Department of Urology. Istanbul Medeniyet University Faculty of Medicine. Istanbul. Turkey.
Department of Urology. Gaziantep University. School of Medicine. Gaziantep. Turkey.
Arch Esp Urol. 2021 Nov;74(9):875-882.
To evaluate the oncological results of hyperthermic Mitomycin C (MMC) in adjuvant treatment of high-risk non-muscle invasive bladder cancer and to assess its side-effect profile.
Patients who were followed up in two reference university hospitals due to high-risk non-muscle invasive bladder tumors were included in the study. High-risk patients according to the EAU non-muscle invasive bladder cancer guideline, patients who were rejected early cystectomy, patients who could not be treated with BCG due to a shortage, and patients for whom the cystectomy would be too risky due to their comorbidities were included in the study. All patients were followed up forat least 24 months with physical examination, cystoscopy, and urine cytology at 3-month intervals. Transurethral tumor resection was performed in all patients and a non-muscle invasive urothelial carcinoma was diagnosed pathologically. Hyperthermic MMC was administered with Synergo system SB-TS 101. Records were kept prospectively and evaluated retrospectively.
Fifty-eight high-risk group patients 18 (31%) of whom were at pTa stage and 40 (69%) at pT1 stage were included in the study. During a mean follow-up of 42 months, 34 (58%) patients had recurrence, while 5 (8%) patients progressed to muscle-invasive disease. Eleven (19%) of the patients under went radical cystectomy. The mean time to relapse was 10 months (3-34 months), and the mean time to progression was 41 months (6-87 months). Five-year overall survival, cancer-specific survival, progression-free survival, and relapse-free survival of the patients were 76%, 88%, 90% and 38%, respectively. Multifocality alone was found to be an independent risk factor (HR: 0.26; 95% Cl: 0.08-0.78; p=0.016) affecting recurrence. The observed side effects included tachycardia, cystitis, dysuria, macrohematuria, procedure-related pain, and allergic skin reactions. Treatment had to be discontinued in one patient due to a diffuse skin reaction.
Thermal intravesical MMC therapyis a safe treatment and it could be effective treatment option in preventing disease progression in patients with high risk and non-muscle invasive bladder cancer with unsuccessful Bacillus Calmette-Guérin (BCG) or who could not be treated with BCG for other reasons.
评估热疗丝裂霉素 C（MMC）在高危非肌层浸润性膀胱癌辅助治疗中的肿瘤学结果，并评估其副作用谱。
本研究纳入了因高危非肌层浸润性膀胱肿瘤在两所参考大学医院接受随访的患者。根据 EAU 非肌层浸润性膀胱癌指南，高危患者、因早期膀胱切除术被拒绝的患者、因短缺而无法接受 BCG 治疗的患者，以及因合并症而使膀胱切除术风险过高的患者均被纳入研究。所有患者均接受至少 24 个月的随访，每 3 个月进行一次体格检查、膀胱镜检查和尿液细胞学检查。所有患者均行经尿道肿瘤切除术，病理诊断为非肌层浸润性尿路上皮癌。采用 Synergo 系统 SB-TS 101 进行热疗 MMC 治疗。记录前瞻性保存，并进行回顾性评估。
本研究纳入了 58 例高危组患者，其中 18 例（31%）处于 pTa 期，40 例（69%）处于 pT1 期。在平均随访 42 个月期间，34 例（58%）患者复发，5 例（8%）患者进展为肌层浸润性疾病。11 例（19%）患者接受了根治性膀胱切除术。复发的平均时间为 10 个月（3-34 个月），进展的平均时间为 41 个月（6-87 个月）。患者的 5 年总生存率、癌症特异性生存率、无进展生存率和无复发生存率分别为 76%、88%、90%和 38%。多病灶是唯一影响复发的独立危险因素（HR：0.26；95%Cl：0.08-0.78；p=0.016）。观察到的副作用包括心动过速、膀胱炎、排尿困难、肉眼血尿、与操作相关的疼痛和过敏皮肤反应。由于弥漫性皮肤反应，1 例患者不得不停止治疗。
热腔内 MMC 治疗是一种安全的治疗方法，对于卡介苗（BCG）治疗不成功或因其他原因无法接受 BCG 治疗的高危非肌层浸润性膀胱癌患者，它可能是预防疾病进展的有效治疗选择。
