scholarly journals Understanding contemporary molecular biomarker testing rates and trends for metastatic NSCLC among community oncologists

2021 ◽  
Author(s):  
David M Waterhouse ◽  
Wan-Yu Tseng ◽  
Janet L Espirito ◽  
Nicholas J. Robert
Keyword(s):  
Molecular Biomarker ◽  
Metastatic Nsclc ◽  
Biomarker Testing

Racial disparities in biomarker testing and clinical trial enrollment in non-small cell lung cancer (NSCLC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9005-9005
Author(s):  
Debora S. Bruno ◽  
Lisa M. Hess ◽  
Xiaohong Li ◽  
Eric Wen Su ◽  
Yajun Emily Zhu ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Racial Disparities ◽  
Trial Participation ◽  
First Line ◽  
Metastatic Nsclc ◽  
Black Patients ◽  
Biomarker Testing ◽  
Clinical Trial Enrollment ◽  
White Patients

9005 Background: Cancer racial disparities may exist at many levels in the health care system, from screening to timely diagnosis and treatments received, as well as clinical trial enrollment. This study investigated differences in black versus white race among patients with NSCLC undergoing biomarker testing and clinical trial enrollment in the US. Methods: This retrospective observational study utilized the Flatiron Health database, which includes longitudinal data of patients with advanced/metastatic NSCLC. Patients were eligible if they had evidence of systemic therapy in the database from 1/1/2017 through 10/30/2020. Descriptive analyses summarized differences by race in biomarker testing and trial enrollment. Multivariable regression examined the relationship between these factors. Results: A total of 14,768 patients were eligible: 9,793 (66.3%) were white and 1,288 (8.7%) were black. 76.4% of white patients and 73.6% of black patients underwent at least one single molecular test or comprehensive genomic analysis (p = 0.03). Next-generation sequencing (NGS) was performed among 50.1% of white patients and 39.8% of black patients (p < 0.0001. Trial participation was observed among 3.9% of white and 1.9% of black patients (p = 0.0002). There was a statistically significant association between race (white vs black) and both biomarker testing (ever vs never) and trial participation (yes vs no) (both p < 0.001, unadjusted chi square). Differences in NGS testing, baseline biomarker testing, and race were retained as statistically significant (p < 0.01) in adjusted regression analyses. The receipt of first-line targeted therapy was comparable between white and black patients (10.2% and 9.2%, respectively, p = 0.24); however, this summary did not consider biomarker test results. First line use of pembrolizumab+carboplatin+pemetrexed was observed among 19.8% of white and 22.6% of black patients; carboplatin+paclitaxel was observed among 16.5% and 18.6%, and single-agent pembrolizumab was observed among 14.8% and 11.5%, respectively. Conclusions: The use of NGS-based testing, which is recommended by the National Comprehensive Cancer Network Clinical Guidelines in Oncology for patients with advanced/metastatic NSCLC, is the most notable disparity among black patients, with more than a 10 percentage-point difference in receipt of this testing versus white counterparts. This may in part contribute to the more than double the rate of participation in clinical trials observed among white patients, as many second line and beyond trials utilize molecular targets as inclusion criteria. While multiple factors are known to impact health care disparities, access to and receipt of appropriate biomarker testing may be an attenable goal in order to ensure equal access to quality care.

scholarly journals Genetic Testing in Natural History Studies: A Review of the Regulatory and Legal Landscape

2021 ◽  
Vol 24 (3-4) ◽  
pp. 75-88
Author(s):  
Andrew Bevan ◽  
Delphine Saragoussi ◽  
Laura Sayegh ◽  
Moira Ringo ◽  
Fiona Kearney
Keyword(s):  
Genetic Testing ◽  
Natural History ◽  
Pharmaceutical Product ◽  
Supplementary Information ◽  
Molecular Biomarker ◽  
Regulatory Pathways ◽  
Pharmaceutical Product Development ◽  
Natural History Studies ◽  
Biomarker Testing

