JP3974938B2 - タキサン誘導体を含有する抗腫瘍組成物 - Google Patents
タキサン誘導体を含有する抗腫瘍組成物 Download PDFInfo
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Description
価値ある抗腫瘍特性および抗白血病特性を有するタキソール、タキソテレおよびそれらの同族体は、卵巣癌、乳癌または肺癌の処置において特に有用である。
タキソール、タキソテレおよびそれらの同族体の製造法は、例えば、ヨーロッパ特許EP0,253,738およびヨーロッパ特許EP0,253,739並びに国際出願PCT WO 92/09,589の主題をなす。
一般的には、使用される投与量は処置する患者に特有の要素に依存し、1〜10mg/kgの間で腹腔内投与され、または1〜3mg/kgの間で静脈内投与される。
タキソール、タキソテレおよびそれらの誘導体を、抗癌処置において治療上有用であり且つタキソール誘導体の機構と同一もしくは相異なる機構を有する少なくとも1種の物質と組み合わせて投与する時に、それらの効果が相当改良されることを見いだし、そしてそれが本発明の主題をなす。
タキソール、タキソテレおよびそれらの誘導体と組み合わせて使用することができる物質の中では、アルキル化剤、例えばシクロホスファミド、イソスファミド、メルファラン、ヘキサメチルメラミン、チオテパもしくはダカルバジン;代謝拮抗物質(antimetabolites)、例えばピリミジン同族体、例えば5−フルオロウラシルおよびシタラビンもしくはその同族体、例えば2−フルオロデオキシシチジン;または葉酸同族体、例えばメトトレキセート、イダトレキセートもしくはトリメトレキセート;ビンカアルカロイド類、例えばビンブラスチンもしくはビンクリスチンまたはそれらの合成同族体、例えばナベルビンを包含する紡錘毒(spindle poisons);またはエストラムスチンもしくはタキソイド類;エピドフィロトキシン類、例えばエトポシドもしくはテニポシド;抗生物質、例えばダウノルビシン、ドキソルビシン、ブレオマイシンもしくはマイトマイシン;酵素、例えばL−アスパラギナーゼ;トポイソメラーゼ阻害剤、例えばGPT−11およびトポテカンから選択されるカンプトテシン誘導体またはピリドベンゾインドール誘導体;並びに種々の物質、例えばプロカルバジズン、ミトキサントロン、白金配位錯体、例えばシスプラチンもしくはカルボプラチン;並びに生物学的応答改良剤または成長因子阻害剤(growth factor inhibitors)、例えばインターフェロン類およびインターロイキン類が挙げられる。
さらに、生成物の活性は使用される投与量に依存するため、比較的高い投与量を使用すること並びに例えばG−CSFもしくはGM−CSFの如き造血型の成長因子またはある種のインターロイキン類をタキソール、タキソテレおよびそれらの誘導体と組み合わせることにより或いはそれらの組み合わせ物を他の治療上活性な物質と組み合わせることにより毒性現象を減少させるか或いはそれらの活性開始を遅らせながら活性を増加させることもできる。
本発明に従う組み合わせ物または会合体は多面耐性現象すなわち「複合薬品耐性」を回避して遅らせることができる。
より特に、本発明はタキソール、タキソテレおよびそれらの誘導体とビンカアルカロイド類、シクロホスファミド、5−フルオロウラシル、ドキソルビシン、シスプラチンおよびエトポシドの組み合わせ物に関する。
本発明に従う組み合わせ物の改良された効果は治療相乗性の測定により示される。
本発明に従う組み合わせ物の効果は各成分の活性を加算することによっても特徴づけられる。
組み合わせ物は最適投与量で使用される一方または他方の成分より治療上優れているなら、それは治療相乗性を示すこととなる[T.H.コルベット(CORBETT)他、キャンサー・トリートメント・レポーツ(Cancer Treatment Reports)、66、1187(1982)]。
組み合わせ物の効果を示すためには、当該研究では最大許容投与量の組み合わせ物を別個の各最大許容投与量の成分と比較することが必要である。この効果は、例えば、log10死滅細胞により定量化することができ、それは下記式:
log10死滅細胞=T−C(日数)/3.32×Td
