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基于风险的评估:在疑似低级别、非肌肉浸润性膀胱癌(NMIBC)切除术后,膀胱内治疗对无复发生存率的影响:西南肿瘤协作组(SWOG)S0337 事后分析。

Risk-Based Assessment Of the Impact Of Intravesical Therapy on Recurrence-Free Survival Rate Following Resection of Suspected Low-grade, Non-muscle-invasive Bladder Cancer (NMIBC): A Southwest Oncology Groups (SWOG) S0337 Posthoc Analysis.

机构信息

Vattikuti Urology Institute Center for Outcomes Research, Analytics and Evaluation (VCORE), Henry Ford Hospital, Detroit, MI; Wayne State University School of Medicine, Detroit, MI.

Department of Urology, University of Rochester, Rochester, NY.

出版信息

Clin Genitourin Cancer. 2022 Dec;20(6):e498-e505. doi: 10.1016/j.clgc.2022.06.015. Epub 2022 Jun 25.

DOI:10.1016/j.clgc.2022.06.015
PMID:35871040
Abstract

BACKGROUND

Nonmuscle invasive bladder cancer (NMIBC) has an elevated risk of recurrence, and immediate postresection intravesical instillation of chemotherapy (IVC) significantly reduces the risk of recurrence. Questions remain about which subpopulation may maximally benefit from IVC. Our aim was to develop risk groups based on recurrence risk in NMIBC, and then evaluate the impact of a single, postoperative instillation of IVC on the subsequent risk of recurrence for each risk group.

MATERIAL AND METHODS

Using the SWOG S0337 trial cohort, we performed a posthoc analysis of 345 patients who were diagnosed with suspected low-grade NMIBC, underwent transurethral resection of the bladder tumor (TURBT), and received post-operative IVC (gemcitabine vs. saline). Using regression tree analysis, the regression tree stratified patients based on their risk of recurrence into low-risk - single tumor and aged < 57 years, intermediate-risk - single tumor and aged ≥ 57 years, and high-risk - multiple tumors. We used Cox proportional hazard models to test the impact of recurrence-free rate, and after adjustment to available covariates.

RESULTS

Median age of the cohort was 66.5 (IQR: 59.7-75.8 years) with 85% of patients being males. Median overall follow-up time was 3.07 years (IQR: 0.75-4.01 years). When testing the impact of treatment in each risk group separately, we found that patients in the intermediate-risk treated with gemcitabine had a 24-month recurrence free rate of 77% (95% CI: 68%-86%) vs. 59% (95% CI: 49%-70%) in the saline group. This survival difference was confirmed on multivariable analysis (hazard ratio: 0.39, 95% CI: 23%-66%, P < 0.001). This group represented 53% of our cohort. Conversely, we did not observe a significant difference in recurrence-free survival among patients in the low- (P = 0.7) and high-risk (P = 0.4) groups.

CONCLUSION

Our findings indicate that older patients with a single tumor of suspected low-grade NMIBC at TURBT maximally benefit from immediate postresection IVC (gemcitabine).

摘要

背景

非肌肉浸润性膀胱癌(NMIBC)有较高的复发风险,而术后即刻膀胱内化疗(IVC)灌注显著降低了复发风险。但哪种亚群可能最大程度地受益于 IVC 仍存在疑问。我们的目的是基于 NMIBC 的复发风险建立风险组,然后评估单次术后 IVC 对每个风险组随后复发风险的影响。

材料和方法

使用 SWOG S0337 试验队列,我们对 345 例诊断为疑似低级别 NMIBC、接受经尿道膀胱肿瘤切除术(TURBT)并接受术后 IVC(吉西他滨与生理盐水)的患者进行了一项回顾性分析。采用回归树分析,根据患者的复发风险,将患者分为低危组-单发肿瘤且年龄<57 岁、中危组-单发肿瘤且年龄≥57 岁和高危组-多发肿瘤。我们使用 Cox 比例风险模型测试无复发生存率的影响,并在调整了可用协变量后进行了测试。

结果

队列的中位年龄为 66.5(IQR:59.7-75.8 岁),85%为男性。中位总随访时间为 3.07 年(IQR:0.75-4.01 年)。当分别测试每个风险组中治疗的影响时,我们发现中危组中接受吉西他滨治疗的患者在 24 个月时无复发生存率为 77%(95%CI:68%-86%),而生理盐水组为 59%(95%CI:49%-70%)。这种生存差异在多变量分析中得到了证实(风险比:0.39,95%CI:23%-66%,P<0.001)。该组占我们队列的 53%。相反,我们在低危(P=0.7)和高危(P=0.4)组的患者中未观察到无复发生存率的显著差异。

结论

我们的研究结果表明,在 TURBT 中诊断为疑似低级别 NMIBC 的单发肿瘤的老年患者最大程度地受益于即刻术后 IVC(吉西他滨)。

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