Vinflunine Maintenance in Advanced Urothelial Carcinoma
In patients with advanced urothelial carcinoma who achieved disease control with first-line chemotherapy, progression-free survival was longer in patients who received vinflunine maintenance than in those who received best supportive care, according to new research published by Jesus García-Donas, MD, of the Spanish National Cancer Research Center, Madrid, Spain, and colleagues, in The Lancet Oncology.
The phase II trial enrolled 87 evaluable patients from 21 sites in Spain; they had locally advanced, surgically unresectable, or metastatic transitional cell carcinoma of the urothelial tract, adequate organ function, and disease control after 4 to 6 cycles of cisplatin and gemcitabine (carboplatin allowed after cycle 4). Patients were randomly assigned to receive vinflunine (n=44) or best supportive care (n=43). The primary endpoint was median progression-free survival longer than 5.3 months in the vinflunine group.
After a median follow-up of 15.6 months, 29 patients (66%) in the vinflunine group had disease progression and 24 patients (55%) had died, compared with 36 patients (84%) and 32 patients (74%) in the best supportive care group, respectively. Median progression-free survival was 6.5 months in the vinflunine group and 4.2 months in the supportive care group. Vinflunine maintenance had an acceptable safety profile, although serious adverse events were more common in the group treated with the drug.