The Veterans Health Administration Precision Oncology Program for Advanced Prostate Cancer Patients: Expanding tumor NGS opportunities to a broader patient population.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 193-193 ◽  
Author(s):  
Alexandra Sokolova ◽  
Heather H. Cheng ◽  
Bradley J Hintze ◽  
Michael J. Kelley ◽  
Neil L Spector ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Rural Areas ◽  
Advanced Prostate Cancer ◽  
Sequence Data ◽  
Clinical Care ◽  
Precision Oncology ◽  
Veterans Health ◽  
Health Administration ◽  
Prostate Tumors ◽  
Primary Tumors

193 Background: Progress in understanding molecular changes in advanced prostate cancer has led to promising precision oncology opportunities; to date, most have been concentrated at tertiary research centers and urban centers and unequally available to patients. The VHA is the largest integrated healthcare system in the U.S. and provides medical care to >6 million veterans (~40% living in rural areas). The VHA has implemented a system-wide National Precision Oncology Program (NPOP) to offer tumor NGS testing to veterans with cancer. Methods: VHA patients with advanced stage cancers were offered targeted NGS gene panels (Personalis ACE Extended Cancer Panel; PGDx CancerSELECT/PlasmaSELECT) as part of clinical care. Annotated sequence data is collected by NPOP. We report preliminary findings of the participating veterans with prostate cancer. Results: 372 veterans from 81 sites underwent NGS sequencing of their prostate tumors (n=311) or cfDNA (n=61). Tumors from 165 (44%) were found to have mutations (allelic ratio ≥5%) in 47 genes. Of 372, 62 harbored mutations in TP53 (17%), 9 in NOTCH1 (2%), 16 in PTEN (4%), 16 in AR (4%), 13 in ATM (4%), 11 in BRCA2 (3%), 2 in MSH2 (0.5%), 1 in NBN (0.3%), and 1 in PALB2 (0.3%). 7 men (1.8%) had adequate tumor, but no identifiable somatic mutations. NPOP findings were compared to the existing databases SU2C/PCF (of metastatic biopsies in metastatic castration resistant disease) and TCGA (of primary tumors in localized disease), see table. Findings will be updated at presentation. Conclusions: The VA NPOP has been successfully implemented, and prostate tumors from veterans were found to carry potentially actionable mutations, including BRCA2 and ATM, for which there are precision treatment trials. The program will be expanded and will facilitate more diverse and equitable distribution of access to precision oncology diagnostics and therapeutic opportunities, in alignment with the Cancer Moonshot Initiative. (e.g. VA-ABCD clinicaltrials.gov; NCT02985021). [Table: see text]

Implementation of precision oncology in the Veterans Health Administration (VHA).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6507-6507 ◽  
Author(s):  
Michael J. Kelley ◽  
Jill Duffy ◽  
Bradley J Hintze ◽  
Christina D. Williams ◽  
Neil L Spector
Keyword(s):  
Clinical Trial ◽  
Healthcare System ◽  
Program Implementation ◽  
Rural Areas ◽  
Precision Oncology ◽  
Veterans Health ◽  
Health Administration ◽  
National Implementation ◽  
Sample Test ◽  
Oncology Care

6507 Background: VHA is the US’s largest integrated healthcare system providing care to over 6 million Veterans (~40% in rural areas). Precision Oncology offers the promise of effective, low-toxicity targeted therapies tailored to individual tumor genomics but is unequally available to patients in the US. As part of the Cancer Moonshot, VHA is implementing a system-wide Precision Oncology Program (POP) including patients in rural areas, where specialty oncology care has historically had limited availability. Methods: Patients tested with multigene NGS tumor sequencing through 1 of 2 contracted vendors were identified from POP records and cancer characteristics were extracted from POP and medical records. Drug use data was obtained from the VA Corporate Data Warehouse. NGS testing results and annotations were extracted from POP records. Results: A total of 978 tumor samples were sent for NGS testing since program inception in 2015. The most common diagnoses are lung (464: adeno 314, squamous 107), GI (87), LN (75), liver (56), H&N (52), and prostate (43). The rate of sample test requests increased rapidly after national implementation in July 2016 (mean 23 samples/month prior to implementation to mean 126 samples/month 3 months later) as did the number of participating facilities (mean 8/month to 27/month). Sequencing success rate increased from 68% to 71% over the same interval while mean turn around time remained similar at 19.7 and 19.1 d, respectively. NGS results are available for a cohort of 344 patients including: lung 200 (adeno 138, squamous 51), skin 28, LN 20, liver 19, GI 16. 979 variants were found including TP53 278, KRAS 106, STK11, APC 38, PIK3CA 38, and CDKN2A 37. 228 patients had actionable results (on-label drug 24, off-label drug 165, clinical trial 213). To date, 8 patients received a recommended drug outside a clinical trial between 11 and 288 d after testing (median 82 d); 4 additional patients had received an NGS-recommended drug prior to testing. Conclusions: Implementation of tumor NGS testing as part of Precision Oncology Program in a US distributed healthcare system is feasible. Further program implementation and provision of appropriate targeted drugs both on and off study will be necessary to impact patient outcomes.

