Citation

Novello S, Camps C, Grossi F, Mazieres J, Abrey L, Vernejoux JM, Thall A, Patyna S, Usari T, Wang Z, Chao RC, Scagliotti G. Journal of Thoracic Oncology 2011; 6(7): 1260-1266.

Copyright

(Copyright © 2011)

DOI

10.1097/JTO.0b013e318219a973

PMID

unavailable

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.

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.

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.

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.

Language: en

Keywords

Safety; adult; human; suicide; female; male; pain; morbidity; fatigue; article; major clinical study; risk; disease association; neutropenia; priority journal; disease course; constipation; lung embolism; drug safety; cancer patient; follow up; dysphagia; lymphocytopenia; hypertension; relapse; brain hemorrhage; chronic obstructive lung disease; hypothyroidism; dyspnea; hemoptysis; cancer survival; drug dose reduction; drug dose increase; open study; phase 2 clinical trial; progression free survival; overall survival; antineoplastic activity; decreased appetite; multiple cycle treatment; lung non small cell cancer; brain metastasis; sunitinib; three dimensional imaging; lung adenocarcinoma; Brain metastases; lung squamous cell carcinoma; mouth pain; Non-small cell lung cancer; phase 2 clinical trial (topic); Sunitinib