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杨为潇, 邵彦翔, 胡旭, 等. 卡介苗对比表柔比星膀胱内灌注治疗非肌层浸润性膀胱癌的随机对照研究[J]. 四川大学学报(医学版), 2021, 52(2): 326-333. DOI: 10.12182/20210360203
引用本文: 杨为潇, 邵彦翔, 胡旭, 等. 卡介苗对比表柔比星膀胱内灌注治疗非肌层浸润性膀胱癌的随机对照研究[J]. 四川大学学报(医学版), 2021, 52(2): 326-333. DOI: 10.12182/20210360203
YANG Wei-xiao, SHAO Yan-xiang, HU Xu, et al. A Randomized Controlled Study of Intravesical Instillation Therapy of Bacillus Calmette-Guérin vs. Epirubicinin Treating Non-muscular Invasive Bladder Cancer[J]. Journal of Sichuan University (Medical Sciences), 2021, 52(2): 326-333. DOI: 10.12182/20210360203
Citation: YANG Wei-xiao, SHAO Yan-xiang, HU Xu, et al. A Randomized Controlled Study of Intravesical Instillation Therapy of Bacillus Calmette-Guérin vs. Epirubicinin Treating Non-muscular Invasive Bladder Cancer[J]. Journal of Sichuan University (Medical Sciences), 2021, 52(2): 326-333. DOI: 10.12182/20210360203

卡介苗对比表柔比星膀胱内灌注治疗非肌层浸润性膀胱癌的随机对照研究

A Randomized Controlled Study of Intravesical Instillation Therapy of Bacillus Calmette-Guérin vs. Epirubicinin Treating Non-muscular Invasive Bladder Cancer

  • 摘要:
      目的  探索非肌层浸润性膀胱癌(NMIBC)患者膀胱灌注治疗的最佳方案,并探讨影响灌注治疗后肿瘤复发的临床病理因素。评估现有NMIBC预后预测模型在我院NMIBC人群中的使用价值。
      方法  自2016年起,将在本院行经尿道膀胱肿瘤电切术(TURBT)后确诊为中高危NMIBC的患者纳入研究。将患者随机分为卡介苗(BCG)19次、15次组及表柔比星(EPI,治疗18次)组,入组人数比例为2∶2∶1,进行膀胱灌注治疗。记录灌注前、中、后患者临床病理资料,采用无复发生存为终点指标,绘制生存曲线,评估比较上述3种方案的治疗效果,并对病理及临床资料进行分析,探索各项因素与灌注治疗后肿瘤复发的关系。采用一致性指数(c-index)评估西班牙泌尿肿瘤研究组(CUETO)预后预测模型及欧洲肿瘤研究及治疗组织(EORTC)预后预测模型对患者的预测准确性。
      结果  本研究共纳入93例NMIBC患者(BCG19组35例,BCG15组37例,EPI组21例),中位随访时间33.46个月。其中22例患者肿瘤复发,8例患者出现肿瘤进展。生存曲线示,BCG组无复发生存优于EPI组(P=0.002),而BCG19和BCG15两组间的无复发生存的差异无统计学意义。虽然BCG组的并发症发生率高于EPI组患者(84.7% vs. 61.9%,P=0.022),但均未出现3~5级并发症。CUETO模型及EORTC模型的c-index高于单纯根据肿瘤T分期、核分级或EAU风险分层预测,且在BCG组中的c-index较在整体患者中更高。
      结论  在本研究人群中,BCG膀胱灌注治疗的膀胱癌复发率较EPI膀胱灌注治疗低。CUETO模型及EORTC模型更适合对BCG膀胱灌注治疗的患者而非对整体患者进行预测。

     

    Abstract:
      Objective  To explore the best treatment plan of intravesical instillation for patients with non-muscular invasive bladder cancer (NMIBC), to explore recurrence-related clinicopathological factors after intravesical instillation, and to evaluate the value of the prognosis and prediction models currently used for NMIBC patients.
      Methods  Starting from 2016, patients who underwent transurethral resection of bladder tumor (TURBT) in our hospital and who received post-surgery diagnosis of having intermediate or high risks for NMIBC were enrolled in the study. They were randomly assigned to different group sat a ratio of 2∶2∶1 for receiving intravesical instillation therapy of Bacillus Calmette-Guérin (BCG) for 19 times, BCG for 15 times, and epirubicin (EPI) for 18 times. The clinicopathological data of the patients were recorded before, during and after instillation therapy, and survival curves were drawn to evaluate the effects of the three regimens, using recurrence-free survival as the endpoint. Clinicopathological data were analyzed to study the associations between various factors and post-instillation recurrence. The consistency index (c-index) was used to evaluate the predictive accuracy of the scoring model of the Spanish Urological Club for Oncological Treatment (CUETO) and the risk tables of European Organization for Research and Treatment of Cancer (EORTC).
      Results  A total of 93 NMIBC patients (35 in the 19-time BCG group, 37 in the 15-time BCG group, and 21 in the EPI group) were included, with a median follow-up time of 33.46 months. Twenty-two patients experienced tumor recurrence and eight, tumor progression. The survival curve showed that the BCG group had better recurrence-free survival than the EPI group (P=0.002), while the difference in recurrence-free survival between 19-time BCG and 15-time BCG groups was not statistically significant. Higher general complication rate was seen in the BCG groups compared with the EPI group (84.7% vs. 61.9%, P=0.022), but there was no grade 3-5 adverse events in any group. The c-index of CUETO scoring model and EORTC risk tables was higher than that of the prediction based solely on T stage, nuclear grade, or EAU risk stratification. In addition, the c-index in the BCG group was higher than that in the whole cohort.
      Conclusion  Among the subjects of this study, the recurrence rate of bladder cancer in the intravesical BCG instillation groups was lower than that of the epirubicin group. EORTC risk tables and CUETO scoring model exhibited higher predictive accuracies in BCG-treated patients than its performance for the whole NMIBC cohort.

     

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