Morikawa Naoto, Minegishi Yuji, Inoue Akira, Maemondo Makoto, Kobayashi Kunihiko, Sugawara Shunichi, Harada Masao, Hagiwara Koichi, Okinaga Shoji, Oizumi Satoshi, Nukiwa Toshihiro, Gemma Akihiko
Iwate Medical University School of Medicine, Division of Pulmonary Medicine, Allergy, and Rheumatology, Department of Internal Medicine , 19-1 Uchimaru, Morioka, Iwate 020-8505 , Japan +81 19 651 5111 (ext. 2334) ; +81 19 626 8040 ;
Expert Opin Pharmacother. 2015 Mar;16(4):465-72. doi: 10.1517/14656566.2015.1002396. Epub 2015 Jan 19.
To assess outcomes of elderly patients with advanced NSCLC harboring an EGFR mutation treated with gefitinib, as well as safety and impact on quality of life (QoL).
We performed a retrospective analysis of pooled data from one Phase III and two Phase II studies of 71 patients aged ≥ 70 years with a performance status of 0 - 2. The main outcome measures were progression-free survival (PFS), overall survival (OS) and response rate (RR), as well as incidence of adverse events and time to 9.1% deterioration in QoL.
Median PFS (14.3 vs 5.7 months, p < 0.001) and overall RR (73.2 vs 26.5%, p < 0.001) in the gefitinib group were superior to those in the standard chemotherapy group, whereas median OS was not significantly different (30.8 vs 26.4 months, p = 0.42). Elevation of aspartate transaminase and/or alanine transaminase (18.3%) was the most common adverse event, and one treatment-related death (pneumonitis) occurred. Time to 9.1% deterioration in the QoL domains of pain and dyspnea, anxiety, and daily functioning was similar between the two age groups.
First-line gefitinib is efficacious with acceptable toxicity in relatively fit elderly patients with advanced NSCLC harboring an EGFR mutation.
评估吉非替尼治疗携带表皮生长因子受体（EGFR）突变的晚期非小细胞肺癌（NSCLC）老年患者的疗效、安全性及对生活质量（QoL）的影响。
我们对一项III期和两项II期研究的汇总数据进行了回顾性分析，这些研究纳入了71例年龄≥70岁、体能状态为0 - 2的患者。主要结局指标为无进展生存期（PFS）、总生存期（OS）和缓解率（RR），以及不良事件发生率和生活质量恶化9.1%的时间。
吉非替尼组的中位PFS（14.3个月对5.7个月，p < 0.001）和总缓解率（73.2%对26.5%，p < 0.001）优于标准化疗组，而中位OS无显著差异（30.8个月对26.4个月，p = 0.42）。最常见的不良事件是天门冬氨酸转氨酶和/或丙氨酸转氨酶升高（18.3%），发生了1例与治疗相关的死亡（肺炎）。两个年龄组在疼痛、呼吸困难、焦虑和日常功能等生活质量领域恶化9.1%的时间相似。
对于相对健康、携带EGFR突变的晚期NSCLC老年患者，一线使用吉非替尼有效且毒性可接受。
