Arora Amandeep, Godse Sugam, Pal Mahendra, Misra Ankit, Sepuri Ravi Teja, Mallikarjun Naveen Thimiri, Gujela Ajit, Patel Sachin, Sharma Anuj, Menon Santosh, Bakshi Ganesh, Prakash Gagan
Division of Uro-Oncology, Department of Surgical Oncology Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Homi Bhabha National Institute Mumbai India.
Division of Uro-Oncology, Department of Surgical Oncology Tata Memorial Hospital, Homi Bhabha National Institute Mumbai India.
BJUI Compass. 2025 Jun 10;6(6):e70034. doi: 10.1002/bco2.70034. eCollection 2025 Jun.
This study aims to determine the oncological effectiveness and adverse-effect profile of the Moscow strain of intravesical bacille Calmette-Guérin (BCG) for intermediate and high-risk non-muscle invasive bladder cancer (NMIBC).
We performed a retrospective search of consecutive intermediate and high-risk non-muscle invasive bladder cancer patients who were started on intravesical BCG at 80 mg dose from January 2020 to December 2021. Data were collected for oncological outcomes and adverse effects of BCG. High-grade recurrence-free survival (HGRFS) was defined as any relapse of high-grade (HG) urothelial cancer or carcinoma in situ (CIS). The primary outcome was to determine the HGRFS for those with originally HG disease. The RFS and HGRFS were calculated for the entire cohort, and also stratified by whether the patients had received adequate BCG or not.
We identified 166 patients during the study period, of which 79.6% had HG disease. There were 25 recurrences (15.1%) in the entire cohort over a median follow-up of 29 months. The RFS for the entire cohort at 12 and 24 months was 89.8% and 86.7%, respectively. For those with baseline HG disease, the 12- and 24-month HG-RFS was 90.9% and 87.1%. For the overall cohort, those who had received adequate BCG ( = 130, 78.3%) had a 12- and 24-month RFS of 96.9% and 95.4%, which was significantly higher than those who were not able to receive adequate BCG ( = 31, 18.6%) (12- and 24-month RFS of 74.2% and 64.5%), < 0.001. Around 10% patients dropped out at each sequential maintenance phase, either because of BCG intolerance or because of failure to comply with the BCG instillation schedule. Severe side effects led to BCG discontinuation in 38.5% patients.
The Moscow strain BCG at 80 mg dose has excellent oncological outcomes, especially in patients who can take adequate BCG instillations, but BCG intolerance is a problem in a significant proportion of patients.
本研究旨在确定莫斯科株卡介苗（BCG）膀胱内灌注治疗中高危非肌层浸润性膀胱癌（NMIBC）的肿瘤学疗效和不良反应情况。
我们对2020年1月至2021年12月期间开始接受80mg剂量膀胱内BCG灌注治疗的连续性中高危非肌层浸润性膀胱癌患者进行了回顾性研究。收集了BCG的肿瘤学结局和不良反应数据。高级别无复发生存期（HGRFS）定义为高级别（HG）尿路上皮癌或原位癌（CIS）的任何复发。主要结局是确定最初患有HG疾病患者的HGRFS。计算了整个队列的无复发生存期（RFS）和HGRFS，并根据患者是否接受了足够剂量的BCG进行分层。
在研究期间，我们确定了166例患者，其中79.6%患有HG疾病。在中位随访29个月期间，整个队列中有25例复发（15.1%）。整个队列在12个月和24个月时的RFS分别为89.8%和86.7%。对于基线患有HG疾病的患者，12个月和24个月时的HG-RFS分别为90.9%和87.1%。对于整个队列，接受了足够剂量BCG的患者（n = 130，78.3%）在12个月和24个月时的RFS分别为96.9%和95.4%，显著高于未接受足够剂量BCG的患者（n = 31，18.6%）（12个月和24个月时的RFS分别为74.2%和64.5%），P < 0.001。在每个连续的维持阶段，约10%的患者退出，要么是因为对BCG不耐受，要么是因为未遵守BCG灌注计划。严重的副作用导致38.5%的患者停止使用BCG。
80mg剂量的莫斯科株BCG具有出色的肿瘤学结局，尤其是在能够接受足够剂量BCG灌注的患者中，但BCG不耐受在相当一部分患者中是一个问题。
