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Quality of life predicts chemo tolerance in early breast cancer
a new analysis found.
Baseline quality-of-life measures, most often fatigue and physical functioning, have “been associated with survival in various cancers,” the authors explain. These latest findings signal that assessing fatigue and physical functioning prior to treatment “could help to identify patients who are at risk for poor chemotherapy tolerability.”
The findings were published online in the journal Cancer.
Although quality of life is recognized as a predictor of survival in patients with advanced cancer, the evidence is less clear in early-stage breast cancer.
To understand the role quality-of-life measures play in early breast cancer, the investigators performed an ancillary analysis of the French Cancer and Toxicities (CANTO) study, which enrolled women with newly diagnosed stage I-III invasive breast cancer at 26 centers in France.
The ancillary CANTO‐PRED study was designed to explore the association between baseline quality of life measures and chemotherapy dose reductions and postchemotherapy toxicities among 3,079 patients with early breast cancer. This included 718 patients who received chemotherapy in the neoadjuvant setting and 2,361 who received chemotherapy as adjuvant treatment.
Most patients received taxanes (94.2%) and/or anthracyclines (90.5%). Other major adjuvant treatments were breast radiation therapy (92.6%), trastuzumab (21%), and endocrine therapy (74%), and all women underwent either breast-conserving surgery (74%) and/or lymph node dissection (60%). Fatigue and physical functioning were measured using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30.
Among the 3,079 patients, 15.5% experienced chemotherapy dose reductions and 31% developed postchemotherapy toxicities.
After multivariable adjustment for clinical and patient factors, those with baseline fatigue scores greater than 39 (vs. 39 or less) had higher odds of chemotherapy dose reductions (odds ratio, 1.43) and postchemotherapy toxicities (OR, 1.32). Those with baseline physical functioning scores less than 83 (vs. 83 or higher) also had higher odds of chemotherapy dose reductions (OR, 1.54) and postchemotherapy toxicities (OR, 1.50), the authors found.
In addition, cognitive functioning, pain, sleep disturbances, and appetite loss dimensions were associated with both chemotherapy dose reductions and postchemotherapy toxicities, whereas nausea, vomiting, and dyspnea were associated with postchemotherapy toxicities.
The researchers also found that performance status was not associated with chemotherapy dose reductions or postchemotherapy toxicities, suggesting patient-reported quality of life may be a better predictor of outcomes, the authors said.
“The ability to predict important toxicities with baseline information could lead to improvements in the prevention and management of adverse treatment effects by targeting a group of patients who may need [dose reductions] or may have residual toxicities,” the authors concluded.
This study was funded by the French National Research Agency. The authors reported various relevant financial relationships.
A version of this article first appeared on Medscape.com.
a new analysis found.
Baseline quality-of-life measures, most often fatigue and physical functioning, have “been associated with survival in various cancers,” the authors explain. These latest findings signal that assessing fatigue and physical functioning prior to treatment “could help to identify patients who are at risk for poor chemotherapy tolerability.”
The findings were published online in the journal Cancer.
Although quality of life is recognized as a predictor of survival in patients with advanced cancer, the evidence is less clear in early-stage breast cancer.
To understand the role quality-of-life measures play in early breast cancer, the investigators performed an ancillary analysis of the French Cancer and Toxicities (CANTO) study, which enrolled women with newly diagnosed stage I-III invasive breast cancer at 26 centers in France.
The ancillary CANTO‐PRED study was designed to explore the association between baseline quality of life measures and chemotherapy dose reductions and postchemotherapy toxicities among 3,079 patients with early breast cancer. This included 718 patients who received chemotherapy in the neoadjuvant setting and 2,361 who received chemotherapy as adjuvant treatment.
Most patients received taxanes (94.2%) and/or anthracyclines (90.5%). Other major adjuvant treatments were breast radiation therapy (92.6%), trastuzumab (21%), and endocrine therapy (74%), and all women underwent either breast-conserving surgery (74%) and/or lymph node dissection (60%). Fatigue and physical functioning were measured using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30.
Among the 3,079 patients, 15.5% experienced chemotherapy dose reductions and 31% developed postchemotherapy toxicities.
After multivariable adjustment for clinical and patient factors, those with baseline fatigue scores greater than 39 (vs. 39 or less) had higher odds of chemotherapy dose reductions (odds ratio, 1.43) and postchemotherapy toxicities (OR, 1.32). Those with baseline physical functioning scores less than 83 (vs. 83 or higher) also had higher odds of chemotherapy dose reductions (OR, 1.54) and postchemotherapy toxicities (OR, 1.50), the authors found.
In addition, cognitive functioning, pain, sleep disturbances, and appetite loss dimensions were associated with both chemotherapy dose reductions and postchemotherapy toxicities, whereas nausea, vomiting, and dyspnea were associated with postchemotherapy toxicities.
The researchers also found that performance status was not associated with chemotherapy dose reductions or postchemotherapy toxicities, suggesting patient-reported quality of life may be a better predictor of outcomes, the authors said.
“The ability to predict important toxicities with baseline information could lead to improvements in the prevention and management of adverse treatment effects by targeting a group of patients who may need [dose reductions] or may have residual toxicities,” the authors concluded.
This study was funded by the French National Research Agency. The authors reported various relevant financial relationships.
A version of this article first appeared on Medscape.com.
a new analysis found.
Baseline quality-of-life measures, most often fatigue and physical functioning, have “been associated with survival in various cancers,” the authors explain. These latest findings signal that assessing fatigue and physical functioning prior to treatment “could help to identify patients who are at risk for poor chemotherapy tolerability.”
The findings were published online in the journal Cancer.
Although quality of life is recognized as a predictor of survival in patients with advanced cancer, the evidence is less clear in early-stage breast cancer.
To understand the role quality-of-life measures play in early breast cancer, the investigators performed an ancillary analysis of the French Cancer and Toxicities (CANTO) study, which enrolled women with newly diagnosed stage I-III invasive breast cancer at 26 centers in France.
The ancillary CANTO‐PRED study was designed to explore the association between baseline quality of life measures and chemotherapy dose reductions and postchemotherapy toxicities among 3,079 patients with early breast cancer. This included 718 patients who received chemotherapy in the neoadjuvant setting and 2,361 who received chemotherapy as adjuvant treatment.
Most patients received taxanes (94.2%) and/or anthracyclines (90.5%). Other major adjuvant treatments were breast radiation therapy (92.6%), trastuzumab (21%), and endocrine therapy (74%), and all women underwent either breast-conserving surgery (74%) and/or lymph node dissection (60%). Fatigue and physical functioning were measured using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30.
Among the 3,079 patients, 15.5% experienced chemotherapy dose reductions and 31% developed postchemotherapy toxicities.
After multivariable adjustment for clinical and patient factors, those with baseline fatigue scores greater than 39 (vs. 39 or less) had higher odds of chemotherapy dose reductions (odds ratio, 1.43) and postchemotherapy toxicities (OR, 1.32). Those with baseline physical functioning scores less than 83 (vs. 83 or higher) also had higher odds of chemotherapy dose reductions (OR, 1.54) and postchemotherapy toxicities (OR, 1.50), the authors found.
In addition, cognitive functioning, pain, sleep disturbances, and appetite loss dimensions were associated with both chemotherapy dose reductions and postchemotherapy toxicities, whereas nausea, vomiting, and dyspnea were associated with postchemotherapy toxicities.
The researchers also found that performance status was not associated with chemotherapy dose reductions or postchemotherapy toxicities, suggesting patient-reported quality of life may be a better predictor of outcomes, the authors said.
“The ability to predict important toxicities with baseline information could lead to improvements in the prevention and management of adverse treatment effects by targeting a group of patients who may need [dose reductions] or may have residual toxicities,” the authors concluded.
This study was funded by the French National Research Agency. The authors reported various relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CANCER
Black patients less likely to receive opioids for advanced cancer
Opioids are widely regarded as a linchpin in the treatment of moderate to severe cancer-related pain and end-of-life symptoms; however, a new study suggests.
Black patients were more likely to undergo urine drug screening (UDS) despite being less likely to receive any opioids for pain management and receiving lower daily doses of opioids in comparison with White patients, the study found.
The inequities were particularly stark for Black men. “We found that Black men were far less likely to be prescribed reasonable doses than White men were,” said the study’s senior author, Alexi Wright, MD, MPH, a gynecologic oncologist and a researcher in the division of population sciences at Dana-Farber Cancer Institute, Boston. “And Black men were less likely to receive long-acting opioids, which are essential for many patients dying of cancer. Our findings are startling because everyone should agree that cancer patients should have equal access to pain relief at the end of life.”
The study was published on in the Journal of Clinical Oncology.
The researchers gathered data on 318,549 Medicare beneficiaries older than 65 years with poor-prognosis cancers who died between 2007 and 2019. During this time frame, for all groups, access to opioids declined and urine drug testing expanded, owing to the overall opioid epidemic in the United States. Overall, the proportion of patients near end of life (EOL) who received any opioid or long-acting opioids decreased from 42.2% to 32.7% and from 17.9% to 9.4%, respectively.
The investigators used National Drug Codes to identify all Medicare Part D claims for outpatient opioid prescriptions, excluding addiction treatments, cough suppressants, and parenteral opioids. They focused on prescriptions that were filled at least 30 days before death or hospice enrollment.
Among the study participants, the majority (85.5%) of patients were White, 29,555 patients (9.3%) were Black, and 16,636 patients (5.2%) were Hispanic.
Black and Hispanic patients were statistically less likely than White patients to receive opioid prescriptions near EOL (Black, –4.3 percentage points; Hispanic, –3.6 percentage points). They were also less likely to receive long-acting opioid prescriptions (Black, –3.1 percentage points; Hispanic, –2.2 percentage points).
“It’s not just that patients of color are less likely to get opioids, but when they do get them, they get lower doses, and they also are less likely to get long-acting opioids, which a lot of people view as sort of more potential for addiction, which isn’t necessarily true but kind of viewed with heightened concern or suspicion,” the study’s lead author, Andrea Enzinger, MD, a gastrointestinal oncologist and a researcher in Dana-Farber’s division of population sciences, said in an interview.
Dr. Enzinger added that she believes systemic racism and preconceived biases toward minorities and drug addiction may be contributing to these trends.
When Black patients did receive at least one opioid prescription, they received daily doses that were 10.5 morphine milligram equivalents (MMEs) lower than doses given to White patients. Compared with the total opioid dose filled per White decedent near EOL, the total dose filled per Black decedent was 210 MMEs lower.
“We all need to be worried about the potential for misuse or addiction, but this is the one setting that is very low on my priority list when somebody is dying. I mean, we’re looking at the last month of life, so nobody has the potential to become addicted,” Dr. Enzinger commented.
The team also evaluated rates or urine drug screening (UDS), but as these rates were relatively low, they expanded the time frame to 180 days before death or hospice. They found that disparities in UDS disproportionately affected Black men.
From 2007 to 2019, the proportion of patients who underwent UDS increased from 0.6% to 6.7% in the 180 days before death or hospice; however, Black decedents were tested more often than White or Hispanic decedents.
Black decedents were 0.5 percentage points more likely than White decedents to undergo UDS near EOL.
“The disparities in urine drug screening are modest but important, because they hint at underlying systematic racism in recommending patients for screening,” Dr. Wright said. “Screening needs to either be applied uniformly or not at all for patients in this situation.”
The researchers acknowledged that their findings likely do not represent the full spectrum of prescribing disparities and believe that the work should be expanded among younger populations. Nevertheless, the investigators believe the work highlights the persistent racial and ethnic disparities in opioid access.
The study was supported by a grant from the Agency for Healthcare Research and Policy.
A version of this article first appeared on Medscape.com.
Opioids are widely regarded as a linchpin in the treatment of moderate to severe cancer-related pain and end-of-life symptoms; however, a new study suggests.
Black patients were more likely to undergo urine drug screening (UDS) despite being less likely to receive any opioids for pain management and receiving lower daily doses of opioids in comparison with White patients, the study found.
The inequities were particularly stark for Black men. “We found that Black men were far less likely to be prescribed reasonable doses than White men were,” said the study’s senior author, Alexi Wright, MD, MPH, a gynecologic oncologist and a researcher in the division of population sciences at Dana-Farber Cancer Institute, Boston. “And Black men were less likely to receive long-acting opioids, which are essential for many patients dying of cancer. Our findings are startling because everyone should agree that cancer patients should have equal access to pain relief at the end of life.”
The study was published on in the Journal of Clinical Oncology.
The researchers gathered data on 318,549 Medicare beneficiaries older than 65 years with poor-prognosis cancers who died between 2007 and 2019. During this time frame, for all groups, access to opioids declined and urine drug testing expanded, owing to the overall opioid epidemic in the United States. Overall, the proportion of patients near end of life (EOL) who received any opioid or long-acting opioids decreased from 42.2% to 32.7% and from 17.9% to 9.4%, respectively.
The investigators used National Drug Codes to identify all Medicare Part D claims for outpatient opioid prescriptions, excluding addiction treatments, cough suppressants, and parenteral opioids. They focused on prescriptions that were filled at least 30 days before death or hospice enrollment.
Among the study participants, the majority (85.5%) of patients were White, 29,555 patients (9.3%) were Black, and 16,636 patients (5.2%) were Hispanic.
Black and Hispanic patients were statistically less likely than White patients to receive opioid prescriptions near EOL (Black, –4.3 percentage points; Hispanic, –3.6 percentage points). They were also less likely to receive long-acting opioid prescriptions (Black, –3.1 percentage points; Hispanic, –2.2 percentage points).
“It’s not just that patients of color are less likely to get opioids, but when they do get them, they get lower doses, and they also are less likely to get long-acting opioids, which a lot of people view as sort of more potential for addiction, which isn’t necessarily true but kind of viewed with heightened concern or suspicion,” the study’s lead author, Andrea Enzinger, MD, a gastrointestinal oncologist and a researcher in Dana-Farber’s division of population sciences, said in an interview.
Dr. Enzinger added that she believes systemic racism and preconceived biases toward minorities and drug addiction may be contributing to these trends.
When Black patients did receive at least one opioid prescription, they received daily doses that were 10.5 morphine milligram equivalents (MMEs) lower than doses given to White patients. Compared with the total opioid dose filled per White decedent near EOL, the total dose filled per Black decedent was 210 MMEs lower.
“We all need to be worried about the potential for misuse or addiction, but this is the one setting that is very low on my priority list when somebody is dying. I mean, we’re looking at the last month of life, so nobody has the potential to become addicted,” Dr. Enzinger commented.
The team also evaluated rates or urine drug screening (UDS), but as these rates were relatively low, they expanded the time frame to 180 days before death or hospice. They found that disparities in UDS disproportionately affected Black men.
From 2007 to 2019, the proportion of patients who underwent UDS increased from 0.6% to 6.7% in the 180 days before death or hospice; however, Black decedents were tested more often than White or Hispanic decedents.
Black decedents were 0.5 percentage points more likely than White decedents to undergo UDS near EOL.
“The disparities in urine drug screening are modest but important, because they hint at underlying systematic racism in recommending patients for screening,” Dr. Wright said. “Screening needs to either be applied uniformly or not at all for patients in this situation.”
The researchers acknowledged that their findings likely do not represent the full spectrum of prescribing disparities and believe that the work should be expanded among younger populations. Nevertheless, the investigators believe the work highlights the persistent racial and ethnic disparities in opioid access.
The study was supported by a grant from the Agency for Healthcare Research and Policy.
A version of this article first appeared on Medscape.com.
Opioids are widely regarded as a linchpin in the treatment of moderate to severe cancer-related pain and end-of-life symptoms; however, a new study suggests.
Black patients were more likely to undergo urine drug screening (UDS) despite being less likely to receive any opioids for pain management and receiving lower daily doses of opioids in comparison with White patients, the study found.
The inequities were particularly stark for Black men. “We found that Black men were far less likely to be prescribed reasonable doses than White men were,” said the study’s senior author, Alexi Wright, MD, MPH, a gynecologic oncologist and a researcher in the division of population sciences at Dana-Farber Cancer Institute, Boston. “And Black men were less likely to receive long-acting opioids, which are essential for many patients dying of cancer. Our findings are startling because everyone should agree that cancer patients should have equal access to pain relief at the end of life.”
The study was published on in the Journal of Clinical Oncology.
