Original Article Genomic testing for pancreatic cancer in clinical practice as real-world evidence Hideyuki Hayashi a, * , Shigeki Tanishima b , Kyoko Fujii a , Ryo Mori b , Yasunobu Okamura b , Emmy Yanagita a , Ryosuke Matsuoka a , Toraji Amano c , Ichiro Kinoshita d , Yoshito Komatsu e , Hirotoshi Dosaka-Akita a, d , Hiroshi Nishihara a a Division of Clinical Cancer Genomics, Hokkaido University Hospital, Sapporo, Japan b Department of Biomedical Informatics Development, Mitsubishi Space Software Co., Ltd, Tokyo, Japan c Hokkaido University Hospital Clinical Research and Medical Innovation Center, Sapporo, Japan d Department of Medical Oncology, Hokkaido University Graduate School of Medicine, Sapporo, Japan e Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan article info Article history: Received 9 April 2018 Received in revised form 20 June 2018 Accepted 12 July 2018 Available online xxx Keywords: Clinical sequencing Gene alterations Precision medicine Turnaround time abstract Background: Precision medicine guided by comprehensive genome sequencing represents a potential treatment strategy for pancreatic cancer. However, clinical sequencing for pancreatic cancer entails several practical difficulties. We have launched an in-house clinical sequencing system and started genomic testing for patients with cancer in clinical practice. We have analyzed the clinical utility of this system in pancreatic cancer. Methods: We retrospectively reviewed 20 patients with pancreatic cancer who visited our division. Genomic DNA was extracted from both tumor tissue and peripheral blood mononuclear cells obtained from the patients. We performed a comprehensive genomic testing using targeted amplicon sequencing for 160 cancer-related genes. The primary endpoints were the detection rates of potential actionable and druggable gene alterations. The secondary endpoints were the detection rate of secondary germline findings, the rate of re-biopsy required for genome sequencing, survival time after the initial visit (post- sequencing survival time), and turnaround time. Results: Although re-biopsy was required for 25% (5/20) of all patients, genomic testing was performed in all patients. Actionable and druggable gene alterations were detected in 100% (20/20) and 35% (7/20) of patients, respectively, whereas secondary germline findings were detected in 5% (1/20) of patients. The median turnaround times for physicians and patients were 20 and 26 days, respectively. The median post-sequencing survival time was 10.3 months. Only 10% (2/20) of all patients were treated with therapeutic agents based on the outcomes of genomic testing. Conclusions: The clinical application of comprehensive genomic testing for pancreatic cancer was feasible and promising in clinical practice. © 2018 IAP and EPC. Published by Elsevier B.V. All rights reserved. 1. Introduction Pancreatic cancer is one of the most lethal malignancies, and both morbidity and mortality are increasing [1]. In addition, pancreatic cancer is projected to become the second leading cause of cancer-related deaths in the United States by 2030 [2]. Surgical resection is the only curative treatment for the disease; however, most pancreatic cancer patients are diagnosed with unresectable disease at the initial visit, and many of those who undergo surgery eventually experience recurrence within a few post-operative years. The median survival time in major clinical trials for advanced pancreatic cancer is 5e11 months [3e7], and the only molecular-targeted drug approved for its treatment is erlotinib, a molecular-targeted agent that blocks the kinase activity of the epidermal growth factor receptor (EGFR) protein. Recently, the utility of treatment strategies based on gene profiles that aid in the selection of effective molecular-targeted agents has been * Corresponding author. Division of Clinical Cancer Genomics, Hokkaido Uni- versity Hospital, North 15, West 7, Kita-ku, Sapporo, 060-8648, Japan. E-mail address: rock-hayashi-pop@rhythm.ocn.ne.jp (H. Hayashi). Contents lists available at ScienceDirect Pancreatology journal homepage: www.elsevier.com/locate/pan https://doi.org/10.1016/j.pan.2018.07.006 1424-3903/© 2018 IAP and EPC. Published by Elsevier B.V. All rights reserved. Pancreatology xxx (2018) 1e8 Please cite this article in press as: Hayashi H, et al., Genomic testing for pancreatic cancer in clinical practice as real-world evidence, Pancreatology (2018), https://doi.org/10.1016/j.pan.2018.07.006