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The Use of Aromatherapy as a Complementary Alternative Medicine in the Management of Cancer-Related Pain

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Purpose

To identify the effectiveness of aromatherapy as an adjunct in improving pain and overall sense of well-being among patients with cancer receiving hospice care.

Background

There is limited data available on the use of aromatherapy for pain management among patients with cancer receiving end-of-life care. This project identifies the benefits of aromatherapy in a population where it was not previously evaluated.

Methods

Patients with cancer who were admitted to the hospice unit of a local hospital within a large healthcare system for at least 24 hours and taking opioids for neoplasm related pain at least once a day were included in the study. Patients with allergy to essential oils, and those suffering from allergic rhinitis and common cold, and a history of asthma were excluded. Patients who were unable to consent for study participation were also excluded.

Data Analysis

Retrospective chart analysis and surveys were used to collect the data. Univariate descriptive statistics were used for patient characteristics. A Wilcoxon Signed Rank Test was used to determine opioid use before and after aromatherapy. The t test was used to compare pain scores before and after aromatherapy. A 5-point Likert scale was used to evaluate how soothing the participants found the treatment to be. The Numeric Pain Intensity Scale was used for pain scores.

Results

There was a total of 40 participants, all of whom were male with an average age of 69 years. Pain scores before and after treatment were found to be statistically significant at an average of 5.15/10 vs 3.68/10, respectively. On a scale from 1-5 with 5 being the most soothing, there was an average rating of 3.87 among participants. There was not a statistically significant decline in opioid use from pre-treatment to post-treatment. Higher pain scores before intervention were associated with rating the lotion as more soothing.

Conclusions

The use of aromatherapy as a complement to opioids for cancer-related pain in the end-of-life was associated with an increase sense of well-being, resulted in lower pain scores and seems to have subjective comfort merit.

Implications

This study shows the potential benefits of using aromatherapy in end-of-life care among patients with cancer.

 

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Purpose

To identify the effectiveness of aromatherapy as an adjunct in improving pain and overall sense of well-being among patients with cancer receiving hospice care.

Background

There is limited data available on the use of aromatherapy for pain management among patients with cancer receiving end-of-life care. This project identifies the benefits of aromatherapy in a population where it was not previously evaluated.

Methods

Patients with cancer who were admitted to the hospice unit of a local hospital within a large healthcare system for at least 24 hours and taking opioids for neoplasm related pain at least once a day were included in the study. Patients with allergy to essential oils, and those suffering from allergic rhinitis and common cold, and a history of asthma were excluded. Patients who were unable to consent for study participation were also excluded.

Data Analysis

Retrospective chart analysis and surveys were used to collect the data. Univariate descriptive statistics were used for patient characteristics. A Wilcoxon Signed Rank Test was used to determine opioid use before and after aromatherapy. The t test was used to compare pain scores before and after aromatherapy. A 5-point Likert scale was used to evaluate how soothing the participants found the treatment to be. The Numeric Pain Intensity Scale was used for pain scores.

Results

There was a total of 40 participants, all of whom were male with an average age of 69 years. Pain scores before and after treatment were found to be statistically significant at an average of 5.15/10 vs 3.68/10, respectively. On a scale from 1-5 with 5 being the most soothing, there was an average rating of 3.87 among participants. There was not a statistically significant decline in opioid use from pre-treatment to post-treatment. Higher pain scores before intervention were associated with rating the lotion as more soothing.

Conclusions

The use of aromatherapy as a complement to opioids for cancer-related pain in the end-of-life was associated with an increase sense of well-being, resulted in lower pain scores and seems to have subjective comfort merit.

Implications

This study shows the potential benefits of using aromatherapy in end-of-life care among patients with cancer.

 

Purpose

To identify the effectiveness of aromatherapy as an adjunct in improving pain and overall sense of well-being among patients with cancer receiving hospice care.

Background

There is limited data available on the use of aromatherapy for pain management among patients with cancer receiving end-of-life care. This project identifies the benefits of aromatherapy in a population where it was not previously evaluated.

Methods

Patients with cancer who were admitted to the hospice unit of a local hospital within a large healthcare system for at least 24 hours and taking opioids for neoplasm related pain at least once a day were included in the study. Patients with allergy to essential oils, and those suffering from allergic rhinitis and common cold, and a history of asthma were excluded. Patients who were unable to consent for study participation were also excluded.

Data Analysis

Retrospective chart analysis and surveys were used to collect the data. Univariate descriptive statistics were used for patient characteristics. A Wilcoxon Signed Rank Test was used to determine opioid use before and after aromatherapy. The t test was used to compare pain scores before and after aromatherapy. A 5-point Likert scale was used to evaluate how soothing the participants found the treatment to be. The Numeric Pain Intensity Scale was used for pain scores.

Results

There was a total of 40 participants, all of whom were male with an average age of 69 years. Pain scores before and after treatment were found to be statistically significant at an average of 5.15/10 vs 3.68/10, respectively. On a scale from 1-5 with 5 being the most soothing, there was an average rating of 3.87 among participants. There was not a statistically significant decline in opioid use from pre-treatment to post-treatment. Higher pain scores before intervention were associated with rating the lotion as more soothing.

Conclusions

The use of aromatherapy as a complement to opioids for cancer-related pain in the end-of-life was associated with an increase sense of well-being, resulted in lower pain scores and seems to have subjective comfort merit.

Implications

This study shows the potential benefits of using aromatherapy in end-of-life care among patients with cancer.

 

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Academic/Research Facility Utilization and Survival Outcomes in Osteosarcoma: An NCDB Analysis

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Background

Previous studies have reported that treatment at academic/research facilities is associated with improved survival in cancer patients. The objective of this study was to investigate the impact of treatment facility type on overall survival for patients presenting with osteosarcoma.

Methods

The National Cancer Database (NCDB) was used to identify patients diagnosed with Osteosarcoma from 2004 to 2018. Facility types were identified as assigned by the Commission on Cancer Accreditation program. Data was analyzed using SPSS and statistical significance was set at P = .05.

Results

Of 2085 patients queried, 39.6% were treated at an academic/research program. The stage-adjusted difference in median survival between academic/research and non-academic programs was found to be statistically significant on log-rank comparison (P < .001). At each NCDB analytic stage (stage I-IV), academic/research programs were associated with decreased hazard and improved median survival. A Cox proportional hazards model showed a decreased likelihood of mortality in patients with osteosarcoma who underwent treatment at an academic/research program (HR, 0.882; 95% CI, .802-.969; P = .009). Chi-square testing revealed that patients at academic/research programs were more likely than those at non-academic/research centers to have private insurance, less likely to have Medicare, and more likely to live in counties of > 1 million people. These facilities were also more likely to have undergone Medicaid expansion in 2014. (P < .05). Patients at non-academic/research programs were more likely to have advanced disease (stage III and IV) and higher comorbidity scores. Additionally, they were less likely to receive surgery and/or chemotherapy at the institution in which they were diagnosed. (P < .05).

Conclusions

This study showed that Osteosarcoma patients treated in an academic/research program facility experienced increased survival compared with non-academic/research facilities. Patients at academic/research facilities tend to have less comorbidities, have private insurance, and present with more treatable disease. Despite these favorable prognostic factors, the data suggest an intrinsic benefit to being treated at an academic/research facility.

 

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Background

Previous studies have reported that treatment at academic/research facilities is associated with improved survival in cancer patients. The objective of this study was to investigate the impact of treatment facility type on overall survival for patients presenting with osteosarcoma.

Methods

The National Cancer Database (NCDB) was used to identify patients diagnosed with Osteosarcoma from 2004 to 2018. Facility types were identified as assigned by the Commission on Cancer Accreditation program. Data was analyzed using SPSS and statistical significance was set at P = .05.

Results

Of 2085 patients queried, 39.6% were treated at an academic/research program. The stage-adjusted difference in median survival between academic/research and non-academic programs was found to be statistically significant on log-rank comparison (P < .001). At each NCDB analytic stage (stage I-IV), academic/research programs were associated with decreased hazard and improved median survival. A Cox proportional hazards model showed a decreased likelihood of mortality in patients with osteosarcoma who underwent treatment at an academic/research program (HR, 0.882; 95% CI, .802-.969; P = .009). Chi-square testing revealed that patients at academic/research programs were more likely than those at non-academic/research centers to have private insurance, less likely to have Medicare, and more likely to live in counties of > 1 million people. These facilities were also more likely to have undergone Medicaid expansion in 2014. (P < .05). Patients at non-academic/research programs were more likely to have advanced disease (stage III and IV) and higher comorbidity scores. Additionally, they were less likely to receive surgery and/or chemotherapy at the institution in which they were diagnosed. (P < .05).

Conclusions

This study showed that Osteosarcoma patients treated in an academic/research program facility experienced increased survival compared with non-academic/research facilities. Patients at academic/research facilities tend to have less comorbidities, have private insurance, and present with more treatable disease. Despite these favorable prognostic factors, the data suggest an intrinsic benefit to being treated at an academic/research facility.

 

Background

Previous studies have reported that treatment at academic/research facilities is associated with improved survival in cancer patients. The objective of this study was to investigate the impact of treatment facility type on overall survival for patients presenting with osteosarcoma.

Methods

The National Cancer Database (NCDB) was used to identify patients diagnosed with Osteosarcoma from 2004 to 2018. Facility types were identified as assigned by the Commission on Cancer Accreditation program. Data was analyzed using SPSS and statistical significance was set at P = .05.

Results

Of 2085 patients queried, 39.6% were treated at an academic/research program. The stage-adjusted difference in median survival between academic/research and non-academic programs was found to be statistically significant on log-rank comparison (P < .001). At each NCDB analytic stage (stage I-IV), academic/research programs were associated with decreased hazard and improved median survival. A Cox proportional hazards model showed a decreased likelihood of mortality in patients with osteosarcoma who underwent treatment at an academic/research program (HR, 0.882; 95% CI, .802-.969; P = .009). Chi-square testing revealed that patients at academic/research programs were more likely than those at non-academic/research centers to have private insurance, less likely to have Medicare, and more likely to live in counties of > 1 million people. These facilities were also more likely to have undergone Medicaid expansion in 2014. (P < .05). Patients at non-academic/research programs were more likely to have advanced disease (stage III and IV) and higher comorbidity scores. Additionally, they were less likely to receive surgery and/or chemotherapy at the institution in which they were diagnosed. (P < .05).

