Khene Zine-Eddine, Bhanvadia Raj, Attia Sarah, Ito Willian, Trevino Ivan, Woldu Solomon L, Margulis Vitaly, Lotan Yair
Department of Urology, UT Southwestern Medical Center, Dallas, Texas.
J Urol. 2025 Jun;213(6):730-738. doi: 10.1097/JU.0000000000004472. Epub 2025 Feb 10.
Patients with intermediate-risk (IR) nonmuscle-invasive bladder cancer (NMIBC) are recommended to receive induction intravesical chemotherapy or immunotherapy. However, the comparison between gemcitabine and bacillus Calmette-Guérin (BCG) in treatment-naïve patients with low-grade IR-NMIBC remains underexplored. The aim of this study was to evaluate the efficacy of gemcitabine compared with BCG in a cohort of treatment-naïve patients with IR-NMIBC.
A retrospective analysis was conducted on patients with low-grade IR-NMIBC, classified according to International Bladder Cancer Group criteria, with no history of induction intravesical treatment. Patients received either induction intravesical BCG or gemcitabine. Recurrence was defined as histologically confirmed cancer during follow-up, while progression included stage/grade progression. Kaplan-Meier estimates were used for survival analysis, and multivariable Cox analysis identified factors associated with recurrence and progression.
Of the 151 patients with IR-NMIBC, 78 received BCG and 73 received gemcitabine. Both groups completed the 6-week induction treatment at similar rates (100%), and maintenance therapy was administered to 47% of BCG-treated patients and 53% of gemcitabine-treated patients ( = .46). The median number of maintenance doses was 6 (IQR: 3-9) in the BCG group and 8 (IQR: 4-10) in the gemcitabine group ( = .83). Median follow-up was 54 months for patients receiving BCG and 36 months for patients receiving gemcitabine. After adjusting for age, International Bladder Cancer Group subgroups, year of treatment, single postoperative instillation, and maintenance therapy, gemcitabine was associated with a higher risk of recurrence compared with BCG ( = .02), while the risk of progression remained similar between the 2 groups ( = .87). Adverse events were observed in 62% of patients treated with BCG and 38% of patients treated with gemcitabine ( = .02).
Gemcitabine is associated with a higher risk of recurrence than BCG in treatment-naïve patients with IR-NMIBC. However, both treatments show comparable efficacy in preventing disease progression.
推荐中危（IR）非肌层浸润性膀胱癌（NMIBC）患者接受膀胱内诱导化疗或免疫治疗。然而，对于初治的低级别IR-NMIBC患者，吉西他滨与卡介苗（BCG）之间的比较仍未得到充分研究。本研究的目的是评估吉西他滨与BCG在一组初治的IR-NMIBC患者中的疗效。
对根据国际膀胱癌组标准分类的低级别IR-NMIBC患者进行回顾性分析，这些患者无膀胱内诱导治疗史。患者接受膀胱内BCG或吉西他滨诱导治疗。复发定义为随访期间组织学确诊的癌症，而进展包括分期/分级进展。采用Kaplan-Meier估计进行生存分析，多变量Cox分析确定与复发和进展相关的因素。
在151例IR-NMIBC患者中，78例接受BCG治疗，73例接受吉西他滨治疗。两组以相似的比例（100%）完成了6周的诱导治疗，47%接受BCG治疗的患者和53%接受吉西他滨治疗的患者接受了维持治疗（P = 0.46）。BCG组维持剂量的中位数为6（IQR：3-9），吉西他滨组为8（IQR：4-10）（P = 0.83）。接受BCG治疗的患者中位随访时间为54个月，接受吉西他滨治疗的患者为36个月。在调整年龄、国际膀胱癌组亚组、治疗年份、术后单次灌注和维持治疗后，与BCG相比，吉西他滨与更高的复发风险相关（P = 0.02），而两组之间的进展风险仍然相似（P = 0.87）。62%接受BCG治疗的患者和38%接受吉西他滨治疗的患者观察到不良事件（P = 0.02）。
在初治的IR-NMIBC患者中，吉西他滨与比BCG更高的复发风险相关。然而，两种治疗在预防疾病进展方面显示出相当的疗效。