Clinically relevant genomic alterations identified by targeted exome sequencing in U.S. veterans with prostate cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17599-e17599
Author(s):  
Eman Dadashian ◽  
Michael Nakazawa ◽  
Neil Rohit Parikh ◽  
Nathisha Kalpage ◽  
Nicholas George Nickols ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
General Population ◽  
Large Scale ◽  
Mapk Pathway ◽  
Clinical Care ◽  
Cancer Tissue ◽  
Precision Oncology ◽  
Genomic Alterations ◽  
Primary Tumors ◽  
Prostate Cancers

e17599 Background: Amongst male United States Veterans, prostate cancer accounts for one third of cancer diagnoses and is the second leading cause of cancer death. Prostate cancers in the Veteran population may have differing frequencies of clinically relevant genomic alterations than the general population owing to chemical exposures, military service, or other unknown factors. Veterans, however, have been underrepresented in large-scale prostate cancer sequencing cohorts to date. Methods: Archival or fresh prostate cancer tissue from Veterans cared for by our team within the VA Greater Los Angeles Healthcare System (a VA Prostate Cancer Center of Excellence) undergo targeted sequencing as part of routine clinical care through the VA Precision Oncology Program. Sequencing covers over 181 genes frequently mutated in cancers. Prostate cancers from 81 Veterans (76 primary tumors, 5 metastases) have been sequenced through the Personalis ACE CancerPlus platform. Results: 43% of Veterans had primary tumors with clinically relevant genomic alterations, including 6.2% with activating mutations in MAPK pathway members (KRAS, ERBB2, or BRAF), 3.7% with somatic mutations in DDR genes (BRCA2 or ATR), 7.3% with mutations in TP53 or RB1, 4.9% in APC, 1.2% in the WNT pathway (CTNNB1), 3.7% with mutations in the PI3K/AKT pathway (PIK3R1 or AKT1), 3.7% with PTEN deletions, and 22.2% had alterations involving an AR regulated gene (SLC45A3 or TMPRSS). Of the five metastatic tumors sequenced, one had a mutation in TP53 and another had an ETS gene fusion detected. Half of the Veterans who underwent tumor sequencing consented for screening for, or enrollment on, active clinical trials at VA Greater LA. Conclusions: Large-scale sequencing of prostate cancers within VA is feasible and may facilitate enrollment in precision oncology trials specifically designed for Veterans. These data suggest that clinically relevant genomic alterations within the primary tumors may differ between Veterans and the general population; larger data sets along with more robust sequencing platforms are required for clarification.

scholarly journals Genomic Analysis of Metastatic Solid Tumors in Veterans: Findings From the VHA National Precision Oncology Program

2019 ◽  
pp. 1-13
Author(s):  
Pradeep J. Poonnen ◽  
Jill E. Duffy ◽  
Bradley Hintze ◽  
Maulik Shukla ◽  
Thomas S. Brettin ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Rural Areas ◽  
Kinase Inhibitors ◽  
Checkpoint Inhibitors ◽  
Occupational Exposures ◽  
The United States ◽  
Precision Oncology ◽  
Veterans Health ◽  
Health Administration ◽  
Clinical Implementation

