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Poster Discussion session -Gastrointestinal, non-colorectal

1869 - The nationwide cancer genome screening project in Japan, SCRUM Japan GISCREEN: Efficient identification of cancer genome alterations in advanced Biliary Tract Cancer.


19 Oct 2018


Poster Discussion session -Gastrointestinal, non-colorectal


Translational Research

Tumour Site

Hepatobiliary Cancers


Chigusa Morizane


Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282


C. Morizane1, Y. Komatsu2, H. Takahashi3, M. Ueno4, J. Furuse5, T. Kudo6, S. Itoh7, S. Shimizu8, K. Nakamura9, K. Kamata10, K. Ohtsubo11, T. Mizukami12, Y. Kagawa13, S. Nomura14, T. Kuwata15, S. Fujii16, W. Okamoto17, K. Shitara18, A. Ohtsu18, T. Yoshino18

Author affiliations

  • 1 Department Of Hepatobiliary And Pancreatic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 2 Division Of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo/JP
  • 3 Department Of Hepatobiliary And Pancreatic Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 4 Department Of Gastroenterology, Hepatobiliary And Pancreatic Medical Oncology Division,, Kanagawa Cancer Center, 2410815 - Yokohama/JP
  • 5 Department Of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo/JP
  • 6 Department Of Frontier Science For Cancer And Chemotherapy, Gradeate School of Medicine Osaka University, 565-0871 - Suita/JP
  • 7 Department Of Surgery And Science, Graduate School Of Medical Sciences, Kyushu University, 812-8582 - Fukuoka/JP
  • 8 Department Of Gastroenterology, Saitama Cancer Center, Kitaadachigun/JP
  • 9 Department Of Gastroenterology, Chiba Cancer Center, 260-8717 - Chiba/JP
  • 10 Department Of Gastroenterology And Hepatology, Kindai University Faculty of Medicine, ina/JP
  • 11 Division Of Medical Oncology, Cancer Research Institute, Kanazawa University, 920-1192 - Kanazawa/JP
  • 12 Department Of Clinical Oncology, St. Marianna University School of Medicine, 216-8511 - Kawasaki/JP
  • 13 Department Of Surgery, Kansai Rosai Hospital, Amagasaki/JP
  • 14 Clinical research Support Office, National Cancer Center Hospital East, Kashiwa/JP
  • 15 Department Of Pathology And Clinical Laboratories, National Cancer Center Hospital East, Kashiwa/JP
  • 16 Division Of Pathology, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center, 277-8577 - Kashiwa/JP
  • 17 Biobank Translational Research Support Section, Translational Research Management Division, Clinical research Support Office, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 18 Department Of Gastroenterology And Gastrointestinal Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP


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Abstract 1869


We initiated the Nationwide Cancer Genome Screening Project in Japan since February 2014. From October 2015, we have introduced the Next Generation Sequencing to detect cancer genome alterations in advanced biliary tract cancer (aBTC; intrahepatic bile duct, extrahepatic bile duct, gallbladder, and ampulla of Vater), called as the SCRUM-Japan GI-SCREEN. The objective is to evaluate the frequency of cancer genome alterations and to identify patients who are candidate for clinical trial with corresponding targeting agents.


This study is ongoing with 20 major cancer centers. Patients with aBTC who plan to or receive chemotherapy were eligible. DNA and RNA were extracted from formalin-fixed paraffin embedded tumor samples and were analyzed by the Oncomine Cancer Research Panel (OCP) which allows to detect mutations, copy number variant (CNV) and fusion genes in a CLIA certified CAP accredited lab. The detected genomic variant data were classified according to genetic drivers of cancer, including gain- and loss-of-function or single nucleotide variant based on the Oncomine Knowledgebase.


As of March 31st 2017, a total of 167 aBTC patients were enrolled and 140 samples were analyzed. The sequence was successfully performed in 92 tumors (65.7%). The frequently detected gene alterations were shown in table. No gene fusion was detected. We will show the clinical outcome based on certain key cancer genome alterations.Table: 623PD

IHBD n = 36EHBD 35GB 14VP 7
TP53 mutation(m)9(25)11(31)8(57)4(57)
KRAS m12(33)11(31)2(14)4(57)
IDH1 m5(14)1(3)00
ERBB3 m1(3)3(9)1(7)0
ERBB2 m CNV ( > 7copies)0 02(6) 1(3)1(7) 1(7)0 0
CTNNB1 m1(3)1(3)1(7)2(29)
PIK3CA m004(29)1(14)
CDKN2A m3(8)02(14)0
APC m2(6)1(3)01(14)
ATM m1(3)2(6)1(7)0
FGFR3 m CNV1(3) 00 2(6)0 1(7)0 0
MDM2 CNV1(3)1(3)1(7)1(14)
SMAD4 m2(6)1(3)01(14)
STK11 m02(6)1(7)1(14)
TET2 m01(3)2(14)1(14)
CCNE1 m1(3)03(21)0


This nationwide screening system is efficient to detect rare gene alterations in aBTC. This novel knowledge provides an intriguing background to investigate new targeted approaches in these patients and to progress precision medicine.

Clinical trial identification

UMIN000016344. Date of disclosure of the study information2015/01/26.

