Catumaxomab In Malignant Ascites
Catumaxomab In Malignant Ascites
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DOI：
10.2165/11209040-000000000-00000
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发表时间：
2012-01-01
期刊：
影响因子：
11.5
通讯作者：
Frampton, James E.
中科院分区：
文献类型：
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作者：
Frampton, James E.
Catumaxomab是一种大鼠/小鼠杂交、三功能、双特异性(抗人上皮细胞黏附分子[EpCAM]x抗CD3)的单抗。在一项随机、开放、多中心、关键的II/III期试验中，与单纯穿刺术相比，在EPCAM阳性且对常规化疗耐药的肿瘤患者中，穿刺术和Catumaxomab治疗显著延长了无需穿刺术的生存期和重复穿刺术的时间。Catumaxomab的好处在广泛的上皮性卵巢和非卵巢癌中都可以看到，无论Catumaxomab接受者是否产生了人抗鼠抗体。与单独穿刺术相比，Catumaxomab与穿刺术联合使用还可以导致更明显和更长时间的腹水症状和腹水症状的减少，以及与健康相关的生活质量的延迟恶化。尽管这项研究没有设计或提供动力来评估总体存活率，但在对胃癌患者的安全人群和亚群的分析中，可以看到在穿刺术中加入Catumaxomab的显著差异。Catumaxomab在关键的II/III期试验中总体耐受性良好。Catumaxomab治疗最常见的不良事件包括与细胞因子释放相关的症状，这些症状大多是轻度到中度的，可以通过标准的对症治疗来控制。
Catumaxomab is a rat/murine hybrid, trifunctional, bispecific (anti-human epithelial cell adhesion molecule [EpCAM] x anti-CD3) monoclonal antibody.Compared with paracentesis alone, paracentesis followed by catumaxomab therapy was associated with significant prolongation of paracentesis-free survival and time to repeat paracentesis in a randomized, open-label, multicentre, pivotal phase II/III trial in patients with recurrent symptomatic malignant ascites due to EpCAM-positive tumours who were resistant to conventional chemotherapy. The benefits of catumaxomab were seen across a broad range of epithelial ovarian and nonovarian cancers, and irrespective of whether or not catumaxomab recipients developed human anti-mouse antibodies.Combining catumaxomab with paracentesis also resulted in more pronounced and prolonged reductions in ascites signs and symptoms and a delayed deterioration in health-related quality of life compared with paracentesis alone. Despite the study not being designed or powered to evaluate overall survival, significant differences favouring the addition of catumaxomab to paracentesis were seen in analyses of the safety population and the subpopulation of patients with gastric cancer.Catumaxomab was generally well tolerated in the pivotal phase II/III trial. The most frequent adverse events attributed to catumaxomab treatment included cytokine-release-related symptoms, which were mostly of mild to moderate severity and manageable with standard symptomatic treatment.