Conclusions

This study showed that Osteosarcoma patients treated in an academic/research program facility experienced increased survival compared with non-academic/research facilities. Patients at academic/research facilities tend to have less comorbidities, have private insurance, and present with more treatable disease. Despite these favorable prognostic factors, the data suggest an intrinsic benefit to being treated at an academic/research facility.

 

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Development of an Informatics Infrastructure and Frontend Dashboard for Monitoring Clinical Operations of the National TeleOncology Service

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Background

Since inception, the Veterans Affairs (VA) National TeleOncology (NTO) service has monitored clinical operations through data tools produced by the Veterans Health Administration Support Service Center (VSSC). Unfortunately, pertinent data are spread across multiple reports, making it difficult to continually harmonize needed information. Further, the VSSC does not account for NTO’s hub and spoke clinical model, leading to inaccuracies when attempting to analyze unique encounters. To address these challenges, NTO partnered with the VA Salt Lake City Health Care System Informatics, Decision-Enhancement, and Analytic Sciences Center (IDEAS) to develop an informatics architecture and frontend NTO Clinical Operations Dashboard (NCOD). Here, we summarize our dashboard development process and the finalized key reporting components of the NCOD.

Methods

The VA Corporate Data Warehouse (CDW) serves as the primary data source for the NCOD. SQL Server Integration Services was used to build the backend data architecture. Data from the CDW were isolated into a staging data mart for reporting purposes using an extract, transform, load (ETL) approach. The frontend user interface was developed using Power BI. We used a participatory approach1 in determining reporting requirements. Stakeholders included the IDEAS dashboard development team and potential end users from NTO, including leadership, program managers, support assistants, and telehealth coordinators.

Results

The NCOD ETL is scheduled to refresh the data nightly to provide end users with a near real-time experience. The NCOD is comprised of the following four data views: clinic availability, team productivity, patient summary, and encounter summary. The clinic availability view summarizes clinic capacity, no shows, overbookings, and percent utilization. Relative value unit- based productivity is summarized in the team productivity view. The patient summary view presents aggregated data for veterans served by NTO, including geographic distribution, with patient-level drill down displaying demographics, cancer characteristics, and treatment history. Lastly, the encounter view displays utilization trends by modality, while accurately accounting for the hub and spoke clinical model.

Conclusions

An informatics architecture and frontend information display that is capable of synthesizing EHR data into a consumable format has been pivotal in obtaining accurate and timely insight into the demand and capacity of services provided by NTO.

References
  1. Esquer Rochin MA, Gutierrez-Garcia JO, Rosales JH, Rodriguez LF. Design and evaluation of a dashboard to support the comprehension of the progression.
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Background

Since inception, the Veterans Affairs (VA) National TeleOncology (NTO) service has monitored clinical operations through data tools produced by the Veterans Health Administration Support Service Center (VSSC). Unfortunately, pertinent data are spread across multiple reports, making it difficult to continually harmonize needed information. Further, the VSSC does not account for NTO’s hub and spoke clinical model, leading to inaccuracies when attempting to analyze unique encounters. To address these challenges, NTO partnered with the VA Salt Lake City Health Care System Informatics, Decision-Enhancement, and Analytic Sciences Center (IDEAS) to develop an informatics architecture and frontend NTO Clinical Operations Dashboard (NCOD). Here, we summarize our dashboard development process and the finalized key reporting components of the NCOD.

Methods

The VA Corporate Data Warehouse (CDW) serves as the primary data source for the NCOD. SQL Server Integration Services was used to build the backend data architecture. Data from the CDW were isolated into a staging data mart for reporting purposes using an extract, transform, load (ETL) approach. The frontend user interface was developed using Power BI. We used a participatory approach1 in determining reporting requirements. Stakeholders included the IDEAS dashboard development team and potential end users from NTO, including leadership, program managers, support assistants, and telehealth coordinators.

Results

The NCOD ETL is scheduled to refresh the data nightly to provide end users with a near real-time experience. The NCOD is comprised of the following four data views: clinic availability, team productivity, patient summary, and encounter summary. The clinic availability view summarizes clinic capacity, no shows, overbookings, and percent utilization. Relative value unit- based productivity is summarized in the team productivity view. The patient summary view presents aggregated data for veterans served by NTO, including geographic distribution, with patient-level drill down displaying demographics, cancer characteristics, and treatment history. Lastly, the encounter view displays utilization trends by modality, while accurately accounting for the hub and spoke clinical model.

Conclusions

An informatics architecture and frontend information display that is capable of synthesizing EHR data into a consumable format has been pivotal in obtaining accurate and timely insight into the demand and capacity of services provided by NTO.

Background

Since inception, the Veterans Affairs (VA) National TeleOncology (NTO) service has monitored clinical operations through data tools produced by the Veterans Health Administration Support Service Center (VSSC). Unfortunately, pertinent data are spread across multiple reports, making it difficult to continually harmonize needed information. Further, the VSSC does not account for NTO’s hub and spoke clinical model, leading to inaccuracies when attempting to analyze unique encounters. To address these challenges, NTO partnered with the VA Salt Lake City Health Care System Informatics, Decision-Enhancement, and Analytic Sciences Center (IDEAS) to develop an informatics architecture and frontend NTO Clinical Operations Dashboard (NCOD). Here, we summarize our dashboard development process and the finalized key reporting components of the NCOD.

Methods

The VA Corporate Data Warehouse (CDW) serves as the primary data source for the NCOD. SQL Server Integration Services was used to build the backend data architecture. Data from the CDW were isolated into a staging data mart for reporting purposes using an extract, transform, load (ETL) approach. The frontend user interface was developed using Power BI. We used a participatory approach1 in determining reporting requirements. Stakeholders included the IDEAS dashboard development team and potential end users from NTO, including leadership, program managers, support assistants, and telehealth coordinators.

Results

The NCOD ETL is scheduled to refresh the data nightly to provide end users with a near real-time experience. The NCOD is comprised of the following four data views: clinic availability, team productivity, patient summary, and encounter summary. The clinic availability view summarizes clinic capacity, no shows, overbookings, and percent utilization. Relative value unit- based productivity is summarized in the team productivity view. The patient summary view presents aggregated data for veterans served by NTO, including geographic distribution, with patient-level drill down displaying demographics, cancer characteristics, and treatment history. Lastly, the encounter view displays utilization trends by modality, while accurately accounting for the hub and spoke clinical model.

Conclusions

An informatics architecture and frontend information display that is capable of synthesizing EHR data into a consumable format has been pivotal in obtaining accurate and timely insight into the demand and capacity of services provided by NTO.

References
  1. Esquer Rochin MA, Gutierrez-Garcia JO, Rosales JH, Rodriguez LF. Design and evaluation of a dashboard to support the comprehension of the progression.
References
  1. Esquer Rochin MA, Gutierrez-Garcia JO, Rosales JH, Rodriguez LF. Design and evaluation of a dashboard to support the comprehension of the progression.
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Team-based Genetic Consultation: An Effective System of Care for Delivery of Precision Oncology Services

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Objectives

US Department of Veterans Affairs (VA) patients with genetics referrals are 1.5 times more likely to have multiple cancer screening and preventive procedures if they completed their genetic consultations, but only when completed under a VA traditional model staffed by a team of clinical geneticists and genetic counselors versus a VA nontraditional, centralized telehealth model staffed by genetic counselors working independently. We sought to understand the reasons for these differences in cancer screening and prevention uptake.

Methods

We reviewed randomly selected medical records of patients with cancer genetics referrals stratified by model (142 records from each model). We conducted semi-structured interviews with 15 genetics providers and 36 referring clinicians from 13 VA facilities using purposive sampling. We analyzed annotated medical records and interview transcripts using a rapid assessment process. We characterized annotations as personalized recommendations (eg, begin colonoscopy at age 30 then every 1-2 years), options (eg, consider bilateral mastectomy), and generic messages (eg, refer to guidelines or another provider).

Results

Cancer screening or prevention was documented in 80 traditional-model records (141 annotations) and 106 nontraditional-model records (143 annotations). Personalized recommendations comprised 69% (97/141) of annotations within traditional-model records and 30% (43/143) within nontraditional-model records. Generic messages comprised 17% (24/141) of annotations in traditional-model records and 51% (73/143) in nontraditional-model records. From interview data, referring clinicians expected a broad range of services from genetics providers, including management and screening recommendations, and stated their role was to follow through on recommendations made. Under the traditional model, geneticists formulated recommendations documented by genetic counselors. Under the nontraditional model, scope of practice limited how genetic counselors addressed cancer screening and prevention.

Conclusions/Impacts

Personalized recommendations were typical of traditional-model records, whereas nontraditional-model records usually had generic messages. Compared with the nontraditional model, the traditional model was more patient-centered and better meets expectations of referring clinicians, which might explain in part the differences in patient uptake of cancer screening and preventive procedures.

As the demand for genetic services grows, the VA should promote team-based care under the traditional model for a more patient-centered, coordinated, and effective system of care for precision oncology.

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Objectives

US Department of Veterans Affairs (VA) patients with genetics referrals are 1.5 times more likely to have multiple cancer screening and preventive procedures if they completed their genetic consultations, but only when completed under a VA traditional model staffed by a team of clinical geneticists and genetic counselors versus a VA nontraditional, centralized telehealth model staffed by genetic counselors working independently. We sought to understand the reasons for these differences in cancer screening and prevention uptake.

Methods

We reviewed randomly selected medical records of patients with cancer genetics referrals stratified by model (142 records from each model). We conducted semi-structured interviews with 15 genetics providers and 36 referring clinicians from 13 VA facilities using purposive sampling. We analyzed annotated medical records and interview transcripts using a rapid assessment process. We characterized annotations as personalized recommendations (eg, begin colonoscopy at age 30 then every 1-2 years), options (eg, consider bilateral mastectomy), and generic messages (eg, refer to guidelines or another provider).

