Icotinib demonstrated superior intracranial progression-free survival (iPFS), progression-free survival (PFS), and overall response rate (ORR) with a well-tolerated safety profile compared to whole-brain radiotherapy (WBI) plus chemotherapy among patients with non-small cell lung cancer (NSCLC) and brain metastases, according to results presented at the International Association for the Study of Lung Cancer (IASLC) 17th Annual World Conference on Lung Cancer in Austria.1

WBI is the standard of care for patients with NSCLC and brain metastases, but the median survival is only 4-6 months. Until now, there have been no prospective randomized clinical trials that investigated the efficacy of tyrosine kinase inhibitors (TKIs) on brain metastases.

From December 2012 to June 2015, 176 patients at 17 sites were randomized to receive WBI plus chemotherapy (91 patients) or icotinib (85 patients). The patients’ median age was 58, 87.2% had a performance status assessment of 1, and 70.9% were non-smokers. Most patients had adenocarcinoma and 16.5% had symptomatic brain metastases. Crossover from WBI to icotinib was permitted.

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Patients treated with icotinib had a median iPFS of 10 months and a median PFS of 6.8 months, compared to 4.8 months and 3.4 months, respectively, for those treated with WBI and chemotherapy. Median overall survival (OS) was 18 months for patients treated with icotinib compared to 20.5 months for those treated with WBI and chemotherapy. Intracranial overall response rate (ORR) was 67.1% for those treated with icotinib and 40.9% for WBI plus chemotherapy.

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Grade 3 or higher adverse events (AEs) were reported in 8.2% (7) of patients treated with icotinib and 26.2% (28) treated with WBI plus chemotherapy. The most common AEs in the icotinib arm were increased liver transaminase and rash, and the most common AE in the WBI plus chemotherapy arm was hematologic toxicity.

The authors of the study concluded that icotinib could be considered a treatment option for this patient population.


  1. Wu YL, Yang J, Zhou C, et al. BRAIN: A phase III trial comparing WBI and chemotherapy with icotinib in NSCLC with brain metastases harboring EGFR mutations (CTONG 1201). Paper presented at: International Association for the Study of Lung Cancer 17th World Conference on Lung Cancer; December 2016; Vienna, Austria.