Evidence map›Paper›PMID 27619632›Full record

Trial reportJournal of hematology & oncology2016

Serial cfDNA assessment of response and resistance to EGFR-TKI for patients with EGFR-L858R mutant lung cancer from a prospective clinical trial.

Qing Zhou, Jin-Ji Yang, Zhi-Hong Chen, Xu-Chao Zhang, Hong-Hong Yan, Chong-Rui Xu, Jian Su, Hua-Jun Chen, Hai-Yan Tu, Wen-Zhao Zhong and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of hematology & oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01024413 (A Randomized, Controlled Phase III Trial to Evaluate the Efficacy of Elortinib vs Gefitinib in Advanced Non-small-cell Lung Cancer With EGFR Exon 19 or 21 Mutations), which is not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT01024413 phase3completednot on this map

A Randomized, Controlled Phase III Trial to Evaluate the Efficacy of Elortinib vs Gefitinib in Advanced Non-small-cell Lung Cancer With EGFR Exon 19 or 21 Mutations

TypeinterventionalSponsorChinese Society of Lung CancerRan2009 to 2015Enrolled256ConditionsThoracic NeoplasmsArmserlotinib, gefitinib
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. A CMTM6 Nanobody Overcomes EGFR-TKI Resistance in Non-Small Cell Lung Cancer.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
    Article
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
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  13. Assessment ofArchives of medical science : AMS · 2020
    Article
  14. Article
  15. Circulating free tumor-derived DNA to detectJournal of thoracic disease · 2019
    Article
  16. Review
  17. Review
  18. Review
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  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Qing ZhouGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China.
Jin-Ji YangGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China.
Zhi-Hong ChenGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China.
Xu-Chao ZhangGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China.
Hong-Hong YanGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China.
Chong-Rui XuGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China.
Jian SuGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China.
Hua-Jun ChenGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China.
Hai-Yan TuGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China.
Wen-Zhao ZhongGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China.
Xue-Ning YangGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China.
Yi-Long WuGuangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou, 510080, China. syylwu@live.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDetecting epidermal growth factor receptor (EGFR) activating mutations in plasma could guide EGFR-tyrosine kinase inhibitor (EGFR-TKI) treatment for advanced non-small cell lung cancer (NSCLC). However, dynamic quantitative changes of plasma EGFR mutations during the whole course of EGFR-TKI treatment and its correlation with clinical outcomes were not determined. The aim of this study was to measure changes of plasma EGFR L858R mutation during EGFR-TKI treatment and to determine its correlation with the response and resistance to EGFR-TKI.

methodsThis study was a pre-planned exploratory analysis of a randomized phase III trial conducted from 2009 to 2014 comparing erlotinib with gefitinib in advanced NSCLC harboring EGFR mutations in tumor (CTONG0901). Totally, 256 patients were enrolled in CTONG0901 and randomized to receive erlotinib or gefitinib. One hundred and eight patients harbored L858R mutation in their tumors and 80 patients provided serial blood samples as pre-planned scheduled. Serial plasma L858R was detected using quantitative polymerase chain reaction. Dynamic types of plasma L858R were analyzed using Ward's hierarchical clustering method. Progression-free survival (PFS) and overall survival (OS) were compared between different types.

resultsAs a whole, the quantity of L858R decreased and reached the lowest level at the time of best response to EGFR-TKI. After the analysis of Ward's hierarchical clustering method, two dynamic types were found. In 61 patients, L858R increased to its highest level when disease progressed (ascend type), while in 19 patients, L858R maintained a stable level when disease progressed (stable type). Median PFS was 11.1 months (95 % CI, 6.6-15.6) and 7.5 months (95 % CI, 1.4-13.6) in patients with ascend and stable types, respectively (P = 0.023). Median OS was 19.7 months (95 % CI, 16.5-22.9) and 16.0 months (95 % CI, 13.4-18.5), respectively (P = 0.050).

conclusionsThis is the first report finding two different dynamic types of plasma L858R mutation during EGFR-TKI treatment based on a prospective randomized study. Different dynamic types were correlated with benefits from EGFR-TKI. The impact of plasma L858R levels at disease progression on subsequent treatment strategy needs further exploration.

trial registrationClinicalTrials.gov, NCT01024413.

Indexed as

MutationAdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungCluster AnalysisDisease-Free SurvivalDNADrug Resistance, NeoplasmErbB ReceptorsErlotinib HydrochlorideFemaleGefitinibHumansLung NeoplasmsMaleDNAEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideGefitinibProtein Kinase InhibitorsQuinazolinesCirculating free DNAEGFR-TKILung cancerPlasma EGFR mutationQuantitative change

Identifiers

PMID27619632
PMCPMC5020532

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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.