The continuing role of chemotherapy in the management of advanced urothelial cancer.

24 , 25 A borderline significant survival benefit was seen with DD-M-VAC at an updated analysis of this trial [5-year survival rate 21.8% versus 13.5%; hazard ratio (HR) 0.76, p = 0.042]. 25 Finally, patients receiving DD-M-VAC had fewer neutropenia and febrile neutropenia episodes, without increased nonhaematological toxicities. 24 These results prompted a shift toward the preferential use of DD-M-VAC rather than conventional M-VAC when considering this four-drug regimen.

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Yet, in the intent-to-treat population, the 2-month survival advantage (6.9 months versus 4.6 months) was achieved but did not reach statistical significance. 6 , 79 These results led to the approval of vinflunine by the EMA in 2009, although this drug has never been approved by the US FDA.

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