Feasibility of next-generation sequencing (Oncomine™ DX Target Test) for the screening of oncogenic mutations in advanced non-small-cell lung cancer patients

Takeyasu, Yuki; Yoshida, Tatsuya; Motoi, Noriko; Teishikata, Takashi; Tanaka, Midori; Shinno, Yuki; Okuma, Yusuke; Goto, Yasushi; Horinouchi, Hidehito; Kakishima, Hiroki; Tsuchida, Takaaki; Yamamoto, Noboru; Ohe, Yuichiro; Yatabe, Yasushi

doi:10.1093/jjco/hyab059

Cited by 20 publications

(33 citation statements)

References 13 publications

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“…After detecting the target lesion, conventional biopsies using a forceps (FB-15C-1 or FB-231D, Olympus) or an aspiration needle (NA-1C-1, Olympus) were performed. Forceps biopsies were repeated 5–10 times to collect tissue samples [ 23 , 24 ]. The occurrence of pneumothorax was routinely checked by fluoroscopy at every biopsies.…”

Section: Methodsmentioning

confidence: 99%

Safety profile and risk factors for bleeding in transbronchial cryobiopsy using a two-scope technique for peripheral pulmonary lesions

et al. 2022

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Background A balloon occlusion technique is suggested for use in cryobiopsy for interstitial lung diseases because of the bleeding risk. However, it may interfere with selection of the involved bronchus for peripheral pulmonary lesions (PPLs). A two-scope technique, in which two scopes are prepared and hemostasis is started using the second scope immediately after cryobiopsy, has also been reported. This study aimed to evaluate the safety and diagnostic utility of transbronchial cryobiopsy using the two-scope technique for PPLs. Methods Data of patients who underwent conventional biopsy followed by cryobiopsy using the two-scope technique for PPLs from November 2019 to March 2021 were collected. The incidence of complications and risk factors for clinically significant bleeding (moderate to life-threatening) were investigated. Diagnostic yields were also compared among conventional biopsy, cryobiopsy, and the combination of them. Results A total of 139 patients were analyzed. Moderate bleeding occurred in 25 (18.0%) patients without severe/life-threatening bleeding. Although five cases required transbronchial instillation of thrombin, all bleeding was completely controlled using the two-scope technique. Other complications included two pneumothoraces and one asthmatic attack. On multivariable analysis, only ground-glass features (P < 0.001, odds ratio: 9.30) were associated with clinically significant bleeding. The diagnostic yields of conventional biopsy and cryobiopsy were 76.3% and 81.3%, respectively (P = 0.28). The total diagnostic yield was 89.9%, significantly higher than conventional biopsy alone (P < 0.001). Conclusions The two-scope technique provides useful hemostasis for safe cryobiopsy for PPLs, with a careful decision needed for ground-glass lesions.

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Section: Methodsmentioning

confidence: 99%

Safety profile and risk factors for bleeding in transbronchial cryobiopsy using a two-scope technique for peripheral pulmonary lesions

et al. 2022

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“…NGS panels vary according to institution and country. We used ODxTT, which is a relatively small-panel NGS testing method that can analyze 46 cancer-related genes [5,[9][10][11][12][13].…”

Section: Discussionmentioning

confidence: 99%

“…NGS panels vary according to institution and country. We used ODxTT, which is a relatively small-panel NGS testing method that can analyze 46 cancer-related genes [ 5 , 9 , 10 , 11 , 12 , 13 ]. A previous retrospective study reported no difference in the success rates of NGS panel testing for 50 and 1213 cancer-related genes (98% and 91%, respectively) using cytology specimens obtained using EBUS-TBNA [ 16 ].…”

Section: Discussionmentioning

confidence: 99%

“…In 2017, the US Food and Drug Administration approved the Oncomine TM Dx Target Test (ODxTT; Thermo Fisher Scientific, San Jose, CA, USA) as an NGS-based companion diagnosis for NSCLC. Using as little as 10 ng of DNA or RNA, it can simultaneously evaluate 46 cancer-related genes [ 5 , 9 , 10 , 11 , 12 , 13 , 14 ]; further, it facilitates companion diagnosis of the following driver oncogenes: EGFR , EML4/ALK , ROS1 , and BRAF . The ODxTT multi-companion diagnostics (CDx) system is a common NGS test covered by insurance in Japan.…”

