The application of adjuvant autologous antravesical macrophage cell therapy vs. BCG in non-muscle invasive bladder cancer: a multicenter, randomized trial
The application of adjuvant autologous antravesical macrophage cell therapy vs. BCG in non-muscle invasive bladder cancer: a multicenter, randomized trial
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DOI：
10.1186/1479-5876-8-54
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发表时间：
2010-06-08
影响因子：
7.4
通讯作者：
Sherman, Jeff
中科院分区：
文献类型：
--
作者：
Burger, Maximilian;Thiounn, Nicolas;Sherman, Jeff
虽然卡介苗（BCG）辅助免疫治疗对非肌肉浸润性膀胱癌（BC）有效，但不良事件（ae）相当可观。单核细胞衍生的活化杀伤细胞（MAK）在抗肿瘤免疫应答中是必不可少的，但它们的应用可能意味着风险。本试验比较了经尿道BC切除术（TURB）后自体膀胱内巨噬细胞治疗（BEXIDEM (R)）和卡介苗治疗。材料和方法：这项开放标签试验纳入了137例TaG1-3、T1G1-2多焦点或单焦点肿瘤患者，并在24个月内出现>= 2，于2004年6月至2007年3月进行。无复发患者的中位随访时间为12个月。患者随机分为卡介苗组和体外细胞加工活化（BEXIDEM）后单核细胞组。在第3个月和第6个月，每组治疗包括6周注射和2个周期的3周注射。评估毒性概况（主要终点）和预防效果（次要终点）。结果：患者特征分布均匀。在接受BCG治疗的73名患者和接受BEXIDEM治疗的64名患者中，分别有85%对45%和26%对14%的严重ae （SAE）发生（p < 0.001）。卡介苗组的复发率明显低于BEXIDEM组（12% vs 38%; p < 0.001）。讨论：自体膀胱内巨噬细胞治疗BC的初步报告表明BEXIDEM治疗是安全的。然而，卡介苗组的复发率明显降低。由于BEXIDEM的疗效仍不确定，因此需要进一步的数据，例如标志物病变研究。
Introduction: While adjuvant immunotherapy with Bacille Calmette Guerin (BCG) is effective in non-muscle-invasive bladder cancer (BC), adverse events (AEs) are considerable. Monocyte-derived activated killer cells (MAK) are discussed as essential in antitumoural immunoresponse, but their application may imply risks. The present trial compared autologous intravesical macrophage cell therapy (BEXIDEM (R)) to BCG in patients after transurethral resection (TURB) of BC.Materials and methods: This open-label trial included 137 eligible patients with TaG1-3, T1G1-2 plurifocal or unifocal tumours and >= 2 occurrences within 24 months and was conducted from June 2004 to March 2007. Median follow-up for patients without recurrence was 12 months. Patients were randomized to BCG or mononuclear cells collected by apheresis after ex vivo cell processing and activation (BEXIDEM). Either arm treatment consisted of 6 weekly instillations and 2 cycles of 3 weekly instillations at months 3 and 6. Toxicity profile (primary endpoint) and prophylactic effects (secondary endpoint) were assessed.Results: Patient characteristics were evenly distributed. Of 73 treated with BCG and 64 with BEXIDEM, 85% vs. 45% experienced AEs and 26% vs. 14% serious AEs (SAE), respectively (p < 0.001). Recurrence occurred significantly less frequent with BCG than with BEXIDEM (12% vs. 38%; p < 0.001).Discussion: This initial report of autologous intravesical macrophage cell therapy in BC demonstrates BEXIDEM treatment to be safe. Recurrence rates were significantly lower with BCG however. As the efficacy of BEXIDEM remains uncertain, further data, e. g. marker lesions studies, are warranted.