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CXR-Net: An AI-based diagnostic tool for COVID-19
The system, called CXR-Net, was trained to differentiate SARS-CoV-2 chest x-rays (CXRs) from CXRs that are either normal or non–COVID-19 lung pathologies, explained Abdulah Haikal, an MD candidate at Wayne State University, Detroit.
Mr. Haikal described CXR-Net at the AACR Virtual Meeting: COVID-19 and Cancer (Abstract S11-04).
CXR-Net is a two-module pipeline, Mr. Haikal explained. Module I is based on Res-CR-Net, a type of neural network originally designed for the semantic segmentation of microscopy images, with the ability to retain the original resolution of the input images in the feature maps of all layers and in the final output.
Module II is a hybrid convolutional neural network in which the first convolutional layer with learned coefficients is replaced by a layer with fixed coefficients provided by the Wavelet Scattering Transform. Module II inputs patients’ CXRs and corresponding lung masks quantified by Module I, and generates as outputs a class assignment (COVID-19 or non–COVID-19) and high-resolution heat maps that detect the severe acute respiratory syndrome–-associated lung regions.
“The system is trained to differentiate COVID and non-COVID pathologies and produces a highly discriminative heat map to point to lung regions where COVID is suspected,” Mr. Haikal said. “The Wavelet Scattering Transform allows for fast determination of COVID versus non-COVID CXRs.”
Preliminary results and implications
CXR-Net was piloted on a small dataset of CXRs from non–COVID-19 and polymerase chain reaction–confirmed COVID-19 patients acquired at a single center in Detroit.
Upon fivefold cross validation of the training set with 2,265 images, 90% accuracy was observed when the training set was tested against the validation set. However, once 1,532 new images were introduced, a 76% accuracy rate was observed.
The F1 scores were 0.81 and 0.70 for the training and test sets, respectively.
“I’m really excited about this new approach, and I think AI will allow us to do more with less, which is exciting,” said Ross L. Levine, MD, of Memorial Sloan Kettering Cancer Center in New York, who led a discussion session with Mr. Haikal about CXR-Net.
One question raised during the discussion was whether the technology will help health care providers be more thoughtful about when and how they image COVID-19 patients.
“The more data you feed into the system, the stronger and more accurate it becomes,” Mr. Haikal said. “However, until we have data sharing from multiple centers, we won’t see improved accuracy results.”
Another question was whether this technology could be integrated with more clinical parameters.
“Some individuals are afraid that AI will replace the job of a professional, but it will only make it better for us,” Mr. Haikal said. “We don’t rely on current imaging techniques to make a definitive diagnosis, but rather have a specificity and sensitivity to establish a diagnosis, and AI can be used in the same way as a diagnostic tool.”
Mr. Haikal and Dr. Levine disclosed no conflicts of interest. No funding sources were reported in the presentation.
The system, called CXR-Net, was trained to differentiate SARS-CoV-2 chest x-rays (CXRs) from CXRs that are either normal or non–COVID-19 lung pathologies, explained Abdulah Haikal, an MD candidate at Wayne State University, Detroit.
Mr. Haikal described CXR-Net at the AACR Virtual Meeting: COVID-19 and Cancer (Abstract S11-04).
CXR-Net is a two-module pipeline, Mr. Haikal explained. Module I is based on Res-CR-Net, a type of neural network originally designed for the semantic segmentation of microscopy images, with the ability to retain the original resolution of the input images in the feature maps of all layers and in the final output.
Module II is a hybrid convolutional neural network in which the first convolutional layer with learned coefficients is replaced by a layer with fixed coefficients provided by the Wavelet Scattering Transform. Module II inputs patients’ CXRs and corresponding lung masks quantified by Module I, and generates as outputs a class assignment (COVID-19 or non–COVID-19) and high-resolution heat maps that detect the severe acute respiratory syndrome–-associated lung regions.
“The system is trained to differentiate COVID and non-COVID pathologies and produces a highly discriminative heat map to point to lung regions where COVID is suspected,” Mr. Haikal said. “The Wavelet Scattering Transform allows for fast determination of COVID versus non-COVID CXRs.”
Preliminary results and implications
CXR-Net was piloted on a small dataset of CXRs from non–COVID-19 and polymerase chain reaction–confirmed COVID-19 patients acquired at a single center in Detroit.
Upon fivefold cross validation of the training set with 2,265 images, 90% accuracy was observed when the training set was tested against the validation set. However, once 1,532 new images were introduced, a 76% accuracy rate was observed.
The F1 scores were 0.81 and 0.70 for the training and test sets, respectively.
“I’m really excited about this new approach, and I think AI will allow us to do more with less, which is exciting,” said Ross L. Levine, MD, of Memorial Sloan Kettering Cancer Center in New York, who led a discussion session with Mr. Haikal about CXR-Net.
One question raised during the discussion was whether the technology will help health care providers be more thoughtful about when and how they image COVID-19 patients.
“The more data you feed into the system, the stronger and more accurate it becomes,” Mr. Haikal said. “However, until we have data sharing from multiple centers, we won’t see improved accuracy results.”
Another question was whether this technology could be integrated with more clinical parameters.
“Some individuals are afraid that AI will replace the job of a professional, but it will only make it better for us,” Mr. Haikal said. “We don’t rely on current imaging techniques to make a definitive diagnosis, but rather have a specificity and sensitivity to establish a diagnosis, and AI can be used in the same way as a diagnostic tool.”
Mr. Haikal and Dr. Levine disclosed no conflicts of interest. No funding sources were reported in the presentation.
The system, called CXR-Net, was trained to differentiate SARS-CoV-2 chest x-rays (CXRs) from CXRs that are either normal or non–COVID-19 lung pathologies, explained Abdulah Haikal, an MD candidate at Wayne State University, Detroit.
Mr. Haikal described CXR-Net at the AACR Virtual Meeting: COVID-19 and Cancer (Abstract S11-04).
CXR-Net is a two-module pipeline, Mr. Haikal explained. Module I is based on Res-CR-Net, a type of neural network originally designed for the semantic segmentation of microscopy images, with the ability to retain the original resolution of the input images in the feature maps of all layers and in the final output.
Module II is a hybrid convolutional neural network in which the first convolutional layer with learned coefficients is replaced by a layer with fixed coefficients provided by the Wavelet Scattering Transform. Module II inputs patients’ CXRs and corresponding lung masks quantified by Module I, and generates as outputs a class assignment (COVID-19 or non–COVID-19) and high-resolution heat maps that detect the severe acute respiratory syndrome–-associated lung regions.
“The system is trained to differentiate COVID and non-COVID pathologies and produces a highly discriminative heat map to point to lung regions where COVID is suspected,” Mr. Haikal said. “The Wavelet Scattering Transform allows for fast determination of COVID versus non-COVID CXRs.”
Preliminary results and implications
CXR-Net was piloted on a small dataset of CXRs from non–COVID-19 and polymerase chain reaction–confirmed COVID-19 patients acquired at a single center in Detroit.
Upon fivefold cross validation of the training set with 2,265 images, 90% accuracy was observed when the training set was tested against the validation set. However, once 1,532 new images were introduced, a 76% accuracy rate was observed.
The F1 scores were 0.81 and 0.70 for the training and test sets, respectively.
“I’m really excited about this new approach, and I think AI will allow us to do more with less, which is exciting,” said Ross L. Levine, MD, of Memorial Sloan Kettering Cancer Center in New York, who led a discussion session with Mr. Haikal about CXR-Net.
One question raised during the discussion was whether the technology will help health care providers be more thoughtful about when and how they image COVID-19 patients.
“The more data you feed into the system, the stronger and more accurate it becomes,” Mr. Haikal said. “However, until we have data sharing from multiple centers, we won’t see improved accuracy results.”
Another question was whether this technology could be integrated with more clinical parameters.
“Some individuals are afraid that AI will replace the job of a professional, but it will only make it better for us,” Mr. Haikal said. “We don’t rely on current imaging techniques to make a definitive diagnosis, but rather have a specificity and sensitivity to establish a diagnosis, and AI can be used in the same way as a diagnostic tool.”
Mr. Haikal and Dr. Levine disclosed no conflicts of interest. No funding sources were reported in the presentation.
FROM AACR: COVID-19 AND CANCER 2021
Asymptomatic screening for COVID-19 in cancer patients still debated
Of more than 2,000 patients, less than 1% were found to be COVID-19 positive on asymptomatic screening, an investigator reported at the AACR Virtual Meeting: COVID-19 and Cancer (Abstract S09-04).
While several models have been proposed to screen for COVID-19 among cancer patients, the optimal strategy remains unknown, said investigator Justin A. Shaya, MD, of the University of California, San Diego.
The most commonly used approach is symptom/exposure-based screening and testing. However, other models have combined this method with polymerase chain reaction (PCR) testing for asymptomatic high-risk patients (such as those undergoing bone marrow transplant, receiving chemotherapy, or with hematologic malignancies) or with PCR testing for all asymptomatic cancer patients.
Dr. Shaya’s institution implemented a novel COVID-19 screening protocol for cancer patients receiving infusional therapy in May 2020.
The protocol required SARS-CoV-2 PCR testing for asymptomatic patients 24-96 hours prior to infusion. However, testing was only required before the administration of anticancer therapy. Infusion visits for supportive care interventions did not require previsit testing.
The researchers retrospectively analyzed data from patients with active cancer receiving infusional anticancer therapy who had at least one asymptomatic SARS-CoV-2 PCR test between June 1 and Dec. 1, 2020. The primary outcome was the rate of COVID-19 positivity among asymptomatic patients.
Results
Among 2,202 patients identified, 21 (0.95%) were found to be COVID-19 positive on asymptomatic screening. Most of these patients (90.5%) had solid tumors, but two (9.5%) had hematologic malignancies.
With respect to treatment, 16 patients (76.2%) received cytotoxic chemotherapy, 2 (9.5%) received targeted therapy, 1 (4.7%) received immunotherapy, and 2 (9.5%) were on a clinical trial.
At a median follow-up of 174 days from a positive PCR test (range, 55-223 days), only two patients (9.5%) developed COVID-related symptoms. Both patients had acute leukemia, and one required hospitalization for COVID-related complications.
In the COVID-19–positive cohort, 20 (95.2%) patients had their anticancer therapy delayed or deferred, with a median delay of 21 days (range, 7-77 days).
In the overall cohort, an additional 26 patients (1.2%) developed symptomatic COVID-19 during the study period.
“These results are particularly interesting because they come from a high-quality center that sees a large number of patients,” said Solange Peters, MD, PhD, of the University of Lausanne (Switzerland), who was not involved in this study.
“As they suggest, it is still a debate on how efficient routine screening is, asking the question whether we’re really detecting COVID-19 infection in our patients. Of course, it depends on the time and environment,” Dr. Peters added.
Dr. Shaya acknowledged that the small sample size was a key limitation of the study. Thus, the results may not be generalizable to other regions.
“One of the most striking things is that asymptomatic patients suffer very few consequences of COVID-19 infection, except for patients with hematologic malignancies,” Dr. Shaya said during a live discussion. “The majority of our patients had solid tumors and failed to develop any signs/symptoms of COVID infection.
“Routine screening provides a lot of security, and our institution is big enough to allow for it, and it seems our teams enjoy the fact of knowing the COVID status for each patient,” he continued.
Dr. Shaya and Dr. Peters disclosed no conflicts of interest. No funding sources were reported in the presentation.
Of more than 2,000 patients, less than 1% were found to be COVID-19 positive on asymptomatic screening, an investigator reported at the AACR Virtual Meeting: COVID-19 and Cancer (Abstract S09-04).
While several models have been proposed to screen for COVID-19 among cancer patients, the optimal strategy remains unknown, said investigator Justin A. Shaya, MD, of the University of California, San Diego.
The most commonly used approach is symptom/exposure-based screening and testing. However, other models have combined this method with polymerase chain reaction (PCR) testing for asymptomatic high-risk patients (such as those undergoing bone marrow transplant, receiving chemotherapy, or with hematologic malignancies) or with PCR testing for all asymptomatic cancer patients.
Dr. Shaya’s institution implemented a novel COVID-19 screening protocol for cancer patients receiving infusional therapy in May 2020.
The protocol required SARS-CoV-2 PCR testing for asymptomatic patients 24-96 hours prior to infusion. However, testing was only required before the administration of anticancer therapy. Infusion visits for supportive care interventions did not require previsit testing.
The researchers retrospectively analyzed data from patients with active cancer receiving infusional anticancer therapy who had at least one asymptomatic SARS-CoV-2 PCR test between June 1 and Dec. 1, 2020. The primary outcome was the rate of COVID-19 positivity among asymptomatic patients.
