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阿替利珠单抗与化疗用于铂类治疗后局部晚期或转移性尿路上皮癌患者:来自 III 期 IMvigor211 临床试验的长期总生存和安全性更新。

Atezolizumab Versus Chemotherapy in Patients with Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: A Long-term Overall Survival and Safety Update from the Phase 3 IMvigor211 Clinical Trial.

机构信息

Netherlands Cancer Institute, Amsterdam, The Netherlands.

Gustave Roussy, Paris, France.

出版信息

Eur Urol. 2021 Jul;80(1):7-11. doi: 10.1016/j.eururo.2021.03.024. Epub 2021 Apr 23.

Abstract

Atezolizumab is an anti-PD-L1 immune checkpoint inhibitor recommended for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) after prior platinum-containing chemotherapy, regardless of PD-L1 status, among other treatment settings. We conducted a long-term follow-up to the exploratory analysis of overall survival (OS) and safety for the IMvigor211 intent-to-treat (ITT) population. Patients with mUC and disease progression during or following platinum-based chemotherapy were randomised 1:1 to receive atezolizumab 1200 mg or chemotherapy (vinflunine 320 mg/m, paclitaxel 175 mg/m, or docetaxel 75 mg/m according to investigator choice) intravenously every 3 wk. Although the primary analysis did not demonstrate statistically significant longer OS for patients receiving atezolizumab versus chemotherapy, updated OS showed long-term durable remission. With a median of 33 mo of follow-up, the 24-mo OS rate was 23% with atezolizumab and 13% with chemotherapy. Safety findings were consistent with the primary analysis, with no new signals detected. Chemotherapy-treated patients experienced more grade 3/4 treatment-related adverse events (AEs; 43% vs 22%) and more AEs leading to treatment discontinuation (18% vs 9%). Atezolizumab-treated patients experienced more AEs of special interest (35% vs 20%), which tended to be grade 1-2. Our findings support the use of atezolizumab in platinum-treated patients with mUC regardless of PD-L1 status. PATIENT SUMMARY: We report follow-up results from a study of an immunotherapy treatment, atezolizumab, in patients with bladder cancer who had already received platinum-containing chemotherapy. This analysis compared the effectiveness of atezolizumab with chemotherapy over 2.5 years after starting treatment. The results show that patients who received atezolizumab lived longer and had manageable side effects compared with patients who received chemotherapy. This trial is registered at ClinicalTrials.gov as NCT02302807.

摘要

阿特珠单抗是一种抗 PD-L1 免疫检查点抑制剂,推荐用于先前含铂化疗后局部晚期或转移性尿路上皮癌(mUC)的治疗,无论 PD-L1 状态如何,其他治疗方案也可。我们对总生存期(OS)和安全性的探索性分析进行了长期随访,这是 IMvigor211 意向治疗(ITT)人群的分析。mUC 患者在含铂化疗期间或之后疾病进展,按 1:1 比例随机接受阿特珠单抗 1200mg 或化疗(根据研究者选择,长春氟宁 320mg/m2、紫杉醇 175mg/m2 或多西他赛 75mg/m2)静脉输注,每 3 周一次。尽管主要分析未显示接受阿特珠单抗治疗的患者 OS 显著长于化疗组,但更新的 OS 显示出长期持久的缓解。中位随访 33 个月时,阿特珠单抗组 24 个月 OS 率为 23%,化疗组为 13%。安全性发现与主要分析一致,未发现新的信号。化疗组患者经历更多的 3/4 级治疗相关不良事件(AE;43% vs 22%)和更多导致治疗终止的 AE(18% vs 9%)。阿特珠单抗组患者经历更多的特殊关注 AE(35% vs 20%),这些 AE 倾向于为 1-2 级。我们的研究结果支持在 mUC 铂类治疗患者中无论 PD-L1 状态如何使用阿特珠单抗。患者总结:我们报告了免疫治疗药物阿特珠单抗在接受含铂化疗的膀胱癌患者中的随访结果。该分析比较了阿特珠单抗与化疗在治疗开始后 2.5 年的疗效。结果表明,与接受化疗的患者相比,接受阿特珠单抗治疗的患者生存期更长,且副作用可管理。这项试验在 ClinicalTrials.gov 注册,编号为 NCT02302807。

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