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在 III 期 IMpower133 研究和 III 期 IMbrella A 扩展研究中,接受阿替利珠单抗治疗的广泛期小细胞肺癌患者的 5 年生存情况。

Five-year survival in patients with extensive-stage small cell lung cancer treated with atezolizumab in the Phase III IMpower133 study and the Phase III IMbrella A extension study.

机构信息

Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany.

Faculty of Medicine, Department of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.

出版信息

Lung Cancer. 2024 Oct;196:107924. doi: 10.1016/j.lungcan.2024.107924. Epub 2024 Aug 10.

Abstract

OBJECTIVES

IMbrella A is a Phase III extension study that allowed rollover from Roche/Genentech-sponsored atezolizumab trials, including IMpower133, a Phase I/III trial of first-line atezolizumab or placebo plus carboplatin/etoposide in extensive-stage small cell lung cancer. We report outcomes from an exploratory analysis of IMpower133 with extended time-to-event data for patients who rolled over to IMbrella A.

MATERIALS AND METHODS

IMpower133 patients could roll over to IMbrella A to receive atezolizumab 1200 mg intravenously every three weeks if they continued to receive atezolizumab at IMpower133 closure or were in survival follow-up after atezolizumab discontinuation. Overall survival and safety were assessed; only serious adverse events and AEs of special interest were collected in IMbrella A.

RESULTS

Eighteen of 26 eligible patients rolled over to IMbrella A. At clinical cutoff (March 16, 2023), median follow-up in the atezolizumab plus carboplatin/etoposide arm (IMpower133 and IMbrella A) was 59.4 months. The three-, four-, and five-year overall survival (95 % CI) estimates were 16 % (11 %-21 %), 13 % (8 %-18 %), and 12 % (7 %-17 %), respectively. In IMbrella A, serious adverse events occurred in three patients (16.7 %), and one adverse event of special interest was reported (grade two hypothyroidism).

CONCLUSION

This long-term analysis of patients from IMbrella A previously enrolled in IMpower133 provides the first report of five-year overall survival outcomes in patients with extensive-stage small cell lung cancer treated with first-line cancer immunotherapy and chemotherapy. While limited by small patient numbers and lack of long-term data for the IMpower133 control arm, exploratory overall survival analyses in patients treated with atezolizumab plus carboplatin/etoposide compared favorably with historical data with chemotherapy alone. NCT03148418.

摘要

目的

IMbrella A 是一项 III 期扩展研究,允许罗氏/基因泰克赞助的阿特珠单抗试验(包括 IMpower133 试验)的患者进行滚动入组,该试验是一项在广泛期小细胞肺癌中一线阿特珠单抗或安慰剂联合卡铂/依托泊苷的 I/III 期试验。我们报告了来自 IMpower133 的探索性分析结果,该分析包括了具有扩展时间事件数据的患者,这些患者滚动入组至 IMbrella A。

材料和方法

如果患者在 IMpower133 关闭时继续接受阿特珠单抗治疗,或者在停止阿特珠单抗治疗后处于生存随访中,那么 IMpower133 的患者可以滚动入组至 IMbrella A,接受阿特珠单抗 1200mg 静脉注射,每 3 周一次。评估了总生存期和安全性;仅在 IMbrella A 中收集严重不良事件和特别关注的不良事件。

结果

26 名符合条件的患者中有 18 名滚动入组至 IMbrella A。在临床截止日期(2023 年 3 月 16 日),阿特珠单抗联合卡铂/依托泊苷组(IMpower133 和 IMbrella A)的中位随访时间为 59.4 个月。三年、四年和五年总生存率(95%CI)估计值分别为 16%(11%-21%)、13%(8%-18%)和 12%(7%-17%)。在 IMbrella A 中,有 3 名患者(16.7%)发生了严重不良事件,报告了 1 例特别关注的不良事件(二级甲状腺功能减退症)。

结论

这项来自 IMbrella A 的患者的长期分析,这些患者先前在 IMpower133 中入组,提供了接受一线癌症免疫疗法和化疗治疗的广泛期小细胞肺癌患者五年总生存率的首次报告。虽然由于患者数量较少且缺乏 IMpower133 对照组的长期数据,对接受阿特珠单抗联合卡铂/依托泊苷治疗的患者进行探索性总生存分析结果与单独化疗的历史数据相比具有优势。NCT03148418。

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