Clinical Study

British Journal of Cancer (2009) 101, 1543–1548. doi:10.1038/sj.bjc.6605346 www.bjcancer.com
Published online 13 October 2009

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

S Novello1, G V Scagliotti1, R Rosell2, M A Socinski3, J Brahmer4, J Atkins5, C Pallares6, R Burgess7, L Tye8, P Selaru8, E Wang8, R Chao8 and R Govindan9

  1. 1Department of Clinical and Biological Sciences, Thoracic Oncology Unit, University of Turin, Orbassano, Turin, Italy
  2. 2Department of Medical Oncology, Catalan Institute of Oncology, Barcelona, Spain
  3. 3Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC, USA
  4. 4Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Cockeysville, MD, USA
  5. 5Southeastern Medical Oncology Center, Goldsboro, NC, USA
  6. 6Department of Oncology, Hospital de San Pablo, Barcelona, Spain
  7. 7Department of Internal Medicine, Eastern Carolina Internal Medicine, Pollocksville, NC, USA
  8. 8Pfizer Global Research and Development, La Jolla, CA, USA
  9. 9Department of Medicine, Washington University School of Medicine, St Louis, MO, USA

Correspondence: Dr S Novello, E-mail: silvia.novello@unito.it

Received 30 March 2009; Revised 27 August 2009; Accepted 3 September 2009; Published online 13 October 2009.

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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 greater than or equal to18 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) greater than or equal to8 weeks. Five patients had SD>6 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.

Keywords:

non-small cell lung cancer, phase II, sunitinib, tyrosine kinase inhibitor