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Use and Toxicity of Checkpoint Inhibitors for Solid Tumor Treatment in a Veteran Population
Purpose: The purpose of this study is to evaluate the use and dosing strategies of programmed death protein (PD-1) inhibitors and selected immune-mediated adverse effects within the Veteran’s Health Administration (VHA).
Background: The PD-1 inhibitors, nivolumab and pembrolizumab, are two agents used in the treatment of a number of solid tumors. Their dosing varied in clinical trials supporting a change in FDA approved labeling from weight-based to standardized dosing. While these agents have demonstrated efficacy, immune-mediated adverse-effects (IrAEs) have been associated with their use.
Methods: This is a retrospective review of veterans receiving nivolumab or pembrolizumab for the treatment of solid tumors within the VHA between January 2015 and July 2017. Data were collected from the VA Corporate Data Warehouse through the VA Informatics and Computing Infrastructure. The dosing strategy for PD-1 inhibitor was categorized into weight-based versus fixeddosing, where possible, and used to identify actual and potential cost-savings opportunities. The incidence of prespecified IrAEs thyroid dysfunction, pneumonitis, and colitis, was quantified and their management was described. Descriptive statistics will be used for the primary and secondary outcomes.
Results: Nivolumab was the primary PD-1 inhibitor utilized for solid tumor treatment. Both nivolumab and pembrolizumab were primarily dosed based on patient weight. For nivolumab orders there was a total of $8,514,300 estimated actual cost savings with $5,591,250 estimated remaining cost-savings potential identified. Of patients who received nivolumab, 514 (15.8%) developed primary hypothyroidism and 299 (9.2%) developed primary hyperthyroidism. At our local institution, one (1.7%) patient developed pneumonitis and one (1.7%) patient developed colitis which was determined to be related to nivolumab therapy.
Conclusions: Nivolumab was the primary PD-1 inhibitor used, with the primary dosing strategy being weightbased. Pembrolizumab dosing was primarily fixed dosing, which may be due to the available vial size(s). There were substantial actual and potential cost-savings opportunities identified. The incidence of the prespecified IrAEs was similar to the incidence currently available in published literature. This supports the recommendation for continued thyroid laboratory monitoring and recognition of signs and symptoms of IrAEs by all health care providers.
Purpose: The purpose of this study is to evaluate the use and dosing strategies of programmed death protein (PD-1) inhibitors and selected immune-mediated adverse effects within the Veteran’s Health Administration (VHA).
Background: The PD-1 inhibitors, nivolumab and pembrolizumab, are two agents used in the treatment of a number of solid tumors. Their dosing varied in clinical trials supporting a change in FDA approved labeling from weight-based to standardized dosing. While these agents have demonstrated efficacy, immune-mediated adverse-effects (IrAEs) have been associated with their use.
Methods: This is a retrospective review of veterans receiving nivolumab or pembrolizumab for the treatment of solid tumors within the VHA between January 2015 and July 2017. Data were collected from the VA Corporate Data Warehouse through the VA Informatics and Computing Infrastructure. The dosing strategy for PD-1 inhibitor was categorized into weight-based versus fixeddosing, where possible, and used to identify actual and potential cost-savings opportunities. The incidence of prespecified IrAEs thyroid dysfunction, pneumonitis, and colitis, was quantified and their management was described. Descriptive statistics will be used for the primary and secondary outcomes.
Results: Nivolumab was the primary PD-1 inhibitor utilized for solid tumor treatment. Both nivolumab and pembrolizumab were primarily dosed based on patient weight. For nivolumab orders there was a total of $8,514,300 estimated actual cost savings with $5,591,250 estimated remaining cost-savings potential identified. Of patients who received nivolumab, 514 (15.8%) developed primary hypothyroidism and 299 (9.2%) developed primary hyperthyroidism. At our local institution, one (1.7%) patient developed pneumonitis and one (1.7%) patient developed colitis which was determined to be related to nivolumab therapy.
Conclusions: Nivolumab was the primary PD-1 inhibitor used, with the primary dosing strategy being weightbased. Pembrolizumab dosing was primarily fixed dosing, which may be due to the available vial size(s). There were substantial actual and potential cost-savings opportunities identified. The incidence of the prespecified IrAEs was similar to the incidence currently available in published literature. This supports the recommendation for continued thyroid laboratory monitoring and recognition of signs and symptoms of IrAEs by all health care providers.
Purpose: The purpose of this study is to evaluate the use and dosing strategies of programmed death protein (PD-1) inhibitors and selected immune-mediated adverse effects within the Veteran’s Health Administration (VHA).
Background: The PD-1 inhibitors, nivolumab and pembrolizumab, are two agents used in the treatment of a number of solid tumors. Their dosing varied in clinical trials supporting a change in FDA approved labeling from weight-based to standardized dosing. While these agents have demonstrated efficacy, immune-mediated adverse-effects (IrAEs) have been associated with their use.
Methods: This is a retrospective review of veterans receiving nivolumab or pembrolizumab for the treatment of solid tumors within the VHA between January 2015 and July 2017. Data were collected from the VA Corporate Data Warehouse through the VA Informatics and Computing Infrastructure. The dosing strategy for PD-1 inhibitor was categorized into weight-based versus fixeddosing, where possible, and used to identify actual and potential cost-savings opportunities. The incidence of prespecified IrAEs thyroid dysfunction, pneumonitis, and colitis, was quantified and their management was described. Descriptive statistics will be used for the primary and secondary outcomes.
Results: Nivolumab was the primary PD-1 inhibitor utilized for solid tumor treatment. Both nivolumab and pembrolizumab were primarily dosed based on patient weight. For nivolumab orders there was a total of $8,514,300 estimated actual cost savings with $5,591,250 estimated remaining cost-savings potential identified. Of patients who received nivolumab, 514 (15.8%) developed primary hypothyroidism and 299 (9.2%) developed primary hyperthyroidism. At our local institution, one (1.7%) patient developed pneumonitis and one (1.7%) patient developed colitis which was determined to be related to nivolumab therapy.
Conclusions: Nivolumab was the primary PD-1 inhibitor used, with the primary dosing strategy being weightbased. Pembrolizumab dosing was primarily fixed dosing, which may be due to the available vial size(s). There were substantial actual and potential cost-savings opportunities identified. The incidence of the prespecified IrAEs was similar to the incidence currently available in published literature. This supports the recommendation for continued thyroid laboratory monitoring and recognition of signs and symptoms of IrAEs by all health care providers.
Impact of A Veteran Health Affairs Centralized Model for Lung Cancer Screening
Background: Lung cancer is the leading cause of cancer-related deaths in the US In 2011, the National Lung Screening Trial (NLST) showed a 1.1% incidence of lung cancer in low-dose CT (LDCT) screened patients and a 20% relative risk reduction in mortality through LDCT screening. An estimated 900,000 out of 6.7 million veterans meet lung cancer screening criteria; therefore, an effective model to ensure proper screening is critical.
