August 15, 2023
1 min read
Patients with muscle-invasive bladder cancer receiving dose-dense methotrexate, vinblastine, doxorubicin and cisplatinhad improved OS at 5 years compared with gemcitabine and cisplatin, according to a presentation at ASCO Annual Meeting.
Christian Pfister, MD, PhD, of Rouen University Hospital, France, said the phase 3 VESPER trial had a primary endpoint of PFS of 3 years and reported on OS and disease-specific survival (DSS) at 5 years.
During the study, 500 patients from 28 French centers received either four cycles of gemcitabine and cisplatin (GC) every 3 weeks or six cycles of dose-dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) every 2 weeks before surgery (neoadjuvant group) or after surgery (adjuvant group).
At a final median of follow-up was 5 years and 3 months, 190 deaths occurred. OS at 5 years improved in the dd-MVAC arm at 64% vs. 56% (HR = 0.77; 95% CI, 0.58-1.03) as well as DSS at 72% vs. 59% (HR = 0.63; 95% CI, 0.46-0.86).
Bladder cancer progression was the main cause of death (83%).
In the adjuvant group, the results were not conclusive due to the limited sample size, but in the neoadjuvant group OS was significantly superior in the dd-MVAC arm (5-year rate, 66% vs. 57%; HR = 0.71 (95% CI, 0.52-0.97) as well as DSS (5-year rate, 75% vs. 60%, HR=0.56 (95% CI, 0.39-0.8).
“VESPER trial is practice-changing and will impact clinical cancer research in bladder cancer,” Pfister said in the presentation.