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Safety and efficacy of first-line dacomitinib in Asian patients with EGFR mutation-positive non-small cell lung cancer: Results from a randomized, open-label, phase 3 trial (ARCHER 1050)(Open Access)

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机构： [a]Jilin Provincial Cancer Hospital, Changchun, China [b]State Key Laboratory of Translational Oncology, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong, China [c]First Affiliated Hospital of Third Military Medical University, Chongqing, China [d]Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China [e]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China [f]First Affiliated Hospital of Zhejiang University, Hangzhou, China [g]The First Affiliated Hospital of Anhui Medical University, Hefei, China [h]Sichuan Cancer Hospital, Chengdu, China [i]Department of Lung Cancer, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China [j]Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, China [k]Department of Thoracic Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China [l]Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China [m]Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea [n]Kindai University Hospital, Osaka, Japan [o]SFJ Pharmaceuticals Inc., Pleasanton, CA, USA [p]Pfizer Pte. Ltd., Singapore [q]Pfizer Oncology, La Jolla, CA, USA [r]Pfizer Investment Co., Ltd., Shanghai, China [s]Pfizer Inc., San Diego, CA, USA

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关键词： Asian Dacomitinib Epidermal growth factor receptor Non-small cell lung cancer Tyrosine kinase inhibitor

摘要：

Objectives: To compare efficacy and safety of dacomitinib versus gefitinib as first-line therapy for EGFR mutation-positive advanced NSCLC in Asian patients enrolled in the ongoing ARCHER 1050 trial. Materials and methods: In this ongoing, randomized, open-label, phase 3 trial (NCT01774721), eligible patients with newly diagnosed advanced EGFR mutation-positive NSCLC were randomized (1:1) to receive oral dacomitinib 45 mg/day or oral gefitinib 250 mg/day. Randomization, by a central computer system, was stratified by race and EGFR mutation type (exon 19 deletion mutation/exon 21 L858R substitution mutation). The primary endpoint was PFS by blinded independent review. Results: Of 346 Asian patients, 170 were randomized to dacomitinib and 176 to gefitinib. The hazard ratio (HR) for PFS with dacomitinib versus gefitinib was 0.509 (95 % confidence interval [CI]: 0.391–0.662; 1-sided p < 0.0001; median 16.5 months [95 % CI: 12.9–18.4] vs. 9.3 months [95 % CI: 9.2–11.0]). HR for OS with dacomitinib versus gefitinib was 0.759 (95 % CI: 0.578–0.996; median 37.7 months [95 % CI: 30.2–44.7] vs. 29.1 months [95 % CI: 25.6–36.0]). The OS benefit was still maintained in those patients who had a stepwise dose reduction of dacomitinib (to 30 and 15 mg/day). The most common adverse events (AEs) were diarrhea (154 [90.6 %] patients), paronychia (110 [64.7 %]), dermatitis acneiform (96 [56.5 %]), and stomatitis (87 [51.2 %]) with dacomitinib, and diarrhea (100 [56.8 %]), alanine aminotransferase increased (81 [46.0 %]), and aspartate aminotransferase increased (75 [42.6 %]) with gefitinib. Treatment-related serious AEs were reported in 16 (9.4 %) and 8 (4.5 %) patients treated with dacomitinib and gefitinib, respectively. Conclusion: First-line dacomitinib was associated with significant prolongation of PFS and improved OS compared with gefitinib in Asian patients with EGFR mutation-positive advanced NSCLC. The AE profiles of dacomitinib and gefitinib in Asian patients were consistent with the overall ARCHER 1050 population. © 2021 The Authors

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出版当年[2021]版：

大类 | 2 区医学

小类 | 2 区肿瘤学 2 区呼吸系统

最新[2023]版：

大类 | 2 区医学

小类 | 3 区肿瘤学 3 区呼吸系统

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出版当年[2021]版：

Q1 RESPIRATORY SYSTEM Q2 ONCOLOGY

最新[2023]版：

Q1 RESPIRATORY SYSTEM Q1 ONCOLOGY

影响因子： 4.5 最新[2023版] 4.7 最新五年平均 6.081 出版当年[2021版] 5.894 出版当年五年平均 5.705 出版前一年[2020版] 5.3 出版后一年[2022版]

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第一作者机构： [a]Jilin Provincial Cancer Hospital, Changchun, China

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通讯作者：

通讯机构： [e]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China [*1]Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan Er Rd, Guangzhou, Guangdong, 510080, China

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Safety and efficacy of first-line dacomitinib in Asian patients with EGFR mutation-positive non-small cell lung cancer: Results from a randomized, open-label, phase 3 trial (ARCHER 1050)(Open Access)

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