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A randomized, phase II study of vandetanib maintenance for advanced or metastatic non-small-cell lung cancer following first-line platinum-doublet chemotherapy

Authors
Ahn, Jin SeokLee, Ki HyeongSun, Jong-MuPark, KeunchilKang, Eun-SukCho, Eun KyungLee, Dae HoKim, Sang-WeLee, Gyeong-WonKang, Jin-HyoungLee, Jong-SeokLee, Jae-WonAhn, Myung-Ju
Issue Date
12월-2013
Publisher
ELSEVIER IRELAND LTD
Keywords
Vandetanib; Maintenance; Chemotherapy; Lung cancer; Progression-free survival; Target therapy
Citation
LUNG CANCER, v.82, no.3, pp.455 - 460
Indexed
SCIE
SCOPUS
Journal Title
LUNG CANCER
Volume
82
Number
3
Start Page
455
End Page
460
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/101391
DOI
10.1016/j.lungcan.2013.08.027
ISSN
0169-5002
Abstract
Background: This randomized, phase II study investigated whether benefit could be obtained by giving vandetanib, an oral inhibitor of vascular endothelial and epithelial growth factor receptor, as a maintenance treatment in non-small cell lung cancer (NSCLC). Methods: Patients were randomly assigned to either vandetanib or placebo after completion of 4 cycles of first-line chemotherapy. A progression-free survival (PFS) rate at 3 months was selected as the primary endpoint. We set a maximum PFS rate at 3 months to 30% (null hypothesis), and a minimum PFS rate at 3 months to 50% (alternative hypothesis). Results: At the interim analysis, 9 of 24 patients in the vandetanib arm were progression-free at 3 months, whereas 7 of 24 in the placebo arm were progression-free. The placebo arm was closed at the first stage. The vandetanib arm proceeded to the second stage, and recruited a total of 75 patients. At the second stage, 28 out of 63 evaluable patients receiving vandetanib achieved PFS at 3 months. The alternative hypothesis that the PFS rate at 3 months is at least 50% was accepted. The median PFS was 2.7 months (95% CI, 1.9-4.4 months) in the vandetanib arm and 1.7 months (95% CI, 0.9-2.6 months) in the placebo arm. The most common adverse events in patients receiving vandetanib were rash (77.3%) and diarrhea (60.0%). Conclusions: Maintenance therapy with vandetanib for patients with NSCLC after standard platinum doublet chemotherapy is well tolerated and may prolong PFS compared with placebo, and needs additional investigation. (C) 2013 Elsevier Ireland Ltd. All rights reserved.
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