Methods: From December 2015 to May 2018, Salisbury VA Medical Center (SBYVAMC), Kernersville Health Care Center (KHCC), and Charlotte Health Care Center (CHCC) primary care providers screened and referred veterans to a centralized Lung Cancer Screening Program. Patients
were seen by providers in the Lung Cancer Screening Program and participated in shared decision making. Providers sought to ensure guidelines established by NLST and the Center for Medicare and Medicaid Services (CMS) for LDCT screening were met. Each patient’s age, sex, race, smoking history, LDCT date, results, and follow-up plan were recorded in a secured database. Data were queried for these patient characteristics and the appropriateness for LDCT screening was evaluated. Cases of cancer found on LDCT were clinically verified through a VA EMR review.
Results: Of 1124 screened, 1,104 (98.2%) veterans received an appropriate LDCT, according to strict CMS criteria. By NLST inclusion criteria, 1,088 of 1124 (96.8%) met strict criteria. Tumors were detected in 14 SBYVAMC patients (2.92%), 13 KHCC patients (3.05%), and 7 CHCC patients (3.21%). In total, 34 veterans (3.02%) had a tumor detected by LDCT. Of the 34, 27 veterans had primary lung cancer (79.4%) and 22 of these veterans had stage 1 lung cancer (64.7%).
Conclusions/Implications: This model of lung cancer screening demonstrates a high rate of appropriate LDCT screenings. Appropriate screening is critical to reducing unnecessary costs and potential harms to veterans. Additionally, a nearly three-fold higher incidence of cancer was found in this veteran population compared to the NLST trial.
Background: Lung cancer is the leading cause of cancer-related deaths in the US In 2011, the National Lung Screening Trial (NLST) showed a 1.1% incidence of lung cancer in low-dose CT (LDCT) screened patients and a 20% relative risk reduction in mortality through LDCT screening. An estimated 900,000 out of 6.7 million veterans meet lung cancer screening criteria; therefore, an effective model to ensure proper screening is critical.
Methods: From December 2015 to May 2018, Salisbury VA Medical Center (SBYVAMC), Kernersville Health Care Center (KHCC), and Charlotte Health Care Center (CHCC) primary care providers screened and referred veterans to a centralized Lung Cancer Screening Program. Patients
were seen by providers in the Lung Cancer Screening Program and participated in shared decision making. Providers sought to ensure guidelines established by NLST and the Center for Medicare and Medicaid Services (CMS) for LDCT screening were met. Each patient’s age, sex, race, smoking history, LDCT date, results, and follow-up plan were recorded in a secured database. Data were queried for these patient characteristics and the appropriateness for LDCT screening was evaluated. Cases of cancer found on LDCT were clinically verified through a VA EMR review.
Results: Of 1124 screened, 1,104 (98.2%) veterans received an appropriate LDCT, according to strict CMS criteria. By NLST inclusion criteria, 1,088 of 1124 (96.8%) met strict criteria. Tumors were detected in 14 SBYVAMC patients (2.92%), 13 KHCC patients (3.05%), and 7 CHCC patients (3.21%). In total, 34 veterans (3.02%) had a tumor detected by LDCT. Of the 34, 27 veterans had primary lung cancer (79.4%) and 22 of these veterans had stage 1 lung cancer (64.7%).
Conclusions/Implications: This model of lung cancer screening demonstrates a high rate of appropriate LDCT screenings. Appropriate screening is critical to reducing unnecessary costs and potential harms to veterans. Additionally, a nearly three-fold higher incidence of cancer was found in this veteran population compared to the NLST trial.
Background: Lung cancer is the leading cause of cancer-related deaths in the US In 2011, the National Lung Screening Trial (NLST) showed a 1.1% incidence of lung cancer in low-dose CT (LDCT) screened patients and a 20% relative risk reduction in mortality through LDCT screening. An estimated 900,000 out of 6.7 million veterans meet lung cancer screening criteria; therefore, an effective model to ensure proper screening is critical.
Methods: From December 2015 to May 2018, Salisbury VA Medical Center (SBYVAMC), Kernersville Health Care Center (KHCC), and Charlotte Health Care Center (CHCC) primary care providers screened and referred veterans to a centralized Lung Cancer Screening Program. Patients
were seen by providers in the Lung Cancer Screening Program and participated in shared decision making. Providers sought to ensure guidelines established by NLST and the Center for Medicare and Medicaid Services (CMS) for LDCT screening were met. Each patient’s age, sex, race, smoking history, LDCT date, results, and follow-up plan were recorded in a secured database. Data were queried for these patient characteristics and the appropriateness for LDCT screening was evaluated. Cases of cancer found on LDCT were clinically verified through a VA EMR review.
Results: Of 1124 screened, 1,104 (98.2%) veterans received an appropriate LDCT, according to strict CMS criteria. By NLST inclusion criteria, 1,088 of 1124 (96.8%) met strict criteria. Tumors were detected in 14 SBYVAMC patients (2.92%), 13 KHCC patients (3.05%), and 7 CHCC patients (3.21%). In total, 34 veterans (3.02%) had a tumor detected by LDCT. Of the 34, 27 veterans had primary lung cancer (79.4%) and 22 of these veterans had stage 1 lung cancer (64.7%).
Conclusions/Implications: This model of lung cancer screening demonstrates a high rate of appropriate LDCT screenings. Appropriate screening is critical to reducing unnecessary costs and potential harms to veterans. Additionally, a nearly three-fold higher incidence of cancer was found in this veteran population compared to the NLST trial.
Lessons and Implications of Establishing A VA Cancer Biobanking Program
Purpose: To examine the feasibility of establishing a biobanking program at a tertiary VA facility
Background/Rationale: Biobanking holds promise for the discovery of new biomarkers and development of targeted therapy through access to large amounts of molecular and electronic health record data. The Department of Defense’s (DOD) John P. Murtha Cancer Center (MCC), of the Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center, provided funding for a pilot biobanking implementation at a VA facility in hopes of facilitating a VA-wide biobank network to support federal research initiatives.
Methods: After funding and staff resources were secured, four months were required to complete contract negotiation, regulatory review, and a comprehensive assessment of inter-departmental operational requirements. We initiated with two different surgical specialties—thoracic and gastrointestinal oncology—for the initial stage to establish the system and process flow of the tissue procurement protocol, from pre-operative case screening and consenting to specimen collection (blood, urine, tissue) and tissue storage.
Results: From its inception in March 2018 through May 2018, monthly consent numbers were 1, 2, and 7, respectively. From these, fresh specimen collection occurred in most (6 patients with 8 tumor aliquots). Blood collection and questionnaire completion were obtained in all patients. All samples were shipped safely to the long-term storage facility of the MCC and therefore ready for distribution for researchers.
Conclusions: We are now ready to move beyond the pilot stage by including other cancer types. Our goal is to collect biospecimens on 2 cases per week or 100 cases per year. From preparation to implementation, we learned the success of the program relies heavily on adequate funding, supportive leadership with surgery, pathology, and oncology buy-in and proactive communication among the team members. We conclude that establishing a VA nationwide oncology biobanking program that mirrors that of the DOD is feasible, with high potential merit for veterans and civilians alike.
Purpose: To examine the feasibility of establishing a biobanking program at a tertiary VA facility
Background/Rationale: Biobanking holds promise for the discovery of new biomarkers and development of targeted therapy through access to large amounts of molecular and electronic health record data. The Department of Defense’s (DOD) John P. Murtha Cancer Center (MCC), of the Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center, provided funding for a pilot biobanking implementation at a VA facility in hopes of facilitating a VA-wide biobank network to support federal research initiatives.
