@article{3cb1d630de604ff990c5b85e5793120d,
title = "Challenges relating to solid tumour brain metastases in clinical trials, part 2: Neurocognitive, neurological, and quality-of-life outcomes. A report from the RANO group",
abstract = "Neurocognitive function, neurological symptoms, functional independence, and health-related quality of life are major concerns for patients with brain metastases. The inclusion of these endpoints in trials of brain metastases and the methods by which these measures are assessed vary substantially. If functional independence or health-related quality of life are planned as key study outcomes, then the reliability and validity of these endpoints can be crucial because methodological issues might affect the interpretation and acceptance of findings. The Response Assessment in Neuro-Oncology (RANO) working group is an independent, international, and collaborative effort to improve the design of clinical trials in patients with brain tumours. In this report, the second in a two-part series, we review clinical trials of brain metastases in relation to measures of clinical benefit and provide a framework for the design and conduct of future trials.",
author = "Lin, {Nancy U.} and Wefel, {Jeffrey S.} and Lee, {Eudocia Q.} and David Schiff and {van den Bent}, {Martin J.} and Riccardo Soffietti and Suh, {John H.} and Vogelbaum, {Michael A.} and Mehta, {Minesh P.} and Janet Dancey and Linskey, {Mark E.} and Camidge, {D. Ross} and Hidefumi Aoyama and Brown, {Paul D.} and Chang, {Susan M.} and Kalkanis, {Steven N.} and Barani, {Igor J.} and Baumert, {Brigitta G.} and Gaspar, {Laurie E.} and Hodi, {F. Stephen} and Macdonald, {David R.} and Wen, {Patrick Y.}",
note = "Funding Information: NUL received research funding from Genentech, Geron, GlaxoSmithKline, and Novartis; and has served as a paid consultant to GlaxoSmithKline, and Novartis and an unpaid consultant to to-BBB. IJB has received research grants from BrainLab, North American Gamma Knife Consortium, and Varian. MJvdB has been a consultant for Roche, Abbott, and Merck; and has received honoraria from MSD, and support for clinical research from Roche. FSH has been an unpaid consultant for and received clinical trial support from Bristol-Myers Squibb, Genentech, Novartis, and Merck. DRM has served as a consultant for Merck Canada and Roche Canada; and has received honoraria from Merck Canada and other remuneration from Merck Canada, Roche Canada, and EMD Serono. MPM has been a consultant for Abbott, Bristol-Myers Squibb, Elekta, Genentech, Merck, Novartis, Novocure, and Viewray, and has stock options in Accuray, and Pharmacyclics. He has served on the board of directors for Pharmacyclics and as a speaker for Merck. JHS has been a consultant for Abbott Oncology, and has received travel funds from Varian. MAV has received honoraria from Merck, Pharmaco-Kinesis, and Neuralstem. All other authors declare that they have no conflicts of interest. Funding Information: This work was supported in part by the Breast Cancer Research Foundation (grant to NUL), but the organisation did not directly influence the authors in the writing of this report or the decision to submit it for publication. ",
year = "2013",
month = sep,
doi = "10.1016/S1470-2045(13)70308-5",
language = "English (US)",
volume = "14",
pages = "e407--e416",
journal = "The lancet oncology",
issn = "1470-2045",
publisher = "Lancet Publishing Group",
number = "10",
}