A phase II trial of green tea in the treatment of patients with androgen independent metastatic prostate carcinoma
A phase II trial of green tea in the treatment of patients with androgen independent metastatic prostate carcinoma
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DOI：
10.1002/cncr.11200
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发表时间：
2003-03-15
期刊：
影响因子：
6.2
通讯作者：
Flynn, PJ
中科院分区：
文献类型：
--
作者：
Jatoi, A;Ellison, N;Flynn, PJ
背景资料。最近的实验室和流行病学研究表明，绿茶对前列腺癌患者有抗肿瘤作用。这项第二阶段的试验探讨了绿茶在雄激素非依赖性前列腺癌患者中的抗肿瘤作用。方法：这项研究由北中癌症治疗小组进行，评估了42名无症状、激素治疗后前列腺特异性抗原(PSA)进行性升高的患者。允许继续使用促黄体激素释放激素激动剂；但是，如果患者在之前4周内接受了其他治疗，或者如果他们在之前6周内接受了长效抗雄激素治疗，则不符合条件。指导患者每天分6次口服绿茶6克。每剂含有100卡路里和46毫克咖啡因。每月监测患者的反应和毒性。结果：肿瘤反应，定义为基线PSA值下降大于或等于50%，发生在单个患者，或队列的2%(95%可信区间，1-14%)。这一反应没有持续超过2个月。在第一个月末，队列的PSA值与基线相比的中位数变化增加了43%。绿茶毒性，通常为1级或2级，发生在69%的患者中，包括恶心、呕吐、失眠、乏力、腹泻、腹痛和神志不清。然而，也发生了6次3级毒性和1次4级毒性，后者表现为严重混淆。结论：绿茶在雄激素非依赖性前列腺癌患者中的抗肿瘤活性有限，其定义为PSA水平下降。(C)2003年美国癌症协会。
BACKGROUND. Recent laboratory and epidemiologic studies have suggested that green tea has antitumor effects in patients with prostate carcinoma. This Phase II trial explored green tea's antineoplastic effects in patients with androgen independent prostate carcinoma.METHODS. This study, which was conducted by the North Central Cancer Treatment Group, evaluated 42 patients who were asymptomatic and had manifested, progressive prostate specific antigen (PSA) elevation with hormone therapy. Continued use of luteinizing hormone-releasing hormone agonist was permitted; however, patients were ineligible if they had received other treatments for their disease in the preceding 4 weeks or if they had received a long-acting antiandrogen therapy in the preceding 6 weeks. Patients were instructed to take 6 grams of green tea per day orally in 6 divided doses. Each dose contained 100 calories and 46 mg of caffeine. Patients were monitored monthly for response and toxicity.RESULTS. Tumor response, defined as a decline greater than or equal to 50% in the baseline PSA value, occurred in a single patient, or 2% of the cohort (95% confidence interval, 1-14%). This one response was not sustained beyond 2 months. At the end of the first month, the median change in the PSA value from baseline for the cohort increased by 43%. Green tea toxicity, usually Grade 1 or 2, occurred in 69% of patients and included nausea, emesis, insomnia, fatigue, diarrhea, abdominal pain, and confusion. However, six episodes of Grade 3 toxicity and one episode of Grade 4 toxicity also occurred, with the latter manifesting as severe confusion.CONCLUSIONS. Green tea carries limited antineoplastic activity, as defined by a decline in PSA levels, among patients with androgen independent prostate carcinoma. (C) 2003 American Cancer Society.