Legal entity responsible for the study



15 SCRUM-Japan collaborating pharmaceutical companies, AMED, NCC.

Editorial Acknowledgement


C. Morizane: Honoraria: Pfizer, Novartis, Yakult Honsha, Lilly, Nobelpharma, Fujifilm, Teijin Pharma, Taiho Pharmaceutical; Consulting or advisory role: Yakult Honsha, Novartis, Taiho Pharmaceutical; Research funding (to institution): Pfizer, Nobelpharma, Eisai, Yakult Honsha, Ono Pharmaceutical, Taiho Pharmaceutical. Y. Komatsu: Honoraria: Pfizer, Novartis, Bayer,Yakult Honsha, Lilly, Merck, Taiho, Takeda, Sanofi, Chugai, Ono, Asahi-kasei, Kirin-Kyowa, Nipro, Towa. H. Takahashi: Honoraria: Taiho Pharmaceutical; Research funding: Bayer Pharmaceutical, Bristol-Myers Squibb. M. Ueno: Honoraria: Taiho Pharmaceutical, Yakult Honsha, AstraZeneca, Novartis, Lilly, Teijin Pharma, Shire, Ono Pharmaceutical; Research funding: Taiho Pharmaceutical, Shire, Daiichi Sankyo, Eisai, AstraZeneca, Ono Pharmaceutical, MSD, Merck Serono, NanoCarrier, Dainippon Sumitomo Pharma, Incyte. J. Furuse: Honoraria: Taiho, Chugai, Yakult, Sumitomo Dainippon, Eli Lilly Japan, Astellas, Ono, Pfizer, Bayer, Novartis, Merck Serono, Takeda, Eisai, MSD, Shionogi, J-Pharma, Daiichi Sankyo, Mochida, Nippon Kayaku, EA pharma, Sawai, Teijin Pharma; Consulting or advisory role: Taiho, Chugai, Yakult, Sumitomo Dainippon, Eli Lilly Japan, Astellas, Ono, Pfizer, Bayer, Novartis, Merck Serono, Takeda, Eisai, MSD, Shionogi, J-Pharma, Daiichi Sankyo, Kyowa Hakko Kirin, Sanofy, Sandoz, Otsuka, Zeria, Fujifilm, AstraZeneca, Asahi Kasei, Shire; Research funding (to institution): J-Pharma, Taiho, Sumitomo Dainippon, Janssen, Daiichi Sankyo, MSD, Yakult, Takeda, Chugai, Ono, Astellas, Zeria, Novartis, Nanocarrier, Shionogi, Onco Therapy Science, Eli Lilly Japan, Bayer, Bristol-Myers Squibb, Merck Serono, Kyowa Hakko Kirin, Eisai, NanoCarrier, Mochida, Baxalta, Sanofi. T. Kudo: Research grants: Yakult Honsha, Chugai Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bayer Yakuhin, Ltd. S. Itoh: Speakers\' bureau: Otsuka Pharmaceutical, Asahi Kasei Phama; Consulting or advisory role: Asahi Kasei Phama, Takeda; Research funding (to institution): Taiho, Sumitomo Dainippon, Daiichi Sankyo, MSD, Yakult, Chugai, Ono, Astellas, CSL Behring, Novartis, Shionogi, Eli Lilly Japan, Bayer, Merck Serono, Kyowa Hakko Kirin, Sanofy, Pfizer, Boehringer Ingelheim, Asahi Kasei Phama, Taisho Toyama Pharmaceutical, Kaken Pharmaceutical, Hisamitsu Pharmaceutical, Nihon Pharmaceutical, Nihon Blood Products Organization, Kowa Company, Medtronic, Johnson and Johnson. S. Shimizu: Honoraria: Novartis, Taiho Pharmaceutical. T. Mizukami: Speakers\' bureau: Taiho Pharma, Teijin Pharm. Inc., Otsuka Pharmaceutical Co., Ltd. Consulting or Advisory role: Merck Serono. S. Nomura: Honoraria: Taiho Pharmaceutical. T. Kuwata: Honoraria: Chugai Pharm, Daiichi-Sankyo; Research Funding (to institution): Daiichi-Sankyo. W. Okamoto: Grants: MSD, outside the submitted work. K. Shitara: Consulting or advisory role: Astellas Pharma, Lilly, Bristol-Myers Squibb, Takeda, Pfizer, Ono Pharmaceutical; Personal fees: Novartis, AbbVie, Yakult; Research funding (to institution): Lilly, Ono Pharmaceutical, Dainippon Sumoitomo Pharma, Daiichi Sankyo, Taiho Pharmaceutical, Chugai Pharma, MSD. A. Ohtsu: Honoraria: Chugai, Ono Pharmaceuticals, BMS; Research Funding: BMS. T. Yoshino: Grants: MSD K.K., Sumitomo Dainippon Pharma Co., Ltd., GlaxoSmithKline K.K., Nippon Boehringer Ingelheim Co., Ltd.; Grants and personal fees: Sanofi K.K., Chugai Pharmaceutical Co., Ltd, Personal fees: Eli Lilly Japan K.K, Merck Serono Co., Ltd., outside the submitted work. All other authors have declared no conflicts of interest.

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