Varga Z, de Mulder P, Kruit W, Hegele A, Hofmann R, Lamers C, Warnaar S, Mala C, Ullrich S, Mulders P
Department of Urology, Philipps-University Marburg, Germany.
Folia Biol (Praha). 2003;49(2):74-7.
cG250 is an IgG1 kappa light-chain chimeric monoclonal antibody that binds to a cell surface antigen found on 95% of clear-cell renal cancer. A multicentre phase II study was performed to evaluate the safety and efficacy of repeated doses of cG250. Thirty-six patients with metastatic RCC were included. All patients were nephrectomized for the primary tumour. Twenty-one patients were pretreated (e.g. with IL-2, IFN-alpha). A weekly dose of 50 mg cG250 was given by i.v. infusion for 12 weeks. Patients with SD or tumour response (PR, CR) after 12 weeks of treatment could receive additional treatment for 8 more weeks. None of the 36 enrolled patients had any cG250 grade III or IV toxicity. Only three patients had grade II toxicity possibly related to the study medication. ELISA testing gave no evidence for relevant amounts of HACA. Eleven patients presented with SD and ten were eligible for extension treatment. After the end of the study in the follow-up period, one patient demonstrated a CR in week 38 and another patient with SD showed a significant reduction of the overall tumour load in week 44. Six additional patients with progressive disease at study entry were stable for more than six months after the treatment start. The weekly schedule of i.v. cG250 in patients with metastatic RCC was safe, very well tolerated and non-immunogenic in a 12-week treatment regimen. cG250 showed anti-tumour activity.
cG250是一种IgG1 κ轻链嵌合单克隆抗体，可与95%的透明细胞肾癌中发现的一种细胞表面抗原结合。进行了一项多中心II期研究，以评估重复剂量的cG250的安全性和疗效。纳入了36例转移性肾细胞癌患者。所有患者均因原发性肿瘤接受了肾切除术。21例患者接受过预处理（如使用白细胞介素-2、α干扰素）。每周静脉输注50 mg cG250，共12周。治疗12周后病情稳定或有肿瘤反应（部分缓解、完全缓解）的患者可再接受8周的额外治疗。36例入组患者中无一例出现cG250 III级或IV级毒性反应。只有3例患者出现可能与研究药物相关的II级毒性反应。酶联免疫吸附测定检测未发现有相关量的人抗嵌合抗体。11例患者病情稳定，10例符合延长治疗条件。在研究结束后的随访期内，1例患者在第38周出现完全缓解，另1例病情稳定的患者在第44周总体肿瘤负荷显著降低。另外6例在研究开始时病情进展的患者在治疗开始后病情稳定超过6个月。在转移性肾细胞癌患者中，每周静脉注射cG250的方案在12周治疗方案中是安全的，耐受性良好且无免疫原性。cG250显示出抗肿瘤活性。
