scholarly journals Recommendation on Advanced Molecular Testing in Hematolymphoid Malignancies in the Veterans Population

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4983-4983
Author(s):  
Jadee L Neff ◽  
Claudio A. Mosse ◽  
Jessica Wang-Rodriguez ◽  
Sara Ahmed ◽  
Michael Kelley
Keyword(s):  
Cancer Care ◽  
Clinical Pathways ◽  
Hematologic Malignancy ◽  
Tumor Board ◽  
Molecular Testing ◽  
Precision Oncology ◽  
Veterans Health ◽  
Health Administration ◽  
Prognostic Information ◽  
Acute Leukemias

Abstract The Veterans Health Administration is the largest integrated provider of cancer services in the nation, with approximately 50,000 new cancer cases diagnosed each year. The goal of the VA's National Oncology Program is to establish a System of Excellence in cancer care with the help of tools, resources, programs, and best practices across the enterprise to ensure every veteran, regardless of location, receives the same high level of cancer care and access to precision diagnostics. This is mediated through a variety of programs, including the National TeleOncology Service and the National Precision Oncology Program which includes standardized clinical pathways for molecular testing, a second opinion service on diagnostic consultations, test result interpretation and treatment recommendations, as well as a molecular oncology tumor board. The VA National Oncology Program and the Pathology and Laboratory Medicine Program offices have collaborated on a recommended guideline for advanced laboratory and molecular testing algorithm in hematologic diagnosis. We aim to offer best practice for all VA providers who must decide the type of ancillary tests at the time of initial clinical presentation in order to gain prognostic information and guide therapy. The recommendations include traditional laboratory tests, such as morphology, flow cytometry, and immunohistochemistry, as well as the use of fluorescent in situ hybridization (FISH), karyotype, polymerase chain reaction (PCR), and next generation sequencing (NGS). An overview of the draft algorithm for acute leukemias and chronic myeloid neoplasms is presented in Table 1; details will be discussed at the annual meeting. Conclusion: The joint effort from VA Oncology and Pathology presents advanced testing algorithms in a variety of hematolymphoid malignancies as a systematic approach to hematopathology diagnosis, classification, as well as offering prognostic and therapeutic information. The recommendations across VA Healthcare would ensure standardized care for all VA patients with hematologic malignancy to benefit from the latest advances in precision medicine. Figure 1 Figure 1. Disclosures Neff: Spring Discovery: Consultancy, Ended employment in the past 24 months; EUSA Pharma: Speakers Bureau; Enzyvant: Consultancy.

scholarly journals Race-Based Differences in Routine Cytogenetic Profiles of Patients with Multiple Myeloma

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2619-2619
Author(s):  
Brandon Jamaal Blue ◽  
Kristen M. Sanfilippo ◽  
Arun Ganti ◽  
Jason Gumbel ◽  
Katiuscia O'Brian ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Racial Differences ◽  
Hematologic Malignancy ◽  
Molecular Testing ◽  
Veterans Health ◽  
Health Administration ◽  
Chromosome 14 ◽  
Exact Test ◽  
Black Patients ◽  
White Patients

