Azuri Wadi, Jaunarena Jorge Horacio, Camean Juan Jorge, Chemi Joaquín, Villaronga Alberto, Daneshmand Siamak, Villoldo Gustavo Martín
Instituto Alexander Fleming, Buenos Aires, Argentina.
Sanatorio Argentino, San Juan, Argentina.
Bladder Cancer. 2023 Sep 25;9(3):227-236. doi: 10.3233/BLC-230044. eCollection 2023.
Bacillus Calmette-Guerin (BCG) is the standard adjuvant treatment for intermediate and high-risk non-muscle invasive bladder cancer (NMIBC) following transurethral resection of the bladder (TURB). However, the optimal dose, strain, and schedule of BCG remain unclear.
To evaluate the impact of BCG dose reduction on oncological outcomes and toxicity in patients with non-muscle invasive bladder cancer.
We performed a systematic review of the literature in PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases. Selected studies were analyzed for Meta Analysis using PRISMA criteria. The study focused on disease recurrence, progression, and toxicity. We also compared the oncological outcomes of the different BCG strains.
A total of 2963 patients in 13 randomized controlled trials were included. In recurrence analysis, we found a non-significant difference between the full dose and any dose reduction of BCG (RR = 1.17, [1.06-1.28], I2 = 0%, = 0.7). In terms of progression, the difference was also non-statistically significant (RR: 1.12 [0.89 - 1.41], I2 = 0%, = 0.93). In the toxicity analysis, there were more local (RR: 0.81 [0.67-0.99] I2 = 76%; < 0.01) and systemic (RR: 0.53 [0.34-0.82] I2 = 83%; < 0.01) side effects in the full dose group than in the dose reduction group. There were no statistically significant differences in oncological outcomes between the analyzed BCG strains.
Dose reduction did not affect the oncological outcomes of patients with NMIBC who received adjuvant therapy with BCG. On the other hand, dose reduction showed a significant trend towards fewer systemic and local side effects. Further studies comparing oncological and toxicity outcomes using different strains are needed.
卡介苗（BCG）是经尿道膀胱肿瘤电切术（TURB）后中高危非肌层浸润性膀胱癌（NMIBC）的标准辅助治疗方法。然而，卡介苗的最佳剂量、菌株和给药方案仍不明确。
评估卡介苗剂量减少对非肌层浸润性膀胱癌患者肿瘤学结局和毒性的影响。
我们对PubMed、EMBASE、Cochrane对照试验中央注册库和ClinicalTrials.gov数据库中的文献进行了系统评价。使用PRISMA标准对所选研究进行Meta分析。该研究关注疾病复发、进展和毒性。我们还比较了不同卡介苗菌株的肿瘤学结局。
共纳入13项随机对照试验中的2963例患者。在复发分析中，我们发现卡介苗全剂量组与任何剂量减少组之间无显著差异（RR = 1.17，[1.06 - 1.28]，I² = 0%，P = 0.7）。在进展方面，差异也无统计学意义（RR：1.12 [0.89 - 1.41]，I² = 0%，P = 0.93）。在毒性分析中，全剂量组的局部（RR：0.81 [0.67 - 0.99]，I² = 76%；P < 0.01）和全身（RR：0.53 [0.34 - 0.82]，I² = 83%；P < 0.01）副作用比剂量减少组更多。分析的卡介苗菌株之间在肿瘤学结局上无统计学显著差异。
剂量减少不影响接受卡介苗辅助治疗的非肌层浸润性膀胱癌患者的肿瘤学结局。另一方面，剂量减少显示出全身和局部副作用明显减少的趋势。需要进一步研究比较使用不同菌株的肿瘤学和毒性结局。
