• The lancet oncology · Sep 2013

    Review

    Challenges relating to solid tumour brain metastases in clinical trials, part 1: patient population, response, and progression. A report from the RANO group.

    • Nancy U Lin, Eudocia Q Lee, Hidefumi Aoyama, Igor J Barani, Brigitta G Baumert, Paul D Brown, D Ross Camidge, Susan M Chang, Janet Dancey, Laurie E Gaspar, Gordon J Harris, F Stephen Hodi, Steven N Kalkanis, Kathleen R Lamborn, Mark E Linskey, David R Macdonald, Kim Margolin, Minesh P Mehta, David Schiff, Riccardo Soffietti, John H Suh, Martin J van den Bent, Michael A Vogelbaum, Jeffrey S Wefel, Patrick Y Wen, and Response Assessment in Neuro-Oncology (RANO) group.
    • Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: nlin@partners.org.
    • Lancet Oncol. 2013 Sep 1; 14 (10): e396-406.

    AbstractTherapeutic outcomes for patients with brain metastases need to improve. A critical review of trials specifically addressing brain metastases shows key issues that could prevent acceptance of results by regulatory agencies, including enrolment of heterogeneous groups of patients and varying definitions of clinical endpoints. Considerations specific to disease, modality, and treatment are not consistently addressed. Additionally, the schedule of CNS imaging and consequences of detection of new or progressive brain metastases in trials mainly exploring the extra-CNS activity of systemic drugs are highly variable. The Response Assessment in Neuro-Oncology (RANO) working group is an independent, international, collaborative effort to improve the design of trials in patients with brain tumours. In this two-part series, we review the state of clinical trials of brain metastases and suggest a consensus recommendation for the development of criteria for future clinical trials. Copyright © 2013 Elsevier Ltd. All rights reserved.

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