Abstract Background: Multiple myeloma (MM) is a common hematologic malignancy for which standard therapy does not offer a cure. Incidence of MM in African-Americans is twice that of Caucasians, suggesting differences in either environmental or genetic risk factors. Historically, black patients have also had a slightly better prognosis than white patients, suggesting racial differences in prognostic factors such as cytogenetics. Since metaphase cytogenetic profiles are routinely collected in MM patients, we sought to determine if race-based differences in cytogenetics exist, using data from the Veterans Health Administration (VHA) cancer registry. Methods: Using CPT codes, 88271-88275, 88291, 88299, 88365, 83896, 88237, 88261-88264, 88280, 88283, and 88285, we identified 988 patients with MM diagnosed between 1998 and 2009, who also had standard metaphase cytogenetic analysis performed on a bone marrow specimen at the time of diagnosis (228 Black and 585 White) . Fisher’s exact test was used to assess for race-based differences in the following cytogenetic abnormalities: 13q deletion, Hypodiploidy, Hyperdiploidy, and translocations involving chromosome 14. Results: Among the 988 patients in the cohort, normal cytogenetic profiles, isolated Y chromosome deletion, or no mitotic activity were observed in 704(71%) patients. Translocations involving the immunoglobulin heavy chain (chromosome 14) (n=4) were uncommonly observed on routine cytogenetics, such that no statistical conclusions could be drawn. Hyperdiploidy was noted in 13/228(5.7%) of the black and 45/585(7.7%) of the white patients (p=0.32). Similarly 13q deletions were detected in 8/228(3.5%) black patients, and 21/585(3.6%) of the white patients (p=0.96). Hypodiploidy was also not significantly different in black 4/228(1.8%) and white patients 12/585(2.0%). Conclusion: This is the largest study of race-based differences in MM cyogenetics presented to date. We found no significant race-based differences in standard metaphase cytogenetics. Future studies should focus on determining if race-based differences can be discovered using fluorescent in situ hybridization (FISH) or molecular testing not available for this retrospective study. Our study adds to this growing body of evidence suggesting that metaphase cytogenetic differences are not a significant factor in MM outcome disparities. Disclosures Carson: Spectrum Pharmaceuticals: Honoraria, Research Funding, Speakers Bureau.

scholarly journals Implementing Precision Medicine in Community-Based Oncology Programs: Three Models

2019 ◽  
Vol 15 (6) ◽  
pp. 325-329 ◽  
Author(s):  
Laura A. Levit ◽  
Edward S. Kim ◽  
Barbara L. McAneny ◽  
Lincoln D. Nadauld ◽  
Kathryn Levit ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Cancer Care ◽  
Large Scale ◽  
Administrative Support ◽  
Clinical Pathways ◽  
Clinical Decision ◽  
Successful Implementation ◽  
Precision Oncology ◽  
Community Based ◽  
Tumor Boards

The use of precision medicine and the number of genomic-based treatments and immunotherapies is increasing. Nevertheless, oncology providers face challenges to implementing precision medicine, including in community practices, where most patients receive treatment. On January 31, 2018, ASCO hosted Precision Medicine: Expanding Opportunities, the inaugural event in ASCO’s new State of Cancer Care in America (SOCCA) event series. This article draws from the inaugural SOCCA event and the experiences of the SOCCA event participants to summarize the opportunities and challenges of precision medicine, and to highlight three successful models of implementing precision oncology in large, multisite community practices or networks: (1) Intermountain Healthcare, (2) Levine Cancer Institute, Atrium Health, and (3) National Cancer Care Alliance. The experience of these practices suggests that practice innovations that offer clinical decision support through molecular tumor boards and clinical pathways, and administrative support for prior authorization and clinical trial matching are key to successful implementation of large-scale, community-based precision medicine programs.

First Results of the Interdisciplinary Comprehensive Cancer Center Freiburg (CCCF) Tumor Board (TB) Multiple Myeloma (MM) Assessing TB-Questions, TB-Advice Adherence, TB-Satisfaction of Patients, Participants and Referring Physicians, Inclusion of Difficult-to-Treat-MM Pts in Clinical Trials (CT) and Patient Outcome

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2635-2635
Author(s):  
Ricarda Selder ◽  
Masa Pandurevic ◽  
Mandy-Deborah Möller ◽  
Johannes Waldschmidt ◽  
Milena Pantic ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Care ◽  
Clinical Pathways ◽  
Symptom Control ◽  
Tumor Board ◽  
Comprehensive Cancer Center ◽  
Stream Line ◽  
Line Treatment ◽  
Tumor Boards ◽  
Referring Physicians

