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Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial
Karen Kelly 1, Nasser K Altorki 2, Wilfried E E Eberhardt 2, Mary E R O'Brien 2, David R Spigel 2, Lucio Crinò 2, Chun-Ming Tsai 2, Joo-Hang Kim 2, Eun Kyung Cho 2, Philip C Hoffman 2, Sergey V Orlov 2, Piotr Serwatowski 2, Jiuzhou Wang 2, Margaret A Foley 2, Julie D Horan 2, Frances A Shepherd 2
RADIANT是一个正在进行的随机双盲对照试验，试验对象为完全手术切除同时表皮生长因子受体(EGFR)高表达(免疫组织化学法或荧光原位杂交法阳性)的Ⅰ、Ⅱ、ⅢA期NSCLC患者，随机分为厄洛替尼治疗组及安慰剂组，本试验拟入组患者945例，以无病生存期(DFS)为评价终点，同时分析EGFR以及其他生物学标志物在预测疗效及预后方面的作用。、
RADIANT试验的研究者调查EGFR阳性表达的可切除NSCLC辅助化疗加用厄洛替尼（erlotinib）疗效是否有所不同。
RADIANT研究是IB-IIIA期NSCLC患者，EGFR表达阳性，术后先予4周期含铂方案化疗，然后厄洛替尼持续两年辅助治疗，主要终点为无疾病生存期。
RADIANT研究评价了厄洛替尼在辅助治疗中的作用，但其结果似不能完全回答辅助靶向治疗是否优于辅助化疗，也难以明确EGFR状态与靶向治疗疗效间的关系。
Purpose: Epidermal growth factor receptor (EGFR) -tyrosine kinase inhibitors have proven efficacy in advanced non-small-cell lung cancer (NSCLC). We hypothesized that erlotinib would be efficacious in the adjuvant setting. Patients and methods: An international randomized, double-blind, placebo-controlled study was conducted in patients with completely resected IB to IIIA NSCLC whose tumors expressed EGFR protein by immunohistochemistry or EGFR amplification by fluorescence in situ hybridization. Patients were assigned 2:1 to erlotinib 150 mg once per day or placebo for 2 years. Stratification factors were stage, histology, previous adjuvant chemotherapy, smoking status, EGFR amplification status, and country. The primary end point was disease-free survival (DFS); key secondary end points were overall survival (OS) and DFS and OS in patients whose tumors had EGFR-activating mutations (EGFRm-positive). Results: A total of 973 patients were randomly assigned (November 26, 2007, to July 7, 2010). There was no statistically significant difference in DFS (median, 50.5 months for erlotinib and 48.2 months for placebo; hazard ratio, 0.90; 95% CI, 0.74 to 1.10; P = .324). Among the 161 patients (16.5%) in the EGFRm-positive subgroup, DFS favored erlotinib (median, 46.4 v 28.5 months; hazard ratio, 0.61; 95% CI, 0.38 to 0.98; P = .039), but this was not statistically significant because of the hierarchical testing procedure. OS data are immature. Rash and diarrhea were common adverse events occurring in 528 (86.4%) and 319 (52.2%) patients treated with erlotinib, respectively, versus 110 (32.1%) and 54 (15.7%) patients receiving placebo. The most common grade 3 adverse events in patients treated with erlotinib were rash (22.3%) and diarrhea (6.2%). Conclusion: Adjuvant erlotinib did not prolong DFS in patients with EGFR-expressing NSCLC or in the EGFRm-positive subgroup. Further evaluation of erlotinib is warranted in the EGFRm-positive subgroup.
Kelly K, Altorki NK, Eberhardt WE, O'Brien ME, Spigel DR, Crinò L, Tsai CM, Kim JH, Cho EK, Hoffman PC, Orlov SV, Serwatowski P, Wang J, Foley MA, Horan JD, Shepherd FA. Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2015 Dec 1;33(34):4007-14. doi: 10.1200/JCO.2015.61.8918. Epub 2015 Aug 31. PMID: 26324372.
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