Results

Cancer screening or prevention was documented in 80 traditional-model records (141 annotations) and 106 nontraditional-model records (143 annotations). Personalized recommendations comprised 69% (97/141) of annotations within traditional-model records and 30% (43/143) within nontraditional-model records. Generic messages comprised 17% (24/141) of annotations in traditional-model records and 51% (73/143) in nontraditional-model records. From interview data, referring clinicians expected a broad range of services from genetics providers, including management and screening recommendations, and stated their role was to follow through on recommendations made. Under the traditional model, geneticists formulated recommendations documented by genetic counselors. Under the nontraditional model, scope of practice limited how genetic counselors addressed cancer screening and prevention.

Conclusions/Impacts

Personalized recommendations were typical of traditional-model records, whereas nontraditional-model records usually had generic messages. Compared with the nontraditional model, the traditional model was more patient-centered and better meets expectations of referring clinicians, which might explain in part the differences in patient uptake of cancer screening and preventive procedures.

As the demand for genetic services grows, the VA should promote team-based care under the traditional model for a more patient-centered, coordinated, and effective system of care for precision oncology.

Objectives

US Department of Veterans Affairs (VA) patients with genetics referrals are 1.5 times more likely to have multiple cancer screening and preventive procedures if they completed their genetic consultations, but only when completed under a VA traditional model staffed by a team of clinical geneticists and genetic counselors versus a VA nontraditional, centralized telehealth model staffed by genetic counselors working independently. We sought to understand the reasons for these differences in cancer screening and prevention uptake.

Methods

We reviewed randomly selected medical records of patients with cancer genetics referrals stratified by model (142 records from each model). We conducted semi-structured interviews with 15 genetics providers and 36 referring clinicians from 13 VA facilities using purposive sampling. We analyzed annotated medical records and interview transcripts using a rapid assessment process. We characterized annotations as personalized recommendations (eg, begin colonoscopy at age 30 then every 1-2 years), options (eg, consider bilateral mastectomy), and generic messages (eg, refer to guidelines or another provider).

Results

Cancer screening or prevention was documented in 80 traditional-model records (141 annotations) and 106 nontraditional-model records (143 annotations). Personalized recommendations comprised 69% (97/141) of annotations within traditional-model records and 30% (43/143) within nontraditional-model records. Generic messages comprised 17% (24/141) of annotations in traditional-model records and 51% (73/143) in nontraditional-model records. From interview data, referring clinicians expected a broad range of services from genetics providers, including management and screening recommendations, and stated their role was to follow through on recommendations made. Under the traditional model, geneticists formulated recommendations documented by genetic counselors. Under the nontraditional model, scope of practice limited how genetic counselors addressed cancer screening and prevention.

Conclusions/Impacts

Personalized recommendations were typical of traditional-model records, whereas nontraditional-model records usually had generic messages. Compared with the nontraditional model, the traditional model was more patient-centered and better meets expectations of referring clinicians, which might explain in part the differences in patient uptake of cancer screening and preventive procedures.

As the demand for genetic services grows, the VA should promote team-based care under the traditional model for a more patient-centered, coordinated, and effective system of care for precision oncology.

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Duty to Assist: Assisting Veterans With Exposures to Hazardous Materials

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Background

Veterans are not well informed of the presumptive conditions associated with toxic exposures endured during military service. A quality improvement project was created to increase awareness. The purpose of this project was to: Raise awareness of presumptive conditions associated with Agent Orange, Camp LeJeune contaminated water and Southwest Asia Burn Pit (fine particulate) exposure, to notify veterans how to initiate the disability benefits application process, and to inform veterans and providers of new changes in legislation (ie, Blue Water and Southwest Asia).

Methods

Using the Cancer Registry, the cancer access coordinator identified veterans with a diagnosis on each of the 3 presumptive condition lists for Agent Orange, Camp Lejeune, and Southwest Asia. These lists were then forwarded to informatics who further screened for military service history. Informative mailers were then sent to the identified veterans, alerting them to their potential eligibility for disability benefits. In addition, the mailers informed veterans how to initiate the benefits application process, how to schedule Disability Benefit Questionnaire (DBQ) exams to expedite the process, as well as contact information for local Veteran’s Service Commission (VSC) and the Veterans Benefits Administration (VBA) for further assistance. These letters were also distributed throughout the medical facility and was shared at cancer committee meetings to increase provider awareness.

Results

In 2021, 604 veterans were identified as potentially eligible for disability benefits and were contacted via mailer. As a result, 153 veterans have been granted service-connected benefits for their identified condition. An additional 91 mailers have been sent since January 2022.

Conclusions

Utilizing this simple practice increases both veteran and provider awareness of presumptive conditions, and aids in veterans receiving the disability compensation they are entitled to. In addition, this practice improves the overall quality of care the veterans receive through the VA and gives us a chance to give back to our veterans.

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Background

Veterans are not well informed of the presumptive conditions associated with toxic exposures endured during military service. A quality improvement project was created to increase awareness. The purpose of this project was to: Raise awareness of presumptive conditions associated with Agent Orange, Camp LeJeune contaminated water and Southwest Asia Burn Pit (fine particulate) exposure, to notify veterans how to initiate the disability benefits application process, and to inform veterans and providers of new changes in legislation (ie, Blue Water and Southwest Asia).

Methods

Using the Cancer Registry, the cancer access coordinator identified veterans with a diagnosis on each of the 3 presumptive condition lists for Agent Orange, Camp Lejeune, and Southwest Asia. These lists were then forwarded to informatics who further screened for military service history. Informative mailers were then sent to the identified veterans, alerting them to their potential eligibility for disability benefits. In addition, the mailers informed veterans how to initiate the benefits application process, how to schedule Disability Benefit Questionnaire (DBQ) exams to expedite the process, as well as contact information for local Veteran’s Service Commission (VSC) and the Veterans Benefits Administration (VBA) for further assistance. These letters were also distributed throughout the medical facility and was shared at cancer committee meetings to increase provider awareness.

Results

In 2021, 604 veterans were identified as potentially eligible for disability benefits and were contacted via mailer. As a result, 153 veterans have been granted service-connected benefits for their identified condition. An additional 91 mailers have been sent since January 2022.

Conclusions

Utilizing this simple practice increases both veteran and provider awareness of presumptive conditions, and aids in veterans receiving the disability compensation they are entitled to. In addition, this practice improves the overall quality of care the veterans receive through the VA and gives us a chance to give back to our veterans.

Background

Veterans are not well informed of the presumptive conditions associated with toxic exposures endured during military service. A quality improvement project was created to increase awareness. The purpose of this project was to: Raise awareness of presumptive conditions associated with Agent Orange, Camp LeJeune contaminated water and Southwest Asia Burn Pit (fine particulate) exposure, to notify veterans how to initiate the disability benefits application process, and to inform veterans and providers of new changes in legislation (ie, Blue Water and Southwest Asia).

Methods

Using the Cancer Registry, the cancer access coordinator identified veterans with a diagnosis on each of the 3 presumptive condition lists for Agent Orange, Camp Lejeune, and Southwest Asia. These lists were then forwarded to informatics who further screened for military service history. Informative mailers were then sent to the identified veterans, alerting them to their potential eligibility for disability benefits. In addition, the mailers informed veterans how to initiate the benefits application process, how to schedule Disability Benefit Questionnaire (DBQ) exams to expedite the process, as well as contact information for local Veteran’s Service Commission (VSC) and the Veterans Benefits Administration (VBA) for further assistance. These letters were also distributed throughout the medical facility and was shared at cancer committee meetings to increase provider awareness.

Results

In 2021, 604 veterans were identified as potentially eligible for disability benefits and were contacted via mailer. As a result, 153 veterans have been granted service-connected benefits for their identified condition. An additional 91 mailers have been sent since January 2022.

Conclusions

Utilizing this simple practice increases both veteran and provider awareness of presumptive conditions, and aids in veterans receiving the disability compensation they are entitled to. In addition, this practice improves the overall quality of care the veterans receive through the VA and gives us a chance to give back to our veterans.

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Oncologists’ wealth and debt: COVID had little impact

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2021 bought welcome relief to oncologists, whose incomes generally rose as practices reopened after COVID-19 restrictions were lifted and patients ventured out again, concludes the latest Medscape Oncologist Wealth & Debt Report 2022.

Comparing the findings with those in the larger Medscape Physician Wealth & Debt Report 2022, which surveyed more than 13,000 physicians in 29 specialties, the findings for oncologists show how they compare with those who chose other paths in medicine.

Oncologists’ income rose, on average, by 2% in the past year and now stands at an average of $411,000 annually, up from $403,000 in the 2021 report.

This puts oncologists in the top third of specialties, with plastic surgeons again in the top slot (with average income of $576,000 in 2022).

One-fifth (20%) of oncologists surveyed reported a family worth of more than $5 million, which represents substantial family wealth, the report comments.

However, 22% of oncologists reported that their family net worth was less than $500,000, and another 10% estimated that it to fall between $500,000 and $1 million.

For comparison, the average U.S. family net worth is about $749,000, according to data from the Federal Reserve.
 

Most live ‘within their means’

Most oncologists (94%) and also most (94%) of all of the physicians surveyed said that they live within or below their means.

How does one do this? Just paying off credit cards each month and contributing enough to a 401(k) account to receive an employer match does not meet this standard, said Joel Greenwald MD, CFP, a wealth management advisor for physicians. To live within or below your means, you also need to be saving at least 20% toward retirement, pay down student loans, contribute to your kids’ college savings, and set aside rainy day cash, he explained.

When physicians were asked about their favorite cost-cutting tactics, replies included bringing lunch to work, keeping a car for 15 years, and carrying out their own household maintenance and repairs. One doctor described a “24-hour rule” when it comes to shopping: “Revisit the desired purchase after 24 hours to see if it’s still desired.”

But how well do these tactics go down with ‘the other half’ and the rest of the household? Two-thirds (66%) of oncologists, and a similar proportion of all physicians, said that they argue with their significant other about spending. This appears to be high in comparison with the finding from a recent survey that across the United States, about one in four couples (25%) argue about money at least once a month.

Regarding spending, the top expense among oncologists was for childcare (16%), private tuition for offspring (14%), mortgage on a second home (14%), college tuition for offspring (14%), and a car lease (12%).

Around 17% of oncologists reported that they are still paying off their own college or medical school loans. For this statistic, they are about in the middle of all specialties.

The report notes that freeing oneself from medical school debt is very costly. Physicians in the United States pay an average of $356,000-$440,000, about half of which is interest.
 

