维迪西妥单抗联合替雷利珠单抗在晚期转移性尿路上皮癌一线治疗中的临床疗效与安全性分析

Clinical efficacy and safety analysis of disitamab vedotin combined with tislelizumab in first-line treatment of advanced metastatic urothelial carcinoma

    摘要
  • 摘要:
    目的 转移性尿路上皮癌（metastatic urothelial carcinoma，mUC）患者通常接受含铂化疗作为一线治疗。近年来，抗体-药物偶联物（antibody-drug conjugates，ADCs）联合程序性死亡受体-1（programmed death-1，PD-1）抗体在mUC治疗中展现出良好的疗效和安全性。HER2阳性虽与不良预后相关，但可从抗HER2-ADC维迪西妥单抗（disitamab vedotin，RC48-ADC）中获益。本研究旨在评估RC48-ADC联合替雷利珠单抗（tislelizumab）在初治mUC患者中的疗效和安全性。
    方法 回顾性分析2022年7月至2023年12月在内蒙古自治区人民医院接受治疗的70例mUC患者，其中30例接受RC48-ADC联合替雷利珠单抗治疗（DT）组，40例接受吉西他滨联合顺铂（gemcitabine plus cisplatin，GC）组。主要研究终点包括客观缓解率（objective response rate，ORR）、疾病控制率（disease control rate，DCR）、无进展生存期（progression-free survival，PFS）、总生存期（overall survival，OS）及治疗相关不良事件（treatment-related adverse events，TRAEs）。
    结果 DT组ORR（73.3% vs. 47.5%）及DCR（86.7% vs. 62.5%）均显著高于GC组（P<0.05）。DT组mPFS较GC组更长（10.98个月 vs. 7.67个月，P<0.005），OS亦有延长中位总生存期（median OS，mOS）：未达到 vs. 11.34个月），两组安全性相似（P>0.05）。最常见TRAEs包括骨髓抑制、胃肠道及肝胆系统损害、乏力、脱发和皮疹，未报告≥3级TRAEs或治疗相关死亡事件。
    结论  RC48-ADC联合替雷利珠单抗在初治mUC患者中表现出优越的疗效和良好的安全性，支持其作为一线治疗的潜在选择。

     

    Abstract:
    Objective  Patients with metastatic urothelial carcinoma (mUC) usually receive platinum-based chemotherapy as the first-line treatment. Recently, antibody-drug conjugates (ADCs) combined with programmed death-1 antibody (PD-1 antibody) have shown promising efficacy and safety in the treatment of mUC. HER2 positivity is associated with poor prognosis, patients can benefit from anti-HER2 ADC therapy such as disitamab vedotin (RC48-ADC). This study aimed to evaluate the efficacy and safety of RC48-ADC combined with tislelizumab in treatment-naïve patients with mUC.
    Methods A retrospective analysis was performed on 70 mUC patients treated between July 2022 and December 2023, including 30 patients receiving RC48-ADC combined with tislelizumab (DT group) and 40 patients receiving gemcitabine plus cisplatin (GC group). Primary endpoints included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs).
    Results The ORR (73.3% vs. 47.5%) and DCR (86.7% vs. 62.5%) were significantly higher in the DT group compared to the GC group (P<0.05). The DT group also demonstrated longer PFS (10.98 months vs. 7.67 months, P<0.005) and prolonged OS (median OS: not reached vs. 11.34 months). The most common TRAEs included myelosuppression, gastrointestinal and hepatobiliary toxicities, fatigue, alopecia, and rash. No grade ≥3 TRAEs or treatment-related deaths were reported.
    Conclusions RC48-ADC combined with tislelizumab demonstrated superior efficacy and favorable safety in treatment-naïve patients with mUC, supporting its potential as a first-line therapeutic option.

     

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