Patient & Survivor Care

The diagnosis was straightforward. My patient’s reaction was not.

One Saturday evening, I receive a call from the emergency room about a man with a very high white blood cell count. For the past 7 years, he had chronic myeloid leukemia – a cancer, but one of the few that can be well controlled for years. The discovery of the medications that can do it revolutionized care for the disease.

For the last 7 years, Mr. C didn’t take that medication regularly. He was young, with no other medical problems, and this was the only medication he was supposed to take. But his use was sporadic at best.

What was it, I wondered? Cost? Side effects? Not understanding the seriousness of having leukemia? No, the medication was fully covered by his insurance. No, he tolerated it well. Instead, his on-and-off medication schedule came across as a strange sense of apathy. He didn’t seem to recognize his agency in his own life.

Now, not only is his white count extremely high, but the majority are the cancerous cells. I look at his blood under the microscope – blasts everywhere. He has progressed from a chronic, indolent disease that can be kept at bay into the dreaded blast crisis, which is essentially an acute leukemia but even more challenging to treat.

It is very serious. I tell him this. “I am worried your leukemia has progressed into what we call a blast crisis,” I say. “Has anyone ever talked to you about this before?”

“Hmm, I think Dr. M may have said something,” he says. His medical chart over the last 7 years was populated with notes from his hematologist documenting their discussions of this possibility.

“This is serious,” I continue. “You will need to come into the hospital and we need to start medication to lower your white count. Otherwise you could have a stroke.”

“Okay.”

“As the white count comes down, your cells will break open and the chemicals in them can make you very sick. So we will have to check your blood often to watch for this.”

“Got it.”

“And we will change your chemotherapy pill.” I pause, letting it sink in, then repeat for emphasis: “This is very serious.”

“Sure thing, Doc.”

“I know I’ve said a lot. What are your thoughts?”

He looks at his wife, then back at me. He seems unfazed. Just as unfazed as when his hematologist warned this could happen. Just as unfazed as the day he learned his diagnosis.

He smiles and shrugs. “What will be, will be.”

As I listened to him, I honestly couldn’t tell if this was the best coping mechanism I had ever seen or the worst.

On one hand, his apathy had hurt him, clearly and indisputably. Refusing to acknowledge his agency in his medical outcomes allowed him to be cavalier about taking the cure. The cure was in a bottle on his kitchen shelf, an arm’s reach away, and he chose to reach elsewhere.

On the other hand, it was unusual to see someone so at peace with being so critically ill. His acceptance of his new reality was refreshing. There were no heartbreaking questions about whether this was his fault. There was no agonizing over what could have been. His apathy gave him closure and his loved ones comfort.

I’ve written before about how a cancer diagnosis involves holding two seemingly competing ideas in one’s mind at once. Last month, I wrote about how it is possible to be realistic about a grim prognosis while retaining hope that a treatment may work. I discussed that realism and hopefulness are compatible beliefs, and it’s okay – preferred, even – to hold them at once.

Mr. C’s strange sense of apathy made me think about another mental limbo, this one involving control. As doctors and patients, we like when we have agency over outcomes. Take these medications, and you will be okay. Undergo this procedure, and you will reduce your risk of recurrence. At the same time, poor outcomes still occur when everything is done “right.” When that happens, it can be psychologically beneficial to relinquish control. Doing so discards the unhelpful emotions of guilt and blame in favor of acceptance.

Mr. C’s apathy seemed to be present from day 1. But now, in a dire blast crisis, what was once a harmful attitude actually became a helpful one.

His “what will be, will be” attitude wasn’t inherently maladaptive; it was ill timed. Under the right circumstances, well-placed apathy can be leveraged as a positive coping mechanism.

But alas, if only there were a switch to turn on the right emotion at the right time. There’s no right or wrong or sensible reaction to cancer. There’s only a swirl of messy, overwhelming feelings. It’s trying to bring effective emotions to light at the right time while playing whack-a-mole with the others. It’s cognitive dissonance. It’s exhausting. Cancer doesn’t create personalities; it surfaces them.

It’s the last day of Mr. C’s hospitalization. His blast crisis is amazingly under good control.

“So,” I say. “Will you take your medications now?”

“Sure,” he says instinctively. I look at him. “I mean, honestly, Doc? I’m not sure.”

As we shake hands, I wonder if I’ll ever truly understand Mr. C’s motivations. But I can’t wonder too long. I can only control my part: I hand him his medications and wish him luck.

Minor details of this story were changed to protect privacy.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

The diagnosis was straightforward. My patient’s reaction was not.

One Saturday evening, I receive a call from the emergency room about a man with a very high white blood cell count. For the past 7 years, he had chronic myeloid leukemia – a cancer, but one of the few that can be well controlled for years. The discovery of the medications that can do it revolutionized care for the disease.

For the last 7 years, Mr. C didn’t take that medication regularly. He was young, with no other medical problems, and this was the only medication he was supposed to take. But his use was sporadic at best.

What was it, I wondered? Cost? Side effects? Not understanding the seriousness of having leukemia? No, the medication was fully covered by his insurance. No, he tolerated it well. Instead, his on-and-off medication schedule came across as a strange sense of apathy. He didn’t seem to recognize his agency in his own life.

Now, not only is his white count extremely high, but the majority are the cancerous cells. I look at his blood under the microscope – blasts everywhere. He has progressed from a chronic, indolent disease that can be kept at bay into the dreaded blast crisis, which is essentially an acute leukemia but even more challenging to treat.

It is very serious. I tell him this. “I am worried your leukemia has progressed into what we call a blast crisis,” I say. “Has anyone ever talked to you about this before?”

“Hmm, I think Dr. M may have said something,” he says. His medical chart over the last 7 years was populated with notes from his hematologist documenting their discussions of this possibility.

“This is serious,” I continue. “You will need to come into the hospital and we need to start medication to lower your white count. Otherwise you could have a stroke.”

“Okay.”

“As the white count comes down, your cells will break open and the chemicals in them can make you very sick. So we will have to check your blood often to watch for this.”

“Got it.”

“And we will change your chemotherapy pill.” I pause, letting it sink in, then repeat for emphasis: “This is very serious.”

“Sure thing, Doc.”

“I know I’ve said a lot. What are your thoughts?”

He looks at his wife, then back at me. He seems unfazed. Just as unfazed as when his hematologist warned this could happen. Just as unfazed as the day he learned his diagnosis.

He smiles and shrugs. “What will be, will be.”

As I listened to him, I honestly couldn’t tell if this was the best coping mechanism I had ever seen or the worst.

On one hand, his apathy had hurt him, clearly and indisputably. Refusing to acknowledge his agency in his medical outcomes allowed him to be cavalier about taking the cure. The cure was in a bottle on his kitchen shelf, an arm’s reach away, and he chose to reach elsewhere.

On the other hand, it was unusual to see someone so at peace with being so critically ill. His acceptance of his new reality was refreshing. There were no heartbreaking questions about whether this was his fault. There was no agonizing over what could have been. His apathy gave him closure and his loved ones comfort.

I’ve written before about how a cancer diagnosis involves holding two seemingly competing ideas in one’s mind at once. Last month, I wrote about how it is possible to be realistic about a grim prognosis while retaining hope that a treatment may work. I discussed that realism and hopefulness are compatible beliefs, and it’s okay – preferred, even – to hold them at once.

Mr. C’s strange sense of apathy made me think about another mental limbo, this one involving control. As doctors and patients, we like when we have agency over outcomes. Take these medications, and you will be okay. Undergo this procedure, and you will reduce your risk of recurrence. At the same time, poor outcomes still occur when everything is done “right.” When that happens, it can be psychologically beneficial to relinquish control. Doing so discards the unhelpful emotions of guilt and blame in favor of acceptance.

Mr. C’s apathy seemed to be present from day 1. But now, in a dire blast crisis, what was once a harmful attitude actually became a helpful one.

His “what will be, will be” attitude wasn’t inherently maladaptive; it was ill timed. Under the right circumstances, well-placed apathy can be leveraged as a positive coping mechanism.

But alas, if only there were a switch to turn on the right emotion at the right time. There’s no right or wrong or sensible reaction to cancer. There’s only a swirl of messy, overwhelming feelings. It’s trying to bring effective emotions to light at the right time while playing whack-a-mole with the others. It’s cognitive dissonance. It’s exhausting. Cancer doesn’t create personalities; it surfaces them.

It’s the last day of Mr. C’s hospitalization. His blast crisis is amazingly under good control.

“So,” I say. “Will you take your medications now?”

“Sure,” he says instinctively. I look at him. “I mean, honestly, Doc? I’m not sure.”

As we shake hands, I wonder if I’ll ever truly understand Mr. C’s motivations. But I can’t wonder too long. I can only control my part: I hand him his medications and wish him luck.

Minor details of this story were changed to protect privacy.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

The diagnosis was straightforward. My patient’s reaction was not.

One Saturday evening, I receive a call from the emergency room about a man with a very high white blood cell count. For the past 7 years, he had chronic myeloid leukemia – a cancer, but one of the few that can be well controlled for years. The discovery of the medications that can do it revolutionized care for the disease.

For the last 7 years, Mr. C didn’t take that medication regularly. He was young, with no other medical problems, and this was the only medication he was supposed to take. But his use was sporadic at best.

What was it, I wondered? Cost? Side effects? Not understanding the seriousness of having leukemia? No, the medication was fully covered by his insurance. No, he tolerated it well. Instead, his on-and-off medication schedule came across as a strange sense of apathy. He didn’t seem to recognize his agency in his own life.

Now, not only is his white count extremely high, but the majority are the cancerous cells. I look at his blood under the microscope – blasts everywhere. He has progressed from a chronic, indolent disease that can be kept at bay into the dreaded blast crisis, which is essentially an acute leukemia but even more challenging to treat.

It is very serious. I tell him this. “I am worried your leukemia has progressed into what we call a blast crisis,” I say. “Has anyone ever talked to you about this before?”

“Hmm, I think Dr. M may have said something,” he says. His medical chart over the last 7 years was populated with notes from his hematologist documenting their discussions of this possibility.

“This is serious,” I continue. “You will need to come into the hospital and we need to start medication to lower your white count. Otherwise you could have a stroke.”

“Okay.”

“As the white count comes down, your cells will break open and the chemicals in them can make you very sick. So we will have to check your blood often to watch for this.”

“Got it.”

“And we will change your chemotherapy pill.” I pause, letting it sink in, then repeat for emphasis: “This is very serious.”

“Sure thing, Doc.”

“I know I’ve said a lot. What are your thoughts?”

He looks at his wife, then back at me. He seems unfazed. Just as unfazed as when his hematologist warned this could happen. Just as unfazed as the day he learned his diagnosis.

He smiles and shrugs. “What will be, will be.”

As I listened to him, I honestly couldn’t tell if this was the best coping mechanism I had ever seen or the worst.

On one hand, his apathy had hurt him, clearly and indisputably. Refusing to acknowledge his agency in his medical outcomes allowed him to be cavalier about taking the cure. The cure was in a bottle on his kitchen shelf, an arm’s reach away, and he chose to reach elsewhere.

On the other hand, it was unusual to see someone so at peace with being so critically ill. His acceptance of his new reality was refreshing. There were no heartbreaking questions about whether this was his fault. There was no agonizing over what could have been. His apathy gave him closure and his loved ones comfort.

I’ve written before about how a cancer diagnosis involves holding two seemingly competing ideas in one’s mind at once. Last month, I wrote about how it is possible to be realistic about a grim prognosis while retaining hope that a treatment may work. I discussed that realism and hopefulness are compatible beliefs, and it’s okay – preferred, even – to hold them at once.

Mr. C’s strange sense of apathy made me think about another mental limbo, this one involving control. As doctors and patients, we like when we have agency over outcomes. Take these medications, and you will be okay. Undergo this procedure, and you will reduce your risk of recurrence. At the same time, poor outcomes still occur when everything is done “right.” When that happens, it can be psychologically beneficial to relinquish control. Doing so discards the unhelpful emotions of guilt and blame in favor of acceptance.

Mr. C’s apathy seemed to be present from day 1. But now, in a dire blast crisis, what was once a harmful attitude actually became a helpful one.

His “what will be, will be” attitude wasn’t inherently maladaptive; it was ill timed. Under the right circumstances, well-placed apathy can be leveraged as a positive coping mechanism.

But alas, if only there were a switch to turn on the right emotion at the right time. There’s no right or wrong or sensible reaction to cancer. There’s only a swirl of messy, overwhelming feelings. It’s trying to bring effective emotions to light at the right time while playing whack-a-mole with the others. It’s cognitive dissonance. It’s exhausting. Cancer doesn’t create personalities; it surfaces them.

