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激素阳性 HER2 阴性乳腺癌新辅助化疗内分泌治疗的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of concomitant chemo-endocrine therapy in neoadjuvant treatment of hormone-positive HER2-negative breast cancer: a systemic review and meta-analysis.

机构信息

Department of Medical Oncology, Batman World Hospital, Batman, Turkey.

Department of Medical Oncology, Ankara City Hospital, Ankara, Turkey.

出版信息

Expert Opin Drug Saf. 2023 Apr;22(4):313-322. doi: 10.1080/14740338.2023.2203485. Epub 2023 Apr 16.

Abstract

BACKGROUND

The rate of pathological complete response (pCR) with both chemotherapy alone (CT) and endocrine therapy (ET) in the neoadjuvant (Na) treatment of hormone receptor (HR)-positive/HER2-negative breast cancer (BC) is unsatisfactory. Limited data on neoadjuvant concomitant chemotherapy and endocrine therapy (NaCET) are available.

RESEARCH DESIGN AND METHODS

In this meta-analysis analyzed the efficacy and safety of randomized controlled trials (RCT) comparing the use of NaCET in HR-positive/HER2-negative BC. A comprehensive search was performed on PubMed, Cochrane Library and EMBASE databases, and congress paper lists for studies published/presented until 1 December 2022.

RESULTS

Five RCTs involving a total of 630 patients were included. A pooled analysis of the five studies demonstrated that the pCR ratio was numerically higher in the NaCET arm than in the NaCT arm, but the difference was not statistically significant (6.5% vs. 3.8%; OR:1.72, 95% CI 0.82-3.62). Nonetheless, the NaCET arm exhibited a significantly higher objective response rate (ORR) (82% vs. 72.7%; OR:1.77, 95% CI 1.20-2.62). There was no difference between the arms in terms of grade 3-5 adverse events.

CONCLUSIONS

In HR-positive/HER2-negative BC, NaCET significantly increases ORR without an increase in serious adverse events. Although the pCR rate increased numerically, it was not statistically significant.

摘要

背景

在激素受体(HR)阳性/HER2 阴性乳腺癌(BC)的新辅助(Neoadjuvant,Na)治疗中,单独化疗(CT)和内分泌治疗(ET)的病理完全缓解(pCR)率并不令人满意。关于新辅助同时化疗和内分泌治疗(NaCET)的有限数据。

研究设计与方法

本 meta 分析分析了比较 HR 阳性/HER2 阴性 BC 中使用 NaCET 的随机对照试验(RCT)的疗效和安全性。对 PubMed、Cochrane 图书馆和 EMBASE 数据库以及截至 2022 年 12 月 1 日的会议论文列表进行了全面检索。

结果

纳入了 5 项共涉及 630 例患者的 RCT。对这 5 项研究的汇总分析表明,NaCET 组的 pCR 比例高于 NaCT 组,但差异无统计学意义(6.5% vs. 3.8%;OR:1.72,95%CI 0.82-3.62)。然而,NaCET 组的客观缓解率(ORR)显著更高(82% vs. 72.7%;OR:1.77,95%CI 1.20-2.62)。两组在 3-5 级不良事件方面无差异。

结论

在 HR 阳性/HER2 阴性 BC 中,NaCET 显著增加 ORR,而不会增加严重不良事件。尽管 pCR 率有数值上的增加,但无统计学意义。

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