Interim results from a national multicenter phase II trial of combination bacillus Calmette-Guerin plus interferon alfa-2b for superficial bladder cancer
Interim results from a national multicenter phase II trial of combination bacillus Calmette-Guerin plus interferon alfa-2b for superficial bladder cancer
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DOI：
10.1097/01.ju.0000136446.37840.0a
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发表时间：
2004-09-01
影响因子：
6.6
通讯作者：
Leopold, C
中科院分区：
文献类型：
--
作者：
O'Donnell, MA;Lilli, K;Leopold, C
目的：提供卡介苗(BCG)联合干扰素(干扰素)α-2b治疗卡介苗初治(BCG-N)和既往卡介苗失败(BCG-F)浅表性膀胱癌的大型多中心试验的中期结果。材料和方法：对1999年5月至2000年5月入选的490例浅表性膀胱癌患者进行分析，中位随访时间为24个月。BCG-N组(259例)在诱导后3、9、15个月给予标准剂量卡介苗+5000万单位干扰素诱导6周，然后用减量卡介苗(1/(3)至(1)/(10))加5000万单位干扰素维持3、3周。结果：BCG-N组和BCG-F组的单纯性肿瘤复发率分别为40%和52%，Kaplan-Meier对24个月后无瘤生存率的估计分别为57%和42%。进展为肌肉侵犯分别为5%和4.3%，转移分别为2.3%和2.6%。每组3.9%的患者接受了膀胱切除术，每组均有2例患者死于膀胱癌。严重不良事件发生率为5.5%，与感染相关的严重不良事件在BCG-F组中的发生率较低(2.6%比5.4%)。与毒性相关的退出、治疗延迟和/或进一步减少卡介苗剂量，以及对症状药物的需求相似。BCG-F组诱导期中至重度局部不良反应发生率较高(6.2%比16.9%)，但维持治疗期间达到平衡。结论：这项多中心试验为卡介苗联合干扰素作为前期抢救治疗的有效性和安全性提供了一个基准。干扰素的增量价值不能从这项研究中确定。
Purpose: Interim results are provided from a large multicenter trial of combination bacillus Calmette-Guerin (BCG) plus interferon (IFN) alfa-2b for BCG naive (BCG-N) and previous BCG failure (BCG-F) cases of superficial bladder cancer.Materials and Methods: A total of 490 patients enrolled from May 1999 to May 2000 with a median of 24 months of followup were analyzed. The BCG-N group (259) was treated with a 6-week induction course of standard dose BCG plus 50 million units of IFN followed by 3, 3-week maintenance cycles of reduced dose BCG ((1)/(3) to (1)/(10)) plus 50 million units IFN at 3, 9 and 15 months after induction. The BCG-F group (231) was treated similarly except induction therapy began at a decreased ((1)/(3) to (1)/(10)) BCG dose.Results: The simple tumor recurrence rates for BCG-N and BCG-F groups were 40% and 52%, and the Kaplan-Meier estimates for disease freedom at 24 months were 57% and 42%, respectively. Progression to muscle invasion occurred in 5% and 4.3% while metastasis occurred in 2.3% and 2.6%, respectively. In each group 3.9% of patients underwent cystectomy and 2 patients in each group died of bladder cancer. Serious adverse events occurred in 5.5% with infection related serious adverse events being less prevalent in the BCG-F group (2.6% vs 5.4%). Toxicity related dropout, treatment delay and/or further BCG dose reduction, and need for symptomatic drugs were similar. Moderate to severe local side effects during induction were higher in the BCG-F group (6.2% vs 16.9%) but equilibrated during maintenance therapy. Systemic reactions were rare.Conclusions: This multicenter trial provides a benchmark for the efficacy and safety of combination BCG and IFN as up front and salvage therapy. The incremental value of IFN cannot be determined from this study.