Section: Introductionmentioning

confidence: 99%

“…Compared with previous companion diagnostic tests, NGS requires tumor tissues with sufficient quantity and quality, including tumor content ratio and the number of tumor cells in the specimens. Moreover, recent studies have reported on the success rate of NGS using bronchoscopic specimens [ 8 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 ].…”

Section: Introductionmentioning

confidence: 99%

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The Impact of Core Tissues on Successful Next-Generation Sequencing Analysis of Specimens Obtained through Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Uchimura¹,

Yanase

Imabayashi³

et al. 2021

Cancers

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The success rate of next-generation sequencing (NGS) with specimens obtained through endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) among patients with lung cancer as well as the related clinical factors remain unclear. We aimed to determine the optimal number of punctures and core tissues during EBUS-TBNA for NGS in patients with non-small-cell lung cancer (NSCLC) as well as the association of chest computed tomography (CT) and EBUS findings with successful NGS. We retrospectively reviewed 156 consecutive patients with NSCLC who underwent EBUS-TBNA for NGS (OncomineTM Dx Target Test). Using the receiver operating characteristic curve, we calculated the optimal numbers of punctures and core tissues for NGS and evaluated CT and EBUS findings suggestive of necrosis and vascular pattern within the lesion. The success rate of NGS was 83.3%. The cut-off value for the number of core tissues was 4, and the sensitivity and specificity of successful NGS were 73.8% and 61.5%, respectively. Logistic regression analysis revealed that the number of core tissues (≥4) was the sole predictor of successful NGS. CT and EBUS findings were not associated with successful NGS. Bronchoscopists should obtain sufficient core tissues for successful NGS using EBUS-TBNA specimens.

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Clinical utility of the Oncomine Dx Target Test multi‐CDx system and the possibility of utilizing those original sequence data

Saito,

Terai,

Kim

et al. 2024

Cancer Medicine

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BackgroundCompanion diagnostic tests play a crucial role in guiding treatment decisions for patients with non‐small cell lung cancer (NSCLC). The Oncomine Dx Target Test (ODxTT) Multi‐CDx System has emerged as a prominent companion diagnostic method. However, its efficacy in detecting driver gene mutations, particularly rare mutations, warrants investigation.AimsThis study aimed to assess the performance of the ODxTT in detecting driver gene mutations in NSCLC patients. Specifically, we aimed to evaluate its sensitivity in detecting epidermal growth factor receptor (EGFR) mutations, a key determinant of treatment selection in NSCLC.Materials and MethodsWe conducted a retrospective analysis of NSCLC patients who underwent testing with the ODxTT at Keio University Hospital between May 2020 and March 2022. Patient samples were subjected to both DNA and RNA tests. Driver gene mutation status was assessed, and instances of missed mutations were meticulously examined.ResultsOf the 90 patients, five had nucleic acid quality problems, while 85 underwent both DNA and RNA tests. Driver gene mutations were detected in 56/90 (62.2%) patients. Of the 34 patient specimens, driver mutations were not detected using the ODxTT; however, epidermal growth factor receptor (EGFR) mutations were detected using polymerase chain reaction‐based testing in two patients, and a KRAS mutation was detected by careful examination of the sequence data obtained using the ODxTT in one patient. For the above three cases, carefully examining the gene sequence information obtained using the ODxTT could identify driver mutations that were not mentioned in the returned test results. Additionally, we confirmed comparable instances of overlook results for EGFR mutations in the dataset from South Korea, implying that this type of oversight could occur in other countries using the ODxTT. EGFR mutation was missed in ODxTT in Japan (6.3%, 2/32), South Korea (2.0%, 1/49), and overall (3.7%, 3/81).ConclusionEven if sufficient tumor samples are obtained, rare EGFR mutations (which are excluded from the ODxTT's genetic mutation list) might not be detected using the current ODxTT system due to the program used for sequence analysis. However, such rare EGFR mutations can still be accurately detected on ODxTT's sequence data using next‐generation sequencing.

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Feasibility of next-generation sequencing (Oncomine™ DX Target Test) for the screening of oncogenic mutations in advanced non-small-cell lung cancer patients

Cited by 20 publications

References 13 publications

Safety profile and risk factors for bleeding in transbronchial cryobiopsy using a two-scope technique for peripheral pulmonary lesions

Safety profile and risk factors for bleeding in transbronchial cryobiopsy using a two-scope technique for peripheral pulmonary lesions

The Impact of Core Tissues on Successful Next-Generation Sequencing Analysis of Specimens Obtained through Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Clinical utility of the Oncomine Dx Target Test multi‐CDx system and the possibility of utilizing those original sequence data

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