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顺行腔内吉西他滨联合多西他赛与卡介苗治疗上尿路原位癌的比较。

Sequential endoluminal gemcitabine and docetaxel vs. Bacillus Calmette-Guérin for the treatment of upper tract carcinoma in situ.

机构信息

Carver College of Medicine, University of Iowa, Iowa City, IA.

Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA.

出版信息

Urol Oncol. 2024 Jul;42(7):221.e9-221.e16. doi: 10.1016/j.urolonc.2024.03.012. Epub 2024 Apr 11.

DOI:10.1016/j.urolonc.2024.03.012
PMID:38609747
Abstract

INTRODUCTION

Nephroureterectomy is commonly performed for high-grade (HG) upper tract (UT) urothelial carcinoma (UC). However, some patients may benefit from a de-escalation of surgical management, particularly for noninvasive disease and carcinoma in situ (CIS). Bacillus Calmette-Guerin (BCG) is currently the only guideline-recommended endoluminal treatment option. Gemcitabine/Docetaxel (Gem/Doce) has shown promising efficacy as a treatment for noninvasive HG UTUC, though a comparison to BCG is lacking. We report the outcomes of patients treated with endoluminal Gem/Doce vs. BCG for UT-CIS.

METHODS

A single-institutional retrospective review of patients treated with Gem/Doce vs. BCG for UT-CIS was performed. Treatment was instilled via nephrostomy or retrograde ureteral catheter. In both treatment groups, induction consisted of 6 weekly instillations. Maintenance was initiated if disease-free and consisted of 6 monthly instillations in the Gem/Doce group and a reduced dose (one-tenth) 3-week course at 3 months in the BCG group. Recurrence was defined as biopsy-proven disease or HG cytology.

RESULTS

The final cohort included 53 patients with 65 upper tract units; 31 received BCG and 34 received Gem/Doce. Median follow-up was 88 and 29 months in the BCG and Gem/Doce groups, respectively. Presenting pathology included biopsy-proven CIS and HG cytology in 9.7% and 90% of the BCG group, and 8.8% and 91% of the Gem/Doce group, respectively. The 2-year estimates for recurrence-free and nephroureterectomy-free survival were 61% and 89% for the BCG group and 54% and 100% for the Gem/Doce group, respectively. Upon multivariable analysis, instillation via percutaneous nephrostomy tube was associated with an increased risk of recurrence (HR 3.89, 95% CI 1.59-9.53). The development of any symptom was not statistically different between treatment groups (P = 0.12). There were 2 treatment-related deaths that occurred, 1 within each treatment group.

CONCLUSION

Endoluminal Gem/Doce and BCG have similar oncological outcomes and major adverse event rates in the treatment of UT-CIS. Further prospective evaluation is warranted.

摘要

介绍

肾输尿管切除术通常用于治疗高级别(HG)上尿路(UT)尿路上皮癌(UC)。然而,对于某些非浸润性疾病和原位癌(CIS)患者,可能需要降低手术管理级别,特别是对于非浸润性疾病和 CIS 患者。卡介苗(BCG)目前是唯一被指南推荐的腔内治疗选择。吉西他滨/多西他赛(Gem/Doce)已显示出作为非浸润性 HG UTUC 治疗方法的良好疗效,尽管缺乏与 BCG 的比较。我们报告了用腔内 Gem/Doce 与 BCG 治疗 UT-CIS 的患者的结局。

方法

对接受 Gem/Doce 与 BCG 治疗 UT-CIS 的患者进行了单机构回顾性研究。通过经皮肾造瘘管或逆行输尿管导管进行治疗。在两组治疗中,诱导治疗均为每周 6 次灌注。如果无疾病,则开始维持治疗,吉西他滨/多西他赛组为 6 个月每月一次,BCG 组为 3 个月时剂量减少(十分之一)的 3 周疗程。复发定义为活检证实的疾病或 HG 细胞学检查阳性。

结果

最终队列包括 53 例患者,共 65 个上尿路单位;31 例接受 BCG 治疗,34 例接受 Gem/Doce 治疗。BCG 组和 Gem/Doce 组的中位随访时间分别为 88 个月和 29 个月。BCG 组和 Gem/Doce 组的首发病理分别为活检证实的 CIS 和 HG 细胞学阳性占 9.7%和 90%,8.8%和 91%。BCG 组的 2 年无复发生存率和无肾输尿管切除术生存估计分别为 61%和 89%,Gem/Doce 组分别为 54%和 100%。多变量分析显示,经皮肾造瘘管灌注与复发风险增加相关(HR 3.89,95%CI 1.59-9.53)。两组之间治疗相关症状的发生没有统计学差异(P=0.12)。两组各有 1 例与治疗相关的死亡。

结论

腔内 Gem/Doce 和 BCG 在治疗 UT-CIS 中的肿瘤学结果和主要不良事件发生率相似。需要进一步进行前瞻性评估。

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