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

Jin Seok Ahn, Ki Hyeong Lee, Jong Mu Sun, Keunchil Park, Eun Suk Kang, Eun Kyung Cho, Dae Ho Lee, Sang We Kim, Gyeong Won Lee, Jin Hyoung Kang, Jong Seok Lee, Jae Won Lee, Myung Ju Ahn

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29 Scopus citations

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.

Original languageEnglish
Pages (from-to)455-460
Number of pages6
JournalLung Cancer
Volume82
Issue number3
DOIs
StatePublished - Dec 2013

Bibliographical note

Funding Information:
Funding source : This study was sponsored by AstraZeneca.

Keywords

  • Chemotherapy
  • Lung cancer
  • Maintenance
  • Progression-free survival
  • Target therapy
  • Vandetanib

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