Assessment of adherence and relative dose intensity with oral chemotherapy in oncology clinical trials at an academic medical center

Jeff A Engle; Anne M Traynor; Toby C Campbell; Kari B Wisinski; Noelle LoConte; Glenn Liu; George Wilding; Jill M Kolesar

doi:10.1177/1078155217704989

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Assessment of adherence and relative dose intensity with oral chemotherapy in oncology clinical trials at an academic medical center

Journal article

Peer reviewed

Assessment of adherence and relative dose intensity with oral chemotherapy in oncology clinical trials at an academic medical center

Jeff A Engle, Anne M Traynor, Toby C Campbell, Kari B Wisinski, Noelle LoConte, Glenn Liu, George Wilding and Jill M Kolesar

Journal of oncology pharmacy practice, Vol.24(5), pp.348-353

07/01/2018

DOI: 10.1177/1078155217704989

PMCID: PMC5932265

PMID: 28457192

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Abstract

Background/Aims Oral chemotherapy is increasingly utilized leaving the patient responsible for self-administering an often complex regimen where adverse effects are common. Non-adherence and reduced relative dose intensity are both associated with poorer outcomes in the community setting but are rarely reported in clinical trials. The purpose of this study is to quantify adherence and relative dose intensity in oncology clinical trials and to determine patient and study related factors that influence adherence and relative dose intensity. Methods Patients were identified from non-industry-funded clinical trials conducted between 1 January 2009 and 31 March 2013 at the University of Wisconsin Carbone Cancer Center. Data were extracted from primary research records. Descriptive statistics and linear regression modeling was performed using SAS 9.4. Results A total of 17 clinical trials and 266 subjects were included. Mean adherence was greater than 97% for the first eight cycles. Mean relative dose intensity was less than 90% for the first cycle and declined over time. Male gender, a performance status of 1 or 2, metastatic disease, and traveling more than 90 miles to reach the cancer center were associated with higher relative dose intensity. Conclusions Patients with cancer enrolled in clinical trials are highly adherent but unlikely to achieve protocol specified relative dose intensity. Given that determining the phase II dose is the primary endpoint of phase I trials, incorporating relative dose intensity into this determination should be considered.

Academic Medical Centers

Administration, Oral

Aged

Antineoplastic Agents - administration & dosage

Female

Humans

Male

Medication Adherence

Middle Aged

Neoplasms - drug therapy

Details

Title: Subtitle: Assessment of adherence and relative dose intensity with oral chemotherapy in oncology clinical trials at an academic medical center
Creators: Jeff A Engle - University of Wisconsin–Madison
Anne M Traynor - University of Wisconsin Carbone Cancer Center
Toby C Campbell - University of Wisconsin–Madison
Kari B Wisinski - University of Wisconsin Carbone Cancer Center
Noelle LoConte - University of Wisconsin Carbone Cancer Center
Glenn Liu - University of Wisconsin Carbone Cancer Center
George Wilding - The University of Texas MD Anderson Cancer Center
Jill M Kolesar - University of Kentucky
Resource Type: Journal article
Publication Details: Journal of oncology pharmacy practice, Vol.24(5), pp.348-353
DOI: 10.1177/1078155217704989
PMID: 28457192
PMCID: PMC5932265
NLM abbreviation: J Oncol Pharm Pract
ISSN: 1078-1552
eISSN: 1477-092X
Grant note: P30 CA177558 / NCI NIH HHS P30 CA014520 / NCI NIH HHS
Language: English
Date published: 07/01/2018
Academic Unit: Pharmacy; Pharmaceutical Sciences and Experimental Therapeutics
Record Identifier: 9984696554002771

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