不可切除的局部晚期非小细胞肺癌 (LA-NSCLC) 的标准治疗包括放化疗，然后是度瓦鲁单抗。然而，对于体能状态为 2 岁或年龄≥75 岁的 LA-NSCLC 患者，放化疗后杜瓦鲁单抗的临床意义仍不清楚。因此，我们研究了每日卡铂联合胸部同步放疗后 durvalumab 的临床获益。 在这项前瞻性 II 期研究中，前 20 次放疗前每日给予小剂量卡铂 (30 mg/m2) 和同步放疗 (60 Gy) ），然后是度瓦鲁单抗。主要终点是从 durvalumab 开始后 12 个月的无进展生存 (PFS) 率。次要终点包括治疗完成率、PFS、总生存率、客观缓解率和安全性。 2019 年 9 月至 2021 年 10 月期间接受每日卡铂化放疗的 86 名患者中，61 名 (70.9%) 接受了 durvalumab 巩固治疗。 28 名（45.9%）、26 名（42.6%）和 7 名（11.5%）患者的体能状态分别为 0、1 和 2。 durvalumab 的治疗完成率为 26.2% (16/61)。 durvalumab 启动后 12 个月的 PFS 率为 51.0%，表明达到了主要终点，因为超出了先前研究计算的 35% 的预期值。放化疗和durvalumab治疗后的客观缓解率分别为47.0%和57.4%。中位 PFS 和总生存期分别为 12.3 个月和 28.1 个月。 3 级或 4 级最常见的不良事件是肺炎（8.2%）。一名患者因间质性肺炎死亡。每日卡铂联合放疗后进行 Durvalumab 巩固治疗对于 LA-NSCLC 易感患者是有效且可耐受的。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。

Standard care for unresectable locally advanced non-small-cell lung cancer (LA-NSCLC) involves chemoradiotherapy followed by durvalumab. The clinical significance of durvalumab after chemoradiotherapy in patients with LA-NSCLC having a performance status of 2 or aged ≥75 years, however, remains unclear. Therefore, we investigated the clinical benefit of durvalumab after daily carboplatin plus thoracic concurrent radiotherapy.In this prospective phase II study, daily low-dose carboplatin (30 mg/m2) was administered before radiotherapy for the first 20 fractions and concurrent radiotherapy (60 Gy) followed by durvalumab. The primary endpoint was 12 months progression-free survival (PFS) rate from durvalumab initiation. The secondary endpoints included rate of therapeutic completion, PFS, overall survival, objective response rate, and safety.Of 86 patients who underwent chemoradiotherapy with daily carboplatin from September 2019 to October 2021, 61 (70.9%) received durvalumab consolidation. The performance status was 0, 1, and 2 in 28 (45.9%), 26 (42.6%), and 7 (11.5%) patients, respectively. The rate of therapeutic completion for durvalumab was 26.2% (16/61). The PFS rate of 12 months after durvalumab initiation was 51.0%, indicating that the primary endpoint was achieved because the expected value of 35% calculated from previous studies was exceeded. The objective response rate after chemoradiotherapy and durvalumab was 47.0% and 57.4%, respectively. The median PFS and overall survival were 12.3 and 28.1 months, respectively. The most common adverse event in grades 3 or 4 was pneumonitis (8.2%). One patient died because of interstitial pneumonitis.Durvalumab consolidation after daily carboplatin with radiotherapy was effective and tolerable for LA-NSCLC vulnerable patients.Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.