JPWO2018124153A1 - 抗vegfr−2抗体医薬品の治療効果を予測するバイオマーカー、検査方法、及び検査キット - Google Patents
抗vegfr−2抗体医薬品の治療効果を予測するバイオマーカー、検査方法、及び検査キット Download PDFInfo
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Abstract
Description
(2)(1)記載の検査方法であって、さらに、VEGF−D、sVEGFR−2、SDF−1α、cNRP1の少なくとも1つ以上の濃度を測定することを特徴とする検査方法。
(3)(2)記載の検査方法であって、VEGF−A、及びVEGF-D濃度を測定することを特徴とする検査方法。
(4)(1)〜(3)いずれか1つ記載の検査方法であって、前記抗VEGFR-2抗体医薬品がラムシルマブであることを特徴とする検査方法。
(5)(1)〜(4)いずれか1つ記載の検査方法であって、前記試料が血液、血漿、又は血清であることを特徴とする検査方法。
(6)抗VEGFR-2抗体医薬品投与による治療効果予測及び/又は予後予測を検査するためのキットであって、患者試料中のVEGF−A濃度を測定するための試薬を含むことを特徴とする検査キット。
(7)(6)記載のキットであって、さらに、VEGF−D、sVEGFR−2、SDF−1α、cNRP1の少なくとも1つ以上の濃度を測定するための試薬を含むことを特徴とする検査キット。
(8)(7)記載のキットであって、VEGF−A、及びVEGF-D濃度を測定するための試薬を含むことを特徴とするキット。
(9)(6)〜(8)いずれか1つ記載の検査キットであって、前記抗VEGFR-2抗体医薬品がラムシルマブであることを特徴とする検査キット。
(10)VEGF−A、VEGF-D、sVEGFR−2、SDF−1α、cNRP1のいずれかであることを特徴とする抗VEGFR-2抗体医薬品投与による治療効果予測及び/又は予後予測のためのバイオマーカー。
(11)前記抗VEGFR-2抗体医薬品がラムシルマブであることを特徴とする(10)記載のバイオマーカー。
公益財団法人がん研究会有明病院でインフォームドコンセントが得られた患者を対象とし、以下の基準にしたがって、解析対象を選択した。
選択基準
以下の条件を満たす症例を対象とする。
1)病理組織学的に切除不能進行再発胃癌の診断がついている。
2)2次治療以降にラムシルマブ併用化学療法、ラムシルマブ単剤療法およびタキサン(パクリタキセル)単独療法が施行される症例。
3)腫瘍臓器機能が保たれている症例。
4)重篤な出血、血栓症、蛋白尿および高血圧症等が合併していない症例。
5)書面にて同意が得られている症例。
除外基準
1)本人からの同意が得らない症例。
2)本研究への参加が不適切と判断された症例。
図1に示すように、ラムシルマブ(rum)とパクリタキセル(Pac)併用、あるいはラムシルマブ単独で投与を行った。パクリタキセル/ラムシルマブ併用療法はパクリタキセル(4週を1サイクルとして80mg/m2(体表面積)を1日目、8日目、15日目)に加えて2週おきにラムシルマブ8mg/kgを投与する。ラムシルマブ単独で投与する場合には2週おきにラムシルマブ8mg/kgを投与する。治療は原病増悪もしくは用量調節困難な重篤な有害事象が発現するまで継続する。
ラムシルマブの初回治療開始前、初回治療開始後8日目(以下、D8と記載する場合もある。)、病状増悪期(PD:Progressive Disease)に約5mLの血液を採取し、血漿を分離して−80℃で保存する。候補としたサイトカインをELISAで測定した。
Claims (11)
- 抗VEGFR-2抗体医薬品投与による治療効果予測及び/又は予後予測の検査方法であって、
患者より採取された治療開始前、及び治療開始後早期の試料中のVEGF−A濃度を測定することを特徴とする検査方法。 - 請求項1記載の検査方法であって、
さらに、VEGF−D、sVEGFR−2、SDF−1α、cNRP1の少なくとも1つ以上の濃度を測定することを特徴とする検査方法。 - 請求項2記載の検査方法であって、
VEGF−A、及びVEGF-D濃度を測定することを特徴とする検査方法。 - 請求項1〜3いずれか1項記載の検査方法であって、
前記抗VEGFR-2抗体医薬品がラムシルマブであることを特徴とする検査方法。 - 請求項1〜4いずれか1項記載の検査方法であって、
前記試料が血液、血漿、又は血清であることを特徴とする検査方法。 - 抗VEGFR-2抗体医薬品投与による治療効果予測及び/又は予後予測を検査するためのキットであって、
患者試料中のVEGF−A濃度を測定するための試薬を含むことを特徴とする検査キット。 - 請求項6記載のキットであって、
さらに、VEGF−D、sVEGFR−2、SDF−1α、cNRP1の少なくとも1つ以上の濃度を測定するための試薬を含むことを特徴とする検査キット。 - 請求項7記載のキットであって、
VEGF−A、及びVEGF-D濃度を測定するための試薬を含むことを特徴とするキット。 - 請求項6〜8いずれか1項記載の検査キットであって、
前記抗VEGFR-2抗体医薬品がラムシルマブであることを特徴とする検査キット。 - VEGF−A、VEGF-D、sVEGFR−2、SDF−1α、cNRP1のいずれかであることを特徴とする抗VEGFR-2抗体医薬品投与による治療効果予測及び/又は予後予測のためのバイオマーカー。
- 前記抗VEGFR-2抗体医薬品がラムシルマブであることを特徴とする請求項10記載のバイオマーカー。
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