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Safety of Nivolumab: A Medication Use Evaluation

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Background: Nivolumab (Opdivo) was initially FDAapproved at a dose of 3mg/kg by intravenous infusion over 60 minutes every 2 weeks. In September 2016, nivolumab’s FDA approved dosing was changed from 3mg/kg to a 240mg flat dose. In January 2018, nivolumab’s FDA approved dosing was updated to reflect a decreased infusion time of 30 minutes. In March 2018, nivolumab’s FDA approved dosing was again modified from 240mg every 2 weeks to 480mg every 4 weeks. The VA Northeast Ohio Healthcare System (VANEOHS) adopted the 480mg every 4 weeks regimen in March 2018. The increased nivolumab dose and shortened infusion time raised some concern regarding immune-mediated toxicities which was the rationale behind this medication use evaluation (MUE).

Methods: This retrospective chart review was completed to compare the incidence of toxicity between the every 2 week and the every 4 week dosing schedules and evaluate the adoption of every 4 week dosing regimen by VANEOHS prescribers. Patients newly initiated on nivolumab between 10/1/17 and 9/30/18 were reviewed for the occurrence of immune-mediated adverse events (AEs) within the first 3 months of treatment.

Results: Sixty-five patients were included in the MUE, with 21 (46%) initiated on 240mg every 2 weeks and 25 (54%) initiated on 480mg every 4 weeks. All patients initiated on 240mg every 2 weeks were either converted to 480mg every 4 weeks, or nivolumab therapy was discontinued prior to VANEOHS adoption of the 4 week dosing regimen. Immune-mediated AEs potentially related to nivolumab therapy were documented in 8 (32%) patients receiving 480mg, and 4 (36%) patients receiving 240mg. Of patients who switched from nivolumab 240mg to 480mg, 3 (30%) experienced an AE while receiving 240mg, and 1 (10%) while receiving 480mg.

Conclusion: The nivolumab 480mg every 4 week dosing regimen was readily adopted by oncology providers at VANEOHS and the rate of patients experiencing AEs with nivolumab 480mg every 4 weeks compared to 240mg every 2 weeks, was similar between treatment groups. The results of this MUE support continued prescribing of the nivolumab 480mg every 4 week dosing regimen with close monitoring for adverse reactions.

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Background: Nivolumab (Opdivo) was initially FDAapproved at a dose of 3mg/kg by intravenous infusion over 60 minutes every 2 weeks. In September 2016, nivolumab’s FDA approved dosing was changed from 3mg/kg to a 240mg flat dose. In January 2018, nivolumab’s FDA approved dosing was updated to reflect a decreased infusion time of 30 minutes. In March 2018, nivolumab’s FDA approved dosing was again modified from 240mg every 2 weeks to 480mg every 4 weeks. The VA Northeast Ohio Healthcare System (VANEOHS) adopted the 480mg every 4 weeks regimen in March 2018. The increased nivolumab dose and shortened infusion time raised some concern regarding immune-mediated toxicities which was the rationale behind this medication use evaluation (MUE).

Methods: This retrospective chart review was completed to compare the incidence of toxicity between the every 2 week and the every 4 week dosing schedules and evaluate the adoption of every 4 week dosing regimen by VANEOHS prescribers. Patients newly initiated on nivolumab between 10/1/17 and 9/30/18 were reviewed for the occurrence of immune-mediated adverse events (AEs) within the first 3 months of treatment.

Results: Sixty-five patients were included in the MUE, with 21 (46%) initiated on 240mg every 2 weeks and 25 (54%) initiated on 480mg every 4 weeks. All patients initiated on 240mg every 2 weeks were either converted to 480mg every 4 weeks, or nivolumab therapy was discontinued prior to VANEOHS adoption of the 4 week dosing regimen. Immune-mediated AEs potentially related to nivolumab therapy were documented in 8 (32%) patients receiving 480mg, and 4 (36%) patients receiving 240mg. Of patients who switched from nivolumab 240mg to 480mg, 3 (30%) experienced an AE while receiving 240mg, and 1 (10%) while receiving 480mg.

Conclusion: The nivolumab 480mg every 4 week dosing regimen was readily adopted by oncology providers at VANEOHS and the rate of patients experiencing AEs with nivolumab 480mg every 4 weeks compared to 240mg every 2 weeks, was similar between treatment groups. The results of this MUE support continued prescribing of the nivolumab 480mg every 4 week dosing regimen with close monitoring for adverse reactions.

Background: Nivolumab (Opdivo) was initially FDAapproved at a dose of 3mg/kg by intravenous infusion over 60 minutes every 2 weeks. In September 2016, nivolumab’s FDA approved dosing was changed from 3mg/kg to a 240mg flat dose. In January 2018, nivolumab’s FDA approved dosing was updated to reflect a decreased infusion time of 30 minutes. In March 2018, nivolumab’s FDA approved dosing was again modified from 240mg every 2 weeks to 480mg every 4 weeks. The VA Northeast Ohio Healthcare System (VANEOHS) adopted the 480mg every 4 weeks regimen in March 2018. The increased nivolumab dose and shortened infusion time raised some concern regarding immune-mediated toxicities which was the rationale behind this medication use evaluation (MUE).

Methods: This retrospective chart review was completed to compare the incidence of toxicity between the every 2 week and the every 4 week dosing schedules and evaluate the adoption of every 4 week dosing regimen by VANEOHS prescribers. Patients newly initiated on nivolumab between 10/1/17 and 9/30/18 were reviewed for the occurrence of immune-mediated adverse events (AEs) within the first 3 months of treatment.

Results: Sixty-five patients were included in the MUE, with 21 (46%) initiated on 240mg every 2 weeks and 25 (54%) initiated on 480mg every 4 weeks. All patients initiated on 240mg every 2 weeks were either converted to 480mg every 4 weeks, or nivolumab therapy was discontinued prior to VANEOHS adoption of the 4 week dosing regimen. Immune-mediated AEs potentially related to nivolumab therapy were documented in 8 (32%) patients receiving 480mg, and 4 (36%) patients receiving 240mg. Of patients who switched from nivolumab 240mg to 480mg, 3 (30%) experienced an AE while receiving 240mg, and 1 (10%) while receiving 480mg.

Conclusion: The nivolumab 480mg every 4 week dosing regimen was readily adopted by oncology providers at VANEOHS and the rate of patients experiencing AEs with nivolumab 480mg every 4 weeks compared to 240mg every 2 weeks, was similar between treatment groups. The results of this MUE support continued prescribing of the nivolumab 480mg every 4 week dosing regimen with close monitoring for adverse reactions.

