JP2017502686A - 発現プロファイリングによりリンパ腫のタイプをサブタイピングするための方法 - Google Patents
発現プロファイリングによりリンパ腫のタイプをサブタイピングするための方法 Download PDFInfo
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Abstract
Description
リンパ腫を同定及び分類するための様々なシステムが過去25年間にわたり提案されている。1980年代には、形態学的及び臨床的特徴に基づきリンパ腫を分類する方法としてWorking Formulationが導入された。1990年代には、リンパ腫を分類する際に免疫表現型的特徴及び遺伝的特徴を考慮に入れようと、Revised European-American Lymphoma(REAL)システムが導入された(Harris 1994)。世界保健機関(World Health Organization:WHO)により定められたごく最近のスタンダードは、これら従前のシステムに基づくよう試みられている(Swerdlow et al., eds., WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues, 4th ed., International Agency for Research on Cancer;World Health Organization(2008);及びJaffe, E.S., Pathology & Genetics:Tumours of Haematopoietic and Lymphoid Tissues, WHO Classification of Tumours, Pathology and Genetics series(2001)を参照)。リンパ腫のWHO分類は、腫瘍の形態、免疫表現型、反復性遺伝子異常及び臨床的特徴を含むいくつかの因子に基づく。
本発明は、活性化B細胞様びまん性大細胞型B細胞リンパ腫(activated B cell-like diffuse large B cell lymphoma:ABC DLBCL)対象、胚中心B細胞様びまん性大細胞型B細胞リンパ腫(germinal center B cell-like diffuse large B cell lymphoma:GCB DLBCL)対象、縦隔原発B細胞リンパ腫(primary mediastinal B cell lymphoma:PMBL)対象、バーキットリンパ腫(Burkitt lymphoma:BL)対象、又はマントル細胞リンパ腫(mantle cell lymphoma:MCL)対象のために治療選択肢を選択するための方法を提供する。当該方法は以下を含む:(a)リンパ腫対象由来の生検サンプルから遺伝子発現産物を単離すること;(b)単離された遺伝子発現産物からデジタル遺伝子発現データを得ることであって、ここで、デジタル遺伝子発現データは、遺伝子発現シグネチャー(gene expression signature)における遺伝子についてのデータを含み、該遺伝子発現シグネチャーは、表2に列挙する遺伝子のうち少なくとも1つを含むものであること;(c)遺伝子発現シグネチャーからの遺伝子の加重平均発現レベルを作成し、それにより遺伝子発現シグネチャー値を得ること;(d)該遺伝子発現シグネチャー値に基づき予測スコア(predictor score)を算出すること;(e)(d)の予測スコアに基づき、以下のグループの1つに属するとして対象を分類すること:(i)ABC DLBCL、(ii)GCB DLBCL、(iii)PMBL、(iv)BL、又は(v)MCL;(f)(e)における対象の分類に基づき、該対象のために治療選択肢を選択すること;及び(g)該対象に該治療選択肢を提供すること。
癌細胞又は生検の遺伝子発現プロファイリングは、診断時における癌の分子表現型を反映する。結果として、ゲノム発現パターンにより提供される詳細な像は、新規な系統的癌分類についての根拠を提供し、生存率及び治療に対する反応性のより正確な予測因子を提供する。本発明は、リンパ腫、リンパ性悪性腫瘍又はリンパ増殖性障害をその遺伝子発現パターンに基づき同定、診断及び/又は分類するための方法を開示する。これらの方法を用いて得られた情報は、特定の対象に関して用いられるべき最適な治療アプローチを評価するのに有用であるだろう。
(1)MCLサブモデルが1の値を有する場合、サンプルはMCLとコールされる。
MCLサブモデルが0の値を有する場合、サンプルは、分類不能だがボーダーライン(unclassifiable but borderline)のMCLとコールされる。
MCLサブモデルが-1の値を有する場合、ステップ2に進む。
(2)BL non-mycサブモデルが1の値を有する場合、ステップ3に進む。
