AVAHO

Background: Next-generation sequencing (NGS) of cancer gene panels is now standard-of-care for patients with advanced solid tumors. In July 2016, the Veterans Health Administration (VHA) launched the National Precision Oncology Program (NPOP) to increase access to NGS testing to VHA cancer patients across the country. A review of the prescription patterns among patients with highly actionable mutations is warranted to measure the impact of NPOP.

Purpose: The objective of this study is to assess the use of targeted therapies among patients with advanced solid tumors who received a Level 1, 2A, or R1 recommendation based on NGS results. For cases in which patients failed to receive targeted agents, underlying reasons will be identified. Study results will be used to improve outcomes of veterans undergoing NGS testing and the cost-benefit of NPOP.

Methods: This study will be conducted as a retrospective analysis of veterans who received oncologic care through the VHA and underwent NGS testing. From program inception in July 2016 until January 2019, the tumor samples of 5,897 patients have undergone NGS testing through NPOP. NGS results were categorized by Watson for Genomics (WfG), an artificial intelligence decision-support system. Among these, 608 (10.3%) samples noted to have at least one genetic variant with Level 1 or 2A actionability. The NPOP database will be queried to identify these patients who had a recommendation to receive a targeted agent. Prescribed and dispensed drugs will be identified from the Corporate Data Warehouse to indicate patients who have received targeted agents through VHA and compute the percentage of those who were not prescribed therapy through VHA. The medical records of patients who did not receive a corresponding targeted drug will be reviewed to identify non-VA drug use and code reasons if no record of drug administration is recorded. These codes will be examined for association with patients and tumor characteristics, sites of treating oncologists, and types of cancers. The most frequent coded reasons will be recorded, and assessment of this data will be performed to identify potential interventions to improve the utility of NGS testing for veterans.

Background: Next-generation sequencing (NGS) of cancer gene panels is now standard-of-care for patients with advanced solid tumors. In July 2016, the Veterans Health Administration (VHA) launched the National Precision Oncology Program (NPOP) to increase access to NGS testing to VHA cancer patients across the country. A review of the prescription patterns among patients with highly actionable mutations is warranted to measure the impact of NPOP.

Purpose: The objective of this study is to assess the use of targeted therapies among patients with advanced solid tumors who received a Level 1, 2A, or R1 recommendation based on NGS results. For cases in which patients failed to receive targeted agents, underlying reasons will be identified. Study results will be used to improve outcomes of veterans undergoing NGS testing and the cost-benefit of NPOP.

Methods: This study will be conducted as a retrospective analysis of veterans who received oncologic care through the VHA and underwent NGS testing. From program inception in July 2016 until January 2019, the tumor samples of 5,897 patients have undergone NGS testing through NPOP. NGS results were categorized by Watson for Genomics (WfG), an artificial intelligence decision-support system. Among these, 608 (10.3%) samples noted to have at least one genetic variant with Level 1 or 2A actionability. The NPOP database will be queried to identify these patients who had a recommendation to receive a targeted agent. Prescribed and dispensed drugs will be identified from the Corporate Data Warehouse to indicate patients who have received targeted agents through VHA and compute the percentage of those who were not prescribed therapy through VHA. The medical records of patients who did not receive a corresponding targeted drug will be reviewed to identify non-VA drug use and code reasons if no record of drug administration is recorded. These codes will be examined for association with patients and tumor characteristics, sites of treating oncologists, and types of cancers. The most frequent coded reasons will be recorded, and assessment of this data will be performed to identify potential interventions to improve the utility of NGS testing for veterans.

Background: Next-generation sequencing (NGS) of cancer gene panels is now standard-of-care for patients with advanced solid tumors. In July 2016, the Veterans Health Administration (VHA) launched the National Precision Oncology Program (NPOP) to increase access to NGS testing to VHA cancer patients across the country. A review of the prescription patterns among patients with highly actionable mutations is warranted to measure the impact of NPOP.

Purpose: The objective of this study is to assess the use of targeted therapies among patients with advanced solid tumors who received a Level 1, 2A, or R1 recommendation based on NGS results. For cases in which patients failed to receive targeted agents, underlying reasons will be identified. Study results will be used to improve outcomes of veterans undergoing NGS testing and the cost-benefit of NPOP.

Methods: This study will be conducted as a retrospective analysis of veterans who received oncologic care through the VHA and underwent NGS testing. From program inception in July 2016 until January 2019, the tumor samples of 5,897 patients have undergone NGS testing through NPOP. NGS results were categorized by Watson for Genomics (WfG), an artificial intelligence decision-support system. Among these, 608 (10.3%) samples noted to have at least one genetic variant with Level 1 or 2A actionability. The NPOP database will be queried to identify these patients who had a recommendation to receive a targeted agent. Prescribed and dispensed drugs will be identified from the Corporate Data Warehouse to indicate patients who have received targeted agents through VHA and compute the percentage of those who were not prescribed therapy through VHA. The medical records of patients who did not receive a corresponding targeted drug will be reviewed to identify non-VA drug use and code reasons if no record of drug administration is recorded. These codes will be examined for association with patients and tumor characteristics, sites of treating oncologists, and types of cancers. The most frequent coded reasons will be recorded, and assessment of this data will be performed to identify potential interventions to improve the utility of NGS testing for veterans.

Background: Prostate cancer is the most common cancer in men in the United States. Death in prostate cancer patients is often reported to be non-prostate cancer related, attributed to other medical conditions, cardiovascular disease, or malignancies. As prostate cancer is associated with a prolonged survival, especially in those with low burden of disease, care of these patients includes not only treating their malignancy, but also optimizing their other co-morbidities, such as cardiovascular disease. Statins are lipid-lowering medications, proven to reduce mortality in cardiovascular disease. There are multiple reports and epidemiological studies of statins decreasing the risk, progression, and overall mortality of prostate cancer. Methods: This is a retrospective observational study with chart review of 300 patients diagnosed with prostate cancer from 1995 to 2010, in a VA Hospital in San Antonio, Texas. Variables included age of diagnosis, statin use, type of statin (1st, 2nd, or 3rd generation), dose of statin (6 levels of dosage were identified), length of statin use, time followed in months (from time of diagnosis to either death or the end of the study period), death, and cause of death. The Cox proportional hazards regression model was used to estimate the hazard function, with age at diagnosis used as a covariate. Primary end point was death by prostate cancer (21 patients) and secondary end points- death by any cancer (52 patients patients), and death by all causes (136 patients). Results: The hazard ratio for use of statins at least 6 months was 0.33, with 95% confidence limits of 0.13 to 0.83, and P = 0.018, indicating that using statins has a statistically significant positive effect at delaying death by prostate cancer. Secondary endpoints of death by any cancer and death by all causes were also significantly affected by the statins. The study was unable to conclude if the type of statin, dose of statin or the length of statin use had a significant effect in reaching the different end points.

Conclusion: Concomitant statin use may prevent death from prostate cancer, death from any cancer, as well as death from all causes.

Background: Prostate cancer is the most common cancer in men in the United States. Death in prostate cancer patients is often reported to be non-prostate cancer related, attributed to other medical conditions, cardiovascular disease, or malignancies. As prostate cancer is associated with a prolonged survival, especially in those with low burden of disease, care of these patients includes not only treating their malignancy, but also optimizing their other co-morbidities, such as cardiovascular disease. Statins are lipid-lowering medications, proven to reduce mortality in cardiovascular disease. There are multiple reports and epidemiological studies of statins decreasing the risk, progression, and overall mortality of prostate cancer. Methods: This is a retrospective observational study with chart review of 300 patients diagnosed with prostate cancer from 1995 to 2010, in a VA Hospital in San Antonio, Texas. Variables included age of diagnosis, statin use, type of statin (1st, 2nd, or 3rd generation), dose of statin (6 levels of dosage were identified), length of statin use, time followed in months (from time of diagnosis to either death or the end of the study period), death, and cause of death. The Cox proportional hazards regression model was used to estimate the hazard function, with age at diagnosis used as a covariate. Primary end point was death by prostate cancer (21 patients) and secondary end points- death by any cancer (52 patients patients), and death by all causes (136 patients). Results: The hazard ratio for use of statins at least 6 months was 0.33, with 95% confidence limits of 0.13 to 0.83, and P = 0.018, indicating that using statins has a statistically significant positive effect at delaying death by prostate cancer. Secondary endpoints of death by any cancer and death by all causes were also significantly affected by the statins. The study was unable to conclude if the type of statin, dose of statin or the length of statin use had a significant effect in reaching the different end points.

Conclusion: Concomitant statin use may prevent death from prostate cancer, death from any cancer, as well as death from all causes.

Background: Prostate cancer is the most common cancer in men in the United States. Death in prostate cancer patients is often reported to be non-prostate cancer related, attributed to other medical conditions, cardiovascular disease, or malignancies. As prostate cancer is associated with a prolonged survival, especially in those with low burden of disease, care of these patients includes not only treating their malignancy, but also optimizing their other co-morbidities, such as cardiovascular disease. Statins are lipid-lowering medications, proven to reduce mortality in cardiovascular disease. There are multiple reports and epidemiological studies of statins decreasing the risk, progression, and overall mortality of prostate cancer. Methods: This is a retrospective observational study with chart review of 300 patients diagnosed with prostate cancer from 1995 to 2010, in a VA Hospital in San Antonio, Texas. Variables included age of diagnosis, statin use, type of statin (1st, 2nd, or 3rd generation), dose of statin (6 levels of dosage were identified), length of statin use, time followed in months (from time of diagnosis to either death or the end of the study period), death, and cause of death. The Cox proportional hazards regression model was used to estimate the hazard function, with age at diagnosis used as a covariate. Primary end point was death by prostate cancer (21 patients) and secondary end points- death by any cancer (52 patients patients), and death by all causes (136 patients). Results: The hazard ratio for use of statins at least 6 months was 0.33, with 95% confidence limits of 0.13 to 0.83, and P = 0.018, indicating that using statins has a statistically significant positive effect at delaying death by prostate cancer. Secondary endpoints of death by any cancer and death by all causes were also significantly affected by the statins. The study was unable to conclude if the type of statin, dose of statin or the length of statin use had a significant effect in reaching the different end points.

Conclusion: Concomitant statin use may prevent death from prostate cancer, death from any cancer, as well as death from all causes.

Background: Angioimmunoblastic T-cell lymphoma (AITL) is a rare and aggressive malignancy, representing approximately 18.5% of Peripheral T-cell lymphomas. The clinical presentation varies greatly, and literature describing this disease is limited. In this study we utilize the National Cancer Database (NCDB) to describe the patient characteristics, demographics, and overall survival of AITL.

Methods: The NCDB for non-Hodgkin’s lymphoma was used to identify 3,708 patients diagnosed with AITL between 2004 and 2016. We examined demographic information including age, race, gender, stage, and treatment modality. Kaplan-Meier analysis was used to analyze overall survival and compare survival by patient age, stage, and year of diagnosis. Bivariate and multivariate analysis was used to obtain hazard ratios and assess the association of patient characteristics and treatment methods with survival.

Results: The majority of AITL patients were white 87.8%, males 53%, with an average age of 67 years. 90% of patients received treatment, with 77.4% receiving chemotherapy, 10.8% receiving hematopoietic transplant, and 2.6% receiving radiation. B symptoms were present in 57% of patients. 43% were diagnosed with stage III disease and 43.5% at stage IV.

Median survival was 22 months (CI 19.7-24.4), with a 5- and 10-year survival of 30% and 22%. Median survival for patients aged 35-50 was 74 months, 50-65 was 37.7 months, 65-80 was 20.5 months, and for patients aged > 80 years old median survival was 6.4 months. Patients with stage I disease survived 35.1 months whereas those with stage IV disease survived 17.2 months. On multivariate analysis black race, increasing age, charleson-deyo comorbidity score, and stage at diagnoses were signi cantly associated with increased mortality risk. All forms of treatment, including chemotherapy, hematopoietic transplant, and radiation were all associated with improved survival.

Discussion: Our study found that the majority of AITL patients present with late stage disease, often with B symptoms, and have poor prognosis. We found a five-year survival of 30% for this malignancy when all stages of disease were combined. Knowledge of the patient characteristics, treatment modalities, and overall survival in AITL can serve to enhance the care of providers who encounter this uncommon diagnosis.

Background: Angioimmunoblastic T-cell lymphoma (AITL) is a rare and aggressive malignancy, representing approximately 18.5% of Peripheral T-cell lymphomas. The clinical presentation varies greatly, and literature describing this disease is limited. In this study we utilize the National Cancer Database (NCDB) to describe the patient characteristics, demographics, and overall survival of AITL.

Methods: The NCDB for non-Hodgkin’s lymphoma was used to identify 3,708 patients diagnosed with AITL between 2004 and 2016. We examined demographic information including age, race, gender, stage, and treatment modality. Kaplan-Meier analysis was used to analyze overall survival and compare survival by patient age, stage, and year of diagnosis. Bivariate and multivariate analysis was used to obtain hazard ratios and assess the association of patient characteristics and treatment methods with survival.

Results: The majority of AITL patients were white 87.8%, males 53%, with an average age of 67 years. 90% of patients received treatment, with 77.4% receiving chemotherapy, 10.8% receiving hematopoietic transplant, and 2.6% receiving radiation. B symptoms were present in 57% of patients. 43% were diagnosed with stage III disease and 43.5% at stage IV.

Median survival was 22 months (CI 19.7-24.4), with a 5- and 10-year survival of 30% and 22%. Median survival for patients aged 35-50 was 74 months, 50-65 was 37.7 months, 65-80 was 20.5 months, and for patients aged > 80 years old median survival was 6.4 months. Patients with stage I disease survived 35.1 months whereas those with stage IV disease survived 17.2 months. On multivariate analysis black race, increasing age, charleson-deyo comorbidity score, and stage at diagnoses were signi cantly associated with increased mortality risk. All forms of treatment, including chemotherapy, hematopoietic transplant, and radiation were all associated with improved survival.

Discussion: Our study found that the majority of AITL patients present with late stage disease, often with B symptoms, and have poor prognosis. We found a five-year survival of 30% for this malignancy when all stages of disease were combined. Knowledge of the patient characteristics, treatment modalities, and overall survival in AITL can serve to enhance the care of providers who encounter this uncommon diagnosis.

Background: Angioimmunoblastic T-cell lymphoma (AITL) is a rare and aggressive malignancy, representing approximately 18.5% of Peripheral T-cell lymphomas. The clinical presentation varies greatly, and literature describing this disease is limited. In this study we utilize the National Cancer Database (NCDB) to describe the patient characteristics, demographics, and overall survival of AITL.

Methods: The NCDB for non-Hodgkin’s lymphoma was used to identify 3,708 patients diagnosed with AITL between 2004 and 2016. We examined demographic information including age, race, gender, stage, and treatment modality. Kaplan-Meier analysis was used to analyze overall survival and compare survival by patient age, stage, and year of diagnosis. Bivariate and multivariate analysis was used to obtain hazard ratios and assess the association of patient characteristics and treatment methods with survival.

Results: The majority of AITL patients were white 87.8%, males 53%, with an average age of 67 years. 90% of patients received treatment, with 77.4% receiving chemotherapy, 10.8% receiving hematopoietic transplant, and 2.6% receiving radiation. B symptoms were present in 57% of patients. 43% were diagnosed with stage III disease and 43.5% at stage IV.

Median survival was 22 months (CI 19.7-24.4), with a 5- and 10-year survival of 30% and 22%. Median survival for patients aged 35-50 was 74 months, 50-65 was 37.7 months, 65-80 was 20.5 months, and for patients aged > 80 years old median survival was 6.4 months. Patients with stage I disease survived 35.1 months whereas those with stage IV disease survived 17.2 months. On multivariate analysis black race, increasing age, charleson-deyo comorbidity score, and stage at diagnoses were signi cantly associated with increased mortality risk. All forms of treatment, including chemotherapy, hematopoietic transplant, and radiation were all associated with improved survival.

Discussion: Our study found that the majority of AITL patients present with late stage disease, often with B symptoms, and have poor prognosis. We found a five-year survival of 30% for this malignancy when all stages of disease were combined. Knowledge of the patient characteristics, treatment modalities, and overall survival in AITL can serve to enhance the care of providers who encounter this uncommon diagnosis.

Background: The utilization of rituximab for a variety of different indications has historically been associated with logistical challenges related to time and labor. Institutions across the country have implemented protocols to shorten the infusion time of rituximab in order to help alleviate these challenges. The purpose of this study was to support the safe implementation of a 90-minute rapid infusion protocol for rituximab at the Richard L. Roudebush VA Medical Center and improve staff perception regarding similar initiatives in the future with other therapies.

Methods: Proactive measures were taken to educate physicians, pharmacists, and nurses about their role in the implementation of the protocol. A weekly report of patients receiving rituximab was generated from November 1st, 2018 to April 1st, 2019. Patients were then screened for future eligibility for rapid infusions of the drug based on prespecified criteria and providers were notified regarding potential candidates. After patients received their rapid infusions, a retrospective chart review was performed to evaluate patient tolerability and assess for any safety concerns.

Data Analysis: The primary endpoint for this study was the incidence of grade 3 and 4 infusion related reactions associated with the rapid infusions of rituximab based on criteria from CTCAE version 5.0. Secondary endpoints were savings in infusion clinic chair time and the proportion of patients experiencing a grade 3 or 4 infusion related reaction to the rapid infusion that received proper treatment according to the institution’s hypersensitivity protocol. All endpoints were analyzed using descriptive statistics.

Results: During the study period, 11 patients received a total of 24 rapid infusions of rituximab. One out of 24 infusions (4.17%) resulted in a grade 3 infusion related reaction. This patient was treated appropriately by nurses according to the institution’s hypersensitivity protocol. The average savings in infusion clinic chair time by rapid infusions was 39.3 minutes.

Conclusion: This study proved that a rapid infusion protocol for rituximab can be successfully implemented at the Richard L. Roudebush VA Medical Center. The proactive measures utilized to implement the protocol improved provider prescribing rates and nursing satisfaction. Future plans involve implementing a rapid infusion protocol for daratumumab.

Background: The utilization of rituximab for a variety of different indications has historically been associated with logistical challenges related to time and labor. Institutions across the country have implemented protocols to shorten the infusion time of rituximab in order to help alleviate these challenges. The purpose of this study was to support the safe implementation of a 90-minute rapid infusion protocol for rituximab at the Richard L. Roudebush VA Medical Center and improve staff perception regarding similar initiatives in the future with other therapies.

Methods: Proactive measures were taken to educate physicians, pharmacists, and nurses about their role in the implementation of the protocol. A weekly report of patients receiving rituximab was generated from November 1st, 2018 to April 1st, 2019. Patients were then screened for future eligibility for rapid infusions of the drug based on prespecified criteria and providers were notified regarding potential candidates. After patients received their rapid infusions, a retrospective chart review was performed to evaluate patient tolerability and assess for any safety concerns.

Data Analysis: The primary endpoint for this study was the incidence of grade 3 and 4 infusion related reactions associated with the rapid infusions of rituximab based on criteria from CTCAE version 5.0. Secondary endpoints were savings in infusion clinic chair time and the proportion of patients experiencing a grade 3 or 4 infusion related reaction to the rapid infusion that received proper treatment according to the institution’s hypersensitivity protocol. All endpoints were analyzed using descriptive statistics.

Results: During the study period, 11 patients received a total of 24 rapid infusions of rituximab. One out of 24 infusions (4.17%) resulted in a grade 3 infusion related reaction. This patient was treated appropriately by nurses according to the institution’s hypersensitivity protocol. The average savings in infusion clinic chair time by rapid infusions was 39.3 minutes.

Conclusion: This study proved that a rapid infusion protocol for rituximab can be successfully implemented at the Richard L. Roudebush VA Medical Center. The proactive measures utilized to implement the protocol improved provider prescribing rates and nursing satisfaction. Future plans involve implementing a rapid infusion protocol for daratumumab.

Background: The utilization of rituximab for a variety of different indications has historically been associated with logistical challenges related to time and labor. Institutions across the country have implemented protocols to shorten the infusion time of rituximab in order to help alleviate these challenges. The purpose of this study was to support the safe implementation of a 90-minute rapid infusion protocol for rituximab at the Richard L. Roudebush VA Medical Center and improve staff perception regarding similar initiatives in the future with other therapies.

