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Immunotherapy-related toxicities may be more common than reported in trials
SAN DIEGO – Certain immune-related adverse events related to PD1/PD-L1 treatment of patients with non–small cell lung cancer (NSCLC) may be more common than reported in clinical trials, a recent analysis of administrative claims data suggests.
Pneumonitis was seen in 10.9% of patients up to 60 days after the last dose of immunotherapy, according to the analysis of data from a large, U.S. commercial insurance database, presented at the Palliative and Supportive Care in Oncology Symposium.
By comparison, pneumonitis was reported in just 5.8% of NSCLC patients during treatment with the PD-1 (programmed cell death-1) inhibitor pembrolizumab in KEYNOTE-024, a pivotal randomized phase 3 clinical trial, said Elizabeth Jane Cathcart-Rake, MD, senior study author and an oncology fellow at the Mayo Clinic, Rochester, Minn.
Rates of immune-related adverse events in this study were generally higher than in clinical trials, both for common side effects and more rare conditions such as hypophysitis, according to Dr. Cathcart-Rake.
These new claims-based data might be considered complementary to clinical trial data, the researcher said.
“Together, they may give us a better sense of the broader implications of these adverse events,” she said in an interview.
Joe Rotella, MD, a board member of the American Academy for Hospice and Palliative Care Medicine, said results of this insurance database study provide a perspective on the real-world incidence of adverse events associated with immune checkpoint inhibitors.
“We’ve only been using these therapies for a few years, so this new analysis gives us more information on the prevalence of these side effects in patients as the therapies gain wider use,” Dr. Rotella said in a news release.
In the study, Dr. Cathcart-Rake and coinvestigators queried the OptumLabs Data Warehouse to identify 3,164 patients with NSCLC who received PD-1 or PD-L1 (programmed death-ligand 1) inhibitors between 2015 and 2017. They looked at incidence of adverse events both at the time of the last immunotherapy dose and at 60 days after the last dose.
The incidence of pneumonitis, just 4.9% on the last date of immunotherapy, increased to 10.9% at 60 days after the last dose, Dr. Cathcart-Rake reported.
Beyond pneumonitis, the most common immunotherapy-related toxicities at 60 days were hypothyroidism in 7.0%, arrhythmia in 6.1%, and nephritis or acute kidney injury in 5.4%, according to the investigators.
Dr. Cathcart-Rake also highlighted the incidence of some less common immunotherapy-related toxicities such as hypophysitis or hypothalamic-pituitary-adrenal axis toxicity, seen in 2.8% of patients by 60 days.
“That’s a small number, but hypophysitis can be really profound, and frequently leads to hospitalization,” she said. “I think this just gives us enough of a signal that providers really need to be on top of looking for these adverse events and to counsel patients beforehand.”
These data could also be helpful for advising hospitalists, emergency room physicians, and other providers who may not be attuned to the potential risks of cancer immunotherapy as compared with traditional cytotoxic chemotherapy, Dr. Cathcart-Rake said at the meeting cosponsored by AAHPM, ASCO, ASTRO, and MASCC.
“A patient with cancer may be on immunotherapy and their risk for infection is quite low, but they may be at a huge risk for pneumonitis, which is treated completely differently,” she said. “So I think this should just raise alarms that close clinical monitoring for these conditions is really important.”
Dr. Cathcart-Rake disclosed that her institution receives research funding from Novartis. One study coinvestigator reported consulting or advisory roles with Trovagene, Genentech, Bristol-Myers Squibb, and Abbvie.
SOURCE: Cathcart-Rake EJ et al. 2018 Palliative and Supportive Care in Oncology Symposium. Abstract 184.
SAN DIEGO – Certain immune-related adverse events related to PD1/PD-L1 treatment of patients with non–small cell lung cancer (NSCLC) may be more common than reported in clinical trials, a recent analysis of administrative claims data suggests.
Pneumonitis was seen in 10.9% of patients up to 60 days after the last dose of immunotherapy, according to the analysis of data from a large, U.S. commercial insurance database, presented at the Palliative and Supportive Care in Oncology Symposium.
By comparison, pneumonitis was reported in just 5.8% of NSCLC patients during treatment with the PD-1 (programmed cell death-1) inhibitor pembrolizumab in KEYNOTE-024, a pivotal randomized phase 3 clinical trial, said Elizabeth Jane Cathcart-Rake, MD, senior study author and an oncology fellow at the Mayo Clinic, Rochester, Minn.
Rates of immune-related adverse events in this study were generally higher than in clinical trials, both for common side effects and more rare conditions such as hypophysitis, according to Dr. Cathcart-Rake.
These new claims-based data might be considered complementary to clinical trial data, the researcher said.
“Together, they may give us a better sense of the broader implications of these adverse events,” she said in an interview.
Joe Rotella, MD, a board member of the American Academy for Hospice and Palliative Care Medicine, said results of this insurance database study provide a perspective on the real-world incidence of adverse events associated with immune checkpoint inhibitors.
“We’ve only been using these therapies for a few years, so this new analysis gives us more information on the prevalence of these side effects in patients as the therapies gain wider use,” Dr. Rotella said in a news release.
In the study, Dr. Cathcart-Rake and coinvestigators queried the OptumLabs Data Warehouse to identify 3,164 patients with NSCLC who received PD-1 or PD-L1 (programmed death-ligand 1) inhibitors between 2015 and 2017. They looked at incidence of adverse events both at the time of the last immunotherapy dose and at 60 days after the last dose.
The incidence of pneumonitis, just 4.9% on the last date of immunotherapy, increased to 10.9% at 60 days after the last dose, Dr. Cathcart-Rake reported.
Beyond pneumonitis, the most common immunotherapy-related toxicities at 60 days were hypothyroidism in 7.0%, arrhythmia in 6.1%, and nephritis or acute kidney injury in 5.4%, according to the investigators.
Dr. Cathcart-Rake also highlighted the incidence of some less common immunotherapy-related toxicities such as hypophysitis or hypothalamic-pituitary-adrenal axis toxicity, seen in 2.8% of patients by 60 days.
“That’s a small number, but hypophysitis can be really profound, and frequently leads to hospitalization,” she said. “I think this just gives us enough of a signal that providers really need to be on top of looking for these adverse events and to counsel patients beforehand.”
These data could also be helpful for advising hospitalists, emergency room physicians, and other providers who may not be attuned to the potential risks of cancer immunotherapy as compared with traditional cytotoxic chemotherapy, Dr. Cathcart-Rake said at the meeting cosponsored by AAHPM, ASCO, ASTRO, and MASCC.
“A patient with cancer may be on immunotherapy and their risk for infection is quite low, but they may be at a huge risk for pneumonitis, which is treated completely differently,” she said. “So I think this should just raise alarms that close clinical monitoring for these conditions is really important.”
Dr. Cathcart-Rake disclosed that her institution receives research funding from Novartis. One study coinvestigator reported consulting or advisory roles with Trovagene, Genentech, Bristol-Myers Squibb, and Abbvie.
SOURCE: Cathcart-Rake EJ et al. 2018 Palliative and Supportive Care in Oncology Symposium. Abstract 184.
SAN DIEGO – Certain immune-related adverse events related to PD1/PD-L1 treatment of patients with non–small cell lung cancer (NSCLC) may be more common than reported in clinical trials, a recent analysis of administrative claims data suggests.
Pneumonitis was seen in 10.9% of patients up to 60 days after the last dose of immunotherapy, according to the analysis of data from a large, U.S. commercial insurance database, presented at the Palliative and Supportive Care in Oncology Symposium.
By comparison, pneumonitis was reported in just 5.8% of NSCLC patients during treatment with the PD-1 (programmed cell death-1) inhibitor pembrolizumab in KEYNOTE-024, a pivotal randomized phase 3 clinical trial, said Elizabeth Jane Cathcart-Rake, MD, senior study author and an oncology fellow at the Mayo Clinic, Rochester, Minn.
Rates of immune-related adverse events in this study were generally higher than in clinical trials, both for common side effects and more rare conditions such as hypophysitis, according to Dr. Cathcart-Rake.
These new claims-based data might be considered complementary to clinical trial data, the researcher said.
“Together, they may give us a better sense of the broader implications of these adverse events,” she said in an interview.
Joe Rotella, MD, a board member of the American Academy for Hospice and Palliative Care Medicine, said results of this insurance database study provide a perspective on the real-world incidence of adverse events associated with immune checkpoint inhibitors.
“We’ve only been using these therapies for a few years, so this new analysis gives us more information on the prevalence of these side effects in patients as the therapies gain wider use,” Dr. Rotella said in a news release.
In the study, Dr. Cathcart-Rake and coinvestigators queried the OptumLabs Data Warehouse to identify 3,164 patients with NSCLC who received PD-1 or PD-L1 (programmed death-ligand 1) inhibitors between 2015 and 2017. They looked at incidence of adverse events both at the time of the last immunotherapy dose and at 60 days after the last dose.
The incidence of pneumonitis, just 4.9% on the last date of immunotherapy, increased to 10.9% at 60 days after the last dose, Dr. Cathcart-Rake reported.
Beyond pneumonitis, the most common immunotherapy-related toxicities at 60 days were hypothyroidism in 7.0%, arrhythmia in 6.1%, and nephritis or acute kidney injury in 5.4%, according to the investigators.
Dr. Cathcart-Rake also highlighted the incidence of some less common immunotherapy-related toxicities such as hypophysitis or hypothalamic-pituitary-adrenal axis toxicity, seen in 2.8% of patients by 60 days.
“That’s a small number, but hypophysitis can be really profound, and frequently leads to hospitalization,” she said. “I think this just gives us enough of a signal that providers really need to be on top of looking for these adverse events and to counsel patients beforehand.”
These data could also be helpful for advising hospitalists, emergency room physicians, and other providers who may not be attuned to the potential risks of cancer immunotherapy as compared with traditional cytotoxic chemotherapy, Dr. Cathcart-Rake said at the meeting cosponsored by AAHPM, ASCO, ASTRO, and MASCC.
“A patient with cancer may be on immunotherapy and their risk for infection is quite low, but they may be at a huge risk for pneumonitis, which is treated completely differently,” she said. “So I think this should just raise alarms that close clinical monitoring for these conditions is really important.”
Dr. Cathcart-Rake disclosed that her institution receives research funding from Novartis. One study coinvestigator reported consulting or advisory roles with Trovagene, Genentech, Bristol-Myers Squibb, and Abbvie.
SOURCE: Cathcart-Rake EJ et al. 2018 Palliative and Supportive Care in Oncology Symposium. Abstract 184.
REPORTING FROM PALLONC 2018
Key clinical point: In non–small cell lung cancer patients treated with PD-1/PD-L1 inhibitors, immune-related adverse events may occur more frequently than has been suggested by clinical trial data.
Major finding: Pneumonitis was seen in nearly 11% of patients up to 60 days after the last immunotherapy dose, which investigators said was higher than reported in a pivotal phase 3 study.
Study details: Analysis of administrative claims data for 3,164 NSCLC patients treated between 2015 and 2017.
Disclosures: Researchers reported institutional research funding from Novartis. One researcher reported consulting or advisory roles with Trovagene, Genentech, Bristol-Myers Squibb, and Abbvie.
Source: Cathcart-Rake EJ et al. Palliative and Supportive Care in Oncology Symposium. Abstract 184.
NHL patients report fear, isolation during chemo
Patients undergoing chemotherapy for non-Hodgkin lymphoma (NHL) report feeling isolated and uncertain, and in some cases suicidal, according to a small qualitative study.
Daren Chircop, MS, and Josianne Scerri, PhD, of the University of Malta performed in-depth interviews with four men and two women with aggressive NHL who were midway through CHOP chemotherapy at a cancer center in Malta.
The findings, which were published in the European Journal of Oncology Nursing, highlight three overarching themes. Patients reported that they felt like they were living on an “emotional roller coaster, they were becoming dependent on others, and they were facing an uncertain future.
Specifically, being admitted to a hospital for chemotherapy brought on a fear of the unknown. While being released from the hospital caused anxiety about what would happen once they left the around-the-clock care of doctors and nurses.
The side effects of the chemotherapy – particularly fatigue – led to feelings of being dependent of others and a fear of becoming a burden to families, and even to nurses.
For four of the patients, who were not allowed to leave their hospital rooms during treatment, they reported feeling “imprisoned” and isolated.
Uncertainty was another common theme, with all of the patients reporting that they did not know if they would recover from their cancer and feeling that they had no control over the future.
Additionally, two of the patients experienced suicidal thoughts related to the side effects of treatment.
While many of these feelings are similar to reports by patients with other types of cancer, the researchers suggested that NHL patients experience a greater sense of isolation because they may not be able to leave their hospital rooms while undergoing chemotherapy due to a higher risk of infection.
“There is the need for ongoing psychological support to be available throughout the treatment period,” the researchers wrote. “Moreover, as NHL patients are affected both physically and emotionally whilst undergoing chemotherapy, the engagement of these individuals in some physical activity could be of benefit to them.”
There was no outside funding for the study and the researchers reported having no financial disclosures.
SOURCE: Chircop D et al. Eur J Oncol Nurs. 2018 Aug;35:117-21.
Patients undergoing chemotherapy for non-Hodgkin lymphoma (NHL) report feeling isolated and uncertain, and in some cases suicidal, according to a small qualitative study.
Daren Chircop, MS, and Josianne Scerri, PhD, of the University of Malta performed in-depth interviews with four men and two women with aggressive NHL who were midway through CHOP chemotherapy at a cancer center in Malta.
The findings, which were published in the European Journal of Oncology Nursing, highlight three overarching themes. Patients reported that they felt like they were living on an “emotional roller coaster, they were becoming dependent on others, and they were facing an uncertain future.
Specifically, being admitted to a hospital for chemotherapy brought on a fear of the unknown. While being released from the hospital caused anxiety about what would happen once they left the around-the-clock care of doctors and nurses.
The side effects of the chemotherapy – particularly fatigue – led to feelings of being dependent of others and a fear of becoming a burden to families, and even to nurses.
For four of the patients, who were not allowed to leave their hospital rooms during treatment, they reported feeling “imprisoned” and isolated.
Uncertainty was another common theme, with all of the patients reporting that they did not know if they would recover from their cancer and feeling that they had no control over the future.
Additionally, two of the patients experienced suicidal thoughts related to the side effects of treatment.
While many of these feelings are similar to reports by patients with other types of cancer, the researchers suggested that NHL patients experience a greater sense of isolation because they may not be able to leave their hospital rooms while undergoing chemotherapy due to a higher risk of infection.
“There is the need for ongoing psychological support to be available throughout the treatment period,” the researchers wrote. “Moreover, as NHL patients are affected both physically and emotionally whilst undergoing chemotherapy, the engagement of these individuals in some physical activity could be of benefit to them.”
There was no outside funding for the study and the researchers reported having no financial disclosures.
SOURCE: Chircop D et al. Eur J Oncol Nurs. 2018 Aug;35:117-21.
Patients undergoing chemotherapy for non-Hodgkin lymphoma (NHL) report feeling isolated and uncertain, and in some cases suicidal, according to a small qualitative study.
Daren Chircop, MS, and Josianne Scerri, PhD, of the University of Malta performed in-depth interviews with four men and two women with aggressive NHL who were midway through CHOP chemotherapy at a cancer center in Malta.
The findings, which were published in the European Journal of Oncology Nursing, highlight three overarching themes. Patients reported that they felt like they were living on an “emotional roller coaster, they were becoming dependent on others, and they were facing an uncertain future.
Specifically, being admitted to a hospital for chemotherapy brought on a fear of the unknown. While being released from the hospital caused anxiety about what would happen once they left the around-the-clock care of doctors and nurses.
The side effects of the chemotherapy – particularly fatigue – led to feelings of being dependent of others and a fear of becoming a burden to families, and even to nurses.
For four of the patients, who were not allowed to leave their hospital rooms during treatment, they reported feeling “imprisoned” and isolated.
Uncertainty was another common theme, with all of the patients reporting that they did not know if they would recover from their cancer and feeling that they had no control over the future.
Additionally, two of the patients experienced suicidal thoughts related to the side effects of treatment.
While many of these feelings are similar to reports by patients with other types of cancer, the researchers suggested that NHL patients experience a greater sense of isolation because they may not be able to leave their hospital rooms while undergoing chemotherapy due to a higher risk of infection.
“There is the need for ongoing psychological support to be available throughout the treatment period,” the researchers wrote. “Moreover, as NHL patients are affected both physically and emotionally whilst undergoing chemotherapy, the engagement of these individuals in some physical activity could be of benefit to them.”
There was no outside funding for the study and the researchers reported having no financial disclosures.
SOURCE: Chircop D et al. Eur J Oncol Nurs. 2018 Aug;35:117-21.
FROM EUROPEAN JOURNAL OF ONCOLOGY NURSING
Key clinical point:
Major finding: Patients reported three themes while undergoing chemotherapy: living an emotional roller coaster, becoming dependent on others, and facing an uncertain future.
Study details: A qualitative study of six adults patients with non-Hodgkin lymphoma who were undergoing chemotherapy.
Disclosures: There was no outside funding for the study and the researchers reported having no financial disclosures.
Source: Chircop D et al. Eur J Oncol Nurs. 2018 Aug;35:117-21.
Palliative-rehab combo may improve QoL in newly diagnosed cancer patients
In patients with a new diagnosis of advanced cancer, an intervention that combined palliative care with rehabilitation helped improve quality of life, results of a randomized, single-center study suggest.
Patients had a significant improvement in their most pressing quality-of-life issues after participating in the intervention, which included individualized palliative care consultations and a patient/caregiver “school” of lectures, discussion, and physical exercise, investigators said.
These findings suggest that every patient facing an advanced cancer diagnosis should at least have an initial exploratory consultation with a specialized palliative care team, and should be offered not only the usual components of palliative care, but also cancer rehabilitation, said Lise Nottelmann, MD, of the department of oncology at Vejle Hospital in Denmark.
“We should be active as a health care system in approaching these patients and offering them this intervention, or at least a consultation exploring these aspects of quality of life,” Dr. Nottelmann said in an interview at the 2018 Palliative and Supportive Care in Oncology Symposium.
The study by Dr. Nottelmann and her colleagues, presented at the symposium, comprised 301 patients with nonresectable solid tumors, including lung, gastrointestinal, prostate, and others. Those patients were randomly allocated to the palliative rehabilitation intervention or to standard care only.
Every patient participated in two consultations with a specialized palliative care team, and then had the opportunity for individualized contact with the team in a 12-week open contact period. They were also invited to participate in the school sessions, each of which included a 20-minute lecture on topics such as physical activity and good nutrition plus a 40-minute discussion period, followed by an exercise session.
Of the patients randomized to the palliative rehabilitation intervention, 26 participated only in the initial consultations, while 59 participated in the group program, and 47 had individual consultations, Dr. Nottelmann reported.
To measure quality of life, the investigators asked patients to identify a “primary problem” that corresponded to one of 12 scales in the EORTC QLQ-C30 questionnaire related to physical and role functioning, emotional and cognitive functioning, or symptoms.
The primary endpoint of the analysis was improvement in QLQ-C30 scores at 12 weeks. The analysis was done on specific scales in the patients who identified a primary problem, combined with global QLQ-C30 scores for the remaining one-quarter of the patients who did not, Dr. Nottelmann said.
After 12 weeks, the patients in the intervention arm had a significant improvement versus the no-intervention arm as measured by a version of the EORTC QLQ-C30 questionnaire. The absolute between-group difference in scores was 3.0 (95% confidence interval, 0.0-6.0; P less than .047), according to researchers.
Starting palliative care earlier in the course of cancer, as done in this intervention, is an increasingly accepted practice, supported by large studies and recent clinical practice guidelines that recommend early integration of palliative care into the seriously ill patient’s care plan.
What was different about this intervention was the integration of rehabilitation aspects into palliative care, Dr. Nottelmann said in the interview. While not traditionally thought of as a component of palliative care, the concept of palliative rehabilitation is gaining ground, she said.
The goal of rehabilitative palliative care is to help individuals with life-limiting or terminal conditions actively self-manage their conditions so they can “live fully” and enjoy the best quality of life possible, according to Hospice UK, a national charity for hospice care in the United Kingdom.
The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC. Dr. Nottelmann and her colleagues reported research funding from the Danish Cancer Society. Dr. Nottelmann had no disclosures related to the presentation. One coauthor provided disclosures related to Roche, Amgen, Bayer, and Merck Sharp & Dohme.
SOURCE: Nottelmann L et al. PallOnc 2018, Abstract 75.
In patients with a new diagnosis of advanced cancer, an intervention that combined palliative care with rehabilitation helped improve quality of life, results of a randomized, single-center study suggest.
Patients had a significant improvement in their most pressing quality-of-life issues after participating in the intervention, which included individualized palliative care consultations and a patient/caregiver “school” of lectures, discussion, and physical exercise, investigators said.
These findings suggest that every patient facing an advanced cancer diagnosis should at least have an initial exploratory consultation with a specialized palliative care team, and should be offered not only the usual components of palliative care, but also cancer rehabilitation, said Lise Nottelmann, MD, of the department of oncology at Vejle Hospital in Denmark.
“We should be active as a health care system in approaching these patients and offering them this intervention, or at least a consultation exploring these aspects of quality of life,” Dr. Nottelmann said in an interview at the 2018 Palliative and Supportive Care in Oncology Symposium.
The study by Dr. Nottelmann and her colleagues, presented at the symposium, comprised 301 patients with nonresectable solid tumors, including lung, gastrointestinal, prostate, and others. Those patients were randomly allocated to the palliative rehabilitation intervention or to standard care only.
Every patient participated in two consultations with a specialized palliative care team, and then had the opportunity for individualized contact with the team in a 12-week open contact period. They were also invited to participate in the school sessions, each of which included a 20-minute lecture on topics such as physical activity and good nutrition plus a 40-minute discussion period, followed by an exercise session.
Of the patients randomized to the palliative rehabilitation intervention, 26 participated only in the initial consultations, while 59 participated in the group program, and 47 had individual consultations, Dr. Nottelmann reported.
To measure quality of life, the investigators asked patients to identify a “primary problem” that corresponded to one of 12 scales in the EORTC QLQ-C30 questionnaire related to physical and role functioning, emotional and cognitive functioning, or symptoms.
The primary endpoint of the analysis was improvement in QLQ-C30 scores at 12 weeks. The analysis was done on specific scales in the patients who identified a primary problem, combined with global QLQ-C30 scores for the remaining one-quarter of the patients who did not, Dr. Nottelmann said.
After 12 weeks, the patients in the intervention arm had a significant improvement versus the no-intervention arm as measured by a version of the EORTC QLQ-C30 questionnaire. The absolute between-group difference in scores was 3.0 (95% confidence interval, 0.0-6.0; P less than .047), according to researchers.
Starting palliative care earlier in the course of cancer, as done in this intervention, is an increasingly accepted practice, supported by large studies and recent clinical practice guidelines that recommend early integration of palliative care into the seriously ill patient’s care plan.
What was different about this intervention was the integration of rehabilitation aspects into palliative care, Dr. Nottelmann said in the interview. While not traditionally thought of as a component of palliative care, the concept of palliative rehabilitation is gaining ground, she said.
The goal of rehabilitative palliative care is to help individuals with life-limiting or terminal conditions actively self-manage their conditions so they can “live fully” and enjoy the best quality of life possible, according to Hospice UK, a national charity for hospice care in the United Kingdom.
The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC. Dr. Nottelmann and her colleagues reported research funding from the Danish Cancer Society. Dr. Nottelmann had no disclosures related to the presentation. One coauthor provided disclosures related to Roche, Amgen, Bayer, and Merck Sharp & Dohme.
SOURCE: Nottelmann L et al. PallOnc 2018, Abstract 75.
In patients with a new diagnosis of advanced cancer, an intervention that combined palliative care with rehabilitation helped improve quality of life, results of a randomized, single-center study suggest.
Patients had a significant improvement in their most pressing quality-of-life issues after participating in the intervention, which included individualized palliative care consultations and a patient/caregiver “school” of lectures, discussion, and physical exercise, investigators said.
These findings suggest that every patient facing an advanced cancer diagnosis should at least have an initial exploratory consultation with a specialized palliative care team, and should be offered not only the usual components of palliative care, but also cancer rehabilitation, said Lise Nottelmann, MD, of the department of oncology at Vejle Hospital in Denmark.
“We should be active as a health care system in approaching these patients and offering them this intervention, or at least a consultation exploring these aspects of quality of life,” Dr. Nottelmann said in an interview at the 2018 Palliative and Supportive Care in Oncology Symposium.
The study by Dr. Nottelmann and her colleagues, presented at the symposium, comprised 301 patients with nonresectable solid tumors, including lung, gastrointestinal, prostate, and others. Those patients were randomly allocated to the palliative rehabilitation intervention or to standard care only.
Every patient participated in two consultations with a specialized palliative care team, and then had the opportunity for individualized contact with the team in a 12-week open contact period. They were also invited to participate in the school sessions, each of which included a 20-minute lecture on topics such as physical activity and good nutrition plus a 40-minute discussion period, followed by an exercise session.
Of the patients randomized to the palliative rehabilitation intervention, 26 participated only in the initial consultations, while 59 participated in the group program, and 47 had individual consultations, Dr. Nottelmann reported.
To measure quality of life, the investigators asked patients to identify a “primary problem” that corresponded to one of 12 scales in the EORTC QLQ-C30 questionnaire related to physical and role functioning, emotional and cognitive functioning, or symptoms.
The primary endpoint of the analysis was improvement in QLQ-C30 scores at 12 weeks. The analysis was done on specific scales in the patients who identified a primary problem, combined with global QLQ-C30 scores for the remaining one-quarter of the patients who did not, Dr. Nottelmann said.
After 12 weeks, the patients in the intervention arm had a significant improvement versus the no-intervention arm as measured by a version of the EORTC QLQ-C30 questionnaire. The absolute between-group difference in scores was 3.0 (95% confidence interval, 0.0-6.0; P less than .047), according to researchers.
Starting palliative care earlier in the course of cancer, as done in this intervention, is an increasingly accepted practice, supported by large studies and recent clinical practice guidelines that recommend early integration of palliative care into the seriously ill patient’s care plan.
What was different about this intervention was the integration of rehabilitation aspects into palliative care, Dr. Nottelmann said in the interview. While not traditionally thought of as a component of palliative care, the concept of palliative rehabilitation is gaining ground, she said.
The goal of rehabilitative palliative care is to help individuals with life-limiting or terminal conditions actively self-manage their conditions so they can “live fully” and enjoy the best quality of life possible, according to Hospice UK, a national charity for hospice care in the United Kingdom.
The symposium was cosponsored by AAHPM, ASCO, ASTRO, and MASCC. Dr. Nottelmann and her colleagues reported research funding from the Danish Cancer Society. Dr. Nottelmann had no disclosures related to the presentation. One coauthor provided disclosures related to Roche, Amgen, Bayer, and Merck Sharp & Dohme.
SOURCE: Nottelmann L et al. PallOnc 2018, Abstract 75.
FROM PALLONC 2018
Key clinical point: An intervention combining palliative care and rehabilitation aspects improved quality of life in patients with newly diagnosed, advanced cancers.
Major finding: Patients in the rehabilitative palliative care program had a significant improvement, compared with no intervention (absolute between-group difference in EORTC QLQ-30 scores, 3.0; 95% CI, 0.0-6.0; P less than .047).
Study details: A single-center randomized study of 301 patients with a newly diagnosed advanced solid tumor cancers.
Disclosures: Research funding came from the Danish Cancer Society. One study coauthor had disclosures related to Roche, Amgen, Bayer, and Merck Sharp & Dohme.
Source: Nottelmann L et al. 2018 Palliative and Supportive Care in Oncology Symposium Abstract 75.
Refractory immune-mediated colitis: Fecal transplant may be the answer
WASHINGTON – , according to Yinghong Wang, MD.
In two patients who developed severe, refractory, immune-mediated colitis (IMC), FMT led to recovery, Dr. Wang of M.D. Anderson Cancer Center, Houston, reported at the annual meeting of the Society for Immunotherapy of Cancer.
Patient 1 was a woman with renal cell cancer who developed grade 2+ IMC within 1 month of initiation of treatment with combined ipilimumab and nivolumab. Infectious etiology was ruled out, and her symptoms and ulcers persisted despite 3 months of treatment with corticosteroids, two doses of infliximab, and one dose of vedolizumab.
A single FMT delivered via colonoscopy led to complete symptom resolution within 10 days, and a repeat colonoscopy showed “very nice healing of inflammation and ulcers,” Dr. Wang said.
Patient 2 was a man with prostate cancer who developed grade 2+ IMC 3 months after receiving two doses of ipilimumab. Infectious etiologies were ruled out, and like patient 1, his symptoms and mucosal ulcerations persisted despite 5 months of immunosuppression with corticosteroids, two doses of infliximab, and three doses of vedolizumab. He underwent two FMTs via colonoscopy.
“The first fecal transplant achieved partial response, and the second fecal transplant achieved complete clinical response, and this remission was sustained for a total of 8 months,” Dr. Wang said.
Immune checkpoint inhibitor–related IMC is typically treated with immunosuppressive therapy that is associated with significant morbidity, including a possible adverse impact on the antitumor effects of checkpoint inhibitors, Dr. Wang said.
However, studies have suggested that “the microbiome in healthy people potentially plays a very important and synergistic role for tumor regression in combination with immunotherapy,” and animal models also suggest that patients who develop IMC have differential bacterial signatures in their gut microbiome, she said.
“Based on that preliminary information, we performed fecal transplant as a compassionate treatment for cases refractory to all immunosuppression in June 2017 at M.D. Anderson,” she said.
Stool microbiome analyses showed successful engraftment of donor microbiome in recipient stool samples, and microbiome taxonomy showed increases in specific Escherichia species that “we think potentially play a role in this colitis recovery,” she said.
“Fecal transplant is safe and effective based on our preliminary study,” she said, adding that restoration of a healthy microbiome seems to reverse IMC. “Future large-scale studies are needed to evaluate this finding.”
Dr. Wang reported having no disclosures.
SOURCE: Wang Y et al. SITC 2018, Abstract P194.
WASHINGTON – , according to Yinghong Wang, MD.
