针对HER2突变的非小细胞肺癌(NSCLC)的靶向治疗仍未得到满足。在这项研究中，我们在一项单臂、开放标签的II期研究中评估波齐替尼对HER2外显子20突变晚期NSCLC患者的疗效和安全性。

晚期HER2外显子20突变型非小细胞肺癌患者被纳入接受剂量为16 mg/d的波唑替尼治疗，为期28天。主要终点是RECIST版的客观缓解率。从最初的影像学反应开始至少28天进行确认性扫描。

30名患者接受了波唑替尼治疗。在基线时，90%的患者之前接受过基于铂的化疗，53%的患者之前有两个或更多的系统治疗。截至2021年3月1日数据截止，确认的客观有效率为27% (95% CI, 12 - 46)。在HER2外显子20突变亚型中观察到应答。中位缓解持续时间为5.0个月(95% CI, 4.0至不可估计)。中位无进展生存期为5.5个月(95% CI, 4.0 - 7.0)。中位总生存期为15个月(95% CI, 9.0至不可估计)。最常见的3级治疗相关不良事件是皮疹(47%)和腹泻(20%)。一例肺炎治疗相关死亡。

Abstract

Purpose: Targeted therapies against non-small-cell lung cancer (NSCLC) harboring HER2 mutations remain an unmet need. In this study, we assessed the efficacy and safety of poziotinib in patients with HER2 exon 20 mutant advanced NSCLC in a single-arm, open-label, phase II study.

Patients and methods: Patients with advanced HER2 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.

Results: 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 HER2 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.

Conclusion: Poziotinib showed promising antitumor activity in patients with HER2 exon 20 mutant NSCLC including patients who had previously received platinum-based chemotherapy.

原文链接

pubmed.ncbi.nlm.nih.gov/33843798/

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