Immunotherapy response assessment in neuro-oncology: a report of the RANO working group - 03/11/15

Doi : 10.1016/S1470-2045(15)00088-1

Hideho Okada, ProfMD ^a,^{^{†
Contributed equally},}^⁎ , Michael Weller, ProfMD ^b, Raymond Huang, MD ^c, Gaetano Finocchiaro, MD ^d, Mark R Gilbert, MD ^e, Wolfgang Wick, ProfMD ^f, Benjamin M Ellingson, PhD ^h, Naoya Hashimoto, MD ^k, Ian F Pollack, ProfMD ^l, Alba A Brandes, MD ⁿ, Enrico Franceschi, MD ⁿ, Christel Herold-Mende, ProfPhD ^g, Lakshmi Nayak, MD ^o, Ashok Panigrahy, MD ^m, Whitney B Pope, MD ⁱ, Robert Prins, PhD ^j, John H Sampson, ProfMD ^p, Patrick Y Wen, ProfMD ^o, David A Reardon, MD ^o,^{^{†
Contributed equally}}

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

^b Department of Neurology, University Hospital Zurich, Zurich, Switzerland

^c Department of Radiology, Brigham and Women’s Hospital, Boston, MA, USA

^d Department of Neuro-Oncology, Istituto Neurologico Besta, Milan, Italy

^e Neuro-Oncology Branch, National Institutes of Health, Bethesda, MD, USA

^f Department of Neurooncology, Heidelberg University Hospital, Heidelberg, Germany

^g Department of Neurosurgery, Division of Experimental Neurosurgery, Heidelberg University Hospital, Heidelberg, Germany

^h Departments of Radiological Sciences, Bioengineering, Biomedical Physics, and Psychiatry, David Geffen School of Medicine University of California, Los Angeles, CA, USA

ⁱ Department of Radiology, David Geffen School of Medicine University of California, Los Angeles, CA, USA

^j Department of Neurosurgery, David Geffen School of Medicine University of California, Los Angeles, CA, USA

^k Department of Neurosurgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan

^l Department of Neurological Surgery, University of Pittsburgh School of Medicine, Children’s Hospital of Pittsburgh, Pittsburgh, PA, USA

^m Department of Radiology, University of Pittsburgh School of Medicine, Children’s Hospital of Pittsburgh, Pittsburgh, PA, USA

ⁿ Department of Medical Oncology, Azienda USL–IRCCS Institute of Neurological Science, Bologna, Italy

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

^p Department of Neurosurgery, Duke University School of Medicine, Durham, NC, USA

^* Correspondence to: Prof Hideho Okada, Department of Neurological Surgery, University of California, San Francisco, CA 94158–0520, USA Correspondence to: Prof Hideho Okada Department of Neurological Surgery University of California San Francisco CA 94158–0520 USA

Summary

Immunotherapy is a promising area of therapy in patients with neuro-oncological malignancies. However, early-phase studies show unique challenges associated with the assessment of radiological changes in response to immunotherapy reflecting delayed responses or therapy-induced inflammation. Clinical benefit, including long-term survival and tumour regression, can still occur after initial disease progression or after the appearance of new lesions. Refinement of the response assessment criteria for patients with neuro-oncological malignancies undergoing immunotherapy is therefore warranted. Herein, a multinational and multidisciplinary panel of neuro-oncology immunotherapy experts describe immunotherapy Response Assessment for Neuro-Oncology (iRANO) criteria based on guidance for the determination of tumour progression outlined by the immune-related response criteria and the RANO working group. Among patients who demonstrate imaging findings meeting RANO criteria for progressive disease within 6 months of initiating immunotherapy, including the development of new lesions, confirmation of radiographic progression on follow-up imaging is recommended provided that the patient is not significantly worse clinically. The proposed criteria also include guidelines for the use of corticosteroids. We review the role of advanced imaging techniques and the role of measurement of clinical benefit endpoints including neurological and immunological functions. The iRANO guidelines put forth in this Review will evolve successively to improve their usefulness as further experience from immunotherapy trials in neuro-oncology accumulate.

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Plan

Introduction

Ongoing evolution of response assessment in neuro-oncology

Interpretation of worsened radiographic findings after immunotherapy

New lesions

Confirmation of radiographic progression to define progressive disease

When is confirmation of radiographic progression appropriate?

3-month period to confirm radiographic progression

Tissue acquisition to aid response assessment

Immunotherapy continuation pending confirmation of progression

iRANO criteria

Corticosteroids

Conclusion

Search strategy and selection criteria

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Vol 16 - N° 15

P. e534-e542 - novembre 2015 Retour au numéro

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Immunotherapy response assessment in neuro-oncology: a report of the RANO working group - 03/11/15

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