ST LOUIS (MD Consult) - On October 19, 2009, GlaxoSmithKline and the US Food and Drug Administration (FDA) announced the approval of Votrient (pazopanib) for the treatment of advanced renal cell carcinoma. Votrient is an oral, once-daily, angiogenesis inhibitor.
The safety and effectiveness of Votrient were evaluated in a 435-patient study that assessed progression-free survival (PFS). In this phase 3 trial, the overall median PFS was 9.2 months for patients receiving pazopanib and 4.2 months for patients receiving placebo. Treatment-naive patients who received Votrient experienced 11.1 months of median PFS versus 2.8 months with placebo. Additionally, patients who had previously received cytokine -based treatment achieved 7.4 months of median PFS with Votrient versus 4.2 months with placebo.
Adverse reactions during the trial included diarrhea, hypertension, hair color changes, nausea, loss of appetite, vomiting, fatigue, weakness, abdominal pain, and headache. Votrient can cause severe and fatal liver toxicity. Liver function should therefore be monitored before and during treatment.
Warnings and precautions included in the product label for Votrient relate to QT prolongation and torsade de pointes, hemorrhagic events, arterial thrombotic events, gastrointestinal perforation and fistula, hypertension, impaired wound healing, hypothyroidism, proteinuria, and pregnancy.
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圣路易斯(MD Consult) ——2009年10月19日，葛兰素史克公司和美国食品药品管理局(FDA)宣布批准Votrient(帕唑帕尼)用于进展性肾细胞癌的治疗。Votrient是一种口服(每日1次)血管生成抑制剂。
一项纳入435例患者、旨在评估无进展生存(PFS)的研究评价了Votrient的安全性和有效性，这是一项III期研究。在该研究中，接受帕唑帕尼治疗的患者总体中位PFS为9.2个月，而接受安慰剂的患者则为4.2个月。初次接受治疗的患者应用Votrient后中位PFS可达11.1个月，而安慰剂组则为2.8个月。此外，曾接受过以细胞因子为基础治疗方案治疗的患者使用Votrient后中位PFS可达7.4个月，而安慰剂组则为4.2个月。
不良反应包括：腹泻、高血压、发色改变、恶心、无食欲、呕吐、疲乏、虚弱、腹痛和头疼。Votrient还可引起严重的甚者致死性的肝毒性。故治疗前和治疗期间应监测患者的肝功能。
Votrient产品标签上的警告及注意事项涉及下列问题：QT波延长及尖端扭转型室性心动过速、出血事件、动脉血栓形成事件、胃肠穿孔及瘘、高血压、伤口愈合不良、甲状腺功能减退、蛋白尿和妊娠。
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