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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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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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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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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How Detection and Prevention of Gynecologic Carcinomas at One Major Veteran Affairs Medical Center (VAMC) is Superior to the Private Sector: A Review of Cervical Squamous Intraepithelial Neoplasia, Grade 3 (CIN III) and Invasive Carcinomas from 2008

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Purpose: With an increasing emphasis on Veteran Women’s Health, we designed a study to see how our VAMC was doing at detecting invasive carcinomas and lesions that progress to carcinoma of the gynecologic tract.

Background: Cervical Cytology (also called a Pap smear) is reported to only be sensitive in detecting CIN II-III or carcinoma in 44%-72% of patients in the private sector. Is it higher in the VA System with higher standards of Quality Control?

Methods: Histology to cytology correlation statistics (all biopsies, cervical cones, and cervical resections), cervical smear diagnosis data, and righ-risk HPV (HR-HPV) status maintained by the Director of Cytopathology at the Houston VAMC (Quality Assurance Program) were reviewed from 2008 to 2018. Only patients with CIN III (severe dysplasia or carcinoma in situ) or invasive squamous cell carcinoma and adenocarcinoma were used for outcomes. All PAP smears are screened by both Staff Cytotechnologists and Staff Cytopathologists.

Results: From 2008-2018, there were 21,086 cervical smears performed and 184 cases of CIN III or Carcinoma were detected. Of the 6 invasive carcinomas, 2 had no previous pap smear and 4 had their 1st PAP smear show CIN III or Carcinoma. In CIN III, which includes Carcinoma In Situ, the first PAP smear showed 58 High Grade Squamous Intraepithelial Neoplasia, 68 Low Grade Squamous Intraepithelial Neoplasia and 52 Atypical Squamous Cells of Undetermined Significance warranting biopsy. Three patients had no VA Pap smear but presented with abnormal cytology in the private sector.

Implications: Compared to the private sector, the Houston VAMC had a 100% detection rate for CIN III and invasive carcinomas when there was a screening pap smear. None of the patients with CINIII/CIS progressed to an invasive carcinoma because they had been treated for their CIN III/CIS. When a strong QA program is used in Cytopathology, results can exceed the private sector.

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Purpose: With an increasing emphasis on Veteran Women’s Health, we designed a study to see how our VAMC was doing at detecting invasive carcinomas and lesions that progress to carcinoma of the gynecologic tract.

Background: Cervical Cytology (also called a Pap smear) is reported to only be sensitive in detecting CIN II-III or carcinoma in 44%-72% of patients in the private sector. Is it higher in the VA System with higher standards of Quality Control?

Methods: Histology to cytology correlation statistics (all biopsies, cervical cones, and cervical resections), cervical smear diagnosis data, and righ-risk HPV (HR-HPV) status maintained by the Director of Cytopathology at the Houston VAMC (Quality Assurance Program) were reviewed from 2008 to 2018. Only patients with CIN III (severe dysplasia or carcinoma in situ) or invasive squamous cell carcinoma and adenocarcinoma were used for outcomes. All PAP smears are screened by both Staff Cytotechnologists and Staff Cytopathologists.

Results: From 2008-2018, there were 21,086 cervical smears performed and 184 cases of CIN III or Carcinoma were detected. Of the 6 invasive carcinomas, 2 had no previous pap smear and 4 had their 1st PAP smear show CIN III or Carcinoma. In CIN III, which includes Carcinoma In Situ, the first PAP smear showed 58 High Grade Squamous Intraepithelial Neoplasia, 68 Low Grade Squamous Intraepithelial Neoplasia and 52 Atypical Squamous Cells of Undetermined Significance warranting biopsy. Three patients had no VA Pap smear but presented with abnormal cytology in the private sector.

Implications: Compared to the private sector, the Houston VAMC had a 100% detection rate for CIN III and invasive carcinomas when there was a screening pap smear. None of the patients with CINIII/CIS progressed to an invasive carcinoma because they had been treated for their CIN III/CIS. When a strong QA program is used in Cytopathology, results can exceed the private sector.

