Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
BMC Urol. 2022 Aug 20;22(1):128. doi: 10.1186/s12894-022-01083-8.
Combining immune checkpoint inhibitors with chemotherapy can synergistically improve antitumor activity and are generally well tolerated. Recently, the efficacy and safety of combination therapy has been demonstrated for many cancers, including urothelial carcinomas. The aim of this retrospective pilot study was to evaluate the efficacy and safety of tislelizumab plus chemotherapy as first-line adjuvant treatment for locally advanced or metastatic bladder cancer.
We conducted a retrospective analysis of 31 patients with locally advanced or metastatic bladder cancer from December 2020 to January 2022 with an Eastern Cooperative Oncology Group performance status of 0/1. Of the 31 patients, 14 patients received tislelizumab (200 mg i.v. every 3 weeks, Q3W) plus 21 days cycles of chemotherapy (gemcitabine, 1000 mg/m i.v. on days 1 and 8 of each cycle + cisplatin, 70 mg/m i.v. on day 2 of each cycle) (TGC) treatment and 17 patients received gemcitabine plus cisplatin chemotherapy (GC) treatment. All patients treated with bladder cytoreductive surgery and were treated for four 21 days cycles until disease progression or intolerable treatment-related adverse events (TRAEs). The objective progression-free survival (PFS), overall survival (OS), overall response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR) and TRAEs were recorded and reviewed.
As of the cut-off date (March 25, 2022), PFS, OS, ORR, DCR, CBR and TRAEs were evaluated in 14 patients receiving combination therapy and 17 patients in the chemotherapy alone group. The median PFS was 36.0 [95% confidence interval (CI) 33.1-38.9] weeks in the TGC group and 29.0 (95% CI 25.4-32.6) weeks in the GC group [hazard ratio (HR) 0.15 (95% CI 0.04-0.55)]. In the GC group, the median OS was 48.0 (95% CI 39.7-56.3) weeks; the median OS was not yet mature for the TGC group [HR 0.26 (95% CI 0.07-0.94)]. Treatment with TGC resulted in improved DCR (TGC 71.4%; GC 65.0%) and CBR (TGC 64.3%; GC 52.9%) compared with GC. However, although higher incidences of grade ≥ 3 TRAEs were observed with TGC compared with GC (35.7% vs 23.5%), the difference was not statistically significant (p = 0.47).
This study suggested that TGC provided survivors of locally advanced or metastatic bladder cancer with encouraging antitumor activity and was generally well tolerated.
联合免疫检查点抑制剂和化疗可以协同提高抗肿瘤活性，且通常具有良好的耐受性。最近，联合治疗的疗效和安全性已在许多癌症中得到证实，包括尿路上皮癌。本回顾性初步研究的目的是评估替雷利珠单抗联合化疗作为局部晚期或转移性膀胱癌一线辅助治疗的疗效和安全性。
我们对 2020 年 12 月至 2022 年 1 月期间 31 例 ECOG 体能状态为 0/1 的局部晚期或转移性膀胱癌患者进行了回顾性分析。31 例患者中，14 例接受替雷利珠单抗（200mg，静脉注射，每 3 周 1 次，Q3W）联合 21 天周期化疗（吉西他滨，1000mg/m2，静脉注射，每个周期的第 1 和第 8 天+顺铂，70mg/m2，静脉注射，每个周期的第 2 天）（TGC）治疗，17 例接受吉西他滨联合顺铂化疗（GC）治疗。所有患者均接受膀胱减瘤手术治疗，并接受 4 个 21 天周期的治疗，直至疾病进展或出现无法耐受的治疗相关不良事件（TRAEs）。记录并评估客观无进展生存期（PFS）、总生存期（OS）、总缓解率（ORR）、疾病控制率（DCR）、临床获益率（CBR）和 TRAEs。
截至截止日期（2022 年 3 月 25 日），在接受联合治疗的 14 例患者和单独化疗的 17 例患者中评估了 PFS、OS、ORR、DCR、CBR 和 TRAEs。TGC 组中位 PFS 为 36.0[95%置信区间（CI）33.1-38.9]周，GC 组为 29.0[95%CI 25.4-32.6]周[风险比（HR）0.15（95%CI 0.04-0.55）]。GC 组中位 OS 为 48.0[95%CI 39.7-56.3]周；TGC 组的中位 OS 尚未成熟[HR 0.26（95%CI 0.07-0.94）]。与 GC 相比，TGC 治疗可提高 DCR（TGC 71.4%；GC 65.0%）和 CBR（TGC 64.3%；GC 52.9%）。然而，尽管与 GC 相比，TGC 治疗组观察到更高比例的≥3 级 TRAEs（35.7%比 23.5%），但差异无统计学意义（p=0.47）。
本研究表明，TGC 为局部晚期或转移性膀胱癌幸存者提供了令人鼓舞的抗肿瘤活性，且通常具有良好的耐受性。