Abstract Introduction: Tumor boards have become a crucial institution in oncology practice to provide paramount interdisciplinary cancer treatment, stream-line patient (pt) entries and to ensure treatment according to clinical pathways (CP). We initiated a weekly MM-TB at our institution in 6/2012. Participating experts are hematologist-oncologists, pathologists/cytogenetic specialists, orthopedists, radiotherapists, immunologists/rheumatologists and, if needed, nephrologists, cardiologists and others. Pt applications to be discussed are centrally organized through our CCCF, with the TB advice being centrally stored within our electronic pt information system. Recommended TB advice is made according to best current literature/knowledge and international CP. The development of mandatory CCCF-CP and transparency of decision making are key quality criteria. Methods: This first analysis focused on a) discussed TB questions, b) given recommendations, c) pt characteristics, d) pts’, referring- and participating-physicians' satisfaction with the TB, e) inclusion of these challenging-to-treat pts in clinical trials (CT) and f) PFS/OS of TB pts as compared to the literature (Kumar SK. Leukemia 2012). Grades of recommendations were assigned using the GRADE criteria (Engelhardt M. Haematologica 2014) and meticulously assessed, as well as whether TB recommendations were pursued. Pts’, referring- and participating-physicians' satisfaction with the TB was evaluated via standardized questionnaires, the aimed sample size being n=100 for consecutive pts and ~n=30 each for participating and referring physicians. Results: From 6/2012-5/2014, 483 pts have been discussed within 90 MM-TB sessions, substantially increasing these from 2011 to 2012, 2013 and 2014 by 12-fold. Of the entire MM cohort seen at our institution, 60% of these challenging-to-treat pts were discussed within the TB in 2012, increasing to 71% in 2013. We have currently assessed 200 TB-protocols for pt characteristics, clinical outcome and adherence to TB decisions. Of those, 2% were presented for explicit diagnosis-finding, 17% had newly diagnosed MM, 41% relapsed/refractory MM and 40% had attained stable disease or better with their last-line therapy and were discussed to resolve their ongoing treatment. Expectedly, most pts (89%) were discussed for their next-line treatment, 43% due to strains with comorbidities, symptom control, side effects, diagnosis finding and MM-staging, and 11% due to various other reasons (multiple entries possible). Mean treatment lines of pts discussed in the TB was 2 (range 0-10), deciding on their 3rd-line-treatment. Within the TB cohort, 70% were presented once, but 30% several times (mean 2, range 2-4). Of these multiple presentations, most pts had relapsed or refractory MM, this rate further increasing towards the 3rd and 4th TB-presentation. The adherence to TB-recommendations was excellent with 93% of decisions being pursued. Reasons for adapted approaches were practicable issues or disagreement of the pt, family or referring physician. Of currently 80/100 interviewed pts, 95% were entirely satisfied with their care, treating oncologists/MM-expert team and very supportively perceived the MM-TB. Of note, 94% considered their cancer care ideally achieved by the TB, 92% that their local physician profited greatly and 88% that their personal preferences were also accounted for. Of 30 interviewed participating physicians, 97% considered themselves well-educated and their time well-spent. Of currently 18 referring physicians, 73% were unconditionally satisfied with all TB-diagnostics and -therapies, with the university centers' cooperation and 65% acknowledged no information loss. Of 288 pts assessed for their CT suitability, 28% were suggested by the TB to be included, with 53% actually being able to enter therein. Thus, 15% of our MM-TB cohort could be included in a CT, which is considerable since these were challenging-to-treat pts who had received extensive prior therapies and showed several comorbidities. This also confirms current CT accrual rates for cancer pts of 5-15%, which can be increased with well-structured TB. Conclusions: Our preliminary results suggest that this MM-TB is a highly relevant exchange platform and allows physicians from different disciplines to intensely and rewardingly collaborate for state-of-the-art cancer care. Disclosures No relevant conflicts of interest to declare.