Methods: Proactive measures were taken to educate physicians, pharmacists, and nurses about their role in the implementation of the protocol. A weekly report of patients receiving rituximab was generated from November 1st, 2018 to April 1st, 2019. Patients were then screened for future eligibility for rapid infusions of the drug based on prespecified criteria and providers were notified regarding potential candidates. After patients received their rapid infusions, a retrospective chart review was performed to evaluate patient tolerability and assess for any safety concerns.

Data Analysis: The primary endpoint for this study was the incidence of grade 3 and 4 infusion related reactions associated with the rapid infusions of rituximab based on criteria from CTCAE version 5.0. Secondary endpoints were savings in infusion clinic chair time and the proportion of patients experiencing a grade 3 or 4 infusion related reaction to the rapid infusion that received proper treatment according to the institution’s hypersensitivity protocol. All endpoints were analyzed using descriptive statistics.

Results: During the study period, 11 patients received a total of 24 rapid infusions of rituximab. One out of 24 infusions (4.17%) resulted in a grade 3 infusion related reaction. This patient was treated appropriately by nurses according to the institution’s hypersensitivity protocol. The average savings in infusion clinic chair time by rapid infusions was 39.3 minutes.

Conclusion: This study proved that a rapid infusion protocol for rituximab can be successfully implemented at the Richard L. Roudebush VA Medical Center. The proactive measures utilized to implement the protocol improved provider prescribing rates and nursing satisfaction. Future plans involve implementing a rapid infusion protocol for daratumumab.

Background: The VA Connecticut Healthcare System Cancer Center developed and implemented a standardized pre-screening process and infrastructure to help identify patients for clinical trials and increase enrollment. Participation rate of cancer patients in clinical trials in the US is low, and the rate of enrollment of veterans with cancer into clinical trials is even lower than in the non-VA population. We hypothesized that a standardized process to prospectively identify potential patients for available clinical trials would increase enrollment of veteran cancer patients.

Methods: Our process uses the Research Electronic Data Capture (REDCap) system to pre-screen patients for clinical trials and to create a registry of potential research subjects. Patients are initially identified through multiple resources (clinic lists, tumor boards, cancer registry), and a standardized medical chart review is used to manually populate customized data fields in REDCap. Limited data fields are entered on all cancer patients, and more detailed information including stage, previous treatments and comorbidities is captured in patients for which we have active clinical trials. Providers are alerted prior to clinic when a potential research subject is scheduled, and have the opportunity to confirm eligibility, review the protocol, and set aside adequate time in clinic to discuss the study with the patient. The pre-screening protocol is approved by our IRB.

Reasults: From March 2017 through March 2019, research coordinators pre-screened and entered 4,959 unique patients into REDCap and identified 1,282 potential participants for trials. Of these, 756 patients met study specific criteria. Of those who were approached, 439 patients consented and proceeded with study specific screening procedures. We also routinely use our REDCap™ database to help estimate the likelihood of meeting enrollment targets when considering new clinical trials. Our clinical trials enrollment numbers have increased from 66 in 2016 to 238 in 2018, and the number of open trials has increased from 16 to 26 during this period.

Conclusion: An IRB-approved prescreening protocol which utilizes a data capturing system such as REDCap can help increase cancer clinical trials enrollment. Next steps will be to expand this concept across VA sites and to automate portions of data capture.

Background: The VA Connecticut Healthcare System Cancer Center developed and implemented a standardized pre-screening process and infrastructure to help identify patients for clinical trials and increase enrollment. Participation rate of cancer patients in clinical trials in the US is low, and the rate of enrollment of veterans with cancer into clinical trials is even lower than in the non-VA population. We hypothesized that a standardized process to prospectively identify potential patients for available clinical trials would increase enrollment of veteran cancer patients.

Methods: Our process uses the Research Electronic Data Capture (REDCap) system to pre-screen patients for clinical trials and to create a registry of potential research subjects. Patients are initially identified through multiple resources (clinic lists, tumor boards, cancer registry), and a standardized medical chart review is used to manually populate customized data fields in REDCap. Limited data fields are entered on all cancer patients, and more detailed information including stage, previous treatments and comorbidities is captured in patients for which we have active clinical trials. Providers are alerted prior to clinic when a potential research subject is scheduled, and have the opportunity to confirm eligibility, review the protocol, and set aside adequate time in clinic to discuss the study with the patient. The pre-screening protocol is approved by our IRB.

Reasults: From March 2017 through March 2019, research coordinators pre-screened and entered 4,959 unique patients into REDCap and identified 1,282 potential participants for trials. Of these, 756 patients met study specific criteria. Of those who were approached, 439 patients consented and proceeded with study specific screening procedures. We also routinely use our REDCap™ database to help estimate the likelihood of meeting enrollment targets when considering new clinical trials. Our clinical trials enrollment numbers have increased from 66 in 2016 to 238 in 2018, and the number of open trials has increased from 16 to 26 during this period.

Conclusion: An IRB-approved prescreening protocol which utilizes a data capturing system such as REDCap can help increase cancer clinical trials enrollment. Next steps will be to expand this concept across VA sites and to automate portions of data capture.

Background: The VA Connecticut Healthcare System Cancer Center developed and implemented a standardized pre-screening process and infrastructure to help identify patients for clinical trials and increase enrollment. Participation rate of cancer patients in clinical trials in the US is low, and the rate of enrollment of veterans with cancer into clinical trials is even lower than in the non-VA population. We hypothesized that a standardized process to prospectively identify potential patients for available clinical trials would increase enrollment of veteran cancer patients.

Methods: Our process uses the Research Electronic Data Capture (REDCap) system to pre-screen patients for clinical trials and to create a registry of potential research subjects. Patients are initially identified through multiple resources (clinic lists, tumor boards, cancer registry), and a standardized medical chart review is used to manually populate customized data fields in REDCap. Limited data fields are entered on all cancer patients, and more detailed information including stage, previous treatments and comorbidities is captured in patients for which we have active clinical trials. Providers are alerted prior to clinic when a potential research subject is scheduled, and have the opportunity to confirm eligibility, review the protocol, and set aside adequate time in clinic to discuss the study with the patient. The pre-screening protocol is approved by our IRB.

Reasults: From March 2017 through March 2019, research coordinators pre-screened and entered 4,959 unique patients into REDCap and identified 1,282 potential participants for trials. Of these, 756 patients met study specific criteria. Of those who were approached, 439 patients consented and proceeded with study specific screening procedures. We also routinely use our REDCap™ database to help estimate the likelihood of meeting enrollment targets when considering new clinical trials. Our clinical trials enrollment numbers have increased from 66 in 2016 to 238 in 2018, and the number of open trials has increased from 16 to 26 during this period.

Conclusion: An IRB-approved prescreening protocol which utilizes a data capturing system such as REDCap can help increase cancer clinical trials enrollment. Next steps will be to expand this concept across VA sites and to automate portions of data capture.