<b><i>Background:</i></b> Natural history (NH) studies, using observational methods, are common in rare and orphan diseases (80% of which have a genetic component). There is profound interest in identifying genetic mutations driving these diseases in these studies to support the formulation of targeted precision medicines. The global regulatory classification of NH studies with novel molecular biomarker collection has not been clearly delineated, presenting researchers with the challenge of determining how these studies are classified and regulated across multiple geographies. <b><i>Objective:</i></b> The aim of this investigation was to conduct a review of regulations related to NH studies and genetic testing to elucidate regulatory pathways to inform clinical researchers in the field. <b><i>Methods:</i></b> Regulatory provisions for NH studies and genetic testing were obtained from Pharmaceutical Product Development (PPD)’s propriety regulatory intelligence database and by surveying the company’s country-specific regulatory experts. A literature search was conducted in the Google Scholar search engine and PubMed for supplementary information. <b><i>Results:</i></b> Nineteen countries were evaluated; 37% classified NH studies with biomarker collection as noninterventional and 26% required regulatory approval (increasing to 47% when molecular biomarker testing was introduced). No regulatory provisions for genetic testing could be identified in 32% of countries, and 58% did not have binding requirements for genetic counseling. <b><i>Conclusion:</i></b> Lack of harmonization of regulations governing NH studies with molecular biomarker collection contributes to the operational complexity of conducting multinational studies in orphan and rare diseases. A set of harmonized international guidelines for these studies would improve efficiency, and this may be on the horizon with the recent adaption of International Conference on Harmonisation (ICH) guideline E18.

scholarly journals Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology

2017 ◽  
Vol 35 (13) ◽  
pp. 1453-1486 ◽  
Author(s):  
Antonia R. Sepulveda ◽  
Stanley R. Hamilton ◽  
Carmen J. Allegra ◽  
Wayne Grody ◽  
Allison M. Cushman-Vokoun ◽  
...  
Keyword(s):  
Clinical Oncology ◽  
Molecular Pathology ◽  
Targeted Therapies ◽  
Clinical Pathology ◽  
Molecular Biomarkers ◽  
Molecular Testing ◽  
Evidence Based ◽  
Molecular Biomarker ◽  
Biomarker Testing ◽  
American Society

Purpose Molecular testing of colorectal cancers (CRCs) to improve patient care and outcomes of targeted and conventional therapies has been the center of many recent studies, including clinical trials. Evidence-based recommendations for the molecular testing of CRC tissues to guide epidermal growth factor receptor (EGFR) –targeted therapies and conventional chemotherapy regimens are warranted in clinical practice. The purpose of this guideline is to develop evidence-based recommendations to help establish standard molecular biomarker testing for CRC through a systematic review of the literature. Methods The American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to develop an evidence-based guideline to help establish standard molecular biomarker testing, guide targeted therapies, and advance personalized care for patients with CRC. A comprehensive literature search that included over 4,000 articles was conducted to gather data to inform this guideline. Results Twenty-one guideline statements (eight recommendations, 10 expert consensus opinions and three no recommendations) were established. Recommendations Evidence supports mutational testing for genes in the EGFR signaling pathway, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize molecular testing for predictive and prognostic molecular biomarkers involve selection of assays, type of specimens to be tested, timing of ordering of tests and turnaround time for testing results. Additional information is available at: www.asco.org/CRC-markers-guideline and www.asco.org/guidelineswiki

scholarly journals KNOWLEDGE AND PRACTICE PATTERNS AMONG PULMONOLOGISTS FOR MOLECULAR BIOMARKER TESTING IN ADVANCED NON-SMALL CELL LUNG CANCER

CHEST Journal ◽  
2020 ◽  
Vol 158 (4) ◽  
pp. A1466-A1467
Author(s):  
Adam Fox ◽  
James Jett ◽  
Jennifer King ◽  
Upal Basu Roy ◽  
Robert Smith ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Practice Patterns ◽  
Small Cell ◽  
Small Cell Lung ◽  
Molecular Biomarker ◽  
Biomarker Testing ◽  
Knowledge And Practice