Little change over 2021

The COVID pandemic had much less of an impact on physicians than it had on the general population when it comes to keeping up with payments, and most physicians were not affected. Only 3% of oncologists said they fell behind with payments for mortgage; 6% fell behind with payments for other bills.

In comparison, nearly half (46%) of Americans missed one or more payments of rent or mortgage because of COVID, according to a 2021 industry survey.

Over the past year, most oncologists (70%) did not change their spending habits, and only 11% cut expenses by deferring or refinancing loans. Also, most oncologists (75%) avoided major financial loses. Only 8% reported financial losses because of problems at their medical practice.

However, a slightly higher percentage of oncologists reported a stock or company investment that had turned sour in 2022 (37%) in comparison with 2021 (28%).

A version of this article first appeared on Medscape.com.

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2021 bought welcome relief to oncologists, whose incomes generally rose as practices reopened after COVID-19 restrictions were lifted and patients ventured out again, concludes the latest Medscape Oncologist Wealth & Debt Report 2022.

Comparing the findings with those in the larger Medscape Physician Wealth & Debt Report 2022, which surveyed more than 13,000 physicians in 29 specialties, the findings for oncologists show how they compare with those who chose other paths in medicine.

Oncologists’ income rose, on average, by 2% in the past year and now stands at an average of $411,000 annually, up from $403,000 in the 2021 report.

This puts oncologists in the top third of specialties, with plastic surgeons again in the top slot (with average income of $576,000 in 2022).

One-fifth (20%) of oncologists surveyed reported a family worth of more than $5 million, which represents substantial family wealth, the report comments.

However, 22% of oncologists reported that their family net worth was less than $500,000, and another 10% estimated that it to fall between $500,000 and $1 million.

For comparison, the average U.S. family net worth is about $749,000, according to data from the Federal Reserve.
 

Most live ‘within their means’

Most oncologists (94%) and also most (94%) of all of the physicians surveyed said that they live within or below their means.

How does one do this? Just paying off credit cards each month and contributing enough to a 401(k) account to receive an employer match does not meet this standard, said Joel Greenwald MD, CFP, a wealth management advisor for physicians. To live within or below your means, you also need to be saving at least 20% toward retirement, pay down student loans, contribute to your kids’ college savings, and set aside rainy day cash, he explained.

When physicians were asked about their favorite cost-cutting tactics, replies included bringing lunch to work, keeping a car for 15 years, and carrying out their own household maintenance and repairs. One doctor described a “24-hour rule” when it comes to shopping: “Revisit the desired purchase after 24 hours to see if it’s still desired.”

But how well do these tactics go down with ‘the other half’ and the rest of the household? Two-thirds (66%) of oncologists, and a similar proportion of all physicians, said that they argue with their significant other about spending. This appears to be high in comparison with the finding from a recent survey that across the United States, about one in four couples (25%) argue about money at least once a month.

Regarding spending, the top expense among oncologists was for childcare (16%), private tuition for offspring (14%), mortgage on a second home (14%), college tuition for offspring (14%), and a car lease (12%).

Around 17% of oncologists reported that they are still paying off their own college or medical school loans. For this statistic, they are about in the middle of all specialties.

The report notes that freeing oneself from medical school debt is very costly. Physicians in the United States pay an average of $356,000-$440,000, about half of which is interest.
 

Little change over 2021

The COVID pandemic had much less of an impact on physicians than it had on the general population when it comes to keeping up with payments, and most physicians were not affected. Only 3% of oncologists said they fell behind with payments for mortgage; 6% fell behind with payments for other bills.

In comparison, nearly half (46%) of Americans missed one or more payments of rent or mortgage because of COVID, according to a 2021 industry survey.

Over the past year, most oncologists (70%) did not change their spending habits, and only 11% cut expenses by deferring or refinancing loans. Also, most oncologists (75%) avoided major financial loses. Only 8% reported financial losses because of problems at their medical practice.

However, a slightly higher percentage of oncologists reported a stock or company investment that had turned sour in 2022 (37%) in comparison with 2021 (28%).

A version of this article first appeared on Medscape.com.

 

2021 bought welcome relief to oncologists, whose incomes generally rose as practices reopened after COVID-19 restrictions were lifted and patients ventured out again, concludes the latest Medscape Oncologist Wealth & Debt Report 2022.

Comparing the findings with those in the larger Medscape Physician Wealth & Debt Report 2022, which surveyed more than 13,000 physicians in 29 specialties, the findings for oncologists show how they compare with those who chose other paths in medicine.

Oncologists’ income rose, on average, by 2% in the past year and now stands at an average of $411,000 annually, up from $403,000 in the 2021 report.

This puts oncologists in the top third of specialties, with plastic surgeons again in the top slot (with average income of $576,000 in 2022).

One-fifth (20%) of oncologists surveyed reported a family worth of more than $5 million, which represents substantial family wealth, the report comments.

However, 22% of oncologists reported that their family net worth was less than $500,000, and another 10% estimated that it to fall between $500,000 and $1 million.

For comparison, the average U.S. family net worth is about $749,000, according to data from the Federal Reserve.
 

Most live ‘within their means’

Most oncologists (94%) and also most (94%) of all of the physicians surveyed said that they live within or below their means.

How does one do this? Just paying off credit cards each month and contributing enough to a 401(k) account to receive an employer match does not meet this standard, said Joel Greenwald MD, CFP, a wealth management advisor for physicians. To live within or below your means, you also need to be saving at least 20% toward retirement, pay down student loans, contribute to your kids’ college savings, and set aside rainy day cash, he explained.

When physicians were asked about their favorite cost-cutting tactics, replies included bringing lunch to work, keeping a car for 15 years, and carrying out their own household maintenance and repairs. One doctor described a “24-hour rule” when it comes to shopping: “Revisit the desired purchase after 24 hours to see if it’s still desired.”

But how well do these tactics go down with ‘the other half’ and the rest of the household? Two-thirds (66%) of oncologists, and a similar proportion of all physicians, said that they argue with their significant other about spending. This appears to be high in comparison with the finding from a recent survey that across the United States, about one in four couples (25%) argue about money at least once a month.

Regarding spending, the top expense among oncologists was for childcare (16%), private tuition for offspring (14%), mortgage on a second home (14%), college tuition for offspring (14%), and a car lease (12%).

Around 17% of oncologists reported that they are still paying off their own college or medical school loans. For this statistic, they are about in the middle of all specialties.

The report notes that freeing oneself from medical school debt is very costly. Physicians in the United States pay an average of $356,000-$440,000, about half of which is interest.
 

Little change over 2021

The COVID pandemic had much less of an impact on physicians than it had on the general population when it comes to keeping up with payments, and most physicians were not affected. Only 3% of oncologists said they fell behind with payments for mortgage; 6% fell behind with payments for other bills.

In comparison, nearly half (46%) of Americans missed one or more payments of rent or mortgage because of COVID, according to a 2021 industry survey.

Over the past year, most oncologists (70%) did not change their spending habits, and only 11% cut expenses by deferring or refinancing loans. Also, most oncologists (75%) avoided major financial loses. Only 8% reported financial losses because of problems at their medical practice.

However, a slightly higher percentage of oncologists reported a stock or company investment that had turned sour in 2022 (37%) in comparison with 2021 (28%).

A version of this article first appeared on Medscape.com.

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Federal Health Care Data Trends 2022

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Federal Health Care Data Trends (click to view the digital edition) is a special supplement to Federal Practitioner highlighting the latest research and study outcomes related to the health of veteran and active-duty populations. 

 

In this issue:

Federal Practitioner would like to thank the following experts for their review of content and helpful guidance in developing this issue: 

Kelvin N.V. Bush, MD, FACC, CCDS; Sonya Borrero, MD, MS; Kenneth L. Cameron, PhD, MPH, ATC, FNATA; Jason DeViva, PhD; Ellen Lockard Edens, MD; Leonard E. Egede, MD, MS; Amy Justice, MD, PhD; Stephanie Knudson, MD; Willis H. Lyford, MD; Sarah O. Meadows, PhD; Tamara Schult, PhD, MPH; Eric L. Singman, MD, PhD; Art Wallace, MD, PhD; Elizabeth Waterhouse, MD, FAAN

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Federal Health Care Data Trends (click to view the digital edition) is a special supplement to Federal Practitioner highlighting the latest research and study outcomes related to the health of veteran and active-duty populations. 

 

In this issue:

Federal Practitioner would like to thank the following experts for their review of content and helpful guidance in developing this issue: 

Kelvin N.V. Bush, MD, FACC, CCDS; Sonya Borrero, MD, MS; Kenneth L. Cameron, PhD, MPH, ATC, FNATA; Jason DeViva, PhD; Ellen Lockard Edens, MD; Leonard E. Egede, MD, MS; Amy Justice, MD, PhD; Stephanie Knudson, MD; Willis H. Lyford, MD; Sarah O. Meadows, PhD; Tamara Schult, PhD, MPH; Eric L. Singman, MD, PhD; Art Wallace, MD, PhD; Elizabeth Waterhouse, MD, FAAN

Federal Health Care Data Trends (click to view the digital edition) is a special supplement to Federal Practitioner highlighting the latest research and study outcomes related to the health of veteran and active-duty populations. 

 

In this issue:

Federal Practitioner would like to thank the following experts for their review of content and helpful guidance in developing this issue: 

Kelvin N.V. Bush, MD, FACC, CCDS; Sonya Borrero, MD, MS; Kenneth L. Cameron, PhD, MPH, ATC, FNATA; Jason DeViva, PhD; Ellen Lockard Edens, MD; Leonard E. Egede, MD, MS; Amy Justice, MD, PhD; Stephanie Knudson, MD; Willis H. Lyford, MD; Sarah O. Meadows, PhD; Tamara Schult, PhD, MPH; Eric L. Singman, MD, PhD; Art Wallace, MD, PhD; Elizabeth Waterhouse, MD, FAAN

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One in four NSCLC patients respond poorly to COVID-19 vaccine

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About one in four patients with non–small cell lung cancer (NSCLC) have an unsatisfactory antibody response to the Omicron variant following COVID-19 vaccination, according to a new study.

The study was published in the Journal of Clinical Oncology.

