Immunotherapy response assessment in neuro-oncology: a report of the RANO working group

Hideho Okada, Michael Weller, Raymond Huang, Gaetano Finocchiaro, Mark R Gilbert, Wolfgang Wick, Benjamin M Ellingson, Naoya Hashimoto, Ian F Pollack, Alba A Brandes, Enrico Franceschi, Christel Herold-Mende, Lakshmi Nayak, Ashok Panigrahy, Whitney B Pope, Robert Prins, John H Sampson, Patrick Y Wen, David A Reardon, Hideho Okada, Michael Weller, Raymond Huang, Gaetano Finocchiaro, Mark R Gilbert, Wolfgang Wick, Benjamin M Ellingson, Naoya Hashimoto, Ian F Pollack, Alba A Brandes, Enrico Franceschi, Christel Herold-Mende, Lakshmi Nayak, Ashok Panigrahy, Whitney B Pope, Robert Prins, John H Sampson, Patrick Y Wen, David A Reardon

Abstract

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.

Copyright © 2015 Elsevier Ltd. All rights reserved.

Figures

Figure 1
Figure 1
(A) Axial T1 contrast Gd-enhanced and FLAIR images obtained prior to, and 7 and 13 weeks after initiation of CTLA-4 immune checkpoint blockade. (B) Axial T2 FLAIR and T1 Gd-enhanced images obtained post 2nd (left), at 11 days post 3rd (middle) and 19 days post 3rd (right) vaccinations (NCT01678352) in a patient with recurrent WHO grade II oliodendroglioma.
Figure 1
Figure 1
(A) Axial T1 contrast Gd-enhanced and FLAIR images obtained prior to, and 7 and 13 weeks after initiation of CTLA-4 immune checkpoint blockade. (B) Axial T2 FLAIR and T1 Gd-enhanced images obtained post 2nd (left), at 11 days post 3rd (middle) and 19 days post 3rd (right) vaccinations (NCT01678352) in a patient with recurrent WHO grade II oliodendroglioma.
Figure 2
Figure 2
Algorithm for evaluation of progressive imaging findings among neuro-oncology patients undergoing immune-based therapies.

Source: PubMed

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