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Rethink urologic cancer treatment in the era of COVID-19
according to an editorial set to be published in European Urology.
“Regimens with a clear survival advantage should be prioritized, with curative treatments remaining mandatory,” wrote Silke Gillessen Sommer, MD, of Istituto Oncologico della Svizzera Italiana in Bellizona, Switzerland, and Thomas Powles, MD, of Barts Cancer Institute in London.
However, it may be appropriate to stop or delay therapies with modest or unproven survival benefits. “Delaying the start of therapy ... is an appropriate measure for many of the therapies in urology cancer,” they wrote.
Timely recommendations for oncologists
The COVID-19 pandemic is limiting resources for cancer, noted Zachery Reichert, MD, PhD, a urological oncologist and assistant professor at the University of Michigan, Ann Arbor, who was asked for his thoughts about the editorial.
Oncologists and oncology nurses are being shifted to care for COVID-19 patients, space once devoted to cancer care is being repurposed for the pandemic, and personal protective equipment needed to prepare chemotherapies is in short supply.
Meanwhile, cancer patients are at increased risk of dying from the virus (Lancet Oncol. 2020;21:335-7), so there’s a need to minimize their contact with the health care system to protect them from nosocomial infection, and a need to keep their immune system as strong as possible to fight it off.
To help cancer patients fight off infection and keep them out of the hospital, the editorialists recommended growth factors and prophylactic antibiotics after chemotherapy, palliative therapies at doses that avoid febrile neutropenia, discontinuing steroids or at least reducing their doses, and avoiding bisphosphonates if they involve potential COVID-19 exposure in medical facilities.
The advice in the editorial mirrors many of the discussions going on right now at the University of Michigan, Dr. Reichert said, and perhaps other oncology services across the United States.
It will come down to how severe the pandemic becomes locally, but he said it seems likely “a lot of us are going to be wearing a different hat for a while.”
Patients who have symptoms from a growing tumor will likely take precedence at the university, but treatment might be postponed until after COVID-19 peaks if tumors don’t affect quality of life. Also, bladder cancer surgery will probably remain urgent “because the longer you wait, the worse the outcomes,” but perhaps not prostate and kidney cancer surgery, where delay is safer, Dr. Reichert said.
Prostate/renal cancers and germ cell tumors
The editorialists noted that oral androgen receptor therapy should be preferred over chemotherapy for prostate cancer. Dr. Reichert explained that’s because androgen blockade is effective, requires less contact with health care providers, and doesn’t suppress the immune system or tie up hospital resources as much as chemotherapy. “In the world we are in right now, oral pills are a better choice,” he said.
The editorialists recommended against both nephrectomy for metastatic renal cancer and adjuvant therapy after orchidectomy for stage 1 germ cell tumors for similar reasons, and also because there’s minimal evidence of benefit.
Dr. Powles and Dr. Gillessen Sommer suggested considering a break from immune checkpoint inhibitors (ICIs) and oral vascular endothelial growth factors (VEGFs) for renal cancer patients who have been on them a year or two. It’s something that would be considered even under normal circumstances, Dr. Reichert explained, but it’s more urgent now to keep people out of the hospital. VEGFs should also be prioritized over ICIs; they have similar efficacy in renal cancer, but VEGFs are a pill.
They also called for oncologists to favor conventional-dose treatments for germ cell tumors over high-dose treatments, meaning bone marrow transplants or high-intensity chemotherapy. Amid a pandemic, the preference is for options “that don’t require a hospital bed,” Dr. Reichert said.
Urothelial cancer
Dr. Powles and Dr. Gillessen Sommer suggested not starting or continuing second-line chemotherapies in urothelial cancer patients refractory to first-line platinum-based therapies. The chance they will respond to second-line options is low, perhaps around 10%. That might have been enough before the pandemic, but it’s less justified amid resource shortages and the risk of COVID-19 in the infusion suite, Dr. Reichert explained.
Along the same lines, they also suggested reconsidering perioperative chemotherapy for urothelial cancer, and, if it’s still a go, recommended against going past three cycles, as the benefits in both scenarios are likely marginal. However, if COVID-19 cancels surgeries, neoadjuvant therapy might be the right – and only – call, according to the editorialists.
They recommended prioritizing ICIs over chemotherapy in patients with metastatic urothelial cancer who are positive for programmed death-ligand 1 (PD-L1). PD-L1–positive patients have a good chance of responding, and ICIs don’t suppress the immune system.
“Chemotherapy still has a slightly higher percent response, but right now, this is a better choice for” PD-L1-positive patients, Dr. Reichert said.
Dr. Gillessen Sommer and Dr. Powles disclosed ties to Bristol-Myers Squibb, Roche, and numerous other companies. Dr. Reichert has no relevant disclosures.
SOURCE: Gillessen Sommer S, Powles T. “Advice regarding systemic therapy in patients with urological cancers during the COVID-19 pandemic.” Eur Urol. https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/eururo/EURUROL-D-20-00382-1585928967060.pdf.
according to an editorial set to be published in European Urology.
“Regimens with a clear survival advantage should be prioritized, with curative treatments remaining mandatory,” wrote Silke Gillessen Sommer, MD, of Istituto Oncologico della Svizzera Italiana in Bellizona, Switzerland, and Thomas Powles, MD, of Barts Cancer Institute in London.
However, it may be appropriate to stop or delay therapies with modest or unproven survival benefits. “Delaying the start of therapy ... is an appropriate measure for many of the therapies in urology cancer,” they wrote.
Timely recommendations for oncologists
The COVID-19 pandemic is limiting resources for cancer, noted Zachery Reichert, MD, PhD, a urological oncologist and assistant professor at the University of Michigan, Ann Arbor, who was asked for his thoughts about the editorial.
Oncologists and oncology nurses are being shifted to care for COVID-19 patients, space once devoted to cancer care is being repurposed for the pandemic, and personal protective equipment needed to prepare chemotherapies is in short supply.
Meanwhile, cancer patients are at increased risk of dying from the virus (Lancet Oncol. 2020;21:335-7), so there’s a need to minimize their contact with the health care system to protect them from nosocomial infection, and a need to keep their immune system as strong as possible to fight it off.
To help cancer patients fight off infection and keep them out of the hospital, the editorialists recommended growth factors and prophylactic antibiotics after chemotherapy, palliative therapies at doses that avoid febrile neutropenia, discontinuing steroids or at least reducing their doses, and avoiding bisphosphonates if they involve potential COVID-19 exposure in medical facilities.
The advice in the editorial mirrors many of the discussions going on right now at the University of Michigan, Dr. Reichert said, and perhaps other oncology services across the United States.
It will come down to how severe the pandemic becomes locally, but he said it seems likely “a lot of us are going to be wearing a different hat for a while.”
Patients who have symptoms from a growing tumor will likely take precedence at the university, but treatment might be postponed until after COVID-19 peaks if tumors don’t affect quality of life. Also, bladder cancer surgery will probably remain urgent “because the longer you wait, the worse the outcomes,” but perhaps not prostate and kidney cancer surgery, where delay is safer, Dr. Reichert said.
Prostate/renal cancers and germ cell tumors
The editorialists noted that oral androgen receptor therapy should be preferred over chemotherapy for prostate cancer. Dr. Reichert explained that’s because androgen blockade is effective, requires less contact with health care providers, and doesn’t suppress the immune system or tie up hospital resources as much as chemotherapy. “In the world we are in right now, oral pills are a better choice,” he said.
The editorialists recommended against both nephrectomy for metastatic renal cancer and adjuvant therapy after orchidectomy for stage 1 germ cell tumors for similar reasons, and also because there’s minimal evidence of benefit.
Dr. Powles and Dr. Gillessen Sommer suggested considering a break from immune checkpoint inhibitors (ICIs) and oral vascular endothelial growth factors (VEGFs) for renal cancer patients who have been on them a year or two. It’s something that would be considered even under normal circumstances, Dr. Reichert explained, but it’s more urgent now to keep people out of the hospital. VEGFs should also be prioritized over ICIs; they have similar efficacy in renal cancer, but VEGFs are a pill.
They also called for oncologists to favor conventional-dose treatments for germ cell tumors over high-dose treatments, meaning bone marrow transplants or high-intensity chemotherapy. Amid a pandemic, the preference is for options “that don’t require a hospital bed,” Dr. Reichert said.
Urothelial cancer
Dr. Powles and Dr. Gillessen Sommer suggested not starting or continuing second-line chemotherapies in urothelial cancer patients refractory to first-line platinum-based therapies. The chance they will respond to second-line options is low, perhaps around 10%. That might have been enough before the pandemic, but it’s less justified amid resource shortages and the risk of COVID-19 in the infusion suite, Dr. Reichert explained.
Along the same lines, they also suggested reconsidering perioperative chemotherapy for urothelial cancer, and, if it’s still a go, recommended against going past three cycles, as the benefits in both scenarios are likely marginal. However, if COVID-19 cancels surgeries, neoadjuvant therapy might be the right – and only – call, according to the editorialists.
They recommended prioritizing ICIs over chemotherapy in patients with metastatic urothelial cancer who are positive for programmed death-ligand 1 (PD-L1). PD-L1–positive patients have a good chance of responding, and ICIs don’t suppress the immune system.
“Chemotherapy still has a slightly higher percent response, but right now, this is a better choice for” PD-L1-positive patients, Dr. Reichert said.
Dr. Gillessen Sommer and Dr. Powles disclosed ties to Bristol-Myers Squibb, Roche, and numerous other companies. Dr. Reichert has no relevant disclosures.
SOURCE: Gillessen Sommer S, Powles T. “Advice regarding systemic therapy in patients with urological cancers during the COVID-19 pandemic.” Eur Urol. https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/eururo/EURUROL-D-20-00382-1585928967060.pdf.
according to an editorial set to be published in European Urology.
“Regimens with a clear survival advantage should be prioritized, with curative treatments remaining mandatory,” wrote Silke Gillessen Sommer, MD, of Istituto Oncologico della Svizzera Italiana in Bellizona, Switzerland, and Thomas Powles, MD, of Barts Cancer Institute in London.
However, it may be appropriate to stop or delay therapies with modest or unproven survival benefits. “Delaying the start of therapy ... is an appropriate measure for many of the therapies in urology cancer,” they wrote.
Timely recommendations for oncologists
The COVID-19 pandemic is limiting resources for cancer, noted Zachery Reichert, MD, PhD, a urological oncologist and assistant professor at the University of Michigan, Ann Arbor, who was asked for his thoughts about the editorial.
Oncologists and oncology nurses are being shifted to care for COVID-19 patients, space once devoted to cancer care is being repurposed for the pandemic, and personal protective equipment needed to prepare chemotherapies is in short supply.
Meanwhile, cancer patients are at increased risk of dying from the virus (Lancet Oncol. 2020;21:335-7), so there’s a need to minimize their contact with the health care system to protect them from nosocomial infection, and a need to keep their immune system as strong as possible to fight it off.
To help cancer patients fight off infection and keep them out of the hospital, the editorialists recommended growth factors and prophylactic antibiotics after chemotherapy, palliative therapies at doses that avoid febrile neutropenia, discontinuing steroids or at least reducing their doses, and avoiding bisphosphonates if they involve potential COVID-19 exposure in medical facilities.
The advice in the editorial mirrors many of the discussions going on right now at the University of Michigan, Dr. Reichert said, and perhaps other oncology services across the United States.
It will come down to how severe the pandemic becomes locally, but he said it seems likely “a lot of us are going to be wearing a different hat for a while.”
Patients who have symptoms from a growing tumor will likely take precedence at the university, but treatment might be postponed until after COVID-19 peaks if tumors don’t affect quality of life. Also, bladder cancer surgery will probably remain urgent “because the longer you wait, the worse the outcomes,” but perhaps not prostate and kidney cancer surgery, where delay is safer, Dr. Reichert said.
Prostate/renal cancers and germ cell tumors
The editorialists noted that oral androgen receptor therapy should be preferred over chemotherapy for prostate cancer. Dr. Reichert explained that’s because androgen blockade is effective, requires less contact with health care providers, and doesn’t suppress the immune system or tie up hospital resources as much as chemotherapy. “In the world we are in right now, oral pills are a better choice,” he said.
The editorialists recommended against both nephrectomy for metastatic renal cancer and adjuvant therapy after orchidectomy for stage 1 germ cell tumors for similar reasons, and also because there’s minimal evidence of benefit.
Dr. Powles and Dr. Gillessen Sommer suggested considering a break from immune checkpoint inhibitors (ICIs) and oral vascular endothelial growth factors (VEGFs) for renal cancer patients who have been on them a year or two. It’s something that would be considered even under normal circumstances, Dr. Reichert explained, but it’s more urgent now to keep people out of the hospital. VEGFs should also be prioritized over ICIs; they have similar efficacy in renal cancer, but VEGFs are a pill.
They also called for oncologists to favor conventional-dose treatments for germ cell tumors over high-dose treatments, meaning bone marrow transplants or high-intensity chemotherapy. Amid a pandemic, the preference is for options “that don’t require a hospital bed,” Dr. Reichert said.
Urothelial cancer
Dr. Powles and Dr. Gillessen Sommer suggested not starting or continuing second-line chemotherapies in urothelial cancer patients refractory to first-line platinum-based therapies. The chance they will respond to second-line options is low, perhaps around 10%. That might have been enough before the pandemic, but it’s less justified amid resource shortages and the risk of COVID-19 in the infusion suite, Dr. Reichert explained.
Along the same lines, they also suggested reconsidering perioperative chemotherapy for urothelial cancer, and, if it’s still a go, recommended against going past three cycles, as the benefits in both scenarios are likely marginal. However, if COVID-19 cancels surgeries, neoadjuvant therapy might be the right – and only – call, according to the editorialists.
They recommended prioritizing ICIs over chemotherapy in patients with metastatic urothelial cancer who are positive for programmed death-ligand 1 (PD-L1). PD-L1–positive patients have a good chance of responding, and ICIs don’t suppress the immune system.
“Chemotherapy still has a slightly higher percent response, but right now, this is a better choice for” PD-L1-positive patients, Dr. Reichert said.
Dr. Gillessen Sommer and Dr. Powles disclosed ties to Bristol-Myers Squibb, Roche, and numerous other companies. Dr. Reichert has no relevant disclosures.
SOURCE: Gillessen Sommer S, Powles T. “Advice regarding systemic therapy in patients with urological cancers during the COVID-19 pandemic.” Eur Urol. https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/eururo/EURUROL-D-20-00382-1585928967060.pdf.
FROM EUROPEAN UROLOGY
Advice from the front lines: How cancer centers can cope with COVID-19
according to the medical director of a cancer care alliance in the first U.S. epicenter of the coronavirus outbreak.
Jennie R. Crews, MD, the medical director of the Seattle Cancer Care Alliance (SCCA), discussed the SCCA experience and offered advice for other cancer centers in a webinar hosted by the Association of Community Cancer Centers.
Dr. Crews highlighted the SCCA’s use of algorithms to predict which patients can be managed via telehealth and which require face-to-face visits, human resource issues that arose at SCCA, screening and testing procedures, and the importance of communication with patients, caregivers, and staff.
Communication
Dr. Crews stressed the value of clear, regular, and internally consistent staff communication in a variety of formats. SCCA sends daily email blasts to their personnel regarding policies and procedures, which are archived on the SCCA intranet site.
SCCA also holds weekly town hall meetings at which leaders respond to staff questions regarding practical matters they have encountered and future plans. Providers’ up-to-the-minute familiarity with policies and procedures enables all team members to uniformly and clearly communicate to patients and caregivers.
Dr. Crews emphasized the value of consistency and “over-communication” in projecting confidence and preparedness to patients and caregivers during an unsettling time. SCCA has developed fact sheets, posted current information on the SCCA website, and provided education during doorway screenings.
Screening and testing
All SCCA staff members are screened daily at the practice entrance so they have personal experience with the process utilized for patients. Because symptoms associated with coronavirus infection may overlap with cancer treatment–related complaints, SCCA clinicians have expanded the typical coronavirus screening questionnaire for patients on cancer treatment.
