Prediction of sorafenib response by FGF3 gene amplification for patients with hepatocellular carcinoma

• Project/Area Number: 24240122
• Research Category: Grant-in-Aid for Scientific Research (A)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Clinical oncology
• Research Institution: Kinki University
• Principal Investigator: NISHIO Kazuto 近畿大学, 医学部, 教授 (10208134)
• Co-Investigator(Kenkyū-buntansha): KUDO Masatoshi 近畿大学, 医学部, 教授 (10298953) ; 鈴木 俊宏 明治薬科大学, 薬学部, 講師 (80322527) ; 荒尾 徳三 近畿大学, 医学部, 講師 (20441074)
• Project Period (FY): 2012-10-31 – 2015-03-31
• Project Status: Completed (Fiscal Year 2014)
• Budget Amount: ¥44,460,000 (Direct Cost: ¥34,200,000、Indirect Cost: ¥10,260,000); Fiscal Year 2014: ¥9,100,000 (Direct Cost: ¥7,000,000、Indirect Cost: ¥2,100,000); Fiscal Year 2013: ¥17,940,000 (Direct Cost: ¥13,800,000、Indirect Cost: ¥4,140,000); Fiscal Year 2012: ¥17,420,000 (Direct Cost: ¥13,400,000、Indirect Cost: ¥4,020,000)
• Keywords: 肝細胞がん / ソラフェニブ / バイオマーカー / TGF-α / PECAM1 / NRG1 / 肝細胞癌 / 遺伝子増幅 / FGFRシグナル

Outline of Final Research Achievements

We have analyzed the copy number variation of hepatocellular carcinoma (HCC) tumor in a multicenter clinical study. We found increased copy number of FGF19 was a new predictive biomarker for sorafenib response in addition to FGF3/FGF4 gene amplification in HCC. Separately, we conducted DNA and RNA sequencing of tumor FFPE samples in another multicenter clinical trials for HCC patients treated with sorafenib. DNA amplicon sequencing and RNA sequencing targeted 50 candidate genes were performed using FFPE tumor samples obtained by liver core needle biopsy. HCC tumor with low oncogene mutation numbers were sensitive to sorafenib treatment, suggesting that oncogene mutational burden in the tumor might be associated with the clinical response to sorafenib. We have also identified candidate genes (TGF-, PECAM1, and NRG1) for the prediction of sorafenib response and progression free survival by RNA sequencing.

