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Lancet Oncol:经皮雌激素治疗前列腺癌可减少并发症的发生

2013-03-07 echo1166 DXY

6个月时研究者所报道的毒性反应 应用促黄体激素释放激素激动剂(LHRHa)治疗前列腺癌患者通常会带来包括骨质疏松在内的长期毒性反应。采用肠外雌激素治疗不仅能避免这种与LHRHa相关的长期并发症的干扰,也能避免与口服雌激素相关的血栓栓塞并发症的产生。为了针对上述问题进行研究,来自英国MRC临床研究中心的Ruth E Langley等针对上述问题进行了相关研究,他们的研究结果发表在Lancet


6个月时研究者所报道的毒性反应
应用促黄体激素释放激素激动剂(LHRHa)治疗前列腺癌患者通常会带来包括骨质疏松在内的长期毒性反应。采用肠外雌激素治疗不仅能避免这种与LHRHa相关的长期并发症的干扰,也能避免与口服雌激素相关的血栓栓塞并发症的产生。为了针对上述问题进行研究,来自英国MRC临床研究中心的Ruth E Langley等针对上述问题进行了相关研究,他们的研究结果发表在Lancet Oncol 3月最新的在线期刊上。
本研究是一个多中心、开放标签式、临床随机对照2期研究,研究者所纳入的受试者为局部晚期前列腺癌或转移性前列腺癌男性患者,并且这些患者计划开始接受长期激素治疗。研究者采用最小化随机法、按照2:1的比例将符合入组标准的受试者随机分为两组,一组患者自行外贴雌激素贴片(每24小时100μg),每周更换2次;另一组中的患者则根据其所在中心的临床经验应用LHRHa进行治疗。在睾酮浓度达到1.7nmol/L或更低时,患者开始接受3片雌激素外贴治疗,同样每周更换2次。本研究的主要终点是心血管事件的发病率和死亡率,研究者采用改良意向治疗分析法对结果进行分析,研究者也通过治疗方案对患者进行分析,以防在疾病出现进展可以及时更换治疗方案。本研究在ClinicalTrials.gov注册,注册号为NCT00303784。
有85名患者接受LHRHa治疗,另有169名患者被分入雌激素贴片治疗。LHRHa组中85名患者都开始了LHRHa治疗,而在雌激素贴片组中168人开始治疗。在第3个月时,75名接受LHRHa治疗的患者中有70人(93%)达到了去势治疗要求的睾酮浓度水平,而在121名雌激素贴片组的患者中有111人(92%)达到了去势治疗要求的睾酮浓度水平。在19个月的中位随访期(IQR 12–31)之后,研究者报道了24例心血管并发症事件,在LHRHa组的6名患者发生了6例心血管不良反应事件(7.1%),而在雌激素贴片组的17名患者发生了18例心血管不良反应事件(10.1%)。其中雌激素贴片组中发生的18例事件中有9例是发生在治疗方案转换为LHRHa治疗后。快速血糖浓度在12个月后的变化在LHRHa组为0.33mmol/L,而在雌激素贴片组为-0.16mmol/L,两组差异具有显著统计学意义,而胆固醇浓度变化在两组分别为0.20mmol/L(4.1%)和-0.23mmol/L(-3.3%),差异同样具有显著统计学意义。在6个月时研究者所报道的其他不良反应事件包括男性乳房发育(LHRHa组中有15人(19%)/雌激素贴片组为104人(75%))、潮热(LHRHa组中有44人(56%)/雌激素贴片组为35人(25%))和皮肤问题(LHRHa组中有10人(13%)/雌激素贴片组为58人(42%))。
研究结果指出,在证实了肠外雌激素治疗的有效作用之后,它可以作为前列腺癌患者LHRHa治疗以外的治疗选择。基于本研究的结果,可以进一步扩大PATCH研究中患者的入组,将研究的主要终点设定为疾病无进展生存期。

Background
Luteinising-hormone-releasing-hormone agonists (LHRHa) to treat prostate cancer are associated with long-term toxic effects, including osteoporosis. Use of parenteral oestrogen could avoid the long-term complications associated with LHRHa and the thromboembolic complications associated with oral oestrogen.
Methods
In this multicentre, open-label, randomised, phase 2 trial, we enrolled men with locally advanced or metastatic prostate cancer scheduled to start indefinite hormone therapy. Randomisation was by minimisation, in a 2:1 ratio, to four self-administered oestrogen patches (100 μg per 24 h) changed twice weekly or LHRHa given according to local practice. After castrate testosterone concentrations were reached (1·7 nmol/L or lower) men received three oestrogen patches changed twice weekly. The primary outcome, cardiovascular morbidity and mortality, was analysed by modified intention to treat and by therapy at the time of the event to account for treatment crossover in cases of disease progression. This study is registered with ClinicalTrials.gov, number NCT00303784.
Findings
85 patients were randomly assigned to receive LHRHa and 169 to receive oestrogen patches. All 85 patients started LHRHa, and 168 started oestrogen patches. At 3 months, 70 (93%) of 75 receiving LHRHa and 111 (92%) of 121 receiving oestrogen had achieved castrate testosterone concentrations. After a median follow-up of 19 months (IQR 12—31), 24 cardiovascular events were reported, six events in six (7·1%) men in the LHRHa group (95% CI 2·7—14·9) and 18 events in 17 (10·1%) men in the oestrogen-patch group (6·0—15·6). Nine (50%) of 18 events in the oestrogen group occurred after crossover to LHRHa. Mean 12-month changes in fasting glucose concentrations were 0·33 mmol/L (5·5%) in the LHRHa group and −0·16 mmol/L (−2·4%) in the oestrogen-patch group (p=0·004), and for fasting cholesterol were 0·20 mmol/L (4·1%) and −0·23 mmol/L (−3·3%), respectively (p<0·0001). Other adverse events reported by 6 months included gynaecomastia (15 [19%] of 78 patients in the LHRHa group vs 104 [75%] of 138 in the oestrogen-patch group), hot flushes (44 [56%] vs 35 [25%]), and dermatological problems (10 [13%] vs 58 [42%]).
Interpretation
Parenteral oestrogen could be a potential alternative to LHRHa in management of prostate cancer if efficacy is confirmed. On the basis of our findings, enrolment in the PATCH trial has been extended, with a primary outcome of progression-free survival.

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    2014-02-20 丁鹏鹏
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    2013-06-28 howi
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    2013-07-08 minlingfeng
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