Precision oncology for the treatment of salivary gland tumors.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17577-e17577
Author(s):  
Damian Tobias Rieke ◽  
Mario Lamping ◽  
Serge Leyvraz ◽  
Theo Daniel Kim ◽  
Lutz Brinkmann ◽  
...  
Keyword(s):  
Salivary Gland ◽  
Rna Sequencing ◽  
Salivary Gland Tumors ◽  
Tumor Board ◽  
Molecular Testing ◽  
Precision Oncology ◽  
Rna Seq ◽  
Mixed Response ◽  
Antiandrogen Therapy ◽  
Panel Sequencing

e17577 Background: Salivary gland tumors (SGT) represent a rare and heterogeneous group of malignancies. No standard treatment exists in the advanced situation and the prognosis is poor. We here report characteristics and clinical outcomes of patients with SGT discussed at the Charité molecular tumor board (MTB). Methods: Patients with advanced cancer and no curative treatment option were discussed at the Charité MTB. Eligible patients underwent fresh tissue sampling and subsequent whole exome (WES) and RNA sequencing (RNA-seq) and immunohistochemical analyses (EGFR, HER2, AR as well as validation tests) or panel sequencing. Results from molecular testing were discussed at the MTB and patients were followed-up after recommendations were made. Results: 24 patients (median age 56 years, 13 male, 11 female) with advanced SGT were presented at the MTB between 2016 and 2019 (9 adenoidcystic carcinomas, 5 adenocarcinomas, 3 mucoepidermoid, 2 carcinosarcoma, 5 miscellaneous). WES/RNA sequencing was performed on tumor tissue from 16 patients. 2 patients were not included in the sequencing program and WES/RNA-Seq was ongoing for another 4 patients at the time of analysis. For another 2 patients, panel sequencing and IHC analysis, respectively was done. Results from analyses were discussed and a median of 2 recommendations, ranked by priority according to prespecified evidence levels, were made for 17 patients, each. Most commonly proposed treatment options by the MTB were FGFR inhibitors in 6 patients, mTOR or PARP inhibitors in 5 each, EGFR, HDAC inhibitors or antiandrogen therapy in 4, each. Treatments following MTB recommendations were initiated in 8 patients, 1 of which received a second recommended therapy after progression (antiandrogen therapy in 4, EGFR inhibitor in 2, a PDGFR, mTOR and PARP inhibitor in 1, each). A clinical benefit (CR = 1; Mixed Response = 1, SD = 3) was achieved in 5 patients, including a complete response in a patient with a metastatic adenocarcinoma of the parotid gland, treated with antiandrogen therapy. Conclusions: Precision oncology represents a feasible treatment strategy in patients with advanced SGT and shows early evidence of activity in a subset of patients. These results suggest further exploration of personalized therapy in these hard-to-treat tumors.

scholarly journals Precision Genomic Practice in Oncology: Pharmacist Role and Experience in an Ambulatory Care Clinic

Pharmacy ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 32 ◽  
Author(s):  
Farah Raheem ◽  
Pauline Kim ◽  
Meagan Grove ◽  
Patrick J. Kiel
Keyword(s):  
Clinical Trial Design ◽  
Cost Effective ◽  
Standard Of Care ◽  
The United States ◽  
Tumor Board ◽  
Patient Specific ◽  
Cancer Center ◽  
Molecular Testing ◽  
Precision Oncology ◽  
Care Clinic

Recent advancements in molecular testing, the availability of cost-effective technology, and novel approaches to clinical trial design have facilitated the implementation of tumor genome sequencing into standard of care oncology practices. Current models of precision oncology practice include specialized clinics or consultation services based on a molecular tumor board (MTB) approach. MTBs are comprised of interprofessional teams of clinicians and scientists who evaluate tumors at the molecular level to guide patient-specific targeted therapy. The practice of precision oncology utilizing MTB-based models is an emerging approach, transforming precision genomics from a novel concept into clinical practice. This rapid shift in practice from cytotoxic therapy to targeted medicine poses challenges, yet brings exciting opportunities to clinical pharmacists practicing in hematology and oncology. Only a few precision genomics programs in the United States have a strong pharmacy presence with oncology pharmacists serving in leadership roles in research, interpreting genomic sequencing, making treatment recommendations, and facilitating off-label drug procurement. This article describes the experience of the precision medicine clinic at the Indiana University Health Simon Cancer Center, with emphasis on the role of the pharmacist in the precision oncology initiative.