Research Products

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• [Journal Article] Activated MET acts as a salvage signal after treatment with alectinib, a selective ALK inhibitor, in ALK-positive non-small cell lung cancer. (2015)
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• [Journal Article] MEK inhibitor for gastric cancer with MEK1 mutations. (2014)
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• [Journal Article] Hypoxia induces resistance to ALK inhibitors in the H3122 non-small cell lung cancer cell line with an ALK rearrangement via epitherial-mesenchymal transition. (2014)
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• [Journal Article] KIAA1199 interacts with glycogen phosphorylase kinase b-subunit (PHKB) to promote glycogen breakdown and cancer cell survival. (2014)
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• [Journal Article] Clinical utility of erlotinib for the treatment of non-small-cell lung cancer in Japanese patients: current evidence. (2014)
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• [Journal Article] Frequent amplification of ORAOV1 gene in esophageal squamous cell cancer promotes an aggressive phenotype via proline metabolism and ROS production. (2014)
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• [Journal Article] Biomarkers of reactive resistance and early disease progression during chemotherapy plus bevacizumab treatment for colorectal carcinoma. (2014)
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• [Journal Article] Homozygous deletion of the activin A receptor, type IB gene is associated with an aggressive cancer phenotype in pancreatic cancer. (2014)
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• [Journal Article] Melanoma transition is frequently accompanied by a loss of cytoglobin expression in melanocytes: a novel expression site of cytoglobin. (2014)
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• [Journal Article] Analytical performance of the cobas EGFR (2014)
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• [Journal Article] Human papillomavirus DNA and p16 expression in Japanese patients with oropharyngeal squamous cell carcinoma. (2013)
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• [Journal Article] Novel single nucleotide polymorphism markers for low dose aspirin-associated small bowel bleeding. (2013)
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• [Journal Article] The OCT4 pseudogene POU5F1B is amplified and promotes an aggressive phenotype in gastric cancer. (2013)
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• [Journal Article] EGFR T790M Mutation as a Possible Target for Immunotherapy; Identification of HLA-A*0201-Restricted T Cell Epitopes Derived from the EGFR T790M Mutation. (2013)
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  • Journal Title: PLOS ONE Volume: 8(11)
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• [Journal Article] The novel VEGF receptor/MET-targeted kinase inhibitor, TAS-115, has marked in vivo anti-tumor properties and a favorable tolerability profile. (2013)
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• [Journal Article] A phase I, pharmacokinetic and pharmacodynamic study of nimotuzumab in Japanese patients with advanced solid tumors. (2013)
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• [Journal Article] Overexpression of heparan sulfate 6 O sulfotransferase 2 in colorectal cancer. (2013)
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• [Journal Article] Phase 1 study of lenvatinib combined with carboplatin and paclitaxel in patients with non-small-cell lung cancer. (2013)
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  • Journal Title: Br J Cancer Volume: 109(3) Issue: 3 Pages: 538-44
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• [Journal Article] Influence of novel supramolecular substance, [2] rotaxane, on the caspase signaling pathway in melanoma and colon cancer cells in vitro. (2013)
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• [Journal Article] Detection of EGFR T790M mutation in plasma DNA from patients refractory to EGFR tyrosine kinase inhibitor. (2013)
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• [Journal Article] LUZ-Lung 4: A phase II traial of afatinib in patients with advanced, non-small cell lung cancer who progressed on prior treatment with erlotinib, gefitinib, or both. (2013)
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• [Journal Article] A microarray-based gene expression analysis to identify diagnostic biomarkers for unknown primary cancer. (2013)
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• [Journal Article] Slug increases sensitivity to tubulin-binding agents via the downregulation of βIII and βIVa-tubulin in lung cancer cells (2013)
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• [Journal Article] MET amplification as a potential therapeutic target in gastric cancer. (2013)
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• [Journal Article] FGF3/FGF4 amplification and multiple lung metastases in responders to sorafenib in hepatocellular carcinoma. Hepatology. (2012)
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• [Journal Article] Hypoxia induces gefitinib ersistance in non-small cell lung cancer with both mutant wild-type epidermal growth factor receptors. (2012)
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• [Journal Article] Activation of HER family signaling as a mechanism of acquired resistance to ALK inhibitors in EML4-ALK-positive non-small cell lung cancer: Clin. Cancer Res (2012)