Background: The use of oral chemotherapy in cancer patients continues to increase and proper documentation of patient adherence, duration of treatment and side effects while on these medications is important. The Quality Oncology Practice Initiative (QOPI) identified oral chemotherapy documentation as an area in need of improvement.

Methods: We used the QOPI audit to create a quality improvement project with the goal of improving our provider oral chemotherapy documentation including cycle number, adherence and side effects. An existing oral chemotherapy best practice alert template in our electronic medical record had already been created to help our providers document oral chemotherapy administration, and we sought to improve our documentation by increasing our provider compliance in completing this template. We utilized Plan-Do-Study- Act (PDSA) cycles to accomplish our goal. For the first PDSA cycle, we made bypassing the oral chemotherapy documentation template in our electronic medical record more difficult for our providers. Our providers were required to acknowledge the template by either following the link to complete the template or documenting a reason why the template was not completed. Requiring the provider to document a reason why the template was not completed made bypassing the template more difficult.

Results: By making this change to the template, we successfully improved our provider compliance with following the link to complete the template from 38% (83/220) to 71% (121/169). For the second PDSA cycle, we educated our medical oncology providers via email about the importance of utilizing the template to improve our oral chemotherapy documentation. By educating our providers, we improved our provider compliance with following the link to complete the template to 86.5% (155/179).

Conclusion: Our project showed how the QOPI audit can be used to create a quality improvement project. Our project also demonstrated how templates within the electronic medical record can be utilized to complete a successful quality improvement project.

Background: The use of oral chemotherapy in cancer patients continues to increase and proper documentation of patient adherence, duration of treatment and side effects while on these medications is important. The Quality Oncology Practice Initiative (QOPI) identified oral chemotherapy documentation as an area in need of improvement.

Methods: We used the QOPI audit to create a quality improvement project with the goal of improving our provider oral chemotherapy documentation including cycle number, adherence and side effects. An existing oral chemotherapy best practice alert template in our electronic medical record had already been created to help our providers document oral chemotherapy administration, and we sought to improve our documentation by increasing our provider compliance in completing this template. We utilized Plan-Do-Study- Act (PDSA) cycles to accomplish our goal. For the first PDSA cycle, we made bypassing the oral chemotherapy documentation template in our electronic medical record more difficult for our providers. Our providers were required to acknowledge the template by either following the link to complete the template or documenting a reason why the template was not completed. Requiring the provider to document a reason why the template was not completed made bypassing the template more difficult.

Results: By making this change to the template, we successfully improved our provider compliance with following the link to complete the template from 38% (83/220) to 71% (121/169). For the second PDSA cycle, we educated our medical oncology providers via email about the importance of utilizing the template to improve our oral chemotherapy documentation. By educating our providers, we improved our provider compliance with following the link to complete the template to 86.5% (155/179).

Conclusion: Our project showed how the QOPI audit can be used to create a quality improvement project. Our project also demonstrated how templates within the electronic medical record can be utilized to complete a successful quality improvement project.

Background: The use of oral chemotherapy in cancer patients continues to increase and proper documentation of patient adherence, duration of treatment and side effects while on these medications is important. The Quality Oncology Practice Initiative (QOPI) identified oral chemotherapy documentation as an area in need of improvement.

Methods: We used the QOPI audit to create a quality improvement project with the goal of improving our provider oral chemotherapy documentation including cycle number, adherence and side effects. An existing oral chemotherapy best practice alert template in our electronic medical record had already been created to help our providers document oral chemotherapy administration, and we sought to improve our documentation by increasing our provider compliance in completing this template. We utilized Plan-Do-Study- Act (PDSA) cycles to accomplish our goal. For the first PDSA cycle, we made bypassing the oral chemotherapy documentation template in our electronic medical record more difficult for our providers. Our providers were required to acknowledge the template by either following the link to complete the template or documenting a reason why the template was not completed. Requiring the provider to document a reason why the template was not completed made bypassing the template more difficult.

Results: By making this change to the template, we successfully improved our provider compliance with following the link to complete the template from 38% (83/220) to 71% (121/169). For the second PDSA cycle, we educated our medical oncology providers via email about the importance of utilizing the template to improve our oral chemotherapy documentation. By educating our providers, we improved our provider compliance with following the link to complete the template to 86.5% (155/179).

Conclusion: Our project showed how the QOPI audit can be used to create a quality improvement project. Our project also demonstrated how templates within the electronic medical record can be utilized to complete a successful quality improvement project.

Background: The utilization of oral chemotherapy agents is becoming increasingly widespread due to expanding indications in the oncology world. This change represents a shift in managing patients with cancer from intermittent intravenous therapy to self-administered chronic oral therapy which presents unique issues regarding patient safety. A previous study conducted in Toronto, Canada showed that the formation of a multidisciplinary oral chemotherapy clinic helped improve patient outcomes (Disperati et al, 2017).

To address these concerns at our facility, an oral chemotherapy clinic was implemented to provide closer monitoring of patients on oral chemotherapeutic agents. The pharmacy driven oral chemotherapy clinic includes a multidisciplinary team of an oncology pharmacist, oncology physicians, and support staff. The oncology pharmacist provides counseling on proper medication administration, ensures medication adherence, and manages adverse drug events.

Physicians collaborate with the oncology pharmacist to enroll patients into the clinic by placing an intrafacility consult. Referred patients may be newly starting oral chemotherapy or continuing an oral chemotherapy regimen. Patients are not eligible if partial care is provided by a community oncologist. Pharmacist appointments may be face to face or telephone and are in addition to routine physician provider visits.

Results: After the first 4 months of initiating the oral chemotherapy clinic, there were 10 patients enrolled. There were 22 documented interventions, 16 pharmacist interventions and 6 physician interventions. The most common pharmacist interventions included medication adjustments and initiation of supplemental medications to treat adverse events. Patients engaged in 49 encounters, including 17 traditional visits, 21 oral chemotherapy clinic visits, 8 scheduled telehealth visits, and 3 unscheduled telehealth visits with only 1 emergency department visit. Notably, no emergency visits were due to a patient’s oral chemotherapy regimen.

Additional outcomes were analyzed showing 100% patient compliance, 100% proper renal/hepatic dosing and the oral chemo clinic achieved 84% appropriate lab monitoring (improved from 36% in the control group).

Implications: A multidisciplinary approach and integrating the pharmacist run oral chemotherapy clinic improved patient monitoring, drug compliance and patient access to care. With these positive results, we hope to expand the program and incorporate a fulltime pharmacist.

Background: The utilization of oral chemotherapy agents is becoming increasingly widespread due to expanding indications in the oncology world. This change represents a shift in managing patients with cancer from intermittent intravenous therapy to self-administered chronic oral therapy which presents unique issues regarding patient safety. A previous study conducted in Toronto, Canada showed that the formation of a multidisciplinary oral chemotherapy clinic helped improve patient outcomes (Disperati et al, 2017).

