立即新辅助电动滴注丝裂霉素 C 联合卡介苗与单独使用卡介苗治疗非肌层浸润性膀胱癌的效果:一项随机对照试验。
The effect of immediate neoadjuvant electromotive instillation of mitomycin C with Bacillus Calmette-Guérin versus BCG alone in non-muscle-invasive bladder cancer: A randomized controlled trial.
发表日期:2023 Nov
作者:
Abdalla El Azab, Ahmed Abdelbary, Aly El Faqeh M Okasha, Hatem Aboulkassem, Ashraf Saad Zaghloul, Riham Mohamed Karkeet, Ibrahim Abdelrahman
来源:
CLINICAL PHARMACOLOGY & THERAPEUTICS
摘要:
在经尿道膀胱肿瘤切除术(TURBT)之前进行新辅助膀胱内灌注化疗的临床效果一直是最近研究的主题。本研究的目的是评估经尿道切除术前立即新辅助电动滴注丝裂霉素 C 对非肌层浸润性膀胱尿路上皮癌患者的效果。我们的研究是对 50 名诊断为非肌层浸润性膀胱癌的患者进行的一项随机临床试验。 - 浸润性膀胱尿路上皮癌。将患者分为两组:I组由25名患者组成,在TURBT前接受丝裂霉素C新辅助电动药物给药,每周膀胱内注射卡介苗(BCG),持续6周;第二组由 25 名患者组成,他们接受 TURBT 治疗,然后每周接受膀胱内 BCG 治疗,持续 6 周(标准护理)。通过膀胱镜对患者进行3、6、12和18个月的随访。 TURBT前接受丝裂霉素C新辅助电动药物给药联合卡介苗的患者与单独接受卡介苗的患者相比,复发率较低(12.0% vs. 12.0%)。分别为 48.0%;p=0.012)和更长的无病间隔(分别为 88.0% 与 52.0%;p=0.012)。在单独使用卡介苗组中,有 4 名患者进展为肌肉浸润性疾病 (16.0%)。然而,这种差异并不具有统计学意义(p=0.516)。关于不良反应,各组间无统计学差异。TURBT前新辅助膀胱内电动药物给予丝裂霉素C是安全的;与 TURBT 后单独使用 BCG 相比,可降低复发率并延长无病间隔。© 韩国泌尿外科协会。
The clinical effect of neoadjuvant intravesical instillation of chemotherapy immediately before transurethral resection of bladder tumors (TURBT) has been a subject of recent research. The aim of this study was to assess the effect of immediate neoadjuvant electromotive instillation of mitomycin C before transurethral resection for patients with non-muscle-invasive urothelial bladder cancer.Our study was a randomized clinical trial carried out on 50 patients diagnosed with non-muscle-invasive urothelial bladder cancer. Patients were classified into two groups: Group I consisted of 25 patients who received neoadjuvant electromotive drug administration of mitomycin C before TURBT and intravesical bacille Calmette-Guerin (BCG) per week for 6 weeks; Group II consisted of 25 patients who were treated with TURBT followed by intravesical BCG per week for 6 weeks alone (standard of care). Patients were followed up at 3, 6, 12, and 18 months by cystoscopy.Patients who received neoadjuvant electromotive drug administration of mitomycin C before TURBT in combination with BCG had a low recurrence rate compared with those who received BCG alone (12.0% vs. 48.0%, respectively; p=0.012) and a longer disease-free interval (88.0% vs. 52.0%, respectively; p=0.012). Four patients developed progression to muscle-invasive disease (16.0%) in the BCG alone group. However, this difference was not statistically significant (p=0.516). Regarding adverse effects, there were no statistically significant differences between the groups.Neoadjuvant intravesical electromotive drug administration of mitomycin C before TURBT is safe; reduces recurrence rates and enhances the disease-free interval compared with TURBT followed by BCG alone.© The Korean Urological Association.