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• W4310252865 abstract "Pancreatic cancer (PC) is one of the most lethal malignancies and its mortality rate has worsened to become the fourth leading cause of cancer mortality in Japan. Even with recent advances in understanding of the genetic alternations that drive PC and the development of new therapies such as gemcitabine +nab-paclitaxel or FOLFIRINOX, the 5-year survival rate remains low, at around 10%. However, there is some hope that offering individualized treatments such as platinum-based therapy following poly (adenosine diphosphate-ribose) polymerase inhibitors or immune checkpoint inhibitors based on tumor genomic profiling might improve the response rate and survival rate.1 Comprehensive genomic profiling (CGP) is recommended to assess the background tumor genesis and select matched therapy in precision medicine. Access to this technology varies widely according to the social background and insurance system of each country. CGP tests that are currently available and covered by the national insurance system are the OncoGuide NCC Oncopanel System (NOP; Sysmex, Hyogo, Japan), which covers 124 genes and 13 fusion genes, and FoundationOne CDx (F1CDx; Foundation Medicine, Cambridge, MA, USA), which can analyze 324 genes and 36 fusion genes. The NOP system requires tumor cellularity of ≥20% and tissue area of ≥16 mm2, for which 200 ng DNA is considered necessary. As F1CDx handles a larger number of genetic analyses compared to NOP, this system requires tumor cellularity of ≥30% and tissue area of ≥25 mm2. The need for such a large amount of tissue makes it difficult to perform CGP for PC because most cases of PC are diagnosed at an unresectable stage. Therefore, tissue acquisition by needle biopsy is mandatory and the role of endoscopic ultrasound-guided tissue acquisition (EUS-TA) for this purpose is increasing. Tissue sampling by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) was first applied for K-ras mutation analysis to improve the differential diagnostic rate over cytopathological diagnosis.2, 3 Several recent studies have shown the feasibility of liquid samples such as residual liquid-based cytology specimens or FNA needle washing fluid for K-ras gene analysis.4 Following single gene analysis, FNA samples were used for multiple genetic analyses to assess chemosensitivity to anticancer agents, such as gemcitabine.5 However, panel testing did not become widespread due to the limited number of anticancer drug options for PC and the limited sample volume obtained by EUS-FNA. The development of next-generation sequencing (NGS) has revolutionized the clinical approach to cancer treatment, as it enables the application of multiple genetic analyses simultaneously. Alongside the development of NGS, there has been significant improvement in puncture needles. It has been reported that improvements in endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) needle design have increased the diagnostic performance as well as the quantity and quality of obtained tissue specimens, and that its diagnostic performance matches that of FNA needles, with fewer punctures.6 Although the amount of tissue that can be obtained by EUS-TA has increased, total sample volume is sometimes insufficient for CGP. Most genetic profiling reported previously has been performed in the research setting using surgical materials. There is significant variation in the reported success rates of EUS-TA samples for CGP analysis, from 42.9% to 100%, which appear to depend on the number of target genes of each panel.7 Larson et al.8 investigated the success rates of F1CDx using different sample types, including EUS-FNB (n = 54), EUS-FNA (n = 7), percutaneous core biopsies (n = 8), and endoscopic forceps biopsies (n = 5). They reported that larger needle gauge (P = 0.0047) and FNB needle (P = 0.05) were associated with adequacy for F1CDx. In 50 patients, Kandel et al.9 conducted a tandem, randomized controlled trial that compared 19G and 22G FNB needles with a 25G FNA needle for specimen adequacy of F1CDx analysis. The FNB needles showed a higher DNA concentration (P = 0.01) and a higher specimen adequacy rate for NGS of 39/50 (78%) for EUS-FNB (19 and 22G), compared to 7/50 (14%) for EUS-FNA (25G). The findings of these previous reports suggest that sample adequacy and success rate for NGS appear to be related to the larger size of the FNB needle. However, EUS-TA with a large needle is sometimes difficult in the clinical setting, especially from the duodenum, and the effects of other background factors on the success of CGP remain unclear. In this issue of Digestive Endoscopy, Ikeda et al.10 performed a retrospective study assessing the CGP criteria suitability using EUS-TA samples in a larger number of patients (n = 150) than the previous reports. They categorized EUS-TA samples obtained from unresected PC into four groups depending on tissue area. Of the 150 patients whose suitability was evaluated for CGP analysis with each of NOP and F1CDx, 39.2% met the NOP criteria but 0% met the F1CDx criteria. Among the 30 patients who met the NOP criteria and underwent NOP analysis, all analyses were successful and the amount of DNA was sufficient (>200 ng) in 29/30 (median, 992 ng; range, 139–7351 ng). They also performed multivariate analyses of factors associated with adequate tissue sampling for NOP, and identified EUS-FNB needle (odds ratio [OR] 3.57; 95% confidence interval [CI] 1.05–12.20; P = 0.041) and 19G needle (OR 2.53; 95% CI 1.15–5.57; P = 0.021) as significant independent factors for meeting the NOP criteria, in agreement with previous studies. In the present study,10 the authors concluded that 19G and FNB needles are suitable for CGP analysis, but also that larger needles require a higher degree of skill for puncture and that the complication rate is concerning, although it did not reach the level of significant difference. Moreover, as 22G FNB needles are currently the most commonly used needle type in the real-world setting, further investigation is warranted in terms of appropriate puncture number, puncture method, and ingenuity in obtaining formalin-fixed paraffin-embedded samples. Moreover, because the present study used pathological criteria of CGP for analysis, direct factors affecting the performance of CGP analysis in the real-world setting are unclear because CGP analysis can be successful if the number of slide submissions is increased, even in cases in which tumor cellularity or tissue area is insufficient to meet the criteria. Moreover, for CGP analysis in particular, it is recommended to submit multiple specimens all together to increase the tissue area in one slide, rather than submit specimens for each puncture individually. In summary, EUS-TA is feasible for CGP analysis, particularly when performed using an EUS-FNB needle and needle size of 19G; however, a full investigation of needle types and puncture techniques has not been performed. Although 19G seems to be suitable for CGP analysis, puncture with a large gauge needle can be difficult, especially for lesions located at the uncinate of the pancreas. Therefore, the most appropriate puncture number when using a thin FNB needle needs to be clarified, and the usefulness of image-enhanced EUS-TA such as elastography or with contrast enhancement need to be investigated in a future study. Authors declare no conflict of interest for this article. None." @default.
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• W4310252865 date "2022-11-27" @default.
• W4310252865 modified "2023-10-16" @default.
• W4310252865 title "Is endoscopic ultrasound‐guided tissue acquisition suitable for comprehensive genetic profiling?" @default.
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