PURPOSE The Veterans Health Administration (VHA) is the largest cancer care provider in the United States, with the added challenge of serving more than twice the percentage of patients with cancer in rural areas than the national average. The VHA established the National Precision Oncology Program in 2016 to implement and standardize the practice of precision oncology across the diverse VHA system. METHODS Tumor or peripheral blood specimens from veterans with advanced solid tumors who were eligible for treatment were submitted for next-generation sequencing (NGS) at two commercial laboratories. Annotated results were generated by the laboratories and independently using IBM Watson for Genomics. Levels-of-evidence treatment recommendations were based on OncoKB criteria. RESULTS From July 2016 to June 2018, 3,698 samples from 72 VHA facilities were submitted for NGS testing, of which 3,182 samples (86%) were successfully sequenced. Most samples came from men with lung, prostate, and colorectal cancers. Thirty-four percent of samples were from patients who lived in a rural area. TP53, ATM, and KRAS were among the most commonly mutated genes. Approximately 70% of samples had at least one actionable mutation, with clinical trials identified as the recommended option in more than 50%. Mutations in genes associated with a neuroendocrine prostate cancer phenotype were expressed at increased frequency among veterans than in the general population. The most frequent therapies prescribed in response to NGS testing were immune checkpoint inhibitors, EGFR kinase inhibitors, and PARP inhibitors. CONCLUSION Clinical implementation of precision oncology is feasible across the VHA health care system, including rural sites. Veterans have unique occupational exposures that might inform the nature of the mutational signatures identified here. Importantly, these results underscore the importance of increasing clinical trial availability to veterans.

Communication and psychological safety in veterans health administration work environments

2014 ◽  
Vol 28 (6) ◽  
pp. 754-776 ◽  
Author(s):  
Nancy J. Yanchus ◽  
Ryan Derickson ◽  
Scott C. Moore ◽  
Daniele Bologna ◽  
Katerine Osatuke
Keyword(s):  
Health Care Providers ◽  
Care Delivery ◽  
Clinical Care ◽  
Psychological Safety ◽  
Veterans Health Administration ◽  
Employee Perceptions ◽  
Veterans Health ◽  
Health Administration ◽  
Care Providers ◽  
Content Type

Purpose – The purpose of this paper is to explore employee perceptions of communication in psychologically safe and unsafe clinical care environments. Design/methodology/approach – Clinical providers at the USA Veterans Health Administration were interviewed as part of planning organizational interventions. They discussed strengths, weaknesses, and desired changes in their workplaces. A subset of respondents also discussed workplace psychological safety (i.e. employee perceptions of being able to speak up or report errors without retaliation or ostracism – Edmondson, 1999). Two trained coders analysed the interview data using a grounded theory-based method. They excerpted passages that discussed job-related communication and summarized specific themes. Subsequent analyses compared frequencies of themes across workgroups defined as having psychologically safe vs unsafe climate based upon an independently administered employee survey. Findings – Perceptions of work-related communication differed across clinical provider groups with high vs low psychological safety. The differences in frequencies of communication-related themes across the compared groups matched the expected pattern of problem-laden communication characterizing psychologically unsafe workplaces. Originality/value – Previous research implied the existence of a connection between communication and psychological safety whereas this study offers substantive evidence of it. The paper summarized the differences in perceptions of communication in high vs low psychological safety environments drawing from qualitative data that reflected clinical providers’ direct experience on the job. The paper also illustrated the conclusions with multiple specific examples. The findings are informative to health care providers seeking to improve communication within care delivery teams.

Bone modifying agents in veterans with castration-resistant prostate cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6582-6582
Author(s):  
Jordan Bauman ◽  
Kyle Kumbier ◽  
Jennifer A. Burns ◽  
Jordan Sparks ◽  
Phoebe A. Tsao ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Specific Antigen ◽  
Veterans Health ◽  
Health Administration ◽  
Castration Resistant Prostate Cancer ◽  
National Guidelines ◽  
Castration Resistant ◽  
Unit Increase

6582 Background: Skeletal related events (SREs) are a known complication for the 80% of men with metastatic prostate cancer who have bone metastases. Previous studies have demonstrated that bone modifying agents (BMAs) such as zoledronic acid and denosumab reduce SREs in men with metastatic castration-resistant prostate cancer who have bone metastases and are now recommended by national guidelines. We sought to investigate factors associated with use of BMAs in Veterans with CRPC across the Veterans Health Administration (VA). Methods: Using the VA Corporate Data Warehouse, consisting of aggregated medical record data from 130 facilities, we used an algorithm previously published to identify men with a diagnosis of castration-resistant prostate cancer (CRPC) based on rising prostate specific antigen (PSA) levels while on androgen deprivation therapy and who received systemic treatment for CRPC with one of the commonly used therapies: abiraterone, enzalutamide, docetaxel, ketoconazole between 2010 and 2017. To account for clustering among facilities, we used a multilevel multivariable logistic regression to determine the association of patient and disease-specific variables on the odds of a patient receiving a BMA after they started treatment for CRPC. Results: Of 4,998 patients with CRPC in our cohort, 2223 (44%) received either zoledronic acid or denosumab at some point after they were initiated on treatment for CRPC. After adjusting for other variables and accounting for a facility, the odds of receiving a BMA decreased by 3% for every additional year of age (odds ratio [OR] 0.97, 95% confidence interval [CI] 0.96-0.98), and decreased significantly with increasing comorbid conditions (OR 0.94, 95% CI 0.72-0.98 for Charlson Comorbidity Index [CCI] of 1; OR 0.69, 95% CI 0.59-0.81 for CCI 2+). Patients who were Black had 25% lower odds of receiving a BMA than patients who were White (OR 0.75, 95% CI 0.65-0.87). PSA at time of CRPC treatment start had a small but not significant effect on receipt of a BMA (OR 1.04, 95% CI 1.00-1.08) for every unit increase of PSA on the log scale. PSA doubling time was not associated with receipt of a BMA. The presence of a diagnosis code for bone metastases was far lower than expected in this cohort of patients with CRPC (40.7%), and thus was not included in the model. We did not expect the presence of bone metastases to vary significantly among the other independent variables. Conclusions: Despite most patients with CRPC historically having bone metastases, less than half of patients with CRPC received a BMA. Patients who are older, had more comorbidities, or were Black were less likely to receive a BMA after starting treatment for CRPC. Understanding factors that lead to different patterns of treatment can guide initiatives toward more guideline-concordant care.

scholarly journals N-cadherin increases after androgen deprivation and is associated with metastasis in prostate cancer

2010 ◽  
Vol 17 (2) ◽  
pp. 469-479 ◽  
Author(s):  
Karin Jennbacken ◽  
Tajana Tešan ◽  
Wanzhong Wang ◽  
Heléne Gustavsson ◽  
Jan-Erik Damber ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Epithelial Mesenchymal Transition ◽  
Neuroendocrine Differentiation ◽  
Hormonal Treatment ◽  
Androgen Deprivation ◽  
Prostate Tumors ◽  
Primary Tumors ◽  
Mesenchymal Transition ◽  
Molecular Alterations

Androgen-deprivation therapy (ADT) is the standard treatment for metastatic prostate cancer. One factor that has been implicated in the metastatic process is the cell adhesion molecule N-cadherin. In this study, we investigated if the expression of N-cadherin was influenced by androgen deprivation and was associated with metastasis in prostate cancer. The effect of androgen deprivation on N-cadherin expression was initially studied in androgen-dependent (AD) LNCaP and androgen-independent (AI) LNCaP-19 and PC-3 prostate cancer cell lines. Expression of N-cadherin increased in the absence of androgens in AI LNCaP-19 primary tumors and metastases and also in vitro, but not in AI PC-3 tumors, indicating a possible involvement of the androgen receptor in the regulation of N-cadherin. N-cadherin was absent in AD LNCaP tumors. No clear associations between N-cadherin and factors related with epithelial–mesenchymal transition or neuroendocrine differentiation could be established. In addition, N-cadherin was evaluated by immunohistochemistry in human prostate tumors. Expression of N-cadherin was more frequently found in tumors from patients treated with ADT than in tumors from patients with no prior hormonal treatment. N-cadherin expression was also associated with metastasis and Gleason score. Furthermore, increased N-cadherin was detected in prostate cancer biopsies already 3 months after initiation of ADT when tumors were in a regressed state. In summary the results indicate that androgen deprivation induces N-cadherin in prostate tumors. Moreover, N-cadherin was increased in castration-resistant tumors in patients with established metastases. This might indicate that castration induces molecular alterations in the tumor cells, resulting in a more invasive and metastatic phenotype.

