The optimal perioperative chemotherapy regimen for patients (pts) with MIBC is not defined.
Between February 2013 and February 2018, 500 pts were randomized in 28 French centres and received either 4 cycles of GC every 3 weeks or 6 cycles of dd-MVAC every 2 weeks before surgery (neoadjuvant group) or after surgery (adjuvant group). The primary endpoint of the VESPER trial was the progression-free survival (PFS) at 3 years (clinicaltrials.gov NCT 018 12369).
437 patients (88%) received neoadjuvant chemotherapy, 60% of pts received the planned 6 cycles in the dd-MVAC arm and 84% received 4 cycles in the GC arm. Thereafter, 91% and 90% of pts underwent surgery, respectively. Organ-confined response (< ypT3N0) was observed more frequently in the dd-MVAC arm (77% vs 63%, p=0.001). In the adjuvant group, 40% of pts received 6 cycles in the dd-MVAC arm, 81% received 4 cycles in the GC arm. In the perioperative setting of the VESPER trial, PFS at 3 years was improved in the dd-MVAC arm (64% vs 56%, HR=0.77 (95% CI, 0.57-1.02), p=0.066), as was also time to progression (TTP) (3-year rate: 69% vs 58%, HR=0.68 (95% CI, 0.50-0.93), p=0.014). In the neoadjuvant group, the PFS at 3 years was significantly higher for the dd-MVAC arm (66% vs 56%, HR=0.70 (95% CI, 0.51-0.96), p=0.025). In the adjuvant group, the results were not conclusive due to the limited sample size (n=56).
In the VESPER phase III trial, we reported a benefit on PFS at 3 years for the dd-MVAC arm. In the neoadjuvant group, a better bladder tumour local control with a significant improvement on PFS at 3 years were observed in the dd-MVAC arm.
Clinical trial identification
NCT 018 12369.
Legal entity responsible for the study
Grant from the French Ministry of Health (PHRC 2011-037).
All authors have declared no conflicts of interest.