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• [Journal Article] An evaluation study of EGFR mutation tests utilized for non-small-cell lung cancer in the diagnostic setting. (2012)
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• [Journal Article] Clinical outcome for EML4-ALK-positive patients with advanced non-small-cell lung cancer treated with first-line platinum-based chemotherapy. (2012)
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• [Presentation] New insights for sequencing data in lung cancer. (2014)
  • Author(s): Nishio K.
  • Organizer: The ESMO 2014 Congress
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  • Year and Date: 2014-09-26 – 2014-09-30
  • Invited
• [Presentation] Serum biomarker analysis of WJOG4107: A randomized phase II trial of adjuvant chemotherapy with S-1 versus CDDP+S-1 for resected stage Ii-IIIA non-small cell lung cancer (NSCLC). (2014)
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  • Organizer: American Society of Clinical Oncology Annual Meeting 2014
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  • Year and Date: 2014-05-30 – 2014-06-03
• [Presentation] Transcriptional expression of Bcl-2 as predictive of response to neoadjuvant chemotherapy with trastuzumab in HER2-positive ER-positive breast cancer patients. (2014)
  • Author(s): Tanioka M, Sakai K, Sudo T, Sakuma T, Hirokaga K, Takao S, Minami H, Negoro S, Nakagawa K, Nishio K.
  • Organizer: American Society of Clinical Oncology Annual Meeting 2014
  • Place of Presentation: Chicago
  • Year and Date: 2014-05-30 – 2014-06-03
• [Presentation] Early phase trials in the future-Basic resaercher's perspective. (2014)
  • Author(s): Nishio K.
  • Organizer: 3rd Japan Taiwan Oncoloy PhaseI Trial Conference (JTOPIC)
  • Place of Presentation: Taipei
  • Year and Date: 2014-04-19
  • Invited
• [Presentation] Homozygous deletion of the activin A receptor, type IB gene is associated with an aggressive cancer phenotype in pancreatic cancer. (2014)
  • Author(s): Togashi Y, Sakamoto H, Hayashi H, Terashima M, Velasco MA, Fujita Y, Kodera Y, Sakai K, Tomida S, Kitano M, Kudo M, Nishio K.
  • Organizer: American Association for Cancer Research 104th Annual Meeting 2014
  • Place of Presentation: San Diego
  • Year and Date: 2014-04-05 – 2014-04-09
• [Presentation] A microarray-based gene expression analysis identified diagnostic biomarkers for unknown primary cancer. (2014)
  • Author(s): Fujita Y, Kurahashi I, Kurata T, Koh Y, Sakai K, Nakagawa K, Nishio K.
  • Organizer: American Association for Cancer Research 104th Annual Meeting 2014
  • Place of Presentation: San Diego
  • Year and Date: 2014-04-05 – 2014-04-09
• [Presentation] Noninvasive analysis of acquired resistance to EGFR-TKI. (2014)
  • Author(s): Kimura H, Nishio M, Daito T, Nishio K.
  • Organizer: American Association for Cancer Research 104th Annual Meeting 2014
  • Place of Presentation: San Diego
  • Year and Date: 2014-04-05 – 2014-04-09
• [Presentation] Activation of HER Family signaling as a mechanism of acquired to ALK Inhibitors in EML4-ALK-posotive Non-Small Cell Lung Cancer. (2013)
  • Author(s): Tanizaki J, Okamoto I, Okabe T, Sakai K, Tanaka K, Hayashi H, Kaneda H, Takezawa K, Nishio K, Nakagwa K.
  • Organizer: American Association for Cancer Research 103rd Annual Meeting 2013
  • Place of Presentation: Washington, DC
• [Presentation] MET amplification as a potential therapeutic target in gastric cancer. (2013)
  • Author(s): Kawakami H, Okamoto I, Arao T, Okamoto W, Matsumoto K, Taniguchi H, Kuwata K, Yamaguchi H, Nishio K, Nakagawa K.
  • Organizer: American Association for Cancer Research 103rd Annual Meeting 2013
  • Place of Presentation: Washington, DC
• [Presentation] Biomarker analysis of WJOG4107, arandomized phase II traial of adjuvant chemotherapy with S-1 versys (2013)
  • Author(s): Mitsudomi T, Iwamoto Y, Nishio K, Yamanaka T, Yoshioka H, Tada H, Yoshimura M, Yoshino I, Okamoto I, Sugawara S, Kudoh S, Yamamoto N, Ohta M, Ichinose Y, Atagi S, Okada M, Saka H, Katakami N, Nakagawa K, Nakanishi Y, Nakanishi Y.
  • Organizer: American Society of Clinical Oncology Annual Meeting 2011
  • Place of Presentation: Chicago
• [Presentation] Detection of EGFR T790M mutation in plasma DNA from patients refractory to EGFR tyrosine kinase inhibitor.(EGFR-TKI耐性症例の血しょう中DNAにおけるT790M遺伝子変異の検出） (2013)
  • Author(s): 坂井和子、堀池篤、アーウィン・ダリル、工藤慶太、藤田至彦、大柳文義、西尾誠人、西尾和人
  • Organizer: 第11回日本臨腫瘍学会学術集会
  • Place of Presentation: 仙台市
• [Presentation] 食道扁平上皮癌で高頻度に増殖しているORAOV1遺伝子は腫瘍増大と低分化な組織型に関与している (2013)
  • Author(s): 冨樫庸介、荒尾徳三、加藤寛章、松本和子、寺嶋雅人、林秀敏、藤田至彦、安田卓司、塩﨑均、西尾和人
  • Organizer: 第11回日本臨腫瘍学会学術集会
  • Place of Presentation: 仙台市
• [Presentation] 三次元培養における抗がん剤の評価系の構築 (2013)
  • Author(s): 寺嶋雅人、坂井和子、藤田至彦、西尾和人、マルコ・デベラスコ
  • Organizer: 第11回日本臨腫瘍学会学術集会
  • Place of Presentation: 仙台市
• [Presentation] Optimization of multiplex mutation analysis based on minimum amount of lung cancer specimen.(NGSによる極微量検体を用いたmultiplex mutation analysisの最適化） (2013)
  • Author(s): 冨田秀太、坂井和子、藤田至彦、寺嶋雅人、冨樫庸介、デベラスコマルコ、光冨徹哉、中川和彦、西尾和人
  • Organizer: 第72回日本癌学会学術総会
  • Place of Presentation: 横浜市
• [Patent(Industrial Property Rights)] Use of Eribulin and S-1as combination therapy for the treatment of cancer (2014)
  • Inventor(s): Kazuto Nishio
  • Industrial Property Rights Holder: エーザイ
  • Industrial Property Rights Type: 特許
  • Filing Date: 2014-06-24
  • Overseas
• [Patent(Industrial Property Rights)] FGF4遺伝子増幅腫瘍の医薬組成物 (2013)
  • Inventor(s): 西尾和人、他
  • Industrial Property Rights Holder: 近畿大学 他
  • Industrial Property Rights Type: 特許
  • Industrial Property Number: 2013-208361
  • Filing Date: 2013-10-03