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Oral Anticancer Medication (OAM) Adherence & Safety Monitoring Among US Veterans at the VA Portland Health Care System (VAPORHCS)

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Background: Poor adherence to oral anticancer medications (OAMs) is a well-recognized problem in oncology, however adherence to OAMs among veterans is largely unknown. Medication cost is often mitigated, however higher rates of comorbidities within the veteran population may contribute to impaired adherence. Additionally veterans living outside local catchments may be at increased risk for non-adherence or inadequate follow up due to geographic burden.

Cancer rates nationwide are projected to increase over the next 10-20 years. The Veterans Health Administration is the largest integrated health care system in the US, and characterizing OAM adherence and any potential barriers is valuable in improving veterans’ care.

Project Description: The purpose of this study is to investigate and characterize adherence to OAMs and recommend safety monitoring studies among US veterans enrolled at the VAPORHCS, as part of a fellowship quality improvement program initiative. This is a retrospective chart review of all veterans followed within the VAPORHCS hematology/oncology fellows’ clinic, who were taking OAMs from March 1, 2018 to March 1, 2019. Fellows reviewed their own panels, with an internal medicine faculty member performing an independent review on a portion of the charts. Information collected includes adherence to medications as well as recommended monitoring, as determined by provider notes, pharmacy records, and lab and imaging records. Additional information collected includes demographics, co-morbidities, polypharmacy, and service connection.

Results: Primary co-objectives of this project will be determining adherence to both medications and recommended routine monitoring studies (ie labs, imaging, and follow-up appointments). Secondary objectives will be characterizing adherence in relation to other patient factors, such as age, geographic location, primary malignancy, co-morbidities, polypharmacy, and service connection. This project was initiated in fall of 2018. The data has currently been all collected and is undergoing review and analysis. Full results should be available by end of July 2019.

Data Analysis: Initial data processing and univariate analysis is currently ongoing. We currently have plans to pursue multivariate analysis of the results through the Oregon Health and Science University Biostatics Shared Resource (BSR) Department.

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Background: Poor adherence to oral anticancer medications (OAMs) is a well-recognized problem in oncology, however adherence to OAMs among veterans is largely unknown. Medication cost is often mitigated, however higher rates of comorbidities within the veteran population may contribute to impaired adherence. Additionally veterans living outside local catchments may be at increased risk for non-adherence or inadequate follow up due to geographic burden.

Cancer rates nationwide are projected to increase over the next 10-20 years. The Veterans Health Administration is the largest integrated health care system in the US, and characterizing OAM adherence and any potential barriers is valuable in improving veterans’ care.

Project Description: The purpose of this study is to investigate and characterize adherence to OAMs and recommend safety monitoring studies among US veterans enrolled at the VAPORHCS, as part of a fellowship quality improvement program initiative. This is a retrospective chart review of all veterans followed within the VAPORHCS hematology/oncology fellows’ clinic, who were taking OAMs from March 1, 2018 to March 1, 2019. Fellows reviewed their own panels, with an internal medicine faculty member performing an independent review on a portion of the charts. Information collected includes adherence to medications as well as recommended monitoring, as determined by provider notes, pharmacy records, and lab and imaging records. Additional information collected includes demographics, co-morbidities, polypharmacy, and service connection.

Results: Primary co-objectives of this project will be determining adherence to both medications and recommended routine monitoring studies (ie labs, imaging, and follow-up appointments). Secondary objectives will be characterizing adherence in relation to other patient factors, such as age, geographic location, primary malignancy, co-morbidities, polypharmacy, and service connection. This project was initiated in fall of 2018. The data has currently been all collected and is undergoing review and analysis. Full results should be available by end of July 2019.

Data Analysis: Initial data processing and univariate analysis is currently ongoing. We currently have plans to pursue multivariate analysis of the results through the Oregon Health and Science University Biostatics Shared Resource (BSR) Department.

Background: Poor adherence to oral anticancer medications (OAMs) is a well-recognized problem in oncology, however adherence to OAMs among veterans is largely unknown. Medication cost is often mitigated, however higher rates of comorbidities within the veteran population may contribute to impaired adherence. Additionally veterans living outside local catchments may be at increased risk for non-adherence or inadequate follow up due to geographic burden.

Cancer rates nationwide are projected to increase over the next 10-20 years. The Veterans Health Administration is the largest integrated health care system in the US, and characterizing OAM adherence and any potential barriers is valuable in improving veterans’ care.

Project Description: The purpose of this study is to investigate and characterize adherence to OAMs and recommend safety monitoring studies among US veterans enrolled at the VAPORHCS, as part of a fellowship quality improvement program initiative. This is a retrospective chart review of all veterans followed within the VAPORHCS hematology/oncology fellows’ clinic, who were taking OAMs from March 1, 2018 to March 1, 2019. Fellows reviewed their own panels, with an internal medicine faculty member performing an independent review on a portion of the charts. Information collected includes adherence to medications as well as recommended monitoring, as determined by provider notes, pharmacy records, and lab and imaging records. Additional information collected includes demographics, co-morbidities, polypharmacy, and service connection.

Results: Primary co-objectives of this project will be determining adherence to both medications and recommended routine monitoring studies (ie labs, imaging, and follow-up appointments). Secondary objectives will be characterizing adherence in relation to other patient factors, such as age, geographic location, primary malignancy, co-morbidities, polypharmacy, and service connection. This project was initiated in fall of 2018. The data has currently been all collected and is undergoing review and analysis. Full results should be available by end of July 2019.

Data Analysis: Initial data processing and univariate analysis is currently ongoing. We currently have plans to pursue multivariate analysis of the results through the Oregon Health and Science University Biostatics Shared Resource (BSR) Department.

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Expanding Access to Care with Palliative Video Telehealth

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Background: Tele-palliative care is an effective method of providing care for patients who wish to receive their care locally. In an effort to provide care to veterans that live remotely the Palliative Care program at the Pittsburgh VAMC created a Palliative Care Telemedicine clinic. The clinic provides a patient centered approach by working with primary care and subspecialists to manage symptoms, establish patient’s expectations with treatment and to determine what the patient is willing to endure to reach his/her goals. Patient focused care provides better quality of care and may result in a decrease in unwanted and inappropriate admissions, readmissions, tests, procedures and transfers to a higher level of care that may not align with the patient’s goals of care.

Methods: In 2018 the Palliative Care program partnered with Oncology to provide comprehensive patient care by CVT. Patients who requested that their chemotherapy/ immunotherapy be done at the local VA were seen by Oncology in Pittsburgh with subsequent visits and treatment done in the infusion clinic at the local VA. Patients were seen by Oncology by CVT prior to each treatment, Patients with stage IV disease or who had extensive symptom burden were referred for telepalliative care and were seen on the same day that they were seen by their Oncologist.