It’s the last day of Mr. C’s hospitalization. His blast crisis is amazingly under good control.

“So,” I say. “Will you take your medications now?”

“Sure,” he says instinctively. I look at him. “I mean, honestly, Doc? I’m not sure.”

As we shake hands, I wonder if I’ll ever truly understand Mr. C’s motivations. But I can’t wonder too long. I can only control my part: I hand him his medications and wish him luck.

Minor details of this story were changed to protect privacy.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

NEWPORT BEACH, CALIF. – Researchers say they have identified biomarkers that may help guide early treatment decisions in patients with acute graft-versus-host disease (GVHD).

The biomarkers, ST2 and REG3-alpha, were measured during the first month of GVHD treatment and proved more accurate than clinical response for predicting 6-month nonrelapse mortality (NRM). In fact, biomarker assessment revealed patients who responded to treatment but had a high risk of NRM and nonresponders who had a low risk of NRM.

The researchers also found that biomarkers changed over the first month of treatment but remained significant predictors of NRM. This suggests that modifying treatment according to biomarker findings at various time points could result in better outcomes for patients.

“We think this is going to transform the way we treat graft-versus-host disease,” said James L.M. Ferrara, MD, DSc, of the Icahn School of Medicine at Mount Sinai, New York.

Dr. Ferrara and Hrishikesh Srinagesh, along with their colleagues at Mount Sinai, have conducted extensive research with these biomarkers and presented some of their findings at the Acute Leukemia Forum of Hemedicus.

Comparing biomarkers and response

In one study, the researchers evaluated 355 patients who had undergone allogeneic hematopoietic stem cell transplant at 1 of 20 Mount Sinai Acute GVHD International Consortium (MAGIC) centers between January 2016 and February 2018. All patients developed acute GVHD and received systemic steroids as treatment.

Patients provided blood samples weekly for the first month of treatment, and concentrations of ST2 and REG3-alpha were measured in each sample. Both biomarker concentrations were used to calculate the biomarker probability of NRM.

“The concentration of those two biomarkers are put into a computer, and we get … a single number, and that gives us the probability of mortality,” Dr. Ferrara said. “[W]e call this the MAGIC algorithm probability, or MAP. And when a MAP is low, the patient has a very low chance of dying from graft-versus-host disease, when it’s intermediate, they have an intermediate risk, and when it’s high, they have a high risk.”

The researchers then compared the MAP and clinical response for their ability to predict 6-month NRM throughout the first month of therapy for acute GVHD.

MAP bests response

After 1 month of therapy, the MAP was more accurate than clinical response for predicting 6-month NRM. The area under the curve was 0.84 and 0.65, respectively (P less than .001).

Likewise, the MAP after 1 week of therapy was more accurate than clinical response at 1 month for predicting 6-month NRM. The area under the curve was 0.80 and 0.65, respectively (P less than .001).

“[T]he clinical responses were good, but not great, at predicting long-term outcome, where the biomarker, the MAP, was significantly better,” Dr. Ferrara said. “[A]t every time point we tested, the biomarkers were better than the clinical responses.”

The researchers also identified subgroups of clinical responders and nonresponders for whom MAP more accurately predicted 6-month NRM.

The team found that 61% of clinical nonresponders were actually low risk according to MAP. And the incidence of 6-month NRM was significantly lower in the MAP-designated low-risk patients than in MAP-designated high-risk patients – 22% and 56%, respectively (P less than .001).

On the other hand, 10% of clinical responders were high risk according to MAP. The incidence of 6-month NRM was significantly higher in the high-risk patients than in the low-risk patients – 40% and 13%, respectively (P less than .001).

Assessing changes over time

The researchers found that patients who were initially high risk by MAP but had not experienced NRM by 6 months had significant decreases in their MAP after 4 weeks of treatment (P = .003). Patients who did experience NRM had a significant increase in their MAP whether their initial MAP was low (P = .007) or high (P = .024).

“What we found was that patients who lived tended to either have low biomarkers at the start of treatment and stay low or start out with high biomarkers and have reductions over the first month of therapy,” Mr. Srinagesh said. “Conversely, patients who tended to do worse were those who had either increases in their biomarkers or stayed high at all time points.”

The researchers identified a threshold – 0.290 – for separating patients by mortality risk.

“Patients who started out above the threshold and then went below it had a 5-fold reduction in mortality, whereas patients who started out below the threshold and rose above it had a 5-fold increase in mortality,” Mr. Srinagesh said.

MAP in clinical trials and practice

Based on these findings and results from related studies, the researchers theorize that MAP would be a better endpoint for clinical trials than clinical response.

At present, there are three trials in which researchers are using MAP as an endpoint to assess the efficacy of treatment for GVHD (NCT02133924, NCT03459040, and NCT03846479). Dr. Ferrara said a fourth trial is set to begin this summer.

Additionally, MAP is being used in clinical practice. A company called Viracor Eurofins Clinical Diagnostics licensed the MAGIC algorithm and provides three related tests for consumer use.

Viracor’s aGVHD Pre-Symptomatic Algorithm assigns patients to high- and low-risk groups based on results from samples collected 7 days after transplant. The aGVHD Symptomatic Onset Algorithm assigns patients to high-, intermediate-, and low-risk groups. The aGVHD Post-Treatment Algorithm, which can be used 7 days or more after GVHD treatment initiation, stratifies steroid-resistant patients into high- or low-risk groups for both NRM and overall survival.

“We are still in early days of figuring out how to use [the biomarker tests], but … what I’ve heard is that people are finding them to be useful in their clinical practice,” Dr. Ferrara said.

Dr. Ferrara has an ownership interest in and receives royalties from Viracor. Mr. Srinagesh reported having no relevant conflicts of interest. The research was supported by grants from the National Cancer Institute and the American Cancer Society.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – Researchers say they have identified biomarkers that may help guide early treatment decisions in patients with acute graft-versus-host disease (GVHD).

The biomarkers, ST2 and REG3-alpha, were measured during the first month of GVHD treatment and proved more accurate than clinical response for predicting 6-month nonrelapse mortality (NRM). In fact, biomarker assessment revealed patients who responded to treatment but had a high risk of NRM and nonresponders who had a low risk of NRM.

The researchers also found that biomarkers changed over the first month of treatment but remained significant predictors of NRM. This suggests that modifying treatment according to biomarker findings at various time points could result in better outcomes for patients.

“We think this is going to transform the way we treat graft-versus-host disease,” said James L.M. Ferrara, MD, DSc, of the Icahn School of Medicine at Mount Sinai, New York.

Dr. Ferrara and Hrishikesh Srinagesh, along with their colleagues at Mount Sinai, have conducted extensive research with these biomarkers and presented some of their findings at the Acute Leukemia Forum of Hemedicus.

Comparing biomarkers and response

In one study, the researchers evaluated 355 patients who had undergone allogeneic hematopoietic stem cell transplant at 1 of 20 Mount Sinai Acute GVHD International Consortium (MAGIC) centers between January 2016 and February 2018. All patients developed acute GVHD and received systemic steroids as treatment.

Patients provided blood samples weekly for the first month of treatment, and concentrations of ST2 and REG3-alpha were measured in each sample. Both biomarker concentrations were used to calculate the biomarker probability of NRM.

“The concentration of those two biomarkers are put into a computer, and we get … a single number, and that gives us the probability of mortality,” Dr. Ferrara said. “[W]e call this the MAGIC algorithm probability, or MAP. And when a MAP is low, the patient has a very low chance of dying from graft-versus-host disease, when it’s intermediate, they have an intermediate risk, and when it’s high, they have a high risk.”

The researchers then compared the MAP and clinical response for their ability to predict 6-month NRM throughout the first month of therapy for acute GVHD.

MAP bests response

After 1 month of therapy, the MAP was more accurate than clinical response for predicting 6-month NRM. The area under the curve was 0.84 and 0.65, respectively (P less than .001).

Likewise, the MAP after 1 week of therapy was more accurate than clinical response at 1 month for predicting 6-month NRM. The area under the curve was 0.80 and 0.65, respectively (P less than .001).

“[T]he clinical responses were good, but not great, at predicting long-term outcome, where the biomarker, the MAP, was significantly better,” Dr. Ferrara said. “[A]t every time point we tested, the biomarkers were better than the clinical responses.”

The researchers also identified subgroups of clinical responders and nonresponders for whom MAP more accurately predicted 6-month NRM.

The team found that 61% of clinical nonresponders were actually low risk according to MAP. And the incidence of 6-month NRM was significantly lower in the MAP-designated low-risk patients than in MAP-designated high-risk patients – 22% and 56%, respectively (P less than .001).

On the other hand, 10% of clinical responders were high risk according to MAP. The incidence of 6-month NRM was significantly higher in the high-risk patients than in the low-risk patients – 40% and 13%, respectively (P less than .001).

Assessing changes over time

The researchers found that patients who were initially high risk by MAP but had not experienced NRM by 6 months had significant decreases in their MAP after 4 weeks of treatment (P = .003). Patients who did experience NRM had a significant increase in their MAP whether their initial MAP was low (P = .007) or high (P = .024).

“What we found was that patients who lived tended to either have low biomarkers at the start of treatment and stay low or start out with high biomarkers and have reductions over the first month of therapy,” Mr. Srinagesh said. “Conversely, patients who tended to do worse were those who had either increases in their biomarkers or stayed high at all time points.”

The researchers identified a threshold – 0.290 – for separating patients by mortality risk.

“Patients who started out above the threshold and then went below it had a 5-fold reduction in mortality, whereas patients who started out below the threshold and rose above it had a 5-fold increase in mortality,” Mr. Srinagesh said.

MAP in clinical trials and practice

Based on these findings and results from related studies, the researchers theorize that MAP would be a better endpoint for clinical trials than clinical response.

At present, there are three trials in which researchers are using MAP as an endpoint to assess the efficacy of treatment for GVHD (NCT02133924, NCT03459040, and NCT03846479). Dr. Ferrara said a fourth trial is set to begin this summer.

Additionally, MAP is being used in clinical practice. A company called Viracor Eurofins Clinical Diagnostics licensed the MAGIC algorithm and provides three related tests for consumer use.

Viracor’s aGVHD Pre-Symptomatic Algorithm assigns patients to high- and low-risk groups based on results from samples collected 7 days after transplant. The aGVHD Symptomatic Onset Algorithm assigns patients to high-, intermediate-, and low-risk groups. The aGVHD Post-Treatment Algorithm, which can be used 7 days or more after GVHD treatment initiation, stratifies steroid-resistant patients into high- or low-risk groups for both NRM and overall survival.

“We are still in early days of figuring out how to use [the biomarker tests], but … what I’ve heard is that people are finding them to be useful in their clinical practice,” Dr. Ferrara said.

Dr. Ferrara has an ownership interest in and receives royalties from Viracor. Mr. Srinagesh reported having no relevant conflicts of interest. The research was supported by grants from the National Cancer Institute and the American Cancer Society.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – Researchers say they have identified biomarkers that may help guide early treatment decisions in patients with acute graft-versus-host disease (GVHD).

The biomarkers, ST2 and REG3-alpha, were measured during the first month of GVHD treatment and proved more accurate than clinical response for predicting 6-month nonrelapse mortality (NRM). In fact, biomarker assessment revealed patients who responded to treatment but had a high risk of NRM and nonresponders who had a low risk of NRM.

The researchers also found that biomarkers changed over the first month of treatment but remained significant predictors of NRM. This suggests that modifying treatment according to biomarker findings at various time points could result in better outcomes for patients.

“We think this is going to transform the way we treat graft-versus-host disease,” said James L.M. Ferrara, MD, DSc, of the Icahn School of Medicine at Mount Sinai, New York.

Dr. Ferrara and Hrishikesh Srinagesh, along with their colleagues at Mount Sinai, have conducted extensive research with these biomarkers and presented some of their findings at the Acute Leukemia Forum of Hemedicus.

Comparing biomarkers and response

In one study, the researchers evaluated 355 patients who had undergone allogeneic hematopoietic stem cell transplant at 1 of 20 Mount Sinai Acute GVHD International Consortium (MAGIC) centers between January 2016 and February 2018. All patients developed acute GVHD and received systemic steroids as treatment.

Patients provided blood samples weekly for the first month of treatment, and concentrations of ST2 and REG3-alpha were measured in each sample. Both biomarker concentrations were used to calculate the biomarker probability of NRM.

