羟基喜树碱膀胱灌注化疗联合体外热电场热疗预防浅表性膀胱癌复发的临床研究

Preventing recurrence of superficial bladder cancer with intravesical chemotherapy of HCPT combined with external electric field hyperthermia

目的探讨羟基喜树碱(HCPT)膀胱内灌注化疗联合体外热电场热疗预防浅表性膀胱癌复发的疗效及安全性。方法 83例原发性或复发性浅表性膀胱移形上皮细胞癌患者,均行经尿道膀胱肿瘤电切术(TURBT),术后随机分配到疗法1组及疗法2组,疗法1组为羟基喜树碱膀胱内灌注化疗联合体外热场热疗(42例),疗法2组为单独应用羟基喜树碱膀胱内灌注化疗(41例)。本研究的有效性评估终点是无复发生存率及复发概率的估计评价(应用Kaplan-Meier分析及Log-rank检验)。最小随访时间为24个月。安全评价包括主观和客观的副作用和并症发。结果在随机分配的83例患者中,76例坚持完成研究并进行有效的统计分析。其中疗法1组39例6例复发(15.4%),疗法2组37例,14例复发(37.8%)。两种治疗法经Log-rank检验显示其无复发生存率有显著性差异(P=0.017),疗法2组的复发率高于疗法1组(P=0.03)。结论羟基喜树碱膀胱内灌注化疗联合体外热电场热疗效果明显优于单独应用羟基喜树碱膀胱内灌注化疗,患者耐受性良好,安全可行。

Objective To investigate the efficacy and safety of preventing the recurrence of superficial bladder cancer with intravesical chemotherapy of hydroxycamptothecine （HCPT） combined with external electric field hyperthermia. Meth- ods A total of 83 patients with primary or recurrent superficial bladder transitional cell carcinoma treated with TURBT were randomly divided into 2 groups. Group 1 （n = 42） received intravesical chemotherapy of HCPT combined with external thermal field thermotherapy, and group 2（n =41） underwent intravesical chemotherapy of HCPT alone. The effectiveness evaluation end points of this study were evaluation of recurrence free survival and the estimated probability of recurrence （For the efficacy end point, Kaplan-Meier analysis was employed, with the log-rank test for significance）. Minimum follow-up lasted for 24 months. The safety evaluation end points included subjective and objective side effects and complications. Results Of all 83 patients, 76 completed the study and were statistically valid. In group 1, 6 of 39 cases recurred （15.4%）, in group 2, 14 of 37 cases recurred （37.8%）, with significant difference between the two groups （P=0. 017）. According to Log-rank test, the rate of recurrence in group 2 was higher than in group 1 （P = 0.03）. Conclusion Intravesical chemotherapy of HCPT combined with external electric field hyperthermia is more effective than intravesical chemotherapy of HCPT alone. It is safe and effec- tive, with good tolerance for patients.