Results: Since 2018, 51 patients with the diagnosis of cancer were referred for both Oncology and Palliative Care CVT. There were a total of 211 clinic visits. Patents were primarily referred for symptom management and goals of care. Since January 2018, 22 patients are alive, 24 patients have died and 5 patients are currently receiving hospice care. 21 patients died at home or in a CLC—1 died in the hospital and 2 sites of death are unknown.

Conclusion: Preliminary data suggests that tele-palliative care can provide effective symptom management and may reduce deaths in an acute care setting. The palliative care program plans to expand tele-palliative care by offering this service to other facilities in the VISN as well as partnering with home hospice agencies to provide VVC for patients that are on hospice.

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Background: Tele-palliative care is an effective method of providing care for patients who wish to receive their care locally. In an effort to provide care to veterans that live remotely the Palliative Care program at the Pittsburgh VAMC created a Palliative Care Telemedicine clinic. The clinic provides a patient centered approach by working with primary care and subspecialists to manage symptoms, establish patient’s expectations with treatment and to determine what the patient is willing to endure to reach his/her goals. Patient focused care provides better quality of care and may result in a decrease in unwanted and inappropriate admissions, readmissions, tests, procedures and transfers to a higher level of care that may not align with the patient’s goals of care.

Methods: In 2018 the Palliative Care program partnered with Oncology to provide comprehensive patient care by CVT. Patients who requested that their chemotherapy/ immunotherapy be done at the local VA were seen by Oncology in Pittsburgh with subsequent visits and treatment done in the infusion clinic at the local VA. Patients were seen by Oncology by CVT prior to each treatment, Patients with stage IV disease or who had extensive symptom burden were referred for telepalliative care and were seen on the same day that they were seen by their Oncologist.

Results: Since 2018, 51 patients with the diagnosis of cancer were referred for both Oncology and Palliative Care CVT. There were a total of 211 clinic visits. Patents were primarily referred for symptom management and goals of care. Since January 2018, 22 patients are alive, 24 patients have died and 5 patients are currently receiving hospice care. 21 patients died at home or in a CLC—1 died in the hospital and 2 sites of death are unknown.

Conclusion: Preliminary data suggests that tele-palliative care can provide effective symptom management and may reduce deaths in an acute care setting. The palliative care program plans to expand tele-palliative care by offering this service to other facilities in the VISN as well as partnering with home hospice agencies to provide VVC for patients that are on hospice.

Background: Tele-palliative care is an effective method of providing care for patients who wish to receive their care locally. In an effort to provide care to veterans that live remotely the Palliative Care program at the Pittsburgh VAMC created a Palliative Care Telemedicine clinic. The clinic provides a patient centered approach by working with primary care and subspecialists to manage symptoms, establish patient’s expectations with treatment and to determine what the patient is willing to endure to reach his/her goals. Patient focused care provides better quality of care and may result in a decrease in unwanted and inappropriate admissions, readmissions, tests, procedures and transfers to a higher level of care that may not align with the patient’s goals of care.

Methods: In 2018 the Palliative Care program partnered with Oncology to provide comprehensive patient care by CVT. Patients who requested that their chemotherapy/ immunotherapy be done at the local VA were seen by Oncology in Pittsburgh with subsequent visits and treatment done in the infusion clinic at the local VA. Patients were seen by Oncology by CVT prior to each treatment, Patients with stage IV disease or who had extensive symptom burden were referred for telepalliative care and were seen on the same day that they were seen by their Oncologist.

Results: Since 2018, 51 patients with the diagnosis of cancer were referred for both Oncology and Palliative Care CVT. There were a total of 211 clinic visits. Patents were primarily referred for symptom management and goals of care. Since January 2018, 22 patients are alive, 24 patients have died and 5 patients are currently receiving hospice care. 21 patients died at home or in a CLC—1 died in the hospital and 2 sites of death are unknown.

Conclusion: Preliminary data suggests that tele-palliative care can provide effective symptom management and may reduce deaths in an acute care setting. The palliative care program plans to expand tele-palliative care by offering this service to other facilities in the VISN as well as partnering with home hospice agencies to provide VVC for patients that are on hospice.

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Low-Dose Screening CT for Lung Cancer in Selected High-Risk Veterans with a Significant Smoking History: The Providence VA’s Experience

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Background: In the US, Lung cancer is the second most common malignancy, but the most common cause of cancer deaths. In 2010, the National Lung Screening Trial described a 20.3% reduction in lung cancer mortality in high-risk patients screened by low-dose spiral CT (LDCT). In 2012, multiple groups established screening guidelines. The National Comprehensive Cancer Network recommended yearly screening for patients aged 55 to 75 years, 30 packyears of smoking, or smoking cessation within 15 years. In late 2013, LDCT screening for lung cancer was initiated at the Providence VA Medical Center. It was anticipated that over time there would be a rise in early stage cancers and decrease in late stage cancers. We submitted preliminary data at AVAHO in 2015 with increased earlier detection as anticipated. We have now completed 5 years of screening and are presenting data from 2014 through 2018.

Results: The number of screening CTs has increased almost every year (1929, 1875, 1916, 2201, 2336 respectively), and the number with cancer decreased from 1.34% (2014) to 0.008% (2018). The majority of NSCLCs found have been early stage, but with Small Cell Lung Cancer, 50% had limited and 50% extensive disease. Yearly screening is not likely to increase early detection of Small Cell Lung Cancer. Percentages of stage I & II for NSCLC prior to screening were 30% and 27% in 2012 and 2013 respectively. In 2014 – 2018 percentages were 69%, 60%, 50%, 83% and 50%. In 2016 and 2018, several veterans came to the VA to establish care with a known nodule, or had their first screening CT here, and they were found to have late stage disease. When we subtracted those first time screens the percentages of stage I & II were 69%, 60%, 78%, 83%, and 56%.

Discussion: As expected, for NSCLC yearly LDCT screening increased “pickup” of early stage disease. Unanswered questions include: How long should annual screening continue; What is the financial, emotional and radiation exposure impact of frequent screening, especially for those who need to be followed at more frequent intervals.

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Background: In the US, Lung cancer is the second most common malignancy, but the most common cause of cancer deaths. In 2010, the National Lung Screening Trial described a 20.3% reduction in lung cancer mortality in high-risk patients screened by low-dose spiral CT (LDCT). In 2012, multiple groups established screening guidelines. The National Comprehensive Cancer Network recommended yearly screening for patients aged 55 to 75 years, 30 packyears of smoking, or smoking cessation within 15 years. In late 2013, LDCT screening for lung cancer was initiated at the Providence VA Medical Center. It was anticipated that over time there would be a rise in early stage cancers and decrease in late stage cancers. We submitted preliminary data at AVAHO in 2015 with increased earlier detection as anticipated. We have now completed 5 years of screening and are presenting data from 2014 through 2018.

