卡介苗菌株治疗非肌肉浸润性膀胱癌的疗效：系统评价和网络荟萃分析。
Efficacy of bacillus Calmette-Guérin Strains for Treatment of Nonmuscle Invasive Bladder Cancer: A Systematic Review and Network Meta-Analysis.
机构信息
Department of Urology, University of Texas Health San Antonio, San Antonio, Texas; Department of Biostatistics (JEC), University of Texas Health San Antonio, San Antonio, Texas.
Department of Urology, University of Texas Health San Antonio, San Antonio, Texas; Department of Biostatistics (JEC), University of Texas Health San Antonio, San Antonio, Texas.
出版信息
J Urol. 2017 Sep;198(3):503-510. doi: 10.1016/j.juro.2017.01.086. Epub 2017 Mar 10.
PURPOSE
We sought to determine the efficacy of genetically distinct bacillus Calmette-Guérin strains in preventing disease recurrence in patients with nonmuscle invasive bladder cancer.
MATERIALS AND METHODS
We conducted a systematic review and network meta-analysis of trials evaluating bacillus Calmette-Guérin strains against all possible comparators (different bacillus Calmette-Guérin strains, chemotherapy and nonbacillus Calmette-Guérin biological therapies) with intravesical chemotherapy as the common comparator. MEDLINE® (http://www.ncbi.nlm.nih.gov/pubmed) served as the primary data source, with the search from inception to October 2016 for clinical trials involving patients with nonmuscle invasive bladder cancer receiving bacillus Calmette-Guérin. Primary outcome measure was bladder cancer recurrence, defined as recurrent bladder tumor of any grade or stage. Random effect network meta-analysis provided estimates for outcomes and is presented as odds ratios.
RESULTS
Across all possible comparators (65 trials, 12,246 patients, 9 strains) there were 2,177 recurrences in 5,642 treated patients (38.6%) and 2,316 recurrences in 5,441 comparators (42.6%). With chemotherapy as the common comparator (28 trials, 5,757 patients, 5 strains) Tokyo-172 (OR 0.39, 95% CI 0.16-0.93), Pasteur (OR 0.49, 95% CI 0.28-0.86) and TICE® (OR 0.61, 95% CI 0.40-0.93) strains were significantly better than chemotherapy at preventing recurrence. No bacillus Calmette-Guérin strain demonstrated significant superiority when compared to any other strain at preventing recurrence in the network meta-analysis.
CONCLUSIONS
Bacillus Calmette-Guérin strains exhibited significant differences in efficacy compared to chemotherapy. However, no definitive conclusions could be reached regarding strain superiority, and head-to-head trials are greatly needed to further understand the importance of strain selection in determining bacillus Calmette-Guérin efficacy.
目的
我们旨在确定不同卡介苗菌株在预防非肌层浸润性膀胱癌患者疾病复发方面的疗效。
材料与方法
我们对评估卡介苗菌株的临床试验进行了系统评价和网络荟萃分析，将所有可能的对照物（不同的卡介苗菌株、化疗和非卡介苗生物治疗）作为对照，以膀胱内化疗作为共同对照。我们以 MEDLINE®（http://www.ncbi.nlm.nih.gov/pubmed）为主要数据源，检索自成立至 2016 年 10 月期间涉及接受卡介苗治疗的非肌层浸润性膀胱癌患者的临床试验。主要结局指标为膀胱癌复发，定义为任何分级或分期的复发性膀胱肿瘤。随机效应网络荟萃分析提供了对结局的估计，并以比值比表示。
结果
在所有可能的对照物（65 项试验，12246 例患者，9 种菌株）中，在 5642 例治疗患者中，有 2177 例（38.6%）复发，在 5441 例对照中，有 2316 例（42.6%）复发。以化疗作为共同对照（28 项试验，5757 例患者，5 种菌株），东京 172（OR 0.39，95%CI 0.16-0.93）、巴斯德（OR 0.49，95%CI 0.28-0.86）和 TICE®（OR 0.61，95%CI 0.40-0.93）菌株在预防复发方面明显优于化疗。在网络荟萃分析中，没有任何一种卡介苗菌株在预防复发方面显示出明显优于其他菌株的优势。
结论
卡介苗菌株在疗效上与化疗有显著差异。然而，对于菌株的优势，我们无法得出明确的结论，并且非常需要头对头试验来进一步了解在确定卡介苗疗效方面菌株选择的重要性。
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