“Booster vaccination increased binding and neutralizing antibody titers to Omicron, but antibody titers declined after 3 months. These data highlight the concern for patients with cancer given the rapid spread of SARS-CoV-2 Omicron variant,” wrote the authors, who were led by Rafi Ahmed, PhD, Emory University, Atlanta.

Researchers found that 18% had no detectable antibody at all and active treatment type had no association with vaccine response.

Researchers examined antibody titers among 82 NSCLC patients and 53 healthy volunteers. They collected blood samples longitudinally for analysis. While most patients had binding and neutralizing antibody titers that were comparable with healthy volunteers, 25% had poor responses, which led to six- to sevenfold lower titers than healthy controls. There was no association between worse vaccine responses and history of programmed death–1 monotherapy, chemotherapy, or both in combination. Receipt of a booster vaccine improved binding and neutralizing antibody titers to both the wild type and the Omicron variant, but 2-4 months after the booster there was a five- to sevenfold decrease in neutralizing titers to both the wild type and Omicron variant.

“This study indicates both the need to monitor our patients with lung cancer for response to COVID-19 mRNA vaccines, identify the nonresponders for follow-up and further attempts at immunization, and continue collecting and analyzing clinicodemographic information and biospecimens from our patients,” wrote the authors of an accompanying editorial.

Although the findings reveal potential concerns, the good news is that most patients NSCLC patients do respond normally to COVID-19 vaccination, said John D. Minna, MD, University of Texas Southwestern Medical Center, Dallas, lead author of the editorial.

He offered some advice to physicians. “You can test your patients using currently available [Clinical Laboratory Improvement Amendments]–approved lab tests to determine what their antibody titers are. This should be done after boosting since titers will go down after time. We know that if a patient has lung cancer and they do get infected with SARS-CoV-2 that potentially they could develop serious COVID-19 disease. Besides giving antiviral treatment, it is important that they be closely monitored for symptoms of progression so if they need to be hospitalized it can be done in a prudent manner,” said Dr. Minna, who is director of the Hamon Center for Therapeutic Oncology Research at the University of Texas Southwestern Medical Center.

No clinical details have emerged that might predict which patients have an insufficient response to vaccination. “When we started these studies, a lot of us thought that anyone who did not develop a good antibody response would be weak or sicker. For example, [patients with] late-stage disease, or having had a lot of therapy, or perhaps immune checkpoint blockade. However, none of these things are correlated. The main advice we are giving our lung cancer patients are to get vaccinated, get boosted (double boosted), and just do the smart thing to protect yourself from exposure,” he said.

For example, when traveling on a plane, patients should wear a mask. They should also avoid large indoor events. He also recommended that, following vaccination and boosters, patients seek out CLIA-certified tests to get their titer checked.

“Upon any COVID infection, even if their titer is at or above 80%, patients should see their physician to consider treatment with Paxlovid (nirmatrelvir/ritonavir), which has emergency use authorization. For patients with a lower titer, it’s important to seek out a physician and consider Paxlovid and possibly antibody therapy. But these are individual decisions to be made with your doctor,” Dr. Minna said.

The next important research question is what happens to T-cell immune response following vaccination. “We know that a good cellular immune response is also important in preventing infection and severe infection, but we don’t yet know which persons (with or without cancer) have good T-cell responses. This information will also likely impact what we tell our patients and will add to the antibody data,” he said.

Studies are ongoing to determine specific T-cell responses to mRNA vaccines, and how well those T-cell responses respond to SARS-CoV-2 infection in the laboratory.

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About one in four patients with non–small cell lung cancer (NSCLC) have an unsatisfactory antibody response to the Omicron variant following COVID-19 vaccination, according to a new study.

The study was published in the Journal of Clinical Oncology.

“Booster vaccination increased binding and neutralizing antibody titers to Omicron, but antibody titers declined after 3 months. These data highlight the concern for patients with cancer given the rapid spread of SARS-CoV-2 Omicron variant,” wrote the authors, who were led by Rafi Ahmed, PhD, Emory University, Atlanta.

Researchers found that 18% had no detectable antibody at all and active treatment type had no association with vaccine response.

Researchers examined antibody titers among 82 NSCLC patients and 53 healthy volunteers. They collected blood samples longitudinally for analysis. While most patients had binding and neutralizing antibody titers that were comparable with healthy volunteers, 25% had poor responses, which led to six- to sevenfold lower titers than healthy controls. There was no association between worse vaccine responses and history of programmed death–1 monotherapy, chemotherapy, or both in combination. Receipt of a booster vaccine improved binding and neutralizing antibody titers to both the wild type and the Omicron variant, but 2-4 months after the booster there was a five- to sevenfold decrease in neutralizing titers to both the wild type and Omicron variant.

“This study indicates both the need to monitor our patients with lung cancer for response to COVID-19 mRNA vaccines, identify the nonresponders for follow-up and further attempts at immunization, and continue collecting and analyzing clinicodemographic information and biospecimens from our patients,” wrote the authors of an accompanying editorial.

Although the findings reveal potential concerns, the good news is that most patients NSCLC patients do respond normally to COVID-19 vaccination, said John D. Minna, MD, University of Texas Southwestern Medical Center, Dallas, lead author of the editorial.

He offered some advice to physicians. “You can test your patients using currently available [Clinical Laboratory Improvement Amendments]–approved lab tests to determine what their antibody titers are. This should be done after boosting since titers will go down after time. We know that if a patient has lung cancer and they do get infected with SARS-CoV-2 that potentially they could develop serious COVID-19 disease. Besides giving antiviral treatment, it is important that they be closely monitored for symptoms of progression so if they need to be hospitalized it can be done in a prudent manner,” said Dr. Minna, who is director of the Hamon Center for Therapeutic Oncology Research at the University of Texas Southwestern Medical Center.

No clinical details have emerged that might predict which patients have an insufficient response to vaccination. “When we started these studies, a lot of us thought that anyone who did not develop a good antibody response would be weak or sicker. For example, [patients with] late-stage disease, or having had a lot of therapy, or perhaps immune checkpoint blockade. However, none of these things are correlated. The main advice we are giving our lung cancer patients are to get vaccinated, get boosted (double boosted), and just do the smart thing to protect yourself from exposure,” he said.

For example, when traveling on a plane, patients should wear a mask. They should also avoid large indoor events. He also recommended that, following vaccination and boosters, patients seek out CLIA-certified tests to get their titer checked.

“Upon any COVID infection, even if their titer is at or above 80%, patients should see their physician to consider treatment with Paxlovid (nirmatrelvir/ritonavir), which has emergency use authorization. For patients with a lower titer, it’s important to seek out a physician and consider Paxlovid and possibly antibody therapy. But these are individual decisions to be made with your doctor,” Dr. Minna said.

The next important research question is what happens to T-cell immune response following vaccination. “We know that a good cellular immune response is also important in preventing infection and severe infection, but we don’t yet know which persons (with or without cancer) have good T-cell responses. This information will also likely impact what we tell our patients and will add to the antibody data,” he said.

Studies are ongoing to determine specific T-cell responses to mRNA vaccines, and how well those T-cell responses respond to SARS-CoV-2 infection in the laboratory.

About one in four patients with non–small cell lung cancer (NSCLC) have an unsatisfactory antibody response to the Omicron variant following COVID-19 vaccination, according to a new study.

The study was published in the Journal of Clinical Oncology.

“Booster vaccination increased binding and neutralizing antibody titers to Omicron, but antibody titers declined after 3 months. These data highlight the concern for patients with cancer given the rapid spread of SARS-CoV-2 Omicron variant,” wrote the authors, who were led by Rafi Ahmed, PhD, Emory University, Atlanta.

Researchers found that 18% had no detectable antibody at all and active treatment type had no association with vaccine response.

Researchers examined antibody titers among 82 NSCLC patients and 53 healthy volunteers. They collected blood samples longitudinally for analysis. While most patients had binding and neutralizing antibody titers that were comparable with healthy volunteers, 25% had poor responses, which led to six- to sevenfold lower titers than healthy controls. There was no association between worse vaccine responses and history of programmed death–1 monotherapy, chemotherapy, or both in combination. Receipt of a booster vaccine improved binding and neutralizing antibody titers to both the wild type and the Omicron variant, but 2-4 months after the booster there was a five- to sevenfold decrease in neutralizing titers to both the wild type and Omicron variant.

“This study indicates both the need to monitor our patients with lung cancer for response to COVID-19 mRNA vaccines, identify the nonresponders for follow-up and further attempts at immunization, and continue collecting and analyzing clinicodemographic information and biospecimens from our patients,” wrote the authors of an accompanying editorial.

Although the findings reveal potential concerns, the good news is that most patients NSCLC patients do respond normally to COVID-19 vaccination, said John D. Minna, MD, University of Texas Southwestern Medical Center, Dallas, lead author of the editorial.

He offered some advice to physicians. “You can test your patients using currently available [Clinical Laboratory Improvement Amendments]–approved lab tests to determine what their antibody titers are. This should be done after boosting since titers will go down after time. We know that if a patient has lung cancer and they do get infected with SARS-CoV-2 that potentially they could develop serious COVID-19 disease. Besides giving antiviral treatment, it is important that they be closely monitored for symptoms of progression so if they need to be hospitalized it can be done in a prudent manner,” said Dr. Minna, who is director of the Hamon Center for Therapeutic Oncology Research at the University of Texas Southwestern Medical Center.

No clinical details have emerged that might predict which patients have an insufficient response to vaccination. “When we started these studies, a lot of us thought that anyone who did not develop a good antibody response would be weak or sicker. For example, [patients with] late-stage disease, or having had a lot of therapy, or perhaps immune checkpoint blockade. However, none of these things are correlated. The main advice we are giving our lung cancer patients are to get vaccinated, get boosted (double boosted), and just do the smart thing to protect yourself from exposure,” he said.

For example, when traveling on a plane, patients should wear a mask. They should also avoid large indoor events. He also recommended that, following vaccination and boosters, patients seek out CLIA-certified tests to get their titer checked.

“Upon any COVID infection, even if their titer is at or above 80%, patients should see their physician to consider treatment with Paxlovid (nirmatrelvir/ritonavir), which has emergency use authorization. For patients with a lower titer, it’s important to seek out a physician and consider Paxlovid and possibly antibody therapy. But these are individual decisions to be made with your doctor,” Dr. Minna said.