Results: The number of screening CTs has increased almost every year (1929, 1875, 1916, 2201, 2336 respectively), and the number with cancer decreased from 1.34% (2014) to 0.008% (2018). The majority of NSCLCs found have been early stage, but with Small Cell Lung Cancer, 50% had limited and 50% extensive disease. Yearly screening is not likely to increase early detection of Small Cell Lung Cancer. Percentages of stage I & II for NSCLC prior to screening were 30% and 27% in 2012 and 2013 respectively. In 2014 – 2018 percentages were 69%, 60%, 50%, 83% and 50%. In 2016 and 2018, several veterans came to the VA to establish care with a known nodule, or had their first screening CT here, and they were found to have late stage disease. When we subtracted those first time screens the percentages of stage I & II were 69%, 60%, 78%, 83%, and 56%.

Discussion: As expected, for NSCLC yearly LDCT screening increased “pickup” of early stage disease. Unanswered questions include: How long should annual screening continue; What is the financial, emotional and radiation exposure impact of frequent screening, especially for those who need to be followed at more frequent intervals.

Background: In the US, Lung cancer is the second most common malignancy, but the most common cause of cancer deaths. In 2010, the National Lung Screening Trial described a 20.3% reduction in lung cancer mortality in high-risk patients screened by low-dose spiral CT (LDCT). In 2012, multiple groups established screening guidelines. The National Comprehensive Cancer Network recommended yearly screening for patients aged 55 to 75 years, 30 packyears of smoking, or smoking cessation within 15 years. In late 2013, LDCT screening for lung cancer was initiated at the Providence VA Medical Center. It was anticipated that over time there would be a rise in early stage cancers and decrease in late stage cancers. We submitted preliminary data at AVAHO in 2015 with increased earlier detection as anticipated. We have now completed 5 years of screening and are presenting data from 2014 through 2018.

Results: The number of screening CTs has increased almost every year (1929, 1875, 1916, 2201, 2336 respectively), and the number with cancer decreased from 1.34% (2014) to 0.008% (2018). The majority of NSCLCs found have been early stage, but with Small Cell Lung Cancer, 50% had limited and 50% extensive disease. Yearly screening is not likely to increase early detection of Small Cell Lung Cancer. Percentages of stage I & II for NSCLC prior to screening were 30% and 27% in 2012 and 2013 respectively. In 2014 – 2018 percentages were 69%, 60%, 50%, 83% and 50%. In 2016 and 2018, several veterans came to the VA to establish care with a known nodule, or had their first screening CT here, and they were found to have late stage disease. When we subtracted those first time screens the percentages of stage I & II were 69%, 60%, 78%, 83%, and 56%.

Discussion: As expected, for NSCLC yearly LDCT screening increased “pickup” of early stage disease. Unanswered questions include: How long should annual screening continue; What is the financial, emotional and radiation exposure impact of frequent screening, especially for those who need to be followed at more frequent intervals.

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Integrating Palliative Care into Inpatient Oncology Service Via “Lightning Rounds”: A Pilot Study

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Background: A growing body of evidence suggests that palliative care is an important element of comprehensive cancer treatment by assisting with symptom management and establishing goals of care. Research suggests that enhanced integration of palliative care and oncology medicine has a positive effect on mortality and quality of life outcomes, and integration of the two is now considered standard care. However, there are no standard models for how this integration might occur. At our facility, there was no formal connection between the Oncology service and the Palliative Care Team.

Methods: The interdisciplinary Palliative Care Consult Team established weekly “Lightning Rounds” with Heme-Onc trainees, in which trainees answered questions about each patient regarding symptoms, prognosis, goals of care, and whether Palliative Care support was needed. In addition, trainees received brief didactics—“ teaching pearls”—that addressed components of palliative medicine (eg, use of opioids).

Trainees completed surveys Pre- and Post- Lightning Rounds, rating on a scale of 1 to 5 (Not at all to Very Much) how much they understand about, how confident they are in explaining, and how supported they feel by Palliative Care.

Results: From November 2017 – April 2019, we rounded on 105 unique patients in 26 Lightning Rounds sessions. Pre- and Post- samples are not paired. Average ratings of Pre- (n=18) and Post- (n=14) data show an increase in Understanding (4.2 to 4.6 on a 5-point scale); Confidence (4.0 to 4.6) and Support (4.8 to 5).

Conclusions: The current project sought to enhance integration between Oncology and Palliative Care by establishing a brief weekly Lightning Rounds in which Oncology trainees met with Palliative Care team members. We found that trainees’ understanding in what a Palliative Care consult can provide; their confidence in knowing when to offer a Palliative Care consult, and how supported they feel by our Palliative Care team, all increased from pre- to post-Lightning Rounds. These findings support our initial hypotheses and are encouraging continued involvement via this medium.

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Correspondence: Anne Day (anne.day2@va.gov)

Background: A growing body of evidence suggests that palliative care is an important element of comprehensive cancer treatment by assisting with symptom management and establishing goals of care. Research suggests that enhanced integration of palliative care and oncology medicine has a positive effect on mortality and quality of life outcomes, and integration of the two is now considered standard care. However, there are no standard models for how this integration might occur. At our facility, there was no formal connection between the Oncology service and the Palliative Care Team.

Methods: The interdisciplinary Palliative Care Consult Team established weekly “Lightning Rounds” with Heme-Onc trainees, in which trainees answered questions about each patient regarding symptoms, prognosis, goals of care, and whether Palliative Care support was needed. In addition, trainees received brief didactics—“ teaching pearls”—that addressed components of palliative medicine (eg, use of opioids).

Trainees completed surveys Pre- and Post- Lightning Rounds, rating on a scale of 1 to 5 (Not at all to Very Much) how much they understand about, how confident they are in explaining, and how supported they feel by Palliative Care.

Results: From November 2017 – April 2019, we rounded on 105 unique patients in 26 Lightning Rounds sessions. Pre- and Post- samples are not paired. Average ratings of Pre- (n=18) and Post- (n=14) data show an increase in Understanding (4.2 to 4.6 on a 5-point scale); Confidence (4.0 to 4.6) and Support (4.8 to 5).

Conclusions: The current project sought to enhance integration between Oncology and Palliative Care by establishing a brief weekly Lightning Rounds in which Oncology trainees met with Palliative Care team members. We found that trainees’ understanding in what a Palliative Care consult can provide; their confidence in knowing when to offer a Palliative Care consult, and how supported they feel by our Palliative Care team, all increased from pre- to post-Lightning Rounds. These findings support our initial hypotheses and are encouraging continued involvement via this medium.

