JP6915804B2 - イリノテカンの治療効果予測方法及びそのためのキット - Google Patents
イリノテカンの治療効果予測方法及びそのためのキット Download PDFInfo
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- JP6915804B2 JP6915804B2 JP2017122569A JP2017122569A JP6915804B2 JP 6915804 B2 JP6915804 B2 JP 6915804B2 JP 2017122569 A JP2017122569 A JP 2017122569A JP 2017122569 A JP2017122569 A JP 2017122569A JP 6915804 B2 JP6915804 B2 JP 6915804B2
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- C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
- C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
- C12Q1/6886—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
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- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
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- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/106—Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
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- C12Q2600/00—Oligonucleotides characterized by their use
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- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
Description
(解析対象)
日本人のイリノテカン投与大腸癌(ステージIV)155症例から、イリノテカン減量投与症例、UGT1A1*6(ホモ)、UGT1A1*28(ホモ)及びこれらのコンパウンドヘテロ(compound heterogeneous)症例を除いた症例のうち、治療効果判定を行った140症例及び当該140症例の中のサブポピュレーション66症例(レジメンの統一されたFOLFIRI症例)を解析対象とした。FOLFIRIとは、フルオロウラシルとl-ロイコボリンとを組み合わせた治療にイリノテカンを同時併用する大腸癌に対する標準治療のひとつである。なお、当該140症例は、イリノテカンを含むレジメンにて治療を受けた日本人大腸がん患者である。本実施例におけるレジメンでは、イリノテカンに加えて、フルオロウラシルとl-ロイコボリンとの併用によるFOLFIRIや、カペシタビンとの併用によるXELIRI、S-1との併用によるIRIS、抗EGFR抗体薬(ベバシズマブ、セツキシマブ、パニツムマブ)との併用療法を含んでいる。
各症例からゲノムDNAを次の方法で調製した。まず、EDTA含有チューブに採取した末梢血を加えた。次に、ヨウ化ナトリウム法(Wang et al., Nucleic Acids Res 34:195-201(2014))に基づいて調製した。調製したDNAは、1mM EDTA・2Naを含む10mM Tris-塩酸緩衝液(pH8.0)に溶解し、使用するまで、4℃又は-20℃で保存した。
調製したゲノムDNAを用い、WO2016/132736(PCT/JP2016/000793)に記載と同様の方法でゲノム網羅的解析(WES解析)を行った。すなわち、コントロール群として、UGT1A遺伝子多型(UGT1A1*6、*27、*28、UGT1A7(387T>G、622T>C)、UGT1A9*1b、UGT1A1*60の7箇所)が全て副作用リスクの低いホモ接合型かつイリノテカン副作用の見られなかった症例(n=5)、ケース群には、コントロール群と同じUGT1A遺伝子多型であったにもかかわらず副作用(Grade 3, entire course)がみられた症例(n=5)及び何れかのUGT1A遺伝子多型をヘテロに有するイリノテカン初回投与時から副作用(Grade 4)がみられた症例(n=5)の3つの症例を設定し、ケース・コントロール解析を行った。Validationとして加水分解プローブによるジェノタイピングを行った。遺伝子多型と副作用発生頻度及び奏効率との統計解析にはCochran-Armitage trend testを用いた。
Claims (3)
- 被検者から採取された生体試料中のゲノムDNAに存在する、配列番号1に示すAPCDD1L遺伝子の塩基配列における186番目における、野生型がアデニンであり変異型がグアニンであるrs1980576で特定される遺伝子多型を分析し、当該遺伝子多型の遺伝子型を判定し、判定した遺伝子型に基づいて上記rs1980576で特定される遺伝子多型が野生型のホモである場合にはイリノテカンの治療効果が高いと判定し、変異型と野生型のヘテロである場合にはイリノテカンの治療効果を有すると判定し、変異型のホモである場合にはイリノテカンの治療効果が低いと判定する、イリノテカンによる治療効果を判定する方法。
- 配列番号1に示すAPCDD1L遺伝子の塩基配列における186番目における、野生型がアデニンであり変異型がグアニンであるrs1980576で特定される遺伝子多型を含む連続する15〜40塩基の領域と相補的なオリゴヌクレオチドを含む、イリノテカンによる治療効果判定用プローブセット。
- 上記rs1980576で特定される遺伝子多型における野生型に対応する野生型プローブと、当該遺伝子多型における変異型に対応する変異型プローブとを含む請求項2記載の治療効果判定用プローブセット。
Priority Applications (5)
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JP2017122569A JP6915804B2 (ja) | 2017-06-22 | 2017-06-22 | イリノテカンの治療効果予測方法及びそのためのキット |
PCT/JP2018/023773 WO2018235937A1 (ja) | 2017-06-22 | 2018-06-22 | イリノテカンの治療効果予測方法及びそのためのキット |
CN201880051010.4A CN110997945A (zh) | 2017-06-22 | 2018-06-22 | 伊立替康的治疗效果预测方法及应用该方法的试剂盒 |