Patients with ambiguous symptoms are masked, taken to a physically separate area of the SCCA clinics, and screened further by an advanced practice provider. The patients are then triaged to either the clinic for treatment or to the emergency department for further triage and care.
Although testing processes and procedures have been modified, Dr. Crews advised codifying those policies and procedures, including notification of results and follow-up for both patients and staff. Dr. Crews also stressed the importance of clearly articulated return-to-work policies for staff who have potential exposure and/or positive test results.
At the University of Washington’s virology laboratory, they have a test turnaround time of less than 12 hours.
Planning ahead
Dr. Crews highlighted the importance of community-based surge planning, utilizing predictive models to assess inpatient capacity requirements and potential repurposing of providers.
The SCCA is prepared to close selected community sites and shift personnel to other locations if personnel needs cannot be met because of illness or quarantine. Contingency plans include specialized pharmacy services for patients requiring chemotherapy.
The SCCA has not yet experienced shortages of personal protective equipment (PPE). However, Dr. Crews said staff require detailed education regarding the use of PPE in order to safeguard the supply while providing maximal staff protection.
Helping the helpers
During the pandemic, SCCA has dealt with a variety of challenging human resource issues, including:
- Extending sick time beyond what was previously “stored” in staff members’ earned time off.
- Childcare during an extended hiatus in school and daycare schedules.
- Programs to maintain and/or restore employee wellness (including staff-centered support services, spiritual care, mindfulness exercises, and town halls).
Dr. Crews also discussed recruitment of community resources to provide meals for staff from local restaurants with restricted hours and transportation resources for staff and patients, as visitors are restricted (currently one per patient).
Managing care
Dr. Crews noted that the University of Washington had a foundational structure for a telehealth program prior to the pandemic. Their telehealth committee enabled SCCA to scale up the service quickly with their academic partners, including training modules for and certification of providers, outfitting off-site personnel with dedicated lines and hardware, and provision of personal Zoom accounts.
SCCA also devised algorithms for determining when face-to-face visits, remote management, or deferred visits are appropriate in various scenarios. The algorithms were developed by disease-specialized teams.
As a general rule, routine chemotherapy and radiation are administered on schedule. On-treatment and follow-up office visits are conducted via telehealth if possible. In some cases, initiation of chemotherapy and radiation has been delayed, and screening services have been suspended.
In response to questions about palliative care during the pandemic, Dr. Crews said SCCA has encouraged their patients to complete, review, or update their advance directives. The SCCA has not had the need to resuscitate a coronavirus-infected outpatient but has instituted policies for utilizing full PPE on any patient requiring resuscitation.
In her closing remarks, Dr. Crews stressed that the response to COVID-19 in Washington state has required an intense collaboration among colleagues, the community, and government leaders, as the actions required extended far beyond medical decision makers alone.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
according to the medical director of a cancer care alliance in the first U.S. epicenter of the coronavirus outbreak.
Jennie R. Crews, MD, the medical director of the Seattle Cancer Care Alliance (SCCA), discussed the SCCA experience and offered advice for other cancer centers in a webinar hosted by the Association of Community Cancer Centers.
Dr. Crews highlighted the SCCA’s use of algorithms to predict which patients can be managed via telehealth and which require face-to-face visits, human resource issues that arose at SCCA, screening and testing procedures, and the importance of communication with patients, caregivers, and staff.
Communication
Dr. Crews stressed the value of clear, regular, and internally consistent staff communication in a variety of formats. SCCA sends daily email blasts to their personnel regarding policies and procedures, which are archived on the SCCA intranet site.
SCCA also holds weekly town hall meetings at which leaders respond to staff questions regarding practical matters they have encountered and future plans. Providers’ up-to-the-minute familiarity with policies and procedures enables all team members to uniformly and clearly communicate to patients and caregivers.
Dr. Crews emphasized the value of consistency and “over-communication” in projecting confidence and preparedness to patients and caregivers during an unsettling time. SCCA has developed fact sheets, posted current information on the SCCA website, and provided education during doorway screenings.
Screening and testing
All SCCA staff members are screened daily at the practice entrance so they have personal experience with the process utilized for patients. Because symptoms associated with coronavirus infection may overlap with cancer treatment–related complaints, SCCA clinicians have expanded the typical coronavirus screening questionnaire for patients on cancer treatment.
Patients with ambiguous symptoms are masked, taken to a physically separate area of the SCCA clinics, and screened further by an advanced practice provider. The patients are then triaged to either the clinic for treatment or to the emergency department for further triage and care.
Although testing processes and procedures have been modified, Dr. Crews advised codifying those policies and procedures, including notification of results and follow-up for both patients and staff. Dr. Crews also stressed the importance of clearly articulated return-to-work policies for staff who have potential exposure and/or positive test results.
At the University of Washington’s virology laboratory, they have a test turnaround time of less than 12 hours.
Planning ahead
Dr. Crews highlighted the importance of community-based surge planning, utilizing predictive models to assess inpatient capacity requirements and potential repurposing of providers.
The SCCA is prepared to close selected community sites and shift personnel to other locations if personnel needs cannot be met because of illness or quarantine. Contingency plans include specialized pharmacy services for patients requiring chemotherapy.
The SCCA has not yet experienced shortages of personal protective equipment (PPE). However, Dr. Crews said staff require detailed education regarding the use of PPE in order to safeguard the supply while providing maximal staff protection.
Helping the helpers
During the pandemic, SCCA has dealt with a variety of challenging human resource issues, including:
- Extending sick time beyond what was previously “stored” in staff members’ earned time off.
- Childcare during an extended hiatus in school and daycare schedules.
- Programs to maintain and/or restore employee wellness (including staff-centered support services, spiritual care, mindfulness exercises, and town halls).
Dr. Crews also discussed recruitment of community resources to provide meals for staff from local restaurants with restricted hours and transportation resources for staff and patients, as visitors are restricted (currently one per patient).
Managing care
Dr. Crews noted that the University of Washington had a foundational structure for a telehealth program prior to the pandemic. Their telehealth committee enabled SCCA to scale up the service quickly with their academic partners, including training modules for and certification of providers, outfitting off-site personnel with dedicated lines and hardware, and provision of personal Zoom accounts.
SCCA also devised algorithms for determining when face-to-face visits, remote management, or deferred visits are appropriate in various scenarios. The algorithms were developed by disease-specialized teams.
As a general rule, routine chemotherapy and radiation are administered on schedule. On-treatment and follow-up office visits are conducted via telehealth if possible. In some cases, initiation of chemotherapy and radiation has been delayed, and screening services have been suspended.
In response to questions about palliative care during the pandemic, Dr. Crews said SCCA has encouraged their patients to complete, review, or update their advance directives. The SCCA has not had the need to resuscitate a coronavirus-infected outpatient but has instituted policies for utilizing full PPE on any patient requiring resuscitation.
In her closing remarks, Dr. Crews stressed that the response to COVID-19 in Washington state has required an intense collaboration among colleagues, the community, and government leaders, as the actions required extended far beyond medical decision makers alone.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
according to the medical director of a cancer care alliance in the first U.S. epicenter of the coronavirus outbreak.
Jennie R. Crews, MD, the medical director of the Seattle Cancer Care Alliance (SCCA), discussed the SCCA experience and offered advice for other cancer centers in a webinar hosted by the Association of Community Cancer Centers.
Dr. Crews highlighted the SCCA’s use of algorithms to predict which patients can be managed via telehealth and which require face-to-face visits, human resource issues that arose at SCCA, screening and testing procedures, and the importance of communication with patients, caregivers, and staff.
Communication
Dr. Crews stressed the value of clear, regular, and internally consistent staff communication in a variety of formats. SCCA sends daily email blasts to their personnel regarding policies and procedures, which are archived on the SCCA intranet site.
SCCA also holds weekly town hall meetings at which leaders respond to staff questions regarding practical matters they have encountered and future plans. Providers’ up-to-the-minute familiarity with policies and procedures enables all team members to uniformly and clearly communicate to patients and caregivers.
Dr. Crews emphasized the value of consistency and “over-communication” in projecting confidence and preparedness to patients and caregivers during an unsettling time. SCCA has developed fact sheets, posted current information on the SCCA website, and provided education during doorway screenings.
Screening and testing
All SCCA staff members are screened daily at the practice entrance so they have personal experience with the process utilized for patients. Because symptoms associated with coronavirus infection may overlap with cancer treatment–related complaints, SCCA clinicians have expanded the typical coronavirus screening questionnaire for patients on cancer treatment.
Patients with ambiguous symptoms are masked, taken to a physically separate area of the SCCA clinics, and screened further by an advanced practice provider. The patients are then triaged to either the clinic for treatment or to the emergency department for further triage and care.
Although testing processes and procedures have been modified, Dr. Crews advised codifying those policies and procedures, including notification of results and follow-up for both patients and staff. Dr. Crews also stressed the importance of clearly articulated return-to-work policies for staff who have potential exposure and/or positive test results.
At the University of Washington’s virology laboratory, they have a test turnaround time of less than 12 hours.
Planning ahead
Dr. Crews highlighted the importance of community-based surge planning, utilizing predictive models to assess inpatient capacity requirements and potential repurposing of providers.
The SCCA is prepared to close selected community sites and shift personnel to other locations if personnel needs cannot be met because of illness or quarantine. Contingency plans include specialized pharmacy services for patients requiring chemotherapy.
The SCCA has not yet experienced shortages of personal protective equipment (PPE). However, Dr. Crews said staff require detailed education regarding the use of PPE in order to safeguard the supply while providing maximal staff protection.
Helping the helpers
During the pandemic, SCCA has dealt with a variety of challenging human resource issues, including:
- Extending sick time beyond what was previously “stored” in staff members’ earned time off.
- Childcare during an extended hiatus in school and daycare schedules.
- Programs to maintain and/or restore employee wellness (including staff-centered support services, spiritual care, mindfulness exercises, and town halls).
Dr. Crews also discussed recruitment of community resources to provide meals for staff from local restaurants with restricted hours and transportation resources for staff and patients, as visitors are restricted (currently one per patient).
Managing care
Dr. Crews noted that the University of Washington had a foundational structure for a telehealth program prior to the pandemic. Their telehealth committee enabled SCCA to scale up the service quickly with their academic partners, including training modules for and certification of providers, outfitting off-site personnel with dedicated lines and hardware, and provision of personal Zoom accounts.
SCCA also devised algorithms for determining when face-to-face visits, remote management, or deferred visits are appropriate in various scenarios. The algorithms were developed by disease-specialized teams.
As a general rule, routine chemotherapy and radiation are administered on schedule. On-treatment and follow-up office visits are conducted via telehealth if possible. In some cases, initiation of chemotherapy and radiation has been delayed, and screening services have been suspended.
In response to questions about palliative care during the pandemic, Dr. Crews said SCCA has encouraged their patients to complete, review, or update their advance directives. The SCCA has not had the need to resuscitate a coronavirus-infected outpatient but has instituted policies for utilizing full PPE on any patient requiring resuscitation.
In her closing remarks, Dr. Crews stressed that the response to COVID-19 in Washington state has required an intense collaboration among colleagues, the community, and government leaders, as the actions required extended far beyond medical decision makers alone.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
No staff COVID-19 diagnoses after plan at Chinese cancer center
Short-term results
No staff members or patients were diagnosed with COVID-19 after “strict protective measures” for screening and managing patients were implemented at the National Cancer Center/Cancer Hospital, Chinese Academy of Sciences, in Beijing, according to a report published online April 1 in JAMA Oncology.
However, the time period for the analysis, which included nearly 3000 patients, was short — only about 3 weeks (February 12 to March 3). Also, Beijing is more than 1100 kilometers from Wuhan, the center of the Chinese outbreak of COVID-19.
The Beijing cancer hospital implemented a multipronged safety plan in February in order to “avoid COVID-19 related nosocomial cross-infection between patients and medical staff,” explain the authors, led by medical oncologist Zhijie Wang, MD.
Notably, “all of the measures taken in China are actively being implemented and used in major oncology centers in the United States,” Robert Carlson, MD, chief executive officer, National Comprehensive Cancer Network (NCCN), told Medscape Medical News.
John Greene, MD, section chief, Infectious Disease and Tropical Medicine, Moffitt Cancer Center, Tampa, Florida, pointed out that the Chinese safety plan, which is full of “good measures,” is being largely used at his center. However, he observed that one tool — doing a temperature check at the hospital front door — is not well supported by most of the literature. “It gives good optics and looks like you are doing the most you possibly can, but scientifically it may not be as effective [as other screening measures],” he said.
The Chinese plan consists of four broad elements
First, the above-mentioned on-site temperature tests are performed at the entrances of the hospital, outpatient clinic, and wards. Contact and travel histories related to the Wuhan epidemic area are also established and recorded.
Second, an outpatient appointment scheduling system allows both online scheduling and on-site registration. Online consultation channels are open daily, featuring instruction on medication taking and cancer-related symptom management. These “substantially reduced the flow of people in the hospital,” write the authors. On-site patients must wear a mask and have their own disinfectant.
Third, for patients with cancer preparing to be admitted to hospital, symptoms associated with COVID-19, such as fever and cough, are recorded. Mandatory blood tests and CT scans of the lungs are performed. COVID-19 virus nucleic acid tests are performed for patients with suspected pneumonia on imaging.
Fourth, some anticancer drugs conventionally administered by infusion have been changed to oral administration, such as etoposide and vinorelbine. For adjuvant or maintenance chemotherapy, the infusion intervals were appropriately prolonged depending on patients’ conditions.
Eight out of 2,900 patients had imaging suspicious for infection
The Chinese authors report that a total of 2,944 patients with cancer were seen for clinic consultation and treatment in the wards (2795 outpatients and 149 inpatients).
Patients with cancer are believed to have a higher probability of severe illness and increased mortality compared with the healthy population once infected with COVID-19, point out the authors.
Under the new “strict screening strategy,” 27 patients showed radiologic manifestations of inflammatory changes or multiple-site exudative pneumonia in the lungs, including eight suspected of having COVID-19 infection. “Fortunately, negative results from nucleic acid testing ultimately excluded COVID-19 infection in all these patients,” the authors report.
However, two of these patients “presented with recovered pneumonia after symptomatic treatment.” Commenting on this finding, Moffitt’s Greene said that may mean these two patients were tested and found to be positive but were early in the infection and not yet shedding the virus, or they were infected after the initial negative result.
Greene said his center has implemented some measures not mentioned in the Chinese plan. For example, the Florida center no longer allows inpatient visitation. Also, one third of staff now work from home, resulting in less social interaction. Social distancing in meetings, the cafeteria, and hallways is being observed “aggressively,” and most meetings are now on Zoom, he said.
Moffitt has not been hard hit with COVID-19 and is at level one preparedness, the lowest rung. The center has performed 60 tests to date, with only one positive for the virus (< 2%), Greene told Medscape Medical News.
Currently, in the larger Tampa Bay community setting, about 12% of tests are positive.
The low percentage found among the Moffitt patients “tells you that a lot of cancer patients have fever and respiratory symptoms due to other viruses and, more importantly, other reasons, whether it’s their immunotherapy or chemotherapy or their cancer,” said Greene.
NCCN’s Carlson said the publication of the Chinese data was a good sign in terms of international science.
“This is a strong example of how the global oncology community rapidly shares information and experience whenever it makes a difference in patient care,” he commented.
The authors, as well as Carlson and Greene, have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Short-term results
Short-term results
No staff members or patients were diagnosed with COVID-19 after “strict protective measures” for screening and managing patients were implemented at the National Cancer Center/Cancer Hospital, Chinese Academy of Sciences, in Beijing, according to a report published online April 1 in JAMA Oncology.
However, the time period for the analysis, which included nearly 3000 patients, was short — only about 3 weeks (February 12 to March 3). Also, Beijing is more than 1100 kilometers from Wuhan, the center of the Chinese outbreak of COVID-19.
