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

Lesley Seymour; Jan Bogaerts; Andrea Perrone; Robert Ford; Lawrence H. Schwartz; Sumithra Mandrekar; Nancy U. Lin; Saskia Litiere; Janet Dancey; Alice Chen; F. Stephen Hodi; Patrick Therasse; Otto S. Hoekstra; Lalitha K. Shankar; Jedd D. Wolchok; Marcus Ballinger; Caroline Caramella; Elisabeth G. E. de Vries; RECIST Working Grp

doi:10.1016/S1470-2045(17)30074-8

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

Lesley Seymour^*, Jan Bogaerts, Andrea Perrone, Robert Ford, Lawrence H. Schwartz, Sumithra Mandrekar, Nancy U. Lin, Saskia Litiere, Janet Dancey, Alice Chen, F. Stephen Hodi, Patrick Therasse, Otto S. Hoekstra, Lalitha K. Shankar, Jedd D. Wolchok, Marcus Ballinger, Caroline Caramella, Elisabeth G. E. de Vries, RECIST Working Grp

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

1810 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	E143-E152
Number of pages	10
Journal	Lancet Oncology
Volume	18
Issue number	3
DOIs	https://doi.org/10.1016/S1470-2045(17)30074-8
Publication status	Published - Mar-2017

Keywords

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

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Seymour, L., Bogaerts, J., Perrone, A., Ford, R., Schwartz, L. H., Mandrekar, S., Lin, N. U., Litiere, S., Dancey, J., Chen, A., Hodi, F. S., Therasse, P., Hoekstra, O. S., Shankar, L. K., Wolchok, J. D., Ballinger, M., Caramella, C., de Vries, E. G. E., & RECIST Working Grp (2017). iRECIST: Guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncology, 18(3), E143-E152. https://doi.org/10.1016/S1470-2045(17)30074-8

@article{786948bbd52d414c97de06ed99a2cc2b,

title = "iRECIST: Guidelines for response criteria for use in trials testing immunotherapeutics",

abstract = "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.",

keywords = "CELL LUNG-CANCER, IMMUNE-RELATED RESPONSE, SOLID TUMORS, UNTREATED MELANOMA, DOUBLE-BLIND, NIVOLUMAB, IPILIMUMAB, PEMBROLIZUMAB, CARBOPLATIN, COMBINATION",

author = "Lesley Seymour and Jan Bogaerts and Andrea Perrone and Robert Ford and Schwartz, {Lawrence H.} and Sumithra Mandrekar and Lin, {Nancy U.} and Saskia Litiere and Janet Dancey and Alice Chen and Hodi, {F. Stephen} and Patrick Therasse and Hoekstra, {Otto S.} and Shankar, {Lalitha K.} and Wolchok, {Jedd D.} and Marcus Ballinger and Caroline Caramella and {de Vries}, {Elisabeth G. E.} and {RECIST Working Grp}",

year = "2017",

month = mar,

doi = "10.1016/S1470-2045(17)30074-8",

language = "English",

volume = "18",

pages = "E143--E152",

journal = "Lancet Oncology",

issn = "1470-2045",

publisher = "ELSEVIER SCIENCE INC",

number = "3",

}

Seymour, L, Bogaerts, J, Perrone, A, Ford, R, Schwartz, LH, Mandrekar, S, Lin, NU, Litiere, S, Dancey, J, Chen, A, Hodi, FS, Therasse, P, Hoekstra, OS, Shankar, LK, Wolchok, JD, Ballinger, M, Caramella, C, de Vries, EGE & RECIST Working Grp 2017, 'iRECIST: Guidelines for response criteria for use in trials testing immunotherapeutics', Lancet Oncology, vol. 18, no. 3, pp. E143-E152. https://doi.org/10.1016/S1470-2045(17)30074-8

TY - JOUR

T1 - iRECIST

T2 - Guidelines for response criteria for use in trials testing immunotherapeutics

AU - Seymour, Lesley

AU - Bogaerts, Jan

AU - Perrone, Andrea

AU - Ford, Robert

AU - Schwartz, Lawrence H.

AU - Mandrekar, Sumithra

AU - Lin, Nancy U.

AU - Litiere, Saskia

AU - Dancey, Janet

AU - Chen, Alice

AU - Hodi, F. Stephen

AU - Therasse, Patrick

AU - Hoekstra, Otto S.

AU - Shankar, Lalitha K.

AU - Wolchok, Jedd D.

AU - Ballinger, Marcus

AU - Caramella, Caroline

AU - de Vries, Elisabeth G. E.

AU - RECIST Working Grp

PY - 2017/3

Y1 - 2017/3

N2 - 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.

AB - 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.

KW - CELL LUNG-CANCER

KW - IMMUNE-RELATED RESPONSE

KW - SOLID TUMORS

KW - UNTREATED MELANOMA

KW - DOUBLE-BLIND

KW - NIVOLUMAB

KW - IPILIMUMAB

KW - PEMBROLIZUMAB

KW - CARBOPLATIN

KW - COMBINATION

U2 - 10.1016/S1470-2045(17)30074-8

DO - 10.1016/S1470-2045(17)30074-8

M3 - Review article

SN - 1470-2045

VL - 18

SP - E143-E152

JO - Lancet Oncology

JF - Lancet Oncology

IS - 3

ER -

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

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Keywords

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