In two patients who developed severe, refractory, immune-mediated colitis (IMC), FMT led to recovery, Dr. Wang of M.D. Anderson Cancer Center, Houston, reported at the annual meeting of the Society for Immunotherapy of Cancer.
Patient 1 was a woman with renal cell cancer who developed grade 2+ IMC within 1 month of initiation of treatment with combined ipilimumab and nivolumab. Infectious etiology was ruled out, and her symptoms and ulcers persisted despite 3 months of treatment with corticosteroids, two doses of infliximab, and one dose of vedolizumab.
A single FMT delivered via colonoscopy led to complete symptom resolution within 10 days, and a repeat colonoscopy showed “very nice healing of inflammation and ulcers,” Dr. Wang said.
Patient 2 was a man with prostate cancer who developed grade 2+ IMC 3 months after receiving two doses of ipilimumab. Infectious etiologies were ruled out, and like patient 1, his symptoms and mucosal ulcerations persisted despite 5 months of immunosuppression with corticosteroids, two doses of infliximab, and three doses of vedolizumab. He underwent two FMTs via colonoscopy.
“The first fecal transplant achieved partial response, and the second fecal transplant achieved complete clinical response, and this remission was sustained for a total of 8 months,” Dr. Wang said.
Immune checkpoint inhibitor–related IMC is typically treated with immunosuppressive therapy that is associated with significant morbidity, including a possible adverse impact on the antitumor effects of checkpoint inhibitors, Dr. Wang said.
However, studies have suggested that “the microbiome in healthy people potentially plays a very important and synergistic role for tumor regression in combination with immunotherapy,” and animal models also suggest that patients who develop IMC have differential bacterial signatures in their gut microbiome, she said.
“Based on that preliminary information, we performed fecal transplant as a compassionate treatment for cases refractory to all immunosuppression in June 2017 at M.D. Anderson,” she said.
Stool microbiome analyses showed successful engraftment of donor microbiome in recipient stool samples, and microbiome taxonomy showed increases in specific Escherichia species that “we think potentially play a role in this colitis recovery,” she said.
“Fecal transplant is safe and effective based on our preliminary study,” she said, adding that restoration of a healthy microbiome seems to reverse IMC. “Future large-scale studies are needed to evaluate this finding.”
Dr. Wang reported having no disclosures.
SOURCE: Wang Y et al. SITC 2018, Abstract P194.
WASHINGTON – , according to Yinghong Wang, MD.
In two patients who developed severe, refractory, immune-mediated colitis (IMC), FMT led to recovery, Dr. Wang of M.D. Anderson Cancer Center, Houston, reported at the annual meeting of the Society for Immunotherapy of Cancer.
Patient 1 was a woman with renal cell cancer who developed grade 2+ IMC within 1 month of initiation of treatment with combined ipilimumab and nivolumab. Infectious etiology was ruled out, and her symptoms and ulcers persisted despite 3 months of treatment with corticosteroids, two doses of infliximab, and one dose of vedolizumab.
A single FMT delivered via colonoscopy led to complete symptom resolution within 10 days, and a repeat colonoscopy showed “very nice healing of inflammation and ulcers,” Dr. Wang said.
Patient 2 was a man with prostate cancer who developed grade 2+ IMC 3 months after receiving two doses of ipilimumab. Infectious etiologies were ruled out, and like patient 1, his symptoms and mucosal ulcerations persisted despite 5 months of immunosuppression with corticosteroids, two doses of infliximab, and three doses of vedolizumab. He underwent two FMTs via colonoscopy.
“The first fecal transplant achieved partial response, and the second fecal transplant achieved complete clinical response, and this remission was sustained for a total of 8 months,” Dr. Wang said.
Immune checkpoint inhibitor–related IMC is typically treated with immunosuppressive therapy that is associated with significant morbidity, including a possible adverse impact on the antitumor effects of checkpoint inhibitors, Dr. Wang said.
However, studies have suggested that “the microbiome in healthy people potentially plays a very important and synergistic role for tumor regression in combination with immunotherapy,” and animal models also suggest that patients who develop IMC have differential bacterial signatures in their gut microbiome, she said.
“Based on that preliminary information, we performed fecal transplant as a compassionate treatment for cases refractory to all immunosuppression in June 2017 at M.D. Anderson,” she said.
Stool microbiome analyses showed successful engraftment of donor microbiome in recipient stool samples, and microbiome taxonomy showed increases in specific Escherichia species that “we think potentially play a role in this colitis recovery,” she said.
“Fecal transplant is safe and effective based on our preliminary study,” she said, adding that restoration of a healthy microbiome seems to reverse IMC. “Future large-scale studies are needed to evaluate this finding.”
Dr. Wang reported having no disclosures.
SOURCE: Wang Y et al. SITC 2018, Abstract P194.
REPORTING FROM SITC 2018
Key clinical point: FMT lead to recovery in two patients with refractory IMC.
Major finding: FMT was effective for the treatment of IMC in two patients.
Study details: Two case reports.
Disclosures: Dr. Wang reported having no disclosures.
Source: Wang Y et al. SITC 2018, Abstract P194.
FDA approves second pegfilgrastim biosimilar
The Food and Drug Administration has approved a second biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy and are at risk of febrile neutropenia.
Approval of pegfilgrastim-cbqv, previously known as CHS-1701, was based on analyses establishing biosimilarity, including pharmacokinetic, pharmacodynamic, and immunogenicity studies. Clinical trial results were presented at the 2017 ASCO Annual Meeting.
The most common adverse reactions with pegfilgrastim-cbqv are bone pain and pain in extremities.
The FDA approved the first pegfilgrastim biosimilar, pegfilgrastim-jmdb (Fulphila) in June.
Pegfilgrastim-cbqv will be marketed as Udenyca by Coherus BioSciences.
“Udenyca’s robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects,” Barbara Finck, MD, chief medical officer of Coherus BioSciences, said in a press release.
“In support of that study, and as part of our commitment to ensuring patient safety, we deployed a battery of sensitive immunogenicity assays. This effort not only supported the biosimilarity of Udenyca but also advanced the understanding of the immunogenic response of pegfilgrastim products.”
Coherus BioSciences plans to provide details about pricing and the launch of pegfilgrastim-cbqv during an earnings call on Nov. 8.
The Food and Drug Administration has approved a second biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy and are at risk of febrile neutropenia.
Approval of pegfilgrastim-cbqv, previously known as CHS-1701, was based on analyses establishing biosimilarity, including pharmacokinetic, pharmacodynamic, and immunogenicity studies. Clinical trial results were presented at the 2017 ASCO Annual Meeting.
The most common adverse reactions with pegfilgrastim-cbqv are bone pain and pain in extremities.
The FDA approved the first pegfilgrastim biosimilar, pegfilgrastim-jmdb (Fulphila) in June.
Pegfilgrastim-cbqv will be marketed as Udenyca by Coherus BioSciences.
“Udenyca’s robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects,” Barbara Finck, MD, chief medical officer of Coherus BioSciences, said in a press release.
“In support of that study, and as part of our commitment to ensuring patient safety, we deployed a battery of sensitive immunogenicity assays. This effort not only supported the biosimilarity of Udenyca but also advanced the understanding of the immunogenic response of pegfilgrastim products.”
Coherus BioSciences plans to provide details about pricing and the launch of pegfilgrastim-cbqv during an earnings call on Nov. 8.
The Food and Drug Administration has approved a second biosimilar to pegfilgrastim (Neulasta) to decrease the chance of infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy and are at risk of febrile neutropenia.
Approval of pegfilgrastim-cbqv, previously known as CHS-1701, was based on analyses establishing biosimilarity, including pharmacokinetic, pharmacodynamic, and immunogenicity studies. Clinical trial results were presented at the 2017 ASCO Annual Meeting.
The most common adverse reactions with pegfilgrastim-cbqv are bone pain and pain in extremities.
The FDA approved the first pegfilgrastim biosimilar, pegfilgrastim-jmdb (Fulphila) in June.
Pegfilgrastim-cbqv will be marketed as Udenyca by Coherus BioSciences.
“Udenyca’s robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects,” Barbara Finck, MD, chief medical officer of Coherus BioSciences, said in a press release.
“In support of that study, and as part of our commitment to ensuring patient safety, we deployed a battery of sensitive immunogenicity assays. This effort not only supported the biosimilarity of Udenyca but also advanced the understanding of the immunogenic response of pegfilgrastim products.”
Coherus BioSciences plans to provide details about pricing and the launch of pegfilgrastim-cbqv during an earnings call on Nov. 8.
Novel risk factors for febrile neutropenia in NHL, solid tumors
A retrospective study has revealed new potential risk factors for chemotherapy-induced febrile neutropenia in patients with solid tumors and non-Hodgkin lymphoma (NHL).
Researchers found the timing and duration of corticosteroid use were both associated with febrile neutropenia. The team also observed “marginal” associations between febrile neutropenia and certain dermatologic and mucosal conditions, as well as the use of intravenous antibiotics before chemotherapy.
However, there was no association found between oral antibiotic use and febrile neutropenia or between radiation therapy and febrile neutropenia.
Chun Rebecca Chao, PhD, of the Kaiser Permanente Southern California in Pasadena, and her colleagues reported these findings in the Journal of the National Comprehensive Cancer Network.
“Febrile neutropenia is life threatening and often requires hospitalization,” Dr. Chao said in a statement. “Furthermore, [febrile neutropenia] can lead to chemotherapy dose delay and dose reduction, which, in turn, negatively impacts antitumor efficacy. However, it can be prevented if high-risk individuals are identified and treated prophylactically.”
With this in mind, Dr. Chao and her colleagues set out to identify novel risk factors for febrile neutropenia by analyzing 15,971 patients who were treated with myelosuppressive chemotherapy at Kaiser Permanente Southern California between 2000 and 2009.
Patients had been diagnosed with NHL (n = 1,617) or breast (n = 6,323), lung (n = 3,584), colorectal (n = 3,062), ovarian (n = 924), or gastric (n = 461) cancers. In all, 4.3% of patients developed febrile neutropenia during their first cycle of chemotherapy.
The researchers found that corticosteroid use was associated with an increased risk of febrile neutropenia in a propensity score–adjusted (PSA) model. The hazard ratio was 1.53 (95% confidence interval, 1.17-1.98; P less than .01) for patients who received corticosteroids.
A longer duration of corticosteroid use was associated with a greater risk of febrile neutropenia. The adjusted HR, compared with no corticosteroid use, was 1.78 for corticosteroid treatment lasting less than 15 days and rose to 2.86 for treatment lasting 45-90 days.
“One way to reduce the incidence rate for [febrile neutropenia] could be to schedule prior corticosteroid use and subsequent chemotherapy with at least 2 weeks between them, given the magnitude of the risk increase and prevalence of this risk factor,” Dr. Chao said.
The researchers found a “marginally” increased risk of febrile neutropenia in patients with certain dermatologic conditions (dermatitis, psoriasis, pruritus) and mucosal conditions (gastritis, stomatitis, mucositis). In the PSA model, the HR was 1.40 (95% CI, 0.98-1.93; P = 0.05) for patients with these conditions.
Intravenous antibiotic use was also found to be marginally associated with an increased risk of febrile neutropenia in a restricted analysis covering patients treated in 2008 and 2009. In the PSA model, the HR was 1.35 (95% CI, 0.97-1.87; P = .08).
There was no association found between febrile neutropenia and oral antibiotic use in the restricted analysis. In the PSA model, the HR was 1.07 (95% CI, 0.77-1.48; P = .70) for patients who received oral antibiotics.
Dr. Chao and her colleagues wrote that these results suggest intravenous antibiotics may have a more profound impact than oral antibiotics on the balance of bacterial flora and other immune functions. Another possible explanation is that patients who received intravenous antibiotics were generally sicker and more prone to severe infection than patients who received oral antibiotics.
The researchers also found no association between febrile neutropenia and prior surgery, prior radiation therapy, and concurrent radiation therapy in the PSA model.
The study was funded by Amgen. Three of the authors reported being employees and stockholders of Amgen.
[email protected]
SOURCE: Chao CR et al. J Natl Compr Canc Netw. 2018;16(10):1201-8.
A retrospective study has revealed new potential risk factors for chemotherapy-induced febrile neutropenia in patients with solid tumors and non-Hodgkin lymphoma (NHL).
Researchers found the timing and duration of corticosteroid use were both associated with febrile neutropenia. The team also observed “marginal” associations between febrile neutropenia and certain dermatologic and mucosal conditions, as well as the use of intravenous antibiotics before chemotherapy.
However, there was no association found between oral antibiotic use and febrile neutropenia or between radiation therapy and febrile neutropenia.
Chun Rebecca Chao, PhD, of the Kaiser Permanente Southern California in Pasadena, and her colleagues reported these findings in the Journal of the National Comprehensive Cancer Network.
“Febrile neutropenia is life threatening and often requires hospitalization,” Dr. Chao said in a statement. “Furthermore, [febrile neutropenia] can lead to chemotherapy dose delay and dose reduction, which, in turn, negatively impacts antitumor efficacy. However, it can be prevented if high-risk individuals are identified and treated prophylactically.”
With this in mind, Dr. Chao and her colleagues set out to identify novel risk factors for febrile neutropenia by analyzing 15,971 patients who were treated with myelosuppressive chemotherapy at Kaiser Permanente Southern California between 2000 and 2009.
Patients had been diagnosed with NHL (n = 1,617) or breast (n = 6,323), lung (n = 3,584), colorectal (n = 3,062), ovarian (n = 924), or gastric (n = 461) cancers. In all, 4.3% of patients developed febrile neutropenia during their first cycle of chemotherapy.
The researchers found that corticosteroid use was associated with an increased risk of febrile neutropenia in a propensity score–adjusted (PSA) model. The hazard ratio was 1.53 (95% confidence interval, 1.17-1.98; P less than .01) for patients who received corticosteroids.
A longer duration of corticosteroid use was associated with a greater risk of febrile neutropenia. The adjusted HR, compared with no corticosteroid use, was 1.78 for corticosteroid treatment lasting less than 15 days and rose to 2.86 for treatment lasting 45-90 days.
“One way to reduce the incidence rate for [febrile neutropenia] could be to schedule prior corticosteroid use and subsequent chemotherapy with at least 2 weeks between them, given the magnitude of the risk increase and prevalence of this risk factor,” Dr. Chao said.
The researchers found a “marginally” increased risk of febrile neutropenia in patients with certain dermatologic conditions (dermatitis, psoriasis, pruritus) and mucosal conditions (gastritis, stomatitis, mucositis). In the PSA model, the HR was 1.40 (95% CI, 0.98-1.93; P = 0.05) for patients with these conditions.
Intravenous antibiotic use was also found to be marginally associated with an increased risk of febrile neutropenia in a restricted analysis covering patients treated in 2008 and 2009. In the PSA model, the HR was 1.35 (95% CI, 0.97-1.87; P = .08).
There was no association found between febrile neutropenia and oral antibiotic use in the restricted analysis. In the PSA model, the HR was 1.07 (95% CI, 0.77-1.48; P = .70) for patients who received oral antibiotics.
