Anlotinib plus icotinib as a potential treatment option for EGFR-mutated advanced non-squamous non-small cell lung cancer with concurrent mutations: final analysis of the prospective phase 2, multicenter ALTER-L004 study

Molecular Cancer

Research

Cuiying Zhang¹  Diansheng Zhong²  Linlin Zhang²  Yan Zhang³  Dingzhi Huang⁴  Xiangli Jiang⁴  Zhujun Liu⁴  Peng Chen⁴  Richeng Jiang⁴  Jingya Wang⁴  Jing Wang⁴  Chun Huang⁴  Yan Liang⁴  Liuchun Wang⁴  Jinliang Chen⁴  Xinyue Wang⁴  Zhaoting Meng⁴  Yanhong Shang⁵ 

[1]Cancer center, Inner Mongolia Autonomous Region People’s Hospital, Huhhot, People’s Republic of China

[2]Department of Medical Oncology, Tianjin Medical University General Hospital, No.154, Anshandao, Heping District, 300052, Tianjin, China

[3]Department of Oncology IV, First Hospital of Shijiazhuang, Shijiazhuang, China

[4]Department of Thoracic Oncology, Tianjin Lung Cancer Center, Key Laboratory of Cancer Prevention and Therapy, Tianjin’s Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Tianjin Cancer Institute & Hospital, Tianjin Medical University, 300060, Tianjin, P. R. China

[5]Hebei Key Laboratory of Cancer Radiotherapy and Chemotherapy, Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding, China

关键词: Non-small-cell lung cancer;    ErbB receptors;    Prognosis;    Safety;    Anlotinib;    Icotinib;   

DOI  :  10.1186/s12943-023-01823-w

 received in 2023-04-18, accepted in 2023-07-13,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundNon-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation and concurrent mutations have a poor prognosis. This study aimed to examine anlotinib plus icotinib as a first-line treatment option for advanced NSCLC carrying EGFR mutation with or without concurrent mutations.MethodsThis phase 2, single-arm, multicenter trial (ClinicalTrials.gov NCT03736837) was performed at five hospitals in China from December 2018 to November 2020. Non-squamous NSCLC cases with EGFR-sensitizing mutations were treated with anlotinib and icotinib. The primary endpoint was progression-free survival (PFS). Secondary endpoints included the objective response rate (ORR), disease control rate (DCR), overall survival (OS), and toxicity.ResultsSixty participants were enrolled, including 31 (52%) and 29 (48%) with concurrent mutations and pathogenic concurrent mutations, respectively. The median follow-up was 26.9 (range, 15.0-38.9) months. ORR and DCR were 68.5% and 98.2%, respectively. Median PFS was 15.1 (95%CI: 12.6–17.6) months which met the primary endpoint, median DoR was 13.5 (95%CI: 10.0-17.1) months, and median OS was 30.0 (95%CI: 25.5–34.5) months. Median PFS and OS in patients with pathogenic concurrent mutations were 15.6 (95%CI: 12.5–18.7) months and not reached (95%CI: 17.46 months to not reached), respectively. All patients experienced TRAEs, including 26 (43%) and 1 (1.7%) who had grade ≥ 3 and serious treatment-related adverse events (TRAEs).ConclusionsAnlotinib combined with icotinib was effective and well-tolerated as a first-line treatment option for EGFR mutation-positive advanced NSCLC with or without concurrent mutations.Trial registrationClinicalTrials.gov identifier: NCT03736837.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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