Purpose

To retrospectively evaluate the tislelizumab-based chemoimmunotherapy combined with gemcitabine/cisplatin for bladder-sparing in patients with muscle-invasive bladder cancer (MIBC).

Methods

Forty-five patients who received bladder-sparing treatment or radical cystectomy (RC) for MIBC (cT2-T4a, NxM0) were retrospectively enrolled. All patients received maximal transurethral resection of bladder tumor (mTURBT), followed by four cycles of chemo-immunotherapy with tislelizumab (PD-L1 inhibitor), gemcitabine, and cisplatin. Clinical efficacy was evaluated to compare the benefit of bladder-sparing treatment on clinical CR (cCR) and RC for non-cCR patients. The primary outcomes were bladder intact disease-free survival (BIDFS) and overall survival (OS), and the secondary outcomes were adverse effects. The PD-L1 status and molecular subtypes of tumors were analyzed.

Results

The overall survival rate was 88.8% (95%CI: 79.6%, 98.0%) at 12 months, 85.7% (95%CI: 74.9%, 96.5%) at 18 months, and 66.6% (95%CI: 45.2%, 88.0%) at 24 months. Twenty-nine patients (64.4%) achieved cCR and their OS rate was 96.6% (95%CI: 89.9%, 100%). Sixteen patients were in the non-cCR group, and their OS rate was 75.0% (95%CI: 53.8%, 96.2%) at 12 months, 65.6% (95%CI: 40.3%, 90.9%) at 18 months, and 52.5% (95%CI: 21.9%, 83.1%) at 24 months. The BIDFS rate for patients who received bladder-sparing treatment was 96.0% (95%CI: 88.4%, 100%) from 12 to 24 months. Four patients (8.8%) were PD-L1 positive and 41 patients (91.2%) were PD-L1 negative.

Conclusions

Our retrospective study of patients with MIBC suggests that tislelizumab-based neoadjuvant therapy was a safe and effective bladder-sparing treatment.

中文翻译：

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使用替雷利珠单抗联合吉西他滨/顺铂对选定的肌层浸润性膀胱癌患者进行膀胱保留治疗：一项真实世界研究

目的

回顾性评估基于替雷利珠单抗的化学免疫疗法联合吉西他滨/顺铂对肌层浸润性膀胱癌（MIBC）患者膀胱保留的效果。

方法

回顾性纳入 45 名因 MIBC（cT2-T4a，NxM0）接受膀胱保留治疗或根治性膀胱切除术 (RC) 的患者。所有患者均接受经尿道膀胱肿瘤最大切除术 (mTURBT)，随后接受 4 个周期的替雷利珠单抗（PD-L1 抑制剂）、吉西他滨和顺铂化疗免疫治疗。评估临床疗效，比较膀胱保留治疗对非 cCR 患者的临床 CR (cCR) 和 RC 的益处。主要结局是膀胱完整无病生存期（BIDFS）和总生存期（OS），次要结局是不良反应。分析肿瘤的PD-L1状态和分子亚型。

结果

12个月时的总生存率为88.8%（95%CI：79.6%、98.0%），18个月时的总生存率为85.7%（95%CI：74.9%、96.5%），18个月时的总生存率为66.6%（95%CI：45.2%）。 88.0%）24 个月时。29 例患者 (64.4%) 达到 cCR，OS 率为 96.6% (95%CI: 89.9%, 100%)。非 cCR 组有 16 名患者，12 个月时 OS 率为 75.0%（95%CI：53.8%，96.2%），18 个月时 OS 率为 65.6%（95%CI：40.3%，90.9%）， 24 个月时为 52.5%（95%CI：21.9%、83.1%）。接受膀胱保留治疗的患者 12 至 24 个月的 BIDFS 率为 96.0%（95%CI：88.4%，100%）。4 名患者（8.8%）为 PD-L1 阳性，41 名患者（91.2%）为 PD-L1 阴性。

结论

我们对 MIBC 患者的回顾性研究表明，基于替雷利珠单抗的新辅助治疗是一种安全有效的膀胱保留治疗。