Methods: After funding and staff resources were secured, four months were required to complete contract negotiation, regulatory review, and a comprehensive assessment of inter-departmental operational requirements. We initiated with two different surgical specialties—thoracic and gastrointestinal oncology—for the initial stage to establish the system and process flow of the tissue procurement protocol, from pre-operative case screening and consenting to specimen collection (blood, urine, tissue) and tissue storage.
Results: From its inception in March 2018 through May 2018, monthly consent numbers were 1, 2, and 7, respectively. From these, fresh specimen collection occurred in most (6 patients with 8 tumor aliquots). Blood collection and questionnaire completion were obtained in all patients. All samples were shipped safely to the long-term storage facility of the MCC and therefore ready for distribution for researchers.
Conclusions: We are now ready to move beyond the pilot stage by including other cancer types. Our goal is to collect biospecimens on 2 cases per week or 100 cases per year. From preparation to implementation, we learned the success of the program relies heavily on adequate funding, supportive leadership with surgery, pathology, and oncology buy-in and proactive communication among the team members. We conclude that establishing a VA nationwide oncology biobanking program that mirrors that of the DOD is feasible, with high potential merit for veterans and civilians alike.
Purpose: To examine the feasibility of establishing a biobanking program at a tertiary VA facility
Background/Rationale: Biobanking holds promise for the discovery of new biomarkers and development of targeted therapy through access to large amounts of molecular and electronic health record data. The Department of Defense’s (DOD) John P. Murtha Cancer Center (MCC), of the Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center, provided funding for a pilot biobanking implementation at a VA facility in hopes of facilitating a VA-wide biobank network to support federal research initiatives.
Methods: After funding and staff resources were secured, four months were required to complete contract negotiation, regulatory review, and a comprehensive assessment of inter-departmental operational requirements. We initiated with two different surgical specialties—thoracic and gastrointestinal oncology—for the initial stage to establish the system and process flow of the tissue procurement protocol, from pre-operative case screening and consenting to specimen collection (blood, urine, tissue) and tissue storage.
Results: From its inception in March 2018 through May 2018, monthly consent numbers were 1, 2, and 7, respectively. From these, fresh specimen collection occurred in most (6 patients with 8 tumor aliquots). Blood collection and questionnaire completion were obtained in all patients. All samples were shipped safely to the long-term storage facility of the MCC and therefore ready for distribution for researchers.
Conclusions: We are now ready to move beyond the pilot stage by including other cancer types. Our goal is to collect biospecimens on 2 cases per week or 100 cases per year. From preparation to implementation, we learned the success of the program relies heavily on adequate funding, supportive leadership with surgery, pathology, and oncology buy-in and proactive communication among the team members. We conclude that establishing a VA nationwide oncology biobanking program that mirrors that of the DOD is feasible, with high potential merit for veterans and civilians alike.
Evaluation of Implementation of Tumor Next-Generation Sequencing Within the Veterans Health Administration (VHA)
Background: Routine use of next-generation sequencing (NGS) gene panel testing is now widely adopted for therapeutic decision-making in patients with advanced solid malignancies. The VA National Precision Oncology Program was launched in 2016 to standardize and facilitate the adoption of NGS testing within VHA. As part of the 2016 Cancer Moonshot initiative, VHA began using IBM Watson for Genomics (WfG) to assist with annotation of NGS results.
Purpose/Rationale: The primary objective of this program evaluation is to investigate the impact of NGS testing and WfG annotation on therapeutic decision-making by VA providers. Secondary objectives will include assessing the efficiency and efficacy of precision oncology, the attitudes of patients and providers towards the process, and the cost-effectiveness of these techniques.
Methods: Evaluation will be performed as a mixed-methods study using a combination of provider survey and retrospective analysis of veterans who received their oncologic care through VHA and underwent NGS testing. We will review health records from approximately 150 patients who underwent NGS testing and review via expert “precision oncology consultation,” as well as a sampling of 150 patients who underwent NGS testing alone. We will query the medical record to identify the timing of testing and reporting of results to the ordering providers. Changes in provider decision-making based on NGS results/consultation will be directly assessed by reviewing the medical record for proposed therapy prior to testing/consultation in addition to pharmacy data for choice of therapeutic agent following formal reporting of NGS results. Survey data will be used to evaluate physician attitudes towards NGS testing, reasons for seeking expert consultation, as well as satisfaction with the overall process. We will identify and implement prospective methods of data collection for future NGS testing and “precision oncology consultation”, including common criteria for consultation and proposed decision-making before and after testing/consultation. Further outcome assessments will convey the financial toxicity of the treatment changes and the impact on patient outcomes.
Background: Routine use of next-generation sequencing (NGS) gene panel testing is now widely adopted for therapeutic decision-making in patients with advanced solid malignancies. The VA National Precision Oncology Program was launched in 2016 to standardize and facilitate the adoption of NGS testing within VHA. As part of the 2016 Cancer Moonshot initiative, VHA began using IBM Watson for Genomics (WfG) to assist with annotation of NGS results.
Purpose/Rationale: The primary objective of this program evaluation is to investigate the impact of NGS testing and WfG annotation on therapeutic decision-making by VA providers. Secondary objectives will include assessing the efficiency and efficacy of precision oncology, the attitudes of patients and providers towards the process, and the cost-effectiveness of these techniques.
Methods: Evaluation will be performed as a mixed-methods study using a combination of provider survey and retrospective analysis of veterans who received their oncologic care through VHA and underwent NGS testing. We will review health records from approximately 150 patients who underwent NGS testing and review via expert “precision oncology consultation,” as well as a sampling of 150 patients who underwent NGS testing alone. We will query the medical record to identify the timing of testing and reporting of results to the ordering providers. Changes in provider decision-making based on NGS results/consultation will be directly assessed by reviewing the medical record for proposed therapy prior to testing/consultation in addition to pharmacy data for choice of therapeutic agent following formal reporting of NGS results. Survey data will be used to evaluate physician attitudes towards NGS testing, reasons for seeking expert consultation, as well as satisfaction with the overall process. We will identify and implement prospective methods of data collection for future NGS testing and “precision oncology consultation”, including common criteria for consultation and proposed decision-making before and after testing/consultation. Further outcome assessments will convey the financial toxicity of the treatment changes and the impact on patient outcomes.
Background: Routine use of next-generation sequencing (NGS) gene panel testing is now widely adopted for therapeutic decision-making in patients with advanced solid malignancies. The VA National Precision Oncology Program was launched in 2016 to standardize and facilitate the adoption of NGS testing within VHA. As part of the 2016 Cancer Moonshot initiative, VHA began using IBM Watson for Genomics (WfG) to assist with annotation of NGS results.
Purpose/Rationale: The primary objective of this program evaluation is to investigate the impact of NGS testing and WfG annotation on therapeutic decision-making by VA providers. Secondary objectives will include assessing the efficiency and efficacy of precision oncology, the attitudes of patients and providers towards the process, and the cost-effectiveness of these techniques.
