2026-04-13T07:12:38Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/139092025-10-24T02:03:14Zcom_2072_378070com_2072_378040col_2072_378092

urn:hdl:11351/13909 Neoadjuvant Osimertinib for Resectable EGFR-Mutated Non–Small Cell Lung Cancer He, Jianxing Tsuboi, Masahiro Weder, Walter Chen, Keneng Hochmair, Maximilian Shih, Jin-Yuan MARTINEZ-MARTI, ALEX Pulmons - Càncer - Tractament Quimioteràpia combinada Anomalies cromosòmiques Medicaments antineoplàstics - Ús terapèutic ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols PHENOMENA AND PROCESSES::Genetic Phenomena::Genetic Variation::Mutation ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Combined Modality Therapy::Neoadjuvant Therapy DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Carcinoma, Non-Small-Cell Lung Other subheadings::Other subheadings::Other subheadings::/drug therapy TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada FENÓMENOS Y PROCESOS::fenómenos genéticos::variación genética::mutación TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::tratamiento combinado::tratamiento neoadyuvante ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia Neoadjuvant; Resectable; Non-small cell lung cancer Neoadyuvante; Resecable; Cáncer de pulmón de células no pequeñas Neoadjuvant; Resecable; Càncer de pulmó de cèl·lules no petites Purpose: Adjuvant osimertinib is the standard of care for patients with resected epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Neoadjuvant treatment could improve surgical and long-term outcomes. Methods: In this randomized, controlled, phase III study, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC were randomly assigned (1:1:1) to receive neoadjuvant osimertinib (80 mg orally once daily for ≥9 weeks) plus platinum-based chemotherapy (once every 3 weeks for three cycles), osimertinib monotherapy (for ≥9 weeks), or placebo plus platinum-based chemotherapy (control), followed by surgical resection. Adjuvant osimertinib was offered to eligible patients after completion of surgery. The primary end point was major pathologic response (MPR) by blinded central pathology review. Event-free survival (EFS) was a secondary end point. Results: Overall, 358 patients were randomly assigned to receive osimertinib plus chemotherapy (121 patients), osimertinib monotherapy (117 patients), or placebo plus chemotherapy (120 patients). Osimertinib plus chemotherapy (MPR rate 26%) and osimertinib monotherapy (25%) demonstrated statistically significant improvement in the MPR rate versus placebo plus chemotherapy (2%), with corresponding odds ratios of 19.82 (95.002% CI, 4.60 to 85.33; P < .0001) and 19.28 (99.9% CI, 1.71 to 217.39; P < .0001), respectively. With 15% data maturity, the EFS rates at 12 months were 93%, 95%, and 83% with osimertinib plus chemotherapy, osimertinib monotherapy, and placebo plus chemotherapy, respectively. In the neoadjuvant period, grade ≥3 adverse events of any cause occurred in 36%, 13%, and 33% of patients with osimertinib plus chemotherapy, osimertinib monotherapy, and placebo plus chemotherapy, respectively. No new safety concerns were identified. Conclusion: Neoadjuvant osimertinib with or without chemotherapy demonstrated statistically significant improvement in the MPR rate over chemotherapy alone in patients with resectable, EGFR-mutated, stage II-IIIB NSCLC. Trial registration: ClinicalTrials.gov NCT04351555. J.E.C. acknowledges the support of the National Institutes of Health (NIH) through the P30 grant (NCI Cancer Center Support Grant P30 CA008784 PI Vickers). The authors acknowledge Aaron Korpal, PhD, of Ashfield MedComms, an Inizio company, for medical writing support that was funded by AstraZeneca in accordance with Good Publications Practice (GPP) guidelines (https://www.ismpp.org/gpp-2022). A complete list of the NeoADAURA trial investigators is provided in the Appendix (online only). 2025-10-22T09:28:36Z 2025-10-22T09:28:36Z 2025-09-10 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Journal of Clinical Oncology;43(26) https://doi.org/10.1200/JCO-25-00883 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess American Society of Clinical Oncology Scientia