Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Department of Thoracic Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX.
J Clin Oncol. 2022 Mar 1;40(7):702-709. doi: 10.1200/JCO.21.01113. Epub 2021 Sep 22.
Targeted therapies against non-small-cell lung cancer (NSCLC) harboring mutations remain an unmet need. In this study, we assessed the efficacy and safety of poziotinib in patients with exon 20 mutant advanced NSCLC in a single-arm, open-label, phase II study.
Patients with advanced exon 20 mutant NSCLC were enrolled to receive poziotinib at a dose of 16 mg/d for 28-day cycles. The primary end point was objective response rate per RECIST version 1.1. Confirmatory scans were performed at least 28 days from initial radiologic response.
Thirty patients received poziotinib treatment. At baseline, 90% of patients received prior platinum-based chemotherapy and 53% had two lines or more prior systemic therapies. As of data cutoff on March 1, 2021, the confirmed objective response rate was 27% (95% CI, 12 to 46). Responses were observed across exon 20 mutation subtypes. The median duration of response was 5.0 months (95% CI, 4.0 to not estimable). The median progression-free survival was 5.5 months (95% CI, 4.0 to 7.0). The median overall survival was 15 months (95% CI, 9.0 to not estimable). The most common grade 3 treatment-related adverse events were skin rash (47%) and diarrhea (20%). There was one possible treatment-related death because of pneumonitis.
Poziotinib showed promising antitumor activity in patients with exon 20 mutant NSCLC including patients who had previously received platinum-based chemotherapy.
针对携带 突变的非小细胞肺癌（NSCLC）的靶向治疗仍然是一个未满足的需求。在这项研究中，我们评估了在一项单臂、开放标签、II 期研究中，波齐替尼在携带 外显子 20 突变的晚期 NSCLC 患者中的疗效和安全性。
招募晚期携带 外显子 20 突变的 NSCLC 患者，接受波齐替尼 16mg/d 的剂量治疗，28 天为一个周期。主要终点是根据 RECIST 版本 1.1 评估的客观缓解率。确认性扫描在初始影像学缓解后至少 28 天进行。
30 名患者接受了波齐替尼治疗。基线时，90%的患者接受了铂类化疗，53%的患者接受了两种或更多的系统治疗。截至 2021 年 3 月 1 日数据截止，确认的客观缓解率为 27%（95%CI，12 至 46）。观察到各种 外显子 20 突变亚型均有缓解。缓解持续时间的中位数为 5.0 个月（95%CI，4.0 至无法估计）。无进展生存期的中位数为 5.5 个月（95%CI，4.0 至 7.0）。总生存期的中位数为 15 个月（95%CI，9.0 至无法估计）。最常见的 3 级治疗相关不良事件是皮疹（47%）和腹泻（20%）。有一例可能与治疗相关的死亡是由于肺炎。
波齐替尼在携带 外显子 20 突变的 NSCLC 患者中表现出有前景的抗肿瘤活性，包括那些先前接受过铂类化疗的患者。