Methods: Evaluation will be performed as a mixed-methods study using a combination of provider survey and retrospective analysis of veterans who received their oncologic care through VHA and underwent NGS testing. We will review health records from approximately 150 patients who underwent NGS testing and review via expert “precision oncology consultation,” as well as a sampling of 150 patients who underwent NGS testing alone. We will query the medical record to identify the timing of testing and reporting of results to the ordering providers. Changes in provider decision-making based on NGS results/consultation will be directly assessed by reviewing the medical record for proposed therapy prior to testing/consultation in addition to pharmacy data for choice of therapeutic agent following formal reporting of NGS results. Survey data will be used to evaluate physician attitudes towards NGS testing, reasons for seeking expert consultation, as well as satisfaction with the overall process. We will identify and implement prospective methods of data collection for future NGS testing and “precision oncology consultation”, including common criteria for consultation and proposed decision-making before and after testing/consultation. Further outcome assessments will convey the financial toxicity of the treatment changes and the impact on patient outcomes.
Process Improvement Initiative to Streamline Lung Cancer Evaluation from Imaging to Treatment: A Single Center VA Experience
Purpose: To streamline the diagnostic evaluation of lung cancer.
Background: Lung cancer remains the leading cause of cancer death in the United States. Although more than half of cases present with metastatic disease, prognosis is still poor for earlier stage tumors. While most guidelines recommend a multidisciplinary approach to the diagnostic evaluation, recommendations and data for the timeliness of the process are lacking. Highly specialized diagnostic imaging tests and procedures are required to make the diagnosis, which can result in delays in the initiation of treatment. In the metastatic setting, the emergence of immunotherapies and targeted therapies requires additional tissue testing for predictive biomarkers and molecular alterations, increasing the importance of adequate biopsy specimens and tissue preservation. We reviewed the diagnostic evaluation process at our hospital in order to formulate a Plan, Do, Study, Act (PDSA) quality improvement project aimed at improving the efficiency of our process.
Methods: We performed a retrospective analysis of all cases of non-small cell lung cancer (NSCLC) diagnosed at the Birmingham VA Medical Center (BVAMC) from 2015-2017. Cases for which the entire evaluation was not performed at BVAMC were excluded. Outcomes of interest were time from imaging suggestive of lung cancer (T1) to pathologic diagnosis (T2) and to date of first treatment (T3).
Results: At the time of data submission, 171 cases had been analyzed. Mean time from suspicious imaging to pathologic diagnosis (T1-T2) was 59.5 days. Mean time from pathologic diagnosis to treatment initiation (T2-T3) was 69.4 days. Mean time spent in the diagnostic evaluation
(T1-T3) was 128.9 days. The data will be stratified further to identify opportunities for improvement. We have since instituted a multidisciplinary lung tumor board and are using CPRS-based tracking software to prospectively analyze cases and improve the efficiency of our process.
Conclusions: The diagnostic evaluation of lung cancer is a multi-step process, and unique factors contribute to delays at each step. It is essential to have a multidisciplinary team to help identify, predict and alleviate these barriers. Analysis of other variables including age, performance status, pulmonary function tests (PFTs), smoking, number of biopsies performed and utilization of positive emission tomography (PET) scans is underway.
Purpose: To streamline the diagnostic evaluation of lung cancer.
Background: Lung cancer remains the leading cause of cancer death in the United States. Although more than half of cases present with metastatic disease, prognosis is still poor for earlier stage tumors. While most guidelines recommend a multidisciplinary approach to the diagnostic evaluation, recommendations and data for the timeliness of the process are lacking. Highly specialized diagnostic imaging tests and procedures are required to make the diagnosis, which can result in delays in the initiation of treatment. In the metastatic setting, the emergence of immunotherapies and targeted therapies requires additional tissue testing for predictive biomarkers and molecular alterations, increasing the importance of adequate biopsy specimens and tissue preservation. We reviewed the diagnostic evaluation process at our hospital in order to formulate a Plan, Do, Study, Act (PDSA) quality improvement project aimed at improving the efficiency of our process.
Methods: We performed a retrospective analysis of all cases of non-small cell lung cancer (NSCLC) diagnosed at the Birmingham VA Medical Center (BVAMC) from 2015-2017. Cases for which the entire evaluation was not performed at BVAMC were excluded. Outcomes of interest were time from imaging suggestive of lung cancer (T1) to pathologic diagnosis (T2) and to date of first treatment (T3).
Results: At the time of data submission, 171 cases had been analyzed. Mean time from suspicious imaging to pathologic diagnosis (T1-T2) was 59.5 days. Mean time from pathologic diagnosis to treatment initiation (T2-T3) was 69.4 days. Mean time spent in the diagnostic evaluation
(T1-T3) was 128.9 days. The data will be stratified further to identify opportunities for improvement. We have since instituted a multidisciplinary lung tumor board and are using CPRS-based tracking software to prospectively analyze cases and improve the efficiency of our process.
Conclusions: The diagnostic evaluation of lung cancer is a multi-step process, and unique factors contribute to delays at each step. It is essential to have a multidisciplinary team to help identify, predict and alleviate these barriers. Analysis of other variables including age, performance status, pulmonary function tests (PFTs), smoking, number of biopsies performed and utilization of positive emission tomography (PET) scans is underway.
Purpose: To streamline the diagnostic evaluation of lung cancer.
Background: Lung cancer remains the leading cause of cancer death in the United States. Although more than half of cases present with metastatic disease, prognosis is still poor for earlier stage tumors. While most guidelines recommend a multidisciplinary approach to the diagnostic evaluation, recommendations and data for the timeliness of the process are lacking. Highly specialized diagnostic imaging tests and procedures are required to make the diagnosis, which can result in delays in the initiation of treatment. In the metastatic setting, the emergence of immunotherapies and targeted therapies requires additional tissue testing for predictive biomarkers and molecular alterations, increasing the importance of adequate biopsy specimens and tissue preservation. We reviewed the diagnostic evaluation process at our hospital in order to formulate a Plan, Do, Study, Act (PDSA) quality improvement project aimed at improving the efficiency of our process.
Methods: We performed a retrospective analysis of all cases of non-small cell lung cancer (NSCLC) diagnosed at the Birmingham VA Medical Center (BVAMC) from 2015-2017. Cases for which the entire evaluation was not performed at BVAMC were excluded. Outcomes of interest were time from imaging suggestive of lung cancer (T1) to pathologic diagnosis (T2) and to date of first treatment (T3).
Results: At the time of data submission, 171 cases had been analyzed. Mean time from suspicious imaging to pathologic diagnosis (T1-T2) was 59.5 days. Mean time from pathologic diagnosis to treatment initiation (T2-T3) was 69.4 days. Mean time spent in the diagnostic evaluation
(T1-T3) was 128.9 days. The data will be stratified further to identify opportunities for improvement. We have since instituted a multidisciplinary lung tumor board and are using CPRS-based tracking software to prospectively analyze cases and improve the efficiency of our process.
Conclusions: The diagnostic evaluation of lung cancer is a multi-step process, and unique factors contribute to delays at each step. It is essential to have a multidisciplinary team to help identify, predict and alleviate these barriers. Analysis of other variables including age, performance status, pulmonary function tests (PFTs), smoking, number of biopsies performed and utilization of positive emission tomography (PET) scans is underway.
