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CME

Duke Molecular Tumor Board: Tackling Barriers to Precision Cancer Medicine

  • Authors: John Strickler, MD (Faculty); Edward Allan Racela Sison, MD (Writer)
  • CME Released: 1/27/2022
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 1/27/2023
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Target Audience and Goal Statement

Target Audience 

This activity is intended for clinical oncologists, pathologists, hereditary geneticists, clinical trial coordinators, clinical researchers, basic scientists, bioinformaticians, radiation therapists, genetic counselors, oncology pharmacists, and patient advocates.

Statement of Need 

Fueled by rapid advances in next-generation sequencing technologies, comprehensive genomic profiling of patients with advanced cancer is becoming increasingly common. However, the volume and complexity of alterations uncovered through genomic profiling make it difficult for oncologists to choose the most appropriate therapy for their patients. Furthermore, the Duke Cancer Institute at Duke University struggled to integrate medical reports received from external vendors into patients’ electronic health records, thereby impeding their goal in providing precision cancer medicine. To address these concerns, Duke University developed a molecular tumor board and the molecular registry of tumors, whereby a multidisciplinary team (pathologists, oncologists, scientists, medical geneticists, pharmacists, and clinical trial teams) assembles to review genomic test results for all Duke University Health System cancer patients, provide notifications for targeted therapies, match patients to biomarker-driven clinical trials, identify patients for germline testing, and monitor the molecular landscape of tumors sequenced at Duke.

Learning Objective

Upon completion of this activity, participants will be able to:

  1. Discuss the development of a precision cancer medicine program aimed at providing timely targeted therapy selection for providers and patients


Disclosures

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Disclosure Statement:

The content of this activity has been peer reviewed and has been approved for compliance. The faculty and contributors have indicated the following financial relationships, which have been mitigated through an established COI mitigation process, and have stated that these reported relationships will not have any impact on their ability to give an unbiased presentation.

Statement of Evidenced-Based Content:

Educational activities that assist physicians in carrying out their professional responsibilities more effectively and efficiently are consistent with the ACCME definition of continuing medical education (CME). As an ACCME-accredited provider of CME, Med-IQ has a policy to review and ensure that all the content and any recommendations, treatments, and manners of practicing medicine in CME activities are scientifically based, valid, and relevant to the practice of medicine. Med-IQ is responsible for validating the content of the CME activities it provides. Specifically, (1) all recommendations addressing the medical care of patients must be based on evidence that is scientifically sound and recognized as such within the profession; (2) all scientific research referred to, reported, or used in CME in support or justification of a patient care recommendation must conform to generally accepted standards of experimental design, data collection, and analysis. 

Med-IQ is not liable for any decision made or action taken in reliance upon the information provided through this activity. 


Faculty

  • John Strickler, MD

    Medical Oncologist
    Associate Professor of Medicine
    Member of the Duke Cancer Institute
    Duke University School of Medicine
    Durham, North Carolina

    Disclosures

    John Strickler, MD, has disclosed the following relevant financial relationships:  
    Consulting fees/advisory boards: AbbVie Inc.; AstraZeneca; Bayer HealthCare Pharmaceuticals; GlaxoSmithKline; Inivata Ltd; Mereo BioPharma; Natera; Pfizer, Inc.; Seagan; Silverback Therapeutics; Viatris.
    Contracted research: AbbVie Inc.; Amgen; Astar 3D; Bayer HealthCare Pharmaceuticals; Curegenix; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche Ltd; Genentech; Gossamer Bio; Nektar; Sanofi-Aventis U.S. Inc.; Seagan; Silverback Therapeutics.

Planners/Reviewers

  • Edward Allan Racela Sison, MD

    Writer
    Missouri City, Texas

    Disclosures

    Edward Allan Racela Sison, MD, has disclosed the following relevant financial relationships: 
    Salary: Arcus Biosciences; Precision Medicine Group. 
    Ownership interest (stocks/stock options – excluding mutual funds): Arcus Biosciences; LabCorp; Moderna, Inc.; UnitedHealth Group. 

  • Kia Jones, PhD

    Clinical Content Manager
    Med-IQ
    Baltimore, Maryland

  • Rebecca L. Julian, MS, ELS

    Senior Manager, Editorial
    Med-IQ
    Baltimore, Maryland

  • Samantha Gordon, MS

    Accreditation Manager
    Med-IQ
    Baltimore, Maryland

  • Amy Sison

    Director of CME
    Med-IQ
    Baltimore, Maryland

The peer reviewers and other activity planners have no financial relationships to disclose.


Accreditation Statements

    For Physicians

  • Med-IQ is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

    Med-IQ designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Contact Med-IQ at (toll-free) 866 858 7434 or email [email protected].  