Purpose: With an increasing emphasis on Veteran Women’s Health, we designed a study to see how our VAMC was doing at detecting invasive carcinomas and lesions that progress to carcinoma of the gynecologic tract.

Background: Cervical Cytology (also called a Pap smear) is reported to only be sensitive in detecting CIN II-III or carcinoma in 44%-72% of patients in the private sector. Is it higher in the VA System with higher standards of Quality Control?

Methods: Histology to cytology correlation statistics (all biopsies, cervical cones, and cervical resections), cervical smear diagnosis data, and righ-risk HPV (HR-HPV) status maintained by the Director of Cytopathology at the Houston VAMC (Quality Assurance Program) were reviewed from 2008 to 2018. Only patients with CIN III (severe dysplasia or carcinoma in situ) or invasive squamous cell carcinoma and adenocarcinoma were used for outcomes. All PAP smears are screened by both Staff Cytotechnologists and Staff Cytopathologists.

Results: From 2008-2018, there were 21,086 cervical smears performed and 184 cases of CIN III or Carcinoma were detected. Of the 6 invasive carcinomas, 2 had no previous pap smear and 4 had their 1st PAP smear show CIN III or Carcinoma. In CIN III, which includes Carcinoma In Situ, the first PAP smear showed 58 High Grade Squamous Intraepithelial Neoplasia, 68 Low Grade Squamous Intraepithelial Neoplasia and 52 Atypical Squamous Cells of Undetermined Significance warranting biopsy. Three patients had no VA Pap smear but presented with abnormal cytology in the private sector.

Implications: Compared to the private sector, the Houston VAMC had a 100% detection rate for CIN III and invasive carcinomas when there was a screening pap smear. None of the patients with CINIII/CIS progressed to an invasive carcinoma because they had been treated for their CIN III/CIS. When a strong QA program is used in Cytopathology, results can exceed the private sector.

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Unusual Case of Renal Cell Carcinoma Metastasis To Duodenum Presenting as Gastrointestinal Bleeding

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Background: Renal Cell carcinoma (RCC) possesses the ability to metastasize to distant places most commonly lungs, lymph nodes, liver, bone, and brain. While RCC can metastasize potentially to any organ, the gastrointestinal tract involvement is exceedingly rare.

Case Presentation: A 76-year-old male veteran presented with complain of hematuria and was diagnosed initially with stage 3 (pT3cN0M0) clear cell RCC of the right kidney. He underwent right radical nephrectomy with caval thrombectomy. He was then followed for surveillance during which, based on his radiological imaging, he was found to have a mesenteric mass inseparable from the transverse colon, multiple pulmonary nodules, and a large hypo density in the liver. He underwent subsequent biopsy of the mesenteric mass, which confirmed metastatic RCC (clear cell).

He was started on sunitinib 50mg based on NCCN guidelines. He did well on sunitinib for a while, but repeat CT chest, abdomen, and pelvis scans showed progression of his disease. He was started on nivolumab as a second line agent as per the NCCN guidelines. While on nivolumab, he presented in early 2019 with an episode of GI bleeding (melena). He underwent repeat radiological imaging as well as an endoscopy, which showed medium size friable soft tissue mass in the 2nd part of duodenum. Biopsy of that mass con rmed RCC eroding into the duodenal mucosa. His case was discussed at the tumor board, and it was recommended that palliative surgery and radiation were not an option for him. A recommendation for palliative and supportive treatment were made. The patient’s condition was discussed with him, and given that he was asymptomatic and at his general baseline health, he opted to continue with the immunotherapy.

Conclusion: RCC metastasis to GI tract is rare. The duodenum is reported to be the least involved segment of the small intestine. The number of cases reports in literature on duodenal metastasis from RCC is estimated to be around 20-25.Treatment of RCC with duodenal metastases depends upon the location and extent of the tumor as well as patient’s fitness for different modalities.

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Background: Renal Cell carcinoma (RCC) possesses the ability to metastasize to distant places most commonly lungs, lymph nodes, liver, bone, and brain. While RCC can metastasize potentially to any organ, the gastrointestinal tract involvement is exceedingly rare.

