Comparison of the analytical performance of the Oncomine dx target test focusing on bronchoscopic biopsy forceps size in non‐small cell lung cancer

Abstract

Background Next‐generation sequencing (NGS) has been implemented in clinical oncology to analyze multiple genes and to guide targeted therapy. Although the pathological diagnosis and biomarker tests for patients with advanced lung cancer have mostly been obtained with small biopsy samples, especially with bronchoscopic approaches, the performance for NGS with respect to the different sizes of biopsy forceps remains little known. Methods We retrospectively reviewed consecutive patients with non‐small cell lung cancer, whose FFPE samples were obtained by endobronchial biopsy/transbronchial biopsy and were submitted for the Oncomine Dx Target Test (ODxTT). We compared the analytical performance for ODxTT with respect to the size of biopsy forceps. Results A total of 103 samples were identified. The success rate of the ODxTT for the group with all samples obtained with small forceps biopsies (70%) was lower than that of the group with some or all samples obtained with standard forceps biopsies (83%), although without a statistically significant difference (p = 0.20). With regard to the reason for unsuccessful analysis, the proportion of the samples which did not pass the nucleic acid concentration threshold in the former group (15%) was higher compared with that of the latter group (4%) (p = 0.08). The proportion of tissue size 4 mm2 or larger in the former group (70%) was lower than that in the latter group (93%) (p = 0.01). Conclusion The analysis of ODxTT for specimens biopsied using only small forceps is prone to be unsuccessful due to an insufficient amount of nucleic acid.

The Current Achievements of Multi-Gene Panel Tests in Clinical Settings for Patients with Non-Small-Cell Lung Cancer

“…A recent report suggests that a multi-gene panel test performed prior to the initiation of systemic treatment can potentially enhance prognosis by detecting a wider range of driver oncogene alterations than multiple single-gene tests [5], and therefore the improvement in the submission rate and success rate of multi-gene panel tests is expected to contribute to a good prognosis for patients with NSCLC in clinical practice. This improvement has come from various efforts to submit samples of appropriate quantity and quality [13,16], learning from other reports [12,17], the availability of AmoyDx-multi testing, and improved handling proficiency in laboratory inspections. A previous report showed that tissue size and tumor cell content were significantly associated with a good ODxTT success rate in small biopsy samples, especially when specimens with a tissue size of 4 mm 2 or larger and a tumor cell content of 20% or more are available [17].…”

Computed Tomography Bronchus Sign Subclassification during Radial Endobronchial Ultrasound-Guided Transbronchial Biopsy: A Retrospective Analysis

“…These findings will guide pulmonologists in determining the appropriate sampling devices such as selecting the GS size, adding TBNA, or switching to other methods, including the non-GS method. This should consider not only diagnostic performance, but also the cost and amount of tissue samples required for molecular analysis in advanced lung cancer [ 39 ].…”

Diagnostic yield and the number of tumor cells of ultrathin bronchoscopy for peripheral lung lesions: A comparison with thin bronchoscopy

“…This is presumably because the number of tumor cells was similar in both cases. In a previous report, the success rate of ODxTT in the group that performed TBB using only small forceps was 70% [ 17 ]. In the present study, the success rate of the ODxTT in the ultrathin bronchoscopy cases was not inferior, and it was possible to collect specimens suitable for ODxTT.…”