To address these concerns at our facility, an oral chemotherapy clinic was implemented to provide closer monitoring of patients on oral chemotherapeutic agents. The pharmacy driven oral chemotherapy clinic includes a multidisciplinary team of an oncology pharmacist, oncology physicians, and support staff. The oncology pharmacist provides counseling on proper medication administration, ensures medication adherence, and manages adverse drug events.

Physicians collaborate with the oncology pharmacist to enroll patients into the clinic by placing an intrafacility consult. Referred patients may be newly starting oral chemotherapy or continuing an oral chemotherapy regimen. Patients are not eligible if partial care is provided by a community oncologist. Pharmacist appointments may be face to face or telephone and are in addition to routine physician provider visits.

Results: After the first 4 months of initiating the oral chemotherapy clinic, there were 10 patients enrolled. There were 22 documented interventions, 16 pharmacist interventions and 6 physician interventions. The most common pharmacist interventions included medication adjustments and initiation of supplemental medications to treat adverse events. Patients engaged in 49 encounters, including 17 traditional visits, 21 oral chemotherapy clinic visits, 8 scheduled telehealth visits, and 3 unscheduled telehealth visits with only 1 emergency department visit. Notably, no emergency visits were due to a patient’s oral chemotherapy regimen.

Additional outcomes were analyzed showing 100% patient compliance, 100% proper renal/hepatic dosing and the oral chemo clinic achieved 84% appropriate lab monitoring (improved from 36% in the control group).

Implications: A multidisciplinary approach and integrating the pharmacist run oral chemotherapy clinic improved patient monitoring, drug compliance and patient access to care. With these positive results, we hope to expand the program and incorporate a fulltime pharmacist.

Background: The utilization of oral chemotherapy agents is becoming increasingly widespread due to expanding indications in the oncology world. This change represents a shift in managing patients with cancer from intermittent intravenous therapy to self-administered chronic oral therapy which presents unique issues regarding patient safety. A previous study conducted in Toronto, Canada showed that the formation of a multidisciplinary oral chemotherapy clinic helped improve patient outcomes (Disperati et al, 2017).

To address these concerns at our facility, an oral chemotherapy clinic was implemented to provide closer monitoring of patients on oral chemotherapeutic agents. The pharmacy driven oral chemotherapy clinic includes a multidisciplinary team of an oncology pharmacist, oncology physicians, and support staff. The oncology pharmacist provides counseling on proper medication administration, ensures medication adherence, and manages adverse drug events.

Physicians collaborate with the oncology pharmacist to enroll patients into the clinic by placing an intrafacility consult. Referred patients may be newly starting oral chemotherapy or continuing an oral chemotherapy regimen. Patients are not eligible if partial care is provided by a community oncologist. Pharmacist appointments may be face to face or telephone and are in addition to routine physician provider visits.

Results: After the first 4 months of initiating the oral chemotherapy clinic, there were 10 patients enrolled. There were 22 documented interventions, 16 pharmacist interventions and 6 physician interventions. The most common pharmacist interventions included medication adjustments and initiation of supplemental medications to treat adverse events. Patients engaged in 49 encounters, including 17 traditional visits, 21 oral chemotherapy clinic visits, 8 scheduled telehealth visits, and 3 unscheduled telehealth visits with only 1 emergency department visit. Notably, no emergency visits were due to a patient’s oral chemotherapy regimen.

Additional outcomes were analyzed showing 100% patient compliance, 100% proper renal/hepatic dosing and the oral chemo clinic achieved 84% appropriate lab monitoring (improved from 36% in the control group).

Implications: A multidisciplinary approach and integrating the pharmacist run oral chemotherapy clinic improved patient monitoring, drug compliance and patient access to care. With these positive results, we hope to expand the program and incorporate a fulltime pharmacist.

Background: Oligodendrogliomas represent about 12% of all brain tumors. Our goal was to compare the demographic factors of patients diagnosed with oligodendroglioma from 2004-2014 identified in the National Cancer Database (NCDB). We also examined the survival of patients based off of the number of their comorbidities.

Methods: We identified 7525 patients diagnosed with oligodendroglioma in the NCDB diagnosed between 2004-2014. Many demographic factors were examined such as age, gender, race, facility treated at, comorbidities, and surgery type. Between-insurance survival differences were estimated by the Kaplan-Meier method and associated log-rank tests; Tukey-Kramer adjusted P < .05 indicated statistical significance.

Results: More men were diagnosed with the tumor than females (55% vs 45%). Average age of patients at diagnosis was 43.5 years old. 66% of patients had private insurance, while 7% of patients were uninsured. 88.9% of patients were white, while 5.5% of patients were black. Patients that were treated at an academic/ research program were 32% of the sample size. 17% of the sample size were treated at a comprehensive community cancer program. Those with no comorbidities had the highest mean survival time of 111 months, those with one comorbidity had a mean survival time of 97 months, and those with two comorbidities had the lowest mean survival time of 75 months. 12.8% of patients had radical, total gross resection of tumor, lesion, or mass in their brain and 10% of patients had less than half of the lobe involved with the tumor resection. 20.1% of patients had systemic therapy after surgery. 59% of patients had no systemic therapy or surgery.

Conclusion: Our study shows men were affected more than women and that the mean age at diagnosis was 44 years old. The greater number of comorbidities a patient had, the lower the mean survival time was. Majority of patients were treated at an academic/research program. This is one of the largest studies to examine the demographics of patients with oligodendroglioma. Understanding who and how patients are affected can allow us to provide better resources and treatment.

Background: Oligodendrogliomas represent about 12% of all brain tumors. Our goal was to compare the demographic factors of patients diagnosed with oligodendroglioma from 2004-2014 identified in the National Cancer Database (NCDB). We also examined the survival of patients based off of the number of their comorbidities.

Methods: We identified 7525 patients diagnosed with oligodendroglioma in the NCDB diagnosed between 2004-2014. Many demographic factors were examined such as age, gender, race, facility treated at, comorbidities, and surgery type. Between-insurance survival differences were estimated by the Kaplan-Meier method and associated log-rank tests; Tukey-Kramer adjusted P < .05 indicated statistical significance.

Results: More men were diagnosed with the tumor than females (55% vs 45%). Average age of patients at diagnosis was 43.5 years old. 66% of patients had private insurance, while 7% of patients were uninsured. 88.9% of patients were white, while 5.5% of patients were black. Patients that were treated at an academic/ research program were 32% of the sample size. 17% of the sample size were treated at a comprehensive community cancer program. Those with no comorbidities had the highest mean survival time of 111 months, those with one comorbidity had a mean survival time of 97 months, and those with two comorbidities had the lowest mean survival time of 75 months. 12.8% of patients had radical, total gross resection of tumor, lesion, or mass in their brain and 10% of patients had less than half of the lobe involved with the tumor resection. 20.1% of patients had systemic therapy after surgery. 59% of patients had no systemic therapy or surgery.

