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标题
Comparison of EGFR Mutation Status in Matched Baseline Tumor and Plasma 1 Samples (Screened Population)
内容
Comparison of EGFR Mutation Status in Matched Baseline Tumor and Plasma 1 Samples (Screened Population)

Fewer patients were identified as having EGFR mutation-positive status using plasma 1-derived ctDNA (detection rate, 10.5%; 82 of 784 patients) than with tumor-derived DNA (detection rate, 13.7%, 118 of 859 patients). Due to technical problems with tumor samples (e.g., low tumor content, poor sample quality, insufficient quantity, poor/inappropriate fixation, no DNA), 201 of 1060 screened patients (19.0%) had an unknown EGFR mutation status; 12 of these patients were subsequently found to have a positive EGFR mutation status in their corresponding plasma 1 samples.

A total of 652 patients provided matched baseline tumor and plasma 1 samples that were evaluable for EGFR mutation status using both sample types. A comparison of EGFR mutation status between tumor and plasma 1 samples is shown in Table ​Table1.1. Concordance between baseline tumor and plasma 1 EGFR mutation status for patients evaluable for both samples was 94.3% (95% CI, 92.3–96.0), with a sensitivity of 65.7% (95% CI, 55.8–74.7) and specificity of 99.8% (95% CI, 99.0–100.0). Positive-predictive value and negative-predictive value of EGFR mutation status detection between baseline tumor and plasma 1 samples for patients evaluable for both samples are also shown. A comparison of EGFR mutation status by mutation subtype for baseline tumor and plasma 1 samples is presented in Table ​Table2.2. When analyzed by mutation subtype, concordance between baseline tumor and plasma 1 EGFR mutation status for patients evaluable for both samples was 96.5% (95% CI, 94.8–97.8) for exon 19 deletions and 97.9% (95% CI, 96.4–98.8) for L858R point mutations; sensitivity was 67.6% (95% CI, 55.5–78.2) and 61.8% (95% CI, 43.6–77.8), and specificity was 100.0% (95% CI, 99.4–100.0) and 99.8% (95% CI, 99.1–100.0), respectively.
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来源
J Thorac Oncol. 2014 Sep; 9(9): 1345–1353.
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