Original Article
Esophageal
Icotinib in Patients with Pretreated Advanced Esophageal Squamous Cell Carcinoma with EGFR Overexpression or EGFR Gene Amplification: A Single-Arm, Multicenter Phase 2 Study

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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.

Keywords

Esophageal carcinoma
Squamous cell carcinoma
Icotinib
EGFR overexpression
EGFR amplification

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Disclosure: Dr. Tan is a salaried employee of Betta Pharmaceuticals Co., Ltd. The remaining authors declare no conflict of interest.

Clinical Trial Registration: A Phase II, Prospective Study for Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression or Positive FISH as Second-line Treatment. NCT01855854.