首页|Efficacy and safety of dacomitinib as first-line treatment for advanced non-small cell lung cancer patients with epidermal growth factor receptor 21L858R mutation:A multicenter,case-series study in China

Efficacy and safety of dacomitinib as first-line treatment for advanced non-small cell lung cancer patients with epidermal growth factor receptor 21L858R mutation:A multicenter,case-series study in China

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Objective:To provide real-world evidence for the application of first-line dacomitinib treatment for epidermal growth factor receptor(EGFR)21L858R mutant non-small cell lung cancer(NSCLC)patients in China and to explore the factors influencing the efficacy and safety.Methods:A longitudinal,consecutive case-series,multicenter study with mixed prospective and retrospective data was conducted.The primary endpoint was progression-free survival(PFS),and the secondary endpoints included duration of treatment(DOT),overall survival(OS),objective response rate(ORR),disease control rate(DCR)and safety.Results:A total of 155 EGFR 21L858R mutant patients treated with first-line dacomitinib were included.The median follow-up time for these patients was 20.4 months.Among 134 patients with evaluable lesions,the ORR was 70.9％and the DCR was 96.3％.The median PFS was 16.3[95％confidence interval(95％CI),13.7-18.9]months.Multivariate Cox regression analysis suggested that the baseline brain metastasis(BM)status[with vs.without BM:hazard ratio(HR),1.331;95％CI,0.720-2.458;P=0.361]and initial doses(45 mg vs.30 mg:HR,0.837;95％CI,0.427-1.641;P=0.604)did not significantly affect the median PFS.The median DOT was 21.0(95％CI,17.5-24.6)months and the median OS was not reached.Genetic tests were performed in 64 patients after progression,among whom 29(45.3％)patients developed the EGFR 20T790M mutation.In addition,among the 46 patients who discontinued dacomitinib treatment after progression,31(67.4％)patients received subsequent third-generation EGFR-tyrosine kinase inhibitors.The most common grade 3-4 adverse events were rash(10.4％),diarrhea(9.1％),stomatitis(7.1％)and paronychia(4.5％).The incidence of grade 3-4 rash was significantly higher in the 45 mg group than that in the 30 mg group(21.9％vs.7.5％,P=0.042).Conclusions:First-line dacomitinib treatment demonstrated promising efficacy and tolerable adverse events among EGFR 21L858R mutant NSCLC patients in China.

Epidermal growth factor receptormolecular targeted therapynon-small cell lung cancersafetytreatment efficacy

Shouzheng Wang、Jiayu Liu、Yan Wang、Ying Hu、Ziling Liu、Yu Yao、Li Liang、Yutao Liu、Lin Wang、Junling Li、Puyuan Xing

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Department of Medical Oncology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China

Department of Medical Oncology,Beijing Chest Hospital,Capital Medical University,Beijing Tuberculosis and Thoracic Tumor Research Institute,Beijing 101149,China

Cancer Center,the First Hospital of Jilin University,Changchun 130021,China

Department of Medical Oncology,the First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China

Department of Medical Oncology and Radiation Sickness,Peking University Third Hospital,Beijing 100191,China

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Pfizer

2024

10.21147/j.issn.1000-9604.2024.04.04

中国癌症研究(英文版)
中国抗癌协会 北京市肿瘤研究所

中国癌症研究(英文版)

CSTPCD
影响因子：1.592
ISSN：1000-9604
年,卷(期)：2024.36(4)