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Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2.

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

Author information

1
Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada. Electronic address: lseymour@ctg.queensu.ca.
2
EORTC Headquarters, Brussels, Belgium.
3
Translational Medicine, Merck & Co, Kenilworth, NJ, USA.
4
Clinical Trials Imaging Consulting, LLC, Belle Mead, NJ, USA.
5
Department of Radiology, Columbia University Medical Center, New York, NY, USA; New York Presbyterian Hospital, New York, NY, USA.
6
Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.
7
Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
8
Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
9
Early Clinical Trials Development Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
10
Institut de Recherche International Servier, Paris, France.
11
Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, Netherlands.
12
Diagnostic Imaging Branch, National Cancer Institute, Bethesda, MD, USA.
13
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
14
Weill Cornell Medical and Graduate Colleges, New York, NY, USA; Ludwig Institute for Cancer Research, New York, NY, USA; Genentech Inc, San Francisco, CA, USA.
15
Department of Radiology, Gustav Roussy Cancer Campus, Villejuif, France.
16
Department of Medical Oncology, University Medical Center Groningen, Groningen, Netherlands.

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.

PMID:
28271869
PMCID:
PMC5648544
DOI:
10.1016/S1470-2045(17)30074-8
[Indexed for MEDLINE]
Free PMC Article

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