TY - JOUR
T1 - Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer
AU - Novello, S.
AU - Scagliotti, G. V.
AU - Rosell, R.
AU - Socinski, M. A.
AU - Brahmer, J.
AU - Atkins, J.
AU - Pallares, C.
AU - Burgess, R.
AU - Tye, L.
AU - Selaru, P.
AU - Wang, E.
AU - Chao, R.
AU - Govindan, R.
N1 - Funding Information:
Editorial assistance was provided by ACUMED (Tytherington, UK) and was funded by Pfizer Inc. This study was sponsored by Pfizer Inc.
PY - 2009/11/3
Y1 - 2009/11/3
N2 - 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.
AB - 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.
KW - Non-small cell lung cancer
KW - Phase II
KW - Sunitinib
KW - Tyrosine kinase inhibitor
UR - https://www.scopus.com/pages/publications/70350655546
U2 - 10.1038/sj.bjc.6605346
DO - 10.1038/sj.bjc.6605346
M3 - Article
C2 - 19826424
AN - SCOPUS:70350655546
SN - 0007-0920
VL - 101
SP - 1543
EP - 1548
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 9
ER -