US16/624,469 US11384385B2 (en) | 2017-06-22 | 2018-06-22 | Method for predicting therapeutic effects of irinotecan, and kit for same |
EP18820917.5A EP3643791A4 (en) | 2017-06-22 | 2018-06-22 | PROCEDURE FOR PREDICTING THE THERAPEUTIC EFFECTS OF IRINOTECAN AND KIT FOR IT |
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JP2017122569A JP6915804B2 (ja) | 2017-06-22 | 2017-06-22 | イリノテカンの治療効果予測方法及びそのためのキット |
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JP2019004743A JP2019004743A (ja) | 2019-01-17 |
JP6915804B2 true JP6915804B2 (ja) | 2021-08-04 |
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US (1) | US11384385B2 (ja) |
EP (1) | EP3643791A4 (ja) |
JP (1) | JP6915804B2 (ja) |
CN (1) | CN110997945A (ja) |
WO (1) | WO2018235937A1 (ja) |
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CN113140275B (zh) * | 2021-05-07 | 2023-03-24 | 四川大学华西医院 | 一种肝癌靶向治疗疗效的监测系统及方法 |
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JP4884899B2 (ja) | 2006-09-19 | 2012-02-29 | 東洋鋼鈑株式会社 | イリノテカンの副作用の発生危険度を判定する方法およびそのためのキット |
JP5376841B2 (ja) * | 2008-06-19 | 2013-12-25 | ソニー株式会社 | イリノテカンの副作用の発生危険度を判定する方法、及びこれに用いられるdnaチップとキット |
WO2010025952A1 (en) * | 2008-09-05 | 2010-03-11 | Medizinische Hochschule Hannover | Method for genotyping ugt1a1*28 promoter region variant and systems useful therefor |
US9107918B2 (en) * | 2009-03-13 | 2015-08-18 | Kabushiki Kaisha Yakult Honsha | Method for determining sensitivity to irinotecan and use thereof |
WO2010124239A2 (en) * | 2009-04-24 | 2010-10-28 | University Of Southern California | Genetic polymorphisms associated with clinical outcomes of topoisomerase inhibitor therapy for cancer |
CN101928754A (zh) * | 2009-06-26 | 2010-12-29 | 上海主健生物工程有限公司 | 伊立替康辅助治疗肠癌疗效检测 |
JP2011250726A (ja) | 2010-06-01 | 2011-12-15 | Toyo Kohan Co Ltd | イリノテカンの副作用の発生危険度を判定する方法及びそのためのキット |
CN102643906A (zh) * | 2012-04-01 | 2012-08-22 | 周宏灏 | 焦磷酸测序法检测伊立替康个体化用药基因多态性的试剂盒及方法 |
CN107208163B (zh) | 2015-02-17 | 2021-01-08 | 国立大学法人山口大学 | 辅助对伊立替康副作用的发生风险的预测的方法 |
DK178990B1 (en) | 2015-12-29 | 2017-07-31 | Maersk Line As | Fremgangsmåde til bestemmelse af, hvornår en afrimningscyklus i en kølecontainer skal afsluttes |
CN105671199A (zh) * | 2016-04-22 | 2016-06-15 | 浙江中迪生物科技有限公司 | 结肠癌化疗药物伊立替康敏感性相关基因ugt1a1的snp检测试剂盒及其使用方法 |
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- 2017-06-22 JP JP2017122569A patent/JP6915804B2/ja active Active
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2018
- 2018-06-22 US US16/624,469 patent/US11384385B2/en active Active
- 2018-06-22 WO PCT/JP2018/023773 patent/WO2018235937A1/ja unknown
- 2018-06-22 CN CN201880051010.4A patent/CN110997945A/zh active Pending
- 2018-06-22 EP EP18820917.5A patent/EP3643791A4/en active Pending
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Publication number | Publication date |
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WO2018235937A1 (ja) | 2018-12-27 |
EP3643791A4 (en) | 2021-03-17 |
EP3643791A1 (en) | 2020-04-29 |
US11384385B2 (en) | 2022-07-12 |
US20200115740A1 (en) | 2020-04-16 |
CN110997945A (zh) | 2020-04-10 |
JP2019004743A (ja) | 2019-01-17 |
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