Randomized Phase II Trial of Polyphenon E versus Placebo in Patients at High Risk of Recurrent Colonic Neoplasia
Rattachement africain : us, hu. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Abstract Polyphenon E (Poly E) is a green tea polyphenol preparation whose most active component is epigallocatechin gallate (EGCG). We studied the cancer preventive efficacy and safety of Poly E in subjects with rectal aberrant crypt foci (ACF), which represent putative precursors of colorectal cancers. Eligible subjects had prior colorectal advanced adenomas or cancers, and had ≥5 rectal ACF at a preregistration chromoendoscopy. Subjects (N = 39) were randomized to 6 months of oral Poly E (780 mg EGCG) daily or placebo. Baseline characteristics were similar by treatment arm (all P >0.41); 32 of 39 (82%) subjects completed 6 months of treatment. The primary endpoint was percent reduction in rectal ACF at chromoendoscopy comparing before and after treatment. Among 32 subjects (15 Poly E, 17 placebo), percent change in rectal ACF number (baseline vs. 6 months) did not differ significantly between study arms (3.7% difference of means; P = 0.28); total ACF burden was also similar (−2.3% difference of means; P = 0.83). Adenoma recurrence rates at 6 months were similar by arm (P > 0.35). Total drug received did not differ significantly by study arm; 31 (79%) subjects received ≥70% of prescribed Poly E. Poly E was well tolerated and adverse events (AE) did not differ significantly by arm. One subject on placebo had two grade 3 AEs; one subject had grade 2 hepatic transaminase elevations attributed to treatment. In conclusion, Poly E for 6 months did not significantly reduce rectal ACF number relative to placebo. Poly E was well tolerated and without significant toxicity at the dose studied. Prevention Relevance: We report a chemoprevention trial of polyphenon E in subjects at high risk of colorectal cancer. The results show that polyphenon E was well tolerated, but did not significantly reduce the number of rectal aberrant crypt foci, a surrogate endpoint biomarker of colorectal cancer.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Randomized Phase II Trial of Polyphenon E versus Placebo in Patients at High Risk of Recurrent Colonic Neoplasia
- Date Crossref
- 01/03/2021
- Éditeur
- American Association for Cancer Research (AACR)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
-
Mayo Clinic pays non établi dans la noticeÉtablissement de santé
-
Mayo Clinic in Arizona pays non établi dans la noticeÉtablissement de santé
-
Mayo Clinic in Florida pays non établi dans la noticeÉtablissement de santé
-
Semmelweis University pays non établi dans la noticeUniversité ou école supérieure
-
National Cancer Institute Division of Cancer Prevention pays non établi dans la noticeOrganisme public
-
The State University of New Jersey Rutgers pays non établi dans la noticeUniversité ou école supérieure
-
Jr. VA Hospital Edward Hines pays non établi dans la noticeÉtablissement de santé
-
Ernest Mario School of Pharmacy pays non établi dans la noticeUniversité ou école supérieure
Mayo Clinic, Mayo Clinic in Arizona et Mayo Clinic in Florida, avec 5 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.