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。

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，每2周接受6个周期的剂量密集甲氨喋呤、长春碱、阿霉素和顺铂(dd-MVAC)，或每3周接受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)。我们报告了GETUG-AFU V05 VESPER试验的主要终点(ClinicalTrials.gov标示:NCT01812369): 3年无进展生存期(PFS)。次要终点为进展时间和总生存时间。

437例(88%)患者接受新辅助化疗;60%的患者在dd-MVAC组接受了计划的6个周期，84%的患者在GC组接受了4个周期，之后分别有91%和90%的患者接受了手术。Organ-confined响应(& lt;在dd-MVAC组中更易观察到ypT3N0 (77% v 63%， P = .001)。在辅助组中，40%的患者在dd-MVAC组接受了6个周期的治疗，81%的患者在GC组接受了4个周期的治疗。对于临床试验中的所有患者，dd-MVAC组的3年PFS得到改善，但该研究未达到其主要终点(3年率:64% v 56%，风险比[HR] = 0.77 [95% CI, 0.57 ~ 1.02]， P = .066);然而，dd-MVAC臂的进展时间明显更长(3年比率:69% v 58%， HR = 0.68 [95% CI, 0.50 ~ 0.93]， P = .014)。在新辅助治疗组中，dd-MVAC组3年PFS显著高于对照组(66% v 56%， HR = 0.70 [95% CI, 0.51 ~ 0.96]， P = .025)。在VESPER试验中，dd-MVAC比GC提高了3年的PFS。在新辅助组中，dd-MVAC组膀胱肿瘤局部控制更好，3年PFS明显改善。

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.

原文链接

pubmed.ncbi.nlm.nih.gov/35254888/

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