Evidence map›Paper›PMID 29216356›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2018

Improved EGFR mutation detection using combined exosomal RNA and circulating tumor DNA in NSCLC patient plasma.

A K Krug, D Enderle, C Karlovich, T Priewasser, S Bentink, A Spiel, K Brinkmann, J Emenegger, D G Grimm, E Castellanos-Rizaldos and 9 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 150 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
150citing papers in PubMed, 1 pooled it
6.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01526928 phase1 / phase2terminatednot on this map

A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral Rociletinib in Patients With Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorClovis Oncology, Inc.Ran2012 to 2018Enrolled612ConditionsLocally Advanced or Metastatic Non Small Cell Lung CancerArmsRociletinib
NCT06388967 recruitingnot on this mapstarted 2023, after this paper: background citation

Early Detection of Pancreatic Cancer: Prospective Study

TypeobservationalSponsorCity of Hope Medical CenterRan2023 to 2030Enrolled2,000ConditionsPancreatic Cancer, Pancreatic Carcinoma, Pancreatic Adenocarcinoma, Pancreatic Ductal AdenocarcinomaArmsPANcreatic cancer Exosome Early detectiON (PANXEON)
3 · Its place in the literature

Who cites it

150 citing papers in PubMed, 1 synthesis or guideline pooled it, 272 citations in OpenAlex.

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  11. Extracellular vesicles inEXO : beyond the cell · 2026
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90 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 8 institutions in 2 countries.

A K KrugExosome Diagnostics GmbH, Martinsried, Germany.
D EnderleExosome Diagnostics GmbH, Martinsried, Germany.
C KarlovichClovis Oncology Inc., San Francisco.
T PriewasserExosome Diagnostics GmbH, Martinsried, Germany.
S BentinkExosome Diagnostics GmbH, Martinsried, Germany.
A SpielExosome Diagnostics GmbH, Martinsried, Germany.
K BrinkmannExosome Diagnostics GmbH, Martinsried, Germany.
J EmeneggerExosome Diagnostics GmbH, Martinsried, Germany.
D G GrimmExosome Diagnostics GmbH, Martinsried, Germany.
E Castellanos-RizaldosExosome Diagnostics Inc, Waltham.
J W GoldmanUniversity of California Los Angeles, Los Angeles.
L V SequistMassachusetts General Hospital, Boston, USA.
J-C SoriaInstitut Gustave Roussy, Villejuif; University Paris-Sud, Paris, France.
D R CamidgeUniversity of Colorado, Denver.
S M GadgeelKarmanos Cancer Institute, Detroit; Wayne State University, Detroit.
H A WakeleeStanford University, Stanford, USA.
M RaponiClovis Oncology Inc., San Francisco.
M NoerholmExosome Diagnostics GmbH, Martinsried, Germany.
J SkogExosome Diagnostics Inc, Waltham. Electronic address: johan@exosomedx.com.
Clovis Oncology (United States) · USExosome Diagnostics (United States) · USInstitut Gustave Roussy · FRMassachusetts General Hospital · USStanford University · USUniversity of California, Los Angeles · USUniversity of Colorado Denver · USWayne State University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: A major limitation of circulating tumor DNA (ctDNA) for somatic mutation detection has been the low level of ctDNA found in a subset of cancer patients. We investigated whether using a combined isolation of exosomal RNA (exoRNA) and cell-free DNA (cfDNA) could improve blood-based liquid biopsy for EGFR mutation detection in non-small-cell lung cancer (NSCLC) patients. Patients and methods: Matched pretreatment tumor and plasma were collected from 84 patients enrolled in TIGER-X (NCT01526928), a phase 1/2 study of rociletinib in mutant EGFR NSCLC patients. The combined isolated exoRNA and cfDNA (exoNA) was analyzed blinded for mutations using a targeted next-generation sequencing panel (EXO1000) and compared with existing data from the same samples using analysis of ctDNA by BEAMing. Results: For exoNA, the sensitivity was 98% for detection of activating EGFR mutations and 90% for EGFR T790M. The corresponding sensitivities for ctDNA by BEAMing were 82% for activating mutations and 84% for T790M. In a subgroup of patients with intrathoracic metastatic disease (M0/M1a; n = 21), the sensitivity increased from 26% to 74% for activating mutations (P = 0.003) and from 19% to 31% for T790M (P = 0.5) when using exoNA for detection. Conclusions: Combining exoRNA and ctDNA increased the sensitivity for EGFR mutation detection in plasma, with the largest improvement seen in the subgroup of M0/M1a disease patients known to have low levels of ctDNA and poses challenges for mutation detection on ctDNA alone. Clinical Trials: NCT01526928.

Indexed as

AcrylamidesAdultAgedAntineoplastic AgentsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCirculating Tumor DNADNA Mutational AnalysisErbB ReceptorsExosomesFemaleGenes, erbB-1HumansLiquid BiopsyLung NeoplasmsMaleAcrylamidesAntineoplastic AgentsBiomarkers, TumorCirculating Tumor DNAEGFR protein, humanErbB ReceptorsPyrimidinesRNArociletinib

Identifiers

PMID29216356
PMCPMC5889041
OpenAlexW2773899600

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.