吉西他滨膀胱灌注治疗复发性非肌层浸润性膀胱癌的临床研究

The clinical study of intravesical gemcitabine after first-line intravesical chemotherapy failure in the treatment of non-musde-invasive bladder cancer

目的评价吉西他滨膀胱灌注化疗治疗常规膀胱灌注化疗失败的非肌层浸润性膀胱癌(NMIBC)的有效性及耐受性。方法采用随机数表法将48例持续常规膀胱灌注化疗1年内出现肿瘤复发的NMIBC患者均分为A、B、C三组,每组各16例。A组患者给予1000 mg吉西他滨灌洗,B组患者给予2000 mg吉西他滨灌洗,C组患者则继续采用原化疗方案灌洗。分析三组患者2年肿瘤复发率、复发进展率及不良反应发生情况。结果 A、B组患者2年肿瘤无复发生存率(68.75%,75.00%)明显高于C组(18.75%),通过log-rank test检验,A、B组与C组比较差异具有显著性(P<0.05),但A组与B组差异无显著性(χ2=0.246,P=0.620)。三组患者2年肿瘤复发进展率分别为25.00%、18.75%、25.00%,组间比较差异无显著性(χ2=0.253,P=0.881)。三组患者不良反应发生率分别为31.25%、25.00%、37.50%,组间比较差异无显著性(χ2=0.582,P=0.748)。不良反应主要表现为尿频、尿急、尿痛等,经对症治疗后缓解,未发生严重的血液学不良反应。结论吉西他滨膀胱灌注化疗对常规膀胱灌注化疗后复发的NMIBC疗效显著,降低高危NMIBC复发率,但对膀胱肿瘤进展无明显预防作用,且不同剂量间的疗效未见明显差异。

Objective To evaluate the efficacy and tolerability of intravesical gemcitabine after first-line in travesical chemotherapy failure in the treatment of non-muscle-invasive bladdercancer（NMIBC）. Method48 patients with NMIBC, who had tumor recurrence within one year of first-line intravesical chemotherapy, were assigned to 3 groups（16 cases in each group）. Group A received intravesical gemcitabine in a dose of 1000 mg, group B received 2000 mg gemcitabine, and group C received original intravesical chemotherapy. Analyzed three groups of patients 2 years tunor recurrence rates, incidence of recurrence rate and adverse reaction. Result Group A and B of 2 years tumor free survival（68.75%, 75.00%） were higher than that in group C（18.75%）, by log-rank-test tested between group A, B and group C were statistically significant differences（P〈0.05）, but group A and group B had no significant difference（χ^2= 0.246, P = 0.620）. Three groups of 2 year recurrence progression rates were 25.00%, 18.75%, 25.00%, and no significant difference between three groups（χ^2= 0.253, P = 0.881）. Three groups of adverse reaction rate were 31.25%, 25.00%, 37.50%, there was no statistical difference between groups（χ^2= 0.582, P = 0.748）. Adverse reactions among three groups weres urinary frequency, urgency, dysuria, hematuria, relieved by symptomatic treatment, no serious haematological adverse reactions. Conclusion Intravesical chemotherapy with gemcitabine is well tolerated and effective for patients with high risk NMIBC, however, which treatment dose not reduce tumor progress, and the effect of different dose have no significant difference.