JCO oncology practicePub Date : 2024-11-01Epub Date: 2024-11-12DOI: 10.1200/OP.24.00040
Carol J Farhangfar, Kathryn F Mileham, Antoinette R Tan
{"title":"Interpretation of Reports and Translation to Community Oncologists: An Overview of Approaches.","authors":"Carol J Farhangfar, Kathryn F Mileham, Antoinette R Tan","doi":"10.1200/OP.24.00040","DOIUrl":"https://doi.org/10.1200/OP.24.00040","url":null,"abstract":"","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":"20 11","pages":"1452-1459"},"PeriodicalIF":4.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2024-11-01Epub Date: 2024-11-12DOI: 10.1200/OP.24.00191
Nury M Steuerwald, Sarah Morris, D Grace Nguyen, Jai N Patel
{"title":"Understanding the Biology and Testing Techniques for Pharmacogenomics in Oncology: A Practical Guide for the Clinician.","authors":"Nury M Steuerwald, Sarah Morris, D Grace Nguyen, Jai N Patel","doi":"10.1200/OP.24.00191","DOIUrl":"https://doi.org/10.1200/OP.24.00191","url":null,"abstract":"<p><p>Pharmacogenomic (PGx) testing is a growing area of personalized medicine with demonstrated clinical utility in improving patient outcomes in oncology. PGx testing of pharmacogenes affecting drug pharmacokinetics, pharmacodynamics, and response can help inform drug selection and dosing of several anticancer therapies and supportive care medications. Several PGx testing techniques exist including polymerase chain reaction (PCR), MassARRAY, microarray, and sequencing. This review article provides a clinician-friendly guide of these techniques. Understanding the advantages, limitations, ideal use, and potential clinical applications of each platform can help clinicians choose the appropriate PGx testing platform for specific use cases.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":"20 11","pages":"1441-1451"},"PeriodicalIF":4.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2024-11-01Epub Date: 2024-11-12DOI: 10.1200/OP.24.00274
Jing Xi, Cynthia X Ma, Joyce O'Shaughnessy
{"title":"Current Clinical Utility of Circulating Tumor DNA Testing in Breast Cancer: A Practical Approach.","authors":"Jing Xi, Cynthia X Ma, Joyce O'Shaughnessy","doi":"10.1200/OP.24.00274","DOIUrl":"https://doi.org/10.1200/OP.24.00274","url":null,"abstract":"<p><p>Circulating tumor DNA (ctDNA) refers to DNA fragments released from cancer cells into the bloodstream. Clinical utility of ctDNA in breast cancer has been explored in both metastatic breast cancer (MBC) and early-stage breast cancer (EBC) settings. In MBC, ctDNA can detect therapeutically targetable genomic alterations and has shown great potential in predicting treatment response or resistance. Accumulating data suggest that ctDNA might also have prognostic value in MBC. In EBC, emerging data have shown ctDNA's predictive and/or prognostic value in both neoadjuvant and adjuvant settings. Minimal residual disease (MRD) detection via ctDNA to detect clinical recurrence after curative therapy is a rapidly advancing field. In this review, we discuss the existing and emerging data regarding ctDNA utility in both MBC and EBC settings.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":"20 11","pages":"1460-1470"},"PeriodicalIF":4.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2024-11-01Epub Date: 2024-11-12DOI: 10.1200/OP.24.00226
Alexa K Dowdell, Ryan C Meng, Ann Vita, Bela Bapat, Douglas Hanes, Shu-Ching Chang, Lauren Harold, Cliff Wong, Hoifung Poon, Brock Schroeder, Roshanthi Weerasinghe, Rom Leidner, Walter J Urba, Carlo B Bifulco, Brian D Piening
{"title":"Widespread Adoption of Precision Anticancer Therapies After Implementation of Pathologist-Directed Comprehensive Genomic Profiling Across a Large US Health System.","authors":"Alexa K Dowdell, Ryan C Meng, Ann Vita, Bela Bapat, Douglas Hanes, Shu-Ching Chang, Lauren Harold, Cliff Wong, Hoifung Poon, Brock Schroeder, Roshanthi Weerasinghe, Rom Leidner, Walter J Urba, Carlo B Bifulco, Brian D Piening","doi":"10.1200/OP.24.00226","DOIUrl":"https://doi.org/10.1200/OP.24.00226","url":null,"abstract":"<p><strong>Purpose: </strong>Precision therapies and immunotherapies have revolutionized cancer care, with novel genomic biomarker-associated therapies being introduced into clinical practice rapidly, resulting in notable gains in patient survival. Despite this, there is significant variability in the utilization of tumor molecular profiling that spans the timing of test ordering, comprehensiveness of gene panels, and clinical decision support through therapy and trial recommendations.