Carver College of Medicine, University of Iowa, Iowa City, Iowa.
Department of Urology, University of Iowa, Iowa City, Iowa.
J Urol. 2022 Sep;208(3):589-599. doi: 10.1097/JU.0000000000002740. Epub 2022 Jul 27.
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.
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.
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.
Gem/Doce is an effective and well-tolerated therapy for BCG-naïve NMIBC. Further investigation is warranted.
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。
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。
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。
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。
