Shah Kamran A, Shah Syed Rafiuddin, Khan Waqas Ahmed, Nisar Sara, Zaidi Syeda Farwa, Asif Muhammad, Gul Farah, Ullah Farid
General Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, GBR.
Urology, Sindh Institute of Urology and Transplantation, Karachi, PAK.
Cureus. 2025 Jun 22;17(6):e86524. doi: 10.7759/cureus.86524. eCollection 2025 Jun.
Background Bacillus Calmette-Guérin (BCG) and mitomycin C (MMC) are the two most commonly used intravesical therapies for non-muscle-invasive bladder cancer (NMIBC), yet variability in treatment outcomes and tolerability continues to challenge clinical decision-making. Updated comparisons reflecting current treatment protocols and adherence patterns are needed to inform practice. Objective The objective of this study is to evaluate and compare the efficacy and safety of intravesical BCG versus MMC in the contemporary treatment of NMIBC, focusing on recurrence, progression, and adverse effects over a 24-month follow-up. Methods This comparative study was conducted at the Khyber Teaching Hospital over a two-year period from January 2023 to December 2024. A total of 286 patients were enrolled, with 143 patients in each treatment group. Patients who had a complete transurethral resection of bladder tumor, were confirmed to have NMIBC, were at least 18 years old, and were eligible for intravesical therapy with either BCG or MMC were included in the study. Patients with muscle-invasive bladder cancer, BCG or MMC contraindications, active UTIs, severe immunosuppression, or serious comorbid diseases that might affect therapy results were excluded. Results The BCG group had much lower rates of cancer returning after 12 months (19 out of 143 patients, 13.29%, vs. 32 out of 143 patients, 22.38%; p = 0.037) and 24 months (34 out of 143 patients, 23.78%, vs. 49 out of 143 patients, 34.27%; p = 0.043), a longer average time before cancer returned (14.20 ± 4.80 months vs. 10.90 ± 5.30 months; p = 0.026), and less disease progression after 24 months (15 out of 143 patients, 10.49%, vs. 29 out of 143 patients, 20.28%; p = 0.021). Adverse effects were more frequent in the BCG group (n = 67, 46.85% vs. n = 58, 40.55%; p = 0.312), with fever (n = 19, 13.28% vs. n = 6, 4.19%; p = 0.012) and flu-like symptoms (n = 24, 16.78% vs. n = 8, 5.59%; p = 0.004) occurring more commonly. Conclusions BCG demonstrated superior efficacy over MMC in reducing recurrence and progression rates in patients with NMIBC, with a higher frequency of systemic adverse effects.
卡介苗（BCG）和丝裂霉素C（MMC）是用于非肌层浸润性膀胱癌（NMIBC）的两种最常用的膀胱内治疗药物，但治疗结果和耐受性的差异仍在挑战临床决策。需要反映当前治疗方案和依从模式的最新比较来为实践提供参考。
本研究的目的是评估和比较膀胱内注射BCG与MMC在当代NMIBC治疗中的疗效和安全性，重点关注24个月随访期内的复发、进展和不良反应。
这项比较研究于2023年1月至2024年12月在开伯尔教学医院进行，为期两年。共纳入286例患者，每个治疗组143例。纳入研究的患者需满足膀胱肿瘤经尿道完全切除、确诊为NMIBC、年龄至少18岁且有资格接受BCG或MMC膀胱内治疗。排除患有肌层浸润性膀胱癌、BCG或MMC禁忌证、活动性尿路感染、严重免疫抑制或可能影响治疗结果的严重合并症的患者。
BCG组在12个月（143例患者中有19例，13.29%， vs. 143例患者中有32例，22.38%；p = 0.037）和24个月（143例患者中有34例，23.78%， vs. 143例患者中有49例，34.27%；p = 0.043）时癌症复发率低得多，癌症复发前的平均时间更长（14.20 ± 4.80个月 vs. 10.90 ± 5.30个月；p = 0.026），且24个月后疾病进展较少（143例患者中有15例，10.49%， vs. 143例患者中有29例，20.28%；p = 0.021）。BCG组的不良反应更频繁（n = 67，46.85% vs. n = 58，40.55%；p = 0.312），发热（n = 19，13.28% vs. n = 6，4.19%；p = 0.012）和流感样症状（n = 24，16.78% vs. n = 8，5.59%；p = 0.004）更常见。
在降低NMIBC患者的复发率和进展率方面，BCG显示出优于MMC的疗效，但全身不良反应的发生率更高。