Dr. Chao and her colleagues wrote that these results suggest intravenous antibiotics may have a more profound impact than oral antibiotics on the balance of bacterial flora and other immune functions. Another possible explanation is that patients who received intravenous antibiotics were generally sicker and more prone to severe infection than patients who received oral antibiotics.
The researchers also found no association between febrile neutropenia and prior surgery, prior radiation therapy, and concurrent radiation therapy in the PSA model.
The study was funded by Amgen. Three of the authors reported being employees and stockholders of Amgen.
[email protected]
SOURCE: Chao CR et al. J Natl Compr Canc Netw. 2018;16(10):1201-8.
A retrospective study has revealed new potential risk factors for chemotherapy-induced febrile neutropenia in patients with solid tumors and non-Hodgkin lymphoma (NHL).
Researchers found the timing and duration of corticosteroid use were both associated with febrile neutropenia. The team also observed “marginal” associations between febrile neutropenia and certain dermatologic and mucosal conditions, as well as the use of intravenous antibiotics before chemotherapy.
However, there was no association found between oral antibiotic use and febrile neutropenia or between radiation therapy and febrile neutropenia.
Chun Rebecca Chao, PhD, of the Kaiser Permanente Southern California in Pasadena, and her colleagues reported these findings in the Journal of the National Comprehensive Cancer Network.
“Febrile neutropenia is life threatening and often requires hospitalization,” Dr. Chao said in a statement. “Furthermore, [febrile neutropenia] can lead to chemotherapy dose delay and dose reduction, which, in turn, negatively impacts antitumor efficacy. However, it can be prevented if high-risk individuals are identified and treated prophylactically.”
With this in mind, Dr. Chao and her colleagues set out to identify novel risk factors for febrile neutropenia by analyzing 15,971 patients who were treated with myelosuppressive chemotherapy at Kaiser Permanente Southern California between 2000 and 2009.
Patients had been diagnosed with NHL (n = 1,617) or breast (n = 6,323), lung (n = 3,584), colorectal (n = 3,062), ovarian (n = 924), or gastric (n = 461) cancers. In all, 4.3% of patients developed febrile neutropenia during their first cycle of chemotherapy.
The researchers found that corticosteroid use was associated with an increased risk of febrile neutropenia in a propensity score–adjusted (PSA) model. The hazard ratio was 1.53 (95% confidence interval, 1.17-1.98; P less than .01) for patients who received corticosteroids.
A longer duration of corticosteroid use was associated with a greater risk of febrile neutropenia. The adjusted HR, compared with no corticosteroid use, was 1.78 for corticosteroid treatment lasting less than 15 days and rose to 2.86 for treatment lasting 45-90 days.
“One way to reduce the incidence rate for [febrile neutropenia] could be to schedule prior corticosteroid use and subsequent chemotherapy with at least 2 weeks between them, given the magnitude of the risk increase and prevalence of this risk factor,” Dr. Chao said.
The researchers found a “marginally” increased risk of febrile neutropenia in patients with certain dermatologic conditions (dermatitis, psoriasis, pruritus) and mucosal conditions (gastritis, stomatitis, mucositis). In the PSA model, the HR was 1.40 (95% CI, 0.98-1.93; P = 0.05) for patients with these conditions.
Intravenous antibiotic use was also found to be marginally associated with an increased risk of febrile neutropenia in a restricted analysis covering patients treated in 2008 and 2009. In the PSA model, the HR was 1.35 (95% CI, 0.97-1.87; P = .08).
There was no association found between febrile neutropenia and oral antibiotic use in the restricted analysis. In the PSA model, the HR was 1.07 (95% CI, 0.77-1.48; P = .70) for patients who received oral antibiotics.
Dr. Chao and her colleagues wrote that these results suggest intravenous antibiotics may have a more profound impact than oral antibiotics on the balance of bacterial flora and other immune functions. Another possible explanation is that patients who received intravenous antibiotics were generally sicker and more prone to severe infection than patients who received oral antibiotics.
The researchers also found no association between febrile neutropenia and prior surgery, prior radiation therapy, and concurrent radiation therapy in the PSA model.
The study was funded by Amgen. Three of the authors reported being employees and stockholders of Amgen.
[email protected]
SOURCE: Chao CR et al. J Natl Compr Canc Netw. 2018;16(10):1201-8.
FROM THE JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK
Key clinical point:
Major finding: Corticosteroid use was associated with an increased risk of febrile neutropenia, compared with no corticosteroid use (hazard ratio, 1.53; P less than .01).
Study details: This retrospective study included 15,971 patients with non-Hodgkin lymphoma or five solid tumors.
Disclosures: The study was funded by Amgen. Three of the authors reported being employers and stockholders of Amgen.
Source: Chao CR et al. J Natl Compr Canc Netw. 2018;16(10):1201-8.
Information overload
The evening James Wu (not his real name) learned he had leukemia, he asked his nurse to please get his doctor. There was something important he had to ask her.
“I have this mole. On my back.” He squirmed anxiously. “Doctor, is it dangerous?”
James did have something dangerous – though it had nothing to do with a skin blemish he’d had his whole life. Earlier that day, I had pulled up a chair and told him we had final results from the bone marrow biopsy I had done the day before. It was unfortunately what we suspected. James had cancer. It was a type of cancer called acute lymphoblastic leukemia, a cancer of the blood.
James had said nothing. He looked down, shocked, and crestfallen. Even though we had planted the seeds early that this was likely cancer, the confirmation is always heartbreaking. It closes the door on optimism, shutting out the slim hope that it could be something else. Anything else.
I could have said more. But I waited.
We could go on, spelling out the next steps and treatment options. But patients usually don’t retain it. The details don’t mean anything right now.
Instead, I usually just hint at what’s to come. Most importantly, I reassure them that we are with them now, every step of the way. This will be a road we’ll walk together.
It was silent for a while. Finally, James spoke.
“OK,” he said. “So … it’s not something in my diet?”
“No. It’s a leukemia.”
“It cannot be related to stress?”
“No. You did nothing to cause this.”
For most, it’s a process. After dropping the diagnostic bomb, treatment is another conversation. Prognosis another. If I have the luxury of continuity, I try to carve the information into chunks, giving patients time to process each piece.
This felt especially salient for James, who was in his mid-30s and had never even been in a hospital before, much less dealt with a serious diagnosis. His grandparents had died of “old age,” and no one in his family had been sick. He had never interacted with the health care system in a meaningful way. Even words like chemotherapy seemed beyond him, existing in a different world from the one he lived in. Cancer was abstract.
“Would I be awake during chemotherapy?”
“Yes. Completely.”
James had a wife, a 2-year-old, and a full-time job. Watching his daughter aimlessly wander around the hospital room, I wondered, were they planning on having more children? We could get the fertility specialist to see him before starting chemotherapy.
I looked at his nightstand, where his laptop was open to data-packed spreadsheets, and I wondered what his work meant for him. Would he want to continue working through his treatment? We could have our social worker write a letter to his employer.
There would be time for all of that. Later.
I said that, for tonight, there would be nothing else. Tomorrow, we would do an ultrasound of his heart and arrange for a special IV to administer chemotherapy. Then, I would come back, and we would talk about the treatment, and what it all means, in a lot more detail.
I asked James if he had any questions right now. As expected, he said no. Until a few hours later, when I was called about his very important question.
That day, looking into the terrified face of a previously healthy 30-something-year-old, I could see the future. I could see the month-long hospital stay. The chemotherapy would kill his immune system, he would get fevers, and bacteria would grow in his bloodstream. He’d get short of breath and we’d find fungus growing in his lungs. He’d take an antifungal and it would make him hallucinate. Maybe he’d spend a few days in the ICU, requiring a large catheter in his neck just to maintain his blood pressure. He would bleed; we would transfuse him with blood. He would get so many bone marrow biopsies and lumbar punctures that his skin would be marked, and he would tell each proceduralist where to go. It would be months of treatment. And then miraculously, it would go into remission. He would celebrate; his wife would cry. Maybe he’d get a bone marrow transplant; we’d find out his brother was a match, and he’d fly in from thousands of miles away. He would get graft-versus-host disease, and his skin would harden. And even after all of that, even if his bone marrow was clear of disease, he would not say he was “cured.” He would live in fear of this because he would know how likely it was to relapse. Maybe in a few months, maybe in a few years. Every cough would be a catastrophe. Every ache a fear of the worst. He would become intimately familiar with words like minimal residual disease and neutropenia, frequent the message boards, and always have a bag packed in case he needed to come back to the hospital. Everything else, from that moment on, would come in second place.
There, then, with his toddler playfully tugging at his hospital gown, I said none of that.
Instead, I examined his back. I told him his mole looked fine.
“Wow,” he breathed a long sigh of relief. “Thank you, doctor. That’s good news.”
Certain details of this story were modified slightly to protect privacy.
Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.
The evening James Wu (not his real name) learned he had leukemia, he asked his nurse to please get his doctor. There was something important he had to ask her.
“I have this mole. On my back.” He squirmed anxiously. “Doctor, is it dangerous?”
James did have something dangerous – though it had nothing to do with a skin blemish he’d had his whole life. Earlier that day, I had pulled up a chair and told him we had final results from the bone marrow biopsy I had done the day before. It was unfortunately what we suspected. James had cancer. It was a type of cancer called acute lymphoblastic leukemia, a cancer of the blood.
James had said nothing. He looked down, shocked, and crestfallen. Even though we had planted the seeds early that this was likely cancer, the confirmation is always heartbreaking. It closes the door on optimism, shutting out the slim hope that it could be something else. Anything else.
I could have said more. But I waited.
We could go on, spelling out the next steps and treatment options. But patients usually don’t retain it. The details don’t mean anything right now.
Instead, I usually just hint at what’s to come. Most importantly, I reassure them that we are with them now, every step of the way. This will be a road we’ll walk together.
It was silent for a while. Finally, James spoke.
“OK,” he said. “So … it’s not something in my diet?”
“No. It’s a leukemia.”
“It cannot be related to stress?”
“No. You did nothing to cause this.”
For most, it’s a process. After dropping the diagnostic bomb, treatment is another conversation. Prognosis another. If I have the luxury of continuity, I try to carve the information into chunks, giving patients time to process each piece.
This felt especially salient for James, who was in his mid-30s and had never even been in a hospital before, much less dealt with a serious diagnosis. His grandparents had died of “old age,” and no one in his family had been sick. He had never interacted with the health care system in a meaningful way. Even words like chemotherapy seemed beyond him, existing in a different world from the one he lived in. Cancer was abstract.
“Would I be awake during chemotherapy?”
“Yes. Completely.”
James had a wife, a 2-year-old, and a full-time job. Watching his daughter aimlessly wander around the hospital room, I wondered, were they planning on having more children? We could get the fertility specialist to see him before starting chemotherapy.
I looked at his nightstand, where his laptop was open to data-packed spreadsheets, and I wondered what his work meant for him. Would he want to continue working through his treatment? We could have our social worker write a letter to his employer.
There would be time for all of that. Later.
I said that, for tonight, there would be nothing else. Tomorrow, we would do an ultrasound of his heart and arrange for a special IV to administer chemotherapy. Then, I would come back, and we would talk about the treatment, and what it all means, in a lot more detail.
I asked James if he had any questions right now. As expected, he said no. Until a few hours later, when I was called about his very important question.
That day, looking into the terrified face of a previously healthy 30-something-year-old, I could see the future. I could see the month-long hospital stay. The chemotherapy would kill his immune system, he would get fevers, and bacteria would grow in his bloodstream. He’d get short of breath and we’d find fungus growing in his lungs. He’d take an antifungal and it would make him hallucinate. Maybe he’d spend a few days in the ICU, requiring a large catheter in his neck just to maintain his blood pressure. He would bleed; we would transfuse him with blood. He would get so many bone marrow biopsies and lumbar punctures that his skin would be marked, and he would tell each proceduralist where to go. It would be months of treatment. And then miraculously, it would go into remission. He would celebrate; his wife would cry. Maybe he’d get a bone marrow transplant; we’d find out his brother was a match, and he’d fly in from thousands of miles away. He would get graft-versus-host disease, and his skin would harden. And even after all of that, even if his bone marrow was clear of disease, he would not say he was “cured.” He would live in fear of this because he would know how likely it was to relapse. Maybe in a few months, maybe in a few years. Every cough would be a catastrophe. Every ache a fear of the worst. He would become intimately familiar with words like minimal residual disease and neutropenia, frequent the message boards, and always have a bag packed in case he needed to come back to the hospital. Everything else, from that moment on, would come in second place.
There, then, with his toddler playfully tugging at his hospital gown, I said none of that.
Instead, I examined his back. I told him his mole looked fine.
“Wow,” he breathed a long sigh of relief. “Thank you, doctor. That’s good news.”
Certain details of this story were modified slightly to protect privacy.
Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.
The evening James Wu (not his real name) learned he had leukemia, he asked his nurse to please get his doctor. There was something important he had to ask her.
“I have this mole. On my back.” He squirmed anxiously. “Doctor, is it dangerous?”
James did have something dangerous – though it had nothing to do with a skin blemish he’d had his whole life. Earlier that day, I had pulled up a chair and told him we had final results from the bone marrow biopsy I had done the day before. It was unfortunately what we suspected. James had cancer. It was a type of cancer called acute lymphoblastic leukemia, a cancer of the blood.
James had said nothing. He looked down, shocked, and crestfallen. Even though we had planted the seeds early that this was likely cancer, the confirmation is always heartbreaking. It closes the door on optimism, shutting out the slim hope that it could be something else. Anything else.
I could have said more. But I waited.
We could go on, spelling out the next steps and treatment options. But patients usually don’t retain it. The details don’t mean anything right now.
Instead, I usually just hint at what’s to come. Most importantly, I reassure them that we are with them now, every step of the way. This will be a road we’ll walk together.
It was silent for a while. Finally, James spoke.
“OK,” he said. “So … it’s not something in my diet?”
“No. It’s a leukemia.”
“It cannot be related to stress?”
“No. You did nothing to cause this.”
For most, it’s a process. After dropping the diagnostic bomb, treatment is another conversation. Prognosis another. If I have the luxury of continuity, I try to carve the information into chunks, giving patients time to process each piece.
This felt especially salient for James, who was in his mid-30s and had never even been in a hospital before, much less dealt with a serious diagnosis. His grandparents had died of “old age,” and no one in his family had been sick. He had never interacted with the health care system in a meaningful way. Even words like chemotherapy seemed beyond him, existing in a different world from the one he lived in. Cancer was abstract.
“Would I be awake during chemotherapy?”
“Yes. Completely.”
James had a wife, a 2-year-old, and a full-time job. Watching his daughter aimlessly wander around the hospital room, I wondered, were they planning on having more children? We could get the fertility specialist to see him before starting chemotherapy.
I looked at his nightstand, where his laptop was open to data-packed spreadsheets, and I wondered what his work meant for him. Would he want to continue working through his treatment? We could have our social worker write a letter to his employer.
There would be time for all of that. Later.
I said that, for tonight, there would be nothing else. Tomorrow, we would do an ultrasound of his heart and arrange for a special IV to administer chemotherapy. Then, I would come back, and we would talk about the treatment, and what it all means, in a lot more detail.
I asked James if he had any questions right now. As expected, he said no. Until a few hours later, when I was called about his very important question.
