Abstract 5499: Efficacy of icotinib as adjuvant therapy for patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma: a multicenter, open-label, single-arm, phase II study (ICAPE)

Abstract

Abstract Background: Currently, epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) have been proved to significantly improve the clinical outcome of patients with EGFR-mutant non-small-cell lung cancer (NSCLC). Icotinib is an oral, reversible and selective first-generation EGFR-TKI. The survival benefits of 1-year and 2-year adjuvant icotinib in patients with EGFR-mutant NSCLC have been confirmed in previous studies. However, the optimal duration of adjuvant icotinib remains unknown. This study (ICAPE) evaluated the efficacy of 1.5-year adjuvant therapy with icotinib for patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma. Methods: Patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma were enrolled in the multicenter, open-label, single-arm, phase II study. Eligible patients received oral icotinib 125 mg thrice daily for 1.5 years after complete surgical resection. Primary endpoint was disease-free survival (DFS). Secondary endpoints included 1-year, 3-year, as well as 5-year OS rates, and the DFS according to the BIM mutation status (mutant-type and wild-type) and EGFR mutation types (19 del and 21 L858R). Results: Between March 2014 and January 2018, 79 patients were enrolled. The median follow-up time was 39.7 months with a median DFS and overall survival (OS) of 41.4 months (95% CI: 33.6-51.8) and 67.0 months (95% CI: 21.2-not reached [NR]), respectively. The 1-year, 3-year and 5-year OS rates were 100%, 83.3%, and 61.7%, respectively. No significant difference was found in the median DFS between patients with Bcl-2 interacting mediator of cell death (BIM) mutant-type and wild-type (NR vs. 41.7 months; p=0.75) and no significant difference was found in the median DFS according to EGFR mutation types (all p>0.05). Conclusions: The phase II ICAPE study demonstrated that 1.5-year adjuvant therapy with icotinib had a favorable survival benefit in patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma with a long median DFS and high 5-year OS rates which is consistent with other icotinib’s study. Icotinib is suggested to be used as an adjuvant therapy option in IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma. Citation Format: Kun Qian, Bin Hu, Ming He, Zi-Tong Wang, Yu Liu, Hua-Gang Liang, Zhi-Yong Su, Yu-Shang Cui, Li-Jun Liu, Yi Zhang. Efficacy of icotinib as adjuvant therapy for patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma: a multicenter, open-label, single-arm, phase II study (ICAPE) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5499.