Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA.
Cancer. 2013 Jan 15;119(2):363-70. doi: 10.1002/cncr.27719. Epub 2012 Jul 3.
The objective of the current study was to follow up the results of phase 1 testing by evaluating the clinical efficacy of the green tea extract Polyphenon E for patients with early stage chronic lymphocytic leukemia (CLL).
Previously untreated patients with asymptomatic, Rai stage 0 to II CLL and an absolute lymphocyte count (ALC) ≥ 10 × 10(9) /L were eligible for this phase 2 trial. Polyphenon E with a standardized dose of epigallocatechin gallate (EGCG) (2000 mg per dose) was administered twice daily.
A total of 42 patients received Polyphenon E at a dose of 2000 mg twice daily for up to 6 months. Of these patients, 29 (69%) had Rai stage I to II disease. Patients received a median of 6 cycles of treatment (range, 1 cycle-6 cycles). The most common grade 3 side effects (according to National Cancer Institute Common Terminology Criteria for Adverse Events) were transaminitis (1 patient), abdominal pain (1 patient), and fatigue (1 patient). Clinical activity was observed, with 13 patients (31%) experiencing a sustained reduction of ≥ 20% in the ALC and 20 of 29 patients (69%) with palpable adenopathy experiencing at least a 50% reduction in the sum of the products of all lymph node areas. EGCG plasma levels after 1 month of therapy were found to be correlated with reductions in lymphadenopathy (correlation co-efficient, 0.44; P = .02). Overall, 29 patients (69%) fulfilled the criteria for a biologic response with either a sustained decline ≥ 20% in the ALC and/or a reduction ≥ 30% in the sum of the products of all lymph node areas at some point during the 6 months of active treatment.
Daily oral EGCG in the Polyphenon E preparation was well tolerated by patients with CLL in this phase 2 trial. Durable declines in the ALC and/or lymphadenopathy were observed in the majority of patients.
本研究旨在延续 1 期临床试验结果，评估绿茶提取物 Polyphenon E 对早期慢性淋巴细胞白血病（CLL）患者的临床疗效。
符合本 2 期试验条件的患者为无症状、Rai 分期 0 至 II 期且绝对淋巴细胞计数（ALC）≥10×10(9)/L 的初治患者。给予标准化剂量表没食子儿茶素没食子酸酯（EGCG）（2000mg/剂）的 Polyphenon E，每日两次。
共 42 例患者接受了 2000mg 每日两次的 Polyphenon E 剂量治疗，最长达 6 个月。其中 29 例（69%）患者的 Rai 分期为 I 期至 II 期疾病。患者接受中位数为 6 个周期的治疗（范围：1 个周期至 6 个周期）。最常见的 3 级不良事件（根据国家癌症研究所不良事件通用术语标准）为转氨酸血症（1 例）、腹痛（1 例）和乏力（1 例）。观察到临床活性，13 例（31%）患者的 ALC 持续降低≥20%，29 例患者中有 20 例（69%）可触及的淋巴结肿大患者的所有淋巴结区域产品之和至少降低 50%。治疗 1 个月后的 EGCG 血浆水平与淋巴结病的减少相关（相关系数，0.44；P=0.02）。总体而言，29 例（69%）患者符合生物反应标准，即在 6 个月的积极治疗期间，ALC 持续下降≥20%和/或所有淋巴结区域产品之和下降≥30%。
在本 2 期试验中，CLL 患者口服 Polyphenon E 中的每日 EGCG 耐受良好。大多数患者观察到 ALC 和/或淋巴结病的持久下降。
