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EHA webinar addresses treating AML patients with COVID-19
A hematologist in Italy shared his personal experience addressing the intersection of COVID-19 and the care of acute myeloid leukemia (AML) patients during a webinar hosted by the European Hematology Association (EHA).
Felicetto Ferrara, MD, of Cardarelli Hospital in Naples, Italy, discussed the main difficulties in administering optimal treatment for AML patients who become infected with SARS-CoV-2.
The major problems include the need to isolate patients while simultaneously allowing for collaboration with pulmonologists and intensivists, the delays in AML treatment caused by COVID-19, and the risk of drug-drug interactions while treating AML patients with COVID-19.
The need to isolate AML patients with COVID-19 is paramount, according to Dr. Ferrara. Isolation can be accomplished, ideally, by the creation of a dedicated COVID-19 unit or, alternatively, with the use of single-patient negative pressure rooms. Dr. Ferrara stressed that all patients with AML should be tested for COVID-19 before admission.
Delaying or reducing AML treatment
Treatment delays are of particular concern, according to Dr. Ferrara, and some patients may require dose reductions, especially for AML treatments that might have a detrimental effect on the immune system.
Decisions must be made as to whether planned approaches to induction or consolidation therapy should be changed, and special concern has to be paid to elderly AML patients, who have the highest risks of bad COVID-19 outcomes.
Specific attention should be paid to patients with acute promyelocytic leukemia as well, according to Dr. Ferrara. These patients are of concern in the COVID-19 era because of their risk of differentiation syndrome, which can induce respiratory distress.
In all cases, autologous or allogeneic stem cell transplant should be deferred until confirmed COVID-19–negative test results are obtained.
Continuing AML treatment
Of particular concern is the fact that, without a standard therapy for COVID-19, many different drugs might be used in treatment efforts. This raises the potential for serious drug-drug interactions with the patient’s AML medications, so close attention should be paid to an individual patient’s medications.
In terms of continuing AML treatment for younger adults (less than 65 years) who are positive for COVID-19, symptomatic and asymptomatic patients should be treated differently, Dr. Ferarra said.
Symptomatic patients should be given hydroxyurea until symptom resolution, and unless urgent, any further AML treatments should be delayed. However, if treatment is needed immediately, it should be given in a COVID-19–dedicated unit.
The restrictions are much looser for young adult asymptomatic COVID-19 patients with AML. Standard induction therapy should be given, with intermediate-dose cytarabine used as consolidation therapy.
Therapy in elderly patients with AML and COVID-19 should be based on symptom status as well, said Dr. Ferrara.
Asymptomatic but otherwise fit elderly patients should have standard induction therapy if they are in the European Leukemia Network favorable genetic subgroup. Asymptomatic elderly patients with high-risk molecular disease can receive venetoclax with a hypomethylating agent.
Symptomatic elderly patients should continue with hydroxyurea until symptom resolution, and any other treatments should be delayed in nonemergency cases.
Relapsed AML patients with COVID-19 should have their treatments postponed until they obtain negative COVID-19 test results whenever possible, Dr. Ferarra said. However, if treatment is necessary, molecularly targeted therapies (gilteritinib, ivosidenib, and enasidenib) are preferable to high-dose chemotherapy.
In all cases, treatment decisions should be made in conjunction with pulmonologists and intensivists, Dr. Ferrera noted.
Webinar moderator Francesco Cerisoli, MD, head of research and mentoring at EHA, highlighted the fact that EHA has published specific recommendations for treating AML patients during the COVID-19 pandemic. The majority of these were discussed by and are aligned with the recommendations presented by Dr. Ferrara.
The EHA webinar contains a disclaimer that the content discussed was based on the personal experiences and opinions of the speakers and that no general, evidence-based guidance could be derived from the discussion. There were no disclosures given.
A hematologist in Italy shared his personal experience addressing the intersection of COVID-19 and the care of acute myeloid leukemia (AML) patients during a webinar hosted by the European Hematology Association (EHA).
Felicetto Ferrara, MD, of Cardarelli Hospital in Naples, Italy, discussed the main difficulties in administering optimal treatment for AML patients who become infected with SARS-CoV-2.
The major problems include the need to isolate patients while simultaneously allowing for collaboration with pulmonologists and intensivists, the delays in AML treatment caused by COVID-19, and the risk of drug-drug interactions while treating AML patients with COVID-19.
The need to isolate AML patients with COVID-19 is paramount, according to Dr. Ferrara. Isolation can be accomplished, ideally, by the creation of a dedicated COVID-19 unit or, alternatively, with the use of single-patient negative pressure rooms. Dr. Ferrara stressed that all patients with AML should be tested for COVID-19 before admission.
Delaying or reducing AML treatment
Treatment delays are of particular concern, according to Dr. Ferrara, and some patients may require dose reductions, especially for AML treatments that might have a detrimental effect on the immune system.
Decisions must be made as to whether planned approaches to induction or consolidation therapy should be changed, and special concern has to be paid to elderly AML patients, who have the highest risks of bad COVID-19 outcomes.
Specific attention should be paid to patients with acute promyelocytic leukemia as well, according to Dr. Ferrara. These patients are of concern in the COVID-19 era because of their risk of differentiation syndrome, which can induce respiratory distress.
In all cases, autologous or allogeneic stem cell transplant should be deferred until confirmed COVID-19–negative test results are obtained.
Continuing AML treatment
Of particular concern is the fact that, without a standard therapy for COVID-19, many different drugs might be used in treatment efforts. This raises the potential for serious drug-drug interactions with the patient’s AML medications, so close attention should be paid to an individual patient’s medications.
In terms of continuing AML treatment for younger adults (less than 65 years) who are positive for COVID-19, symptomatic and asymptomatic patients should be treated differently, Dr. Ferarra said.
Symptomatic patients should be given hydroxyurea until symptom resolution, and unless urgent, any further AML treatments should be delayed. However, if treatment is needed immediately, it should be given in a COVID-19–dedicated unit.
The restrictions are much looser for young adult asymptomatic COVID-19 patients with AML. Standard induction therapy should be given, with intermediate-dose cytarabine used as consolidation therapy.
Therapy in elderly patients with AML and COVID-19 should be based on symptom status as well, said Dr. Ferrara.
Asymptomatic but otherwise fit elderly patients should have standard induction therapy if they are in the European Leukemia Network favorable genetic subgroup. Asymptomatic elderly patients with high-risk molecular disease can receive venetoclax with a hypomethylating agent.
Symptomatic elderly patients should continue with hydroxyurea until symptom resolution, and any other treatments should be delayed in nonemergency cases.
Relapsed AML patients with COVID-19 should have their treatments postponed until they obtain negative COVID-19 test results whenever possible, Dr. Ferarra said. However, if treatment is necessary, molecularly targeted therapies (gilteritinib, ivosidenib, and enasidenib) are preferable to high-dose chemotherapy.
In all cases, treatment decisions should be made in conjunction with pulmonologists and intensivists, Dr. Ferrera noted.
Webinar moderator Francesco Cerisoli, MD, head of research and mentoring at EHA, highlighted the fact that EHA has published specific recommendations for treating AML patients during the COVID-19 pandemic. The majority of these were discussed by and are aligned with the recommendations presented by Dr. Ferrara.
The EHA webinar contains a disclaimer that the content discussed was based on the personal experiences and opinions of the speakers and that no general, evidence-based guidance could be derived from the discussion. There were no disclosures given.
A hematologist in Italy shared his personal experience addressing the intersection of COVID-19 and the care of acute myeloid leukemia (AML) patients during a webinar hosted by the European Hematology Association (EHA).
Felicetto Ferrara, MD, of Cardarelli Hospital in Naples, Italy, discussed the main difficulties in administering optimal treatment for AML patients who become infected with SARS-CoV-2.
The major problems include the need to isolate patients while simultaneously allowing for collaboration with pulmonologists and intensivists, the delays in AML treatment caused by COVID-19, and the risk of drug-drug interactions while treating AML patients with COVID-19.
The need to isolate AML patients with COVID-19 is paramount, according to Dr. Ferrara. Isolation can be accomplished, ideally, by the creation of a dedicated COVID-19 unit or, alternatively, with the use of single-patient negative pressure rooms. Dr. Ferrara stressed that all patients with AML should be tested for COVID-19 before admission.
Delaying or reducing AML treatment
Treatment delays are of particular concern, according to Dr. Ferrara, and some patients may require dose reductions, especially for AML treatments that might have a detrimental effect on the immune system.
Decisions must be made as to whether planned approaches to induction or consolidation therapy should be changed, and special concern has to be paid to elderly AML patients, who have the highest risks of bad COVID-19 outcomes.
Specific attention should be paid to patients with acute promyelocytic leukemia as well, according to Dr. Ferrara. These patients are of concern in the COVID-19 era because of their risk of differentiation syndrome, which can induce respiratory distress.
In all cases, autologous or allogeneic stem cell transplant should be deferred until confirmed COVID-19–negative test results are obtained.
Continuing AML treatment
Of particular concern is the fact that, without a standard therapy for COVID-19, many different drugs might be used in treatment efforts. This raises the potential for serious drug-drug interactions with the patient’s AML medications, so close attention should be paid to an individual patient’s medications.
In terms of continuing AML treatment for younger adults (less than 65 years) who are positive for COVID-19, symptomatic and asymptomatic patients should be treated differently, Dr. Ferarra said.
Symptomatic patients should be given hydroxyurea until symptom resolution, and unless urgent, any further AML treatments should be delayed. However, if treatment is needed immediately, it should be given in a COVID-19–dedicated unit.
The restrictions are much looser for young adult asymptomatic COVID-19 patients with AML. Standard induction therapy should be given, with intermediate-dose cytarabine used as consolidation therapy.
Therapy in elderly patients with AML and COVID-19 should be based on symptom status as well, said Dr. Ferrara.
Asymptomatic but otherwise fit elderly patients should have standard induction therapy if they are in the European Leukemia Network favorable genetic subgroup. Asymptomatic elderly patients with high-risk molecular disease can receive venetoclax with a hypomethylating agent.
Symptomatic elderly patients should continue with hydroxyurea until symptom resolution, and any other treatments should be delayed in nonemergency cases.
Relapsed AML patients with COVID-19 should have their treatments postponed until they obtain negative COVID-19 test results whenever possible, Dr. Ferarra said. However, if treatment is necessary, molecularly targeted therapies (gilteritinib, ivosidenib, and enasidenib) are preferable to high-dose chemotherapy.
In all cases, treatment decisions should be made in conjunction with pulmonologists and intensivists, Dr. Ferrera noted.