The researchers gathered data on 318,549 Medicare beneficiaries older than 65 years with poor-prognosis cancers who died between 2007 and 2019. During this time frame, for all groups, access to opioids declined and urine drug testing expanded, owing to the overall opioid epidemic in the United States. Overall, the proportion of patients near end of life (EOL) who received any opioid or long-acting opioids decreased from 42.2% to 32.7% and from 17.9% to 9.4%, respectively.
The investigators used National Drug Codes to identify all Medicare Part D claims for outpatient opioid prescriptions, excluding addiction treatments, cough suppressants, and parenteral opioids. They focused on prescriptions that were filled at least 30 days before death or hospice enrollment.
Among the study participants, the majority (85.5%) of patients were White, 29,555 patients (9.3%) were Black, and 16,636 patients (5.2%) were Hispanic.
Black and Hispanic patients were statistically less likely than White patients to receive opioid prescriptions near EOL (Black, –4.3 percentage points; Hispanic, –3.6 percentage points). They were also less likely to receive long-acting opioid prescriptions (Black, –3.1 percentage points; Hispanic, –2.2 percentage points).
“It’s not just that patients of color are less likely to get opioids, but when they do get them, they get lower doses, and they also are less likely to get long-acting opioids, which a lot of people view as sort of more potential for addiction, which isn’t necessarily true but kind of viewed with heightened concern or suspicion,” the study’s lead author, Andrea Enzinger, MD, a gastrointestinal oncologist and a researcher in Dana-Farber’s division of population sciences, said in an interview.
Dr. Enzinger added that she believes systemic racism and preconceived biases toward minorities and drug addiction may be contributing to these trends.
When Black patients did receive at least one opioid prescription, they received daily doses that were 10.5 morphine milligram equivalents (MMEs) lower than doses given to White patients. Compared with the total opioid dose filled per White decedent near EOL, the total dose filled per Black decedent was 210 MMEs lower.
“We all need to be worried about the potential for misuse or addiction, but this is the one setting that is very low on my priority list when somebody is dying. I mean, we’re looking at the last month of life, so nobody has the potential to become addicted,” Dr. Enzinger commented.
The team also evaluated rates or urine drug screening (UDS), but as these rates were relatively low, they expanded the time frame to 180 days before death or hospice. They found that disparities in UDS disproportionately affected Black men.
From 2007 to 2019, the proportion of patients who underwent UDS increased from 0.6% to 6.7% in the 180 days before death or hospice; however, Black decedents were tested more often than White or Hispanic decedents.
Black decedents were 0.5 percentage points more likely than White decedents to undergo UDS near EOL.
“The disparities in urine drug screening are modest but important, because they hint at underlying systematic racism in recommending patients for screening,” Dr. Wright said. “Screening needs to either be applied uniformly or not at all for patients in this situation.”
The researchers acknowledged that their findings likely do not represent the full spectrum of prescribing disparities and believe that the work should be expanded among younger populations. Nevertheless, the investigators believe the work highlights the persistent racial and ethnic disparities in opioid access.
The study was supported by a grant from the Agency for Healthcare Research and Policy.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Loneliness risk elevated among young cancer survivors
findings from a large retrospective study suggest.
Young cancer survivors were more than twice as likely to report loneliness at study baseline and follow-up. Loneliness at these times was associated with an almost 10-fold increased risk for anxiety and a nearly 18-fold increased risk for depression.
“We observed an elevated prevalence of loneliness in survivors, compared to sibling controls, and found that loneliness was associated with emotional, behavioral, and physical health morbidities,” lead study author Chiara Papini, PhD, of St. Jude Children’s Research Hospital, Memphis, and her colleagues write. “Our results highlight the importance of identifying and screening young adult survivors of childhood cancer for loneliness and the need for targeted interventions to reduce loneliness.”
The article was published online in the journal Cancer.
Most young cancer survivors in the United States reach adulthood and need to play catch-up: make up for missed school and work, become reacquainted with old friends, and develop new friendships, social networks, and intimate relationships. Meeting these needs may be hindered by adverse physical and psychosocial problems that linger or develop after treatment, which may leave cancer survivors feeling isolated.
“Young adult survivors of childhood cancer are navigating a developmental period marked by increased social expectations, during which loneliness may have significant impact on physical and mental health,” Dr. Papini and colleagues say.
To better understand the risks for loneliness among young cancer survivors, Dr. Papini and her colleagues analyzed data from the retrospective Childhood Cancer Survivor Study, which followed young survivors who had been diagnosed with a range of cancers before age 21 years. Study participants had been treated at one of 31 study sites in North America and had survived 5 years or longer after diagnosis.
The 9,664 survivors and 2,221 randomly sampled siblings ranged in age from 19 to 39 years at the time they completed a survey that assessed emotional distress at baseline and at follow‐up a median of 6.6 years. At baseline, the median age of the survivors was 27 years, and a median of 17.5 years had passed from the time of their diagnosis.
The most common diagnoses were leukemia (35%), Hodgkin lymphoma (15%), central nervous system (CNS) tumors (14%), and bone tumors (10%). More than half (56%) had received radiation therapy.
Using multivariable models, the researchers found that survivors were more likely than siblings to report moderate to extreme loneliness at either baseline or follow‐up (prevalence ratio, 1.04) and were more than two times more likely to report loneliness at both baseline and follow‐up (PR, 2.21).
Loneliness at baseline and follow‐up was associated with a much greater risk for anxiety (relative risk, 9.75) and depression (RR, 17.86). Loneliness at follow‐up was linked with increased risks for suicidal ideation (RR, 1.52), heavy or risky alcohol consumption (RR, 1.27), and any grade 2-4 new‐onset chronic health condition (RR, 1.29), especially those that were neurologic (RR, 4.37).
Survivors of CNS tumors (odds ratio, 2.59) and leukemia (OR, 2.52) were most likely to report loneliness at both baseline and follow‐up, though survivors of four other cancer types also faced an elevated risk for loneliness: neuroblastoma (OR, 2.32), bone tumor (OR, 2.12), soft tissue sarcoma (OR, 1.78), and Hodgkin lymphoma (OR, 1.69).
Treatment type appeared to matter as well. Survivors who underwent amputation (OR, 1.82) or were treated with cranial radiation greater than or equal to 20 Gy (OR, 1.56) or corticosteroids (OR, 1.31) were more likely to report loneliness at baseline and follow‐up, compared with those who reported no loneliness at both time points.
The authors acknowledge limitations to the study, including the fact that roughly 90% of survivors and siblings were White, which limits the applicability of their results to diverse groups. In addition, the responses were self-reported without external validation.
Overall, though, the findings provide a framework for clinicians to understand and identify loneliness among young cancer survivors and help them cope with their emotions.
“The Childhood Cancer Survivor Study provides the largest and the most comprehensive dataset on childhood cancer survivors and healthy-sibling comparisons, giving us powerful data on survivorship, late effects, and psychosocial and health outcomes,” Rachel M. Moore, PhD, child psychologist at Children’s Mercy Kansas City, Mo., said in an interview.
Asking a simple question – “Are you feeling lonely?” – can identify at-risk survivors and enable health care teams to provide timely interventions that address young patients’ physical and psychological needs, said Dr. Moore, who was not involved in the study.
Dr. Moore noted that within her clinical practice, “adolescent and young adult survivors frequently discuss loneliness in their daily lives. They feel different from their peers and misunderstood. Having a conversation early in survivorship care about the experience of loneliness as a product of cancer treatment can open the door to regular screening and destigmatizing mental health services.”
Supporting young people throughout their survivorship journey is important, said Rusha Bhandari, MD, medical director of the Childhood, Adolescent, and Young Adult Cancer Survivorship Program at City of Hope, Duarte, Calif. This study can help ensure that clinicians “provide comprehensive care, including psychosocial screening and support, to meet the unique needs of our young adult survivors,” said Dr. Bhandari, who also was not involved in the research.
The National Cancer Institute and the American Lebanese Syrian Associated Charities supported the study. One co-author reported receiving corporate consulting fees. Dr. Papini, the remaining co-authors, Dr. Moore, and Dr. Bhandari report no relevant financial involvements.
A version of this article first appeared on Medscape.com.
findings from a large retrospective study suggest.
Young cancer survivors were more than twice as likely to report loneliness at study baseline and follow-up. Loneliness at these times was associated with an almost 10-fold increased risk for anxiety and a nearly 18-fold increased risk for depression.
“We observed an elevated prevalence of loneliness in survivors, compared to sibling controls, and found that loneliness was associated with emotional, behavioral, and physical health morbidities,” lead study author Chiara Papini, PhD, of St. Jude Children’s Research Hospital, Memphis, and her colleagues write. “Our results highlight the importance of identifying and screening young adult survivors of childhood cancer for loneliness and the need for targeted interventions to reduce loneliness.”
The article was published online in the journal Cancer.
Most young cancer survivors in the United States reach adulthood and need to play catch-up: make up for missed school and work, become reacquainted with old friends, and develop new friendships, social networks, and intimate relationships. Meeting these needs may be hindered by adverse physical and psychosocial problems that linger or develop after treatment, which may leave cancer survivors feeling isolated.
“Young adult survivors of childhood cancer are navigating a developmental period marked by increased social expectations, during which loneliness may have significant impact on physical and mental health,” Dr. Papini and colleagues say.
To better understand the risks for loneliness among young cancer survivors, Dr. Papini and her colleagues analyzed data from the retrospective Childhood Cancer Survivor Study, which followed young survivors who had been diagnosed with a range of cancers before age 21 years. Study participants had been treated at one of 31 study sites in North America and had survived 5 years or longer after diagnosis.
The 9,664 survivors and 2,221 randomly sampled siblings ranged in age from 19 to 39 years at the time they completed a survey that assessed emotional distress at baseline and at follow‐up a median of 6.6 years. At baseline, the median age of the survivors was 27 years, and a median of 17.5 years had passed from the time of their diagnosis.
The most common diagnoses were leukemia (35%), Hodgkin lymphoma (15%), central nervous system (CNS) tumors (14%), and bone tumors (10%). More than half (56%) had received radiation therapy.
Using multivariable models, the researchers found that survivors were more likely than siblings to report moderate to extreme loneliness at either baseline or follow‐up (prevalence ratio, 1.04) and were more than two times more likely to report loneliness at both baseline and follow‐up (PR, 2.21).
Loneliness at baseline and follow‐up was associated with a much greater risk for anxiety (relative risk, 9.75) and depression (RR, 17.86). Loneliness at follow‐up was linked with increased risks for suicidal ideation (RR, 1.52), heavy or risky alcohol consumption (RR, 1.27), and any grade 2-4 new‐onset chronic health condition (RR, 1.29), especially those that were neurologic (RR, 4.37).
Survivors of CNS tumors (odds ratio, 2.59) and leukemia (OR, 2.52) were most likely to report loneliness at both baseline and follow‐up, though survivors of four other cancer types also faced an elevated risk for loneliness: neuroblastoma (OR, 2.32), bone tumor (OR, 2.12), soft tissue sarcoma (OR, 1.78), and Hodgkin lymphoma (OR, 1.69).
Treatment type appeared to matter as well. Survivors who underwent amputation (OR, 1.82) or were treated with cranial radiation greater than or equal to 20 Gy (OR, 1.56) or corticosteroids (OR, 1.31) were more likely to report loneliness at baseline and follow‐up, compared with those who reported no loneliness at both time points.
The authors acknowledge limitations to the study, including the fact that roughly 90% of survivors and siblings were White, which limits the applicability of their results to diverse groups. In addition, the responses were self-reported without external validation.
Overall, though, the findings provide a framework for clinicians to understand and identify loneliness among young cancer survivors and help them cope with their emotions.
“The Childhood Cancer Survivor Study provides the largest and the most comprehensive dataset on childhood cancer survivors and healthy-sibling comparisons, giving us powerful data on survivorship, late effects, and psychosocial and health outcomes,” Rachel M. Moore, PhD, child psychologist at Children’s Mercy Kansas City, Mo., said in an interview.
Asking a simple question – “Are you feeling lonely?” – can identify at-risk survivors and enable health care teams to provide timely interventions that address young patients’ physical and psychological needs, said Dr. Moore, who was not involved in the study.
Dr. Moore noted that within her clinical practice, “adolescent and young adult survivors frequently discuss loneliness in their daily lives. They feel different from their peers and misunderstood. Having a conversation early in survivorship care about the experience of loneliness as a product of cancer treatment can open the door to regular screening and destigmatizing mental health services.”
Supporting young people throughout their survivorship journey is important, said Rusha Bhandari, MD, medical director of the Childhood, Adolescent, and Young Adult Cancer Survivorship Program at City of Hope, Duarte, Calif. This study can help ensure that clinicians “provide comprehensive care, including psychosocial screening and support, to meet the unique needs of our young adult survivors,” said Dr. Bhandari, who also was not involved in the research.
The National Cancer Institute and the American Lebanese Syrian Associated Charities supported the study. One co-author reported receiving corporate consulting fees. Dr. Papini, the remaining co-authors, Dr. Moore, and Dr. Bhandari report no relevant financial involvements.
A version of this article first appeared on Medscape.com.
findings from a large retrospective study suggest.
Young cancer survivors were more than twice as likely to report loneliness at study baseline and follow-up. Loneliness at these times was associated with an almost 10-fold increased risk for anxiety and a nearly 18-fold increased risk for depression.
“We observed an elevated prevalence of loneliness in survivors, compared to sibling controls, and found that loneliness was associated with emotional, behavioral, and physical health morbidities,” lead study author Chiara Papini, PhD, of St. Jude Children’s Research Hospital, Memphis, and her colleagues write. “Our results highlight the importance of identifying and screening young adult survivors of childhood cancer for loneliness and the need for targeted interventions to reduce loneliness.”
The article was published online in the journal Cancer.
Most young cancer survivors in the United States reach adulthood and need to play catch-up: make up for missed school and work, become reacquainted with old friends, and develop new friendships, social networks, and intimate relationships. Meeting these needs may be hindered by adverse physical and psychosocial problems that linger or develop after treatment, which may leave cancer survivors feeling isolated.
“Young adult survivors of childhood cancer are navigating a developmental period marked by increased social expectations, during which loneliness may have significant impact on physical and mental health,” Dr. Papini and colleagues say.
To better understand the risks for loneliness among young cancer survivors, Dr. Papini and her colleagues analyzed data from the retrospective Childhood Cancer Survivor Study, which followed young survivors who had been diagnosed with a range of cancers before age 21 years. Study participants had been treated at one of 31 study sites in North America and had survived 5 years or longer after diagnosis.
The 9,664 survivors and 2,221 randomly sampled siblings ranged in age from 19 to 39 years at the time they completed a survey that assessed emotional distress at baseline and at follow‐up a median of 6.6 years. At baseline, the median age of the survivors was 27 years, and a median of 17.5 years had passed from the time of their diagnosis.
The most common diagnoses were leukemia (35%), Hodgkin lymphoma (15%), central nervous system (CNS) tumors (14%), and bone tumors (10%). More than half (56%) had received radiation therapy.
Using multivariable models, the researchers found that survivors were more likely than siblings to report moderate to extreme loneliness at either baseline or follow‐up (prevalence ratio, 1.04) and were more than two times more likely to report loneliness at both baseline and follow‐up (PR, 2.21).
Loneliness at baseline and follow‐up was associated with a much greater risk for anxiety (relative risk, 9.75) and depression (RR, 17.86). Loneliness at follow‐up was linked with increased risks for suicidal ideation (RR, 1.52), heavy or risky alcohol consumption (RR, 1.27), and any grade 2-4 new‐onset chronic health condition (RR, 1.29), especially those that were neurologic (RR, 4.37).
Survivors of CNS tumors (odds ratio, 2.59) and leukemia (OR, 2.52) were most likely to report loneliness at both baseline and follow‐up, though survivors of four other cancer types also faced an elevated risk for loneliness: neuroblastoma (OR, 2.32), bone tumor (OR, 2.12), soft tissue sarcoma (OR, 1.78), and Hodgkin lymphoma (OR, 1.69).
Treatment type appeared to matter as well. Survivors who underwent amputation (OR, 1.82) or were treated with cranial radiation greater than or equal to 20 Gy (OR, 1.56) or corticosteroids (OR, 1.31) were more likely to report loneliness at baseline and follow‐up, compared with those who reported no loneliness at both time points.
The authors acknowledge limitations to the study, including the fact that roughly 90% of survivors and siblings were White, which limits the applicability of their results to diverse groups. In addition, the responses were self-reported without external validation.