scholarly journals A virtual molecular tumor board to improve efficiency and scalability of delivering precision oncology to physicians and their patients

JAMIA Open ◽  
2019 ◽  
Vol 2 (4) ◽  
pp. 505-515 ◽  
Author(s):  
Michael J Pishvaian ◽  
Edik M Blais ◽  
R Joseph Bender ◽  
Shruti Rao ◽  
Simina M Boca ◽  
...  
Keyword(s):  
Treatment Plan ◽  
Critical Role ◽  
Tumor Board ◽  
Care Process ◽  
Molecular Profile ◽  
Molecular Testing ◽  
Precision Oncology ◽  
Therapy Options ◽  
Scoring Model ◽  
Molecular Tumor Board

Abstract Objectives Scalable informatics solutions that provide molecularly tailored treatment recommendations to clinicians are needed to streamline precision oncology in care settings. Materials and Methods We developed a cloud-based virtual molecular tumor board (VMTB) platform that included a knowledgebase, scoring model, rules engine, an asynchronous virtual chat room and a reporting tool that generated a treatment plan for each of the 1725 patients based on their molecular profile, previous treatment history, structured trial eligibility criteria, clinically relevant cancer gene-variant assertions, biomarker-treatment associations, and current treatment guidelines. The VMTB systematically allows clinician users to combine expert-curated data and structured data from clinical charts along with molecular testing data to develop consensus on treatments, especially those that require off-label and clinical trial considerations. Results The VMTB was used as part of the cancer care process for a focused subset of 1725 patients referred by advocacy organizations wherein resultant personalized reports were successfully delivered to treating oncologists. Median turnaround time from data receipt to report delivery decreased from 14 days to 4 days over 4 years while the volume of cases increased nearly 2-fold each year. Using a novel scoring model for ranking therapy options, oncologists chose to implement the VMTB-derived therapies over others, except when pursuing immunotherapy options without molecular support. Discussion VMTBs will play an increasingly critical role in precision oncology as the compendium of biomarkers and associated therapy options available to a patient continues to expand. Conclusion Further development of such clinical augmentation tools that systematically combine patient-derived molecular data, real-world evidence from electronic health records and expert curated knowledgebases on biomarkers with computational tools for ranking best treatments can support care pathways at point of care.

Temporal trends of inpatient C. difficile infections within the Veterans Health Administration hospitals: An analysis of the effect of molecular testing, time to testing, and mandatory reporting

2019 ◽  
Vol 41 (1) ◽  
pp. 44-51 ◽  
Author(s):  
Zarchi E. Sumon ◽  
Alan J. Lesse ◽  
John A. Sellick ◽  
Sheldon Tetewsky ◽  
Kari A. Mergenhagen
Keyword(s):  
Temporal Trends ◽  
Healthcare Facility ◽  
Veterans Health Administration ◽  
Mandatory Reporting ◽  
Molecular Testing ◽  
Testing Time ◽  
Third Generation ◽  
Veterans Health ◽  
Health Administration ◽  
Third Generation Cephalosporins