Webinar moderator Francesco Cerisoli, MD, head of research and mentoring at EHA, highlighted the fact that EHA has published specific recommendations for treating AML patients during the COVID-19 pandemic. The majority of these were discussed by and are aligned with the recommendations presented by Dr. Ferrara.
The EHA webinar contains a disclaimer that the content discussed was based on the personal experiences and opinions of the speakers and that no general, evidence-based guidance could be derived from the discussion. There were no disclosures given.
ASCO panel outlines cancer care challenges during COVID-19 pandemic
The COVID-19 pandemic continues to exact a heavy price on cancer patients, cancer care, and clinical trials, an expert panel reported during a presscast.
“Limited data available thus far are sobering: In Italy, about 20% of COVID-related deaths occurred in people with cancer, and, in China, COVID-19 patients who had cancer were about five times more likely than others to die or be placed on a ventilator in an intensive care unit,” said Howard A “Skip” Burris, MD, president of the American Society of Clinical Oncology and president and CEO of the Sarah Cannon Cancer Institute in Nashville, Tenn.
“We also have little evidence on returning COVID-19 patients with cancer. Physicians have to rely on limited data, anecdotal reports, and their own professional expertise” regarding the extent of increased risk to cancer patients with COVID-19, whether to interrupt or modify treatment, and the effects of cancer on recovery from COVID-19 infection, Dr. Burris said during the ASCO-sponsored online presscast.
Care of COVID-free patients
For cancer patients without COVID-19, the picture is equally dim, with the prospect of delayed surgery, chemotherapy, or screening; shortages of medications and equipment needed for critical care; the shift to telemedicine that may increase patient anxiety; and the potential loss of access to innovative therapies through clinical trials, Dr. Burris said.
“We’re concerned that some hospitals have effectively deemed all cancer surgeries to be elective, requiring them to be postponed. For patients with fast-moving or hard-to-treat cancer, this delay may be devastating,” he said.
Dr. Burris also cited concerns about delayed cancer diagnosis. “In a typical month, roughly 150,000 Americans are diagnosed with cancer. But right now, routine screening visits are postponed, and patients with pain or other warning signs may put off a doctor’s visit because of social distancing,” he said.
The pandemic has also exacerbated shortages of sedatives and opioid analgesics required for intubation and mechanical ventilation of patients.
Trials halted or slowed
Dr. Burris also briefly discussed results of a new survey, which were posted online ahead of publication in JCO Oncology Practice. The survey showed that, of 14 academic and 18 community-based cancer programs, 59.4% reported halting screening and/or enrollment for at least some clinical trials and suspending research-based clinical visits except for those where cancer treatment was delivered.
“Half of respondents reported ceasing research-only blood and/or tissue collections,” the authors of the article reported.
“Trial interruptions are devastating news for thousands of patients; in many cases, clinical trials are the best or only appropriate option for care,” Dr. Burris said.
The article authors, led by David Waterhouse, MD, of Oncology Hematology Care in Cincinnati, pointed to a silver lining in the pandemic cloud in the form of opportunities to improve clinical trials going forward.
“Nearly all respondents (90.3%) identified telehealth visits for participants as a potential improvement to clinical trial conduct, and more than three-quarters (77.4%) indicated that remote patient review of symptoms held similar potential,” the authors wrote.
Other potential improvements included remote site visits from trial sponsors and/or contract research organizations, more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessments of adverse events, and streamlined data collection.
Lessons from the front lines
Another member of the presscast panel, Melissa Dillmon, MD, of the Harbin Clinic Cancer Center in Rome, Georgia, described the experience of community oncologists during the pandemic.
Her community, located in northeastern Georgia, experienced a COVID-19 outbreak in early March linked to services at two large churches. Community public health authorities issued a shelter-in-place order before the state government issued stay-at-home guidelines and shuttered all but essential business, some of which were allowed by state order to reopen as of April 24.
Dr. Dillmon’s center began screening patients for COVID-19 symptoms at the door, limited visitors or companions, instituted virtual visits and tumor boards, and set up a cancer treatment triage system that would allow essential surgeries to proceed and most infusions to continue, while delaying the start of chemotherapy when possible.
“We have encouraged patients to continue on treatment, especially if treatment is being given with curative intent, or if the cancer is responding well already to treatment,” she said.
The center, located in a community with a high prevalence of comorbidities and high incidence of lung cancer, has seen a sharp decline in colonoscopies, mammograms, and lung scans as patient shelter in place.
“We have great concerns about patients missing their screening lung scans, as this program has already proven to be finding earlier lung cancers that are curable,” Dr. Dillmon said.
A view from Washington state
Another panel member, Gary Lyman, MD, of the Fred Hutchinson Cancer Research Center in Seattle, described the response by the state of Washington, the initial epicenter of the COVID-19 outbreak in the United States.
Following identification of infections in hospitalized patients and at a nursing home in Kirkland, Washington, “our response, which began in early March and progressed through the second and third week in March at the state level, was to restrict large gatherings; progressively, schools were closed; larger businesses closed; and, by March 23, a stay-at-home policy was implemented, and all nonessential businesses were closed,” Dr. Lyman said.
“We believe, based on what has happened since that time, that this has considerably flattened the curve,” he continued.
Lessons from the Washington experience include the need to plan for a long-term disruption or alteration of cancer care, expand COVID-19 testing to all patients coming into hospitals or major clinics, institute aggressive supportive care measures, prepare for subsequent waves of infection, collect and share data, and, for remote or rural areas, identify lifelines to needed resources, Dr. Lyman said.
ASCO resources
Also speaking at the presscast, Jonathan Marron, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, outlined ASCO’s guidance on allocation of scarce resources during the COVID-19 pandemic.
Richard L. Schilsky, MD, ASCO chief medical officer and executive vice president, outlined community-wide collaborations, data initiatives, and online resources for both clinicians and patients.
The COVID-19 pandemic continues to exact a heavy price on cancer patients, cancer care, and clinical trials, an expert panel reported during a presscast.
“Limited data available thus far are sobering: In Italy, about 20% of COVID-related deaths occurred in people with cancer, and, in China, COVID-19 patients who had cancer were about five times more likely than others to die or be placed on a ventilator in an intensive care unit,” said Howard A “Skip” Burris, MD, president of the American Society of Clinical Oncology and president and CEO of the Sarah Cannon Cancer Institute in Nashville, Tenn.
“We also have little evidence on returning COVID-19 patients with cancer. Physicians have to rely on limited data, anecdotal reports, and their own professional expertise” regarding the extent of increased risk to cancer patients with COVID-19, whether to interrupt or modify treatment, and the effects of cancer on recovery from COVID-19 infection, Dr. Burris said during the ASCO-sponsored online presscast.
Care of COVID-free patients
For cancer patients without COVID-19, the picture is equally dim, with the prospect of delayed surgery, chemotherapy, or screening; shortages of medications and equipment needed for critical care; the shift to telemedicine that may increase patient anxiety; and the potential loss of access to innovative therapies through clinical trials, Dr. Burris said.
“We’re concerned that some hospitals have effectively deemed all cancer surgeries to be elective, requiring them to be postponed. For patients with fast-moving or hard-to-treat cancer, this delay may be devastating,” he said.
Dr. Burris also cited concerns about delayed cancer diagnosis. “In a typical month, roughly 150,000 Americans are diagnosed with cancer. But right now, routine screening visits are postponed, and patients with pain or other warning signs may put off a doctor’s visit because of social distancing,” he said.
The pandemic has also exacerbated shortages of sedatives and opioid analgesics required for intubation and mechanical ventilation of patients.
Trials halted or slowed
Dr. Burris also briefly discussed results of a new survey, which were posted online ahead of publication in JCO Oncology Practice. The survey showed that, of 14 academic and 18 community-based cancer programs, 59.4% reported halting screening and/or enrollment for at least some clinical trials and suspending research-based clinical visits except for those where cancer treatment was delivered.
“Half of respondents reported ceasing research-only blood and/or tissue collections,” the authors of the article reported.
“Trial interruptions are devastating news for thousands of patients; in many cases, clinical trials are the best or only appropriate option for care,” Dr. Burris said.
The article authors, led by David Waterhouse, MD, of Oncology Hematology Care in Cincinnati, pointed to a silver lining in the pandemic cloud in the form of opportunities to improve clinical trials going forward.
“Nearly all respondents (90.3%) identified telehealth visits for participants as a potential improvement to clinical trial conduct, and more than three-quarters (77.4%) indicated that remote patient review of symptoms held similar potential,” the authors wrote.
Other potential improvements included remote site visits from trial sponsors and/or contract research organizations, more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessments of adverse events, and streamlined data collection.
Lessons from the front lines
Another member of the presscast panel, Melissa Dillmon, MD, of the Harbin Clinic Cancer Center in Rome, Georgia, described the experience of community oncologists during the pandemic.
Her community, located in northeastern Georgia, experienced a COVID-19 outbreak in early March linked to services at two large churches. Community public health authorities issued a shelter-in-place order before the state government issued stay-at-home guidelines and shuttered all but essential business, some of which were allowed by state order to reopen as of April 24.
Dr. Dillmon’s center began screening patients for COVID-19 symptoms at the door, limited visitors or companions, instituted virtual visits and tumor boards, and set up a cancer treatment triage system that would allow essential surgeries to proceed and most infusions to continue, while delaying the start of chemotherapy when possible.
“We have encouraged patients to continue on treatment, especially if treatment is being given with curative intent, or if the cancer is responding well already to treatment,” she said.
The center, located in a community with a high prevalence of comorbidities and high incidence of lung cancer, has seen a sharp decline in colonoscopies, mammograms, and lung scans as patient shelter in place.
“We have great concerns about patients missing their screening lung scans, as this program has already proven to be finding earlier lung cancers that are curable,” Dr. Dillmon said.
A view from Washington state
Another panel member, Gary Lyman, MD, of the Fred Hutchinson Cancer Research Center in Seattle, described the response by the state of Washington, the initial epicenter of the COVID-19 outbreak in the United States.
Following identification of infections in hospitalized patients and at a nursing home in Kirkland, Washington, “our response, which began in early March and progressed through the second and third week in March at the state level, was to restrict large gatherings; progressively, schools were closed; larger businesses closed; and, by March 23, a stay-at-home policy was implemented, and all nonessential businesses were closed,” Dr. Lyman said.
“We believe, based on what has happened since that time, that this has considerably flattened the curve,” he continued.
Lessons from the Washington experience include the need to plan for a long-term disruption or alteration of cancer care, expand COVID-19 testing to all patients coming into hospitals or major clinics, institute aggressive supportive care measures, prepare for subsequent waves of infection, collect and share data, and, for remote or rural areas, identify lifelines to needed resources, Dr. Lyman said.
ASCO resources
Also speaking at the presscast, Jonathan Marron, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, outlined ASCO’s guidance on allocation of scarce resources during the COVID-19 pandemic.
Richard L. Schilsky, MD, ASCO chief medical officer and executive vice president, outlined community-wide collaborations, data initiatives, and online resources for both clinicians and patients.
The COVID-19 pandemic continues to exact a heavy price on cancer patients, cancer care, and clinical trials, an expert panel reported during a presscast.
“Limited data available thus far are sobering: In Italy, about 20% of COVID-related deaths occurred in people with cancer, and, in China, COVID-19 patients who had cancer were about five times more likely than others to die or be placed on a ventilator in an intensive care unit,” said Howard A “Skip” Burris, MD, president of the American Society of Clinical Oncology and president and CEO of the Sarah Cannon Cancer Institute in Nashville, Tenn.
“We also have little evidence on returning COVID-19 patients with cancer. Physicians have to rely on limited data, anecdotal reports, and their own professional expertise” regarding the extent of increased risk to cancer patients with COVID-19, whether to interrupt or modify treatment, and the effects of cancer on recovery from COVID-19 infection, Dr. Burris said during the ASCO-sponsored online presscast.
Care of COVID-free patients
For cancer patients without COVID-19, the picture is equally dim, with the prospect of delayed surgery, chemotherapy, or screening; shortages of medications and equipment needed for critical care; the shift to telemedicine that may increase patient anxiety; and the potential loss of access to innovative therapies through clinical trials, Dr. Burris said.
“We’re concerned that some hospitals have effectively deemed all cancer surgeries to be elective, requiring them to be postponed. For patients with fast-moving or hard-to-treat cancer, this delay may be devastating,” he said.
Dr. Burris also cited concerns about delayed cancer diagnosis. “In a typical month, roughly 150,000 Americans are diagnosed with cancer. But right now, routine screening visits are postponed, and patients with pain or other warning signs may put off a doctor’s visit because of social distancing,” he said.
The pandemic has also exacerbated shortages of sedatives and opioid analgesics required for intubation and mechanical ventilation of patients.
Trials halted or slowed
Dr. Burris also briefly discussed results of a new survey, which were posted online ahead of publication in JCO Oncology Practice. The survey showed that, of 14 academic and 18 community-based cancer programs, 59.4% reported halting screening and/or enrollment for at least some clinical trials and suspending research-based clinical visits except for those where cancer treatment was delivered.
“Half of respondents reported ceasing research-only blood and/or tissue collections,” the authors of the article reported.
“Trial interruptions are devastating news for thousands of patients; in many cases, clinical trials are the best or only appropriate option for care,” Dr. Burris said.
The article authors, led by David Waterhouse, MD, of Oncology Hematology Care in Cincinnati, pointed to a silver lining in the pandemic cloud in the form of opportunities to improve clinical trials going forward.
“Nearly all respondents (90.3%) identified telehealth visits for participants as a potential improvement to clinical trial conduct, and more than three-quarters (77.4%) indicated that remote patient review of symptoms held similar potential,” the authors wrote.
Other potential improvements included remote site visits from trial sponsors and/or contract research organizations, more efficient study enrollment through secure electronic platforms, direct shipment of oral drugs to patients, remote assessments of adverse events, and streamlined data collection.
Lessons from the front lines
Another member of the presscast panel, Melissa Dillmon, MD, of the Harbin Clinic Cancer Center in Rome, Georgia, described the experience of community oncologists during the pandemic.
Her community, located in northeastern Georgia, experienced a COVID-19 outbreak in early March linked to services at two large churches. Community public health authorities issued a shelter-in-place order before the state government issued stay-at-home guidelines and shuttered all but essential business, some of which were allowed by state order to reopen as of April 24.
Dr. Dillmon’s center began screening patients for COVID-19 symptoms at the door, limited visitors or companions, instituted virtual visits and tumor boards, and set up a cancer treatment triage system that would allow essential surgeries to proceed and most infusions to continue, while delaying the start of chemotherapy when possible.
“We have encouraged patients to continue on treatment, especially if treatment is being given with curative intent, or if the cancer is responding well already to treatment,” she said.
The center, located in a community with a high prevalence of comorbidities and high incidence of lung cancer, has seen a sharp decline in colonoscopies, mammograms, and lung scans as patient shelter in place.
“We have great concerns about patients missing their screening lung scans, as this program has already proven to be finding earlier lung cancers that are curable,” Dr. Dillmon said.
A view from Washington state
Another panel member, Gary Lyman, MD, of the Fred Hutchinson Cancer Research Center in Seattle, described the response by the state of Washington, the initial epicenter of the COVID-19 outbreak in the United States.
Following identification of infections in hospitalized patients and at a nursing home in Kirkland, Washington, “our response, which began in early March and progressed through the second and third week in March at the state level, was to restrict large gatherings; progressively, schools were closed; larger businesses closed; and, by March 23, a stay-at-home policy was implemented, and all nonessential businesses were closed,” Dr. Lyman said.
“We believe, based on what has happened since that time, that this has considerably flattened the curve,” he continued.
Lessons from the Washington experience include the need to plan for a long-term disruption or alteration of cancer care, expand COVID-19 testing to all patients coming into hospitals or major clinics, institute aggressive supportive care measures, prepare for subsequent waves of infection, collect and share data, and, for remote or rural areas, identify lifelines to needed resources, Dr. Lyman said.
ASCO resources
Also speaking at the presscast, Jonathan Marron, MD, of Boston Children’s Hospital and Harvard Medical School, Boston, outlined ASCO’s guidance on allocation of scarce resources during the COVID-19 pandemic.
Richard L. Schilsky, MD, ASCO chief medical officer and executive vice president, outlined community-wide collaborations, data initiatives, and online resources for both clinicians and patients.
Six million childhood cancer deaths could be prevented over the next 30 years
Unless global investments are made to improve care worldwide, 11.1 million children will die from cancer over the next 30 years; 9.3 million of them (84%) will be in low- and lower-middle–income countries, according to a report in Lancet Oncology.
The report suggests that one in two new cases of childhood cancer are undiagnosed in low- and middle-income countries. If that trend continues, the number of children with cancer who are never diagnosed over the next 3 decades will exceed the number of those who are diagnosed.
Childhood cancer “is not complex, expensive, difficult to diagnose, or complicated to treat,” yet there’s a “worldwide inequity and a bleak picture for children with cancer” in low-income and middle-income countries, according to the report authors. The authors are 44 oncologists, pediatricians, and global health experts from around the world, led by Rifat Atun, MD, a professor of global health systems at Harvard University in Boston.
“For too long, there has been a widespread misconception that caring for children with cancer in low- and middle-income countries is expensive, unattainable, and inappropriate because of competing health priorities. Nothing could be further from the truth,” Dr. Atun said in a statement.
Dr. Atun and colleagues argued that the burden of childhood cancer “could be vastly reduced with new funding to scale up cost-effective interventions.” In fact, the authors estimated that scaling up interventions could prevent 6.2 million childhood cancer deaths between 2020 and 2050.
The reduction in deaths would translate to 318.4 million life-years gained, which would, in turn, translate to a global lifetime productivity gain of $2,580 billion, four times greater than the cumulative cost of $594 billion. This would mean a net return of $3 for every $1 spent.
Potential funders include governments, professional organizations, philanthropic groups, and industry, according to the authors. They also laid out the following six-pronged framework on how to proceed:
- Include childhood cancer in universal health coverage.
- Develop national cancer control plans for low-income and middle-income countries.
- End out-of-pocket costs for childhood cancer.
- Establish national and regional cancer networks to increase access to care.
- Expand population-based cancer registries to include children.
- Invest in research and innovations in low-income and middle-income countries.
“Success will be attained through political leadership, global solidarity, collective action, inclusive participation of all major stakeholders, and alignment of national and global efforts to expand access to effective and sustainable care for children with cancer,” the authors wrote.
No funding sources were reported. The authors didn’t have any disclosures.
SOURCE: Atun R et al. Lancet Oncol. 2020 Apr;21(4):e185-224.
Unless global investments are made to improve care worldwide, 11.1 million children will die from cancer over the next 30 years; 9.3 million of them (84%) will be in low- and lower-middle–income countries, according to a report in Lancet Oncology.
The report suggests that one in two new cases of childhood cancer are undiagnosed in low- and middle-income countries. If that trend continues, the number of children with cancer who are never diagnosed over the next 3 decades will exceed the number of those who are diagnosed.
Childhood cancer “is not complex, expensive, difficult to diagnose, or complicated to treat,” yet there’s a “worldwide inequity and a bleak picture for children with cancer” in low-income and middle-income countries, according to the report authors. The authors are 44 oncologists, pediatricians, and global health experts from around the world, led by Rifat Atun, MD, a professor of global health systems at Harvard University in Boston.
“For too long, there has been a widespread misconception that caring for children with cancer in low- and middle-income countries is expensive, unattainable, and inappropriate because of competing health priorities. Nothing could be further from the truth,” Dr. Atun said in a statement.
Dr. Atun and colleagues argued that the burden of childhood cancer “could be vastly reduced with new funding to scale up cost-effective interventions.” In fact, the authors estimated that scaling up interventions could prevent 6.2 million childhood cancer deaths between 2020 and 2050.
The reduction in deaths would translate to 318.4 million life-years gained, which would, in turn, translate to a global lifetime productivity gain of $2,580 billion, four times greater than the cumulative cost of $594 billion. This would mean a net return of $3 for every $1 spent.
Potential funders include governments, professional organizations, philanthropic groups, and industry, according to the authors. They also laid out the following six-pronged framework on how to proceed:
- Include childhood cancer in universal health coverage.
- Develop national cancer control plans for low-income and middle-income countries.
- End out-of-pocket costs for childhood cancer.
- Establish national and regional cancer networks to increase access to care.
- Expand population-based cancer registries to include children.
- Invest in research and innovations in low-income and middle-income countries.
“Success will be attained through political leadership, global solidarity, collective action, inclusive participation of all major stakeholders, and alignment of national and global efforts to expand access to effective and sustainable care for children with cancer,” the authors wrote.
No funding sources were reported. The authors didn’t have any disclosures.
SOURCE: Atun R et al. Lancet Oncol. 2020 Apr;21(4):e185-224.
Unless global investments are made to improve care worldwide, 11.1 million children will die from cancer over the next 30 years; 9.3 million of them (84%) will be in low- and lower-middle–income countries, according to a report in Lancet Oncology.
The report suggests that one in two new cases of childhood cancer are undiagnosed in low- and middle-income countries. If that trend continues, the number of children with cancer who are never diagnosed over the next 3 decades will exceed the number of those who are diagnosed.
