Department of Urology, University Hospital San Cecilio, Av. del Conocimiento, s/n, 18016, Granada, Spain.
J Cancer Res Clin Oncol. 2023 Aug;149(10):7453-7459. doi: 10.1007/s00432-023-04688-0. Epub 2023 Mar 23.
BACKGROUND: Bacillus Calmette-Guerin (BCG) maintenance therapy is the standard adjuvant treatment of high- and intermediate-risk non-muscle-invasive bladder cancer (NMIBC). However, the problems of shortages and the adverse effects, both local and systemic, that it causes lead to the search for alternatives with devices that improve the penetration of intravesical chemotherapeutics. MATERIALS AND METHODS: Prospective observational study was conducted from August 2018 to August 2022. Patients diagnosed with intermediate and high-risk NMIBC without CIS who received one of the following three treatments were included: BCG in induction protocol with six weekly instillations and maintenance with three weekly instillations at months 3, 6, and 12. MMC was applied by Physionizer 30 device with a current of 20 mA for 30 min was used in an induction protocol of 6 weekly instillations followed by 6 monthly instillations as maintenance (EMDA group). MMC was applied by COMBAT BRS System V2.0 device at 43 ± 0.5 ℃ for 60 min was used in an induction protocol of 6 weekly instillations followed by 6 monthly instillations as maintenance (HIVEC group). The primary objective was to compare the 24-month recurrence-free rate between the three groups. The secondary objectives were to evaluate the rate free of progression at 24 months and the degree of toxicity of the treatments. RESULTS: One hundred and eighty-three patients divided into a HIVEC group with sixty-one patients, EMDA group with fifty-nine patients, and BCG group with sixty-three patients. After a mean follow-up of 25 months (IQR 13-36), the 24-month recurrence-free rate was 82.1% for HIVEC, 80% for EMDA, and 84.6% for BCG (p > 0.05), and a progression-free rate at 24 months of 95.6% for HIVEC, 98.3% for EMDA, and 92.9% for BCG (p > 0.05). No statistically significant differences were found between the three groups with respect to the degree of reported adverse events. CONCLUSION: Adjuvant treatment with BCG or MMC applied with COMBAT or EMDA does not present differences in the recurrence-free rate and progression at 24 months in our population of patients with intermediate- and high-risk NMBC without CIS.
背景：卡介苗（BCG）维持治疗是高风险和中风险非肌肉浸润性膀胱癌（NMIBC）的标准辅助治疗。然而，由于其短缺和引起局部和全身不良反应的问题，导致人们寻找使用能够提高膀胱内化疗药物渗透的设备的替代方法。
材料和方法：本研究为前瞻性观察研究，于 2018 年 8 月至 2022 年 8 月进行。纳入诊断为无 CIS 的中高危 NMIBC 患者，他们接受以下三种治疗之一：BCG 诱导方案（每周 6 次灌注）和第 3、6、12 个月的每周 3 次维持治疗。MMC 通过 Physionizer 30 设备（电流 20 mA，持续 30 分钟）应用于诱导方案（每周 6 次灌注），随后作为维持治疗（每月 6 次灌注）（EMDA 组）。MMC 通过 COMBAT BRS System V2.0 设备（43±0.5℃，持续 60 分钟）应用于诱导方案（每周 6 次灌注），随后作为维持治疗（每月 6 次灌注）（HIVEC 组）。主要目的是比较三组 24 个月无复发生存率。次要目标是评估 24 个月时无进展率和治疗毒性程度。
结果：共纳入 183 例患者，分为 HIVEC 组（61 例）、EMDA 组（59 例）和 BCG 组（63 例）。在平均 25 个月（IQR 13-36）的随访后，HIVEC 组的 24 个月无复发生存率为 82.1%，EMDA 组为 80%，BCG 组为 84.6%（p>0.05），HIVEC 组的 24 个月无进展率为 95.6%，EMDA 组为 98.3%，BCG 组为 92.9%（p>0.05）。三组间不良反应的报告程度无统计学差异。
结论：在我们的无 CIS 中高危 NMBC 患者人群中，BCG 或 MMC 联合 COMBAT 或 EMDA 辅助治疗在 24 个月时无复发生存率和进展方面无差异。
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