Introduction:Intravesical Bacillus Calmette-Guérin (BCG) immunotherapy is the standard of care for high-risk and intermediate-risk non-muscle-invasive bladder cancer (NMIBC) as well as for Carcinoma in situ (CIS). Evidence supports that the different BCG strains, despite genetic variability, are equally effective clinically for preventing the recurrence and progression of papillary NMIBC. The available evidence regarding possible differences in clinical efficacy between various BCG strains in CIS is lacking.Methods:We reviewed the literature on the efficacy of different BCG strains in patients with CIS (whether primary, secondary, concomitant, or unifocal/multifocal), including randomized clinical trials (RCTs), phase II/prospective trials, and retrospective studies with complete response rates (CRR), recurrence-free survival (RFS), or progression-free survival (PFS) as endpoints.Results:In most studies, being RCTs, phase II prospective trials, or retrospective studies, genetic differences between BCG strains did not translate into meaningful differences in clinical efficacy against CIS, regardless of the CIS subset (primary, secondary, or concurrent) or CIS focality (unifocal or multifocal). CRR, RFS, and PFS were not statistically different between various BCG strains. None of these trials were designed as head-to-head comparisons between BCG strains focusing specifically on CIS. Limitations include the small sample size of many studies and most comparisons between strains being indirect rather than head-to-head.Conclusions:This review suggests that the clinical efficacy of the various BCG strains appears similar, irrespective of CIS characteristics. However, based on the weak level of evidence available and underpowered studies, randomized studies in this space should be encouraged as no definitive conclusion can be drawn at this stage.
引言：膀胱内灌注卡介苗（BCG）免疫疗法是高危和中危非肌层浸润性膀胱癌（NMIBC）以及原位癌（CIS）的标准治疗方案。现有证据表明，尽管不同BCG菌株存在遗传差异，但在预防乳头状NMIBC复发和进展方面具有同等的临床疗效。关于不同BCG菌株对CIS临床疗效可能存在的差异，目前尚缺乏相关证据。 方法：我们系统回顾了关于不同BCG菌株治疗CIS（包括原发性、继发性、伴随性或单灶性/多灶性）疗效的文献，涵盖随机临床试验（RCTs）、II期/前瞻性试验以及以完全缓解率（CRR）、无复发生存期（RFS）或无进展生存期（PFS）为终点的回顾性研究。 结果：在大多数研究（包括RCTs、II期前瞻性试验和回顾性研究）中，无论CIS亚型（原发性、继发性或伴随性）或病灶特征（单灶性或多灶性），BCG菌株间的遗传差异并未转化为临床疗效的显著差异。不同BCG菌株间的CRR、RFS和PFS均无统计学差异。现有试验均未专门针对CIS设计不同BCG菌株的头对头比较研究。研究局限性包括多数样本量较小，且菌株间比较多为间接性而非头对头设计。 结论：本综述表明，无论CIS特征如何，不同BCG菌株的临床疗效似乎相近。然而，基于现有证据等级较弱且研究效力不足，现阶段尚不能得出明确结论，有必要鼓励开展该领域的随机对照研究。
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