1. In the perioperative setting, there was no difference between dd-MVAC vs. GC on overall 5-year survival.
2. In the neoadjuvant subgroup, findings from the VESPER trial revealed a notable improvement in 5-year overall survival and time to death from bladder cancer among individuals treated with dd-MVP compared to those receiving the GC regimen.
Evidence Rating Level: 1
Study Rundown: The primary objective of the VESPER trial was to evaluate and compare the efficacy of two chemotherapy regimens—dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC), and gemcitabine and cisplatin (GC)—in patients with muscle-invasive bladder cancer undergoing radical cystectomy. This trial initially assessed three-year survival and time to death of bladder cancer in both perioperative patients and a sub-group analysis of patients undergoing these chemotherapy regimens as neoadjuvant therapy. In the perioperative setting, there was no significant improvement in three-year progression-free survival between the regimens. However, in subgroup analyses of those undergoing chemotherapy as neoadjuvant therapy, there was an improvement in progression-free survival in the dd-MVAC group compared to the GC treatment arm. The present study is a follow-up analysis that assesses the outcomes of those enrolled in the VESPER trial at 5 years. The VESPER trial was a phase 3 randomized controlled trial conducted in France. Patients were randomized to either receive six cycles of the dd-MVAC regimen or four cycles of GC therapy. At the five year follow up, in the subgroup analysis of patients receiving neoadjuvant chemotherapy, those treated with dd-MVAC had improved progression-free survival and overall survival. Time to death from bladder cancer was lower in the dd-MVAC group. This trial’s strengths include a large sample size (493 participants) from 48 university sites and a robust 5-year follow-up time. Moreover, the trial evaluated chemotherapy regimens in diverse contexts, enabling comparisons in both neoadjuvant and adjuvant settings. The limitations of this study include the unblinded nature of the trial. Despite these limitations, this trial provides new evidence that dd-MVAC may improve overall survival when received as neoadjuvant therapy in comparison to GC therapy.
Click to read the study in Lancet Oncology
In-Depth [randomized controlled trial]: The VESER Trial is a phase 3 randomized controlled trial that compared dd-MVAC vs GC as chemotherapy regimens in the perioperative and neoadjuvant contexts in patients with muscle-invasive bladder cancer. The initial trial was completed at the 3-year follow-up. The present analysis evaluated outcomes in patients enrolled in this trial at 5 years. Overall, their outcomes mimicked the results that were found in the previous trial at 3 years. In those undergoing chemotherapy in the perioperative setting, there was no significant difference between dd-MVAC and GC treatment on overall survival (95% CI:0.59-1.02). However, dd-MVAC did demonstrate superiority to GC when assessing progression-free survival ((95% CI 0.52-0.97) and overall survival in the neoadjuvant therapy subgroup at 5 years (95% CI 0.55-0.99). Time to death due to bladder cancer was superior in the MVAC group vs. GC (27% vs. 40%, 95% CI 0.45-0.84). Overall, these results provide evidence for the use of dd-MVAC over GC as neoadjuvant therapy in muscle-invasive bladder cancer.
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