“The concentration of those two biomarkers are put into a computer, and we get … a single number, and that gives us the probability of mortality,” Dr. Ferrara said. “[W]e call this the MAGIC algorithm probability, or MAP. And when a MAP is low, the patient has a very low chance of dying from graft-versus-host disease, when it’s intermediate, they have an intermediate risk, and when it’s high, they have a high risk.”

The researchers then compared the MAP and clinical response for their ability to predict 6-month NRM throughout the first month of therapy for acute GVHD.

MAP bests response

After 1 month of therapy, the MAP was more accurate than clinical response for predicting 6-month NRM. The area under the curve was 0.84 and 0.65, respectively (P less than .001).

Likewise, the MAP after 1 week of therapy was more accurate than clinical response at 1 month for predicting 6-month NRM. The area under the curve was 0.80 and 0.65, respectively (P less than .001).

“[T]he clinical responses were good, but not great, at predicting long-term outcome, where the biomarker, the MAP, was significantly better,” Dr. Ferrara said. “[A]t every time point we tested, the biomarkers were better than the clinical responses.”

The researchers also identified subgroups of clinical responders and nonresponders for whom MAP more accurately predicted 6-month NRM.

The team found that 61% of clinical nonresponders were actually low risk according to MAP. And the incidence of 6-month NRM was significantly lower in the MAP-designated low-risk patients than in MAP-designated high-risk patients – 22% and 56%, respectively (P less than .001).

On the other hand, 10% of clinical responders were high risk according to MAP. The incidence of 6-month NRM was significantly higher in the high-risk patients than in the low-risk patients – 40% and 13%, respectively (P less than .001).

Assessing changes over time

The researchers found that patients who were initially high risk by MAP but had not experienced NRM by 6 months had significant decreases in their MAP after 4 weeks of treatment (P = .003). Patients who did experience NRM had a significant increase in their MAP whether their initial MAP was low (P = .007) or high (P = .024).

“What we found was that patients who lived tended to either have low biomarkers at the start of treatment and stay low or start out with high biomarkers and have reductions over the first month of therapy,” Mr. Srinagesh said. “Conversely, patients who tended to do worse were those who had either increases in their biomarkers or stayed high at all time points.”

The researchers identified a threshold – 0.290 – for separating patients by mortality risk.

“Patients who started out above the threshold and then went below it had a 5-fold reduction in mortality, whereas patients who started out below the threshold and rose above it had a 5-fold increase in mortality,” Mr. Srinagesh said.

MAP in clinical trials and practice

Based on these findings and results from related studies, the researchers theorize that MAP would be a better endpoint for clinical trials than clinical response.

At present, there are three trials in which researchers are using MAP as an endpoint to assess the efficacy of treatment for GVHD (NCT02133924, NCT03459040, and NCT03846479). Dr. Ferrara said a fourth trial is set to begin this summer.

Additionally, MAP is being used in clinical practice. A company called Viracor Eurofins Clinical Diagnostics licensed the MAGIC algorithm and provides three related tests for consumer use.

Viracor’s aGVHD Pre-Symptomatic Algorithm assigns patients to high- and low-risk groups based on results from samples collected 7 days after transplant. The aGVHD Symptomatic Onset Algorithm assigns patients to high-, intermediate-, and low-risk groups. The aGVHD Post-Treatment Algorithm, which can be used 7 days or more after GVHD treatment initiation, stratifies steroid-resistant patients into high- or low-risk groups for both NRM and overall survival.

“We are still in early days of figuring out how to use [the biomarker tests], but … what I’ve heard is that people are finding them to be useful in their clinical practice,” Dr. Ferrara said.

Dr. Ferrara has an ownership interest in and receives royalties from Viracor. Mr. Srinagesh reported having no relevant conflicts of interest. The research was supported by grants from the National Cancer Institute and the American Cancer Society.

The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.

[email protected]

Officials at the Centers for Disease Control and Prevention are warning against the misapplication of the agency’s 2016 guidelines on opioid prescribing, as well as clarifying dosage recommendations for patients starting or stopping pain medications.

In a perspective published in the New England Journal of Medicine on April 24, lead author Deborah Dowell, MD, chief medical officer for the CDC’s National Center for Injury Prevention and Control, conveyed concern that some policies and practices derived from the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain are inconsistent with the recommendations and often go beyond their scope.

Misapplication examples include inappropriately applying the guideline to patients in active cancer treatment, patients experiencing acute sickle cell crises, or patients experiencing postsurgical pain, Dr. Dowell wrote.

The guideline offers guidance to clinicians treating chronic pain in adults who are already receiving opioids long-term at high dosages, she noted. It includes advice on maximizing nonopioid treatment, reviewing risks associated with continuing high-dose opioids, and collaborating with patients who agree to taper dosage, among other guidance.

Any application of the guideline’s dosage recommendation that results in hard limits or “cutting off” opioids is also an incorrect use of the recommendations, according to Dr. Dowell.

While the guideline advises clinicians to start opioids at the lowest effective dosage and avoid increasing dosage to 90 morphine milligram equivalents per day or more, that statement does not suggest discontinuation of opioids already prescribed at high dosages, according to the CDC’s clarification.

The guidance also does not apply to patients receiving or starting medication-assisted treatment for opioid use disorder.

The commentary comes after a trio of organizations raised concerns that insurers are inappropriately applying the recommendations to active cancer patients when making coverage determinations.

The American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the American Society of Hematology, raised the issue in a letter to the CDC in February. In response, Dr. Dowell clarified that the recommendations are not intended to deny clinically appropriate opioid therapy to any patients who suffer chronic pain, but rather to ensure that physicians and patients consider all safe and effective treatment options.

In the perspective, Dr. Dowell wrote that the CDC is evaluating the intended and unintended impact of the 2016 opioid-prescribing guideline on clinician and patient outcomes and that the agency is committed to updating the recommendations when new evidence is available.
 

[email protected]

Officials at the Centers for Disease Control and Prevention are warning against the misapplication of the agency’s 2016 guidelines on opioid prescribing, as well as clarifying dosage recommendations for patients starting or stopping pain medications.

In a perspective published in the New England Journal of Medicine on April 24, lead author Deborah Dowell, MD, chief medical officer for the CDC’s National Center for Injury Prevention and Control, conveyed concern that some policies and practices derived from the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain are inconsistent with the recommendations and often go beyond their scope.

Misapplication examples include inappropriately applying the guideline to patients in active cancer treatment, patients experiencing acute sickle cell crises, or patients experiencing postsurgical pain, Dr. Dowell wrote.

The guideline offers guidance to clinicians treating chronic pain in adults who are already receiving opioids long-term at high dosages, she noted. It includes advice on maximizing nonopioid treatment, reviewing risks associated with continuing high-dose opioids, and collaborating with patients who agree to taper dosage, among other guidance.

Any application of the guideline’s dosage recommendation that results in hard limits or “cutting off” opioids is also an incorrect use of the recommendations, according to Dr. Dowell.

While the guideline advises clinicians to start opioids at the lowest effective dosage and avoid increasing dosage to 90 morphine milligram equivalents per day or more, that statement does not suggest discontinuation of opioids already prescribed at high dosages, according to the CDC’s clarification.

The guidance also does not apply to patients receiving or starting medication-assisted treatment for opioid use disorder.

The commentary comes after a trio of organizations raised concerns that insurers are inappropriately applying the recommendations to active cancer patients when making coverage determinations.

The American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the American Society of Hematology, raised the issue in a letter to the CDC in February. In response, Dr. Dowell clarified that the recommendations are not intended to deny clinically appropriate opioid therapy to any patients who suffer chronic pain, but rather to ensure that physicians and patients consider all safe and effective treatment options.

In the perspective, Dr. Dowell wrote that the CDC is evaluating the intended and unintended impact of the 2016 opioid-prescribing guideline on clinician and patient outcomes and that the agency is committed to updating the recommendations when new evidence is available.
 

[email protected]

Officials at the Centers for Disease Control and Prevention are warning against the misapplication of the agency’s 2016 guidelines on opioid prescribing, as well as clarifying dosage recommendations for patients starting or stopping pain medications.

In a perspective published in the New England Journal of Medicine on April 24, lead author Deborah Dowell, MD, chief medical officer for the CDC’s National Center for Injury Prevention and Control, conveyed concern that some policies and practices derived from the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain are inconsistent with the recommendations and often go beyond their scope.

Misapplication examples include inappropriately applying the guideline to patients in active cancer treatment, patients experiencing acute sickle cell crises, or patients experiencing postsurgical pain, Dr. Dowell wrote.

The guideline offers guidance to clinicians treating chronic pain in adults who are already receiving opioids long-term at high dosages, she noted. It includes advice on maximizing nonopioid treatment, reviewing risks associated with continuing high-dose opioids, and collaborating with patients who agree to taper dosage, among other guidance.

Any application of the guideline’s dosage recommendation that results in hard limits or “cutting off” opioids is also an incorrect use of the recommendations, according to Dr. Dowell.

While the guideline advises clinicians to start opioids at the lowest effective dosage and avoid increasing dosage to 90 morphine milligram equivalents per day or more, that statement does not suggest discontinuation of opioids already prescribed at high dosages, according to the CDC’s clarification.

The guidance also does not apply to patients receiving or starting medication-assisted treatment for opioid use disorder.

The commentary comes after a trio of organizations raised concerns that insurers are inappropriately applying the recommendations to active cancer patients when making coverage determinations.

The American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the American Society of Hematology, raised the issue in a letter to the CDC in February. In response, Dr. Dowell clarified that the recommendations are not intended to deny clinically appropriate opioid therapy to any patients who suffer chronic pain, but rather to ensure that physicians and patients consider all safe and effective treatment options.

In the perspective, Dr. Dowell wrote that the CDC is evaluating the intended and unintended impact of the 2016 opioid-prescribing guideline on clinician and patient outcomes and that the agency is committed to updating the recommendations when new evidence is available.
 

[email protected]

For patients with multiple myeloma in relapse after an autologous stem cell transplant (ASCT), salvage ASCT is associated with reduced quality of life and greater pain in the near term, compared with nontransplantation consolidation (NTC) therapy, a secondary analysis from the United Kingdom’s Myeloma X trial suggested.

Courtesy Wikimedia Commons/KGH/Creative Commons License

But global health status scores for salvage ASCT (sASCT) lagged only in the first 100 days after randomization, whereas pain scores were worse with salvage transplantation in the first 2 years but slightly better thereafter, reported Sam H. Ahmedzai, MBChB, from the University of Sheffield, England, and his colleagues.

“The small and diminishing differences in global health status and side effects of treatment need to be considered alongside the results of Myeloma X, which showed a significant benefit of sASCT on [overall survival]. The benefits of sASCT should be considered alongside the relatively short-term negative effects on [quality of life] and pain when making patient treatment decisions and further support the use of sASCT,” they wrote in the Journal of Clinical Oncology.

The BSBMT/UKMF Myeloma X trial was a multicenter, randomized, phase 3 trial comparing sASCT with weekly oral cyclophosphamide in patients with multiple myeloma who had relapsed after a prior ASCT. In the final overall survival analysis, median overall survival was superior for the sASCT, at 67 months vs. 52 months for nontransplantation consolidation (P = .022; hazard ratio, 0.56; P = .0169).

In the current study, the investigators reported on secondary patient-reported pain and quality of life outcomes assessed using the validated European Organization for Research and Treatment of Cancer Questionnaire (QLQ-C30) and its myeloma-specific module, QLQ-MY20; the Brief Pain Inventory (Short Form), and the Leeds Assessment of Neuropathic Symptoms and Signs (Self-Assessment) scale.

Of the 297 patients enrolled, 288 had consented to the quality of life portion of the study, and of this group, 171 (88 assigned to sASCT and 83 assigned to NTC) were included.

After a median follow-up of 52 months, the QLQ-C30 global health status scores were 9.2 points higher (indicating better) for patients in the nontransplantation group (P = .0496) at 100 days after transplantation, but there were no significant differences between the groups for this measure at any later time point.

“This deterioration in global health status for patients receiving sASCT, compared with NTC, dissipated to a trivial difference at 6 months and a smaller trivial difference at 1 year,” Dr. Ahmedzai and his colleagues wrote.

At 2 years, the pendulum had swung to favor sASCT, but also by a “trivial” amount.

The side effects of treatment subscale was slightly higher (worse) with sASCT at 100 days and 6 months after treatment, but this difference dwindled thereafter.

Pain interference scores adjusted for baseline score and baseline neuropathic pain level were not significantly different 100 days after randomization, but there were significant differences at both 6 months and up to 2 years. At all the time points considered, pain interference scores were approximately 1 point lower in the NTC group, which the authors noted is a clinically relevant difference.

Patients who had undergone sASCT and reported below-median scores on a side-effect subscale had significantly longer time to progression, compared with patients who received NTC (HR, 0.24; P = .003), a difference that held up on multivariable regression analysis (HR, 0.20; P = .0499).

Pain scores were not significantly predictive of either time to progression or overall survival, however.

The study was supported by Cancer Research UK, Janssen-Cilag, and Chugai Pharma UK. Dr. Ahmedzai reported honoraria, consulting, research funding, and travel fees from various companies, not including the study sponsors.

SOURCE: Ahmedzai SH et al. J Clin Oncol. 2019 Apr 10. doi: 10.1200/JCO.18.01006.

For patients with multiple myeloma in relapse after an autologous stem cell transplant (ASCT), salvage ASCT is associated with reduced quality of life and greater pain in the near term, compared with nontransplantation consolidation (NTC) therapy, a secondary analysis from the United Kingdom’s Myeloma X trial suggested.

Courtesy Wikimedia Commons/KGH/Creative Commons License

But global health status scores for salvage ASCT (sASCT) lagged only in the first 100 days after randomization, whereas pain scores were worse with salvage transplantation in the first 2 years but slightly better thereafter, reported Sam H. Ahmedzai, MBChB, from the University of Sheffield, England, and his colleagues.

“The small and diminishing differences in global health status and side effects of treatment need to be considered alongside the results of Myeloma X, which showed a significant benefit of sASCT on [overall survival]. The benefits of sASCT should be considered alongside the relatively short-term negative effects on [quality of life] and pain when making patient treatment decisions and further support the use of sASCT,” they wrote in the Journal of Clinical Oncology.

The BSBMT/UKMF Myeloma X trial was a multicenter, randomized, phase 3 trial comparing sASCT with weekly oral cyclophosphamide in patients with multiple myeloma who had relapsed after a prior ASCT. In the final overall survival analysis, median overall survival was superior for the sASCT, at 67 months vs. 52 months for nontransplantation consolidation (P = .022; hazard ratio, 0.56; P = .0169).

In the current study, the investigators reported on secondary patient-reported pain and quality of life outcomes assessed using the validated European Organization for Research and Treatment of Cancer Questionnaire (QLQ-C30) and its myeloma-specific module, QLQ-MY20; the Brief Pain Inventory (Short Form), and the Leeds Assessment of Neuropathic Symptoms and Signs (Self-Assessment) scale.

Of the 297 patients enrolled, 288 had consented to the quality of life portion of the study, and of this group, 171 (88 assigned to sASCT and 83 assigned to NTC) were included.

After a median follow-up of 52 months, the QLQ-C30 global health status scores were 9.2 points higher (indicating better) for patients in the nontransplantation group (P = .0496) at 100 days after transplantation, but there were no significant differences between the groups for this measure at any later time point.

“This deterioration in global health status for patients receiving sASCT, compared with NTC, dissipated to a trivial difference at 6 months and a smaller trivial difference at 1 year,” Dr. Ahmedzai and his colleagues wrote.

At 2 years, the pendulum had swung to favor sASCT, but also by a “trivial” amount.

The side effects of treatment subscale was slightly higher (worse) with sASCT at 100 days and 6 months after treatment, but this difference dwindled thereafter.

Pain interference scores adjusted for baseline score and baseline neuropathic pain level were not significantly different 100 days after randomization, but there were significant differences at both 6 months and up to 2 years. At all the time points considered, pain interference scores were approximately 1 point lower in the NTC group, which the authors noted is a clinically relevant difference.

Patients who had undergone sASCT and reported below-median scores on a side-effect subscale had significantly longer time to progression, compared with patients who received NTC (HR, 0.24; P = .003), a difference that held up on multivariable regression analysis (HR, 0.20; P = .0499).

Pain scores were not significantly predictive of either time to progression or overall survival, however.

The study was supported by Cancer Research UK, Janssen-Cilag, and Chugai Pharma UK. Dr. Ahmedzai reported honoraria, consulting, research funding, and travel fees from various companies, not including the study sponsors.

SOURCE: Ahmedzai SH et al. J Clin Oncol. 2019 Apr 10. doi: 10.1200/JCO.18.01006.

For patients with multiple myeloma in relapse after an autologous stem cell transplant (ASCT), salvage ASCT is associated with reduced quality of life and greater pain in the near term, compared with nontransplantation consolidation (NTC) therapy, a secondary analysis from the United Kingdom’s Myeloma X trial suggested.

Courtesy Wikimedia Commons/KGH/Creative Commons License

But global health status scores for salvage ASCT (sASCT) lagged only in the first 100 days after randomization, whereas pain scores were worse with salvage transplantation in the first 2 years but slightly better thereafter, reported Sam H. Ahmedzai, MBChB, from the University of Sheffield, England, and his colleagues.

“The small and diminishing differences in global health status and side effects of treatment need to be considered alongside the results of Myeloma X, which showed a significant benefit of sASCT on [overall survival]. The benefits of sASCT should be considered alongside the relatively short-term negative effects on [quality of life] and pain when making patient treatment decisions and further support the use of sASCT,” they wrote in the Journal of Clinical Oncology.

The BSBMT/UKMF Myeloma X trial was a multicenter, randomized, phase 3 trial comparing sASCT with weekly oral cyclophosphamide in patients with multiple myeloma who had relapsed after a prior ASCT. In the final overall survival analysis, median overall survival was superior for the sASCT, at 67 months vs. 52 months for nontransplantation consolidation (P = .022; hazard ratio, 0.56; P = .0169).

In the current study, the investigators reported on secondary patient-reported pain and quality of life outcomes assessed using the validated European Organization for Research and Treatment of Cancer Questionnaire (QLQ-C30) and its myeloma-specific module, QLQ-MY20; the Brief Pain Inventory (Short Form), and the Leeds Assessment of Neuropathic Symptoms and Signs (Self-Assessment) scale.

Of the 297 patients enrolled, 288 had consented to the quality of life portion of the study, and of this group, 171 (88 assigned to sASCT and 83 assigned to NTC) were included.

After a median follow-up of 52 months, the QLQ-C30 global health status scores were 9.2 points higher (indicating better) for patients in the nontransplantation group (P = .0496) at 100 days after transplantation, but there were no significant differences between the groups for this measure at any later time point.

“This deterioration in global health status for patients receiving sASCT, compared with NTC, dissipated to a trivial difference at 6 months and a smaller trivial difference at 1 year,” Dr. Ahmedzai and his colleagues wrote.

At 2 years, the pendulum had swung to favor sASCT, but also by a “trivial” amount.

The side effects of treatment subscale was slightly higher (worse) with sASCT at 100 days and 6 months after treatment, but this difference dwindled thereafter.

Pain interference scores adjusted for baseline score and baseline neuropathic pain level were not significantly different 100 days after randomization, but there were significant differences at both 6 months and up to 2 years. At all the time points considered, pain interference scores were approximately 1 point lower in the NTC group, which the authors noted is a clinically relevant difference.

Patients who had undergone sASCT and reported below-median scores on a side-effect subscale had significantly longer time to progression, compared with patients who received NTC (HR, 0.24; P = .003), a difference that held up on multivariable regression analysis (HR, 0.20; P = .0499).

Pain scores were not significantly predictive of either time to progression or overall survival, however.

The study was supported by Cancer Research UK, Janssen-Cilag, and Chugai Pharma UK. Dr. Ahmedzai reported honoraria, consulting, research funding, and travel fees from various companies, not including the study sponsors.

SOURCE: Ahmedzai SH et al. J Clin Oncol. 2019 Apr 10. doi: 10.1200/JCO.18.01006.

NEWPORT BEACH, CALIF. – Researchers have shown they can identify transgender leukemia patients by detecting gender-karyotype mismatches, but some transgender patients may be overlooked with this method.

The researchers’ work also highlights how little we know about transgender patients with leukemia and other cancers.

Alison Alpert, MD, of the University of Rochester (N.Y.) Medical Center, and her colleagues conducted this research and presented their findings in a poster at the Acute Leukemia Forum of Hemedicus.

“There’s almost no data about transgender people with cancer ... in terms of prevalence or anything else,” Dr. Alpert noted. “And because we don’t know which patients with cancer are transgender, we can’t begin to answer any of the other big questions for patients.”

Specifically, it’s unclear what kinds of cancer transgender patients have, if there are health disparities among transgender patients, if it is safe to continue hormone therapy during cancer treatment, and if it is possible to do transition-related surgeries in the context of cancer care.

With this in mind, Dr. Alpert and her colleagues set out to identify transgender patients by detecting gender-karyotype mismatches. The team analyzed data on patients with acute myeloid leukemia (AML) or myelodysplastic syndromes enrolled in five Southwest Oncology Group (SWOG) trials.

Of the 1,748 patients analyzed, six (0.3%) had a gender-karyotype mismatch. Five patients had a 46,XY karyotype and identified as female, and one patient had a 46,XX karyotype and identified as male.

“Some transgender patients have their gender identity accurately reflected in the electronic medical record, [but] some transgender patients probably don’t,” Dr. Alpert noted. “So we identified some, but probably not all, and probably not even most, transgender patients with leukemia in this cohort.”

All six of the transgender patients identified had AML, and all were white. They ranged in age from 18 to 57 years. Four patients had achieved a complete response to therapy, and two had refractory disease.

Four patients, including one who was refractory, were still alive at last follow-up. The remaining two patients, including one who had achieved a complete response, had died.

The transgender patients identified in this analysis represent a very small percentage of the population studied, Dr. Alpert noted. Therefore, the researchers could not draw any conclusions about transgender patients with AML.

“Mostly, what we did was, we pointed out how little information we have,” Dr. Alpert said. “Oncologists don’t routinely collect gender identity information, and this information doesn’t exist in cooperative group databases either.”

“But going forward, what probably really needs to happen is that oncologists need to ask their patients whether they are transgender or not. And then, ideally, consent forms for large cooperative groups like SWOG would include gender identity data, and then we would be able to answer some of our other questions and better counsel our patients.”

Dr. Alpert and her colleagues are hoping to gain insights regarding transgender patients with lymphoma as well. The researchers are analyzing the lymphoma database at the University of Rochester Medical Center, which includes about 2,200 patients.

The team is attempting to identify transgender lymphoma patients using gender-karyotype mismatch as well as other methods, including assessing patients’ medication and surgical histories, determining whether patients have any aliases, and looking for the word “transgender” in patient charts.

“Given that the country is finally starting to talk about transgender patients, their health disparities, and their needs and experiences, it’s really time that we start collecting this data,” Dr. Alpert said.

“[I]f we are able to start to collect this data, it can help us build relationships with our patients, improve their care and outcomes, and, hopefully, be able to better counsel them about hormones and surgery.”

Dr. Alpert and her colleagues did not disclose any conflicts of interest.

The Acute Leukemia Forum is organized by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – Researchers have shown they can identify transgender leukemia patients by detecting gender-karyotype mismatches, but some transgender patients may be overlooked with this method.

The researchers’ work also highlights how little we know about transgender patients with leukemia and other cancers.

Alison Alpert, MD, of the University of Rochester (N.Y.) Medical Center, and her colleagues conducted this research and presented their findings in a poster at the Acute Leukemia Forum of Hemedicus.

“There’s almost no data about transgender people with cancer ... in terms of prevalence or anything else,” Dr. Alpert noted. “And because we don’t know which patients with cancer are transgender, we can’t begin to answer any of the other big questions for patients.”

Specifically, it’s unclear what kinds of cancer transgender patients have, if there are health disparities among transgender patients, if it is safe to continue hormone therapy during cancer treatment, and if it is possible to do transition-related surgeries in the context of cancer care.

With this in mind, Dr. Alpert and her colleagues set out to identify transgender patients by detecting gender-karyotype mismatches. The team analyzed data on patients with acute myeloid leukemia (AML) or myelodysplastic syndromes enrolled in five Southwest Oncology Group (SWOG) trials.

Of the 1,748 patients analyzed, six (0.3%) had a gender-karyotype mismatch. Five patients had a 46,XY karyotype and identified as female, and one patient had a 46,XX karyotype and identified as male.

“Some transgender patients have their gender identity accurately reflected in the electronic medical record, [but] some transgender patients probably don’t,” Dr. Alpert noted. “So we identified some, but probably not all, and probably not even most, transgender patients with leukemia in this cohort.”