Childhood cancer “is not complex, expensive, difficult to diagnose, or complicated to treat,” yet there’s a “worldwide inequity and a bleak picture for children with cancer” in low-income and middle-income countries, according to the report authors. The authors are 44 oncologists, pediatricians, and global health experts from around the world, led by Rifat Atun, MD, a professor of global health systems at Harvard University in Boston.
“For too long, there has been a widespread misconception that caring for children with cancer in low- and middle-income countries is expensive, unattainable, and inappropriate because of competing health priorities. Nothing could be further from the truth,” Dr. Atun said in a statement.
Dr. Atun and colleagues argued that the burden of childhood cancer “could be vastly reduced with new funding to scale up cost-effective interventions.” In fact, the authors estimated that scaling up interventions could prevent 6.2 million childhood cancer deaths between 2020 and 2050.
The reduction in deaths would translate to 318.4 million life-years gained, which would, in turn, translate to a global lifetime productivity gain of $2,580 billion, four times greater than the cumulative cost of $594 billion. This would mean a net return of $3 for every $1 spent.
Potential funders include governments, professional organizations, philanthropic groups, and industry, according to the authors. They also laid out the following six-pronged framework on how to proceed:
- Include childhood cancer in universal health coverage.
- Develop national cancer control plans for low-income and middle-income countries.
- End out-of-pocket costs for childhood cancer.
- Establish national and regional cancer networks to increase access to care.
- Expand population-based cancer registries to include children.
- Invest in research and innovations in low-income and middle-income countries.
“Success will be attained through political leadership, global solidarity, collective action, inclusive participation of all major stakeholders, and alignment of national and global efforts to expand access to effective and sustainable care for children with cancer,” the authors wrote.
No funding sources were reported. The authors didn’t have any disclosures.
SOURCE: Atun R et al. Lancet Oncol. 2020 Apr;21(4):e185-224.
FROM LANCET ONCOLOGY
Will coronavirus restrictions lead to more advanced cancers?
My pathology lab once faced a daily flood of colon polyps, pap smears, and prostate biopsies. Suddenly, our work has dried up. The coronavirus pandemic has cleared out operating rooms and clinics across the country. Endoscopy and radiology suites have gone dark.
Pathology is largely driven by mass screening programs, and the machinery of screening has grinded to a halt during the COVID-19 pandemic. The American Cancer Society currently recommends that “no one should go to a health care facility for routine cancer screening at this time.”
But malignancies are still growing and spreading even though a great deal of medical care is on hold. The most urgent cancer care is still taking place; the risks of delaying treatment for patients with advanced or symptomatic cancer are obvious—these tumors can cause severe pain and life-threatening complications.
But that leaves us with a more complex and uncomfortable question: Will the pause in screening ultimately leave patients with tiny, asymptomatic cancers or precursor lesions worse off? What will a delay mean for those with ductal carcinoma in situ or small breast cancers? What’s the long-term effect of all those dysplastic nevi and early melanoma left unexcised by dermatologists? Perhaps more troubling, what about the spreading kidney cancer that may have turned up as an incidental finding on a CT scan?
COVID-19: A natural experiment
For many years, we’ve been dealing with the other side of the screening question: overdiagnosing and treating cancers that would probably never harm the patient. Overdiagnosis has been on a decades-long rise due to organized screening like PSA testing and mammography, as well as through ad hoc detection from heavier use of medical imaging. All of these have been disrupted by the pandemic.
Because the correlation between medical interventions and cancer overdiagnosis is clear, we can safely assume that overdiagnosis will decline during the pandemic. But what will be the net effect? Early detection of cancer undoubtedly saves some lives, but how many and at what cost has been a seemingly intractable debate.
Until now.
The coronavirus outbreak will be a natural experiment like no other. Economists and epidemiologists love to study “natural experiments” – systemic shocks that shed light on a complex phenomenon.
The unexpected nationwide delay in screening will undoubtedly inform the debate on overdiagnosis. For one, we can learn whether less intensive screening leads to more advanced cancers. Because screening will probably return to normal at different times across the country, we can almost simulate a randomized trial. Will this transformative data be a silver lining to this awful time?
The pressure to ‘fight’
The pandemic has also raised a question about cancer screening that goes beyond data: Why has the loud epidemic of coronavirus so thoroughly trumped cancer’s silent one? To me, the necessary urgency of our coronavirus response stands in stark contrast to the overly aggressive public health messaging used for cancer screening.
The tools used to fight the coronavirus epidemic have been forceful. We’re all diligently washing our hands and staying inside. We’re making sacrifices in our jobs and personal lives to stop the virus’ spread.
Cancer screening has similarly been touted as dogma – an urgent public health intervention that only a fool would turn down. The American Cancer Society once ran an infamous advertisement suggesting that if you decline mammography, you “need more than your breasts examined.” Even today, well-intentioned organizations run cancer screening drives pushing people to pledge to “get screened now.” It is no surprise, then, that I have had patients and family members confide in me that they feel guilty about not pursuing all of their recommended screening tests. The thought of anyone feeling like they caused their own cancer appalls me.
This pressure extends into the clinic. In many practices, primary care doctors are evaluated based on how many patients “comply” with screening recommendations. There seems to be a relentless drive to reach 100% screening penetration. These oversimplified tactics run counter to the shared decision making and informed consent we profess to value in medicine.
The tricky thing about cancer screening is that because most people will never develop the cancer being screened for, we know that most people can also never be helped by it. This doesn’t make screening useless, just as washing your hands can help even if it doesn’t guarantee that you won’t catch coronavirus. We know that some individuals benefit, which we detect at the population level. Overdiagnosis arises in the same way, as a phenomenon detected within populations and not individuals. These aspects of screening are what has led to cancer being viewed as a “societal disease” requiring a uniform response – 100% screening compliance.
Metaphors of war
These assumptions fall apart now that we are facing a real societal disease, an infectious disease outbreak. Coronavirus has made us reflect on what actions individuals should take in order to protect others. But cancer is not a contagion. When we decide whether and how to screen, we make intimate decisions affecting primarily ourselves and our family – not society at large.
Countless articles have been written about the use of metaphor in cancer, perhaps most famously by essayist and breast cancer patient Susan Sontag. Sontag and others have been critical of the rampant use of war metaphors in the cancer community. Wars invoke sacrifice, duty, and suffering. The “battle” against coronavirus really puts the “war on cancer” in perspective. These pandemic weeks have terrified me. I have been willing to do anything to protect myself and others. They’ve also exhausted me. We can’t be at war forever.
When this current war ends, will the “war on cancer” resume unchanged? Screening will no doubt begin again, hopefully improved by data from the coronavirus natural experiment. But I wonder whether we will tolerate the same kinds of public health messages – and whether we should – having now experienced an infectious disease outbreak where our actions as individuals really do have an impact on the health of others.
After feeling helpless, besieged, and even guilt-ridden during the pandemic, I think many people would appreciate regaining a sense of control over other aspects of their health. Cancer screening can save lives, but it’s a choice we should make for ourselves based on an understanding of the trade-offs and our own preferences. When screening restarts, I hope its paternalistic dogma can be replaced by nuanced, empowering tactics more appropriate for peacetime.
Benjamin Mazer, MD, MBA, is an anatomic and clinical pathology resident at Yale with interests in diagnostic surgical pathology, laboratory management, and evidence-based medicine.
This article first appeared on Medscape.com.
My pathology lab once faced a daily flood of colon polyps, pap smears, and prostate biopsies. Suddenly, our work has dried up. The coronavirus pandemic has cleared out operating rooms and clinics across the country. Endoscopy and radiology suites have gone dark.
Pathology is largely driven by mass screening programs, and the machinery of screening has grinded to a halt during the COVID-19 pandemic. The American Cancer Society currently recommends that “no one should go to a health care facility for routine cancer screening at this time.”
But malignancies are still growing and spreading even though a great deal of medical care is on hold. The most urgent cancer care is still taking place; the risks of delaying treatment for patients with advanced or symptomatic cancer are obvious—these tumors can cause severe pain and life-threatening complications.
But that leaves us with a more complex and uncomfortable question: Will the pause in screening ultimately leave patients with tiny, asymptomatic cancers or precursor lesions worse off? What will a delay mean for those with ductal carcinoma in situ or small breast cancers? What’s the long-term effect of all those dysplastic nevi and early melanoma left unexcised by dermatologists? Perhaps more troubling, what about the spreading kidney cancer that may have turned up as an incidental finding on a CT scan?
COVID-19: A natural experiment
For many years, we’ve been dealing with the other side of the screening question: overdiagnosing and treating cancers that would probably never harm the patient. Overdiagnosis has been on a decades-long rise due to organized screening like PSA testing and mammography, as well as through ad hoc detection from heavier use of medical imaging. All of these have been disrupted by the pandemic.
Because the correlation between medical interventions and cancer overdiagnosis is clear, we can safely assume that overdiagnosis will decline during the pandemic. But what will be the net effect? Early detection of cancer undoubtedly saves some lives, but how many and at what cost has been a seemingly intractable debate.
Until now.
The coronavirus outbreak will be a natural experiment like no other. Economists and epidemiologists love to study “natural experiments” – systemic shocks that shed light on a complex phenomenon.
The unexpected nationwide delay in screening will undoubtedly inform the debate on overdiagnosis. For one, we can learn whether less intensive screening leads to more advanced cancers. Because screening will probably return to normal at different times across the country, we can almost simulate a randomized trial. Will this transformative data be a silver lining to this awful time?
The pressure to ‘fight’
The pandemic has also raised a question about cancer screening that goes beyond data: Why has the loud epidemic of coronavirus so thoroughly trumped cancer’s silent one? To me, the necessary urgency of our coronavirus response stands in stark contrast to the overly aggressive public health messaging used for cancer screening.
The tools used to fight the coronavirus epidemic have been forceful. We’re all diligently washing our hands and staying inside. We’re making sacrifices in our jobs and personal lives to stop the virus’ spread.
Cancer screening has similarly been touted as dogma – an urgent public health intervention that only a fool would turn down. The American Cancer Society once ran an infamous advertisement suggesting that if you decline mammography, you “need more than your breasts examined.” Even today, well-intentioned organizations run cancer screening drives pushing people to pledge to “get screened now.” It is no surprise, then, that I have had patients and family members confide in me that they feel guilty about not pursuing all of their recommended screening tests. The thought of anyone feeling like they caused their own cancer appalls me.
This pressure extends into the clinic. In many practices, primary care doctors are evaluated based on how many patients “comply” with screening recommendations. There seems to be a relentless drive to reach 100% screening penetration. These oversimplified tactics run counter to the shared decision making and informed consent we profess to value in medicine.
