Cited by 269Lung Cancer Treatments and MutationsCancer Genomics and DiagnosticsLung Cancer Diagnosis and Treatment

Plasma ctDNA Analysis for Detection of the EGFR T790M Mutation in Patients with Advanced Non–Small Cell Lung Cancer

Open access
Jenkins, Suzanne, Yang, James C-H., Ramalingam, Suresh S., Yu, Karen, Patel, Sabina, Weston, Susie, Hodge, Rachel, Cantarini, Mireille +3 more·2017·Journal of Thoracic Oncology

Abstract

Introduction Tumor biopsies for detecting EGFR mutations in advanced NSCLC are invasive, costly, and not always feasible for patients with late-stage disease. The clinical utility of the cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc., Pleasanton, CA) with plasma samples from patients with NSCLC at disease progression after previous EGFR tyrosine kinase inhibitor therapy was investigated to determine eligibility for osimertinib treatment.Methods Matched tumor tissue and plasma samples from patients screened for the AURA extension and AURA2 phase II studies were tested for EGFR mutations by using tissue- and plasma-based cobas EGFR mutation tests. Plasma test performance was assessed by using the cobas tissue test and a next-generation sequencing method (MiSeq [Illumina Inc., San Diego, CA]) as references. The objective response rate, measured by blinded independent central review, was assessed in patients receiving osimertinib with a plasma T790M mutation-positive status.Results During screening, 551 patients provided matched tumor tissue and plasma samples. Pooled analysis of the positive and negative percent agreements between the cobas plasma and tissue tests for detection of T790M mutation were 61% and 79%, respectively. Comparing cobas plasma test with next-generation sequencing demonstrated positive and negative percent agreements of 90% or higher. The objective response rate was 64% (95% confidence interval: 57-70) in T790M mutation-positive patients by both cobas tissue and plasma tests (evaluable for response).Conclusions The cobas plasma test detected the T790M mutation in 61% of tumor tissue T790M mutation-positive patients. To mitigate the risk of false-negative plasma results, patients with a negative plasma result should undergo a tissue test where feasible.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1016/j.jtho.2017.04.003

Cites

35 of 35 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Liquid biopsies from plasma can detect resistance mutations such as acquired T790M with 60-80% sensitivity and specificity approaching 100%.

    “use of liquid biopsies from plasma to monitor tumor progression and identify EGFR mutations associated with resistance to therapy (e.g., acquired T790M) has been documented, with such biopsies showing 60–80% sensitivity and specificity approaching 100% in detecting specific resistance mutations.”

    From Afatinib for the treatment of <i>EGFR</i> mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [16]

    The Percent Agreement section (page unavailable) reports 61% positive agreement for plasma T790M detection against tissue testing, supporting the claimed sensitivity range. It reports 79% negative agreement against tissue; the cobas and MiSeq NGS Concordance section reports 92% negative agreement against plasma NGS. Neither result establishes specificity approaching 100%. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Authors
Jenkins, S., Yang, J. C.-H., Ramalingam, S. S., Yu, K., Patel, S., Weston, S., Hodge, R., Cantarini, M., Jänne, P. A., Mitsudomi, T., & Goss, G. D.
Affiliations
  • AstraZeneca (United Kingdom) (GB)
  • National Taiwan University Hospital (TW)
  • Winship Cancer Institute (US)
  • Kindai University (JP)
  • Ottawa Hospital Research Institute (CA)
Corresponding author
Jenkins, Suzanne
Venue
Journal of Thoracic Oncology
Publisher
Elsevier BV
Published
2017-07
Volume
12
Issue
7
Pages
1061-1070
ISSN
1556-0864 (ISSN-L)
OpenAlex
W2607454228
Cited by
269
References
35
Citations by year
2026: 6 · 2025: 9 · 2024: 11 · 2023: 24 · 2022: 26 · 2021: 46 · 2020: 55 · 2019: 35 · 2018: 43 · 2017: 14
FWCI
33.21
Type
journal article
Language
en
Open access
Locations
  • Journal of Thoracic Oncology (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • Pfizer
  • AstraZeneca (NCT02094261, NCT01802632)
  • Astellas Pharma
  • Ono Pharmaceutical
  • Chugai Pharmaceutical
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords
T790M mutation, circulating tumor DNA, liquid biopsy, non-small cell lung cancer, osimertinib, EGFR tyrosine kinase inhibitor resistance, objective response rate
MeSH terms
Carcinoma, Non-Small-Cell Lung, DNA, Neoplasm, Female, Humans, Lung Neoplasms, Male, Mutation, ErbB Receptors

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review