Results
Among 2,202 patients identified, 21 (0.95%) were found to be COVID-19 positive on asymptomatic screening. Most of these patients (90.5%) had solid tumors, but two (9.5%) had hematologic malignancies.
With respect to treatment, 16 patients (76.2%) received cytotoxic chemotherapy, 2 (9.5%) received targeted therapy, 1 (4.7%) received immunotherapy, and 2 (9.5%) were on a clinical trial.
At a median follow-up of 174 days from a positive PCR test (range, 55-223 days), only two patients (9.5%) developed COVID-related symptoms. Both patients had acute leukemia, and one required hospitalization for COVID-related complications.
In the COVID-19–positive cohort, 20 (95.2%) patients had their anticancer therapy delayed or deferred, with a median delay of 21 days (range, 7-77 days).
In the overall cohort, an additional 26 patients (1.2%) developed symptomatic COVID-19 during the study period.
“These results are particularly interesting because they come from a high-quality center that sees a large number of patients,” said Solange Peters, MD, PhD, of the University of Lausanne (Switzerland), who was not involved in this study.
“As they suggest, it is still a debate on how efficient routine screening is, asking the question whether we’re really detecting COVID-19 infection in our patients. Of course, it depends on the time and environment,” Dr. Peters added.
Dr. Shaya acknowledged that the small sample size was a key limitation of the study. Thus, the results may not be generalizable to other regions.
“One of the most striking things is that asymptomatic patients suffer very few consequences of COVID-19 infection, except for patients with hematologic malignancies,” Dr. Shaya said during a live discussion. “The majority of our patients had solid tumors and failed to develop any signs/symptoms of COVID infection.
“Routine screening provides a lot of security, and our institution is big enough to allow for it, and it seems our teams enjoy the fact of knowing the COVID status for each patient,” he continued.
Dr. Shaya and Dr. Peters disclosed no conflicts of interest. No funding sources were reported in the presentation.
Of more than 2,000 patients, less than 1% were found to be COVID-19 positive on asymptomatic screening, an investigator reported at the AACR Virtual Meeting: COVID-19 and Cancer (Abstract S09-04).
While several models have been proposed to screen for COVID-19 among cancer patients, the optimal strategy remains unknown, said investigator Justin A. Shaya, MD, of the University of California, San Diego.
The most commonly used approach is symptom/exposure-based screening and testing. However, other models have combined this method with polymerase chain reaction (PCR) testing for asymptomatic high-risk patients (such as those undergoing bone marrow transplant, receiving chemotherapy, or with hematologic malignancies) or with PCR testing for all asymptomatic cancer patients.
Dr. Shaya’s institution implemented a novel COVID-19 screening protocol for cancer patients receiving infusional therapy in May 2020.
The protocol required SARS-CoV-2 PCR testing for asymptomatic patients 24-96 hours prior to infusion. However, testing was only required before the administration of anticancer therapy. Infusion visits for supportive care interventions did not require previsit testing.
The researchers retrospectively analyzed data from patients with active cancer receiving infusional anticancer therapy who had at least one asymptomatic SARS-CoV-2 PCR test between June 1 and Dec. 1, 2020. The primary outcome was the rate of COVID-19 positivity among asymptomatic patients.
Results
Among 2,202 patients identified, 21 (0.95%) were found to be COVID-19 positive on asymptomatic screening. Most of these patients (90.5%) had solid tumors, but two (9.5%) had hematologic malignancies.
With respect to treatment, 16 patients (76.2%) received cytotoxic chemotherapy, 2 (9.5%) received targeted therapy, 1 (4.7%) received immunotherapy, and 2 (9.5%) were on a clinical trial.
At a median follow-up of 174 days from a positive PCR test (range, 55-223 days), only two patients (9.5%) developed COVID-related symptoms. Both patients had acute leukemia, and one required hospitalization for COVID-related complications.
In the COVID-19–positive cohort, 20 (95.2%) patients had their anticancer therapy delayed or deferred, with a median delay of 21 days (range, 7-77 days).
In the overall cohort, an additional 26 patients (1.2%) developed symptomatic COVID-19 during the study period.
“These results are particularly interesting because they come from a high-quality center that sees a large number of patients,” said Solange Peters, MD, PhD, of the University of Lausanne (Switzerland), who was not involved in this study.
“As they suggest, it is still a debate on how efficient routine screening is, asking the question whether we’re really detecting COVID-19 infection in our patients. Of course, it depends on the time and environment,” Dr. Peters added.
Dr. Shaya acknowledged that the small sample size was a key limitation of the study. Thus, the results may not be generalizable to other regions.
“One of the most striking things is that asymptomatic patients suffer very few consequences of COVID-19 infection, except for patients with hematologic malignancies,” Dr. Shaya said during a live discussion. “The majority of our patients had solid tumors and failed to develop any signs/symptoms of COVID infection.
“Routine screening provides a lot of security, and our institution is big enough to allow for it, and it seems our teams enjoy the fact of knowing the COVID status for each patient,” he continued.
Dr. Shaya and Dr. Peters disclosed no conflicts of interest. No funding sources were reported in the presentation.
FROM AACR: COVID-19 AND CANCER 2021
Managing cancer outpatients during the pandemic: Tips from MSKCC
“We’ve tried a lot of new things to ensure optimal care for our patients,” said Tiffany A. Traina, MD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York. “We need to effectively utilize all resources at our disposal to keep in touch with our patients during this time.”
Dr. Traina described the approach to outpatient management used at MSKCC during a presentation at the AACR Virtual Meeting: COVID-19 and Cancer.
Four guiding principles
MSKCC has established four guiding principles on how to manage cancer patients during the pandemic: openness, safety, technology, and staffing.
Openness ensures that decisions are guided by clinical priorities to provide optimal patient care and allow for prioritization of clinical research and education, Dr. Traina said.
The safety of patients and staff is of the utmost importance, she added. To ensure safety in the context of outpatient care, several operational levers were developed, including COVID surge planning, universal masking and personal protective equipment guidelines, remote work, clinical levers, and new dashboards and communications.
Dr. Traina said data analytics and dashboards have been key technological tools used to support evidence-based decision-making and deliver care remotely for patients during the pandemic.
Staffing resources have also shifted to support demand at different health system locations.
Screening, cohorting, and telemedicine
One measure MSKCC adopted is the MSK Engage Questionnaire, a COVID-19 screening questionnaire assigned to every patient with a scheduled outpatient visit. After completing the questionnaire, patients receive a response denoting whether they need to come into the outpatient setting.
On the staffing side, clinic coordinators prepare appointments accordingly, based on the risk level for each patient.
“We also try to cohort COVID-positive patients into particular areas within the outpatient setting,” Dr. Traina explained. “In addition, we control flow through ambulatory care locations by having separate patient entrances and use other tools to make flow as efficient as possible.”
On the technology side, interactive dashboards are being used to model traffic through different buildings.
“These data and analytics are useful for operational engineering, answering questions such as (1) Are there backups in chemotherapy? and (2) Are patients seeing one particular physician?” Dr. Traina explained. “One important key takeaway is the importance of frequently communicating simple messages through multiple mechanisms, including signage, websites, and dedicated resources.”
Other key technological measures are leveraging telemedicine to convert inpatient appointments to a virtual setting, as well as developing and deploying a system for centralized outpatient follow-up of COVID-19-positive patients.
“We saw a 3,000% increase in telemedicine utilization from February 2020 to June 2020,” Dr. Traina reported. “In a given month, we have approximately 230,000 outpatient visits, and a substantial proportion of these are now done via telemedicine.”
Dr. Traina also noted that multiple organizations have released guidelines addressing when to resume anticancer therapy in patients who have been COVID-19 positive. Adherence is important, as unnecessary COVID-19 testing may delay cancer therapy and is not recommended.
During a live discussion, Louis P. Voigt, MD, of MSKCC, said Dr. Traina’s presentation provided “a lot of good ideas for other institutions who may be facing similar challenges.”
Dr. Traina and Dr. Voigt disclosed no conflicts of interest. No funding sources were reported.
“We’ve tried a lot of new things to ensure optimal care for our patients,” said Tiffany A. Traina, MD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York. “We need to effectively utilize all resources at our disposal to keep in touch with our patients during this time.”
Dr. Traina described the approach to outpatient management used at MSKCC during a presentation at the AACR Virtual Meeting: COVID-19 and Cancer.
Four guiding principles
MSKCC has established four guiding principles on how to manage cancer patients during the pandemic: openness, safety, technology, and staffing.
Openness ensures that decisions are guided by clinical priorities to provide optimal patient care and allow for prioritization of clinical research and education, Dr. Traina said.
The safety of patients and staff is of the utmost importance, she added. To ensure safety in the context of outpatient care, several operational levers were developed, including COVID surge planning, universal masking and personal protective equipment guidelines, remote work, clinical levers, and new dashboards and communications.
Dr. Traina said data analytics and dashboards have been key technological tools used to support evidence-based decision-making and deliver care remotely for patients during the pandemic.
Staffing resources have also shifted to support demand at different health system locations.
Screening, cohorting, and telemedicine
One measure MSKCC adopted is the MSK Engage Questionnaire, a COVID-19 screening questionnaire assigned to every patient with a scheduled outpatient visit. After completing the questionnaire, patients receive a response denoting whether they need to come into the outpatient setting.
On the staffing side, clinic coordinators prepare appointments accordingly, based on the risk level for each patient.
“We also try to cohort COVID-positive patients into particular areas within the outpatient setting,” Dr. Traina explained. “In addition, we control flow through ambulatory care locations by having separate patient entrances and use other tools to make flow as efficient as possible.”
On the technology side, interactive dashboards are being used to model traffic through different buildings.
“These data and analytics are useful for operational engineering, answering questions such as (1) Are there backups in chemotherapy? and (2) Are patients seeing one particular physician?” Dr. Traina explained. “One important key takeaway is the importance of frequently communicating simple messages through multiple mechanisms, including signage, websites, and dedicated resources.”
Other key technological measures are leveraging telemedicine to convert inpatient appointments to a virtual setting, as well as developing and deploying a system for centralized outpatient follow-up of COVID-19-positive patients.
“We saw a 3,000% increase in telemedicine utilization from February 2020 to June 2020,” Dr. Traina reported. “In a given month, we have approximately 230,000 outpatient visits, and a substantial proportion of these are now done via telemedicine.”
Dr. Traina also noted that multiple organizations have released guidelines addressing when to resume anticancer therapy in patients who have been COVID-19 positive. Adherence is important, as unnecessary COVID-19 testing may delay cancer therapy and is not recommended.
During a live discussion, Louis P. Voigt, MD, of MSKCC, said Dr. Traina’s presentation provided “a lot of good ideas for other institutions who may be facing similar challenges.”
Dr. Traina and Dr. Voigt disclosed no conflicts of interest. No funding sources were reported.
“We’ve tried a lot of new things to ensure optimal care for our patients,” said Tiffany A. Traina, MD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York. “We need to effectively utilize all resources at our disposal to keep in touch with our patients during this time.”
Dr. Traina described the approach to outpatient management used at MSKCC during a presentation at the AACR Virtual Meeting: COVID-19 and Cancer.
Four guiding principles
MSKCC has established four guiding principles on how to manage cancer patients during the pandemic: openness, safety, technology, and staffing.
Openness ensures that decisions are guided by clinical priorities to provide optimal patient care and allow for prioritization of clinical research and education, Dr. Traina said.
The safety of patients and staff is of the utmost importance, she added. To ensure safety in the context of outpatient care, several operational levers were developed, including COVID surge planning, universal masking and personal protective equipment guidelines, remote work, clinical levers, and new dashboards and communications.
Dr. Traina said data analytics and dashboards have been key technological tools used to support evidence-based decision-making and deliver care remotely for patients during the pandemic.
Staffing resources have also shifted to support demand at different health system locations.
Screening, cohorting, and telemedicine
One measure MSKCC adopted is the MSK Engage Questionnaire, a COVID-19 screening questionnaire assigned to every patient with a scheduled outpatient visit. After completing the questionnaire, patients receive a response denoting whether they need to come into the outpatient setting.
On the staffing side, clinic coordinators prepare appointments accordingly, based on the risk level for each patient.
“We also try to cohort COVID-positive patients into particular areas within the outpatient setting,” Dr. Traina explained. “In addition, we control flow through ambulatory care locations by having separate patient entrances and use other tools to make flow as efficient as possible.”
On the technology side, interactive dashboards are being used to model traffic through different buildings.
“These data and analytics are useful for operational engineering, answering questions such as (1) Are there backups in chemotherapy? and (2) Are patients seeing one particular physician?” Dr. Traina explained. “One important key takeaway is the importance of frequently communicating simple messages through multiple mechanisms, including signage, websites, and dedicated resources.”