The tricky thing about cancer screening is that because most people will never develop the cancer being screened for, we know that most people can also never be helped by it. This doesn’t make screening useless, just as washing your hands can help even if it doesn’t guarantee that you won’t catch coronavirus. We know that some individuals benefit, which we detect at the population level. Overdiagnosis arises in the same way, as a phenomenon detected within populations and not individuals. These aspects of screening are what has led to cancer being viewed as a “societal disease” requiring a uniform response – 100% screening compliance.
Metaphors of war
These assumptions fall apart now that we are facing a real societal disease, an infectious disease outbreak. Coronavirus has made us reflect on what actions individuals should take in order to protect others. But cancer is not a contagion. When we decide whether and how to screen, we make intimate decisions affecting primarily ourselves and our family – not society at large.
Countless articles have been written about the use of metaphor in cancer, perhaps most famously by essayist and breast cancer patient Susan Sontag. Sontag and others have been critical of the rampant use of war metaphors in the cancer community. Wars invoke sacrifice, duty, and suffering. The “battle” against coronavirus really puts the “war on cancer” in perspective. These pandemic weeks have terrified me. I have been willing to do anything to protect myself and others. They’ve also exhausted me. We can’t be at war forever.
When this current war ends, will the “war on cancer” resume unchanged? Screening will no doubt begin again, hopefully improved by data from the coronavirus natural experiment. But I wonder whether we will tolerate the same kinds of public health messages – and whether we should – having now experienced an infectious disease outbreak where our actions as individuals really do have an impact on the health of others.
After feeling helpless, besieged, and even guilt-ridden during the pandemic, I think many people would appreciate regaining a sense of control over other aspects of their health. Cancer screening can save lives, but it’s a choice we should make for ourselves based on an understanding of the trade-offs and our own preferences. When screening restarts, I hope its paternalistic dogma can be replaced by nuanced, empowering tactics more appropriate for peacetime.
Benjamin Mazer, MD, MBA, is an anatomic and clinical pathology resident at Yale with interests in diagnostic surgical pathology, laboratory management, and evidence-based medicine.
This article first appeared on Medscape.com.
My pathology lab once faced a daily flood of colon polyps, pap smears, and prostate biopsies. Suddenly, our work has dried up. The coronavirus pandemic has cleared out operating rooms and clinics across the country. Endoscopy and radiology suites have gone dark.
Pathology is largely driven by mass screening programs, and the machinery of screening has grinded to a halt during the COVID-19 pandemic. The American Cancer Society currently recommends that “no one should go to a health care facility for routine cancer screening at this time.”
But malignancies are still growing and spreading even though a great deal of medical care is on hold. The most urgent cancer care is still taking place; the risks of delaying treatment for patients with advanced or symptomatic cancer are obvious—these tumors can cause severe pain and life-threatening complications.
But that leaves us with a more complex and uncomfortable question: Will the pause in screening ultimately leave patients with tiny, asymptomatic cancers or precursor lesions worse off? What will a delay mean for those with ductal carcinoma in situ or small breast cancers? What’s the long-term effect of all those dysplastic nevi and early melanoma left unexcised by dermatologists? Perhaps more troubling, what about the spreading kidney cancer that may have turned up as an incidental finding on a CT scan?
COVID-19: A natural experiment
For many years, we’ve been dealing with the other side of the screening question: overdiagnosing and treating cancers that would probably never harm the patient. Overdiagnosis has been on a decades-long rise due to organized screening like PSA testing and mammography, as well as through ad hoc detection from heavier use of medical imaging. All of these have been disrupted by the pandemic.
Because the correlation between medical interventions and cancer overdiagnosis is clear, we can safely assume that overdiagnosis will decline during the pandemic. But what will be the net effect? Early detection of cancer undoubtedly saves some lives, but how many and at what cost has been a seemingly intractable debate.
Until now.
The coronavirus outbreak will be a natural experiment like no other. Economists and epidemiologists love to study “natural experiments” – systemic shocks that shed light on a complex phenomenon.
The unexpected nationwide delay in screening will undoubtedly inform the debate on overdiagnosis. For one, we can learn whether less intensive screening leads to more advanced cancers. Because screening will probably return to normal at different times across the country, we can almost simulate a randomized trial. Will this transformative data be a silver lining to this awful time?
The pressure to ‘fight’
The pandemic has also raised a question about cancer screening that goes beyond data: Why has the loud epidemic of coronavirus so thoroughly trumped cancer’s silent one? To me, the necessary urgency of our coronavirus response stands in stark contrast to the overly aggressive public health messaging used for cancer screening.
The tools used to fight the coronavirus epidemic have been forceful. We’re all diligently washing our hands and staying inside. We’re making sacrifices in our jobs and personal lives to stop the virus’ spread.
Cancer screening has similarly been touted as dogma – an urgent public health intervention that only a fool would turn down. The American Cancer Society once ran an infamous advertisement suggesting that if you decline mammography, you “need more than your breasts examined.” Even today, well-intentioned organizations run cancer screening drives pushing people to pledge to “get screened now.” It is no surprise, then, that I have had patients and family members confide in me that they feel guilty about not pursuing all of their recommended screening tests. The thought of anyone feeling like they caused their own cancer appalls me.
This pressure extends into the clinic. In many practices, primary care doctors are evaluated based on how many patients “comply” with screening recommendations. There seems to be a relentless drive to reach 100% screening penetration. These oversimplified tactics run counter to the shared decision making and informed consent we profess to value in medicine.
The tricky thing about cancer screening is that because most people will never develop the cancer being screened for, we know that most people can also never be helped by it. This doesn’t make screening useless, just as washing your hands can help even if it doesn’t guarantee that you won’t catch coronavirus. We know that some individuals benefit, which we detect at the population level. Overdiagnosis arises in the same way, as a phenomenon detected within populations and not individuals. These aspects of screening are what has led to cancer being viewed as a “societal disease” requiring a uniform response – 100% screening compliance.
Metaphors of war
These assumptions fall apart now that we are facing a real societal disease, an infectious disease outbreak. Coronavirus has made us reflect on what actions individuals should take in order to protect others. But cancer is not a contagion. When we decide whether and how to screen, we make intimate decisions affecting primarily ourselves and our family – not society at large.
Countless articles have been written about the use of metaphor in cancer, perhaps most famously by essayist and breast cancer patient Susan Sontag. Sontag and others have been critical of the rampant use of war metaphors in the cancer community. Wars invoke sacrifice, duty, and suffering. The “battle” against coronavirus really puts the “war on cancer” in perspective. These pandemic weeks have terrified me. I have been willing to do anything to protect myself and others. They’ve also exhausted me. We can’t be at war forever.
When this current war ends, will the “war on cancer” resume unchanged? Screening will no doubt begin again, hopefully improved by data from the coronavirus natural experiment. But I wonder whether we will tolerate the same kinds of public health messages – and whether we should – having now experienced an infectious disease outbreak where our actions as individuals really do have an impact on the health of others.
After feeling helpless, besieged, and even guilt-ridden during the pandemic, I think many people would appreciate regaining a sense of control over other aspects of their health. Cancer screening can save lives, but it’s a choice we should make for ourselves based on an understanding of the trade-offs and our own preferences. When screening restarts, I hope its paternalistic dogma can be replaced by nuanced, empowering tactics more appropriate for peacetime.
Benjamin Mazer, MD, MBA, is an anatomic and clinical pathology resident at Yale with interests in diagnostic surgical pathology, laboratory management, and evidence-based medicine.
This article first appeared on Medscape.com.
FDA approves ibrutinib-rituximab combo for newly diagnosed CLL, SLL in adults
The Food and Drug Administration has expanded the indication for ibrutinib (Imbruvica) to allow its combination with rituximab for frontline treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults.
The approval, announced April 21, was based on findings from the randomized, controlled, open-label, phase 3 E1912 trial of 529 patients, which demonstrated significantly improved progression-free survival (PFS) among those who received ibrutinib plus rituximab, compared with those who received fludarabine, cyclophosphamide, and rituximab (FCR) (87% vs. 75%; hazard ratio, 0.34). Median PFS was not reached in either arm after a median follow-up of 37 months.
E1912 was the first study to show superiority of a chemotherapy-free regimen over FCR chemoimmunotherapy, considered the gold standard for newly diagnosed CLL and SLL for the past 2 decades.
The recommended dosage for the newly approved combination is a once-daily 420-mg dose of ibrutinib taken with a glass of water, with rituximab initiation in the second cycle at doses of 50 mg/m2 on day 1, 325 mg/m2 on day 2, and 500 mg/m2 on days 1-5 of subsequent cycles for a total of six cycles.
The Food and Drug Administration has expanded the indication for ibrutinib (Imbruvica) to allow its combination with rituximab for frontline treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults.
The approval, announced April 21, was based on findings from the randomized, controlled, open-label, phase 3 E1912 trial of 529 patients, which demonstrated significantly improved progression-free survival (PFS) among those who received ibrutinib plus rituximab, compared with those who received fludarabine, cyclophosphamide, and rituximab (FCR) (87% vs. 75%; hazard ratio, 0.34). Median PFS was not reached in either arm after a median follow-up of 37 months.
E1912 was the first study to show superiority of a chemotherapy-free regimen over FCR chemoimmunotherapy, considered the gold standard for newly diagnosed CLL and SLL for the past 2 decades.
The recommended dosage for the newly approved combination is a once-daily 420-mg dose of ibrutinib taken with a glass of water, with rituximab initiation in the second cycle at doses of 50 mg/m2 on day 1, 325 mg/m2 on day 2, and 500 mg/m2 on days 1-5 of subsequent cycles for a total of six cycles.
The Food and Drug Administration has expanded the indication for ibrutinib (Imbruvica) to allow its combination with rituximab for frontline treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults.
The approval, announced April 21, was based on findings from the randomized, controlled, open-label, phase 3 E1912 trial of 529 patients, which demonstrated significantly improved progression-free survival (PFS) among those who received ibrutinib plus rituximab, compared with those who received fludarabine, cyclophosphamide, and rituximab (FCR) (87% vs. 75%; hazard ratio, 0.34). Median PFS was not reached in either arm after a median follow-up of 37 months.
E1912 was the first study to show superiority of a chemotherapy-free regimen over FCR chemoimmunotherapy, considered the gold standard for newly diagnosed CLL and SLL for the past 2 decades.
The recommended dosage for the newly approved combination is a once-daily 420-mg dose of ibrutinib taken with a glass of water, with rituximab initiation in the second cycle at doses of 50 mg/m2 on day 1, 325 mg/m2 on day 2, and 500 mg/m2 on days 1-5 of subsequent cycles for a total of six cycles.
