JP4997345B2 - Egfr経路を標的にする薬物による治療のための結腸直腸癌患者の選択 - Google Patents
Egfr経路を標的にする薬物による治療のための結腸直腸癌患者の選択 Download PDFInfo
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Description
本発明は、癌患者について、上皮増殖因子受容体(EGFR)経路を標的にする薬物による治療が有効である可能性が高いことを同定する分野に関する。治療の最初の選択の同定は、該患者から採取した血液サンプルの質量スペクトル分析を、該疾患を有する他の患者から得たクラス標識したスペクトル(class-labeled spectra)の訓練集合(training set)を用いた分類アルゴリズムと併用することを含む。
我々は、我々の先願の特許出願に記載した患者サンプルの質量スペクトル分析の方法および訓練集合(training set)を用いた分類が、NSCLC患者について、EGFR経路を標的にする薬物が有効である可能性が高いことを最初に同定する選択手段を提供するだけではなく、該方法が該薬物、特にモノクローナル抗体であるEGFR−阻害剤(EGFR−I)、例えばセツキシマブ(エルビタックス)およびパニツムマブによる治療についてのCRC患者の選択のための選択手段を提供することも発見した。
a)該患者より採取した血液に基づくサンプルから質量スペクトルを得ること;
b)ステップa)にて得られた質量スペクトルに、1つ以上の所定の前処理ステップを行うこと;
c)ステップb)にて質量スペクトルに前処理ステップを行った後、1つ以上の所定のm/z範囲で、該スペクトルの選択された特徴の積分強度値を得ること;および
d)該薬物による治療が有効である可能性が高いか低いかについて該患者を同定するために、他の患者より採取した血液に基づくサンプルから作成したクラス標識したスペクトル(class-labeled spectra)を含む訓練集合(training set)を用いる分類アルゴリズムに、ステップc)にて得られた値を用いること
の各ステップを含む方法を開示する。
我々は、EGFR−Iで治療した再発性および/または転移性のNSCLCおよびCRC患者から採取した血清または血漿サンプルのみならず、EGFR−Iで治療しなかった患者から採取したサンプルからもMS特性を調べた。MALDI質量スペクトルは各サンプルから得、生存比較のために各患者を「良好」または「不良」転帰群に分類した。我々は、MS特性が全てのEGFRI治療コホート(cohorts)において生存転帰を予測するものであることを発見した。
5732〜5795
5811〜5875
6398〜6469
11376〜11515
11459〜11599
11614〜11756
11687〜11831
11830〜11976
12375〜12529
23183〜23525
23279〜23622および
65902〜67502。
a)該患者より採取した血液に基づくサンプルから質量スペクトルを得ること;
b)ステップa)にて得られた質量スペクトルに、1つ以上の所定の前処理ステップを行うこと;
c)ステップb)にて質量スペクトルに前処理ステップを行った後、1つ以上の所定のm/z範囲で、該スペクトルの選択された特徴の積分強度値を得ること;および
d)該薬物による治療が有効である可能性が高いか低いかについて該患者を同定するために、他の患者より採取した血液に基づくサンプルから作成したクラス標識したスペクトル(class-labeled spectra)を含む訓練集合(training set)を用いる分類アルゴリズムに、ステップc)にて得られた値を用いること
の各ステップを含む方法を記載した。
5732〜5795
5811〜5875
6398〜6469
11376〜11515
11459〜11599
11614〜11756
11687〜11831
11830〜11976
12375〜12529
23183〜23525
23279〜23622および
65902〜67502
からなるm/z範囲の群から選択される1つ以上のm/z範囲を含む。
Claims (6)
- 結腸直腸癌(CRC)患者について、EGFR経路を標的にするモノクローナル抗体である上皮増殖因子受容体阻害剤による治療が有効である可能性が高いかどうかを決定する方法であって、
a)該CRC患者より採取した血液に基づくサンプルから質量スペクトルを得ること;
b)ステップa)にて得られた質量スペクトルに、1つ以上の所定の前処理ステップを行うこと;
c)ステップb)にて質量スペクトルに前処理ステップを行った後、1つ以上の所定のm/z範囲で、該スペクトルの選択された特徴の積分強度値を得ること;および
d)モノクローナル抗体である該上皮増殖因子受容体阻害剤による治療が有効である可能性が高いか低いかについて該CRC患者を同定するために、他の癌患者より採取した血液に基づくサンプルから作成したクラス標識したスペクトル(class-labeled spectra)を含む訓練集合(training set)を用いる分類アルゴリズムに、ステップc)にて得られた値を用いること
の各ステップを含む方法であって、
1つ以上のm/z範囲が、
5732〜5795
5811〜5875
6398〜6469
11376〜11515
11459〜11599
11614〜11756
11687〜11831
11830〜11976
12375〜12529
23183〜23525
23279〜23622および
65902〜67502
からなるm/z範囲の群から選択される1つ以上のm/z範囲を含む方法。 - 質量スペクトルがMALDI質量分析計から得られたものである、請求項1の方法。
- 所定の前処理ステップが、バックグラウンド減算スペクトルを作成するバックグラウンド減算ステップ、およびバックグラウンド減算スペクトルの正規化を行う正規化ステップを含む、請求項1の方法。
- 訓練集合(training set)が非小細胞肺癌患者より得られた血液に基づくサンプルから作成したクラス標識したスペクトル(class-labeled spectra)を含む、請求項1の方法。
- モノクローナル抗体である上皮増殖因子受容体阻害剤がセツキシマブまたはその均等物を含む、請求項1の方法。
- モノクローナル抗体である上皮増殖因子受容体阻害剤がパニツムマブまたはその均等物を含む、請求項1の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/321,394 | 2009-01-20 | ||
US12/321,394 US7858390B2 (en) | 2006-03-31 | 2009-01-20 | Selection of colorectal cancer patients for treatment with drugs targeting EGFR pathway |
PCT/US2009/006267 WO2010085234A1 (en) | 2009-01-20 | 2009-11-20 | Selection of colorectal cancer patients for treatment with drugs targeting egfr pathway |
