In the open-label, single arm, phase 2 SELECT (Surgically Resected EGFR-Mutant Lung Cancer With Adjuvant Erlotinib Cancer Treatment) study of adjuvant erlotinib following adjuvant chemotherapy with or without radiation therapy in patients with resected early-stage, EGFR-mutant non-small cell lung cancer (NSCLC), individuals showed improved 2-year disease-free survival (DFS) compared with genotype-matched historical controls. The trial results were published in the Journal of Clinical Oncology.1
Study-eligible patients had stage IA to IIIA NSCLC characterized by an activating EGFR mutation, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2, and had undergone surgical resection within 6 months or 9 months of enrollment, depending on prior adjuvant therapy (ie, 6 months if only adjuvant chemotherapy received; 9 months if both adjuvant chemotherapy and radiation therapy received). The primary objective of the study was 2-year DFS.
One hundred patients were treated with oral erlotinib once daily at a dose of 150 mg for up to 2 years, and 69% of patients completed at least 22 months of treatment. The median follow-up was 5.2 years, and the 2-year DFS was 88% (95% CI, 80%-93%). DFS and overall survival at 5 years were 56% (95% confidence interval [CI], 45%-66%) and 86% (95% CI, 77%-92%), respectively.
The 2-year DFS of 88% was significantly higher compared with that observed for historical controls (76%) who were not treated with adjuvant erlotinib (P = .0047). Although no grade 4 or grade 5 adverse events were reported, erlotinib dose reductions were required in 40% of patients, with grade 3 rash occurring in 13% of patients.
Of the 40% of patients who developed recurrent disease, the majority experienced disease recurrence following cessation of erlotinib therapy, and responded to retreatment with erlotinib. EGFR testing was possible in 20 of patients with recurrent disease. Whereas the presence of the original EGFR-activating mutation was observed in all of these specimens, an EGFR T790M acquired-resistance mutation was detected in only 1 specimen.
“Ongoing and future randomized trials will formally define the clinical benefit of adjuvant EGFR tyrosine kinase inhibitors” in the setting of early-stage NSCLC, the authors wrote in conclusion.
- Pennell NA, Neal JW, Chaft JE, et al. SELECT: a phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small-cell lung cancer. J Clin Oncol. 2019;37(2):97-104. doi: 10.1200/JCO.18.00131