Prescrire international · 2011
Vinflunine.
Сравнительное исследованиеСтатьяОбзорНазвание и аннотация: Перевод в очереди
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Аннотация
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.