Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung
Authors Lu S, Li W, Zhou C, Hu CP, Qin S, Cheng G, Feng J, Wang J, Cseh A, Peil B, Gibson N, Ehrnrooth E, Zhang L
Received 6 January 2018
Accepted for publication 8 May 2018
Published 30 November 2018 Volume 2018:11 Pages 8565—8573
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Cristina Weinberg
Peer reviewer comments 2
Editor who approved publication: Dr Samir Farghaly
Shun Lu,1 Wei Li,2 Caicun Zhou,3 Cheng-Ping Hu,4 Shukui Qin,5 Gang Cheng,6 Jifeng Feng,7 Jie Wang,8,9 Agnieszka Cseh,10 Barbara Peil,11 Neil Gibson,12 Eva Ehrnrooth,13 Li Zhang14
1Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China; 2Cancer Center, First Hospital of Jilin University, Changchun, China; 3Department of Oncology, Shanghai Pulmonary Hospital, Shanghai, China; 4Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China; 5People’s Liberation Army Cancer Center, Nanjing Bayi Hospital, Nanjing, Jiangsu, China; 6Department of Medical Oncology, Beijing Hospital, National Center of Gerontology, Beijing, China; 7Department of Internal Medicine, Jiangsu Provincial Tumor Hospital, Nanjing, China; 8Department of Internal Medicine, Capital Medical University, Beijing, China; 9Peking University School of Oncology, Beijing Cancer Hospital, Beijing, China; 10Department of Medical Affairs, Boehringer Ingelheim RCV GmbH & Co. KG, Vienna, Austria; 11Biostatistics, Boehringer Ingelheim Pharma GmbH & Co. KG. Ingelheim, Germany; 12Translational Medicine and Clinical Oncology, Boehringer Ingelheim Pharma GmbH & Co. KG. Biberach, Germany; 13Division of Oncology, Boehringer Ingelheim, Danmark A/S, Copenhagen, Denmark; 14Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China
Background: The global Phase III LUX-Lung 8 trial (ClinicalTrials.gov: NCT01523587) identified significant improvements in progression-free survival (PFS), overall survival (OS), and patient-reported outcomes (PROs) with second-line afatinib vs erlotinib in patients with advanced squamous cell carcinoma (SCC) of the lung.
Materials and methods: We conducted a post hoc analysis of data for patients in LUX-Lung 8 from mainland China (n=67). Compared with erlotinib, afatinib reduced the risk of disease progression or death (PFS) in the Chinese subgroup by 30% (HR=0.70; 95% CI: 0.38–1.27).
Results: The risk of death was reduced by 31% (HR=0.69; 95% CI: 0.39–1.21). The proportion of Chinese patients with improvements in PROs also favored afatinib vs erlotinib (global health status/quality of life [QoL], 52.8% vs 29.6%, P=0.072; dyspnea, 47% vs 26%, P=0.091; “dyspnea walked”, 44% vs 15%, P=0.017; QoL rate, 53% vs 26%, P=0.037).
Discussion: While this analysis was not powered to demonstrate differences compared to the overall trial population (OTP), and there were some differences in baseline characteristics (eg, the proportion of patients aged ≥65 years old), the benefits of afatinib treatment in Chinese patients with SCC of the lung appeared to be at least comparable to that observed in LUX-Lung 8. As with the OTP, the most common adverse events (AEs) with afatinib in the Chinese subgroup were diarrhea and rash/acne, and the incidence and type of the most frequently occurring AEs were similar.
Conclusion: The results suggest that afatinib represents a feasible treatment option for Chinese patients with advanced SCC of the lung following progression on platinum-based chemotherapy.
Keywords: afatinib, NSCLC, squamous cell carcinoma, second-line, Phase III, Chinese patients
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