Conclusion: Our study shows men were affected more than women and that the mean age at diagnosis was 44 years old. The greater number of comorbidities a patient had, the lower the mean survival time was. Majority of patients were treated at an academic/research program. This is one of the largest studies to examine the demographics of patients with oligodendroglioma. Understanding who and how patients are affected can allow us to provide better resources and treatment.

Background: Oligodendrogliomas represent about 12% of all brain tumors. Our goal was to compare the demographic factors of patients diagnosed with oligodendroglioma from 2004-2014 identified in the National Cancer Database (NCDB). We also examined the survival of patients based off of the number of their comorbidities.

Methods: We identified 7525 patients diagnosed with oligodendroglioma in the NCDB diagnosed between 2004-2014. Many demographic factors were examined such as age, gender, race, facility treated at, comorbidities, and surgery type. Between-insurance survival differences were estimated by the Kaplan-Meier method and associated log-rank tests; Tukey-Kramer adjusted P < .05 indicated statistical significance.

Results: More men were diagnosed with the tumor than females (55% vs 45%). Average age of patients at diagnosis was 43.5 years old. 66% of patients had private insurance, while 7% of patients were uninsured. 88.9% of patients were white, while 5.5% of patients were black. Patients that were treated at an academic/ research program were 32% of the sample size. 17% of the sample size were treated at a comprehensive community cancer program. Those with no comorbidities had the highest mean survival time of 111 months, those with one comorbidity had a mean survival time of 97 months, and those with two comorbidities had the lowest mean survival time of 75 months. 12.8% of patients had radical, total gross resection of tumor, lesion, or mass in their brain and 10% of patients had less than half of the lobe involved with the tumor resection. 20.1% of patients had systemic therapy after surgery. 59% of patients had no systemic therapy or surgery.

Conclusion: Our study shows men were affected more than women and that the mean age at diagnosis was 44 years old. The greater number of comorbidities a patient had, the lower the mean survival time was. Majority of patients were treated at an academic/research program. This is one of the largest studies to examine the demographics of patients with oligodendroglioma. Understanding who and how patients are affected can allow us to provide better resources and treatment.

Background: Prostate cancer is the second most common cancer in men. The American Cancer Society estimated about 164,690 new cases of prostate cancer in 2018. Since opening its doors in 1932, the New Mexico VA Healthcare System (NMVAHCS) had not held a prostate cancer support group. A review of the literature suggests that older prostate cancer patients benefit from the continuous social support in face-toface support groups. In light of the American Cancer Society estimates and the predominately male population served at the NMVAHCS, of which nearly 1300 of these veterans are living with prostate cancer, the need for a support group warranted investigation.

Methods: A needs assessment was completed with 50 veterans diagnosed with prostate and receiving care in the Urology Section of the New Mexico VA Healthcare System. This assessment included a 3 question survey aimed at determining veteran awareness of the Albuquerque community prostate cancer support group, attendance at this support group and lastly if they would attend a veteran centered prostate cancer support group on the NMVAHCS campus.

Results: Of the 50 veterans surveyed, 40% were aware of the community based prostate cancer support group while 12% had actually attended a meeting. 60% of the respondents stated that they would attend a veterans-centered prostate cancer support group on the NMVAHCS campus. 50% of those who responded that they would not attend a meeting stated that they lived too far away from the main campus but would attend via a telehealth meeting at their local community based outpatient clinic (CBOC).

Conclusion: Based on the survey findings, the decision was made to launch a Veteran Center Prostate Cancer Support Group. Men Talking to Men about Prostate Cancer held its inaugural meeting June 6, 2018 and has continued to meet bi-monthly. Sessions are facilitated by the New Mexico Prostate Cancer Support Association and include a multidisciplinary presentation of issues common to the veteran prostate cancer patient as well as a physician led question and answer session.

Background: Prostate cancer is the second most common cancer in men. The American Cancer Society estimated about 164,690 new cases of prostate cancer in 2018. Since opening its doors in 1932, the New Mexico VA Healthcare System (NMVAHCS) had not held a prostate cancer support group. A review of the literature suggests that older prostate cancer patients benefit from the continuous social support in face-toface support groups. In light of the American Cancer Society estimates and the predominately male population served at the NMVAHCS, of which nearly 1300 of these veterans are living with prostate cancer, the need for a support group warranted investigation.

Methods: A needs assessment was completed with 50 veterans diagnosed with prostate and receiving care in the Urology Section of the New Mexico VA Healthcare System. This assessment included a 3 question survey aimed at determining veteran awareness of the Albuquerque community prostate cancer support group, attendance at this support group and lastly if they would attend a veteran centered prostate cancer support group on the NMVAHCS campus.

Results: Of the 50 veterans surveyed, 40% were aware of the community based prostate cancer support group while 12% had actually attended a meeting. 60% of the respondents stated that they would attend a veterans-centered prostate cancer support group on the NMVAHCS campus. 50% of those who responded that they would not attend a meeting stated that they lived too far away from the main campus but would attend via a telehealth meeting at their local community based outpatient clinic (CBOC).

Conclusion: Based on the survey findings, the decision was made to launch a Veteran Center Prostate Cancer Support Group. Men Talking to Men about Prostate Cancer held its inaugural meeting June 6, 2018 and has continued to meet bi-monthly. Sessions are facilitated by the New Mexico Prostate Cancer Support Association and include a multidisciplinary presentation of issues common to the veteran prostate cancer patient as well as a physician led question and answer session.

Background: Prostate cancer is the second most common cancer in men. The American Cancer Society estimated about 164,690 new cases of prostate cancer in 2018. Since opening its doors in 1932, the New Mexico VA Healthcare System (NMVAHCS) had not held a prostate cancer support group. A review of the literature suggests that older prostate cancer patients benefit from the continuous social support in face-toface support groups. In light of the American Cancer Society estimates and the predominately male population served at the NMVAHCS, of which nearly 1300 of these veterans are living with prostate cancer, the need for a support group warranted investigation.

Methods: A needs assessment was completed with 50 veterans diagnosed with prostate and receiving care in the Urology Section of the New Mexico VA Healthcare System. This assessment included a 3 question survey aimed at determining veteran awareness of the Albuquerque community prostate cancer support group, attendance at this support group and lastly if they would attend a veteran centered prostate cancer support group on the NMVAHCS campus.

Results: Of the 50 veterans surveyed, 40% were aware of the community based prostate cancer support group while 12% had actually attended a meeting. 60% of the respondents stated that they would attend a veterans-centered prostate cancer support group on the NMVAHCS campus. 50% of those who responded that they would not attend a meeting stated that they lived too far away from the main campus but would attend via a telehealth meeting at their local community based outpatient clinic (CBOC).