[式中、T−Cは細胞が成長するのにかかる時間を表し、それは処置された群(T)の腫瘍および処置された群(C)の腫瘍が予め決められた値(例えば1g)に達するための平均時間(日数)であり、そしてTdは腫瘍の容積が対象動物中で二倍になるのに必要な時間(日数)を表す[T.H.コルベット他、キャンサー(Cancer)、40、2660.2680(1977);F.M.シャベル(SCHABEL)他、キャンサー・ドラッグ・デベロップメント(Cancer Drug Development)、B部、メソッズ・イン・キャンサー・リサーチ(Methods in Cancer Research)、17、3−51、ニューヨーク、アカデミック・プレス・インコーポレーテッド(Academic Press Inc.)、(1979)]。log10死滅細胞が0.7より大きいかまたは等しいと生成物は活性であると考えられる。log10死滅細胞が2.8より大きいと生成物は非常に活性であると考えられる。
log10死滅細胞が単独投与時の最も良い成分のlog10死滅細胞の値より大きい時には、それ自体の最大許容投与量で使用される組み合わせ物は治療相乗性を示し、そこでは各成分は一般的にその最大許容投与量を越えない投与量で存在するであろう。
固体腫瘍に対する組み合わせ物の効果は下記の方法で実験的に測定できる:
実験にかけられた動物、一般的にはハツカネズミ、に0日目に30〜60mgの腫瘍断片を左右対称的に皮下移植する。腫瘍を有する動物を種々の処置および対照処置を受ける前に混ぜる。進行した腫瘍の処置の場合には、腫瘍を希望する寸法となるまで成長させるが、不充分に成長した腫瘍を有する動物は除く。選択された動物を不規則的に分布させて、処置および対照処置を受けさせる。腫瘍に対する特異的効果から毒性効果を分離できるようにするために、腫瘍のない動物も腫瘍を有する動物と同じ処置を受けさせる。腫瘍の型によるが、化学療法を一般的には移植後3−22日に開始し、そして動物を毎日観察する。別の動物群を最大体重減少が得られるまで1週間に3もしくは4回体重測定し、そして群を次に試験終了まで少なくとも1週間に1回体重測定する。
腫瘍が約2gに達するまでまたは腫瘍が2gに達する前に死亡するなら動物が死亡するまで、腫瘍を1週間に2もしくは3回測定する。動物を死亡時に解剖する。
抗腫瘍活性を記録された種々のパラメーターに従い測定する。
白血病に対する組み合わせ物の研究のためには、動物に特定数の細胞を移植し、そして対照物に比べての処置されたハツカネズミの生存時間における増加により抗腫瘍活性を測定する。P388白血病の場合には、生存時間の増加が27%より多いと生成物は活性であると考えられ、そしてそれが75%より多いと非常に活性であると考えられる。
タキソテレおよび種々の化学療法剤、例えばシクロホスファミド(アルキル化剤)、5−フルオロウラシル(代謝拮抗物質)、エトポシド(半合成ポドフィロトキシン剤)およびビンクリスチン(ビンカアルカロイド)の組み合わせ物で得られた結果は下表に示され、該組み合わせ物はそれらの最適投与量で使用された。
本発明は本発明に従う組み合わせ物を含有する薬剤組成物にも関する。
組み合わせ物を構成する生成物は同時に、別個にまたはある時間にわたり間隔をあけて投与して組み合わせ物の最大効果を得ることができ、各々の投与期間は迅速投与から連続的注射にわたり変動させることができる。
その結果、本発明の目的のためには組み合わせ物は成分の物理的会合体により得られるものだけでなく同時にまたはある時間にわたり間隔をあけられた別個投与に限定されるものではない。
本発明に従う組み合わせ物は好ましくは非経口的に投与しうる組成物である。しかしながら、これらの組成物を局所的領域療法の場合に経口的にまたは腹腔内に投与することもできる。
非経口的投与のための組成物は一般的に薬学的に許容可能な殺菌性溶液または懸濁液であり、それらは場合により使用する時に必要に応じて調合することができる。非−水性溶液または懸濁液の調合のためには、中性植物油、例えばオリーブ油、ゴマ油または液体石油または注射用有機エステル類、例えばオレイン酸エチルを使用することができる。殺菌性水溶液は生成物の水中溶液からなることができる。水溶液はpHが適切に調節されるなら静脈投与に適しており、そして該溶液は例えば充分量の塩化ナトリウムまたはグルコースで等張性にされる。殺菌は加熱することによりまたは組成物に悪影響を与えない他の手段により実施しうる。組み合わせ物はリポソームの形態または例えばシクロデキストリン類もしくはポリエチレングリコール類の如き担体との会合体の形態をとることもできる。
経口的または腹腔内投与のための組成物は好適には水性懸濁液または溶液である。
本発明に従う組み合わせ物においては、その成分の適用は同時であっても、別個であってもまたはある時間にわたり間隔をあけてもよく、タキサン誘導体の量が組み合わせ物の10〜90%であることが特に有利であり、この含有量は組み合わされる物質の性質、求められる効果および処置しようとする癌の性質に応じて変動させうる。