That day, looking into the terrified face of a previously healthy 30-something-year-old, I could see the future. I could see the month-long hospital stay. The chemotherapy would kill his immune system, he would get fevers, and bacteria would grow in his bloodstream. He’d get short of breath and we’d find fungus growing in his lungs. He’d take an antifungal and it would make him hallucinate. Maybe he’d spend a few days in the ICU, requiring a large catheter in his neck just to maintain his blood pressure. He would bleed; we would transfuse him with blood. He would get so many bone marrow biopsies and lumbar punctures that his skin would be marked, and he would tell each proceduralist where to go. It would be months of treatment. And then miraculously, it would go into remission. He would celebrate; his wife would cry. Maybe he’d get a bone marrow transplant; we’d find out his brother was a match, and he’d fly in from thousands of miles away. He would get graft-versus-host disease, and his skin would harden. And even after all of that, even if his bone marrow was clear of disease, he would not say he was “cured.” He would live in fear of this because he would know how likely it was to relapse. Maybe in a few months, maybe in a few years. Every cough would be a catastrophe. Every ache a fear of the worst. He would become intimately familiar with words like minimal residual disease and neutropenia, frequent the message boards, and always have a bag packed in case he needed to come back to the hospital. Everything else, from that moment on, would come in second place.
There, then, with his toddler playfully tugging at his hospital gown, I said none of that.
Instead, I examined his back. I told him his mole looked fine.
“Wow,” he breathed a long sigh of relief. “Thank you, doctor. That’s good news.”
Certain details of this story were modified slightly to protect privacy.
Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.
Collaboration is key to bridging the AYA cancer care divide
Survival gains among adolescents and young adults (AYAs) with cancer continue to lag behind outcomes for children and older adult patients. It’s a trend that spans decades, but clinicians and researchers are finally getting serious about trying to understand the underlying causes and are re-examining prevailing practices in an effort to address the discrepancies.
“This is a very heterogeneous group of disorders,” Rabi Hanna, MD, a pediatric hematologist and oncologist at Cleveland Clinic Children’s Hospital, Ohio, said in an interview. He’s specifically referring to the cancers that affect AYAs, who are broadly defined as patients aged 15 through 39 years. “A few cancers, such as [acute lymphoblastic leukemia], are more common in children, and others, such as breast cancer, are more common in adults. The biology may be different in the adolescent and young adult patients, which may lead to different outcomes.”
In addition, the psychosocial needs in this age group differ vastly from those in other groups. “Many of these patients are in college or have just started their families, so we have to pay more attention to [issues related to] financial toxicity and fertility, for example,” said Dr Hanna, who is the director of pediatric bone marrow transplantation at the clinic. (The term “financial toxicity” describes the cumulative negative impact of the high cost of care, lost work time, and delays in reaching educational and career goals on patients with cancer and their families.)
Another factor that likely contributes to the outcome disparities between AYAs and other populations with cancer is the relative lack of clinical trial involvement among AYAs.
A recent series of articles published in the journal Blood addressed these and other issues, among them, whether AYAs with acute lymphoblastic leukemia (ALL)1 or aggressive B-cell non-Hodgkin lymphomas (NHLs) 2 should be treated as children or adults; treatment strategies for those with acute myeloid leukemias (AMLs); 3 management of Hodgkin lymphoma;4 and psychosocial challenges and health-related quality of life (QoL) in AYAs with hematologic malignancies.5
In the introduction to the series, Jorge Cortes, MD, an assistant editor on the journal, wrote that hematologic malignancies in AYAs “represent a unique challenge because of their special biological features and distinctive therapeutic requirements, as well as the unique medical, social, and psychological characteristics of this patient population.”6
He noted, however, that “not much has been done to explore unique molecular and biological features of AYA hematologic malignancies. The discussion on the management of AYAs often centers on whether these patients should be treated in a pediatric setting or an adult setting, or with regimens designed for children or for adults,” noted Dr Cortes, professor and chair of the chronic myeloid leukemia section in the department of leukemia at the University of Texas MD Anderson Cancer Center, Houston.
Therapeutic options: pediatric or adult protocols?
In their article on ALL in AYAs, Nicolas Boissel, MD, and André Baruchel, MD, note that the use of “fully pediatric protocols” in patients aged 15 through 20 years is supported by findings from numerous studies. In young adults, evidence increasingly supports “pediatric-inspired or even fully pediatric approaches” because they have been shown to significantly improve outcomes, with long-term survival rates nearing 70%.1 Patients in these age groups require specific programs that factor in access to care and to trials, an increased risk of acute toxicities, and treatment adherence, which can be particularly problematic in AYAs, they concluded.
However, Kristen O’Dwyer, MD, and colleagues, argue in an article on AML treatment in AYAs that neither the pediatric nor adult approaches are ideally suited for AYAs because of the “distinguishing characteristics of AYAs with AML.” Rather, they conclude that AYA-specific approaches merit consideration.3
Similarly, Kieron Dunleavy, MD, and Thomas G Gross, MD, note in an article on managing aggressive B-cell NHLs in AYAs that there is a “remarkable divide” in the treatment of patients younger than 18 years with lymphoma compared with their young adult counterparts, and that it underscores the need for collaboration in developing consensus regarding treatment of AYAs.2
Clinical setting: pediatric or adult?
Consideration is also being given to the clinical setting in which AYA patients receive their treatment. Lori Muffly, MD, MS, and colleagues have reported that survival was superior for AYA patients with ALL who were treated in pediatric cancer settings,7 and other researchers have reported similar findings.
However, those improved outcomes in the pediatric setting might be offset by a higher use of resources and therefore higher costs, based on recent findings in a Canadian study by Paul C Nathan, MD, and colleagues.8 Among 1,356 patients aged 15-17 years who were diagnosed with cancer between 1996 and 2010, the authors found that the cost of care was higher when treatment took place in a pediatric setting compared with in an adult institution, and that it was driven in part by higher hospitalization rates and longer hospital stays. These findings were true across different diagnoses, including leukemias, lymphomas, sarcomas, and germ cell tumors, but only during the initial treatment phase.
In an accompanying editorial, Helen M Parsons, PhD, and her co-authors wrote that adolescents who receive treatment in the pediatric setting “tended to seek more [emergency department (ED)] care immediately before diagnosis and during the initial treatment phase; these adolescents also used more home care services during initial treatment and survivorship.9 They pointed out that the findings of higher inpatient days in the pediatric setting was not surprising given that induction therapies for pediatric ALL tend to be more complex and intensive than therapies commonly used in adults with ALL, and that pediatric cancer hospitals tend to have a wider array of services, including psychosocial and family support services.
“What is less clear is why individuals seen in pediatric settings have higher rates of ED care directly before diagnosis and during the initial treatment phase,” they wrote, adding that further investigation was needed on this topic to better understand those trends. “The finding that adolescents treated in pediatric institutions had higher resource use across diagnostic groups demonstrates that resource utilization may be driven just as much by care setting as diagnosis.” 9
The authors of the editorial emphasized that because of the differences in health care delivery and payment structures between the United States and Canada, where the Nathan study was done, it was important that similar studies are done in the United States to confirm these findings.
Disease and developmental biology
As Dr Hanna noted, biological differences and changes over time suggest that different age groups need varying approaches to treatment and that they may have different outcomes with the same treatments.
For example, the biology of AML is known to change with age, Dr O'Dwyer and her colleagues noted,3 citing a recent European study of 5,564 patients with de novo AML that showed that the frequency of favorable cytogenetics was low in infants (13.7%), increased in children (25%) and young adults (44%), and decreased again in middle age and older patients.10
“Most unfavorable cytogenetic abnormalities are rare across all age groups, though complex cytogenetics are relatively more frequent in infants, decrease in frequency in AYAs, and then increase in frequency beyond AYA,” Dr O'Dwyer and her colleagues wrote.3 It was also becoming more apparent that age influences the presence of AML-related molecular abnormalities, and recognition of age-related differences in disease biology “will provide the best opportunity to improve the clinical outcomes that have been static for decades.”
Dr Boissel and Dr Baruchel also noted in their report that light was finally being shed on the “black hole” of understanding ALL biology in AYAs, and research has shown that there is a continuum between childhood and adult ALL.1 They concluded that “risk stratification based on recent biology findings and sequential [minimum residual disease] evaluations should now be implemented, as well as new therapeutic options including immunotherapy and targeted therapies, at best within the setting of integrated pediatric and AYA protocols.”
Psychosocial factors
“Cancer is a non-normative event for AYAs. It is extremely disruptive to them physically, psychologically, and vocationally ... and this poses significant challenges,” John Salsman, PhD, director of clinical research in AYA oncology at Wake Forest University, Winston-Salem, NC, said in an interview.
These patients have 5-year survival rates that haven’t improved in tandem with those in pediatric and adult populations over the last 3 decades, and in addition to the financial toxicity and strain, they also have higher rates of depression and anxiety, including fear of recurrence, he added. “Quality of life is incredibly important, and these things need to be addressed because of the developmental changes AYAs are navigating; there are issues of positive body image, family and career decisions ... these are challenging for anyone, and when you throw a cancer diagnosis into the mix they become disproportionately so.”
In a 2014 study, Dr Salsman and his colleagues found that AYAs with cancer had poorer physical and emotional quality of life when compared with matched controls, but better social quality of life.11 The latter finding was surprising and highlights the importance of the social dimension in the lives of AYAs. “Patient after patient will say ‘I found out who my real friends are,’ ” he said. “There’s this refinement and deepening of the social network among some posttreatment survivors.”
Dr Salsman and his colleagues are using those findings to develop interventions that can maximize self-care in posttreatment survivorship – a time when AYAs may feel they have a new lease on life and may be more motivated to adhere to recommendations and take care of themselves. For example, a randomized controlled pilot study that incorporates social media apps and other technologies to build on the positive social components of their lives in promoting physical activity interventions is underway.
Another intervention targets emotional well-being through the use of web-based tools to increase positive affect. A proof-of-concept study showed that the approach was feasible and well received, and a larger-scale randomized controlled trial is being planned, he said.
Dr Salsman also praised the PRISM (Promoting Resilience in Stress Management) tool developed by researchers at Seattle Children’s Hospital. It was created to help AYAs with cancer and other illnesses learn coping skills to manage stress after their diagnosis and to boost quality of life beyond treatment. A digital app has also been developed to be used in conjunction with the program.
Trial enrollment
In his editorial introducing the Blood series on AYAs and cancer, Dr Cortes noted a paucity of clinical trials specifically designed for this population. “At the time of this writing, I could identify four therapeutic trials registered at www.clinicaltrials.gov that appeared to be somewhat specifically designed for AYAs (some included children also),” he wrote, describing AYA enrollment in clinical trials in cancer as “suboptimal at best.”6
Dr Salsman said these dismal enrolment numbers could in part be related to treatment setting. Data suggest that most AYAs with cancer are treated in community-based practices rather than comprehensive cancer centers where the bulk of research is being done, he explained.
Dr Hanna agreed that more research involving AYAs was needed as is a better understanding of why enrollment is so much lower in this population. He pointed out that in 2017 the American Society of Clinical Oncology and Friends of Cancer Research released a statement recommending that pediatric patients be considered for enrollment in later-phase trials for cancer types that span both adults and children.12 The organizations said that individuals aged 12 years and older should routinely be included in such trials because their drug metabolism is similar to adults, and inclusion of younger patients may also be appropriate if they are part of the population affected by the disease, depending on specific disease biology, action of the drug, and available safety information.
Officials at the Food and Drug Administration are considering that possibility, Dr Hanna said.
Dr Salsman added there has been an increase in recent years in the attention paid to disparities in survival improvements and trial involvement among AYAs with cancer, compared with other age groups. For example, about 5 years ago, the National Clinical Trials Network formed a working group that developed a number of specific objectives for incorporating more AYAs into cancer trials and finding better ways to study this population;13 the Institute of Medicine held a forum on the care of AYAs with cancer;14 and the National Cancer Institute held a state-of-the-science meeting that focused on identifying strategic priorities for AYA oncology,15 he noted.
Dr Hanna added that “scientific groups such as Southwest Oncology Group (SWOG) and Children’s Oncology Group (COG) also have AYA committees now. One of the success stories of working together between SWOG and COG was the intergroup study C10403 for patients with ALL. And now there are efforts for an intergroup AYA-AML task force to include representatives from each of the cooperative groups that historically co-ordinated myeloid disease clinical trials – COG, SWOG, Alliance, and ECOG-ACRIN,” he said.
In fact, all of the National Clinical Trials Network groups have some initiative in place to address AYA concerns, said Dr Salsman, who chairs the ECOG-ACRIN AYA oncology subcommittee.
Despite these efforts, and many others, long-term survival improvements among AYAs with cancer still fall short, compared with those of other age groups.16
Next steps
Among the recommendations from authors in the AYA series in Blood is a call for assessing AYA-specific therapy in future clinical trials, as well as improved collaboration between adult and pediatric teams and the involvement of multidisciplinary teams in care for this population.
Many centers are already working on models for collaborative care, Dr Salsman said, citing the Fort Worth AYA Oncology Coalition led by medical director Karen Albritton, MD, as an example of a program that has been successful in helping clinical and supportive caregivers and their AYA patients “have a shared vision” as they work to maximize improvements in outcomes.
Patients are also taking the lead in demanding better care and attention to their psychosocial needs, Dr Hanna said. In the case of the community-powered advocacy organization Critical Mass, members have succeeded in getting lawmakers to introduce a bill in the US House of Representatives that would allow college students to defer loan payments while undergoing cancer treatment.
1. Boissel N, Baruchel A. Acute lymphoblastic leukemia in adolescent and young adults: treat as adults or as children? Blood. 2018;132:351-361.
2. Dunleavy K, Gross TG. Management of aggressive B-cell NHLs in the AYA population: an adult vs pediatric perspective. Blood. 2018;132:369-375.
3. O’Dwyer K, Freyer DR, Horan JT. Treatment strategies for adolescent and young adult patients with acute myeloid leukemia. Blood. 2018;132:362-368.
4. Flerlage JE, Metzger ML, Bhakta N. The management of Hodgkin lymphoma in adolescents and young adults: burden of disease or burden of choice? Blood. 2018;132:376-384.
5. Husson O, Huijgens PC, van der Graaf WTA. Psychosocial challenges and health-related quality of life of adolescents and young adults with hematologic malignancies. Blood. 2018;132:385-392.
6. Cortes J. Introduction to a review series on adolescent and young adult malignant hematology. Blood. 2018;132:345-346.
7. Muffly L, Alvarez E, Lichtensztajn D, Abrahão R, Gomez SL, Keegan T. Patterns of care and outcomes in adolescent and young adult acute lymphoblastic leukemia: a population-based study. Blood Adv. 2018;2(8):895-903.
8. Nathan PC, Bremner KE, Liu N, et al. Resource utilization and costs in adolescents treated for cancer in pediatric vs adult institutions. J Natl Cancer Inst. July 19, 2018. [Epub ahead of print.]
9. Parsons HM, Muffly L, Alvarez EM, Keegan THM. Does treatment setting matter? Evaluating resource utilization for adolescents treated in pediatric vs adult cancer institutions. https://academic.oup.com/jnci/advance-article/doi/10.1093/jnci/djy123/5056313?searchresult=1. Published July 19, 2018. Last accessed October 12, 2018.
