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 Litière, 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 group

Research output: Contribution to journalReview articleAcademicpeer-review

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 languageEnglish
Pages (from-to)e143-e152
JournalThe Lancet Oncology
Volume18
Issue number3
DOIs
Publication statusPublished - 1 Mar 2017

Cite this

Seymour, L., Bogaerts, J., Perrone, A., Ford, R., Schwartz, L. H., Mandrekar, S., ... RECIST working group (2017). iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. The Lancet Oncology, 18(3), e143-e152. https://doi.org/10.1016/S1470-2045(17)30074-8
Seymour, Lesley ; Bogaerts, Jan ; Perrone, Andrea ; Ford, Robert ; Schwartz, Lawrence H. ; Mandrekar, Sumithra ; Lin, Nancy U. ; Litière, Saskia ; Dancey, Janet ; Chen, Alice ; Hodi, F. Stephen ; Therasse, Patrick ; Hoekstra, Otto S. ; Shankar, Lalitha K. ; Wolchok, Jedd D. ; Ballinger, Marcus ; Caramella, Caroline ; de Vries, Elisabeth G.E. ; RECIST working group. / iRECIST : guidelines for response criteria for use in trials testing immunotherapeutics. In: The Lancet Oncology. 2017 ; Vol. 18, No. 3. pp. e143-e152.
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Seymour, L, Bogaerts, J, Perrone, A, Ford, R, Schwartz, LH, Mandrekar, S, Lin, NU, Litière, S, Dancey, J, Chen, A, Hodi, FS, Therasse, P, Hoekstra, OS, Shankar, LK, Wolchok, JD, Ballinger, M, Caramella, C, de Vries, EGE & RECIST working group 2017, 'iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics' The Lancet Oncology, vol. 18, no. 3, pp. e143-e152. https://doi.org/10.1016/S1470-2045(17)30074-8

iRECIST : guidelines for response criteria for use in trials testing immunotherapeutics. / Seymour, Lesley; Bogaerts, Jan; Perrone, Andrea; Ford, Robert; Schwartz, Lawrence H.; Mandrekar, Sumithra; Lin, Nancy U.; Litière, Saskia; Dancey, Janet; Chen, Alice; Hodi, F. Stephen; Therasse, Patrick; Hoekstra, Otto S.; Shankar, Lalitha K.; Wolchok, Jedd D.; Ballinger, Marcus; Caramella, Caroline; de Vries, Elisabeth G.E.; RECIST working group.

In: The Lancet Oncology, Vol. 18, No. 3, 01.03.2017, p. e143-e152.

Research output: Contribution to journalReview articleAcademicpeer-review

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AU - Ford, Robert

AU - Schwartz, Lawrence H.

AU - Mandrekar, Sumithra

AU - Lin, Nancy U.

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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.

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Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S et al. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. The Lancet Oncology. 2017 Mar 1;18(3):e143-e152. https://doi.org/10.1016/S1470-2045(17)30074-8