’ chance of getting DLBCL for the first time. This is why even a slight increase in the progression-free survival rate with the addition of pola is so significant,” Dr. Andreadis noted.
Historically, patients with relapsed or refractory (RR) DLBCL who did not respond to R-CHOP or who experienced disease relapse less than a year after primary intervention were treated with alternative chemotherapy regimens, often followed by autologous stem cell transplants (ASCT). Randomized control studies have shown that CAR T-cell therapies yield higher success rates than chemotherapy and ASCT, leading to the SoC in RR patients being CAR-T cell therapy directly following failed primary treatment.
“There are many new CAR T-cell platforms in development, as well as novel combination strategies that aim to target critical genetic pathways,” Kieron Dunleavy, MD, professor of medicine at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital, said in an interview. “While access to CAR T-cell therapies is becoming easier and more feasible in many centers, fast access continues to be an issue for many patients, often depending on geography and socioeconomic factors.”
Asked about the latest breakthroughs in treating DLBCL, Dr. Dunleavy said, “A significant proportion of patients with relapsed or refractory DLBCL do not have easy access to CAR T-cell therapies, so this needs to be addressed and improved. Sometimes the rapidity of clinical progression in DLBCL can make these therapies challenging to deliver, considering logistical issues like apheresis and insurance approvals, which are frequently complex. This highlights the need for alternative and ‘easier to deliver’ CAR-T cells and our continued prioritization of developing alternative effective agents for DLBCL.
“Currently, commercially approved CAR T-cells in DLBCL target the CD-19 marker on lymphoma cells but CAR T-cells targeting other and more than one antigen as well as alternative anti CD19 agents like loncastuximab and tafasitamab are similarly FDA approved and available for patients,” Dr. Dunleavy concluded.
Dr. Dunleavy is affiliated with the MedStar Georgetown Lymphoma group, where Rep. Raskin publicly announced that he had completed 4 months of chemotherapy treatment for DLBCL. On April 27, in an open letter to the U.S. public, he wrote that he rang the bell at MedStar to mark his preliminary diagnosis of being “in remission,” with a “90% prognosis of no relapse.”
Interviewed about the latest advances in treating DLBCL, Jason Westin, MD, associate professor of lymphoma and myeloma at the MD Anderson Cancer Center in Houston, said that even with improvements in overall survival possible with CAR T-cell therapies, “usually, a clinical trial should be considered strongly, as it is often the best option for patients, both in a newly diagnosed or in a relapsed setting, as they allow access to tomorrow’s breakthrough therapies today.”
Dr. Westin cited the example of bispecific T-cell engagers (BITE) as a promising therapy that is available to patients in clinical trials. These agents bind to one side to the lymphoma cell, but they also have a binding arm for T-cells, so they activate a patient’s own immune cells to kill lymphoma cells, in some cases offering a cure when CAR T-cell therapy has failed.
The first BITE to be approved, mosunetuzumab, is authorized only for the treatment of follicular lymphoma. However, data from a recent clinical study indicated that the agent yields complete responses in 24% of heavily pretreated patients with RR DLBCL.
Another BITE, glofitamab, was approved in Canada in March 2023 for use in RR DLBCL. Based on its high efficacy, it soon may be approved elsewhere.
Dr. Andreadis noted, “We are finally at a point where for both treatment naive and RR DLBCL patients, there are several promising options on the horizon that don’t involve ASCT. Furthermore, these breakthroughs reinforce each other, as there are studies in which therapies like BITE are being brought to the front line and pola to RR cases.”
The growing field of new frontline and RR DLBCL therapies lend credence to the optimism of specialists who treat DLBCL – and to the sanguine note that Congressman Raskin struck in published comments about his treatment for DLBCL.
Dr. Andreadis reported ties with BMS, Novartis, Roche, Genmab, Merck, Gilead, AbbVie, and J&J. Dr. Dunleavy disclosed relationships with ONO Pharmaceuticals, Kymera, Merck, Genentech, AstraZeneca, Amgen, ADC Therapeutics, MorphoSys and Incyte, Kite/Gilead, Cellectar. Dr. Westin reported ties with Kite/Gilead, BMS, Novartis, Genentech, AstraZeneca, Morphosys/Incyte, ADC Therapeutics, Kymera, Nurix, and MonteRosa.
Significant breakthroughs have come in just the past few weeks and months, through the use of CAR T-cell and immunotherapies and with the approval in April by the Food and Drug Administration of polatuzumab for frontline DLBCL.
“Until the publishing of data from the POLARIX study (NCT03274492), which led to the approval of polatuzumab vedotin plus rituximab-cyclophosphamide, doxorubicin, and prednisone (pola + R-CHP), we had not had a breakthrough in frontline DLBCL therapies since the addition of rituximab 22 years ago,” said Dr. Charalambos Andreadis, MD, of the University of California at San Francisco’s Helen Diller Family Comprehensive Cancer Center.
“Pola + R-CHP is an improvement over the standard-of-care treatment, R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone), giving treatment naive patients an increase in PFS without an increase in side effects,” Dr. Andreadis said.
R-CHP-polatuzumab was approved only for patients with an International Prognostic Indices score between 2 and 5, leaving patients with IPI scores of 0 or 1 with the frontline standard of care (SoC) treatment of R-CHOP, which has a cure rate of between 60% and 70%.
“The highest likelihood of relapse is in the first year following treatment. After 2 years in remission, patients’ chance of relapsing is the same as the general populations’ chance of getting DLBCL for the first time. This is why even a slight increase in the progression-free survival rate with the addition of pola is so significant,” Dr. Andreadis noted.
Historically, patients with relapsed or refractory (RR) DLBCL who did not respond to R-CHOP or who experienced disease relapse less than a year after primary intervention were treated with alternative chemotherapy regimens, often followed by autologous stem cell transplants (ASCT). Randomized control studies have shown that CAR T-cell therapies yield higher success rates than chemotherapy and ASCT, leading to the SoC in RR patients being CAR-T cell therapy directly following failed primary treatment.
“There are many new CAR T-cell platforms in development, as well as novel combination strategies that aim to target critical genetic pathways,” Kieron Dunleavy, MD, professor of medicine at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital, said in an interview. “While access to CAR T-cell therapies is becoming easier and more feasible in many centers, fast access continues to be an issue for many patients, often depending on geography and socioeconomic factors.”
Asked about the latest breakthroughs in treating DLBCL, Dr. Dunleavy said, “A significant proportion of patients with relapsed or refractory DLBCL do not have easy access to CAR T-cell therapies, so this needs to be addressed and improved. Sometimes the rapidity of clinical progression in DLBCL can make these therapies challenging to deliver, considering logistical issues like apheresis and insurance approvals, which are frequently complex. This highlights the need for alternative and ‘easier to deliver’ CAR-T cells and our continued prioritization of developing alternative effective agents for DLBCL.
“Currently, commercially approved CAR T-cells in DLBCL target the CD-19 marker on lymphoma cells but CAR T-cells targeting other and more than one antigen as well as alternative anti CD19 agents like loncastuximab and tafasitamab are similarly FDA approved and available for patients,” Dr. Dunleavy concluded.
Dr. Dunleavy is affiliated with the MedStar Georgetown Lymphoma group, where Rep. Raskin publicly announced that he had completed 4 months of chemotherapy treatment for DLBCL. On April 27, in an open letter to the U.S. public, he wrote that he rang the bell at MedStar to mark his preliminary diagnosis of being “in remission,” with a “90% prognosis of no relapse.”
Interviewed about the latest advances in treating DLBCL, Jason Westin, MD, associate professor of lymphoma and myeloma at the MD Anderson Cancer Center in Houston, said that even with improvements in overall survival possible with CAR T-cell therapies, “usually, a clinical trial should be considered strongly, as it is often the best option for patients, both in a newly diagnosed or in a relapsed setting, as they allow access to tomorrow’s breakthrough therapies today.”
Dr. Westin cited the example of bispecific T-cell engagers (BITE) as a promising therapy that is available to patients in clinical trials. These agents bind to one side to the lymphoma cell, but they also have a binding arm for T-cells, so they activate a patient’s own immune cells to kill lymphoma cells, in some cases offering a cure when CAR T-cell therapy has failed.
The first BITE to be approved, mosunetuzumab, is authorized only for the treatment of follicular lymphoma. However, data from a recent clinical study indicated that the agent yields complete responses in 24% of heavily pretreated patients with RR DLBCL.
Another BITE, glofitamab, was approved in Canada in March 2023 for use in RR DLBCL. Based on its high efficacy, it soon may be approved elsewhere.
Dr. Andreadis noted, “We are finally at a point where for both treatment naive and RR DLBCL patients, there are several promising options on the horizon that don’t involve ASCT. Furthermore, these breakthroughs reinforce each other, as there are studies in which therapies like BITE are being brought to the front line and pola to RR cases.”
The growing field of new frontline and RR DLBCL therapies lend credence to the optimism of specialists who treat DLBCL – and to the sanguine note that Congressman Raskin struck in published comments about his treatment for DLBCL.
Dr. Andreadis reported ties with BMS, Novartis, Roche, Genmab, Merck, Gilead, AbbVie, and J&J. Dr. Dunleavy disclosed relationships with ONO Pharmaceuticals, Kymera, Merck, Genentech, AstraZeneca, Amgen, ADC Therapeutics, MorphoSys and Incyte, Kite/Gilead, Cellectar. Dr. Westin reported ties with Kite/Gilead, BMS, Novartis, Genentech, AstraZeneca, Morphosys/Incyte, ADC Therapeutics, Kymera, Nurix, and MonteRosa.
Teledermatology follow-up after Mohs surgery gets a thumbs up from patients
SEATTLE – The , according to new findings.
In addition, nearly all patients surveyed (91.4%) were willing to go through electronic follow-up again.
“A big takeaway from our study is that streamlining this process is really essential for successful implementation,” said study author Laura Rezac, MD, a PGY IV dermatology resident at the University of Mississippi, Jackson. “This study demonstrated the flexibility and convenience for both patients and surgeons and can serve as a prototype for future innovation.”
The study results were presented at the annual meeting of the American College of Mohs Surgery.
The role of telehealth has rapidly expanded over the past decade, with its use accelerating during the COVID-19 pandemic and transforming into an indispensable resource. It can be synchronous, Dr. Rezac explained, which is when telehealth happens in live, real-time settings where the patient interacts with a clinician. This usually occurs via phone or video, and providers and patients communicate directly.
Conversely, asynchronous telehealth, also known as “store-and-forward,” is often used for patient intake or follow-up care. For example, in dermatology, a patient can send a photo of a skin condition that is then reviewed by a dermatologist later.
“A pilot survey regarding the adoption of telemedicine in Mohs surgery found that, although most dermatologic surgeons felt that it can play a role, most said that they didn’t plan on using it after the pandemic,” said Dr. Rezac.
The survey, which was reported by this news organization, found that 80% of surveyed surgeons said that they turned to telemedicine during the pandemic, compared with just 23% who relied on the technology prior to the pandemic.
There were numerous perceived barriers to the use of telemedicine, and the one most commonly cited was the uncertainty of how telemedicine fits in the workflow of clinical practice. Other limitations reported were for physical exams (88%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).
“The survey did identify one key use of telemedicine in Mohs and that was for [postoperative] visits,” she said. “But thus far, a postoperative evaluation after Mohs via an integrated asynchronous ‘store and forward’ teledermatology platform has not yet been evaluated.”
In the study, Dr. Rezac and colleagues sought to evaluate feasibility and efficacy, as well as patient attitudes, using a telemedicine platform for postoperative follow-up. A total of 163 patients who were treated with Mohs at a single academic institution during the 9-month study period (December 2021 through August 2022) responded to a survey and elected to participate in postoperative follow-up using telemedicine.
Dr. Rezac explained how their procedure was implemented for the patient. “On the day of the follow-up, the patient receives a text with a link that takes them to the MyChart website or app on their phone,” she said. “Once they log in, they see that they have a message telling them that they have a teledermatology message waiting for them. When they view it, they are taken to the curated message with instructions and a phone call if they need assistance, and then at the bottom, it shows they have a task to complete, which is the questionnaire.”
The patient will then be prompted to upload photos, which can be taken with their phone camera. The next step is to answer questions regarding the surgical site or pain concerns, and finally, patients are asked to respond to a few short questions about this type of follow-up. Once submitted, then they wait to be contacted by the surgeon.
On the surgeon’s side, these answers come into their EPIC inbox, and they can respond via a MyChart message.
Patient response was overwhelmingly positive, Dr. Rezac noted. Of the patients, 80.4% found the electronic surgery follow-up process to be “easy” or “very easy,” while only 4% found it “difficult” or “very difficult,” she said. “Also, 75.5% preferred electronic follow-up while 17.2% preferred in-person follow-up.”
There were limitations to this study, primarily that the asynchronous method does reduce live interaction, which could be an issue, depending on person’s needs, she pointed out. “But it is easy to schedule a phone call or video call or office visit.”
“The universal barrier is how to adopt it into the workflow, which includes training of staff,” she continued, “But this was a very streamlined process and gave very detailed instructions to the staff. Additionally, widespread use is limited to dermatological proficiency and access, and patients have to be amenable to it, so there is a selection bias since these patients chose to participate.”
Asked to comment on the study, Vishal Patel, MD, director of cutaneous oncology at George Washington University in Washington, said: “The COVID pandemic changed how practices and providers considered follow-up visits for small routine matters. Postoperative visits are often simple and do not require an in-depth, in-person evaluation.” Dr. Patel was not involved with this research.
“This study highlights the comfort of the vast majority of patients to have follow-up postoperative visits conducted via teledermatology – an approach that can help cut overall costs and also increase access for patients who are more in need of in-office care,” he added.
No external funding of the study was reported. Dr. Rezac reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
A version of this article originally appeared on Medscape.com.
SEATTLE – The , according to new findings.
In addition, nearly all patients surveyed (91.4%) were willing to go through electronic follow-up again.
“A big takeaway from our study is that streamlining this process is really essential for successful implementation,” said study author Laura Rezac, MD, a PGY IV dermatology resident at the University of Mississippi, Jackson. “This study demonstrated the flexibility and convenience for both patients and surgeons and can serve as a prototype for future innovation.”
The study results were presented at the annual meeting of the American College of Mohs Surgery.
The role of telehealth has rapidly expanded over the past decade, with its use accelerating during the COVID-19 pandemic and transforming into an indispensable resource. It can be synchronous, Dr. Rezac explained, which is when telehealth happens in live, real-time settings where the patient interacts with a clinician. This usually occurs via phone or video, and providers and patients communicate directly.
Conversely, asynchronous telehealth, also known as “store-and-forward,” is often used for patient intake or follow-up care. For example, in dermatology, a patient can send a photo of a skin condition that is then reviewed by a dermatologist later.
“A pilot survey regarding the adoption of telemedicine in Mohs surgery found that, although most dermatologic surgeons felt that it can play a role, most said that they didn’t plan on using it after the pandemic,” said Dr. Rezac.
The survey, which was reported by this news organization, found that 80% of surveyed surgeons said that they turned to telemedicine during the pandemic, compared with just 23% who relied on the technology prior to the pandemic.
There were numerous perceived barriers to the use of telemedicine, and the one most commonly cited was the uncertainty of how telemedicine fits in the workflow of clinical practice. Other limitations reported were for physical exams (88%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).
“The survey did identify one key use of telemedicine in Mohs and that was for [postoperative] visits,” she said. “But thus far, a postoperative evaluation after Mohs via an integrated asynchronous ‘store and forward’ teledermatology platform has not yet been evaluated.”
In the study, Dr. Rezac and colleagues sought to evaluate feasibility and efficacy, as well as patient attitudes, using a telemedicine platform for postoperative follow-up. A total of 163 patients who were treated with Mohs at a single academic institution during the 9-month study period (December 2021 through August 2022) responded to a survey and elected to participate in postoperative follow-up using telemedicine.
Dr. Rezac explained how their procedure was implemented for the patient. “On the day of the follow-up, the patient receives a text with a link that takes them to the MyChart website or app on their phone,” she said. “Once they log in, they see that they have a message telling them that they have a teledermatology message waiting for them. When they view it, they are taken to the curated message with instructions and a phone call if they need assistance, and then at the bottom, it shows they have a task to complete, which is the questionnaire.”
The patient will then be prompted to upload photos, which can be taken with their phone camera. The next step is to answer questions regarding the surgical site or pain concerns, and finally, patients are asked to respond to a few short questions about this type of follow-up. Once submitted, then they wait to be contacted by the surgeon.
On the surgeon’s side, these answers come into their EPIC inbox, and they can respond via a MyChart message.
Patient response was overwhelmingly positive, Dr. Rezac noted. Of the patients, 80.4% found the electronic surgery follow-up process to be “easy” or “very easy,” while only 4% found it “difficult” or “very difficult,” she said. “Also, 75.5% preferred electronic follow-up while 17.2% preferred in-person follow-up.”
There were limitations to this study, primarily that the asynchronous method does reduce live interaction, which could be an issue, depending on person’s needs, she pointed out. “But it is easy to schedule a phone call or video call or office visit.”
“The universal barrier is how to adopt it into the workflow, which includes training of staff,” she continued, “But this was a very streamlined process and gave very detailed instructions to the staff. Additionally, widespread use is limited to dermatological proficiency and access, and patients have to be amenable to it, so there is a selection bias since these patients chose to participate.”
Asked to comment on the study, Vishal Patel, MD, director of cutaneous oncology at George Washington University in Washington, said: “The COVID pandemic changed how practices and providers considered follow-up visits for small routine matters. Postoperative visits are often simple and do not require an in-depth, in-person evaluation.” Dr. Patel was not involved with this research.
“This study highlights the comfort of the vast majority of patients to have follow-up postoperative visits conducted via teledermatology – an approach that can help cut overall costs and also increase access for patients who are more in need of in-office care,” he added.
No external funding of the study was reported. Dr. Rezac reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
A version of this article originally appeared on Medscape.com.
SEATTLE – The , according to new findings.
In addition, nearly all patients surveyed (91.4%) were willing to go through electronic follow-up again.
“A big takeaway from our study is that streamlining this process is really essential for successful implementation,” said study author Laura Rezac, MD, a PGY IV dermatology resident at the University of Mississippi, Jackson. “This study demonstrated the flexibility and convenience for both patients and surgeons and can serve as a prototype for future innovation.”
The study results were presented at the annual meeting of the American College of Mohs Surgery.
The role of telehealth has rapidly expanded over the past decade, with its use accelerating during the COVID-19 pandemic and transforming into an indispensable resource. It can be synchronous, Dr. Rezac explained, which is when telehealth happens in live, real-time settings where the patient interacts with a clinician. This usually occurs via phone or video, and providers and patients communicate directly.
Conversely, asynchronous telehealth, also known as “store-and-forward,” is often used for patient intake or follow-up care. For example, in dermatology, a patient can send a photo of a skin condition that is then reviewed by a dermatologist later.
“A pilot survey regarding the adoption of telemedicine in Mohs surgery found that, although most dermatologic surgeons felt that it can play a role, most said that they didn’t plan on using it after the pandemic,” said Dr. Rezac.
The survey, which was reported by this news organization, found that 80% of surveyed surgeons said that they turned to telemedicine during the pandemic, compared with just 23% who relied on the technology prior to the pandemic.
There were numerous perceived barriers to the use of telemedicine, and the one most commonly cited was the uncertainty of how telemedicine fits in the workflow of clinical practice. Other limitations reported were for physical exams (88%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).
“The survey did identify one key use of telemedicine in Mohs and that was for [postoperative] visits,” she said. “But thus far, a postoperative evaluation after Mohs via an integrated asynchronous ‘store and forward’ teledermatology platform has not yet been evaluated.”
In the study, Dr. Rezac and colleagues sought to evaluate feasibility and efficacy, as well as patient attitudes, using a telemedicine platform for postoperative follow-up. A total of 163 patients who were treated with Mohs at a single academic institution during the 9-month study period (December 2021 through August 2022) responded to a survey and elected to participate in postoperative follow-up using telemedicine.
Dr. Rezac explained how their procedure was implemented for the patient. “On the day of the follow-up, the patient receives a text with a link that takes them to the MyChart website or app on their phone,” she said. “Once they log in, they see that they have a message telling them that they have a teledermatology message waiting for them. When they view it, they are taken to the curated message with instructions and a phone call if they need assistance, and then at the bottom, it shows they have a task to complete, which is the questionnaire.”
The patient will then be prompted to upload photos, which can be taken with their phone camera. The next step is to answer questions regarding the surgical site or pain concerns, and finally, patients are asked to respond to a few short questions about this type of follow-up. Once submitted, then they wait to be contacted by the surgeon.
On the surgeon’s side, these answers come into their EPIC inbox, and they can respond via a MyChart message.
Patient response was overwhelmingly positive, Dr. Rezac noted. Of the patients, 80.4% found the electronic surgery follow-up process to be “easy” or “very easy,” while only 4% found it “difficult” or “very difficult,” she said. “Also, 75.5% preferred electronic follow-up while 17.2% preferred in-person follow-up.”
There were limitations to this study, primarily that the asynchronous method does reduce live interaction, which could be an issue, depending on person’s needs, she pointed out. “But it is easy to schedule a phone call or video call or office visit.”
“The universal barrier is how to adopt it into the workflow, which includes training of staff,” she continued, “But this was a very streamlined process and gave very detailed instructions to the staff. Additionally, widespread use is limited to dermatological proficiency and access, and patients have to be amenable to it, so there is a selection bias since these patients chose to participate.”
Asked to comment on the study, Vishal Patel, MD, director of cutaneous oncology at George Washington University in Washington, said: “The COVID pandemic changed how practices and providers considered follow-up visits for small routine matters. Postoperative visits are often simple and do not require an in-depth, in-person evaluation.” Dr. Patel was not involved with this research.
“This study highlights the comfort of the vast majority of patients to have follow-up postoperative visits conducted via teledermatology – an approach that can help cut overall costs and also increase access for patients who are more in need of in-office care,” he added.
No external funding of the study was reported. Dr. Rezac reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
A version of this article originally appeared on Medscape.com.
AT ACMS 2023