REACH2: Ruxolitinib outperformed control treatment for refractory acute GVHD
Ruxolitinib produced significantly better efficacy outcomes in patients with glucocorticoid-refractory acute graft-versus-host disease (GVHD), compared with investigator’s choice of control therapy, in the phase 3 REACH2 trial.
However, there was a higher incidence of thrombocytopenia with ruxolitinib than with control treatment, according to a report by Robert Zeiser, MD, of University of Freiburg (Germany) and colleagues on behalf of the REACH2 research group. The report was published in the New England Journal of Medicine.
The REACH2 trial (NCT02913261) is a randomized, open-label, phase 3 trial comparing the efficacy and safety of oral ruxolitinib (10 mg twice daily) with investigator’s choice of therapy for control treatment using a list of nine commonly used options.
Patients were 12 years of age or older with glucocorticoid-refractory acute GVHD after allogeneic stem cell transplant. A total of 154 patients were assigned to the ruxolitinib group, and 155 patients were in the control group.
Most patients – 152 in the ruxolitinib group and 150 in the control group – received at least one dose of trial treatment.
Treatment discontinuation occurred in 72% (111/154) of patients in the ruxolitinib group and in 85% (132/155) of those in the control group. The most common reason for discontinuation was lack of efficacy (in 21% and 44%, respectively).
Outcomes
The overall response at day 28 (the primary endpoint) was significantly higher in the ruxolitinib group than in the control group (62% vs. 39%; odds ratio, 2.64; P < .001). The durable overall response at day 56 was also significantly higher in the ruxolitinib group than in the control group (40% vs. 22%; OR, 2.38; P < .001).
The estimated cumulative incidence of loss of response at 6 months was 10% in the ruxolitinib group compared with 39% in the control group.
The median failure-free survival was considerably longer with ruxolitinib than with control treatment (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non–relapse-related death, or the use of new systemic therapy for acute GVHD, 0.46).
The median overall survival was 11.1 months in the ruxolitinib group and 6.5 months in the control group (HR, 0.83).
Overall, 72 patients (47%) in the ruxolitinib group and 77 (51%) in the control group died by the data cutoff date. Most deaths were attributed to acute GVHD (22% in the ruxolitinib group and 25% in the control group).
The most common adverse events at day 28 (in the ruxolitinib and control arms, respectively) were thrombocytopenia (33% and 18%), anemia (30% and 28%), and cytomegalovirus infection (26% and 21%).
Praise for ‘successful’ randomized trial in GVHD
“The authors are to be congratulated for completing this successful randomized trial, which showed convincingly that ruxolitinib was more effective than the investigator’s choice of therapy ... in patients in whom glucocorticoid therapy had failed,” wrote Nelson Chao, MD, of Duke University in Durham, N.C., in his invited editorial.
He went on to speculate on the possible mechanism for ruxolitinib in these patients, discussing the possible role of the STAT3 and STAT1 signaling pathways.
Dr. Chao also found it “interesting that the incidence of infectious complications or relapse was apparently not greater with ruxolitinib than with control therapy,” but he noted that the total follow-up time was short.
“As with all good research, these observations raise important questions and set the stage for further work in this area,” he concluded.
The REACH2 trial was funded by Novartis. The study authors disclosed relationships with a variety of pharmaceutical companies, including Novartis. Dr. Chao reported having no relevant disclosures.
SOURCE: Zeiser R et al. N Engl J Med. 2020. doi: 10.1056/NEJMoa1917635.
Ruxolitinib produced significantly better efficacy outcomes in patients with glucocorticoid-refractory acute graft-versus-host disease (GVHD), compared with investigator’s choice of control therapy, in the phase 3 REACH2 trial.
However, there was a higher incidence of thrombocytopenia with ruxolitinib than with control treatment, according to a report by Robert Zeiser, MD, of University of Freiburg (Germany) and colleagues on behalf of the REACH2 research group. The report was published in the New England Journal of Medicine.
The REACH2 trial (NCT02913261) is a randomized, open-label, phase 3 trial comparing the efficacy and safety of oral ruxolitinib (10 mg twice daily) with investigator’s choice of therapy for control treatment using a list of nine commonly used options.
Patients were 12 years of age or older with glucocorticoid-refractory acute GVHD after allogeneic stem cell transplant. A total of 154 patients were assigned to the ruxolitinib group, and 155 patients were in the control group.
Most patients – 152 in the ruxolitinib group and 150 in the control group – received at least one dose of trial treatment.
Treatment discontinuation occurred in 72% (111/154) of patients in the ruxolitinib group and in 85% (132/155) of those in the control group. The most common reason for discontinuation was lack of efficacy (in 21% and 44%, respectively).
Outcomes
The overall response at day 28 (the primary endpoint) was significantly higher in the ruxolitinib group than in the control group (62% vs. 39%; odds ratio, 2.64; P < .001). The durable overall response at day 56 was also significantly higher in the ruxolitinib group than in the control group (40% vs. 22%; OR, 2.38; P < .001).
The estimated cumulative incidence of loss of response at 6 months was 10% in the ruxolitinib group compared with 39% in the control group.
The median failure-free survival was considerably longer with ruxolitinib than with control treatment (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non–relapse-related death, or the use of new systemic therapy for acute GVHD, 0.46).
The median overall survival was 11.1 months in the ruxolitinib group and 6.5 months in the control group (HR, 0.83).
Overall, 72 patients (47%) in the ruxolitinib group and 77 (51%) in the control group died by the data cutoff date. Most deaths were attributed to acute GVHD (22% in the ruxolitinib group and 25% in the control group).
The most common adverse events at day 28 (in the ruxolitinib and control arms, respectively) were thrombocytopenia (33% and 18%), anemia (30% and 28%), and cytomegalovirus infection (26% and 21%).
Praise for ‘successful’ randomized trial in GVHD
“The authors are to be congratulated for completing this successful randomized trial, which showed convincingly that ruxolitinib was more effective than the investigator’s choice of therapy ... in patients in whom glucocorticoid therapy had failed,” wrote Nelson Chao, MD, of Duke University in Durham, N.C., in his invited editorial.
He went on to speculate on the possible mechanism for ruxolitinib in these patients, discussing the possible role of the STAT3 and STAT1 signaling pathways.
Dr. Chao also found it “interesting that the incidence of infectious complications or relapse was apparently not greater with ruxolitinib than with control therapy,” but he noted that the total follow-up time was short.
“As with all good research, these observations raise important questions and set the stage for further work in this area,” he concluded.
The REACH2 trial was funded by Novartis. The study authors disclosed relationships with a variety of pharmaceutical companies, including Novartis. Dr. Chao reported having no relevant disclosures.
SOURCE: Zeiser R et al. N Engl J Med. 2020. doi: 10.1056/NEJMoa1917635.
Ruxolitinib produced significantly better efficacy outcomes in patients with glucocorticoid-refractory acute graft-versus-host disease (GVHD), compared with investigator’s choice of control therapy, in the phase 3 REACH2 trial.
However, there was a higher incidence of thrombocytopenia with ruxolitinib than with control treatment, according to a report by Robert Zeiser, MD, of University of Freiburg (Germany) and colleagues on behalf of the REACH2 research group. The report was published in the New England Journal of Medicine.
The REACH2 trial (NCT02913261) is a randomized, open-label, phase 3 trial comparing the efficacy and safety of oral ruxolitinib (10 mg twice daily) with investigator’s choice of therapy for control treatment using a list of nine commonly used options.
Patients were 12 years of age or older with glucocorticoid-refractory acute GVHD after allogeneic stem cell transplant. A total of 154 patients were assigned to the ruxolitinib group, and 155 patients were in the control group.
Most patients – 152 in the ruxolitinib group and 150 in the control group – received at least one dose of trial treatment.
Treatment discontinuation occurred in 72% (111/154) of patients in the ruxolitinib group and in 85% (132/155) of those in the control group. The most common reason for discontinuation was lack of efficacy (in 21% and 44%, respectively).
Outcomes
The overall response at day 28 (the primary endpoint) was significantly higher in the ruxolitinib group than in the control group (62% vs. 39%; odds ratio, 2.64; P < .001). The durable overall response at day 56 was also significantly higher in the ruxolitinib group than in the control group (40% vs. 22%; OR, 2.38; P < .001).
The estimated cumulative incidence of loss of response at 6 months was 10% in the ruxolitinib group compared with 39% in the control group.
The median failure-free survival was considerably longer with ruxolitinib than with control treatment (5.0 months vs. 1.0 month; hazard ratio for relapse or progression of hematologic disease, non–relapse-related death, or the use of new systemic therapy for acute GVHD, 0.46).
The median overall survival was 11.1 months in the ruxolitinib group and 6.5 months in the control group (HR, 0.83).
Overall, 72 patients (47%) in the ruxolitinib group and 77 (51%) in the control group died by the data cutoff date. Most deaths were attributed to acute GVHD (22% in the ruxolitinib group and 25% in the control group).
The most common adverse events at day 28 (in the ruxolitinib and control arms, respectively) were thrombocytopenia (33% and 18%), anemia (30% and 28%), and cytomegalovirus infection (26% and 21%).
Praise for ‘successful’ randomized trial in GVHD
“The authors are to be congratulated for completing this successful randomized trial, which showed convincingly that ruxolitinib was more effective than the investigator’s choice of therapy ... in patients in whom glucocorticoid therapy had failed,” wrote Nelson Chao, MD, of Duke University in Durham, N.C., in his invited editorial.
He went on to speculate on the possible mechanism for ruxolitinib in these patients, discussing the possible role of the STAT3 and STAT1 signaling pathways.
Dr. Chao also found it “interesting that the incidence of infectious complications or relapse was apparently not greater with ruxolitinib than with control therapy,” but he noted that the total follow-up time was short.
“As with all good research, these observations raise important questions and set the stage for further work in this area,” he concluded.
The REACH2 trial was funded by Novartis. The study authors disclosed relationships with a variety of pharmaceutical companies, including Novartis. Dr. Chao reported having no relevant disclosures.
SOURCE: Zeiser R et al. N Engl J Med. 2020. doi: 10.1056/NEJMoa1917635.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Ruxolitinib was significantly more effective against acute graft-versus-host disease than was control treatment.
Major finding: The overall response at day 28 was significantly higher in the ruxolitinib group than in the control group (62% vs. 39%; P < .001).
Study details: Phase 3 trial of 154 patients randomized to ruxolitinib and 155 patients randomized to investigator’s choice of control therapy.
Disclosures: The trial was funded by Novartis. Authors disclosed relationships with a variety of pharmaceutical companies, including Novartis.
