评估接受吉西他滨/多西他赛膀胱内灌注治疗非肌层浸润性膀胱癌患者的每月维持治疗。

An evaluation of monthly maintenance therapy among patients receiving intravesical combination gemcitabine/docetaxel for nonmuscle-invasive bladder cancer.

机构信息

James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD.

Department of Urology, Montefiore Medical Center, Albert Einstein College of Medicine, New York, NY.

出版信息

Urol Oncol. 2020 Feb;38(2):40.e17-40.e24. doi: 10.1016/j.urolonc.2019.07.022. Epub 2019 Aug 28.

DOI:10.1016/j.urolonc.2019.07.022

PMID:31473090

Abstract

PURPOSE

To report our experience with sequential maintenance intravesical gemcitabine/docetaxel (GEM/DOCE) for patients with nonmuscle-invasive bladder cancer.

MATERIALS AND METHODS

Fifty-nine patients who received full GEM/DOCE for nonmuscle-invasive bladder cancer between 2013 and 2018, per the protocol adapted from University of Iowa, were identified and characterized. Patients were treated with 6 weekly instillations of GEM/DOCE and subsequent monthly maintenance installations for those with no evidence of disease at the first surveillance. Student's t test and χ test were used to compare continuous and categorical variables as appropriate. For survival analyses, Kaplan-Meier (KM) curves were created to assess disease-free survival (DFS). Overall comparisons of KM survival analysis were conducted using the Wilcoxon test.

RESULTS

Among all patients, median follow-up was 24 months. Sixty-six percent of patients received ≥2 intravesical induction therapies prior to receiving GEM/DOCE. Thirty-one patients (63%) failed ≥2 induction courses of Bacillus Calmette-Guérin (BCG) before receiving GEM/DOCE. Overall DFS was 49% at 1 year and 29% at 2 years. For patients who failed ≥1 induction courses of BCG, overall DFS was 48% at 1 year and 32% at 2 years. GEM/DOCE appears to be effective for therapy naïve and patients who have failed previous intravesical therapies (P = 0.39). There were 41 (69.5%) patients who had no evidence of disease at the first surveillance and were eligible for maintenance therapy. Among these patients, 24 were managed with observation alone and 17 with monthly maintenance. Median follow-up for observed patients was 36 months and 26 months for patients with maintenance. DFS at 1 year was 42% for observed patients and 81% for patients receiving maintenance (P = 0.04). DFS at 2 years was 32% for observed patients and 59% for patients receiving maintenance therapy (P = 0.45). For maintenance eligible patients who received ≥1 induction courses of BCG, DFS was 42% for observed patients and 81% for patients receiving maintenance therapy at 1 year and 34% for observed patients and 59% for patients receiving maintenance therapy at 2 years. Pathologic stage at recurrence was similar between observed patients and those receiving maintenance (P = 0.83). KM analyses showed greater DFS for patients receiving maintenance therapy compared to observed patients (P = 0.04).

CONCLUSION

Patients who demonstrate initial complete response to GEM/DOCE may benefit from maintenance GEM/DOCE.

摘要

目的

报告我们使用序贯膀胱内吉西他滨/多西他赛（GEM/DOCE）维持治疗非肌层浸润性膀胱癌的经验。

材料与方法

2013 年至 2018 年间，根据爱荷华大学的方案，对 59 例接受完整 GEM/DOCE 治疗的非肌层浸润性膀胱癌患者进行了识别和特征描述。对于首次监测时无疾病证据的患者，采用 6 周 1 次的 GEM/DOCE 膀胱内灌注治疗，随后进行每月的维持性灌注治疗。采用 Student t 检验和 χ 检验比较连续变量和分类变量。采用 Kaplan-Meier（KM）曲线评估无疾病生存（DFS），进行生存分析。采用 Wilcoxon 检验对 KM 生存分析进行总体比较。

结果

所有患者的中位随访时间为 24 个月。66%的患者在接受 GEM/DOCE 治疗前接受了≥2 次膀胱内诱导治疗。31 例（63%）患者在接受 GEM/DOCE 治疗前接受了≥2 次卡介苗（BCG）诱导治疗后仍复发。1 年时的总 DFS 为 49%，2 年时为 29%。对于≥1 次 BCG 诱导治疗失败的患者，1 年时的总 DFS 为 48%，2 年时为 32%。GEM/DOCE 似乎对初治患者和既往膀胱内治疗失败的患者均有效（P=0.39）。41 例（69.5%）患者在首次监测时无疾病证据，有资格接受维持治疗。其中 24 例患者接受观察治疗，17 例患者接受每月维持治疗。观察组患者的中位随访时间为 36 个月，维持治疗组患者的中位随访时间为 26 个月。1 年时，观察组患者的 DFS 为 42%，维持治疗组患者的 DFS 为 81%（P=0.04）。2 年时，观察组患者的 DFS 为 32%，维持治疗组患者的 DFS 为 59%（P=0.45）。对于接受≥1 次 BCG 诱导治疗且有维持治疗资格的患者，1 年时观察组患者的 DFS 为 42%，维持治疗组患者的 DFS 为 81%，2 年时观察组患者的 DFS 为 34%，维持治疗组患者的 DFS 为 59%。复发时的病理分期在观察组和接受维持治疗的患者之间相似（P=0.83）。KM 分析显示，与观察组患者相比，接受维持治疗的患者具有更好的 DFS（P=0.04）。