@article{ref1,
title="Phase II study of sunitinib in patients with non-small cell lung cancer and irradiated brain metastases",
journal="Journal of Thoracic Oncology",
year="2011",
author="Novello, S. and Camps, C. and Grossi, F. and Mazieres, J. and Abrey, L. and Vernejoux, J.-m. and Thall, A. and Patyna, S. and Usari, T. and Wang, Z. and Chao, R.C. and Scagliotti, G.",
volume="6",
number="7",
pages="1260-1266",
abstract="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>",
language="en",
issn="1556-0864",
doi="10.1097/JTO.0b013e318219a973",
url="http://dx.doi.org/10.1097/JTO.0b013e318219a973"
}