Lashay Alireza, Taleghani Saeed, Masoumi Navid
Department of urology, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran/Iran.
Urology Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran/Iran.
Urol J. 2021 May 8;19(2):106-110. doi: 10.22037/uj.v18i.6491.
To compare the efficacy and complication rate of monthly instillations of Bacillus Calmette-Guerin (BCG) as maintenance therapy in intermediate and high risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients with the current standard Southwest Oncology Group (SWOG) protocol.
In this observational retrospective study, 40 intermediate and high risk NMIBC patients, receiving standard BCG maintenance regimen, were compared with another 40 NMIBC patients, undergoing monthly intra-vesical instillations of BCG with regard to recurrence, progression and major and minor adverse effects.
The two groups were similar in their basic characteristics except for the older age in the monthly instillation group ( 70.95 ± 9.66 years vs. 64 ± 8.8, p = 0.001). Study objectives between the monthly instillation group and the standard group, including recurrence ( 17.5 % vs. 25%, p = 0.34) and progression rate ( 7.5% vs. 10%, p = 0.54) did not show statistically significant difference. Major and minor complication rate also did not show any difference between the two groups.
In addition to the currently recommended standard protocol of BCG maintenance therapy, our study shows that the monthly regimen can be recommended in intermediate and high risk NMIBC patients without compromising the efficacy of the treatment.
比较每月膀胱灌注卡介苗(BCG)作为维持治疗在中高危非肌层浸润性膀胱癌(NMIBC)患者中的疗效和并发症发生率与当前标准的西南肿瘤协作组(SWOG)方案。
在这项观察性回顾性研究中,将40例接受标准BCG维持方案的中高危NMIBC患者与另外40例每月接受膀胱内BCG灌注的NMIBC患者在复发、进展以及主要和次要不良反应方面进行比较。
两组患者的基本特征相似,但每月灌注组患者年龄较大(70.95±9.66岁 vs. 64±8.8岁,p = 0.001)。每月灌注组与标准组之间的研究目标,包括复发率(17.5% vs. 25%,p = 0.34)和进展率(7.5% vs. 10%,p = 0.54),均未显示出统计学上的显著差异。两组之间的主要和次要并发症发生率也没有差异。
除了目前推荐的BCG维持治疗标准方案外,我们的研究表明,在不影响治疗效果的情况下,每月方案可推荐用于中高危NMIBC患者。