Cancer Treatment

Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer

In a recent publication in the New England Journal of Medicine, investigators tested the efficacy and safety of osimertinib in the adjuvant setting for EGFR mutated non-small cell lung cancer. The study was a double-blind, phase 3 clinical trial, which randomly assigned patients with completely resected EGFR mutated non-small cell lung cancer in a one-to-one fashion to either 80 mg daily osimertinib or placebo. Patients were treated for up to 3 years. The primary endpoint was disease free survival, in patients with stage II to stage IIIa disease. The secondary endpoints included overall survival, safety, and disease-free survival in the overall population of patients with stage Ib to stage IIIa disease. 682 patients were randomized. The osimertinib arm included 339 patients while the placebo group had 343 patients. At the 2-year mark, 90% of patients with stage II to stage III disease in the osimertinib arm and 44% of those in the placebo arm were alive and disease-free. The overall hazard ratio for disease recurrence or death was 0.17, p-value < 0.001 , with a confidence interval of 0.11–0.26. In the overall population, 89% in the treatment arm and 52% in the placebo arm were alive and disease-free at 24 months. The overall hazard ratio for disease recurrence or death was 0.20, with a p-value < 0.001 with a confidence interval of 0.14–0.30. At 24 months, 90% of patients in the osimertinib group, and 85% of those in the placebo group were alive and did not have central nervous system disease, with a hazard ratio for disease recurrence or death of 0.18. The investigators concluded that for patients with EGFR mutated stage Ib to stage IIIa non-small cell lung cancer, disease-free survival was significantly longer among those who are treated with osimertinib and placebo.

https://www.nejm.org/doi/full/10.1056/NEJMoa2027071?query=featured_hematology-oncology

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