TY  - JOUR
PY  - 2011//
TI  - Phase II study of sunitinib in patients with non-small cell lung cancer and irradiated brain metastases
JO  - Journal of Thoracic Oncology
A1  - Novello, S.
A1  - Camps, C.
A1  - Grossi, F.
A1  - Mazieres, J.
A1  - Abrey, L.
A1  - Vernejoux, J.-m.
A1  - Thall, A.
A1  - Patyna, S.
A1  - Usari, T.
A1  - Wang, Z.
A1  - Chao, R.C.
A1  - Scagliotti, G.
SP  - 1260
EP  - 1266
VL  - 6
IS  - 7
N2  - INTRODUCTION: Brain metastases frequently cause significant morbidity in patients with non-small cell lung cancer (NSCLC). Sunitinib is a multitargeted inhibitor of tyrosine kinase receptors, including vascular endothelial growth factor receptors and platelet-derived growth factor receptors, which has single-agent antitumor activity in refractory NSCLC. This phase II study evaluated the antitumor activity and safety of sunitinib in patients with pretreated NSCLC and irradiated brain metastases. <br><br>METHODS: Patients received sunitinib 37.5 mg on a continuous daily dosing schedule. The primary end point was progression-free survival. Secondary end points included overall survival, patient-reported outcomes, and safety, including risk of intracranial hemorrhage (ICH) associated with focal neurological deficit. <br><br>RESULTS: Sixty-four patients received sunitinib (median age 61 years), most (83%) had received prior systemic therapy, 63% had adenocarcinoma, and 19% had squamous cell carcinoma; most (55%) were never-smokers. Median progression-free survival was 9.4 weeks (90% confidence interval [CI]: 7.5-13.1), and median overall survival was 25.1 weeks (95% CI: 13.4-35.5). The most common treatment-emergent (all-causality) nonhematologic toxicities (any grade) were fatigue (38%) and decreased appetite and constipation (both 25%). The most common grade 3/4 nonhematologic toxicities were dyspnea (9%) and fatigue (8%). Lymphopenia (20%) and neutropenia (13%) were the most common grade 3/4 hematologic abnormalities. Serious neurologic adverse events occurred in six patients (9%), and none were treatment-related. No cases of ICH were reported. <br><br>CONCLUSIONS: Sunitinib administration on a continuous daily dosing schedule in patients with NSCLC and brain metastases was safe and manageable, with no increased risk of ICH. Copyright © 2011 by the International Association for the Study of Lung Cancer.<p /> <p>Language: en</p>
LA  - en
SN  - 1556-0864
UR  - http://dx.doi.org/10.1097/JTO.0b013e318219a973
ID  - ref1
ER  -