Department of Urology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong Province, P.R.China; Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, Hebei Province, P.R.China.
Department of Urology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong Province, P.R.China.
Urol Oncol. 2024 Dec;42(12):450.e1-450.e12. doi: 10.1016/j.urolonc.2024.09.026. Epub 2024 Oct 4.
Up to 45% of patients with high-risk non-muscle-invasive bladder cancer (NMIBC) will not benefit from adjuvant intravesical instillation. We aimed to introduce intra-arterial chemotherapy (IAC) to existing intravesical treatment and evaluate its feasibility and safety.
We collected data from 170 patients who had been diagnosed with high-risk NMIBC and underwent transurethral resection of bladder tumor (TURBT) over the last 5 years. Twenty-seven patients were excluded according to specific exclusion criteria. The remaining 143 patients were divided into 3 groups according to their treatment: intravesical instillation of Bacillus Calmette - Guerin (BCG), BCG+ intra-arterial chemotherapy (IAC), and intravesical chemotherapy (IVC)+IAC groups. All groups received standard intravesical instillation of BCG or chemotherapeutic agents. In contrast, both the BCG+IAC and IVC+IAC groups received four courses of IAC (injection of cisplatin [60 mg/m] and epirubicin [50 mg/m] in the internal iliac arteries via Seldinger's percutaneous technique).
The median follow-up time was 47 months, ranging from 20 to 60 months. The restricted mean survival time (RMST), which represents the recurrence and progression rate of the BCG+IAC group, differed significantly when compared with the BCG group (P = 0.029 and 0.004, respectively) and the IVC+IAC group (P = 0.004 and 0.006, respectively). Kaplan-Meier plots revealed that the recurrence and progression-free survival of the BCG+IAC group were significantly higher than the BCG and IVC+IAC groups (P = 0.033 and 0.028, respectively). In contrast, the BCG and IVC+IAC groups showed similar RMST (P = 0.156 and 0.935, respectively), recurrence (P = 0.627), and progression-free (P = 0.931) survival. A small proportion of patients (20%) suffered from the adverse effects of IAC while 65% suffered from adverse reactions to intravesical instillation. Most adverse effects were ranked as grade I or II according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Analysis showed that tumor recurrence and progression rate in the BCG+IAC group was lower than the BCG and IVC+IAC groups while patients in the IVC+IAC group suffered from milder adverse effects in cystitis and flu-like symptoms. Our findings may provide a new perspective for urologists when treating patients with high-risk NMIBC.
高达 45%的高危非肌肉浸润性膀胱癌（NMIBC）患者将无法从辅助膀胱内灌注中获益。我们旨在引入动脉内化疗（IAC）作为现有膀胱内治疗方法，并评估其可行性和安全性。
我们收集了过去 5 年中因高危 NMIBC 接受经尿道膀胱肿瘤切除术（TURBT）的 170 名患者的数据。根据具体排除标准，排除了 27 名患者。其余 143 名患者根据治疗方法分为 3 组：膀胱内灌注卡介苗（BCG）、BCG+动脉内化疗（IAC）和膀胱内化疗（IVC）+IAC 组。所有组均接受标准膀胱内 BCG 或化疗药物灌注。相比之下，BCG+IAC 和 IVC+IAC 组均接受了 4 个疗程的 IAC（通过 Seldinger 经皮技术在内髂动脉内注射顺铂[60mg/m]和表柔比星[50mg/m]）。
中位随访时间为 47 个月，范围为 20 至 60 个月。BCG+IAC 组的受限平均生存时间（RMST），代表复发和进展率，与 BCG 组（P=0.029 和 0.004，分别）和 IVC+IAC 组（P=0.004 和 0.006，分别）相比差异有统计学意义。Kaplan-Meier 图显示，BCG+IAC 组的复发和无进展生存率明显高于 BCG 和 IVC+IAC 组（P=0.033 和 0.028，分别）。相比之下，BCG 和 IVC+IAC 组的 RMST（P=0.156 和 0.935，分别）、复发（P=0.627）和无进展（P=0.931）生存率相似。少数患者（20%）出现 IAC 的不良反应，65%出现膀胱内灌注的不良反应。大多数不良反应根据 CTCAE 版本 4.0 评为 1 级或 2 级。
分析显示，BCG+IAC 组的肿瘤复发和进展率低于 BCG 和 IVC+IAC 组，而 IVC+IAC 组患者膀胱炎和流感样症状的不良反应较轻。我们的研究结果可能为泌尿科医生治疗高危 NMIBC 患者提供了新视角。