Other key technological measures are leveraging telemedicine to convert inpatient appointments to a virtual setting, as well as developing and deploying a system for centralized outpatient follow-up of COVID-19-positive patients.
“We saw a 3,000% increase in telemedicine utilization from February 2020 to June 2020,” Dr. Traina reported. “In a given month, we have approximately 230,000 outpatient visits, and a substantial proportion of these are now done via telemedicine.”
Dr. Traina also noted that multiple organizations have released guidelines addressing when to resume anticancer therapy in patients who have been COVID-19 positive. Adherence is important, as unnecessary COVID-19 testing may delay cancer therapy and is not recommended.
During a live discussion, Louis P. Voigt, MD, of MSKCC, said Dr. Traina’s presentation provided “a lot of good ideas for other institutions who may be facing similar challenges.”
Dr. Traina and Dr. Voigt disclosed no conflicts of interest. No funding sources were reported.
FROM AACR: COVID-19 AND CANCER 2021
COVID-19 vaccination in cancer patients: NCCN outlines priorities
Vaccination timing considerations vary based on factors such as cancer and treatment type, and reasons for delaying vaccination in the general public also apply to cancer patients (recent COVID-19 exposure, for example).
In general, however, patients with cancer should be assigned to Centers for Disease Control and Prevention priority group 1 b/c and immunized when vaccination is available to them, the guidelines state. Exceptions to this recommendation include:
- Patients undergoing hematopoietic stem cell transplant or receiving engineered cellular therapy such as chimeric antigen receptor T-cell therapy. Vaccination should be delayed for at least 3 months in these patients to maximize vaccine efficacy. Caregivers of these patients, however, should be immunized when possible.
- Patients with hematologic malignancies who are receiving intensive cytotoxic chemotherapy, such as cytarabine- or anthracycline-based regimens for acute myeloid leukemia. Vaccination in these patients should be delayed until absolute neutrophil count recovery.
- Patients undergoing major surgery. Vaccination should occur at least a few days before or after surgery.
- Patients who have experienced a severe or immediate adverse reaction to any of the ingredients in the mRNA COVID-19 vaccines.
Conversely, vaccination should occur when available in patients with hematologic malignancies and marrow failure who are expected to have limited or no recovery, patients with hematologic malignancies who are on long-term maintenance therapy, and patients with solid tumors who are receiving cytotoxic chemotherapy, targeted therapy, checkpoint inhibitors and other immunotherapy, or radiotherapy.
Caregivers, household contacts, and other close contacts who are 16 years of age and older should be vaccinated whenever they are eligible.
Unique concerns in patients with cancer
The NCCN recommendations were developed to address the unique issues and concerns with respect to patients with cancer, who have an increased risk of severe illness from SARS-CoV-2 infection. But the guidelines come with a caveat: “[t]here are limited safety and efficacy data in these patients,” the NCCN emphasized in a press statement.
“Right now, there is urgent need and limited data,” Steven Pergam, MD, co-leader of the NCCN COVID-19 Vaccination Committee, said in the statement.
“Our number one goal is helping to get the vaccine to as many people as we can,” Dr. Pergam said. “That means following existing national and regional directions for prioritizing people who are more likely to face death or severe illness from COVID-19.”
Dr. Pergam, associate professor at Fred Hutchinson Cancer Research Center in Seattle, further explained that “people receiving active cancer treatment are at greater risk for worse outcomes from COVID-19, particularly if they are older and have additional comorbidities, like immunosuppression.”
NCCN’s recommendations couldn’t have come at a better time for patients with cancer, according to Nora Disis, MD, a professor at the University of Washington in Seattle.
“The NCCN’s recommendations to prioritize COVID vaccinations for cancer patients on active treatment is an important step forward in protecting our patients from the infection,” Dr. Disis said in an interview.
“Cancer patients may be at higher risk for the complications seen with infection. In addition, cancer is a disease of older people, and a good number of our patients have the comorbidities that would predict a poorer outcome if they should become sick,” Dr. Disis added. “With the correct treatment, many patients with cancer will be long-term survivors. It is important that they be protected from infection with COVID to realize their best outcome.”
Additional vaccine considerations
The NCCN recommendations also address several other issues of importance for cancer patients, including:
- Deprioritizing other vaccines. COVID-19 vaccines should take precedence over other vaccines because data on dual vaccination are lacking. The NCCN recommends waiting 14 days after COVID-19 vaccination to deliver other vaccines.
- Vaccinating clinical trial participants. Trial leads should be consulted to prevent protocol violations or exclusions.
- Decision-making in the setting of limited vaccine availability. The NCCN noted that decisions on allocation must be made in accordance with state and local vaccine guidance but suggests prioritizing appropriate patients on active treatment, those planning to start treatment, and those who have just completed treatment. Additional risk factors for these patients, as well as other factors associated with risk for adverse COVID-19 outcomes, should also be considered. These include advanced age, comorbidities, and adverse social and demographic factors such as poverty and limited health care access.
- The need for ongoing prevention measures. Vaccines have been shown to decrease the incidence of COVID-19 and related complications, but it remains unclear whether vaccines prevent infection and subsequent transmission. This means everyone should continue following prevention recommendations, such as wearing masks and avoiding crowds.
The NCCN stressed that these recommendations are “intended to be a living document that is constantly evolving – it will be updated rapidly whenever new data comes out, as well as any potential new vaccines that may get approved in the future.” The NCCN also noted that the advisory committee will meet regularly to refine the recommendations as needed.
Dr. Pergam disclosed relationships with Chimerix Inc., Merck & Co., Global Life Technologies Inc., and Sanofi-Aventis. Dr. Disis disclosed grants from Pfizer, Bavarian Nordisk, Janssen, and Precigen. She is the founder of EpiThany and editor-in-chief of JAMA Oncology.
Vaccination timing considerations vary based on factors such as cancer and treatment type, and reasons for delaying vaccination in the general public also apply to cancer patients (recent COVID-19 exposure, for example).
In general, however, patients with cancer should be assigned to Centers for Disease Control and Prevention priority group 1 b/c and immunized when vaccination is available to them, the guidelines state. Exceptions to this recommendation include:
- Patients undergoing hematopoietic stem cell transplant or receiving engineered cellular therapy such as chimeric antigen receptor T-cell therapy. Vaccination should be delayed for at least 3 months in these patients to maximize vaccine efficacy. Caregivers of these patients, however, should be immunized when possible.
- Patients with hematologic malignancies who are receiving intensive cytotoxic chemotherapy, such as cytarabine- or anthracycline-based regimens for acute myeloid leukemia. Vaccination in these patients should be delayed until absolute neutrophil count recovery.
- Patients undergoing major surgery. Vaccination should occur at least a few days before or after surgery.
- Patients who have experienced a severe or immediate adverse reaction to any of the ingredients in the mRNA COVID-19 vaccines.
Conversely, vaccination should occur when available in patients with hematologic malignancies and marrow failure who are expected to have limited or no recovery, patients with hematologic malignancies who are on long-term maintenance therapy, and patients with solid tumors who are receiving cytotoxic chemotherapy, targeted therapy, checkpoint inhibitors and other immunotherapy, or radiotherapy.
Caregivers, household contacts, and other close contacts who are 16 years of age and older should be vaccinated whenever they are eligible.
Unique concerns in patients with cancer
The NCCN recommendations were developed to address the unique issues and concerns with respect to patients with cancer, who have an increased risk of severe illness from SARS-CoV-2 infection. But the guidelines come with a caveat: “[t]here are limited safety and efficacy data in these patients,” the NCCN emphasized in a press statement.
“Right now, there is urgent need and limited data,” Steven Pergam, MD, co-leader of the NCCN COVID-19 Vaccination Committee, said in the statement.
“Our number one goal is helping to get the vaccine to as many people as we can,” Dr. Pergam said. “That means following existing national and regional directions for prioritizing people who are more likely to face death or severe illness from COVID-19.”
Dr. Pergam, associate professor at Fred Hutchinson Cancer Research Center in Seattle, further explained that “people receiving active cancer treatment are at greater risk for worse outcomes from COVID-19, particularly if they are older and have additional comorbidities, like immunosuppression.”
NCCN’s recommendations couldn’t have come at a better time for patients with cancer, according to Nora Disis, MD, a professor at the University of Washington in Seattle.
“The NCCN’s recommendations to prioritize COVID vaccinations for cancer patients on active treatment is an important step forward in protecting our patients from the infection,” Dr. Disis said in an interview.
“Cancer patients may be at higher risk for the complications seen with infection. In addition, cancer is a disease of older people, and a good number of our patients have the comorbidities that would predict a poorer outcome if they should become sick,” Dr. Disis added. “With the correct treatment, many patients with cancer will be long-term survivors. It is important that they be protected from infection with COVID to realize their best outcome.”
Additional vaccine considerations
The NCCN recommendations also address several other issues of importance for cancer patients, including:
- Deprioritizing other vaccines. COVID-19 vaccines should take precedence over other vaccines because data on dual vaccination are lacking. The NCCN recommends waiting 14 days after COVID-19 vaccination to deliver other vaccines.
- Vaccinating clinical trial participants. Trial leads should be consulted to prevent protocol violations or exclusions.
- Decision-making in the setting of limited vaccine availability. The NCCN noted that decisions on allocation must be made in accordance with state and local vaccine guidance but suggests prioritizing appropriate patients on active treatment, those planning to start treatment, and those who have just completed treatment. Additional risk factors for these patients, as well as other factors associated with risk for adverse COVID-19 outcomes, should also be considered. These include advanced age, comorbidities, and adverse social and demographic factors such as poverty and limited health care access.
- The need for ongoing prevention measures. Vaccines have been shown to decrease the incidence of COVID-19 and related complications, but it remains unclear whether vaccines prevent infection and subsequent transmission. This means everyone should continue following prevention recommendations, such as wearing masks and avoiding crowds.
The NCCN stressed that these recommendations are “intended to be a living document that is constantly evolving – it will be updated rapidly whenever new data comes out, as well as any potential new vaccines that may get approved in the future.” The NCCN also noted that the advisory committee will meet regularly to refine the recommendations as needed.
Dr. Pergam disclosed relationships with Chimerix Inc., Merck & Co., Global Life Technologies Inc., and Sanofi-Aventis. Dr. Disis disclosed grants from Pfizer, Bavarian Nordisk, Janssen, and Precigen. She is the founder of EpiThany and editor-in-chief of JAMA Oncology.
Vaccination timing considerations vary based on factors such as cancer and treatment type, and reasons for delaying vaccination in the general public also apply to cancer patients (recent COVID-19 exposure, for example).
In general, however, patients with cancer should be assigned to Centers for Disease Control and Prevention priority group 1 b/c and immunized when vaccination is available to them, the guidelines state. Exceptions to this recommendation include:
- Patients undergoing hematopoietic stem cell transplant or receiving engineered cellular therapy such as chimeric antigen receptor T-cell therapy. Vaccination should be delayed for at least 3 months in these patients to maximize vaccine efficacy. Caregivers of these patients, however, should be immunized when possible.
- Patients with hematologic malignancies who are receiving intensive cytotoxic chemotherapy, such as cytarabine- or anthracycline-based regimens for acute myeloid leukemia. Vaccination in these patients should be delayed until absolute neutrophil count recovery.
- Patients undergoing major surgery. Vaccination should occur at least a few days before or after surgery.
- Patients who have experienced a severe or immediate adverse reaction to any of the ingredients in the mRNA COVID-19 vaccines.
Conversely, vaccination should occur when available in patients with hematologic malignancies and marrow failure who are expected to have limited or no recovery, patients with hematologic malignancies who are on long-term maintenance therapy, and patients with solid tumors who are receiving cytotoxic chemotherapy, targeted therapy, checkpoint inhibitors and other immunotherapy, or radiotherapy.
Caregivers, household contacts, and other close contacts who are 16 years of age and older should be vaccinated whenever they are eligible.
Unique concerns in patients with cancer
The NCCN recommendations were developed to address the unique issues and concerns with respect to patients with cancer, who have an increased risk of severe illness from SARS-CoV-2 infection. But the guidelines come with a caveat: “[t]here are limited safety and efficacy data in these patients,” the NCCN emphasized in a press statement.
“Right now, there is urgent need and limited data,” Steven Pergam, MD, co-leader of the NCCN COVID-19 Vaccination Committee, said in the statement.
“Our number one goal is helping to get the vaccine to as many people as we can,” Dr. Pergam said. “That means following existing national and regional directions for prioritizing people who are more likely to face death or severe illness from COVID-19.”
Dr. Pergam, associate professor at Fred Hutchinson Cancer Research Center in Seattle, further explained that “people receiving active cancer treatment are at greater risk for worse outcomes from COVID-19, particularly if they are older and have additional comorbidities, like immunosuppression.”
