Irrecist and irecist: the devil is in the details

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

Type de document :

Article dans une revue scientifique: Lettre à l'éditeur

DOI :

10.1093/annonc/mdx168

PMID :

28383646

URL permanente :

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

Titre :

Irrecist and irecist: the devil is in the details

Auteur(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]

Titre de la revue :

Annals of Oncology

Nom court de la revue :

Ann. Oncol.

Numéro :

Pagination :

1676-1678

Éditeur :

Elsevier

Date de publication :

2017-07-01

ISSN :

0923-7534

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [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 ...
Lire la suite >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 therapiesLire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

CHU Lille
Université de Lille

Collections :

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

Date de dépôt :

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

Numéro de version	Lien	Date de modification
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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