Tamoxifen as prophylaxis for prevention of gynaecomastia and breast pain associated with bicalutamide 150 mg monotherapy in patients with prostate cancer: A randomised, placebo-controlled, dose-response study
Tamoxifen as prophylaxis for prevention of gynaecomastia and breast pain associated with bicalutamide 150 mg monotherapy in patients with prostate cancer: A randomised, placebo-controlled, dose-response study
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DOI：
10.1016/j.eururo.2007.01.031
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发表时间：
2007-07-01
期刊：
影响因子：
23.4
通讯作者：
Navani, Sunil
中科院分区：
文献类型：
--
作者：
Fradet, Yves;Egerdie, Blair;Navani, Sunil
目的：确定在不影响疾病控制的情况下，减少比卡洛胺(Casodex(TM))150 mg单一治疗引起的乳腺事件(即女性乳房发育症或乳房疼痛或两者兼有)的最佳他莫昔芬剂量。方法：282例前列腺癌患者随机分成两组，每天服用比卡鲁胺150 mg加他莫昔芬(1、2.5、5、10或20 mg)或安慰剂治疗12个月，然后单用比卡鲁胺治疗12个月。主要终点是乳房事件和前列腺特异性抗原(PSA)抑制的发生率，并在6个月(初步分析)、12和24个月进行分析。结果：在6个月和12个月时，他莫昔芬以剂量依赖的方式降低了乳房事件的发生率，在服用他莫昔芬1、2.5、5、10和20 mg的患者中，乳房事件的发生率分别为86.2%、60.0%、55.3%、23.5%和8.8%，而服用安慰剂的患者在6个月时的乳房事件发生率为96.7%。在24个月(即，在比卡鲁胺单一治疗12个月后)，所有组的乳房事件的发生率都很高。在任何评估中，都没有证据表明对PSA抑制有负面影响。除了他莫昔芬剂量=5毫克时潮热增加外，其他非乳房不良反应在两组间都是相似的。结论：这些研究结果表明，预防性服用他莫昔芬20毫克/天是减少比卡鲁胺引起的乳房事件的有效剂量，似乎不会影响基于PSA抑制的疾病控制。(C)2007年欧洲泌尿外科协会。爱思唯尔出版，版权所有。
Objective: To define the optimum tamoxifen dose for reducing bicalutamide (CASODEX (TM)) 150 mg monotherapy-induced breast events (ie, gynaecomastia or breast pain or both) without compromising disease control.Methods: This was a double-blind, parallel-group, multicentre trial in which 282 patients with prostate cancer were randomised to receive bicalutamide 150 mg/d plus either daily tamoxifen (1, 2.5, 5, 10, or 20 mg) or placebo for 12 mo, followed by 12 mo of treatment with bicalutamide only. Primary end points were incidence of breast events and prostate -specific antigen (PSA) inhibition and were analysed at 6 mo (the primary analysis) and also at 12 and 24 mo.Results: At 6 and 12 mo, tamoxifen decreased the incidence of breast events in a dose-dependent manner, with breast events observed in 86.2%, 60.0%, 55.3%, 23.5%, and 8.8% of patients receiving tamoxifen 1, 2.5, 5, 10, and 20 mg, respectively, compared with 96.7% of patients receiving placebo at 6 mo. At 24 mo (ie, after 12 mo of bicalutamide monotherapy), a high incidence of breast events was seen in all groups. There was no evidence of a negative effect on PSA inhibition at any assessment. other nonbreast adverse effects were similar across groups, except for an increase in hot flushes with tamoxifen doses >= 5 mg.Conclusion: These findings suggest that prophylactic tamoxifen 20 mg/d is an effective dose for reduction of bicalutamide-induced breast events and does not appear to affect disease control based on PSA suppression. (c) 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved.