| Title | A Phase IIIb Open-Label, Single-Arm Study of Afatinib in EGFR TKI-Naive Patients with EGFRm plus NSCLC: Final Analysis, with a Focus on Patients Enrolled at Sites in China |
| Authors | Tu, Hai-Yan Feng, Jifeng Shi, Meiqi Zhao, Jun Wang, Yuyan Chang, Jianhua Wang, Jialei Cheng, Ying Zhu, Jing Tan, Eng-Huat Li, Kai Zhang, Yiping Lee, Victor Yang, Cheng-Ta Su, Wu-Chou Lam, David Chi-Leung Srinivasa, B. J. Rajappa, Senthil Ho, Ching-Liang Lam, Kwok Chi Hu, Yi Bondarde, Shailesh Arjun Liu, Xiaoqing Tian, Yahui Xue, Zhiyi Cseh, Agnieszka Huang, Dennis Chin-Lun Zhou, Caicun Wu, Yi-Long |
| Affiliation | Guangdong Prov Peoples Hosp, Guangdong Lung Canc Inst, Guangzhou 510080, Peoples R China Guangdong Acad Med Sci, Guangzhou 510080, Peoples R China Nanjing Med Univ, Jiangsu Canc Hosp, Dept Med Oncol, Nanjing 210029, Peoples R China Nanjing Med Univ, Jiangsu Inst Canc Res, Nanjing 210029, Peoples R China Nanjing Med Univ, Affiliated Canc Hosp, Nanjing 210029, Peoples R China Peking Univ, Key Lab Carcinogenesis & Translat Res, Dept Thorac Oncol Med 1, Minist Educ Beijing,Canc Hosp & Inst, Beijing 100142, Peoples R China Fudan Univ, Shanghai Canc Ctr, Shanghai 200032, Peoples R China Jilin Prov Canc Hosp, Div Thorac Oncol, Changchun 130012, Peoples R China Natl Canc Ctr, Dept Med Oncol, Singapore 169610, Singapore Tianjin Med Univ Canc Inst & Hosp, Tianjin 300060, Peoples R China Zhejiang Canc Hosp, Hangzhou 310022, Peoples R China Univ Hong Kong, Queen Mary Hosp, Dept Clin Oncol, Hong Kong, Peoples R China Univ Hong Kong, Shenzhen Hosp, Clin Oncol Ctr, Shenzhen 518053, Peoples R China Linkou Chang Gung Mem Hosp, Dept Thorac Med, Taoyuan 333, Taiwan Natl Cheng Kung Univ Hosp, Tainan 704, Taiwan Univ Hong Kong, Queen Mary Hosp, Dept Clin Oncol & Med, Hong Kong, Peoples R China HCG Hosp, Bangalore 560020, Karnataka, India Basavatarakam Indoamer Canc Hosp & Res Inst, Hyderabad 500034, India Natl Def Med Ctr, Triserv Gen Hosp, Div Hematol Oncol, Tokyo 114, Japan Prince Wales Hosp, Shatin, Hong Kong, Peoples R China Chinese Peoples Liberat Army Gen Hosp, Dept Oncol, Beijing 100853, Peoples R China Shatabdi Superspecial Hosp, Nasik 422005, India 307th Hosp PLA, Beijing 100070, Peoples R China Boehringer Ingelheim China Investment Co Ltd, Shanghai, Peoples R China Boehringer Ingelheim Int GmbH, D-55216 Ingelheim, Germany Boehringer Ingelheim Taiwan Ltd, Taipei 104, Taiwan Tongji Univ, Shanghai Pulm Hosp, Shanghai 200433, Peoples R China |
| Keywords | CELL LUNG-CANCER 1ST-LINE TREATMENT ADENOCARCINOMA HISTOLOGY ASIAN PATIENTS REAL-WORLD MUTATIONS CHEMOTHERAPY GEFITINIB SAFETY ERLOTINIB |
| Issue Date | Jan-2022 |
| Publisher | TARGETED ONCOLOGY |
| Abstract | Background Afatinib has been shown as a suitable option for the treatment of epidermal growth factor receptor mutation-positive (EGFRm+) non-small-cell lung cancer (NSCLC) in randomized controlled trials. However, patients treated in real-world clinical practice, including elderly patients, and those with brain metastases or poor Eastern Cooperative Oncology Group (ECOG) performance statuses, are often excluded from these studies. Objective To report the final results, with a particular focus on patients enrolled in China, from a prospective phase IIIb, "near real-world" study of afatinib in tyrosine kinase inhibitor (TKI)-naive Asian patients with EGFRm+ NSCLC. Patients and Methods NCT01953913 was conducted at 34 centers across Asia. Entry criteria were broad to reflect real-world settings. Patients received afatinib 40 mg/day until tumor progression, lack of clinical benefit, or poor tolerability. Assessments included safety, time to symptomatic progression (TTSP), and progression-free survival (PFS). Results 541 patients were treated, of whom 412 were enrolled in China. Dose reductions were implemented in 28.7% of patients overall, and 17.7% of patients from China. Safety findings were consistent with phase III studies of afatinib. Median TTSP in all patients was 14.0 months (95% CI 12.9-15.9), and median PFS was 12.1 months (95% CI 11.0-13.6). Median TTSP (13.8 months, 95% CI 12.7-16.1) and PFS (11.4 months, 95% CI 10.9-13.7) were similar in patients from China to the overall population. Among patients from China who had dose reductions, TTSP was numerically longer than in those who did not (16.4 vs. 13.8 months; P = 0.0703), while PFS was significantly longer (13.9 vs. 11.1 months; P = 0.0275). Among patients from China with brain metastases, TTSP was numerically shorter than in those without (11.0 vs. 14.4 months; P = 0.0869), whereas PFS was significantly shorter (9.2 vs. 12.9 months; P = 0.0075). Conclusions Safety data for afatinib when used in a "near real-world" setting in patients with EGFRm+ NSCLC was consistent with the known safety profile of afatinib. Supporting efficacy data of afatinib were provided in all patients, and in those enrolled in China. Tolerability-guided afatinib dose reduction allowed patients to remain on treatment and continue to experience clinical benefit. |
| URI | http://hdl.handle.net/20.500.11897/634805 |
| ISSN | 1776-2596 |
| DOI | 10.1007/s11523-021-00859-6 |
| Indexed | SCI(E) |
| Appears in Collections: | 北京肿瘤医院 |