NCCN’s recommendations couldn’t have come at a better time for patients with cancer, according to Nora Disis, MD, a professor at the University of Washington in Seattle.
“The NCCN’s recommendations to prioritize COVID vaccinations for cancer patients on active treatment is an important step forward in protecting our patients from the infection,” Dr. Disis said in an interview.
“Cancer patients may be at higher risk for the complications seen with infection. In addition, cancer is a disease of older people, and a good number of our patients have the comorbidities that would predict a poorer outcome if they should become sick,” Dr. Disis added. “With the correct treatment, many patients with cancer will be long-term survivors. It is important that they be protected from infection with COVID to realize their best outcome.”
Additional vaccine considerations
The NCCN recommendations also address several other issues of importance for cancer patients, including:
- Deprioritizing other vaccines. COVID-19 vaccines should take precedence over other vaccines because data on dual vaccination are lacking. The NCCN recommends waiting 14 days after COVID-19 vaccination to deliver other vaccines.
- Vaccinating clinical trial participants. Trial leads should be consulted to prevent protocol violations or exclusions.
- Decision-making in the setting of limited vaccine availability. The NCCN noted that decisions on allocation must be made in accordance with state and local vaccine guidance but suggests prioritizing appropriate patients on active treatment, those planning to start treatment, and those who have just completed treatment. Additional risk factors for these patients, as well as other factors associated with risk for adverse COVID-19 outcomes, should also be considered. These include advanced age, comorbidities, and adverse social and demographic factors such as poverty and limited health care access.
- The need for ongoing prevention measures. Vaccines have been shown to decrease the incidence of COVID-19 and related complications, but it remains unclear whether vaccines prevent infection and subsequent transmission. This means everyone should continue following prevention recommendations, such as wearing masks and avoiding crowds.
The NCCN stressed that these recommendations are “intended to be a living document that is constantly evolving – it will be updated rapidly whenever new data comes out, as well as any potential new vaccines that may get approved in the future.” The NCCN also noted that the advisory committee will meet regularly to refine the recommendations as needed.
Dr. Pergam disclosed relationships with Chimerix Inc., Merck & Co., Global Life Technologies Inc., and Sanofi-Aventis. Dr. Disis disclosed grants from Pfizer, Bavarian Nordisk, Janssen, and Precigen. She is the founder of EpiThany and editor-in-chief of JAMA Oncology.
Model predicts acute kidney injury in cancer patients a month in advance
A model that crunches data from routine blood tests can accurately identify cancer patients who will develop acute kidney injury (AKI) up to a month before it happens, according to a cohort study.
The algorithm spotted nearly 74% of the patients who went on to develop AKI within 30 days, providing a window for intervention and possibly prevention, according to investigators.
These results were reported at the AACR Virtual Special Conference: Artificial Intelligence, Diagnosis, and Imaging (abstract PR-11).
“Cancer patients are a high-risk population for AKI due to the nature of their treatment and illness,” said presenter Lauren A. Scanlon, PhD, a data scientist at The Christie NHS Foundation Trust in Huddersfield, England. “AKI causes a huge disruption in treatment and distress for the patient, so it would be amazing if we could, say, predict the AKI before it occurs and prevent it from even happening.”
U.K. health care providers are already using an algorithm to monitor patients’ creatinine levels, comparing new values against historic ones, Dr. Scanlon explained. When that algorithm detects AKI, it issues an alert that triggers implementation of an AKI care bundle, including measures such as fluid monitoring and medication review, within 24 hours.
Taking this concept further, Dr. Scanlon and colleagues developed a random forest model, a type of machine learning algorithm, that incorporates other markers from blood tests routinely obtained for all patients, with the aim of predicting AKI up to 30 days in advance.
“Using routinely collected blood test results will ensure that the model is applicable to all our patients and can be implemented in an automated manner,” Dr. Scanlon noted.
The investigators developed and trained the model using 597,403 blood test results from 48,865 patients undergoing cancer treatment between January 2017 and May 2020.
The model assigns patients to five categories of risk for AKI in the next 30 days: very low, low, medium, high, and very high.
“We wanted the model to output in this way so that it could be used by clinicians alongside their own insight and knowledge on a case-by-case basis,” Dr. Scanlon explained.
The investigators then prospectively validated the model and its risk categories in another 9,913 patients who underwent cancer treatment between June and August 2020.
Using a model threshold of medium risk or higher, the model correctly predicted AKI in 330 (73.8%) of the 447 patients in the validation cohort who ultimately developed AKI.
“This is pretty amazing and shows that this model really is working and can correctly detect these AKIs up to 30 days before they occur, giving a huge window to put in place preventive strategies,” Dr. Scanlon said.
Among the 154 patients in whom the model incorrectly predicted AKI, 9 patients had only a single follow-up blood test and 17 patients did not have any, leaving their actual outcomes unclear.
“Given that AKI detection uses blood tests, an AKI in these patients was never confirmed,” Dr. Scanlon noted. “So this could give a potential benefit of the model that we never intended: It could reduce undiagnosed AKI by flagging those who are at risk.”
“Our next steps are to test the model through a technology clinical trial to see if putting intervention strategies in place does prevent these AKIs from taking place,” Dr. Scanlon concluded. “We are also going to move to ongoing monitoring of the model performance.”
Dr. Scanlon disclosed no conflicts of interest. The study did not receive specific funding.
A model that crunches data from routine blood tests can accurately identify cancer patients who will develop acute kidney injury (AKI) up to a month before it happens, according to a cohort study.
The algorithm spotted nearly 74% of the patients who went on to develop AKI within 30 days, providing a window for intervention and possibly prevention, according to investigators.
These results were reported at the AACR Virtual Special Conference: Artificial Intelligence, Diagnosis, and Imaging (abstract PR-11).
“Cancer patients are a high-risk population for AKI due to the nature of their treatment and illness,” said presenter Lauren A. Scanlon, PhD, a data scientist at The Christie NHS Foundation Trust in Huddersfield, England. “AKI causes a huge disruption in treatment and distress for the patient, so it would be amazing if we could, say, predict the AKI before it occurs and prevent it from even happening.”
U.K. health care providers are already using an algorithm to monitor patients’ creatinine levels, comparing new values against historic ones, Dr. Scanlon explained. When that algorithm detects AKI, it issues an alert that triggers implementation of an AKI care bundle, including measures such as fluid monitoring and medication review, within 24 hours.
Taking this concept further, Dr. Scanlon and colleagues developed a random forest model, a type of machine learning algorithm, that incorporates other markers from blood tests routinely obtained for all patients, with the aim of predicting AKI up to 30 days in advance.
“Using routinely collected blood test results will ensure that the model is applicable to all our patients and can be implemented in an automated manner,” Dr. Scanlon noted.
The investigators developed and trained the model using 597,403 blood test results from 48,865 patients undergoing cancer treatment between January 2017 and May 2020.
The model assigns patients to five categories of risk for AKI in the next 30 days: very low, low, medium, high, and very high.
“We wanted the model to output in this way so that it could be used by clinicians alongside their own insight and knowledge on a case-by-case basis,” Dr. Scanlon explained.
The investigators then prospectively validated the model and its risk categories in another 9,913 patients who underwent cancer treatment between June and August 2020.
Using a model threshold of medium risk or higher, the model correctly predicted AKI in 330 (73.8%) of the 447 patients in the validation cohort who ultimately developed AKI.
“This is pretty amazing and shows that this model really is working and can correctly detect these AKIs up to 30 days before they occur, giving a huge window to put in place preventive strategies,” Dr. Scanlon said.
Among the 154 patients in whom the model incorrectly predicted AKI, 9 patients had only a single follow-up blood test and 17 patients did not have any, leaving their actual outcomes unclear.
“Given that AKI detection uses blood tests, an AKI in these patients was never confirmed,” Dr. Scanlon noted. “So this could give a potential benefit of the model that we never intended: It could reduce undiagnosed AKI by flagging those who are at risk.”
“Our next steps are to test the model through a technology clinical trial to see if putting intervention strategies in place does prevent these AKIs from taking place,” Dr. Scanlon concluded. “We are also going to move to ongoing monitoring of the model performance.”
Dr. Scanlon disclosed no conflicts of interest. The study did not receive specific funding.
A model that crunches data from routine blood tests can accurately identify cancer patients who will develop acute kidney injury (AKI) up to a month before it happens, according to a cohort study.
The algorithm spotted nearly 74% of the patients who went on to develop AKI within 30 days, providing a window for intervention and possibly prevention, according to investigators.
These results were reported at the AACR Virtual Special Conference: Artificial Intelligence, Diagnosis, and Imaging (abstract PR-11).
“Cancer patients are a high-risk population for AKI due to the nature of their treatment and illness,” said presenter Lauren A. Scanlon, PhD, a data scientist at The Christie NHS Foundation Trust in Huddersfield, England. “AKI causes a huge disruption in treatment and distress for the patient, so it would be amazing if we could, say, predict the AKI before it occurs and prevent it from even happening.”
U.K. health care providers are already using an algorithm to monitor patients’ creatinine levels, comparing new values against historic ones, Dr. Scanlon explained. When that algorithm detects AKI, it issues an alert that triggers implementation of an AKI care bundle, including measures such as fluid monitoring and medication review, within 24 hours.
Taking this concept further, Dr. Scanlon and colleagues developed a random forest model, a type of machine learning algorithm, that incorporates other markers from blood tests routinely obtained for all patients, with the aim of predicting AKI up to 30 days in advance.
“Using routinely collected blood test results will ensure that the model is applicable to all our patients and can be implemented in an automated manner,” Dr. Scanlon noted.
The investigators developed and trained the model using 597,403 blood test results from 48,865 patients undergoing cancer treatment between January 2017 and May 2020.
The model assigns patients to five categories of risk for AKI in the next 30 days: very low, low, medium, high, and very high.
“We wanted the model to output in this way so that it could be used by clinicians alongside their own insight and knowledge on a case-by-case basis,” Dr. Scanlon explained.
The investigators then prospectively validated the model and its risk categories in another 9,913 patients who underwent cancer treatment between June and August 2020.
Using a model threshold of medium risk or higher, the model correctly predicted AKI in 330 (73.8%) of the 447 patients in the validation cohort who ultimately developed AKI.
“This is pretty amazing and shows that this model really is working and can correctly detect these AKIs up to 30 days before they occur, giving a huge window to put in place preventive strategies,” Dr. Scanlon said.
Among the 154 patients in whom the model incorrectly predicted AKI, 9 patients had only a single follow-up blood test and 17 patients did not have any, leaving their actual outcomes unclear.
“Given that AKI detection uses blood tests, an AKI in these patients was never confirmed,” Dr. Scanlon noted. “So this could give a potential benefit of the model that we never intended: It could reduce undiagnosed AKI by flagging those who are at risk.”
“Our next steps are to test the model through a technology clinical trial to see if putting intervention strategies in place does prevent these AKIs from taking place,” Dr. Scanlon concluded. “We are also going to move to ongoing monitoring of the model performance.”
Dr. Scanlon disclosed no conflicts of interest. The study did not receive specific funding.
FROM AACR: AI, DIAGNOSIS, AND IMAGING 2021
New technique uses voice to evaluate thyroid nodules
However, it has not yet been tested for cancer detection.
The new approach involves holding a linear ultrasound probe to the throat of the patient, who is then requested to vocalize an “eee” sound at 150 Hz. A loudspeaker plays a 150-Hz sound to guide the patient.
The vocal vibrations generated, called shear waves, are detected by the probe as they pass through the thyroid. Software the researchers developed calculates the velocity of the shear waves, which move faster through stiffer tissue. The software produces a stiffness map that is then superimposed onto a gray-scale (B mode) thyroid image from the ultrasound.
Cancerous tissue is stiffer than healthy tissue and benign nodules, so shear waves pass through it more quickly, the researchers explained. Areas of particular stiffness that are revealed by the test are a concern.
The study was published online Jan. 12 in Applied Physics Letters.
The new approach is a noninvasive method that “would reduce the stress of patients during their medical exams. Having to sing during a medical exam can perhaps help release some of the nervous tension even more,” lead investigator Steve Beuve, PhD, of the Université de Tours (France), said in a press release. The main benefit of this technique is that it is “quick and easy,” he added. Data acquisition takes about a second, and no specialized equipment is required. Imaging can be rendered by any Doppler ultrasound set at an ultrafast frame rate to track the shear waves. The computer program automatically calculates wave velocity through various parts of the thyroid.
The technique, dubbed vocal passive elastography (VPE), has not yet been tested to see how well it distinguishes cancerous from benign thyroid nodules.
“We want to cooperate with physicians to propose protocols to verify [VPE’s] relevance,” Dr. Beuve said.
