Suramin therapy for patients with symptomatic hormone-refractory prostate cancer: Results of a randomized phase III trial comparing suramin plus hydrocortisone to placebo plus hydrocortisone
Suramin therapy for patients with symptomatic hormone-refractory prostate cancer: Results of a randomized phase III trial comparing suramin plus hydrocortisone to placebo plus hydrocortisone
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DOI：
10.1200/jco.2000.18.7.1440
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发表时间：
2000-04-01
影响因子：
45.3
通讯作者：
Eisenberger, M
中科院分区：
文献类型：
--
作者：
Small, EJ;Meyer, M;Eisenberger, M
目的：苏拉明是一种新的药物，已被证明在难治性前列腺癌（HRPC）的抗肿瘤活性的初步证据。一项前瞻性随机临床试验的目的是评估疼痛和阿片类镇痛剂的摄入量作为替代抗肿瘤反应的HRPC患者显着，阿片类镇痛剂依赖pain.Patients和方法：一个双盲，安慰剂对照试验随机患者接受78天，门诊治疗方案的苏拉明加氢化可的松（HC，40毫克/天）或安慰剂加HC。当发生疾病进展或剂量限制性毒性时，治疗分配是非盲的;允许安慰剂患者交叉至开放标签苏拉明加HC。除了疼痛和阿片类镇痛剂的摄入量，前列腺特异性抗原（PSA）的反应，疾病进展的时间，生活质量，性能状态，和survival.Results：总体平均减少合并疼痛和阿片类镇痛剂的摄入量更大苏拉明加HC（秩和P = .0001）。接受苏拉明治疗的患者中疼痛缓解的比例高于安慰剂组（43% vs28%; P = 0.001），苏拉明应答者的缓解持续时间更长（中位数，240 vs 69天; P = 0.0027）。接受苏拉明治疗的患者中，至疾病进展的时间较长（相对危险度= 1.5; 95%置信区间，1.2 - 1.9），PSA湿重下降超过50%的患者比例较高（33% vs16%; P = 0.01）。无论是生活质量，也没有性能状态下降苏拉明治疗，总生存率是相似的，桅杆不良事件是轻度或中度强度，易于管理medicinal.Conclusion：门诊治疗苏拉明加HC是耐受性良好，并提供了中度姑息性的好处和延迟疾病进展的症状HRPC患者。(C)2000年，美国临床肿瘤学会。
Purpose: Suramin is a novel agent that has demonstrated preliminary evidence of antitumor activity in hormone-refractory prostate cancer (HRPC). A prospective randomized clinical trial was designed to evaluate pain and opioid analgesic intake as surrogates for antitumor response in HRPC patients with significant, opioid analgesic-dependent pain.Patients and Methods: A double-blind, placebo-controlled trial randomized patients to receive a 78-day, outpatient regimen of either suramin plus hydrocortisone (HC, 40 mg/d) or placebo plus HC. treatment assignment was unblinded when either disease progression or dose-limiting toxicity occurred; placebo patients were allowed to cross-over to open-label suramin plus HC. In addition to pain and opioid analgesic intake, prostate-specific antigen (PSA) response, time to disease progression, quality of life, performance status, and survival were compared.Results: Overall mean reductions in combined pain and opioid analgesic intake were greater for suramin plus HC (rank sum P = .0001). Pain response was achieved in a higher proportion of patients receiving suramin than placebo (43% v 28%; P = .001), and duration of response war longer for suramin responders (median, 240 v 69 days; P = .0027). Time to disease progression was longer (relative risk = 1.5; 95% confidence interval, 1.2 to 1.9) and the proportion of patients with a greater than 50% decline in PSA wets higher (33% v 16%; P = .01) in patients who received suramin. Neither quality of life nor performance status was decreased by suramin treatment, and overall survival was similar, Mast adverse events were of mild or moderate intensity and were easily managed medically.Conclusion: Outpatient treatment with suramin plus HC is well tolerated and provides moderate palliative benefit and delay in disease progression for patients with symptomatic HRPC. (C) 2000 by American Society of Clinical Oncology.