Shsm Hadi, Fahmy Usama A, Alhakamy Nabil A, Khairul-Asri Mohd G, Fahmy Omar
Department of Urology, Royal Cornwall Hospital, Truro TR1 3LJ, UK.
Department of Pharmaceutics & Industrial Pharmacy, Faculty of Pharmacy, King Abdulaziz University, Jeddah 21589, Saudi Arabia.
J Pers Med. 2021 Nov 13;11(11):1195. doi: 10.3390/jpm11111195.
Neoadjuvant chemotherapy is the standard of care before radical cystectomy for muscle invasive bladder cancer. Recently, checkpoint inhibitors have been investigated as a neoadjuvant treatment after the reported efficacy of checkpoint inhibitors in metastatic urothelial carcinoma.
The aim of this systematic review is to investigate the role of checkpoint inhibitors as a neoadjuvant treatment for muscle invasive bladder cancer before radical cystectomy.
Based on the PRISMA statement, a systematic review of the literature was conducted through online databases and the American Society of Clinical Oncology (ASCO) Meeting Library. Suitable publications were subjected to full-text assessment. The primary outcome of this review was to identify the impact of neoadjuvant immunotherapy on the oncological outcomes and survival benefits.
From the retrieved 254 results, 8 studies including 404 patients were included. Complete response varied between 30% and 50%. Downstaging varied between 50% and 74%. ≥Grade 3 AEs were recorded in 8.6% of patients who received monotherapy with either Atezolizumab or Pembrolizumab. In patients who received combination treatment, the incidence of ≥Grade 3 AEs was 16.3% for chemoimmunotherapy and 36.5% for combined immunotherapy. A total of 373 patients (92%) underwent radical cystectomy. ≥Grade 3 Clavien-Dindo surgical complications were reported in 21.7% of the patients. One-year overall survival (OS) and relapse-free survival (RFS) varied between 81% and 92%, and 70% and 88%, respectively.
The evidence on the use of immune checkpoint inhibitors in the setting of pre-radical cystectomy is quite limited, with noted variability within published trials. Combination with chemotherapy or another checkpoint inhibitor may boost response, although prospective studies with extended follow-up are needed to report on the survival advantages.
新辅助化疗是肌层浸润性膀胱癌根治性膀胱切除术之前的标准治疗方法。最近，在报道了检查点抑制剂在转移性尿路上皮癌中的疗效后，其作为新辅助治疗方法受到了研究。
本系统评价的目的是研究检查点抑制剂在根治性膀胱切除术之前作为肌层浸润性膀胱癌新辅助治疗的作用。
根据PRISMA声明，通过在线数据库和美国临床肿瘤学会（ASCO）会议文库对文献进行系统评价。对合适的出版物进行全文评估。本评价的主要结果是确定新辅助免疫治疗对肿瘤学结局和生存获益的影响。
从检索到的254项结果中，纳入了8项研究，共404例患者。完全缓解率在30%至50%之间。降期率在50%至74%之间。接受阿替利珠单抗或帕博利珠单抗单药治疗的患者中，8.6%记录到≥3级不良事件。在接受联合治疗的患者中，化疗免疫治疗的≥3级不良事件发生率为16.3%，联合免疫治疗为36.5%。共有373例患者（92%）接受了根治性膀胱切除术。21.7%的患者报告了≥3级Clavien-Dindo手术并发症。1年总生存率（OS）和无复发生存率（RFS）分别在81%至92%和70%至88%之间。
在根治性膀胱切除术之前使用免疫检查点抑制剂的证据相当有限，已发表的试验中存在明显差异。与化疗或另一种检查点抑制剂联合使用可能会提高反应率，尽管需要进行长期随访的前瞻性研究来报告生存优势。
