A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC)

H. J. M. Groen*, M. A. Socinski, F. Grossi, E. Juhasz, C. Gridelli, P. Baas, C. A. Butts, E. Chmielowska, T. Usari, P. Selaru, C. Harmon, J. A. Williams, F. Gao, L. Tye, R. C. Chao, G. R. Blumenschein

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

42 Citations (Scopus)

Abstract

Combined inhibition of vascular, platelet-derived, and epidermal growth factor receptor (EGFR) pathways may overcome refractoriness to single agents in platinum-pretreated non-small-cell lung cancer (NSCLC).

This randomized, double-blind, multicenter, phase II trial evaluated sunitinib 37.5 mg/day plus erlotinib 150 mg/day versus placebo plus erlotinib continuously in 4-week cycles. Eligible patients had histologically confirmed stage IIIB or IV NSCLC previously treated with one or two chemotherapy regimens, including one platinum-based regimen. The primary end point was progression-free survival (PFS) by an independent central review.

One hundred and thirty-two patients were randomly assigned, and the median duration of follow-up was 17.7 months. The median PFS was 2.8 versus 2.0 months for the combination versus erlotinib alone (HR 0.898, P = 0.321). The median overall survival (OS) was 8.2 versus 7.6 months (HR 1.066, P = 0.617). Objective response rates (ORRs) were 4.6% and 3.0%, respectively. Sunitinib plus erlotinib was fairly well tolerated although most treatment-related adverse events (AEs) were more frequent than with erlotinib alone: diarrhea (55% versus 33%), rash (41% versus 30%), fatigue (31% versus 25%), decreased appetite (30% versus 13%), nausea (28% versus 14%), and thrombocytopenia (13% versus 0%).

The addition of sunitinib to erlotinib did not significantly improve PFS in patients with advanced, platinum-pretreated NSCLC.

Original languageEnglish
Pages (from-to)2382-2389
Number of pages8
JournalAnnals of Oncology
Volume24
Issue number9
DOIs
Publication statusPublished - Sep-2013

Keywords

  • combination therapy
  • efficacy
  • erlotinib
  • non-small-cell lung cancer
  • safety
  • sunitinib
  • TYROSINE KINASE INHIBITOR
  • ENDOTHELIAL GROWTH-FACTOR
  • PLUS ERLOTINIB
  • ANTITUMOR-ACTIVITY
  • IN-VIVO
  • TRIAL
  • SU11248
  • BEVACIZUMAB
  • CHEMOTHERAPY
  • CARCINOMA

Cite this