Identification of high-risk drugs related to chemotherapy-induced peripheral neuropathy in Cancer Therapy Evaluation Program-sponsored phase I trials.
Adult
Adverse Drug Reaction Reporting Systems
Aged
Aged, 80 and over
Angiogenesis Inhibitors
/ adverse effects
Antineoplastic Agents
/ adverse effects
Clinical Trials, Phase I as Topic
Databases, Factual
Female
Humans
Incidence
Male
Middle Aged
National Cancer Institute (U.S.)
Peripheral Nervous System
/ drug effects
Peripheral Nervous System Diseases
/ chemically induced
Platinum Compounds
/ adverse effects
Proteasome Inhibitors
/ adverse effects
Risk Assessment
Risk Factors
Severity of Illness Index
Thalidomide
/ adverse effects
Tubulin Modulators
/ adverse effects
United States
Adverse events
Bortezomib
CIPN
Chemotherapy-induced peripheral neuropathy
Ixabepilone
Paclitaxel
Phase I
Journal
European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373
Informations de publication
Date de publication:
07 2019
07 2019
Historique:
received:
12
02
2019
revised:
11
04
2019
accepted:
13
04
2019
pubmed:
28
5
2019
medline:
2
6
2020
entrez:
28
5
2019
Statut:
ppublish
Résumé
Chemotherapy-induced peripheral neuropathy (CIPN) is a significant and debilitating side effect. However, there have been no studies of the relative risk of CIPN with known causative agents. We examined the risk of CIPN in patients taking such agents as a part of the National Cancer Institute (NCI) Cancer Therapy Evaluation Program-sponsored phase I trials. CIPN events in each patient were graded according to the Clinical Terminology of Common Adverse Effects and compared among several high-risk chemotherapeutic agent groups, adjusting for possible confounding factors. Patients receiving tubulin-targeted agents were analysed separately for specific background factors associated with CIPN. In 135 phase I clinical trials, 259 of 3614 patients were identified as developing CIPN during chemotherapy. Tubulin-targeting agents and proteasome inhibitors were identified as high-risk agents (hazard ratio 9.04 and 5.01, respectively) for CIPN, whereas platinum-complex agents and thalidomide analogues imparted lower risk (hazard ratio 1.52 and 1.11, respectively). Age, sex and medical history of diabetes were not significantly related to CIPN. CIPN developed over time as the number of chemotherapy cycles increased. Among patients with CIPN, treatment with tubulin-targeting agents resulted in a significantly higher rate of chemotherapy schedule modification compared with treatments with other chemotherapeutic agents. Tubulin-targeting agents and proteasome inhibitors were associated with a greatly increased risk of CIPN compared with other agents. CIPN tended to develop in later chemotherapy cycles. These findings will help to minimise the risk of CIPN by encouraging increased surveillance and earlier dose adjustment of high-risk agents in phase I trials.
Sections du résumé
BACKGROUND
Chemotherapy-induced peripheral neuropathy (CIPN) is a significant and debilitating side effect. However, there have been no studies of the relative risk of CIPN with known causative agents. We examined the risk of CIPN in patients taking such agents as a part of the National Cancer Institute (NCI) Cancer Therapy Evaluation Program-sponsored phase I trials.
METHODS
CIPN events in each patient were graded according to the Clinical Terminology of Common Adverse Effects and compared among several high-risk chemotherapeutic agent groups, adjusting for possible confounding factors. Patients receiving tubulin-targeted agents were analysed separately for specific background factors associated with CIPN.
RESULTS
In 135 phase I clinical trials, 259 of 3614 patients were identified as developing CIPN during chemotherapy. Tubulin-targeting agents and proteasome inhibitors were identified as high-risk agents (hazard ratio 9.04 and 5.01, respectively) for CIPN, whereas platinum-complex agents and thalidomide analogues imparted lower risk (hazard ratio 1.52 and 1.11, respectively). Age, sex and medical history of diabetes were not significantly related to CIPN. CIPN developed over time as the number of chemotherapy cycles increased. Among patients with CIPN, treatment with tubulin-targeting agents resulted in a significantly higher rate of chemotherapy schedule modification compared with treatments with other chemotherapeutic agents.
CONCLUSIONS
Tubulin-targeting agents and proteasome inhibitors were associated with a greatly increased risk of CIPN compared with other agents. CIPN tended to develop in later chemotherapy cycles. These findings will help to minimise the risk of CIPN by encouraging increased surveillance and earlier dose adjustment of high-risk agents in phase I trials.
Identifiants
pubmed: 31132741
pii: S0959-8049(19)30277-1
doi: 10.1016/j.ejca.2019.04.023
pmc: PMC8170839
mid: NIHMS1528679
pii:
doi:
Substances chimiques
Angiogenesis Inhibitors
0
Antineoplastic Agents
0
Platinum Compounds
0
Proteasome Inhibitors
0
Tubulin Modulators
0
Thalidomide
4Z8R6ORS6L
Types de publication
Comparative Study
Journal Article
Research Support, N.I.H., Intramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
111-119Subventions
Organisme : Intramural NIH HHS
ID : Z01 BC010476
Pays : United States
Organisme : Intramural NIH HHS
ID : Z99 CA999999
Pays : United States
Organisme : Intramural NIH HHS
ID : ZIA BC010476
Pays : United States
Informations de copyright
Published by Elsevier Ltd.
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