Background: A growing body of evidence suggests that palliative care is an important element of comprehensive cancer treatment by assisting with symptom management and establishing goals of care. Research suggests that enhanced integration of palliative care and oncology medicine has a positive effect on mortality and quality of life outcomes, and integration of the two is now considered standard care. However, there are no standard models for how this integration might occur. At our facility, there was no formal connection between the Oncology service and the Palliative Care Team.

Methods: The interdisciplinary Palliative Care Consult Team established weekly “Lightning Rounds” with Heme-Onc trainees, in which trainees answered questions about each patient regarding symptoms, prognosis, goals of care, and whether Palliative Care support was needed. In addition, trainees received brief didactics—“ teaching pearls”—that addressed components of palliative medicine (eg, use of opioids).

Trainees completed surveys Pre- and Post- Lightning Rounds, rating on a scale of 1 to 5 (Not at all to Very Much) how much they understand about, how confident they are in explaining, and how supported they feel by Palliative Care.

Results: From November 2017 – April 2019, we rounded on 105 unique patients in 26 Lightning Rounds sessions. Pre- and Post- samples are not paired. Average ratings of Pre- (n=18) and Post- (n=14) data show an increase in Understanding (4.2 to 4.6 on a 5-point scale); Confidence (4.0 to 4.6) and Support (4.8 to 5).

Conclusions: The current project sought to enhance integration between Oncology and Palliative Care by establishing a brief weekly Lightning Rounds in which Oncology trainees met with Palliative Care team members. We found that trainees’ understanding in what a Palliative Care consult can provide; their confidence in knowing when to offer a Palliative Care consult, and how supported they feel by our Palliative Care team, all increased from pre- to post-Lightning Rounds. These findings support our initial hypotheses and are encouraging continued involvement via this medium.

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Oral Chemotherapy Monitoring at the W.G. Hefner VA Medical Center: A Quality Practice Initiative (QOPI)- Based Program

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Background: The use of oral chemotherapy, both as monotherapy and in combination with parenteral chemotherapy, has drastically increased. Goals of oral chemotherapy monitoring include initial patient education, assessment of adherence during therapy, ensuring baseline and routine lab monitoring, and testing. The provision of cost savings is performed when possible. To achieve these goals, a QI initiative was implemented to determine the feasibility of a multi-disciplinary oral chemotherapy monitoring program within a VA oncology clinic.

Methods: The QI initiative was started in February 2019. To facilitate and standardize communication between Oncology providers, Oncology Nursing staff and the Oncology Clinical Pharmacist (CPS), an “Oncology Chemotherapy Consult” was created. Entry of the consult in CPRS by the Oncology Provider alerts Oncology Nursing and Oncology Pharmacy staff to a new patient starting oral chemotherapy. The Oncology CPS receives and reviews the consult and verifies that a pharmacy Prior Authorization Drug Request Consult (PADR) has been entered, if applicable. All available labs are reviewed, and any additional baseline labs or testing are requested by the CPS. The Oncology RN designated for chemotherapy education provides face-to-face education for the medication(s) on the same day of the provider visit and determines the date of the return appointment for a toxicity screen approximately 14 days later. Once the PADR is reviewed and approved, the CPS completes the consult and orders a split-fill (15-day supply) of medication.

Results: The QI initiative to improve oral chemotherapy delivery and monitoring was proven effective and feasible. 95% of new oral chemotherapy patients have been enrolled in this program since its inception. Cost savings analysis is in progress and data will be available prior to the AVAHO meeting. Interventions performed to improve adherence and education will also be available

Conclusion: Based on results since initiation of this quality practice initiative, improved treatment adherence has been observed, early identification and management of toxicity has occurred, and utilization of a split-fill strategy for initial dosing has resulted in cost savings. Even in the early phase of this initiative, feasibility has been identified and increased benefit is predicted.

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Background: The use of oral chemotherapy, both as monotherapy and in combination with parenteral chemotherapy, has drastically increased. Goals of oral chemotherapy monitoring include initial patient education, assessment of adherence during therapy, ensuring baseline and routine lab monitoring, and testing. The provision of cost savings is performed when possible. To achieve these goals, a QI initiative was implemented to determine the feasibility of a multi-disciplinary oral chemotherapy monitoring program within a VA oncology clinic.

Methods: The QI initiative was started in February 2019. To facilitate and standardize communication between Oncology providers, Oncology Nursing staff and the Oncology Clinical Pharmacist (CPS), an “Oncology Chemotherapy Consult” was created. Entry of the consult in CPRS by the Oncology Provider alerts Oncology Nursing and Oncology Pharmacy staff to a new patient starting oral chemotherapy. The Oncology CPS receives and reviews the consult and verifies that a pharmacy Prior Authorization Drug Request Consult (PADR) has been entered, if applicable. All available labs are reviewed, and any additional baseline labs or testing are requested by the CPS. The Oncology RN designated for chemotherapy education provides face-to-face education for the medication(s) on the same day of the provider visit and determines the date of the return appointment for a toxicity screen approximately 14 days later. Once the PADR is reviewed and approved, the CPS completes the consult and orders a split-fill (15-day supply) of medication.

Results: The QI initiative to improve oral chemotherapy delivery and monitoring was proven effective and feasible. 95% of new oral chemotherapy patients have been enrolled in this program since its inception. Cost savings analysis is in progress and data will be available prior to the AVAHO meeting. Interventions performed to improve adherence and education will also be available

Conclusion: Based on results since initiation of this quality practice initiative, improved treatment adherence has been observed, early identification and management of toxicity has occurred, and utilization of a split-fill strategy for initial dosing has resulted in cost savings. Even in the early phase of this initiative, feasibility has been identified and increased benefit is predicted.

Background: The use of oral chemotherapy, both as monotherapy and in combination with parenteral chemotherapy, has drastically increased. Goals of oral chemotherapy monitoring include initial patient education, assessment of adherence during therapy, ensuring baseline and routine lab monitoring, and testing. The provision of cost savings is performed when possible. To achieve these goals, a QI initiative was implemented to determine the feasibility of a multi-disciplinary oral chemotherapy monitoring program within a VA oncology clinic.

Methods: The QI initiative was started in February 2019. To facilitate and standardize communication between Oncology providers, Oncology Nursing staff and the Oncology Clinical Pharmacist (CPS), an “Oncology Chemotherapy Consult” was created. Entry of the consult in CPRS by the Oncology Provider alerts Oncology Nursing and Oncology Pharmacy staff to a new patient starting oral chemotherapy. The Oncology CPS receives and reviews the consult and verifies that a pharmacy Prior Authorization Drug Request Consult (PADR) has been entered, if applicable. All available labs are reviewed, and any additional baseline labs or testing are requested by the CPS. The Oncology RN designated for chemotherapy education provides face-to-face education for the medication(s) on the same day of the provider visit and determines the date of the return appointment for a toxicity screen approximately 14 days later. Once the PADR is reviewed and approved, the CPS completes the consult and orders a split-fill (15-day supply) of medication.

