Tata Memorial Hospital, Parel, Maharashtra, India.
Tata Memorial Hospital, Parel, Maharashtra, India.
Clin Lung Cancer. 2022 Jul;23(5):410-418. doi: 10.1016/j.cllc.2022.04.002. Epub 2022 Apr 30.
Plasma cfDNA-based mutation analysis has shown disease-monitoring potential in various cancers. We assessed the potential of cfDNA-based EGFR mutation testing as a monitoring tool in patients with NSCLC.
Patients with NSCLC harboring EGFR mutations receiving first-line treatment as per institutional protocol were enrolled. EGFR mutation status was determined using plasma samples at baseline and post treatment initiation. Patients in whom EGFR mutation was detected or persisted after treatment initiation were considered circulating tumor DNA (ctDNA)-positive. Progression-free survival (PFS) and overall survival (OS) for ctDNA-positive and negative patients post treatment initiation were the primary endpoints; concordance for baseline EGFR status between tissue and plasma and proportion of patients who were ctDNA-positive post treatment initiation were the secondary endpoints.
We enrolled 158 patients; 76 received gefitinib, and 82 received gefitinib plus chemotherapy. Median follow-up duration was 42 months. About 25% of patients were ctDNA-positive post treatment initiation. Median PFS for ctDNA-negative patients post treatment initiation was 14 (95% confidence interval [CI], 12.0-17.0) months, while that for ctDNA-positive patients was 8 (95% CI, 6.0-10.0) months. Median OS for ctDNA-negative patients post treatment initiation was 27 (95% CI, 24.0-32.0) months, while that for ctDNA-positive patients was 15 (95% CI, 11.0-19.0) months. Concordance at baseline between tissue and plasma samples was 75.4%.
Plasma-based EGFR mutation detection post treatment initiation can be used as a predictive marker for outcome in patients with EGFR-mutant NSCLC receiving first-line treatment.
基于血浆 cfDNA 的突变分析已显示出在各种癌症中具有疾病监测潜力。我们评估了基于 cfDNA 的 EGFR 突变检测作为非小细胞肺癌（NSCLC）患者监测工具的潜力。
我们招募了接受机构治疗方案一线治疗的 EGFR 突变型 NSCLC 患者。在基线和治疗开始后使用血浆样本确定 EGFR 突变状态。在治疗开始后检测到 EGFR 突变或持续存在的患者被认为是循环肿瘤 DNA（ctDNA）阳性。治疗开始后 ctDNA 阳性和阴性患者的无进展生存期（PFS）和总生存期（OS）是主要终点；基线时组织和血浆 EGFR 状态的一致性以及治疗开始后 ctDNA 阳性患者的比例是次要终点。
我们共招募了 158 名患者；其中 76 名接受吉非替尼治疗，82 名接受吉非替尼联合化疗。中位随访时间为 42 个月。约 25%的患者在治疗开始后为 ctDNA 阳性。治疗开始后 ctDNA 阴性患者的中位 PFS 为 14 个月（95%置信区间[CI]，12.0-17.0），而 ctDNA 阳性患者为 8 个月（95% CI，6.0-10.0）。治疗开始后 ctDNA 阴性患者的中位 OS 为 27 个月（95% CI，24.0-32.0），而 ctDNA 阳性患者为 15 个月（95% CI，11.0-19.0）。基线时组织和血浆样本的一致性为 75.4%。
治疗开始后基于血浆的 EGFR 突变检测可作为接受一线治疗的 EGFR 突变型 NSCLC 患者预后的预测标志物。
