JP2022525040A - 非小細胞肺がんの女性非喫煙者の処置方法 - Google Patents
非小細胞肺がんの女性非喫煙者の処置方法 Download PDFInfo
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Abstract
Description
米国がん協会は、2018年の米国における234,030人の新規肺がん症例のうち、112,350人が女性であったと推定している。NSCLCは、肺がん(肺がんのおよそ85%)の最もよく見られる形態であり、有病率の高い順で腺がん、扁平上皮がん及び大細胞がんの3つのサブタイプがある。全ての肺がんの約10~15%は、喫煙未経験者に発生し、喫煙未経験者の肺がんは、がん関連死亡率の主な原因の1つとなっている。この疾患の影響を考慮すると、喫煙未経験者における肺がんの記述疫学に関して利用可能な情報がほとんどないのは驚くべきことである。がん登録も日常的に収集される死亡証明書も生涯の喫煙歴に関する信頼できる情報を提供するものではないので、一般的な人口統計はほとんど情報価値がない。さらに、近親者から、又は医療記録における喫煙に関する報告は不完全であり、信頼できないことが多い。大規模コホート研究のみが、喫煙未経験者における年齢及び性別特異的肺がん率の合理的な精度での測定を可能にするもので、これらは一般に、発生率ではなく死亡率を研究している。現在、非小細胞肺がんすなわちNSCLCを有する非喫煙者の増大している適応症について特に承認された治療法はない。
一実施形態は、2,2’-ジチオ-ビス-エタンスルホナート又は塩が非小細胞肺がん腫の患者に治療有効量で投与される、非小細胞肺がん腫又は非小細胞肺がん腫の女性患者における生存時間を増加させる方法を含む。一例において、2,2’-ジチオ-ビス-エタンスルホナート又はその塩は、1つ又はそれ以上の化学療法剤の投与の前に、それと同時に、又はそれに続いて投与される場合がある。一例では、女性患者は非喫煙者である。別の特定の実施形態では、本方法は、非小細胞肺がんに罹患している女性で非喫煙者の患者を処置するために使用される。
以下の例は、具体例を挙げる目的のために含まれ、本発明の範囲を限定することを意図してはいない。
標的が女性において過剰発現されることが多いNSCLC腺がんにはいくつかの経路があり、2,2’-ジチオ-ビス-エタンスルホン酸二ナトリウム塩により調節される。したがって、2,2’-ジチオ-ビス-エタンスルホン酸二ナトリウム塩は、以下の重要な経路内で標的を定める:1)重要なシグナル伝達経路に関与するキナーゼ(ALK、ROS、MET、EGFR)、2)DNAの合成及び修復に重要な酵素(ERCC1、RNR1、RNR2)、並びに3)細胞の酸化還元状態の調節に重要な酵素及びタンパク質(Trx、Prx、Grx、PDI)。2,2’-ジチオ-ビス-エタンスルホン酸二ナトリウム塩によって標的とされ、かつ調節される突然変異及び過剰発現は、肺腺がんを有する女性、特に非喫煙者においてより多く起こると思われる。
図1は、第III相臨床試験ID DMS32212R(ClinicalTrials.gov識別番号:NCT00966914)からのシスプラチン/パクリタキセルを投与されたNSCLC腺がん患者の遡及的サブグループ分析を示し、全体的生存率の改善によって示されるように、2,2’-ジチオ-ビス-エタンスルホナート処置群の女性、非喫煙者及び女性非喫煙者について顕著に生存率が高いことを示した。
Claims (20)
- 非小細胞肺がんに罹患している女性患者を処置する方法であって、2,2’-ジチオ-ビス-エタンスルホナート又はその医薬的に許容され得る塩の組成物を、その投与を必要とする患者に投与する段階を含む方法。
- 前記患者が非喫煙者である、請求項1に記載の方法。
- 前記非小細胞肺がんが肺腺がんである、請求項2に記載の方法。
- 非小細胞肺がんの処置に有用な第2の治療薬を、その投与を必要とする患者に同時投与するさらなる段階をさらに含む、請求項1に記載の方法。
- 前記第2の治療薬がパクリタキセル又はシスプラチンである、請求項4に記載の方法。
- 前記第2の治療薬が、カンプトテシン誘導体、パクリタキセル、ドセタキセル、エポチロンB、5-FU、ゲムシタビン、オキサリプラチン、シスプラチナム、カルボプラチン、メルファラム、ダカルバジン、テモゾロミド、ドキソルビシン、イマチニブ、エルロチニブ、ベバシズマブ及びセツキシマブから選択される、請求項4に記載の方法。
- 前記非小細胞肺がんが、EGFR変異陽性非小細胞肺がんである、請求項4に記載の方法。
- 一用量あたり10~40グラムの2,2’-ジチオ-ビス-エタンスルホナート又は医薬的に許容され得る塩が患者に投与される、請求項1に記載の方法。
- 前記患者が喫煙未経験者である、請求項1に記載の方法。
- 女性患者において進行及び/又は転移性非小細胞肺がんを処置する方法であって、二次治療又はより高次の治療を受けた非小細胞肺がんを有するヒト患者に、2,2’-ジチオ-ビス-エタンスルホナート又はその医薬的に許容され得る塩及び第2の治療薬の医薬組成物を投与することを含む方法。
- 非小細胞肺がんがEGFR変異陰性非小細胞肺がんである、請求項10に記載の方法。
- 前記第2の治療薬がパクリタキセル又はシスプラチンである、請求項10に記載の方法。
- 非小細胞肺がんに罹患している女性の非喫煙患者を処置する方法であって、
a.前記患者が非喫煙者であるかどうかを判定する段階、及び
b.前記非喫煙者に、2,2’-ジチオ-ビス-エタンスルホナート、又はその医薬的に許容され得る塩の組成物を投与する段階
を含む方法。 - EGFR変異体について試験することをさらに含む、請求項13に記載の方法。
- 非小細胞肺がんの処置に有用な第2の治療薬を、投与を必要とする患者に同時投与するさらなる段階をさらに含む、請求項13に記載の方法。
- 前記第2の治療薬がパクリタキセル又はシスプラチンである、請求項15に記載の方法。
- 前記第2の治療薬が、カンプトテシン誘導体、パクリタキセル、ドセタキセル、エポチロンB、5-FU、ゲムシタビン、オキサリプラチン、シスプラチナム、カルボプラチン、メルファラム、ダカルバジン、テモゾロミド、ドキソルビシン、イマチニブ、エルロチニブ、ベバシズマブ及びセツキシマブから選択される、請求項15に記載の方法。
- 2,2’-ジチオ-ビス-エタンスルホナート又はその医薬的に許容され得る塩の範囲の有効量が、1用量当たり0.01~10グラムの範囲である、請求項16に記載の方法。
- 前記非小細胞肺がんが、ALK、ROS、MET、EGFRについて、ALK、ROS、MET、EGFR変異陽性非小細胞肺がんであると判定することをさらに含む、請求項13に記載の方法。
- 前記非小細胞肺がんが、ALK遺伝子及びROS1遺伝子の融合/再編成、EGFR遺伝子の変異/欠失、並びにMET/HGFR遺伝子の増幅を含むと判定することを含む、請求項13に記載の方法。
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