Results: The QI initiative to improve oral chemotherapy delivery and monitoring was proven effective and feasible. 95% of new oral chemotherapy patients have been enrolled in this program since its inception. Cost savings analysis is in progress and data will be available prior to the AVAHO meeting. Interventions performed to improve adherence and education will also be available

Conclusion: Based on results since initiation of this quality practice initiative, improved treatment adherence has been observed, early identification and management of toxicity has occurred, and utilization of a split-fill strategy for initial dosing has resulted in cost savings. Even in the early phase of this initiative, feasibility has been identified and increased benefit is predicted.

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Investigation of Outpatient Infusion Space Utilization to Increase Access to Same-Day Transfusion for Hematology/Oncology Patients

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Background: Approximately 15% of patients with cancer require transfusion for treatment of disease- or chemotherapy-induced anemia. Previous studies have shown that anemia adversely affects patient quality of life (QoL), but QoL significant improves with transfusion. At the BVAMC, providers noted increasing delays in outpatient transfusion access averaging 2-3 days, resulting in prolongation of patient symptom burden (Plan). Additionally, outpatient transfusion is associated with significant patient time burden, patient travel burden, and health care cost, so delay in transfusion delivery also exacerbates these challenges.

Intervention: We created a process map for outpatient transfusion (Do). We learned that if a patient requires same-day transfusion, the patient must be admitted, resulting in a minimum cost of $3000 for a 24-hour hospitalization. We also learned that the outpatient infusion clinic is performing an increasing number of transfusions and non-transfusion related clinical services for other subspecialties, specifically infusion of iron, intravenous immunoglobulin, and biologic medications (i.e. infliximab, tocilizumab). There was a 2.6- times increase in blood transfusions per year since 2013 (78 to 205 units of pack red cells), possibly due to improved oncologic therapies prolonging patient survival. Furthermore, there was a 2-times increase in patient encounters for iron infusions (463 to 923) and a 1.4-times increase for biologics (876 to 1248) since 2010. This significantly increased demand has resulted in limited infusion chair access, precluding same-day transfusion availability (Study).

Outcome: The repercussions of decreased same-day transfusion access was presented to BVAMC administration. New space has been made available for seven additional chairs with transfusion capability. Iron infusions have been moved to the Hematology/Oncology chemotherapy center to increase ease of access, with a plan to move most transfusion to this space as well (Act). We project that access to same-day transfusion will avoid 2 hospitalizations per month at an annual cost of $72,000.

Implications: Access to same-day transfusion for treatment of anemia in patients with cancer decreases patient symptom and time burden and also results in cost savings. We encourage other facilities to explore their infusion space utilization, as demands will likely increase with growing use of intravenous therapies across specialties.

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Background: Approximately 15% of patients with cancer require transfusion for treatment of disease- or chemotherapy-induced anemia. Previous studies have shown that anemia adversely affects patient quality of life (QoL), but QoL significant improves with transfusion. At the BVAMC, providers noted increasing delays in outpatient transfusion access averaging 2-3 days, resulting in prolongation of patient symptom burden (Plan). Additionally, outpatient transfusion is associated with significant patient time burden, patient travel burden, and health care cost, so delay in transfusion delivery also exacerbates these challenges.

Intervention: We created a process map for outpatient transfusion (Do). We learned that if a patient requires same-day transfusion, the patient must be admitted, resulting in a minimum cost of $3000 for a 24-hour hospitalization. We also learned that the outpatient infusion clinic is performing an increasing number of transfusions and non-transfusion related clinical services for other subspecialties, specifically infusion of iron, intravenous immunoglobulin, and biologic medications (i.e. infliximab, tocilizumab). There was a 2.6- times increase in blood transfusions per year since 2013 (78 to 205 units of pack red cells), possibly due to improved oncologic therapies prolonging patient survival. Furthermore, there was a 2-times increase in patient encounters for iron infusions (463 to 923) and a 1.4-times increase for biologics (876 to 1248) since 2010. This significantly increased demand has resulted in limited infusion chair access, precluding same-day transfusion availability (Study).

Outcome: The repercussions of decreased same-day transfusion access was presented to BVAMC administration. New space has been made available for seven additional chairs with transfusion capability. Iron infusions have been moved to the Hematology/Oncology chemotherapy center to increase ease of access, with a plan to move most transfusion to this space as well (Act). We project that access to same-day transfusion will avoid 2 hospitalizations per month at an annual cost of $72,000.

Implications: Access to same-day transfusion for treatment of anemia in patients with cancer decreases patient symptom and time burden and also results in cost savings. We encourage other facilities to explore their infusion space utilization, as demands will likely increase with growing use of intravenous therapies across specialties.

Background: Approximately 15% of patients with cancer require transfusion for treatment of disease- or chemotherapy-induced anemia. Previous studies have shown that anemia adversely affects patient quality of life (QoL), but QoL significant improves with transfusion. At the BVAMC, providers noted increasing delays in outpatient transfusion access averaging 2-3 days, resulting in prolongation of patient symptom burden (Plan). Additionally, outpatient transfusion is associated with significant patient time burden, patient travel burden, and health care cost, so delay in transfusion delivery also exacerbates these challenges.

Intervention: We created a process map for outpatient transfusion (Do). We learned that if a patient requires same-day transfusion, the patient must be admitted, resulting in a minimum cost of $3000 for a 24-hour hospitalization. We also learned that the outpatient infusion clinic is performing an increasing number of transfusions and non-transfusion related clinical services for other subspecialties, specifically infusion of iron, intravenous immunoglobulin, and biologic medications (i.e. infliximab, tocilizumab). There was a 2.6- times increase in blood transfusions per year since 2013 (78 to 205 units of pack red cells), possibly due to improved oncologic therapies prolonging patient survival. Furthermore, there was a 2-times increase in patient encounters for iron infusions (463 to 923) and a 1.4-times increase for biologics (876 to 1248) since 2010. This significantly increased demand has resulted in limited infusion chair access, precluding same-day transfusion availability (Study).

Outcome: The repercussions of decreased same-day transfusion access was presented to BVAMC administration. New space has been made available for seven additional chairs with transfusion capability. Iron infusions have been moved to the Hematology/Oncology chemotherapy center to increase ease of access, with a plan to move most transfusion to this space as well (Act). We project that access to same-day transfusion will avoid 2 hospitalizations per month at an annual cost of $72,000.