10. Creutzig U, Zimmermann M, Reinhardt D, et al. Changes in cytogenetics and molecular genetics in acute myeloid leukemia from childhood to adult age groups. Cancer. 2016;122(24):3821-3830.
11. Salsman JM, Garcia SF, Yanez B, et al. Physical, emotional, and social health differences between posttreatment young adults with cancer and matched healthy controls. Cancer. 2014;120(15):2247-2254.
12. Kim ES, Bruinooge SS, Roberts S, et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research joint research statement. J Clin Oncol. 2017;35(33):3737-3744.
13. Freyer DR, Seibel NL. The clinical trials gap for adolescents and young adults with cancer: recent progress and conceptual framework for continued research. Curr Pediatr Rep. Published online February 18, 2015. DOI 10.1007/s40124-015-0075-y.
14. Nass SJ, Beaupin LK, Demark-Wahnefried W, et al. Identifying and addressing the needs of adolescents and young adults with cancer: summary of an Institute of Medicine workshop. Oncologist. 2015;20(2):186-195.
15. Wilder Smith A, Seibel NL, Lewis DR, et al. Next steps for adolescent and young adult oncology workshop: An update on progress and recommendations for the future. Cancer. 2016;122(7):988-999.
16. Keegan THM, Ries LAG, Barr RD, et al. Comparison of cancer survival trends in the United States of adolescents and young adults with those in children and older adults. Cancer. 2016;122(7):1009-1016.
Survival gains among adolescents and young adults (AYAs) with cancer continue to lag behind outcomes for children and older adult patients. It’s a trend that spans decades, but clinicians and researchers are finally getting serious about trying to understand the underlying causes and are re-examining prevailing practices in an effort to address the discrepancies.
“This is a very heterogeneous group of disorders,” Rabi Hanna, MD, a pediatric hematologist and oncologist at Cleveland Clinic Children’s Hospital, Ohio, said in an interview. He’s specifically referring to the cancers that affect AYAs, who are broadly defined as patients aged 15 through 39 years. “A few cancers, such as [acute lymphoblastic leukemia], are more common in children, and others, such as breast cancer, are more common in adults. The biology may be different in the adolescent and young adult patients, which may lead to different outcomes.”
In addition, the psychosocial needs in this age group differ vastly from those in other groups. “Many of these patients are in college or have just started their families, so we have to pay more attention to [issues related to] financial toxicity and fertility, for example,” said Dr Hanna, who is the director of pediatric bone marrow transplantation at the clinic. (The term “financial toxicity” describes the cumulative negative impact of the high cost of care, lost work time, and delays in reaching educational and career goals on patients with cancer and their families.)
Another factor that likely contributes to the outcome disparities between AYAs and other populations with cancer is the relative lack of clinical trial involvement among AYAs.
A recent series of articles published in the journal Blood addressed these and other issues, among them, whether AYAs with acute lymphoblastic leukemia (ALL)1 or aggressive B-cell non-Hodgkin lymphomas (NHLs) 2 should be treated as children or adults; treatment strategies for those with acute myeloid leukemias (AMLs); 3 management of Hodgkin lymphoma;4 and psychosocial challenges and health-related quality of life (QoL) in AYAs with hematologic malignancies.5
In the introduction to the series, Jorge Cortes, MD, an assistant editor on the journal, wrote that hematologic malignancies in AYAs “represent a unique challenge because of their special biological features and distinctive therapeutic requirements, as well as the unique medical, social, and psychological characteristics of this patient population.”6
He noted, however, that “not much has been done to explore unique molecular and biological features of AYA hematologic malignancies. The discussion on the management of AYAs often centers on whether these patients should be treated in a pediatric setting or an adult setting, or with regimens designed for children or for adults,” noted Dr Cortes, professor and chair of the chronic myeloid leukemia section in the department of leukemia at the University of Texas MD Anderson Cancer Center, Houston.
Therapeutic options: pediatric or adult protocols?
In their article on ALL in AYAs, Nicolas Boissel, MD, and André Baruchel, MD, note that the use of “fully pediatric protocols” in patients aged 15 through 20 years is supported by findings from numerous studies. In young adults, evidence increasingly supports “pediatric-inspired or even fully pediatric approaches” because they have been shown to significantly improve outcomes, with long-term survival rates nearing 70%.1 Patients in these age groups require specific programs that factor in access to care and to trials, an increased risk of acute toxicities, and treatment adherence, which can be particularly problematic in AYAs, they concluded.
However, Kristen O’Dwyer, MD, and colleagues, argue in an article on AML treatment in AYAs that neither the pediatric nor adult approaches are ideally suited for AYAs because of the “distinguishing characteristics of AYAs with AML.” Rather, they conclude that AYA-specific approaches merit consideration.3
Similarly, Kieron Dunleavy, MD, and Thomas G Gross, MD, note in an article on managing aggressive B-cell NHLs in AYAs that there is a “remarkable divide” in the treatment of patients younger than 18 years with lymphoma compared with their young adult counterparts, and that it underscores the need for collaboration in developing consensus regarding treatment of AYAs.2
Clinical setting: pediatric or adult?
Consideration is also being given to the clinical setting in which AYA patients receive their treatment. Lori Muffly, MD, MS, and colleagues have reported that survival was superior for AYA patients with ALL who were treated in pediatric cancer settings,7 and other researchers have reported similar findings.
However, those improved outcomes in the pediatric setting might be offset by a higher use of resources and therefore higher costs, based on recent findings in a Canadian study by Paul C Nathan, MD, and colleagues.8 Among 1,356 patients aged 15-17 years who were diagnosed with cancer between 1996 and 2010, the authors found that the cost of care was higher when treatment took place in a pediatric setting compared with in an adult institution, and that it was driven in part by higher hospitalization rates and longer hospital stays. These findings were true across different diagnoses, including leukemias, lymphomas, sarcomas, and germ cell tumors, but only during the initial treatment phase.
In an accompanying editorial, Helen M Parsons, PhD, and her co-authors wrote that adolescents who receive treatment in the pediatric setting “tended to seek more [emergency department (ED)] care immediately before diagnosis and during the initial treatment phase; these adolescents also used more home care services during initial treatment and survivorship.9 They pointed out that the findings of higher inpatient days in the pediatric setting was not surprising given that induction therapies for pediatric ALL tend to be more complex and intensive than therapies commonly used in adults with ALL, and that pediatric cancer hospitals tend to have a wider array of services, including psychosocial and family support services.
“What is less clear is why individuals seen in pediatric settings have higher rates of ED care directly before diagnosis and during the initial treatment phase,” they wrote, adding that further investigation was needed on this topic to better understand those trends. “The finding that adolescents treated in pediatric institutions had higher resource use across diagnostic groups demonstrates that resource utilization may be driven just as much by care setting as diagnosis.” 9
The authors of the editorial emphasized that because of the differences in health care delivery and payment structures between the United States and Canada, where the Nathan study was done, it was important that similar studies are done in the United States to confirm these findings.
Disease and developmental biology
As Dr Hanna noted, biological differences and changes over time suggest that different age groups need varying approaches to treatment and that they may have different outcomes with the same treatments.
For example, the biology of AML is known to change with age, Dr O'Dwyer and her colleagues noted,3 citing a recent European study of 5,564 patients with de novo AML that showed that the frequency of favorable cytogenetics was low in infants (13.7%), increased in children (25%) and young adults (44%), and decreased again in middle age and older patients.10
“Most unfavorable cytogenetic abnormalities are rare across all age groups, though complex cytogenetics are relatively more frequent in infants, decrease in frequency in AYAs, and then increase in frequency beyond AYA,” Dr O'Dwyer and her colleagues wrote.3 It was also becoming more apparent that age influences the presence of AML-related molecular abnormalities, and recognition of age-related differences in disease biology “will provide the best opportunity to improve the clinical outcomes that have been static for decades.”
Dr Boissel and Dr Baruchel also noted in their report that light was finally being shed on the “black hole” of understanding ALL biology in AYAs, and research has shown that there is a continuum between childhood and adult ALL.1 They concluded that “risk stratification based on recent biology findings and sequential [minimum residual disease] evaluations should now be implemented, as well as new therapeutic options including immunotherapy and targeted therapies, at best within the setting of integrated pediatric and AYA protocols.”
Psychosocial factors
“Cancer is a non-normative event for AYAs. It is extremely disruptive to them physically, psychologically, and vocationally ... and this poses significant challenges,” John Salsman, PhD, director of clinical research in AYA oncology at Wake Forest University, Winston-Salem, NC, said in an interview.
These patients have 5-year survival rates that haven’t improved in tandem with those in pediatric and adult populations over the last 3 decades, and in addition to the financial toxicity and strain, they also have higher rates of depression and anxiety, including fear of recurrence, he added. “Quality of life is incredibly important, and these things need to be addressed because of the developmental changes AYAs are navigating; there are issues of positive body image, family and career decisions ... these are challenging for anyone, and when you throw a cancer diagnosis into the mix they become disproportionately so.”
In a 2014 study, Dr Salsman and his colleagues found that AYAs with cancer had poorer physical and emotional quality of life when compared with matched controls, but better social quality of life.11 The latter finding was surprising and highlights the importance of the social dimension in the lives of AYAs. “Patient after patient will say ‘I found out who my real friends are,’ ” he said. “There’s this refinement and deepening of the social network among some posttreatment survivors.”
Dr Salsman and his colleagues are using those findings to develop interventions that can maximize self-care in posttreatment survivorship – a time when AYAs may feel they have a new lease on life and may be more motivated to adhere to recommendations and take care of themselves. For example, a randomized controlled pilot study that incorporates social media apps and other technologies to build on the positive social components of their lives in promoting physical activity interventions is underway.
Another intervention targets emotional well-being through the use of web-based tools to increase positive affect. A proof-of-concept study showed that the approach was feasible and well received, and a larger-scale randomized controlled trial is being planned, he said.
Dr Salsman also praised the PRISM (Promoting Resilience in Stress Management) tool developed by researchers at Seattle Children’s Hospital. It was created to help AYAs with cancer and other illnesses learn coping skills to manage stress after their diagnosis and to boost quality of life beyond treatment. A digital app has also been developed to be used in conjunction with the program.
Trial enrollment
In his editorial introducing the Blood series on AYAs and cancer, Dr Cortes noted a paucity of clinical trials specifically designed for this population. “At the time of this writing, I could identify four therapeutic trials registered at www.clinicaltrials.gov that appeared to be somewhat specifically designed for AYAs (some included children also),” he wrote, describing AYA enrollment in clinical trials in cancer as “suboptimal at best.”6
Dr Salsman said these dismal enrolment numbers could in part be related to treatment setting. Data suggest that most AYAs with cancer are treated in community-based practices rather than comprehensive cancer centers where the bulk of research is being done, he explained.
Dr Hanna agreed that more research involving AYAs was needed as is a better understanding of why enrollment is so much lower in this population. He pointed out that in 2017 the American Society of Clinical Oncology and Friends of Cancer Research released a statement recommending that pediatric patients be considered for enrollment in later-phase trials for cancer types that span both adults and children.12 The organizations said that individuals aged 12 years and older should routinely be included in such trials because their drug metabolism is similar to adults, and inclusion of younger patients may also be appropriate if they are part of the population affected by the disease, depending on specific disease biology, action of the drug, and available safety information.
Officials at the Food and Drug Administration are considering that possibility, Dr Hanna said.
Dr Salsman added there has been an increase in recent years in the attention paid to disparities in survival improvements and trial involvement among AYAs with cancer, compared with other age groups. For example, about 5 years ago, the National Clinical Trials Network formed a working group that developed a number of specific objectives for incorporating more AYAs into cancer trials and finding better ways to study this population;13 the Institute of Medicine held a forum on the care of AYAs with cancer;14 and the National Cancer Institute held a state-of-the-science meeting that focused on identifying strategic priorities for AYA oncology,15 he noted.
Dr Hanna added that “scientific groups such as Southwest Oncology Group (SWOG) and Children’s Oncology Group (COG) also have AYA committees now. One of the success stories of working together between SWOG and COG was the intergroup study C10403 for patients with ALL. And now there are efforts for an intergroup AYA-AML task force to include representatives from each of the cooperative groups that historically co-ordinated myeloid disease clinical trials – COG, SWOG, Alliance, and ECOG-ACRIN,” he said.
In fact, all of the National Clinical Trials Network groups have some initiative in place to address AYA concerns, said Dr Salsman, who chairs the ECOG-ACRIN AYA oncology subcommittee.
Despite these efforts, and many others, long-term survival improvements among AYAs with cancer still fall short, compared with those of other age groups.16
Next steps
Among the recommendations from authors in the AYA series in Blood is a call for assessing AYA-specific therapy in future clinical trials, as well as improved collaboration between adult and pediatric teams and the involvement of multidisciplinary teams in care for this population.
Many centers are already working on models for collaborative care, Dr Salsman said, citing the Fort Worth AYA Oncology Coalition led by medical director Karen Albritton, MD, as an example of a program that has been successful in helping clinical and supportive caregivers and their AYA patients “have a shared vision” as they work to maximize improvements in outcomes.
Patients are also taking the lead in demanding better care and attention to their psychosocial needs, Dr Hanna said. In the case of the community-powered advocacy organization Critical Mass, members have succeeded in getting lawmakers to introduce a bill in the US House of Representatives that would allow college students to defer loan payments while undergoing cancer treatment.
Survival gains among adolescents and young adults (AYAs) with cancer continue to lag behind outcomes for children and older adult patients. It’s a trend that spans decades, but clinicians and researchers are finally getting serious about trying to understand the underlying causes and are re-examining prevailing practices in an effort to address the discrepancies.
“This is a very heterogeneous group of disorders,” Rabi Hanna, MD, a pediatric hematologist and oncologist at Cleveland Clinic Children’s Hospital, Ohio, said in an interview. He’s specifically referring to the cancers that affect AYAs, who are broadly defined as patients aged 15 through 39 years. “A few cancers, such as [acute lymphoblastic leukemia], are more common in children, and others, such as breast cancer, are more common in adults. The biology may be different in the adolescent and young adult patients, which may lead to different outcomes.”
In addition, the psychosocial needs in this age group differ vastly from those in other groups. “Many of these patients are in college or have just started their families, so we have to pay more attention to [issues related to] financial toxicity and fertility, for example,” said Dr Hanna, who is the director of pediatric bone marrow transplantation at the clinic. (The term “financial toxicity” describes the cumulative negative impact of the high cost of care, lost work time, and delays in reaching educational and career goals on patients with cancer and their families.)
Another factor that likely contributes to the outcome disparities between AYAs and other populations with cancer is the relative lack of clinical trial involvement among AYAs.
A recent series of articles published in the journal Blood addressed these and other issues, among them, whether AYAs with acute lymphoblastic leukemia (ALL)1 or aggressive B-cell non-Hodgkin lymphomas (NHLs) 2 should be treated as children or adults; treatment strategies for those with acute myeloid leukemias (AMLs); 3 management of Hodgkin lymphoma;4 and psychosocial challenges and health-related quality of life (QoL) in AYAs with hematologic malignancies.5
In the introduction to the series, Jorge Cortes, MD, an assistant editor on the journal, wrote that hematologic malignancies in AYAs “represent a unique challenge because of their special biological features and distinctive therapeutic requirements, as well as the unique medical, social, and psychological characteristics of this patient population.”6
He noted, however, that “not much has been done to explore unique molecular and biological features of AYA hematologic malignancies. The discussion on the management of AYAs often centers on whether these patients should be treated in a pediatric setting or an adult setting, or with regimens designed for children or for adults,” noted Dr Cortes, professor and chair of the chronic myeloid leukemia section in the department of leukemia at the University of Texas MD Anderson Cancer Center, Houston.
