BACKGROUND: The Response Assessment in Neuro-Oncology (RANO) Working Group is an international, multidisciplinary effort to develop new standardized response criteria for clinical trials in brain tumors. The RANO group identified knowledge gaps relating to the definitions of tumor response and progression after the use of surgical or surgically based treatments.
OBJECTIVE: To outline a proposal for new response and progression criteria for the assessment of the effects of surgery and surgically delivered therapies for patients with gliomas.
METHODS: The Surgery Working Group of RANO identified surgically related end-point evaluation problems that were not addressed in the original Macdonald criteria, performed an extensive literature review, and used a consensus-building process to develop recommendations for how to address these issues in the setting of clinical trials.
RESULTS: Recommendations were formulated for surgically related issues, including imaging changes associated with surgical resection or surgically mediated adjuvant local therapies, the determination of progression in the setting where all enhancing tumor has been removed, and how new enhancement should be interpreted in the setting where local therapies that are known to produce nonspecific enhancement have been used. Additionally, the terminology used to describe the completeness of surgical resections has been recognized to be inconsistently applied to enhancing vs nonenhancing tumors, and a new set of descriptors is proposed.
CONCLUSION: The RANO process is intended to produce end-point criteria for clinical trials that take into account the effects of prior and ongoing therapies. The RANO criteria will continue to evolve as new therapies and technologies are introduced into clinical trial and/or practice.
‡Brain Tumor and Neuro-Oncology Center, Department of Neurosurgery, Cleveland Clinic, Cleveland Ohio
§Ivy Center for Advanced Brain Tumor Treatment, Department of Neurosurgery, Swedish Neuroscience Institute, Seattle, Washington
¶Department of Neurological Surgery, University of California, San Francisco, California
‖Department of Neurosurgery, University of Texas MD Anderson Cancer Center, Houston, Texas
#Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina
**Center for Neuro-Oncology, Dana Farber/Brigham and Women's Cancer Center and Division of Neurology, Brigham and Women's Hospital, Boston, Massachusetts
‡‡Department of Oncology, Medical Oncology, London Regional Cancer Program, University of Western Ontario, London, Ontario, Canada
§§Neuro-Oncology Unit, Daniel den Hoed Cancer Center/Erasmus University Hospital Rotterdam, Rotterdam, the Netherlands
¶¶Division of Neuro-Oncology, Department of Neurological Surgery, University of California, San Francisco, California
* These authors contributed equally.
Correspondence: Michael A. Vogelbaum, MD, PhD, FACS, Brain Tumor and Neuro-Oncology Center, Department of Neurosurgery/Neurological Institute, Cleveland Clinic, 9500 Euclid Avenue/ND40, Cleveland, OH 44195. E-mail: email@example.com
Received July 8, 2010
Accepted April 21, 2011