Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 510080, Guangzhou, China.
Peking University Cancer Hospital and Institute, 100142, Beijing, China.
Signal Transduct Target Ther. 2023 Feb 24;8(1):76. doi: 10.1038/s41392-022-01286-3.
EMERGING-CTONG 1103 showed improved progression-free survival (PFS) with neoadjuvant erlotinib vs. chemotherapy for patients harbouring EGFR sensibility mutations and R0 resected stage IIIA-N2 non-small cell lung cancer (NSCLC) (NCT01407822). Herein, we report the final results. Recruited patients were randomly allocated 1:1 to the erlotinib group (150 mg/day orally; neoadjuvant phase for 42 days and adjuvant phase to 12 months) or to the GC group (gemcitabine 1250 mg/m plus cisplatin 75 mg/m intravenously; 2 cycles in neoadjuvant phase and 2 cycles in adjuvant phase). Objective response rate (ORR), complete pathologic response (pCR), PFS, and overall survival (OS) were assessed along with safety. Post hoc analysis was performed for subsequent treatments after disease recurrence. Among investigated 72 patients (erlotinib, n = 37; GC, n = 35), the median follow-up was 62.5 months. The median OS was 42.2 months (erlotinib) and 36.9 months (GC) (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.47-1.47; p = 0.513). The 3- and 5-year OS rates were 58.6% and 40.8% with erlotinib and 55.9% and 27.6% with GC (p = 0.819, p = 0.252). Subsequent treatment was administered in 71.9% and 81.8% of patients receiving erlotinib and GC, respectively; targeted therapy contributed mostly to OS (HR, 0.35; 95% CI, 0.18-0.70). After disease progression, the ORR was 53.3%, and the median PFS was 10.9 months during the EGFR-TKI rechallenge. During postoperative therapy, grade 3 or 4 adverse events (AEs) were 13.5% in the erlotinib group and 29.4% in the GC group. No serious adverse events were observed. Erlotinib exhibited clinical feasibility for resectable IIIA-N2 NSCLC over chemotherapy in the neoadjuvant setting.
EMERGING-CTONG 1103 研究表明，与化疗相比，新辅助厄洛替尼可改善携带 EGFR 敏感性突变且 R0 切除的 IIIA-N2 期非小细胞肺癌（NSCLC）患者的无进展生存期（PFS）（NCT01407822）。在此，我们报告最终结果。招募的患者按 1:1 随机分配至厄洛替尼组（150mg/天口服；新辅助阶段 42 天，辅助阶段 12 个月）或 GC 组（吉西他滨 1250mg/m2 加顺铂 75mg/m2 静脉注射；新辅助阶段 2 个周期，辅助阶段 2 个周期）。评估了客观缓解率（ORR）、完全病理缓解（pCR）、PFS 和总生存期（OS）以及安全性。对疾病复发后的后续治疗进行了事后分析。在入组的 72 例患者（厄洛替尼组 n=37，GC 组 n=35）中，中位随访时间为 62.5 个月。中位 OS 为 42.2 个月（厄洛替尼）和 36.9 个月（GC）（风险比[HR]，0.83；95%置信区间[CI]，0.47-1.47；p=0.513）。厄洛替尼组 3 年和 5 年 OS 率分别为 58.6%和 40.8%，GC 组分别为 55.9%和 27.6%（p=0.819，p=0.252）。分别有 71.9%和 81.8%的接受厄洛替尼和 GC 治疗的患者接受了后续治疗；主要是靶向治疗对 OS 有贡献（HR，0.35；95%CI，0.18-0.70）。疾病进展后，ORR 为 53.3%，再次接受 EGFR-TKI 治疗的中位 PFS 为 10.9 个月。在术后治疗期间，厄洛替尼组 3 级或 4 级不良事件（AE）发生率为 13.5%，GC 组为 29.4%。未观察到严重不良事件。与新辅助化疗相比，厄洛替尼在可切除的 IIIA-N2 NSCLC 患者中具有临床可行性。
