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Authors Wu YL, Xu CR, Hu CP, Feng J, Lu S, Huang Y, Li W, Hou M, Shi JH, Märten A, Fan J, Peil B, Zhou C
Received 21 December 2017
Accepted for publication 14 May 2018
Published 30 November 2018 Volume 2018:11 Pages 8575—8587
DOI https://doi.org/10.2147/OTT.S160358
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 2
Editor who approved publication: Prof. Dr. Geoffrey Pietersz
Introduction: Non-small-cell
lung cancer (NSCLC) is the leading cause of cancer death in China. Four
epidermal growth factor receptor (EGFR)-targeted tyrosine kinase inhibitors –
afatinib, erlotinib, icotinib, and gefitinib – are available for first-line
treatment of NSCLC in China; however, there are few data to guide treatment
choice. The Phase III LUX-Lung 6 trial compared afatinib with platinum-based
chemotherapy for first-line treatment of patients from Southeast Asia
with EGFR mutation-positive
advanced NSCLC. This post hoc analysis assessed the findings from LUX-Lung 6 in
Chinese patients.
Clinical trial registration: ClinicalTrials.gov: NCT01121393.
Materials and methods: Previously untreated patients with EGFR mutation-positive
stage IIIB/IV lung adenocarcinoma were randomized 2:1 to receive afatinib or ≤6
cycles of gemcitabine/cisplatin. The key outcomes were progression-free
survival (PFS; primary), objective response rate, disease control rate, overall
survival (OS), duration of response and disease control, patient-reported
outcomes, and safety. Three hundred and twenty-seven patients from mainland
China were treated (89.8% of overall LUX-Lung 6 population; afatinib 217,
gemcitabine/cisplatin 110).
Results: PFS
was significantly longer with afatinib than gemcitabine/cisplatin (median 11.0
versus 5.6 months; hazard ratio [HR], 0.30 [95% CI, 0.21, 0.43]; P <0.0001).
Overall, there was no significant difference in OS between treatment arms;
however, in a subgroup analysis, afatinib significantly improved OS versus gemcitabine/cisplatin
in patients with an EGFR Del19 mutation (median 31.6 versus 16.3
months; HR, 0.61 [95% CI, 0.41, 0.91]; P =0.0146). Afatinib was well tolerated, with most
treatment-related adverse events (TRAEs) being of grade 1 or 2 severity. The
most common grade 3/4 TRAEs with afatinib were rash/acne (15.9%/0.5%),
stomatitis (6.1%/0%), and diarrhea (5.6%/0%). TRAEs leading to permanent
discontinuation were reported in 12 patients (5.6%) receiving afatinib and 43
(41.7%) receiving gemcitabine/cisplatin. Afatinib significantly improved PFS
compared with standard first-line chemotherapy in Chinese patients with EGFR mutation-positive
NSCLC and demonstrated a manageable safety profile.
Conclusion: The
findings support the rationale for using afatinib as a first-line treatment
option for this patient population.
Keywords: afatinib,
NSCLC, EGFR, first-line, Phase III, Chinese patients
摘要视频链接:Afatinib versus
gemcitabine/cisplatin for advanced NSCLC in Chinese patients