JP6005076B2 - 限局的光線力学的治療法 - Google Patents
限局的光線力学的治療法 Download PDFInfo
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- KCIDZIIHRGYJAE-YGFYJFDDSA-L dipotassium;[(2r,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl] phosphate Chemical class [K+].[K+].OC[C@H]1O[C@H](OP([O-])([O-])=O)[C@H](O)[C@@H](O)[C@H]1O KCIDZIIHRGYJAE-YGFYJFDDSA-L 0.000 description 3
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- GPIVNYFDHQDTDZ-GDUCSYRESA-L oih1h7cjcj Chemical compound [Pd+2].[N-]1C(C=C2[C@H]([C@H](CCC(O)=O)C(=N2)C2=C3[N-]C(=C4)C(C)=C3C(=O)[C@@H]2C(=O)OC)C)=C(C)C(C(C)=O)=C1C=C1[C@H](C)[C@@H](CC)C4=N1 GPIVNYFDHQDTDZ-GDUCSYRESA-L 0.000 description 1
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Classifications
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- A61N5/00—Radiation therapy
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- A61N5/062—Photodynamic therapy, i.e. excitation of an agent
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
- A61K41/0057—Photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N5/0601—Apparatus for use inside the body
- A61N5/0603—Apparatus for use inside the body for treatment of body cavities
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
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- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
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- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
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- A61N2005/0612—Apparatus for use inside the body using probes penetrating tissue; interstitial probes
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- A—HUMAN NECESSITIES
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- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N2005/063—Radiation therapy using light comprising light transmitting means, e.g. optical fibres
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Description
光密度指数(「LDI」)は、以下のように算出される
LDI=Σ(n)L/PTV
[式中、Σ(n)Lは、すべての照射ファイバーの全長であり、PTVは、計画された治療体積である]。通常の実施形態では、すべての照射ファイバーの長さは、センチメートルで測定され、計画された治療体積は、ミリリットルで測定される。
治療に有効なLDI閾値は、治療に先立って決定される。通常の実施形態では、治療に有効なLDI閾値は、過去の臨床データから事前に決定される。
治療有効性を予測するためのLDIパラメータの有効性は、光感作薬、パラジウム31−オキソ−l5−メトキシカルボニルメチル−ロドバクテリオクロリン 131−(2−スルホエチル)アミド(WST11;TOOKAD(登録商標)Soluble(商標))をジカリウム塩として使用して実証された。
Mは、2H又は二価のPd、Pt、Co、Sn、Ni、Cu、Zn及びMnならびに三価のFe、Mn及びCrから選択される金属原子を表し;
R1、R2及びR4は、各々独立に、Y−R5であり;
Yは、O、S又はNR5R6であり;
R3は、−CH=CH2、−C(=O)−CH3、−C(=O)−H、−CH=NR7、−C(CH3)=NR7、−CH2−OR7、−CH2−SR7、−CH2−NR7R’7、−CH(CH3)−OR7、−CH(CH3)−SR7、−CH(CH3)−NR7R’7、−CH(CH3)Hal、−CH2−Hal、−CH2−R7、−CH=CR7R’7、−C(CH3)=CR7R’7、−CH=CR7Hal、−C(CH3)=CR7Hal及び−C≡CR7から選択され;
R5、R6、R7及びR’7は、各々独立に、Hであるか、又は、以下からなる群から選択される:
(a)任意に1個以上のヘテロ原子、炭素環式若しくは複素環式部分を含有していてもよく、及び/又は、任意にハロゲン、オキソ、OH、SH、CHO、NH2、CONH2、負に帯電している基及び生理学的pHで負に帯電している基に変換される酸性基からなる群から選択される1個以上の官能基によって置換されていてもよい、C1−C25ヒドロカルビル(hydrocarbyl);
(b)アミノ酸、ペプチド又はタンパク質の残基;及び
(c)YがO又はSである場合は、R5は、さらにR8 +であってもよく;
mは、0又は1であり;
R8 +は、H+又は陽イオンであるが、
ただし、
(i)R5、R6、R7及びR’7のうち少なくとも1つ、好ましくは2つは、負に帯電した基によって、又は生理学的pHで負に帯電した基に変換される酸性基によって置換された上記(a)において定義されるような炭化水素鎖であるか、又は
(ii)R1、R2及びR4のうち少なくとも1つ、好ましくは2つは、OH、SH、O−R8 +若しくはS−R8 +であるか;又は
(iii)R1、R2及びR4のうち少なくとも1つは、OH、SH、O−R8 +若しくはS−R8 +であり、R5、R6、R7及びR’7のうち少なくとも1つは、負に帯電した基によって、若しくは生理学的pHで負に帯電した基に変換される酸性基によって置換された炭化水素鎖であるか;又は
(iv)R1、R2及びR4のうち少なくとも1つは、OH、SH、O−R8 +若しくはS−R8 +であり、R5、R6、R7及びR’7のうち少なくとも1つは、アミノ酸、ペプチド、若しくはタンパク質の残基であるか;又は
(v)R5、R6、R7及びR’7のうち少なくとも1つは、負に帯電した基によって、若しくは生理学的pHで負に帯電した基に変換される酸性基によって置換された炭化水素鎖であり、R5、R6、R7及びR’7のうち少なくとも1つは、アミノ酸、ペプチド、若しくはタンパク質の残基であるが、
Mが、定義されるとおりであり、R3が、−C(=O)CH3であり、R1がOH若しくはOR8 +であり、R2が−OCH3である式Iの化合物、及びMが2Hであり、R3が−C(=O)CH3であり、R1、R2及びR4が、OHであり、mが0又は1である式IIの化合物は除外する。
Mは、2H、二価のPd、Cu若しくはZn又は三価のMnを表し;
R1は、−O−R8 +、−NH−(CH2)n−SO3 −R8 +、−NH−(CH2)n−COO−R8 +;−NH−(CH2)n−PO3 2−(R8 +)2;又はY−R5であり、式中、Yは、O、S若しくはNHであり、R5は、アミノ酸、ペプチド又はタンパク質の残基であり;
R2は、メトキシ、エトキシ、プロポキシ、ブトキシなどのC1−C6アルコキシ、より好ましくは、メトキシであり;
R3は、−C(=O)−CH3、−CH=N−(CH2)n−SO3 −R8 +;−CH=N−(CH2)n−COO− 8 +;−CH=N−(CH2)n−PO3 2−(R8 +)2;−CH2−NH−(CH2)n−SO3 −R8 +;−NH−(CH2)n−COO−R8 +;又は−NH−(CH2)n−PO3 2−(R8 +)2であり;
R4は、−NH−(CH2)n−SO3 −R8 +;−NH−(CH2)n−COO−R8 +;−NH−(CH2)n−PO3 2(R8 +)2であり;R8 +は、K+、Na+、Li+、NH4 +などの一価の陽イオン、より好ましくは、K+であり;
mは1であり、nは、1〜10の整数であり、好ましくは、2又は3である。
Mは、二価のPdであり;
R1は、−O−R8 +、−NH−(CH2)n−SO3 −R8 +又はY−R5であり、式中、Yは、O、S又はNHであり、R5は、アミノ酸、ペプチド又はタンパク質の残基であり;
R2は、C1−C6アルコキシ、好ましくは、メトキシであり;
R3は、−C(=O)−CH3、−CH=N−(CH2)n−SO3 −R8 +又は−CH2−NH−(CH2)n−SO3 −R8 +であり;
