目的:评估非肌层浸润性膀胱癌(NMIBC)患者减量与全剂量BCG方案的肿瘤学结局和安全性。
方法:我们根据系统评价和荟萃分析(PRISMA)的首选报告项目进行了系统评价。PubMed,Embase,和WebofScience数据库在2022年1月搜索了分析肿瘤结局的研究,并比较了减少剂量和全剂量BCG方案.
结果:包括3757名患者在内的17项研究符合我们的纳入标准。接受小剂量卡介苗治疗的患者复发率明显较高(OR1.19;95CI,1.03-1.36;p=0.02)。进展为肌肉侵入性BC的风险(OR1.04;95CI,0.83-1.32;p=0.71),转移(OR0.82;95CI,0.55-1.22;p=0.32),BC死亡(OR0.80;95CI,0.57-1.14;p=0.22),全因死亡(OR0.82;95CI,0.53-1.27;p=0.37)无统计学差异。当将分析限制在随机对照试验时,我们发现了类似的结果。在亚组分析中,在仅使用诱导方案的研究中,减少剂量与较高的BC复发率相关(OR1.70;95CI,1.19-2.42;p=0.004),但在使用维持治疗方案时并非如此(OR1.07;95CI,0.96-1.29;p=0.17).关于副作用,减少剂量的BCG方案与较少的发热发作相关(p=0.003),和治疗中断(p=0.03)。
结论:本综述发现BCG剂量与BC进展无关联,转移,和死亡率。减少剂量与BC复发之间存在关联,当使用维持方案时,这不再显著。在BCG短缺的时候,可以为BC患者提供减量方案.
To assess the oncologic outcomes and the safety profile of a reduced-dose versus full-dose BCG regimen in patients with non-muscle-invasive bladder cancer (NMIBC).
We performed a systematic
review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The PubMed, Embase, and Web of Science databases were searched in January 2022 for studies that analyzed oncological outcomes and compared between reduced- and full-dose BCG regimens.
Seventeen studies including 3757 patients met our inclusion criteria. Patients who received reduced-dose BCG had significantly higher recurrence rates (OR 1.19; 95%CI, 1.03-1.36; p = 0.02). The risks of progression to muscle-invasive BC (OR 1.04; 95%CI, 0.83-1.32; p = 0.71), metastasis (OR 0.82; 95%CI, 0.55-1.22; p = 0.32), death from BC (OR 0.80; 95%CI, 0.57-1.14; p = 0.22), and all-cause death (OR 0.82; 95%CI, 0.53-1.27; p = 0.37) were not statistically different. When restricting the analyses to randomized controlled trials, we found similar results. In subgroup analysis, reduced dose was associated with a higher rate of BC recurrence in studies that used only an induction regimen (OR 1.70; 95%CI, 1.19-2.42; p = 0.004), but not when a maintenance regimen was used (OR 1.07; 95%CI, 0.96-1.29; p = 0.17). Regarding side effects, the reduced-dose BCG regimen was associated with fewer episodes of fever (p = 0.003), and therapy discontinuation (p = 0.03).
This
review found no association between BCG dose and BC progression, metastasis, and mortality. There was an association between reduced dose and BC recurrence, which was no longer significant when a maintenance regimen was used. In times of BCG
shortage, reduced-dose regimens could be offered to BC patients.