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.

中文翻译：

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Polyphenon E 与安慰剂在复发性结肠肿瘤高风险患者中的随机 II 期试验

Polyphenon E (Poly E) 是一种绿茶多酚制剂，其最有效的成分是表没食子儿茶素没食子酸酯 (EGCG)。我们研究了 Poly E 在直肠异常隐窝灶 (ACF) 受试者中的癌症预防功效和安全性，ACF 代表了结肠直肠癌的假定前体。符合条件的受试者既往患有结直肠晚期腺瘤或癌症，并且在预先登记的色素内镜检查中具有≥5 个直肠 ACF。受试者 (N = 39) 被随机分配到每天口服 Poly E (780 mg EGCG) 或安慰剂 6 个月。治疗组的基线特征相似（所有 P > 0.41）；39 名受试者中有 32 名（82%）完成了 6 个月的治疗。主要终点是与治疗前后相比，色素内镜检查时直肠 ACF 减少的百分比。在 32 名受试者（15 名 Poly E，17 名安慰剂）中，直肠 ACF 数量的百分比变化（基线 vs. 6 个月）在研究组之间没有显着差异（均值差异 3.7%；P = 0.28）；总 ACF 负担也相似（均值差异 -2.3%；P = 0.83）。6 个月时的腺瘤复发率各组相似（ P > 0.35）。研究组接受的药物总量没有显着差异；31 名 (79%) 受试者接受了≥70% 的处方 Poly E。Poly E 耐受性良好，不良事件 (AE) 各组之间没有显着差异。一名服用安慰剂的受试者有两个 3 级 AE；一名受试者因治疗而出现 2 级肝转氨酶升高。总之，与安慰剂相比，Poly E 6 个月没有显着减少直肠 ACF 数量。在所研究的剂量下，Poly E 具有良好的耐受性并且没有明显的毒性。预防相关：我们报告了一项针对结肠直肠癌高风险受试者的多酚 E 化学预防试验。结果表明，polyphenon E 具有良好的耐受性，但并未显着减少直肠异常隐窝病灶（结肠直肠癌的替代终点生物标志物）的数量。