Case Presentation: A 76-year-old male veteran presented with complain of hematuria and was diagnosed initially with stage 3 (pT3cN0M0) clear cell RCC of the right kidney. He underwent right radical nephrectomy with caval thrombectomy. He was then followed for surveillance during which, based on his radiological imaging, he was found to have a mesenteric mass inseparable from the transverse colon, multiple pulmonary nodules, and a large hypo density in the liver. He underwent subsequent biopsy of the mesenteric mass, which confirmed metastatic RCC (clear cell).

He was started on sunitinib 50mg based on NCCN guidelines. He did well on sunitinib for a while, but repeat CT chest, abdomen, and pelvis scans showed progression of his disease. He was started on nivolumab as a second line agent as per the NCCN guidelines. While on nivolumab, he presented in early 2019 with an episode of GI bleeding (melena). He underwent repeat radiological imaging as well as an endoscopy, which showed medium size friable soft tissue mass in the 2nd part of duodenum. Biopsy of that mass con rmed RCC eroding into the duodenal mucosa. His case was discussed at the tumor board, and it was recommended that palliative surgery and radiation were not an option for him. A recommendation for palliative and supportive treatment were made. The patient’s condition was discussed with him, and given that he was asymptomatic and at his general baseline health, he opted to continue with the immunotherapy.

Conclusion: RCC metastasis to GI tract is rare. The duodenum is reported to be the least involved segment of the small intestine. The number of cases reports in literature on duodenal metastasis from RCC is estimated to be around 20-25.Treatment of RCC with duodenal metastases depends upon the location and extent of the tumor as well as patient’s fitness for different modalities.

Background: Renal Cell carcinoma (RCC) possesses the ability to metastasize to distant places most commonly lungs, lymph nodes, liver, bone, and brain. While RCC can metastasize potentially to any organ, the gastrointestinal tract involvement is exceedingly rare.

Case Presentation: A 76-year-old male veteran presented with complain of hematuria and was diagnosed initially with stage 3 (pT3cN0M0) clear cell RCC of the right kidney. He underwent right radical nephrectomy with caval thrombectomy. He was then followed for surveillance during which, based on his radiological imaging, he was found to have a mesenteric mass inseparable from the transverse colon, multiple pulmonary nodules, and a large hypo density in the liver. He underwent subsequent biopsy of the mesenteric mass, which confirmed metastatic RCC (clear cell).

He was started on sunitinib 50mg based on NCCN guidelines. He did well on sunitinib for a while, but repeat CT chest, abdomen, and pelvis scans showed progression of his disease. He was started on nivolumab as a second line agent as per the NCCN guidelines. While on nivolumab, he presented in early 2019 with an episode of GI bleeding (melena). He underwent repeat radiological imaging as well as an endoscopy, which showed medium size friable soft tissue mass in the 2nd part of duodenum. Biopsy of that mass con rmed RCC eroding into the duodenal mucosa. His case was discussed at the tumor board, and it was recommended that palliative surgery and radiation were not an option for him. A recommendation for palliative and supportive treatment were made. The patient’s condition was discussed with him, and given that he was asymptomatic and at his general baseline health, he opted to continue with the immunotherapy.

Conclusion: RCC metastasis to GI tract is rare. The duodenum is reported to be the least involved segment of the small intestine. The number of cases reports in literature on duodenal metastasis from RCC is estimated to be around 20-25.Treatment of RCC with duodenal metastases depends upon the location and extent of the tumor as well as patient’s fitness for different modalities.

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Combination Immunotherapy Leading to Severe Hepatotoxicity and Fatal Aplastic Anemia: Case Report and Review of the Literature

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Background: Dual immune checkpoint blockade (DICB) is utilized for a variety of malignancies. These therapies have a unique and often unpredictable side effect profile compared to conventional chemotherapy. We describe a lethal case of aplastic anemia (AA) as a result of DICB and a review of the literature regarding this rare entity.

Case Presentation: A 64-year-old male underwent complete resection for right renal cell carcinoma. He developed metastasis 1 year after resection and was started on nivolumab 240 mg and ipilimumab 1mg/kg every 21 days. After 4 cycles, he had an asymptomatic elevation of liver function tests (LFT) with a total bilirubin of 6.4 mg/DL (Ref Range 0.2-1.2 mg/dL). Immunotherapy was discontinued, and he started IV methylprednisolone. His LFTs normalized after 5 weeks of steroid taper and CT demonstrated complete response.

6 months after his final dose of DICB, he developed progressive fatigue and a petechial rash. Labs were signi cant for white blood cell count of 0.9 K/cm2 (absolute neutrophil count of 0.3 k/cm2), hemoglobin of 12 g/dL and platelets of 11 K/cm2. His complete blood count 2 weeks prior was normal. A bone marrow biopsy demonstrated severely hypocellular marrow (10%) with marked decrease in all hematopoietic precursors. He was treated for DICB AA and started on 1mg/kg prednisone, granulocyte colony stimulating factor and erythropoietin.

After no count recovery he was started on antithymocyte globulin and received 7 doses. Despite aggressive supportive care and prophylactic antibiotics, he developed bacteremia and died of septic shock four weeks after admission.

Discussion: On review of the literature, there are only two reported cases of DICB AA. Our particular case has a few unique features. First, hepatotoxicity developed prior to AA. Second, pancytopenia occurred 6 months after his last dose of DICB. There are no other case reports of AA so far out from last infusion.

Conclusion: This case demonstrates the need to promptly recognize rare toxicities of immunotherapies such as AA and identify effective therapies for serious toxicities that are not steroid responsive.

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Background: Dual immune checkpoint blockade (DICB) is utilized for a variety of malignancies. These therapies have a unique and often unpredictable side effect profile compared to conventional chemotherapy. We describe a lethal case of aplastic anemia (AA) as a result of DICB and a review of the literature regarding this rare entity.

Case Presentation: A 64-year-old male underwent complete resection for right renal cell carcinoma. He developed metastasis 1 year after resection and was started on nivolumab 240 mg and ipilimumab 1mg/kg every 21 days. After 4 cycles, he had an asymptomatic elevation of liver function tests (LFT) with a total bilirubin of 6.4 mg/DL (Ref Range 0.2-1.2 mg/dL). Immunotherapy was discontinued, and he started IV methylprednisolone. His LFTs normalized after 5 weeks of steroid taper and CT demonstrated complete response.

6 months after his final dose of DICB, he developed progressive fatigue and a petechial rash. Labs were signi cant for white blood cell count of 0.9 K/cm2 (absolute neutrophil count of 0.3 k/cm2), hemoglobin of 12 g/dL and platelets of 11 K/cm2. His complete blood count 2 weeks prior was normal. A bone marrow biopsy demonstrated severely hypocellular marrow (10%) with marked decrease in all hematopoietic precursors. He was treated for DICB AA and started on 1mg/kg prednisone, granulocyte colony stimulating factor and erythropoietin.

After no count recovery he was started on antithymocyte globulin and received 7 doses. Despite aggressive supportive care and prophylactic antibiotics, he developed bacteremia and died of septic shock four weeks after admission.

Discussion: On review of the literature, there are only two reported cases of DICB AA. Our particular case has a few unique features. First, hepatotoxicity developed prior to AA. Second, pancytopenia occurred 6 months after his last dose of DICB. There are no other case reports of AA so far out from last infusion.

Conclusion: This case demonstrates the need to promptly recognize rare toxicities of immunotherapies such as AA and identify effective therapies for serious toxicities that are not steroid responsive.

Background: Dual immune checkpoint blockade (DICB) is utilized for a variety of malignancies. These therapies have a unique and often unpredictable side effect profile compared to conventional chemotherapy. We describe a lethal case of aplastic anemia (AA) as a result of DICB and a review of the literature regarding this rare entity.

Case Presentation: A 64-year-old male underwent complete resection for right renal cell carcinoma. He developed metastasis 1 year after resection and was started on nivolumab 240 mg and ipilimumab 1mg/kg every 21 days. After 4 cycles, he had an asymptomatic elevation of liver function tests (LFT) with a total bilirubin of 6.4 mg/DL (Ref Range 0.2-1.2 mg/dL). Immunotherapy was discontinued, and he started IV methylprednisolone. His LFTs normalized after 5 weeks of steroid taper and CT demonstrated complete response.

