Pfister C, J Clin Oncol. 2022 Jun 20;40(18):2013-2022. 

非转移性肌肉浸润性膀胱癌患者的最佳围手术期化疗方案尚未确定。

在 2013 年 2 月至 2018 年 3 月期间，500 名患者被随机分配到 28 个法国中心，并接受 6 个周期的剂量密集型甲氨蝶呤、长春碱、多柔比星和顺铂 (dd-MVAC)，每 2 周一次或 4 个周期的吉西他滨和顺铂。 GC) 术前（新辅助组）或术后（辅助组）每 3 周一次。本研究报告GETUG-AFU V05 VESPER 试验（ClinicalTrials.gov 标识符：NCT01812369）的主要终点：3 年无进展生存期 (PFS)。次要终点是进展时间和总生存期。

在 VESPER 试验中，dd-MVAC 比 GC 提高了 3 年的 PFS。在新辅助组中，在 dd-MVAC 组中观察到更好的膀胱肿瘤局部控制和 3 年 PFS 的显着改善

Abstract

Purpose: The optimal perioperative chemotherapy regimen for patients with nonmetastatic muscle-invasive bladder cancer is not defined.

Patients and methods: Between February 2013 and March 2018, 500 patients were randomly assigned in 28 French centers and received either six cycles of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) once every 2 weeks or four cycles of gemcitabine and cisplatin (GC) once every 3 weeks before surgery (neoadjuvant group) or after surgery (adjuvant group). We report the primary end point of the GETUG-AFU V05 VESPER trial (ClinicalTrials.gov identifier: NCT01812369): progression-free survival (PFS) at 3 years. Secondary end points were time to progression and overall survival.

Results: Four hundred thirty-seven patients (88%) received neoadjuvant chemotherapy; 60% of patients received the planned six cycles in the dd-MVAC arm, 84% received four cycles in the GC arm, and thereafter, 91% and 90% of patients underwent surgery, respectively. Organ-confined response (< ypT3N0) was observed more frequently in the dd-MVAC arm (77% v 63%, P = .001). In the adjuvant group, 40% of patients received six cycles in the dd-MVAC arm, and 81% of patients received four cycles in the GC arm. For all patients in the clinical trial, 3-year PFS was improved in the dd-MVAC arm, but the study did not meet its primary end point (3-year rate: 64% v 56%, hazard ratio [HR] = 0.77 [95% CI, 0.57 to 1.02], P = .066); nevertheless, the dd-MVAC arm was associated with a significantly longer time to progression (3-year rate: 69% v 58%, HR = 0.68 [95% CI, 0.50 to 0.93], P = .014). In the neoadjuvant group, PFS at 3 years was significantly higher in the dd-MVAC arm (66% v 56%, HR = 0.70 [95% CI, 0.51 to 0.96], P = .025).

Conclusion: In the VESPER trial, dd-MVAC improved 3-years PFS over GC. In the neoadjuvant group, a better bladder tumor local control and a significant improvement in 3-year PFS were observed in the dd-MVAC arm.

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