@article{dc825c291b5449cfbb1dba093d3562b3,
title = "Phase II study of sunitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer",
abstract = "This open-label, phase II study evaluated the antitumor activity and safety of sunitinib monotherapy as maintenance treatment following first-line chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Following treatment with standard doublet chemotherapy (paclitaxel and carboplatin), patients received oral sunitinib (starting dose 50. mg/day) in 6-week cycles (Schedule 4/2: 4 weeks on treatment, 2 weeks off treatment) until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoint was probability of survival at 1 year ≥55%. Of 84 patients who received first-line chemotherapy, 66 (79%) received sunitinib maintenance therapy (median sunitinib cycles started: 2 [range 1-20]). Probability of survival at 1 year was 40.5% (95% confidence interval [CI]: 29.8, 51.0). Median overall survival was 10.4 months (95% CI: 8.0, 12.2). The objective response rate was 27.4% (95% CI: 18.2, 38.2). The most frequently reported all-causality adverse events of any grade during sunitinib maintenance therapy were fatigue/asthenia (55%), diarrhea (36%), and nausea (32%). These data suggest that maintenance therapy may have value in NSCLC, although the primary endpoint of the study was not met.",
author = "Radj Gervais and Hainsworth, {John D.} and Normand Blais and Benjamin Besse and Janessa Laskin and Hamm, {John T.} and Allan Lipton and Albain, {Kathy S.} and Masters, {Gregory A.} and Natale, {Ronald B.} and Paulina Selaru and Kim, {Sindy T.} and Chao, {Richard C.} and Page, {Ray D.}",
note = "Funding Information: This study was funded by Pfizer Inc. The study sponsor was involved in the design of the study and the collection, analysis and interpretation of data. All listed authors were also involved in data interpretation, manuscript writing, and in the decision to submit the manuscript for publication. Funding Information: Radj Gervais: No conflicts to disclose; John D. Hainsworth: No conflicts to disclose; Normand Blais: Consultant for Pfizer and has received clinical trial grants; Benjamin Besse: His institution received grants from Pfizer for translational research; Janessa Laskin: No conflicts to disclose; John T. Hamm: No conflicts to disclose; Allan Lipton: Consulting fees: Amgen Inc. ; Cephalon Inc. ; Novartis Pharmaceuticals ; Thar Pharmaceuticals . Speakers Bureau: Amgen Inc, Genentech, Novartis Pharmaceuticals. Research support: Novartis Pharmaceuticals, Monogram Biosciences, Oncogene Science. Expert testimony: Novartis Pharmaceuticals. Kathy S. Albain: Serves on an independent data safety and monitoring committee for a phase III trial run by Pfizer (compensated). Gregory A. Masters: No conflicts to disclose; Ronald B. Natale: Clinical Research Grant Support: Amgen, Eli Lilly, Novartis Consulting (less than $10,000 per year): Amgen, Eli Lilly, Roche/Genentech; Paulina Selaru: Pfizer employee with Pfizer stock; Sindy T. Kim: Pfizer employee with Pfizer stock; Richard C. Chao: Pfizer employee with Pfizer stock; Ray D. Page: No conflicts to disclose. Funding Information: The authors would like to thank all of the participating patients and their families, as well as the global network of investigators, research nurses, study coordinators, and operations staff. Medical writing assistance was provided by Nicola Crofts at ACUMED {\textregistered} (Tytherington, UK) and was sponsored by Pfizer Inc. Copyright: Copyright 2012 Elsevier B.V., All rights reserved.",
year = "2011",
month = dec,
doi = "10.1016/j.lungcan.2011.05.004",
language = "English (US)",
volume = "74",
pages = "474--480",
journal = "Lung Cancer",
issn = "0169-5002",
publisher = "Elsevier Ireland Ltd",
number = "3",
}
