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联合雄激素阻断(CAB)与黄体生成素释放激素(LHRH)激动剂单药治疗用于雄激素剥夺治疗。

Combined androgen blockade (CAB) versus luteinizing hormone-releasing hormone (LHRH) agonist monotherapy for androgen deprivation therapy.

机构信息

Department of Urology, Eulji University Hospital, Eulji University School of Medicine, 95 Dunsanseoro, Seo-gu, Daejeon, 35233, South Korea.

Department of Urology, Kyung Hee University School of Medicine, Seoul, South Korea.

出版信息

World J Urol. 2020 Apr;38(4):971-979. doi: 10.1007/s00345-019-02847-y. Epub 2019 Jun 11.

Abstract

PURPOSE

Combined androgen blockade (CAB) and luteinizing hormone-releasing hormone (LHRH) agonist monotherapy are commonly used in androgen deprivation therapy (ADT). In this randomized clinical trial, we aimed to compare the two methods of ADT in terms of quality of life (QOL).

METHODS

Eighty patients who underwent primary ADT for newly diagnosed prostate cancer were randomly assigned to CAB group (Group 1) and LHRH agonist monotherapy group (Group 2). Leuprolide and anti-androgen (bicalutamide 50 mg) were used to minimize the confounding effects caused by medication. QOL was evaluated at baseline, 3 months and 6 months post-ADT using validated EORTC QLQ-C30, PR25, and depression questionnaires. A difference of > 10 points in the EORTC domain scores was defined as 'clinically significant'.

RESULTS

In the baseline characteristics, there was no significant difference between the two groups. At 3 months after ADT, Group 1 had significantly lower pain scores than Group 2 (p = 0.004), while Group 1 had significantly poorer diarrhea symptom score than Group 2, without clinical significance (p = 0.047). No significant differences were observed in the C30, PR25 domains, and the depression score at 3 months. At 6 months, the QOL scores of all the groups were similar.

CONCLUSIONS

There was no difference in the patient's QOL, except that CAB group was associated with significantly better pain relief than LHRH agonist monotherapy at 3 months following ADT, which was not sustained thereafter. Our results suggest that the benefit of prolonged (≥ 3 months) CAB is questionable in terms of patients' QOL.

摘要

目的

联合雄激素阻断(CAB)和促黄体生成素释放激素(LHRH)激动剂单药治疗常用于雄激素剥夺治疗(ADT)。在这项随机临床试验中,我们旨在比较两种 ADT 方法在生活质量(QOL)方面的差异。

方法

80 例新诊断为前列腺癌的患者接受初次 ADT,随机分为 CAB 组(第 1 组)和 LHRH 激动剂单药治疗组(第 2 组)。使用亮丙瑞林和抗雄激素(比卡鲁胺 50mg)来最小化药物引起的混杂效应。使用经过验证的 EORTC QLQ-C30、PR25 和抑郁问卷在 ADT 后 3 个月和 6 个月时评估 QOL。EORTC 域评分的差异超过 10 分被定义为“具有临床意义”。

结果

在基线特征方面,两组间无显著差异。ADT 后 3 个月时,第 1 组的疼痛评分明显低于第 2 组(p=0.004),而第 1 组的腹泻症状评分明显差于第 2 组,但无临床意义(p=0.047)。3 个月时,C30、PR25 域和抑郁评分无显著差异。6 个月时,所有组的 QOL 评分相似。

结论

除了 ADT 后 3 个月 CAB 组的疼痛缓解明显优于 LHRH 激动剂单药治疗外(此后不再持续),两组患者的 QOL 没有差异。我们的结果表明,在患者的 QOL 方面,延长(≥3 个月)CAB 的获益值得怀疑。

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