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JP2012507033A JP2012507033A (ja) | 2012-03-22 |
JP2012507033A5 JP2012507033A5 (ja) | 2012-05-10 |
JP4997345B2 true JP4997345B2 (ja) | 2012-08-08 |
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JP2011534536A Expired - Fee Related JP4997345B2 (ja) | 2009-01-20 | 2009-11-20 | Egfr経路を標的にする薬物による治療のための結腸直腸癌患者の選択 |
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US (1) | US7858390B2 (ja) |
EP (1) | EP2347261B1 (ja) |
JP (1) | JP4997345B2 (ja) |
KR (1) | KR101131231B1 (ja) |
AU (1) | AU2009338173B2 (ja) |
CA (1) | CA2744394A1 (ja) |
ES (1) | ES2392805T3 (ja) |
HK (1) | HK1156696A1 (ja) |
IL (1) | IL211944A (ja) |
TW (1) | TWI366671B (ja) |
WO (1) | WO2010085234A1 (ja) |
Families Citing this family (14)
Publication number | Priority date | Publication date | Assignee | Title |
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US7906342B2 (en) * | 2006-03-31 | 2011-03-15 | Biodesix, Inc. | Monitoring treatment of cancer patients with drugs targeting EGFR pathway using mass spectrometry of patient samples |
US7858390B2 (en) | 2006-03-31 | 2010-12-28 | Biodesix, Inc. | Selection of colorectal cancer patients for treatment with drugs targeting EGFR pathway |
US7736905B2 (en) | 2006-03-31 | 2010-06-15 | Biodesix, Inc. | Method and system for determining whether a drug will be effective on a patient with a disease |
JP2013520681A (ja) * | 2010-02-24 | 2013-06-06 | バイオデシックス・インコーポレイテッド | 質量スペクトル分析を用いた、治療薬投与のための癌患者のセレクション |
CN103339509A (zh) | 2011-01-28 | 2013-10-02 | 佰欧迪塞克斯公司 | 针对激素和联合疗法选择转移性乳腺癌病人的预测性测试 |
EP2864792A1 (en) | 2012-06-26 | 2015-04-29 | Biodesix, Inc. | Mass-spectral method for selection, and de-selection, of cancer patients for treatment with immune response generating therapies |
US8718996B2 (en) | 2012-07-05 | 2014-05-06 | Biodesix, Inc. | Method for predicting whether a cancer patient will not benefit from platinum-based chemotherapy agents |
US10037874B2 (en) | 2014-12-03 | 2018-07-31 | Biodesix, Inc. | Early detection of hepatocellular carcinoma in high risk populations using MALDI-TOF mass spectrometry |
WO2017011439A1 (en) | 2015-07-13 | 2017-01-19 | Biodesix, Inc. | Predictive test for melanoma patient benefit from pd-1 antibody drug and classifier development methods |
CN115308145A (zh) | 2016-01-21 | 2022-11-08 | 蛋白质动态解决方案有限公司 | 用于光谱数据分析的方法和系统 |
US11710539B2 (en) | 2016-02-01 | 2023-07-25 | Biodesix, Inc. | Predictive test for melanoma patient benefit from interleukin-2 (IL2) therapy |
WO2017176423A1 (en) | 2016-04-08 | 2017-10-12 | Biodesix, Inc. | Classifier generation methods and predictive test for ovarian cancer patient prognosis under platinum chemotherapy |
WO2018129301A1 (en) * | 2017-01-05 | 2018-07-12 | Biodesix, Inc. | Method for identification of cancer patients with durable benefit from immunotherapy in overall poor prognosis subgroups |
CA3085765A1 (en) | 2017-12-15 | 2019-06-20 | Iovance Biotherapeutics, Inc. | Systems and methods for determining the beneficial administration of tumor infiltrating lymphocytes, and methods of use thereof and beneficial administration of tumor infiltrating lymphocytes, and methods of use thereof |
