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Better survival with neoadjuvant dose-dense MVAC regimen in MIBC

Presented by
Dr Christian Pfister, Rouen University Hospital, France
ESMO 2021
Phase 3, VESPER
Dose-dense MVAC outperforms gemcitabine/cisplatin as neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC), results from the phase 3 VESPER trial showed.

The optimal neoadjuvant chemotherapy regimen for patients with MIBC is not defined. Therefore, the VESPER trial (NCT01812369) randomised 493 MIBC patient 1:1 to either 4 cycles of gemcitabine/cisplatin every 3 weeks or 6 cycles of dose-dense methotrexate/vinblastine/doxorubicin/cisplatin (dd-MVAC) every 2 weeks, before surgery. Primary endpoint was progression-free survival (PFS) at 3 years. Dr Christian Pfister (Rouen University Hospital, France) presented the results [1].

A total of 437 patients (88%) received neoadjuvant chemotherapy, 56 patients (12%) received adjuvant chemotherapy; 60% patients received all planned 6 cycles in the dd-MVAC arm and 84% received all 4 cycles in the gemcitabine/cisplatin arm. Thereafter, 91% and 90% of patients underwent surgery, respectively. Organ-confined response (<ypT3N0) was observed more frequently in the dd-MVAC arm (77% vs 63%; P=0.001). PFS rate at 3 years was improved in the neoadjuvant dd-MVAC arm (66% vs 56%; HR 0.70; P=0.025). In addition, both time to progression and overall survival were improved in the neoadjuvant dd-MVAC arm (HR 0.62 and 0.66 vs gemcitabine/cisplatin, respectively; see Figure). Results of the adjuvant arm were inconclusive due to the limited number of patients included.

Figure: Overall survival with dd-MVAC in VESPER [1]

“These results suggest dd-MVAC should become the gold standard for neoadjuvant chemotherapy because of higher local control and a significant improvement in 3-year PFS,” concluded Dr Pfister.

  1. Pfister C, 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. Abstract 652O, ESMO Congress 2021, 16–21 September.


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