Drug-drug interactions in subjects enrolled in SWOG trials of oral chemotherapy

Background Patients with cancer are at increased risk of drug-drug interactions (DDI), which can increase treatment toxicity or decrease efficacy. It is especially important to thoroughly screen DDI in oncology clinical trial subjects to ensure trial subject safety and data accuracy. This study dete...

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Veröffentlicht in:BMC cancer Jg. 21; H. 1; S. 324 - 6
Hauptverfasser: Marcath, Lauren A., Finley, Colin M., Wong, Siu Fun, Hertz, Daniel L.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: London BioMed Central 26.03.2021
BioMed Central Ltd
Springer Nature B.V
BMC
Schlagworte:
Acids
Administration, Oral
Analgesics
Antacids
Antimitotic agents
Antineoplastic agents
Antineoplastic Agents - therapeutic use
Biomedical and Life Sciences
Biomedicine
Cancer
Cancer Research
Cancer therapies
Chemotherapy
Clinical trials
Complications and side effects
Contraindications
Drug interactions
Drug Interactions - physiology
Enrollments
Epidemiology
Female
Health Promotion and Disease Prevention
Humans
Inhibitor drugs
Male
Medicine/Public Health
Neoplasms - drug therapy
Oncology
Oncology clinical trial drug interaction
Oral cancer
Oral medication
Patient safety
Pharmaceutical research
prevention and public health
Research Article
Standard deviation
Statistical analysis
Surgical Oncology
Testing
Toxicity
United States
Oncology clinical trial drug interaction
ISSN:1471-2407, 1471-2407
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Zusammenfassung:Background Patients with cancer are at increased risk of drug-drug interactions (DDI), which can increase treatment toxicity or decrease efficacy. It is especially important to thoroughly screen DDI in oncology clinical trial subjects to ensure trial subject safety and data accuracy. This study determined the prevalence of potential DDI involving oral anti-cancer trial agents in subjects enrolled in two SWOG clinical trials. Methods Completed SWOG clinical trials of commercially available agents with possible DDI that had complete concomitant medication information available at enrollment were included. Screening for DDI was conducted through three methods: protocol-guided screening, Lexicomp® screening, and pharmacist determination of clinical relevance. Descriptive statistics were calculated. Results SWOG trials S0711 (dasatinib, n  = 83) and S0528 (everolimus/lapatinib, n  = 84) were included. Subjects received an average of 6.6 medications (standard deviation = 4.9, range 0–29) at enrollment. Based on the clinical trial protocols, at enrollment 18.6% (31/167) of subjects had a DDI and 12.0% (20/167) had a DDI that violated a protocol exclusion criterion. According to Lexicomp®, 28.7% of subjects (48/167) had a DDI classified as moderate or worse, whereas pharmacist review indicated that 7.2% of subjects (12/167) had a clinically relevant interaction. The majority of clinically relevant DDI identified were due to the coadministration of acid suppression therapies with dasatinib (83.3%, 10/12). Conclusions The high DDI prevalence in subjects enrolled on SWOG clinical trials, including a high prevalence that violate trial exclusion criteria, support the need for improved processes for DDI screening to ensure trial subject safety and trial data accuracy.
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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ISSN:1471-2407
1471-2407
DOI:10.1186/s12885-021-08050-w