The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study

Xingsheng Hu, Li Zhang, Yuankai Shi, Caicun Zhou, Xiaoqing Liu, Dong Wang, Yong Song, Qiang Li, Jifeng Feng, Shukui Qin, Nong Xv, Jianying Zhou, Li Zhang, Chunhong Hu, Shucai Zhang, Rongcheng Luo, Jie Wang, Fenlai Tan, Yinxiang Wang, Lieming Ding, Yan Sun, Xingsheng Hu, Li Zhang, Yuankai Shi, Caicun Zhou, Xiaoqing Liu, Dong Wang, Yong Song, Qiang Li, Jifeng Feng, Shukui Qin, Nong Xv, Jianying Zhou, Li Zhang, Chunhong Hu, Shucai Zhang, Rongcheng Luo, Jie Wang, Fenlai Tan, Yinxiang Wang, Lieming Ding, Yan Sun

Abstract

Background: Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.

Methods: Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125 mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety.

Results: From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9-6.6 m) and 5.4 months (95%CI 3.1-7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127).

Conclusions: In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy.

Trial registration: ClinicalTrials.gov NCT02486354.

Conflict of interest statement

Competing Interests: The authors of this manuscript have the following competing interests: Fenlai Tan, Yinxiang Wang, and Lieming Ding are salaried employees of Betta Pharmaceuticals Co, Ltd. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials. All other authors had no competing interests.

Figures

Fig 1. Study profile.
Fig 1. Study profile.
Fig 2. Kaplan-Meier analysis of primary and…
Fig 2. Kaplan-Meier analysis of primary and secondary endpoints in full-analysis set (FAS).
Kaplan-Meier curves for progression-free survival (A), time to progression (B), and overall survival (C).

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