Comparison of the analytical performance of the Oncomine Dx Target Test focusing on bronchoscopic biopsy forceps size in non-small-cell lung cancer.
T. Sakaguchi*a (Dr), Y. Nishiia (Dr), S. Esumia (Dr), M. Esumia (Dr), Y. Nakamuraa (Dr), Y. Suzukia (Dr), K. Itoa (Dr), K. Fujiwaraa (Dr), H. Yasuia (Dr), O. Taguchia (Dr), O. Hatajia (Dr)
a Matsusaka Municipal Hospital, Matsusaka, JAPAN
* iwbd0524@yahoo.co.jp
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). As for the reason of 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 4mm2 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.
Disclosure of funding source(s):
Matsusaka Municipal Hospital received research grant funding from Novartis, GlaxoSmithKline, AstraZeneca, Daiichi Sankyo, Bayer, and Boehringer Ingelheim. K. Ito has received speaker fees as honoraria from Eli Lilly Japan, Chugai, AstraZeneca, MSD, Boehringer Ingelheim Japan, Ono, and Pfizer Japan. O. Taguchi received speaker fees as honoraria from AstraZeneca. O. Hataji received speaker fees as honoraria from Novartis Pharma, AstraZeneca, and Boehringer Ingelheim Japan. The remaining authors declare no conflict of interest.