The randomized phase III controlled GETUG/AFU VESPER V05 trial was designed to compare the efficacy of two perioperative treatment regimens—gemcitabine/cisplatin or dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC)—in patients with muscle-invasive bladder cancer. The results of the study were presented by Pfister et al at the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract 652O).
The research team explained to the audience that the optimal perioperative chemotherapy regimen for patients with muscle-invasive bladder cancer has yet to be truly defined.
GETUG/AFU VESPER V05 Details
Between February 2013 and February 2018, the study team randomly assigned 500 patients from 28 French cancer centers to receive either four cycles of gemcitabine and cisplatin every 3 weeks, or six cycles of dd-MVAC every 2 weeks before surgery in the neoadjuvant group or after surgery in the adjuvant group. The study primary endpoint was progression-free survival at 3 years.
In total, 437 patients (88%) received neoadjuvant chemotherapy; of those, 60% of patients received the planned six cycles in the dd-MVAC arm and 84% received four cycles of gemcitabine/cisplatin. Subsequently, 91% and 90% of patients underwent surgery. Organ-confined response, defined as < ypT3N0, was observed more frequently in the dd-MVAC arm, 77% vs 63% (P = .001). In the adjuvant group, 40% of patients received six cycles in the dd-MVAC arm and 81% received four cycles in the gemcitabine/cisplatin arm.
Progression-Free Survival
In the perioperative setting of this study, the progression-free survival at 3 years was improved in the dd-MVAC arm, 64% vs 56% (hazard ratio [HR] = 0.77, 95% confidence interval [CI] = 0.57–1.02, P = .066). Time to progression was also improved in the dd-MVAC arm, with 3-year rates of 69% vs 58% (HR = 0.68, 95% CI = 0.50–0.93, P = .014). In the neoadjuvant group, progression-free survival at 3 years was significantly higher for the dd-MVAC arm, 66% vs 56% (HR = 0.70, 95% CI = 0.51–0.96, P = .025). In the adjuvant group, the results were not conclusive due to the limited sample size.
In this academic phase III study, the authors reported a benefit in progression-free survival at 3 years in the dd-MVAC arm. In the neoadjuvant group, better bladder tumor local control and a significant improvement in progression-free survival at 3 years were both observed.
Disclosure: This study was funded by a grant from the French Ministry of Health. For full disclosures of the study authors, visit oncologypro.esmo.org.
