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

被引:507
作者
Okada, Hideho [1 ]
Weller, Michael [2 ]
Huang, Raymond [3 ]
Finocchiaro, Gaetano [4 ]
Gilbert, Mark R. [5 ]
Wick, Wolfgang [6 ]
Ellingson, Benjamin M. [8 ,9 ,10 ,11 ]
Hashimoto, Naoya [14 ]
Pollack, Ian F. [15 ]
Brandes, Alba A. [17 ]
Franceschi, Enrico [17 ]
Herold-Mende, Christel [7 ]
Nayak, Lakshmi [18 ]
Panigrahy, Ashok [16 ]
Pope, Whitney B. [12 ]
Prins, Robert [13 ]
Sampson, John H. [19 ]
Wen, Patrick Y. [18 ]
Reardon, David A. [18 ]
机构
[1] Univ Calif San Francisco, Dept Neurol Surg, San Francisco, CA 94158 USA
[2] Univ Hosp Zurich, Dept Neurol, Zurich, Switzerland
[3] Brigham & Womens Hosp, Dept Radiol, Boston, MA USA
[4] Ist Neurol Besta, Dept Neurooncol, Milan, Italy
[5] NIH, Neurooncol Branch, Bethesda, MD USA
[6] Heidelberg Univ Hosp, Dept Neurooncol, Heidelberg, Germany
[7] Heidelberg Univ Hosp, Dept Neurosurg, Div Expt Neurosurg, Heidelberg, Germany
[8] Univ Calif Los Angeles, David Geff Sch Med, Dept Radiol Sci, Los Angeles, CA USA
[9] Univ Calif Los Angeles, David Geff Sch Med, Dept Bioengn, Los Angeles, CA USA
[10] Univ Calif Los Angeles, David Geff Sch Med, Dept Biomed Phys, Los Angeles, CA USA
[11] Univ Calif Los Angeles, David Geff Sch Med, Dept Psychiat, Los Angeles, CA USA
[12] Univ Calif Los Angeles, David Geff Sch Med, Dept Radiol, Los Angeles, CA USA
[13] Univ Calif Los Angeles, David Geff Sch Med, Dept Neurosurg, Los Angeles, CA USA
[14] Osaka Univ, Grad Sch Med, Dept Neurosurg, Suita, Osaka, Japan
[15] Univ Pittsburgh, Sch Med, Childrens Hosp Pittsburgh, Dept Neurol Surg, Pittsburgh, PA USA
[16] Univ Pittsburgh, Sch Med, Childrens Hosp Pittsburgh, Dept Radiol, Pittsburgh, PA USA
[17] Azienda USL IRCCS, Inst Neurol Sci, Dept Med Oncol, Bologna, Italy
[18] Dana Farber Canc Inst, Ctr Neuro Oncol, Boston, MA USA
[19] Duke Univ, Sch Med, Dept Neurosurg, Durham, NC USA
基金
美国国家卫生研究院;
关键词
CONCOMITANT RADIOCHEMOTHERAPY; ASSESSMENT CRITERIA; ADVANCED MELANOMA; BRAIN METASTASES; PLUS IPILIMUMAB; END-POINTS; PHASE-II; T-CELLS; PSEUDOPROGRESSION; SAFETY;
D O I
10.1016/S1470-2045(15)00088-1
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:E534 / E542
页数:9
相关论文
共 52 条
[11]   Chimeric Antigen Receptor-Modified T Cells for Acute Lymphoid Leukemia [J].
Grupp, Stephan A. ;
Kalos, Michael ;
Barrett, David ;
Aplenc, Richard ;
Porter, David L. ;
Rheingold, Susan R. ;
Teachey, David T. ;
Chew, Anne ;
Hauck, Bernd ;
Wright, J. Fraser ;
Milone, Michael C. ;
Levine, Bruce L. ;
June, Carl H. .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 368 (16) :1509-1518
[12]   Systemic immune suppression in glioblastoma: the interplay between CD14+HLA-DRlo/neg monocytes, tumor factors, and dexamethasone [J].
Gustafson, Michael P. ;
Lin, Yi ;
New, Kent C. ;
Bulur, Peggy A. ;
O'Neill, Brian Patrick ;
Gastineau, Dennis A. ;
Dietz, Allan B. .
NEURO-ONCOLOGY, 2010, 12 (07) :631-644
[13]   Safety and Tumor Responses with Lambrolizumab (Anti-PD-1) in Melanoma [J].
