Observational studyCancer medicine2025
Circulating Tumour DNA in Patients With EGFR-Mutated Non-Small-Cell Lung Cancer and Early Disease Progression After First-Line Osimertinib Treatment: The ELUCIDATOR Multicentre Prospective Observational Study.
Observational study in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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.
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.
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Who cites it
1 citing paper in PubMed.
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Corrections and comments
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Authors and funding
17 authors.
Funding
Abstract
backgroundOsimertinib is the standard therapy for patients with chemotherapy-naive advanced non-small-cell lung cancer (NSCLC) harbouring sensitising epidermal growth factor receptor (EGFR) mutations. However, some patients treated with osimertinib experience progressive disease (PD). Therefore, this study aimed to explore mechanisms underlying osimertinib resistance, focusing on early PD (within 6 months).
methodsThis multicentre prospective observational study enrolled patients with advanced NSCLC receiving osimertinib as the first-line anti-cancer therapy. Mutations in cancer-associated genes were analysed using next-generation sequencing of circulating tumour DNA samples collected before osimertinib treatment and on detection of PD.
findingsBetween May 2019 and January 2021, 188 patients were enrolled, of whom 125 (66%) were women and 96 (51%) had EGFR exon 19 deletion mutations. In this interim analysis, 78 patients experienced PD and 36 experienced early PD. Compared with patients without early PD, those with early PD were more likely to test positive for EGFR-activating mutations at baseline (86.1% vs. 63.4%, p = 0.009) and had significantly more co-occurring gene mutations in addition to EGFR mutations (2.89 ± 1.49 vs. 1.97 ± 1.37, p = 0.002). In three patients with early PD, one patient each had a germline BRCA1, BRCA2 and BRINP3 mutation.
conclusionEGFR mutations in ctDNA and multiple co-occurring gene mutations at baseline are associated with poor outcomes and early PD. Plasma-based serial comprehensive gene profiling could help predict and identify patients who are unlikely to benefit from osimertinib treatment.
trial registrationJapanese Register of Clinical Trials JRCT: registration number: jRCTs031180051.
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