The next important research question is what happens to T-cell immune response following vaccination. “We know that a good cellular immune response is also important in preventing infection and severe infection, but we don’t yet know which persons (with or without cancer) have good T-cell responses. This information will also likely impact what we tell our patients and will add to the antibody data,” he said.

Studies are ongoing to determine specific T-cell responses to mRNA vaccines, and how well those T-cell responses respond to SARS-CoV-2 infection in the laboratory.

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Taste dysfunction in head and neck cancer due to radiation dose

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Fri, 08/05/2022 - 09:32

High oral cavity doses of radiotherapy are associated with greater risk of taste dysfunction in patients with head and neck cancer, finds a new study from JAMA Otolaryngology–Head & Neck Surgery.

Taste dysfunction can affect up to 90% of patients undergoing radiotherapy for head and neck cancer. While the ability to taste usually returns after the treatment concludes, some patients can still feel the lingering effects of radiotherapy on taste function long after the treatment concludes. It can lead to weight loss and dry mouth which can, in turn, negatively affect quality of life.

“Taste dysfunction has profound effects on quality of life in patients with head and neck cancer, and the oral cavity dose could be significantly lower with modern radiotherapy techniques,” wrote the researchers, who were led by Miao-Fen Chen, MD, PhD, of Chang Gung University, Taoyuan City, Taiwan. “This study provides useful dose constraints of the oral cavity that may be associated with reduced taste dysfunction.”

Degradation of taste is an important quality of life factor for head and neck cancer patients. A 2021 systematic review published in the journal Radiotherapy and Oncology found that acute taste dysfunction affected 96% of patients as measured objectively, and 79% as measured subjectively. While most patients recover an estimated 23-53% of patients experience long-term dysfunction.

In 2019, a study published in the journal Chemical Senses found that 31% of head and neck cancer patients had long-term changes to taste at 27 months after intensity-modulated radiotherapy (IMRT), with dysfunction associated with glossectomy and oral cavity radiation doses greater than 50 Gy, but the study only used one quality of life subjective measure to evaluate taste function.

In the new JAMA study, researchers reported the results of a longitudinal using the whole-mouth solution method for basic tastes, including salt, sweet, sour, and bitter.
 

Study methodology

The study included 87 patients (mean age, 58 years; 90% men) who were enrolled between 2017 and 2020 from a single hospital. 45 patients received primary intensity-modulated radiotherapy and 42 received postoperative radiotherapy. 78 patients received volumetric arc therapy, and 9 received intensity-modulated radiotherapy. The radiotherapy was directed to minimize the effect on the parotid glands and oral cavity.

Researchers measured taste dysfunction according to detection thresholds based on solutions with different concentrations. After moving the solution around the mouth and spitting it out, patients were asked to identify taste components. Following a water rinse, they tested a solution with another concentration of taste components. A number was assigned based on the concentration level they were able to detect, with nigher numbers indicating greater sensitivity.

Two to four weeks after initiation of radiotherapy, there were drops in taste scores for salt (4.7 to 1.4), sweet (4.2 to 1.8), sour (4.5 to 2.3), and bitter (4.7 to 1.2). 1 week after radiotherapy, those mean scores increased to 2.6, 2.6, 2.9, and 2.3 respectively. Over the following 3 months, mean scores reflected general recovery to near preradiotherapy levels (4.2, 3.9, 4.1, and 4.0, respectively). At 6 months and 1 year, the scores were equivalent to preradiotherapy levels.

Objective taste tests were performed on 81 participants. 33.3% had taste dysfunction 6 months after radiotherapy. 6 months after, 8.9% had taste dysfunction. At 3 months following radiotherapy, taste dysfunction was associated with an oral cavity mean dose of 4,000 cGy or higher (relative risk, 2.87; 95% confidence interval, 1.21-6.81) or 5,000 cGy or higher (RR, 2.04; 95% CI, 1.12-3.72). At 6 months, taste dysfunction was predicted by glossectomy (RR, 5.63; 95% CI, 1.12-28.15) and oral cavity mean dose 5,000 cGy or greater (RR, 7.79; 95% CI, 0.93-64.92).

The researchers quantified the relationship between mean oral cavity dose and probability of developing taste dysfunction at 3 and 6 months. 3 months after radiotherapy, 25 Gy predicted a 15% chance, 38 Gy predicted a 25% chance, and 60 Gy predicted a 50% chance. At 6 months, the numbers were 57, 60, and 64 Gy.

The study was limited by being conducted at a single center and its small sample size, and it recruited patients varied significantly in treatment modality and disease subtype.

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High oral cavity doses of radiotherapy are associated with greater risk of taste dysfunction in patients with head and neck cancer, finds a new study from JAMA Otolaryngology–Head & Neck Surgery.

Taste dysfunction can affect up to 90% of patients undergoing radiotherapy for head and neck cancer. While the ability to taste usually returns after the treatment concludes, some patients can still feel the lingering effects of radiotherapy on taste function long after the treatment concludes. It can lead to weight loss and dry mouth which can, in turn, negatively affect quality of life.

“Taste dysfunction has profound effects on quality of life in patients with head and neck cancer, and the oral cavity dose could be significantly lower with modern radiotherapy techniques,” wrote the researchers, who were led by Miao-Fen Chen, MD, PhD, of Chang Gung University, Taoyuan City, Taiwan. “This study provides useful dose constraints of the oral cavity that may be associated with reduced taste dysfunction.”

Degradation of taste is an important quality of life factor for head and neck cancer patients. A 2021 systematic review published in the journal Radiotherapy and Oncology found that acute taste dysfunction affected 96% of patients as measured objectively, and 79% as measured subjectively. While most patients recover an estimated 23-53% of patients experience long-term dysfunction.

In 2019, a study published in the journal Chemical Senses found that 31% of head and neck cancer patients had long-term changes to taste at 27 months after intensity-modulated radiotherapy (IMRT), with dysfunction associated with glossectomy and oral cavity radiation doses greater than 50 Gy, but the study only used one quality of life subjective measure to evaluate taste function.

In the new JAMA study, researchers reported the results of a longitudinal using the whole-mouth solution method for basic tastes, including salt, sweet, sour, and bitter.
 

Study methodology

The study included 87 patients (mean age, 58 years; 90% men) who were enrolled between 2017 and 2020 from a single hospital. 45 patients received primary intensity-modulated radiotherapy and 42 received postoperative radiotherapy. 78 patients received volumetric arc therapy, and 9 received intensity-modulated radiotherapy. The radiotherapy was directed to minimize the effect on the parotid glands and oral cavity.

Researchers measured taste dysfunction according to detection thresholds based on solutions with different concentrations. After moving the solution around the mouth and spitting it out, patients were asked to identify taste components. Following a water rinse, they tested a solution with another concentration of taste components. A number was assigned based on the concentration level they were able to detect, with nigher numbers indicating greater sensitivity.

Two to four weeks after initiation of radiotherapy, there were drops in taste scores for salt (4.7 to 1.4), sweet (4.2 to 1.8), sour (4.5 to 2.3), and bitter (4.7 to 1.2). 1 week after radiotherapy, those mean scores increased to 2.6, 2.6, 2.9, and 2.3 respectively. Over the following 3 months, mean scores reflected general recovery to near preradiotherapy levels (4.2, 3.9, 4.1, and 4.0, respectively). At 6 months and 1 year, the scores were equivalent to preradiotherapy levels.

Objective taste tests were performed on 81 participants. 33.3% had taste dysfunction 6 months after radiotherapy. 6 months after, 8.9% had taste dysfunction. At 3 months following radiotherapy, taste dysfunction was associated with an oral cavity mean dose of 4,000 cGy or higher (relative risk, 2.87; 95% confidence interval, 1.21-6.81) or 5,000 cGy or higher (RR, 2.04; 95% CI, 1.12-3.72). At 6 months, taste dysfunction was predicted by glossectomy (RR, 5.63; 95% CI, 1.12-28.15) and oral cavity mean dose 5,000 cGy or greater (RR, 7.79; 95% CI, 0.93-64.92).

The researchers quantified the relationship between mean oral cavity dose and probability of developing taste dysfunction at 3 and 6 months. 3 months after radiotherapy, 25 Gy predicted a 15% chance, 38 Gy predicted a 25% chance, and 60 Gy predicted a 50% chance. At 6 months, the numbers were 57, 60, and 64 Gy.

The study was limited by being conducted at a single center and its small sample size, and it recruited patients varied significantly in treatment modality and disease subtype.

High oral cavity doses of radiotherapy are associated with greater risk of taste dysfunction in patients with head and neck cancer, finds a new study from JAMA Otolaryngology–Head & Neck Surgery.

Taste dysfunction can affect up to 90% of patients undergoing radiotherapy for head and neck cancer. While the ability to taste usually returns after the treatment concludes, some patients can still feel the lingering effects of radiotherapy on taste function long after the treatment concludes. It can lead to weight loss and dry mouth which can, in turn, negatively affect quality of life.

“Taste dysfunction has profound effects on quality of life in patients with head and neck cancer, and the oral cavity dose could be significantly lower with modern radiotherapy techniques,” wrote the researchers, who were led by Miao-Fen Chen, MD, PhD, of Chang Gung University, Taoyuan City, Taiwan. “This study provides useful dose constraints of the oral cavity that may be associated with reduced taste dysfunction.”

Degradation of taste is an important quality of life factor for head and neck cancer patients. A 2021 systematic review published in the journal Radiotherapy and Oncology found that acute taste dysfunction affected 96% of patients as measured objectively, and 79% as measured subjectively. While most patients recover an estimated 23-53% of patients experience long-term dysfunction.

In 2019, a study published in the journal Chemical Senses found that 31% of head and neck cancer patients had long-term changes to taste at 27 months after intensity-modulated radiotherapy (IMRT), with dysfunction associated with glossectomy and oral cavity radiation doses greater than 50 Gy, but the study only used one quality of life subjective measure to evaluate taste function.

In the new JAMA study, researchers reported the results of a longitudinal using the whole-mouth solution method for basic tastes, including salt, sweet, sour, and bitter.
 

