iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics

被引：1782

作者：

Seymour, Lesley ^{[1
]}

Bogaerts, Jan ^{[2
]}

Perrone, Andrea ^{[3
]}

Ford, Robert ^{[4
]}

Schwartz, Lawrence H. ^{[5
,6
]}

Mandrekar, Sumithra ^{[7
]}

Lin, Nancy U. ^{[8
]}

Litiere, Saskia ^{[2
]}

Dancey, Janet ^{[1
]}

Chen, Alice ^{[9
]}

Hodi, F. Stephen ^{[8
]}

Therasse, Patrick ^{[10
]}

Hoekstra, Otto S. ^{[11
]}

Shankar, Lalitha K. ^{[12
]}

Wolchok, Jedd D. ^{[13
]}

Ballinger, Marcus ^{[14
,15
,16
]}

Caramella, Caroline ^{[17
]}

de Vries, Elisabeth G. E. ^{[18
]}

机构：

[1] Queens Univ, Canadian Canc Trials Grp, Kingston, ON K7L 3N6, Canada

[2] EORTC Headquarters, Brussels, Belgium

[3] Merck & Co Inc, Translat Med, Kenilworth, NJ USA

[4] Clin Trials Imaging Consulting LLC, Belle Mead, NJ USA

[5] Columbia Univ, Med Ctr, Dept Radiol, New York, NY USA

[6] New York Presbyterian Hosp, New York, NY USA

[7] Mayo Clin, Div Biomed Stat & Informat, Rochester, MN USA

[8] Harvard Med Sch, Dana Farber Canc Inst, Dept Med Oncol, Boston, MA USA

[9] NCI, Early Clin Trials Dev Program, Div Canc Treatment & Diag, Bethesda, MD 20892 USA

[10] Inst Rech Int Servier, Paris, France

[11] Vrije Univ Amsterdam, Dept Radiol & Nucl Med, Med Ctr, Amsterdam, Netherlands

[12] NCI, Diagnost Imaging Branch, Bethesda, MD 20892 USA

[13] Mem Sloan Kettering Canc Ctr, Dept Med, 1275 York Ave, New York, NY 10021 USA

[14] Weill Cornell Med & Grad Coll, New York, NY USA

[15] Ludwig Inst Canc Res, New York, NY USA

[16] Genentech Inc, 460 Point San Bruno Blvd, San Francisco, CA 94080 USA

[17] Gustav Roussy Canc Campus, Dept Radiol, Villejuif, France

[18] Univ Med Ctr Groningen, Dept Med Oncol, Groningen, Netherlands

来源：

LANCET ONCOLOGY | 2017年 / 18卷 / 03期

关键词：

CELL LUNG-CANCER; IMMUNE-RELATED RESPONSE; SOLID TUMORS; UNTREATED MELANOMA; DOUBLE-BLIND; NIVOLUMAB; IPILIMUMAB; PEMBROLIZUMAB; CARBOPLATIN; COMBINATION;

D O I：

10.1016/S1470-2045(17)30074-8

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Tumours respond differently to immunotherapies compared with chemotherapeutic drugs, raising questions about the assessment of changes in tumour burden-a mainstay of evaluation of cancer therapeutics that provides key information about objective response and disease progression. A consensus guideline-iRECIST-was developed by the RECIST working group for the use of modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials, to ensure consistent design and data collection, facilitate the ongoing collection of trial data, and ultimate validation of the guideline. This guideline describes a standard approach to solid tumour measurements and definitions for objective change in tumour size for use in trials in which an immunotherapy is used. Additionally, it defines the minimum datapoints required from future trials and those currently in development to facilitate the compilation of a data warehouse to use to later validate iRECIST. An unprecedented number of trials have been done, initiated, or are planned to test new immune modulators for cancer therapy using a variety of modified response criteria. This guideline will allow consistent conduct, interpretation, and analysis of trials of immunotherapies.

引用

页码：E143 / E152

页数：10

共 36 条

[1]

[Anonymous], P AM SOC CLIN ONCOL

[2] Safety and antitumour activity of durvalumab plus tremelimumab in non-small-cell lung cancer: a multicentre, phase 1b study [J].

Antonia, Scott ;

Goldberg, Sarah B. ;

Balmanoukian, Ani ;

Chaft, Jamie E. ;

Sanborn, Rachel E. ;

Gupta, Ashok ;

Narwal, Rajesh ;

Steele, Keith ;

Gu, Yu ;

Karakunnel, Joyson J. ;

Rizvi, Naiyer A. .

