How to report toxicity associated with ...
Document type :
Article dans une revue scientifique: Article original
DOI :
PMID :
Permalink :
Title :
How to report toxicity associated with targeted therapies?
Author(s) :
Cabarrou, B. [Auteur]
Boher, Jean Marie [Auteur]
Bogart, Emilie [Auteur]
Tresch-Bruneel, Emmanuelle [Auteur]
Penel, Nicolas [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Ravaud, A. [Auteur]
Escudier, B. [Auteur]
Mahier Ait-Oukhatar, C. [Auteur]
Delord, J. P. [Auteur]
Roche, H. [Auteur]
Filleron, T. [Auteur]
Boher, Jean Marie [Auteur]
Bogart, Emilie [Auteur]
Tresch-Bruneel, Emmanuelle [Auteur]
Penel, Nicolas [Auteur]

METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Ravaud, A. [Auteur]
Escudier, B. [Auteur]
Mahier Ait-Oukhatar, C. [Auteur]
Delord, J. P. [Auteur]
Roche, H. [Auteur]
Filleron, T. [Auteur]
Journal title :
Annals of oncology . official journal of the European Society for Medical Oncology
Abbreviated title :
Ann. Oncol.
Volume number :
27
Pages :
1633-1638
Publication date :
2016-08-01
ISSN :
0923-7534
English keyword(s) :
target therapy
Q-TWiST
prevalence
worst grade
toxicity analysis
Q-TWiST
prevalence
worst grade
toxicity analysis
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
In the era of personalized medicine, molecularly targeted therapies (MTT) have modified the outcome of some cancer types. The price of tumor control needs to be balanced with toxicity since these new therapies are administered ...
Show more >In the era of personalized medicine, molecularly targeted therapies (MTT) have modified the outcome of some cancer types. The price of tumor control needs to be balanced with toxicity since these new therapies are administered continuously for several months or sometimes for several years. For cytotoxic drugs, the incidence of adverse event (AE) was traditionally reported as frequency and intensity. This simple measure is not sufficient to capture the recurrent nature and duration of AE. This paper presents two methods to better describe the toxicity burden across the time: prevalence and Q-TWiST. Limitation of worst-grade method and advantages of prevalence and Q-TWiST in the analysis of toxicity were illustrated using data from a phase II trial and a hypothetically simulated clinical trial. Prevalence integrates the recurrent nature of AE. Using prevalence, it is possible to obtain a time profile of AE. Q-TWiST method evaluates the weighted time spent in each health state and also considers the recurrent nature of side-effects in order to assess the 'risk-benefit' ratio of a treatment. When interpreting Q-TWiST results, it is necessary to take into account overall survival and progression-free survival and to define a clinically relevant difference according to the setting. The two methods presented here capture different effects. They are helpful for physicians in their treatment choice (balance benefit risk), to counsel patients and to optimize supportive care. In order to ensure consistency and provide critical information required for medical decision-making, it is important to encourage the use of alternative statistical methods in the analysis of toxicities associated with MTT. NCT00541008.Show less >
Show more >In the era of personalized medicine, molecularly targeted therapies (MTT) have modified the outcome of some cancer types. The price of tumor control needs to be balanced with toxicity since these new therapies are administered continuously for several months or sometimes for several years. For cytotoxic drugs, the incidence of adverse event (AE) was traditionally reported as frequency and intensity. This simple measure is not sufficient to capture the recurrent nature and duration of AE. This paper presents two methods to better describe the toxicity burden across the time: prevalence and Q-TWiST. Limitation of worst-grade method and advantages of prevalence and Q-TWiST in the analysis of toxicity were illustrated using data from a phase II trial and a hypothetically simulated clinical trial. Prevalence integrates the recurrent nature of AE. Using prevalence, it is possible to obtain a time profile of AE. Q-TWiST method evaluates the weighted time spent in each health state and also considers the recurrent nature of side-effects in order to assess the 'risk-benefit' ratio of a treatment. When interpreting Q-TWiST results, it is necessary to take into account overall survival and progression-free survival and to define a clinically relevant difference according to the setting. The two methods presented here capture different effects. They are helpful for physicians in their treatment choice (balance benefit risk), to counsel patients and to optimize supportive care. In order to ensure consistency and provide critical information required for medical decision-making, it is important to encourage the use of alternative statistical methods in the analysis of toxicities associated with MTT. NCT00541008.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
CHU Lille
Université de Lille
Université de Lille
Submission date :
2019-12-09T18:15:19Z