Igawa M, Urakami S, Shirakawa H, Shiina H, Ishibe T, Kadena H, Usui T, Kawanishi M
Department of Urology, Shimane Medical University, Izumo, Japan.
Br J Urol. 1996 Mar;77(3):358-62. doi: 10.1046/j.1464-410x.1996.08486.x.
To evaluate whether the intravesical instillation of epirubicin is effective in preventing the recurrence of tumour in the bladder where dysplastic mucosa remains after transurethral resection of tumour.
Biopsy specimens were taken from apparently normal areas of the bladder mucosa in patients undergoing transurethral resection of the primary tumours. Of the 75 evaluable patients, 18 (24%) had abnormalities in at least one or more specimens. The patients were divided into two groups, 57 with normal and 18 with abnormal biopsy results. Intravesical chemotherapy with epirubicin (20 mg/40 mL saline) was randomized to patients in each group. Tumour recurrence rates were estimated and compared amongst the groups. Factors related to tumour recurrence were evaluated using univariate and multivariate analyses.
The risks of tumour recurrence and progression were evaluated in 18 patients with concomitant mucosal abnormalities. All 10 patients with abnormal biopsy results who were treated with epirubicin had recurrence of tumour within a mean interval of 9 months, whereas six of eight controls had recurrence within a mean of 10.9 months. While there was progression in grade in four of 10 patients with abnormal biopsy results and treated with epirubicin, none of the recurrent tumours in six control patients with mucosal abnormalities progressed in grade. The overall recurrence-free rate of the patients with mucosal abnormalities was higher in controls than in those receiving epirubicin, but the difference was not statistically significant. There were no significant differences in recurrence rate for those treated with epirubicin and controls in the 57 patients with normal biopsy results. Univariate analysis showed that the recurrence-free rates were significantly influenced by tumour multiplicity and the mucosal biopsy results (P < 0.001 and P = 0.02, respectively). In a Cox proportional-hazards model, tumour multiplicity alone had prognostic significance for tumour recurrence (P = 0.002).
The prophylactic intravesical instillation of epirubicin had no effect in preventing tumour recurrence and, conversely, it may promote tumour progression in bladders with dysplastic mucosal changes.
评估经尿道肿瘤切除术后膀胱内灌注表柔比星对于预防膀胱内存在发育异常黏膜的肿瘤复发是否有效。
对接受原发性肿瘤经尿道切除术的患者，从膀胱黏膜表面看似正常的区域获取活检标本。在75例可评估的患者中，18例（24%）至少有一个或多个标本存在异常。患者被分为两组，57例活检结果正常，18例活检结果异常。将表柔比星（20mg/40mL生理盐水）膀胱内化疗随机分配给每组患者。估计并比较各组的肿瘤复发率。使用单因素和多因素分析评估与肿瘤复发相关的因素。
对18例伴有黏膜异常的患者评估了肿瘤复发和进展风险。所有10例活检结果异常且接受表柔比星治疗的患者在平均9个月的间隔内出现肿瘤复发，而8例对照组中有6例在平均10.9个月内复发。10例活检结果异常且接受表柔比星治疗的患者中有4例出现分级进展，而6例有黏膜异常的对照组复发肿瘤均未出现分级进展。黏膜异常患者的总体无复发率在对照组中高于接受表柔比星治疗的患者，但差异无统计学意义。57例活检结果正常的患者中，接受表柔比星治疗的患者与对照组的复发率无显著差异。单因素分析表明，无复发率受肿瘤多灶性和黏膜活检结果的显著影响（分别为P<0.001和P = 0.02）。在Cox比例风险模型中，仅肿瘤多灶性对肿瘤复发具有预后意义（P = 0.002）。
预防性膀胱内灌注表柔比星对预防肿瘤复发无效，相反，它可能促进存在发育异常黏膜改变的膀胱肿瘤进展。