BL non-mycサブモデルが0の値を有する場合、サンプルは、分類不能だがボーダーラインのBLとコールされる。
BL non-mycサブモデルが-1の値を有する場合、ステップ4に進む。
(3)BL mycサブモデルが0又は1の値を有する場合、サンプルはBLとコールされる。
BL mycサブモデルが-1の値を有する場合、サンプルは、分類不能だがボーダーラインのBLとコールされる。
(4)PMBLサブモデルが1の値を有する場合、サンプルはPMBLとコールされる。
PMBLサブモデルが0の値を有する場合、サンプルは、分類不能だがボーダーラインのPMBLとコールされる。
PMBLサブモデルが-1の値を有する場合、ステップ5に進む。
(5)ABC/GCBサブモデルが1の値を有する場合、サンプルはABCとコールされる。
ABC/GCBサブモデルが0の値を有する場合、サンプルは未分類(unclassified)DLBCLとコールされる。
ABC/GCBサブモデルが-1の値を有する場合、サンプルはGCBとコールされる。
ABC/GCBサブモデルが1の値を有する場合、サンプルはABCとコールされる。
ABC/GCBサブモデルが0の値を有する場合、サンプルは未分類DLBCLとコールされる。
ABC/GCBサブモデルが-1の値を有する場合、サンプルはGCBとコールされる。
本実施例は、ホルマリン固定パラフィン包埋組織における遺伝子発現プロファイリングを用いて、びまん性大細胞型B細胞リンパ腫(DLBCL)のサブタイプを決定するための方法を実証する。
本実施例は、ホルマリン固定パラフィン包埋組織における遺伝子発現プロファイリングを用いて、侵攻性B細胞非ホジキンリンパ腫(agg-B-NHL)のサブタイプを決定するための方法を実証する。
Claims (8)
- 活性化B細胞様びまん性大細胞型B細胞リンパ腫(ABC DLBCL)対象、胚中心B細胞様びまん性大細胞型B細胞リンパ腫(GCB DLBCL)対象、縦隔原発B細胞リンパ腫(PMBL)対象、バーキットリンパ腫(BL)対象、又はマントル細胞リンパ腫(MCL)対象のために治療選択肢を選択するための方法であって、以下のステップ:
(a)リンパ腫対象由来の生検サンプルから遺伝子発現産物を単離すること;
(b)単離された遺伝子発現産物からデジタル遺伝子発現データを得ることであって、ここで、デジタル遺伝子発現データは、遺伝子発現シグネチャーにおける遺伝子についてのデータを含み、該遺伝子発現シグネチャーは、表2に列挙する遺伝子のうち少なくとも1つを含むものであること;
(c)遺伝子発現シグネチャーからの遺伝子の加重平均発現レベルを作成し、それにより遺伝子発現シグネチャー値を得ること;
(d)該遺伝子発現シグネチャー値に基づき予測スコアを算出すること;
(e)(d)の予測スコアに基づき、以下のグループの1つに属するとして対象を分類すること:(i)ABC DLBCL、(ii)GCB DLBCL、(iii)PMBL、(iv)BL、又は(v)MCL;
(f)(e)における対象の分類に基づき、該対象のために治療選択肢を選択すること;及び
(g)該対象に該治療選択肢を提供すること
を含む、方法。 - びまん性大細胞型B細胞リンパ腫(DLBCL)対象のために治療選択肢を選択するための方法であって、以下のステップ:
(a)DLBCL対象由来の生検サンプルから遺伝子発現産物を単離すること;
(b)単離された遺伝子発現産物からデジタル遺伝子発現データを得ることであって、ここで、デジタル遺伝子発現データは、遺伝子発現シグネチャーにおける遺伝子についてのデータを含み、該遺伝子発現シグネチャーは、以下の遺伝子のうち少なくとも1つを含むものであること:ASB13(GenBankアクセッション番号NM_024701.3)、CCDC50(GenBankアクセッション番号NM_174908.3)、CREB3L2(GenBankアクセッション番号NM_194071.2)、CYB5R2(GenBankアクセッション番号NM_016229.3)、IRF4(GenBankアクセッション番号NM_002460.1)、ISY1(GenBankアクセッション番号NM_020701.2)、ITPKB(GenBankアクセッション番号NM_002221.3)、LIMD1(GenBankアクセッション番号NM_014240.2)、MAML3(GenBankアクセッション番号NM_018717.4)、MME(GenBankアクセッション番号NM_000902.2)、MYBL1(GenBankアクセッション番号XM_034274.14)、PIM2(GenBankアクセッション番号NM_006875.2)、R3HDM1(GenBankアクセッション番号NM_015361.2)、RAB7L1(GenBankアクセッション番号NM_001135664.1)、S1PR2(GenBankアクセッション番号NM_004230.2)、SERPINA9(GenBankアクセッション番号NM_001042518.1)、TNFRSF13B(GenBankアクセッション番号NM_012452.2)、TRIM56(GenBankアクセッション番号NM_030961.1)、UBXN4(GenBankアクセッション番号NM_014607.3)、及びWDR55(GenBankアクセッション番号NM_017706.4);
