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Abstract：
OBJECTIVE: This study investigated the efficacy of intravesical gemcitabine as an alternative to bacillus Calmette-Guérin (BCG) therapy.
METHODS: Data were retrospectively collected across seven institutions from February 1999 to May 2023. Inclusion criteria included patients with intermediate- or high-risk non-muscle invasive bladder cancer (NMIBC) who underwent transurethral resection of bladder tumors (TURBT) and received at least four sessions of intravesical gemcitabine or BCG induction therapy. Patient characteristics, complete remission (CR), occurrence, and progression rates were compared.
RESULTS: In total, 149 patients were included in this study (gemcitabine, 63; BCG, 86). No differences were apparent between the two groups in baseline characteristics, except for the follow-up period (gemcitabine, 9.2±5.9 months vs. BCG, 43.9±41.4 months, p<0.001). There were no consistent significant differences observed between the two groups in the 3-month (gemcitabine, 98.4% vs. BCG, 95.3%; p=0.848), 6-month (94.9% vs. 90.0%, respectively; p=0.793) and 1-year CR rates (84.2% vs. 83.3%, respectively; p=0.950). Also, there was no significant statistical difference in progression-free survival between the two groups (p=0.953). The occurrence rates of adverse events were similar between the groups (22.2% vs. 22.1%; p=0.989); however, the rate of Clavien-Dindo grade 2 or higher was significantly higher in the BCG group (1.6% vs. 16.3%, respectively; p<0.001).
CONCLUSIONS: Intravesical gemcitabine demonstrated efficacy comparable to BCG therapy for the first year in patients with intermediate- and high-risk NMIBC. However, long-term follow-up studies are warranted.
METHODS: Data were retrospectively collected across seven institutions from February 1999 to May 2023. Inclusion criteria included patients with intermediate- or high-risk non-muscle invasive bladder cancer (NMIBC) who underwent transurethral resection of bladder tumors (TURBT) and received at least four sessions of intravesical gemcitabine or BCG induction therapy. Patient characteristics, complete remission (CR), occurrence, and progression rates were compared.
RESULTS: In total, 149 patients were included in this study (gemcitabine, 63; BCG, 86). No differences were apparent between the two groups in baseline characteristics, except for the follow-up period (gemcitabine, 9.2±5.9 months vs. BCG, 43.9±41.4 months, p<0.001). There were no consistent significant differences observed between the two groups in the 3-month (gemcitabine, 98.4% vs. BCG, 95.3%; p=0.848), 6-month (94.9% vs. 90.0%, respectively; p=0.793) and 1-year CR rates (84.2% vs. 83.3%, respectively; p=0.950). Also, there was no significant statistical difference in progression-free survival between the two groups (p=0.953). The occurrence rates of adverse events were similar between the groups (22.2% vs. 22.1%; p=0.989); however, the rate of Clavien-Dindo grade 2 or higher was significantly higher in the BCG group (1.6% vs. 16.3%, respectively; p<0.001).
CONCLUSIONS: Intravesical gemcitabine demonstrated efficacy comparable to BCG therapy for the first year in patients with intermediate- and high-risk NMIBC. However, long-term follow-up studies are warranted.
摘要：
目的：本研究调查了膀胱内吉西他滨替代卡介苗（BCG）治疗的疗效。
方法：从1999年2月至2023年5月，对七个机构的数据进行了回顾性收集。纳入标准包括中危或高危非肌层浸润性膀胱癌（NMIBC）患者，他们接受了经尿道膀胱肿瘤电切术（TURBT），并接受了至少四次膀胱内吉西他滨或BCG诱导治疗。患者特征,完全缓解（CR），发生,并比较进展率。
结果：总计，本研究包括149名患者(吉西他滨，63;BCG,86).两组基线特征无明显差异,除了随访期(吉西他滨，9.2±5.9个月vs.BCG,43.9±41.4个月，p<0.001)。在3个月内，两组之间没有观察到一致的显着差异（吉西他滨，98.4%vs.BCG,95.3%；p=0.848），6个月（94.9%与90.0%,分别为；p=0.793）和1年期CR率（84.2%与83.3%,分别为；p=0.950)。此外，两组无进展生存期无显著统计学差异(p=0.953).两组之间的不良事件发生率相似（22.2%vs.22.1%；p=0.989)；然而，卡介苗组Clavien-Dindo2级或更高的比率明显更高(1.6%vs.16.3%,分别为；p<0.001)。
结论：吉西他滨在中危和高危NMIBC患者的第一年膀胱内治疗效果与卡介苗治疗相当。然而,有必要进行长期随访研究.
方法：从1999年2月至2023年5月，对七个机构的数据进行了回顾性收集。纳入标准包括中危或高危非肌层浸润性膀胱癌（NMIBC）患者，他们接受了经尿道膀胱肿瘤电切术（TURBT），并接受了至少四次膀胱内吉西他滨或BCG诱导治疗。患者特征,完全缓解（CR），发生,并比较进展率。
结果：总计，本研究包括149名患者(吉西他滨，63;BCG,86).两组基线特征无明显差异,除了随访期(吉西他滨，9.2±5.9个月vs.BCG,43.9±41.4个月，p<0.001)。在3个月内，两组之间没有观察到一致的显着差异（吉西他滨，98.4%vs.BCG,95.3%；p=0.848），6个月（94.9%与90.0%,分别为；p=0.793）和1年期CR率（84.2%与83.3%,分别为；p=0.950)。此外，两组无进展生存期无显著统计学差异(p=0.953).两组之间的不良事件发生率相似（22.2%vs.22.1%；p=0.989)；然而，卡介苗组Clavien-Dindo2级或更高的比率明显更高(1.6%vs.16.3%,分别为；p<0.001)。
结论：吉西他滨在中危和高危NMIBC患者的第一年膀胱内治疗效果与卡介苗治疗相当。然而,有必要进行长期随访研究.