Study methodology

The study included 87 patients (mean age, 58 years; 90% men) who were enrolled between 2017 and 2020 from a single hospital. 45 patients received primary intensity-modulated radiotherapy and 42 received postoperative radiotherapy. 78 patients received volumetric arc therapy, and 9 received intensity-modulated radiotherapy. The radiotherapy was directed to minimize the effect on the parotid glands and oral cavity.

Researchers measured taste dysfunction according to detection thresholds based on solutions with different concentrations. After moving the solution around the mouth and spitting it out, patients were asked to identify taste components. Following a water rinse, they tested a solution with another concentration of taste components. A number was assigned based on the concentration level they were able to detect, with nigher numbers indicating greater sensitivity.

Two to four weeks after initiation of radiotherapy, there were drops in taste scores for salt (4.7 to 1.4), sweet (4.2 to 1.8), sour (4.5 to 2.3), and bitter (4.7 to 1.2). 1 week after radiotherapy, those mean scores increased to 2.6, 2.6, 2.9, and 2.3 respectively. Over the following 3 months, mean scores reflected general recovery to near preradiotherapy levels (4.2, 3.9, 4.1, and 4.0, respectively). At 6 months and 1 year, the scores were equivalent to preradiotherapy levels.

Objective taste tests were performed on 81 participants. 33.3% had taste dysfunction 6 months after radiotherapy. 6 months after, 8.9% had taste dysfunction. At 3 months following radiotherapy, taste dysfunction was associated with an oral cavity mean dose of 4,000 cGy or higher (relative risk, 2.87; 95% confidence interval, 1.21-6.81) or 5,000 cGy or higher (RR, 2.04; 95% CI, 1.12-3.72). At 6 months, taste dysfunction was predicted by glossectomy (RR, 5.63; 95% CI, 1.12-28.15) and oral cavity mean dose 5,000 cGy or greater (RR, 7.79; 95% CI, 0.93-64.92).

The researchers quantified the relationship between mean oral cavity dose and probability of developing taste dysfunction at 3 and 6 months. 3 months after radiotherapy, 25 Gy predicted a 15% chance, 38 Gy predicted a 25% chance, and 60 Gy predicted a 50% chance. At 6 months, the numbers were 57, 60, and 64 Gy.

The study was limited by being conducted at a single center and its small sample size, and it recruited patients varied significantly in treatment modality and disease subtype.

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FROM JAMA OTOLARYNGOLOGY–HEAD AND NECK SURGERY

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Fewer transplants for MM with quadruplet therapy?

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Mon, 08/01/2022 - 17:10

New results with quadruple drug therapy in the frontline treatment of multiple myeloma (MM) are prompting experts to speculate that stem cell transplantation may soon be able to take a back seat in the treatment of newly diagnosed disease.

“It is not a big leap of faith to imagine that, in the near future, with the availability of quadruplets and T-cell therapies, the role of high-dose melphalan and autologous stem cell transplant will be diminished,” said Dickran Kazandjian, MD, and Ola Landgren, MD, PhD, of the myeloma division, Sylvester Comprehensive Cancer Center, University of Miami.

They commented in a editorial in JAMA Oncology, prompted by a paper describing new results with a novel quadruple combination of therapies. These treatments included the monoclonal antibody elotuzumab (Empliciti) added onto the established backbone of carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (known as KRd).

“Regardless of what the future holds for elotuzumab-based combinations, it is clear that the new treatment paradigm of newly diagnosed MM will incorporate antibody-based quadruplet regimens,” the editorialists commented.

“Novel immunotherapies are here to stay,” they added, “as they are already transforming the lives of patients with multiple MM and bringing a bright horizon to the treatment landscape.”
 

Study details

The trial of the novel quadruplet regimen was a multicenter, single-arm, phase 2 study that involved 46 patients with newly diagnosed multiple myeloma, explain first author Benjamin A. Derman, MD, of the University of Chicago Medical Center, and colleagues.

These patients had a median age of 62; more than two-thirds were male (72%) and White (70%). About half (48%) had high-risk cytogenetic abnormalities.

All patients were treated with 12 cycles of the quadruple therapy Elo-KRd regimen. They underwent bone marrow assessment of measurable residual disease (MRD; with 10-5 sensitivity) after cycle 8 and cycle 12.

“An MRD-adapted treatment approach is rational because it may identify which patients can be administered shorter courses of intensive therapy without compromising efficacy,” the authors explained.

Patients who had MRD negativity at both time points did not receive further Elo-KRd, while patients who converted from MRD positivity to negativity in between cycles 8 and 12 received 6 additional cycles of Elo-KRd. Those who remained MRD positive or converted to positivity after 12 cycles received an additional 12 cycles of Elo-KRd.

Following Elo-KRd treatment, all patients transitioned to triple therapy with Elo-Rd (with no carfilzomib), for indefinite maintenance therapy or until disease progression.

For the primary endpoint, the rate of stringent complete response and/or MRD-negativity after cycle 8 was 58% (26 of 45), meeting the predefined definition of efficacy. 

Importantly, 26% of patients converted from MRD positivity after cycle 8 to negativity at a later time point, while 50% of patients reached 1-year sustained MRD negativity.

Overall, the estimated 3-year, progression-free survival was 72%, and the rate was 92% for patients with MRD-negativity at cycle 8. The overall survival rate was 78%.

The most common grade 3 or 4 adverse events were lung and nonpulmonary infections (13% and 11%, respectively), and one patient had a grade 5 MI. Three patients discontinued the treatment because of intolerance.

“An MRD-adapted design using elotuzumab and weekly KRd without autologous stem cell transplantation showed a high rate of stringent complete response (sCR) and/or MRD-negativity and durable responses,” the authors wrote.

“This approach provides support for further evaluation of MRD-guided de-escalation of therapy to decrease treatment exposure while sustaining deep responses.”

To better assess the difference of the therapy versus treatment including stem cell transplantation, a phase 3, randomized trial is currently underway to compare the Elo-KRd regimen against KRd with autologous stem cell transplant in newly diagnosed MM.

“If Elo-KRd proves superior, a randomized comparison of Elo versus anti-CD38 mAb-based quadruplets would help determine the optimal combination of therapies in the frontline setting,” the authors noted.
 

 

 

Randomized trial anticipated to clarify benefit

In their editorial, Dr. Kazandjian and Dr. Landgren agreed with the authors that the role of elotuzumab needs to be better clarified in a randomized trial setting.

Elotuzumab received FDA approval in 2015 based on results from the ELOQUENT-2 study, which showed improved progression-free survival and overall survival with the addition of elotuzumab to lenalidomide and dexamethasone in patients with multiple myeloma who have previously received one to three other therapies.

However, the editorialists pointed out that recently published results from the randomized ELOQUENT-1 trial of lenalidomide and dexamethasone with and without elotuzumab showed the addition of elotuzumab was not associated with a statistically significant difference in progression-free survival.

The editorialists also pointed out that, in the setting of newly diagnosed multiple myeloma, another recent, similarly designed study found that the backbone regimen of carfilzomib, lenalidomide, and dexamethasone – on its own – was also associated with a favorable MRD-negative rate of 62%.

In addition, several studies involving novel quadruple treatments with the monoclonal antibody daratumumab (Darzalex) instead of elotuzumab, have also shown benefit in newly diagnosed multiple myeloma, resulting in high rates of MRD negativity.

Collectively, the findings bode well for the quadruple regimens in the treatment of MM, the editorialists emphasized.

“Importantly, with the rate of deep remissions observed with antibody-based quadruplet therapies, one may question the role of using early high-dose melphalan and autologous stem cell transplant in every patient, especially in those who have achieved MRD negativity with the quadruplet alone,” they added.

The study was sponsored in part by Amgen, Bristol-Myers Squibb, and the Multiple Myeloma Research Consortium. Dr. Derman reported advisory board fees from Sanofi, Janssen, and COTA Healthcare; honoraria from PleXus Communications and MJH Life Sciences. Dr. Kazandjian declares receiving advisory board or consulting fees from Bristol-Myers Squibb, Sanofi, and Arcellx outside the submitted work. Dr. Landgren has received grant support from numerous organizations and pharmaceutical companies. Dr. Landgren has also received honoraria for scientific talks/participated in advisory boards for Adaptive Biotech, Amgen, Binding Site, Bristol-Myers Squibb, Celgene, Cellectis, Glenmark, Janssen, Juno, and Pfizer, and served on independent data monitoring committees for international randomized trials by Takeda, Merck, Janssen, and Theradex.

A version of this article first appeared on Medscape.com.

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New results with quadruple drug therapy in the frontline treatment of multiple myeloma (MM) are prompting experts to speculate that stem cell transplantation may soon be able to take a back seat in the treatment of newly diagnosed disease.

“It is not a big leap of faith to imagine that, in the near future, with the availability of quadruplets and T-cell therapies, the role of high-dose melphalan and autologous stem cell transplant will be diminished,” said Dickran Kazandjian, MD, and Ola Landgren, MD, PhD, of the myeloma division, Sylvester Comprehensive Cancer Center, University of Miami.

They commented in a editorial in JAMA Oncology, prompted by a paper describing new results with a novel quadruple combination of therapies. These treatments included the monoclonal antibody elotuzumab (Empliciti) added onto the established backbone of carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (known as KRd).

“Regardless of what the future holds for elotuzumab-based combinations, it is clear that the new treatment paradigm of newly diagnosed MM will incorporate antibody-based quadruplet regimens,” the editorialists commented.

“Novel immunotherapies are here to stay,” they added, “as they are already transforming the lives of patients with multiple MM and bringing a bright horizon to the treatment landscape.”
 

Study details

The trial of the novel quadruplet regimen was a multicenter, single-arm, phase 2 study that involved 46 patients with newly diagnosed multiple myeloma, explain first author Benjamin A. Derman, MD, of the University of Chicago Medical Center, and colleagues.

These patients had a median age of 62; more than two-thirds were male (72%) and White (70%). About half (48%) had high-risk cytogenetic abnormalities.

All patients were treated with 12 cycles of the quadruple therapy Elo-KRd regimen. They underwent bone marrow assessment of measurable residual disease (MRD; with 10-5 sensitivity) after cycle 8 and cycle 12.

“An MRD-adapted treatment approach is rational because it may identify which patients can be administered shorter courses of intensive therapy without compromising efficacy,” the authors explained.

