AustralieFrV1, Main, Exploration, bibRecord, 006A49

Heterogeneity in the definition of dose-limiting toxicity in phase I cancer clinical trials of molecularly targeted agents: A review of the literature

Identifieur interne : 006A49 ( Main/Exploration ); précédent : 006A48; suivant : 006A50

Heterogeneity in the definition of dose-limiting toxicity in phase I cancer clinical trials of molecularly targeted agents: A review of the literature

Auteurs : Christophe Le Tourneau [France] ; Albiruni R. A. Razak [Canada] ; Hui K. Gan [Australie] ; Simona Pop [France] ; Véronique Dieras [France] ; Patricia Tresca [France] ; Xavier Paoletti [France]

Source :

European journal of cancer : (1990) [ 0959-8049 ] ; 2011.

RBID : Pascal:11-0309704

Descripteurs français

Pascal (Inist)
- Essai clinique phase I, Hétérogénéité, Définition, Cancer, Dose, Toxicité, Tumeur maligne, Revue bibliographique, Réversibilité, Thérapeutique ciblée, Cancérologie, Traitement.
Wicri :
- topic : Cancer.

English descriptors

KwdEn :
- Bibliographic review, Cancer, Cancerology, Definition, Dose, Heterogeneity, Malignant tumor, Phase I trial, Reversibility, Targeted therapy, Toxicity, Treatment.

Abstract

Aim: There is no consensus about what constitutes a dose-limiting toxicity (DLT) in phase I cancer clinical trials. We aimed to evaluate how DLTs are defined in phase I trials of molecularly targeted agents (MTA). Methods: We retrieved all phase I trials testing monotherapy with an MTA published over the last decade. In each trial, all items used to define DLTs were recorded. Results: Reports of 155 phase I trials evaluating 111 different MTAs were reviewed. The most frequent determinant of whether a toxicity was regarded as a DLT was severity, usually assessed using the NCI CTCAE classification. However, for any given toxicity, there was substantial variability in the degree of severity required for a toxicity to be considered a DLT. Specifications about minimum duration of toxicity, degree of reversibility, the need to delay treatment and to reduce dose-intensity because of toxicity were infrequently incorporated in the definition of DLT. The definition of DLT varied with administration schedule. Discrepancies between the initial and the final definition of DLTwere reported in 25% of trials. Conclusions: While our results do not support a standardisation of the definition of DLT, the inclusion of following specifications in its definition when relevant would reduce the heterogeneity observed across trials: (1) DLT assessment period, (2) absolute severity according to NCI CTCAE classification as well as severity relative to baseline status, (3) minimum duration of toxicity, (4) reversibility of toxicity within a certain period of time, and (5) necessity to delay treatment or to reduce dose-intensity.

Affiliations:

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Le document en format XML

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<front><div type="abstract" xml:lang="en">Aim: There is no consensus about what constitutes a dose-limiting toxicity (DLT) in phase I cancer clinical trials. We aimed to evaluate how DLTs are defined in phase I trials of molecularly targeted agents (MTA). Methods: We retrieved all phase I trials testing monotherapy with an MTA published over the last decade. In each trial, all items used to define DLTs were recorded. Results: Reports of 155 phase I trials evaluating 111 different MTAs were reviewed. The most frequent determinant of whether a toxicity was regarded as a DLT was severity, usually assessed using the NCI CTCAE classification. However, for any given toxicity, there was substantial variability in the degree of severity required for a toxicity to be considered a DLT. Specifications about minimum duration of toxicity, degree of reversibility, the need to delay treatment and to reduce dose-intensity because of toxicity were infrequently incorporated in the definition of DLT. The definition of DLT varied with administration schedule. Discrepancies between the initial and the final definition of DLTwere reported in 25% of trials. Conclusions: While our results do not support a standardisation of the definition of DLT, the inclusion of following specifications in its definition when relevant would reduce the heterogeneity observed across trials: (1) DLT assessment period, (2) absolute severity according to NCI CTCAE classification as well as severity relative to baseline status, (3) minimum duration of toxicity, (4) reversibility of toxicity within a certain period of time, and (5) necessity to delay treatment or to reduce dose-intensity.</div>
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Heterogeneity in the definition of dose-limiting toxicity in phase I cancer clinical trials of molecularly targeted agents: A review of the literature

Heterogeneity in the definition of dose-limiting toxicity in phase I cancer clinical trials of molecularly targeted agents: A review of the literature

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri