Flutamide versus prednisone in patients with prostate cancer symptomatically progressing after androgen-ablative therapy:: A phase III study of the European Organization for Research and Treatment of Cancer Genitourinary Group
Flutamide versus prednisone in patients with prostate cancer symptomatically progressing after androgen-ablative therapy:: A phase III study of the European Organization for Research and Treatment of Cancer Genitourinary Group
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DOI：
10.1200/jco.2001.19.1.62
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发表时间：
2001-01-01
影响因子：
45.3
通讯作者：
Collette, L
中科院分区：
文献类型：
--
作者：
Foss책, SD;Slee, PHT;Collette, L
目的：比较激素抵抗型前列腺癌(HRPC)患者强的松(5 mg，每天4次)和氟他胺(250 mg，每天3次)治疗的进展时间(TTP)、总生存率和生活质量(QL)。患者和方法：有症状的患者随机分为强的松(101例)和氟他胺(100例)。主观反应是基于表现状态、镇痛剂的使用和应用替代姑息治疗的需要来评估的。记录基于前列腺特异性抗原(PSA)的生化反应(大于或等于基线PSA下降50%)。在基线和随访期间每隔6周，患者完成欧洲癌症研究和治疗组织生活质量问卷C-30。结果：两组患者的TTP中位数(泼尼松3.4个月；氟他胺2.3个月)或总生存期(强的松10.6个月；氟他胺11.2个月)没有差异。在泼尼松组，56%的患者经历了主观反应，而在氟他胺组，这一比例为45%(P=.18)。泼尼松和氟他胺的中位反应持续时间分别为4.8个月和4.2个月。泼尼松和氟他胺组分别有21%和23%的患者出现生化反应。胃肠道毒性是7名接受氟他胺治疗和2名接受强的松治疗的患者停止试验的原因。在疼痛、疲乏、角色功能、食欲不振、胃肠不适和总体QL方面，生活质量评价参数倾向于使用强的松，差异有统计学意义。结论：在有症状的HRPC中，强的松和氟他胺治疗的TTP和总存活率相似，而主观和生化反应无差异。QL结果支持在HRPC患者中使用低成本的泼尼松。《旧约》19：62-71。(C)2001年，由美国临床肿瘤学会主办。
Purpose: Time to progression (TTP), overall survival, and quality of life (QL) were compared in patients with hormone-resistant prostate cancer (HRPC) treated with prednisone (5 mg orally, four times a day) or flutamide (250 mg orally, three times a day).Patients and Methods: Symptomatic patients were randomized to receive either prednisone (101 patients) or flutamide (100 patients). Subjective response was assessed based on performance status, the use of analgesics, and the need to apply alternative palliative treatment. prostate-specific antigen (PSA)-based biochemical response (greater than or equal to 50% reduction of baseline PSA) was recorded. At baseline and at 6-week intervals during follow-up, patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30.Results: There was no difference between the groups in median TTp (prednisone, 3.4 months; flutamide, 2.3 months) or overall survival (prednisone, 10.6 months; flutamide, 11.2 months). In the prednisone group, 56% of the patients experienced a subjective response, compared with 45% in the flutamide group (P = .18). The median response duration war 4.8 months for prednisone and 4.2 months for flutamide. A biochemical response was observed in 21% and 23% of the prednisone and flutamide groups, respectively. Gastrointestinal toxicity war the reason for trial discontinuation in seven patients receiving flutamide and two patients receiving prednisone. The QL assessment parameters favored the use of prednisone with statistically significant differences in pain, fatigue, role functioning, appetite loss, gastrointestinal distress, and overall QL.Conclusion: In symptomatic HRPC, treatment with prednisone or flutamide leads to similar rates of TTP and overall survival and no difference in subjective or biochemical response. The QL results favor the use of low-cost prednisone in patients with HRPC. J Clin Oncol 19:62-71. (C) 2001 by American Society of Clinical Oncology.