Phase II Trial of Adjuvant Atezolizumab Therapy in Elderly Patients with Completely Resected Stage II/III Non-Small Cell Lung Cancer: RELIANCE Trial

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC

ACS Applied Electronic Materials Pub Date : 2024-05-01 DOI:10.1016/j.cllc.2024.01.009

Taichi Matsubara , Masafumi Yamaguchi , Mototsugu Shimokawa , Isamu Okamoto

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Abstract

Introduction

Atezolizumab following platinum chemotherapy and complete pulmonary resection has become the new standard of adjuvant care for patients with stage II-III non-small cell lung cancer (NSCLC) expressing programmed death-ligand 1 (PD-L1). However, the efficacy and safety of postoperative adjuvant therapy and subsequent atezolizumab in patients aged 75 and older have not been established.

Methods

Patients with completely resected stage II–III NSCLC aged 75 and older will be prospectively registered in this single-arm phase II study. The enrolled patients will receive cisplatin plus vinorelbine (CDDP + VNR) followed by atezolizumab for up to 12 months. PD-L1 expression in at least 1% of cells will be confirmed by immunohistochemical staining. We plan to enroll 33 patients over 1 year at 25 institutions in Japan. The primary endpoint is the completion rate of adjuvant treatment (CDDP + VNR initiation to atezolizumab completion).

Conclusion

The present study represents the first prospective trial of the tolerability of postoperative adjuvant therapy with immune checkpoint inhibitors in elderly individuals. The results of this trial might help promote postoperative adjuvant immunotherapy in the future for the elderly.

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对完全切除的 II/III 期非小细胞肺癌老年患者进行阿特珠单抗辅助治疗的 II 期试验：RELIANCE试验

简介：对于表达程序性死亡配体1（PD-L1）的II-III期非小细胞肺癌（NSCLC）患者，在铂类化疗和完全肺切除术后使用阿特珠单抗已成为辅助治疗的新标准。方法75岁及以上完全切除的II-III期NSCLC患者将在这项单臂II期研究中进行前瞻性登记。入组患者将接受顺铂加长春瑞滨（CDDP + VNR）治疗，然后接受阿特珠单抗治疗，疗程长达12个月。PD-L1在至少1%细胞中的表达将通过免疫组化染色确认。我们计划在日本 25 家机构招募 33 名患者，为期 1 年。主要终点是辅助治疗的完成率（从 CDDP + VNR 开始到 atezolizumab 完成）。结论：本研究是首个针对老年人术后使用免疫检查点抑制剂进行辅助治疗的耐受性的前瞻性试验。本试验的结果可能有助于促进未来针对老年人的术后辅助免疫疗法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

ACS Applied Electronic Materials Multiple-

CiteScore

7.20

自引率

4.30%

发文量

567