激素受体阳性早期乳腺癌女性的延长辅助内分泌治疗：一项随机对照试验的荟萃分析及试验序贯分析

Extended adjuvant endocrine therapy for women with hormone receptor-positive early breast cancer: A meta-analysis with trial sequential analysis of randomized controlled trials.

作者信息

Xie Ming, Zhong Yan, Yang Yide, Shen Fang, Nie Yue

机构信息

Department of Science and Education, The Third Hospital of Changsha, Changsha, China.

Department of Preventive Medicine, School of Medicine, Hunan Normal University, Changsha, China.

出版信息

Front Oncol. 2022 Oct 27;12:1039320. doi: 10.3389/fonc.2022.1039320. eCollection 2022.

OBJECTIVES

The aim of the current study is to explore the association between extended adjuvant endocrine treatment and prognosis of women with hormone receptor-positive (HR+) early breast cancer.

METHODS

Databases including PubMed, Web of Science, Embase and the Cochrane Library databases were electronically searched to identify randomized controlled trials (RCTs) that reported extended endocrine therapy for women with HR+ early breast cancer. The retrieval time was limited from inception to September 2022. Two reviewers independently screened literature, extracted data, and assessed risk bias of included studies. Meta-analysis was performed by using R software Version 4.1.2 and STATA Version 12.0.

RESULTS

A total of 15 RCTs involving 29497 cases were included. The overall analysis showed that compared with the control, extended adjuvant endocrine therapy increased disease-free survival (DFS) (HR=0.814, 95% CI: 0.720-0.922, 95% PI: 0.556-1.194), overall survival (OS) (HR=0.885, 95% CI: 0.822-0.953, 95% PI: 0.771-1.035), relapse-free survival (RFS) (HR=0.833, 95% CI: 0.747-0.927, 95% PI: 0.575-1.159), distant metastatic-free survival (DMFS) (HR=0.824, 95% CI: 0.694-0.979, 95% PI: 0.300-2.089) and reduced new breast cancer cumulative incidence (NBCCI) (HR=0.484, 95% CI: 0.403-0.583, 95% PI: 0.359-0.654). For adverse events, extended adjuvant endocrine treatment was associated with a significantly higher risk of bone fracture (RR=1.446, 95% CI: 1.208-1.730, 95% PI: 1.154-1.854) and osteoporosis (RR=1.377, 95% CI: 1.018-1.862, 95% PI: 0.347-5.456).

CONCLUSION

Our study showed that extended adjuvant endocrine therapy increased DFS, OS, RFS, DMFS, the incidence of bone fracture and osteoporosis, and reduced NBCCI.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero, identifier (CRD42022351295).

目的

本研究旨在探讨延长辅助内分泌治疗与激素受体阳性（HR+）早期乳腺癌女性预后之间的关联。

方法

通过电子检索包括PubMed、Web of Science、Embase和Cochrane图书馆数据库在内的数据库，以识别报告针对HR+早期乳腺癌女性进行延长内分泌治疗的随机对照试验（RCT）。检索时间限制为从数据库建立至2022年9月。两名 reviewers 独立筛选文献、提取数据并评估纳入研究的风险偏倚。使用R软件4.1.2版和STATA 12.0版进行荟萃分析。

结果

共纳入15项RCT，涉及29497例病例。总体分析显示，与对照组相比，延长辅助内分泌治疗可提高无病生存期（DFS）（HR=0.814，95%CI：0.720-0.922，95%PI：0.556-1.194）、总生存期（OS）（HR=0.885，95%CI：0.822-0.953，95%PI：0.771-1.035）、无复发生存期（RFS）（HR=0.833，95%CI：0.747-0.927，95%PI：0.575-1.159）、远处无转移生存期（DMFS）（HR=0.824，95%CI：0.694-0.979，95%PI：0.300-2.089），并降低新发乳腺癌累积发病率（NBCCI）（HR=0.484，95%CI：0.403-0.583，95%PI：0.359-0.654）。对于不良事件，延长辅助内分泌治疗与骨折风险显著升高（RR=1.446，95%CI：1.208-1.730，95%PI：1.154-1.854）和骨质疏松症风险显著升高（RR=1.377，95%CI：1.018-1.862，95%PI：0.347-5.456）相关。