Overall, though, the findings provide a framework for clinicians to understand and identify loneliness among young cancer survivors and help them cope with their emotions.
“The Childhood Cancer Survivor Study provides the largest and the most comprehensive dataset on childhood cancer survivors and healthy-sibling comparisons, giving us powerful data on survivorship, late effects, and psychosocial and health outcomes,” Rachel M. Moore, PhD, child psychologist at Children’s Mercy Kansas City, Mo., said in an interview.
Asking a simple question – “Are you feeling lonely?” – can identify at-risk survivors and enable health care teams to provide timely interventions that address young patients’ physical and psychological needs, said Dr. Moore, who was not involved in the study.
Dr. Moore noted that within her clinical practice, “adolescent and young adult survivors frequently discuss loneliness in their daily lives. They feel different from their peers and misunderstood. Having a conversation early in survivorship care about the experience of loneliness as a product of cancer treatment can open the door to regular screening and destigmatizing mental health services.”
Supporting young people throughout their survivorship journey is important, said Rusha Bhandari, MD, medical director of the Childhood, Adolescent, and Young Adult Cancer Survivorship Program at City of Hope, Duarte, Calif. This study can help ensure that clinicians “provide comprehensive care, including psychosocial screening and support, to meet the unique needs of our young adult survivors,” said Dr. Bhandari, who also was not involved in the research.
The National Cancer Institute and the American Lebanese Syrian Associated Charities supported the study. One co-author reported receiving corporate consulting fees. Dr. Papini, the remaining co-authors, Dr. Moore, and Dr. Bhandari report no relevant financial involvements.
A version of this article first appeared on Medscape.com.
FROM CANCER
My patient chose quality of life over treatment
Several decades ago, a new patient came to my office with her family. She was elderly, in good health, spoke no English, and her extended family translated for her. Their request: “Don’t tell her that she has cancer.” Sharing her diagnosis with her would cause too much stress, they said. Their mother would not be able to tolerate the bad news, they said. She would “give up.”
I asked her (through her family and an interpreter) how much she wanted to know about what was going on, or would she prefer I confine my remarks to her family? It turns out that she did want to know her diagnosis and prognosis, and after a thorough discussion in front of her family about her treatment options, she decided she did not want to proceed with additional therapy. She wanted to focus on quality of life. I did not get the impression that this is what her family would have opted for.
The patient’s voice can take multiple directions, such as making informed decisions about their own care. When empowered, patients can and will express their wants, needs, feelings, and priorities to their providers, and they’ll participate in directing their own care. There is a growing body of evidence that shows patients who are more engaged and share decision-making with their health care professionals have better health outcomes and care experiences. Engaged patients feel more empowered and are more motivated to take action. They’re also more likely to follow treatment plans, take their medications, and heed their provider’s recommendations. By virtue of better treatments for lung cancer, many patients are living longer and better lives. Some of these patients even become “experts” on their own care, often bringing questions about research and clinical trials to the attention of their providers.
The patient’s voice in research and advocacy
The patient’s perspective is also key to a meaningful, successful clinical research project. Rather than being carried out to, about, or for the patient, patient involvement means research being carried out with or by patients. A patient and researcher may have different research goals. For example, patients may value being able to work, be with family, and live without pain, whereas a clinical researcher’s goal may be inducing responses. Patient involvement is important in both laboratory research and clinical research. The best-designed projects involve patient advocates from the beginning of the project to help make research relevant and meaningful to patients and include these perspectives through project completion.
More and more pharmaceutical companies are actively involving patients at all levels of protocol development, including protocol design and selection of relevant outcomes to patients. Benefits of engaging patients as partners in research include inclusion of real-world data, increased study enrollment, and translation of results to the cancer community in an understandable and accessible manner.
Accelerated research
Advocating for accelerated research is another area where the patient’s voice is important. Patients can and do identify research priorities for researchers, funding agencies, and pharma. Patients who support research advocacy are frequently part of meetings and panel discussions with researchers, the Food and Drug Administration, and the National Cancer Institute. And, they serve on advisory boards for pharmaceutical companies. They participate in grant reviews and institutional review boards, review manuscripts, and are active members of the cooperative groups and other professional societies. In fact, patient-led advocacy groups are raising money to help fund research they feel is most important to them. In lung cancer, for example, there are many groups organized around biomarkers, including the EGFR Resisters, ALK Positive, ROS1ders, MET Crusaders, and KRAS Kickers, who have raised hundreds of thousands of dollars to fund investigator-led translational research that would not have occurred without their involvement.
It is important to recognize that all patients are different and have different values and motivations that are important to them and influence their life decisions. Some patients want to know more about their condition and their preferences should be respected. Similarly, it’s critical to understand that not every patient is an advocate and not every advocate is a research advocate. Research advocates have more in-depth knowledge about the science of lung cancer and focus on representing the patient perspective for all lung cancer patients.
So, getting back to my original story: Did my patient “give up” by choosing palliative care without chemotherapy? Perhaps, but I don’t think she considered her decision “giving up.” Instead, she made the best decision possible for herself. What would have happened had she not been told of her diagnosis? She probably would not have spent extra quality time with her family, as they tried to ignore the obvious. And, after all, quality time with her family was all she wanted.
Dr. Schiller is a medical oncologist and founding member of Oncologists United for Climate and Health. She is a former board member of the International Association for the Study of Lung Cancer and a current board member of the Lung Cancer Research Foundation. Ivy Elkins, cofounder of EGFR Resisters, a patient, survivor, and caregiver advocacy group, contributed to this article.
Several decades ago, a new patient came to my office with her family. She was elderly, in good health, spoke no English, and her extended family translated for her. Their request: “Don’t tell her that she has cancer.” Sharing her diagnosis with her would cause too much stress, they said. Their mother would not be able to tolerate the bad news, they said. She would “give up.”
I asked her (through her family and an interpreter) how much she wanted to know about what was going on, or would she prefer I confine my remarks to her family? It turns out that she did want to know her diagnosis and prognosis, and after a thorough discussion in front of her family about her treatment options, she decided she did not want to proceed with additional therapy. She wanted to focus on quality of life. I did not get the impression that this is what her family would have opted for.
The patient’s voice can take multiple directions, such as making informed decisions about their own care. When empowered, patients can and will express their wants, needs, feelings, and priorities to their providers, and they’ll participate in directing their own care. There is a growing body of evidence that shows patients who are more engaged and share decision-making with their health care professionals have better health outcomes and care experiences. Engaged patients feel more empowered and are more motivated to take action. They’re also more likely to follow treatment plans, take their medications, and heed their provider’s recommendations. By virtue of better treatments for lung cancer, many patients are living longer and better lives. Some of these patients even become “experts” on their own care, often bringing questions about research and clinical trials to the attention of their providers.
The patient’s voice in research and advocacy
The patient’s perspective is also key to a meaningful, successful clinical research project. Rather than being carried out to, about, or for the patient, patient involvement means research being carried out with or by patients. A patient and researcher may have different research goals. For example, patients may value being able to work, be with family, and live without pain, whereas a clinical researcher’s goal may be inducing responses. Patient involvement is important in both laboratory research and clinical research. The best-designed projects involve patient advocates from the beginning of the project to help make research relevant and meaningful to patients and include these perspectives through project completion.
More and more pharmaceutical companies are actively involving patients at all levels of protocol development, including protocol design and selection of relevant outcomes to patients. Benefits of engaging patients as partners in research include inclusion of real-world data, increased study enrollment, and translation of results to the cancer community in an understandable and accessible manner.
Accelerated research
Advocating for accelerated research is another area where the patient’s voice is important. Patients can and do identify research priorities for researchers, funding agencies, and pharma. Patients who support research advocacy are frequently part of meetings and panel discussions with researchers, the Food and Drug Administration, and the National Cancer Institute. And, they serve on advisory boards for pharmaceutical companies. They participate in grant reviews and institutional review boards, review manuscripts, and are active members of the cooperative groups and other professional societies. In fact, patient-led advocacy groups are raising money to help fund research they feel is most important to them. In lung cancer, for example, there are many groups organized around biomarkers, including the EGFR Resisters, ALK Positive, ROS1ders, MET Crusaders, and KRAS Kickers, who have raised hundreds of thousands of dollars to fund investigator-led translational research that would not have occurred without their involvement.
It is important to recognize that all patients are different and have different values and motivations that are important to them and influence their life decisions. Some patients want to know more about their condition and their preferences should be respected. Similarly, it’s critical to understand that not every patient is an advocate and not every advocate is a research advocate. Research advocates have more in-depth knowledge about the science of lung cancer and focus on representing the patient perspective for all lung cancer patients.
So, getting back to my original story: Did my patient “give up” by choosing palliative care without chemotherapy? Perhaps, but I don’t think she considered her decision “giving up.” Instead, she made the best decision possible for herself. What would have happened had she not been told of her diagnosis? She probably would not have spent extra quality time with her family, as they tried to ignore the obvious. And, after all, quality time with her family was all she wanted.
Dr. Schiller is a medical oncologist and founding member of Oncologists United for Climate and Health. She is a former board member of the International Association for the Study of Lung Cancer and a current board member of the Lung Cancer Research Foundation. Ivy Elkins, cofounder of EGFR Resisters, a patient, survivor, and caregiver advocacy group, contributed to this article.
Several decades ago, a new patient came to my office with her family. She was elderly, in good health, spoke no English, and her extended family translated for her. Their request: “Don’t tell her that she has cancer.” Sharing her diagnosis with her would cause too much stress, they said. Their mother would not be able to tolerate the bad news, they said. She would “give up.”
I asked her (through her family and an interpreter) how much she wanted to know about what was going on, or would she prefer I confine my remarks to her family? It turns out that she did want to know her diagnosis and prognosis, and after a thorough discussion in front of her family about her treatment options, she decided she did not want to proceed with additional therapy. She wanted to focus on quality of life. I did not get the impression that this is what her family would have opted for.
The patient’s voice can take multiple directions, such as making informed decisions about their own care. When empowered, patients can and will express their wants, needs, feelings, and priorities to their providers, and they’ll participate in directing their own care. There is a growing body of evidence that shows patients who are more engaged and share decision-making with their health care professionals have better health outcomes and care experiences. Engaged patients feel more empowered and are more motivated to take action. They’re also more likely to follow treatment plans, take their medications, and heed their provider’s recommendations. By virtue of better treatments for lung cancer, many patients are living longer and better lives. Some of these patients even become “experts” on their own care, often bringing questions about research and clinical trials to the attention of their providers.
The patient’s voice in research and advocacy
The patient’s perspective is also key to a meaningful, successful clinical research project. Rather than being carried out to, about, or for the patient, patient involvement means research being carried out with or by patients. A patient and researcher may have different research goals. For example, patients may value being able to work, be with family, and live without pain, whereas a clinical researcher’s goal may be inducing responses. Patient involvement is important in both laboratory research and clinical research. The best-designed projects involve patient advocates from the beginning of the project to help make research relevant and meaningful to patients and include these perspectives through project completion.
More and more pharmaceutical companies are actively involving patients at all levels of protocol development, including protocol design and selection of relevant outcomes to patients. Benefits of engaging patients as partners in research include inclusion of real-world data, increased study enrollment, and translation of results to the cancer community in an understandable and accessible manner.
Accelerated research
Advocating for accelerated research is another area where the patient’s voice is important. Patients can and do identify research priorities for researchers, funding agencies, and pharma. Patients who support research advocacy are frequently part of meetings and panel discussions with researchers, the Food and Drug Administration, and the National Cancer Institute. And, they serve on advisory boards for pharmaceutical companies. They participate in grant reviews and institutional review boards, review manuscripts, and are active members of the cooperative groups and other professional societies. In fact, patient-led advocacy groups are raising money to help fund research they feel is most important to them. In lung cancer, for example, there are many groups organized around biomarkers, including the EGFR Resisters, ALK Positive, ROS1ders, MET Crusaders, and KRAS Kickers, who have raised hundreds of thousands of dollars to fund investigator-led translational research that would not have occurred without their involvement.
It is important to recognize that all patients are different and have different values and motivations that are important to them and influence their life decisions. Some patients want to know more about their condition and their preferences should be respected. Similarly, it’s critical to understand that not every patient is an advocate and not every advocate is a research advocate. Research advocates have more in-depth knowledge about the science of lung cancer and focus on representing the patient perspective for all lung cancer patients.
So, getting back to my original story: Did my patient “give up” by choosing palliative care without chemotherapy? Perhaps, but I don’t think she considered her decision “giving up.” Instead, she made the best decision possible for herself. What would have happened had she not been told of her diagnosis? She probably would not have spent extra quality time with her family, as they tried to ignore the obvious. And, after all, quality time with her family was all she wanted.
Dr. Schiller is a medical oncologist and founding member of Oncologists United for Climate and Health. She is a former board member of the International Association for the Study of Lung Cancer and a current board member of the Lung Cancer Research Foundation. Ivy Elkins, cofounder of EGFR Resisters, a patient, survivor, and caregiver advocacy group, contributed to this article.
Over half of ED visits from cancer patients could be prevented
Overall, researchers found that 18.3 million (52%) ED visits among patients with cancer between 2012 and 2019 were potentially avoidable. Pain was the most common reason for such a visit. Notably, the number of potentially preventable ED visits documented each year increased over the study period.
“These findings highlight the need for cancer care programs to implement evidence-based interventions to better manage cancer treatment complications, such as uncontrolled pain, in outpatient and ambulatory settings,” said the authors, led by Amir Alishahi Tabriz, MD, PhD, MPH, department of health outcomes and behavior, Moffitt Cancer Center, Tampa.
Authors of an accompanying editorial agree, noting that “patients at risk for having uncontrolled pain could potentially be identified earlier, and steps could be taken that would address their pain and help prevent acute care visits.”
The study and the editorial were published online Jan. 19, 2022, in JAMA Network Open.
Patients with cancer experience a range of side effects from their cancer and treatment. Many such problems can be managed in the ambulatory setting but are often managed in the ED, which is far from optimal for patients with cancer from both a complications and cost perspective. Still, little is known about whether ED visits among patients with cancer are avoidable.
To better understand unnecessary emergency care use by these patients, Dr. Tabriz and colleagues evaluated trends and characteristics of potentially preventable ED visits among adults with cancer who had an ED visit between 2012 and 2019. The authors used the Centers for Medicare & Medicaid Services definition for a potentially preventable ED visit among patients receiving chemotherapy.
Among the 35.5 million ED visits made by patients with cancer during the study period, 18.3 million (52%) were identified as potentially preventable. Nearly 5.8 million of these visits (21%) were classified as being of “high acuity,” and almost 30% resulted in unplanned hospitalizations.
Pain was the most common reason for potentially preventable ED visits, accounting for 37% of these visits.
The absolute number of potentially preventable ED visits among cancer patients increased from about 1.8 million in 2012 to 3.2 million in 2019. The number of patients who visited the ED because of pain more than doubled, from roughly 1.2 million in 2012 to 2.4 million in 2019.
“The disproportionate increase in the number of ED visits by patients with cancer has put a substantial burden on EDs that are already operating at peak capacity” and “reinforces the need for cancer care programs to devise innovative ways to manage complications associated with cancer treatment in the outpatient and ambulatory settings,” Dr. Tabriz and coauthors wrote.
The increase could be an “unintended” consequence of efforts to decrease overall opioid administration in response to the opioid epidemic, Dr. Tabriz and colleagues noted. For example, the authors point to a recent study that found that about half of patients with cancer who had severe pain did not receive outpatient opioids in the week before visiting the ED.
“Even access to outpatient care does not mean patients can get the care they need outside an ED,” wrote editorialists Erek Majka, MD, with Summerlin Hospital, Las Vegas, and N. Seth Trueger, MD, MPH, with Northwestern University, Chicago. Thus, “it is no surprise that patients are sent to the ED if the alternatives do not have the staff or diagnostic and therapeutic capabilities the patients need.”
Overall, however, the “goal is not to eliminate ED visits for their own sake; rather, the goal is better care of patients with cancer, and secondarily, in a manner that is cost-effective,” Dr. Majka and Dr. Trueger explained.
No specific funding for the study was reported. The authors disclosed no relevant financial relationships. Dr. Trueger is digital media editor of JAMA Network Open, but he was not involved in decisions regarding review of the manuscript or its acceptance.
A version of this article first appeared on Medscape.com.