AbstractBackground:Clostridium difficile infection (CDI) is a reportable hospital metric associated with significant healthcare expenditures. The epidemiology of CDI is pivotal to the implementation of preventative measures.Objective:To portray temporal CDI trends in Veterans Health Administration (VA) hospitals.Design:A retrospective analysis of veterans who had stool testing for C. difficile.Setting:VA acute-care hospitals within the continental United States.Methods:Data were mined from the VA’s Corporate Data Warehouse. CDI is reported per 10,000 patient days.Results:From 2006 to 2016, 472,346 patients had C. difficile testing. Overall, decreases in incidence of total CDI (16.81 to 13.66) and hospital-onset healthcare facility-associated (HO-HCFA) CDI (10.87 to 6.41) were observed. Temporal increases in the incidence of total and HO-HCFA CDI were associated with the increased use of molecular testing (P < .0001). Decreased use of fluoroquinolones (P < .0001), clindamycin (P = .0006), and third-generation cephalosporins (P = .0002) correlated with decreased rates of CDI, but VA mandatory reporting did not influence CDI rates (P = .24). The overall crude 30-day mortality of patients with CDI decreased from 2.17 deaths per 10,000 patient days in 2006 to 1.41 in 2016. The frequency of International Classification of Disease, Ninth/Tenth Revision (ICD-9/10) discharge diagnosis for CDI was 73.3%.Conclusion:Molecular testing was associated with increased incidence of CDI. Controlling CDI is likely multifactorial. Although the VA initiative to report cases of hospital-acquired CDI was not significant in our model, the advent of stewardship programs throughout the VA and reductions in the use of third-generation cephalosporins, fluoroquinolones, and clindamycin were significantly associated with reduced rates of CDI.

Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT2): Challenges and Opportunities in Conducting an MD Anderson Randomized Study in Precision Oncology.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3140-3140
Author(s):  
Henry Hiep Vo ◽  
Siqing Fu ◽  
David S. Hong ◽  
Daniel D. Karp ◽  
Sarina Anne Anne Piha-Paul ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Advanced Cancer ◽  
Patient Preference ◽  
Randomized Study ◽  
Tumor Board ◽  
Molecular Testing ◽  
Precision Oncology ◽  
Phase I Clinical Trials ◽  
Metastatic Setting ◽  
Patient Resources

3140 Background: Precision oncology is associated with favorable outcomes in selected patients with cancer. Our first IMPACT trial (IMPACT1) demonstrated that in sequential patients with advanced cancer who had tumor molecular testing and participated in phase I clinical trials, matched targeted therapy (MTT) was associated with superior rates of response, progression-free survival (PFS) and overall survival compared with those of patients who received non-MTT. Despite the statistical significance for these outcomes, the study was non-randomized. Recognizing that it would be difficult to randomize patients we nonetheless undertook IMPACT2, a phase 2 randomized study to determine whether patients treated on the basis of tumor genomic alterations have longer PFS compared to those whose treatment is not selected on the basis of molecular alteration analysis. Methods: Patients with metastatic cancer undergo a tumor biopsy and genomic profiling. Patients are presented at tumor board and are offered to be randomized between two arms: MTT or non-MTT, when criteria (biomarker present, available clinical trial, eligibility criteria met, insurance approval) are met. In April 2019, we amended the trial to include a “patient-preference” cohort for each arm. Patients who decline randomization are offered choice of arm (ClinicalTrials.gov: NCT02152254). The primary analysis will use both randomized and patient-preference cohorts based on a Bayesian hierarchical model that “borrows” from the patient-preference cohorts to the extent to which its PFS agrees with that in the randomization cohort. Results: The key barriers randomizing patients with actionable molecular alterations are patient-related (advanced, metastatic setting requiring immediate intervening therapy; decline in performance status, organ function; or death); drug-related (FDA-approved drug available; or unavailable MTT against key driver biomarker) or financial (no insurance coverage of MTT; lack of patient resources to participate in trials). As the study spans over a few years, some investigational agents that were considered non-MTT at the time of treatment assignment were later proven to be MTT (e.g., immunotherapeutic agents targeting high tumor mutational burden); and/or were approved by the FDA. Conclusions: Although randomized trials have been considered the gold standard in drug development, such studies in the advanced metastatic setting are complicated. The benefit of Precision Oncology has been exemplified in individual patients who were treated with biomarker-selected therapy. The adaptive design of IMPACT2 enables patient randomization despite the evolving tumor biomarkers and the plethora of investigational drugs. IMPACT2 provides insights for the development of cancer genome-based medicine. Outcomesfor randomized patients are awaited. Clinical trial information: NCT02152254.

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