Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer

S. Novello, G. V. Scagliotti, R. Rosell, M. A. Socinski, J. Brahmer, J. Atkins, C. Pallares, R. Burgess, L. Tye, P. Selaru, E. Wang, R. Chao, R. Govindan

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Abstract

Background: Sunitinib malate (SUTENT) has promising single-agent activity given on Schedule 4/2 (4 weeks on treatment followed by 2 weeks off treatment) in advanced non-small cell lung cancer (NSCLC).Methods:We examined the activity of sunitinib on a continuous daily dosing (CDD) schedule in an open-label, multicentre phase II study in patients with previously treated, advanced NSCLC. Patients 18 years with stage IIIB/IV NSCLC after failure with platinum-based chemotherapy, received sunitinib 37.5 mg per day. The primary end point was objective response rate (ORR). Secondary end points included progression-free survival (PFS), overall survival (OS), 1-year survival rate, and safety.Results:Of 47 patients receiving sunitinib, one patient achieved a confirmed partial response (ORR 2.1% (95% confidence interval (CI) 0.1, 11.3)) and 11 (23.4%) had stable disease (SD) 8 weeks. Five patients had SD6 months. Median PFS was 11.9 weeks (95% CI 8.6, 14.1) and median OS was 37.1 weeks (95% CI 31.1, 69.7). The 1-year survival probability was 38.4% (95% CI 24.2, 52.5). Treatment was generally well tolerated.Conclusions:The safety profile and time-to-event analyses, albeit relatively low response rate of 2%, suggest single-agent sunitinib on a CDD schedule may be a potential therapeutic agent for patients with advanced, refractory NSCLC.

Original languageEnglish
Pages (from-to)1543-1548
Number of pages6
JournalBritish Journal of Cancer
Volume101
Issue number9
DOIs
StatePublished - Nov 3 2009

Keywords

  • Non-small cell lung cancer
  • Phase II
  • Sunitinib
  • Tyrosine kinase inhibitor

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    Novello, S., Scagliotti, G. V., Rosell, R., Socinski, M. A., Brahmer, J., Atkins, J., Pallares, C., Burgess, R., Tye, L., Selaru, P., Wang, E., Chao, R., & Govindan, R. (2009). Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer. British Journal of Cancer, 101(9), 1543-1548. https://doi.org/10.1038/sj.bjc.6605346