Prognostic Factors, Treatment and Survival in Primary Cardiac Sarcoma
Background: Primary cardiac sarcomas are rare and highly lethal tumors. Current understanding of clinicopathologic characteristics associated with primary cardiac sarcoma is limited to case reports and small case series. To the best of our knowledge, this is the largest study to evaluate clinicopathologic characteristics of primary cardiac sarcoma, and survival benefit of treatment modalities.
Methods: The National Cancer Database was utilized to retrospectively identify 404 patients diagnosed with a single primary cardiac sarcoma between 2004 and 2015. Kaplan-Meier methods were used to estimate survival distribution. Log-rank tests compared survival distributions between groups.
Results: Median age at diagnosis was 50 years. Men (50.7%) and women (49.3%) were affected equally. The most common histology types were hemangiosarcoma (40.1%), sarcoma NOS (14.9%), spindle cell sarcoma (6.9%) and leiomyosarcoma (5.9%). The most common stage at presentation was stage IV (38.1%). 37% of patients presented with metastases at the time of diagnosis, and the most common site of distant metastasis was the
lung (12.6%). Median overall survival (OS) for the entire cohort was 12 months. Median OS for stages I-IV was 23.06, 22.34, 12.98 and 8.08 months, respectively. 63% of patients underwent surgical resection. 58.4% received chemotherapy, and 22% received radiotherapy. Patients who underwent surgery had improved OS compared to those not receiving surgery (15.74 vs. 7.62 months, respectively). In patients with metastatic disease, OS was improved when treated with chemotherapy (11.14 months), compared to surgery alone (5.22 months). Combined treatment of surgery with chemotherapy did not improve outcomes compared to chemotherapy alone (P = .091 on log-rank test). In non-metastatic disease,
patients receiving multi-modality treatment (radiotherapy, chemotherapy and surgery) had improved OS (27.73 months) compared to those who underwent surgery alone, chemotherapy alone or chemotherapy with surgery (6.67, 14.88 and 20.99 months, respectively).
Conclusions: The median age of diagnosis was 50 years, and men and women are affected equally. Stage IV is the most common stage at diagnosis, and prognosis of Stages III and IV are worse in comparison to Stages I and II. In metastatic disease, receipt of chemotherapy is associated with improved survivorship. Multimodality treatment regimens may be recommended in non-metastatic cases.
Background: Primary cardiac sarcomas are rare and highly lethal tumors. Current understanding of clinicopathologic characteristics associated with primary cardiac sarcoma is limited to case reports and small case series. To the best of our knowledge, this is the largest study to evaluate clinicopathologic characteristics of primary cardiac sarcoma, and survival benefit of treatment modalities.
Methods: The National Cancer Database was utilized to retrospectively identify 404 patients diagnosed with a single primary cardiac sarcoma between 2004 and 2015. Kaplan-Meier methods were used to estimate survival distribution. Log-rank tests compared survival distributions between groups.
Results: Median age at diagnosis was 50 years. Men (50.7%) and women (49.3%) were affected equally. The most common histology types were hemangiosarcoma (40.1%), sarcoma NOS (14.9%), spindle cell sarcoma (6.9%) and leiomyosarcoma (5.9%). The most common stage at presentation was stage IV (38.1%). 37% of patients presented with metastases at the time of diagnosis, and the most common site of distant metastasis was the
lung (12.6%). Median overall survival (OS) for the entire cohort was 12 months. Median OS for stages I-IV was 23.06, 22.34, 12.98 and 8.08 months, respectively. 63% of patients underwent surgical resection. 58.4% received chemotherapy, and 22% received radiotherapy. Patients who underwent surgery had improved OS compared to those not receiving surgery (15.74 vs. 7.62 months, respectively). In patients with metastatic disease, OS was improved when treated with chemotherapy (11.14 months), compared to surgery alone (5.22 months). Combined treatment of surgery with chemotherapy did not improve outcomes compared to chemotherapy alone (P = .091 on log-rank test). In non-metastatic disease,
patients receiving multi-modality treatment (radiotherapy, chemotherapy and surgery) had improved OS (27.73 months) compared to those who underwent surgery alone, chemotherapy alone or chemotherapy with surgery (6.67, 14.88 and 20.99 months, respectively).
Conclusions: The median age of diagnosis was 50 years, and men and women are affected equally. Stage IV is the most common stage at diagnosis, and prognosis of Stages III and IV are worse in comparison to Stages I and II. In metastatic disease, receipt of chemotherapy is associated with improved survivorship. Multimodality treatment regimens may be recommended in non-metastatic cases.
Background: Primary cardiac sarcomas are rare and highly lethal tumors. Current understanding of clinicopathologic characteristics associated with primary cardiac sarcoma is limited to case reports and small case series. To the best of our knowledge, this is the largest study to evaluate clinicopathologic characteristics of primary cardiac sarcoma, and survival benefit of treatment modalities.
Methods: The National Cancer Database was utilized to retrospectively identify 404 patients diagnosed with a single primary cardiac sarcoma between 2004 and 2015. Kaplan-Meier methods were used to estimate survival distribution. Log-rank tests compared survival distributions between groups.
Results: Median age at diagnosis was 50 years. Men (50.7%) and women (49.3%) were affected equally. The most common histology types were hemangiosarcoma (40.1%), sarcoma NOS (14.9%), spindle cell sarcoma (6.9%) and leiomyosarcoma (5.9%). The most common stage at presentation was stage IV (38.1%). 37% of patients presented with metastases at the time of diagnosis, and the most common site of distant metastasis was the
lung (12.6%). Median overall survival (OS) for the entire cohort was 12 months. Median OS for stages I-IV was 23.06, 22.34, 12.98 and 8.08 months, respectively. 63% of patients underwent surgical resection. 58.4% received chemotherapy, and 22% received radiotherapy. Patients who underwent surgery had improved OS compared to those not receiving surgery (15.74 vs. 7.62 months, respectively). In patients with metastatic disease, OS was improved when treated with chemotherapy (11.14 months), compared to surgery alone (5.22 months). Combined treatment of surgery with chemotherapy did not improve outcomes compared to chemotherapy alone (P = .091 on log-rank test). In non-metastatic disease,
patients receiving multi-modality treatment (radiotherapy, chemotherapy and surgery) had improved OS (27.73 months) compared to those who underwent surgery alone, chemotherapy alone or chemotherapy with surgery (6.67, 14.88 and 20.99 months, respectively).
Conclusions: The median age of diagnosis was 50 years, and men and women are affected equally. Stage IV is the most common stage at diagnosis, and prognosis of Stages III and IV are worse in comparison to Stages I and II. In metastatic disease, receipt of chemotherapy is associated with improved survivorship. Multimodality treatment regimens may be recommended in non-metastatic cases.
High Risk Breast Cancer Screening Pilot Program in Accordance With National Guidelines
Purpose: Assess breast cancer (BC) risk, lifestyle factors, post-traumatic stress disorder (PTSD) status, chemoprevention and genetic consultations in women Veterans.