Patients who had MRD negativity at both time points did not receive further Elo-KRd, while patients who converted from MRD positivity to negativity in between cycles 8 and 12 received 6 additional cycles of Elo-KRd. Those who remained MRD positive or converted to positivity after 12 cycles received an additional 12 cycles of Elo-KRd.

Following Elo-KRd treatment, all patients transitioned to triple therapy with Elo-Rd (with no carfilzomib), for indefinite maintenance therapy or until disease progression.

For the primary endpoint, the rate of stringent complete response and/or MRD-negativity after cycle 8 was 58% (26 of 45), meeting the predefined definition of efficacy. 

Importantly, 26% of patients converted from MRD positivity after cycle 8 to negativity at a later time point, while 50% of patients reached 1-year sustained MRD negativity.

Overall, the estimated 3-year, progression-free survival was 72%, and the rate was 92% for patients with MRD-negativity at cycle 8. The overall survival rate was 78%.

The most common grade 3 or 4 adverse events were lung and nonpulmonary infections (13% and 11%, respectively), and one patient had a grade 5 MI. Three patients discontinued the treatment because of intolerance.

“An MRD-adapted design using elotuzumab and weekly KRd without autologous stem cell transplantation showed a high rate of stringent complete response (sCR) and/or MRD-negativity and durable responses,” the authors wrote.

“This approach provides support for further evaluation of MRD-guided de-escalation of therapy to decrease treatment exposure while sustaining deep responses.”

To better assess the difference of the therapy versus treatment including stem cell transplantation, a phase 3, randomized trial is currently underway to compare the Elo-KRd regimen against KRd with autologous stem cell transplant in newly diagnosed MM.

“If Elo-KRd proves superior, a randomized comparison of Elo versus anti-CD38 mAb-based quadruplets would help determine the optimal combination of therapies in the frontline setting,” the authors noted.
 

 

 

Randomized trial anticipated to clarify benefit

In their editorial, Dr. Kazandjian and Dr. Landgren agreed with the authors that the role of elotuzumab needs to be better clarified in a randomized trial setting.

Elotuzumab received FDA approval in 2015 based on results from the ELOQUENT-2 study, which showed improved progression-free survival and overall survival with the addition of elotuzumab to lenalidomide and dexamethasone in patients with multiple myeloma who have previously received one to three other therapies.

However, the editorialists pointed out that recently published results from the randomized ELOQUENT-1 trial of lenalidomide and dexamethasone with and without elotuzumab showed the addition of elotuzumab was not associated with a statistically significant difference in progression-free survival.

The editorialists also pointed out that, in the setting of newly diagnosed multiple myeloma, another recent, similarly designed study found that the backbone regimen of carfilzomib, lenalidomide, and dexamethasone – on its own – was also associated with a favorable MRD-negative rate of 62%.

In addition, several studies involving novel quadruple treatments with the monoclonal antibody daratumumab (Darzalex) instead of elotuzumab, have also shown benefit in newly diagnosed multiple myeloma, resulting in high rates of MRD negativity.

Collectively, the findings bode well for the quadruple regimens in the treatment of MM, the editorialists emphasized.

“Importantly, with the rate of deep remissions observed with antibody-based quadruplet therapies, one may question the role of using early high-dose melphalan and autologous stem cell transplant in every patient, especially in those who have achieved MRD negativity with the quadruplet alone,” they added.

The study was sponsored in part by Amgen, Bristol-Myers Squibb, and the Multiple Myeloma Research Consortium. Dr. Derman reported advisory board fees from Sanofi, Janssen, and COTA Healthcare; honoraria from PleXus Communications and MJH Life Sciences. Dr. Kazandjian declares receiving advisory board or consulting fees from Bristol-Myers Squibb, Sanofi, and Arcellx outside the submitted work. Dr. Landgren has received grant support from numerous organizations and pharmaceutical companies. Dr. Landgren has also received honoraria for scientific talks/participated in advisory boards for Adaptive Biotech, Amgen, Binding Site, Bristol-Myers Squibb, Celgene, Cellectis, Glenmark, Janssen, Juno, and Pfizer, and served on independent data monitoring committees for international randomized trials by Takeda, Merck, Janssen, and Theradex.

A version of this article first appeared on Medscape.com.

New results with quadruple drug therapy in the frontline treatment of multiple myeloma (MM) are prompting experts to speculate that stem cell transplantation may soon be able to take a back seat in the treatment of newly diagnosed disease.

“It is not a big leap of faith to imagine that, in the near future, with the availability of quadruplets and T-cell therapies, the role of high-dose melphalan and autologous stem cell transplant will be diminished,” said Dickran Kazandjian, MD, and Ola Landgren, MD, PhD, of the myeloma division, Sylvester Comprehensive Cancer Center, University of Miami.

They commented in a editorial in JAMA Oncology, prompted by a paper describing new results with a novel quadruple combination of therapies. These treatments included the monoclonal antibody elotuzumab (Empliciti) added onto the established backbone of carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (known as KRd).

“Regardless of what the future holds for elotuzumab-based combinations, it is clear that the new treatment paradigm of newly diagnosed MM will incorporate antibody-based quadruplet regimens,” the editorialists commented.

“Novel immunotherapies are here to stay,” they added, “as they are already transforming the lives of patients with multiple MM and bringing a bright horizon to the treatment landscape.”
 

Study details

The trial of the novel quadruplet regimen was a multicenter, single-arm, phase 2 study that involved 46 patients with newly diagnosed multiple myeloma, explain first author Benjamin A. Derman, MD, of the University of Chicago Medical Center, and colleagues.

These patients had a median age of 62; more than two-thirds were male (72%) and White (70%). About half (48%) had high-risk cytogenetic abnormalities.

All patients were treated with 12 cycles of the quadruple therapy Elo-KRd regimen. They underwent bone marrow assessment of measurable residual disease (MRD; with 10-5 sensitivity) after cycle 8 and cycle 12.

“An MRD-adapted treatment approach is rational because it may identify which patients can be administered shorter courses of intensive therapy without compromising efficacy,” the authors explained.

Patients who had MRD negativity at both time points did not receive further Elo-KRd, while patients who converted from MRD positivity to negativity in between cycles 8 and 12 received 6 additional cycles of Elo-KRd. Those who remained MRD positive or converted to positivity after 12 cycles received an additional 12 cycles of Elo-KRd.

Following Elo-KRd treatment, all patients transitioned to triple therapy with Elo-Rd (with no carfilzomib), for indefinite maintenance therapy or until disease progression.

For the primary endpoint, the rate of stringent complete response and/or MRD-negativity after cycle 8 was 58% (26 of 45), meeting the predefined definition of efficacy. 

Importantly, 26% of patients converted from MRD positivity after cycle 8 to negativity at a later time point, while 50% of patients reached 1-year sustained MRD negativity.

Overall, the estimated 3-year, progression-free survival was 72%, and the rate was 92% for patients with MRD-negativity at cycle 8. The overall survival rate was 78%.

The most common grade 3 or 4 adverse events were lung and nonpulmonary infections (13% and 11%, respectively), and one patient had a grade 5 MI. Three patients discontinued the treatment because of intolerance.

“An MRD-adapted design using elotuzumab and weekly KRd without autologous stem cell transplantation showed a high rate of stringent complete response (sCR) and/or MRD-negativity and durable responses,” the authors wrote.

“This approach provides support for further evaluation of MRD-guided de-escalation of therapy to decrease treatment exposure while sustaining deep responses.”

To better assess the difference of the therapy versus treatment including stem cell transplantation, a phase 3, randomized trial is currently underway to compare the Elo-KRd regimen against KRd with autologous stem cell transplant in newly diagnosed MM.

“If Elo-KRd proves superior, a randomized comparison of Elo versus anti-CD38 mAb-based quadruplets would help determine the optimal combination of therapies in the frontline setting,” the authors noted.
 

 

 

Randomized trial anticipated to clarify benefit

In their editorial, Dr. Kazandjian and Dr. Landgren agreed with the authors that the role of elotuzumab needs to be better clarified in a randomized trial setting.

Elotuzumab received FDA approval in 2015 based on results from the ELOQUENT-2 study, which showed improved progression-free survival and overall survival with the addition of elotuzumab to lenalidomide and dexamethasone in patients with multiple myeloma who have previously received one to three other therapies.

However, the editorialists pointed out that recently published results from the randomized ELOQUENT-1 trial of lenalidomide and dexamethasone with and without elotuzumab showed the addition of elotuzumab was not associated with a statistically significant difference in progression-free survival.

The editorialists also pointed out that, in the setting of newly diagnosed multiple myeloma, another recent, similarly designed study found that the backbone regimen of carfilzomib, lenalidomide, and dexamethasone – on its own – was also associated with a favorable MRD-negative rate of 62%.

In addition, several studies involving novel quadruple treatments with the monoclonal antibody daratumumab (Darzalex) instead of elotuzumab, have also shown benefit in newly diagnosed multiple myeloma, resulting in high rates of MRD negativity.

Collectively, the findings bode well for the quadruple regimens in the treatment of MM, the editorialists emphasized.

“Importantly, with the rate of deep remissions observed with antibody-based quadruplet therapies, one may question the role of using early high-dose melphalan and autologous stem cell transplant in every patient, especially in those who have achieved MRD negativity with the quadruplet alone,” they added.

The study was sponsored in part by Amgen, Bristol-Myers Squibb, and the Multiple Myeloma Research Consortium. Dr. Derman reported advisory board fees from Sanofi, Janssen, and COTA Healthcare; honoraria from PleXus Communications and MJH Life Sciences. Dr. Kazandjian declares receiving advisory board or consulting fees from Bristol-Myers Squibb, Sanofi, and Arcellx outside the submitted work. Dr. Landgren has received grant support from numerous organizations and pharmaceutical companies. Dr. Landgren has also received honoraria for scientific talks/participated in advisory boards for Adaptive Biotech, Amgen, Binding Site, Bristol-Myers Squibb, Celgene, Cellectis, Glenmark, Janssen, Juno, and Pfizer, and served on independent data monitoring committees for international randomized trials by Takeda, Merck, Janssen, and Theradex.

A version of this article first appeared on Medscape.com.

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FROM JAMA ONCOLOGY

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