(c)遺伝子発現シグネチャーからの遺伝子の加重平均発現レベルを作成し、それにより遺伝子発現シグネチャー値を得ること;
(d)該遺伝子発現シグネチャー値に基づき予測スコアを算出すること;
(e)(d)の予測スコアに基づき、以下のグループの1つに属するとして対象を分類すること:(i)活性化B細胞様びまん性大細胞型B細胞リンパ腫(ABC DLBCL)又は(ii)胚中心B細胞様びまん性大細胞型B細胞リンパ腫(GCB DLBCL);
(f)(e)における対象の分類に基づき、該対象のために治療選択肢を選択すること;並びに
(g)該対象に該治療選択肢を提供すること
を含む、方法。 - 治療選択肢が、以下:
CHOP療法、R-CHOP療法、CODOX-M/IVAC療法、R-EPOCH療法 CNS予防、放射線療法、免疫療法、骨髄移植、幹細胞移植、及び/又は手術
の1つ以上を含む、請求項1又は2に記載の方法。 - R-CHOP(リツキサン、シクロホスファミド、ヒドロキシダウノルビシン、オンコビン(ビンクリスチン)及びブレドニゾン)療法で治療するために、胚中心B細胞様びまん性大細胞型B細胞リンパ腫(GCB DLBCL)対象を選択するための方法であって、以下のステップ:
(a)DLBCL対象由来の生検サンプルから遺伝子発現産物を単離すること;
(b)単離された遺伝子発現産物からデジタル遺伝子発現データを得ることであって、ここで、デジタル遺伝子発現データは、遺伝子発現シグネチャーにおける遺伝子についてのデータを含み、該遺伝子発現シグネチャーは、以下の遺伝子のうち少なくとも1つを含むものであること:ASB13(GenBankアクセッション番号NM_024701.3)、CCDC50(GenBankアクセッション番号NM_174908.3)、CREB3L2(GenBankアクセッション番号NM_194071.2)、CYB5R2(GenBankアクセッション番号NM_016229.3)、IRF4(GenBankアクセッション番号NM_002460.1)、ISY1(GenBankアクセッション番号NM_020701.2)、ITPKB(GenBankアクセッション番号NM_002221.3)、LIMD1(GenBankアクセッション番号NM_014240.2)、MAML3(GenBankアクセッション番号NM_018717.4)、MME(GenBankアクセッション番号NM_000902.2)、MYBL1(GenBankアクセッション番号XM_034274.14)、PIM2(GenBankアクセッション番号NM_006875.2)、R3HDM1(GenBankアクセッション番号NM_015361.2)、RAB7L1(GenBankアクセッション番号NM_001135664.1)、S1PR2(GenBankアクセッション番号NM_004230.2)、SERPINA9(GenBankアクセッション番号NM_001042518.1)、TNFRSF13B(GenBankアクセッション番号NM_012452.2)、TRIM56(GenBankアクセッション番号NM_030961.1)、UBXN4(GenBankアクセッション番号NM_014607.3)、及びWDR55(GenBankアクセッション番号NM_017706.4);
(c)遺伝子発現シグネチャーからの遺伝子の加重平均発現レベルを作成し、それにより遺伝子発現シグネチャー値を得ること;
(d)該遺伝子発現シグネチャー値に基づき予測スコアを算出すること;
(e)(d)の予測スコアに基づき、以下のグループの1つに属するとして対象を分類すること:(i)活性化B細胞様びまん性大細胞型B細胞リンパ腫(ABC DLBCL)又は(ii)胚中心B細胞様びまん性大細胞型B細胞リンパ腫(GCB DLBCL);
(f)R-CHOP療法のために、GCB DLBCL対象を選択すること;並びに
(g)GCB DLBCL対象にR-CHOP療法を提供し、ABC DLBCL対象に異なる療法を提供すること
を含む、方法。 - ABC DLBCL対象に、CODOX-M/IVAC療法、R-EPOCH療法 CNS予防、放射線療法、免疫療法、骨髄移植、幹細胞移植、及び/又は手術を提供することを含む、請求項4に記載の方法。
- 遺伝子発現産物が、対象由来のホルマリン固定パラフィン包埋(FFPE)生検サンプルから単離される、請求項1〜6のいずれか一項に記載の方法。
- デジタル遺伝子発現データが、NANOSTRINGTMアッセイを用いて得られる、請求項1〜7のいずれか一項に記載の方法。
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