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After surgery for early-stage EGFR-mutated lung cancer, three years of osimertinib cut recurrences by about 80% and later reduced deaths by half.
Double-blind, placebo-controlled phase 3 trial of 682 patients with completely resected stage IB-IIIA EGFR-mutated NSCLC, with or without adjuvant chemotherapy, randomised to three years of osimertinib or placebo. Primary endpoint was disease-free survival in stage II-IIIA.
The trial was unblinded early: DFS HR 0.17 in stage II-IIIA and 0.20 overall, with 24-month DFS 89% vs 52%. The 2023 overall survival report showed 5-year OS 88% vs 78% (HR 0.49). It made adjuvant osimertinib standard and established EGFR testing of resected tumours.
Every resected non-squamous lung cancer should be tested for EGFR mutations, because patients who carry one live longer if they take osimertinib for three years after surgery. The trial does not tell us whether adjuvant chemotherapy can be omitted, nor what happens on relapse after osimertinib, and the three-year duration was chosen empirically.
Adjuvant treatment for lung cancer is now chosen by genotype. A resected ALK-positive tumour is treated with two years of a tablet instead of four cycles of platinum, which is a different life as well as a different outcome.
Stage III lung cancer is now treated by genotype as well as by stage: an EGFR mutation moves a patient from durvalumab consolidation to osimertinib consolidation. It is also the strongest hazard ratio in the lung cancer literature, which is a reason to read the overall survival data carefully when they arrive.
The rule that a patient with a resected stage II or III lung cancer is offered chemotherapy and a patient with a small stage I tumour is not. Everything added to adjuvant treatment since has had to beat, or be added to, this 5 percent.
Shares Shun Lu, Yi-Long Wu, Roy S. Herbst, ADAURA.
Shares Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC, Osimertinib, EGFR-mutated non-small-cell lung cancer, EGFR.
Shares Oncogene addiction, Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch, Osimertinib, EGFR-mutated non-small-cell lung cancer.
Shares Shun Lu, Yi-Long Wu, ADAURA, Non-small-cell lung cancer.
Shares Yi-Long Wu, ADAURA, Oncogene addiction, Osimertinib.
Shares Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group, Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch, Dormant cells and minimal residual disease, Minimal / molecular residual disease (MRD).
Shares Osimertinib, Resectable stage I to III non-small-cell lung cancer, EGFR-mutated non-small-cell lung cancer, AstraZeneca.
Shares Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC, ADAURA, Oncogene addiction, Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch.