Irrecist and irecist: the devil is in the details

Le Lay, J.; Jarraya, Hajer; Lebellec, Loic; Penel, Nicolas

Document type :

Article dans une revue scientifique: Lettre à l'éditeur

DOI :

10.1093/annonc/mdx168

PMID :

28383646

Permalink :

http://hdl.handle.net/20.500.12210/17058

Title :

Irrecist and irecist: the devil is in the details

Author(s) :

Le Lay, J. [Auteur]
Jarraya, Hajer [Auteur]
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]
Lebellec, Loic [Auteur]
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]
Penel, Nicolas [Auteur]

Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]

Journal title :

Annals of Oncology

Abbreviated title :

Ann. Oncol.

Volume number :

Pages :

1676-1678

Publisher :

Elsevier

Publication date :

2017-07-01

ISSN :

0923-7534

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Modification of tumor size is commonly used to define the activity of investigational new drugs in phase II cancer trials (metric to define objective response) and to measure drug activity in a large portion of phase III ...
Show more >Modification of tumor size is commonly used to define the activity of investigational new drugs in phase II cancer trials (metric to define objective response) and to measure drug activity in a large portion of phase III trials (metric to define progression-free survival or time to progression). The use of standardized criteria to define tumor shrinkage, stable disease, and progressive disease (PD) are of major importance when designing clinical trials and defining endpoints. Different standardized methods have been proposed to objectively measure the tumor size change (WHO criteria, RECIST 1.1) [1]. RECIST 1.1 is undoubtedly accepted as an accurate metric to define burden tumor change with classical chemotherapy agents. The use of RECIST 1.1 is further discussed with regard to molecular targeted therapies [2]. Immune-stimulating agents, such as anti-CTLA4 and anti-PD(L)1 antibodies, induce specific patterns of response with transient pseudo-progression (probably due to immune cells tumor infiltration, inflammation, or necrosis) followed by long-lasting partial response or stable disease in some cases. As a consequence, RECIST-based immune criteria (ir-RECIST) have been proposed to assess pseudo-progression/transient flare [3]. Please note that partial/complete response classically required confirmation 1month later in RECIST 1.1. Currently, ir-RECIST requires confirmation of disease progression 4–6weeks later. However, the definition of confirmed PD largely differs per sponsor (Table 1). In brief, there are at least three major differences: retention of clinical stability as a component of confirmed PD definition (with a precise definition of what is the clinical stability), inclusion of the size of increasing non-target lesions, and the size of new lesions to calculate the overall size compared with the nadir and retention of only new lesion that continue to grow between imaging documenting initial PD and imaging confirming the PD according to ir-RECIST. These discrepancies lead to complexities in patient management within these clinical trials (whether to discontinue the investigational drug) and later at the time of final study analysis. Furthermore, in current and future comparative clinical trials, it will be very interesting to carefully assess the use of ir-RECIST in non-immune-stimulating agent comparative arms, such as chemotherapy or molecular-targeted therapiesShow less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
Université de Lille

Collections :

METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Submission date :

2019-12-09T16:54:49Z
2024-12-18T09:30:07Z

Version	Link	Modification date
2	20.500.12210/17058*	2024-12-18T09:23:34Z
1	20.500.12210/17058.1	2019-12-09T16:54:49Z

Irrecist and irecist: the devil is in the details

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Irrecist and irecist: the devil is in the details

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