Because no data are currently available on how accurate VPE is in diagnosing malignant nodules, it is not possible to comment on its potential usefulness, Aya Kamaya, MD, a radiology professor at Stanford (Calif.) University Medical Center, said in an interview.
Ultrasound elastography for diagnosing thyroid disease has been in development for years. More than 100 reports have been published in the medical literature since 2005. Various devices are available commercially, but for now, elastography for thyroid nodules remains investigational, she said.
Another expert who was approached for comment was more critical.
Lisa Orloff, MD, a professor and director of endocrine head and neck surgery and the thyroid tumor program at Stanford University, noted that, in general, “elastography has not gained more traction in thyroid evaluation to date because it does not appear to reduce the need for [fine-needle aspiration] of suspicious nodules based on gray-scale ultrasound alone, without elastography.”
As for the French report, she said that “while the voice might be a convenient shear wave source, I am very skeptical at many levels. I get the impression that [this is] a laboratory-based concept that is fraught with confounding factors in attempting real-world application.
“One concern is that the thyroid gland and nodule stiffness are affected by factors including underlying goiter, autoimmune disease, fluid content of nodules, calcifications, and other variables that can be present in benign or malignant conditions. And there are so many variables that would affect an individual patient’s ability (or not) to phonate at 150 Hz,” Dr. Orloff said.
VPE is an extension of passive elastography, which extracts elasticity data from the natural vibrations caused by the heart, blood pulsatility, and muscle activity, the authors explained. The team turned to vocalization at 150 Hz in part to overcome the physiological background noise in the thyroid from carotid pulsation at about 1-10 Hz.
The group is exploring vocalizations at other frequencies and is working to improve the computer program interface. They are also exploring VPE for other organs, including the brain.
The source of funding for the study and the authors’ relevant financial relationships were not reported.
A version of this article first appeared on Medscape.com.
However, it has not yet been tested for cancer detection.
The new approach involves holding a linear ultrasound probe to the throat of the patient, who is then requested to vocalize an “eee” sound at 150 Hz. A loudspeaker plays a 150-Hz sound to guide the patient.
The vocal vibrations generated, called shear waves, are detected by the probe as they pass through the thyroid. Software the researchers developed calculates the velocity of the shear waves, which move faster through stiffer tissue. The software produces a stiffness map that is then superimposed onto a gray-scale (B mode) thyroid image from the ultrasound.
Cancerous tissue is stiffer than healthy tissue and benign nodules, so shear waves pass through it more quickly, the researchers explained. Areas of particular stiffness that are revealed by the test are a concern.
The study was published online Jan. 12 in Applied Physics Letters.
The new approach is a noninvasive method that “would reduce the stress of patients during their medical exams. Having to sing during a medical exam can perhaps help release some of the nervous tension even more,” lead investigator Steve Beuve, PhD, of the Université de Tours (France), said in a press release. The main benefit of this technique is that it is “quick and easy,” he added. Data acquisition takes about a second, and no specialized equipment is required. Imaging can be rendered by any Doppler ultrasound set at an ultrafast frame rate to track the shear waves. The computer program automatically calculates wave velocity through various parts of the thyroid.
The technique, dubbed vocal passive elastography (VPE), has not yet been tested to see how well it distinguishes cancerous from benign thyroid nodules.
“We want to cooperate with physicians to propose protocols to verify [VPE’s] relevance,” Dr. Beuve said.
Because no data are currently available on how accurate VPE is in diagnosing malignant nodules, it is not possible to comment on its potential usefulness, Aya Kamaya, MD, a radiology professor at Stanford (Calif.) University Medical Center, said in an interview.
Ultrasound elastography for diagnosing thyroid disease has been in development for years. More than 100 reports have been published in the medical literature since 2005. Various devices are available commercially, but for now, elastography for thyroid nodules remains investigational, she said.
Another expert who was approached for comment was more critical.
Lisa Orloff, MD, a professor and director of endocrine head and neck surgery and the thyroid tumor program at Stanford University, noted that, in general, “elastography has not gained more traction in thyroid evaluation to date because it does not appear to reduce the need for [fine-needle aspiration] of suspicious nodules based on gray-scale ultrasound alone, without elastography.”
As for the French report, she said that “while the voice might be a convenient shear wave source, I am very skeptical at many levels. I get the impression that [this is] a laboratory-based concept that is fraught with confounding factors in attempting real-world application.
“One concern is that the thyroid gland and nodule stiffness are affected by factors including underlying goiter, autoimmune disease, fluid content of nodules, calcifications, and other variables that can be present in benign or malignant conditions. And there are so many variables that would affect an individual patient’s ability (or not) to phonate at 150 Hz,” Dr. Orloff said.
VPE is an extension of passive elastography, which extracts elasticity data from the natural vibrations caused by the heart, blood pulsatility, and muscle activity, the authors explained. The team turned to vocalization at 150 Hz in part to overcome the physiological background noise in the thyroid from carotid pulsation at about 1-10 Hz.
The group is exploring vocalizations at other frequencies and is working to improve the computer program interface. They are also exploring VPE for other organs, including the brain.
The source of funding for the study and the authors’ relevant financial relationships were not reported.
A version of this article first appeared on Medscape.com.
However, it has not yet been tested for cancer detection.
The new approach involves holding a linear ultrasound probe to the throat of the patient, who is then requested to vocalize an “eee” sound at 150 Hz. A loudspeaker plays a 150-Hz sound to guide the patient.
The vocal vibrations generated, called shear waves, are detected by the probe as they pass through the thyroid. Software the researchers developed calculates the velocity of the shear waves, which move faster through stiffer tissue. The software produces a stiffness map that is then superimposed onto a gray-scale (B mode) thyroid image from the ultrasound.
Cancerous tissue is stiffer than healthy tissue and benign nodules, so shear waves pass through it more quickly, the researchers explained. Areas of particular stiffness that are revealed by the test are a concern.
The study was published online Jan. 12 in Applied Physics Letters.
The new approach is a noninvasive method that “would reduce the stress of patients during their medical exams. Having to sing during a medical exam can perhaps help release some of the nervous tension even more,” lead investigator Steve Beuve, PhD, of the Université de Tours (France), said in a press release. The main benefit of this technique is that it is “quick and easy,” he added. Data acquisition takes about a second, and no specialized equipment is required. Imaging can be rendered by any Doppler ultrasound set at an ultrafast frame rate to track the shear waves. The computer program automatically calculates wave velocity through various parts of the thyroid.
The technique, dubbed vocal passive elastography (VPE), has not yet been tested to see how well it distinguishes cancerous from benign thyroid nodules.
“We want to cooperate with physicians to propose protocols to verify [VPE’s] relevance,” Dr. Beuve said.
Because no data are currently available on how accurate VPE is in diagnosing malignant nodules, it is not possible to comment on its potential usefulness, Aya Kamaya, MD, a radiology professor at Stanford (Calif.) University Medical Center, said in an interview.
Ultrasound elastography for diagnosing thyroid disease has been in development for years. More than 100 reports have been published in the medical literature since 2005. Various devices are available commercially, but for now, elastography for thyroid nodules remains investigational, she said.
Another expert who was approached for comment was more critical.
Lisa Orloff, MD, a professor and director of endocrine head and neck surgery and the thyroid tumor program at Stanford University, noted that, in general, “elastography has not gained more traction in thyroid evaluation to date because it does not appear to reduce the need for [fine-needle aspiration] of suspicious nodules based on gray-scale ultrasound alone, without elastography.”
As for the French report, she said that “while the voice might be a convenient shear wave source, I am very skeptical at many levels. I get the impression that [this is] a laboratory-based concept that is fraught with confounding factors in attempting real-world application.
“One concern is that the thyroid gland and nodule stiffness are affected by factors including underlying goiter, autoimmune disease, fluid content of nodules, calcifications, and other variables that can be present in benign or malignant conditions. And there are so many variables that would affect an individual patient’s ability (or not) to phonate at 150 Hz,” Dr. Orloff said.
VPE is an extension of passive elastography, which extracts elasticity data from the natural vibrations caused by the heart, blood pulsatility, and muscle activity, the authors explained. The team turned to vocalization at 150 Hz in part to overcome the physiological background noise in the thyroid from carotid pulsation at about 1-10 Hz.
The group is exploring vocalizations at other frequencies and is working to improve the computer program interface. They are also exploring VPE for other organs, including the brain.
The source of funding for the study and the authors’ relevant financial relationships were not reported.
A version of this article first appeared on Medscape.com.
Global thyroid cancer overdiagnosis in children and adolescents
Global patterns of the incidence of thyroid cancer in children and adolescents closely correspond to the increases seen in recent decades in adults. The patterns point to the same culprit in both groups – overdiagnosis. The finding underscores recommendations to limit screening.
“Our findings suggest that recommendations against screening for thyroid cancer in the asymptomatic adult population who are free from risk factors should be extended to explicitly recommend against screening for thyroid cancer in similar populations of children and adolescents,” say the authors, led by Salvatore Vaccarella, PhD, of the International Agency for Research on Cancer, in Lyon, France.
The study was published online Jan. 19 in The Lancet Diabetes and Endocrinology.
In an accompanying comment, Livia Lamartina and colleagues from the department of nuclear medicine and endocrine oncology, Institut Gustave Roussy and the University Paris-Saclay, Villejuif, France, emphasize that unnecessary screening of thyroid cancer in children can have substantial implications.
“Overdiagnosis might transform a child into a thyroid cancer patient for the rest of their life, and overtreatment might induce complications and possibly lead to the requirement of lifelong thyroid hormone treatment,” they write.
“Therefore, screening with ultrasonography should not be recommended in asymptomatic children and adolescents,” they conclude.
Study findings
For the study, Dr. Vaccarella and colleagues evaluated the incidence of thyroid cancer in 49 countries and territories and mortality in 27 countries, using the most up-to-date data from the International Incidence of Childhood Cancer Volume 3 study, the Cancer in Five Continents database, and the World Health Organization mortality database.
Although there was considerable variability between countries, the incidence of thyroid cancer in children and adolescents aged 0-19 years increased rapidly between 1998 and 2002 and again between 2008 and 2012 in nearly all countries.
Country-specific incidence rates strongly correlated with rates in adults (r > 0.8), including the temporal aspects of the incidence rates (r > .0.6).
Of the 8049 thyroid cancers that were detected, 6935 (86.2%) were papillary carcinomas, 682 (8.5%) were follicular carcinomas, and 307 (3.8%) were medullary carcinomas, as determined on the basis of the WHO classification of thyroid carcinomas. Sixty-four tumors (0.8%) were of unspecified subtype. As is commonly observed in adults, rates were higher in girls than in boys and increased with older age for both sexes.
The strong correlation between children and adults in the timing of the increases in incidence was especially notable in countries where overdiagnosis has been identified as having a major role in the increasing thyroid cancer rates. Those countries are South Korea, the United States, Italy, France, and Australia, where 60%-90% of thyroid cancer diagnoses are attributable to overdiagnosis. Overall, the incidence of thyroid cancer was less than 1.5 per one million person-years in children younger than 10 years. There were small variations by country and sex.
Thyroid cancer mortalities remain low
Overall, the rate of thyroid cancer mortality among those younger than 20 years in each country was less than 0.1 per 10 million person-years, “corresponding to less than 10 deaths per year in all of the included countries collectively,” note Dr. Vaccarella and colleagues.
“The epidemiological pattern seen in children and adolescents mirrored that seen in adults. These findings suggest that, in affected countries and territories, there might be overdiagnosis in children and adolescents, as has been observed in adults,” they write.
The incidence of thyroid cancer in children and adolescents between 2008 and 2012 ranged from 0.4 per one million person-years in Uganda and Kenya and 13.4 per 1 million person-years in Belarus, where the increase is believed to be related to the Chernobyl nuclear power plant accident and to increased screening in the years following the accident.
Subclinical discoveries may lead to unnecessary measures
Thyroid cancer was once a rare condition. Rates began to increase steadily in the 1990s, corresponding with rapid advances in noninvasive diagnostic imaging. Currently, thyroid cancer is the fifth most diagnosed cancer worldwide in adult women and the third most common in women aged 50 years and younger.
Diagnostic measures ranging from ultrasound and MRI to fine-needle aspiration biopsy have played a large role in the increase in diagnoses. The diagnostic techniques are revealing subclinical cancers in thyroid glands that previously went undetected and that usually do not cause harm over a person’s lifetime. According to Dr. Vaccarella and colleagues, such discoveries can open the door to a wide range of unnecessary measures.
The possible consequences of overdiagnosis include unnecessary treatments, the need to undergo lifelong medical care, and potential adverse effects, which could negatively affect quality of life.
Recent research from the International Agency for Research on Cancer has indicated that there has been an “epidemic of overdiagnosis” of thyroid cancer. The pattern has even reached less affluent regions as diagnostic technologies have become widely available.
“What is surprising is the magnitude of this,” Dr. Vaccarella said in an interview.
“Without overdiagnosis, thyroid cancer would probably still be a relatively rare cancer,” he said.
The study authors have disclosed no relevant financial relationships. Dr. Lamartina has received personal, advisory board, and clinical trial principal investigator fees from Bayer, personal fees from Eisai, and clinical trial principal investigator fees from AstraZeneca. The other editorialists’ financial relationships are listed in the original article.
A version of this article first appeared on Medscape.com.
Global patterns of the incidence of thyroid cancer in children and adolescents closely correspond to the increases seen in recent decades in adults. The patterns point to the same culprit in both groups – overdiagnosis. The finding underscores recommendations to limit screening.
“Our findings suggest that recommendations against screening for thyroid cancer in the asymptomatic adult population who are free from risk factors should be extended to explicitly recommend against screening for thyroid cancer in similar populations of children and adolescents,” say the authors, led by Salvatore Vaccarella, PhD, of the International Agency for Research on Cancer, in Lyon, France.
The study was published online Jan. 19 in The Lancet Diabetes and Endocrinology.
In an accompanying comment, Livia Lamartina and colleagues from the department of nuclear medicine and endocrine oncology, Institut Gustave Roussy and the University Paris-Saclay, Villejuif, France, emphasize that unnecessary screening of thyroid cancer in children can have substantial implications.
“Overdiagnosis might transform a child into a thyroid cancer patient for the rest of their life, and overtreatment might induce complications and possibly lead to the requirement of lifelong thyroid hormone treatment,” they write.
“Therefore, screening with ultrasonography should not be recommended in asymptomatic children and adolescents,” they conclude.
Study findings
For the study, Dr. Vaccarella and colleagues evaluated the incidence of thyroid cancer in 49 countries and territories and mortality in 27 countries, using the most up-to-date data from the International Incidence of Childhood Cancer Volume 3 study, the Cancer in Five Continents database, and the World Health Organization mortality database.
Although there was considerable variability between countries, the incidence of thyroid cancer in children and adolescents aged 0-19 years increased rapidly between 1998 and 2002 and again between 2008 and 2012 in nearly all countries.
Country-specific incidence rates strongly correlated with rates in adults (r > 0.8), including the temporal aspects of the incidence rates (r > .0.6).
Of the 8049 thyroid cancers that were detected, 6935 (86.2%) were papillary carcinomas, 682 (8.5%) were follicular carcinomas, and 307 (3.8%) were medullary carcinomas, as determined on the basis of the WHO classification of thyroid carcinomas. Sixty-four tumors (0.8%) were of unspecified subtype. As is commonly observed in adults, rates were higher in girls than in boys and increased with older age for both sexes.
The strong correlation between children and adults in the timing of the increases in incidence was especially notable in countries where overdiagnosis has been identified as having a major role in the increasing thyroid cancer rates. Those countries are South Korea, the United States, Italy, France, and Australia, where 60%-90% of thyroid cancer diagnoses are attributable to overdiagnosis. Overall, the incidence of thyroid cancer was less than 1.5 per one million person-years in children younger than 10 years. There were small variations by country and sex.
Thyroid cancer mortalities remain low
Overall, the rate of thyroid cancer mortality among those younger than 20 years in each country was less than 0.1 per 10 million person-years, “corresponding to less than 10 deaths per year in all of the included countries collectively,” note Dr. Vaccarella and colleagues.
“The epidemiological pattern seen in children and adolescents mirrored that seen in adults. These findings suggest that, in affected countries and territories, there might be overdiagnosis in children and adolescents, as has been observed in adults,” they write.
The incidence of thyroid cancer in children and adolescents between 2008 and 2012 ranged from 0.4 per one million person-years in Uganda and Kenya and 13.4 per 1 million person-years in Belarus, where the increase is believed to be related to the Chernobyl nuclear power plant accident and to increased screening in the years following the accident.
Subclinical discoveries may lead to unnecessary measures
Thyroid cancer was once a rare condition. Rates began to increase steadily in the 1990s, corresponding with rapid advances in noninvasive diagnostic imaging. Currently, thyroid cancer is the fifth most diagnosed cancer worldwide in adult women and the third most common in women aged 50 years and younger.
Diagnostic measures ranging from ultrasound and MRI to fine-needle aspiration biopsy have played a large role in the increase in diagnoses. The diagnostic techniques are revealing subclinical cancers in thyroid glands that previously went undetected and that usually do not cause harm over a person’s lifetime. According to Dr. Vaccarella and colleagues, such discoveries can open the door to a wide range of unnecessary measures.
The possible consequences of overdiagnosis include unnecessary treatments, the need to undergo lifelong medical care, and potential adverse effects, which could negatively affect quality of life.
Recent research from the International Agency for Research on Cancer has indicated that there has been an “epidemic of overdiagnosis” of thyroid cancer. The pattern has even reached less affluent regions as diagnostic technologies have become widely available.
“What is surprising is the magnitude of this,” Dr. Vaccarella said in an interview.
“Without overdiagnosis, thyroid cancer would probably still be a relatively rare cancer,” he said.
The study authors have disclosed no relevant financial relationships. Dr. Lamartina has received personal, advisory board, and clinical trial principal investigator fees from Bayer, personal fees from Eisai, and clinical trial principal investigator fees from AstraZeneca. The other editorialists’ financial relationships are listed in the original article.
A version of this article first appeared on Medscape.com.
Global patterns of the incidence of thyroid cancer in children and adolescents closely correspond to the increases seen in recent decades in adults. The patterns point to the same culprit in both groups – overdiagnosis. The finding underscores recommendations to limit screening.
“Our findings suggest that recommendations against screening for thyroid cancer in the asymptomatic adult population who are free from risk factors should be extended to explicitly recommend against screening for thyroid cancer in similar populations of children and adolescents,” say the authors, led by Salvatore Vaccarella, PhD, of the International Agency for Research on Cancer, in Lyon, France.
The study was published online Jan. 19 in The Lancet Diabetes and Endocrinology.
In an accompanying comment, Livia Lamartina and colleagues from the department of nuclear medicine and endocrine oncology, Institut Gustave Roussy and the University Paris-Saclay, Villejuif, France, emphasize that unnecessary screening of thyroid cancer in children can have substantial implications.
“Overdiagnosis might transform a child into a thyroid cancer patient for the rest of their life, and overtreatment might induce complications and possibly lead to the requirement of lifelong thyroid hormone treatment,” they write.
“Therefore, screening with ultrasonography should not be recommended in asymptomatic children and adolescents,” they conclude.
Study findings
For the study, Dr. Vaccarella and colleagues evaluated the incidence of thyroid cancer in 49 countries and territories and mortality in 27 countries, using the most up-to-date data from the International Incidence of Childhood Cancer Volume 3 study, the Cancer in Five Continents database, and the World Health Organization mortality database.
Although there was considerable variability between countries, the incidence of thyroid cancer in children and adolescents aged 0-19 years increased rapidly between 1998 and 2002 and again between 2008 and 2012 in nearly all countries.
Country-specific incidence rates strongly correlated with rates in adults (r > 0.8), including the temporal aspects of the incidence rates (r > .0.6).
Of the 8049 thyroid cancers that were detected, 6935 (86.2%) were papillary carcinomas, 682 (8.5%) were follicular carcinomas, and 307 (3.8%) were medullary carcinomas, as determined on the basis of the WHO classification of thyroid carcinomas. Sixty-four tumors (0.8%) were of unspecified subtype. As is commonly observed in adults, rates were higher in girls than in boys and increased with older age for both sexes.
The strong correlation between children and adults in the timing of the increases in incidence was especially notable in countries where overdiagnosis has been identified as having a major role in the increasing thyroid cancer rates. Those countries are South Korea, the United States, Italy, France, and Australia, where 60%-90% of thyroid cancer diagnoses are attributable to overdiagnosis. Overall, the incidence of thyroid cancer was less than 1.5 per one million person-years in children younger than 10 years. There were small variations by country and sex.
Thyroid cancer mortalities remain low
Overall, the rate of thyroid cancer mortality among those younger than 20 years in each country was less than 0.1 per 10 million person-years, “corresponding to less than 10 deaths per year in all of the included countries collectively,” note Dr. Vaccarella and colleagues.
“The epidemiological pattern seen in children and adolescents mirrored that seen in adults. These findings suggest that, in affected countries and territories, there might be overdiagnosis in children and adolescents, as has been observed in adults,” they write.
The incidence of thyroid cancer in children and adolescents between 2008 and 2012 ranged from 0.4 per one million person-years in Uganda and Kenya and 13.4 per 1 million person-years in Belarus, where the increase is believed to be related to the Chernobyl nuclear power plant accident and to increased screening in the years following the accident.
Subclinical discoveries may lead to unnecessary measures
Thyroid cancer was once a rare condition. Rates began to increase steadily in the 1990s, corresponding with rapid advances in noninvasive diagnostic imaging. Currently, thyroid cancer is the fifth most diagnosed cancer worldwide in adult women and the third most common in women aged 50 years and younger.
Diagnostic measures ranging from ultrasound and MRI to fine-needle aspiration biopsy have played a large role in the increase in diagnoses. The diagnostic techniques are revealing subclinical cancers in thyroid glands that previously went undetected and that usually do not cause harm over a person’s lifetime. According to Dr. Vaccarella and colleagues, such discoveries can open the door to a wide range of unnecessary measures.
The possible consequences of overdiagnosis include unnecessary treatments, the need to undergo lifelong medical care, and potential adverse effects, which could negatively affect quality of life.
Recent research from the International Agency for Research on Cancer has indicated that there has been an “epidemic of overdiagnosis” of thyroid cancer. The pattern has even reached less affluent regions as diagnostic technologies have become widely available.
“What is surprising is the magnitude of this,” Dr. Vaccarella said in an interview.
“Without overdiagnosis, thyroid cancer would probably still be a relatively rare cancer,” he said.
The study authors have disclosed no relevant financial relationships. Dr. Lamartina has received personal, advisory board, and clinical trial principal investigator fees from Bayer, personal fees from Eisai, and clinical trial principal investigator fees from AstraZeneca. The other editorialists’ financial relationships are listed in the original article.
A version of this article first appeared on Medscape.com.
Medicaid to cover routine costs for patients in trials
A boost for patients with cancer and other serious illnesses.
Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.
A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.
Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.
“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.
Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.
“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
Equity issues
Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.
To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.
Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.
That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.
Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.
“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”
The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.
Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.
The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.
There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.
The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.
Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.
“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.
In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.
For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.
Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.
Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.
People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.
“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.
A version of this article first appeared on Medscape.com.
A boost for patients with cancer and other serious illnesses.
A boost for patients with cancer and other serious illnesses.
Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.
A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.
Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.
“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.
Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.
“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
Equity issues
Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.
To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.
Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.
That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.
Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.
“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”
The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.
Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.
The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.
There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.
The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.
Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.
“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.
In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.
For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.
Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.
Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.
People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.
“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.
A version of this article first appeared on Medscape.com.
Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.
A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.
Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.
“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.
Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.
“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
Equity issues
Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.
To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.
Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.
That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.
Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.
“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”
The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.
Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.
The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.
There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.
The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.
Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.
“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.
In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.
For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.
Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.
Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.
People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.
“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.
A version of this article first appeared on Medscape.com.
Reproductive Rounds: Fertility preservation options for cancer patients
What is more stressful in the mind of a patient – a diagnosis of cancer or infertility? An infertile woman’s anxiety and depression scores are equivalent to one with cancer (J Psychosom Obstet Gynecol. 1993;14 Suppl:45-52). These two diseases intersect in the burgeoning field of oncofertility, the collaboration of oncology with reproductive endocrinology to offer patients the option of fertility preservation. The term oncofertility was first coined by Teresa Woodruff, PhD, in 2005 during her invited lecture at the University of Calgary symposium called “Pushing the Boundaries – Advances that Will Change the World in 20 Years.” Her prediction has reached its fruition. This article will review fertility preservation options for female oncology patients.
The ability for oncofertility to exist is the result of improved cancer survival rates and advances in reproductive medicine. Improvements in the treatment of cancer enable many young women to survive and focus on the potential of having a family. Malignancies striking young people, particularly breast, lymphoma, and melanoma, have encouraging 5-year survival rates. If invasive cancer is located only in the breast (affecting 62% of women diagnosed), the 5-year survival rate is 99%. For all with Hodgkin lymphoma, the 5-year survival is 87%, increasing to 92% if the cancer is found in its earliest stages. Among all people with melanoma of the skin, from the time of initial diagnosis, the 5-year survival is 92%.
Long-term survival is expected for 80% of children and adolescents diagnosed with cancer (Obstet Gynecol. 2010;116: 1171-83).
