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Icotinib, an EGFR tyrosine kinase inhibitor, 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)

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Summary

The survival benefit of icotinib (an oral epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor) in patients with advanced lung cancer has been confirmed in several studies. This study (ICAPE) evaluated the efficacy of icotinib as adjuvant therapy for patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma. 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. The primary endpoint was disease-free survival (DFS). 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). No significant difference was found in the median DFS according to EGFR mutation types. Icotinib as adjuvant therapy demonstrated a favorable survival benefit in patients with stage IIA-IIIA EGFR-mutant non-small-cell lung adenocarcinoma, indicating that icotinib might be a promising treatment option for this patient population. The optimal adjuvant duration of icotinib is still not clear and needs more incoming data to answer.

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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

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    Authors and Affiliations

    1. Department of Thoracic Surgery, Xuanwu Hospital, Capital Medical University, No. 45, Changchun Street, Xicheng District, 100053, Beijing, China

      Kun Qian & Yi Zhang

    2. Department of Thoracic Surgery, Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

      Qi-Rui Chen

    3. Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

      Ming He

    4. Department of Thoracic Surgery, Beijing Chest Hospital, Capital Medical University, Beijing, China

      Zi-Tong Wang

    5. Second Department of Thoracic Surgery, Handan Central Hospital, East District, Handan, Hebei, China

      Yu Liu

    6. Department of Thoracic Surgery, The First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China

      Hua-Gang Liang

    7. Department of Thoracic Surgery, Affiliated Hospital of Chifeng University, Chifeng, Neimenggu, China

      Zhi-Yong Su

    8. Department of Thoracic Surgery, Peking Union Medical College Hospital, Beijing, China

      Yu-Shang Cui

    9. Department of Thoracic Surgery, Hebei Province People’s Hospital, Shijiazhuang, Hebei, China

      Li-Jun Liu

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    Contributions

    Conception and design, Y.Z., K.Q., and Q.C.; Provision of study materials or patients, K.Q., Q.C., M.H., Z.W., Y.L., H.L., Z.S., Y.C., and L.L.; Collection and assembly of data, K.Q., Q.C., M.H., Z.W., Y.L., H.L., Z.S., Y.C., and L.L.; Data analysis and interpretation, Y.Z., K.Q. and Q.C.; Drafting article, Y.Z., K.Q. and Q.C.; Administrative support, Y.Z. All the authors have read and approved the final manuscript.

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    Correspondence to Yi Zhang.

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    Ethics approval and consent to participate

    This trial is conducted by the Declaration of Helsinki and Good Clinical Practice Guidelines, and approved by the ethics committee institutional review board of Xuanwu Hospital, Capital Medical University (number: 2015002).

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    All patients have signed the informed consent.

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    Qian, K., Chen, QR., He, M. et al. Icotinib, an EGFR tyrosine kinase inhibitor, 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). Invest New Drugs 41, 44–52 (2023). https://doi.org/10.1007/s10637-022-01316-5

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