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Vol 74, No 1 (2023)
Original paper
Submitted: 2022-09-24
Accepted: 2022-11-21
Published online: 2023-01-18
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The effect and safety of CDK4/6 inhibitors combined endocrine therapy on HR+, HER2-breast cancer: a meta-analysis of randomized controlled trials

Tongmin Huang1, Yujing He1, Chiyuan Yu1, Feiyan Mao2, Yuexiu Si3
DOI: 10.5603/EP.a2023.0007
·
Pubmed: 36704980
·
Endokrynol Pol 2023;74(1):89-105.
Affiliations
  1. The Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China
  2. Department of General Surgery, HwaMei Hospital, University of Chinese Academy of Sciences, Ningbo, Zhejiang, China
  3. School of Basic Medical Sciences, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China, China

open access

Vol 74, No 1 (2023)
Original Paper
Submitted: 2022-09-24
Accepted: 2022-11-21
Published online: 2023-01-18

Abstract

Introduction: The purpose of this meta-analysis is to evaluate the efficacy and safety of cyclin-dependent kinase4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) on hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) breast cancer (BC).

Material and methods: A search was conducted in the PubMed, Embase, Web of Science, and Cochrane Library databases before July 2022.

Results: A total of 19 studies comprising 19,004 patients were eligible for this meta-analysis. This meta-analysis found that for unresectable locally advanced or metastatic HR+, HER2– BC, CDK4/6i combined with ET can significantly improve the progression-free survival (PFS) (hazard ratio = 0.59, p < 0.001), overall survival (OS) (hazard ratio = 0.77, p < 0.001), objective response rate (ORR) [risk ratio (RR) = 1.32, p = 0.001)], disease control rate (DCR) (RR = 1.10, p < 0.001), and clinical benefit response (CBR) (RR = 1.15, p = 0.001). For early HR+, HER2- BC, CDK4/6i combined with ET improved ORR (RR = 1.14, p = 0.05) and invasive disease free survival (iDFS) (hazard ratio = 0.87, p = 0.045) but had no effect on pathologic complete response (pCR) (RR = 1.75, p = 0.33), distant recurrence free survival (DRFS) (hazard
ratio = 0.83, p = 0.311), and OS (hazard ratio = 1.08, p = 0.705).

Conclusion: CDK4/6i combined with ET can improve the prognosis of patients with unresectable locally advanced or metastatic HR+, HER2– BC, but it has no obvious effect on patients with early HR+, HER2– BC. It is generally safe and manageable.

Abstract

Introduction: The purpose of this meta-analysis is to evaluate the efficacy and safety of cyclin-dependent kinase4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) on hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) breast cancer (BC).

Material and methods: A search was conducted in the PubMed, Embase, Web of Science, and Cochrane Library databases before July 2022.

Results: A total of 19 studies comprising 19,004 patients were eligible for this meta-analysis. This meta-analysis found that for unresectable locally advanced or metastatic HR+, HER2– BC, CDK4/6i combined with ET can significantly improve the progression-free survival (PFS) (hazard ratio = 0.59, p < 0.001), overall survival (OS) (hazard ratio = 0.77, p < 0.001), objective response rate (ORR) [risk ratio (RR) = 1.32, p = 0.001)], disease control rate (DCR) (RR = 1.10, p < 0.001), and clinical benefit response (CBR) (RR = 1.15, p = 0.001). For early HR+, HER2- BC, CDK4/6i combined with ET improved ORR (RR = 1.14, p = 0.05) and invasive disease free survival (iDFS) (hazard ratio = 0.87, p = 0.045) but had no effect on pathologic complete response (pCR) (RR = 1.75, p = 0.33), distant recurrence free survival (DRFS) (hazard
ratio = 0.83, p = 0.311), and OS (hazard ratio = 1.08, p = 0.705).

Conclusion: CDK4/6i combined with ET can improve the prognosis of patients with unresectable locally advanced or metastatic HR+, HER2– BC, but it has no obvious effect on patients with early HR+, HER2– BC. It is generally safe and manageable.

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Keywords

hormone receptor-positive; human epidermal growth factor receptor 2-negative; breast cancer; cyclin-dependent kinase4/6 inhibitors; endocrine therapy; meta-analysis

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Title

The effect and safety of CDK4/6 inhibitors combined endocrine therapy on HR+, HER2-breast cancer: a meta-analysis of randomized controlled trials

Journal

Endokrynologia Polska

Issue

Vol 74, No 1 (2023)

Article type

Original paper

Pages

89-105

Published online

2023-01-18

Page views

3357

Article views/downloads

688

DOI

10.5603/EP.a2023.0007

Pubmed

36704980

Bibliographic record

Endokrynol Pol 2023;74(1):89-105.

Keywords

hormone receptor-positive
human epidermal growth factor receptor 2-negative
breast cancer
cyclin-dependent kinase4/6 inhibitors
endocrine therapy
meta-analysis

Authors

Tongmin Huang
Yujing He
Chiyuan Yu
Feiyan Mao
Yuexiu Si

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