Challenges relating to solid tumour brain metastases in clinical trials, part 1: patient population, response, and progression. A report from the RANO group - 02/09/13

Doi : 10.1016/S1470-2045(13)70311-5

Nancy U Lin, DrMD ^a,^⁎ , Eudocia Q Lee, MD ^b, Hidefumi Aoyama, ProfMD ^c, Igor J Barani, MD ^d, Brigitta G Baumert, ProfMD ^g, Paul D Brown, ProfMD ^h, D Ross Camidge, MD ^j, Susan M Chang, ProfMD ^e,^f, Janet Dancey, ProfMD ^k,^l, Laurie E Gaspar, ProfMD ^m, Gordon J Harris, ProfMD ⁿ, F Stephen Hodi, MD ^a, Steven N Kalkanis, MD ^o, Kathleen R Lamborn, ProfPhD ^e, Mark E Linskey, ProfMD ^p, David R Macdonald, MD ^q, Kim Margolin, Prof ^r, Minesh P Mehta, MD ^s, David Schiff, ProfMD ^t, Riccardo Soffietti, ProfMD ^u,^v, John H Suh, ProfMD ^w, Martin J van den Bent, ProfMD ^x, Michael A Vogelbaum, ProfMD ^w, Jeffrey S Wefel, PhD ⁱ, Patrick Y Wen, ProfMD ^b

for the Response Assessment in Neuro-Oncology (RANO) group

^a Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA

^b Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA

^c Department of Radiology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan

^d Department of Radiation Oncology, University of California, San Francisco, CA, USA

^e Department of Neurological Surgery, University of California, San Francisco, CA, USA

^f Department of Neurology, University of California, San Francisco, CA, USA

^g Department of Radiation Oncology, Maastricht University Clinical Centre, Maastricht, Netherlands

^h Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

ⁱ Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

^j University of Colorado Denver, School of Medicine, Division of Medical Oncology, Denver, CO, USA

^k Faculty of Health Sciences, Queen’s University, Kingston, ON, Canada

^l Ontario Institute for Cancer Research, Queen’s University, Kingston, ON, Canada

^m Department of Radiation Oncology, University of Colorado, Aurora, CO, USA

ⁿ Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA

^o Department of Neurosurgery, Henry Ford Health System, Detroit, MI, USA

^p Department of Neurological Surgery, University of California, Irvine, Orange, CA, USA

^q Department of Oncology, London Health Sciences Centre, University of Western Ontario, London, ON, Canada

^r University of Washington School of Medicine Division of Oncology, University of Washington, Seattle Cancer Care Alliance, Seattle, WA, USA

^s University of Maryland, Department of Radiation Oncology, Baltimore, MD, USA

^t Division of Neuro-Oncology, University of Virginia, Charlottesville, VA, USA

^u Department of Neurology, University of Turin, Turin, Italy

^v Department of Neuro-Oncology, University of Turin, Turin, Italy

^w Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center, Cleveland Clinic, Cleveland, OH, USA

^x Neuro-Oncology, Erasmus University Cancer Institute, Rotterdam, Netherlands

^* Correspondence to: Dr Nancy U Lin, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA

Summary

Therapeutic 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.

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Plan

Introduction

Patients in trials of brain metastases

Inclusion of patients with brain metastases in systemic therapy trials

Primary endpoints in phase 2 and 3 trials of brain metastases

Imaging: definitions of progression and response in the CNS

Imaging modality

CNS objective response

Volumetric assessments

Relation with outcomes

Progression-free survival

Special situations

Recommendations and next steps

Search strategy and selection criteria

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Vol 14 - N° 10

P. e396-e406 - septembre 2013 Retour au numéro

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| Article suivant

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
Nancy U Lin, Jeffrey S Wefel, Eudocia Q Lee, David Schiff, Martin J van den Bent, Riccardo Soffietti, John H Suh, Michael A Vogelbaum, Minesh P Mehta, Janet Dancey, Mark E Linskey, D Ross Camidge, Hidefumi Aoyama, Paul D Brown, Susan M Chang, Steven N Kalkanis, Igor J Barani, Brigitta G Baumert, Laurie E Gaspar, F Stephen Hodi, David R Macdonald, Patrick Y Wen, for the Response Assessment in Neuro-Oncology (RANO) group

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Challenges relating to solid tumour brain metastases in clinical trials, part 1: patient population, response, and progression. A report from the RANO group - 02/09/13

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