Icotinib in patients with pretreated advanced esophageal squamous cell Carcinoma with EGFR overexpression or EGFR gene amplification: A single-arm, multicenter phase 2 study

Jing Huang, Qingxia Fan, Ping Lu, Jianming Ying, Changwu Ma, Wei Liu, Ying Liu, Fenlai Tan, Yan Sun

Research output: Contribution to journalArticlepeer-review

39 Scopus citations

Abstract

Introduction: Epidermal growth factor receptor (EGFR) has been reported to be overexpressed and amplified in a high percentage of patients with esophageal squamous cell carcinoma (ESCC). The activity of icotinib, an EGFR tyrosine kinase inhibitor, was assessed in previously treated ESCC with EGFR overexpression or amplification. Methods: For this phase 2, single-arm, multicenter trial undertaken at six hospitals in China, we included Chinese patients with previously treated, histologically confirmed advanced ESCC and EGFR overexpression (immunohistochemical staining sore of 3+) or amplification (positive fluorescence in situ hybridization result). These patients received oral icotinib (250 mg, three times daily).The primary end point was the proportion of patients with objective responses as assessed by an independent radiology review committee. Results: Between December 5, 2013, and May 28, 2015, a total of 281 patients were screened. Fifty-four eligible patients were enrolled. Nine responses were observed, including one complete response and eight partial responses, and 16 patients had stable disease, resulting in a 16.7% objective response rate (95% confidence interval [CI]: 6.7-26.6) and 46.3% disease control rate (95% CI: 33.0-59.6). The median progression-free survival and overall survival times were 52 (95% CI: 40-95) days and 153 (95% CI: 139-218) days, respectively. A total of 43 patients experienced at least one adverse event, but most were only grade 1 to 2 in severity. The most frequent was rash (48.1%), followed by diarrhea (22.2%). Conclusions: Icotinib showed favorable activity in patients with advanced, previously treated ESCC with EGFR overexpression or amplification. These findings suggest further research into EGFR overexpression or amplification for selecting responsive patients.

Original languageEnglish
Pages (from-to)910-917
Number of pages8
JournalJournal of Thoracic Oncology
Volume11
Issue number6
DOIs
StatePublished - 2016

Keywords

  • EGFR amplification
  • EGFR overexpression
  • Esophageal carcinoma
  • Icotinib
  • Squamous cell carcinoma

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