Overall, researchers found that 18.3 million (52%) ED visits among patients with cancer between 2012 and 2019 were potentially avoidable. Pain was the most common reason for such a visit. Notably, the number of potentially preventable ED visits documented each year increased over the study period.
“These findings highlight the need for cancer care programs to implement evidence-based interventions to better manage cancer treatment complications, such as uncontrolled pain, in outpatient and ambulatory settings,” said the authors, led by Amir Alishahi Tabriz, MD, PhD, MPH, department of health outcomes and behavior, Moffitt Cancer Center, Tampa.
Authors of an accompanying editorial agree, noting that “patients at risk for having uncontrolled pain could potentially be identified earlier, and steps could be taken that would address their pain and help prevent acute care visits.”
The study and the editorial were published online Jan. 19, 2022, in JAMA Network Open.
Patients with cancer experience a range of side effects from their cancer and treatment. Many such problems can be managed in the ambulatory setting but are often managed in the ED, which is far from optimal for patients with cancer from both a complications and cost perspective. Still, little is known about whether ED visits among patients with cancer are avoidable.
To better understand unnecessary emergency care use by these patients, Dr. Tabriz and colleagues evaluated trends and characteristics of potentially preventable ED visits among adults with cancer who had an ED visit between 2012 and 2019. The authors used the Centers for Medicare & Medicaid Services definition for a potentially preventable ED visit among patients receiving chemotherapy.
Among the 35.5 million ED visits made by patients with cancer during the study period, 18.3 million (52%) were identified as potentially preventable. Nearly 5.8 million of these visits (21%) were classified as being of “high acuity,” and almost 30% resulted in unplanned hospitalizations.
Pain was the most common reason for potentially preventable ED visits, accounting for 37% of these visits.
The absolute number of potentially preventable ED visits among cancer patients increased from about 1.8 million in 2012 to 3.2 million in 2019. The number of patients who visited the ED because of pain more than doubled, from roughly 1.2 million in 2012 to 2.4 million in 2019.
“The disproportionate increase in the number of ED visits by patients with cancer has put a substantial burden on EDs that are already operating at peak capacity” and “reinforces the need for cancer care programs to devise innovative ways to manage complications associated with cancer treatment in the outpatient and ambulatory settings,” Dr. Tabriz and coauthors wrote.
The increase could be an “unintended” consequence of efforts to decrease overall opioid administration in response to the opioid epidemic, Dr. Tabriz and colleagues noted. For example, the authors point to a recent study that found that about half of patients with cancer who had severe pain did not receive outpatient opioids in the week before visiting the ED.
“Even access to outpatient care does not mean patients can get the care they need outside an ED,” wrote editorialists Erek Majka, MD, with Summerlin Hospital, Las Vegas, and N. Seth Trueger, MD, MPH, with Northwestern University, Chicago. Thus, “it is no surprise that patients are sent to the ED if the alternatives do not have the staff or diagnostic and therapeutic capabilities the patients need.”
Overall, however, the “goal is not to eliminate ED visits for their own sake; rather, the goal is better care of patients with cancer, and secondarily, in a manner that is cost-effective,” Dr. Majka and Dr. Trueger explained.
No specific funding for the study was reported. The authors disclosed no relevant financial relationships. Dr. Trueger is digital media editor of JAMA Network Open, but he was not involved in decisions regarding review of the manuscript or its acceptance.
A version of this article first appeared on Medscape.com.
Overall, researchers found that 18.3 million (52%) ED visits among patients with cancer between 2012 and 2019 were potentially avoidable. Pain was the most common reason for such a visit. Notably, the number of potentially preventable ED visits documented each year increased over the study period.
“These findings highlight the need for cancer care programs to implement evidence-based interventions to better manage cancer treatment complications, such as uncontrolled pain, in outpatient and ambulatory settings,” said the authors, led by Amir Alishahi Tabriz, MD, PhD, MPH, department of health outcomes and behavior, Moffitt Cancer Center, Tampa.
Authors of an accompanying editorial agree, noting that “patients at risk for having uncontrolled pain could potentially be identified earlier, and steps could be taken that would address their pain and help prevent acute care visits.”
The study and the editorial were published online Jan. 19, 2022, in JAMA Network Open.
Patients with cancer experience a range of side effects from their cancer and treatment. Many such problems can be managed in the ambulatory setting but are often managed in the ED, which is far from optimal for patients with cancer from both a complications and cost perspective. Still, little is known about whether ED visits among patients with cancer are avoidable.
To better understand unnecessary emergency care use by these patients, Dr. Tabriz and colleagues evaluated trends and characteristics of potentially preventable ED visits among adults with cancer who had an ED visit between 2012 and 2019. The authors used the Centers for Medicare & Medicaid Services definition for a potentially preventable ED visit among patients receiving chemotherapy.
Among the 35.5 million ED visits made by patients with cancer during the study period, 18.3 million (52%) were identified as potentially preventable. Nearly 5.8 million of these visits (21%) were classified as being of “high acuity,” and almost 30% resulted in unplanned hospitalizations.
Pain was the most common reason for potentially preventable ED visits, accounting for 37% of these visits.
The absolute number of potentially preventable ED visits among cancer patients increased from about 1.8 million in 2012 to 3.2 million in 2019. The number of patients who visited the ED because of pain more than doubled, from roughly 1.2 million in 2012 to 2.4 million in 2019.
“The disproportionate increase in the number of ED visits by patients with cancer has put a substantial burden on EDs that are already operating at peak capacity” and “reinforces the need for cancer care programs to devise innovative ways to manage complications associated with cancer treatment in the outpatient and ambulatory settings,” Dr. Tabriz and coauthors wrote.
The increase could be an “unintended” consequence of efforts to decrease overall opioid administration in response to the opioid epidemic, Dr. Tabriz and colleagues noted. For example, the authors point to a recent study that found that about half of patients with cancer who had severe pain did not receive outpatient opioids in the week before visiting the ED.
“Even access to outpatient care does not mean patients can get the care they need outside an ED,” wrote editorialists Erek Majka, MD, with Summerlin Hospital, Las Vegas, and N. Seth Trueger, MD, MPH, with Northwestern University, Chicago. Thus, “it is no surprise that patients are sent to the ED if the alternatives do not have the staff or diagnostic and therapeutic capabilities the patients need.”
Overall, however, the “goal is not to eliminate ED visits for their own sake; rather, the goal is better care of patients with cancer, and secondarily, in a manner that is cost-effective,” Dr. Majka and Dr. Trueger explained.
No specific funding for the study was reported. The authors disclosed no relevant financial relationships. Dr. Trueger is digital media editor of JAMA Network Open, but he was not involved in decisions regarding review of the manuscript or its acceptance.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Terminally ill cancer patients struggle to access psilocybin
In March 2020, when the world was struck by the news of the COVID-19 pandemic, Erinn Baldeschwiler received her own gut punch. She was diagnosed with stage IV metastatic breast cancer and was given about 2 years to live.
Then 48, the mother of two teenagers had just started a new chapter in her life. She’d gotten divorced, moved to a new home, and left a small business she had spent 18 years cultivating. The prospect that her life story might soon be ending, that she wouldn’t see her children grow up, was a twist of fate almost too devastating to bear.
“Are you kidding me that this is happening?” she thought.
But she also wanted to keep learning and growing in her remaining years, to devote them to creating meaningful memories, contemplating her mortality, and trying to find inner peace.
“The last 2 years have kind of been this dance with Lady Death,” she said.
They have also been a dance with Lady Justice.
In March 2021, Ms. Baldeschwiler, along with Michal Bloom, who also has terminal cancer, and their palliative care physician, Sunil Aggarwal, MD, PhD, decided to sue the Drug Enforcement Administration (DEA) for the right to access psilocybin, the psychoactive ingredient in “magic” mushrooms.
Psilocybin-assisted therapy has been shown to help terminally ill people overcome their fear, anxiety, and despair about death and to experience the kind of peace Ms. Baldeschwiler is seeking.
Psilocybin is illegal in the United States, but the plaintiffs argue they should be able to take the substance through the Right to Try Act. The 2018 federal law says that people with life-threatening conditions who have exhausted all approved treatment options can access drugs that have not yet been approved by the Food and Drug Administration but have passed phase 1 clinical trials.
This case marks the first time patients have fought to use a Schedule I drug under the Right to Try Act.
The push to expand access to psilocybin is picking up steam in the United States. In 2023, facilitated use of psilocybin will become legal in Oregon and Colorado. Recent proposals from the Biden administration and members of Congress could make psilocybin more widely accessible in the next few years.
It is also gaining momentum outside the United States. In Canada, patients are suing the government to help patients obtain psilocybin-assisted therapy for medical purposes.
“I think what we have here is a confluence of events that are driving toward the mandatory opening of a path to access psilocybin for therapeutic use sooner rather than later,” said Kathryn Tucker, lead counsel in the case against the DEA.
Reverberations of Right to Try
The story of Right to Try began with Abigail Burroughs, who was diagnosed with head and neck cancer at age 19.
After conventional therapies failed, Ms. Burroughs’ oncologist recommended cetuximab, a drug targeting EGFR that was experimental at the time. Because the drug was available only through colon cancer trials, she was denied access.
She died in 2001 at age 21.
Ms. Burroughs’ father, Frank Burroughs, formed an organization that in 2003 sued the FDA to provide terminally ill patients access to unapproved drugs. In 2005, they lost, and subsequent attempts to appeal the decision failed.
Still, the case sparked a Right to Try movement.
“Right to Try laws swept the U.S. in a firestorm,” Ms. Tucker said.
Along with the federal law, which passed in 2018, 41 states have enacted Right to Try laws.
The movement intrigued Dr. Aggarwal, codirector of the Advanced Integrative Medical Science (AIMS) Institute in Seattle. Dr. Aggarwal had been treating patients with cannabis, and after taking psilocybin himself and finding it therapeutic, he thought Ms. Baldeschwiler could benefit.
“I always knew that the powerful medicines within Schedule I had a significant role to play in healing,” he said. “That was baked into my decision to become a doctor, to research, and to innovate.”
He applied for the right to cultivate psilocybin mushrooms, but the fungus doesn’t meet Right to Try requirements. He then found a manufacturer willing to supply synthesized psilocybin, but because it’s a Schedule I drug, the manufacturer needed an okay from the DEA.
Dr. Aggarwal joined forces with Ms. Tucker, who has spent 35 years protecting the rights of terminally ill patients. In January 2021, Ms. Tucker contacted the DEA about allowing dying patients, including Ms. Baldeschwiler and Mr. Bloom, to access psilocybin-assisted therapy.
The response, she said, was predictable.
“The DEA’s knee always jerks in the direction of no access,” Ms. Tucker said. “So it said ‘no access.’ “
The reason: In a letter dated February 2021, the DEA said it “has no authority to waive” any requirements of the Controlled Substances Act under Right to Try laws.
Suing the DEA
Dr. Aggarwal and Ms. Tucker did not accept the DEA’s “no access” answer.
They decided to sue.
Dr. Aggarwal and Ms. Tucker took the matter to the Ninth Circuit Court in March 2021. In January 2022, the court dismissed the case after the DEA claimed its initial denial was not final.
The following month, the plaintiffs petitioned the DEA to deliver a concrete answer.
In May, while waiting for a response, demonstrators gathered at the DEA’s headquarters to call for legal access to psilocybin. One of the protesters was Ms. Baldeschwiler, who choked back tears as she told the crowd she was likely missing her last Mother’s Day with her children to attend the event. She was arrested, along with 16 other people.
In late June, the DEA provided its final answer: No access.
In a letter addressed to Ms. Tucker, Thomas W. Prevoznik, the DEA’s deputy assistant administrator, said it “finds no basis” to reconsider its initial denial in February 2021 “because the legal and factual considerations remain unchanged.”
In an appeal, Ms. Tucker wrote: “In denying Petitioners’ requested accommodation in the Final Agency Action, DEA hides behind a smokescreen, neglecting its duty to implement the federal [Right to Try Act] and violating the state [Right to Try law].”
The government’s response is due in January 2023.
Ms. Tucker and her legal team also petitioned the DEA on behalf of Dr. Aggarwal to reschedule psilocybin from Schedule I to Schedule II.
The DEA defines Schedule I substances as “drugs with no currently accepted medical use and a high potential for abuse.” But the FDA has designated psilocybin as a breakthrough therapy for depression, which, Ms. Tucker noted, “reflects that there is a currently accepted medical use.”
Nevertheless, in September, the DEA denied Ms. Tucker’s petition to reschedule psilocybin, and her team is now petitioning the Ninth Circuit Court for a review of that decision.
Despite the setbacks, actions from the Biden administration and members of Congress could help improve access.
In July, Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act to clarify that the federal law includes Schedule I substances. If passed, Ms. Tucker said, it would negate the DEA’s “no access” argument.
And earlier this year, the Biden administration announced plans to establish a federal task force to address the “myriad of complex issues” associated with the anticipated FDA approval of psilocybin to treat depression. The task force will explore “the potential of psychedelic-assisted therapies” to tackle the mental health crisis as well as any “risks to public health” that “may require harm reduction, risk mitigation, and safety monitoring.”
The fight north of the border
In 2016, Canadian resident Thomas Hartle, then 48, awoke from surgery for a bowel obstruction to learn he had stage IV colon cancer.
After another surgery, his doctors believed the tumors were gone. But in 2019, the cancer came back, along with extreme anxiety and distress over his impending death and how his two special-needs children would cope.
Mr. Hartle wanted to try magic mushroom–assisted psychotherapy. The Saskatoon resident sought help from TheraPsil, a Canadian nonprofit organization that advocates for therapeutic psilocybin. They applied for access under Section 56, which allows health officials to exempt patients from certain provisions of drug law.
In 2020, Hartle became the first Canadian to legally obtain psilocybin-assisted therapy.
“It has been nothing short of life changing for me,” Mr. Hartle said at a palliative care conference in Saskatoon this past June. “I am now no longer actively dying. I feel like I am genuinely actively living.”
TheraPsil has obtained Section 56 exemptions for around 60 patients to access psilocybin-assisted therapy as well as 19 health care professionals who are training to become psilocybin-assisted therapists.
But then an election ushered in new health ministers, and in early 2022, the exemptions evaporated. Thousands of patients and health care practitioners on TheraPsil’s waiting list were left in limbo.
Health Canada told CBC News that the rule change came about because “while psilocybin has shown promise in clinical trials for the treatment of some indications, further research is still needed to determine its safety and efficacy.”
As an alternative, TheraPsil began applying for access under Canada’s Special Access Program, which is similar to Right to Try laws in the United States. But Canada’s program doesn’t apply to therapists in training, and the petition process is so slow that many patients die before requests can be approved.
“People like to pretend that the Special Access Program is not political, but it is very political,” said TheraPsil’s CEO, Spencer Hawkswell. “It means a patient and a doctor are asking a politician for access to their medicine, which is absolutely unacceptable.”
Now, TheraPsil is helping patients take the Canadian government to court. In July, Mr. Hartle and seven others with conditions ranging from cancer to chronic pain filed a lawsuit against Canada’s health ministry that challenges the limited legal pathways to the use of psilocybin. The lawsuit argues that patients have a “constitutional right to access psilocybin for medicinal purposes,” and it advocates for access to regulated psilocybin products from licensed dealers, much like Canada’s medical marijuana program already does.
In the filing, TheraPsil said that as of February 2022, it has a wait-list of more than 800 patients who are requesting help in obtaining psilocybin-assisted psychotherapy.
An uncertain future
Despite the groundswell of support, many unknowns remain about the safety of expanding access to psilocybin-assisted therapy.
When Oregon and Colorado launch their psilocybin programs in 2023, the licensed centers will provide testing grounds for the safety and efficacy of broader access to psilocybin for people with depression or terminal cancer as well as those looking to grow spiritually.
Although in clinical trials psilocybin has been found to ease symptoms of depression and end-of-life demoralization for people with life-threatening conditions, it has not been adequately tested in people with a range of mental health problems, traumas, and racial backgrounds.
That uncertainty has given some people pause. In recent months, some researchers and journalists have pushed back against the frenzy over the promise of psychedelics.
In September, David Yaden, PhD, a psychedelics researcher at Johns Hopkins, spoke at the Interdisciplinary Conference on Psychedelic Research in the Netherlands. He encouraged people to pay more attention to potential adverse effects of psychedelics, which could include anything from headaches to lingering dysphoria.