Integration of molecular cancer classification and next-generation sequencing to identify metastatic patients eligible for PARP inhibitors.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e15080-e15080
Author(s):  
Lowell L. Hart ◽  
Kai Treuner ◽  
Li Ma ◽  
Jenna Wong ◽  
Catherine A. Schnabel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Next Generation Sequencing ◽  
Brca Mutation ◽  
Brca1 Mutation ◽  
Brca2 Mutation ◽  
Tumor Type ◽  
Molecular Biomarker ◽  
Biomarker Testing ◽  
Tumor Types ◽  
Generation Sequencing

e15080 Background: Olaparib, rucaparib, and niraparib are 3 poly-ADP-ribose polymerase inhibitors (PARPi) approved by the FDA for ovarian, breast, pancreatic, prostate, fallopian tube and peritoneal cancers with BRCA mutations. Several ongoing clinical trials aim to determine the efficacy of PARPi in various other cancer types, including specific cancer subtypes, such as clear cell renal cell carcinoma and cholangiocarcinoma either as monotherapy or combination therapy; however, eligibility for PARPi therapy requires the identification of the primary tumor type and confirmation of BRCA mutation. The 92-gene assay (CancerTYPE ID) is a validated gene expression classifier of 50 tumor types and subtypes for metastatic patients with unknown or uncertain diagnoses. Multimodal biomarker testing, including next-generation sequencing (NGS), enables identification of actionable biomarkers to guide targeted therapy selection. In the current study, a database of metastatic cases that integrates tumor type with biomarker analysis was characterized to identify those eligible for PARPi treatment. Methods: MOSAIC (Molecular Synergy to Advance Individualized Cancer Care) is an IRB-approved, de-identified database of cases submitted for CancerTYPE ID testing with tissue-guided multimodal biomarker testing by NGS, including tumor mutational burden (TMB) fluorescent in situ hybridization (FISH), and microsatellite instability (MSI), and immunohistochemistry (IHC) (NeoTYPE profiles, Neogenomics). For the current study, metastatic cancers classified as ovarian, breast, pancreatic, or prostate were identified in the database, followed by NGS analysis to detect mutations in BRCA1 or BRCA2. Results: The current analysis included 2151 CancerTYPE ID cases, from which 71 ovarian, 47 breast, 12 pancreatic and 15 prostate cancer cases were identified. Out of 46 cases of ovarian cancer with molecular biomarker results, NGS identified 7 (15.3%) cases with BRCA1 mutation and 4 (8.7%) cases with BRCA2 mutation. Additionally, 4 (10.5%) cases with BRCA1 mutation and 1 (2.6%) case with BRCA2 mutation out of 38 cases of breast cancer with BRCA results were detected. No cases of prostate cancer or pancreatic cancer with mutations in BRCA1 or BRCA2 were detected. Conclusions: These findings in metastatic patients demonstrate the clinical utility of tumor type identification combined with molecular biomarker profiling, leading to additional options for patients with advanced disease. Specifically, analysis of the MOSAIC database identified a subset of patients with metastatic cancers eligible for PARPi therapy based on tumor type and BRCA mutation status. As new and approved PARPi are evaluated for efficacy in additional tumor types, patients can be identified that may be eligible for these targeted cancer drugs.

scholarly journals Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology

2017 ◽  
Vol 141 (5) ◽  
pp. 625-657 ◽  
Author(s):  
Antonia R. Sepulveda ◽  
Stanley R. Hamilton ◽  
Carmen J. Allegra ◽  
Wayne Grody ◽  
Allison M. Cushman-Vokoun ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Oncology ◽  
Molecular Pathology ◽  
Clinical Pathology ◽  
Evidence Based ◽  
Molecular Biomarker ◽  
Egfr Signaling Pathway ◽  
Biomarker Testing ◽  
American Society ◽  
Evidence Based Guideline

Objectives.— To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. Methods.— The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. Results.— Twenty-one guideline statements were established. Conclusions.— Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented.

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