6 months after his final dose of DICB, he developed progressive fatigue and a petechial rash. Labs were signi cant for white blood cell count of 0.9 K/cm2 (absolute neutrophil count of 0.3 k/cm2), hemoglobin of 12 g/dL and platelets of 11 K/cm2. His complete blood count 2 weeks prior was normal. A bone marrow biopsy demonstrated severely hypocellular marrow (10%) with marked decrease in all hematopoietic precursors. He was treated for DICB AA and started on 1mg/kg prednisone, granulocyte colony stimulating factor and erythropoietin.

After no count recovery he was started on antithymocyte globulin and received 7 doses. Despite aggressive supportive care and prophylactic antibiotics, he developed bacteremia and died of septic shock four weeks after admission.

Discussion: On review of the literature, there are only two reported cases of DICB AA. Our particular case has a few unique features. First, hepatotoxicity developed prior to AA. Second, pancytopenia occurred 6 months after his last dose of DICB. There are no other case reports of AA so far out from last infusion.

Conclusion: This case demonstrates the need to promptly recognize rare toxicities of immunotherapies such as AA and identify effective therapies for serious toxicities that are not steroid responsive.

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Development of VET-ROC, the Veterans Radiation Oncology Consortium to Support and Promote VA Clinical Research

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Purpose: To inform stakeholders of a newly formed, VAbased, research oriented collaborative group, the Veterans Radiation Oncology Consortium (VET-ROC).

Background: To strengthen, promote and enhance VA oncology and radiation oncology centered research, VET-ROC was conceived in October 2018 at the San Antonio VA Radiation Oncology Field Based Meeting and formed with the consent of 18 members sites.

Results: An email sent to all 85 known VA radiation oncologists in October 2018 drew 18 positive responses to join a clinical research consortium within VA. Members responded to 2 questionnaires about the state of their program in October 2018 and April 2019. Per their responses, VET-ROC sites consist of approximately 47 FTE Radiation Oncologists and > 26 FTE Physicists. The sites reported a total of 7.1 FTEE Clinical Research Coordinators (CRC’s) in October 2018 and 10.2 FTE CRC’s in April 2019 with most sites sharing CRC’s with other specialties. Five sites reported a lack of any research coordinator in October 2018, and in April 2019, 3 of those 5 sites had received approval from their resource management committees to hire CRCs.

The group had a face to face meeting in FEB 2019 and has held conference calls every 4-6 weeks since then to review opportunities for research, shared best practices, partake in educational webinars, identify barriers to research development, opportunities for research proposals with at least 2 groups of members submitting Merit Review awards to CSR&D that may have been possible as a result of VET-ROC. Feedback on the progress the group has made has been largely positive. Individual responses noted that the group had created opportunities that would not have been possible otherwise. There were suggestions to formalize the structure of the group.

Conclusion: Since its formation, VET-ROC has been a very positive experience for its members who consist of a select group of Radiation Oncologists with shared common interests in clinical research. The group will likely continue to move grow and move forward if it can translate its momentum into research support obtained from a diverse source of funding mechanisms.

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Purpose: To inform stakeholders of a newly formed, VAbased, research oriented collaborative group, the Veterans Radiation Oncology Consortium (VET-ROC).

Background: To strengthen, promote and enhance VA oncology and radiation oncology centered research, VET-ROC was conceived in October 2018 at the San Antonio VA Radiation Oncology Field Based Meeting and formed with the consent of 18 members sites.

Results: An email sent to all 85 known VA radiation oncologists in October 2018 drew 18 positive responses to join a clinical research consortium within VA. Members responded to 2 questionnaires about the state of their program in October 2018 and April 2019. Per their responses, VET-ROC sites consist of approximately 47 FTE Radiation Oncologists and > 26 FTE Physicists. The sites reported a total of 7.1 FTEE Clinical Research Coordinators (CRC’s) in October 2018 and 10.2 FTE CRC’s in April 2019 with most sites sharing CRC’s with other specialties. Five sites reported a lack of any research coordinator in October 2018, and in April 2019, 3 of those 5 sites had received approval from their resource management committees to hire CRCs.

