Department of Urology, Lanzhou University Second Hospital, Lanzhou, 730000, Gansu, China.
Institute of Urology, Lanzhou University Second Hospital, Lanzhou, 730030, Gansu, China.
Int Urol Nephrol. 2024 Jan;56(1):103-120. doi: 10.1007/s11255-023-03765-0. Epub 2023 Sep 2.
To investigate the effectiveness and safety of device-assisted intravesical chemotherapy compared to Bacillus Calmette-Guerin (BCG) in the treatment of patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC).
In February 2023, a systematic search was conducted on the PubMed, Cochrane, and Embase databases. Following the PRISMA guidelines, a systematic review and meta-analysis of the primary outcomes of interest were performed. The review was prospectively registered on PROSPERO under the registration number CRD42023398559.
A total of 10 studies involving 1160 patients were included. The results of the meta-analysis showed that compared to BCG, device-assisted chemotherapy had a lower recurrence rate (OR: 0.63, 95% CI: 0.48-0.84, p = 0.001), longer recurrence-free survival (OR: 0.64, 95% CI: 0.47-0.88, p = 0.006), and lower incidence of fever (OR: 0.18, 95% CI: 0.08-0.44, p = 0.0002). However, no significant differences were observed between the two groups in terms of progression, overall survival, progression-free survival, disease-free survival, overall adverse events, serious adverse events, hematuria, allergy, and general discomfort. Subgroup analysis revealed that neither chemohyperthermia (CHT) nor electromotive drug administration (EMDA) showed statistically significant differences in oncological outcomes compared to BCG. Regarding adverse events, both CHT and EMDA groups showed lower rates of fever compared to the BCG group (OR: 0.26, 95% CI: 0.10-0.67, p = 0.005, and OR: 0.14, 95% CI: 0.05-0.37, p < 0.0001, respectively). No significant differences were observed in the remaining adverse events between either the CHT or EMDA group and the BCG group.
Device-assisted intravesical chemotherapy appears to be a safe and viable alternative to BCG for patients with intermediate and high-risk NMIBC, showing comparable oncological outcomes and adverse events.
研究与卡介苗（BCG）相比，器械辅助膀胱内化疗在治疗中高危非肌肉浸润性膀胱癌（NMIBC）患者中的疗效和安全性。
2023 年 2 月，对 PubMed、Cochrane 和 Embase 数据库进行系统检索。根据 PRISMA 指南，对主要结局进行系统评价和荟萃分析。该综述前瞻性地在 PROSPERO 上以注册号 CRD42023398559 进行了注册。
共纳入 10 项研究，涉及 1160 名患者。荟萃分析结果显示，与 BCG 相比，器械辅助化疗具有更低的复发率（OR：0.63，95%CI：0.48-0.84，p=0.001）、更长的无复发生存时间（OR：0.64，95%CI：0.47-0.88，p=0.006）和更低的发热发生率（OR：0.18，95%CI：0.08-0.44，p=0.0002）。然而，两组在进展、总生存、无进展生存、无病生存、总体不良事件、严重不良事件、血尿、过敏和一般不适方面无显著差异。亚组分析显示，与 BCG 相比，化疗热疗（CHT）和电动力药物输送（EMDA）在肿瘤学结局方面均无统计学差异。关于不良事件，CHT 和 EMDA 组与 BCG 组相比，发热发生率均较低（OR：0.26，95%CI：0.10-0.67，p=0.005，OR：0.14，95%CI：0.05-0.37，p<0.0001）。CHT 或 EMDA 组与 BCG 组之间的其余不良事件无显著差异。
器械辅助膀胱内化疗似乎是中高危 NMIBC 患者替代 BCG 的一种安全可行的方法，具有相似的肿瘤学结局和不良事件。
