Department of Urology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Urol Int. 2022;106(8):784-790. doi: 10.1159/000524098. Epub 2022 Jun 2.
Bacille Calmette-Guerin (BCG) is considered the most effective agent for non-muscle invasive bladder cancer (NMIBC). However, due to BCG-related toxicity, multiple studies have suggested the role of newer chemotherapeutic drugs. The aim of our study was to evaluate intravesical gemcitabine + docetaxel (Gem/Doce) versus BCG with respect to quality of life (QOL), safety, and efficacy in NMIBC.
A total of 60 patients with NMIBC were evaluated between July 2019 and December 2020 in a prospective manner. The sample size calculation was done, keeping in mind the incidence of intravesical BCG-related complications of up to 50-60% and 20-30% for Gem/Doce combination. The p value of 0.05 was kept as statistically significant. The enrollment ratio was kept at 1, and power of study was aimed at 80%. The study population was alternatively assigned to two groups (BCG vs. Gem/Doce) of 30 patients each. Both the groups received 6 weekly doses of induction therapy followed by 6 monthly doses of maintenance therapy if no recurrence was noted at interim follow-up. QOL scores, safety, and efficacy were assessed at beginning of intravesical therapy, end of induction, and 6 months of maintenance therapy. Cystoscopy examination and cytology were performed at the end of induction therapy and 3-monthly thereafter.
The preliminary results at the end of 6 months following maintenance therapy showed that the demographic profile, histological stage, and grade were comparable between two groups. The QOL scores using QLQ-30 and QLQ-BLS-24 showed statistically significant differences with the Gem/Doce arm showing better outcomes. There were no progressions to higher stage, while one recurrence each was seen in both groups. Patient-related side effects measured by CTCAE (Common Terminology Criteria for Adverse Events)version 5 showed that the BCG group had higher toxicity profile as compared to Gem/Doce group.
Gem/Doce combination intravesical therapy is a promising alternative to BCG for treatment of NMIBC, showing better QOL measures and lesser side effects.
卡介苗（BCG）被认为是治疗非肌肉浸润性膀胱癌（NMIBC）最有效的药物。然而，由于 BCG 相关的毒性，多项研究表明了新型化疗药物的作用。我们的研究旨在评估膀胱内注射吉西他滨联合多西他赛（Gem/Doce）与 BCG 治疗 NMIBC 的疗效、安全性和生活质量（QOL）。
2019 年 7 月至 2020 年 12 月，我们以前瞻性的方式评估了 60 例 NMIBC 患者。我们进行了样本量计算，考虑到膀胱内 BCG 相关并发症的发生率高达 50-60%，而 Gem/Doce 联合治疗的发生率为 20-30%。统计学显著水平的 p 值设为 0.05。纳入比例为 1，研究的效能目标为 80%。研究人群被交替分配到两组（BCG 组与 Gem/Doce 组），每组 30 例。两组患者均接受 6 周诱导治疗，然后在中期随访时未发现复发，给予 6 个月维持治疗。在膀胱内治疗开始时、诱导治疗结束时和维持治疗 6 个月时评估 QOL 评分、安全性和疗效。在诱导治疗结束时和此后每 3 个月进行膀胱镜检查和细胞学检查。
维持治疗 6 个月后的初步结果显示，两组患者的人口统计学特征、组织学分期和分级相似。使用 QLQ-30 和 QLQ-BLS-24 评估的 QOL 评分显示出统计学显著差异，Gem/Doce 组的结果更好。没有进展为更高分期，而两组各有 1 例复发。采用 CTCAE（不良事件通用术语标准）版本 5 测量的患者相关不良反应显示，BCG 组的毒性谱高于 Gem/Doce 组。
与 BCG 相比，膀胱内注射 Gem/Doce 联合治疗是治疗 NMIBC 的一种有前途的替代方法，它能提高生活质量并降低不良反应。
