Low-dose vs standard-dose everolimus combined with endocrine therapy in patients with HR-positive, HER2-negative advanced breast cancer: A multicenter real-world study

IF 3.5 3区医学 Q1 SURGERY

Asian Journal of Surgery Pub Date : 2025-04-01 DOI:10.1016/j.asjsur.2024.11.135

Yichen Wang , Huiyun Lv , Yuhua Song , Die Sang , Zheng Lv , Tianyi Ma , Ning Li , Chen Song , Man Li

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引用次数: 0

Abstract

Background

Everolimus (EVE) has been approved by the FDA for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer patients. However, in clinical practice, the toxicity of the standard dose (10 mg/d) limits its use.

Method

This study aimed to compare the efficacy, safety, and compliance of 5 mg/d and 10 mg/d EVE in combination with endocrine therapy in btreast cancer patients.

Results

Compared with the 5 mg/d group, the 10 mg/d group included more primary endocrine-resistant patients (46.7 % vs. 24.6 %; P = 0.036). There was no significant difference in overall ORR and DCR between the two groups and the difference in median PFS and OS was not statistically significant (PFS: 7.07 m vs. 8.07 m, P = 0.663; OS: 29.47 m vs. 30.53 m, P = 0.615). In the subgroup of patients with primary endocrine resistance and premenopausal patients, the PFS benefit of the 10 mg/d group was more significant. In the safety analysis, the 5 mg/d group had lower rates of fatigue (29.2 % vs. 53.3 %; P = 0.038) and diarrhea (10.8 % vs. 33.3 %; P = 0.011). In the compliance analysis, the 5 mg/d group had a lower treatment interruption rate, and fewer patients stopped treatment due to adverse reactions. For most patients, 5 mg/d and 10 mg/d EVE combined with endocrine therapy showed comparable efficacy, but the safety and compliance of 5 mg/d were better.

Conclusions

For patients with primary endocrine resistance and premenopausal patients, using standard-dose EVE resulted in greater PFS benefit.

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低剂量与标准剂量依维莫司联合内分泌治疗hr阳性、her2阴性晚期乳腺癌患者：一项多中心现实世界研究

deverolimus （EVE）已被FDA批准用于激素受体（HR）阳性、人表皮生长因子受体2 （HER2）阴性的晚期乳腺癌患者。然而，在临床实践中，标准剂量（10mg /d）的毒性限制了其使用。方法比较5mg /d和10mg /d EVE联合内分泌治疗乳腺癌患者的疗效、安全性和依从性。结果与5 mg/d组相比，10 mg/d组有更多的原发性内分泌抵抗患者(46.7% vs. 24.6%；p = 0.036)。两组总ORR和DCR比较差异无统计学意义，中位PFS和OS比较差异无统计学意义(PFS: 7.07 m vs 8.07 m, P = 0.663；OS: 29.47 m vs. 30.53 m, P = 0.615)。在原发性内分泌抵抗患者和绝经前患者亚组中，10 mg/d组的PFS获益更为显著。在安全性分析中，5mg /d组的疲劳率较低(29.2% vs. 53.3%；P = 0.038)和腹泻(10.8% vs. 33.3%；p = 0.011)。依从性分析中，5mg /d组治疗中断率较低，因不良反应停止治疗的患者较少。对于大多数患者，5mg /d和10mg /d EVE联合内分泌治疗的疗效相当，但5mg /d的安全性和依从性更好。结论对于原发性内分泌抵抗患者和绝经前患者，使用标准剂量EVE可获得更大的PFS益处。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Asian Journal of Surgery 医学-外科

CiteScore

3.60

自引率

31.40%

发文量

1589

审稿时长

33 days

期刊介绍： Asian Journal of Surgery, launched in 1978, is the official peer-reviewed open access journal of the Asian Surgical Association, the Taiwan Robotic Surgery Association, and the Taiwan Society of Coloproctology. The Journal is published monthly by Elsevier and is indexed in SCIE, Medline, ScienceDirect, Scopus, Embase, Current Contents, PubMed, Current Abstracts, BioEngineering Abstracts, SIIC Data Bases, CAB Abstracts, and CAB Health. ASJSUR has a growing reputation as an important medium for the dissemination of cutting-edge developments in surgery and its related disciplines in the Asia-Pacific region and beyond. Studies on state-of-the-art surgical innovations across the entire spectrum of clinical and experimental surgery are particularly welcome. The journal publishes original articles, review articles, and case reports that are of exceptional and unique importance. The journal publishes original articles, review articles, and case reports that are of exceptional and unique importance.