Hamid, Omid ;
Robert, Caroline ;
Daud, Adil ;
Hodi, F. Stephen ;
Hwu, Wen-Jen ;
Kefford, Richard ;
Wolchok, Jedd D. ;
Hersey, Peter ;
Joseph, Richard W. ;
Weber, Jeffrey S. ;
Dronca, Roxana ;
Gangadhar, Tara C. ;
Patnaik, Amita ;
Zarour, Hassane ;
Joshua, Anthony M. ;
Gergich, Kevin ;
Elassaiss-Schaap, Jeroen ;
Algazi, Alain ;
Mateus, Christine ;
Boasberg, Peter ;
Tumeh, Paul C. ;
Chmielowski, Bartosz ;
Ebbinghaus, Scot W. ;
Li, Xiaoyun Nicole ;
Kang, S. Peter ;
Ribas, Antoni .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 369 (02) :134-144
[14]   Bevacizumab plus Ipilimumab in Patients with Metastatic Melanoma [J].
Hodi, F. Stephen ;
Lawrence, Donald ;
Lezcano, Cecilia ;
Wu, Xinqi ;
Zhou, Jun ;
Sasada, Tetsuro ;
Zeng, Wanyong ;
Giobbie-Hurder, Anita ;
Atkins, Michael B. ;
Ibrahim, Nageatte ;
Friedlander, Philip ;
Flaherty, Keith T. ;
Murphy, George F. ;
Rodig, Scott ;
Velazquez, Elsa F. ;
Mihm, Martin C., Jr. ;
Russell, Sara ;
DiPiro, Pamela J. ;
Yap, Jeffrey T. ;
Ramaiya, Nikhil ;
van den Abbeele, Annick D. ;
Gargano, Maria ;
McDermott, David .
CANCER IMMUNOLOGY RESEARCH, 2014, 2 (07) :632-642
[15]   Improved Survival with Ipilimumab in Patients with Metastatic Melanoma [J].
Hodi, F. Stephen ;
O'Day, Steven J. ;
McDermott, David F. ;
Weber, Robert W. ;
Sosman, Jeffrey A. ;
Haanen, John B. ;
Gonzalez, Rene ;
Robert, Caroline ;
Schadendorf, Dirk ;
Hassel, Jessica C. ;
Akerley, Wallace ;
van den Eertwegh, Alfons J. M. ;
Lutzky, Jose ;
Lorigan, Paul ;
Vaubel, Julia M. ;
Linette, Gerald P. ;
Hogg, David ;
Ottensmeier, Christian H. ;
Lebbe, Celeste ;
Peschel, Christian ;
Quirt, Ian ;
Clark, Joseph I. ;
Wolchok, Jedd D. ;
Weber, Jeffrey S. ;
Tian, Jason ;
Yellin, Michael J. ;
Nichol, Geoffrey M. ;
Hoos, Axel ;
Urba, Walter J. .
NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (08) :711-723
[16]   Evolution of end points for cancer immunotherapy trials [J].
Hoos, A. .
ANNALS OF ONCOLOGY, 2012, 23 :47-52
[17]   A clinical development paradigm for cancer vaccines and related biologics [J].
Hoos, Axel ;
Parmiani, Giorgio ;
Hege, Kristen ;
Sznol, Mario ;
Loibner, Hans ;
Eggermont, Alexander ;
Urba, Walter ;
Blumenstein, Brent ;
Sacks, Natalie ;
Keilholz, Ulrich ;
Nichol, Geoffrey .
JOURNAL OF IMMUNOTHERAPY, 2007, 30 (01) :1-15
[18]   Improved Endpoints for Cancer Immunotherapy Trials [J].
Hoos, Axel ;
Eggermont, Alexander M. M. ;
Janetzki, Sylvia ;
Hodi, F. Stephen ;
Ibrahim, Ramy ;
Anderson, Aparna ;
Humphrey, Rachel ;
Blumenstein, Brent ;
Old, Lloyd ;
Wolchok, Jedd .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2010, 102 (18) :1388-1397
[19]   The immunostimulatory effect of lenalidomide on NK-cell function is profoundly inhibited by concurrent dexamethasone therapy [J].
Hsu, Andy K. ;
Quach, Hang ;
Tai, Tsin ;
Prince, H. Miles ;
Harrison, Simon J. ;
Trapani, Joseph A. ;
Smyth, Mark J. ;
Neeson, Paul ;
Ritchie, David S. .
BLOOD, 2011, 117 (05) :1605-1613
[20]   Pitfalls in le neuroimaging of glioblastoma in le era of antiangiogenic and immuno/targeted therapy - detecting illusive disease, defining response [J].
Huang, Raymond Y. ;
Neagu, Martha R. ;
Reardon, David A. ;
Wen, Patrick Y. .
FRONTIERS IN NEUROLOGY, 2015, 6