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...
| Publicado en: | Clinical Medicine Insights: Oncology Vol. 20; pp. 1 - 9 |
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| Autores principales: | , , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Sage Publications Inc.
5/27/2026
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=194089746&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 194089746 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 11795549 B3KT jtl: Clinical Medicine Insights: Oncology issn: 11795549 maglogo: Y pubinfo: dt: 5/27/2026 vid: 20 pid: 344 pub: Sage Publications Inc. place: Thousand Oaks, California artinfo: ui: 194089746 194089746 194089746 10.1177/11795549261454548 194089746 ppf: 1 ppct: 8 formats: fmt: – @attributes: type: T – @attributes: type: P tig: 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 Male Female Adolescence 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 refInfo: holdings: @attributes: islocal: N |
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