Igawa Satoshi, Kasajima Masashi, Ono Taihei, Ozawa Takahiro, Kakegawa Mikiko, Kusuhara Seiichiro, Sato Takashi, Nakahara Yoshiro, Fukui Tomoya, Yokoba Masanori, Kubota Masaru, Mitsufuji Hisashi, Sasaki Jiichiro, Naoki Katsuhiko
Department of Respiratory Medicine, Kitasato University School of Medicine, Sagamihara-city, Kanagawa, Japan.
School of Allied Health Sciences, Kitasato University, Sagamihara-city, Kanagawa, Japan.
Cancer Manag Res. 2021 Nov 20;13:8695-8705. doi: 10.2147/CMAR.S339891. eCollection 2021.
The clinical outcomes of elderly patients with -mutated non-small cell lung cancer (NSCLC) who are treated with osimertinib have not been sufficiently evaluated. This study aimed to assess the efficacy and safety of osimertinib in elderly chemotherapy-naive patients with NSCLC harboring sensitive mutations.
We assessed the clinical effects of osimertinib as a first-line treatment for elderly NSCLC patients (≥75 years of age) with an exon 19 deletion or exon 21 L858R mutation in . All patients were administered 80 mg/day osimertinib as initial treatment.
Forty-three patients (24 women and 19 men) with adenocarcinoma who were treated between August 2018 and July 2021 were included in this study; their median age was 79 years (range, 75-90 years). The overall objective response rate was 60.5%. The median progression-free survival (PFS) and time to treatment failure (TTF) of the entire patient population were 22.1 months and 14.6 months, respectively. The most common adverse event was rash acneiform (42%), followed by diarrhea (33%) and paronychia (28%); none of these were grades ≥3. Interstitial lung disease developed in 8 patients (18.6%); however, no treatment-related deaths occurred. Multivariate analysis identified performance status and disease stage as predictors of PFS and TTF.
Considering the findings of this study and despite an observed discordance between PFS and TTF, osimertinib appears to be an effective and safe treatment option in elderly patients with advanced NSCLC harboring sensitive mutations. To obtain conclusive results, further studies in a larger elderly population are warranted.
接受奥希替尼治疗的携带EGFR突变的老年非小细胞肺癌（NSCLC）患者的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的携带敏感EGFR突变的老年NSCLC患者中的疗效和安全性。
我们评估了奥希替尼作为一线治疗对年龄≥75岁、存在EGFR外显子19缺失或外显子21 L858R突变的老年NSCLC患者的临床效果。所有患者初始治疗均给予奥希替尼80mg/天。
本研究纳入了2018年8月至2021年7月期间接受治疗的43例腺癌患者（24例女性和19例男性）；他们的中位年龄为79岁（范围75 - 90岁）。总体客观缓解率为60.5%。整个患者群体的中位无进展生存期（PFS）和至治疗失败时间（TTF）分别为22.1个月和14.6个月。最常见的不良事件是皮疹样痤疮（42%），其次是腹泻（33%）和甲沟炎（28%）；这些均无≥3级。8例患者（18.6%）发生间质性肺病；然而，未发生与治疗相关的死亡。多因素分析确定了体能状态和疾病分期是PFS和TTF的预测因素。
考虑到本研究的结果，尽管观察到PFS和TTF之间存在不一致，但奥希替尼似乎是携带敏感EGFR突变的老年晚期NSCLC患者的一种有效且安全的治疗选择。为获得确凿结果，有必要在更大的老年人群中进行进一步研究。
