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Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer
British Journal of Cancer, 10/19/09

Novello S et al. – 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.

Methods

Examination of activity of sunitinib on continuous daily dosing (CDD) schedule in 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
Primary end point 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, 1 patient achieved 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 SD> 6 mos
Median PFS was 11.9 weeks and median OS 37.1 weeks
1-y survival probability 38.4%
Treatment generally well tolerated

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