Therapeutic options: pediatric or adult protocols?
In their article on ALL in AYAs, Nicolas Boissel, MD, and André Baruchel, MD, note that the use of “fully pediatric protocols” in patients aged 15 through 20 years is supported by findings from numerous studies. In young adults, evidence increasingly supports “pediatric-inspired or even fully pediatric approaches” because they have been shown to significantly improve outcomes, with long-term survival rates nearing 70%.1 Patients in these age groups require specific programs that factor in access to care and to trials, an increased risk of acute toxicities, and treatment adherence, which can be particularly problematic in AYAs, they concluded.
However, Kristen O’Dwyer, MD, and colleagues, argue in an article on AML treatment in AYAs that neither the pediatric nor adult approaches are ideally suited for AYAs because of the “distinguishing characteristics of AYAs with AML.” Rather, they conclude that AYA-specific approaches merit consideration.3
Similarly, Kieron Dunleavy, MD, and Thomas G Gross, MD, note in an article on managing aggressive B-cell NHLs in AYAs that there is a “remarkable divide” in the treatment of patients younger than 18 years with lymphoma compared with their young adult counterparts, and that it underscores the need for collaboration in developing consensus regarding treatment of AYAs.2
Clinical setting: pediatric or adult?
Consideration is also being given to the clinical setting in which AYA patients receive their treatment. Lori Muffly, MD, MS, and colleagues have reported that survival was superior for AYA patients with ALL who were treated in pediatric cancer settings,7 and other researchers have reported similar findings.
However, those improved outcomes in the pediatric setting might be offset by a higher use of resources and therefore higher costs, based on recent findings in a Canadian study by Paul C Nathan, MD, and colleagues.8 Among 1,356 patients aged 15-17 years who were diagnosed with cancer between 1996 and 2010, the authors found that the cost of care was higher when treatment took place in a pediatric setting compared with in an adult institution, and that it was driven in part by higher hospitalization rates and longer hospital stays. These findings were true across different diagnoses, including leukemias, lymphomas, sarcomas, and germ cell tumors, but only during the initial treatment phase.
In an accompanying editorial, Helen M Parsons, PhD, and her co-authors wrote that adolescents who receive treatment in the pediatric setting “tended to seek more [emergency department (ED)] care immediately before diagnosis and during the initial treatment phase; these adolescents also used more home care services during initial treatment and survivorship.9 They pointed out that the findings of higher inpatient days in the pediatric setting was not surprising given that induction therapies for pediatric ALL tend to be more complex and intensive than therapies commonly used in adults with ALL, and that pediatric cancer hospitals tend to have a wider array of services, including psychosocial and family support services.
“What is less clear is why individuals seen in pediatric settings have higher rates of ED care directly before diagnosis and during the initial treatment phase,” they wrote, adding that further investigation was needed on this topic to better understand those trends. “The finding that adolescents treated in pediatric institutions had higher resource use across diagnostic groups demonstrates that resource utilization may be driven just as much by care setting as diagnosis.” 9
The authors of the editorial emphasized that because of the differences in health care delivery and payment structures between the United States and Canada, where the Nathan study was done, it was important that similar studies are done in the United States to confirm these findings.
Disease and developmental biology
As Dr Hanna noted, biological differences and changes over time suggest that different age groups need varying approaches to treatment and that they may have different outcomes with the same treatments.
For example, the biology of AML is known to change with age, Dr O'Dwyer and her colleagues noted,3 citing a recent European study of 5,564 patients with de novo AML that showed that the frequency of favorable cytogenetics was low in infants (13.7%), increased in children (25%) and young adults (44%), and decreased again in middle age and older patients.10
“Most unfavorable cytogenetic abnormalities are rare across all age groups, though complex cytogenetics are relatively more frequent in infants, decrease in frequency in AYAs, and then increase in frequency beyond AYA,” Dr O'Dwyer and her colleagues wrote.3 It was also becoming more apparent that age influences the presence of AML-related molecular abnormalities, and recognition of age-related differences in disease biology “will provide the best opportunity to improve the clinical outcomes that have been static for decades.”
Dr Boissel and Dr Baruchel also noted in their report that light was finally being shed on the “black hole” of understanding ALL biology in AYAs, and research has shown that there is a continuum between childhood and adult ALL.1 They concluded that “risk stratification based on recent biology findings and sequential [minimum residual disease] evaluations should now be implemented, as well as new therapeutic options including immunotherapy and targeted therapies, at best within the setting of integrated pediatric and AYA protocols.”
Psychosocial factors
“Cancer is a non-normative event for AYAs. It is extremely disruptive to them physically, psychologically, and vocationally ... and this poses significant challenges,” John Salsman, PhD, director of clinical research in AYA oncology at Wake Forest University, Winston-Salem, NC, said in an interview.
These patients have 5-year survival rates that haven’t improved in tandem with those in pediatric and adult populations over the last 3 decades, and in addition to the financial toxicity and strain, they also have higher rates of depression and anxiety, including fear of recurrence, he added. “Quality of life is incredibly important, and these things need to be addressed because of the developmental changes AYAs are navigating; there are issues of positive body image, family and career decisions ... these are challenging for anyone, and when you throw a cancer diagnosis into the mix they become disproportionately so.”
In a 2014 study, Dr Salsman and his colleagues found that AYAs with cancer had poorer physical and emotional quality of life when compared with matched controls, but better social quality of life.11 The latter finding was surprising and highlights the importance of the social dimension in the lives of AYAs. “Patient after patient will say ‘I found out who my real friends are,’ ” he said. “There’s this refinement and deepening of the social network among some posttreatment survivors.”
Dr Salsman and his colleagues are using those findings to develop interventions that can maximize self-care in posttreatment survivorship – a time when AYAs may feel they have a new lease on life and may be more motivated to adhere to recommendations and take care of themselves. For example, a randomized controlled pilot study that incorporates social media apps and other technologies to build on the positive social components of their lives in promoting physical activity interventions is underway.
Another intervention targets emotional well-being through the use of web-based tools to increase positive affect. A proof-of-concept study showed that the approach was feasible and well received, and a larger-scale randomized controlled trial is being planned, he said.
Dr Salsman also praised the PRISM (Promoting Resilience in Stress Management) tool developed by researchers at Seattle Children’s Hospital. It was created to help AYAs with cancer and other illnesses learn coping skills to manage stress after their diagnosis and to boost quality of life beyond treatment. A digital app has also been developed to be used in conjunction with the program.
Trial enrollment
In his editorial introducing the Blood series on AYAs and cancer, Dr Cortes noted a paucity of clinical trials specifically designed for this population. “At the time of this writing, I could identify four therapeutic trials registered at www.clinicaltrials.gov that appeared to be somewhat specifically designed for AYAs (some included children also),” he wrote, describing AYA enrollment in clinical trials in cancer as “suboptimal at best.”6
Dr Salsman said these dismal enrolment numbers could in part be related to treatment setting. Data suggest that most AYAs with cancer are treated in community-based practices rather than comprehensive cancer centers where the bulk of research is being done, he explained.
Dr Hanna agreed that more research involving AYAs was needed as is a better understanding of why enrollment is so much lower in this population. He pointed out that in 2017 the American Society of Clinical Oncology and Friends of Cancer Research released a statement recommending that pediatric patients be considered for enrollment in later-phase trials for cancer types that span both adults and children.12 The organizations said that individuals aged 12 years and older should routinely be included in such trials because their drug metabolism is similar to adults, and inclusion of younger patients may also be appropriate if they are part of the population affected by the disease, depending on specific disease biology, action of the drug, and available safety information.
Officials at the Food and Drug Administration are considering that possibility, Dr Hanna said.
Dr Salsman added there has been an increase in recent years in the attention paid to disparities in survival improvements and trial involvement among AYAs with cancer, compared with other age groups. For example, about 5 years ago, the National Clinical Trials Network formed a working group that developed a number of specific objectives for incorporating more AYAs into cancer trials and finding better ways to study this population;13 the Institute of Medicine held a forum on the care of AYAs with cancer;14 and the National Cancer Institute held a state-of-the-science meeting that focused on identifying strategic priorities for AYA oncology,15 he noted.
Dr Hanna added that “scientific groups such as Southwest Oncology Group (SWOG) and Children’s Oncology Group (COG) also have AYA committees now. One of the success stories of working together between SWOG and COG was the intergroup study C10403 for patients with ALL. And now there are efforts for an intergroup AYA-AML task force to include representatives from each of the cooperative groups that historically co-ordinated myeloid disease clinical trials – COG, SWOG, Alliance, and ECOG-ACRIN,” he said.
In fact, all of the National Clinical Trials Network groups have some initiative in place to address AYA concerns, said Dr Salsman, who chairs the ECOG-ACRIN AYA oncology subcommittee.
Despite these efforts, and many others, long-term survival improvements among AYAs with cancer still fall short, compared with those of other age groups.16
Next steps
Among the recommendations from authors in the AYA series in Blood is a call for assessing AYA-specific therapy in future clinical trials, as well as improved collaboration between adult and pediatric teams and the involvement of multidisciplinary teams in care for this population.
Many centers are already working on models for collaborative care, Dr Salsman said, citing the Fort Worth AYA Oncology Coalition led by medical director Karen Albritton, MD, as an example of a program that has been successful in helping clinical and supportive caregivers and their AYA patients “have a shared vision” as they work to maximize improvements in outcomes.
Patients are also taking the lead in demanding better care and attention to their psychosocial needs, Dr Hanna said. In the case of the community-powered advocacy organization Critical Mass, members have succeeded in getting lawmakers to introduce a bill in the US House of Representatives that would allow college students to defer loan payments while undergoing cancer treatment.
1. Boissel N, Baruchel A. Acute lymphoblastic leukemia in adolescent and young adults: treat as adults or as children? Blood. 2018;132:351-361.
2. Dunleavy K, Gross TG. Management of aggressive B-cell NHLs in the AYA population: an adult vs pediatric perspective. Blood. 2018;132:369-375.
3. O’Dwyer K, Freyer DR, Horan JT. Treatment strategies for adolescent and young adult patients with acute myeloid leukemia. Blood. 2018;132:362-368.
4. Flerlage JE, Metzger ML, Bhakta N. The management of Hodgkin lymphoma in adolescents and young adults: burden of disease or burden of choice? Blood. 2018;132:376-384.
5. Husson O, Huijgens PC, van der Graaf WTA. Psychosocial challenges and health-related quality of life of adolescents and young adults with hematologic malignancies. Blood. 2018;132:385-392.
6. Cortes J. Introduction to a review series on adolescent and young adult malignant hematology. Blood. 2018;132:345-346.
7. Muffly L, Alvarez E, Lichtensztajn D, Abrahão R, Gomez SL, Keegan T. Patterns of care and outcomes in adolescent and young adult acute lymphoblastic leukemia: a population-based study. Blood Adv. 2018;2(8):895-903.
8. Nathan PC, Bremner KE, Liu N, et al. Resource utilization and costs in adolescents treated for cancer in pediatric vs adult institutions. J Natl Cancer Inst. July 19, 2018. [Epub ahead of print.]
9. Parsons HM, Muffly L, Alvarez EM, Keegan THM. Does treatment setting matter? Evaluating resource utilization for adolescents treated in pediatric vs adult cancer institutions. https://academic.oup.com/jnci/advance-article/doi/10.1093/jnci/djy123/5056313?searchresult=1. Published July 19, 2018. Last accessed October 12, 2018.
10. Creutzig U, Zimmermann M, Reinhardt D, et al. Changes in cytogenetics and molecular genetics in acute myeloid leukemia from childhood to adult age groups. Cancer. 2016;122(24):3821-3830.
11. Salsman JM, Garcia SF, Yanez B, et al. Physical, emotional, and social health differences between posttreatment young adults with cancer and matched healthy controls. Cancer. 2014;120(15):2247-2254.
12. Kim ES, Bruinooge SS, Roberts S, et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research joint research statement. J Clin Oncol. 2017;35(33):3737-3744.
13. Freyer DR, Seibel NL. The clinical trials gap for adolescents and young adults with cancer: recent progress and conceptual framework for continued research. Curr Pediatr Rep. Published online February 18, 2015. DOI 10.1007/s40124-015-0075-y.
14. Nass SJ, Beaupin LK, Demark-Wahnefried W, et al. Identifying and addressing the needs of adolescents and young adults with cancer: summary of an Institute of Medicine workshop. Oncologist. 2015;20(2):186-195.
15. Wilder Smith A, Seibel NL, Lewis DR, et al. Next steps for adolescent and young adult oncology workshop: An update on progress and recommendations for the future. Cancer. 2016;122(7):988-999.
16. Keegan THM, Ries LAG, Barr RD, et al. Comparison of cancer survival trends in the United States of adolescents and young adults with those in children and older adults. Cancer. 2016;122(7):1009-1016.
1. Boissel N, Baruchel A. Acute lymphoblastic leukemia in adolescent and young adults: treat as adults or as children? Blood. 2018;132:351-361.
2. Dunleavy K, Gross TG. Management of aggressive B-cell NHLs in the AYA population: an adult vs pediatric perspective. Blood. 2018;132:369-375.
3. O’Dwyer K, Freyer DR, Horan JT. Treatment strategies for adolescent and young adult patients with acute myeloid leukemia. Blood. 2018;132:362-368.
4. Flerlage JE, Metzger ML, Bhakta N. The management of Hodgkin lymphoma in adolescents and young adults: burden of disease or burden of choice? Blood. 2018;132:376-384.
5. Husson O, Huijgens PC, van der Graaf WTA. Psychosocial challenges and health-related quality of life of adolescents and young adults with hematologic malignancies. Blood. 2018;132:385-392.
6. Cortes J. Introduction to a review series on adolescent and young adult malignant hematology. Blood. 2018;132:345-346.
7. Muffly L, Alvarez E, Lichtensztajn D, Abrahão R, Gomez SL, Keegan T. Patterns of care and outcomes in adolescent and young adult acute lymphoblastic leukemia: a population-based study. Blood Adv. 2018;2(8):895-903.
8. Nathan PC, Bremner KE, Liu N, et al. Resource utilization and costs in adolescents treated for cancer in pediatric vs adult institutions. J Natl Cancer Inst. July 19, 2018. [Epub ahead of print.]
9. Parsons HM, Muffly L, Alvarez EM, Keegan THM. Does treatment setting matter? Evaluating resource utilization for adolescents treated in pediatric vs adult cancer institutions. https://academic.oup.com/jnci/advance-article/doi/10.1093/jnci/djy123/5056313?searchresult=1. Published July 19, 2018. Last accessed October 12, 2018.
10. Creutzig U, Zimmermann M, Reinhardt D, et al. Changes in cytogenetics and molecular genetics in acute myeloid leukemia from childhood to adult age groups. Cancer. 2016;122(24):3821-3830.