Background/Rationale: By 2020, women using Veterans Affairs Medical Centers (VAMC) will rise to 15%. For US women at high risk of BC, national guidelines (ASCO/USPSTF) recommend chemoprevention and genetic counseling for which fewer than 10% accept.
Methods: A pilot program was conducted at two VAMCs in the Bronx, NY and Washington, DC. Participants were enrolled at women’s health visits or education/awareness events. A questionnaire included the Gail Breast Cancer Risk Assessment Tool (BCRAT), the Breast Cancer Genetics Referral Screening Tool (B-RST), and lifestyle questions. Body mass index (BMI) and PTSD status were determined. Chemoprevention was recommended based on 5-year BCRAT > 1.66%; the B-RST was used for genetic counseling referrals. Chemoprevention candidates were given pre- and post-consultation knowledge questions.
Results: 99 women Veterans aged > 35 years with no personal history of BC, average age 54 years, participated between 2015-2018. Of these 35 (35%) had a Gail score of > 1.66%. Of this subset, 46% had prior breast biopsies and 86% had a positive family history. PTSD was present in 31%. Twenty-six (74%) accepted consultations for chemoprevention; 19% accepted chemoprevention; 37% patients were referred for genetic counseling; and 85% increased their awareness of chemoprevention. Among all participants, 79% had overweight or obese BMIs; 58% exercise weekly; 51% drink alcohol; 14% were smokers and 21% consumed 3-4 servings of fruits/vegetables daily.
Conclusions/Implications: Our study demonstrated that three times as many women Veterans are at increased risk of BC compared to the general population, based on a high rate of prior breast biopsies or positive family history. PTSD rates were nearly 3 times the national average and are implicated in poor adherence to medical advice. Chemoprevention utilization was nearly twice the national average. Lifestyle factors were similar to general population rates and unlikely to impact risk levels. Limitations included self-referrals and the large percentage of patients with a family history of BC, making them more likely to seek screening. As the number of Women Veterans increases, chemoprevention options should follow national guidelines.
Purpose: Assess breast cancer (BC) risk, lifestyle factors, post-traumatic stress disorder (PTSD) status, chemoprevention and genetic consultations in women Veterans.
Background/Rationale: By 2020, women using Veterans Affairs Medical Centers (VAMC) will rise to 15%. For US women at high risk of BC, national guidelines (ASCO/USPSTF) recommend chemoprevention and genetic counseling for which fewer than 10% accept.
Methods: A pilot program was conducted at two VAMCs in the Bronx, NY and Washington, DC. Participants were enrolled at women’s health visits or education/awareness events. A questionnaire included the Gail Breast Cancer Risk Assessment Tool (BCRAT), the Breast Cancer Genetics Referral Screening Tool (B-RST), and lifestyle questions. Body mass index (BMI) and PTSD status were determined. Chemoprevention was recommended based on 5-year BCRAT > 1.66%; the B-RST was used for genetic counseling referrals. Chemoprevention candidates were given pre- and post-consultation knowledge questions.
Results: 99 women Veterans aged > 35 years with no personal history of BC, average age 54 years, participated between 2015-2018. Of these 35 (35%) had a Gail score of > 1.66%. Of this subset, 46% had prior breast biopsies and 86% had a positive family history. PTSD was present in 31%. Twenty-six (74%) accepted consultations for chemoprevention; 19% accepted chemoprevention; 37% patients were referred for genetic counseling; and 85% increased their awareness of chemoprevention. Among all participants, 79% had overweight or obese BMIs; 58% exercise weekly; 51% drink alcohol; 14% were smokers and 21% consumed 3-4 servings of fruits/vegetables daily.
Conclusions/Implications: Our study demonstrated that three times as many women Veterans are at increased risk of BC compared to the general population, based on a high rate of prior breast biopsies or positive family history. PTSD rates were nearly 3 times the national average and are implicated in poor adherence to medical advice. Chemoprevention utilization was nearly twice the national average. Lifestyle factors were similar to general population rates and unlikely to impact risk levels. Limitations included self-referrals and the large percentage of patients with a family history of BC, making them more likely to seek screening. As the number of Women Veterans increases, chemoprevention options should follow national guidelines.
Purpose: Assess breast cancer (BC) risk, lifestyle factors, post-traumatic stress disorder (PTSD) status, chemoprevention and genetic consultations in women Veterans.
Background/Rationale: By 2020, women using Veterans Affairs Medical Centers (VAMC) will rise to 15%. For US women at high risk of BC, national guidelines (ASCO/USPSTF) recommend chemoprevention and genetic counseling for which fewer than 10% accept.
Methods: A pilot program was conducted at two VAMCs in the Bronx, NY and Washington, DC. Participants were enrolled at women’s health visits or education/awareness events. A questionnaire included the Gail Breast Cancer Risk Assessment Tool (BCRAT), the Breast Cancer Genetics Referral Screening Tool (B-RST), and lifestyle questions. Body mass index (BMI) and PTSD status were determined. Chemoprevention was recommended based on 5-year BCRAT > 1.66%; the B-RST was used for genetic counseling referrals. Chemoprevention candidates were given pre- and post-consultation knowledge questions.
Results: 99 women Veterans aged > 35 years with no personal history of BC, average age 54 years, participated between 2015-2018. Of these 35 (35%) had a Gail score of > 1.66%. Of this subset, 46% had prior breast biopsies and 86% had a positive family history. PTSD was present in 31%. Twenty-six (74%) accepted consultations for chemoprevention; 19% accepted chemoprevention; 37% patients were referred for genetic counseling; and 85% increased their awareness of chemoprevention. Among all participants, 79% had overweight or obese BMIs; 58% exercise weekly; 51% drink alcohol; 14% were smokers and 21% consumed 3-4 servings of fruits/vegetables daily.
Conclusions/Implications: Our study demonstrated that three times as many women Veterans are at increased risk of BC compared to the general population, based on a high rate of prior breast biopsies or positive family history. PTSD rates were nearly 3 times the national average and are implicated in poor adherence to medical advice. Chemoprevention utilization was nearly twice the national average. Lifestyle factors were similar to general population rates and unlikely to impact risk levels. Limitations included self-referrals and the large percentage of patients with a family history of BC, making them more likely to seek screening. As the number of Women Veterans increases, chemoprevention options should follow national guidelines.
Development of A New Hematology Oncology (H/O) Fellowship Role to Improve Consult Wait Times and Reduce ER Visits
Purpose: In oncology, wait times for new consults create stress and adverse outcomes; wait times for acute problems in established patients lead to ER visits with increased cost, inconvenience, and sometimes admissions, which could have been avoided. In addition, VA wait times are under public scrutiny.
Background: The CVAMC, partnering with UC, previously had 12 fellows in the H/O program, 3 of which were funded by the VA. Fellows have a VA continuity clinic staffed by 4 faculty, and rotate on the inpatient consult service. We applied for an additional fellow position through the VACAA GME program, which was granted, funded, and started in 2016; the way in which we have utilized this position forms the basis for this report.
Methods: We created a mandatory monthly outpatient VA Core rotation, which became the Urgent Fellow because of two of its primary mandates: see all urgent non-lifethreatening problems in established patients, and offer all new malignancy referrals a same or next day appointment. We encouraged referral earlier in the diagnostic evaluation. We tracked time from initial CPRS referral to visit, and % actually seen within 2 weekdays, excluding patients who declined to be seen soon. We also counted all ER visits for established patients with lung and prostate cancer.
