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首页> 外文期刊>Expert opinion on biological therapy >Catumaxomab--trifunctional anti-EpCAM antibody used to treat malignant ascites.
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Catumaxomab--trifunctional anti-EpCAM antibody used to treat malignant ascites.

机译：Catumaxomab-用于治疗恶性腹水的三功能抗EpCAM抗体。

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IMPORTANCE OF THE FIELD: Malignant ascites is a sign of advanced tumour growth and is associated with significant morbidity and a poor prognosis with a median survival time of a few months. Paracentesis is a recommended treatment for malignant ascites, but can cause complications, for example infections, injury of abdominal organs, persistent leakage of ascites, and haematoma/haemorrhage. The European Medicines Agency (EMA) approved the use of a trifunctional bispecific antibody, catumaxomab (Removab), for the intraperitoneal (i.p.) treatment of malignant ascites in April 2009. AREAS COVERED IN THIS REVIEW: This review describes the tailored preclinical and the clinical development of catumaxomab for the i.p. treatment of malignant ascites from 1998 to 2009. WHAT THE READER WILL GAIN: Relevant toxicology and pharmacokinetic findings are reported as well as main results of a large international Phase II/III study that was pivotal in the EMA approval of catumaxomab. TAKE HOME MESSAGE: Catumaxomab i.p. treatment results in a significant and clinically relevant improvement of puncture-free survival time and time to first need for puncture compared with paracentesis alone. The related side effects of catumaxomab treatment are predictable and related to the antibody's mode of action.
机译：领域的重要性：恶性腹水是晚期肿瘤生长的迹象，并与明显的发病率和不良的预后相关，中位生存时间为几个月。腹腔穿刺术是恶性腹水的推荐治疗方法，但会引起并发症，例如感染，腹腔器官损伤，腹水持续漏出和血肿/出血。欧洲药品管理局（EMA）于2009年4月批准使用三功能双特异性抗体catumaxomab（Removab）进行腹膜内（ip）治疗恶性腹水。本综述涉及的领域：本综述描述了量身定制的临床前和临床ip的catumaxomab的开发从1998年至2009年治疗恶性腹水。读者的收获：报道了相关的毒理学和药代动力学研究结果，以及一项大型国际II / III期研究的主要结果，该研究对EMA批准catumaxomab至关重要。留言：Catumaxomab i.p.与仅穿刺穿刺术相比，该疗法可显着改善无穿刺生存时间和首次穿刺所需时间，并在临床上具有重大意义。 catumaxomab治疗的相关副作用是可以预测的，并且与抗体的作用方式有关。

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