Zhong et al¹ recently reported the results of the randomized phase II EMERGING-CTONG 1103 trial (ClinicalTrials.gov identifier: NCT01407822) that explored the safety and efficacy of erlotinib compared with gemcitabine plus cisplatin (GC chemotherapy) for neoadjuvant treatment of patients with stage IIIA-N2 non–small-cell lung cancer (NSCLC) with EGFR mutations in exon 19 or 21. The authors randomly assigned patients one of two groups that received either erlotinib 150 mg/day (neoadjuvant therapy, 42 days; adjuvant therapy, up to 12 months) or gemcitabine 1,250 mg/m² plus cisplatin 75 mg/m² (neoadjuvant therapy, two cycles; adjuvant therapy, up to two cycles). They found that the erlotinib group achieved significant improvement in progression-free survival, a secondary end point, but the primary end point of overall response rate (42 days) and another secondary end point, overall survival (OS), were not met. We certainly recognize the clinical relevance of this topic and congratulate the authors for completing this trial. Using EGFR tyrosine kinase inhibitors (TKIs) as neoadjuvant therapy in patients with stage IIIA-N2 NSCLC is important, even though phase III trials of EGFR TKIs for adjuvant therapy have not been significantly superior to chemotherapy.² However, we think there are several key points that require further discussion.

中文翻译：

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EMERGING-CTONG 1103：用于在随机第二阶段试验中获得高质量的证据。

Zhong等人¹最近报道了EMERGING-CTONG 1103随机II期试验的结果（ClinicalTrials.gov标识符：NCT01407822），该试验探讨了厄洛替尼与吉西他滨加顺铂（GC化疗）相比在新辅助治疗分期患者中的安全性和有效性。 IIIA-N2非小细胞肺癌（NSCLC），其外显子19或21有EGFR突变。作者将患者随机分配为两组，两组分别接受150毫克/天的厄洛替尼治疗（新辅助治疗42天；辅助治疗向上）。至12个月）或吉西他滨1,250 mg / m ²加上顺铂75 mg / m ²（新辅助治疗，两个周期；辅助治疗，最多两个周期）。他们发现，厄洛替尼组在无进展生存，次要终点，但总缓解率的主要终点（42天）和另一个次要终点，总生存（OS）方面均取得了显着改善。我们当然认识到该主题的临床意义，并祝贺作者完成了该试验。尽管EGFR TKIs的III期临床试验并未显着优于化疗，但在ⅢA-N2期NSCLC患者中使用EGFR酪氨酸激酶抑制剂（TKIs）作为新辅助治疗很重要。²但是，我们认为有几个关键点需要进一步讨论。