“Oftentimes, we hear only the positive anecdotes,” Dr. Yaden said. “We don’t hear ... neutral or negative ones. So, I think all of those anecdotes need to be part of the picture.”
A recent piece in Wired noted that mentioning the potential harms of psychedelics amid its renaissance has been “taboo,” but the authors cautioned that as clinical trials involving psychedelics grow larger and the drugs become commercialized, “more negative outcomes are likely to transpire.”
But Ms. Baldeschwiler remains steadfast in her pursuit. While it’s important to approach broader access to psychedelics with caution, “end-of-life patients don’t have time to wait,” she said.
A version of this article first appeared on Medscape.com.
In March 2020, when the world was struck by the news of the COVID-19 pandemic, Erinn Baldeschwiler received her own gut punch. She was diagnosed with stage IV metastatic breast cancer and was given about 2 years to live.
Then 48, the mother of two teenagers had just started a new chapter in her life. She’d gotten divorced, moved to a new home, and left a small business she had spent 18 years cultivating. The prospect that her life story might soon be ending, that she wouldn’t see her children grow up, was a twist of fate almost too devastating to bear.
“Are you kidding me that this is happening?” she thought.
But she also wanted to keep learning and growing in her remaining years, to devote them to creating meaningful memories, contemplating her mortality, and trying to find inner peace.
“The last 2 years have kind of been this dance with Lady Death,” she said.
They have also been a dance with Lady Justice.
In March 2021, Ms. Baldeschwiler, along with Michal Bloom, who also has terminal cancer, and their palliative care physician, Sunil Aggarwal, MD, PhD, decided to sue the Drug Enforcement Administration (DEA) for the right to access psilocybin, the psychoactive ingredient in “magic” mushrooms.
Psilocybin-assisted therapy has been shown to help terminally ill people overcome their fear, anxiety, and despair about death and to experience the kind of peace Ms. Baldeschwiler is seeking.
Psilocybin is illegal in the United States, but the plaintiffs argue they should be able to take the substance through the Right to Try Act. The 2018 federal law says that people with life-threatening conditions who have exhausted all approved treatment options can access drugs that have not yet been approved by the Food and Drug Administration but have passed phase 1 clinical trials.
This case marks the first time patients have fought to use a Schedule I drug under the Right to Try Act.
The push to expand access to psilocybin is picking up steam in the United States. In 2023, facilitated use of psilocybin will become legal in Oregon and Colorado. Recent proposals from the Biden administration and members of Congress could make psilocybin more widely accessible in the next few years.
It is also gaining momentum outside the United States. In Canada, patients are suing the government to help patients obtain psilocybin-assisted therapy for medical purposes.
“I think what we have here is a confluence of events that are driving toward the mandatory opening of a path to access psilocybin for therapeutic use sooner rather than later,” said Kathryn Tucker, lead counsel in the case against the DEA.
Reverberations of Right to Try
The story of Right to Try began with Abigail Burroughs, who was diagnosed with head and neck cancer at age 19.
After conventional therapies failed, Ms. Burroughs’ oncologist recommended cetuximab, a drug targeting EGFR that was experimental at the time. Because the drug was available only through colon cancer trials, she was denied access.
She died in 2001 at age 21.
Ms. Burroughs’ father, Frank Burroughs, formed an organization that in 2003 sued the FDA to provide terminally ill patients access to unapproved drugs. In 2005, they lost, and subsequent attempts to appeal the decision failed.
Still, the case sparked a Right to Try movement.
“Right to Try laws swept the U.S. in a firestorm,” Ms. Tucker said.
Along with the federal law, which passed in 2018, 41 states have enacted Right to Try laws.
The movement intrigued Dr. Aggarwal, codirector of the Advanced Integrative Medical Science (AIMS) Institute in Seattle. Dr. Aggarwal had been treating patients with cannabis, and after taking psilocybin himself and finding it therapeutic, he thought Ms. Baldeschwiler could benefit.
“I always knew that the powerful medicines within Schedule I had a significant role to play in healing,” he said. “That was baked into my decision to become a doctor, to research, and to innovate.”
He applied for the right to cultivate psilocybin mushrooms, but the fungus doesn’t meet Right to Try requirements. He then found a manufacturer willing to supply synthesized psilocybin, but because it’s a Schedule I drug, the manufacturer needed an okay from the DEA.
Dr. Aggarwal joined forces with Ms. Tucker, who has spent 35 years protecting the rights of terminally ill patients. In January 2021, Ms. Tucker contacted the DEA about allowing dying patients, including Ms. Baldeschwiler and Mr. Bloom, to access psilocybin-assisted therapy.
The response, she said, was predictable.
“The DEA’s knee always jerks in the direction of no access,” Ms. Tucker said. “So it said ‘no access.’ “
The reason: In a letter dated February 2021, the DEA said it “has no authority to waive” any requirements of the Controlled Substances Act under Right to Try laws.
Suing the DEA
Dr. Aggarwal and Ms. Tucker did not accept the DEA’s “no access” answer.
They decided to sue.
Dr. Aggarwal and Ms. Tucker took the matter to the Ninth Circuit Court in March 2021. In January 2022, the court dismissed the case after the DEA claimed its initial denial was not final.
The following month, the plaintiffs petitioned the DEA to deliver a concrete answer.
In May, while waiting for a response, demonstrators gathered at the DEA’s headquarters to call for legal access to psilocybin. One of the protesters was Ms. Baldeschwiler, who choked back tears as she told the crowd she was likely missing her last Mother’s Day with her children to attend the event. She was arrested, along with 16 other people.
In late June, the DEA provided its final answer: No access.
In a letter addressed to Ms. Tucker, Thomas W. Prevoznik, the DEA’s deputy assistant administrator, said it “finds no basis” to reconsider its initial denial in February 2021 “because the legal and factual considerations remain unchanged.”
In an appeal, Ms. Tucker wrote: “In denying Petitioners’ requested accommodation in the Final Agency Action, DEA hides behind a smokescreen, neglecting its duty to implement the federal [Right to Try Act] and violating the state [Right to Try law].”
The government’s response is due in January 2023.
Ms. Tucker and her legal team also petitioned the DEA on behalf of Dr. Aggarwal to reschedule psilocybin from Schedule I to Schedule II.
The DEA defines Schedule I substances as “drugs with no currently accepted medical use and a high potential for abuse.” But the FDA has designated psilocybin as a breakthrough therapy for depression, which, Ms. Tucker noted, “reflects that there is a currently accepted medical use.”
Nevertheless, in September, the DEA denied Ms. Tucker’s petition to reschedule psilocybin, and her team is now petitioning the Ninth Circuit Court for a review of that decision.
Despite the setbacks, actions from the Biden administration and members of Congress could help improve access.
In July, Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act to clarify that the federal law includes Schedule I substances. If passed, Ms. Tucker said, it would negate the DEA’s “no access” argument.
And earlier this year, the Biden administration announced plans to establish a federal task force to address the “myriad of complex issues” associated with the anticipated FDA approval of psilocybin to treat depression. The task force will explore “the potential of psychedelic-assisted therapies” to tackle the mental health crisis as well as any “risks to public health” that “may require harm reduction, risk mitigation, and safety monitoring.”
The fight north of the border
In 2016, Canadian resident Thomas Hartle, then 48, awoke from surgery for a bowel obstruction to learn he had stage IV colon cancer.
After another surgery, his doctors believed the tumors were gone. But in 2019, the cancer came back, along with extreme anxiety and distress over his impending death and how his two special-needs children would cope.
Mr. Hartle wanted to try magic mushroom–assisted psychotherapy. The Saskatoon resident sought help from TheraPsil, a Canadian nonprofit organization that advocates for therapeutic psilocybin. They applied for access under Section 56, which allows health officials to exempt patients from certain provisions of drug law.
In 2020, Hartle became the first Canadian to legally obtain psilocybin-assisted therapy.
“It has been nothing short of life changing for me,” Mr. Hartle said at a palliative care conference in Saskatoon this past June. “I am now no longer actively dying. I feel like I am genuinely actively living.”
TheraPsil has obtained Section 56 exemptions for around 60 patients to access psilocybin-assisted therapy as well as 19 health care professionals who are training to become psilocybin-assisted therapists.
But then an election ushered in new health ministers, and in early 2022, the exemptions evaporated. Thousands of patients and health care practitioners on TheraPsil’s waiting list were left in limbo.
Health Canada told CBC News that the rule change came about because “while psilocybin has shown promise in clinical trials for the treatment of some indications, further research is still needed to determine its safety and efficacy.”
As an alternative, TheraPsil began applying for access under Canada’s Special Access Program, which is similar to Right to Try laws in the United States. But Canada’s program doesn’t apply to therapists in training, and the petition process is so slow that many patients die before requests can be approved.
“People like to pretend that the Special Access Program is not political, but it is very political,” said TheraPsil’s CEO, Spencer Hawkswell. “It means a patient and a doctor are asking a politician for access to their medicine, which is absolutely unacceptable.”
Now, TheraPsil is helping patients take the Canadian government to court. In July, Mr. Hartle and seven others with conditions ranging from cancer to chronic pain filed a lawsuit against Canada’s health ministry that challenges the limited legal pathways to the use of psilocybin. The lawsuit argues that patients have a “constitutional right to access psilocybin for medicinal purposes,” and it advocates for access to regulated psilocybin products from licensed dealers, much like Canada’s medical marijuana program already does.
In the filing, TheraPsil said that as of February 2022, it has a wait-list of more than 800 patients who are requesting help in obtaining psilocybin-assisted psychotherapy.
An uncertain future
Despite the groundswell of support, many unknowns remain about the safety of expanding access to psilocybin-assisted therapy.
When Oregon and Colorado launch their psilocybin programs in 2023, the licensed centers will provide testing grounds for the safety and efficacy of broader access to psilocybin for people with depression or terminal cancer as well as those looking to grow spiritually.
Although in clinical trials psilocybin has been found to ease symptoms of depression and end-of-life demoralization for people with life-threatening conditions, it has not been adequately tested in people with a range of mental health problems, traumas, and racial backgrounds.
That uncertainty has given some people pause. In recent months, some researchers and journalists have pushed back against the frenzy over the promise of psychedelics.
In September, David Yaden, PhD, a psychedelics researcher at Johns Hopkins, spoke at the Interdisciplinary Conference on Psychedelic Research in the Netherlands. He encouraged people to pay more attention to potential adverse effects of psychedelics, which could include anything from headaches to lingering dysphoria.
“Oftentimes, we hear only the positive anecdotes,” Dr. Yaden said. “We don’t hear ... neutral or negative ones. So, I think all of those anecdotes need to be part of the picture.”
A recent piece in Wired noted that mentioning the potential harms of psychedelics amid its renaissance has been “taboo,” but the authors cautioned that as clinical trials involving psychedelics grow larger and the drugs become commercialized, “more negative outcomes are likely to transpire.”
But Ms. Baldeschwiler remains steadfast in her pursuit. While it’s important to approach broader access to psychedelics with caution, “end-of-life patients don’t have time to wait,” she said.
A version of this article first appeared on Medscape.com.
In March 2020, when the world was struck by the news of the COVID-19 pandemic, Erinn Baldeschwiler received her own gut punch. She was diagnosed with stage IV metastatic breast cancer and was given about 2 years to live.
Then 48, the mother of two teenagers had just started a new chapter in her life. She’d gotten divorced, moved to a new home, and left a small business she had spent 18 years cultivating. The prospect that her life story might soon be ending, that she wouldn’t see her children grow up, was a twist of fate almost too devastating to bear.
“Are you kidding me that this is happening?” she thought.
But she also wanted to keep learning and growing in her remaining years, to devote them to creating meaningful memories, contemplating her mortality, and trying to find inner peace.
“The last 2 years have kind of been this dance with Lady Death,” she said.
They have also been a dance with Lady Justice.
In March 2021, Ms. Baldeschwiler, along with Michal Bloom, who also has terminal cancer, and their palliative care physician, Sunil Aggarwal, MD, PhD, decided to sue the Drug Enforcement Administration (DEA) for the right to access psilocybin, the psychoactive ingredient in “magic” mushrooms.
Psilocybin-assisted therapy has been shown to help terminally ill people overcome their fear, anxiety, and despair about death and to experience the kind of peace Ms. Baldeschwiler is seeking.
Psilocybin is illegal in the United States, but the plaintiffs argue they should be able to take the substance through the Right to Try Act. The 2018 federal law says that people with life-threatening conditions who have exhausted all approved treatment options can access drugs that have not yet been approved by the Food and Drug Administration but have passed phase 1 clinical trials.
This case marks the first time patients have fought to use a Schedule I drug under the Right to Try Act.
The push to expand access to psilocybin is picking up steam in the United States. In 2023, facilitated use of psilocybin will become legal in Oregon and Colorado. Recent proposals from the Biden administration and members of Congress could make psilocybin more widely accessible in the next few years.
It is also gaining momentum outside the United States. In Canada, patients are suing the government to help patients obtain psilocybin-assisted therapy for medical purposes.
“I think what we have here is a confluence of events that are driving toward the mandatory opening of a path to access psilocybin for therapeutic use sooner rather than later,” said Kathryn Tucker, lead counsel in the case against the DEA.
Reverberations of Right to Try
The story of Right to Try began with Abigail Burroughs, who was diagnosed with head and neck cancer at age 19.
After conventional therapies failed, Ms. Burroughs’ oncologist recommended cetuximab, a drug targeting EGFR that was experimental at the time. Because the drug was available only through colon cancer trials, she was denied access.
She died in 2001 at age 21.
Ms. Burroughs’ father, Frank Burroughs, formed an organization that in 2003 sued the FDA to provide terminally ill patients access to unapproved drugs. In 2005, they lost, and subsequent attempts to appeal the decision failed.
Still, the case sparked a Right to Try movement.
“Right to Try laws swept the U.S. in a firestorm,” Ms. Tucker said.
Along with the federal law, which passed in 2018, 41 states have enacted Right to Try laws.
The movement intrigued Dr. Aggarwal, codirector of the Advanced Integrative Medical Science (AIMS) Institute in Seattle. Dr. Aggarwal had been treating patients with cannabis, and after taking psilocybin himself and finding it therapeutic, he thought Ms. Baldeschwiler could benefit.
“I always knew that the powerful medicines within Schedule I had a significant role to play in healing,” he said. “That was baked into my decision to become a doctor, to research, and to innovate.”
He applied for the right to cultivate psilocybin mushrooms, but the fungus doesn’t meet Right to Try requirements. He then found a manufacturer willing to supply synthesized psilocybin, but because it’s a Schedule I drug, the manufacturer needed an okay from the DEA.
Dr. Aggarwal joined forces with Ms. Tucker, who has spent 35 years protecting the rights of terminally ill patients. In January 2021, Ms. Tucker contacted the DEA about allowing dying patients, including Ms. Baldeschwiler and Mr. Bloom, to access psilocybin-assisted therapy.
The response, she said, was predictable.
“The DEA’s knee always jerks in the direction of no access,” Ms. Tucker said. “So it said ‘no access.’ “
The reason: In a letter dated February 2021, the DEA said it “has no authority to waive” any requirements of the Controlled Substances Act under Right to Try laws.
Suing the DEA
Dr. Aggarwal and Ms. Tucker did not accept the DEA’s “no access” answer.
They decided to sue.
Dr. Aggarwal and Ms. Tucker took the matter to the Ninth Circuit Court in March 2021. In January 2022, the court dismissed the case after the DEA claimed its initial denial was not final.
The following month, the plaintiffs petitioned the DEA to deliver a concrete answer.
In May, while waiting for a response, demonstrators gathered at the DEA’s headquarters to call for legal access to psilocybin. One of the protesters was Ms. Baldeschwiler, who choked back tears as she told the crowd she was likely missing her last Mother’s Day with her children to attend the event. She was arrested, along with 16 other people.
In late June, the DEA provided its final answer: No access.
In a letter addressed to Ms. Tucker, Thomas W. Prevoznik, the DEA’s deputy assistant administrator, said it “finds no basis” to reconsider its initial denial in February 2021 “because the legal and factual considerations remain unchanged.”
In an appeal, Ms. Tucker wrote: “In denying Petitioners’ requested accommodation in the Final Agency Action, DEA hides behind a smokescreen, neglecting its duty to implement the federal [Right to Try Act] and violating the state [Right to Try law].”
