Department of Internal Medicine, NHO Kinki Chuo Chest Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai City, 591-8555, Osaka, Japan.
Center for Biomedical Sciences, Wakayama Medical University, Wakayama, Japan.
BMC Pulm Med. 2024 Aug 24;24(1):407. doi: 10.1186/s12890-024-03212-5.
BACKGROUND/AIM: For patients treated with osimertinib as first-line therapy, there have been no studies comparing both progression-free survival (PFS) and overall survival (OS) according to performance status (PS). Furthermore, no studies have examined differences in baseline genetic abnormalities between patients with poor and good PS. Therefore, we aimed to investigate differences in baseline genetic abnormalities and treatment effects between patients with poor and good PS who received osimertinib as the primary treatment.
This is a secondary analysis of the ELUCIDATOR study, which is a multi-center prospective observational study in Japan that assessed mechanisms underlying resistance to osimertinib as first-line treatment for advanced non-small cell lung cancer with epidermal growth factor receptor mutations.
There were 153 and 25 patients in the good and poor PS groups, respectively. Multivariate analysis revealed no significant between-group differences in PFS (hazards ratio [HR]: 0.98, 95% confidence interval [CI]: 0.52-1.72, p = 0.946). Multivariate analysis of OS revealed that poor PS was a poor prognostic factor (HR: 2.67, 95% CI: 1.43-4.73, p = 0.003). Regarding baseline genetic abnormalities, there was a significant increase in APC-positive cases (20.0% vs. 2.2%, p = 0.009) and a trend toward more CTNNB1-positive cases in the poor PS group than in the good PS group (14.3% vs. 2.9%, p = 0.062).
There was no between-group difference in PFS, although OS was significantly inferior in the poor PS group. Additionally, there was a significant increase in APC-positive cases and a trend toward more CTNNB1-positive cases in the poor PS group.
背景/目的:对于接受奥希替尼作为一线治疗的患者,尚无研究根据体能状态(PS)比较无进展生存期(PFS)和总生存期(OS)。此外,尚无研究检查 PS 差和 PS 好的患者之间基线遗传异常的差异。因此,我们旨在研究接受奥希替尼作为一线治疗的 PS 差和 PS 好的患者之间基线遗传异常和治疗效果的差异。
这是 ELUCIDATOR 研究的二次分析,该研究是一项在日本进行的多中心前瞻性观察性研究,评估了表皮生长因子受体突变的晚期非小细胞肺癌患者接受奥希替尼作为一线治疗的耐药机制。
PS 良好组和 PS 不良组分别有 153 例和 25 例患者。多变量分析显示,两组间 PFS 无显著差异(风险比[HR]:0.98,95%置信区间[CI]:0.52-1.72,p=0.946)。OS 的多变量分析表明,PS 不良是一个不良预后因素(HR:2.67,95%CI:1.43-4.73,p=0.003)。关于基线遗传异常,PS 不良组 APC 阳性病例显著增加(20.0%比 2.2%,p=0.009),CTNNB1 阳性病例也有增加趋势(14.3%比 2.9%,p=0.062)。
两组间 PFS 无差异,尽管 PS 不良组 OS 显著降低。此外,PS 不良组 APC 阳性病例显著增加,CTNNB1 阳性病例有增加趋势。