Source: Zeiser R et al. N Engl J Med. 2020. doi: 10.1056/NEJMoa1917635.
Five prognostic indexes come up short for planning early CLL treatment
Prognostic indexes have been developed recently to assess time to first treatment in early-stage chronic lymphocytic leukemia (CLL) patients. However, none of five indexes evaluated in a study showed more than a moderate prognostic value or were precise enough to permit clinical decisions to be made, according to a report by Spanish researchers.
Their study, published in Clinical Lymphoma, Myeloma and Leukemia, examined the comparative prognostic value of five prognostic indexes – the CLL-IPI, the Barcelona-Brno, the IPS-A, the CLL-01, and the Tailored approach – on evaluating 428 Binet A CLL patients from a multicenter Spanish database which contained the relevant necessary clinical and biological information. The predictive value of the scores was assessed with Harrell´s C index and receiver operating characteristic curve (area under the curve, AUC).
The researchers found a significant association between time to first treatment and risk subgroups for all the indexes used. The most accurate index was the IPS-A (Harrell´s C, 0.72; AUC, 0.76), followed by the CLL-01 (Harrell´s C, 0.69; AUC, 0.70), the CLL-IPI (Harrell´s C, .69; AUC, 0.69), the Barcelona-Brno (Harrell´s C: 0.67, AUC, 0.69) and the Tailored approach (Harrell´s C, 0.61 and 0.58, AUCs, 0.58 and 0.54).
However, the concordance between four of the five indexes (the Tailored approach was not included for technical reasons) compared was low (44%): 146 cases were classified as low risk with all four indexes tested, 36 as intermediate risk, and 4 as high risk. In the remaining 242 patients (56%) at least one discrepancy was detected in the allocation among prognostic subgroups between the indexes. However, only 12 patients (3%) were allocated as low and high risk at the same time with different indexes, showing the extremes of the discordance.
These data suggest that, although all of these indexes “significantly improve clinical staging and help physicians in routine clinical practice, it is necessary to harmonize larger cohorts of patients in order to define the best index for treatment decision making in the real world,” the authors stated.
“All the models had a moderate prognostic value to predict time to first therapy. ... None of them was precise enough to allow clinical decisions based exclusively on it,” the authors concluded.
The study was supported by grants from the Spanish government and a variety of nonprofit institutions. The authors reported no commercial disclosures.
SOURCE: Gascon y Marín IG et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 13. doi: 10.1016/j.clml.2020.03.003.
Prognostic indexes have been developed recently to assess time to first treatment in early-stage chronic lymphocytic leukemia (CLL) patients. However, none of five indexes evaluated in a study showed more than a moderate prognostic value or were precise enough to permit clinical decisions to be made, according to a report by Spanish researchers.
Their study, published in Clinical Lymphoma, Myeloma and Leukemia, examined the comparative prognostic value of five prognostic indexes – the CLL-IPI, the Barcelona-Brno, the IPS-A, the CLL-01, and the Tailored approach – on evaluating 428 Binet A CLL patients from a multicenter Spanish database which contained the relevant necessary clinical and biological information. The predictive value of the scores was assessed with Harrell´s C index and receiver operating characteristic curve (area under the curve, AUC).
The researchers found a significant association between time to first treatment and risk subgroups for all the indexes used. The most accurate index was the IPS-A (Harrell´s C, 0.72; AUC, 0.76), followed by the CLL-01 (Harrell´s C, 0.69; AUC, 0.70), the CLL-IPI (Harrell´s C, .69; AUC, 0.69), the Barcelona-Brno (Harrell´s C: 0.67, AUC, 0.69) and the Tailored approach (Harrell´s C, 0.61 and 0.58, AUCs, 0.58 and 0.54).
However, the concordance between four of the five indexes (the Tailored approach was not included for technical reasons) compared was low (44%): 146 cases were classified as low risk with all four indexes tested, 36 as intermediate risk, and 4 as high risk. In the remaining 242 patients (56%) at least one discrepancy was detected in the allocation among prognostic subgroups between the indexes. However, only 12 patients (3%) were allocated as low and high risk at the same time with different indexes, showing the extremes of the discordance.
These data suggest that, although all of these indexes “significantly improve clinical staging and help physicians in routine clinical practice, it is necessary to harmonize larger cohorts of patients in order to define the best index for treatment decision making in the real world,” the authors stated.
“All the models had a moderate prognostic value to predict time to first therapy. ... None of them was precise enough to allow clinical decisions based exclusively on it,” the authors concluded.
The study was supported by grants from the Spanish government and a variety of nonprofit institutions. The authors reported no commercial disclosures.
SOURCE: Gascon y Marín IG et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 13. doi: 10.1016/j.clml.2020.03.003.
Prognostic indexes have been developed recently to assess time to first treatment in early-stage chronic lymphocytic leukemia (CLL) patients. However, none of five indexes evaluated in a study showed more than a moderate prognostic value or were precise enough to permit clinical decisions to be made, according to a report by Spanish researchers.
Their study, published in Clinical Lymphoma, Myeloma and Leukemia, examined the comparative prognostic value of five prognostic indexes – the CLL-IPI, the Barcelona-Brno, the IPS-A, the CLL-01, and the Tailored approach – on evaluating 428 Binet A CLL patients from a multicenter Spanish database which contained the relevant necessary clinical and biological information. The predictive value of the scores was assessed with Harrell´s C index and receiver operating characteristic curve (area under the curve, AUC).
The researchers found a significant association between time to first treatment and risk subgroups for all the indexes used. The most accurate index was the IPS-A (Harrell´s C, 0.72; AUC, 0.76), followed by the CLL-01 (Harrell´s C, 0.69; AUC, 0.70), the CLL-IPI (Harrell´s C, .69; AUC, 0.69), the Barcelona-Brno (Harrell´s C: 0.67, AUC, 0.69) and the Tailored approach (Harrell´s C, 0.61 and 0.58, AUCs, 0.58 and 0.54).
However, the concordance between four of the five indexes (the Tailored approach was not included for technical reasons) compared was low (44%): 146 cases were classified as low risk with all four indexes tested, 36 as intermediate risk, and 4 as high risk. In the remaining 242 patients (56%) at least one discrepancy was detected in the allocation among prognostic subgroups between the indexes. However, only 12 patients (3%) were allocated as low and high risk at the same time with different indexes, showing the extremes of the discordance.
These data suggest that, although all of these indexes “significantly improve clinical staging and help physicians in routine clinical practice, it is necessary to harmonize larger cohorts of patients in order to define the best index for treatment decision making in the real world,” the authors stated.
“All the models had a moderate prognostic value to predict time to first therapy. ... None of them was precise enough to allow clinical decisions based exclusively on it,” the authors concluded.
The study was supported by grants from the Spanish government and a variety of nonprofit institutions. The authors reported no commercial disclosures.
SOURCE: Gascon y Marín IG et al. Clin Lymphoma Myeloma Leuk. 2020 Apr 13. doi: 10.1016/j.clml.2020.03.003.
FROM CLINICAL LYMPHOMA, MYELOMA AND LEUKEMIA
European cancer centers restructure care in the era of COVID-19
Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.
Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.
A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.
This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.
“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”
The article was published April 16 in Nature Medicine.
The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.
The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.
Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.
“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
Restructuring care
Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.
“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”
For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.
As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.
The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.
Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.
To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.
To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.
Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
Capacity of facilities
Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.
The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.
In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.
Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.
The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.
“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
Future research
Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:
- Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
- Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
- Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
- Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.
The authors have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.
Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.
A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.
This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.
“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”
The article was published April 16 in Nature Medicine.
The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.
The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.
Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.
“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
Restructuring care
Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.
“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”
For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.
As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.
The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.
Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.
To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.
To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.
Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
Capacity of facilities
Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.
The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.
In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.
Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.
The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.
“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
Future research
Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:
- Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
- Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
- Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
- Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.
The authors have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Delivering cancer care during the COVID-19 pandemic has proved particularly challenging, as minimizing the risk of infection must be balanced with maintaining optimal outcomes.
Healthcare systems and oncologists have had to reorganize standard oncologic care in order to protect vulnerable patients from exposure to COVID-19 as well as deal with pandemic-related issues of equipment and staffing shortages.
A new article now describes how seven cancer centers in Europe rapidly reorganized their oncologic services and are tackling this crisis, as well as offering guidance to other institutions.
This was a major undertaking, to work out a system where patients can still get care but in a safer manner, explained coauthor Emile Voest, MD, medical director of the Netherlands Cancer Institute in Amsterdam.
“Decisions needed to be taken based on availability of personnel, protective materials, and urgencies,” he told Medscape Medical News. “Because every country had its own speed of development of the COVID pandemic, there were different scenarios in all institutions, but all with a common factor of key expertise on how to de-escalate in a safe manner.”
The article was published April 16 in Nature Medicine.
The Netherlands Cancer Institute (the Netherlands), Karolinska Institute (Sweden), Institute Gustave Roussy (France), Cambridge Cancer Center (United Kingdom), Istituto Nazionale dei Tumori di Milano (Italy), German Cancer Research Center (Germany), and Vall d’Hebron Institute of Oncology (Spain) have been working closely together in a legal entity since 2014, and have created ‘Cancer Core Europe’ (CCE). The goal is to “maximize coherence and critical mass in cancer research,” the authors note.
The consortium represents roughly 60,000 patients with newly diagnosed cancer, delivers approximately 300,000 treatment courses, and conducts about 1.2 million consultations annually, with more than 1,500 ongoing clinical trials. In a joint effort, the centers collected, translated, and compared the guidelines that had been put in place to treat patients with cancer during the COVID-19 pandemic.
Cancer treatment is multidisciplinary and involves many specialties including surgery, radiology, pathology, radiation oncology, and medical oncology. Coordinating care among disciplines is a very complex process, Voest noted.
“Changing treatment also means that you need to reconsider capacities and requirements,” he said. “Hospitals have installed crisis teams that were very good at coordinating these efforts.”
Restructuring care
Cancer care had to be reorganized on multiple levels, and the CCE centers looked at several aspects that needed to be accounted for, to ensure continuity in cancer care.
“The biggest challenge for the NHS and other healthcare systems is the surge of patients requiring oxygen and/or intensive care, and the nature and infectiousness of the virus,” said coauthor Carlos Caldas, MD, FMedSci, professor of cancer medicine at the University of Cambridge, United Kingdom. “In hospitals that are mostly run close to capacity, and where all kinds of patients are treated, this has created major resource and logistical problems.”