The government’s response is due in January 2023.
Ms. Tucker and her legal team also petitioned the DEA on behalf of Dr. Aggarwal to reschedule psilocybin from Schedule I to Schedule II.
The DEA defines Schedule I substances as “drugs with no currently accepted medical use and a high potential for abuse.” But the FDA has designated psilocybin as a breakthrough therapy for depression, which, Ms. Tucker noted, “reflects that there is a currently accepted medical use.”
Nevertheless, in September, the DEA denied Ms. Tucker’s petition to reschedule psilocybin, and her team is now petitioning the Ninth Circuit Court for a review of that decision.
Despite the setbacks, actions from the Biden administration and members of Congress could help improve access.
In July, Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act to clarify that the federal law includes Schedule I substances. If passed, Ms. Tucker said, it would negate the DEA’s “no access” argument.
And earlier this year, the Biden administration announced plans to establish a federal task force to address the “myriad of complex issues” associated with the anticipated FDA approval of psilocybin to treat depression. The task force will explore “the potential of psychedelic-assisted therapies” to tackle the mental health crisis as well as any “risks to public health” that “may require harm reduction, risk mitigation, and safety monitoring.”
The fight north of the border
In 2016, Canadian resident Thomas Hartle, then 48, awoke from surgery for a bowel obstruction to learn he had stage IV colon cancer.
After another surgery, his doctors believed the tumors were gone. But in 2019, the cancer came back, along with extreme anxiety and distress over his impending death and how his two special-needs children would cope.
Mr. Hartle wanted to try magic mushroom–assisted psychotherapy. The Saskatoon resident sought help from TheraPsil, a Canadian nonprofit organization that advocates for therapeutic psilocybin. They applied for access under Section 56, which allows health officials to exempt patients from certain provisions of drug law.
In 2020, Hartle became the first Canadian to legally obtain psilocybin-assisted therapy.
“It has been nothing short of life changing for me,” Mr. Hartle said at a palliative care conference in Saskatoon this past June. “I am now no longer actively dying. I feel like I am genuinely actively living.”
TheraPsil has obtained Section 56 exemptions for around 60 patients to access psilocybin-assisted therapy as well as 19 health care professionals who are training to become psilocybin-assisted therapists.
But then an election ushered in new health ministers, and in early 2022, the exemptions evaporated. Thousands of patients and health care practitioners on TheraPsil’s waiting list were left in limbo.
Health Canada told CBC News that the rule change came about because “while psilocybin has shown promise in clinical trials for the treatment of some indications, further research is still needed to determine its safety and efficacy.”
As an alternative, TheraPsil began applying for access under Canada’s Special Access Program, which is similar to Right to Try laws in the United States. But Canada’s program doesn’t apply to therapists in training, and the petition process is so slow that many patients die before requests can be approved.
“People like to pretend that the Special Access Program is not political, but it is very political,” said TheraPsil’s CEO, Spencer Hawkswell. “It means a patient and a doctor are asking a politician for access to their medicine, which is absolutely unacceptable.”
Now, TheraPsil is helping patients take the Canadian government to court. In July, Mr. Hartle and seven others with conditions ranging from cancer to chronic pain filed a lawsuit against Canada’s health ministry that challenges the limited legal pathways to the use of psilocybin. The lawsuit argues that patients have a “constitutional right to access psilocybin for medicinal purposes,” and it advocates for access to regulated psilocybin products from licensed dealers, much like Canada’s medical marijuana program already does.
In the filing, TheraPsil said that as of February 2022, it has a wait-list of more than 800 patients who are requesting help in obtaining psilocybin-assisted psychotherapy.
An uncertain future
Despite the groundswell of support, many unknowns remain about the safety of expanding access to psilocybin-assisted therapy.
When Oregon and Colorado launch their psilocybin programs in 2023, the licensed centers will provide testing grounds for the safety and efficacy of broader access to psilocybin for people with depression or terminal cancer as well as those looking to grow spiritually.
Although in clinical trials psilocybin has been found to ease symptoms of depression and end-of-life demoralization for people with life-threatening conditions, it has not been adequately tested in people with a range of mental health problems, traumas, and racial backgrounds.
That uncertainty has given some people pause. In recent months, some researchers and journalists have pushed back against the frenzy over the promise of psychedelics.
In September, David Yaden, PhD, a psychedelics researcher at Johns Hopkins, spoke at the Interdisciplinary Conference on Psychedelic Research in the Netherlands. He encouraged people to pay more attention to potential adverse effects of psychedelics, which could include anything from headaches to lingering dysphoria.
“Oftentimes, we hear only the positive anecdotes,” Dr. Yaden said. “We don’t hear ... neutral or negative ones. So, I think all of those anecdotes need to be part of the picture.”
A recent piece in Wired noted that mentioning the potential harms of psychedelics amid its renaissance has been “taboo,” but the authors cautioned that as clinical trials involving psychedelics grow larger and the drugs become commercialized, “more negative outcomes are likely to transpire.”
But Ms. Baldeschwiler remains steadfast in her pursuit. While it’s important to approach broader access to psychedelics with caution, “end-of-life patients don’t have time to wait,” she said.
A version of this article first appeared on Medscape.com.
Post-transplant diet: Gruel no longer rules
NEW ORLEANS – A new Italian study yields more evidence that stem-cell transplant patients need not lose their appetites along with their immune systems. Low-bacterial, gruel-like diets, once the mainstay of immunity-lowering surgeries, don’t actually provide any protection against infections, researchers reported.
University of Miami hematologist Mikkael A. Sekeres, MD, MS, expressed delight to hear these findings.
“Around the world, we should eliminate these silly neutropenic diets, let people eat what they want, and give them a much better quality of life while they’re in the hospital,” said Dr. Sekeres, moderator of the news briefing where these research results were discussed at the annual meeting of the American Society of Hematology.
In recent decades, physicians and nutritionists have questioned the value of low-bacterial/neutropenic menus, designed to protect people with compromised immune systems from germs in food. These diets can be quite strict, outlawing food such as deli, processed, and cured meats; yogurt; hummus; strawberries and raspberries; lettuce; raw nuts; certain kinds of seafood; and herbs and spices such as pepper, unless they were cooked. Patients may be urged to avoid salad bars, buffets, and potlucks.
MD Anderson Cancer Center pediatrician Karen Moody, MD, MS, who has studied the diet, said in an interview that the diet has been around since the 1970s, despite a lack of evidence supporting it. “Cancer patients often suffer from treatment-related side effects that affect taste, appetite, and tolerance of food,” she said. “Further restricting food options in this population can be burdensome and reduce diet-related satisfaction.”
For the new multi-center, phase 3 study, researchers led by hematology resident Federico Stella, MD, of the University of Milan, randomly assigned consecutive adult patients undergoing hematopoietic stem cells transplantation or high-dose induction chemotherapy to either a low-bacterial diet (n = 224) or a non-restrictive diet (n = 224).
The low-bacterial diet emphasized food cooked to at least 176 degrees Fahrenheit and thick-skinned fruit. Raw fruits/vegetables, yogurt, honey, cold cuts and sausages, and raw fish and meat were forbidden.
The two groups were similar in age (median = 56 years), gender (about 57% male), and reason for admission (97% stem-cell transplants and 3% high-dose chemotherapy). The plan was to follow the patients for 100 days (stem-cell transplant recipients) or 30 days (high-dose chemotherapy patients).
No statistically significant differences between the group were found in the rates of infections of higher than Grade 2 (per CTCAE 4.0): These infections occurred in 38 (34%) of those on the low-bacterial diet and 44 (39%) of those on the non-restrictive diet (P = 0.5).
There were also no statistically significant differences in rates of fever of unknown origin (P = 0.2), sepsis (P = 0.5), and gastrointestinal infection (P = 0.7).
The findings show that the “use of a restrictive diet is an unnecessary burden for our patients’ quality of life,” said study lead author Dr. Stella at the news briefing.
Dr. Sekeres, the news briefing moderator, noted that the findings reflect his own suspicions about the worthlessness of the low-bacterial diet. “I’ve never seen a patient die of an infection that was foodborne. So years ago, when I was still in Cleveland, I eliminated the neutropenic diet on the leukemia floor. That did face a lot of resistance, as you can imagine. There were decades of people saying we should do this.”
Now, Dr. Sekeres said, he feels validated. “I love this study because it formalizes what I thought was true,” he said.
Dr. Moody said it’s difficult to evaluate the study since it’s in abstract form, and details are limited. “However,” she said, “the sample size, study design, and outcomes appear very appropriate, and I think most likely the full-length study will provide additional evidence to support abandonment of the low-microbial diet in transplant patients.”
Also, Dr. Moody said, the study “replicates the same findings of other prospective randomized trials of this diet that say it confers no protection from infection and has no identified health benefit whatsoever. Bottom line? This diet has burden without benefit.”
Moving forward, she said, “we need a lot more research on diet in general for cancer patients. Recently, there is a lot more interest in this topic. I think we are going to learn a lot in the next few decades about the relationship between diet, epigenetics, the microbiome, and various cancer-related health issues.”
No study funding was reported. Dr. Stella reports no disclosures, and other authors report various relationships with industry. Dr. Moody reports no disclosures, and disclosures for Dr. Sekeres were not available.
NEW ORLEANS – A new Italian study yields more evidence that stem-cell transplant patients need not lose their appetites along with their immune systems. Low-bacterial, gruel-like diets, once the mainstay of immunity-lowering surgeries, don’t actually provide any protection against infections, researchers reported.
University of Miami hematologist Mikkael A. Sekeres, MD, MS, expressed delight to hear these findings.
“Around the world, we should eliminate these silly neutropenic diets, let people eat what they want, and give them a much better quality of life while they’re in the hospital,” said Dr. Sekeres, moderator of the news briefing where these research results were discussed at the annual meeting of the American Society of Hematology.
In recent decades, physicians and nutritionists have questioned the value of low-bacterial/neutropenic menus, designed to protect people with compromised immune systems from germs in food. These diets can be quite strict, outlawing food such as deli, processed, and cured meats; yogurt; hummus; strawberries and raspberries; lettuce; raw nuts; certain kinds of seafood; and herbs and spices such as pepper, unless they were cooked. Patients may be urged to avoid salad bars, buffets, and potlucks.
MD Anderson Cancer Center pediatrician Karen Moody, MD, MS, who has studied the diet, said in an interview that the diet has been around since the 1970s, despite a lack of evidence supporting it. “Cancer patients often suffer from treatment-related side effects that affect taste, appetite, and tolerance of food,” she said. “Further restricting food options in this population can be burdensome and reduce diet-related satisfaction.”
For the new multi-center, phase 3 study, researchers led by hematology resident Federico Stella, MD, of the University of Milan, randomly assigned consecutive adult patients undergoing hematopoietic stem cells transplantation or high-dose induction chemotherapy to either a low-bacterial diet (n = 224) or a non-restrictive diet (n = 224).
The low-bacterial diet emphasized food cooked to at least 176 degrees Fahrenheit and thick-skinned fruit. Raw fruits/vegetables, yogurt, honey, cold cuts and sausages, and raw fish and meat were forbidden.
The two groups were similar in age (median = 56 years), gender (about 57% male), and reason for admission (97% stem-cell transplants and 3% high-dose chemotherapy). The plan was to follow the patients for 100 days (stem-cell transplant recipients) or 30 days (high-dose chemotherapy patients).
No statistically significant differences between the group were found in the rates of infections of higher than Grade 2 (per CTCAE 4.0): These infections occurred in 38 (34%) of those on the low-bacterial diet and 44 (39%) of those on the non-restrictive diet (P = 0.5).
There were also no statistically significant differences in rates of fever of unknown origin (P = 0.2), sepsis (P = 0.5), and gastrointestinal infection (P = 0.7).
The findings show that the “use of a restrictive diet is an unnecessary burden for our patients’ quality of life,” said study lead author Dr. Stella at the news briefing.
Dr. Sekeres, the news briefing moderator, noted that the findings reflect his own suspicions about the worthlessness of the low-bacterial diet. “I’ve never seen a patient die of an infection that was foodborne. So years ago, when I was still in Cleveland, I eliminated the neutropenic diet on the leukemia floor. That did face a lot of resistance, as you can imagine. There were decades of people saying we should do this.”
Now, Dr. Sekeres said, he feels validated. “I love this study because it formalizes what I thought was true,” he said.
Dr. Moody said it’s difficult to evaluate the study since it’s in abstract form, and details are limited. “However,” she said, “the sample size, study design, and outcomes appear very appropriate, and I think most likely the full-length study will provide additional evidence to support abandonment of the low-microbial diet in transplant patients.”
Also, Dr. Moody said, the study “replicates the same findings of other prospective randomized trials of this diet that say it confers no protection from infection and has no identified health benefit whatsoever. Bottom line? This diet has burden without benefit.”
Moving forward, she said, “we need a lot more research on diet in general for cancer patients. Recently, there is a lot more interest in this topic. I think we are going to learn a lot in the next few decades about the relationship between diet, epigenetics, the microbiome, and various cancer-related health issues.”
No study funding was reported. Dr. Stella reports no disclosures, and other authors report various relationships with industry. Dr. Moody reports no disclosures, and disclosures for Dr. Sekeres were not available.
NEW ORLEANS – A new Italian study yields more evidence that stem-cell transplant patients need not lose their appetites along with their immune systems. Low-bacterial, gruel-like diets, once the mainstay of immunity-lowering surgeries, don’t actually provide any protection against infections, researchers reported.
University of Miami hematologist Mikkael A. Sekeres, MD, MS, expressed delight to hear these findings.
“Around the world, we should eliminate these silly neutropenic diets, let people eat what they want, and give them a much better quality of life while they’re in the hospital,” said Dr. Sekeres, moderator of the news briefing where these research results were discussed at the annual meeting of the American Society of Hematology.
In recent decades, physicians and nutritionists have questioned the value of low-bacterial/neutropenic menus, designed to protect people with compromised immune systems from germs in food. These diets can be quite strict, outlawing food such as deli, processed, and cured meats; yogurt; hummus; strawberries and raspberries; lettuce; raw nuts; certain kinds of seafood; and herbs and spices such as pepper, unless they were cooked. Patients may be urged to avoid salad bars, buffets, and potlucks.
MD Anderson Cancer Center pediatrician Karen Moody, MD, MS, who has studied the diet, said in an interview that the diet has been around since the 1970s, despite a lack of evidence supporting it. “Cancer patients often suffer from treatment-related side effects that affect taste, appetite, and tolerance of food,” she said. “Further restricting food options in this population can be burdensome and reduce diet-related satisfaction.”
For the new multi-center, phase 3 study, researchers led by hematology resident Federico Stella, MD, of the University of Milan, randomly assigned consecutive adult patients undergoing hematopoietic stem cells transplantation or high-dose induction chemotherapy to either a low-bacterial diet (n = 224) or a non-restrictive diet (n = 224).
The low-bacterial diet emphasized food cooked to at least 176 degrees Fahrenheit and thick-skinned fruit. Raw fruits/vegetables, yogurt, honey, cold cuts and sausages, and raw fish and meat were forbidden.
The two groups were similar in age (median = 56 years), gender (about 57% male), and reason for admission (97% stem-cell transplants and 3% high-dose chemotherapy). The plan was to follow the patients for 100 days (stem-cell transplant recipients) or 30 days (high-dose chemotherapy patients).
No statistically significant differences between the group were found in the rates of infections of higher than Grade 2 (per CTCAE 4.0): These infections occurred in 38 (34%) of those on the low-bacterial diet and 44 (39%) of those on the non-restrictive diet (P = 0.5).
There were also no statistically significant differences in rates of fever of unknown origin (P = 0.2), sepsis (P = 0.5), and gastrointestinal infection (P = 0.7).
The findings show that the “use of a restrictive diet is an unnecessary burden for our patients’ quality of life,” said study lead author Dr. Stella at the news briefing.
Dr. Sekeres, the news briefing moderator, noted that the findings reflect his own suspicions about the worthlessness of the low-bacterial diet. “I’ve never seen a patient die of an infection that was foodborne. So years ago, when I was still in Cleveland, I eliminated the neutropenic diet on the leukemia floor. That did face a lot of resistance, as you can imagine. There were decades of people saying we should do this.”
Now, Dr. Sekeres said, he feels validated. “I love this study because it formalizes what I thought was true,” he said.
Dr. Moody said it’s difficult to evaluate the study since it’s in abstract form, and details are limited. “However,” she said, “the sample size, study design, and outcomes appear very appropriate, and I think most likely the full-length study will provide additional evidence to support abandonment of the low-microbial diet in transplant patients.”
Also, Dr. Moody said, the study “replicates the same findings of other prospective randomized trials of this diet that say it confers no protection from infection and has no identified health benefit whatsoever. Bottom line? This diet has burden without benefit.”
Moving forward, she said, “we need a lot more research on diet in general for cancer patients. Recently, there is a lot more interest in this topic. I think we are going to learn a lot in the next few decades about the relationship between diet, epigenetics, the microbiome, and various cancer-related health issues.”
No study funding was reported. Dr. Stella reports no disclosures, and other authors report various relationships with industry. Dr. Moody reports no disclosures, and disclosures for Dr. Sekeres were not available.
AT ASH 2022
Poorly matched stem cell transplants linked to ancestry
There is “an intersectionality between ancestry and socioeconomic status and an association with donor type, with the most vulnerable patients” – those of non-European ancestry with low socioeconomic status (SES), especially people of African ancestry – “receiving the most complex [i.e., human leukocyte antigen (HLA)–disparate] transplants,” said lead investigator Warren Fingrut, MD, a research fellow in the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center, New York.
“Successful extension of transplant access to minority patients will be contingent on addressing [their] financial hardship,” said Dr. Fingrut, who presented the findings at the meeting.
To better channel support services and ensure that resources are available, he also noted that centers will have to do a better job of identifying patients with financial struggles.
“Household income data is not collected at our center, and neither is it collected at most centers,” hence assessments of SES are based on imperfect surrogates, such as neighborhood poverty by zip code. “Interventions to advance equity will require better SES classifications or detailed recording of household income,” Dr. Fingrut said.
Overall, the study highlights “inequities in the delivery of stem cell transplants,” pointing to opportunities “to improve access to this potentially curative treatment,” said hematologist/oncologist Chancellor Donald, MD, of Tulane University, New Orleans, who moderated the study presentation.
Dr. Donald said that the new research shows “how interactions between racial backgrounds and socioeconomic status relate to the type of allogenic stem cell transplant patients receive.” The team “identified that [people] of non-European ancestry and especially those of low SES, are more likely to receive the most specialized type of allogeneic stem cell transplantation, which notably require the highest level of care,” Dr. Donald said.
The investigators reviewed 372 consecutive adults transplanted at MSKCC from March 2020 to February 2022, mostly for myeloid malignancies.
Thirty-one percent of patients had non-European ancestry, including 11% of African, 9% of Asian, and 8% of White Hispanic descent.
With no information about household income, the team used neighborhood poverty (which affected 5% of patients); Medicaid as the primary insurance (6% of patients), and financial support for living and medical expenses (19%) as surrogates of lower SES. Classification depended largely on what criteria were used, with only 20 patients meeting two criteria and only one patient meeting all three.
Overall, more than half (58%) of non-European ancestry patients received HLA-disparate grafts, compared with 24% of people with European ancestry, including 48% of White Hispanic patients, 58% of Asian patients, and 78% of patients of African decent.
Markers of lower SES were more common among non-European patients. For instance, among people of European ancestry, 4% were on Medicaid and 15% were on financial aid, versus 10% on Medicaid and 29% on financial support among people of other ancestries. Medicaid use (12.5%) and financial aid (42.5%) were highest among patients of African descent.
Among patients who received HLA-disparate grafts, patients of non-European descent were three times more likely to be on Medicaid (12% versus 4%) and more than twice as likely to be on financial support (33% versus 15%).
People of African ancestry who received HLA-disparate grafts had the highest proportions of Medicaid reliance (16%) and financial support (45%).
There is “an intersectionality between ancestry and socioeconomic status and an association with donor type, with the most vulnerable patients” – those of non-European ancestry with low socioeconomic status (SES), especially people of African ancestry – “receiving the most complex [i.e., human leukocyte antigen (HLA)–disparate] transplants,” said lead investigator Warren Fingrut, MD, a research fellow in the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center, New York.
“Successful extension of transplant access to minority patients will be contingent on addressing [their] financial hardship,” said Dr. Fingrut, who presented the findings at the meeting.
To better channel support services and ensure that resources are available, he also noted that centers will have to do a better job of identifying patients with financial struggles.
“Household income data is not collected at our center, and neither is it collected at most centers,” hence assessments of SES are based on imperfect surrogates, such as neighborhood poverty by zip code. “Interventions to advance equity will require better SES classifications or detailed recording of household income,” Dr. Fingrut said.
Overall, the study highlights “inequities in the delivery of stem cell transplants,” pointing to opportunities “to improve access to this potentially curative treatment,” said hematologist/oncologist Chancellor Donald, MD, of Tulane University, New Orleans, who moderated the study presentation.
Dr. Donald said that the new research shows “how interactions between racial backgrounds and socioeconomic status relate to the type of allogenic stem cell transplant patients receive.” The team “identified that [people] of non-European ancestry and especially those of low SES, are more likely to receive the most specialized type of allogeneic stem cell transplantation, which notably require the highest level of care,” Dr. Donald said.
The investigators reviewed 372 consecutive adults transplanted at MSKCC from March 2020 to February 2022, mostly for myeloid malignancies.
Thirty-one percent of patients had non-European ancestry, including 11% of African, 9% of Asian, and 8% of White Hispanic descent.
With no information about household income, the team used neighborhood poverty (which affected 5% of patients); Medicaid as the primary insurance (6% of patients), and financial support for living and medical expenses (19%) as surrogates of lower SES. Classification depended largely on what criteria were used, with only 20 patients meeting two criteria and only one patient meeting all three.
Overall, more than half (58%) of non-European ancestry patients received HLA-disparate grafts, compared with 24% of people with European ancestry, including 48% of White Hispanic patients, 58% of Asian patients, and 78% of patients of African decent.
Markers of lower SES were more common among non-European patients. For instance, among people of European ancestry, 4% were on Medicaid and 15% were on financial aid, versus 10% on Medicaid and 29% on financial support among people of other ancestries. Medicaid use (12.5%) and financial aid (42.5%) were highest among patients of African descent.
Among patients who received HLA-disparate grafts, patients of non-European descent were three times more likely to be on Medicaid (12% versus 4%) and more than twice as likely to be on financial support (33% versus 15%).
People of African ancestry who received HLA-disparate grafts had the highest proportions of Medicaid reliance (16%) and financial support (45%).
There is “an intersectionality between ancestry and socioeconomic status and an association with donor type, with the most vulnerable patients” – those of non-European ancestry with low socioeconomic status (SES), especially people of African ancestry – “receiving the most complex [i.e., human leukocyte antigen (HLA)–disparate] transplants,” said lead investigator Warren Fingrut, MD, a research fellow in the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center, New York.
“Successful extension of transplant access to minority patients will be contingent on addressing [their] financial hardship,” said Dr. Fingrut, who presented the findings at the meeting.
To better channel support services and ensure that resources are available, he also noted that centers will have to do a better job of identifying patients with financial struggles.
“Household income data is not collected at our center, and neither is it collected at most centers,” hence assessments of SES are based on imperfect surrogates, such as neighborhood poverty by zip code. “Interventions to advance equity will require better SES classifications or detailed recording of household income,” Dr. Fingrut said.
Overall, the study highlights “inequities in the delivery of stem cell transplants,” pointing to opportunities “to improve access to this potentially curative treatment,” said hematologist/oncologist Chancellor Donald, MD, of Tulane University, New Orleans, who moderated the study presentation.
Dr. Donald said that the new research shows “how interactions between racial backgrounds and socioeconomic status relate to the type of allogenic stem cell transplant patients receive.” The team “identified that [people] of non-European ancestry and especially those of low SES, are more likely to receive the most specialized type of allogeneic stem cell transplantation, which notably require the highest level of care,” Dr. Donald said.
The investigators reviewed 372 consecutive adults transplanted at MSKCC from March 2020 to February 2022, mostly for myeloid malignancies.
Thirty-one percent of patients had non-European ancestry, including 11% of African, 9% of Asian, and 8% of White Hispanic descent.
With no information about household income, the team used neighborhood poverty (which affected 5% of patients); Medicaid as the primary insurance (6% of patients), and financial support for living and medical expenses (19%) as surrogates of lower SES. Classification depended largely on what criteria were used, with only 20 patients meeting two criteria and only one patient meeting all three.
Overall, more than half (58%) of non-European ancestry patients received HLA-disparate grafts, compared with 24% of people with European ancestry, including 48% of White Hispanic patients, 58% of Asian patients, and 78% of patients of African decent.
Markers of lower SES were more common among non-European patients. For instance, among people of European ancestry, 4% were on Medicaid and 15% were on financial aid, versus 10% on Medicaid and 29% on financial support among people of other ancestries. Medicaid use (12.5%) and financial aid (42.5%) were highest among patients of African descent.
Among patients who received HLA-disparate grafts, patients of non-European descent were three times more likely to be on Medicaid (12% versus 4%) and more than twice as likely to be on financial support (33% versus 15%).
People of African ancestry who received HLA-disparate grafts had the highest proportions of Medicaid reliance (16%) and financial support (45%).
FROM ASH 2022
ASH 2022: New clinical data challenge long-held assumptions
The conference starts in New Orleans on Saturday, Dec. 10, , but a sample of what is to come was given last week in a preview media briefing, moderated by Mikkael A. Sekeres, MD, from the University of Miami. Dr. Sekeres, who recently authored a book on the FDA and how it regulates drug approvals, also serves as chair of the ASH Committee on Communications.
“Feeding Our Patients Gruel”
Dr. Sekeres expressed particular excitement about a multicenter randomized trial done in Italy. It showed that patients who have neutropenia after a stem cell transplant need not be required to eat a bland diet (Abstract 169).
“We for years have been essentially feeding our patients gruel in the hospital, and these are folks who have to be hospitalized for a stem cell transplant or in my case – I’m a leukemia specialist – for acute leukemia, for 4-6 weeks. The neutropenic diet consists of the blandest food you can imagine, with nothing to really spice it up.”
He noted that a neutropenic diet is so unpalatable that family members often sneak food into patient rooms, and “for years we’ve never seen adverse outcomes in any of those folks who instead of having mashed potatoes and oatmeal ate a corned beef sandwich for dinner.”
Now, the results from this trial “actually give us license to finally allow patients to eat whatever they want,” Dr. Sekeres said.
Practice-changing data
ASH experts pointed to two more presentations that are expected to change clinical practice. These include the finding that high-dose methotrexate does not reduce the risk for central nervous system relapse in children with acute lymphoblastic leukemia and lymphoblastic lymphoma (Abstract 214).
Another new study that seems to defy conventional wisdom showed that in adults with relapsed or refractory acute myeloid leukemia, intensive chemotherapy in an effort to achieve remission before a stem cell transplant did not result in better outcomes, compared with sequential conditioning and immediate transplant (Abstract 4).
Premature aging in HL survivors
ASH President Jane N. Winter, MD, from Northwestern University, Chicago, who also spoke at the briefing, highlighted a study that followed adult survivors of pediatric Hodgkin lymphoma. This study, from St. Jude Children’s Research Hospital in Memphis and the Wilmot Cancer Institute at the University of Rochester (N.Y), found that these adult survivors are at significantly elevated risk for epigenetic age acceleration accompanied by neurocognitive deficits when compared with controls (Abstract 902).
“This is an area that is very near and dear to my heart,” she said. “Much of my career has focused on reducing the therapy to reduce the long-term consequences of treatments. Pediatricians have been very much wedded to very intensive therapies and tend to incorporate radiation more commonly in their treatment strategies for children than we do in adults.”
Dr. Winter noted that, although clinicians focus primarily on the link between mediastinal radiation and long-term adverse events such as breast cancer, “now we’re shedding a light on the neurocognitive deficits, which I think are underappreciated. Being able to screen for this impact of our treatment, and perhaps then develop strategies to deal with it or prevent it, will have very wide-ranging impact.”
Inherited thrombophilia and miscarriage
Cynthia E. Dunbar, MD, chief of the translational stem cell biology branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., who also spoke at the briefing, said that one of the abstracts most important to her practice is a study concerning pregnancy. It showed that low-molecular-weight heparin did not prevent miscarriage in pregnant women with confirmed inherited thrombophilia who had two or more prior pregnancy losses, compared with standard surveillance (Abstract LBA-5).
“This is not my field at all; on the other hand, as a hematologist and a woman, that’s what my emails in the middle of the night and my panicked phone calls are often about. Once somebody has one miscarriage, especially if they feel like they’re already over 30 and the clock is ticking, there’s a huge emphasis and a huge amount of pressure on obstetricians to basically work up for everything, kind of a shotgun [approach],” she said.
Those workups may reveal genetic mutations that are associated with mild elevations in risk for clotting. As a result, some pregnant women are put on anticoagulation therapy, which can cause complications for both pregnancy and delivery. These study findings don’t solve the problem of spontaneous pregnancy loss, but they at least rule out inherited thrombophilia as a preventable cause of miscarriages, Dr. Dunbar said.
Another potentially practice-changing abstract is a study showing that, in younger adults with mantle cell lymphoma, the addition of the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) to induction therapy and as maintenance with or without autologous stem cell transplant had strong efficacy and acceptable toxicity (Abstract 1).
“The results show that the ibrutinib-containing regimen without transplant is at least as good as the current standard of care with transplant.” Dr. Winter said. “Additional follow-up will be required to show definitively that an autotransplant is unnecessary if ibrutinib is included in this treatment regimen.”
A version of this article first appeared on Medscape.com.
The conference starts in New Orleans on Saturday, Dec. 10, , but a sample of what is to come was given last week in a preview media briefing, moderated by Mikkael A. Sekeres, MD, from the University of Miami. Dr. Sekeres, who recently authored a book on the FDA and how it regulates drug approvals, also serves as chair of the ASH Committee on Communications.
“Feeding Our Patients Gruel”
Dr. Sekeres expressed particular excitement about a multicenter randomized trial done in Italy. It showed that patients who have neutropenia after a stem cell transplant need not be required to eat a bland diet (Abstract 169).
“We for years have been essentially feeding our patients gruel in the hospital, and these are folks who have to be hospitalized for a stem cell transplant or in my case – I’m a leukemia specialist – for acute leukemia, for 4-6 weeks. The neutropenic diet consists of the blandest food you can imagine, with nothing to really spice it up.”
He noted that a neutropenic diet is so unpalatable that family members often sneak food into patient rooms, and “for years we’ve never seen adverse outcomes in any of those folks who instead of having mashed potatoes and oatmeal ate a corned beef sandwich for dinner.”
Now, the results from this trial “actually give us license to finally allow patients to eat whatever they want,” Dr. Sekeres said.
Practice-changing data
ASH experts pointed to two more presentations that are expected to change clinical practice. These include the finding that high-dose methotrexate does not reduce the risk for central nervous system relapse in children with acute lymphoblastic leukemia and lymphoblastic lymphoma (Abstract 214).
Another new study that seems to defy conventional wisdom showed that in adults with relapsed or refractory acute myeloid leukemia, intensive chemotherapy in an effort to achieve remission before a stem cell transplant did not result in better outcomes, compared with sequential conditioning and immediate transplant (Abstract 4).
Premature aging in HL survivors
ASH President Jane N. Winter, MD, from Northwestern University, Chicago, who also spoke at the briefing, highlighted a study that followed adult survivors of pediatric Hodgkin lymphoma. This study, from St. Jude Children’s Research Hospital in Memphis and the Wilmot Cancer Institute at the University of Rochester (N.Y), found that these adult survivors are at significantly elevated risk for epigenetic age acceleration accompanied by neurocognitive deficits when compared with controls (Abstract 902).
“This is an area that is very near and dear to my heart,” she said. “Much of my career has focused on reducing the therapy to reduce the long-term consequences of treatments. Pediatricians have been very much wedded to very intensive therapies and tend to incorporate radiation more commonly in their treatment strategies for children than we do in adults.”
Dr. Winter noted that, although clinicians focus primarily on the link between mediastinal radiation and long-term adverse events such as breast cancer, “now we’re shedding a light on the neurocognitive deficits, which I think are underappreciated. Being able to screen for this impact of our treatment, and perhaps then develop strategies to deal with it or prevent it, will have very wide-ranging impact.”