The Beijing cancer hospital implemented a multipronged safety plan in February in order to “avoid COVID-19 related nosocomial cross-infection between patients and medical staff,” explain the authors, led by medical oncologist Zhijie Wang, MD.
Notably, “all of the measures taken in China are actively being implemented and used in major oncology centers in the United States,” Robert Carlson, MD, chief executive officer, National Comprehensive Cancer Network (NCCN), told Medscape Medical News.
John Greene, MD, section chief, Infectious Disease and Tropical Medicine, Moffitt Cancer Center, Tampa, Florida, pointed out that the Chinese safety plan, which is full of “good measures,” is being largely used at his center. However, he observed that one tool — doing a temperature check at the hospital front door — is not well supported by most of the literature. “It gives good optics and looks like you are doing the most you possibly can, but scientifically it may not be as effective [as other screening measures],” he said.
The Chinese plan consists of four broad elements
First, the above-mentioned on-site temperature tests are performed at the entrances of the hospital, outpatient clinic, and wards. Contact and travel histories related to the Wuhan epidemic area are also established and recorded.
Second, an outpatient appointment scheduling system allows both online scheduling and on-site registration. Online consultation channels are open daily, featuring instruction on medication taking and cancer-related symptom management. These “substantially reduced the flow of people in the hospital,” write the authors. On-site patients must wear a mask and have their own disinfectant.
Third, for patients with cancer preparing to be admitted to hospital, symptoms associated with COVID-19, such as fever and cough, are recorded. Mandatory blood tests and CT scans of the lungs are performed. COVID-19 virus nucleic acid tests are performed for patients with suspected pneumonia on imaging.
Fourth, some anticancer drugs conventionally administered by infusion have been changed to oral administration, such as etoposide and vinorelbine. For adjuvant or maintenance chemotherapy, the infusion intervals were appropriately prolonged depending on patients’ conditions.
Eight out of 2,900 patients had imaging suspicious for infection
The Chinese authors report that a total of 2,944 patients with cancer were seen for clinic consultation and treatment in the wards (2795 outpatients and 149 inpatients).
Patients with cancer are believed to have a higher probability of severe illness and increased mortality compared with the healthy population once infected with COVID-19, point out the authors.
Under the new “strict screening strategy,” 27 patients showed radiologic manifestations of inflammatory changes or multiple-site exudative pneumonia in the lungs, including eight suspected of having COVID-19 infection. “Fortunately, negative results from nucleic acid testing ultimately excluded COVID-19 infection in all these patients,” the authors report.
However, two of these patients “presented with recovered pneumonia after symptomatic treatment.” Commenting on this finding, Moffitt’s Greene said that may mean these two patients were tested and found to be positive but were early in the infection and not yet shedding the virus, or they were infected after the initial negative result.
Greene said his center has implemented some measures not mentioned in the Chinese plan. For example, the Florida center no longer allows inpatient visitation. Also, one third of staff now work from home, resulting in less social interaction. Social distancing in meetings, the cafeteria, and hallways is being observed “aggressively,” and most meetings are now on Zoom, he said.
Moffitt has not been hard hit with COVID-19 and is at level one preparedness, the lowest rung. The center has performed 60 tests to date, with only one positive for the virus (< 2%), Greene told Medscape Medical News.
Currently, in the larger Tampa Bay community setting, about 12% of tests are positive.
The low percentage found among the Moffitt patients “tells you that a lot of cancer patients have fever and respiratory symptoms due to other viruses and, more importantly, other reasons, whether it’s their immunotherapy or chemotherapy or their cancer,” said Greene.
NCCN’s Carlson said the publication of the Chinese data was a good sign in terms of international science.
“This is a strong example of how the global oncology community rapidly shares information and experience whenever it makes a difference in patient care,” he commented.
The authors, as well as Carlson and Greene, have reported no relevant financial relationships.
This article first appeared on Medscape.com.
No staff members or patients were diagnosed with COVID-19 after “strict protective measures” for screening and managing patients were implemented at the National Cancer Center/Cancer Hospital, Chinese Academy of Sciences, in Beijing, according to a report published online April 1 in JAMA Oncology.
However, the time period for the analysis, which included nearly 3000 patients, was short — only about 3 weeks (February 12 to March 3). Also, Beijing is more than 1100 kilometers from Wuhan, the center of the Chinese outbreak of COVID-19.
The Beijing cancer hospital implemented a multipronged safety plan in February in order to “avoid COVID-19 related nosocomial cross-infection between patients and medical staff,” explain the authors, led by medical oncologist Zhijie Wang, MD.
Notably, “all of the measures taken in China are actively being implemented and used in major oncology centers in the United States,” Robert Carlson, MD, chief executive officer, National Comprehensive Cancer Network (NCCN), told Medscape Medical News.
John Greene, MD, section chief, Infectious Disease and Tropical Medicine, Moffitt Cancer Center, Tampa, Florida, pointed out that the Chinese safety plan, which is full of “good measures,” is being largely used at his center. However, he observed that one tool — doing a temperature check at the hospital front door — is not well supported by most of the literature. “It gives good optics and looks like you are doing the most you possibly can, but scientifically it may not be as effective [as other screening measures],” he said.
The Chinese plan consists of four broad elements
First, the above-mentioned on-site temperature tests are performed at the entrances of the hospital, outpatient clinic, and wards. Contact and travel histories related to the Wuhan epidemic area are also established and recorded.
Second, an outpatient appointment scheduling system allows both online scheduling and on-site registration. Online consultation channels are open daily, featuring instruction on medication taking and cancer-related symptom management. These “substantially reduced the flow of people in the hospital,” write the authors. On-site patients must wear a mask and have their own disinfectant.
Third, for patients with cancer preparing to be admitted to hospital, symptoms associated with COVID-19, such as fever and cough, are recorded. Mandatory blood tests and CT scans of the lungs are performed. COVID-19 virus nucleic acid tests are performed for patients with suspected pneumonia on imaging.
Fourth, some anticancer drugs conventionally administered by infusion have been changed to oral administration, such as etoposide and vinorelbine. For adjuvant or maintenance chemotherapy, the infusion intervals were appropriately prolonged depending on patients’ conditions.
Eight out of 2,900 patients had imaging suspicious for infection
The Chinese authors report that a total of 2,944 patients with cancer were seen for clinic consultation and treatment in the wards (2795 outpatients and 149 inpatients).
Patients with cancer are believed to have a higher probability of severe illness and increased mortality compared with the healthy population once infected with COVID-19, point out the authors.
Under the new “strict screening strategy,” 27 patients showed radiologic manifestations of inflammatory changes or multiple-site exudative pneumonia in the lungs, including eight suspected of having COVID-19 infection. “Fortunately, negative results from nucleic acid testing ultimately excluded COVID-19 infection in all these patients,” the authors report.
However, two of these patients “presented with recovered pneumonia after symptomatic treatment.” Commenting on this finding, Moffitt’s Greene said that may mean these two patients were tested and found to be positive but were early in the infection and not yet shedding the virus, or they were infected after the initial negative result.
Greene said his center has implemented some measures not mentioned in the Chinese plan. For example, the Florida center no longer allows inpatient visitation. Also, one third of staff now work from home, resulting in less social interaction. Social distancing in meetings, the cafeteria, and hallways is being observed “aggressively,” and most meetings are now on Zoom, he said.
Moffitt has not been hard hit with COVID-19 and is at level one preparedness, the lowest rung. The center has performed 60 tests to date, with only one positive for the virus (< 2%), Greene told Medscape Medical News.
Currently, in the larger Tampa Bay community setting, about 12% of tests are positive.
The low percentage found among the Moffitt patients “tells you that a lot of cancer patients have fever and respiratory symptoms due to other viruses and, more importantly, other reasons, whether it’s their immunotherapy or chemotherapy or their cancer,” said Greene.
NCCN’s Carlson said the publication of the Chinese data was a good sign in terms of international science.
“This is a strong example of how the global oncology community rapidly shares information and experience whenever it makes a difference in patient care,” he commented.
The authors, as well as Carlson and Greene, have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Maintaining cancer care in the face of COVID-19
Medical oncologist Anne Chiang, MD, PhD, is scrambling to maintain cancer care in New Haven, Connecticut, while COVID-19 advances unrelentingly. As deputy chief medical officer of the Smilow Cancer Network, the largest cancer care delivery system in Connecticut and Rhode Island, she has no illusions about dodging what’s unfolding just 2 hours down the road in New York City.
“They’re trying their best to continue active cancer treatment but it’s getting harder,” she says of her colleagues in the thick of the pandemic. “We have to be prepared for it here.”
In anticipation of what’s coming, her team has just emptied the top three floors of the Smilow Cancer Hospital, moving 60 patients by ambulance and other medical transport to a different hospital nearby.
The move frees the Smilow Cancer hospital’s negative-pressure wards for the anticipated wave of COVID-19 patients. It will keep the virus sealed off from the rest of the hospital. But in other locations it’s harder to shield patients with cancer from the infection.
Around the state, Smilow Cancer Network’s affiliated hospitals are already treating a growing number of COVID-19 patients, especially at Greenwich Hospital, right on the border with New York state.
To protect patients with cancer, who are among the most vulnerable to the virus, oncologists are embracing telemedicine to allow most patients to stay home.
“We’re really concentrating on decreasing the risk to these patients, with a widespread massive-scale conversion to telehealth,” said Chiang. “This is something that, in the space of about a week, has transformed the care of our patients — it’s a really amazing transformation.”
If anything good comes out of the COVID-19 pandemic, it will be this global adoption of virtual healthcare.
Across the US border in Canada, the medical director of Toronto’s Princess Margaret Cancer Centre is directing a similar transformation.
“We have converted probably about 70% to 80% of our clinic visits to virtual visits,” says radiation oncologist Mary Gospodarowicz, MD.
“We have three priorities: number one, to keep our patients safe; number two, to keep our staff safe, because if staff are sick we won’t be treating anybody; and number three, to treat as many patients with cancer as possible.”
Gospodarowicz woke up last week to a local headline about a woman whose mastectomy had been canceled “because of the coronavirus.” The story exposed the many layers of the COVID-19 crisis. “A lot of hospitals have canceled elective surgeries,” she acknowledged. “For patients who have treatment or surgery deferred, we have a database and we’ll make sure we look after those patients eventually. We have a priority system, so low-risk prostate cancer, very low-risk breast cancer patients are waiting. All the urgent head and neck, breast, and other higher priority surgeries are still being done, but it just depends how it goes. The situation changes every day.”
It’s similar in Los Angeles, at the University of Southern California, says Elizabeth David, MD, a cardiothoracic surgeon with Keck Medicine.
“For thoracic, we just had a conference call with about 30 surgeons around the country going through really nitty-gritty specifics to help with our decision making about what could wait without detriment to the patient – hopefully – and what should be done now,” she told Medscape Medical News.
“There are some hospitals where they are not doing anything but life and death emergency operations, whereas we are still doing our emergent cancer operations in our institution, but we all know – and patients know – that could change from one day to the next. They may think they’re having surgery tomorrow but may get a call saying we can’t do it,” David said.
Many of David’s patients have non–small cell lung cancer, putting them at particular risk with a pulmonary infection like COVID-19. For now, she says delivery of postsurgical chemotherapy and radiotherapy has not been impacted in her area, but her videoconference discussions with patients are much longer – and harder – these days.
“I’ve been in practice a while now and I’ve had numerous conversations with patients this week that I never trained for, and I’ve never known anyone else who has. It’s really hard as a provider to know what to say,” she said.
In cardiothoracic surgery, David said guidance on clinical decision making is coming from the American College of Surgeons, Society of Thoracic Surgery, and American Association of Thoracic Surgeons. Yet, she says each patient is being assessed – and reassessed – individually.
“You have to balance the risk of delaying the intervention with supply issues, hospital exposure issues, the danger to the patient of being in the hospital environment – there’s just so many factors. We’re spending so much time talking through cases, and a lot of times we’re talking about cases we already talked about, but we’re just making sure that based on today’s numbers we should still be moving forward,” she commented.
In Connecticut, Chiang said treatment decisions are also mostly on a case-by-case basis at the moment, although more standardized guidelines are being worked out.
“Our disease teams have been really proactive in terms of offering alternative solutions to patients, creative ways to basically keep them out of the hospital and also reduce the immunosuppressive regimens that we give them,” she said.
Examples include offering endocrine therapy to patients who can’t get breast cancer surgery, or offering alternative drug regimens and dosing schedules. “At this point we haven’t needed to ration actual treatment – patients are continuing to get active therapy if that’s appropriate – it’s more about how can we protect them,” she said. “It’s a complex puzzle of moving pieces.”
In Toronto, Gospodarowicz says newly published medical and radiation oncology guidelines from France are the backbone of her hospital’s policy discussions about treating cancer and protecting patients from COVID-19.
While patients’ concerns are understandable, she says even in the current hot spots of infection, it’s encouraging to know that cancer patients are not being forgotten.
“I recently had email communication with a radiation oncologist in Brescia, one of the worst-affected areas in Italy, and he told me the radiotherapy department has been 60% to 70% capacity, so they still treat 70% these patients, just taking precautions and separating the COVID-positive and negative ones. When we read the stats it looks horrible, but life still goes on and people are still being treated,” she said.
Although telemedicine offers meaningful solutions to the COVID-19 crisis in North America, it may not be possible in other parts of the world.
Web consultations were only just approved in Brazil this week. “We are still discussing how to make it official and reimbursed,” says Rachel Riechelmann, MD, head of clinical oncology at AC Camargo Cancer Center in São Paulo.
To minimize infection risk for patients, Riechelmann says her hospital is doing the following: postponing surgeries in cases where there is good evidence of neoadjuvant treatment, such as total neoadjuvant therapy for rectal cancer; avoiding adjuvant chemo for stage 2 colon cancer; moving to hypofractionated radiotherapy if possible; adopting watchful waiting in grade 1 nonfunctional neuroendocrine tumors; and postponing follow-up visits.
“We do our best,” she wrote in an email. “We keep treating cancer if treatment cannot wait.”
Riechelmann’s center has just launched a trial of hydroxychloroquine and tocilizumab therapy in patients with cancer who have severe COVID-19 and acute respiratory distress syndrome (ARDS).
Meanwhile in New Haven, Chiang says for patients with cancer who are infected with COVID-19, her team is also prognosticating about the fair allocation of limited resources such as ventilators.
“If it ever gets to the point where somebody has to choose between a cancer patient and a noncancer patient in providing life support, it’s really important that people understand that cancer patients are doing very well nowadays and even with a diagnosis of cancer they can potentially live for many years, so that shouldn’t necessarily be a decision-point,” she emphasized.
This article first appeared on Medscape.com.
Medical oncologist Anne Chiang, MD, PhD, is scrambling to maintain cancer care in New Haven, Connecticut, while COVID-19 advances unrelentingly. As deputy chief medical officer of the Smilow Cancer Network, the largest cancer care delivery system in Connecticut and Rhode Island, she has no illusions about dodging what’s unfolding just 2 hours down the road in New York City.
“They’re trying their best to continue active cancer treatment but it’s getting harder,” she says of her colleagues in the thick of the pandemic. “We have to be prepared for it here.”
In anticipation of what’s coming, her team has just emptied the top three floors of the Smilow Cancer Hospital, moving 60 patients by ambulance and other medical transport to a different hospital nearby.
The move frees the Smilow Cancer hospital’s negative-pressure wards for the anticipated wave of COVID-19 patients. It will keep the virus sealed off from the rest of the hospital. But in other locations it’s harder to shield patients with cancer from the infection.
Around the state, Smilow Cancer Network’s affiliated hospitals are already treating a growing number of COVID-19 patients, especially at Greenwich Hospital, right on the border with New York state.
To protect patients with cancer, who are among the most vulnerable to the virus, oncologists are embracing telemedicine to allow most patients to stay home.
“We’re really concentrating on decreasing the risk to these patients, with a widespread massive-scale conversion to telehealth,” said Chiang. “This is something that, in the space of about a week, has transformed the care of our patients — it’s a really amazing transformation.”
If anything good comes out of the COVID-19 pandemic, it will be this global adoption of virtual healthcare.
Across the US border in Canada, the medical director of Toronto’s Princess Margaret Cancer Centre is directing a similar transformation.
“We have converted probably about 70% to 80% of our clinic visits to virtual visits,” says radiation oncologist Mary Gospodarowicz, MD.
“We have three priorities: number one, to keep our patients safe; number two, to keep our staff safe, because if staff are sick we won’t be treating anybody; and number three, to treat as many patients with cancer as possible.”
Gospodarowicz woke up last week to a local headline about a woman whose mastectomy had been canceled “because of the coronavirus.” The story exposed the many layers of the COVID-19 crisis. “A lot of hospitals have canceled elective surgeries,” she acknowledged. “For patients who have treatment or surgery deferred, we have a database and we’ll make sure we look after those patients eventually. We have a priority system, so low-risk prostate cancer, very low-risk breast cancer patients are waiting. All the urgent head and neck, breast, and other higher priority surgeries are still being done, but it just depends how it goes. The situation changes every day.”
It’s similar in Los Angeles, at the University of Southern California, says Elizabeth David, MD, a cardiothoracic surgeon with Keck Medicine.
“For thoracic, we just had a conference call with about 30 surgeons around the country going through really nitty-gritty specifics to help with our decision making about what could wait without detriment to the patient – hopefully – and what should be done now,” she told Medscape Medical News.
“There are some hospitals where they are not doing anything but life and death emergency operations, whereas we are still doing our emergent cancer operations in our institution, but we all know – and patients know – that could change from one day to the next. They may think they’re having surgery tomorrow but may get a call saying we can’t do it,” David said.
Many of David’s patients have non–small cell lung cancer, putting them at particular risk with a pulmonary infection like COVID-19. For now, she says delivery of postsurgical chemotherapy and radiotherapy has not been impacted in her area, but her videoconference discussions with patients are much longer – and harder – these days.
“I’ve been in practice a while now and I’ve had numerous conversations with patients this week that I never trained for, and I’ve never known anyone else who has. It’s really hard as a provider to know what to say,” she said.
In cardiothoracic surgery, David said guidance on clinical decision making is coming from the American College of Surgeons, Society of Thoracic Surgery, and American Association of Thoracic Surgeons. Yet, she says each patient is being assessed – and reassessed – individually.
“You have to balance the risk of delaying the intervention with supply issues, hospital exposure issues, the danger to the patient of being in the hospital environment – there’s just so many factors. We’re spending so much time talking through cases, and a lot of times we’re talking about cases we already talked about, but we’re just making sure that based on today’s numbers we should still be moving forward,” she commented.
In Connecticut, Chiang said treatment decisions are also mostly on a case-by-case basis at the moment, although more standardized guidelines are being worked out.
“Our disease teams have been really proactive in terms of offering alternative solutions to patients, creative ways to basically keep them out of the hospital and also reduce the immunosuppressive regimens that we give them,” she said.
Examples include offering endocrine therapy to patients who can’t get breast cancer surgery, or offering alternative drug regimens and dosing schedules. “At this point we haven’t needed to ration actual treatment – patients are continuing to get active therapy if that’s appropriate – it’s more about how can we protect them,” she said. “It’s a complex puzzle of moving pieces.”
In Toronto, Gospodarowicz says newly published medical and radiation oncology guidelines from France are the backbone of her hospital’s policy discussions about treating cancer and protecting patients from COVID-19.
While patients’ concerns are understandable, she says even in the current hot spots of infection, it’s encouraging to know that cancer patients are not being forgotten.
“I recently had email communication with a radiation oncologist in Brescia, one of the worst-affected areas in Italy, and he told me the radiotherapy department has been 60% to 70% capacity, so they still treat 70% these patients, just taking precautions and separating the COVID-positive and negative ones. When we read the stats it looks horrible, but life still goes on and people are still being treated,” she said.
Although telemedicine offers meaningful solutions to the COVID-19 crisis in North America, it may not be possible in other parts of the world.
Web consultations were only just approved in Brazil this week. “We are still discussing how to make it official and reimbursed,” says Rachel Riechelmann, MD, head of clinical oncology at AC Camargo Cancer Center in São Paulo.
To minimize infection risk for patients, Riechelmann says her hospital is doing the following: postponing surgeries in cases where there is good evidence of neoadjuvant treatment, such as total neoadjuvant therapy for rectal cancer; avoiding adjuvant chemo for stage 2 colon cancer; moving to hypofractionated radiotherapy if possible; adopting watchful waiting in grade 1 nonfunctional neuroendocrine tumors; and postponing follow-up visits.
“We do our best,” she wrote in an email. “We keep treating cancer if treatment cannot wait.”
Riechelmann’s center has just launched a trial of hydroxychloroquine and tocilizumab therapy in patients with cancer who have severe COVID-19 and acute respiratory distress syndrome (ARDS).
Meanwhile in New Haven, Chiang says for patients with cancer who are infected with COVID-19, her team is also prognosticating about the fair allocation of limited resources such as ventilators.
“If it ever gets to the point where somebody has to choose between a cancer patient and a noncancer patient in providing life support, it’s really important that people understand that cancer patients are doing very well nowadays and even with a diagnosis of cancer they can potentially live for many years, so that shouldn’t necessarily be a decision-point,” she emphasized.
This article first appeared on Medscape.com.
Medical oncologist Anne Chiang, MD, PhD, is scrambling to maintain cancer care in New Haven, Connecticut, while COVID-19 advances unrelentingly. As deputy chief medical officer of the Smilow Cancer Network, the largest cancer care delivery system in Connecticut and Rhode Island, she has no illusions about dodging what’s unfolding just 2 hours down the road in New York City.
“They’re trying their best to continue active cancer treatment but it’s getting harder,” she says of her colleagues in the thick of the pandemic. “We have to be prepared for it here.”
In anticipation of what’s coming, her team has just emptied the top three floors of the Smilow Cancer Hospital, moving 60 patients by ambulance and other medical transport to a different hospital nearby.
The move frees the Smilow Cancer hospital’s negative-pressure wards for the anticipated wave of COVID-19 patients. It will keep the virus sealed off from the rest of the hospital. But in other locations it’s harder to shield patients with cancer from the infection.
Around the state, Smilow Cancer Network’s affiliated hospitals are already treating a growing number of COVID-19 patients, especially at Greenwich Hospital, right on the border with New York state.
To protect patients with cancer, who are among the most vulnerable to the virus, oncologists are embracing telemedicine to allow most patients to stay home.
“We’re really concentrating on decreasing the risk to these patients, with a widespread massive-scale conversion to telehealth,” said Chiang. “This is something that, in the space of about a week, has transformed the care of our patients — it’s a really amazing transformation.”
If anything good comes out of the COVID-19 pandemic, it will be this global adoption of virtual healthcare.
Across the US border in Canada, the medical director of Toronto’s Princess Margaret Cancer Centre is directing a similar transformation.
“We have converted probably about 70% to 80% of our clinic visits to virtual visits,” says radiation oncologist Mary Gospodarowicz, MD.
“We have three priorities: number one, to keep our patients safe; number two, to keep our staff safe, because if staff are sick we won’t be treating anybody; and number three, to treat as many patients with cancer as possible.”
Gospodarowicz woke up last week to a local headline about a woman whose mastectomy had been canceled “because of the coronavirus.” The story exposed the many layers of the COVID-19 crisis. “A lot of hospitals have canceled elective surgeries,” she acknowledged. “For patients who have treatment or surgery deferred, we have a database and we’ll make sure we look after those patients eventually. We have a priority system, so low-risk prostate cancer, very low-risk breast cancer patients are waiting. All the urgent head and neck, breast, and other higher priority surgeries are still being done, but it just depends how it goes. The situation changes every day.”
It’s similar in Los Angeles, at the University of Southern California, says Elizabeth David, MD, a cardiothoracic surgeon with Keck Medicine.
“For thoracic, we just had a conference call with about 30 surgeons around the country going through really nitty-gritty specifics to help with our decision making about what could wait without detriment to the patient – hopefully – and what should be done now,” she told Medscape Medical News.
“There are some hospitals where they are not doing anything but life and death emergency operations, whereas we are still doing our emergent cancer operations in our institution, but we all know – and patients know – that could change from one day to the next. They may think they’re having surgery tomorrow but may get a call saying we can’t do it,” David said.
Many of David’s patients have non–small cell lung cancer, putting them at particular risk with a pulmonary infection like COVID-19. For now, she says delivery of postsurgical chemotherapy and radiotherapy has not been impacted in her area, but her videoconference discussions with patients are much longer – and harder – these days.
“I’ve been in practice a while now and I’ve had numerous conversations with patients this week that I never trained for, and I’ve never known anyone else who has. It’s really hard as a provider to know what to say,” she said.
In cardiothoracic surgery, David said guidance on clinical decision making is coming from the American College of Surgeons, Society of Thoracic Surgery, and American Association of Thoracic Surgeons. Yet, she says each patient is being assessed – and reassessed – individually.
“You have to balance the risk of delaying the intervention with supply issues, hospital exposure issues, the danger to the patient of being in the hospital environment – there’s just so many factors. We’re spending so much time talking through cases, and a lot of times we’re talking about cases we already talked about, but we’re just making sure that based on today’s numbers we should still be moving forward,” she commented.
In Connecticut, Chiang said treatment decisions are also mostly on a case-by-case basis at the moment, although more standardized guidelines are being worked out.
“Our disease teams have been really proactive in terms of offering alternative solutions to patients, creative ways to basically keep them out of the hospital and also reduce the immunosuppressive regimens that we give them,” she said.
Examples include offering endocrine therapy to patients who can’t get breast cancer surgery, or offering alternative drug regimens and dosing schedules. “At this point we haven’t needed to ration actual treatment – patients are continuing to get active therapy if that’s appropriate – it’s more about how can we protect them,” she said. “It’s a complex puzzle of moving pieces.”
In Toronto, Gospodarowicz says newly published medical and radiation oncology guidelines from France are the backbone of her hospital’s policy discussions about treating cancer and protecting patients from COVID-19.
While patients’ concerns are understandable, she says even in the current hot spots of infection, it’s encouraging to know that cancer patients are not being forgotten.
“I recently had email communication with a radiation oncologist in Brescia, one of the worst-affected areas in Italy, and he told me the radiotherapy department has been 60% to 70% capacity, so they still treat 70% these patients, just taking precautions and separating the COVID-positive and negative ones. When we read the stats it looks horrible, but life still goes on and people are still being treated,” she said.
Although telemedicine offers meaningful solutions to the COVID-19 crisis in North America, it may not be possible in other parts of the world.
Web consultations were only just approved in Brazil this week. “We are still discussing how to make it official and reimbursed,” says Rachel Riechelmann, MD, head of clinical oncology at AC Camargo Cancer Center in São Paulo.
To minimize infection risk for patients, Riechelmann says her hospital is doing the following: postponing surgeries in cases where there is good evidence of neoadjuvant treatment, such as total neoadjuvant therapy for rectal cancer; avoiding adjuvant chemo for stage 2 colon cancer; moving to hypofractionated radiotherapy if possible; adopting watchful waiting in grade 1 nonfunctional neuroendocrine tumors; and postponing follow-up visits.
“We do our best,” she wrote in an email. “We keep treating cancer if treatment cannot wait.”
Riechelmann’s center has just launched a trial of hydroxychloroquine and tocilizumab therapy in patients with cancer who have severe COVID-19 and acute respiratory distress syndrome (ARDS).
Meanwhile in New Haven, Chiang says for patients with cancer who are infected with COVID-19, her team is also prognosticating about the fair allocation of limited resources such as ventilators.
“If it ever gets to the point where somebody has to choose between a cancer patient and a noncancer patient in providing life support, it’s really important that people understand that cancer patients are doing very well nowadays and even with a diagnosis of cancer they can potentially live for many years, so that shouldn’t necessarily be a decision-point,” she emphasized.
This article first appeared on Medscape.com.
Blood test might detect multiple cancer types, study suggests
Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.
The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.
Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.
Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.
Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.
Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).
The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.
Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.
“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”
“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”
Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.
Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.
The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.
Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.
Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.
Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.
Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).
The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.
Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.
“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”
“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”
Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.
Investigators led by Minetta C. Liu, MD, a medical oncologist with the Mayo Clinic, Rochester, Minn., studied 6,689 participants – 2,482 with cancers of more than 50 types and 4,207 without cancer – drawn from the Circulating Cell-free Genome Atlas Study and the STRIVE Study populations.
The investigators performed bisulfite sequencing that targeted informative methylation regions of plasma cell-free DNA (cfDNA), and developed and validated a molecular classifier using methylation patterns to detect cancer and determine its tissue of origin.
Test performance was assessed both for cancer overall and for a prespecified set of 12 cancers (anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, stomach) that account for about 63% of U.S. cancer deaths annually.
Results reported this week in the Annals of Oncology showed that the test had a specificity of 99.3% in the validation cohort, corresponding to a false-positive rate of just 0.7%.
Sensitivity for detecting stage I-III disease was 43.9% for cancer overall and 67.3% for the prespecified set of cancers accounting for the majority of U.S. cancer deaths.
Test sensitivity increased with stage both for cancer overall (18%, 43%, 81%, and 93% for stage I, II, III, and IV disease, respectively) and for the prespecified set of cancers (39%, 69%, 83%, and 92%, respectively).
The test was able to predict a tissue of origin in 96% of samples in which a cancerlike signal was detected, and in 93% of cases, that prediction was accurate.
Some of the patients who had cancer were symptomatic and therefore would not be considered a screening population, Dr. Liu and coinvestigators acknowledged. Also, the test’s potential for reducing mortality remains unknown, and 1-year follow-up to verify cancer-free status was not yet available for all of the individuals without cancer.
“Together, these data provide compelling evidence that targeted methylation analysis of cfDNA can detect and localize a broad range of nonmetastatic and metastatic cancer types including many common and deadly cancers that lack effective screening strategies,” they maintained. The test’s “specificity and sensitivity performance approach ... the goal for population-level screening.”
“Considering the potential value of early detection in deadly malignancies, further evaluation of this test is justified in prospective population-level studies,” the investigators conclude. “Clinical validation in intended use populations is ongoing ... and a study has been initiated that is returning results to health care providers and patients ....”
Dr. Liu disclosed that the Mayo Clinic was compensated for her advisory board activities for GRAIL Inc. The study was supported by GRAIL, and by Princess Margaret Cancer Centre’s McCain Genitourinary BioBank in the department of surgical oncology.
SOURCE: Liu MC et al. Ann Oncol. 2020 Mar 31. doi: 10.1016/j.annonc.2020.02.011.
FROM ANNALS OF ONCOLOGY
CARAVAGGIO expands DOAC pool in cancer-related VTE
Oral apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) was as effective as subcutaneous dalteparin (Fragmin, Pfizer) for cancer-related venous thromboembolism (VTE) without an increased risk of major bleeding, the CARAVAGGIO study suggests.
Over 6 months of follow-up, the primary efficacy outcome of recurrent thromboembolism occurred in 32 of 576 patients (5.6%) randomly assigned to apixaban and in 46 of 579 patients (7.9%) assigned dalteparin (hazard ratio, 0.63; 95% confidence interval, 0.37-1.07). The risk difference met the criteria for noninferiority (P < .001) but not for superiority (P = .09).
The risk for major bleeding was similar in the apixaban and dalteparin groups (3.8% and 4.0%; P = .60), including major gastrointestinal (GI) bleeds (11 vs 10 events).
There was a numeric excess of clinically relevant nonmajor bleeding in the apixaban group (9.0% vs 6.0%; HR, 1.42; 95% CI, 0.88-2.30).
However, the site of this bleeding “was essentially the genitourinary tract and the upper respiratory tract, so again there was no increase in gastrointestinal bleeding, even when the clinically relevant major bleeding was considered,” said lead author Giancarlo Agnelli, MD, University of Perugia, Italy.
Taken together, “We believe that the findings of CARAVAGGIO expand the proportion of patients with cancer-associated thrombosis who are eligible for treatment with oral direct anticoagulants, including patients with gastrointestinal cancer,” he concluded.
The findings were presented online March 29 at the American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC) and published simultaneously in the New England Journal of Medicine.
Major guidelines recommend the use of low-molecular-weight heparin (LMWH) for the treatment of cancer-related VTE but also support the use of edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) as an alternative based on data from the OKUSAI VTE and SELECT-D trials, respectively. But an increased risk for bleeding was observed among patients with GI cancer in both studies.
“The findings are of clinical relevance because we were able to confirm the efficacy of another [novel oral anticoagulant] NOAC but we have the absence of bleeding, GI bleeding in particular. This is an important point; this is what the clinical community is looking for,” Agnelli told theheart.org | Medscape Cardiology.
The recent ADAM VTE trial testing apixaban, a factor Xa inhibitor, vs dalteparin, a LMWH, reported no major bleeding among patients treated with apixaban (primary safety endpoint) and a significant reduction of VTE (secondary efficacy endpoint). But the trial included only 300 patients with cancer and a more selected population compared with the CARAVAGGIO trial, noted Chiara Melloni, MD, MHS, a cardiologist at Duke Clinical Research Institute, Durham, North Carolina, who was not involved with the trial.
“The trial presented today by Prof. Agnelli provides evidence that apixaban represents an additional valid option, next to edoxaban and rivaroxaban, for the treatment of VTE in cancer patients,” she told theheart.org | Medscape Cardiology in an email. “The subgroup analyses showed consistent results across all different subgroups, but a significant interaction was observed between age groups, with a more favorable profile among those less than 75 years old (and mostly among those <65 years old). This may require more investigation.”
The CARAVAGGIO investigators randomly assigned 576 consecutive patients with cancer who had newly diagnosed symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin 200 IU per kg once daily for 1 month followed by 150 U/kg once daily, both for a total of 6 months. Dose reduction was allowed for dalteparin but not for apixaban during the study.
Various types of cancer were included in the trial, including lung, breast, genitourinary, and upper GI.
The incidence of death was similar in the apixaban and dalteparin groups (23.4% vs 26.4%), with most deaths related to cancer (85.2% vs 88.2%, respectively).
During a discussion of the findings, panelist Bonnie Ky, MD, from the Hospital of the University of Pennsylvania in Philadelphia, and editor in chief of JACC: CardioOncology, congratulated the authors on an “excellent, well-done study” in a high-need cancer population suffering from a clinically significant burden of VTE, reported to be anywhere from 8% to 19% depending on tumor type.
“I was particularly impressed by the low rate of bleeding, which has been traditionally a concern with DOACs, as well the demonstration of noninferiority of apixaban,” she said.
Ky asked why the bleeding rate was lower than observed in other published studies and in whom clinicians shouldn’t be considering apixaban now.
Agnelli said that a head-to-head study is needed to compare the various oral anticoagulant agents but that the gastrointestinal bleeding rate is well known to be reduced with apixaban in patients with atrial fibrillation.
“So whether this is related to the drug or the administration twice daily, it’s something that can be discussed, but honestly the final solution would be to have a comparative study,” he said. “It’s going to be difficult, but it’s what we need.”
As to the clinical application of the data, Agnelli said, “The apixaban data actually extend the number of our patients who could receive the oral agents, including patients with GI cancer. So I do believe this indication about using DOACs in cancer patients will change and the indication expanded. But of course, we are building on something that was already known. We did not discover this all by ourselves.”
Panelist Robert M. Carey, MD, a leader in cardiovascular endocrinology and dean emeritus, University of Virginia School of Medicine in Charlottesville, said the study “conclusively shows noninferiority” but asked for more detail on the subset of patients with GI malignancies and the bleeding rate there.
Agnelli replied that the proportion and number of these patients in CARAVAGGIO is the same as, if not slightly higher than, in other studies. “So we have a population that is representative of all the cancer population, including GI cancer,” he said, adding that subanalyses are underway correlating the site of cancer with the type of bleeding.
Agnes Y.Y. Lee, MD, University of British Columbia, Vancouver Coastal Health, and the British Cancer Agency, all in Vancouver, Canada, notes in a linked editorial that CARAVAGGIO excluded patients with primary and metastatic brain lesions and included few patients with cancers of the upper GI tract, with hematologic cancers, or receiving newer cancer therapies, such as checkpoint inhibitors.
She says clinicians will have to choose carefully which anticoagulant to use but that LMWH is “preferred in patients in whom drug-drug interaction is a concern and in those who have undergone surgery involving the upper gastrointestinal tract because absorption of all direct oral anticoagulants occurs in the stomach or proximal small bowel.”
Warfarin may also be the only option when cost is the “decision driver” in patients with cancer facing major financial healthcare burdens, Lee writes.
Duke’s Melloni also said the cost of oral anticoagulants needs to be taken into account and varies widely for patients based on their insurance and availability of other copay assistance programs. “It is therefore important to discuss with the patients upfront because if the patients are started but cannot afford long term, early discontinuation can impact their safety,” she said.
The trial was sponsored by FADOI (Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti) and was funded by an unrestricted grant from the Bristol-Myers Squibb-Pfizer Alliance. Agnelli reports personal fees from Pfizer and Bayer Healthcare, and “other” from Daiichi Sankyo outside the submitted work. Melloni reports having no relevant conflicts of interest. Lee reports personal fees and nonfinancial support from Bayer; grants, personal fees, and nonfinancial support from Bristol-Myers Squibb; and personal fees from LEO Pharma, Pfizer, and Quercegen Pharmaceuticals outside the submitted work.
This article first appeared on Medscape.com.
Oral apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) was as effective as subcutaneous dalteparin (Fragmin, Pfizer) for cancer-related venous thromboembolism (VTE) without an increased risk of major bleeding, the CARAVAGGIO study suggests.
Over 6 months of follow-up, the primary efficacy outcome of recurrent thromboembolism occurred in 32 of 576 patients (5.6%) randomly assigned to apixaban and in 46 of 579 patients (7.9%) assigned dalteparin (hazard ratio, 0.63; 95% confidence interval, 0.37-1.07). The risk difference met the criteria for noninferiority (P < .001) but not for superiority (P = .09).
The risk for major bleeding was similar in the apixaban and dalteparin groups (3.8% and 4.0%; P = .60), including major gastrointestinal (GI) bleeds (11 vs 10 events).
There was a numeric excess of clinically relevant nonmajor bleeding in the apixaban group (9.0% vs 6.0%; HR, 1.42; 95% CI, 0.88-2.30).
However, the site of this bleeding “was essentially the genitourinary tract and the upper respiratory tract, so again there was no increase in gastrointestinal bleeding, even when the clinically relevant major bleeding was considered,” said lead author Giancarlo Agnelli, MD, University of Perugia, Italy.
Taken together, “We believe that the findings of CARAVAGGIO expand the proportion of patients with cancer-associated thrombosis who are eligible for treatment with oral direct anticoagulants, including patients with gastrointestinal cancer,” he concluded.
The findings were presented online March 29 at the American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC) and published simultaneously in the New England Journal of Medicine.
Major guidelines recommend the use of low-molecular-weight heparin (LMWH) for the treatment of cancer-related VTE but also support the use of edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) as an alternative based on data from the OKUSAI VTE and SELECT-D trials, respectively. But an increased risk for bleeding was observed among patients with GI cancer in both studies.
“The findings are of clinical relevance because we were able to confirm the efficacy of another [novel oral anticoagulant] NOAC but we have the absence of bleeding, GI bleeding in particular. This is an important point; this is what the clinical community is looking for,” Agnelli told theheart.org | Medscape Cardiology.
The recent ADAM VTE trial testing apixaban, a factor Xa inhibitor, vs dalteparin, a LMWH, reported no major bleeding among patients treated with apixaban (primary safety endpoint) and a significant reduction of VTE (secondary efficacy endpoint). But the trial included only 300 patients with cancer and a more selected population compared with the CARAVAGGIO trial, noted Chiara Melloni, MD, MHS, a cardiologist at Duke Clinical Research Institute, Durham, North Carolina, who was not involved with the trial.
“The trial presented today by Prof. Agnelli provides evidence that apixaban represents an additional valid option, next to edoxaban and rivaroxaban, for the treatment of VTE in cancer patients,” she told theheart.org | Medscape Cardiology in an email. “The subgroup analyses showed consistent results across all different subgroups, but a significant interaction was observed between age groups, with a more favorable profile among those less than 75 years old (and mostly among those <65 years old). This may require more investigation.”
The CARAVAGGIO investigators randomly assigned 576 consecutive patients with cancer who had newly diagnosed symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin 200 IU per kg once daily for 1 month followed by 150 U/kg once daily, both for a total of 6 months. Dose reduction was allowed for dalteparin but not for apixaban during the study.
Various types of cancer were included in the trial, including lung, breast, genitourinary, and upper GI.
The incidence of death was similar in the apixaban and dalteparin groups (23.4% vs 26.4%), with most deaths related to cancer (85.2% vs 88.2%, respectively).
During a discussion of the findings, panelist Bonnie Ky, MD, from the Hospital of the University of Pennsylvania in Philadelphia, and editor in chief of JACC: CardioOncology, congratulated the authors on an “excellent, well-done study” in a high-need cancer population suffering from a clinically significant burden of VTE, reported to be anywhere from 8% to 19% depending on tumor type.
“I was particularly impressed by the low rate of bleeding, which has been traditionally a concern with DOACs, as well the demonstration of noninferiority of apixaban,” she said.
Ky asked why the bleeding rate was lower than observed in other published studies and in whom clinicians shouldn’t be considering apixaban now.
Agnelli said that a head-to-head study is needed to compare the various oral anticoagulant agents but that the gastrointestinal bleeding rate is well known to be reduced with apixaban in patients with atrial fibrillation.
“So whether this is related to the drug or the administration twice daily, it’s something that can be discussed, but honestly the final solution would be to have a comparative study,” he said. “It’s going to be difficult, but it’s what we need.”
As to the clinical application of the data, Agnelli said, “The apixaban data actually extend the number of our patients who could receive the oral agents, including patients with GI cancer. So I do believe this indication about using DOACs in cancer patients will change and the indication expanded. But of course, we are building on something that was already known. We did not discover this all by ourselves.”
Panelist Robert M. Carey, MD, a leader in cardiovascular endocrinology and dean emeritus, University of Virginia School of Medicine in Charlottesville, said the study “conclusively shows noninferiority” but asked for more detail on the subset of patients with GI malignancies and the bleeding rate there.
Agnelli replied that the proportion and number of these patients in CARAVAGGIO is the same as, if not slightly higher than, in other studies. “So we have a population that is representative of all the cancer population, including GI cancer,” he said, adding that subanalyses are underway correlating the site of cancer with the type of bleeding.
Agnes Y.Y. Lee, MD, University of British Columbia, Vancouver Coastal Health, and the British Cancer Agency, all in Vancouver, Canada, notes in a linked editorial that CARAVAGGIO excluded patients with primary and metastatic brain lesions and included few patients with cancers of the upper GI tract, with hematologic cancers, or receiving newer cancer therapies, such as checkpoint inhibitors.
She says clinicians will have to choose carefully which anticoagulant to use but that LMWH is “preferred in patients in whom drug-drug interaction is a concern and in those who have undergone surgery involving the upper gastrointestinal tract because absorption of all direct oral anticoagulants occurs in the stomach or proximal small bowel.”
Warfarin may also be the only option when cost is the “decision driver” in patients with cancer facing major financial healthcare burdens, Lee writes.
Duke’s Melloni also said the cost of oral anticoagulants needs to be taken into account and varies widely for patients based on their insurance and availability of other copay assistance programs. “It is therefore important to discuss with the patients upfront because if the patients are started but cannot afford long term, early discontinuation can impact their safety,” she said.
The trial was sponsored by FADOI (Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti) and was funded by an unrestricted grant from the Bristol-Myers Squibb-Pfizer Alliance. Agnelli reports personal fees from Pfizer and Bayer Healthcare, and “other” from Daiichi Sankyo outside the submitted work. Melloni reports having no relevant conflicts of interest. Lee reports personal fees and nonfinancial support from Bayer; grants, personal fees, and nonfinancial support from Bristol-Myers Squibb; and personal fees from LEO Pharma, Pfizer, and Quercegen Pharmaceuticals outside the submitted work.
This article first appeared on Medscape.com.
Oral apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) was as effective as subcutaneous dalteparin (Fragmin, Pfizer) for cancer-related venous thromboembolism (VTE) without an increased risk of major bleeding, the CARAVAGGIO study suggests.
Over 6 months of follow-up, the primary efficacy outcome of recurrent thromboembolism occurred in 32 of 576 patients (5.6%) randomly assigned to apixaban and in 46 of 579 patients (7.9%) assigned dalteparin (hazard ratio, 0.63; 95% confidence interval, 0.37-1.07). The risk difference met the criteria for noninferiority (P < .001) but not for superiority (P = .09).
The risk for major bleeding was similar in the apixaban and dalteparin groups (3.8% and 4.0%; P = .60), including major gastrointestinal (GI) bleeds (11 vs 10 events).
There was a numeric excess of clinically relevant nonmajor bleeding in the apixaban group (9.0% vs 6.0%; HR, 1.42; 95% CI, 0.88-2.30).
However, the site of this bleeding “was essentially the genitourinary tract and the upper respiratory tract, so again there was no increase in gastrointestinal bleeding, even when the clinically relevant major bleeding was considered,” said lead author Giancarlo Agnelli, MD, University of Perugia, Italy.
Taken together, “We believe that the findings of CARAVAGGIO expand the proportion of patients with cancer-associated thrombosis who are eligible for treatment with oral direct anticoagulants, including patients with gastrointestinal cancer,” he concluded.
The findings were presented online March 29 at the American College of Cardiology 2020 Scientific Session (ACC.20)/World Congress of Cardiology (WCC) and published simultaneously in the New England Journal of Medicine.
Major guidelines recommend the use of low-molecular-weight heparin (LMWH) for the treatment of cancer-related VTE but also support the use of edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) as an alternative based on data from the OKUSAI VTE and SELECT-D trials, respectively. But an increased risk for bleeding was observed among patients with GI cancer in both studies.
“The findings are of clinical relevance because we were able to confirm the efficacy of another [novel oral anticoagulant] NOAC but we have the absence of bleeding, GI bleeding in particular. This is an important point; this is what the clinical community is looking for,” Agnelli told theheart.org | Medscape Cardiology.
The recent ADAM VTE trial testing apixaban, a factor Xa inhibitor, vs dalteparin, a LMWH, reported no major bleeding among patients treated with apixaban (primary safety endpoint) and a significant reduction of VTE (secondary efficacy endpoint). But the trial included only 300 patients with cancer and a more selected population compared with the CARAVAGGIO trial, noted Chiara Melloni, MD, MHS, a cardiologist at Duke Clinical Research Institute, Durham, North Carolina, who was not involved with the trial.
“The trial presented today by Prof. Agnelli provides evidence that apixaban represents an additional valid option, next to edoxaban and rivaroxaban, for the treatment of VTE in cancer patients,” she told theheart.org | Medscape Cardiology in an email. “The subgroup analyses showed consistent results across all different subgroups, but a significant interaction was observed between age groups, with a more favorable profile among those less than 75 years old (and mostly among those <65 years old). This may require more investigation.”
The CARAVAGGIO investigators randomly assigned 576 consecutive patients with cancer who had newly diagnosed symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily or subcutaneous dalteparin 200 IU per kg once daily for 1 month followed by 150 U/kg once daily, both for a total of 6 months. Dose reduction was allowed for dalteparin but not for apixaban during the study.
Various types of cancer were included in the trial, including lung, breast, genitourinary, and upper GI.
The incidence of death was similar in the apixaban and dalteparin groups (23.4% vs 26.4%), with most deaths related to cancer (85.2% vs 88.2%, respectively).
