Long-term safety of icotinib in patients with non-small cell lung cancer: a retrospective, real-world study.

ABSTRACT

BACKGROUND: Lung cancer is a global health problem with a high mortality, and the development of target therapy has led to a revolution in the treatment of lung cancer in recent years. Favorable efficacy and safety of icotinib have been demonstrated in patients with non-small cell lung cancer (NSCLC). Currently, minimal data are available to describe the long-term safety of icotinib in NSCLC patients. METHODS: We reviewed the safety data from 1,321 advanced NSCLC patients who were treated with icotinib. The primary endpoint was the long-term safety, defined as any adverse drug reactions (ADRs) occurred after 6 months of icotinib administration. RESULTS: Fewer ADRs were noticed over 6 month administration of icotinib than within 6 months in overall population (24.3% vs. 65.4%), and elderly patients (23.6% vs. 66.9%). The majority of ADRs were grade 1-2 in severity over 6 month exposure of icotinib in overall population as well as elderly patients. In overall population, the most common ADRs of icotinib during long-term use were rash (16.4%) and diarrhea (5.3%), while the incidences were 31.8% and 13.2% in the induction period, respectively. In elderly population, the most common ADRs of icotinib during long-term use were rash (15.7%) and diarrhea (4.7%), while the incidences were 27.8% and 14.9% in the induction period, respectively, and more inching was observed in the induction period as compared with long term use (6.3% vs. 0.3%). CONCLUSIONS: There was an evidence of decreased frequency of icotinib-induced ADRs over time, and icotinib was well-tolerated in elderly NSCLC patients.