Inherited thrombophilia and miscarriage
Cynthia E. Dunbar, MD, chief of the translational stem cell biology branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., who also spoke at the briefing, said that one of the abstracts most important to her practice is a study concerning pregnancy. It showed that low-molecular-weight heparin did not prevent miscarriage in pregnant women with confirmed inherited thrombophilia who had two or more prior pregnancy losses, compared with standard surveillance (Abstract LBA-5).
“This is not my field at all; on the other hand, as a hematologist and a woman, that’s what my emails in the middle of the night and my panicked phone calls are often about. Once somebody has one miscarriage, especially if they feel like they’re already over 30 and the clock is ticking, there’s a huge emphasis and a huge amount of pressure on obstetricians to basically work up for everything, kind of a shotgun [approach],” she said.
Those workups may reveal genetic mutations that are associated with mild elevations in risk for clotting. As a result, some pregnant women are put on anticoagulation therapy, which can cause complications for both pregnancy and delivery. These study findings don’t solve the problem of spontaneous pregnancy loss, but they at least rule out inherited thrombophilia as a preventable cause of miscarriages, Dr. Dunbar said.
Another potentially practice-changing abstract is a study showing that, in younger adults with mantle cell lymphoma, the addition of the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) to induction therapy and as maintenance with or without autologous stem cell transplant had strong efficacy and acceptable toxicity (Abstract 1).
“The results show that the ibrutinib-containing regimen without transplant is at least as good as the current standard of care with transplant.” Dr. Winter said. “Additional follow-up will be required to show definitively that an autotransplant is unnecessary if ibrutinib is included in this treatment regimen.”
A version of this article first appeared on Medscape.com.
The conference starts in New Orleans on Saturday, Dec. 10, , but a sample of what is to come was given last week in a preview media briefing, moderated by Mikkael A. Sekeres, MD, from the University of Miami. Dr. Sekeres, who recently authored a book on the FDA and how it regulates drug approvals, also serves as chair of the ASH Committee on Communications.
“Feeding Our Patients Gruel”
Dr. Sekeres expressed particular excitement about a multicenter randomized trial done in Italy. It showed that patients who have neutropenia after a stem cell transplant need not be required to eat a bland diet (Abstract 169).
“We for years have been essentially feeding our patients gruel in the hospital, and these are folks who have to be hospitalized for a stem cell transplant or in my case – I’m a leukemia specialist – for acute leukemia, for 4-6 weeks. The neutropenic diet consists of the blandest food you can imagine, with nothing to really spice it up.”
He noted that a neutropenic diet is so unpalatable that family members often sneak food into patient rooms, and “for years we’ve never seen adverse outcomes in any of those folks who instead of having mashed potatoes and oatmeal ate a corned beef sandwich for dinner.”
Now, the results from this trial “actually give us license to finally allow patients to eat whatever they want,” Dr. Sekeres said.
Practice-changing data
ASH experts pointed to two more presentations that are expected to change clinical practice. These include the finding that high-dose methotrexate does not reduce the risk for central nervous system relapse in children with acute lymphoblastic leukemia and lymphoblastic lymphoma (Abstract 214).
Another new study that seems to defy conventional wisdom showed that in adults with relapsed or refractory acute myeloid leukemia, intensive chemotherapy in an effort to achieve remission before a stem cell transplant did not result in better outcomes, compared with sequential conditioning and immediate transplant (Abstract 4).
Premature aging in HL survivors
ASH President Jane N. Winter, MD, from Northwestern University, Chicago, who also spoke at the briefing, highlighted a study that followed adult survivors of pediatric Hodgkin lymphoma. This study, from St. Jude Children’s Research Hospital in Memphis and the Wilmot Cancer Institute at the University of Rochester (N.Y), found that these adult survivors are at significantly elevated risk for epigenetic age acceleration accompanied by neurocognitive deficits when compared with controls (Abstract 902).
“This is an area that is very near and dear to my heart,” she said. “Much of my career has focused on reducing the therapy to reduce the long-term consequences of treatments. Pediatricians have been very much wedded to very intensive therapies and tend to incorporate radiation more commonly in their treatment strategies for children than we do in adults.”
Dr. Winter noted that, although clinicians focus primarily on the link between mediastinal radiation and long-term adverse events such as breast cancer, “now we’re shedding a light on the neurocognitive deficits, which I think are underappreciated. Being able to screen for this impact of our treatment, and perhaps then develop strategies to deal with it or prevent it, will have very wide-ranging impact.”
Inherited thrombophilia and miscarriage
Cynthia E. Dunbar, MD, chief of the translational stem cell biology branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., who also spoke at the briefing, said that one of the abstracts most important to her practice is a study concerning pregnancy. It showed that low-molecular-weight heparin did not prevent miscarriage in pregnant women with confirmed inherited thrombophilia who had two or more prior pregnancy losses, compared with standard surveillance (Abstract LBA-5).
“This is not my field at all; on the other hand, as a hematologist and a woman, that’s what my emails in the middle of the night and my panicked phone calls are often about. Once somebody has one miscarriage, especially if they feel like they’re already over 30 and the clock is ticking, there’s a huge emphasis and a huge amount of pressure on obstetricians to basically work up for everything, kind of a shotgun [approach],” she said.
Those workups may reveal genetic mutations that are associated with mild elevations in risk for clotting. As a result, some pregnant women are put on anticoagulation therapy, which can cause complications for both pregnancy and delivery. These study findings don’t solve the problem of spontaneous pregnancy loss, but they at least rule out inherited thrombophilia as a preventable cause of miscarriages, Dr. Dunbar said.
Another potentially practice-changing abstract is a study showing that, in younger adults with mantle cell lymphoma, the addition of the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) to induction therapy and as maintenance with or without autologous stem cell transplant had strong efficacy and acceptable toxicity (Abstract 1).
“The results show that the ibrutinib-containing regimen without transplant is at least as good as the current standard of care with transplant.” Dr. Winter said. “Additional follow-up will be required to show definitively that an autotransplant is unnecessary if ibrutinib is included in this treatment regimen.”
A version of this article first appeared on Medscape.com.
FROM ASH 2022
Diagnosed too late
It had only been 3 weeks since I first met this patient. She presented with an advanced case of colon cancer, but instead of treatment,
Within the course of 2 weeks I saw another new patient, but this time with pancreatic cancer that metastasized to the liver. “When can we start treatment?” he asked. Like my female patient with colon cancer, he was diagnosed too late as he was already in an incurable stage. He was shocked to learn that his condition was in stage 4, that achieving remission would be difficult and a cure, not likely. Certainly, standard of care treatments and clinical trials offered him hope, but they were unlikely to change the outcome.
We take a course in this – that is, in giving bad news, but every doctor has his or her own approach. Some are so uncomfortable with the talk, they choose avoidance and adopt the “look like you gotta go approach.” Or, the doctor may schedule another treatment or another test with the intention of avoiding end-of-life discussions. Other doctors opt for straight talk: “I think you should get your affairs in order. You’ve got 3 months to live.” These are extreme behaviors I wouldn’t recommend.
In my practice, I sit with my patients and explain the diagnosis. After discussing all options and the advanced stage and diagnosis, it ultimately comes down to “Win or lose, I will be here to take care of you.” Sometimes there is therapy that may help, but either way, the patient understands that death is a real possibility.
I find that people just want to know if there is hope. A different treatment regimen or a clinical trial may (or may not) extend their life. And while we cannot predict outcomes, we can give them hope. You can’t shut down hope. True for some people the cup is always half empty, but most people want to live and are optimistic no matter how small the chances are.
These conversations are very difficult. I don’t like them, but then I don’t avoid them either. Fortunately, patients don’t usually come to my office for the first visit presenting with advanced disease. In the cases I described above, one patient had been experiencing unexplained weight loss, but didn’t share it with a physician. And, for the patient with pancreatic cancer, other than some discomfort in the last couple of weeks, the disease was not associated with other symptoms. But the absence of symptoms should not in any way rule out a malignant disease. A diagnosis should be based on a complete evaluation of signs and symptoms followed by testing.
We’ve got to be able to take the time to listen to our patients during these encounters. We may not spend as much time as we should because we’re so busy now and we’re slaves to EMRs. It helps if we take more time to probe symptoms a little longer, especially in the primary care setting.
It is possible for a patient with cancer to be asymptomatic up until the later stages of the disease. A study published in ESMO Open in 2020 found that fewer than half of patients with stage 4 non–small cell lung cancer have only one or two symptoms at diagnosis regardless of whether the patient was a smoker. In this study only 33% of patients reported having a cough and 25% had chest pain.
A study presented in October at the United European Gastroenterology Week found that of 600 pancreatic cancer cases, 46 of these were not detected by CT or MRI conducted 3-18 months prior to diagnosis. Of the 46 cases, 26% were not picked up by the radiologist and the rest were largely as a result of imaging changes over time. Radiology techniques are good, but they cannot pick up lesions that are too small. And some lesions, particularly in pancreatic cancer, can grow and metastasize rather quickly.
When a patient is diagnosed with advanced disease, it is most often simply because of the nature of the disease. But sometimes patients put off scheduling a doctor visit because of fear of the potential for bad news or fear of the doctor belittling their symptoms. Some tell me they were “just hoping the symptoms would disappear.” Waiting too long to see a doctor is never a good idea because timing is crucial. In many cases, there is a small window of opportunity to treat disease if remission is to be achieved.
Dr. Henry is a practicing clinical oncologist with PennMedicine in Philadelphia where he also serves as Vice Chair of the Department of Medicine at Pennsylvania Hospital.
This article was updated 12/7/22.
It had only been 3 weeks since I first met this patient. She presented with an advanced case of colon cancer, but instead of treatment,
Within the course of 2 weeks I saw another new patient, but this time with pancreatic cancer that metastasized to the liver. “When can we start treatment?” he asked. Like my female patient with colon cancer, he was diagnosed too late as he was already in an incurable stage. He was shocked to learn that his condition was in stage 4, that achieving remission would be difficult and a cure, not likely. Certainly, standard of care treatments and clinical trials offered him hope, but they were unlikely to change the outcome.
We take a course in this – that is, in giving bad news, but every doctor has his or her own approach. Some are so uncomfortable with the talk, they choose avoidance and adopt the “look like you gotta go approach.” Or, the doctor may schedule another treatment or another test with the intention of avoiding end-of-life discussions. Other doctors opt for straight talk: “I think you should get your affairs in order. You’ve got 3 months to live.” These are extreme behaviors I wouldn’t recommend.
In my practice, I sit with my patients and explain the diagnosis. After discussing all options and the advanced stage and diagnosis, it ultimately comes down to “Win or lose, I will be here to take care of you.” Sometimes there is therapy that may help, but either way, the patient understands that death is a real possibility.
I find that people just want to know if there is hope. A different treatment regimen or a clinical trial may (or may not) extend their life. And while we cannot predict outcomes, we can give them hope. You can’t shut down hope. True for some people the cup is always half empty, but most people want to live and are optimistic no matter how small the chances are.
These conversations are very difficult. I don’t like them, but then I don’t avoid them either. Fortunately, patients don’t usually come to my office for the first visit presenting with advanced disease. In the cases I described above, one patient had been experiencing unexplained weight loss, but didn’t share it with a physician. And, for the patient with pancreatic cancer, other than some discomfort in the last couple of weeks, the disease was not associated with other symptoms. But the absence of symptoms should not in any way rule out a malignant disease. A diagnosis should be based on a complete evaluation of signs and symptoms followed by testing.
We’ve got to be able to take the time to listen to our patients during these encounters. We may not spend as much time as we should because we’re so busy now and we’re slaves to EMRs. It helps if we take more time to probe symptoms a little longer, especially in the primary care setting.
It is possible for a patient with cancer to be asymptomatic up until the later stages of the disease. A study published in ESMO Open in 2020 found that fewer than half of patients with stage 4 non–small cell lung cancer have only one or two symptoms at diagnosis regardless of whether the patient was a smoker. In this study only 33% of patients reported having a cough and 25% had chest pain.
A study presented in October at the United European Gastroenterology Week found that of 600 pancreatic cancer cases, 46 of these were not detected by CT or MRI conducted 3-18 months prior to diagnosis. Of the 46 cases, 26% were not picked up by the radiologist and the rest were largely as a result of imaging changes over time. Radiology techniques are good, but they cannot pick up lesions that are too small. And some lesions, particularly in pancreatic cancer, can grow and metastasize rather quickly.
When a patient is diagnosed with advanced disease, it is most often simply because of the nature of the disease. But sometimes patients put off scheduling a doctor visit because of fear of the potential for bad news or fear of the doctor belittling their symptoms. Some tell me they were “just hoping the symptoms would disappear.” Waiting too long to see a doctor is never a good idea because timing is crucial. In many cases, there is a small window of opportunity to treat disease if remission is to be achieved.
Dr. Henry is a practicing clinical oncologist with PennMedicine in Philadelphia where he also serves as Vice Chair of the Department of Medicine at Pennsylvania Hospital.
This article was updated 12/7/22.
It had only been 3 weeks since I first met this patient. She presented with an advanced case of colon cancer, but instead of treatment,
Within the course of 2 weeks I saw another new patient, but this time with pancreatic cancer that metastasized to the liver. “When can we start treatment?” he asked. Like my female patient with colon cancer, he was diagnosed too late as he was already in an incurable stage. He was shocked to learn that his condition was in stage 4, that achieving remission would be difficult and a cure, not likely. Certainly, standard of care treatments and clinical trials offered him hope, but they were unlikely to change the outcome.
We take a course in this – that is, in giving bad news, but every doctor has his or her own approach. Some are so uncomfortable with the talk, they choose avoidance and adopt the “look like you gotta go approach.” Or, the doctor may schedule another treatment or another test with the intention of avoiding end-of-life discussions. Other doctors opt for straight talk: “I think you should get your affairs in order. You’ve got 3 months to live.” These are extreme behaviors I wouldn’t recommend.
In my practice, I sit with my patients and explain the diagnosis. After discussing all options and the advanced stage and diagnosis, it ultimately comes down to “Win or lose, I will be here to take care of you.” Sometimes there is therapy that may help, but either way, the patient understands that death is a real possibility.
I find that people just want to know if there is hope. A different treatment regimen or a clinical trial may (or may not) extend their life. And while we cannot predict outcomes, we can give them hope. You can’t shut down hope. True for some people the cup is always half empty, but most people want to live and are optimistic no matter how small the chances are.
These conversations are very difficult. I don’t like them, but then I don’t avoid them either. Fortunately, patients don’t usually come to my office for the first visit presenting with advanced disease. In the cases I described above, one patient had been experiencing unexplained weight loss, but didn’t share it with a physician. And, for the patient with pancreatic cancer, other than some discomfort in the last couple of weeks, the disease was not associated with other symptoms. But the absence of symptoms should not in any way rule out a malignant disease. A diagnosis should be based on a complete evaluation of signs and symptoms followed by testing.
We’ve got to be able to take the time to listen to our patients during these encounters. We may not spend as much time as we should because we’re so busy now and we’re slaves to EMRs. It helps if we take more time to probe symptoms a little longer, especially in the primary care setting.
It is possible for a patient with cancer to be asymptomatic up until the later stages of the disease. A study published in ESMO Open in 2020 found that fewer than half of patients with stage 4 non–small cell lung cancer have only one or two symptoms at diagnosis regardless of whether the patient was a smoker. In this study only 33% of patients reported having a cough and 25% had chest pain.
A study presented in October at the United European Gastroenterology Week found that of 600 pancreatic cancer cases, 46 of these were not detected by CT or MRI conducted 3-18 months prior to diagnosis. Of the 46 cases, 26% were not picked up by the radiologist and the rest were largely as a result of imaging changes over time. Radiology techniques are good, but they cannot pick up lesions that are too small. And some lesions, particularly in pancreatic cancer, can grow and metastasize rather quickly.
When a patient is diagnosed with advanced disease, it is most often simply because of the nature of the disease. But sometimes patients put off scheduling a doctor visit because of fear of the potential for bad news or fear of the doctor belittling their symptoms. Some tell me they were “just hoping the symptoms would disappear.” Waiting too long to see a doctor is never a good idea because timing is crucial. In many cases, there is a small window of opportunity to treat disease if remission is to be achieved.
Dr. Henry is a practicing clinical oncologist with PennMedicine in Philadelphia where he also serves as Vice Chair of the Department of Medicine at Pennsylvania Hospital.
This article was updated 12/7/22.