Pharmacotherapy plan for metastatic hormone-sensitive prostate cancer：a network meta-analysis

SONG Haichi; TANG Zongwei; CHEN Wanyi

doi:10.6039/j.issn.1001-0408.2024.01.15

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Pharmacotherapy plan for metastatic hormone-sensitive prostate cancer：a network meta-analysis

更新时间：2024-01-11

- Pharmacotherapy plan for metastatic hormone-sensitive prostate cancer：a network meta-analysis
- ZHONGGUO YAOFANG Vol. 35, Issue 1, Pages: 84-89(2024)
- 作者机构：
  
  重庆大学附属肿瘤医院药学部，重庆　400030
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.01.15
  CLC： R453.9;R737.25
- Published：15 January 2024，
  
  Received：09 May 2023，
  
  Revised：10 October 2023，
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宋海驰,唐宗伟,陈万一.转移性激素敏感性前列腺癌药物治疗方案的网状Meta分析 ^Δ[J].中国药房,2024,35(01):84-89.

SONG Haichi,TANG Zongwei,CHEN Wanyi.Pharmacotherapy plan for metastatic hormone-sensitive prostate cancer：a network meta-analysis[J].ZHONGGUO YAOFANG,2024,35(01):84-89.
宋海驰,唐宗伟,陈万一.转移性激素敏感性前列腺癌药物治疗方案的网状Meta分析 ^Δ[J].中国药房,2024,35(01):84-89. DOI： 10.6039/j.issn.1001-0408.2024.01.15.

SONG Haichi,TANG Zongwei,CHEN Wanyi.Pharmacotherapy plan for metastatic hormone-sensitive prostate cancer：a network meta-analysis[J].ZHONGGUO YAOFANG,2024,35(01):84-89. DOI： 10.6039/j.issn.1001-0408.2024.01.15.

摘要

目的

确定转移性激素敏感性前列腺癌（mHSPC）的最佳治疗方案，为临床决策提供依据。

方法

系统检索Medline、Embase、BIOSIS preview、the Cochrane Library和ClinicalTrials.gov数据库，收集关于mHSPC药物治疗，且疗效结局为总生存期（OS）和放射学无进展生存期（rPFS）、安全性结局为严重不良事件（SAEs）发生率的随机对照试验。检索时限为建库至2022年3月。由2名研究人员独立筛选文献、提取资料并评价纳入研究的偏倚风险后，进行贝叶斯网状Meta分析。

结果

最终纳入8项研究，共计9 437例患者，比较了7种治疗方案[醋酸阿比特龙、阿帕他胺、达罗他胺+多西他赛、多西他赛、恩杂鲁胺、标准非甾体抗雄激素（SNA）分别联合雄激素剥夺疗法（ADT）和单用ADT]的有效性和安全性。疗效指标中，能使患者OS获益最多的方案（除ADT+SNA外）是ADT+达罗他胺+多西他赛（HR＝0.54，95%CI为0.44～0.66），随后为ADT+醋酸阿比特龙（HR＝0.64，95%CI为0.57～0.71）、阿帕他胺（HR＝0.65，95%CI为0.53～0.79）或恩杂鲁胺（HR＝0.66，95%CI为0.53～0.82），最后是ADT+多西他赛（HR＝0.79，95%CI为0.71～0.88）。能使患者rPFS获益最多的方案（除ADT+SNA外）为ADT+恩杂鲁胺（HR＝0.39，95%CI为0.30～0.50），随后是ADT+阿帕他胺（HR＝0.48，95%CI为0.39～0.60）、醋酸阿比特龙（HR＝0.57，95%CI为0.51～0.64）或多西他赛（HR＝0.62，95%CI为0.56～0.69）；肿瘤负荷亚组分析的结果相同。在安全性方面，ADT+达罗他胺+多西他赛（OR＝25.86，95%CI为14.08～51.33）和ADT+多西他赛（OR＝23.35，95%CI为13.26～44.81）与SAEs发生率显著升高相关，ADT+醋酸阿比特龙（OR＝1.42，95%CI为1.10～1.82）的SAEs发生率稍有增高，其他治疗方案的SAEs发生率无明显差异。

结论

与仅行ADT相比，ADT+达罗他胺+多西他赛三联疗法的OS获益最多，但其SAEs发生率大幅增高；与ADT+多西他赛相比，ADT+醋酸阿比特龙、阿帕他胺或恩杂鲁胺具有更多的OS获益。ADT+恩杂鲁胺在不提高患者SAEs发生率的前提下，提供了较多的rPFS获益。

Abstract

OBJECTIVE

To determine the optimal therapeutic plan for metastatic hormone-sensitive prostate cancer （mHSPC）， and to provide reference for clinical decision-making.

METHODS

Retrieved from Medline， Embase， BIOSIS preview， the Cochrane Library and ClinicalTrials.gov systematically， randomized controlled trials about mHSPC therapy， with overall survival （OS） and radiographic progression-free survival （rPFS） as efficacy outcomes and the incidence of serious adverse events （SAEs） as safety outcome， were collected during the inception-Mar. 2022. Two researchers independently screened the literature， extracted data， and evaluated the risk of bias for the included study before conducting a Bayesian network meta-analysis.

RESULTS

Eight studies with 9 437 patients were finally included. The effectiveness and safety of 7 therapy plans were compared [abiraterone acetate， apalutamide， darolutamide+docetaxel， docetaxel， enzalutamide， standard non-steroidal antiandrogen （SNA） in addition to ADT， and ADT alone]. In terms of efficacy index， the most beneficial regimen （except for ADT+SNA） for OS was ADT+darolutamide+docetaxel （HR＝0.54， 95%CI of 0.44-0.66）， followed by ADT+abiraterone acetate （HR＝0.64，95%CI of 0.57-0.71）， apalutamide （HR＝0.65， 95%CI of 0.53-0.79）， enzalutamide （HR＝0.66， 95%CI of 0.53-0.82）； the least beneficial regimen for OS was ADT+docetaxel （HR＝0.79， 95%CI of 0.71-0.88）. The most beneficial regimen （except for ADT+SNA） for rPFS was ADT+enzalutamide （HR＝0.39， 95%CI of 0.30-0.50）， followed by ADT+apalutamide （HR＝0.48， 95%CI of 0.39-0.60）， abiraterone acetate （HR＝0.57， 95%CI of 0.51-0.64）， docetaxel （HR＝0.62， 95%CI of 0.56-0.69）. The results of the tumor-loading subgroup analysis were the same. In terms of safety， ADT+darolutamide+docetaxel （OR＝25.86， 95%CI of 14.08-51.33）， and ADT+docetaxel （OR＝23.35， 95%CI of 13.26-44.81） were associated with markedly increased SAEs； the incidence of SAEs caused by ADT+abiraterone acetate （OR＝1.42， 95%CI of 1.10-1.82） was slightly increased， and those of other therapy plans had no significant difference.

CONCLUSIONS

Compared with ADT alone， ADT+darolutamide+docetaxel may provide the most significant OS benefit， but the incidence of SAEs is increased greatly； compared with ADT+docetaxel， ADT+abiraterone acetate， apalutamide or enzalutamide provide more OS benefits. ADT+enzalutamide provide optimal rPFS benefits with no increased SAEs.

关键词

转移性激素敏感性前列腺癌雄激素剥夺疗法药物治疗方案网状Meta分析

Keywords

androgen deprivation therapypharmacotherapy plannetwork meta-analysis

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