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长春氟宁

Vinflunine.

出版信息

Prescrire Int. 2011 Jan;20(112):11-3.

Abstract

There is currently no curative treatment for advanced-stage or metastatic transitional cell carcinoma of the uretholial tract. Chemotherapy generally only prolongs survival by a few months. Cisplatin is often used, but there is no consensus protocol. Vinflunine, a fluorinated vinblastine derivative, has been tested in many types of cancer since the 1990s. It was finally authorised in the EU in 2009, but only for second-line treatment of urothelial carcinoma of the bladder. Clinical evaluation of vinflunine in this setting is based on a single unblinded trial in 370 patients with treatment failure. It compared vinflunine plus individually tailored palliative care versus palliative care alone. Vinflunine increased the median overall survival time by 2 months (from 4.6 months to 6.9 months), a difference that was not statistically significant in the protocol-specified primary analysis. Other analyses showed a significant difference, but the gain in survival was still only about 2 months, which is no better than with other cytotoxic drugs. Vinflunine has the same profile of adverse effects as other vinca alkaloids, including frequent, often serious and sometimes fatal haematological disorders, severe constipation, and ileus. Other adverse effects include QT prolongation and cardiac ischaemia. * In practice, vinflunine has an unfavourable risk-benefit balance in patients with bladder cancer. It is better to continue to use better-assessed treatments.

摘要

目前,对于晚期或转移性尿道移行细胞癌尚无治愈性治疗方法。化疗一般仅能将生存期延长几个月。顺铂常被使用,但尚无统一的方案。长春氟宁是一种氟化长春碱衍生物,自20世纪90年代以来已在多种癌症中进行了试验。它最终于2009年在欧盟获批,但仅用于膀胱癌的二线治疗。长春氟宁在此种情况下的临床评估基于一项针对370例治疗失败患者的单组非盲试验。该试验比较了长春氟宁加个体化定制的姑息治疗与单纯姑息治疗。长春氟宁使中位总生存时间延长了2个月(从4.6个月延长至6.9个月),在方案规定的主要分析中,这一差异无统计学意义。其他分析显示存在显著差异,但生存获益仍仅约2个月,并不比其他细胞毒性药物更好。长春氟宁的不良反应谱与其他长春花生物碱相同,包括频繁出现、常较为严重且有时致命的血液系统疾病、严重便秘和肠梗阻。其他不良反应包括QT间期延长和心脏缺血。实际上,长春氟宁在膀胱癌患者中的风险效益比不佳。最好继续使用经过更好评估的治疗方法。

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