During a discussion of the findings, panelist Bonnie Ky, MD, from the Hospital of the University of Pennsylvania in Philadelphia, and editor in chief of JACC: CardioOncology, congratulated the authors on an “excellent, well-done study” in a high-need cancer population suffering from a clinically significant burden of VTE, reported to be anywhere from 8% to 19% depending on tumor type.
“I was particularly impressed by the low rate of bleeding, which has been traditionally a concern with DOACs, as well the demonstration of noninferiority of apixaban,” she said.
Ky asked why the bleeding rate was lower than observed in other published studies and in whom clinicians shouldn’t be considering apixaban now.
Agnelli said that a head-to-head study is needed to compare the various oral anticoagulant agents but that the gastrointestinal bleeding rate is well known to be reduced with apixaban in patients with atrial fibrillation.
“So whether this is related to the drug or the administration twice daily, it’s something that can be discussed, but honestly the final solution would be to have a comparative study,” he said. “It’s going to be difficult, but it’s what we need.”
As to the clinical application of the data, Agnelli said, “The apixaban data actually extend the number of our patients who could receive the oral agents, including patients with GI cancer. So I do believe this indication about using DOACs in cancer patients will change and the indication expanded. But of course, we are building on something that was already known. We did not discover this all by ourselves.”
Panelist Robert M. Carey, MD, a leader in cardiovascular endocrinology and dean emeritus, University of Virginia School of Medicine in Charlottesville, said the study “conclusively shows noninferiority” but asked for more detail on the subset of patients with GI malignancies and the bleeding rate there.
Agnelli replied that the proportion and number of these patients in CARAVAGGIO is the same as, if not slightly higher than, in other studies. “So we have a population that is representative of all the cancer population, including GI cancer,” he said, adding that subanalyses are underway correlating the site of cancer with the type of bleeding.
Agnes Y.Y. Lee, MD, University of British Columbia, Vancouver Coastal Health, and the British Cancer Agency, all in Vancouver, Canada, notes in a linked editorial that CARAVAGGIO excluded patients with primary and metastatic brain lesions and included few patients with cancers of the upper GI tract, with hematologic cancers, or receiving newer cancer therapies, such as checkpoint inhibitors.
She says clinicians will have to choose carefully which anticoagulant to use but that LMWH is “preferred in patients in whom drug-drug interaction is a concern and in those who have undergone surgery involving the upper gastrointestinal tract because absorption of all direct oral anticoagulants occurs in the stomach or proximal small bowel.”
Warfarin may also be the only option when cost is the “decision driver” in patients with cancer facing major financial healthcare burdens, Lee writes.
Duke’s Melloni also said the cost of oral anticoagulants needs to be taken into account and varies widely for patients based on their insurance and availability of other copay assistance programs. “It is therefore important to discuss with the patients upfront because if the patients are started but cannot afford long term, early discontinuation can impact their safety,” she said.
The trial was sponsored by FADOI (Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti) and was funded by an unrestricted grant from the Bristol-Myers Squibb-Pfizer Alliance. Agnelli reports personal fees from Pfizer and Bayer Healthcare, and “other” from Daiichi Sankyo outside the submitted work. Melloni reports having no relevant conflicts of interest. Lee reports personal fees and nonfinancial support from Bayer; grants, personal fees, and nonfinancial support from Bristol-Myers Squibb; and personal fees from LEO Pharma, Pfizer, and Quercegen Pharmaceuticals outside the submitted work.
This article first appeared on Medscape.com.
SABR slashes progression of advanced prostate cancer
Patients with oligometastatic disease who received stereotactic ablative radiotherapy (SABR) had a significant threefold decrease in disease progression at 6 months compared with patients who were randomly assigned to observation alone.
“Local control for SABR-treated lesions was excellent, and the adverse effects associated with SABR were mild and did not appear to affect quality of life,” say the investigators, led by Ryan Phillips, MD, PhD, from the Johns Hopkins Sidney Kimmel Cancer Center in Baltimore.
“Although the approach is controversial, many men are interested in avoiding the unpleasant adverse effects and potential health risks of androgen deprivation therapy (ADT) for as long as is reasonable,” they write.
These results come from outcomes of the Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer (ORIOLE) phase 2 trial and were published online March 26 in JAMA Oncology.
An intriguing finding from the study was evidence that SABR may evoke an immune response.
“We observed enhanced differential clonotype expansion, clusters of similar expanded T-cell receptors, and a clinical benefit to greater baseline clonality seen only in participants treated with SABR,” said senior author Phuoc T. Tran, MD, PhD, from the department of radiation oncology and molecular radiation sciences at Johns Hopkins.
“This the only data I’m aware of that really shows that radiation in isolation can cause a systemic immune response,” Tran told Medscape Medical News.
Previous studies suggesting an immune response with radiation have been confounded by coadministration of radiation and chemotherapy, he said.
Drive the Disease to ‘Near Extinction’
SABR appears to “alter the natural history of prostate oligometastatic disease by removing or greatly affecting signals that promote further development of micrometastatic disease,” write the authors of accompanying editorial.
This hypothesis is consistent with the oligometastatic paradigm, which postulates that this is a transient phase that offers “a window of opportunity for cancer cure if equilibrium-phase lesions are ablated before polymetastatic escape occurs,” write Carlo Greco, MD, and Zvi Fuks, MD, both from the Champalimaud Centre for the Unknown, Lisbon, Portugal; Fuks is also affiliated with Memorial Sloan Kettering Cancer Center, New York.
“Taken together, these observations support the hypothesis that all detectable oligometastatic lesions should be systematically ablated, if feasible, in an effort to maximize oligometastatic cancer cure,” Greco and Fuks comment.
However, there is no clear consensus on what constitutes oligometastatic disease, they point out, and they warn that “a numerical-based decision to withhold lesion ablation may represent a strategic error, potentially reducing the benefit of metastasis-directed therapy (MDT) in the treatment of oligometastatic cancer.”
“We speculate that, if clinically and technically feasible, there should be no restriction to MDT at first oligometastatic presentation and as sequential lesions appear, regardless of lesion numbers, because each lesion may potentially constitute a generator of evolving metastatogenic clonogens,” they add.
Multiple rounds of MDT theoretically could “drive the disease to near extinction” and prevent the development of polymetastatic disease, they contend.
Study Details
For their study, Phillips and colleagues enrolled 54 men with recurrent hormone-sensitive prostate cancer with one, two, or three metastases detectable on conventional imaging who had not received ADT within 6 months of enrollment, or for a total of 3 or more years.
The patients were randomly assigned in a 2:1 ratio to receive either SABR, with dose and fractionation based on the size and location of each lesion, or to observation. The median age in each group was 68 years.
Prostate-specific membrane antigen (PSMA)-targeted PET-CT, a relatively new technique that is more accurate than conventional imaging, was performed during treatment planning and at day 180 of follow-up for patients assigned to SABR, but the investigators were blinded to the results to prevent bias in target-lesion selection.
The primary endpoint of progression at 6 months was measured by prostate-specific antigen increase, radiographic evidence, symptomatic progression, ADT initiation for any reason, or death.
This primary endpoint occurred in 7 of 36 men (19%) who were treated with SABR, compared with 11 of 18 (61%) who underwent observation (P = .005).
Median progression-free survival (PFS) was not reached in the SABR group vs. 5.8 months in the observation group, translating into a hazard ratio of 0.30 (P = .002).
Of the 36 men treated with SABR, 16 had baseline PET-avid lesions that, because of investigator blinding, were not included in the treatment fields.
Among all SABR-treated patients, the rate of progression at 6 months among men for whom all lesions were treated was 5%, compared with 38% for men with any lesions outside the treatment field (P = .03). The median PFS for patients with no untreated lesions was not reached, vs. 11.8 months for men in whom PET-avid lesions were missed (HR, 0.26; P = .006).
Oligometastatic vs. Polymetastatic
In an interview with Medscape Medical News, Tran noted that using PSMA PET-CT for imaging appears to be very important for identifying those patients with numerous or disseminated (polymetastatic) lesions, compared with those patients with limited disease who are most likely to benefit from SABR. He emphasized, however, that the PSMA PET-CT findings were an exploratory endpoint that required further validation.
Another secondary, exploratory endpoint of the study was the use of a circulating tumor DNA (ctDNA) analysis by the CAPP-Seq (cancer personalized profiling by deep sequencing) method.
“We show, in a discovery fashion, that certain mutations in the circulation seem to distinguish patients who would benefit from SABR vs those who would not,” he said.
The study was supported by the Nesbitt-McMaster Foundation, Ronald Rose and Joan Lazar, the Movember Foundation and Prostate Cancer Foundation, and the National Cancer Institute. Phillips reported receiving consulting fees and honoraria from RefleXion Medical outside the submitted work. Tran holds a licensed patent related to ablative radiotherapy compounds and methods (Natsar Pharmaceuticals). Several other authors reported financial disclosures. The full list can be found with the original article. Editorialists Greco and Fuks reported serving as cofounders of and owning stock in Ceramedix Holding, LLC.
This article first appeared on Medscape.com.
Patients with oligometastatic disease who received stereotactic ablative radiotherapy (SABR) had a significant threefold decrease in disease progression at 6 months compared with patients who were randomly assigned to observation alone.
“Local control for SABR-treated lesions was excellent, and the adverse effects associated with SABR were mild and did not appear to affect quality of life,” say the investigators, led by Ryan Phillips, MD, PhD, from the Johns Hopkins Sidney Kimmel Cancer Center in Baltimore.
“Although the approach is controversial, many men are interested in avoiding the unpleasant adverse effects and potential health risks of androgen deprivation therapy (ADT) for as long as is reasonable,” they write.
These results come from outcomes of the Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer (ORIOLE) phase 2 trial and were published online March 26 in JAMA Oncology.
An intriguing finding from the study was evidence that SABR may evoke an immune response.
“We observed enhanced differential clonotype expansion, clusters of similar expanded T-cell receptors, and a clinical benefit to greater baseline clonality seen only in participants treated with SABR,” said senior author Phuoc T. Tran, MD, PhD, from the department of radiation oncology and molecular radiation sciences at Johns Hopkins.
“This the only data I’m aware of that really shows that radiation in isolation can cause a systemic immune response,” Tran told Medscape Medical News.
Previous studies suggesting an immune response with radiation have been confounded by coadministration of radiation and chemotherapy, he said.
Drive the Disease to ‘Near Extinction’
SABR appears to “alter the natural history of prostate oligometastatic disease by removing or greatly affecting signals that promote further development of micrometastatic disease,” write the authors of accompanying editorial.
This hypothesis is consistent with the oligometastatic paradigm, which postulates that this is a transient phase that offers “a window of opportunity for cancer cure if equilibrium-phase lesions are ablated before polymetastatic escape occurs,” write Carlo Greco, MD, and Zvi Fuks, MD, both from the Champalimaud Centre for the Unknown, Lisbon, Portugal; Fuks is also affiliated with Memorial Sloan Kettering Cancer Center, New York.
“Taken together, these observations support the hypothesis that all detectable oligometastatic lesions should be systematically ablated, if feasible, in an effort to maximize oligometastatic cancer cure,” Greco and Fuks comment.
However, there is no clear consensus on what constitutes oligometastatic disease, they point out, and they warn that “a numerical-based decision to withhold lesion ablation may represent a strategic error, potentially reducing the benefit of metastasis-directed therapy (MDT) in the treatment of oligometastatic cancer.”
“We speculate that, if clinically and technically feasible, there should be no restriction to MDT at first oligometastatic presentation and as sequential lesions appear, regardless of lesion numbers, because each lesion may potentially constitute a generator of evolving metastatogenic clonogens,” they add.
Multiple rounds of MDT theoretically could “drive the disease to near extinction” and prevent the development of polymetastatic disease, they contend.
Study Details
For their study, Phillips and colleagues enrolled 54 men with recurrent hormone-sensitive prostate cancer with one, two, or three metastases detectable on conventional imaging who had not received ADT within 6 months of enrollment, or for a total of 3 or more years.
The patients were randomly assigned in a 2:1 ratio to receive either SABR, with dose and fractionation based on the size and location of each lesion, or to observation. The median age in each group was 68 years.
Prostate-specific membrane antigen (PSMA)-targeted PET-CT, a relatively new technique that is more accurate than conventional imaging, was performed during treatment planning and at day 180 of follow-up for patients assigned to SABR, but the investigators were blinded to the results to prevent bias in target-lesion selection.
The primary endpoint of progression at 6 months was measured by prostate-specific antigen increase, radiographic evidence, symptomatic progression, ADT initiation for any reason, or death.
This primary endpoint occurred in 7 of 36 men (19%) who were treated with SABR, compared with 11 of 18 (61%) who underwent observation (P = .005).
Median progression-free survival (PFS) was not reached in the SABR group vs. 5.8 months in the observation group, translating into a hazard ratio of 0.30 (P = .002).
Of the 36 men treated with SABR, 16 had baseline PET-avid lesions that, because of investigator blinding, were not included in the treatment fields.
Among all SABR-treated patients, the rate of progression at 6 months among men for whom all lesions were treated was 5%, compared with 38% for men with any lesions outside the treatment field (P = .03). The median PFS for patients with no untreated lesions was not reached, vs. 11.8 months for men in whom PET-avid lesions were missed (HR, 0.26; P = .006).
Oligometastatic vs. Polymetastatic
In an interview with Medscape Medical News, Tran noted that using PSMA PET-CT for imaging appears to be very important for identifying those patients with numerous or disseminated (polymetastatic) lesions, compared with those patients with limited disease who are most likely to benefit from SABR. He emphasized, however, that the PSMA PET-CT findings were an exploratory endpoint that required further validation.
Another secondary, exploratory endpoint of the study was the use of a circulating tumor DNA (ctDNA) analysis by the CAPP-Seq (cancer personalized profiling by deep sequencing) method.
“We show, in a discovery fashion, that certain mutations in the circulation seem to distinguish patients who would benefit from SABR vs those who would not,” he said.
The study was supported by the Nesbitt-McMaster Foundation, Ronald Rose and Joan Lazar, the Movember Foundation and Prostate Cancer Foundation, and the National Cancer Institute. Phillips reported receiving consulting fees and honoraria from RefleXion Medical outside the submitted work. Tran holds a licensed patent related to ablative radiotherapy compounds and methods (Natsar Pharmaceuticals). Several other authors reported financial disclosures. The full list can be found with the original article. Editorialists Greco and Fuks reported serving as cofounders of and owning stock in Ceramedix Holding, LLC.
This article first appeared on Medscape.com.
Patients with oligometastatic disease who received stereotactic ablative radiotherapy (SABR) had a significant threefold decrease in disease progression at 6 months compared with patients who were randomly assigned to observation alone.
“Local control for SABR-treated lesions was excellent, and the adverse effects associated with SABR were mild and did not appear to affect quality of life,” say the investigators, led by Ryan Phillips, MD, PhD, from the Johns Hopkins Sidney Kimmel Cancer Center in Baltimore.
“Although the approach is controversial, many men are interested in avoiding the unpleasant adverse effects and potential health risks of androgen deprivation therapy (ADT) for as long as is reasonable,” they write.
These results come from outcomes of the Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer (ORIOLE) phase 2 trial and were published online March 26 in JAMA Oncology.
An intriguing finding from the study was evidence that SABR may evoke an immune response.
“We observed enhanced differential clonotype expansion, clusters of similar expanded T-cell receptors, and a clinical benefit to greater baseline clonality seen only in participants treated with SABR,” said senior author Phuoc T. Tran, MD, PhD, from the department of radiation oncology and molecular radiation sciences at Johns Hopkins.
“This the only data I’m aware of that really shows that radiation in isolation can cause a systemic immune response,” Tran told Medscape Medical News.
Previous studies suggesting an immune response with radiation have been confounded by coadministration of radiation and chemotherapy, he said.