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CME

Duke Molecular Tumor Board: Tackling Barriers to Precision Cancer Medicine

Authors: John Strickler, MD (Faculty); Edward Allan Racela Sison, MD (Writer)Faculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME Released: 1/27/2022

Valid for credit through: 1/27/2023

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This brief accredited publication, which features a video providing expert perspective from John Strickler, MD, explores the precision cancer medicine program at Duke University. It discusses the reason the molecular tumor board (MTB) was established at Duke and highlights how it aids in providing timely targeted cancer therapy selection for providers and patients. Additionally, it examines the implementation of a molecular tumor registry, a robust informatics tool designed to complement the MTB by providing a centralized location to store and organize molecular data and make it available for timely physician support.

 

 
 

INTRODUCTION

Improvements in tumor genetic testing have allowed oncologists to practice precision cancer medicine, in which therapies and clinical trials can be selected based on the specific genetic alterations in a tumor.[1] Indeed, next-generation sequencing (NGS) has the potential to match patients to appropriate United States Food and Drug Administration (FDA)-approved targeted therapies and biomarker-driven clinical trials; however, studies have shown that many patients who could benefit from targeted therapies are not undergoing NGS. This brief publication explores factors that contribute to the underuse of genomic testing and highlights an innovative approach developed by Duke Health to overcome some of the barriers associated with connecting patients to precision cancer medicine.

BARRIERS TO PRECISION CANCER MEDICINE

Despite the availability of genomic testing and its potential to help clinicians match patients to targeted therapy, recent data show that many patients are not receiving evidence-based biomarker testing that can connect them to appropriate FDA-approved therapies or innovative clinical trials. For instance, in a study of community oncology practices, testing for anaplastic lymphoma kinase (ALK) rearrangements was performed in only 67% of patients with advanced nonsquamous non–small cell lung cancer (NSCLC), despite the availability of multiple FDA-approved ALK inhibitors.[2] Factors that were associated with a lower likelihood of being tested for ALK included male gender, positive smoking history, location (living in non-Western regions of the United States), noncommercial health insurance, recurrent disease, and squamous histology. Interestingly, older patients were also less likely to be tested than younger patients, even though they would have greatly benefited from ALK testing, given that the presence of an ALK rearrangement can potentially indicate candidacy for a chemotherapy-free treatment plan.[2]

Similarly, in a recent nationwide survey, approximately three-quarters of oncologists reported using NGS to develop therapeutic plans; of those respondents, however, only 27% reported that NGS results “often” inform their treatment recommendations, and 52% stated that NGS results “sometimes” influence their treatment plans.[1] Characteristics of oncologists that were associated with a higher use of NGS testing included being younger (age < 50 years), possessing an academic appointment, having undergone genomics training, caring for more than 50 unique patients per month, and having the ability to consult a molecular tumor board (MTB).[1]

In addition to the underuse of NGS, other reasons for patients not being matched to appropriate clinical trials include long wait times for receiving and interpreting genomic testing results, the use of limited gene panels that are uninformative, and the very short life expectancies of some patients with advanced disease.[3] Furthermore, patients with limited financial resources do not always have access to appropriate FDA-approved targeted treatments or clinical trials. Lastly, clinical trial eligibility criteria exclude many patients with common comorbidities, and only about 3% to 5% of patients with cancer are enrolled in clinical trials.[3]

Another significant challenge is the need to decipher copious amounts of NGS data in a systematic manner to match genomic alterations with targeted therapies.[4] The application of NGS in clinical practice necessitates the use of MTBs, which identify and consider all potential treatment approaches and allow for multidisciplinary discussion of the patient and testing results. Notably, however, an investigation into the use of MTBs across the globe found that only 17.6% of cases discussed were actually treated in accordance with the conclusions of the board, thus highlighting the challenges still faced by precision cancer care providers and patients.[4]

OVERVIEW OF THE DUKE MTB AND MRT

The Duke MTB, a collaboration between the Duke Pathology Department and the Duke Cancer Institute (DCI), is a multidisciplinary team that consists of pathologists, oncologists, scientists, medical geneticists, and clinical trial teams.[5] Its members meet weekly to review genomic results for all Duke University Health System cancer patients. The MTB delivers notifications for available targeted therapies, pairs patients with biomarker-focused clinical trials, identifies patients for germline testing, and observes the molecular landscape of tumors sequenced at Duke. Between 20 and 30 cases are reviewed each week; these discussions generate a variety of research concepts and foster the use of precision medicine within the DCI.[5]

In response to the challenges of organizing and storing large volumes of molecular genetic data, Duke developed an information technology tool called the Molecular Registry of Tumors (MRT), which operates as the foundation for the Duke MTB.[5] Institutionally, Duke was receiving molecular reports from multiple external vendors, but these reports arrived in a format that was not accessible in the electronic health record (EHR) system. As a result, providers struggled to access these reports, and the data could not be integrated with the clinical research teams and clinicians to support the goal of providing precision cancer medicine. Therefore, the MRT was internally developed at Duke as a system that collects genomic profiling results from various sources and normalizes those data. The MRT allows for information to flow freely between the numerous campuses of the DCI and between key clinical stakeholders, such as research teams, clinical teams, and medical geneticists.[5]

Together, Duke’s MTB and MRT provide support for clinicians and research teams in the delivery of precision cancer care. When an oncology provider orders NGS, the workflow of the MRT and MTB begins.[5] Once NGS results are available, they are shared with the ordering provider and laboratory as a document that is scanned into the EHR. At the same time, structured NGS results are sent to the MRT. The MRT then uses these results to generate a case list for the MTB and matches patients to approved targeted therapies and/or available clinical trials. The proposed case list and NGS results from the previous week (as provided by the MRT) are reviewed by the MTB program coordinator, medical oncology coleaders, and a genetic counselor, and cases are then selected for review. Criteria for case selection include the presence of atypical or unexpected results, germline implications, or actionable findings that potentially make the patient eligible for a biomarker-directed clinical trial(s). The cases are then discussed at the MTB meeting, whose members make referrals for genetic counseling and germline testing and/or recommendations for appropriate on- or off-label therapies. Clinical trial alerts are also sent to the oncology provider and specific clinical trial team(s).[5]

To help understand the effects of comprehensive genomic profiling on the treatment of patients at the DCI, researchers performed a chart review of 215 consecutive patients discussed at Duke MTB meetings during a 6-month period.[5] Genomic testing identified 176 actionable therapeutic alterations and 15 resistance alterations among these cases. Notably, although the time from order to result was slightly shorter for liquid biopsy (9 days) than tissue biopsy (13 days), there was no significant difference in the time from test result to discussion by the MTB. Although Duke’s MTB program is considered to be successful overall, only 17% of patients included in the MTB analysis ultimately received a matched targeted therapy. These results are in line with those of other studies that evaluated the use of comprehensive genomic profiling to guide treatment decisions, which found that, although actionable findings were detected in 27% to 75% of patients, only 6% to 23% actually received a targeted therapy.[5]

DUKE MTB GOALS

The Duke MTB has several goals.[5] One goal is to provide a resource—both from an educational and a data perspective—to interpret and act on molecular profiling results. The group seeks to provide “just-in-time” clinical recommendations, share best practices, and disseminate insights and breakthroughs related to clinical genomic testing. The Duke MTB also seeks to maintain state-of-the art capabilities for genomic testing to ensure that clinicians and scientists have access to superior molecular sequencing and comprehensive genomic profiling technologies and that available sequencing assays and clinical use of these assays meet institutional standards of quality and integrity. Another goal of the MTB is to establish a real-time curated database/interface of molecular alterations that is paired to targeted therapy options and outcomes. By reviewing genomic results, the MTB can identify targets for therapeutic clinical trials; establish, support, and maintain an accessible database of clinical outcomes that is paired to molecularly directed interventions; and facilitate participation in national collaborative data-sharing initiatives.[5] One such initiative is the American Association for Cancer Research’s Project GENIE (Genomics Evidence Neoplasia Information Exchange), which is an international pan-cancer registry built through data sharing and driven by openness, transparency, and inclusion.[6]

Project GENIE addresses an unmet need in oncology by creating a multi-institutional and international data-sharing platform that can be used to facilitate scientific and clinical discovery.[6] The founding members of the GENIE consortium included 8 institutions in North America and Europe, all of whom were willing to share clinical cancer genomic data and longitudinal outcomes of their patients.[7] To date, GENIE consists of 19 participating cancer centers, including Duke, who joined in 2018. Each member institution must contribute at least 500 genomic records each year, which helps support the project’s overall goal of improving clinical decision making by linking clinical genotypes to outcomes.[6,7] GENIE data have been used in studies to examine the correlation between overall survival and surrogate endpoints in patients with advanced NSCLC and colorectal cancer and risk factors for developing brain metastases in patients with stage II through IV NSCLC.[8,9]

CONCLUSION

The main goal of the Duke MTB is to advance the practice of precision cancer medicine within the institution. Because the MRT is an informatics platform that can curate genomic test data and offer expedient support to DCI oncologists, the MTB has the unique ability to match patients with therapies and clinical trials. By being fully integrated with Duke community affiliates in Wake County and beyond, the MTB program is achieving the vision of “One Duke.” The success of the MTB allows physicians and scientists to support research, seek extramural funding, and enhance the capabilities of campus laboratories.

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