학술논문

Potential cytochrome P-450 drug-drug interactions in adults with metastatic solid tumors and effect on eligibility for Phase I clinical trials.
Document Type
Article
Source
American Journal of Health-System Pharmacy. 6/1/2015, Vol. 72 Issue 11, p958-965. 8p. 6 Charts.
Subject
*CHI-squared test
*CLINICAL trials
*CONFIDENCE intervals
*DRUG interactions
*HEME
*ISOENZYMES
*METASTASIS
*RESEARCH funding
*LOGISTIC regression analysis
*HUMAN research subjects
*CROSS-sectional method
*RETROSPECTIVE studies
*PATIENT selection
*DATA analysis software
*DESCRIPTIVE statistics
*ODDS ratio
*CHEMICAL inhibitors
Language
ISSN
1079-2082
Abstract
Purpose. Potential cytochrome P-450 (CYP) drug-drug interactions in adults with metastatic solid tumors and their effect on eligibility for Phase I clinical trials were characterized. Methods. This study included adult patients with metastatic solid tumors seen by a medical oncologist from January 2008 through July 2011. The medications used by these patients were identified. Each medication's potential for interacting with CYP isozymes was also characterized. Medication changes required to meet Phase I trial eligibility criteria were also reviewed. Results. Data from 1773 patients were analyzed: 1489 were not enrolled in a Phase I trial and 284 were enrolled in a Phase I trial. Polypharmacy was significantly more prevalent in the group enrolled in a Phase I trial compared with those not enrolled (95% versus 80%, p < 0.001). The majority of patients not enrolled in a Phase I trial were taking at least one CYP isozyme inhibitor (87%) and at least one CYP isozyme inducer (45%). In a separate analysis, four Phase I trials were evaluated. Of 295 screened patients, 3.2% could not enroll due to concurrent medications. Charts from 74 enrolled patients revealed 655 concurrent medications—93 medications required further review for eligibility involving 51 (69%) of patients. Of the 93 medications, 38 (41%) were stopped and 41 (44%) were changed for the study. Conclusion. Polypharmacy and the use of medications that interact with CYP isoyzmes were common in adult patients with metastatic solid tumors. Patients enrolling in Phase I studies often require medication changes to meet eligibility requirements. [ABSTRACT FROM AUTHOR]