Iatrogenic effects
The reproductive risk of cancer treatment is gonadotoxicity and the subsequent iatrogenic primary ovarian insufficiency (POI, prior termed premature ovarian failure) or infertility.
Chemotherapy with alkylating agents, such as cyclophosphamide, is associated with the greatest chance of amenorrhea (Breast Cancer Res Treat. 2014;145:113-28). Chemotherapy with cyclophosphamide, methotrexate, and 5 fluorouracil (CMF – commonly used for the treatment of breast cancer) will usually result in loss of ovarian function in 33% of women under age 30, 50% of women aged 30-35, 75% of women aged 35-40, and 95% of women over age 40 (J Clin Oncol. 2006;24:5769-79).
The dose at which 50% of oocytes are lost due to radiation is under 2 Gy (Hum Reprod. 2003;18:117-21). Unfortunately, the minimum dose decreases with advancing age of the woman, contributed by natural diminishing reserve and an increase in radiosensitivity of oocytes. Age, proximity of the radiation field to the ovaries, and total dose are important factors determining risk of POI. For brain tumors, cranial irradiation may result in hypothalamic amenorrhea.
Protection
The use of GnRH agonist for 6 months during chemotherapy has been controversial with mixed results in avoiding ovarian failure. A recent study suggests a GnRH agonist does reduce the prevalence of POI (J Clin Oncol. 2018;36:1981-90) in women treated for breast cancer but the subsequent ovarian reserve is low (Ann Oncol. 2017;28:1811-6). There are not enough data now to consider this the sole viable option for all patients to preserve fertility.
Patients requiring local pelvic radiation treatment may benefit from transposition of the ovaries to sites away from maximal radiation exposure.
Oocyte cryopreservation (OC) and ovarian tissue cryopreservation (OTC)
Since 2012, the American Society for Reproductive Medicine lifted the experimental designation on OC and, last year, the society removed the same label for OTC, providing an additional fertility preservation option.
Ovarian stimulation and egg retrieval for OC can now occur literally within 2 weeks because of a random start protocol whereby women are stimulated any day in their cycle, pre- and post ovulation. Studies have shown equivalent yield of oocytes.
OC followed by thawing for subsequent fertilization and embryo transfer is employed as a routine matter with egg donation cycles. While there remains debate over whether live birth rates using frozen eggs are inferior to fresh eggs, a learning curve with the new technology may be the important factor (Obstet Gynecol. 2020;135:709-16).
When urgent cancer treatment precludes ovarian stimulation for OC, then OTC is a viable option. Another population that could benefit from OTC are prepubertal girls facing gonadotoxic therapy. More research is required to determine the quality of eggs obtained through ovarian stimulation in adolescent and young adult patients. While leukemic patients are eligible for OTC, there is concern about reseeding malignant cells with future autologous transplantation of tissue.
OTC involves obtaining ovarian cortical tissue, dissecting the tissue into small fragments, and cryopreserving it using either a slow-cool technique or vitrification. Orthotopic transplantation has been the most successful method for using ovarian tissue in humans. To date, live birth rates are modest (Fertil Steril. 2015;104:1097-8).
Recent research has combined the freezing of both mature and immature eggs, the latter undergoing IVM (in-vitro maturation) to maximize the potential for fertilizable eggs. Women with polycystic ovary syndrome and certain cancers or medical conditions that warrant avoiding supraphysiologic levels of estradiol from ovarian stimulation, may benefit from the retrieval of immature eggs from unstimulated ovaries.
Pregnancy outcomes using embryos created from ovaries recently exposed to chemotherapy in humans are not known but animal studies suggest there may be higher rates of miscarriage and birth defects.
Breast cancer – a special scenario
With every breast cancer patient, I review the theoretical concern over increasing estradiol levels during an IVF stimulation cycle with the potential impact on her cancer prognosis. Fortunately, the literature has not demonstrated an increased risk of breast cancer or recurrence after undergoing an IVF cycle. Currently, the use of aromatase inhibitors with gonadotropins along with a GnRH-antagonist is the protocol to maintain a lower estradiol level during stimulation, which may be of benefit for breast cancer prognosis. The use of aromatase inhibitors is an off-label indication for fertility with no definitive evidence of teratogenicity. Preimplantation genetic testing of embryos is available and approved by the American Society for Reproductive Medicine for BRCA gene mutation patients.
Oncofertility is an exciting field to allow cancer survivors the option for a biological child. We recommend all our cancer patients meet with our reproductive psychologist to assist in coping with the overwhelming information presented in a short time frame.
Dr. Trolice is director of Fertility CARE – The IVF Center in Winter Park, Fla., and associate professor of obstetrics and gynecology at the University of Central Florida, Orlando.
What is more stressful in the mind of a patient – a diagnosis of cancer or infertility? An infertile woman’s anxiety and depression scores are equivalent to one with cancer (J Psychosom Obstet Gynecol. 1993;14 Suppl:45-52). These two diseases intersect in the burgeoning field of oncofertility, the collaboration of oncology with reproductive endocrinology to offer patients the option of fertility preservation. The term oncofertility was first coined by Teresa Woodruff, PhD, in 2005 during her invited lecture at the University of Calgary symposium called “Pushing the Boundaries – Advances that Will Change the World in 20 Years.” Her prediction has reached its fruition. This article will review fertility preservation options for female oncology patients.
The ability for oncofertility to exist is the result of improved cancer survival rates and advances in reproductive medicine. Improvements in the treatment of cancer enable many young women to survive and focus on the potential of having a family. Malignancies striking young people, particularly breast, lymphoma, and melanoma, have encouraging 5-year survival rates. If invasive cancer is located only in the breast (affecting 62% of women diagnosed), the 5-year survival rate is 99%. For all with Hodgkin lymphoma, the 5-year survival is 87%, increasing to 92% if the cancer is found in its earliest stages. Among all people with melanoma of the skin, from the time of initial diagnosis, the 5-year survival is 92%.
Long-term survival is expected for 80% of children and adolescents diagnosed with cancer (Obstet Gynecol. 2010;116: 1171-83).
Iatrogenic effects
The reproductive risk of cancer treatment is gonadotoxicity and the subsequent iatrogenic primary ovarian insufficiency (POI, prior termed premature ovarian failure) or infertility.
Chemotherapy with alkylating agents, such as cyclophosphamide, is associated with the greatest chance of amenorrhea (Breast Cancer Res Treat. 2014;145:113-28). Chemotherapy with cyclophosphamide, methotrexate, and 5 fluorouracil (CMF – commonly used for the treatment of breast cancer) will usually result in loss of ovarian function in 33% of women under age 30, 50% of women aged 30-35, 75% of women aged 35-40, and 95% of women over age 40 (J Clin Oncol. 2006;24:5769-79).
The dose at which 50% of oocytes are lost due to radiation is under 2 Gy (Hum Reprod. 2003;18:117-21). Unfortunately, the minimum dose decreases with advancing age of the woman, contributed by natural diminishing reserve and an increase in radiosensitivity of oocytes. Age, proximity of the radiation field to the ovaries, and total dose are important factors determining risk of POI. For brain tumors, cranial irradiation may result in hypothalamic amenorrhea.
Protection
The use of GnRH agonist for 6 months during chemotherapy has been controversial with mixed results in avoiding ovarian failure. A recent study suggests a GnRH agonist does reduce the prevalence of POI (J Clin Oncol. 2018;36:1981-90) in women treated for breast cancer but the subsequent ovarian reserve is low (Ann Oncol. 2017;28:1811-6). There are not enough data now to consider this the sole viable option for all patients to preserve fertility.
Patients requiring local pelvic radiation treatment may benefit from transposition of the ovaries to sites away from maximal radiation exposure.
Oocyte cryopreservation (OC) and ovarian tissue cryopreservation (OTC)
Since 2012, the American Society for Reproductive Medicine lifted the experimental designation on OC and, last year, the society removed the same label for OTC, providing an additional fertility preservation option.
Ovarian stimulation and egg retrieval for OC can now occur literally within 2 weeks because of a random start protocol whereby women are stimulated any day in their cycle, pre- and post ovulation. Studies have shown equivalent yield of oocytes.
OC followed by thawing for subsequent fertilization and embryo transfer is employed as a routine matter with egg donation cycles. While there remains debate over whether live birth rates using frozen eggs are inferior to fresh eggs, a learning curve with the new technology may be the important factor (Obstet Gynecol. 2020;135:709-16).
When urgent cancer treatment precludes ovarian stimulation for OC, then OTC is a viable option. Another population that could benefit from OTC are prepubertal girls facing gonadotoxic therapy. More research is required to determine the quality of eggs obtained through ovarian stimulation in adolescent and young adult patients. While leukemic patients are eligible for OTC, there is concern about reseeding malignant cells with future autologous transplantation of tissue.
OTC involves obtaining ovarian cortical tissue, dissecting the tissue into small fragments, and cryopreserving it using either a slow-cool technique or vitrification. Orthotopic transplantation has been the most successful method for using ovarian tissue in humans. To date, live birth rates are modest (Fertil Steril. 2015;104:1097-8).
Recent research has combined the freezing of both mature and immature eggs, the latter undergoing IVM (in-vitro maturation) to maximize the potential for fertilizable eggs. Women with polycystic ovary syndrome and certain cancers or medical conditions that warrant avoiding supraphysiologic levels of estradiol from ovarian stimulation, may benefit from the retrieval of immature eggs from unstimulated ovaries.
Pregnancy outcomes using embryos created from ovaries recently exposed to chemotherapy in humans are not known but animal studies suggest there may be higher rates of miscarriage and birth defects.
Breast cancer – a special scenario
With every breast cancer patient, I review the theoretical concern over increasing estradiol levels during an IVF stimulation cycle with the potential impact on her cancer prognosis. Fortunately, the literature has not demonstrated an increased risk of breast cancer or recurrence after undergoing an IVF cycle. Currently, the use of aromatase inhibitors with gonadotropins along with a GnRH-antagonist is the protocol to maintain a lower estradiol level during stimulation, which may be of benefit for breast cancer prognosis. The use of aromatase inhibitors is an off-label indication for fertility with no definitive evidence of teratogenicity. Preimplantation genetic testing of embryos is available and approved by the American Society for Reproductive Medicine for BRCA gene mutation patients.
Oncofertility is an exciting field to allow cancer survivors the option for a biological child. We recommend all our cancer patients meet with our reproductive psychologist to assist in coping with the overwhelming information presented in a short time frame.
Dr. Trolice is director of Fertility CARE – The IVF Center in Winter Park, Fla., and associate professor of obstetrics and gynecology at the University of Central Florida, Orlando.
What is more stressful in the mind of a patient – a diagnosis of cancer or infertility? An infertile woman’s anxiety and depression scores are equivalent to one with cancer (J Psychosom Obstet Gynecol. 1993;14 Suppl:45-52). These two diseases intersect in the burgeoning field of oncofertility, the collaboration of oncology with reproductive endocrinology to offer patients the option of fertility preservation. The term oncofertility was first coined by Teresa Woodruff, PhD, in 2005 during her invited lecture at the University of Calgary symposium called “Pushing the Boundaries – Advances that Will Change the World in 20 Years.” Her prediction has reached its fruition. This article will review fertility preservation options for female oncology patients.
The ability for oncofertility to exist is the result of improved cancer survival rates and advances in reproductive medicine. Improvements in the treatment of cancer enable many young women to survive and focus on the potential of having a family. Malignancies striking young people, particularly breast, lymphoma, and melanoma, have encouraging 5-year survival rates. If invasive cancer is located only in the breast (affecting 62% of women diagnosed), the 5-year survival rate is 99%. For all with Hodgkin lymphoma, the 5-year survival is 87%, increasing to 92% if the cancer is found in its earliest stages. Among all people with melanoma of the skin, from the time of initial diagnosis, the 5-year survival is 92%.
Long-term survival is expected for 80% of children and adolescents diagnosed with cancer (Obstet Gynecol. 2010;116: 1171-83).
Iatrogenic effects
The reproductive risk of cancer treatment is gonadotoxicity and the subsequent iatrogenic primary ovarian insufficiency (POI, prior termed premature ovarian failure) or infertility.
Chemotherapy with alkylating agents, such as cyclophosphamide, is associated with the greatest chance of amenorrhea (Breast Cancer Res Treat. 2014;145:113-28). Chemotherapy with cyclophosphamide, methotrexate, and 5 fluorouracil (CMF – commonly used for the treatment of breast cancer) will usually result in loss of ovarian function in 33% of women under age 30, 50% of women aged 30-35, 75% of women aged 35-40, and 95% of women over age 40 (J Clin Oncol. 2006;24:5769-79).
