| Autor: |
S. Frank-Gleich, Katharina L. Schneider, Thomas J. Ettrich, Julia C. Stingl, S. Menzler, Friederike Rohlmann, F. Odemar, Lukas Perkhofer, Alexander Zipprich, Helmut Messmann, Hana Algül, Rainer Muche, U. Hügle, T. Heuer, G. Kleber, R. Behrens, K. Metter, Catharina Scholl, Thomas Seufferlein |
| Rok vydání: |
2019 |
| Předmět: |
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| Zdroj: |
Annals of Oncology. 30:v869 |
| ISSN: |
0923-7534 |
| Popis: |
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. Legal entity responsible for the study Martin-Luther-Universitat Halle-Wittenberg, Germany. Funding German Cancer Aid (Stiftung Deutsche Krebshilfe). Disclosure All authors have declared no conflicts of interest. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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