11. Salsman JM, Garcia SF, Yanez B, et al. Physical, emotional, and social health differences between posttreatment young adults with cancer and matched healthy controls. Cancer. 2014;120(15):2247-2254.
12. Kim ES, Bruinooge SS, Roberts S, et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research joint research statement. J Clin Oncol. 2017;35(33):3737-3744.
13. Freyer DR, Seibel NL. The clinical trials gap for adolescents and young adults with cancer: recent progress and conceptual framework for continued research. Curr Pediatr Rep. Published online February 18, 2015. DOI 10.1007/s40124-015-0075-y.
14. Nass SJ, Beaupin LK, Demark-Wahnefried W, et al. Identifying and addressing the needs of adolescents and young adults with cancer: summary of an Institute of Medicine workshop. Oncologist. 2015;20(2):186-195.
15. Wilder Smith A, Seibel NL, Lewis DR, et al. Next steps for adolescent and young adult oncology workshop: An update on progress and recommendations for the future. Cancer. 2016;122(7):988-999.
16. Keegan THM, Ries LAG, Barr RD, et al. Comparison of cancer survival trends in the United States of adolescents and young adults with those in children and older adults. Cancer. 2016;122(7):1009-1016.
Pathologic superstition
When you believe in things that you don’t understand
Then you suffer
Superstition ain’t the way
– Stevie Wonder
I have always found it odd that airplanes don’t have a 13th row and hotels don’t have a 13th floor. Well, of course they do, but they are not labeled that way. Many people would hesitate to sit in the 13th row of an airplane since 13 is such an unlucky number. At least many people in the United States think the number 13 is unlucky. Thirteen is just a number in much of Asia. There, the number 4 is just as threatening as 13 is to us.
Superstitions like these are familiar to all of us.
One of my favorites is the belief that vacuum cups attached to the skin will somehow draw out toxins and generally improve health. “Cupping,” as the practice is known, is endorsed by several celebrities and famous athletes. After the treatment, a cupped patient exhibits circles of hyperemia, and no other apparent harm. I suspect that about a third of cupped patients truly think they have benefited from a good cupping, about the same number that would benefit from an orally administered placebo.
Superstitions are everywhere. Whether it is a black cat in the United States, infinite reflecting mirrors in Mexico, going back to your house after a wake in the Philippines, or whistling indoors in Lithuania, superstitions are pervasive, deeply held, and generally harmless. They are good for a good laugh as we recognize how ludicrous these unfounded fears are.
Some superstitions, though, are no laughing matter. They can be quite harmful. They are pathologic superstitions.
For example, some people believe vaccines cause autism in children. That pathologic superstition has consequences. A recent CDC report revealed that the population of unvaccinated children in the United States has quadrupled since 2001. This comes as no surprise as we hear about more measles outbreaks – and the deaths associated with them – in populations of unvaccinated children every year. A similar and pervasive pathologic superstition is the fear that an influenza vaccine will cause the flu. I wonder how many people die from this misconception.
Other people believe that their cancer can be treated, if not cured, with unproven, unconventional treatments. I cannot understand how this pathologic superstition developed. The purveyors of unconventional treatment hold much of the blame, but gullibility and ignorance may play a larger role. The consequences are tragic. A recent report demonstrated an approximately twofold increased risk of death in patients who used complementary therapies, compared with those who did not (JAMA Oncol. 2018 Oct 1;4[10]:1375-81).
These are sobering data for those of us who have in the past relented when our patients asked if they could take this or that supplement because we did not think they would cause significant harm.
Superstitions apparently are part of the human condition, evolved to attribute causation and provide order. They are a learned phenomenon. They are learned by reasonable people with normal intelligence and rational thinking. A superstition is born when someone is exposed to a false statement by someone or something they trust – a trusted other.
Trusted others exude certainty. Once established, superstitions are regrettably difficult to remove by those who are less certain, like physicians. How willing are we to say that the flu vaccine is 100% safe? Without certainty, how can a physician debunk a superstition? The techniques that we have been taught usually work, but not when faced with a pathologic superstition.
Science and experience teach us that firmly held superstitions cannot be broken with logical, stepwise reasoning. Jonathan Haidt provides a useful metaphor for this problem in his book “The Happiness Hypothesis” (Basic Books, 2006). He describes a rider on an elephant. The rider represents our rational thought and the elephant represents our emotional foundation. The rider thinks he controls the elephant, but the opposite is more likely true. In order to move the elephant in a certain direction, the rider needs to make the elephant want to turn in that direction. Otherwise, all the cajoling and arguing in the world won’t make the elephant turn. A rational argument made to someone emotionally invested in the counter argument will fail. That is why we cannot convince antivaccine parents to vaccinate their children by trying to persuade them with facts. Neither can we convince global warming skeptics to stop burning coal, gun advocates to vote for restrictions on gun ownership, or cancer patients to accept curative treatment if their values and morals are being challenged.
In a later book, “The Righteous Mind: Why Good People Are Divided by Politics and Religion” (Vintage Books, 2012), Mr. Haidt expands his hypothesis to declare that to change minds, we must appeal to underlying moral values. The challenge is to identify those moral underpinnings in our patients in order to develop an appeal likely to resonate with their emotions and values.
Superstition derives from something people learn either from trusted others or from personal experience. It does no good for physicians to deride patient beliefs and denigrate their agency in an attempt to persuade them to abandon what we consider irrational beliefs. For physicians to penetrate pathologic superstitions, they will have to become the trusted other, to understand moral foundations, to emotionally connect. That does not usually happen the first day we meet a new patient, especially a skeptical one. It takes time, and effort, to reach out and bond with the patient and their family. Only then can pathologic superstitions dissolve and a better patient-doctor relationship evolve.
During this season rife with superstition, remember that your patient’s own superstitions are part of their belief system, and your belief system may be threatening to them. Make your beliefs less threatening, become a trusted other, and appeal to their foundational values, and you can successfully break a pathologic superstition.
Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].
When you believe in things that you don’t understand
Then you suffer
Superstition ain’t the way
– Stevie Wonder
I have always found it odd that airplanes don’t have a 13th row and hotels don’t have a 13th floor. Well, of course they do, but they are not labeled that way. Many people would hesitate to sit in the 13th row of an airplane since 13 is such an unlucky number. At least many people in the United States think the number 13 is unlucky. Thirteen is just a number in much of Asia. There, the number 4 is just as threatening as 13 is to us.
Superstitions like these are familiar to all of us.
One of my favorites is the belief that vacuum cups attached to the skin will somehow draw out toxins and generally improve health. “Cupping,” as the practice is known, is endorsed by several celebrities and famous athletes. After the treatment, a cupped patient exhibits circles of hyperemia, and no other apparent harm. I suspect that about a third of cupped patients truly think they have benefited from a good cupping, about the same number that would benefit from an orally administered placebo.
Superstitions are everywhere. Whether it is a black cat in the United States, infinite reflecting mirrors in Mexico, going back to your house after a wake in the Philippines, or whistling indoors in Lithuania, superstitions are pervasive, deeply held, and generally harmless. They are good for a good laugh as we recognize how ludicrous these unfounded fears are.
Some superstitions, though, are no laughing matter. They can be quite harmful. They are pathologic superstitions.
For example, some people believe vaccines cause autism in children. That pathologic superstition has consequences. A recent CDC report revealed that the population of unvaccinated children in the United States has quadrupled since 2001. This comes as no surprise as we hear about more measles outbreaks – and the deaths associated with them – in populations of unvaccinated children every year. A similar and pervasive pathologic superstition is the fear that an influenza vaccine will cause the flu. I wonder how many people die from this misconception.
Other people believe that their cancer can be treated, if not cured, with unproven, unconventional treatments. I cannot understand how this pathologic superstition developed. The purveyors of unconventional treatment hold much of the blame, but gullibility and ignorance may play a larger role. The consequences are tragic. A recent report demonstrated an approximately twofold increased risk of death in patients who used complementary therapies, compared with those who did not (JAMA Oncol. 2018 Oct 1;4[10]:1375-81).
These are sobering data for those of us who have in the past relented when our patients asked if they could take this or that supplement because we did not think they would cause significant harm.
Superstitions apparently are part of the human condition, evolved to attribute causation and provide order. They are a learned phenomenon. They are learned by reasonable people with normal intelligence and rational thinking. A superstition is born when someone is exposed to a false statement by someone or something they trust – a trusted other.
Trusted others exude certainty. Once established, superstitions are regrettably difficult to remove by those who are less certain, like physicians. How willing are we to say that the flu vaccine is 100% safe? Without certainty, how can a physician debunk a superstition? The techniques that we have been taught usually work, but not when faced with a pathologic superstition.
Science and experience teach us that firmly held superstitions cannot be broken with logical, stepwise reasoning. Jonathan Haidt provides a useful metaphor for this problem in his book “The Happiness Hypothesis” (Basic Books, 2006). He describes a rider on an elephant. The rider represents our rational thought and the elephant represents our emotional foundation. The rider thinks he controls the elephant, but the opposite is more likely true. In order to move the elephant in a certain direction, the rider needs to make the elephant want to turn in that direction. Otherwise, all the cajoling and arguing in the world won’t make the elephant turn. A rational argument made to someone emotionally invested in the counter argument will fail. That is why we cannot convince antivaccine parents to vaccinate their children by trying to persuade them with facts. Neither can we convince global warming skeptics to stop burning coal, gun advocates to vote for restrictions on gun ownership, or cancer patients to accept curative treatment if their values and morals are being challenged.
In a later book, “The Righteous Mind: Why Good People Are Divided by Politics and Religion” (Vintage Books, 2012), Mr. Haidt expands his hypothesis to declare that to change minds, we must appeal to underlying moral values. The challenge is to identify those moral underpinnings in our patients in order to develop an appeal likely to resonate with their emotions and values.
Superstition derives from something people learn either from trusted others or from personal experience. It does no good for physicians to deride patient beliefs and denigrate their agency in an attempt to persuade them to abandon what we consider irrational beliefs. For physicians to penetrate pathologic superstitions, they will have to become the trusted other, to understand moral foundations, to emotionally connect. That does not usually happen the first day we meet a new patient, especially a skeptical one. It takes time, and effort, to reach out and bond with the patient and their family. Only then can pathologic superstitions dissolve and a better patient-doctor relationship evolve.
During this season rife with superstition, remember that your patient’s own superstitions are part of their belief system, and your belief system may be threatening to them. Make your beliefs less threatening, become a trusted other, and appeal to their foundational values, and you can successfully break a pathologic superstition.
Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].
When you believe in things that you don’t understand
Then you suffer
Superstition ain’t the way
– Stevie Wonder
I have always found it odd that airplanes don’t have a 13th row and hotels don’t have a 13th floor. Well, of course they do, but they are not labeled that way. Many people would hesitate to sit in the 13th row of an airplane since 13 is such an unlucky number. At least many people in the United States think the number 13 is unlucky. Thirteen is just a number in much of Asia. There, the number 4 is just as threatening as 13 is to us.
Superstitions like these are familiar to all of us.
One of my favorites is the belief that vacuum cups attached to the skin will somehow draw out toxins and generally improve health. “Cupping,” as the practice is known, is endorsed by several celebrities and famous athletes. After the treatment, a cupped patient exhibits circles of hyperemia, and no other apparent harm. I suspect that about a third of cupped patients truly think they have benefited from a good cupping, about the same number that would benefit from an orally administered placebo.
Superstitions are everywhere. Whether it is a black cat in the United States, infinite reflecting mirrors in Mexico, going back to your house after a wake in the Philippines, or whistling indoors in Lithuania, superstitions are pervasive, deeply held, and generally harmless. They are good for a good laugh as we recognize how ludicrous these unfounded fears are.
Some superstitions, though, are no laughing matter. They can be quite harmful. They are pathologic superstitions.
For example, some people believe vaccines cause autism in children. That pathologic superstition has consequences. A recent CDC report revealed that the population of unvaccinated children in the United States has quadrupled since 2001. This comes as no surprise as we hear about more measles outbreaks – and the deaths associated with them – in populations of unvaccinated children every year. A similar and pervasive pathologic superstition is the fear that an influenza vaccine will cause the flu. I wonder how many people die from this misconception.
Other people believe that their cancer can be treated, if not cured, with unproven, unconventional treatments. I cannot understand how this pathologic superstition developed. The purveyors of unconventional treatment hold much of the blame, but gullibility and ignorance may play a larger role. The consequences are tragic. A recent report demonstrated an approximately twofold increased risk of death in patients who used complementary therapies, compared with those who did not (JAMA Oncol. 2018 Oct 1;4[10]:1375-81).
These are sobering data for those of us who have in the past relented when our patients asked if they could take this or that supplement because we did not think they would cause significant harm.
Superstitions apparently are part of the human condition, evolved to attribute causation and provide order. They are a learned phenomenon. They are learned by reasonable people with normal intelligence and rational thinking. A superstition is born when someone is exposed to a false statement by someone or something they trust – a trusted other.
Trusted others exude certainty. Once established, superstitions are regrettably difficult to remove by those who are less certain, like physicians. How willing are we to say that the flu vaccine is 100% safe? Without certainty, how can a physician debunk a superstition? The techniques that we have been taught usually work, but not when faced with a pathologic superstition.
Science and experience teach us that firmly held superstitions cannot be broken with logical, stepwise reasoning. Jonathan Haidt provides a useful metaphor for this problem in his book “The Happiness Hypothesis” (Basic Books, 2006). He describes a rider on an elephant. The rider represents our rational thought and the elephant represents our emotional foundation. The rider thinks he controls the elephant, but the opposite is more likely true. In order to move the elephant in a certain direction, the rider needs to make the elephant want to turn in that direction. Otherwise, all the cajoling and arguing in the world won’t make the elephant turn. A rational argument made to someone emotionally invested in the counter argument will fail. That is why we cannot convince antivaccine parents to vaccinate their children by trying to persuade them with facts. Neither can we convince global warming skeptics to stop burning coal, gun advocates to vote for restrictions on gun ownership, or cancer patients to accept curative treatment if their values and morals are being challenged.
In a later book, “The Righteous Mind: Why Good People Are Divided by Politics and Religion” (Vintage Books, 2012), Mr. Haidt expands his hypothesis to declare that to change minds, we must appeal to underlying moral values. The challenge is to identify those moral underpinnings in our patients in order to develop an appeal likely to resonate with their emotions and values.
Superstition derives from something people learn either from trusted others or from personal experience. It does no good for physicians to deride patient beliefs and denigrate their agency in an attempt to persuade them to abandon what we consider irrational beliefs. For physicians to penetrate pathologic superstitions, they will have to become the trusted other, to understand moral foundations, to emotionally connect. That does not usually happen the first day we meet a new patient, especially a skeptical one. It takes time, and effort, to reach out and bond with the patient and their family. Only then can pathologic superstitions dissolve and a better patient-doctor relationship evolve.
During this season rife with superstition, remember that your patient’s own superstitions are part of their belief system, and your belief system may be threatening to them. Make your beliefs less threatening, become a trusted other, and appeal to their foundational values, and you can successfully break a pathologic superstition.
Dr. Kalaycio is editor in chief of Hematology News. He chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].
Palliative care update highlights role of nonspecialists
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.