Results: From March 2016 to Jan 2018, median referral to visit days decreased from 5 to 1, and the percent seen in < 2 days rose from 12% to 85.7%. Additional and updated numbers will be presented.
The ER visits by our patients with lung and prostate cancer fell from 230 in 2014-2015 to 114 in 2016-2017.
The Urgent Fellow rotation was the highest rated rotation at the VA / UC as judged by the fellows.
Conclusions: The creation of the Heme Onc Urgent fellow VA rotation has reaped dividends in dramatically reducing both ER visits and wait times for new malignancy referrals. Fellows have the opportunity to do the diagnostic and staging work ups, discuss treatment options, then treat and follow the patient for the remainder of their fellowship. It has improved care, reduced costs, and provided an irreplaceable experience for the fellows.
Purpose: In oncology, wait times for new consults create stress and adverse outcomes; wait times for acute problems in established patients lead to ER visits with increased cost, inconvenience, and sometimes admissions, which could have been avoided. In addition, VA wait times are under public scrutiny.
Background: The CVAMC, partnering with UC, previously had 12 fellows in the H/O program, 3 of which were funded by the VA. Fellows have a VA continuity clinic staffed by 4 faculty, and rotate on the inpatient consult service. We applied for an additional fellow position through the VACAA GME program, which was granted, funded, and started in 2016; the way in which we have utilized this position forms the basis for this report.
Methods: We created a mandatory monthly outpatient VA Core rotation, which became the Urgent Fellow because of two of its primary mandates: see all urgent non-lifethreatening problems in established patients, and offer all new malignancy referrals a same or next day appointment. We encouraged referral earlier in the diagnostic evaluation. We tracked time from initial CPRS referral to visit, and % actually seen within 2 weekdays, excluding patients who declined to be seen soon. We also counted all ER visits for established patients with lung and prostate cancer.
Results: From March 2016 to Jan 2018, median referral to visit days decreased from 5 to 1, and the percent seen in < 2 days rose from 12% to 85.7%. Additional and updated numbers will be presented.
The ER visits by our patients with lung and prostate cancer fell from 230 in 2014-2015 to 114 in 2016-2017.
The Urgent Fellow rotation was the highest rated rotation at the VA / UC as judged by the fellows.
Conclusions: The creation of the Heme Onc Urgent fellow VA rotation has reaped dividends in dramatically reducing both ER visits and wait times for new malignancy referrals. Fellows have the opportunity to do the diagnostic and staging work ups, discuss treatment options, then treat and follow the patient for the remainder of their fellowship. It has improved care, reduced costs, and provided an irreplaceable experience for the fellows.
Purpose: In oncology, wait times for new consults create stress and adverse outcomes; wait times for acute problems in established patients lead to ER visits with increased cost, inconvenience, and sometimes admissions, which could have been avoided. In addition, VA wait times are under public scrutiny.
Background: The CVAMC, partnering with UC, previously had 12 fellows in the H/O program, 3 of which were funded by the VA. Fellows have a VA continuity clinic staffed by 4 faculty, and rotate on the inpatient consult service. We applied for an additional fellow position through the VACAA GME program, which was granted, funded, and started in 2016; the way in which we have utilized this position forms the basis for this report.
Methods: We created a mandatory monthly outpatient VA Core rotation, which became the Urgent Fellow because of two of its primary mandates: see all urgent non-lifethreatening problems in established patients, and offer all new malignancy referrals a same or next day appointment. We encouraged referral earlier in the diagnostic evaluation. We tracked time from initial CPRS referral to visit, and % actually seen within 2 weekdays, excluding patients who declined to be seen soon. We also counted all ER visits for established patients with lung and prostate cancer.
Results: From March 2016 to Jan 2018, median referral to visit days decreased from 5 to 1, and the percent seen in < 2 days rose from 12% to 85.7%. Additional and updated numbers will be presented.
The ER visits by our patients with lung and prostate cancer fell from 230 in 2014-2015 to 114 in 2016-2017.
The Urgent Fellow rotation was the highest rated rotation at the VA / UC as judged by the fellows.
Conclusions: The creation of the Heme Onc Urgent fellow VA rotation has reaped dividends in dramatically reducing both ER visits and wait times for new malignancy referrals. Fellows have the opportunity to do the diagnostic and staging work ups, discuss treatment options, then treat and follow the patient for the remainder of their fellowship. It has improved care, reduced costs, and provided an irreplaceable experience for the fellows.
Bladder Toxicity After Volumetric Arc Radiation Therapy (VMAT) Treatment for Prostate Cancer Following Prostatectomy
Methods: We did a retrospective review of 55 patients with prostate cancer treated using external beam radiation therapy VMAT between 2013 through 2017.
Results: Sixteen were adjuvant/salvage therapy to the prostate fossa (PF) after a prostatectomy while 39 had primary radiation therapy for intact prostate cancer. The dose volume histogram (DVH) institutional bladder constraints were v65 200 cc, 55% when > 150 cc and there were no incidences of hematuria when the PTV was < 150 cc.
Conclusions: (1) Overall incidence of hematuria with VMAT treatment to the prostate was 10/55(18%); (2) Higher bladder DVH v65 volumes correlated with higher incidence of hematuria; (3) Higher PTV in PF group correlated with higher incidence of hematuria with the greatest risk occurring when the PTV was greater than 200 cc. This is due to more bladder in the treatment field; (4) Careful patient selection should be made for surgery to avoid post-surgery radiation therapy; (5) When treating PF keep the PTV volume under 150 cc; and (6) This finding should be studied with larger number of patients.
Methods: We did a retrospective review of 55 patients with prostate cancer treated using external beam radiation therapy VMAT between 2013 through 2017.
Results: Sixteen were adjuvant/salvage therapy to the prostate fossa (PF) after a prostatectomy while 39 had primary radiation therapy for intact prostate cancer. The dose volume histogram (DVH) institutional bladder constraints were v65 200 cc, 55% when > 150 cc and there were no incidences of hematuria when the PTV was < 150 cc.
Conclusions: (1) Overall incidence of hematuria with VMAT treatment to the prostate was 10/55(18%); (2) Higher bladder DVH v65 volumes correlated with higher incidence of hematuria; (3) Higher PTV in PF group correlated with higher incidence of hematuria with the greatest risk occurring when the PTV was greater than 200 cc. This is due to more bladder in the treatment field; (4) Careful patient selection should be made for surgery to avoid post-surgery radiation therapy; (5) When treating PF keep the PTV volume under 150 cc; and (6) This finding should be studied with larger number of patients.
Methods: We did a retrospective review of 55 patients with prostate cancer treated using external beam radiation therapy VMAT between 2013 through 2017.
Results: Sixteen were adjuvant/salvage therapy to the prostate fossa (PF) after a prostatectomy while 39 had primary radiation therapy for intact prostate cancer. The dose volume histogram (DVH) institutional bladder constraints were v65 200 cc, 55% when > 150 cc and there were no incidences of hematuria when the PTV was < 150 cc.
