Abstract | BACKGROUND: METHODS: Our analysis included subjects enrolled in the phase III colorectal adenoma prevention clinical trial investigating DFMO + sulindac versus placebo. Patients were classified by obesity (body mass index, BMI ≥ 30 kg/m(2)) status at baseline. Pearson χ(2) statistic and Mann-Whitney U test were used to compare baseline characteristics, including rectal tissue polyamine levels. Log-binomial regression analysis was used to determine the risk ratio (RR) of recurrent adenomas, adjusted for covariates and an interaction term for obesity and treatment. RESULTS: The final analytic cohort was comprised of 267 patients. In separate regression models, the risk of adenoma recurrence after treatment compared to placebo was similar for obese (RR = 0.32, 95 % CI 15-71) and non-obese patients (RR = 0.27, 95 % CI 15-49). No significant interaction was detected between obesity, treatment, and risk of colorectal adenoma in the full regression model (p (interaction) = 0.91). CONCLUSIONS:
Obesity does not substantially modify the colorectal adenoma risk reduction ascribed to DFMO + sulindac versus placebo.
|
Authors | Jason A Zell, Bruce S Lin, Nikki Madson, Christine E McLaren, Eugene W Gerner, Frank L Meyskens |
Journal | Cancer causes & control : CCC
(Cancer Causes Control)
Vol. 23
Issue 10
Pg. 1739-44
(Oct 2012)
ISSN: 1573-7225 [Electronic] Netherlands |
PMID | 22907422
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Polyamines
- Sulindac
- Eflornithine
|
Topics |
- Adenoma
(prevention & control)
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, therapeutic use)
- Colorectal Neoplasms
(drug therapy, prevention & control)
- Double-Blind Method
- Eflornithine
(administration & dosage)
- Female
- Humans
- Male
- Middle Aged
- Obesity
(drug therapy, metabolism)
- Placebo Effect
- Polyamines
(metabolism)
- Regression Analysis
- Sulindac
(administration & dosage)
- Treatment Outcome
|