LANCET ONCOLOGY, 2016, 17 (03) :299-308

[3]

Bohnsack O, 2014, ANN ONCOL

[4] Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer [J].

Borghaei, H. ;

Paz-Ares, L. ;

Horn, L. ;

Spigel, D. R. ;

Steins, M. ;

Ready, N. E. ;

Chow, L. Q. ;

Vokes, E. E. ;

Felip, E. ;

Holgado, E. ;

Barlesi, F. ;

Kohlhaeufl, M. ;

Arrieta, O. ;

Burgio, M. A. ;

Fayette, J. ;

Lena, H. ;

Poddubskaya, E. ;

Gerber, D. E. ;

Gettinger, S. N. ;

Rudin, C. M. ;

Rizvi, N. ;

Crino, L. ;

Blumenschein, G. R. ;

Antonia, S. J. ;

Dorange, C. ;

Harbison, C. T. ;

Finckenstein, F. Graf ;

Brahmer, J. R. .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (17) :1627-1639

[5] Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer [J].

Brahmer, Julie ;

Reckamp, Karen L. ;

Baas, Paul ;

Crino, Lucio ;

Eberhardt, Wilfried E. E. ;

Poddubskaya, Elena ;

Antonia, Scott ;

Pluzanski, Adam ;

Vokes, Everett E. ;

Holgado, Esther ;

Waterhouse, David ;

Ready, Neal ;

Gainor, Justin ;

Aren Frontera, Osvaldo ;

Havel, Libor ;

Steins, Martin ;

Garassino, Marina C. ;

Aerts, Joachim G. ;

Domine, Manuel ;

Paz-Ares, Luis ;

Reck, Martin ;

Baudelet, Christine ;

Harbison, Christopher T. ;

Lestini, Brian ;

Spigel, David R. .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (02) :123-135

[6] Pseudoprogression and Immune-Related Response in Solid Tumors [J].

Chiou, Victoria L. ;

Burotto, Mauricio .

JOURNAL OF CLINICAL ONCOLOGY, 2015, 33 (31) :3541-+

[7] New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) [J].

Eisenhauer, E. A. ;

Therasse, P. ;

Bogaerts, J. ;

Schwartz, L. H. ;

Sargent, D. ;

Ford, R. ;

Dancey, J. ;

Arbuck, S. ;

Gwyther, S. ;

Mooney, M. ;

Rubinstein, L. ;

Shankar, L. ;

Dodd, L. ;

Kaplan, R. ;

Lacombe, D. ;

Verweij, J. .

EUROPEAN JOURNAL OF CANCER, 2009, 45 (02) :228-247

[8] Control of peripheral T-cell tolerance and autoimmunity via the CTLA-4 and PD-1 pathways [J].

Fife, Brian T. ;

Bluestone, Jeffrey A. .

IMMUNOLOGICAL REVIEWS, 2008, 224 :166-182

[9] Interactions between PD-1 and PD-L1 promote tolerance by blocking the TCR-induced stop signal [J].

Fife, Brian T. ;

Pauken, Kristen E. ;

Eagar, Todd N. ;

Obu, Takashi ;

Wu, Jenny ;

Tang, Qizhi ;

Azuma, Miyuki ;

Krummel, Matthew F. ;

Bluestone, Jeffrey A. .

NATURE IMMUNOLOGY, 2009, 10 (11) :1185-U70

[10] Pembrolizumab for the Treatment of Non-Small-Cell Lung Cancer [J].

Garon, Edward B. ;

Rizvi, Naiyer A. ;

Hui, Rina ;

Leighl, Natasha ;

Balmanoukian, Ani S. ;

Eder, Joseph Paul ;

Patnaik, Amita ;

Aggarwal, Charu ;

Gubens, Matthew ;

Horn, Leora ;

Carcereny, Enric ;

Ahn, Myung-Ju ;

Felip, Enriqueta ;

Lee, Jong-Seok ;

Hellmann, Matthew D. ;

Hamid, Omid ;

Goldman, Jonathan W. ;

Soria, Jean-Charles ;

Dolled-Filhart, Marisa ;

Rutledge, Ruth Z. ;

Zhang, Jin ;

Lunceford, Jared K. ;

Rangwala, Reshma ;

Lubiniecki, Gregory M. ;

Roach, Charlotte ;

Emancipator, Kenneth ;

Gandhi, Leena .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 372 (21) :2018-2028

← 1 2 3 4 →