Assessment of patient satisfaction, financial, and environmental impacts of teleoncology.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 278-278
Author(s):  
Cindy Jiang ◽  
Garth William Strohbehn ◽  
Rachel Dedinsky ◽  
Shelby Raupp ◽  
Brittany Pannecouk ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Rural Areas ◽  
Financial Burden ◽  
Veterans Health ◽  
Health Administration ◽  
Secondary Effects ◽  
Medical Needs ◽  
Care Access ◽  
Strongly Agree

278 Background: There was rapid adoption of teleoncology at Veterans Health Administration (VHA) during the COVID-19 pandemic. One-third of 9 million VHA-enrolled Veterans live in rural areas. While digital solutions can expand capacity, enhance care access, and reduce financial burden, they may also exacerbate rural-urban health disparities. Careful evaluation of patients’ perceptions and policy tradeoffs are necessary to optimize teleoncology post-pandemic. Methods: Patients with ≥1 teleoncology visit with medical, surgical, or radiation oncology between March 2020 and June 2020 identified retrospectively. Validated, Likert-type survey assessing patient satisfaction developed. Follow-up survey conducted on patients with ≥1 teleoncology visit from August 2020 to January 2021. Travel distance, time, cost, and carbon dioxide (CO2) emissions calculated based on zip codes. Results: 100 surveys completed (response rate, 62%). Table with demographics. Patients overall satisfied with teleoncology (83% ‘Agree’ or ‘Strongly Agree’) but felt less satisfied than in-person visits (47% ‘Agree’ or ‘Strongly Agree’). Audiovisual component improved patient perception of involvement in care (two-sided, p = 0.0254), ability to self-manage health/medical needs (p = 0.0167), and comparability to in person visits (p = 0.0223). Follow-up survey demonstrated similar satisfaction. Total travel-related savings: 86,470 miles, 84,374 minutes, $49,720, and 35.5 metric tons of CO2. Conclusions: Veterans are broadly satisfied with teleoncology. Audiovisual capabilities are critical to satisfaction. This is challenging for rural populations with lack of technology access. Patients experienced financial and time savings, and society benefitted from reduced carbon emissions. Continued optimization needed to enhance patient experience and address secondary effects.[Table: see text]

Improving clinic utilization and workload capture for clinical pharmacy specialists

2020 ◽  
Vol 77 (7) ◽  
pp. 552-559
Author(s):  
Allison Steen ◽  
Jessica Bovio Franck
Keyword(s):  
Clinical Pharmacy ◽  
Clinical Care ◽  
Quality Care ◽  
Clinical Pharmacy Service ◽  
Quality Improvement Initiative ◽  
Pharmacy Services ◽  
Veterans Health ◽  
Health Administration ◽  
Post Intervention ◽  
Clinical Pharmacy Services

Abstract Purpose To assess a quality improvement initiative aimed at improving clinic utilization and encounter and intervention workload capture for clinical pharmacy specialists. This initiative aided in justification of clinical pharmacy services, identification of clinical areas for intervention, and incorporation of all modalities to appropriately document clinical care. Methods In order to objectively demonstrate clinical pharmacy service value to stakeholders, pharmacy administrators and clinical pharmacy specialists at the North Florida/South Georgia Veterans Health System performed clinic scheduling and profile reviews using data extracted from the Veterans Health Administration electronic health record and analytic software. Outpatient clinical pharmacy specialty practice areas were primarily investigated; the specialty areas included are as follows: cardiology, infectious disease, mental health, oncology, pain management/palliative care, and specialty clinics (a collection of medical and surgical subspecialties). The first intervention entailed completing a worksheet and assessing clinic utilization data. Then, an evaluation was performed to assess the number of encounters, clinical interventions, clinic modalities, and coding for each clinic. Next, a meeting was arranged with each like clinical pharmacy specialist practice group to discuss this collected data. During these meetings, the delineation of where workload was generated and the activities taking place in an average workday were discussed. Finally, clinics were adjusted to reflect appropriate clinic coding and mapping of the average workday. Metrics were evaluated pre intervention (October through December 2017) and post intervention (July through September 2018). Results After intervention, there were statistically significant increases in clinic utilization, total encounters completed, and total interventions recorded in the composite group of clinical pharmacy specialists. Conclusion The increases in clinic utilization, total encounters, and interventions observed for the clinical pharmacy specialists suggest the beneficial role of pharmacy administrators’ collaboration with clinical pharmacy specialists to improve workload capture and access to quality care, to justify clinical pharmacy services, and to identify opportunities for pharmacy clinical intervention.

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