Abstract

Abstract Introduction: In recent data of ADAURA study, adjuvant osimertinib demonstrated clinically significant improvement in overall survival in completely resected stage IB-IIIA with epidermal growth factor receptor (EGFR)-mutated NSCLC. Among 205 patients who experienced recurrence in the placebo arm, 89.8% of patients received subsequential treatment and 79.0% of patients in the placebo arm received EGFR-TKI after recurrence. Methods: This study included patients with completely resected EGFR-mutated NSCLC who confirmed to pathologic stage II-IIIA between November 2015 and February 2019 at Samsung Medical Center (SMC data). They did not receive adjuvant EGFR-TKI. To compare overall survival between the SMC data and the ADAURA study, the individual patient data (IPD) approach was applied. We assessed the overall survival of individual patient data from real-world experience in comparison to the ADAURA study. Results: A total of 547 patients were included in this study, with 51.0% at stage IB, 23.8% at stage II, and 25.2% at stage IIIA. The median follow-up duration was 71.4 months (range 1-92). At the time of data lock, 241 patients experienced recurrence in the SMC data. Among them, 230 patients (95.4%) received subsequent treatment, and 214 patients (88.8%) received EGFR-TKI after recurrence. In the stage IB and II, there was no difference of overall survival between the SMC data (reference) and the osimertinib arm of the ADAURA study (HR=0.83, 95% CI, 0.36-1.90, p=0.66 in stage IB; HR=1.08, 95% CI, 0.58-2.03, p=0.81 in stage II). However, in the stage IIIA, the 5-year survival rate was 68% in the SMC data and 85% in the osimertinib arm of the ADAURA study (HR=0.42, 95% CI, 0.24-0.73, p<0.01). In the stage IB-IIIA, the 5-year survival rate was 85% in the SMC data (reference), 78% (HR=1.68, 95% CI, 1.25-2.25, p<0.01) in the placebo arm of the ADAURA study, and 88% (HR=0.81, 95% CI, 0.56-1.16, p=0.24) in the osimertinib arm of the ADAURA study. In the stage II-IIIA, the 5-year survival rate was 77% in the SMC data (reference), 73% (HR=1.29, 95% CI, 0.92-1.82, p=0.14) in the placebo arm of the ADAURA study, and 85% (HR=0.62, 95% CI, 0.41-0.93, p= 0.02) in the osimertinib arm of the ADAURA study. Conclusions: In this study, the majority of patients received EGFR-TKIs after recurrence. The 5-year overall survival in the real-world data demonstrated superiority over the placebo arm of the ADAURA study. In stage IB and II disease, there was no significant difference between the SMC data and the osimertinib arm of the ADAURA study. Consequently, patients with pathologic stage IIIA are considered strong candidates for adjuvant osimertinib. Citation Format: Hyun Ae Jung, Junho Lee, Boram Park, Sehhoon Park, Jong-Mu Sun, Se-Hoon Lee, Jin Seok Ahn, Myung-Ju Ahn. Comparison of individual patient data from real-world experience with the ADAURA study for resected stage IB-IIIA EGFR-mutated non-small cell lung cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3830.

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