|The following article features coverage from the European Society for Medical Oncology (ESMO) Congress 2021. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
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.
Read more of Cancer Therapy Advisor’s coverage of ESMO 2021 by visiting the conference page.
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.