Department of Urology, University Vita-Salute San-Raffaele, Milan, Italy.
BJU Int. 2011 Mar;107(6):912-8. doi: 10.1111/j.1464-410X.2010.09654.x. Epub 2010 Oct 4.
• To present long-term efficacy data of intravesical thermochemotherapy vs chemotherapy alone with mitomycin-C (MMC) randomly administered to patients with non-muscle-invasive bladder cancer (NMIBC) as an adjuvant treatment after complete transurethral resection.
• In all, 83 patients with intermediate-/high-risk NMIBC, following complete transurethral resection, were randomly assigned to receive either intravesical thermochemotherapy by means of Synergo® (Medical Enterprises, Amsterdam, The Netherlands) or intravesical chemotherapy alone, for prophylaxis of tumour recurrence. • Two doses of MMC (20 mg dissolved in 50 mL distilled water administered throughout two consecutive sessions) was used as the chemotherapeutic agent in both arms. • In all, 75 patients completed the original study (35 of 42 in the treatment arm, 40 of 41 in the control arm), whose results at minimum 2-year follow-up have already been published. • Recently, the files of these patients have been updated for long-term outcome definition. Data on general health, follow-up examinations, tumour relapse or progression, and cause of death were collected and analysed.
• Updated complete data collection was available for 65/75 (87%) of the original patients. • The median follow-up for tumour-free patients was 91 months. The 10-year disease-free survival rate for thermochemotherapy and chemotherapy alone were 53% and 15%, respectively (P < 0.001). • An intent-to-treat analysis performed to overcome the potential bias introduced by the asymmetrical discontinuation rate still showed a significant advantage of the active treatment over the control treatment. Bladder preservation rates for thermochemotherapy and chemotherapy alone were 86% and 79%, respectively.
• This is the first analysis of long-term follow-up of patients treated with intravesical thermochemotherapy. The high rate (53%) of patients who were tumour-free 10 years after treatment completion, as well as the high rate (86%) of bladder preservation, confirms the efficacy of this adjuvant approach for NMIBC at long-term follow-up, even in patients with multiple tumours.
介绍经尿道膀胱肿瘤切除术（TURBT）后，采用经尿道热化疗（Synergo®）联合丝裂霉素 C（MMC）与单纯化疗预防非肌层浸润性膀胱癌（NMIBC）患者肿瘤复发的长期疗效数据。
83 例中高危 NMIBC 患者 TURBT 后，随机分为接受经尿道热化疗（Synergo®）或单纯膀胱内化疗，预防肿瘤复发。两组均采用 MMC（20mg 溶于 50ml 蒸馏水，连续两天各给药一次）作为化疗药物。
75 例患者完成了原始研究（治疗组 42 例中有 35 例，对照组 41 例中有 40 例），其至少 2 年随访结果已发表。最近，这些患者的资料已更新，以确定长期结果。收集并分析了一般健康状况、随访检查、肿瘤复发或进展以及死亡原因的数据。
75 例患者中有 65 例（87%）完成了完整数据更新。无肿瘤患者的中位随访时间为 91 个月。热化疗和单纯化疗的 10 年无病生存率分别为 53%和 15%（P<0.001）。为克服不对称停药率可能带来的偏倚，进行意向治疗分析仍显示主动治疗优于对照组。热化疗和单纯化疗的膀胱保留率分别为 86%和 79%。
这是首例接受膀胱内热化疗的患者长期随访分析。10 年无肿瘤患者的高比例（53%）以及高膀胱保留率（86%）证实了这种辅助治疗方法对 NMIBC 的长期疗效，即使是在多发性肿瘤患者中也是如此。
