Adjuvant erlotinib did not prolong-disease-free survival in patients with EGFR-expressing non-small cell lung cancer (NSCLC) or in those whose tumors had EGFR-activating mutations a new study published online ahead of print in the Journal of Clinical Oncology has shown.1
Because previous studies have shown EGFR tyrosine kinase inhibitors to be efficacious for advanced NSCLC, researchers sought to evaluate the impact of erlotinib in the adjuvant setting.
For the international, double-blind, placebo-controlled RADIANT study, researchers enrolled 973 patients with completely resected stage 1B to 3A NSCLC whose tumors expressed EGFR protein. Patients were randomly assigned 2:1 to receive erlotinib 150 mg once daily or placebo for 2 years.
Results showed no statistically significant difference in median disease-free survival (50.5 months with erlotinib vs 48.2 months with placebo; HR = 0.90; 95% CI: 0.74, 1.10; P<.001).
Subgroup analyses demonstrated no statistical significant difference in disease-free survival in patients with EGFR-activating mutations, but researchers found that disease-free survival favored erlotinib.
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In regard to safety, the most common erlotinib-related adverse events were rash and diarrhea. The most common grade 3 adverse events were the same.
The findings suggest that further study of adjuvant erlotinib in patients with EGFR-activating mutations is warranted.
- Kelly K, Altorki NK, Eberhardt WEE, et al. Adjuvant erlotinib versus placebo in patients with stage IB-IIIA non-small-cell lung cancer (RADIANT): a randomized, double-blind, phase III trial [published online ahead of print on August 31, 2015]. J Clin Oncol. doi: 10.1200/JCO.2015.61.8918.