PDF(Pubmed)
Abstract：
UNASSIGNED: Response rates of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC) to lower doses of osimertinib [20 mg once daily (OD) and 40 mg OD] are similar to those of the recommended dose of 80 mg OD, but there is a lack of real-world evidence on the effect of the lower doses of osimertinib on survival outcomes. We conducted this study to assess the efficacy and safety of lower osimertinib doses for patients with EGFR-mutated advanced NSCLC whose disease had progressed on earlier generation EGFR tyrosine kinase inhibitors (TKIs) in a real-world clinical practice.
UNASSIGNED: This multicenter, retrospective study included patients with EGFR-mutated advanced NSCLC treated with low doses of osimertinib after failing first- or second-generation EGFR TKIs due to acquired T790M mutation. Data on demographics, staging, treatment history, best overall response rate (ORR) based on RECIST 1.1, and adverse events (AEs) were collected from the patients\' case notes. Descriptive data were described in percentages and medians. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method.
UNASSIGNED: Of the 22 patients studied [males =8 and females =14; Eastern Cooperative Oncology Group (ECOG) 1 or 2 =7 and ECOG 3 or 4 =15], 45.5% were on 40 mg OD, 31.8% were on 80 mg every other day (EOD), and 22.7% on 40 mg EOD. First-line EGFR TKIs used included afatinib, erlotinib, and gefitinib. The ORR with lower doses of second-line osimertinib was 77.3%. Overall, the median PFS was 10.0 months [95% confidence interval (CI): 8.6-11.4] and median OS was 13.0 months (95% CI: 9.4-16.6). In patients with ECOG 1 or 2, the median PFS was 18.0 months (95% CI: 5.8-30.2) and the median OS was not reached at the time of analysis. In patients with poor ECOG performance status of 3 and 4, good survival outcomes were also seen with a median PFS of 7.0 months (95% CI: 4.7-9.3) and median OS of 10.0 months (95% CI: 7.5-12.5). All AEs except one case of paronychia were Grade 1. There were no Grade 3 or 4 AEs.
UNASSIGNED: Treatment with low dose osimertinib demonstrated good efficacy and tolerability in EGFR-mutated advanced NSCLC patients who failed first-line treatment with first- or second-generation EGFR TKIs due to T790M mutation.
UNASSIGNED: This multicenter, retrospective study included patients with EGFR-mutated advanced NSCLC treated with low doses of osimertinib after failing first- or second-generation EGFR TKIs due to acquired T790M mutation. Data on demographics, staging, treatment history, best overall response rate (ORR) based on RECIST 1.1, and adverse events (AEs) were collected from the patients\' case notes. Descriptive data were described in percentages and medians. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method.
UNASSIGNED: Of the 22 patients studied [males =8 and females =14; Eastern Cooperative Oncology Group (ECOG) 1 or 2 =7 and ECOG 3 or 4 =15], 45.5% were on 40 mg OD, 31.8% were on 80 mg every other day (EOD), and 22.7% on 40 mg EOD. First-line EGFR TKIs used included afatinib, erlotinib, and gefitinib. The ORR with lower doses of second-line osimertinib was 77.3%. Overall, the median PFS was 10.0 months [95% confidence interval (CI): 8.6-11.4] and median OS was 13.0 months (95% CI: 9.4-16.6). In patients with ECOG 1 or 2, the median PFS was 18.0 months (95% CI: 5.8-30.2) and the median OS was not reached at the time of analysis. In patients with poor ECOG performance status of 3 and 4, good survival outcomes were also seen with a median PFS of 7.0 months (95% CI: 4.7-9.3) and median OS of 10.0 months (95% CI: 7.5-12.5). All AEs except one case of paronychia were Grade 1. There were no Grade 3 or 4 AEs.
UNASSIGNED: Treatment with low dose osimertinib demonstrated good efficacy and tolerability in EGFR-mutated advanced NSCLC patients who failed first-line treatment with first- or second-generation EGFR TKIs due to T790M mutation.
