Plasma Genotyping at the Time of Diagnostic Tissue Biopsy Decreases Time-to-Treatment in Patients With Advanced NSCLC—Results From a Prospective Pilot Study

Thompson, Jeffrey C.; Aggarwal, Charu; Wong, Jan H.; Nimgaonkar, Vivek; Hwang, Wei–Ting; Andronov, Michelle; DiBardino, David M.; Hutchinson, Christoph T.; Ma, Kristula; Lanfranco, Anthony R.; Moon, Edmund K.; Haas, Andrew R.; Singh, Aditi; Ciunci, Christine; Marmarelis, Melina E.; Davella, Christopher; Cohen, Jeremy; Bauml, Joshua; Cohen, Roger B.; Langer, Corey J.; Vachani, Anil

doi:10.1016/j.jtocrr.2022.100301

Cited by 13 publications

(19 citation statements)

References 9 publications

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“…For example, for some patients, the rapidity of results returning from a liquid biopsy can enable timely first-line therapy that may not be feasible on the basis of how tissue testing is operationalized at their institution. 25 Finally, we found that in patients without any tissue biomarker testing, ctDNA-based CGP can detect a range of actionable alterations, confirming its value in patients with insufficient tissue for genomic analysis. Whereas overall PPA for liquid biopsy in this study was consistent with previous publications, 24 we find that the biomarker detection with liquid CGP depends on levels of ctDNA shed.…”

Section: Discussionmentioning

confidence: 53%

Complementary Roles for Tissue- and Blood-Based Comprehensive Genomic Profiling for Detection of Actionable Driver Alterations in Advanced NSCLC

Schwartzberg

Li²,

Tolba³

et al. 2022

JTO Clinical and Research Reports

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Section: Discussionmentioning

confidence: 53%

Complementary Roles for Tissue- and Blood-Based Comprehensive Genomic Profiling for Detection of Actionable Driver Alterations in Advanced NSCLC

Schwartzberg

Li²,

Tolba³

et al. 2022

JTO Clinical and Research Reports

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“…Preliminary studies suggest that TATs and TTT may be shortened by incorporating a ‘plasma-first’ approach. Thompson et al 23 explored a plasma-first approach in a prospective study of 55 patients with suspected advanced lung cancer in the United States. Plasma-based molecular profiling was performed at the time of diagnostic biopsy.…”

Section: Discussionmentioning

confidence: 99%

“…22 Preliminary studies suggest that turnaround times (TATs) and time to treatment (TTT) may be shortened with a complementary approach. 23,24 However, the role of liquid biopsy in the pre-diagnostic phase, a plasma-first approach, has not yet been established.…”

Section: Introductionmentioning

confidence: 99%

Plasma-first: accelerating lung cancer diagnosis and molecular profiling through liquid biopsy

et al. 2022

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Introduction: Molecular profiling of tumor tissue is the gold standard for treatment decision-making in advanced non-small cell lung cancer (NSCLC). Results may be delayed or unavailable due to insufficient tissue, prolonged wait times for biopsy, pathology assessment and testing. We piloted the use of plasma testing in the initial diagnostic workup for patients with suspected advanced lung cancer. Methods: Patients with ⩽15 pack-year smoking history and suspected advanced lung cancer referred to the lung cancer rapid diagnostic program underwent plasma circulating-tumor DNA testing using a DNA-based mutation panel. Tissue testing was performed per standard of care, including comprehensive next-generation sequencing (NGS). The primary endpoint was time from diagnostic program referral to cancer treatment in stage IV NSCLC patients (Cohort A) compared to a contemporary cohort not enrolled in the study (Cohort B) and an historical pre-COVID cohort referred to the program between 2018 and 2019 (Cohort C). Results: From January to June 2021, 20 patients were enrolled in Cohort A; median age was 70.5 years (range 33–87), 70% were female, 55% Caucasian, 85% never smokers, and 75% were diagnosed with NSCLC. Seven had actionable alterations detected in plasma or tissue (4/7 concordant). Fusions, not tested in plasma, were identified by immunohistochemistry for three patients. Mean result turnaround time was 17.8 days for plasma NGS and 23.6 days for tissue ( p = 0.10). Mean time from referral to treatment initiation was significantly shorter in cohort A at 32.6 days (SD 13.1) versus 62.2 days (SD 31.2) in cohort B and 61.5 days (SD 29.1) in cohort C, both p < 0.0001. Conclusion: Liquid biopsy in the initial diagnostic workup of patients with suspected advanced NSCLC can lead to faster molecular results and shorten time to treatment even with smaller DNA panels. An expansion study using comprehensive NGS plasma testing with faster turnaround time is ongoing (NCT04862924).

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“…“Epi proColon ® (Epigenomics AG, Berlin, Germany)” is a blood-based test which is, for now, the only test that detects tumor-associated epigenetic changes and is FDA-approved for CRC screening [ 22 , 29 ]. These US approvals in effect offer recognition of clinical utility and US studies are revealing unexplored potential in plasma-based NGS performed simultaneously with diagnostic biopsy in suspected advanced NSCLC [ 30 ], while other studies suggest that LB has emerged as a viable approach to guide therapeutic decisions and provide real-time follow-up in NSCLC [ 31 ].…”

Section: State Of Playmentioning

confidence: 99%

Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring

et al. 2022

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Liquid biopsy (LB) is a minimally invasive method which aims to detect circulating tumor-derived components in body fluids. It provides an alternative to current cancer screening methods that use tissue biopsies for the confirmation of diagnosis. This paper attempts to determine how far the regulatory, policy, and governance framework provide support to LB implementation into healthcare systems and how the situation can be improved. For that reason, the European Alliance for Personalised Medicine (EAPM) organized series of expert panels including different key stakeholders to identify different steps, challenges, and opportunities that need to be taken to effectively implement LB technology at the country level across Europe. To accomplish a change of patient care with an LB approach, it is required to establish collaboration between multiple stakeholders, including payers, policymakers, the medical and scientific community, and patient organizations, both at the national and international level. Regulators, pharma companies, and payers could have a major impact in their own domain. Linking national efforts to EU efforts and vice versa could help in implementation of LB across Europe, while patients, scientists, physicians, and kit manufacturers can generate a pull by undertaking more research into biomarkers.

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Plasma Genotyping at the Time of Diagnostic Tissue Biopsy Decreases Time-to-Treatment in Patients With Advanced NSCLC—Results From a Prospective Pilot Study

Cited by 13 publications

References 9 publications

Complementary Roles for Tissue- and Blood-Based Comprehensive Genomic Profiling for Detection of Actionable Driver Alterations in Advanced NSCLC

Complementary Roles for Tissue- and Blood-Based Comprehensive Genomic Profiling for Detection of Actionable Driver Alterations in Advanced NSCLC

Plasma-first: accelerating lung cancer diagnosis and molecular profiling through liquid biopsy

Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring

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