The group had a face to face meeting in FEB 2019 and has held conference calls every 4-6 weeks since then to review opportunities for research, shared best practices, partake in educational webinars, identify barriers to research development, opportunities for research proposals with at least 2 groups of members submitting Merit Review awards to CSR&D that may have been possible as a result of VET-ROC. Feedback on the progress the group has made has been largely positive. Individual responses noted that the group had created opportunities that would not have been possible otherwise. There were suggestions to formalize the structure of the group.

Conclusion: Since its formation, VET-ROC has been a very positive experience for its members who consist of a select group of Radiation Oncologists with shared common interests in clinical research. The group will likely continue to move grow and move forward if it can translate its momentum into research support obtained from a diverse source of funding mechanisms.

Purpose: To inform stakeholders of a newly formed, VAbased, research oriented collaborative group, the Veterans Radiation Oncology Consortium (VET-ROC).

Background: To strengthen, promote and enhance VA oncology and radiation oncology centered research, VET-ROC was conceived in October 2018 at the San Antonio VA Radiation Oncology Field Based Meeting and formed with the consent of 18 members sites.

Results: An email sent to all 85 known VA radiation oncologists in October 2018 drew 18 positive responses to join a clinical research consortium within VA. Members responded to 2 questionnaires about the state of their program in October 2018 and April 2019. Per their responses, VET-ROC sites consist of approximately 47 FTE Radiation Oncologists and > 26 FTE Physicists. The sites reported a total of 7.1 FTEE Clinical Research Coordinators (CRC’s) in October 2018 and 10.2 FTE CRC’s in April 2019 with most sites sharing CRC’s with other specialties. Five sites reported a lack of any research coordinator in October 2018, and in April 2019, 3 of those 5 sites had received approval from their resource management committees to hire CRCs.

The group had a face to face meeting in FEB 2019 and has held conference calls every 4-6 weeks since then to review opportunities for research, shared best practices, partake in educational webinars, identify barriers to research development, opportunities for research proposals with at least 2 groups of members submitting Merit Review awards to CSR&D that may have been possible as a result of VET-ROC. Feedback on the progress the group has made has been largely positive. Individual responses noted that the group had created opportunities that would not have been possible otherwise. There were suggestions to formalize the structure of the group.

Conclusion: Since its formation, VET-ROC has been a very positive experience for its members who consist of a select group of Radiation Oncologists with shared common interests in clinical research. The group will likely continue to move grow and move forward if it can translate its momentum into research support obtained from a diverse source of funding mechanisms.

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Surgical Margins and Other Important Prognostic Factors in Dedifferentiated Liposarcoma Survival

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Background: Liposarcoma is the most common malignant soft tissue sarcoma (STS). Surgical resection is the most utilized therapeutic option. In this study, we aim to explore the effects of varying degrees of surgical margins on survival in patients with dedifferentiated liposarcoma (DDLPS).

Methods: The National Cancer Database (NCDB) was used to select patients with DDLPS to determine if surgical margins and other variables were associated with decreased overall survival after accounting for age, gender, race, Charlson-Deyo score, anatomic site, treatment approach, tumor size, tumor grade, and presence of metastases through multivariable analysis.

Results: Of the 1004 selected patients, 64.4% were male, 87.0% were white, and the median age was 63 years. About 95% had no metastases at the time of diagnosis, and 91.5% had high grade liposarcoma. For the status of surgical margins, 50.8% had no residual tumors, 26.1% had microscopic residual tumors, 4.3% had macroscopic residual tumors. In general, the risk of death was higher for older males (25.8% increased risk of mortality) and those with metastases (312.9% increased risk of mortality) as well as patients with high grade liposarcoma (112.4% increased risk of mortality). Patients with macroscopic residual tumors in comparison to those with no residual tumors had a 96.7% increased risk of death (HR 95% CI:1.24 to 3.13; P=0.004).

