Pathological criteria for multiplex gene-panel testing using next-generation sequencing in non-small cell lung cancer

Mizote, Shihoko; Matsumura, Mai; Sekiya, Motoki; Sugiyama, Misaki; Sekine, Akimasa; Kobayashi, Nobuaki; Kataoka, Toshiaki; Iwashita, Hiromichi; Okihara, Koji

doi:10.1016/j.ctarc.2022.100614

Cited by 4 publications

(2 citation statements)

References 17 publications

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“…Multiplex methods may generate false-positive or false-negative results due to technical errors or biological heterogeneity. Therefore, multiplex methods should be carefully validated and quality-controlled before clinical application [38].…”

Section: Discussionmentioning

confidence: 99%

Tailoring Therapeutic Strategies in Non-Small-Cell Lung Cancer: The Role of Genetic Mutations and Programmed Death Ligand-1 Expression in Survival Outcomes

Kobayashi,

Miura,

Kaneko

et al. 2023

Cancers

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Background: This study aims to assess the real-world impact of advancements in first-line systemic therapies for non-small-cell lung cancer (NSCLC), focusing on the role of driver gene mutations and programmed death-ligand 1 (PD-L1) expression levels. Methods: Conducted across eight medical facilities in Japan, this multicenter, retrospective observational research included 863 patients diagnosed with NSCLC and treated between January 2015 and December 2022. The patients were categorized based on the type of systemic therapy received: cytotoxic agents, molecular targeting agents, immune checkpoint inhibitors, and combination therapies. Comprehensive molecular and immunohistochemical analyses were conducted, and statistical evaluations were performed. Results: The median overall survival (OS) shows significant variations among treatment groups, with targeted therapies demonstrating the longest OS. This study also revealed that high PD-L1 expression was common in the group treated with immune checkpoint inhibitors. Multivariate analysis was used to identify the type of anticancer drug and the expression of PD-L1 at diagnosis as the impactful variables affecting 5-year OS. Conclusions: This study underscores the efficacy of targeted therapies and the critical role of comprehensive molecular diagnostics and PD-L1 expression in affecting OS in NSCLC patients, advocating for their integration into routine clinical practice.

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Section: Discussionmentioning

confidence: 99%

Tailoring Therapeutic Strategies in Non-Small-Cell Lung Cancer: The Role of Genetic Mutations and Programmed Death Ligand-1 Expression in Survival Outcomes

Kobayashi,

Miura,

Kaneko

et al. 2023

Cancers

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“…Given that biopsy specimens of NSCLC are often small in size, determination of proper sample conditions for ODxTT testing is necessary for the optimal application of precision medicine to this disease. Although previous studies have assessed appropriate slide conditions mostly on the basis of the area of tumor specimens, 17 , 21 it is sometimes difficult to calculate this area because tissue sections are often small and have complex forms. In addition, evaluation of the number of nucleated cells other than tumor cells can be difficult because they include various cell types such as neutrophils, lymphocytes, and fibroblasts with heterogeneous distributions and shapes.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of appropriate conditions for Oncomine DxTT testing of FFPE specimens for driver gene alterations in non–small cell lung cancer

Iwama,

Yamamoto,

Okubo

et al. 2023

Thoracic Cancer

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BackgroundThe Oncomine Dx Target Test Multi‐CDx System (ODxTT) is a next‐generation sequencing panel approved as a companion diagnostic for drugs targeted to corresponding gene alterations in non–small cell lung cancer. However, appropriate slide conditions for ODxTT have remained unclear.MethodsWe focused on the production of the number of tumor cells on a formalin‐fixed paraffin‐embedded (FFPE) section and the number of prepared slides, designated the TS value, and determined a TS value of ≥4000 as a target slide condition for ODxTT. We evaluated the impact of this condition on ODxTT testing with tumor specimens found to have a TS of <4000 (n = 23) or a TS of ≥4000 (n = 142).ResultsA positive correlation was apparent between the TS value and the concentrations of both DNA and RNA. Among the 142 samples with a TS of ≥4000, a sufficient concentration of DNA or RNA for ODxTT analysis was achieved in 100% and 98% samples, respectively. Among samples explored for driver gene alterations after determination of the target slide condition (TS ≥4000), most (84.9%) had a TS of ≥4000 and were submitted for ODxTT analysis.ConclusionOur findings indicate that a TS of ≥4000 is a feasible and relevant criterion for ODxTT testing, and its adoption should help to improve the success rate of such testing in clinical practice.

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Nucleic Acid Quality Assessment is Critical to the Success of the Oncomine Dx Target Test for Lung Cancer

et al. 2023

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Pathological criteria for multiplex gene-panel testing using next-generation sequencing in non-small cell lung cancer

Cited by 4 publications

References 17 publications

Tailoring Therapeutic Strategies in Non-Small-Cell Lung Cancer: The Role of Genetic Mutations and Programmed Death Ligand-1 Expression in Survival Outcomes

Tailoring Therapeutic Strategies in Non-Small-Cell Lung Cancer: The Role of Genetic Mutations and Programmed Death Ligand-1 Expression in Survival Outcomes

Evaluation of appropriate conditions for Oncomine DxTT testing of FFPE specimens for driver gene alterations in non–small cell lung cancer

Nucleic Acid Quality Assessment is Critical to the Success of the Oncomine Dx Target Test for Lung Cancer

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