Final results from a national multicenter phase II trial of combination bacillus Calmette-Guerin plus interferon α-2B for reducing recurrence of superficial bladder cancer
Final results from a national multicenter phase II trial of combination bacillus Calmette-Guerin plus interferon α-2B for reducing recurrence of superficial bladder cancer
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DOI：
10.1016/j.urolonc.2005.11.026
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发表时间：
2006-07-01
影响因子：
2.7
通讯作者：
O'Donnell, Michael A.
中科院分区：
文献类型：
--
作者：
Joudi, Fadi N.;Smith, Brian J.;O'Donnell, Michael A.
背景：卡介苗（BCG）和干扰素-α（IFN-α）均对浅表性膀胱癌具有活性。一个国家的多中心II期临床试验的结果，这2种药物的组合使用在广泛的patients.Materials和方法：以前有BCG失败的患者接受IFN-α（50万单位）加减少剂量的BCG，而患者接受相同的IFN-α剂量与标准剂量的BCG。所有无复发的患者在完成诱导后3个月、9个月和15个月接受了另外3个系列的3周减少剂量BCG加IFN-α治疗。3个月评价期间的任何复发均计为Kaplan-Meier分析的治疗失败。进行多变量分析，以确定与recurrence.Results相关的因素：在1,007例有价值的患者中，59%和45%的初次接受BCG治疗的患者和BCG失败的患者，分别在24个月的中位随访时保持无病状态。T1期，肿瘤大小>5厘米，先前BCG失败超过一次，和多灶性都是统计学上显着的风险因素recurrent.Conclusions：虽然BCG加IFN-α可以有效地应用于两个病人幼稚的BCG和那些BCG失败，某些病人和肿瘤的特点影响持久的反应。(C)2006年爱思唯尔公司All rights reserved.
Background: Both bacillus Calmette-Guerin (BCG) and interferon-alpha (IFN-alpha) express activity against superficial bladder cancer. The results of a national multicenter phase II trial of a combination of these 2 agents used in a wide range of patients are reported.Materials and Methods: Patients previously having BCG failure received IFN-alpha (50 million units) plus reduced dose BCG, while patients naive to BCG received the same IFN-alpha dose with standard dose BCG. All patients who were relapse free received an additional 3 series of 3-week reduced dose BCG plus IFN-alpha treatments at 3, 9, and 15 months after completing induction. Any relapse during the 3-month evaluation was counted as a failure of therapy for Kaplan-Meier analysis. Multivariate analysis was performed to identify factors associated with recurrence.Results: Of 1,007 valuable patients, 59% and 45% of patients naive to BCG and those having BCG failure, respectively, remained disease free at 24-month median follow-up. Stage T1, tumor size >5 cm, prior BCG failure more than once, and multifocality were all statistically significant risk factors for recurrence.Conclusions: Although BCG plus IFN-alpha can be effectively applied to both patients naive to BCG and those having BCG failure, certain patient and tumor characteristics influence durable response. (C) 2006 Elsevier Inc. All rights reserved.