</p><p><strong>Methods: </strong>To standardize testing, we designed a pathologist-directed test ordering system at the time of diagnosis using a 523-gene DNA/RNA hybrid comprehensive genomic profiling (CGP) panel and extensive clinical decision support tools. To comprehensively characterize the clinical impact of this protocol, we developed a novel natural language processing (NLP)-based approach to extract clinical features from physician chart notes. We assessed test actionability rates, therapy choice, and outcomes across a set of 3,216 patients with advanced cancer.</p><p><strong>Results: </strong>We observed 49% of patients had at least one actionable genomic biomarker-driven-approved and/or guideline-recommended targeted or immunotherapy (IO) and 53% of patients would have been eligible for a precision therapy clinical trial from three large basket trials. When assessing CGP versus an in silico 50-gene panel, 67% of tumors compared with 33% harbored actionable alterations including clinical trials. Among patients with 6 months or more of follow-up, over 52% received a targeted therapy (TT) or IO, versus 32% who received conventional chemotherapy alone. Furthermore, patients receiving TT had significantly improved overall survival compared with patients receiving chemotherapy alone (<i>P</i> < .001).</p><p><strong>Conclusion: </strong>Overall, these data represent a major shift in standard clinical practice toward molecularly guided treatments (targeted and immunotherapies) over conventional systemic chemotherapy. As guidelines continue to evolve and more precision therapeutics gain approval, we expect this gap to continue to widen.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":"20 11","pages":"1523-1532"},"PeriodicalIF":4.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2024-11-01Epub Date: 2024-11-12DOI: 10.1200/OP-24-00481
Kathryn DeCarli, Angela Bradbury, Ana Maria Lopez, Polo Camacho, Monica S Chatwal, Christopher R Friese, Rachel Jimenez, Liza-Marie Johnson, Amy L McGuire, Rebecca Spence, Jeffrey Peppercorn
{"title":"Ethical and Clinical Considerations in Ordering and Responding to Molecular Diagnostics and Circulating Tumor DNA as the Science Evolves.","authors":"Kathryn DeCarli, Angela Bradbury, Ana Maria Lopez, Polo Camacho, Monica S Chatwal, Christopher R Friese, Rachel Jimenez, Liza-Marie Johnson, Amy L McGuire, Rebecca Spence, Jeffrey Peppercorn","doi":"10.1200/OP-24-00481","DOIUrl":"https://doi.org/10.1200/OP-24-00481","url":null,"abstract":"","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":"20 11","pages":"1508-1514"},"PeriodicalIF":4.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2024-11-01Epub Date: 2024-11-12DOI: 10.1200/OP.23.00812
Lalan Wilfong, Lauren Baggett, Philip Reena, Regina Murphy, Harpreet Singh, Paul Kluetz, Brooke Byrd, Robert McDonough, Shirisha Reddy, Rogelio Roger Brito
{"title":"Administrative Aspects of Molecular Diagnostics-Oversight, Regulatory Approval Process, Clinical and Operational Workflows, and Payment Models.","authors":"Lalan Wilfong, Lauren Baggett, Philip Reena, Regina Murphy, Harpreet Singh, Paul Kluetz, Brooke Byrd, Robert McDonough, Shirisha Reddy, Rogelio Roger Brito","doi":"10.1200/OP.23.00812","DOIUrl":"https://doi.org/10.1200/OP.23.00812","url":null,"abstract":"<p><p>This paper discusses the administrative aspects of molecular diagnostics in oncology, including US Food and Drug Administration (FDA) oversight, the regulatory approval process, clinical, and operational workflows, and payment models. Comprehensive molecular testing is important to deliver optimal oncology care and improve patient outcomes. Despite the potential benefits of testing, utilization remains low. The FDA regulatory approval process is reviewed for in vitro diagnostic products, which includes classification into three regulatory classes on the basis of risk. Companion diagnostic devices are used to guide treatment decisions. The clinical and operational challenges associated with molecular testing in oncology are also discussed, including the rapidly evolving landscape of precision oncology, the wide range of biomarker testing options, and complexities of test ordering, interpretation, and result delivery. There is a need for a multifaceted support approach involving education, technology enhancements, and workflow support to overcome these challenges. In terms of payment models, coverage policies between Medicare and commercial payers are compared with differences in coverage criteria, with Medicare focusing on FDA approval or clearance, whereas commercial payers consider additional factors such as National Comprehensive Cancer Network and ASCO guidelines. Commercial payers tend to cover smaller panels on the basis of guideline-recommended biomarkers, whereas coverage for broad tumor profiling is limited. Several strategies can increase the utilization of molecular testing, including integrating test results into electronic medical record platforms, standardizing billing practices, increasing clinical trials, and primary literature supporting the use of molecular testing, educating physicians, and using tumor boards for result interpretation and treatment discussions.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":"20 11","pages":"1501-1507"},"PeriodicalIF":4.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2024-11-01Epub Date: 2024-11-12DOI: 10.1200/OP.24.00167
Francesca Battaglin, Heinz-Josef Lenz
{"title":"Clinical Applications of Circulating Tumor DNA Profiling in GI Cancers.","authors":"Francesca Battaglin, Heinz-Josef Lenz","doi":"10.1200/OP.24.00167","DOIUrl":"10.1200/OP.24.00167","url":null,"abstract":"<p><p>Over the next few years, the analysis of circulating tumor DNA (ctDNA) through liquid biopsy is expected to enter clinical practice and revolutionize the approach to biomarker testing and treatment selection in GI cancers. In fact, growing evidence support the use of ctDNA testing as a noninvasive, effective, and highly specific tool for molecular profiling in GI cancers. Analysis of blood ctDNA has been investigated in multiple settings including early tumor detection, minimal residual disease evaluation, tumor diagnosis and evaluation of prognostic/predictive biomarkers for targeted treatment selection, longitudinal monitoring of treatment response, and identification of resistance mechanisms. Here, we review the clinical applications, advantages, and limitations of ctDNA profiling for precision oncology in GI cancers.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":"20 11","pages":"1481-1490"},"PeriodicalIF":4.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11567053/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2024-11-01Epub Date: 2024-11-12DOI: 10.1200/OP-24-00648
Joseph G Schroers-Martin, Ash A Alizadeh
{"title":"Cell-Free DNA in Hematologic Malignancies.","authors":"Joseph G Schroers-Martin, Ash A Alizadeh","doi":"10.1200/OP-24-00648","DOIUrl":"https://doi.org/10.1200/OP-24-00648","url":null,"abstract":"<p><p>Liquid biopsy techniques using cell-free DNA (cfDNA) play an increasingly important role in the characterization and surveillance of solid tumors. For blood cancers, molecular response assessment techniques using circulating malignant cells or bone marrow aspirates are well established in clinical care. However, cfDNA has an emerging role in hematology as well, with the opportunity for disease assessment and quantification independent of circulating disease burden or invasive biopsies. In this review, we discuss key technologies and clinical data for the utilization of cfDNA in lymphomas, myeloma, and leukemias.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":"20 11","pages":"1491-1499"},"PeriodicalIF":4.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JCO oncology practicePub Date : 2024-11-01Epub Date: 2024-11-12DOI: 10.1200/OP.24.00230
Jyoti Malhotra, Edward S Kim
{"title":"How to Keep Up With Molecular Testing and Targeted Therapies in Lung Cancer.","authors":"Jyoti Malhotra, Edward S Kim","doi":"10.1200/OP.24.00230","DOIUrl":"https://doi.org/10.1200/OP.24.00230","url":null,"abstract":"<p><p>Until the early 2000s, advanced or metastatic non-small cell lung cancer (NSCLC) was treated as a single disease with all histologic subtypes treated alike with standard chemotherapy agents. Over the past two decades, the treatment paradigms for advanced NSCLC have changed dramatically with the discovery of multiple targeted therapies that are now approved for the treatment of NSCLC tumors with specific oncogene drivers or molecular alterations. Molecular testing has become integrated and critical for the clinical management of advanced NSCLC. The discovery and success of these targeted therapies have reshaped the classification of NSCLC on the basis of molecular classification and enabled a personalized approach in thoracic oncology. In this review, we discuss recent developments in the molecular profiling of NSCLC, and approved and emerging targeted therapies for the treatment of NSCLC.</p>","PeriodicalId":14612,"journal":{"name":"JCO oncology practice","volume":"20 11","pages":"1471-1480"},"PeriodicalIF":4.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142620752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}