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一线奥希替尼治疗 EGFR 突变阳性非小细胞肺癌伴差一般状况患者:一项前瞻性观察研究。

First-line osimertinib for poor performance status patients with EGFR mutation-positive non-small cell lung cancer: A prospective observational study.

机构信息

Department of Respiratory Medicine, Kitasato University School of Medicine, Sagamihara-city, Kanagawa, Japan.

Kitasato University School of Nursing, Sagamihara-city, Kanagawa, Japan.

出版信息

Invest New Drugs. 2022 Apr;40(2):430-437. doi: 10.1007/s10637-021-01195-2. Epub 2021 Nov 22.

Abstract

OBJECTIVE

The clinical outcomes of poor performance status (PS) patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who are treated with osimertinib as a first-line treatment have not been sufficiently evaluated. This study aimed to assess the efficacy and safety of osimertinib in chemotherapy-naive and poor PS (2 or more) patients with NSCLC harboring sensitive EGFR mutations.

MATERIALS AND METHODS

We assessed the clinical effects of osimertinib as a first-line treatment for patients with poor PS NSCLC with an exon 19 deletion or exon 21 L858R mutation in EGFR. All patients were administered osimertinib (80 mg/day) as the initial treatment.

RESULTS

Sixteen patients (nine women and seven men) who were treated between August 2018 and July 2021 were included in this study; their median age was 78 years. The overall objective response rate was 56.3%. The median progression-free survival (PFS) of the entire patient population was 10.5 months and the PS score improved in 8 of 16 patients (50%). The most common adverse event was acneiform rash (42%), followed by diarrhea (36%) and paronychia (36%); none of these were of grade ≥ 3. Interstitial lung disease occurred in 2 patients (12.5%); however, no treatment-related deaths occurred.

CONCLUSION

Considering the findings of this study, osimertinib appears to be an effective and safe treatment option for patients with poor PS and advanced NSCLC harboring sensitive EGFR mutations. To obtain conclusive results, further studies with larger cohorts are warranted.

摘要

目的

对于接受奥希替尼作为一线治疗的表皮生长因子受体(EGFR)突变型非小细胞肺癌(NSCLC)且表现状态(PS)较差的患者,其临床结局尚未得到充分评估。本研究旨在评估奥希替尼在未经化疗且 PS 较差(2 或更高)的 EGFR 敏感突变型 NSCLC 患者中的疗效和安全性。

材料与方法

我们评估了奥希替尼作为 PS 较差(2 或更高)的 EGFR 外显子 19 缺失或外显子 21 L858R 突变型 NSCLC 患者一线治疗的临床效果。所有患者均接受奥希替尼(80mg/天)作为初始治疗。

结果

本研究共纳入 2018 年 8 月至 2021 年 7 月期间接受治疗的 16 例患者(9 名女性和 7 名男性);中位年龄为 78 岁。总体客观缓解率为 56.3%。全患者人群的中位无进展生存期(PFS)为 10.5 个月,16 例患者中有 8 例(50%)PS 评分改善。最常见的不良反应是痤疮样皮疹(42%),其次是腹泻(36%)和甲沟炎(36%);均无 3 级及以上不良反应。2 例(12.5%)患者出现间质性肺病;但无治疗相关死亡。

结论

考虑到本研究的结果,奥希替尼似乎是 PS 较差且晚期 EGFR 敏感突变型 NSCLC 患者的一种有效且安全的治疗选择。为获得更确凿的结果,需要进一步开展更大样本量的研究。

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