Dose-dense methotrexate plus vinblastine, doxorubicin, and cisplatin (dd-MVAC) can improve outcomes when compared with gemcitabine plus cisplatin (GC) in patients with muscle-invasive bladder cancer (MIBC), a phase 3 trial showed.
These results, from the VESPER trial, were presented at the European Society for Medical Oncology (ESMO) Congress 2021.
“The VESPER trial is a milestone in the history of chemotherapy for MIBC,” said study presenter Christian Pfister, MD, PhD, of Rouen University Hospital in France. “dd-MVAC regimen should now become the gold standard for neoadjuvant chemotherapy.”
In the trial (ClinicalTrials.gov Identifier: NCT01812369), patients with MIBC were randomly assigned to receive 4 cycles of GC every 3 weeks or 6 cycles of dd-MVAC every 2 weeks either before surgery (neoadjuvant group) or after surgery (adjuvant group).
There were 493 patients in the intent-to-treat (ITT) population. The median age at baseline was 63 years (range, 58-69 years), about 17% of patients were women, and about 82% had cT2 N0 disease.
Of the 437 patients in the neoadjuvant group, 218 received dd-MVAC and 219 received GC. Of the 56 patients in the adjuvant group, 30 received dd-MVAC and 26 received GC.
The study’s primary endpoint was progression-free survival (PFS) at 3 years.
For the entire ITT population, the 3-year PFS was numerically higher in the dd-MVAC arm than in the GC arm — 64% and 56%, respectively — but the difference was not statistically significant (hazard ratio [HR], 0.77; 95% CI, 0.57-1.02; P =.066).
In the neoadjuvant group, the 3-year PFS rate was significantly higher in the dd-MVAC arm than in the GC arm — 66% and 56%, respectively (HR, 0.70; 95% CI, 0.51-0.96; P =.025).
In the adjuvant group, PFS and other results were not conclusive due to the limited sample size.
Time to progression was significantly better with dd-MVAC in both the ITT population (HR, 0.68; 95% CI, 0.50-0.93; P =.014) and the neoadjuvant group (HR, 0.62; 95% CI, 0.44-0.87; P =.005).
Overall survival was also superior with dd-MVAC in both the ITT population (HR, 0.74; 95% CI, 0.55-1.00) and the neoadjuvant group (HR, 0.66; 95% CI, 0.47-0.92).
“Final data on overall survival are expected to confirm these results,” Dr Pfister said.
Pfister C, Gravis G, Flechon A, et al. Dose-dense methotrexate, vinblastine, doxorubicin and cisplatin (dd-MVAC) or gemcitabine and cisplatin (GC) as perioperative chemotherapy for patients with muscle-invasive bladder cancer (MIBC): Results of the GETUG/AFU VESPER V05 phase III trial. Presented at: European Society for Medical Oncology (ESMO) Congress 2021; September 16-21, 2021. Abstract 652O.
This article originally appeared on Cancer Therapy Advisor