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DK1540010T3 (da) | 2002-08-06 | 2010-07-26 | Univ Johns Hopkins | Anvendelse af biomarkører til påvisning af ovariecancer |
AU2004248140A1 (en) | 2003-05-30 | 2004-12-23 | Cedars-Sinai Medical Center | Gene expression markers for response to EGFR inhibitor drugs |
US20050267689A1 (en) | 2003-07-07 | 2005-12-01 | Maxim Tsypin | Method to automatically identify peak and monoisotopic peaks in mass spectral data for biomolecular applications |
WO2005010492A2 (en) | 2003-07-17 | 2005-02-03 | Yale University | Classification of disease states using mass spectrometry data |
JP2007531879A (ja) | 2004-03-30 | 2007-11-08 | イースタン バージニア メディカル スクール | 肺癌バイオマーカー |
US20060029574A1 (en) | 2004-08-06 | 2006-02-09 | Board Of Regents, The University Of Texas System | Biomarkers for diagnosis, prognosis, monitoring, and treatment decisions for drug resistance and sensitivity |
JP2008546421A (ja) * | 2005-06-28 | 2008-12-25 | ジェネンテック・インコーポレーテッド | Egfrおよびkras変異 |
US7908091B2 (en) * | 2006-03-17 | 2011-03-15 | Prometheus Laboratories Inc. | Methods of predicting and monitoring tyrosine kinase inhibitor therapy |
US7858390B2 (en) | 2006-03-31 | 2010-12-28 | Biodesix, Inc. | Selection of colorectal cancer patients for treatment with drugs targeting EGFR pathway |
US7736905B2 (en) * | 2006-03-31 | 2010-06-15 | Biodesix, Inc. | Method and system for determining whether a drug will be effective on a patient with a disease |
-
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- 2009-01-20 US US12/321,394 patent/US7858390B2/en not_active Expired - Fee Related
- 2009-11-20 CA CA2744394A patent/CA2744394A1/en not_active Abandoned
- 2009-11-20 ES ES09795836T patent/ES2392805T3/es active Active
- 2009-11-20 KR KR1020117007641A patent/KR101131231B1/ko not_active IP Right Cessation
- 2009-11-20 EP EP09795836A patent/EP2347261B1/en not_active Not-in-force
- 2009-11-20 JP JP2011534536A patent/JP4997345B2/ja not_active Expired - Fee Related
- 2009-11-20 AU AU2009338173A patent/AU2009338173B2/en not_active Ceased
- 2009-11-20 WO PCT/US2009/006267 patent/WO2010085234A1/en active Application Filing
- 2009-12-16 TW TW098143181A patent/TWI366671B/zh not_active IP Right Cessation
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- 2011-03-24 IL IL211944A patent/IL211944A/en not_active IP Right Cessation
- 2011-10-14 HK HK11110985.3A patent/HK1156696A1/xx not_active IP Right Cessation
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US20090170216A1 (en) | 2009-07-02 |
KR101131231B1 (ko) | 2012-03-28 |
IL211944A (en) | 2014-01-30 |
KR20110061605A (ko) | 2011-06-09 |
TWI366671B (en) | 2012-06-21 |
WO2010085234A1 (en) | 2010-07-29 |
JP2012507033A (ja) | 2012-03-22 |
IL211944A0 (en) | 2011-06-30 |
CA2744394A1 (en) | 2010-07-29 |
US7858390B2 (en) | 2010-12-28 |
EP2347261A1 (en) | 2011-07-27 |
AU2009338173B2 (en) | 2012-02-16 |
AU2009338173A1 (en) | 2010-07-29 |
EP2347261B1 (en) | 2012-08-15 |
HK1156696A1 (en) | 2012-06-15 |
TW201028687A (en) | 2010-08-01 |
ES2392805T3 (es) | 2012-12-14 |
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