All six of the transgender patients identified had AML, and all were white. They ranged in age from 18 to 57 years. Four patients had achieved a complete response to therapy, and two had refractory disease.

Four patients, including one who was refractory, were still alive at last follow-up. The remaining two patients, including one who had achieved a complete response, had died.

The transgender patients identified in this analysis represent a very small percentage of the population studied, Dr. Alpert noted. Therefore, the researchers could not draw any conclusions about transgender patients with AML.

“Mostly, what we did was, we pointed out how little information we have,” Dr. Alpert said. “Oncologists don’t routinely collect gender identity information, and this information doesn’t exist in cooperative group databases either.”

“But going forward, what probably really needs to happen is that oncologists need to ask their patients whether they are transgender or not. And then, ideally, consent forms for large cooperative groups like SWOG would include gender identity data, and then we would be able to answer some of our other questions and better counsel our patients.”

Dr. Alpert and her colleagues are hoping to gain insights regarding transgender patients with lymphoma as well. The researchers are analyzing the lymphoma database at the University of Rochester Medical Center, which includes about 2,200 patients.

The team is attempting to identify transgender lymphoma patients using gender-karyotype mismatch as well as other methods, including assessing patients’ medication and surgical histories, determining whether patients have any aliases, and looking for the word “transgender” in patient charts.

“Given that the country is finally starting to talk about transgender patients, their health disparities, and their needs and experiences, it’s really time that we start collecting this data,” Dr. Alpert said.

“[I]f we are able to start to collect this data, it can help us build relationships with our patients, improve their care and outcomes, and, hopefully, be able to better counsel them about hormones and surgery.”

Dr. Alpert and her colleagues did not disclose any conflicts of interest.

The Acute Leukemia Forum is organized by Hemedicus, which is owned by the same company as this news organization.

[email protected]

NEWPORT BEACH, CALIF. – Researchers have shown they can identify transgender leukemia patients by detecting gender-karyotype mismatches, but some transgender patients may be overlooked with this method.

The researchers’ work also highlights how little we know about transgender patients with leukemia and other cancers.

Alison Alpert, MD, of the University of Rochester (N.Y.) Medical Center, and her colleagues conducted this research and presented their findings in a poster at the Acute Leukemia Forum of Hemedicus.

“There’s almost no data about transgender people with cancer ... in terms of prevalence or anything else,” Dr. Alpert noted. “And because we don’t know which patients with cancer are transgender, we can’t begin to answer any of the other big questions for patients.”

Specifically, it’s unclear what kinds of cancer transgender patients have, if there are health disparities among transgender patients, if it is safe to continue hormone therapy during cancer treatment, and if it is possible to do transition-related surgeries in the context of cancer care.

With this in mind, Dr. Alpert and her colleagues set out to identify transgender patients by detecting gender-karyotype mismatches. The team analyzed data on patients with acute myeloid leukemia (AML) or myelodysplastic syndromes enrolled in five Southwest Oncology Group (SWOG) trials.

Of the 1,748 patients analyzed, six (0.3%) had a gender-karyotype mismatch. Five patients had a 46,XY karyotype and identified as female, and one patient had a 46,XX karyotype and identified as male.

“Some transgender patients have their gender identity accurately reflected in the electronic medical record, [but] some transgender patients probably don’t,” Dr. Alpert noted. “So we identified some, but probably not all, and probably not even most, transgender patients with leukemia in this cohort.”

All six of the transgender patients identified had AML, and all were white. They ranged in age from 18 to 57 years. Four patients had achieved a complete response to therapy, and two had refractory disease.

Four patients, including one who was refractory, were still alive at last follow-up. The remaining two patients, including one who had achieved a complete response, had died.

The transgender patients identified in this analysis represent a very small percentage of the population studied, Dr. Alpert noted. Therefore, the researchers could not draw any conclusions about transgender patients with AML.

“Mostly, what we did was, we pointed out how little information we have,” Dr. Alpert said. “Oncologists don’t routinely collect gender identity information, and this information doesn’t exist in cooperative group databases either.”

“But going forward, what probably really needs to happen is that oncologists need to ask their patients whether they are transgender or not. And then, ideally, consent forms for large cooperative groups like SWOG would include gender identity data, and then we would be able to answer some of our other questions and better counsel our patients.”

Dr. Alpert and her colleagues are hoping to gain insights regarding transgender patients with lymphoma as well. The researchers are analyzing the lymphoma database at the University of Rochester Medical Center, which includes about 2,200 patients.

The team is attempting to identify transgender lymphoma patients using gender-karyotype mismatch as well as other methods, including assessing patients’ medication and surgical histories, determining whether patients have any aliases, and looking for the word “transgender” in patient charts.

“Given that the country is finally starting to talk about transgender patients, their health disparities, and their needs and experiences, it’s really time that we start collecting this data,” Dr. Alpert said.

“[I]f we are able to start to collect this data, it can help us build relationships with our patients, improve their care and outcomes, and, hopefully, be able to better counsel them about hormones and surgery.”

Dr. Alpert and her colleagues did not disclose any conflicts of interest.

The Acute Leukemia Forum is organized by Hemedicus, which is owned by the same company as this news organization.

[email protected]

Doxepin mouthwash and diphenhydramine/lidocaine/antacid (DLA) mouthwash can offer 4 hours of pain relief for cancer patients with oral mucositis, according to investigators.

Although these agents led to statistical improvements in pain, neither met predetermined clinical efficacy thresholds, reported lead author Terence T. Sio, MD, of the Mayo Clinic Hospital in Phoenix and his colleagues, who suggested that more safety and efficacy research is needed.

“Few pharmacological agents or interventions have been shown to effectively reduce the severity of radiotherapy-related oral mucositis and its associated pain,” the investigators wrote in JAMA.

They noted that this knowledge gap affects everyday practice since “more than 80% of patients develop oral mucositis during radiotherapy, and mouthwashes and systemic analgesic agents are frequently used to treat the condition.”

Small studies have shown that doxepin, a tricyclic antidepressant, could be an effective agent for oral mucositis, while a variety of DLA mouthwashes are commonly prescribed, despite a dearth of relevant Cochrane reviews or randomized placebo-controlled trials.

This background led to the present study, which included 275 patients who had developed oral mucositis while undergoing head and neck radiotherapy for cancer. The patients were randomized evenly into three mouthwash groups: placebo (2.5 mL Ora-Sweet SF oral solution and 2.5 mL of water), doxepin (25 mg in 5 mL solution), or diphenhydramine (12.5 mg in 5 mL alcohol-free solution), lidocaine (2% viscous solution), and antacid (20 mg of simethicone, 200 mg of magnesium hydroxide, and 200 mg of aluminum hydroxide in 355 mL solution). The study was divided into two cycles; in the first, patients used their assigned mouthwash once, whereas in the second cycle, which was optional, patients used their assigned treatment every 4 hours for up to 7 days.

The primary endpoint was oral mucositis pain. Multiple secondary endpoints were assessed, including patient preference for continued therapy and various adverse effects, such as drowsiness and taste. Responses were assessed using a combination of the Oral Mucositis Daily Questionnaire and the Oral Mucositis Weekly Questionnaire–Head and Neck Cancer. This modified questionnaire was conducted prior to treatment, then after treatment at 5, 15, 30, 60, 120, and 240 minutes. Pain improvements were compared by area under the curve after adjustment for baseline score. Clinical improvement was defined as a 3.5 point difference in pain score, compared with placebo.

Data analysis showed that pain in the first 4 hours decreased the most in the DLA group (11.7 points), slightly less in the doxepin group (11.6 points), and least in the placebo group (8.7 points). Compared with placebo, both treatments offered statistical improvements. DLA patients responded the most (3.0 points; P = .004), while, again, the average doxepin response was similar, albeit with a slightly higher P value. (2.9 points; P = .02). The investigators discouraged direct comparisons between the two agents because the study was not designed for this purpose.

Neither intervention met the predetermined 3.5-point threshold for clinical improvement, although the investigators suggested that some patients may have had meaningful responses.

“There is some suggestion in post hoc analyses that the findings may have been clinically relevant for some patients,” the investigators wrote, noting that responder analysis favored treatment with DLA versus placebo, but not doxepin versus placebo. “However,” they noted, “the overall clinical importance of the statistically significant primary findings remains uncertain.”

Compared with placebo, doxepin mouthwash was associated with stinging or burning, unpleasant taste, drowsiness, and fatigue. Of note, fatigue only occurred in the doxepin group, at a rate of 6%. Both treatment groups had a maximum grade 3 adverse event rate of 4%, while the placebo arm had an adverse event rate of 2%.

“Further research is needed to assess longer-term efficacy and safety for both mouthwashes,” the investigators concluded.

The study was funded by the National Cancer Institute and the Mayo Clinic Symptom Intervention Program. One investigator reported a nonfinancial support from CutisPharma. The other investigators declared no conflicts of interest.

SOURCE: Sio TT et al. JAMA. 2019 Apr 16. doi: 10.1001/jama.2019.3504.

Doxepin mouthwash and diphenhydramine/lidocaine/antacid (DLA) mouthwash can offer 4 hours of pain relief for cancer patients with oral mucositis, according to investigators.

Although these agents led to statistical improvements in pain, neither met predetermined clinical efficacy thresholds, reported lead author Terence T. Sio, MD, of the Mayo Clinic Hospital in Phoenix and his colleagues, who suggested that more safety and efficacy research is needed.

“Few pharmacological agents or interventions have been shown to effectively reduce the severity of radiotherapy-related oral mucositis and its associated pain,” the investigators wrote in JAMA.

They noted that this knowledge gap affects everyday practice since “more than 80% of patients develop oral mucositis during radiotherapy, and mouthwashes and systemic analgesic agents are frequently used to treat the condition.”

Small studies have shown that doxepin, a tricyclic antidepressant, could be an effective agent for oral mucositis, while a variety of DLA mouthwashes are commonly prescribed, despite a dearth of relevant Cochrane reviews or randomized placebo-controlled trials.

This background led to the present study, which included 275 patients who had developed oral mucositis while undergoing head and neck radiotherapy for cancer. The patients were randomized evenly into three mouthwash groups: placebo (2.5 mL Ora-Sweet SF oral solution and 2.5 mL of water), doxepin (25 mg in 5 mL solution), or diphenhydramine (12.5 mg in 5 mL alcohol-free solution), lidocaine (2% viscous solution), and antacid (20 mg of simethicone, 200 mg of magnesium hydroxide, and 200 mg of aluminum hydroxide in 355 mL solution). The study was divided into two cycles; in the first, patients used their assigned mouthwash once, whereas in the second cycle, which was optional, patients used their assigned treatment every 4 hours for up to 7 days.

The primary endpoint was oral mucositis pain. Multiple secondary endpoints were assessed, including patient preference for continued therapy and various adverse effects, such as drowsiness and taste. Responses were assessed using a combination of the Oral Mucositis Daily Questionnaire and the Oral Mucositis Weekly Questionnaire–Head and Neck Cancer. This modified questionnaire was conducted prior to treatment, then after treatment at 5, 15, 30, 60, 120, and 240 minutes. Pain improvements were compared by area under the curve after adjustment for baseline score. Clinical improvement was defined as a 3.5 point difference in pain score, compared with placebo.

Data analysis showed that pain in the first 4 hours decreased the most in the DLA group (11.7 points), slightly less in the doxepin group (11.6 points), and least in the placebo group (8.7 points). Compared with placebo, both treatments offered statistical improvements. DLA patients responded the most (3.0 points; P = .004), while, again, the average doxepin response was similar, albeit with a slightly higher P value. (2.9 points; P = .02). The investigators discouraged direct comparisons between the two agents because the study was not designed for this purpose.

Neither intervention met the predetermined 3.5-point threshold for clinical improvement, although the investigators suggested that some patients may have had meaningful responses.

“There is some suggestion in post hoc analyses that the findings may have been clinically relevant for some patients,” the investigators wrote, noting that responder analysis favored treatment with DLA versus placebo, but not doxepin versus placebo. “However,” they noted, “the overall clinical importance of the statistically significant primary findings remains uncertain.”

Compared with placebo, doxepin mouthwash was associated with stinging or burning, unpleasant taste, drowsiness, and fatigue. Of note, fatigue only occurred in the doxepin group, at a rate of 6%. Both treatment groups had a maximum grade 3 adverse event rate of 4%, while the placebo arm had an adverse event rate of 2%.

“Further research is needed to assess longer-term efficacy and safety for both mouthwashes,” the investigators concluded.

The study was funded by the National Cancer Institute and the Mayo Clinic Symptom Intervention Program. One investigator reported a nonfinancial support from CutisPharma. The other investigators declared no conflicts of interest.

