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First-line afatinib vs gefitinib for patients with EGFR mutation-positive NSCLC (LUX-Lung 7): impact of afatinib dose adjustment and analysis of mode of initial progression for patients who continued treatment beyond progression

Cited 24 time in Web of Science Cited 25 time in Scopus
Issue Date
2019-06
Citation
Journal of Cancer Research and Clinical Oncology, Vol.145 No.6, pp.1569-1579
Keywords
AfatinibEGFRNSCLCDose adjustmentTime-to-treatment failure
Abstract
PurposeIn the randomized phase IIb LUX-Lung 7 trial, afatinib significantly improved progression-free survival (PFS) and time-to-treatment failure vs gefitinib in patients with treatment-naive epidermal growth factor receptor mutation-positive non-small cell lung cancer. We report post hoc analyses of tolerability-guided dose adjustment for afatinib and summarize the clinical characteristics of patients who continued afatinib/gefitinib beyond initial radiological progression in LUX-Lung 7.MethodsPatients received afatinib 40mg/day or gefitinib 250mg/day until investigator-assessed progression or beyond if beneficial. In case of selected treatment-related adverse events (TRAEs), the afatinib dose could be reduced by 10-mg decrements to minimum 20mg (only dose interruptions were permitted with gefitinib).ResultsAll randomized patients were treated (afatinib, n=160; gefitinib, n=159). Sixty-three patients had afatinib dose reduction (<40mg/day; 47 within first 6 months). Dose reduction decreased TRAE incidence/severity (before vs after; all grade/grade 3: 100.0%/63.5% vs 90.5%/23.8%). There was no evidence of significant difference in PFS for patients who received<40mg/day vs40mg/day for the first 6 months [median: 12.8 vs 11.0 months; hazard ratio 1.34 (95% confidence interval 0.90-2.00)]. Twenty-four and 26 patients continued afatinib and gefitinib, respectively, beyond progression in target lesions; median time from nadir of target lesion diameters to initial progression was 6.7 months and 5.6 months. Of these patients, similar to 70% had objective response or non-complete response/non-progressive disease in non-target lesions at initial progression.ConclusionsProtocol-defined dose adjustment of afatinib may allow patients to remain on treatment longer, maximizing clinical benefit even in the presence of radiological progression.
ISSN
0171-5216
URI
https://hdl.handle.net/10371/165199
DOI
https://doi.org/10.1007/s00432-019-02862-x
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College of Medicine/School of Medicine (의과대학/대학원)Cancer Research Institute (암연구소)Journal Papers (저널논문_암연구소)
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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