Implications: Access to same-day transfusion for treatment of anemia in patients with cancer decreases patient symptom and time burden and also results in cost savings. We encourage other facilities to explore their infusion space utilization, as demands will likely increase with growing use of intravenous therapies across specialties.

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Effect of Health Literacy Education on Chemotherapy-Induced Nausea and Vomiting

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Purpose: To improve patient understanding of recommended antiemetics and self-reported nausea following chemotherapy with a simple pill-identifying calendar handout.

Background: Chemotherapy-induced nausea and vomiting (CINV) is among the most severe adverse effects and important concerns in cancer patients. While there are multiple antiemetics available, dosing and timing can be confusing for patients, especially those with poor health literacy. Inadequate health literacy has been associated with poor self-management behaviors, and greater risk for non-compliance with treatment.

Methods: We assessed CINV in 25 patients treated in the Medical Oncology clinic at the University of Arkansas for Medical Sciences by using the existing validated Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). We performed a Plan-Do-Study-Act (PDSA) cycle by implementing dosing calendar handouts with images and names of antiemetics scheduled per National Comprehensive Cancer Network (NCCN) guidelines.

Data Analysis: McNemar’s test was used for paired nominal data. Wilcoxon signed-rank test was utilized to evaluate differences in cohort means before and after intervention.

Results: At baseline, we utilized the MAT to document patient-reported incidence and severity of acute and delayed nausea and vomiting on a 10-point scale during one cycle of chemotherapy. Subsequently, we provided handouts for future cycles of chemotherapy. MAT was completed again following this intervention. Nausea was improved in 63% of patients. Vomiting was improved in 82% of patients. Severity of acute and delayed nausea improved from 4.40 (SD 4.25) to 2.54 (SD 2.28; P=0.008) and from 5.84 (SD 3.13) to 3.13 (SD 3.15, P=0.0016), respectively. Mean duration of nausea and vomiting was decreased from 3.72 days (SD 2.79) to 2.0 days (SD 2.55, P=0.0002). In addition, a single question was utilized to assess patient’s confidence in understanding their antiemetic regimen on a 10-point scale, which improved in 16 of 25 patients from a mean score of 7.84 (SD 1.97) to 9.50 (SD 1.18, P=0.0001).

Implications: Our calendar handout with pill images is an effective method to improve understanding of cancer treatment and decrease CINV in patients. As a result, a future PDSA cycle is planned to incorporate these handouts into our institution’s electronic medical record system.

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Purpose: To improve patient understanding of recommended antiemetics and self-reported nausea following chemotherapy with a simple pill-identifying calendar handout.

Background: Chemotherapy-induced nausea and vomiting (CINV) is among the most severe adverse effects and important concerns in cancer patients. While there are multiple antiemetics available, dosing and timing can be confusing for patients, especially those with poor health literacy. Inadequate health literacy has been associated with poor self-management behaviors, and greater risk for non-compliance with treatment.

Methods: We assessed CINV in 25 patients treated in the Medical Oncology clinic at the University of Arkansas for Medical Sciences by using the existing validated Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). We performed a Plan-Do-Study-Act (PDSA) cycle by implementing dosing calendar handouts with images and names of antiemetics scheduled per National Comprehensive Cancer Network (NCCN) guidelines.

Data Analysis: McNemar’s test was used for paired nominal data. Wilcoxon signed-rank test was utilized to evaluate differences in cohort means before and after intervention.

Results: At baseline, we utilized the MAT to document patient-reported incidence and severity of acute and delayed nausea and vomiting on a 10-point scale during one cycle of chemotherapy. Subsequently, we provided handouts for future cycles of chemotherapy. MAT was completed again following this intervention. Nausea was improved in 63% of patients. Vomiting was improved in 82% of patients. Severity of acute and delayed nausea improved from 4.40 (SD 4.25) to 2.54 (SD 2.28; P=0.008) and from 5.84 (SD 3.13) to 3.13 (SD 3.15, P=0.0016), respectively. Mean duration of nausea and vomiting was decreased from 3.72 days (SD 2.79) to 2.0 days (SD 2.55, P=0.0002). In addition, a single question was utilized to assess patient’s confidence in understanding their antiemetic regimen on a 10-point scale, which improved in 16 of 25 patients from a mean score of 7.84 (SD 1.97) to 9.50 (SD 1.18, P=0.0001).

Implications: Our calendar handout with pill images is an effective method to improve understanding of cancer treatment and decrease CINV in patients. As a result, a future PDSA cycle is planned to incorporate these handouts into our institution’s electronic medical record system.

Purpose: To improve patient understanding of recommended antiemetics and self-reported nausea following chemotherapy with a simple pill-identifying calendar handout.

Background: Chemotherapy-induced nausea and vomiting (CINV) is among the most severe adverse effects and important concerns in cancer patients. While there are multiple antiemetics available, dosing and timing can be confusing for patients, especially those with poor health literacy. Inadequate health literacy has been associated with poor self-management behaviors, and greater risk for non-compliance with treatment.

Methods: We assessed CINV in 25 patients treated in the Medical Oncology clinic at the University of Arkansas for Medical Sciences by using the existing validated Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). We performed a Plan-Do-Study-Act (PDSA) cycle by implementing dosing calendar handouts with images and names of antiemetics scheduled per National Comprehensive Cancer Network (NCCN) guidelines.

Data Analysis: McNemar’s test was used for paired nominal data. Wilcoxon signed-rank test was utilized to evaluate differences in cohort means before and after intervention.

Results: At baseline, we utilized the MAT to document patient-reported incidence and severity of acute and delayed nausea and vomiting on a 10-point scale during one cycle of chemotherapy. Subsequently, we provided handouts for future cycles of chemotherapy. MAT was completed again following this intervention. Nausea was improved in 63% of patients. Vomiting was improved in 82% of patients. Severity of acute and delayed nausea improved from 4.40 (SD 4.25) to 2.54 (SD 2.28; P=0.008) and from 5.84 (SD 3.13) to 3.13 (SD 3.15, P=0.0016), respectively. Mean duration of nausea and vomiting was decreased from 3.72 days (SD 2.79) to 2.0 days (SD 2.55, P=0.0002). In addition, a single question was utilized to assess patient’s confidence in understanding their antiemetic regimen on a 10-point scale, which improved in 16 of 25 patients from a mean score of 7.84 (SD 1.97) to 9.50 (SD 1.18, P=0.0001).

Implications: Our calendar handout with pill images is an effective method to improve understanding of cancer treatment and decrease CINV in patients. As a result, a future PDSA cycle is planned to incorporate these handouts into our institution’s electronic medical record system.

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Severe Autoimmune Pancytopenia: An Unusual Presentation of Chronic Lymphocytic Leukemia (CLL)

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Case Report: A 61-year-old African American man presented to his PCP complaining of severe weakness and dyspnea with minimal exertion. The symptoms had begun about 6 weeks prior to the visit and had slowly worsened. The patient denied any bleeding, fever chills or sweats. He had a past, presumed history of ulcerative colitis, inactive, on no medications, as well as benign prostatic hypertrophy (BPH) without therapy. He denied any use of OTC’s; no drug or alcohol use. No risk factors for HIV. In the office he was noticed to be severely anemic with a Hgb of 2.5, on repeat was 2.7 gm/dL. Platelet count was 10 000/uL, confirmed on repeat CBC and examination of the smear. WBC was 4,500 with about 80% normal appearing lymphocytes. LDH was 143(wnl). A B12 level was low at 208, with an elevated MMA of 829. The patient was admitted for evaluation and transfusions. There were no petechiae or echymoses in the visible areas of the skin. The patient initially refused physical exam or any diagnostic procedures. A subsequent flow cytometric assay of his blood was consistent with CLL. Eventually a bone marrow aspirate and biopsy were performed. It showed a hypercellular bone marrow, with major decrease in all myeloid, erythroid and megakaryocytic elements which were replaced by population of mature, small lymphocytes, consistent with the diagnosis of CLL. In particular, histology was characterized by almost complete absence of megakaryocytes, leading to suspicion of an auto-immune component driving disease. The patient was started on pulse dexamethasone vitamin B12, and administered weekly anti-CD20 (Rituximab) for 4 doses. He was also started on eltrombopag and a BTK inhibitor (Ibrutinib) both of which he continues to take to date. His counts have slowly risen, and the patient continues to improve.

Discussion: Severe pancytopenia as a presentation of CLL is uncommon, perhaps in contrast to autoimmune cytopenias which are relatively common events during the lifecycle of patients with CLL and are thought to arise from antibody production by the normal BCells, in this setting of T-cell dysregulation. Given recent trends in the treatment of CLL with BTK inhibitors, which have been both used to treat, as well as believed to have caused auto-immune CLL complications it’s important to review the occurrence of cytopenias and how to manage them in this setting.

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Case Report: A 61-year-old African American man presented to his PCP complaining of severe weakness and dyspnea with minimal exertion. The symptoms had begun about 6 weeks prior to the visit and had slowly worsened. The patient denied any bleeding, fever chills or sweats. He had a past, presumed history of ulcerative colitis, inactive, on no medications, as well as benign prostatic hypertrophy (BPH) without therapy. He denied any use of OTC’s; no drug or alcohol use. No risk factors for HIV. In the office he was noticed to be severely anemic with a Hgb of 2.5, on repeat was 2.7 gm/dL. Platelet count was 10 000/uL, confirmed on repeat CBC and examination of the smear. WBC was 4,500 with about 80% normal appearing lymphocytes. LDH was 143(wnl). A B12 level was low at 208, with an elevated MMA of 829. The patient was admitted for evaluation and transfusions. There were no petechiae or echymoses in the visible areas of the skin. The patient initially refused physical exam or any diagnostic procedures. A subsequent flow cytometric assay of his blood was consistent with CLL. Eventually a bone marrow aspirate and biopsy were performed. It showed a hypercellular bone marrow, with major decrease in all myeloid, erythroid and megakaryocytic elements which were replaced by population of mature, small lymphocytes, consistent with the diagnosis of CLL. In particular, histology was characterized by almost complete absence of megakaryocytes, leading to suspicion of an auto-immune component driving disease. The patient was started on pulse dexamethasone vitamin B12, and administered weekly anti-CD20 (Rituximab) for 4 doses. He was also started on eltrombopag and a BTK inhibitor (Ibrutinib) both of which he continues to take to date. His counts have slowly risen, and the patient continues to improve.

Discussion: Severe pancytopenia as a presentation of CLL is uncommon, perhaps in contrast to autoimmune cytopenias which are relatively common events during the lifecycle of patients with CLL and are thought to arise from antibody production by the normal BCells, in this setting of T-cell dysregulation. Given recent trends in the treatment of CLL with BTK inhibitors, which have been both used to treat, as well as believed to have caused auto-immune CLL complications it’s important to review the occurrence of cytopenias and how to manage them in this setting.

Case Report: A 61-year-old African American man presented to his PCP complaining of severe weakness and dyspnea with minimal exertion. The symptoms had begun about 6 weeks prior to the visit and had slowly worsened. The patient denied any bleeding, fever chills or sweats. He had a past, presumed history of ulcerative colitis, inactive, on no medications, as well as benign prostatic hypertrophy (BPH) without therapy. He denied any use of OTC’s; no drug or alcohol use. No risk factors for HIV. In the office he was noticed to be severely anemic with a Hgb of 2.5, on repeat was 2.7 gm/dL. Platelet count was 10 000/uL, confirmed on repeat CBC and examination of the smear. WBC was 4,500 with about 80% normal appearing lymphocytes. LDH was 143(wnl). A B12 level was low at 208, with an elevated MMA of 829. The patient was admitted for evaluation and transfusions. There were no petechiae or echymoses in the visible areas of the skin. The patient initially refused physical exam or any diagnostic procedures. A subsequent flow cytometric assay of his blood was consistent with CLL. Eventually a bone marrow aspirate and biopsy were performed. It showed a hypercellular bone marrow, with major decrease in all myeloid, erythroid and megakaryocytic elements which were replaced by population of mature, small lymphocytes, consistent with the diagnosis of CLL. In particular, histology was characterized by almost complete absence of megakaryocytes, leading to suspicion of an auto-immune component driving disease. The patient was started on pulse dexamethasone vitamin B12, and administered weekly anti-CD20 (Rituximab) for 4 doses. He was also started on eltrombopag and a BTK inhibitor (Ibrutinib) both of which he continues to take to date. His counts have slowly risen, and the patient continues to improve.

Discussion: Severe pancytopenia as a presentation of CLL is uncommon, perhaps in contrast to autoimmune cytopenias which are relatively common events during the lifecycle of patients with CLL and are thought to arise from antibody production by the normal BCells, in this setting of T-cell dysregulation. Given recent trends in the treatment of CLL with BTK inhibitors, which have been both used to treat, as well as believed to have caused auto-immune CLL complications it’s important to review the occurrence of cytopenias and how to manage them in this setting.

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The Incidence of Immune-Related Adverse Events (irAEs) at a VA Emergency Department (ED) in Cancer Patients Receiving Immune Checkpoint Inhibitors (ICPIs)

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Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).

Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.

Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.

Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.

Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.

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Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).

Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.

Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.

Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.

Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.

Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).

Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.

Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.

Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.

Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.

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