羟基喜树碱膀胱灌注联合口服乌苯美司预防中高危非肌层浸润性膀胱癌术后复发

Intravesical instillation of Hydroxycamptothecin in combination with oral Ubenimex against postoperative recurrence of non-muscle invasive bladder cancer at intermediate or high risk

目的比较羟基喜树碱膀胱灌注联合口服乌苯美司与单独羟基喜树碱膀胱灌注预防中高危非肌层浸润性膀胱癌术后复发的临床疗效。方法 110例中高危非肌层浸润性膀胱癌患者常规行经尿道膀胱肿瘤切除术(TURBT),术后随机分为两组,每组55例。一组给予羟基喜树碱膀胱灌注联合口服乌苯美司,另一组只给予羟基喜树碱膀胱灌注。随访2年,观察灌注后肿瘤复发率。结果中危肿瘤复发率联合治疗组为7.7%,单药治疗组为25.6%,差异有统计学意义(P<0.05);高危肿瘤复发率联合治疗组为31.2%,单药治疗组为37.5%,差异无统计学意义(P>0.05)。结论羟基喜树碱膀胱灌注联合口服乌苯美司预防中危非肌层浸润性膀胱癌术后复发的疗效优于单独羟基喜树碱膀胱灌注。

Objective To evaluate the clinical efficacy of intravesical instillation of Hydroxycamptothecin in combination with oral Ubenimex versus intravesical instillation of hydroxycamptothecin alone against postoperative recurrence of non-muscle invasive bladder cancer at intermediate or high risk. Methods 110 patients with non muscle-invasive bladder cancer at intermediate or high risk after undergoing TUR-BT were randomly assigned to receive either intravesical instillation of Hydroxycamptothecin in combination with oral Ubenimex or intravesical instillation of Hydroxycamptothecin alone, with 55 patients in each group. During the follow-up of 2 years, the recurrence was observed. Results For patients at intermediate risk, the total recurrence rate was 7.7% in the combination therapy group as compared with 25.6% in the single therapy group, and the difference was statistically significant （P〈0. 05）. For patients with high risk cancer, the total recurrence rate was 31.2% in the combination therapy group as compared with 37.5 % in the single therapy group, and the difference was not statistically significant （P 〉 0.05）. Conclusions Hydroxycamptothecin in combination with oral Ubenimex has better efficacy than hydroxycamptothecin alone against postoperative recurrence in patients with non-muscle invasive bladder cancer at intermediate risk.