SOURCE: Sio TT et al. JAMA. 2019 Apr 16. doi: 10.1001/jama.2019.3504.

Doxepin mouthwash and diphenhydramine/lidocaine/antacid (DLA) mouthwash can offer 4 hours of pain relief for cancer patients with oral mucositis, according to investigators.

Although these agents led to statistical improvements in pain, neither met predetermined clinical efficacy thresholds, reported lead author Terence T. Sio, MD, of the Mayo Clinic Hospital in Phoenix and his colleagues, who suggested that more safety and efficacy research is needed.

“Few pharmacological agents or interventions have been shown to effectively reduce the severity of radiotherapy-related oral mucositis and its associated pain,” the investigators wrote in JAMA.

They noted that this knowledge gap affects everyday practice since “more than 80% of patients develop oral mucositis during radiotherapy, and mouthwashes and systemic analgesic agents are frequently used to treat the condition.”

Small studies have shown that doxepin, a tricyclic antidepressant, could be an effective agent for oral mucositis, while a variety of DLA mouthwashes are commonly prescribed, despite a dearth of relevant Cochrane reviews or randomized placebo-controlled trials.

This background led to the present study, which included 275 patients who had developed oral mucositis while undergoing head and neck radiotherapy for cancer. The patients were randomized evenly into three mouthwash groups: placebo (2.5 mL Ora-Sweet SF oral solution and 2.5 mL of water), doxepin (25 mg in 5 mL solution), or diphenhydramine (12.5 mg in 5 mL alcohol-free solution), lidocaine (2% viscous solution), and antacid (20 mg of simethicone, 200 mg of magnesium hydroxide, and 200 mg of aluminum hydroxide in 355 mL solution). The study was divided into two cycles; in the first, patients used their assigned mouthwash once, whereas in the second cycle, which was optional, patients used their assigned treatment every 4 hours for up to 7 days.

The primary endpoint was oral mucositis pain. Multiple secondary endpoints were assessed, including patient preference for continued therapy and various adverse effects, such as drowsiness and taste. Responses were assessed using a combination of the Oral Mucositis Daily Questionnaire and the Oral Mucositis Weekly Questionnaire–Head and Neck Cancer. This modified questionnaire was conducted prior to treatment, then after treatment at 5, 15, 30, 60, 120, and 240 minutes. Pain improvements were compared by area under the curve after adjustment for baseline score. Clinical improvement was defined as a 3.5 point difference in pain score, compared with placebo.

Data analysis showed that pain in the first 4 hours decreased the most in the DLA group (11.7 points), slightly less in the doxepin group (11.6 points), and least in the placebo group (8.7 points). Compared with placebo, both treatments offered statistical improvements. DLA patients responded the most (3.0 points; P = .004), while, again, the average doxepin response was similar, albeit with a slightly higher P value. (2.9 points; P = .02). The investigators discouraged direct comparisons between the two agents because the study was not designed for this purpose.

Neither intervention met the predetermined 3.5-point threshold for clinical improvement, although the investigators suggested that some patients may have had meaningful responses.

“There is some suggestion in post hoc analyses that the findings may have been clinically relevant for some patients,” the investigators wrote, noting that responder analysis favored treatment with DLA versus placebo, but not doxepin versus placebo. “However,” they noted, “the overall clinical importance of the statistically significant primary findings remains uncertain.”

Compared with placebo, doxepin mouthwash was associated with stinging or burning, unpleasant taste, drowsiness, and fatigue. Of note, fatigue only occurred in the doxepin group, at a rate of 6%. Both treatment groups had a maximum grade 3 adverse event rate of 4%, while the placebo arm had an adverse event rate of 2%.

“Further research is needed to assess longer-term efficacy and safety for both mouthwashes,” the investigators concluded.

The study was funded by the National Cancer Institute and the Mayo Clinic Symptom Intervention Program. One investigator reported a nonfinancial support from CutisPharma. The other investigators declared no conflicts of interest.

SOURCE: Sio TT et al. JAMA. 2019 Apr 16. doi: 10.1001/jama.2019.3504.

The findings of two randomized clinical trials indicate that vitamin D supplementation does not improve clinical outcomes in patients with advanced or metastatic colorectal cancer or gastrointestinal cancer. The results of the SUNSHINE and AMATERASU trials were published in JAMA.

The SUNSHINE clinical trial was a double-blind, multicenter, phase 2 study that included 139 patients with metastatic or unresectable advanced colorectal cancer. Participants were randomized to receive either high-dose (8000 IU/day for 2 weeks and 4000 IU/day afterward) or standard-dose (400 IU/day) oral vitamin D₃ that was given concomitantly with standard chemotherapy.

The primary outcome measured was median progression-free survival, while overall survival was measured as a secondary endpoint.

“Participants continued to receive treatment until disease progression, intolerable toxicity, or decision to discontinue treatment,” wrote Kimmie Ng, MD, MPH, of the Dana-Farber Cancer Institute in Boston and her colleagues.

The AMATERASU clinical trial was a double-blind, placebo-controlled study of 417 patients with digestive tract cancers conducted at a single center in Japan. Participants were randomized to receive either oral vitamin D (2000 IU/day) or placebo over a maximum duration of 7.6 years.

The primary outcome measured was relapse-free survival (time to cancer relapse or death); overall survival (time to death of any cause) was also included as a secondary endpoint.

“Safety outcomes comprised bone fractures, urinary stones, serious events requiring admission, and new (de novo) cancer,” Mitsuyoshi Urashima, MD, of Jikei University in Tokyo, Japan, wrote with his colleagues.

After analysis, the results of both trials were found to be comparable because the adjusted measures for progression- or relapse-free survival were similar. In addition, both studies showed no differences in overall survival.

Dr. Ng and her colleagues reported that there was a statistically nonsignificant rise in median progression-free survival in participants given high-dose versus standard dose vitamin D₃ (13 vs. 11 months, respectively; P = .07), according to results from the SUNSHINE study. The overall survival was the same in both arms (median survival, 24.3 months; P = .43).

Dr. Urashima and his colleagues reported that there was no significant improvement in relapse-free survival in patients treated with vitamin D versus those treated with placebo (hazard ratio, 0.76; 95% confidence interval, 0.50-1.14; P = .18), according to results from the AMATERASU study. In addition, no benefit was seen for overall survival (HR, 0.95; 95% CI, 0.57-1.57).

With respect to safety, neither study reported an increase in toxicity from vitamin D supplementation, and a possible benefit of reduced diarrhea was seen in the SUNSHINE study. Given the preliminary nature of these results, further confirmatory studies that include longer follow-up periods and improved measures of survival are necessary.

“These findings warrant further evaluation in a larger multicenter randomized clinical trial,” Dr. Ng and her colleagues wrote.

“Vitamin D supplementation did not improve relapse-free survival among patients with digestive tract cancer,” Dr. Urashima and his colleagues concluded.

The SUNSHINE clinical trial was supported by grant funding from the National Institutes of Health’s National Cancer Institute. Additional funding was provided by the Gloria Spivak Faculty Advancement Award, Friends of Dana-Farber Cancer Institute Award, Project P Fund, Consano, Pharmavite, and Genentech.

The AMATERASU clinical trial was supported by funding from the Japan-Supported Program for the Strategic Research Foundation at Private Universities, the International University of Health and Welfare Hospital, and the Jikei University School of Medicine.

The authors of both studies reported multiple associations with pharmaceutical companies.

SOURCE: Ng K et al. JAMA. 2019 Apr 9. doi: 10.1001/jama.2019.2402; Urashima M et al. JAMA. 2019 Apr 9. doi: 10.1001/jama.2019.2210.

The findings of two randomized clinical trials indicate that vitamin D supplementation does not improve clinical outcomes in patients with advanced or metastatic colorectal cancer or gastrointestinal cancer. The results of the SUNSHINE and AMATERASU trials were published in JAMA.

The SUNSHINE clinical trial was a double-blind, multicenter, phase 2 study that included 139 patients with metastatic or unresectable advanced colorectal cancer. Participants were randomized to receive either high-dose (8000 IU/day for 2 weeks and 4000 IU/day afterward) or standard-dose (400 IU/day) oral vitamin D₃ that was given concomitantly with standard chemotherapy.

The primary outcome measured was median progression-free survival, while overall survival was measured as a secondary endpoint.

“Participants continued to receive treatment until disease progression, intolerable toxicity, or decision to discontinue treatment,” wrote Kimmie Ng, MD, MPH, of the Dana-Farber Cancer Institute in Boston and her colleagues.

The AMATERASU clinical trial was a double-blind, placebo-controlled study of 417 patients with digestive tract cancers conducted at a single center in Japan. Participants were randomized to receive either oral vitamin D (2000 IU/day) or placebo over a maximum duration of 7.6 years.

The primary outcome measured was relapse-free survival (time to cancer relapse or death); overall survival (time to death of any cause) was also included as a secondary endpoint.

“Safety outcomes comprised bone fractures, urinary stones, serious events requiring admission, and new (de novo) cancer,” Mitsuyoshi Urashima, MD, of Jikei University in Tokyo, Japan, wrote with his colleagues.

After analysis, the results of both trials were found to be comparable because the adjusted measures for progression- or relapse-free survival were similar. In addition, both studies showed no differences in overall survival.

Dr. Ng and her colleagues reported that there was a statistically nonsignificant rise in median progression-free survival in participants given high-dose versus standard dose vitamin D₃ (13 vs. 11 months, respectively; P = .07), according to results from the SUNSHINE study. The overall survival was the same in both arms (median survival, 24.3 months; P = .43).

Dr. Urashima and his colleagues reported that there was no significant improvement in relapse-free survival in patients treated with vitamin D versus those treated with placebo (hazard ratio, 0.76; 95% confidence interval, 0.50-1.14; P = .18), according to results from the AMATERASU study. In addition, no benefit was seen for overall survival (HR, 0.95; 95% CI, 0.57-1.57).

With respect to safety, neither study reported an increase in toxicity from vitamin D supplementation, and a possible benefit of reduced diarrhea was seen in the SUNSHINE study. Given the preliminary nature of these results, further confirmatory studies that include longer follow-up periods and improved measures of survival are necessary.

“These findings warrant further evaluation in a larger multicenter randomized clinical trial,” Dr. Ng and her colleagues wrote.

“Vitamin D supplementation did not improve relapse-free survival among patients with digestive tract cancer,” Dr. Urashima and his colleagues concluded.

The SUNSHINE clinical trial was supported by grant funding from the National Institutes of Health’s National Cancer Institute. Additional funding was provided by the Gloria Spivak Faculty Advancement Award, Friends of Dana-Farber Cancer Institute Award, Project P Fund, Consano, Pharmavite, and Genentech.

The AMATERASU clinical trial was supported by funding from the Japan-Supported Program for the Strategic Research Foundation at Private Universities, the International University of Health and Welfare Hospital, and the Jikei University School of Medicine.

The authors of both studies reported multiple associations with pharmaceutical companies.

SOURCE: Ng K et al. JAMA. 2019 Apr 9. doi: 10.1001/jama.2019.2402; Urashima M et al. JAMA. 2019 Apr 9. doi: 10.1001/jama.2019.2210.

The findings of two randomized clinical trials indicate that vitamin D supplementation does not improve clinical outcomes in patients with advanced or metastatic colorectal cancer or gastrointestinal cancer. The results of the SUNSHINE and AMATERASU trials were published in JAMA.

The SUNSHINE clinical trial was a double-blind, multicenter, phase 2 study that included 139 patients with metastatic or unresectable advanced colorectal cancer. Participants were randomized to receive either high-dose (8000 IU/day for 2 weeks and 4000 IU/day afterward) or standard-dose (400 IU/day) oral vitamin D₃ that was given concomitantly with standard chemotherapy.

The primary outcome measured was median progression-free survival, while overall survival was measured as a secondary endpoint.

“Participants continued to receive treatment until disease progression, intolerable toxicity, or decision to discontinue treatment,” wrote Kimmie Ng, MD, MPH, of the Dana-Farber Cancer Institute in Boston and her colleagues.

The AMATERASU clinical trial was a double-blind, placebo-controlled study of 417 patients with digestive tract cancers conducted at a single center in Japan. Participants were randomized to receive either oral vitamin D (2000 IU/day) or placebo over a maximum duration of 7.6 years.

The primary outcome measured was relapse-free survival (time to cancer relapse or death); overall survival (time to death of any cause) was also included as a secondary endpoint.