Drive the Disease to ‘Near Extinction’
SABR appears to “alter the natural history of prostate oligometastatic disease by removing or greatly affecting signals that promote further development of micrometastatic disease,” write the authors of accompanying editorial.
This hypothesis is consistent with the oligometastatic paradigm, which postulates that this is a transient phase that offers “a window of opportunity for cancer cure if equilibrium-phase lesions are ablated before polymetastatic escape occurs,” write Carlo Greco, MD, and Zvi Fuks, MD, both from the Champalimaud Centre for the Unknown, Lisbon, Portugal; Fuks is also affiliated with Memorial Sloan Kettering Cancer Center, New York.
“Taken together, these observations support the hypothesis that all detectable oligometastatic lesions should be systematically ablated, if feasible, in an effort to maximize oligometastatic cancer cure,” Greco and Fuks comment.
However, there is no clear consensus on what constitutes oligometastatic disease, they point out, and they warn that “a numerical-based decision to withhold lesion ablation may represent a strategic error, potentially reducing the benefit of metastasis-directed therapy (MDT) in the treatment of oligometastatic cancer.”
“We speculate that, if clinically and technically feasible, there should be no restriction to MDT at first oligometastatic presentation and as sequential lesions appear, regardless of lesion numbers, because each lesion may potentially constitute a generator of evolving metastatogenic clonogens,” they add.
Multiple rounds of MDT theoretically could “drive the disease to near extinction” and prevent the development of polymetastatic disease, they contend.
Study Details
For their study, Phillips and colleagues enrolled 54 men with recurrent hormone-sensitive prostate cancer with one, two, or three metastases detectable on conventional imaging who had not received ADT within 6 months of enrollment, or for a total of 3 or more years.
The patients were randomly assigned in a 2:1 ratio to receive either SABR, with dose and fractionation based on the size and location of each lesion, or to observation. The median age in each group was 68 years.
Prostate-specific membrane antigen (PSMA)-targeted PET-CT, a relatively new technique that is more accurate than conventional imaging, was performed during treatment planning and at day 180 of follow-up for patients assigned to SABR, but the investigators were blinded to the results to prevent bias in target-lesion selection.
The primary endpoint of progression at 6 months was measured by prostate-specific antigen increase, radiographic evidence, symptomatic progression, ADT initiation for any reason, or death.
This primary endpoint occurred in 7 of 36 men (19%) who were treated with SABR, compared with 11 of 18 (61%) who underwent observation (P = .005).
Median progression-free survival (PFS) was not reached in the SABR group vs. 5.8 months in the observation group, translating into a hazard ratio of 0.30 (P = .002).
Of the 36 men treated with SABR, 16 had baseline PET-avid lesions that, because of investigator blinding, were not included in the treatment fields.
Among all SABR-treated patients, the rate of progression at 6 months among men for whom all lesions were treated was 5%, compared with 38% for men with any lesions outside the treatment field (P = .03). The median PFS for patients with no untreated lesions was not reached, vs. 11.8 months for men in whom PET-avid lesions were missed (HR, 0.26; P = .006).
Oligometastatic vs. Polymetastatic
In an interview with Medscape Medical News, Tran noted that using PSMA PET-CT for imaging appears to be very important for identifying those patients with numerous or disseminated (polymetastatic) lesions, compared with those patients with limited disease who are most likely to benefit from SABR. He emphasized, however, that the PSMA PET-CT findings were an exploratory endpoint that required further validation.
Another secondary, exploratory endpoint of the study was the use of a circulating tumor DNA (ctDNA) analysis by the CAPP-Seq (cancer personalized profiling by deep sequencing) method.
“We show, in a discovery fashion, that certain mutations in the circulation seem to distinguish patients who would benefit from SABR vs those who would not,” he said.
The study was supported by the Nesbitt-McMaster Foundation, Ronald Rose and Joan Lazar, the Movember Foundation and Prostate Cancer Foundation, and the National Cancer Institute. Phillips reported receiving consulting fees and honoraria from RefleXion Medical outside the submitted work. Tran holds a licensed patent related to ablative radiotherapy compounds and methods (Natsar Pharmaceuticals). Several other authors reported financial disclosures. The full list can be found with the original article. Editorialists Greco and Fuks reported serving as cofounders of and owning stock in Ceramedix Holding, LLC.
This article first appeared on Medscape.com.
Perspective from the heartland: Cancer care and research during a public health crisis
I have no knowledge of, or experience with, managing a cancer patient during a pandemic. However, from the published and otherwise shared experience of others, we should not allow ourselves to underestimate the voracity of the coronavirus pandemic on our patients, communities, and health care systems.
Data from China suggest cancer patients infected with SARS-CoV-2 face a 3.5 times higher risk of mechanical ventilation, intensive care unit admission, or death, compared with infected patients without cancer (Lancet Oncol 2020;21:335-7).
Health care workers in Seattle have also shared their experiences battling coronavirus infections in cancer patients (J Natl Compr Canc Netw. 2020 Mar 20. doi: 10.6004/jnccn.2020.7560). Masumi Ueda, MD, of Seattle Cancer Care Alliance, and colleagues reviewed their decisions in multiple domains over a 7-week period, during which the state of Washington went from a single case of SARS-CoV-2 infection to nearly 650 cases and 40 deaths.
Making tough treatment decisions
Dr. Ueda and colleagues contrasted their customary resource-rich, innovation-oriented, cancer-combatting environment with their current circumstance, in which they must prioritize treatment for patients for whom the risk-reward balance has tilted substantially toward “risk.”
The authors noted that their most difficult decisions were those regarding delay of cancer treatment. They suggested that plans for potentially curative adjuvant therapy should likely proceed, but, for patients with metastatic disease, the equation is more nuanced.
In some cases, treatment should be delayed or interrupted with recognition of how that could result in worsening performance status and admission for symptom palliation, further stressing inpatient resources.
The authors suggested scenarios for prioritizing cancer surgery. For example, several months of systemic therapy (ideally, low-risk systemic therapy such as hormone therapy for breast or prostate cancer) and surgical delay may be worthwhile, without compromising patient care.
Patients with aggressive hematologic malignancy requiring urgent systemic treatment (potentially stem cell transplantation and cellular immunotherapies) should be treated promptly. However, even in those cases, opportunities should be sought to lessen immunosuppression and transition care as quickly as possible to the outpatient clinic, according to guidelines from the American Society of Transplantation and Cellular Therapy.
See one, do one, teach one
Rendering patient care during a pandemic would be unique for me. However, I, like all physicians, am familiar with feelings of inadequacy at times of professional challenge. On countless occasions, I have started my day or walked into a patient’s room wondering whether I will have the fortitude, knowledge, creativity, or help I need to get through that day or make that patient “better” by any definition of that word.
We all know the formula: “Work hard. Make evidence-based, personalized decisions for those who have entrusted their care to us. Learn from those encounters. Teach from our knowledge and experience – that is, ‘See one, do one, teach one.’ ”
The Seattle oncologists are living the lives of first responders and deserve our admiration for putting pen to paper so we can learn from their considerable, relevant experience.
Similar admiration is due to Giuseppe Curigliano, MD, of the European Institute of Oncology in Milan. In the ASCO Daily News, Dr. Curigliano described an epidemic that, within 3 weeks, overloaded the health care system across northern Italy.
Hospitalization was needed for over 60% of infected patients, and nearly 15% of those patients needed intensive care unit services for respiratory distress. The Italians centralized oncology care in specialized hubs, with spokes of institutions working in parallel to provide cancer-specific care in a COVID-free environment.
To build upon cancer-specific information from Italy and other areas hard-hit by COVID-19, more than 30 cancer centers have joined together to form the COVID-19 and Cancer Consortium. The consortium’s website hosts a survey designed to “capture details related to cancer patients presumed to have COVID-19.”
Calculating deaths and long-term consequences for cancer care delivery
It is proper that the authors from China, Italy, and Seattle did not focus attention on the case fatality rate from the COVID-19 pandemic among cancer patients. To say the least, it would be complicated to tally the direct mortality – either overall or in clinically important subsets of patients, including country-specific cohorts.
What we know from published reports is that, in Italy, cancer patients account for about 20% of deaths from coronavirus. In China, the case-fatality rate for patients with cancer was 5.6% (JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648).
However, we know nothing about the indirect death toll from malignancy (without coronavirus infection) that was untreated or managed less than optimally because of personnel and physical resources that were diverted to COVID-19–associated cases.
Similarly, we cannot begin to estimate indirect consequences of the pandemic to oncology practices, such as accelerated burnout and posttraumatic stress disorder, as well as the long-range effects of economic turmoil on patients, health care workers, and provider organizations.
What happens to cancer trials?
From China, Italy, and Seattle, thus far, there is little information about how the pandemic will affect the vital clinical research endeavor. The Seattle physicians did say they plan to enroll patients on clinical trials only when the trial offers a high chance of benefiting the patient over standard therapy alone.
Fortunately, the National Institutes of Health and Food and Drug Administration have released guidance documents related to clinical trials.
The National Cancer Institute (NCI) has also released guidance documents (March 13 guidance; March 23 guidance) for patients on clinical trials supported by the NCI Cancer Therapy Evaluation Program (CTEP) and the NCI Community Oncology Research Program (NCORP).
CTEP and NCORP are making reasonable accommodations to suspend monitoring visits and audits, allow tele–follow-up visits for patients, and permit local physicians to provide care for patients on study. In addition, with appropriate procedural adherence and documentation, CTEP and NCORP will allow oral investigational medicines to be mailed directly to patients’ homes.
Planned NCI National Clinical Trials Network meetings will be conducted via remote access webinars, conference calls, and similar technology. These adjustments – and probably many more to come – are geared toward facilitating ongoing care to proceed safely and with minimal risk for patients currently receiving investigational therapies and for the sites and investigators engaged in those studies.
Each of us has probably faced a personal “defining professional moment,” when we had to utilize every skill in our arsenal and examine the motivations that led us to a career in oncology. However, it is clear from the forgoing clinical and research processes and guidelines that the COVID-19 pandemic is such a defining professional moment for each of us, in every community we serve.
Critical junctures like this cause more rapid behavior change and innovation than the slow-moving pace that characterizes our idealized preferences. As oncologists who embrace new data and behavioral change, we stand to learn processes that will facilitate more perfected systems of care than the one that preceded this unprecedented crisis, promote more efficient sharing of high-quality information, and improve the outcome for our future patients.
Dr. Lyss was an oncologist and researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
I have no knowledge of, or experience with, managing a cancer patient during a pandemic. However, from the published and otherwise shared experience of others, we should not allow ourselves to underestimate the voracity of the coronavirus pandemic on our patients, communities, and health care systems.
Data from China suggest cancer patients infected with SARS-CoV-2 face a 3.5 times higher risk of mechanical ventilation, intensive care unit admission, or death, compared with infected patients without cancer (Lancet Oncol 2020;21:335-7).
Health care workers in Seattle have also shared their experiences battling coronavirus infections in cancer patients (J Natl Compr Canc Netw. 2020 Mar 20. doi: 10.6004/jnccn.2020.7560). Masumi Ueda, MD, of Seattle Cancer Care Alliance, and colleagues reviewed their decisions in multiple domains over a 7-week period, during which the state of Washington went from a single case of SARS-CoV-2 infection to nearly 650 cases and 40 deaths.
Making tough treatment decisions
Dr. Ueda and colleagues contrasted their customary resource-rich, innovation-oriented, cancer-combatting environment with their current circumstance, in which they must prioritize treatment for patients for whom the risk-reward balance has tilted substantially toward “risk.”
The authors noted that their most difficult decisions were those regarding delay of cancer treatment. They suggested that plans for potentially curative adjuvant therapy should likely proceed, but, for patients with metastatic disease, the equation is more nuanced.
In some cases, treatment should be delayed or interrupted with recognition of how that could result in worsening performance status and admission for symptom palliation, further stressing inpatient resources.
The authors suggested scenarios for prioritizing cancer surgery. For example, several months of systemic therapy (ideally, low-risk systemic therapy such as hormone therapy for breast or prostate cancer) and surgical delay may be worthwhile, without compromising patient care.
Patients with aggressive hematologic malignancy requiring urgent systemic treatment (potentially stem cell transplantation and cellular immunotherapies) should be treated promptly. However, even in those cases, opportunities should be sought to lessen immunosuppression and transition care as quickly as possible to the outpatient clinic, according to guidelines from the American Society of Transplantation and Cellular Therapy.
See one, do one, teach one
Rendering patient care during a pandemic would be unique for me. However, I, like all physicians, am familiar with feelings of inadequacy at times of professional challenge. On countless occasions, I have started my day or walked into a patient’s room wondering whether I will have the fortitude, knowledge, creativity, or help I need to get through that day or make that patient “better” by any definition of that word.
We all know the formula: “Work hard. Make evidence-based, personalized decisions for those who have entrusted their care to us. Learn from those encounters. Teach from our knowledge and experience – that is, ‘See one, do one, teach one.’ ”
The Seattle oncologists are living the lives of first responders and deserve our admiration for putting pen to paper so we can learn from their considerable, relevant experience.
Similar admiration is due to Giuseppe Curigliano, MD, of the European Institute of Oncology in Milan. In the ASCO Daily News, Dr. Curigliano described an epidemic that, within 3 weeks, overloaded the health care system across northern Italy.
Hospitalization was needed for over 60% of infected patients, and nearly 15% of those patients needed intensive care unit services for respiratory distress. The Italians centralized oncology care in specialized hubs, with spokes of institutions working in parallel to provide cancer-specific care in a COVID-free environment.
To build upon cancer-specific information from Italy and other areas hard-hit by COVID-19, more than 30 cancer centers have joined together to form the COVID-19 and Cancer Consortium. The consortium’s website hosts a survey designed to “capture details related to cancer patients presumed to have COVID-19.”
Calculating deaths and long-term consequences for cancer care delivery
It is proper that the authors from China, Italy, and Seattle did not focus attention on the case fatality rate from the COVID-19 pandemic among cancer patients. To say the least, it would be complicated to tally the direct mortality – either overall or in clinically important subsets of patients, including country-specific cohorts.
What we know from published reports is that, in Italy, cancer patients account for about 20% of deaths from coronavirus. In China, the case-fatality rate for patients with cancer was 5.6% (JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648).
However, we know nothing about the indirect death toll from malignancy (without coronavirus infection) that was untreated or managed less than optimally because of personnel and physical resources that were diverted to COVID-19–associated cases.
Similarly, we cannot begin to estimate indirect consequences of the pandemic to oncology practices, such as accelerated burnout and posttraumatic stress disorder, as well as the long-range effects of economic turmoil on patients, health care workers, and provider organizations.
What happens to cancer trials?
From China, Italy, and Seattle, thus far, there is little information about how the pandemic will affect the vital clinical research endeavor. The Seattle physicians did say they plan to enroll patients on clinical trials only when the trial offers a high chance of benefiting the patient over standard therapy alone.
Fortunately, the National Institutes of Health and Food and Drug Administration have released guidance documents related to clinical trials.
The National Cancer Institute (NCI) has also released guidance documents (March 13 guidance; March 23 guidance) for patients on clinical trials supported by the NCI Cancer Therapy Evaluation Program (CTEP) and the NCI Community Oncology Research Program (NCORP).
CTEP and NCORP are making reasonable accommodations to suspend monitoring visits and audits, allow tele–follow-up visits for patients, and permit local physicians to provide care for patients on study. In addition, with appropriate procedural adherence and documentation, CTEP and NCORP will allow oral investigational medicines to be mailed directly to patients’ homes.
Planned NCI National Clinical Trials Network meetings will be conducted via remote access webinars, conference calls, and similar technology. These adjustments – and probably many more to come – are geared toward facilitating ongoing care to proceed safely and with minimal risk for patients currently receiving investigational therapies and for the sites and investigators engaged in those studies.
Each of us has probably faced a personal “defining professional moment,” when we had to utilize every skill in our arsenal and examine the motivations that led us to a career in oncology. However, it is clear from the forgoing clinical and research processes and guidelines that the COVID-19 pandemic is such a defining professional moment for each of us, in every community we serve.
