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Proffered Paper 2 – Gastrointestinal tumours, colorectal

1890 - MIRACLE: Green tea extract versus placebo for the prevention of colorectal adenomas: a randomized, controlled trial

Date

30 Sep 2019

Session

Proffered Paper 2 – Gastrointestinal tumours, colorectal

Topics

Tumour Site

Colon and Rectal Cancer

Presenters

Thomas Seufferlein

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

T. Seufferlein1, T.J. Ettrich2, S. Menzler3, H. Messmann4, G. Kleber5, A. Zipprich6, S. Frank-Gleich7, H. Algül8, K. Metter9, F. Odemar10, T. Heuer11, U. Hügle12, R. Behrens13, L. Perkhofer2, C. Scholl14, K.L. Schneider14, F. Rohlmann15, R. Muche15, J.C. Stingl16

Author affiliations

  • 1 Department Of Internal Medicine I  , Ulm University Hospital, 89081 - Ulm/DE
  • 2 Department Of Internal Medicine I, Ulm University Hospital, 89081 - Ulm/DE
  • 3 Private Practice, Praxis Klinik Marburg, Marburg/DE
  • 4 Internal Medicine Iii, Augsburg University Hospital, Augsburg/DE
  • 5 First Department Of Medicine, Ostalbklinikum Aalen, 73430 - Aalen/DE
  • 6 Internal Medicine I, Martin-Luther-University Halle-Wittenberg, Halle/DE
  • 7 Private Practice, Onkologie Halle, Halle/DE
  • 8 Department Of Internal Medicine I, Technical University Munich, Munich/DE
  • 9 Department Of Gastroenterology, Alb-Fils-Kliniken, Göppingen/DE
  • 10 Internal Medicine, Amos Klinikum Bernburg, Bernburg/DE
  • 11 Internal Medicine I, St. Bernhard-Hospital, Kamp-Lintfort/DE
  • 12 Gastroenterology, Krankenhaus Köln-Holweide, Cologne/DE
  • 13 Private Practice, Gastroenterologisch-onkologische Praxisklinik, Halle/DE
  • 14 Research Division, Federal Institute of Drugs and Medical Devices, Bonn/DE
  • 15 Institute Of Epidemiology And Medical Biometry, Ulm University, Ulm/DE
  • 16 Centre For Translational Medicine, University Of Bonn Medical School, Federal Institute for Drugs and Medical Devices, Bonn/DE
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Abstract 1890

Background

Prevention of colorectal adenomas (CA) is likely to prevent colorectal cancer (CRC). Nutri- or chemoprevention of CRC is not yet established. NSAIDs show some benefit but also increase the bleeding risk. Agents with a more favourable benefit/risk ratio are desirable. Preclinical and small clinical trials suggest that epigallocatechingallate (EGCG), a major polyphenol in green tea, has a good safety profile and antineoplastic effects in the large bowel, but there are no data from large trials. MIRACLE enrolled 1001 patients to examine the effect of a three year intake of ECGC on the recurrence of CA after polypectomy.

Methods

Double-blinded, placebo-controlled trial, 41 recruiting German centers, recruitment 12/2011-6/2015. Patients aged 50-80 years who underwent polypectomy within the last 6 months and tolerated EGCG well during a one month run-in were randomized to standardized decaffeinated EGCG (150 mg bid) or placebo for 3 years. Primary endpoint: Incidence of metachronous CA at the 3 year follow-up colonoscopy. Secondary endpoints: Occurrence, number, localization, size, histological subtype of CA, frequency of CRC and biomarker. Strata: Study center and intake of low-dose aspirin (≤100 mg/d).

Results

Clinical parameters were well balanced between the groups. Primary endpoint was analysed in the modified ITT set (modITT; n = 309 patients in EGCG, n = 323 in placebo group giving informed consent and undergoing 3 year follow up colonoscopy in the requested time frame). n = 102 patients in the EGCG and n = 103 in the placebo group were excluded due to missing follow up colonoscopy. Incidence of one or more CA after 3 year of placebo or EGCG 150 mg bid was 55.7 % and 51.1%, respectively (one sided adj. P = 0.077, adj. RR 0.904) in the modITT. In the per protocol set constituting all modITT patients completing the study without major protocol violations the respective figures were 54.3 % in the placebo and 48.3% in the EGCG group (one sided adj. P = 0.058, adj. RR 0.883). There were no safety issues and no major differences in AEs between EGCG and placebo during the randomized phase.

Conclusions

300 mg EGCG per day was well tolerated and showed a trend towards a preventive effect on CA in the large bowel though not statistically significant.

Clinical trial identification

NCT01360320.

Editorial acknowledgement

Legal entity responsible for the study

Martin-Luther-Universität Halle-Wittenberg, Germany.

Funding

German Cancer Aid (Stiftung Deutsche Krebshilfe).

Disclosure

All authors have declared no conflicts of interest.

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