序贯膀胱内吉西他滨和多西他赛治疗卡介苗初治高危非肌层浸润性膀胱癌。
Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guérin-Naïve High-Risk Nonmuscle-Invasive Bladder Cancer.
机构信息
Carver College of Medicine, University of Iowa, Iowa City, Iowa.
Department of Urology, University of Iowa, Iowa City, Iowa.
出版信息
J Urol. 2022 Sep;208(3):589-599. doi: 10.1097/JU.0000000000002740. Epub 2022 Jul 27.
PURPOSE
Bacillus Calmette-Guérin (BCG) is currently recommended as adjuvant therapy following complete transurethral resection of bladder tumor for high-risk nonmuscle-invasive bladder cancer (NMIBC). In response to the BCG shortage, gemcitabine plus docetaxel (Gem/Doce) has been utilized at our institution in the BCG-naïve setting. We report the outcomes of patients with high-risk BCG-naïve NMIBC treated with Gem/Doce.
MATERIALS AND METHODS
We retrospectively reviewed patients with BCG-naïve high-risk NMIBC treated with Gem/Doce from May 2013 through April 2021. Patients received 6 weekly intravesical instillations of sequential 1 gm gemcitabine and 37.5 mg docetaxel after complete transurethral resection of bladder tumor. Monthly maintenance of 2 years was initiated if disease-free at first followup. The primary outcome was recurrence-free survival. Survival was assessed with the Kaplan-Meier method, indexed from the first Gem/Doce instillation. Adverse events were reported using CTCAE (Common Terminology Criteria for Adverse Events) v5 (National Cancer Institute, Bethesda, Maryland). Differences were assessed with the log-rank test.
RESULTS
There were 107 patients with a median followup of 15 months included in the analysis. Patients had high-risk characteristics including 47 with any carcinoma and 55 with T1 disease. Recurrence-free survival was 89%, 85% and 82% at 6, 12 and 24 months, respectively. Recurrence rates were similar between patients with or without carcinoma (p=0.42). No patient had disease progression or died of bladder cancer. One patient underwent cystectomy due to end-stage lower urinary tract symptoms. Overall survival was 84% at 24 months. There were 92 adverse events (1 ≥grade 3), and 4 (4%) patients were unable to receive a full induction course.
CONCLUSIONS
Gem/Doce is an effective and well-tolerated therapy for BCG-naïve NMIBC. Further investigation is warranted.
目的
卡介苗（BCG）目前被推荐用于高危非肌肉浸润性膀胱癌（NMIBC）经全膀胱肿瘤经尿道切除术（TURBT）完全切除后作为辅助治疗。为应对 BCG 短缺，我们机构在 BCG 初治患者中应用吉西他滨联合多西他赛（Gem/Doce）。我们报告了用 Gem/Doce 治疗的 BCG 初治高危 NMIBC 患者的结果。
材料和方法
我们回顾性分析了 2013 年 5 月至 2021 年 4 月期间接受 Gem/Doce 治疗的 BCG 初治高危 NMIBC 患者。患者在 TURBT 完全切除后每周接受 6 次膀胱内灌注，依次给予 1g 吉西他滨和 37.5mg 多西他赛。如果首次随访时无疾病，则开始为期 2 年的每月维持治疗。主要结局是无复发生存率。采用 Kaplan-Meier 法评估生存，从首次 Gem/Doce 灌注开始索引。采用 CTCAE（常见不良事件术语标准）v5（美国国立癌症研究所，马里兰州贝塞斯达）报告不良事件。采用对数秩检验评估差异。
结果
共有 107 例患者纳入分析，中位随访时间为 15 个月。患者具有高危特征，包括 47 例有任何癌和 55 例 T1 疾病。6、12 和 24 个月时无复发生存率分别为 89%、85%和 82%。有或无癌的患者复发率无差异（p=0.42）。无患者疾病进展或死于膀胱癌。1 例患者因终末期下尿路症状行膀胱切除术。24 个月时总体生存率为 84%。共有 92 例不良事件（1 例≥3 级），4 例（4%）患者无法完成全诱导疗程。
结论
Gem/Doce 是一种有效且耐受良好的 BCG 初治 NMIBC 治疗方法。需要进一步研究。
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