Efficacy in patients with <i>EGFR</i>-positive non-small-cell lung cancer treated with dacomitinib who had skin adverse events: <i>post hoc</i> analyses from ARCHER 1050
Creators: name: Pu, Xingxiang
name: Li, Juan
name: Zhang, Bo
name: Zhang, Jinyao
name: Mok, Tony S K
name: Nakagawa, Kazuhiko
name: Rosell, Rafael
name: Cheng, Ying
name: Zhou, Xiangdong
name: Miglorino, Maria Rita
name: Niho, Seiji
name: Lee, Ki Hyeong
name: Corral, Jesus
name: Pluzanski, Adam
name: Li, Junling
name: Linke, Rolf
name: Pan, Fang
name: Tang, Yiyun
name: Tan, Weiwei
name: Wu, Lin
Publisher: name: Taylor & Francis
Year: 2024
Subjects: subject: Medicine
subject: Pharmacology
subject: Biotechnology
subject: Immunology
subject: FOS: Clinical medicine
subject: Biological Sciences not elsewhere classified
subject: Developmental Biology
subject: Cancer
subject: Science Policy
subject: Virology

description: <b>Aim:</b> We investigated association between skin adverse events (AEs) and efficacy with dacomitinib in patients with <i>EGFR</i>-positive non-small-cell lung cancer (NSCLC). <b>Methods:</b><i>Post hoc</i> analyses from ARCHER 1050 evaluated efficacy in patients who did and did not experience grade ≥2 skin AEs with dacomitinib. Landmark analyses were performed at 3 and 6 months. <b>Results:</b> In patients who had skin AEs (72.2%) vs. those who did not (27.7%), median progression-free survival was 16.0 vs. 9.2 months, median overall survival (OS) was 37.7 vs. 21.6 months, and objective response rate was 80.2 vs. 61.5%; OS was improved at 3 and 6 months landmark analyses. <b>Conclusion:</b> Presence of grade ≥2 skin AEs was associated with numerically improved efficacy and represents a valuable biomarker of treatment outcome with dacomitinib in patients with advanced NSCLC. <b>Clinical Trial Registration:</b>NCT01774721 (ClinicalTrials.gov) The ARCHER 1050 study assessed how the drugs called dacomitinib and gefitinib affected people with non-small-cell lung cancer (NSCLC) who had mutations in the <i>EGFR</i> gene. In this study, people who were treated with dacomitinib lived longer without their cancer getting worse than people who were treated with gefitinib. Skin adverse reactions were higher in people who were treated with dacomitinib than gefitinib. In this follow-up analysis, researchers wanted to see if the treatment effect of dacomitinib was different between people who had skin adverse reactions and people who did not have skin adverse reactions after treatment with dacomitinib. The results from this analysis showed that after treatment with dacomitinib, half of the people who had skin adverse reactions lived for 16.0 months, and half of the people who did not have skin adverse reactions lived for 9.2 months without their cancer getting worse. This study also showed that half of the people who had skin adverse reactions lived for 37.7 months, and half of the people who did not have skin adverse reactions lived for 21.6 months. In summary, the results from this study showed that the treatment effect of dacomitinib was better in people who had skin adverse reactions after treatment with dacomitinib. Therefore, skin adverse reactions can be a marker of better treatment effect in people with NSCLC who had mutations in the <i>EGFR</i> gene when treated with dacomitinib. In the Phase III ARCHER 1050 study, dacomitinib showed improved progression-free survival vs. gefitinib in patients with <i>EGFR</i>-positive non-small-cell lung cancer (NSCLC). The association between the presence of skin-related adverse events (AEs) and improved efficacy of EGFR tyrosine kinase inhibitors was assessed. The presence of grade ≥2 skin AEs was associated with numerically improved efficacy in patients treated with dacomitinib. Skin AEs may represent a clinically valuable biomarker of treatment outcome in patients with advanced NSCLC treated with dacomitinib.