McElree Ian M, Orzel Joanna, Stubbee Reid, Steinberg Ryan L, Mott Sarah L, O'Donnell Michael A, Packiam Vignesh T
Carver College of Medicine, University of Iowa, Iowa City, IA.
Department of Urology, University of Iowa, Iowa City, IA.
Urol Oncol. 2023 Dec;41(12):485.e1-485.e7. doi: 10.1016/j.urolonc.2023.06.017. Epub 2023 Jul 11.
Adjuvant intravesical therapy is recommended for patients with intermediate-risk NMIBC. While intravesical gemcitabine-docetaxel (Gem/Doce) has demonstrated favorable outcomes for high-risk NMIBC, its utility in the intermediate-risk setting is not well described. We report outcomes of Gem/Doce as an adjuvant treatment for intermediate-risk NMIBC.
We retrospectively identified patients with intermediate-risk NMIBC by AUA criteria treated with Gem/Doce following TURBT between 2012 and 2022. Patients received weekly sequential intravesical instillations of 1 g gemcitabine and 37.5 mg docetaxel for 6 weeks. Monthly maintenance of 2 years was initiated if disease-free at first surveillance. The primary outcome was recurrence-free survival (RFS), assessed using the Kaplan-Meier method.
The cohort included 77 patients with median follow-up of 26 (IQR 14-50) months. Prior to induction, 67 (87%) patients presented with Ta low-grade (LG) lesions, 3 (3.9%) with Ta high-grade (HG), 5 (6.5%) with TaLG plus focal TaHG, and 2 (2.6%) with T1LG. Thirty-three (43%) patients received previous intravesical therapy including BCG (23), mitomycin (13), and docetaxel monotherapy (12). The 2-year RFS was 71% among all patients. Treatment-naïve patients had superior RFS compared to previously treated patients (P = 0.04); 2-year estimates were 79% and 64%, respectively. Twenty-nine (38%) patients experienced adverse events; all were Grade 1 to 2 except 1 (1.3%) Grade 3 (acute oxygen desaturation). Three (3.9%) patients did not tolerate a full induction course.
In this retrospective review of a heterogenous population of patients with intermediate-risk NMIBC, Gem/Doce was an effective and well-tolerated adjuvant therapy. Further prospective evaluation in this setting is needed.
对于中危非肌层浸润性膀胱癌（NMIBC）患者，推荐进行辅助膀胱内治疗。虽然膀胱内吉西他滨 - 多西他赛（Gem/Doce）已在高危NMIBC中显示出良好疗效，但其在中危情况下的应用尚未得到充分描述。我们报告了Gem/Doce作为中危NMIBC辅助治疗的结果。
我们回顾性确定了2012年至2022年间接受经尿道膀胱肿瘤电切术（TURBT）后使用Gem/Doce治疗的符合美国泌尿外科学会（AUA）标准的中危NMIBC患者。患者每周依次膀胱内灌注1 g吉西他滨和37.5 mg多西他赛，共6周。如果首次监测时无疾病复发，则开始为期2年的每月维持治疗。主要结局是无复发生存期（RFS），采用Kaplan-Meier方法评估。
该队列包括77例患者，中位随访时间为26（四分位间距14 - 50）个月。诱导治疗前，67例（87%）患者表现为Ta低级别（LG）病变，3例（3.9%）为Ta高级别（HG），5例（6.5%）为TaLG加局灶性TaHG，2例（2.6%）为T1LG。33例（43%）患者曾接受过膀胱内治疗，包括卡介苗（BCG）（23例）、丝裂霉素（13例）和多西他赛单药治疗（12例）。所有患者的2年RFS为71%。未接受过治疗的患者的RFS优于既往接受过治疗的患者（P = 0.04）；2年估计值分别为79%和64%。29例（38%）患者发生不良事件；除1例（1.3%）3级（急性氧饱和度下降）外，均为1至2级。3例（3.9%）患者无法耐受完整的诱导疗程。
在对异质性中危NMIBC患者群体的这项回顾性研究中，Gem/Doce是一种有效且耐受性良好的辅助治疗方法。在此情况下需要进一步的前瞻性评估。
