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Open Access 01-12-2021 | Proton Pump Inhibitors | Research article

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

Authors: Lauren A. Marcath, Colin M. Finley, Siu Fun Wong, Daniel L. Hertz

Published in: BMC Cancer | Issue 1/2021

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.

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Title: Drug-drug interactions in subjects enrolled in SWOG trials of oral chemotherapy
Authors: Lauren A. Marcath
Colin M. Finley
Siu Fun Wong
Daniel L. Hertz
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Proton Pump Inhibitors
Antacid
Dasatinib
Lapatinib
Published in: BMC Cancer / Issue 1/2021
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-021-08050-w

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Abstract

Background

Methods

Results

Conclusions

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