Conclusion: Based on the survey findings, the decision was made to launch a Veteran Center Prostate Cancer Support Group. Men Talking to Men about Prostate Cancer held its inaugural meeting June 6, 2018 and has continued to meet bi-monthly. Sessions are facilitated by the New Mexico Prostate Cancer Support Association and include a multidisciplinary presentation of issues common to the veteran prostate cancer patient as well as a physician led question and answer session.

Background: Thrombotic events (TEs) are a leading cause of death in patients with polycythemia vera (PV), contributing to lower overall survival compared with age/sex-matched controls. This analysis evaluated the relationship between HCT levels and TEs among patients with PV from the Veteran’s Health Administration (VHA) to replicate the findings of the Cytoreductive Therapy in Polycythemia Vera (CYTO-PV) trial with a real-world patient population.

Methods: This retrospective study used VHA medical record and claims data from first PV diagnosis claim (index) until death, disenrollment, or end of study (collected October 1, 2005, through September 30, 2012). Patients were aged ≥ 18 years at index, had ≥ 2 PV claims (ICD-9-CM code, 238.4) ≥ 30 days apart during the identification period, continuous health plan enrollment from 12 months pre-index until end of study, and ≥ 3 HCT measurements/year during follow-up. This analysis focused on patients with no pre-index TE and all HCT values either < 45% or ≥ 45% during follow-up. Patient demographics and disease characteristics were assessed using descriptive statistics. Associations between HCT levels and TE occurrence were analyzed using unadjusted Cox regression models for patients with ≥ 1 HCT before TE (≥ 1 HCT subgroup). A sensitivity analysis including patients with a history of TE before the index period was also performed.

Results: Patients (n=213) were mean (SD) age 68.9 (11.5) years and predominately white (61.5%). TE during follow-up occurred in 44.1% of patients (mean follow-up, 2.3 y; rate per 100 person-years, 18.9). The 3 most common types of TE were ischemic stroke (21.6%), deep vein thrombosis (12.2%), and transient ischemic attack (9.4%). TE rates for patients with HCT values  45% vs < 45% were 54.2% and 40.3%, respectively. In the  1 HCT subgroup (n=208), the TE risk hazard ratio was 1.61 (95% CI, 1.03–2.51; P=0.036). The sensitivity analysis, which included patients with and without pre-index TEs (n=342), had similar results (76.9% vs 55.6%); hazard ratio in the  1 HCT subgroup (n=322):, 1.95 (95% CI, 1.46–2.61; P<0.0001).

Implications: These results in agreement with CYTOPV study findings and further support effective monitoring and management of HCT levels < 45% to reduce the risk of TE in veterans with PV.

Background: Thrombotic events (TEs) are a leading cause of death in patients with polycythemia vera (PV), contributing to lower overall survival compared with age/sex-matched controls. This analysis evaluated the relationship between HCT levels and TEs among patients with PV from the Veteran’s Health Administration (VHA) to replicate the findings of the Cytoreductive Therapy in Polycythemia Vera (CYTO-PV) trial with a real-world patient population.

Methods: This retrospective study used VHA medical record and claims data from first PV diagnosis claim (index) until death, disenrollment, or end of study (collected October 1, 2005, through September 30, 2012). Patients were aged ≥ 18 years at index, had ≥ 2 PV claims (ICD-9-CM code, 238.4) ≥ 30 days apart during the identification period, continuous health plan enrollment from 12 months pre-index until end of study, and ≥ 3 HCT measurements/year during follow-up. This analysis focused on patients with no pre-index TE and all HCT values either < 45% or ≥ 45% during follow-up. Patient demographics and disease characteristics were assessed using descriptive statistics. Associations between HCT levels and TE occurrence were analyzed using unadjusted Cox regression models for patients with ≥ 1 HCT before TE (≥ 1 HCT subgroup). A sensitivity analysis including patients with a history of TE before the index period was also performed.

Results: Patients (n=213) were mean (SD) age 68.9 (11.5) years and predominately white (61.5%). TE during follow-up occurred in 44.1% of patients (mean follow-up, 2.3 y; rate per 100 person-years, 18.9). The 3 most common types of TE were ischemic stroke (21.6%), deep vein thrombosis (12.2%), and transient ischemic attack (9.4%). TE rates for patients with HCT values  45% vs < 45% were 54.2% and 40.3%, respectively. In the  1 HCT subgroup (n=208), the TE risk hazard ratio was 1.61 (95% CI, 1.03–2.51; P=0.036). The sensitivity analysis, which included patients with and without pre-index TEs (n=342), had similar results (76.9% vs 55.6%); hazard ratio in the  1 HCT subgroup (n=322):, 1.95 (95% CI, 1.46–2.61; P<0.0001).

Implications: These results in agreement with CYTOPV study findings and further support effective monitoring and management of HCT levels < 45% to reduce the risk of TE in veterans with PV.

Background: Thrombotic events (TEs) are a leading cause of death in patients with polycythemia vera (PV), contributing to lower overall survival compared with age/sex-matched controls. This analysis evaluated the relationship between HCT levels and TEs among patients with PV from the Veteran’s Health Administration (VHA) to replicate the findings of the Cytoreductive Therapy in Polycythemia Vera (CYTO-PV) trial with a real-world patient population.

Methods: This retrospective study used VHA medical record and claims data from first PV diagnosis claim (index) until death, disenrollment, or end of study (collected October 1, 2005, through September 30, 2012). Patients were aged ≥ 18 years at index, had ≥ 2 PV claims (ICD-9-CM code, 238.4) ≥ 30 days apart during the identification period, continuous health plan enrollment from 12 months pre-index until end of study, and ≥ 3 HCT measurements/year during follow-up. This analysis focused on patients with no pre-index TE and all HCT values either < 45% or ≥ 45% during follow-up. Patient demographics and disease characteristics were assessed using descriptive statistics. Associations between HCT levels and TE occurrence were analyzed using unadjusted Cox regression models for patients with ≥ 1 HCT before TE (≥ 1 HCT subgroup). A sensitivity analysis including patients with a history of TE before the index period was also performed.

Results: Patients (n=213) were mean (SD) age 68.9 (11.5) years and predominately white (61.5%). TE during follow-up occurred in 44.1% of patients (mean follow-up, 2.3 y; rate per 100 person-years, 18.9). The 3 most common types of TE were ischemic stroke (21.6%), deep vein thrombosis (12.2%), and transient ischemic attack (9.4%). TE rates for patients with HCT values  45% vs < 45% were 54.2% and 40.3%, respectively. In the  1 HCT subgroup (n=208), the TE risk hazard ratio was 1.61 (95% CI, 1.03–2.51; P=0.036). The sensitivity analysis, which included patients with and without pre-index TEs (n=342), had similar results (76.9% vs 55.6%); hazard ratio in the  1 HCT subgroup (n=322):, 1.95 (95% CI, 1.46–2.61; P<0.0001).

Implications: These results in agreement with CYTOPV study findings and further support effective monitoring and management of HCT levels < 45% to reduce the risk of TE in veterans with PV.