Randomized controlled trial of icotinib concurrent with thoracic radiotherapy for treating advanced non-small cell lung cancer (NSCLC)

Objective To compare the efficacy and safety of icotinib therapy alone versus icotinib combined with thoracic radiotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) patients with an activating epidermal growth factor receptor (EGFR) gene mutation. Methods A total of 83 patients with advanced NSCLC harboring an activating EGFR gene mutation was enrolled in this study. All the patients were randomly divided into 2 groups. Patients in group A (n=41) received thoracic radiotherapy (prescribed at 60-66 Gy) combined with icotinib (three times per day, 125 mg once). Patients in group B (n=42) were given icotinib therapy alone (three times per day, 125 mg once). Treatment was continued until disease progression or unacceptable toxicity or death. The primary end points were median progression-free survival (mPFS) and 12 month-PFS rate. The secondary end points included objective response rate (ORR), disease control rate (DCR) and adverse events. Results With a median follow-up of 18.2 months, mPFS was 15.2 months (95% CI : 12.2-17.4) in group A and 13.2 months (95% CI : 10.8-14.9) in group B (χ2=4.29, P=0.036). PFS rates of 12 months for group A and group B were 70.3% and 61.2%, respectively. The ORR were 78.0% vs. 57.1% (χ2=5.16, P=0.028), and the DCR were 95.1% vs. 92.9% (P>0.05) in groups A and group B, respectively. No grade 3-4 adverse events was observed in both groups except the rashes (4 cases in each group). Besides, 10 patients had grade 1-2 radiation-related pneumonitis and 15 patients suffered grade 1-2 radiation-related oesophagitis in group A. Conclusions In advanced NSCLC patients with an activating EGFR gene mutation, the combination of thoracic radiotherapy and icotinib had achieved an improvement on ORR and PFS with good tolerance. Clinical trial registration Chinese clinical trial registry, ChiCTR-INR-16010262. Key words: Non-small cell lung cancer; EGFR; Mutation; Icotinib; Thoracic radiotherapy