Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China.
Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.
J Clin Oncol. 2019 Sep 1;37(25):2235-2245. doi: 10.1200/JCO.19.00075. Epub 2019 Jun 13.
To assess the benefits of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors as neoadjuvant/adjuvant therapies in locally advanced mutation-positive non-small-cell lung cancer.
This was a multicenter (17 centers in China), open-label, phase II, randomized controlled trial of erlotinib versus gemcitabine plus cisplatin (GC chemotherapy) as neoadjuvant/adjuvant therapy in patients with stage IIIA-N2 non-small-cell lung cancer with mutations in exon 19 or 21 (EMERGING). Patients received erlotinib 150 mg/d (neoadjuvant therapy, 42 days; adjuvant therapy, up to 12 months) or gemcitabine 1,250 mg/m plus cisplatin 75 mg/m (neoadjuvant therapy, two cycles; adjuvant therapy, up to two cycles). Assessments were performed at 6 weeks and every 3 months postsurgery. The primary end point was objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; secondary end points were pathologic complete response, progression-free survival (PFS), overall survival, safety, and tolerability.
Of 386 patients screened, 72 were randomly assigned to treatment (intention-to-treat population), and 71 were included in the safety analysis (one patient withdrew before treatment). The ORR for neoadjuvant erlotinib versus GC chemotherapy was 54.1% versus 34.3% (odds ratio, 2.26; 95% CI, 0.87 to 5.84; = .092). No pathologic complete response was identified in either arm. Three (9.7%) of 31 patients and zero of 23 patients in the erlotinib and GC chemotherapy arms, respectively, had a major pathologic response. Median PFS was significantly longer with erlotinib (21.5 months) versus GC chemotherapy (11.4 months; hazard ratio, 0.39; 95% CI, 0.23 to 0.67; < .001). Observed adverse events reflected those most commonly seen with the two treatments.
The primary end point of ORR with 42 days of neoadjuvant erlotinib was not met, but the secondary end point PFS was significantly improved.
评估表皮生长因子受体（EGFR）酪氨酸激酶抑制剂作为局部晚期突变阳性非小细胞肺癌新辅助/辅助治疗的获益。
这是一项在中国的 17 个中心进行的多中心、开放性、Ⅱ期、随机对照试验，评估厄洛替尼对比吉西他滨联合顺铂（GC 化疗）作为 IIIA-N2 期非小细胞肺癌（存在 EGFR 外显子 19 或 21 突变）患者新辅助/辅助治疗的疗效。患者接受厄洛替尼 150 mg/d（新辅助治疗，42 天；辅助治疗，最长 12 个月）或吉西他滨 1250 mg/m²联合顺铂 75 mg/m²（新辅助治疗，两个周期；辅助治疗，最多两个周期）。在手术后 6 周和每 3 个月进行评估。主要终点是根据实体瘤反应评估标准 1.1（RECIST）版评估的客观缓解率（ORR）；次要终点是病理完全缓解率、无进展生存期（PFS）、总生存期、安全性和耐受性。
在 386 例筛选患者中，72 例被随机分配至治疗组（意向治疗人群），71 例纳入安全性分析（1 例患者在治疗前退出）。新辅助厄洛替尼对比 GC 化疗的 ORR 为 54.1%比 34.3%（优势比，2.26；95%CI，0.87 至 5.84；=.092）。两臂均未发现病理完全缓解。厄洛替尼组有 3 例（9.7%）和 GC 化疗组有 0 例（0%）患者发生主要病理缓解。厄洛替尼组的中位 PFS 明显长于 GC 化疗组（21.5 个月比 11.4 个月；风险比，0.39；95%CI，0.23 至 0.67；＜.001）。观察到的不良事件反映了两种治疗方法最常见的不良事件。
新辅助厄洛替尼 42 天的主要终点 ORR 未达到，但次要终点 PFS 显著改善。
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