A SELECT few.
The Study: Virtually all patients with advanced-stage disease are eligible for a variety of non-cytotoxic systemic therapies. Following geftinib’s success in the post-op adjuvant setting, the phase 2 SELECT trial gives erlotinib a shot in 100 patients with resected stage I-IIIA EGFR-mutant NSCLC. All patients were eligible for and received standard adjuvant chemo with the addition of sequential erlotinib 150 mg daily for up to 2 years. The primary endpoint of disease-free survival (DFS) at 2 years in this single-arm study was planned to be compared to a contemporary published rate of 76% among a similar population treated with adjuvant chemo alone. The rate reported here was indeed significantly higher at 88%. This is in contrast to the RADIANT trial which assessed adjuvant erlotinib given for a median of 12 months to patients with EGFR-amplification by IHC or FISH. Importantly, here only one recurrence was found to have developed a treatment-resistant mutation in EGFR-T790M.
Bottom Line: Patients with resected NSCLC with EGFR-mutations on molecular analysis appear to enjoy prolonged disease control with 2 years of adjuvant erlotinib, similar to with its cousin gefitinib. | Pennell, J Clin Oncol 2018