Department of Urology, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.
Investig Clin Urol. 2024 Sep;65(5):435-441. doi: 10.4111/icu.20240047.
In high-risk non-muscle-invasive bladder cancer (NMIBC), intravesical Bacillus Calmette-Guérin (BCG) is the standard adjuvant therapy post-transurethral resection of bladder tumor (TURBT). Intravesical gemcitabine, used as an alternative or second-line therapy amid BCG shortages, lacks outcome studies in the Korean population.
Patients who received weekly intravesical gemcitabine for 6 weeks after TURBT from 2019 to 2022 were retrospectively investigated. Based on the American Urological Association risk classification, patients with high- or very high-risk NMIBC who refused cystectomy were included. Maintenance treatment was performed depending on their risk. Recurrence was defined as histologic confirmation on subsequent cystoscopic biopsies or TURBT. Disease free survival (DFS) was evaluated by the Kaplan-Meier method.
The study included 60 patients, comprising 45 high-risk (group 1) patients with a median age of 76 years and 15 very high-risk (group 2) patients with a median age of 68 years. Among them, 28 patients had previously received intravesical BCG. Over a median follow-up of 22 months, recurrence occurred in 31 patients in group 1 and 11 in group 2. The DFS rates of the high-risk group and the very high-risk group were 57.8% versus 40% at 1 year, 20.7% versus 21.3% at 2 years and 20.7% versus 21.3% at 3 years, respectively (p=0.831). Tis stage (p=0.042) and prostatic urethra invasion (p=0.028) were significant predictors of DFS. Cancer-specific mortality rates were 2.2% in group 1 and 6.7% in group 2 (p=0.441).
Similar DFS outcome between high-risk and very high-risk patients were observed based on short-term results in Korea. This finding is crucial for clinical practice; however, studies analyzing more patients and long-term outcomes are needed.
在高危非肌肉浸润性膀胱癌（NMIBC）中，经尿道膀胱肿瘤切除术（TURBT）后，膀胱内卡介苗（BCG）是标准的辅助治疗方法。在 BCG 短缺的情况下，作为替代或二线治疗方法，膀胱内吉西他滨在韩国人群中的研究结果尚缺乏。
回顾性调查了 2019 年至 2022 年期间接受每周一次膀胱内吉西他滨治疗 6 周的 TURBT 后患者。根据美国泌尿外科学会（AUA）风险分类，纳入拒绝接受膀胱切除术的高危或极高危 NMIBC 患者。根据风险进行维持治疗。复发定义为后续膀胱镜活检或 TURBT 的组织学证实。无病生存（DFS）通过 Kaplan-Meier 方法进行评估。
该研究纳入了 60 例患者，其中 45 例为高危（组 1）患者，中位年龄为 76 岁，15 例为极高危（组 2）患者，中位年龄为 68 岁。其中 28 例患者曾接受过膀胱内 BCG 治疗。中位随访 22 个月时，组 1 中有 31 例患者复发，组 2 中有 11 例患者复发。高危组和极高危组的 1 年 DFS 率分别为 57.8%和 40%，2 年分别为 20.7%和 21.3%，3 年分别为 20.7%和 21.3%（p=0.831）。Tis 期（p=0.042）和前列腺尿道侵犯（p=0.028）是 DFS 的显著预测因素。组 1 的癌症特异性死亡率为 2.2%，组 2 为 6.7%（p=0.441）。
韩国的短期研究结果表明，高危和极高危患者的 DFS 结果相似。这一发现对临床实践具有重要意义，但仍需要更多患者和长期结果的研究。