“Safety outcomes comprised bone fractures, urinary stones, serious events requiring admission, and new (de novo) cancer,” Mitsuyoshi Urashima, MD, of Jikei University in Tokyo, Japan, wrote with his colleagues.

After analysis, the results of both trials were found to be comparable because the adjusted measures for progression- or relapse-free survival were similar. In addition, both studies showed no differences in overall survival.

Dr. Ng and her colleagues reported that there was a statistically nonsignificant rise in median progression-free survival in participants given high-dose versus standard dose vitamin D₃ (13 vs. 11 months, respectively; P = .07), according to results from the SUNSHINE study. The overall survival was the same in both arms (median survival, 24.3 months; P = .43).

Dr. Urashima and his colleagues reported that there was no significant improvement in relapse-free survival in patients treated with vitamin D versus those treated with placebo (hazard ratio, 0.76; 95% confidence interval, 0.50-1.14; P = .18), according to results from the AMATERASU study. In addition, no benefit was seen for overall survival (HR, 0.95; 95% CI, 0.57-1.57).

With respect to safety, neither study reported an increase in toxicity from vitamin D supplementation, and a possible benefit of reduced diarrhea was seen in the SUNSHINE study. Given the preliminary nature of these results, further confirmatory studies that include longer follow-up periods and improved measures of survival are necessary.

“These findings warrant further evaluation in a larger multicenter randomized clinical trial,” Dr. Ng and her colleagues wrote.

“Vitamin D supplementation did not improve relapse-free survival among patients with digestive tract cancer,” Dr. Urashima and his colleagues concluded.

The SUNSHINE clinical trial was supported by grant funding from the National Institutes of Health’s National Cancer Institute. Additional funding was provided by the Gloria Spivak Faculty Advancement Award, Friends of Dana-Farber Cancer Institute Award, Project P Fund, Consano, Pharmavite, and Genentech.

The AMATERASU clinical trial was supported by funding from the Japan-Supported Program for the Strategic Research Foundation at Private Universities, the International University of Health and Welfare Hospital, and the Jikei University School of Medicine.

The authors of both studies reported multiple associations with pharmaceutical companies.

SOURCE: Ng K et al. JAMA. 2019 Apr 9. doi: 10.1001/jama.2019.2402; Urashima M et al. JAMA. 2019 Apr 9. doi: 10.1001/jama.2019.2210.

Erythropoiesis-stimulating agents (ESAs) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin (HgB) has declined to less than 10 g/dL, according to a clinical practice guideline update by the American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH).

Furthermore, ESAs should not be offered to patients with chemotherapy-associated anemia whose cancer treatment is curative in intent, wrote Julia Bohlius, MD, MScPH, of the University of Bern, Switzerland, along with her associates on the expert panel. The report is in the Journal of Clinical Oncology.

The panel members systematically reviewed the body of literature for evidence pertaining to the use of ESAs in patients with cancer. After the review, the team included 15 meta-analyses and 2 randomized controlled trials (RCTs).

“For biosimilar ESAs, the literature search was expanded to include meta-analyses and RCTs in patients with cancer or chronic kidney disease and cohort studies in patients with cancer,” they wrote.

The update addressed 10 key clinical questions and provided recommendations based on the available literature and clinical experience.

The addition of iron to treatment with an ESA may provide better hematopoietic response and lower the chances of RBC transfusion, according to the guidelines.

In addition, the review revealed that biosimilars of epoetin alfa could provide safety and efficacy similar to that of other reference products; however, the evidence in cancer is still unclear.

“ESAs (including biosimilars) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin has declined to less than 10 g/dL,” they recommended.

As an alternative to ESAs, they stated that “RBC transfusion is also an option.”

The panel acknowledged that ESAs should not be provided to the majority of patients with nonchemotherapy-related anemia, excluding certain patients with myelodysplastic syndromes.

More information on the guidelines is available on the ASCO and ASH websites.

The study was funded by the American Society of Clinical Oncology. The expert panel reported financial affiliations with AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Novartis, Takeda, and several others.

SOURCE: Bohlius J et al. J Clin Oncol. 2019 Apr 10. doi: 10.1200/JCO.18.02142.

Erythropoiesis-stimulating agents (ESAs) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin (HgB) has declined to less than 10 g/dL, according to a clinical practice guideline update by the American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH).

Furthermore, ESAs should not be offered to patients with chemotherapy-associated anemia whose cancer treatment is curative in intent, wrote Julia Bohlius, MD, MScPH, of the University of Bern, Switzerland, along with her associates on the expert panel. The report is in the Journal of Clinical Oncology.

The panel members systematically reviewed the body of literature for evidence pertaining to the use of ESAs in patients with cancer. After the review, the team included 15 meta-analyses and 2 randomized controlled trials (RCTs).

“For biosimilar ESAs, the literature search was expanded to include meta-analyses and RCTs in patients with cancer or chronic kidney disease and cohort studies in patients with cancer,” they wrote.

The update addressed 10 key clinical questions and provided recommendations based on the available literature and clinical experience.

The addition of iron to treatment with an ESA may provide better hematopoietic response and lower the chances of RBC transfusion, according to the guidelines.

In addition, the review revealed that biosimilars of epoetin alfa could provide safety and efficacy similar to that of other reference products; however, the evidence in cancer is still unclear.

“ESAs (including biosimilars) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin has declined to less than 10 g/dL,” they recommended.

As an alternative to ESAs, they stated that “RBC transfusion is also an option.”

The panel acknowledged that ESAs should not be provided to the majority of patients with nonchemotherapy-related anemia, excluding certain patients with myelodysplastic syndromes.

More information on the guidelines is available on the ASCO and ASH websites.

The study was funded by the American Society of Clinical Oncology. The expert panel reported financial affiliations with AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Novartis, Takeda, and several others.

SOURCE: Bohlius J et al. J Clin Oncol. 2019 Apr 10. doi: 10.1200/JCO.18.02142.

Erythropoiesis-stimulating agents (ESAs) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin (HgB) has declined to less than 10 g/dL, according to a clinical practice guideline update by the American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH).

Furthermore, ESAs should not be offered to patients with chemotherapy-associated anemia whose cancer treatment is curative in intent, wrote Julia Bohlius, MD, MScPH, of the University of Bern, Switzerland, along with her associates on the expert panel. The report is in the Journal of Clinical Oncology.

The panel members systematically reviewed the body of literature for evidence pertaining to the use of ESAs in patients with cancer. After the review, the team included 15 meta-analyses and 2 randomized controlled trials (RCTs).

“For biosimilar ESAs, the literature search was expanded to include meta-analyses and RCTs in patients with cancer or chronic kidney disease and cohort studies in patients with cancer,” they wrote.

The update addressed 10 key clinical questions and provided recommendations based on the available literature and clinical experience.

The addition of iron to treatment with an ESA may provide better hematopoietic response and lower the chances of RBC transfusion, according to the guidelines.

In addition, the review revealed that biosimilars of epoetin alfa could provide safety and efficacy similar to that of other reference products; however, the evidence in cancer is still unclear.

“ESAs (including biosimilars) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin has declined to less than 10 g/dL,” they recommended.

As an alternative to ESAs, they stated that “RBC transfusion is also an option.”

The panel acknowledged that ESAs should not be provided to the majority of patients with nonchemotherapy-related anemia, excluding certain patients with myelodysplastic syndromes.

More information on the guidelines is available on the ASCO and ASH websites.

The study was funded by the American Society of Clinical Oncology. The expert panel reported financial affiliations with AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Novartis, Takeda, and several others.

SOURCE: Bohlius J et al. J Clin Oncol. 2019 Apr 10. doi: 10.1200/JCO.18.02142.

Officials at the Centers for Disease Control and Prevention have clarified the agency’s guidelines on opioid prescribing after a trio of organizations raised concerns that insurers were inappropriately applying the recommendations to active cancer patients when making coverage determinations.

The CDC guidelines, released in March 2016, address when to initiate or continue opioids for chronic pain, opioid selection, dosage, duration, follow-up, and discontinuation, and assess risk and harms of opioid use. Although the guidelines clearly state they are intended for clinicians prescribing opioids outside of active cancer treatment, insurance companies are still applying the guidelines to opioid coverage decisions for patients with active cancer, according to a Feb. 13, 2019, letter sent to the CDC from leaders at the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the American Society of Hematology.

Additionally, the associations wrote that the CDC’s recommendations pose coverage problems for sickle cell patients and select groups of cancer survivors who may benefit from opioids for pain management. The groups asked the CDC to issue a clarification to ensure appropriate implementation of the opioid recommendations.

In a Feb. 28, 2019, letter to ASCO, NCCN, and ASH, Deborah Dowell, MD, chief medical officer for the CDC’s National Center for Injury Prevention and Control took note of the concerns, clarifying that the recommendations are not intended to deny clinically appropriate opioid therapy to any patients who suffer chronic pain, but rather to ensure that physicians and patients consider all safe and effective treatment options.

The CDC guidance may apply to cancer survivors in certain conditions, Dr. Dowell wrote, namely when survivors experience chronic pain after cancer treatment completion, are in clinical remission, and are under cancer surveillance only. However, she agreed that, for select groups of cancer survivors with persistent pain caused by past cancer, the ratio of opioid benefits to risks for chronic pain is unique. She referred health providers to guidelines by ASCO on chronic pain management for adult cancer survivors and NCCN guidance on managing adult cancer pain when considering opioids for pain control in such populations.

Special considerations in sickle cell disease may also change the balance of opioid risks to benefits for pain management, Dr. Dowell wrote, referring providers and insurers to additional guidance on sickle cell disease from the National Institute of Health when making treatment and reimbursement decisions.

“Clinical decision making should be based on the relationship between the clinician and patient, with an understanding of the patient’s clinical situation, functioning, and life context, as well as careful consideration of the benefits and risk of all treatment options, including opioid therapy,” Dr. Dowell wrote. “CDC encourages physicians to continue using their clinical judgment and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment.”

Clifford A. Hudis, MD, CEO of ASCO, praised the clarification, calling the letter necessary to clear up confusion and prevent inappropriate coverage decisions.

“This clarification from CDC is critically important because, while the agency’s guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” Dr. Hudis said in a statement.

Sickle cell patients suffer from severe, chronic pain, which is debilitating on its own without the added burden of having to constantly appeal coverage denials, added ASH President Roy Silverstein, MD.

“We appreciate CDC’s acknowledgment that the challenges of managing severe and chronic pain in conditions, such as sickle cell disease, require special consideration, and we hope payers will take the CDC’s clarification into account to ensure that patients’ pain management needs are covered,” he said in the same statement.

[email protected]

Officials at the Centers for Disease Control and Prevention have clarified the agency’s guidelines on opioid prescribing after a trio of organizations raised concerns that insurers were inappropriately applying the recommendations to active cancer patients when making coverage determinations.

The CDC guidelines, released in March 2016, address when to initiate or continue opioids for chronic pain, opioid selection, dosage, duration, follow-up, and discontinuation, and assess risk and harms of opioid use. Although the guidelines clearly state they are intended for clinicians prescribing opioids outside of active cancer treatment, insurance companies are still applying the guidelines to opioid coverage decisions for patients with active cancer, according to a Feb. 13, 2019, letter sent to the CDC from leaders at the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the American Society of Hematology.

Additionally, the associations wrote that the CDC’s recommendations pose coverage problems for sickle cell patients and select groups of cancer survivors who may benefit from opioids for pain management. The groups asked the CDC to issue a clarification to ensure appropriate implementation of the opioid recommendations.

In a Feb. 28, 2019, letter to ASCO, NCCN, and ASH, Deborah Dowell, MD, chief medical officer for the CDC’s National Center for Injury Prevention and Control took note of the concerns, clarifying that the recommendations are not intended to deny clinically appropriate opioid therapy to any patients who suffer chronic pain, but rather to ensure that physicians and patients consider all safe and effective treatment options.

The CDC guidance may apply to cancer survivors in certain conditions, Dr. Dowell wrote, namely when survivors experience chronic pain after cancer treatment completion, are in clinical remission, and are under cancer surveillance only. However, she agreed that, for select groups of cancer survivors with persistent pain caused by past cancer, the ratio of opioid benefits to risks for chronic pain is unique. She referred health providers to guidelines by ASCO on chronic pain management for adult cancer survivors and NCCN guidance on managing adult cancer pain when considering opioids for pain control in such populations.

Special considerations in sickle cell disease may also change the balance of opioid risks to benefits for pain management, Dr. Dowell wrote, referring providers and insurers to additional guidance on sickle cell disease from the National Institute of Health when making treatment and reimbursement decisions.

