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. 2021 Mar 26;21(1):324.
doi: 10.1186/s12885-021-08050-w.

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

Lauren A Marcath  1 , Colin M Finley  2 , Siu Fun Wong  3 , Daniel L Hertz  4
Affiliations

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

Lauren A Marcath et al. BMC Cancer. .

Abstract

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.

Keywords: Oncology clinical trial drug interaction.

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Conflict of interest statement

LAM and DLH are working with PEPID LLC to create a drug interaction screening tool for use during clinical trial enrollment. PEPID LLC was not involved in the design, conduct, analysis, or sponsorship of this trial, and had no contribution to the writing of this manuscript. This work was accepted for poster presentation at the 2019 American College of Clinical Pharmacology Annual Meeting. The SWOG Statistics and Data Management Center (CA180819) and SWOG Network Group Operations Center of the NCTN (CA180888) provided the retrospective data to the co-authors of this study.

Figures

Fig. 1
Fig. 1
Prevalence of Clinically Relevant Interactions from Lexicomp® and Protocol-Guided Screening. a. Protocol-guided screening detected drug-drug interactions (DDI) in 18.6% of subjects. b. Lexicomp® detected DDI in 28.7% of subjects. The same subset of interactions detected by protocol-guided screening and Lexicomp® were considered clinically relevant
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