本発明に従う組み合わせ物は乳癌、卵巣癌または肺癌の処置において特に有用である。特に、それらは成分を単独使用時より相当低い投与量で使用できる利点を与える。
下記の実施例は本発明に従う組み合わせ物を説明するものである。
実施例
静脈投与用の100mgのタキソテレを含有する10−cm3アンプルを一般的技術に従い製造した。
静脈投与用の100mgのエトポシドを含有する5−cm3アンプルを一般的技術に従い製造した。
これらの溶液を、適当な希釈後に、灌流により同時に投与した。
部分的もしくは全体的な緩解または治癒があるまで処置を1日に5、6回または1週に5、6回繰り返した。
Claims (4)
- タキソテレ(Taxotere)と、シクロホスファミド、エトポシドおよび5−フルオロウラシルから選択される少なくとも1種の物質とを組み合わせてなる抗腫瘍薬。
- 造血型の成長因子をさらに含んでなることを特徴とする請求の範囲第1項に記載の抗腫瘍薬。
- 10〜90重量%のタキソテレを含有することを特徴とする請求の範囲第1または2項に記載の抗腫瘍薬。
- 抗癌治療において、同時に、別個にまたは時間間隔をおいて使用するための組み合わせ調剤としての、タキソテレと、シクロホスファミド、エトポシドおよび5−フルオロウラシルから選択される少なくとも1種の物質とを含有する製品。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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FR92/13525 | 1992-11-10 | ||
FR9213525A FR2697752B1 (fr) | 1992-11-10 | 1992-11-10 | Compositions antitumorales contenant des dérivés du taxane. |
PCT/FR1993/001096 WO1994010995A1 (fr) | 1992-11-10 | 1993-11-08 | Compositions antitumorales contenant des derives du taxane |
Publications (2)
Publication Number | Publication Date |
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JPH08503205A JPH08503205A (ja) | 1996-04-09 |
JP3974938B2 true JP3974938B2 (ja) | 2007-09-12 |
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Application Number | Title | Priority Date | Filing Date |
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JP51178394A Expired - Lifetime JP3974938B2 (ja) | 1992-11-10 | 1993-11-08 | タキサン誘導体を含有する抗腫瘍組成物 |
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EP (4) | EP1295597A1 (ja) |
JP (1) | JP3974938B2 (ja) |
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AT (2) | ATE165002T1 (ja) |
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FI (1) | FI952248A0 (ja) |
FR (1) | FR2697752B1 (ja) |
GR (2) | GR3026666T3 (ja) |
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RU (1) | RU2131250C1 (ja) |
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TW (1) | TW386877B (ja) |
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1992
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