Initial Low-Dose Dacomitinib for First-Line Treatment of Patients With EGFR Exon 21-Mutated Non-Small-Cell Lung Cancer.

Background: Dacomitinib has demonstrated superior efficacy compared with first-generation tyrosine kinase inhibitors (TKIs) in patients with epidermal growth factor receptor (EGFR) exon 21-mutated non-small-cell lung cancer (NSCLC). However, the standard 45 mg dose often leads to a high incidence of...

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Publicado en:Clinical Medicine Insights: Oncology Vol. 20; pp. 1 - 9
Autores principales: Liu, Ke-Jun, Huang, Lin-Xuan, Jiang, Guan-Ming, Guo, Ning-Ning, Tan, Qing-Lin, Cai, Yan-Min, Chen, Shi-Yuan, Du, Wei, Fang, Nian-Xin, Jia, Jun
Formato: research tables/charts Journal Article
Publicado: Sage Publications Inc. 5/27/2026
Acceso en línea:Ver este registro en EBSCOhost
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      dt: 5/27/2026
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        atl: Initial Low-Dose Dacomitinib for First-Line Treatment of Patients With EGFR Exon 21-Mutated Non-Small-Cell Lung Cancer.
      aug:
        au:
          Liu, Ke-Jun
          Huang, Lin-Xuan
          Jiang, Guan-Ming
          Guo, Ning-Ning
          Tan, Qing-Lin
          Cai, Yan-Min
          Chen, Shi-Yuan
          Du, Wei
          Fang, Nian-Xin
          Jia, Jun
        affil: Department of Oncology, Dongguan Institute of Clinical Cancer Research, Dongguan Key Laboratory of Precision Diagnosis and Treatment for Tumors, The Tenth Affiliated Hospital, Southern Medical University (Dongguan People's Hospital), Dongguan, China
      sug:
        subj:
          Carcinoma, Non-Small-Cell Lung Drug Therapy
          Epidermal Growth Factor Receptors Antagonists and Inhibitors
          Antineoplastic Agents Therapeutic Use
          Tyrosine Kinase Inhibitors Therapeutic Use
          Mutation
          Drug Tolerance
          Drug Efficacy
          Patient Safety
          Dose-Response Relationship, Drug
          Antineoplastic Agents Administration and Dosage
          Human
          Funding Source
          China
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          Female
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          Adult
          Middle Age
          Aged
          Retrospective Design
          Record Review
          Prospective Studies
          Descriptive Statistics
          Data Analysis Software
          Confidence Intervals
          Kaplan-Meier Estimator
          Cox Proportional Hazards Model
          Log-Rank Test
          Multivariate Analysis
          Two-Tailed Test
          Survival Analysis
          Progression-Free Survival
          Overall Survival
          Drug Toxicity
          Antineoplastic Agents Adverse Effects
          Quality of Life
          Comparative Studies
          Carcinoma, Non-Small-Cell Lung Familial and Genetic
          Adolescent: 13-18 years
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Aged: 65+ years
          Male
          Female
      ab: Background: Dacomitinib has demonstrated superior efficacy compared with first-generation tyrosine kinase inhibitors (TKIs) in patients with epidermal growth factor receptor (EGFR) exon 21-mutated non-small-cell lung cancer (NSCLC). However, the standard 45 mg dose often leads to a high incidence of grade 3 and 4 toxicities, limiting its clinical application. This study aimed to evaluate the preliminary efficacy and safety of a proactive low-dose dacomitinib strategy as first-line treatment. Methods: This retrospective cohort study analyzed data from 31 patients with EGFR exon 21-mutated advanced NSCLC consecutively enrolled between August 2019 and April 2023, who initiated dacomitinib at 15 or 30 mg/d. A comparative cohort of 35 patients receiving first-generation EGFR-TKIs was also included. Initial dose selection was based on clinical judgment regarding patient age, comorbidities, and performance status. The reporting of this study conforms to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline. Results: The objective response rate (ORR) in the low-dose dacomitinib group was 67.7%, higher than that observed in the first-generation EGFR-TKI group (P =.009). Subgroup analysis showed ORRs of 75% and 60% in the 15 mg and 30 mg cohorts, respectively (P =.389). The median progression-free survival (PFS) in the low-dose dacomitinib group was 14.2 months (95% confidence interval [CI] = 12.4-15.9 months). Compared with first-generation EGFR-TKIs, low-dose dacomitinib was associated with significantly prolonged PFS (HR = 0.43, 95% CI = 0.25-0.72; P =.001). No significant difference in PFS was observed between the 15 mg and 30 mg groups (HR = 0.81, 95% CI = 0.37-1.76; P =.594). While grade 1 and 2 toxicities were common, the 15 mg group exhibited a significantly lower incidence of grade 3 and 4 rash compared with the 30 mg group (0% vs 33.3%). Conclusions: Initial low-dose dacomitinib demonstrated promising efficacy with an improved safety profile in patients with EGFR exon 21-mutated NSCLC. These findings support the feasibility of a dose-optimization strategy, although further prospective studies are warranted.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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