论文已发表
注册即可获取德孚的最新动态
IF 收录期刊
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
DOI https://doi.org/10.2147/OTT.S161506
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
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