For regular clinical activities, the institutions with dedicated cancer centers (German Cancer Research Center, Institute Gustave Roussy, Istituto Nazionale dei Tumori di Milano, and Netherlands Cancer Institute) have attempted to stay COVID-19 free. This policy would in turn help ensure that sufficient clinical and intensive-care capacity could be reserved for critical cancer surgeries or management of treatment-related side effects, and allow hospitals outside of the CCE to transfer patients with cancer to these centers. The general hospitals can then focus on caring for patients with COVID-19, as well as other illnesses/injuries that require inpatient care.
As the CCE centers located within general hospitals (Cambridge Cancer Center, Vall d’Hebron Institute of Oncology and Karolinska Institute) have to admit patients with suspected and positive cases of COVID-19, being “COVID-19 free” was never a realistic or pursued goal.
The authors note that it is the responsibility of all healthcare professionals to ensure patients are not exposed to COVID-19, and this has meant minimizing hospital visits and person-to-person contact. For example, whenever possible, consultations take place via telephone calls or over the Internet, and nonurgent appointments that would require a patient’s physical presence at the clinic have been postponed. Visitors are also not permitted to accompany patients when admitted to the hospital or during procedures.
Standard-of-care treatment regimens have been adapted across all centers to minimize the number of hospital visits and hospitalizations and prevent “anticancer treatment-induced” complications of COVID-19.
To minimize visits and hospitalizations, strategies include converting intravenous treatments to oral or subcutaneous regimens when possible; switching from cytotoxic chemotherapy to a less-toxic approach to minimize the risk of complications requiring hospitalization; or to pause therapies when possible (stable disease reached or better). In addition, nonemergency surgeries have been postponed or replaced by radiotherapy.
To prevent anticancer treatment-induced complications of COVID-19, most centers use the paradigm that the added benefit for tumor control should be weighed against the potential risk for COVID-19–related morbidity and mortality. To prevent or reduce the risk of neutropenia and lymphopenia, for example, all centers have suggested a de-escalation of cytotoxic chemotherapy or targeted treatment strategies, or to forgo second or subsequent lines of palliative treatments if response rates from up-front therapy are low.
Some of these changes may be here to stay, noted Caldas. “One of the positive messages that comes out of this is that, clearly, care can be delivered in a safe and compassionate manner without requiring as many hospital visits as in the pre-COVID-19 era,” he said. “In the future, we will take heed of the COVID-19 experience to improve delivery of cancer care.”
Capacity of facilities
Many healthcare systems have become overwhelmed as the pandemic has intensified, thus making it necessary to prioritize. To prepare for this possibility, CCE centers have established protocols to categorize and prioritize patients for systemic treatment or surgery. While the protocols vary by center, they are comparable with one another as they prioritize on the basis of anticipated treatment outcome, the authors note.
The guidelines in CCE centers unanimously recommend that neoadjuvant therapies and curative surgeries be the top priority, for the times when operating room and/or ICU capacity is limited. As an alternative, neoadjuvant systemic treatments may be initiated or extended to postpone surgery, and other nonsurgical interventions can be considered.
In addition, some centers agree that certain elective surgeries can be safely delayed if backed by scientific evidence. As an example, an 11-week deferment of surgery may be acceptable for patients with rectal cancer after downstaging.
Cancer centers may also need to upscale and downscale quickly, depending on how the pandemic evolves, and many have already outlined scenarios to prepare for increasing or decreasing their capacity using phased approaches.
The Netherlands Cancer Institute, for example, has defined four phases of increasing severity; in Germany, capacity planning has been coordinated among 18 hospitals and the federal ministry of health, in order to prevent shortages of cancer services.
“We note that the optimal downscaling strategies depend on country- and center-specific capacities and preferences,” they write. “Therefore, it is difficult to propose a common schedule, and it will be most effective if hospitals outline their own phase-specific downscaling strategies based on the prioritization schemes and practical handles discussed above.”
Future research
Better strategies will be needed to reduce the impact of COVID-19 in cancer care, and four research priorities were identified to allow for evidence-based adjustments of cancer care protocols while the pandemic continues:
- Collect real-world data about the effects of adjustment and de-escalation of treatment regimens on outcomes
- Determine the incidence of COVID-19 in both the general population and among patients with cancer who have received systemic therapies, with large-scale serological testing
- Develop an epidemiological model that will allow estimates of the cumulative incidence of COVID-19 for a patient with cancer, within a specific time frame
- Determine COVID-19 related morbidity and mortality in patients with cancer who have been treated with systemic therapies and/or granulocyte colony-stimulating factor (G-CSF). Several projects are currently underway, such as the UK Coronavirus Cancer Monitoring Project.
The authors have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Want to keep cancer patients and providers safe during the pandemic? Here’s how
special feature article in the Journal of the National Comprehensive Cancer Network.
according to the authors of aPrescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.
These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.
“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
Screening patients
Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.
Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.
“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
Telemedicine and treatment
Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.
“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.
When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.
Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
Protecting providers
Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.
The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.
Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.
Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.
“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”
The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.
SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.
special feature article in the Journal of the National Comprehensive Cancer Network.
according to the authors of aPrescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.
These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.
“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
Screening patients
Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.
Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.
“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
Telemedicine and treatment
Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.
“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.
When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.
Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
Protecting providers
Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.
The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.
Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.
Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.
“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”
The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.
SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.
special feature article in the Journal of the National Comprehensive Cancer Network.
according to the authors of aPrescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.
These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.
“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
Screening patients
Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.
Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.
“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
Telemedicine and treatment
Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.
“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.
When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.
Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
Protecting providers
Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.
The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.
Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.
Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.
“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”
The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.
SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.
FROM THE JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK
CLAM trial regimen shown safe, effective for r/r AML
A clofarabine-based treatment was found to be safe and effective in refractory/relapsed acute myeloid leukemia (AML) in the phase 2 CLAM trial.
The CLAM protocol treatment was clofarabine, cytarabine, and mitoxantrone (intravenous infusion, days 1‐5), cytarabine (intravenous infusion starting 4 hours after clofarabine, days 1‐5), and mitoxantrone (intravenous infusion, days 3‐5).
Bone marrow aspiration and trephine biopsy were performed on day 28. A total of 52 patients (16 women), with an age range of 22-65 years and refractory/relapsed AML were treated.
The overall response rate after the first cycle of CLAM was 90.4% (complete remission, 69.2%; CR with incomplete hematologic recovery, 21.2%). In addition, the efficacy of CLAM was not apparently affected by high‐risk karyotypes and genetic mutations among the patients.
Patients with a response (marrow < 5% blasts) received a maximum of two cycles of CLAM consolidation, each at 50% dose reduction, given 6‐8 weeks apart. Responding patients with an HLA‐matched sibling or volunteer‐unrelated donor were offered allogeneic hematopoietic stem cell transplantation (HSCT). Toxicity of CLAM was manageable and did not compromise subsequent allogeneic HSCT, the researchers added.
“In this era of molecular targeting, CLAM might still have a role to play,” according to the researchers. “It offers the advantage of a highly effective regimen that is readily available. It provides a median DOR of 5 months, which is meaningful for organization of HSCT. Delays associated with recruitment into clinical trials or sourcing of targeted drugs are obviated. Precious time is saved, so that patients can quickly be bridged to a potentially curative allogeneic HSCT.”
No disclosures or conflicts of interest were reported.
SOURCE: Gill H et al. Cancer Med. 2020 Mar 20. doi:10.1002/cam4.2865.
A clofarabine-based treatment was found to be safe and effective in refractory/relapsed acute myeloid leukemia (AML) in the phase 2 CLAM trial.
The CLAM protocol treatment was clofarabine, cytarabine, and mitoxantrone (intravenous infusion, days 1‐5), cytarabine (intravenous infusion starting 4 hours after clofarabine, days 1‐5), and mitoxantrone (intravenous infusion, days 3‐5).
Bone marrow aspiration and trephine biopsy were performed on day 28. A total of 52 patients (16 women), with an age range of 22-65 years and refractory/relapsed AML were treated.
The overall response rate after the first cycle of CLAM was 90.4% (complete remission, 69.2%; CR with incomplete hematologic recovery, 21.2%). In addition, the efficacy of CLAM was not apparently affected by high‐risk karyotypes and genetic mutations among the patients.
Patients with a response (marrow < 5% blasts) received a maximum of two cycles of CLAM consolidation, each at 50% dose reduction, given 6‐8 weeks apart. Responding patients with an HLA‐matched sibling or volunteer‐unrelated donor were offered allogeneic hematopoietic stem cell transplantation (HSCT). Toxicity of CLAM was manageable and did not compromise subsequent allogeneic HSCT, the researchers added.
“In this era of molecular targeting, CLAM might still have a role to play,” according to the researchers. “It offers the advantage of a highly effective regimen that is readily available. It provides a median DOR of 5 months, which is meaningful for organization of HSCT. Delays associated with recruitment into clinical trials or sourcing of targeted drugs are obviated. Precious time is saved, so that patients can quickly be bridged to a potentially curative allogeneic HSCT.”
No disclosures or conflicts of interest were reported.
SOURCE: Gill H et al. Cancer Med. 2020 Mar 20. doi:10.1002/cam4.2865.
A clofarabine-based treatment was found to be safe and effective in refractory/relapsed acute myeloid leukemia (AML) in the phase 2 CLAM trial.
The CLAM protocol treatment was clofarabine, cytarabine, and mitoxantrone (intravenous infusion, days 1‐5), cytarabine (intravenous infusion starting 4 hours after clofarabine, days 1‐5), and mitoxantrone (intravenous infusion, days 3‐5).
Bone marrow aspiration and trephine biopsy were performed on day 28. A total of 52 patients (16 women), with an age range of 22-65 years and refractory/relapsed AML were treated.
The overall response rate after the first cycle of CLAM was 90.4% (complete remission, 69.2%; CR with incomplete hematologic recovery, 21.2%). In addition, the efficacy of CLAM was not apparently affected by high‐risk karyotypes and genetic mutations among the patients.
Patients with a response (marrow < 5% blasts) received a maximum of two cycles of CLAM consolidation, each at 50% dose reduction, given 6‐8 weeks apart. Responding patients with an HLA‐matched sibling or volunteer‐unrelated donor were offered allogeneic hematopoietic stem cell transplantation (HSCT). Toxicity of CLAM was manageable and did not compromise subsequent allogeneic HSCT, the researchers added.
“In this era of molecular targeting, CLAM might still have a role to play,” according to the researchers. “It offers the advantage of a highly effective regimen that is readily available. It provides a median DOR of 5 months, which is meaningful for organization of HSCT. Delays associated with recruitment into clinical trials or sourcing of targeted drugs are obviated. Precious time is saved, so that patients can quickly be bridged to a potentially curative allogeneic HSCT.”
No disclosures or conflicts of interest were reported.
SOURCE: Gill H et al. Cancer Med. 2020 Mar 20. doi:10.1002/cam4.2865.
FROM CANCER MEDICINE