摘要：
表皮生长因子受体（EGFR）突变的晚期非小细胞肺癌（NSCLC）对较低剂量奥希替尼[20mg每日一次（OD）和40mgOD]的反应率与推荐剂量80mgOD的反应率相似。但缺乏较低剂量奥希替尼对生存结局影响的现实证据.我们进行了这项研究，以评估较低剂量奥希替尼对EGFR突变的晚期NSCLC患者的疗效和安全性，这些患者的疾病在现实世界的临床实践中使用了早期的EGFR酪氨酸激酶抑制剂（TKIs）。
■这个多中心，回顾性研究纳入了EGFR突变的晚期NSCLC患者,这些患者接受低剂量奥希替尼治疗后,第一代或第二代EGFRTKIs因获得性T790M突变而失效.人口统计数据，分期,治疗史,基于RECIST1.1的最佳总缓解率(ORR)和不良事件(AE)均来自患者的病例记录.描述性数据以百分比和中位数描述。使用Kaplan-Meier方法计算无进展生存期(PFS)和总生存期(OS)。
■在研究的22例患者中[男性=8，女性=14；东部肿瘤协作组（ECOG）1或2=7，ECOG3或4=15]，45.5%是在40毫克OD，31.8%的人每隔一天服用80毫克(EOD)，40毫克EOD时为22.7%。使用的一线EGFRTKIs包括阿法替尼，厄洛替尼,和吉非替尼.较低剂量的二线奥希替尼的ORR为77.3%。总的来说,中位PFS为10.0个月[95%置信区间(CI):8.6~11.4],中位OS为13.0个月(95%CI:9.4~16.6).在ECOG1或2患者中，中位PFS为18.0个月（95％CI：5.8-30.2），在分析时未达到中位OS。在ECOG表现状态差3和4的患者中，也观察到良好的生存结果，中位PFS为7.0个月（95％CI：4.7-9.3），中位OS为10.0个月（95％CI：7.5-12.5）。除1例甲沟炎外，所有不良事件均为1级。没有3级或4级AE。
低剂量奥希替尼治疗在EGFR突变的晚期NSCLC患者中表现出良好的疗效和耐受性，这些患者因T790M突变而一线治疗第一或第二代EGFRTKIs失败。
■这个多中心，回顾性研究纳入了EGFR突变的晚期NSCLC患者,这些患者接受低剂量奥希替尼治疗后,第一代或第二代EGFRTKIs因获得性T790M突变而失效.人口统计数据，分期,治疗史,基于RECIST1.1的最佳总缓解率(ORR)和不良事件(AE)均来自患者的病例记录.描述性数据以百分比和中位数描述。使用Kaplan-Meier方法计算无进展生存期(PFS)和总生存期(OS)。
■在研究的22例患者中[男性=8，女性=14；东部肿瘤协作组（ECOG）1或2=7，ECOG3或4=15]，45.5%是在40毫克OD，31.8%的人每隔一天服用80毫克(EOD)，40毫克EOD时为22.7%。使用的一线EGFRTKIs包括阿法替尼，厄洛替尼,和吉非替尼.较低剂量的二线奥希替尼的ORR为77.3%。总的来说,中位PFS为10.0个月[95%置信区间(CI):8.6~11.4],中位OS为13.0个月(95%CI:9.4~16.6).在ECOG1或2患者中，中位PFS为18.0个月（95％CI：5.8-30.2），在分析时未达到中位OS。在ECOG表现状态差3和4的患者中，也观察到良好的生存结果，中位PFS为7.0个月（95％CI：4.7-9.3），中位OS为10.0个月（95％CI：7.5-12.5）。除1例甲沟炎外，所有不良事件均为1级。没有3级或4级AE。
低剂量奥希替尼治疗在EGFR突变的晚期NSCLC患者中表现出良好的疗效和耐受性，这些患者因T790M突变而一线治疗第一或第二代EGFRTKIs失败。
