A Phase II Trial of Humanized Anti‐Vascular Endothelial Growth Factor Antibody for the Treatment of Androgen‐Independent Prostate Cancer

D. Reese, Paige Fratesi, Michelle Corry, W. Novotny, E. Holmgren, E. Small
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引用次数: 72

Abstract

Objective: Vascular endothelial growth factor (VEGF) is a glycoprotein that is important in promoting tumor angiogenesis. Recombinant humanized anti (rhuMAb)-VEGF is a humanized murine monoclonal antibody that neutralizes VEGF activity and has shown promise in animal tumor models. Methods: To evaluate the efficacy and safety of single-agent rhuMAb VEGF in metastatic androgen-independent prostate cancer (AIPC), we treated 15 patients with 10 mg/kg rhuMAb VEGF every 14 days for six infusions (one cycle), followed by additional treatment for selected patients who had a response or were stable. Results: After one cycle, none of the 15 patients who were evaluable for tumor response had an objective complete or partial response. Three possible mixed responses were observed. No patient achieved a >50% decrease in serum prostate specific antigen (PSA) level after one cycle. Four patients (27%) had a PSA decline of 50%. The median time to objective progression was 118 days, and the median time to PSA progression was 57 days. Toxicity was generally mild, with asthenia present in 6 (40%) of 15 patients. Severe hyponatremia developed in two patients, although the association with rhuMAb VEGF was unclear. Conclusions: We concluded that single-agent rhuMAb VEGF in this dose and with this schedule did not produce significant objective responses in patients with AIPC. Further development of this agent in patients with prostate cancer should focus on earlier stage disease or should evaluate it in combination with other therapies.
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人源化抗血管内皮生长因子抗体治疗雄激素不依赖型前列腺癌的II期临床试验
目的:血管内皮生长因子(VEGF)是一种促进肿瘤血管生成的重要糖蛋白。重组人源化抗(rhuMAb)-VEGF是一种人源化小鼠单克隆抗体,可中和VEGF活性,在动物肿瘤模型中显示出前景。方法:为了评估单药rhuMAb VEGF治疗转移性雄激素非依赖型前列腺癌(AIPC)的疗效和安全性,我们每14天给15例患者10 mg/kg rhuMAb VEGF进行6次输注(一个周期),然后选择有反应或病情稳定的患者进行额外治疗。结果:在一个周期后,15例可评估肿瘤反应的患者中没有一个客观完全或部分缓解。观察到三种可能的混合反应。没有患者在一个周期后血清前列腺特异性抗原(PSA)水平下降超过50%。4例患者(27%)PSA下降50%。到客观进展的中位时间为118天,到PSA进展的中位时间为57天。毒性一般较轻,15例患者中有6例(40%)出现虚弱。两名患者出现严重的低钠血症,尽管与rhuMAb VEGF的关系尚不清楚。结论:我们得出结论,单药rhuMAb VEGF在该剂量和方案下对AIPC患者没有产生显著的客观反应。该药物在前列腺癌患者中的进一步发展应侧重于早期疾病或应与其他疗法联合评估。
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