Δευτέρα, 17 Απριλίου 2017

BENEFITS OF VINFLUNINE MAINTENANCE TREATMENT IN UROTHELIAL CARCINOMA

In a Spanish phase II trial reported in The Lancet Oncology, García-Donas et al found that maintenance therapy with vinflunine improved progression-free survival vs best supportive care alone in patients with advanced urothelial carcinoma with disease control on first-line chemotherapy.
Study Details
In the open-label trial, 87 evaluable patients from 21 sites in Spain with locally advanced, surgically unresectable or metastatic transitional cell carcinoma of the urothelial tract and disease control after 4 to 6 cycles of cisplatin and gemcitabine (carboplatin allowed after cycle 4) were randomized between April 2012 and January 2015 to receive vinflunine plus best supportive care (n = 44) or best supportive care alone (n = 43). Vinflunine was given every 21 days via 20-minute infusion at 320 mg/m² or 280 mg/m² in patients with an Eastern Cooperative Oncology Group performance status of 1, age ≥ 75 years, previous pelvic radiotherapy, or creatinine clearance < 60 mL/min. The primary endpoint was median progression-free survival longer than 5.3 months in the vinflunine group.
Outcomes
Median follow-up was 15.6 months. In the vinflunine group, disease progression occurred in 29 patients (66%) and death in 24 patients (55%), compared with 36 (84%) and 32 patients (74%) in the best supportive care group. Median progression-free survival was 6.5 months (95% confidence interval [CI = 2.0–11.1 months) in the vinflunine group vs 4.2 months (95% CI = 2.1–6.3 months) in the best supportive care group (hazard ratio = 0.59, = .031). Overall survival data are immature. At the time of analysis, median overall survival was 16.7 months vs 13.2 months.
Adverse Events
The most common grade 3 or 4 adverse events in the vinflunine group were neutropenia (18% vs 0% in best supportive care group), asthenia/fatigue (16% vs 2%), and constipation (14% vs 0%). Eighteen serious adverse events were reported in the vinflunine group and 14, in the best supportive care group, with the most common in the vinflunine group consisting of constipation (5%), paralytic ileus (2%), and incarcerated hernia (2%). One patient in the vinflunine group died of treatment-related pneumonia.
The investigators concluded: “In patients with disease control after first-line chemotherapy, progression-free survival exceeded the acceptable threshold with vinflunine maintenance therapy. Moreover, progression-free survival was longer with vinflunine maintenance therapy than with best supportive care. Vinflunine maintenance had an acceptable safety profile. Further studies of the role of vinflunine are warranted.”

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