R4は、−NH−(CH2)n−SO3 −R8 +;NH−(CH2)n−COO−R8 +;NH−(CH2)n−PO3 2−(R8 +)2であり;R8 +は、一価の陽イオン、好ましくは、K+であり;
mは、1であり、nは、2又は3である。
送達される光の波長は、選択された光感作薬にとって適当なものとなり、通常の実施形態では、薬剤の吸収極大に近似する。
材料及び方法
パラジウム31−オキソ−l5−メトキシカルボニルメチル−ロドバクテリオクロリン 131−(2−スルホエチル)アミドジカリウム塩を、開示内容が参照によりその全文が本明細書に組み込まれるWO2004/045492及びUS2006/0142260に記載のとおりに調製した。
2つの研究において、90人の男性を、4mg/kgのTOOKAD(登録商標)Soluble用量及び200J/cmの光用量を用いて治療した。これらのうち89人が、LDIについて分析可能であった。1のLDI閾値を使用する結果を以下に示す。
LDIは、1週間のMRI及び6ヶ月の生検で見られる効果両方に関して、TOOKAD(登録商標)Soluble VTPを使用する治療効果の信頼できる予測因子である。
Claims (8)
- コンピュータが読み込み可能な具体化されたプログラムコードを有する、コンピュータが使用可能な媒体を含むプログラム製品であって、
コンピュータが読み込み可能なプログラムコードが、前立腺癌の光線力学的治療用の、患者に特異的な治療計画を作り出す方法を遂行するコンピュータによって実行されるように適応し
該方法が、計画された治療体積(PTV)及び事前に決定された治療に有効な光密度指数(LDI)閾値に基づいて、有効な治療に必要な照射ファイバーの全長を設定することを含み、
前記の治療に有効なLDI閾値が、同一光感作薬の使用から得られた過去のデータから事前に決定され、そして、
前記の照射ファイバーの全長が、PTV及び前記の事前に決定された治療に有効なLDI閾値の積又はそのスカラー倍として算出される、プログラム製品。 - 治療に有効なLDI閾値が、同一全身投与量で投与された同一光感作薬の使用から得られた過去のデータから事前に決定される、請求項1に記載のコンピュータプログラム製品。
- 治療に有効なLDI閾値が、同一全身投与量で投与された同一光感作薬及び同一波長の送達される光の使用から得られた過去のデータから事前に決定される、請求項2に記載のコンピュータプログラム製品。
- 治療に有効なLDI閾値が、同一全身投与量で投与された同一光感作薬、同一照射光波長及び同一光密度の使用から得られた過去のデータから事前に決定される、請求項3に記載のコンピュータプログラム製品。
- 光線力学的治療による患者の治療を計画するために、コンピュータによって遂行される補助方法であって、
予め決定された光感作薬が、患者に投与され、次いで、治療領域への挿入部の長さにわたって挿入できるように設計された少なくとも1つの照射ファイバーを通る予め決定された波長の照射に付されなければならず、
以下のステップ:
治療領域の計画された治療体積(PTV)を算出するステップ;
治療に有効な光密度指数(LDI)閾値を決定するステップであって、治療に有効なLDI閾値が同一光感作薬の使用から得られた過去のデータから事前に決定されるステップ;次いで、
計画された治療体積(PTV)及び前記の事前に決定された治療に有効な光密度指数閾値に基づいて、治療に使用されるべき前記の少なくとも1つの照射ファイバーの全長を設定するステップであって、照射ファイバーの全長がPTV及び前記の事前に決定された治療に有効なLDI閾値の積又はそのスカラー倍として算出されるステップ、
を含むことを特徴とする補助方法。 - 治療に有効なLDI閾値が、同一全身投与量で投与された同一光感作薬の使用から得られた過去のデータから事前に決定される、請求項5に記載の補助方法。
- 治療に有効なLDI閾値が、同一全身投与量で投与された同一光感作薬及び同一波長の送達される光の使用から得られた過去のデータから事前に決定される、請求項6に記載の補助方法。
- 治療に有効なLDI閾値が、同一全身投与量で投与された同一光感作薬、同一照射光波長及び同一光密度の使用から得られた過去のデータから事前に決定される、請求項7に記載の補助方法。
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PCT/EP2012/054060 WO2012123343A1 (en) | 2011-03-11 | 2012-03-09 | Focal photodynamic therapy methods |
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PT2683441T (pt) | 2016-12-22 |
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