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Clinical Trial
. 2022 Dec;57(12):990-998.
doi: 10.1007/s00535-022-01926-z. Epub 2022 Oct 3.

Proportion of unresectable pancreatic cancer specimens obtained by endoscopic ultrasound-guided tissue acquisition meeting the OncoGuide™ NCC Oncopanel System analysis suitability criteria: a single-arm, phase II clinical trial

Yuya Hisada  1 , Susumu Hijioka  2 , Go Ikeda  1 , Kosuke Maehara  1 , Taiki Hashimoto  3 , Hidetoshi Kitamura  1 , Shota Harai  1 , Motohiro Yoshinari  1 , Yuki Kawasaki  1 , Yumi Murashima  1 , Takehiko Koga  1 , Kotaro Takeshita  1 , Yuta Maruki  1 , Akihiro Ohba  1 , Yoshikuni Nagashio  1 , Shunsuke Kondo  1 , Chigusa Morizane  1 , Hideki Ueno  1 , Yutaka Saito  4 , Yasushi Yatabe  3 , Takuji Okusaka  1
Affiliations
Clinical Trial

Proportion of unresectable pancreatic cancer specimens obtained by endoscopic ultrasound-guided tissue acquisition meeting the OncoGuide™ NCC Oncopanel System analysis suitability criteria: a single-arm, phase II clinical trial

Yuya Hisada et al. J Gastroenterol. 2022 Dec.

Abstract

Background: There are limited studies on the results of comprehensive genomic profiling testing for pancreatic cancer tissue specimens by endoscopic ultrasound-guided tissue acquisition (EUS-TA). This study aimed to evaluate the proportion of specimens obtained by EUS-TA using a 19-gauge (G) fine-needle biopsy (FNB) needle for unresectable pancreatic cancer (UR-PC) that met the OncoGuide™ NCC Oncopanel System (NOP) analysis suitability criteria.

Methods: In this single-arm, prospective, phase II study, EUS-TA was performed using a 19G FNB biopsy needle in patients with suspected UR-PC based on a contrast-enhanced computed tomography scan. The primary endpoint was the proportion of patients who met the NOP analysis suitability criteria, with a threshold, expected value, α-error, and power of 40%, 70%, 0.025, and 0.9, respectively, and the planned number of enrolled patients was 33. The NOP analysis suitability criteria were defined as tumor cell content ≥ 20% and tissue size ≥ 4 mm2.

Results: Thirty-three patients were enrolled. The procedural success rate was 100%, and the cytodiagnosis of class V was observed in all patients. The proportion of patients meeting the NOP analysis suitability criteria was 63.6% (95% CI 47.22-80.05), which satisfied the predefined criteria to be considered valid. Adverse events occurred in 9.0% of the patients.

Conclusions: The proportion of patients with UR-PC who met the NOP analysis suitability criteria for EUS-TA using a 19G FNB needle was effective for achieving the primary endpoint, making it a valid test method. Adverse events occurred at a higher rate than that previously reported.

Keywords: Comprehensive genomic profiling; Endoscopic ultrasound-guided fine-needle biopsy; Endoscopic ultrasound-guided tissue acquisition; Next-generation sequencing; Pancreatic cancer.

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References

    1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA A Cancer J Clin. 2019;69:7–34. - DOI
    1. Tempero MA, Malafa MP, Al-Hawary M, et al. Pancreatic adenocarcinoma, version 2.2021 NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw version 22021. 2021;19:439–57.
    1. Golan T, Hammel P, Reni M, et al. Maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer. N Engl J Med. 2019;381:317–27. - DOI - PubMed - PMC
    1. Le DT, Durham JN, Smith KN, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017;357:409–13. - DOI - PubMed - PMC
    1. Doebele RC, Drilon A, Paz-Ares L, et al. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1–2 trials. Lancet Oncol. 2020;21:271–82. - DOI - PubMed

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