Bacillus Calmette-Guerin Is Superior to a Combination of Epirubicin and Interferon-α2b in the Intravesical Treatment of Patients with Stage T1 Urinary Bladder Cancer. A Prospective, Randomized, Nordic Study
Bacillus Calmette-Guerin Is Superior to a Combination of Epirubicin and Interferon-α2b in the Intravesical Treatment of Patients with Stage T1 Urinary Bladder Cancer. A Prospective, Randomized, Nordic Study
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DOI：
10.1016/j.eururo.2009.09.038
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发表时间：
2010-01-01
期刊：
影响因子：
23.4
通讯作者：
Malmstrom, Per-Uno
中科院分区：
文献类型：
--
作者：
Duchek, Milos;Johansson, Robert;Malmstrom, Per-Uno
背景：卡介苗(BCG)灌注被认为是治疗高级别T1肿瘤和原位癌(CIS)患者最有效的保留膀胱的治疗方法。这种疗法的主要问题是副作用，使维持治疗变得困难，甚至不可能，在一定比例的患者。目的：比较卡介苗和联合用表阿霉素和干扰素-α2b辅助治疗T1肿瘤。设计、背景和参与者：这是一项北欧多中心、前瞻性、随机试验，适用于原发性T1、G2-G3膀胱癌患者。首次经尿道电切术(TUR)后进行二次电切术。患者被随机分成两组，分别接受诱导治疗6wk和维持治疗2年。测量：比较药物复发和进展的时间。此外，副作用也被记录下来。结果和限制：总共250名患者被随机分组。在主要终点，联合组62%的患者无病，而卡介苗组为73%(p=0.065)。在24个月时，接受卡介苗治疗的患者在复发方面存在显著差异(p=0.012)，尽管在进展方面没有差异。亚组分析显示卡介苗的优势主要表现在伴发CIS的人群中。在与复发/进展状态相关的多变量分析中，影响预后的重要变量是药物类型、肿瘤大小、多发性、二次切除时的状态和分级。在两个治疗臂中分别进行相应的分析。对于接受卡介苗治疗的患者来说，肿瘤大小是唯一有意义的变量，而对于接受联合治疗的患者来说，肿瘤多发性、二次切除时的状态和分级是显著的。结论：在预防复发方面，卡介苗比联合治疗更有效。在进展和不良事件方面，两种治疗方法之间没有差异。(C)2009年欧洲泌尿外科协会。爱思唯尔出版，版权所有。
Background: Bacillus Calmette-Guerin (BCG) instillation is regarded as the most effective bladder-sparing treatment for patients with high-grade T1 tumours and carcinoma in situ (CIS). The major problem with this therapy is the side-effects, making maintenance therapy difficult, even impossible, in a proportion of patients. Thus, alternative schedules and drugs have been proposed.Objective: To compare BCG to the combination of epirubicin and interferon-alpha 2b as adjuvant therapy of T1 tumours.Design, setting, and participants: This is a Nordic multicenter, prospective, randomised trial in patients with primary T1 G2-G3 bladder cancer. Initial transurethral resection (TUR) was followed by a second-look resection. Patients were randomised to receive either regimen, given as induction for 6 wk followed by maintenance therapy for 2 yr.Measurements: The drugs were compared with respect to time to recurrence and progression. Also, side-effects were documented.Results and limitations: A total of 250 patients were randomised. At the primary end point, 62% were disease free in the combination arm as opposed to 73% in the BCG arm (p = 0.065). At 24 mo, there was a significant difference in favour of the BCG-treated patients (p = 0.012) regarding recurrence, although there was no difference regarding progression. The subgroup analysis showed that the superiority of BCG was mainly in those with concomitant CIS. In a multivariate analysis of association with recurrence/progression status, significant variables for outcome were type of drug, tumour size, multiplicity, status at second-look resection, and grade. A corresponding analysis was performed separately in the two treatment arms. Tumour size was the only significant variable for BCG-treated patients, while multiplicity, status at second-look resection, and grade were significant for patients treated with the combination.Conclusions: For prophylaxis of recurrence, BCG was more effective than the combination. There were no differences regarding progression and adverse events between the two treatments. (C) 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved.