吉西他滨和多西他赛序贯膀胱内灌注与卡介苗治疗卡介苗无反应性非肌层浸润性膀胱癌患者的肿瘤学结局比较
Oncologic Outcomes of Sequential Intravesical Gemcitabine and Docetaxel Compared with Bacillus Calmette-Guérin in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle Invasive Bladder Cancer.
作者信息
Taylor Jacob, Kamat Ashish M, Annapureddy Drupad, Khene Zine-Eddine, Howard Jeffrey, Tan Wei Shen, McElree Ian M, Facundo Davaro, Yim Kendrick, Harrington Stephen, Dyer Elizabeth, Black Anna J, Kanabur Pratik, Roumiguié Mathieu, Lerner Seth, Black Peter C, Raman Jay D, Preston Mark, Steinberg Gary, Huang William, Li Roger, Packiam Vignesh T, Woldu Solomon L, Lotan Yair, O'Donnell Michael A
机构信息
University of Texas Southwestern Medical Center, Dallas, TX, USA.
UT MD Anderson Cancer Center, Houston, TX, USA.
出版信息
Eur Urol Oncol. 2025 Apr;8(2):469-476. doi: 10.1016/j.euo.2024.12.005. Epub 2024 Dec 17.
BACKGROUND AND OBJECTIVE
Non-muscle-invasive bladder cancer (NMIBC) patients treated with additional bacillus Calmette-Guérin (BCG) may become unresponsive to BCG. Recently, sequential intravesical gemcitabine and docetaxel (gem/doce) are being used for NMIBC. This study aims to compare oncologic outcomes between sequential intravesical gem/doce versus additional BCG in patients with BCG-unresponsive NMIBC.
METHODS
Data were collected from ten academic institutions on patients with BCG-unresponsive NMIBC based on the Food and Drug Administration guidelines. Information on high-grade recurrence-free (HGRFS), progression-free (PFS), cystectomy-free (CFS), metastasis-free (MFS), cancer-specific (CSS), and overall (OS) survival was collected. The Kaplan-Meier method and Cox proportional hazard ratios (HRs) were used to determine differences in oncologic outcomes between the Gem/Doce and BCG groups.
KEY FINDINGS AND LIMITATIONS
Of 299 total patients, 204 underwent additional BCG treatment at the time of BCG unresponsiveness and 95 underwent gem/doce treatment. Rates of PFS (HR 2.6, 95% confidence interval [CI] 1.1-5.0, p = 0.03), CFS (HR 2.0, 95% CI 1.2-3.4, p = 0.01), and CSS (HR 3.7, 95% CI 1.1-12.3, p=0.03) were higher in patients receiving gem/doce. HGRFS, MFS, and OS were similar between both groups.
CONCLUSIONS AND CLINICAL IMPLICATIONS
The findings from this study suggest that intravesical gem/doce is associated with lower rates of progression than additional BCG in patients with BCG-unresponsive NMIBC who decline or are ineligible for cystectomy.
PATIENT SUMMARY
In this report, we looked at outcomes between patients with noninvasive bladder cancer who were treated with additional bacillus Calmette-Guérin (BCG) or gemcitabine-docetaxel combination after not responding to primary BCG therapy. We found that intravesical gemcitabine-docetaxel was associated with fewer progression events than additional salvage BCG therapy.
背景与目的
接受卡介苗（BCG）辅助治疗的非肌层浸润性膀胱癌（NMIBC）患者可能会对BCG产生耐药。近来，序贯膀胱内注射吉西他滨和多西他赛（吉西他滨/多西他赛）被用于治疗NMIBC。本研究旨在比较BCG耐药的NMIBC患者序贯膀胱内注射吉西他滨/多西他赛与BCG辅助治疗的肿瘤学结局。
方法
根据美国食品药品监督管理局指南，从十家学术机构收集BCG耐药的NMIBC患者的数据。收集关于高级别无复发生存率（HGRFS）、无进展生存率（PFS）、无膀胱切除生存率（CFS）、无转移生存率（MFS）、癌症特异性生存率（CSS）和总生存率（OS）的信息。采用Kaplan-Meier法和Cox比例风险比（HR）来确定吉西他滨/多西他赛组与BCG组在肿瘤学结局上的差异。
主要发现与局限性
在总共299例患者中，204例在BCG耐药时接受了BCG辅助治疗，95例接受了吉西他滨/多西他赛治疗。接受吉西他滨/多西他赛治疗的患者的PFS（HR 2.6，95%置信区间[CI] 1.1 - 5.0，p = 0.03）、CFS（HR 2.0，95% CI 1.2 - 3.4，p = 0.01）和CSS（HR 3.7，95% CI 1.1 - 12.3，p = 0.03）率更高。两组之间的HGRFS、MFS和OS相似。
结论与临床意义
本研究结果表明，对于拒绝或不符合膀胱切除术条件的BCG耐药的NMIBC患者，膀胱内注射吉西他滨/多西他赛与较低的疾病进展率相关。
患者总结
在本报告中，我们观察了原发性BCG治疗无效后接受BCG辅助治疗或吉西他滨 - 多西他赛联合治疗的非侵袭性膀胱癌患者的结局。我们发现膀胱内注射吉西他滨 - 多西他赛与挽救性BCG辅助治疗相比，进展事件更少。
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