The dose at which 50% of oocytes are lost due to radiation is under 2 Gy (Hum Reprod. 2003;18:117-21). Unfortunately, the minimum dose decreases with advancing age of the woman, contributed by natural diminishing reserve and an increase in radiosensitivity of oocytes. Age, proximity of the radiation field to the ovaries, and total dose are important factors determining risk of POI. For brain tumors, cranial irradiation may result in hypothalamic amenorrhea.
Protection
The use of GnRH agonist for 6 months during chemotherapy has been controversial with mixed results in avoiding ovarian failure. A recent study suggests a GnRH agonist does reduce the prevalence of POI (J Clin Oncol. 2018;36:1981-90) in women treated for breast cancer but the subsequent ovarian reserve is low (Ann Oncol. 2017;28:1811-6). There are not enough data now to consider this the sole viable option for all patients to preserve fertility.
Patients requiring local pelvic radiation treatment may benefit from transposition of the ovaries to sites away from maximal radiation exposure.
Oocyte cryopreservation (OC) and ovarian tissue cryopreservation (OTC)
Since 2012, the American Society for Reproductive Medicine lifted the experimental designation on OC and, last year, the society removed the same label for OTC, providing an additional fertility preservation option.
Ovarian stimulation and egg retrieval for OC can now occur literally within 2 weeks because of a random start protocol whereby women are stimulated any day in their cycle, pre- and post ovulation. Studies have shown equivalent yield of oocytes.
OC followed by thawing for subsequent fertilization and embryo transfer is employed as a routine matter with egg donation cycles. While there remains debate over whether live birth rates using frozen eggs are inferior to fresh eggs, a learning curve with the new technology may be the important factor (Obstet Gynecol. 2020;135:709-16).
When urgent cancer treatment precludes ovarian stimulation for OC, then OTC is a viable option. Another population that could benefit from OTC are prepubertal girls facing gonadotoxic therapy. More research is required to determine the quality of eggs obtained through ovarian stimulation in adolescent and young adult patients. While leukemic patients are eligible for OTC, there is concern about reseeding malignant cells with future autologous transplantation of tissue.
OTC involves obtaining ovarian cortical tissue, dissecting the tissue into small fragments, and cryopreserving it using either a slow-cool technique or vitrification. Orthotopic transplantation has been the most successful method for using ovarian tissue in humans. To date, live birth rates are modest (Fertil Steril. 2015;104:1097-8).
Recent research has combined the freezing of both mature and immature eggs, the latter undergoing IVM (in-vitro maturation) to maximize the potential for fertilizable eggs. Women with polycystic ovary syndrome and certain cancers or medical conditions that warrant avoiding supraphysiologic levels of estradiol from ovarian stimulation, may benefit from the retrieval of immature eggs from unstimulated ovaries.
Pregnancy outcomes using embryos created from ovaries recently exposed to chemotherapy in humans are not known but animal studies suggest there may be higher rates of miscarriage and birth defects.
Breast cancer – a special scenario
With every breast cancer patient, I review the theoretical concern over increasing estradiol levels during an IVF stimulation cycle with the potential impact on her cancer prognosis. Fortunately, the literature has not demonstrated an increased risk of breast cancer or recurrence after undergoing an IVF cycle. Currently, the use of aromatase inhibitors with gonadotropins along with a GnRH-antagonist is the protocol to maintain a lower estradiol level during stimulation, which may be of benefit for breast cancer prognosis. The use of aromatase inhibitors is an off-label indication for fertility with no definitive evidence of teratogenicity. Preimplantation genetic testing of embryos is available and approved by the American Society for Reproductive Medicine for BRCA gene mutation patients.
Oncofertility is an exciting field to allow cancer survivors the option for a biological child. We recommend all our cancer patients meet with our reproductive psychologist to assist in coping with the overwhelming information presented in a short time frame.
Dr. Trolice is director of Fertility CARE – The IVF Center in Winter Park, Fla., and associate professor of obstetrics and gynecology at the University of Central Florida, Orlando.
COVID-19 vaccines and cancer patients: 4 things to know
Earlier this week, Medscape spoke with Nora Disis, MD, about vaccinating cancer patients. Disis is a medical oncologist and director of both the Institute of Translational Health Sciences and the Cancer Vaccine Institute, the University of Washington, Seattle, Washington. As editor-in-chief of JAMA Oncology, she has watched COVID-19 developments in the oncology community over the past year.
Here are a few themes that Disis said oncologists should be aware of as vaccines eventually begin reaching cancer patients.
We should expect cancer patients to respond to vaccines. Historically, some believed that cancer patients would be unable to mount an immune response to vaccines. Data on other viral vaccines have shown otherwise. For example, there has been a long history of studies of flu vaccination in cancer patients, and in general, those vaccines confer protection. Likewise for pneumococcal vaccine, which, generally speaking, cancer patients should receive.
Special cases may include hematologic malignancies in which the immune system has been destroyed and profound immunosuppression occurs. Data on immunization during this immunosuppressed period are scarce, but what data are available suggest that once cancer patients are through this immunosuppressed period, they can be vaccinated successfully.
The type of vaccine will probably be important for cancer patients. Currently, there are 61 coronavirus vaccines in human clinical trials, and 17 have reached the final stages of testing. At least 85 preclinical vaccines are under active investigation in animals.
Both the Pfizer-BioNTech and Moderna COVID vaccines are mRNA type. There are many other types, including protein-based vaccines, viral vector vaccines based on adenoviruses, and inactivated or attenuated coronavirus vaccines.
The latter vaccines, particularly attenuated live virus vaccines, may not be a good choice for cancer patients. Especially in those with rapidly progressing disease or on chemotherapy, attenuated live viruses may cause a low-grade infection.
Incidentally, the technology used in the genetic, or mRNA, vaccines developed by both Pfizer-BioNTech and Moderna was initially developed for fighting cancer, and studies have shown that patients can generate immune responses to cancer-associated proteins with this type of vaccine.
These genetic vaccines could turn out to be the most effective for cancer patients, especially those with solid tumors.
Our understanding is very limited right now. Neither the Pfizer-BioNTech nor the Moderna early data discuss cancer patients. Two of the most important questions for cancer patients are dosing and booster scheduling. Potential defects in lymphocyte function among cancer patients may require unique initial dosing and booster schedules. In terms of timing, it is unclear how active therapy might affect a patient’s immune response to vaccination and whether vaccines should be timed with therapy cycles.
Vaccine access may depend on whether cancer patients are viewed as a vulnerable population. Those at higher risk for severe COVID-19 clearly have a greater need for vaccination. While there are data suggesting that cancer patients are at higher risk, they are a bit murky, in part because cancer patients are a heterogeneous group. For example, there are data suggesting that lung and blood cancer patients fare worse. There is also a suggestion that, like in the general population, COVID risk in cancer patients remains driven by comorbidities.
It is likely, then, that personalized risk factors such as type of cancer therapy, site of disease, and comorbidities will shape individual choices about vaccination among cancer patients.
A version of this article first appeared on Medscape.com.
Earlier this week, Medscape spoke with Nora Disis, MD, about vaccinating cancer patients. Disis is a medical oncologist and director of both the Institute of Translational Health Sciences and the Cancer Vaccine Institute, the University of Washington, Seattle, Washington. As editor-in-chief of JAMA Oncology, she has watched COVID-19 developments in the oncology community over the past year.
Here are a few themes that Disis said oncologists should be aware of as vaccines eventually begin reaching cancer patients.
We should expect cancer patients to respond to vaccines. Historically, some believed that cancer patients would be unable to mount an immune response to vaccines. Data on other viral vaccines have shown otherwise. For example, there has been a long history of studies of flu vaccination in cancer patients, and in general, those vaccines confer protection. Likewise for pneumococcal vaccine, which, generally speaking, cancer patients should receive.
Special cases may include hematologic malignancies in which the immune system has been destroyed and profound immunosuppression occurs. Data on immunization during this immunosuppressed period are scarce, but what data are available suggest that once cancer patients are through this immunosuppressed period, they can be vaccinated successfully.
The type of vaccine will probably be important for cancer patients. Currently, there are 61 coronavirus vaccines in human clinical trials, and 17 have reached the final stages of testing. At least 85 preclinical vaccines are under active investigation in animals.
Both the Pfizer-BioNTech and Moderna COVID vaccines are mRNA type. There are many other types, including protein-based vaccines, viral vector vaccines based on adenoviruses, and inactivated or attenuated coronavirus vaccines.
The latter vaccines, particularly attenuated live virus vaccines, may not be a good choice for cancer patients. Especially in those with rapidly progressing disease or on chemotherapy, attenuated live viruses may cause a low-grade infection.
Incidentally, the technology used in the genetic, or mRNA, vaccines developed by both Pfizer-BioNTech and Moderna was initially developed for fighting cancer, and studies have shown that patients can generate immune responses to cancer-associated proteins with this type of vaccine.
These genetic vaccines could turn out to be the most effective for cancer patients, especially those with solid tumors.
Our understanding is very limited right now. Neither the Pfizer-BioNTech nor the Moderna early data discuss cancer patients. Two of the most important questions for cancer patients are dosing and booster scheduling. Potential defects in lymphocyte function among cancer patients may require unique initial dosing and booster schedules. In terms of timing, it is unclear how active therapy might affect a patient’s immune response to vaccination and whether vaccines should be timed with therapy cycles.
Vaccine access may depend on whether cancer patients are viewed as a vulnerable population. Those at higher risk for severe COVID-19 clearly have a greater need for vaccination. While there are data suggesting that cancer patients are at higher risk, they are a bit murky, in part because cancer patients are a heterogeneous group. For example, there are data suggesting that lung and blood cancer patients fare worse. There is also a suggestion that, like in the general population, COVID risk in cancer patients remains driven by comorbidities.
It is likely, then, that personalized risk factors such as type of cancer therapy, site of disease, and comorbidities will shape individual choices about vaccination among cancer patients.
A version of this article first appeared on Medscape.com.
Earlier this week, Medscape spoke with Nora Disis, MD, about vaccinating cancer patients. Disis is a medical oncologist and director of both the Institute of Translational Health Sciences and the Cancer Vaccine Institute, the University of Washington, Seattle, Washington. As editor-in-chief of JAMA Oncology, she has watched COVID-19 developments in the oncology community over the past year.
Here are a few themes that Disis said oncologists should be aware of as vaccines eventually begin reaching cancer patients.
We should expect cancer patients to respond to vaccines. Historically, some believed that cancer patients would be unable to mount an immune response to vaccines. Data on other viral vaccines have shown otherwise. For example, there has been a long history of studies of flu vaccination in cancer patients, and in general, those vaccines confer protection. Likewise for pneumococcal vaccine, which, generally speaking, cancer patients should receive.
Special cases may include hematologic malignancies in which the immune system has been destroyed and profound immunosuppression occurs. Data on immunization during this immunosuppressed period are scarce, but what data are available suggest that once cancer patients are through this immunosuppressed period, they can be vaccinated successfully.
The type of vaccine will probably be important for cancer patients. Currently, there are 61 coronavirus vaccines in human clinical trials, and 17 have reached the final stages of testing. At least 85 preclinical vaccines are under active investigation in animals.
Both the Pfizer-BioNTech and Moderna COVID vaccines are mRNA type. There are many other types, including protein-based vaccines, viral vector vaccines based on adenoviruses, and inactivated or attenuated coronavirus vaccines.
The latter vaccines, particularly attenuated live virus vaccines, may not be a good choice for cancer patients. Especially in those with rapidly progressing disease or on chemotherapy, attenuated live viruses may cause a low-grade infection.
Incidentally, the technology used in the genetic, or mRNA, vaccines developed by both Pfizer-BioNTech and Moderna was initially developed for fighting cancer, and studies have shown that patients can generate immune responses to cancer-associated proteins with this type of vaccine.
These genetic vaccines could turn out to be the most effective for cancer patients, especially those with solid tumors.
Our understanding is very limited right now. Neither the Pfizer-BioNTech nor the Moderna early data discuss cancer patients. Two of the most important questions for cancer patients are dosing and booster scheduling. Potential defects in lymphocyte function among cancer patients may require unique initial dosing and booster schedules. In terms of timing, it is unclear how active therapy might affect a patient’s immune response to vaccination and whether vaccines should be timed with therapy cycles.
Vaccine access may depend on whether cancer patients are viewed as a vulnerable population. Those at higher risk for severe COVID-19 clearly have a greater need for vaccination. While there are data suggesting that cancer patients are at higher risk, they are a bit murky, in part because cancer patients are a heterogeneous group. For example, there are data suggesting that lung and blood cancer patients fare worse. There is also a suggestion that, like in the general population, COVID risk in cancer patients remains driven by comorbidities.
It is likely, then, that personalized risk factors such as type of cancer therapy, site of disease, and comorbidities will shape individual choices about vaccination among cancer patients.
A version of this article first appeared on Medscape.com.