一项 II 期研究，评估对于不可切除 III 期非小细胞肺癌且体能状态为 2 的老年患者（≥75 岁），每日给予卡铂联合放疗序贯度伐利尤单抗治疗的疗效：NEJ039A。
A phase II study of daily carboplatin plus irradiation followed by durvalumab therapy for older adults (≥75 years) with unresectable III non-small-cell lung cancer and performance status of 2: NEJ039A.
机构信息
Department of Respiratory Medicine, International Medical Center, Saitama Medical University, Saitama, Japan.
Department of Respiratory Medicine, Kasukabe Medical Center, Kasukabe, Japan.
出版信息
ESMO Open. 2024 Oct;9(10):103939. doi: 10.1016/j.esmoop.2024.103939. Epub 2024 Oct 11.
BACKGROUND
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.
PATIENTS AND METHODS
In this prospective phase II study, daily low-dose carboplatin (30 mg/m) 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.
RESULTS
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.
CONCLUSIONS
Durvalumab consolidation after daily carboplatin with radiotherapy was effective and tolerable for LA-NSCLC vulnerable patients.
背景
标准治疗方案为不可切除局部晚期非小细胞肺癌（LA-NSCLC）患者接受放化疗，然后使用度伐利尤单抗。然而，对于体力状态为 2 级或年龄≥75 岁的 LA-NSCLC 患者，放化疗后使用度伐利尤单抗的临床意义尚不清楚。因此，我们研究了每日卡铂联合胸部同步放疗后使用度伐利尤单抗的临床获益。
患者和方法
在这项前瞻性 II 期研究中，在放疗的前 20 个分次中每天给予低剂量卡铂（30mg/m），然后进行同步放疗（60Gy），接着使用度伐利尤单抗。主要终点是从度伐利尤单抗起始治疗起 12 个月无进展生存期（PFS）率。次要终点包括治疗完成率、PFS、总生存期、客观缓解率和安全性。
结果
在 2019 年 9 月至 2021 年 10 月期间接受每日卡铂放化疗的 86 例患者中，61 例（70.9%）接受了度伐利尤单抗巩固治疗。28 例（45.9%）、26 例（42.6%）和 7 例（11.5%）患者的体力状态分别为 0、1 和 2 级。度伐利尤单抗的治疗完成率为 26.2%（16/61）。度伐利尤单抗起始治疗后 12 个月的 PFS 率为 51.0%，表明主要终点达成，因为超过了从既往研究计算得出的 35%的预期值。放化疗和度伐利尤单抗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%）。1 例患者因间质性肺炎死亡。
结论
对于体力状态不佳的 LA-NSCLC 患者，每日卡铂联合放疗后使用度伐利尤单抗巩固治疗是有效且可耐受的。
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