1. Community Nursing Research Day
Thursday, March 19th, 2015
Bott Building – Michigan State University
Undergraduate Student Abstract-Michigan State University College of Nursing
Title: Secondary Analysis of Oral Anti-cancer Agent Prescription Dosages and FDA
Recommendations
Authors and Affiliations: Shane Doane, Undergraduate Professorial Assistant & Honors
College Scholar; 1 Monica Schueller, BA; 1 and Sandra Spoelstra, PhD, RN; 1 (1) College of
Nursing at Michigan State University, East Lansing, MI
Corresponding author: Shane Doane
Undergraduate Professorial Assistant, Honors College Student
Michigan State University College of Nursing
1355 Bogue Street, Room C340, East Lansing, MI 48824
Phone: 616-536-2329 Email: doanesha@msu.edu
Second author: Monica Schueller, BA
Michigan State University College of Nursing
1355 Bogue Street, Room C340N, East Lansing, MI 48824
Phone: 517-884-4641 Email: Monica.Schueller@hc.msu.edu
Third author: Sandra Spoelstra PhD, RN (Primary Investigator)
Michigan State University College of Nursing
1355 Bogue Street, Room 342, East Lansing, MI 48824
Phone: 517-353-8681 Email: spoelst5@msu.edu
Acknowledgements, credits or disclaimers: This research was supported by grants entitled:
Text Messaging to Improve Symptom Management and Adherence to Oral Chemotherapy Agents
from the McKesson Foundation Inc., Mobilizing for Health Grant Program, in San Francisco,
California; and Text Messaging to Improve Adherence to Oral Chemotherapy Agents from the
National Cancer Institute (Grant Number 1R15CA176595).
Citation: Doane, S., Schueller, M., Spoelstra, S. (To Be Submitted) Secondary Analysis of Oral
Anticancer Agent Prescribed and FDA Recommended Dosagess. Greater Lansing Community
Nursing Research Day, East Lansing, MI on March 19, 2015.
2. ABSTRACT
Title: Secondary Analysis of Oral Anti-cancer Agent Prescription Dosages and FDA
Recommendations
Authors: S. Doane; M. Schueller; and S. Spoelstra
Purpose: The use of oral anti-cancer agents (OAs) is a newer treatment paradigm, and limited
evidence is available on oncologist prescribing patterns. Therapeutically effective dosages of
OAs must be prescribed, to assure effectiveness of the cancer treatment. The purpose of this
secondary analysis was to compare prescribed and FDA recommended OA dosages among
cancer patients prescribed treatment in oral form.
Designand Methodology: This is a secondary analysis of data from two randomized controlled
trails on text messaging to promote OA adherence. Inclusion criteria were: >21 years of age;
diagnosed with cancer; and prescribed an OA for treatment.
Data Analysis: Data on demographics and OA prescriptions were collected and compiled from
baseline interviews. Dosage recommendation data were taken from the FDA website. For this
analysis, dosages were measured in total dosage per 24 hour time period.
Results: 155 patients prescribed 28 different OAs were examined. Mean age was 59.3 years
(standard deviation [SD] 10.32; range 33-82); 57.4% (n=89) were female; 85.8% (n=133)
Caucasian, 10.3% (n=16) African-American, 3.9% (n=6) other, multi-racial, or not reported.
Mean number of comorbid conditions was 1.63 (SD=1.49). Of the 110 patients who had their
cancer staged, 65.5% (n=72) were Stage IV. .
Of the 155 patients, 55.5% (n=86) were prescribed the daily FDA recommended dosage of their
OA; 19.4% (n=30) were prescribed more than the FDA recommended dose; and 25.2% (n=39)
were prescribed less than the FDA recommended dose.
The most common OA prescribed was capecitabine (35.5%, n=55 of 155), most often for breast
or colorectal cancer; with 3 of the 55 patients (5.5%) prescribed the FDA recommended total
dosage. Of those 55 patient on capecitabine, 54.5% (n=30) were prescribed more and 40.0%
(n=22) less than the FDA recommended dosage. The other 14 drugs prescribed less than FDA
recommended dosage included: lenalidomide (n=6); sutent (n=2); axitinib (n=2); temozolmide
(n=1); sorafenib (n=1); erlotinib (n=1); and imatinib (n=1).
Implications for Nursing Practice: One limitation of this study is that we were not aware of the
clinical condition or weight of the patients. However, nurses should be aware of FDA
recommended dosages for patients prescribed OAs under their treatment, as patients receiving
dosages that exceed the FDA recommended may experience increased side effects and adverse
events and may need closer observation.
![ABSTRACT
Title: Secondary Analysis of Oral Anti-cancer Agent Prescription Dosages and FDA
Recommendations
Authors: S. Doane; M. Schueller; and S. Spoelstra
Purpose: The use of oral anti-cancer agents (OAs) is a newer treatment paradigm, and limited
evidence is available on oncologist prescribing patterns. Therapeutically effective dosages of
OAs must be prescribed, to assure effectiveness of the cancer treatment. The purpose of this
secondary analysis was to compare prescribed and FDA recommended OA dosages among
cancer patients prescribed treatment in oral form.
Designand Methodology: This is a secondary analysis of data from two randomized controlled
trails on text messaging to promote OA adherence. Inclusion criteria were: >21 years of age;
diagnosed with cancer; and prescribed an OA for treatment.
Data Analysis: Data on demographics and OA prescriptions were collected and compiled from
baseline interviews. Dosage recommendation data were taken from the FDA website. For this
analysis, dosages were measured in total dosage per 24 hour time period.
Results: 155 patients prescribed 28 different OAs were examined. Mean age was 59.3 years
(standard deviation [SD] 10.32; range 33-82); 57.4% (n=89) were female; 85.8% (n=133)
Caucasian, 10.3% (n=16) African-American, 3.9% (n=6) other, multi-racial, or not reported.
Mean number of comorbid conditions was 1.63 (SD=1.49). Of the 110 patients who had their
cancer staged, 65.5% (n=72) were Stage IV. .
Of the 155 patients, 55.5% (n=86) were prescribed the daily FDA recommended dosage of their
OA; 19.4% (n=30) were prescribed more than the FDA recommended dose; and 25.2% (n=39)
were prescribed less than the FDA recommended dose.
The most common OA prescribed was capecitabine (35.5%, n=55 of 155), most often for breast
or colorectal cancer; with 3 of the 55 patients (5.5%) prescribed the FDA recommended total
dosage. Of those 55 patient on capecitabine, 54.5% (n=30) were prescribed more and 40.0%
(n=22) less than the FDA recommended dosage. The other 14 drugs prescribed less than FDA
recommended dosage included: lenalidomide (n=6); sutent (n=2); axitinib (n=2); temozolmide
(n=1); sorafenib (n=1); erlotinib (n=1); and imatinib (n=1).
Implications for Nursing Practice: One limitation of this study is that we were not aware of the
clinical condition or weight of the patients. However, nurses should be aware of FDA
recommended dosages for patients prescribed OAs under their treatment, as patients receiving
dosages that exceed the FDA recommended may experience increased side effects and adverse
events and may need closer observation.](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)