Conclusion: Older age, presence of metastasis, male patients, retroperitoneal/abdomen primary site, highgrade tumors, and macroscopic or residual tumor present after surgery lead to an increased risk of mortality. These outcomes highlight the importance and benefits of negative or complete surgical margins as prognostic indicators for patients with DDLPS, especially considering that resection is the most commonly utilized therapeutic option. The NCDB contains about 70% of cancer incidents within the US, therefore a future study incorporating the Surveillance, Epidemiology, and End Results (SEER) registry could enhance and possibly add to the results brought forth by this study.

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Background: Liposarcoma is the most common malignant soft tissue sarcoma (STS). Surgical resection is the most utilized therapeutic option. In this study, we aim to explore the effects of varying degrees of surgical margins on survival in patients with dedifferentiated liposarcoma (DDLPS).

Methods: The National Cancer Database (NCDB) was used to select patients with DDLPS to determine if surgical margins and other variables were associated with decreased overall survival after accounting for age, gender, race, Charlson-Deyo score, anatomic site, treatment approach, tumor size, tumor grade, and presence of metastases through multivariable analysis.

Results: Of the 1004 selected patients, 64.4% were male, 87.0% were white, and the median age was 63 years. About 95% had no metastases at the time of diagnosis, and 91.5% had high grade liposarcoma. For the status of surgical margins, 50.8% had no residual tumors, 26.1% had microscopic residual tumors, 4.3% had macroscopic residual tumors. In general, the risk of death was higher for older males (25.8% increased risk of mortality) and those with metastases (312.9% increased risk of mortality) as well as patients with high grade liposarcoma (112.4% increased risk of mortality). Patients with macroscopic residual tumors in comparison to those with no residual tumors had a 96.7% increased risk of death (HR 95% CI:1.24 to 3.13; P=0.004).

Conclusion: Older age, presence of metastasis, male patients, retroperitoneal/abdomen primary site, highgrade tumors, and macroscopic or residual tumor present after surgery lead to an increased risk of mortality. These outcomes highlight the importance and benefits of negative or complete surgical margins as prognostic indicators for patients with DDLPS, especially considering that resection is the most commonly utilized therapeutic option. The NCDB contains about 70% of cancer incidents within the US, therefore a future study incorporating the Surveillance, Epidemiology, and End Results (SEER) registry could enhance and possibly add to the results brought forth by this study.

Background: Liposarcoma is the most common malignant soft tissue sarcoma (STS). Surgical resection is the most utilized therapeutic option. In this study, we aim to explore the effects of varying degrees of surgical margins on survival in patients with dedifferentiated liposarcoma (DDLPS).

Methods: The National Cancer Database (NCDB) was used to select patients with DDLPS to determine if surgical margins and other variables were associated with decreased overall survival after accounting for age, gender, race, Charlson-Deyo score, anatomic site, treatment approach, tumor size, tumor grade, and presence of metastases through multivariable analysis.

Results: Of the 1004 selected patients, 64.4% were male, 87.0% were white, and the median age was 63 years. About 95% had no metastases at the time of diagnosis, and 91.5% had high grade liposarcoma. For the status of surgical margins, 50.8% had no residual tumors, 26.1% had microscopic residual tumors, 4.3% had macroscopic residual tumors. In general, the risk of death was higher for older males (25.8% increased risk of mortality) and those with metastases (312.9% increased risk of mortality) as well as patients with high grade liposarcoma (112.4% increased risk of mortality). Patients with macroscopic residual tumors in comparison to those with no residual tumors had a 96.7% increased risk of death (HR 95% CI:1.24 to 3.13; P=0.004).

Conclusion: Older age, presence of metastasis, male patients, retroperitoneal/abdomen primary site, highgrade tumors, and macroscopic or residual tumor present after surgery lead to an increased risk of mortality. These outcomes highlight the importance and benefits of negative or complete surgical margins as prognostic indicators for patients with DDLPS, especially considering that resection is the most commonly utilized therapeutic option. The NCDB contains about 70% of cancer incidents within the US, therefore a future study incorporating the Surveillance, Epidemiology, and End Results (SEER) registry could enhance and possibly add to the results brought forth by this study.

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Abstract Presented at the 2019 Association of VA Hematology/Oncology Annual Meeting
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