Eur Urol Oncol:膀胱内VPM1002BC治疗常规BCG治疗后的非肌层浸润性膀胱癌(NMIBC)复发

2022-01-24 AlexYang MedSci原创

调查了膀胱内注射VPM1002BC治疗常规卡介苗治疗后,复发的非肌肉浸润性膀胱癌(NMIBC)的疗效、安全性、耐受性和生活质量情况。

随着时间的推移,卡介苗(BCG)已经演化出了不同的类型,并用于非肌层浸润性膀胱癌(NMIBC)的膀胱内免疫治疗。虽然这些卡介苗菌株具有不同的基因组变异特征,但一些比较性的临床研究表明,所选择的菌株之间的治疗效果存在差异

VPM1002BC是一种转基因的牛分枝杆菌卡介苗(BCG)菌株,具有潜在的改善免疫原性和衰减作用。近期,来自瑞士的研究人员在《Eur Urol Oncol》上发表文章,调查了膀胱内注射VPM1002BC治疗常规卡介苗治疗后,复发的非肌肉浸润性膀胱癌(NMIBC)的疗效、安全性、耐受性和生活质量情况

研究人员设计了一项1/2期单臂试验(NCT02371447)。纳入标准为卡介苗诱导±卡介苗维持治疗后复发的NMIBC患者,且有中度至高度癌症进展风险。患者每周注射6次VPM1002BC,并维持1年。在复发的情况下停止治疗。主要终点为试验注册后60周的膀胱无复发率(RFR)。

在排除了2名不符合条件的患者后,40名患者纳入了完整的分析组中。所有接受治疗的肿瘤都是高等级的,并且27名患者(67.5%)出现了原位癌。研究结果发现,试验登记后60周的膀胱无复发率为49.3%(95%置信区间[CI]为32.1-64.4%),试验登记后2年的无复发率为47.4%(95%CI为30.4-62.6%),3年为43.7%(95%CI为26.9-59.4%)。同时,有3名患者进展为肌层浸润性疾病,有4名患者发生转移性疾病。在14.3%、54.8%和4.8%的患者中分别观察到与治疗相关的1、2和3级不良事件(AEs),没有发生≥4级的AEs。42名患者中有2名在诱导期间不能接受5次或更多的灌注。研究的局限性包括单臂试验设计和用于亚组分析的患者数量少。

治疗60周时的无复发率情况

综上所述,在治疗开始1年后,几乎一半的患者在使用VPM100BC治疗后没有复发。该研究的主要终点已经达到,因此,该疗法安全且耐受性良好。

 

原始出处:

Cyrill A Rentsch , George N Thalmann , Ilaria Lucca et al. A Phase 1/2 Single-arm Clinical Trial of Recombinant Bacillus Calmette-Guérin (BCG) VPM1002BC Immunotherapy in Non-muscle-invasive Bladder Cancer Recurrence After Conventional BCG Therapy: SAKK 06/14. Eur Urol Oncol. Jan 2022.

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