Gözen Ali Serdar, Umari Paolo, Scheitlin Walter, Su Fuat Ernis, Akin Yigit, Rassweiler Jens
Department of Urology, SLK-Kliniken, University of Heidelberg, Heilbronn.
Arch Ital Urol Androl. 2017 Jun 30;89(2):102-105. doi: 10.4081/aiua.2017.2.102.
Background&Aim: High grade non-muscle invasive bladder cancer (NMIBC) is common in urological practice. Most of these cancers are or become refractory to intravesical immunotherapy and chemotherapy. Here we evaluated the efficacy of combined local bladder hyperthermia and intravesical mitomycin-C (MMC) instillation in patients with high-risk recurrent NMIBC.
Between February 2014 and December 2015, 18 patients with high risk NMIBC were enrolled. Patients were treated in an outpatient basis with 6 weekly induction sessions followed by monthly maintenance sessions with intravesical MMC in local hyperthermia with bladder wall thermo-chemotherapy (BWT) system (PelvixTT system, Elmedical Ltd., Hod Hasharon, Israel). The follow-up regimen included cystoscopy after the induction cycle and thereafter with regular intervals. Time to disease recurrence was defined as time from the first intravesical treatment to endoscopic or histological documentation of a new bladder tumour. Adverse events were recorded according to CTC 4.0 (Common Toxicity Criteria) score system.
Mean age was 72 (32-87) years. 10 patients had multifocal disease, 9 had CIS, 6 had recurrent disease and 2 had highly recurrent disease (> 3 recurrences in a 24 months period). 6 patients underwent previous intravesical chemotherapy with MMC. The average number of maintenance sessions per patient was 7.6. After a mean follow-up of 433 days, 15 patients (83.3%) were recurrence-free. 3 patients had tumour recurrence after a mean period of 248 days without progression. Side effects were limited to grade 1 in 2 patients and grade 2 in 1 patient.
BWT seems to be feasible and safe in high grade NMIBC. More studies are needed to identify the subgroup of patients who may benefit more from this treatment.
背景与目的:高级别非肌层浸润性膀胱癌(NMIBC)在泌尿外科临床实践中很常见。这些癌症中的大多数对膀胱内免疫治疗和化疗难治或变得难治。在此,我们评估了局部膀胱热疗联合膀胱内丝裂霉素-C(MMC)灌注对高危复发性NMIBC患者的疗效。
2014年2月至2015年12月,纳入18例高危NMIBC患者。患者在门诊接受治疗,每周进行6次诱导治疗,随后每月进行一次维持治疗,使用膀胱壁热化疗(BWT)系统(PelvixTT系统,以色列霍德哈沙龙市Elmedical有限公司)进行局部热疗并膀胱内灌注MMC。随访方案包括诱导周期后及此后定期进行膀胱镜检查。疾病复发时间定义为从首次膀胱内治疗至新膀胱肿瘤的内镜或组织学记录的时间。根据CTC 4.0(通用毒性标准)评分系统记录不良事件。
平均年龄为72(32 - 87)岁。10例患者有多灶性疾病,9例有原位癌,6例有复发性疾病,2例有高度复发性疾病(24个月内复发>3次)。6例患者曾接受过膀胱内MMC化疗。每位患者的平均维持治疗次数为7.6次。平均随访433天后,15例患者(83.3%)无复发。3例患者在平均248天后出现肿瘤复发,无进展。副作用仅限于2例1级和1例2级。
BWT在高级别NMIBC中似乎可行且安全。需要更多研究来确定可能从这种治疗中获益更多的患者亚组。