Critical junctures like this cause more rapid behavior change and innovation than the slow-moving pace that characterizes our idealized preferences. As oncologists who embrace new data and behavioral change, we stand to learn processes that will facilitate more perfected systems of care than the one that preceded this unprecedented crisis, promote more efficient sharing of high-quality information, and improve the outcome for our future patients.
Dr. Lyss was an oncologist and researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
I have no knowledge of, or experience with, managing a cancer patient during a pandemic. However, from the published and otherwise shared experience of others, we should not allow ourselves to underestimate the voracity of the coronavirus pandemic on our patients, communities, and health care systems.
Data from China suggest cancer patients infected with SARS-CoV-2 face a 3.5 times higher risk of mechanical ventilation, intensive care unit admission, or death, compared with infected patients without cancer (Lancet Oncol 2020;21:335-7).
Health care workers in Seattle have also shared their experiences battling coronavirus infections in cancer patients (J Natl Compr Canc Netw. 2020 Mar 20. doi: 10.6004/jnccn.2020.7560). Masumi Ueda, MD, of Seattle Cancer Care Alliance, and colleagues reviewed their decisions in multiple domains over a 7-week period, during which the state of Washington went from a single case of SARS-CoV-2 infection to nearly 650 cases and 40 deaths.
Making tough treatment decisions
Dr. Ueda and colleagues contrasted their customary resource-rich, innovation-oriented, cancer-combatting environment with their current circumstance, in which they must prioritize treatment for patients for whom the risk-reward balance has tilted substantially toward “risk.”
The authors noted that their most difficult decisions were those regarding delay of cancer treatment. They suggested that plans for potentially curative adjuvant therapy should likely proceed, but, for patients with metastatic disease, the equation is more nuanced.
In some cases, treatment should be delayed or interrupted with recognition of how that could result in worsening performance status and admission for symptom palliation, further stressing inpatient resources.
The authors suggested scenarios for prioritizing cancer surgery. For example, several months of systemic therapy (ideally, low-risk systemic therapy such as hormone therapy for breast or prostate cancer) and surgical delay may be worthwhile, without compromising patient care.
Patients with aggressive hematologic malignancy requiring urgent systemic treatment (potentially stem cell transplantation and cellular immunotherapies) should be treated promptly. However, even in those cases, opportunities should be sought to lessen immunosuppression and transition care as quickly as possible to the outpatient clinic, according to guidelines from the American Society of Transplantation and Cellular Therapy.
See one, do one, teach one
Rendering patient care during a pandemic would be unique for me. However, I, like all physicians, am familiar with feelings of inadequacy at times of professional challenge. On countless occasions, I have started my day or walked into a patient’s room wondering whether I will have the fortitude, knowledge, creativity, or help I need to get through that day or make that patient “better” by any definition of that word.
We all know the formula: “Work hard. Make evidence-based, personalized decisions for those who have entrusted their care to us. Learn from those encounters. Teach from our knowledge and experience – that is, ‘See one, do one, teach one.’ ”
The Seattle oncologists are living the lives of first responders and deserve our admiration for putting pen to paper so we can learn from their considerable, relevant experience.
Similar admiration is due to Giuseppe Curigliano, MD, of the European Institute of Oncology in Milan. In the ASCO Daily News, Dr. Curigliano described an epidemic that, within 3 weeks, overloaded the health care system across northern Italy.
Hospitalization was needed for over 60% of infected patients, and nearly 15% of those patients needed intensive care unit services for respiratory distress. The Italians centralized oncology care in specialized hubs, with spokes of institutions working in parallel to provide cancer-specific care in a COVID-free environment.
To build upon cancer-specific information from Italy and other areas hard-hit by COVID-19, more than 30 cancer centers have joined together to form the COVID-19 and Cancer Consortium. The consortium’s website hosts a survey designed to “capture details related to cancer patients presumed to have COVID-19.”
Calculating deaths and long-term consequences for cancer care delivery
It is proper that the authors from China, Italy, and Seattle did not focus attention on the case fatality rate from the COVID-19 pandemic among cancer patients. To say the least, it would be complicated to tally the direct mortality – either overall or in clinically important subsets of patients, including country-specific cohorts.
What we know from published reports is that, in Italy, cancer patients account for about 20% of deaths from coronavirus. In China, the case-fatality rate for patients with cancer was 5.6% (JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648).
However, we know nothing about the indirect death toll from malignancy (without coronavirus infection) that was untreated or managed less than optimally because of personnel and physical resources that were diverted to COVID-19–associated cases.
Similarly, we cannot begin to estimate indirect consequences of the pandemic to oncology practices, such as accelerated burnout and posttraumatic stress disorder, as well as the long-range effects of economic turmoil on patients, health care workers, and provider organizations.
What happens to cancer trials?
From China, Italy, and Seattle, thus far, there is little information about how the pandemic will affect the vital clinical research endeavor. The Seattle physicians did say they plan to enroll patients on clinical trials only when the trial offers a high chance of benefiting the patient over standard therapy alone.
Fortunately, the National Institutes of Health and Food and Drug Administration have released guidance documents related to clinical trials.
The National Cancer Institute (NCI) has also released guidance documents (March 13 guidance; March 23 guidance) for patients on clinical trials supported by the NCI Cancer Therapy Evaluation Program (CTEP) and the NCI Community Oncology Research Program (NCORP).
CTEP and NCORP are making reasonable accommodations to suspend monitoring visits and audits, allow tele–follow-up visits for patients, and permit local physicians to provide care for patients on study. In addition, with appropriate procedural adherence and documentation, CTEP and NCORP will allow oral investigational medicines to be mailed directly to patients’ homes.
Planned NCI National Clinical Trials Network meetings will be conducted via remote access webinars, conference calls, and similar technology. These adjustments – and probably many more to come – are geared toward facilitating ongoing care to proceed safely and with minimal risk for patients currently receiving investigational therapies and for the sites and investigators engaged in those studies.
Each of us has probably faced a personal “defining professional moment,” when we had to utilize every skill in our arsenal and examine the motivations that led us to a career in oncology. However, it is clear from the forgoing clinical and research processes and guidelines that the COVID-19 pandemic is such a defining professional moment for each of us, in every community we serve.
Critical junctures like this cause more rapid behavior change and innovation than the slow-moving pace that characterizes our idealized preferences. As oncologists who embrace new data and behavioral change, we stand to learn processes that will facilitate more perfected systems of care than the one that preceded this unprecedented crisis, promote more efficient sharing of high-quality information, and improve the outcome for our future patients.
Dr. Lyss was an oncologist and researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
Week-old COVID-19 urology guidelines already outdated
Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.
“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.
“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.
“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.
Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”
As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.
He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.
A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.
In less than 20 hours, his post received 290 votes in response.
And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.
People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
One Week Changed Everything
When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”
Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”
As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.
The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.
When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.
The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”
For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”
And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.
This article first appeared on Medscape.com.
Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.
“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.
“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.
“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.
Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”
As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.
He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.
A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.
In less than 20 hours, his post received 290 votes in response.
And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.
People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
One Week Changed Everything
When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”
Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”
As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.
The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.
When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.
The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”
For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”
And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.
This article first appeared on Medscape.com.
Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.
“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.
“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.
“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.
Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”
As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.
He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.
A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.
In less than 20 hours, his post received 290 votes in response.
And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.
People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
One Week Changed Everything
When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”
Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”
As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.
The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.
When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.
The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”
For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”
And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.
This article first appeared on Medscape.com.
Genomic prostate score does not improve risk assessment
A genomic prostate score (GPS) has little value in predicting adverse outcomes in men who have undergone a period of active surveillance before having a radical prostatectomy, according to a study published in the Journal of Clinical of Oncology.
The hazard ratio for adverse pathology using the 17-gene Oncotype DX Genomic Prostate Score did not reach statistical significance in a multivariate model (HR, 1.17; P = .066). This model took into account factors such as the prostate-specific antigen density (PSAD) and the Gleason grade group at diagnosis.
“In our study, the independent association of GPS with adverse pathology after initial active surveillance was not statistically significant,” Daniel W. Lin, MD, of the Fred Hutchinson Cancer Research Center in Seattle, and colleagues wrote.
There was also no association between the GPS and having upgraded biopsy findings during active surveillance.
Active surveillance is the “preferred management strategy” for men with low-risk prostate cancer, observed Dr. Lin and colleagues, but its use is often tempered by the worry that there may be underlying pathology that is not detected using routine clinical measures such as prostate-specific antigen testing. In their study, the investigators looked to see if using the GPS could help risk-stratify men undergoing active surveillance.
They noted that the biopsy-based genomic test had been shown to predict adverse surgical pathology and recurrence in men with low- and intermediate-risk prostate cancer who had undergone immediate radical prostatectomy. The team therefore wanted to clarify the test’s role in men who had been initially managed with a period of active surveillance.
To calculate the GPS, the investigators retrospectively analyzed diagnostic biopsy samples that had been prospectively collected from 432 men in the Canary Prostate Active Surveillance Study. The primary endpoint was adverse pathology in men who underwent radical prostatectomy after initial surveillance. Adverse pathology was defined as a Gleason grade of 3 or greater, a staging of pT3a or higher (with or without N1), or both.
After a median follow-up of 4.6 years, 167 (39%) men experienced upgrading of their prostate cancer at a surveillance biopsy, with 51 (12%) being upgraded to a Gleason grade group of 3 or higher. A total of 101 (23%) men had radical prostatectomy at a median of 2.1 years after their diagnostic biopsy, and just over half (n = 52; 51%) had adverse pathology at this time point.
GPS was associated with adverse pathology when the diagnostic Gleason grade group was taken into account (HR, 1.18; P = .030) but not when the investigators adjusted for both PSAD and diagnostic Gleason grade group. By contrast, PSAD (HR, 1.75; P = .025) was significantly associated with adverse pathology.
“Adding GPS to a model containing PSAD and diagnostic [Gleason grade group] did not significantly improve stratification of risk for [adverse pathology] over the clinical variables alone,” Dr. Lin and colleagues concluded.
This work was supported by the Canary Foundation, the Department of Defense, the National Institutes of Health, and Genomic Health. The authors disclosed relationships with Genomic Health and other companies.
SOURCE: Lin DW et al. J Clin Oncol. 2020 Mar 4. doi: 10.1200/JCO.19.02267.
A genomic prostate score (GPS) has little value in predicting adverse outcomes in men who have undergone a period of active surveillance before having a radical prostatectomy, according to a study published in the Journal of Clinical of Oncology.
The hazard ratio for adverse pathology using the 17-gene Oncotype DX Genomic Prostate Score did not reach statistical significance in a multivariate model (HR, 1.17; P = .066). This model took into account factors such as the prostate-specific antigen density (PSAD) and the Gleason grade group at diagnosis.
“In our study, the independent association of GPS with adverse pathology after initial active surveillance was not statistically significant,” Daniel W. Lin, MD, of the Fred Hutchinson Cancer Research Center in Seattle, and colleagues wrote.
There was also no association between the GPS and having upgraded biopsy findings during active surveillance.
Active surveillance is the “preferred management strategy” for men with low-risk prostate cancer, observed Dr. Lin and colleagues, but its use is often tempered by the worry that there may be underlying pathology that is not detected using routine clinical measures such as prostate-specific antigen testing. In their study, the investigators looked to see if using the GPS could help risk-stratify men undergoing active surveillance.
They noted that the biopsy-based genomic test had been shown to predict adverse surgical pathology and recurrence in men with low- and intermediate-risk prostate cancer who had undergone immediate radical prostatectomy. The team therefore wanted to clarify the test’s role in men who had been initially managed with a period of active surveillance.
To calculate the GPS, the investigators retrospectively analyzed diagnostic biopsy samples that had been prospectively collected from 432 men in the Canary Prostate Active Surveillance Study. The primary endpoint was adverse pathology in men who underwent radical prostatectomy after initial surveillance. Adverse pathology was defined as a Gleason grade of 3 or greater, a staging of pT3a or higher (with or without N1), or both.
After a median follow-up of 4.6 years, 167 (39%) men experienced upgrading of their prostate cancer at a surveillance biopsy, with 51 (12%) being upgraded to a Gleason grade group of 3 or higher. A total of 101 (23%) men had radical prostatectomy at a median of 2.1 years after their diagnostic biopsy, and just over half (n = 52; 51%) had adverse pathology at this time point.
GPS was associated with adverse pathology when the diagnostic Gleason grade group was taken into account (HR, 1.18; P = .030) but not when the investigators adjusted for both PSAD and diagnostic Gleason grade group. By contrast, PSAD (HR, 1.75; P = .025) was significantly associated with adverse pathology.
“Adding GPS to a model containing PSAD and diagnostic [Gleason grade group] did not significantly improve stratification of risk for [adverse pathology] over the clinical variables alone,” Dr. Lin and colleagues concluded.
This work was supported by the Canary Foundation, the Department of Defense, the National Institutes of Health, and Genomic Health. The authors disclosed relationships with Genomic Health and other companies.
SOURCE: Lin DW et al. J Clin Oncol. 2020 Mar 4. doi: 10.1200/JCO.19.02267.
A genomic prostate score (GPS) has little value in predicting adverse outcomes in men who have undergone a period of active surveillance before having a radical prostatectomy, according to a study published in the Journal of Clinical of Oncology.
The hazard ratio for adverse pathology using the 17-gene Oncotype DX Genomic Prostate Score did not reach statistical significance in a multivariate model (HR, 1.17; P = .066). This model took into account factors such as the prostate-specific antigen density (PSAD) and the Gleason grade group at diagnosis.
“In our study, the independent association of GPS with adverse pathology after initial active surveillance was not statistically significant,” Daniel W. Lin, MD, of the Fred Hutchinson Cancer Research Center in Seattle, and colleagues wrote.
There was also no association between the GPS and having upgraded biopsy findings during active surveillance.
Active surveillance is the “preferred management strategy” for men with low-risk prostate cancer, observed Dr. Lin and colleagues, but its use is often tempered by the worry that there may be underlying pathology that is not detected using routine clinical measures such as prostate-specific antigen testing. In their study, the investigators looked to see if using the GPS could help risk-stratify men undergoing active surveillance.
They noted that the biopsy-based genomic test had been shown to predict adverse surgical pathology and recurrence in men with low- and intermediate-risk prostate cancer who had undergone immediate radical prostatectomy. The team therefore wanted to clarify the test’s role in men who had been initially managed with a period of active surveillance.
To calculate the GPS, the investigators retrospectively analyzed diagnostic biopsy samples that had been prospectively collected from 432 men in the Canary Prostate Active Surveillance Study. The primary endpoint was adverse pathology in men who underwent radical prostatectomy after initial surveillance. Adverse pathology was defined as a Gleason grade of 3 or greater, a staging of pT3a or higher (with or without N1), or both.
After a median follow-up of 4.6 years, 167 (39%) men experienced upgrading of their prostate cancer at a surveillance biopsy, with 51 (12%) being upgraded to a Gleason grade group of 3 or higher. A total of 101 (23%) men had radical prostatectomy at a median of 2.1 years after their diagnostic biopsy, and just over half (n = 52; 51%) had adverse pathology at this time point.
GPS was associated with adverse pathology when the diagnostic Gleason grade group was taken into account (HR, 1.18; P = .030) but not when the investigators adjusted for both PSAD and diagnostic Gleason grade group. By contrast, PSAD (HR, 1.75; P = .025) was significantly associated with adverse pathology.
“Adding GPS to a model containing PSAD and diagnostic [Gleason grade group] did not significantly improve stratification of risk for [adverse pathology] over the clinical variables alone,” Dr. Lin and colleagues concluded.
This work was supported by the Canary Foundation, the Department of Defense, the National Institutes of Health, and Genomic Health. The authors disclosed relationships with Genomic Health and other companies.
SOURCE: Lin DW et al. J Clin Oncol. 2020 Mar 4. doi: 10.1200/JCO.19.02267.
FROM THE JOURNAL OF CLINICAL ONCOLOGY