Conclusions: (1) Overall incidence of hematuria with VMAT treatment to the prostate was 10/55(18%); (2) Higher bladder DVH v65 volumes correlated with higher incidence of hematuria; (3) Higher PTV in PF group correlated with higher incidence of hematuria with the greatest risk occurring when the PTV was greater than 200 cc. This is due to more bladder in the treatment field; (4) Careful patient selection should be made for surgery to avoid post-surgery radiation therapy; (5) When treating PF keep the PTV volume under 150 cc; and (6) This finding should be studied with larger number of patients.
Presentation of A Rare Malignancy: Leiomyosarcoma of the Prostate
Background: Prostatic leiomyosarcoma is a rare tumor that accounts for less than 0.1% of all primary prostatic malignancies. This neoplasm is composed of highly aggressive prostatic smooth muscle cells that presents with nonspecific signs and symptoms mimicking other forms of prostatic pathology.
Case Report: A 72-year-old male presented with 6 months of progressive severe lower urinary tract symptoms (LUTS) secondary to bladder outlet obstruction. The patient was refractory to medical management and required multiple emergent bladder catheterizations. Workup with urinalysis, blood biochemistry, and PSA levels were persistently normal. He denied hematuria, weight loss, or perineal pain. On rectal exam, a mass like induration was noted along the right upper lobe of the prostate.
The patient was referred for transurethral resection of the prostate (TURP) for suspected severe BPH. Histopathological examination demonstrated atypical cytology consistent with high-grade leiomyosarcoma. A PET scan revealed a 1.9 cm tumor with uptake of 12.6 SUV in the right posterior prostate.
Discussion: Fewer than 200 cases of prostatic leiomyosarcoma have been reported. Patients typically present between 41-78 years of age (mean age of 61 years) with signs and symptoms related to LUTS (89.4%) and perineal or rectal pain (25.6%). Constitutional symptoms, burning on ejaculation, and hematuria are uncommon. PSA levels remain normal, due to its non-epithelial etiology, which may contribute to delays in diagnosis.
Diagnosis is usually achieved after a TURP procedure or transrectal needle biopsy. Pathology demonstrates neoplastic spindle cells with nuclear atypia, multifocal necrosis, and cystic degeneration. Immunohistochemistry is characteristically positive for desmin, smooth muscle actin, and vimentin. Tumors have been reported to range between 2-31 cm in size, frequently presenting with invasion of local structures. The lungs are the most common site of distant metastasis.
Treatment may include a multimodal approach of surgery, radiation, and chemotherapy. Long-term prognosis is poor due to the tumors aggressive nature, and recurrence is common. Median survival is estimated at 17 months and 50-75% of patients die within 2-5 years of diagnosis. Due to the substantially high risk of death, prostatic leiomyosarcoma may be one of the most aggressive and poorly prognostic malignancies involving the prostate.
Background: Prostatic leiomyosarcoma is a rare tumor that accounts for less than 0.1% of all primary prostatic malignancies. This neoplasm is composed of highly aggressive prostatic smooth muscle cells that presents with nonspecific signs and symptoms mimicking other forms of prostatic pathology.
Case Report: A 72-year-old male presented with 6 months of progressive severe lower urinary tract symptoms (LUTS) secondary to bladder outlet obstruction. The patient was refractory to medical management and required multiple emergent bladder catheterizations. Workup with urinalysis, blood biochemistry, and PSA levels were persistently normal. He denied hematuria, weight loss, or perineal pain. On rectal exam, a mass like induration was noted along the right upper lobe of the prostate.
The patient was referred for transurethral resection of the prostate (TURP) for suspected severe BPH. Histopathological examination demonstrated atypical cytology consistent with high-grade leiomyosarcoma. A PET scan revealed a 1.9 cm tumor with uptake of 12.6 SUV in the right posterior prostate.
Discussion: Fewer than 200 cases of prostatic leiomyosarcoma have been reported. Patients typically present between 41-78 years of age (mean age of 61 years) with signs and symptoms related to LUTS (89.4%) and perineal or rectal pain (25.6%). Constitutional symptoms, burning on ejaculation, and hematuria are uncommon. PSA levels remain normal, due to its non-epithelial etiology, which may contribute to delays in diagnosis.
Diagnosis is usually achieved after a TURP procedure or transrectal needle biopsy. Pathology demonstrates neoplastic spindle cells with nuclear atypia, multifocal necrosis, and cystic degeneration. Immunohistochemistry is characteristically positive for desmin, smooth muscle actin, and vimentin. Tumors have been reported to range between 2-31 cm in size, frequently presenting with invasion of local structures. The lungs are the most common site of distant metastasis.
Treatment may include a multimodal approach of surgery, radiation, and chemotherapy. Long-term prognosis is poor due to the tumors aggressive nature, and recurrence is common. Median survival is estimated at 17 months and 50-75% of patients die within 2-5 years of diagnosis. Due to the substantially high risk of death, prostatic leiomyosarcoma may be one of the most aggressive and poorly prognostic malignancies involving the prostate.
Background: Prostatic leiomyosarcoma is a rare tumor that accounts for less than 0.1% of all primary prostatic malignancies. This neoplasm is composed of highly aggressive prostatic smooth muscle cells that presents with nonspecific signs and symptoms mimicking other forms of prostatic pathology.
Case Report: A 72-year-old male presented with 6 months of progressive severe lower urinary tract symptoms (LUTS) secondary to bladder outlet obstruction. The patient was refractory to medical management and required multiple emergent bladder catheterizations. Workup with urinalysis, blood biochemistry, and PSA levels were persistently normal. He denied hematuria, weight loss, or perineal pain. On rectal exam, a mass like induration was noted along the right upper lobe of the prostate.
The patient was referred for transurethral resection of the prostate (TURP) for suspected severe BPH. Histopathological examination demonstrated atypical cytology consistent with high-grade leiomyosarcoma. A PET scan revealed a 1.9 cm tumor with uptake of 12.6 SUV in the right posterior prostate.
Discussion: Fewer than 200 cases of prostatic leiomyosarcoma have been reported. Patients typically present between 41-78 years of age (mean age of 61 years) with signs and symptoms related to LUTS (89.4%) and perineal or rectal pain (25.6%). Constitutional symptoms, burning on ejaculation, and hematuria are uncommon. PSA levels remain normal, due to its non-epithelial etiology, which may contribute to delays in diagnosis.
Diagnosis is usually achieved after a TURP procedure or transrectal needle biopsy. Pathology demonstrates neoplastic spindle cells with nuclear atypia, multifocal necrosis, and cystic degeneration. Immunohistochemistry is characteristically positive for desmin, smooth muscle actin, and vimentin. Tumors have been reported to range between 2-31 cm in size, frequently presenting with invasion of local structures. The lungs are the most common site of distant metastasis.
Treatment may include a multimodal approach of surgery, radiation, and chemotherapy. Long-term prognosis is poor due to the tumors aggressive nature, and recurrence is common. Median survival is estimated at 17 months and 50-75% of patients die within 2-5 years of diagnosis. Due to the substantially high risk of death, prostatic leiomyosarcoma may be one of the most aggressive and poorly prognostic malignancies involving the prostate.