“Clinical decision making should be based on the relationship between the clinician and patient, with an understanding of the patient’s clinical situation, functioning, and life context, as well as careful consideration of the benefits and risk of all treatment options, including opioid therapy,” Dr. Dowell wrote. “CDC encourages physicians to continue using their clinical judgment and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment.”

Clifford A. Hudis, MD, CEO of ASCO, praised the clarification, calling the letter necessary to clear up confusion and prevent inappropriate coverage decisions.

“This clarification from CDC is critically important because, while the agency’s guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” Dr. Hudis said in a statement.

Sickle cell patients suffer from severe, chronic pain, which is debilitating on its own without the added burden of having to constantly appeal coverage denials, added ASH President Roy Silverstein, MD.

“We appreciate CDC’s acknowledgment that the challenges of managing severe and chronic pain in conditions, such as sickle cell disease, require special consideration, and we hope payers will take the CDC’s clarification into account to ensure that patients’ pain management needs are covered,” he said in the same statement.

[email protected]

Officials at the Centers for Disease Control and Prevention have clarified the agency’s guidelines on opioid prescribing after a trio of organizations raised concerns that insurers were inappropriately applying the recommendations to active cancer patients when making coverage determinations.

The CDC guidelines, released in March 2016, address when to initiate or continue opioids for chronic pain, opioid selection, dosage, duration, follow-up, and discontinuation, and assess risk and harms of opioid use. Although the guidelines clearly state they are intended for clinicians prescribing opioids outside of active cancer treatment, insurance companies are still applying the guidelines to opioid coverage decisions for patients with active cancer, according to a Feb. 13, 2019, letter sent to the CDC from leaders at the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the American Society of Hematology.

Additionally, the associations wrote that the CDC’s recommendations pose coverage problems for sickle cell patients and select groups of cancer survivors who may benefit from opioids for pain management. The groups asked the CDC to issue a clarification to ensure appropriate implementation of the opioid recommendations.

In a Feb. 28, 2019, letter to ASCO, NCCN, and ASH, Deborah Dowell, MD, chief medical officer for the CDC’s National Center for Injury Prevention and Control took note of the concerns, clarifying that the recommendations are not intended to deny clinically appropriate opioid therapy to any patients who suffer chronic pain, but rather to ensure that physicians and patients consider all safe and effective treatment options.

The CDC guidance may apply to cancer survivors in certain conditions, Dr. Dowell wrote, namely when survivors experience chronic pain after cancer treatment completion, are in clinical remission, and are under cancer surveillance only. However, she agreed that, for select groups of cancer survivors with persistent pain caused by past cancer, the ratio of opioid benefits to risks for chronic pain is unique. She referred health providers to guidelines by ASCO on chronic pain management for adult cancer survivors and NCCN guidance on managing adult cancer pain when considering opioids for pain control in such populations.

Special considerations in sickle cell disease may also change the balance of opioid risks to benefits for pain management, Dr. Dowell wrote, referring providers and insurers to additional guidance on sickle cell disease from the National Institute of Health when making treatment and reimbursement decisions.

“Clinical decision making should be based on the relationship between the clinician and patient, with an understanding of the patient’s clinical situation, functioning, and life context, as well as careful consideration of the benefits and risk of all treatment options, including opioid therapy,” Dr. Dowell wrote. “CDC encourages physicians to continue using their clinical judgment and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment.”

Clifford A. Hudis, MD, CEO of ASCO, praised the clarification, calling the letter necessary to clear up confusion and prevent inappropriate coverage decisions.

“This clarification from CDC is critically important because, while the agency’s guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” Dr. Hudis said in a statement.

Sickle cell patients suffer from severe, chronic pain, which is debilitating on its own without the added burden of having to constantly appeal coverage denials, added ASH President Roy Silverstein, MD.

“We appreciate CDC’s acknowledgment that the challenges of managing severe and chronic pain in conditions, such as sickle cell disease, require special consideration, and we hope payers will take the CDC’s clarification into account to ensure that patients’ pain management needs are covered,” he said in the same statement.

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TUCSON, ARIZ. – Concomitant surgeries for endometrial cancer and stress urinary incontinence (SUI) led to better SUI outcomes than did cancer surgery with nonsurgical SUI therapy, according to a study examining the effects of an SUI screen among endometrial cancer patients.

Jim Kling/MDedge News

An estimated 40%-80% of women with endometrial cancer experience SUI. The malignancy often is caught early enough to be treated with curative intent, and that is leading physicians and patients to think more about quality of life outcomes.

And yet, few patients receive concomitant surgery. Twenty percent of the women in the current study opted for concomitant surgeries, yet large database studies show the frequency of concomitant surgeries is about 2.5%. “There’s huge room for improvement in this area. The take-home message is that this is prevalent, this is doable, and this is something that could truly benefit this population,” Evelyn Hall, MD, said in an interview. Dr. Hall is a fellow in female pelvic medicine and reconstructive medicine at Brown University, Providence, R.I. She presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.

It’s not entirely surprising that SUI tends to be overlooked in patients with endometrial cancer. After all, they are going through a life-changing medical diagnosis, and oncologists are laser focused on achieving a cure when possible. But a bigger picture view, especially in light of the high cure rate for endometrial cancer when detected early, should encourage physicians to think differently about patient management.

The biggest trick may be incorporating concomitant surgeries into the surgical work flow. “It can be challenging logistically. It requires surgical planning and coordination between the two surgeons,” said Dr. Hall. But she said the experience at Brown University showed that it was possible with some patience. “It took a while to get the balls rolling, but once we figured out [it] worked for our institution, we’ve seen a continued uptake,” she said.

An important remaining question is the safety of the concomitant surgeries. Dr. Hall did not report any between-group differences in her presentation, but analysis is ongoing. They found a statistically significant increase in the number of readmissions among the concomitant surgery group, but most were deemed unlikely to be related to concomitant surgery.

In the study, 1,322 endometrial surgical candidates were screened for SUI, and 53% tested positive. Of these, 556 patients were offered concomitant surgical or nonsurgical SUI treatment: 21% chose concomitant surgery, 19% chose nonsurgical SUI treatment, and 60% of patients opted for no SUI treatment.

At 6 months after surgery, the concomitant surgery group was more likely to have a Urinary Distress Inventory (UDI)–Stress score of 0 than were those who were treated nonsurgically (odds ratio, 2.8; P = .0001) and those in the no-treatment group (OR, 3.7; P less than .0001). The concomitant group also was more likely to have a surgical site infection (SSI) score of 0 than was the nonsurgical group (OR, 2.9; P = .0008) and the no-treatment group (OR, 2.7; P less than .0001). Severe/very severe SSI scores occurred in 57% of the concomitant group at baseline, and this frequency dropped to 14% at 6 weeks (P less than .0001).

The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Hall has no relevant financial disclosures.

SOURCE: Hall E et al. SGS 2019, oral presentation 12.

TUCSON, ARIZ. – Concomitant surgeries for endometrial cancer and stress urinary incontinence (SUI) led to better SUI outcomes than did cancer surgery with nonsurgical SUI therapy, according to a study examining the effects of an SUI screen among endometrial cancer patients.

Jim Kling/MDedge News

An estimated 40%-80% of women with endometrial cancer experience SUI. The malignancy often is caught early enough to be treated with curative intent, and that is leading physicians and patients to think more about quality of life outcomes.

And yet, few patients receive concomitant surgery. Twenty percent of the women in the current study opted for concomitant surgeries, yet large database studies show the frequency of concomitant surgeries is about 2.5%. “There’s huge room for improvement in this area. The take-home message is that this is prevalent, this is doable, and this is something that could truly benefit this population,” Evelyn Hall, MD, said in an interview. Dr. Hall is a fellow in female pelvic medicine and reconstructive medicine at Brown University, Providence, R.I. She presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.

It’s not entirely surprising that SUI tends to be overlooked in patients with endometrial cancer. After all, they are going through a life-changing medical diagnosis, and oncologists are laser focused on achieving a cure when possible. But a bigger picture view, especially in light of the high cure rate for endometrial cancer when detected early, should encourage physicians to think differently about patient management.

The biggest trick may be incorporating concomitant surgeries into the surgical work flow. “It can be challenging logistically. It requires surgical planning and coordination between the two surgeons,” said Dr. Hall. But she said the experience at Brown University showed that it was possible with some patience. “It took a while to get the balls rolling, but once we figured out [it] worked for our institution, we’ve seen a continued uptake,” she said.

An important remaining question is the safety of the concomitant surgeries. Dr. Hall did not report any between-group differences in her presentation, but analysis is ongoing. They found a statistically significant increase in the number of readmissions among the concomitant surgery group, but most were deemed unlikely to be related to concomitant surgery.

In the study, 1,322 endometrial surgical candidates were screened for SUI, and 53% tested positive. Of these, 556 patients were offered concomitant surgical or nonsurgical SUI treatment: 21% chose concomitant surgery, 19% chose nonsurgical SUI treatment, and 60% of patients opted for no SUI treatment.

At 6 months after surgery, the concomitant surgery group was more likely to have a Urinary Distress Inventory (UDI)–Stress score of 0 than were those who were treated nonsurgically (odds ratio, 2.8; P = .0001) and those in the no-treatment group (OR, 3.7; P less than .0001). The concomitant group also was more likely to have a surgical site infection (SSI) score of 0 than was the nonsurgical group (OR, 2.9; P = .0008) and the no-treatment group (OR, 2.7; P less than .0001). Severe/very severe SSI scores occurred in 57% of the concomitant group at baseline, and this frequency dropped to 14% at 6 weeks (P less than .0001).

The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Hall has no relevant financial disclosures.

SOURCE: Hall E et al. SGS 2019, oral presentation 12.

TUCSON, ARIZ. – Concomitant surgeries for endometrial cancer and stress urinary incontinence (SUI) led to better SUI outcomes than did cancer surgery with nonsurgical SUI therapy, according to a study examining the effects of an SUI screen among endometrial cancer patients.

Jim Kling/MDedge News

An estimated 40%-80% of women with endometrial cancer experience SUI. The malignancy often is caught early enough to be treated with curative intent, and that is leading physicians and patients to think more about quality of life outcomes.

And yet, few patients receive concomitant surgery. Twenty percent of the women in the current study opted for concomitant surgeries, yet large database studies show the frequency of concomitant surgeries is about 2.5%. “There’s huge room for improvement in this area. The take-home message is that this is prevalent, this is doable, and this is something that could truly benefit this population,” Evelyn Hall, MD, said in an interview. Dr. Hall is a fellow in female pelvic medicine and reconstructive medicine at Brown University, Providence, R.I. She presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.

It’s not entirely surprising that SUI tends to be overlooked in patients with endometrial cancer. After all, they are going through a life-changing medical diagnosis, and oncologists are laser focused on achieving a cure when possible. But a bigger picture view, especially in light of the high cure rate for endometrial cancer when detected early, should encourage physicians to think differently about patient management.

The biggest trick may be incorporating concomitant surgeries into the surgical work flow. “It can be challenging logistically. It requires surgical planning and coordination between the two surgeons,” said Dr. Hall. But she said the experience at Brown University showed that it was possible with some patience. “It took a while to get the balls rolling, but once we figured out [it] worked for our institution, we’ve seen a continued uptake,” she said.

An important remaining question is the safety of the concomitant surgeries. Dr. Hall did not report any between-group differences in her presentation, but analysis is ongoing. They found a statistically significant increase in the number of readmissions among the concomitant surgery group, but most were deemed unlikely to be related to concomitant surgery.

In the study, 1,322 endometrial surgical candidates were screened for SUI, and 53% tested positive. Of these, 556 patients were offered concomitant surgical or nonsurgical SUI treatment: 21% chose concomitant surgery, 19% chose nonsurgical SUI treatment, and 60% of patients opted for no SUI treatment.

At 6 months after surgery, the concomitant surgery group was more likely to have a Urinary Distress Inventory (UDI)–Stress score of 0 than were those who were treated nonsurgically (odds ratio, 2.8; P = .0001) and those in the no-treatment group (OR, 3.7; P less than .0001). The concomitant group also was more likely to have a surgical site infection (SSI) score of 0 than was the nonsurgical group (OR, 2.9; P = .0008) and the no-treatment group (OR, 2.7; P less than .0001). Severe/very severe SSI scores occurred in 57% of the concomitant group at baseline, and this frequency dropped to 14% at 6 weeks (P less than .0001).

The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Hall has no relevant financial disclosures.

SOURCE: Hall E et al. SGS 2019, oral presentation 12.