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      Role of dietary polyamines in a phase III clinical trial of difluoromethylornithine (DFMO) and sulindac for prevention of sporadic colorectal adenomas

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          Abstract

          Background:

          The polyamine-inhibitory regimen difluoromethylornithine (DFMO)+sulindac has marked efficacy in preventing metachronous colorectal adenomas. Polyamines are synthesised endogenously and obtained from dietary sources. Here we investigate dietary polyamine intake and outcomes in the DFMO+sulindac colorectal adenoma prevention trial.

          Methods:

          Dietary polyamine data were available for 188 of 267 patients completing the study. Total dietary polyamine content was derived by the sum of dietary putrescine, spermine and spermidine values and categorised into two groups: highest (>75–100%) vs the lower three quartiles (0–25, 25–50 and 50–75%). Baseline tissue polyamine concentration and ODC1 genotype were determined. Logistic regression models were used for risk estimation.

          Results:

          A significant interaction was detected between dietary polyamine group and treatment with regard to adenoma recurrence ( P=0.012). Significant metachronous adenoma risk reduction was observed after DFMO+sulindac treatment in dietary polyamine quartiles 1–3 (risk ratio (RR) 0.19; 95% confidence interval (CI) 0.08–0.42; P<0.0001) but not in quartile 4 (RR 1.51; 95% CI 0.53–4.29; P=0.44). However, a lower number of events in the placebo group within dietary quartile 4 confound the aforementioned risk estimates.

          Conclusion:

          These preliminary findings reveal complex relationships between diet and therapeutic prevention, and they support further clinical trial-based investigations where the dietary intervention itself is controlled.

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          Author and article information

          Journal
          Br J Cancer
          Br. J. Cancer
          British Journal of Cancer
          Nature Publishing Group
          0007-0920
          1532-1827
          19 February 2013
          22 January 2013
          : 108
          : 3
          : 512-518
          Affiliations
          [1 ]Chao Family Comprehensive Cancer Center, University of California , Irvine, CA 92697, USA
          [2 ]Department of Medicine, University of California , Irvine, CA 92697, USA
          [3 ]Department of Epidemiology, University of California , Irvine, CA 92697, USA
          [4 ]Department of Family and Preventive Medicine, Cancer Prevention and Control Program, University of California , La Jolla, San Diego, CA 92093, USA
          [5 ]Department of Cell Biology and Anatomy, College of Medicine, Arizona Cancer Center , Tucson, AZ 85724, USA
          [6 ]Gastrointestinal Cancer Program, Arizona Cancer Center , Tucson, AZ 85724, USA
          Author notes
          Article
          bjc201315
          10.1038/bjc.2013.15
          3593561
          23340449
          6f5ad56c-326a-4876-aefd-4460ccc07394
          Copyright © 2013 Cancer Research UK

          From twelve months after its original publication, this work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/

          History
          : 29 August 2012
          : 11 December 2012
          : 16 December 2012
          Categories
          Clinical Study

          Oncology & Radiotherapy
          adenomas,diet,dfmo,eflornithine,polyamines,sulindac
          Oncology & Radiotherapy
          adenomas, diet, dfmo, eflornithine, polyamines, sulindac

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