达克替尼治疗初治晚期 NSCLC 伴非常见 EGFR 突变患者的疗效和安全性：一项前瞻性队列研究。
Efficacy and safety of dacomitinib in treatment-naïve patients with advanced NSCLC harboring uncommon EGFR mutation: an ambispective cohort study.
机构信息
The Second Department of Thoracic Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, 410000, People's Republic of China.
The Department of Radiotherapy, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, 410000, People's Republic of China.
出版信息
BMC Cancer. 2023 Oct 16;23(1):982. doi: 10.1186/s12885-023-11465-2.
BACKGROUND
About 10% of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations are harbored as uncommon mutations. This study aimed to explore the efficacy and safety of dacomitinib, a second-generation EGFR tyrosine kinase inhibitor (EGFR-TKIs), in treating uncommon EGFR-mutated advanced NSCLC.
METHODS
Treatment-naïve advanced NSCLC patients treated with dacomitinib at Hunan Cancer Hospital with uncommon EGFR mutations were evaluated. The primary endpoint was progression-free survival (PFS). Secondary end points included overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety.
RESULT
Between December 2019 and December 2021, a total of 16 patients was included. Median PFS was 14.0 (95% CI 4.32-23.7) months, and median OS was not reached. ORR was 68.8% (95% CI 41.3 to 89.0%) and DCR was 93.8% (95%CI 69.8 to 99.8%), including three achieving complete remission (CR) and eight achieving partial remission (PR). Median PFS for patients with brain metastasis was 9.0 (95%CI 6.9 to 11.1) months. Intracranial ORR was 100%, including 2 CR and 4 PR. Major treatment-related adverse events (TRAEs) included rash (87.5%), paronychia (62.5%), oral ulcers (50.0%), and diarrhea (50.0%), none of which were ≥ grade 3 TRAEs.
CONCLUSIONS
Dacomitinib showed good activity and manageable toxicity in NSCLC patients with uncommon EGFR mutations.
背景
约 10%的表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者存在不常见突变。本研究旨在探索第二代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）达可替尼治疗不常见 EGFR 突变的晚期 NSCLC 的疗效和安全性。
方法
评估在湖南省肿瘤医院接受达可替尼治疗且存在不常见 EGFR 突变的初治晚期 NSCLC 患者。主要终点为无进展生存期（PFS）。次要终点包括总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）和安全性。
结果
2019 年 12 月至 2021 年 12 月期间，共纳入 16 例患者。中位 PFS 为 14.0（95%CI 4.32-23.7）个月，中位 OS 未达到。ORR 为 68.8%（95%CI 41.3 至 89.0%），DCR 为 93.8%（95%CI 69.8 至 99.8%），包括 3 例完全缓解（CR）和 8 例部分缓解（PR）。脑转移患者的中位 PFS 为 9.0（95%CI 6.9 至 11.1）个月。颅内 ORR 为 100%，包括 2 例 CR 和 4 例 PR。主要治疗相关不良事件（TRAEs）包括皮疹（87.5%）、甲沟炎（62.5%）、口腔溃疡（50.0%）和腹泻（50.0%），均无≥3 级 TRAEs。
结论
达可替尼在不常见 EGFR 突变的 NSCLC 患者中显示出良好的疗效和可管理的毒性。
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