دورية أكاديمية
Lazertinib versus Gefitinib as First-Line Treatment for EGFR-mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset.
| العنوان: | Lazertinib versus Gefitinib as First-Line Treatment for EGFR-mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset. |
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| المؤلفون: | Lee KH; Division of Medical Oncology, Department of Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea., Cho BC; Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea., Ahn MJ; Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Lee YG; Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea., Lee Y; Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea., Lee JS; Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea., Kim JH; CHA Bundang Medical Center, CHA University, Seongnam, Korea., Min YJ; Division of Hematology and Oncology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea., Lee GW; Division of Hemato-Oncology, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University, College of Medicine, Jinju, Korea., Lee SS; Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea., Lee KH; Division of Hematology/Oncology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea., Ko YH; Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea., Shim BY; Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea., Kim SW; Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Shin SW; Division of Oncology/Hematology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea., Choi JH; Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Korea., Kim DW; Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea., Cho EK; Division of Oncology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea., Park KU; Division of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Korea., Kim JS; Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea., Chun SH; Division of Medical Oncology, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea., Wang J; Yuhan Corporation, Seoul, Korea., Choi S; Yuhan Corporation, Seoul, Korea., Kang JH; Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. |
| المصدر: | Cancer research and treatment [Cancer Res Treat] 2024 Jan; Vol. 56 (1), pp. 48-60. Date of Electronic Publication: 2023 Jun 27. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: The Association Country of Publication: Korea (South) NLM ID: 101155137 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2005-9256 (Electronic) Linking ISSN: 15982998 NLM ISO Abbreviation: Cancer Res Treat Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Seoul, Korea : The Association, |
| مواضيع طبية MeSH: | Carcinoma, Non-Small-Cell Lung*/drug therapy , Carcinoma, Non-Small-Cell Lung*/genetics , Lung Neoplasms*/drug therapy , Lung Neoplasms*/genetics , Morpholines* , Pyrazoles* , Pyrimidines*, Humans ; Gefitinib/therapeutic use ; Quinazolines ; ErbB Receptors/genetics ; ErbB Receptors/metabolism ; Republic of Korea ; Mutation ; Protein Kinase Inhibitors/adverse effects |
| مستخلص: | Purpose: This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Materials and Methods: Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS). Results: In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment-related AEs occurred with lazertinib than gefitinib. Conclusion: Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population. |
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| معلومات مُعتمدة: | Yuhan Corporation; Tech Observer Asia Pacific Pte Ltd. |
| فهرسة مساهمة: | Keywords: EGFR mutation; Lazertinib; Non-small-cell lung carcinoma |
| المشرفين على المادة: | S65743JHBS (Gefitinib) 4A2Y23XK11 (lazertinib) 0 (Quinazolines) EC 2.7.10.1 (ErbB Receptors) 0 (Protein Kinase Inhibitors) EC 2.7.10.1 (EGFR protein, human) 0 (Morpholines) 0 (Pyrazoles) 0 (Pyrimidines) |
| تواريخ الأحداث: | Date Created: 20230704 Date Completed: 20240117 Latest Revision: 20240118 |
| رمز التحديث: | 20240118 |
| مُعرف محوري في PubMed: | PMC10789945 |
| DOI: | 10.4143/crt.2023.453 |
| PMID: | 37402411 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2005-9256 |
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| DOI: | 10.4143/crt.2023.453 |