Adjuvant treatment with erlotinib may benefit patients with early-stage non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR)-mutation. A new study published in the Journal of Clinical Oncologyhas found that EGFR-mutant early-stage NSCLC patients treated with erlotinib experienced improved 2-year disease-free survival (DFS) rates compared with historic genotype-matched controls.1Researchers found that recurrences were rare for patients receiving adjuvant erlotinib. In addition, the patients rechallenged with erlotinib after recurrence were found to have a durable benefit.
Nathan A. Pennell, MD, PhD, of the Cleveland Clinic Taussig Cancer Institute in Ohio, and colleagues conducted an open-label phase 2 trial that included 100 patients with resected stage IA to IIIA EGFR-mutant NSCLC. All the patients were treated with the small molecule EGFR tyrosine kinase inhibitor (TKI) erlotinib 150 mg per day for 2 years after standard adjuvant chemotherapy with or without radiotherapy. This agent has demonstrated superiority in patients with metastatic lung cancers harboring an EGFRmutation, and it was theorized that erlotinib could help improve outcomes in patients with early-stage EGFR-mutant lung cancer.
The researchers found no unexpected toxicities and there were no grade 4 or 5 adverse events. However, 40% of the patients required a dose reduction to 100 mg per day and 16% had a dose reduction to 50 mg per day. The intended 2-year course was achieved in 69% of patients.
The researchers found that the 2-year DFS rate was 88% (96% stage I, 78% stage II, 91% stage III) at a median follow-up of 5.2 years. The median DFS and overall survival (OS) rates had not been reached at the time of publication. The study showed that the 5-year DFS rate was 56% and the 5-year OS rate was 86%. Disease recurred in 40 patients, but only 4 recurrences were reported during erlotinib treatment. The median time to recurrence was 25 months after stopping erlotinib.
- 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 [published online November 16, 2018]. J Clin Oncol. doi: 10.1200/JCO.18.00131