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评估激素受体阳性和 HER2 阴性转移性乳腺癌连续内分泌治疗的疗效:一项真实世界的多中心全国性研究。

Assessment of the efficacy of successive endocrine therapies in hormone receptor-positive and HER2-negative metastatic breast cancer: a real-life multicentre national study.

机构信息

Department of Medical Oncology, Léon Bérard Centre, Lyon, France.

Department of Medical Oncology, Léon Bérard Centre, Lyon, France.

出版信息

Eur J Cancer. 2019 Sep;118:131-141. doi: 10.1016/j.ejca.2019.06.014. Epub 2019 Jul 19.

Abstract

BACKGROUND

For luminal metastatic breast cancer (MBC), endocrine therapy (ET) is the recommended initial treatment before chemotherapy. Our objective was to evaluate the efficacy of multiple ET lines in a real-life study.

METHODS

The Breast Cancer Epidemiological Strategy and Medical Economics (ESME) project analysed data from all patients with systemic treatment for MBC initiated between 2008 and 2014 in one of the 18 French Comprehensive Cancer Centres. The primary end-point was the successive progression-free survival (PFS) evaluation.

RESULTS

The ESME research programme included 9921 patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 (HER2) negative (HER2-) MBC. Before any chemotherapy, 4195 (43.4%), 1252 (29.8%) and 279 (6.6%) patients received one, two or three ET ± targeted therapy, respectively. The median PFS for first-, second- and third-line ET ± targeted therapy was 11.5 (95% confidence interval [CI], 10.8-12.1), 5.8 (95% CI, 5.3-6.1) and 5.5 (95% CI, 4.6-6.3) months, respectively. In a multivariate analysis, time from diagnosis to metastatic recurrence (P < 0.0001), presence of symptoms at metastatic relapse (P = 0.01), number of metastatic sites (P = 0.0003) and their localisation (P < 0.0001) were prognostic factors for PFS1. Duration of previous PFS was the only prognostic factor for subsequent PFS (10% threshold). Ten percent of the patients showed long-term response to ET, with a total treatment duration before chemotherapy ≥43.6 months.

CONCLUSIONS

Median PFS in our HR+/HER2- real-life cohort is similar to median first-line PFS reported in clinical trials, regardless of ET used as second- and third-line treatment. Despite the international consensus on early initiation of ET, the latter is not prescribed in most of the cases. Patients with a low tumour burden may achieve prolonged response on ET.

摘要

背景

对于腔道转移性乳腺癌(MBC),内分泌治疗(ET)是化疗前推荐的初始治疗方法。我们的目的是在真实研究中评估多种 ET 方案的疗效。

方法

乳腺癌流行病学策略和医学经济学(ESME)项目分析了 2008 年至 2014 年期间在法国 18 个综合癌症中心之一接受 MBC 全身治疗的所有患者的数据。主要终点是连续无进展生存(PFS)评估。

结果

ESME 研究项目包括 9921 例激素受体阳性(HR+)/人表皮生长因子受体 2(HER2)阴性(HER2-)MBC 患者。在任何化疗之前,4195(43.4%)、1252(29.8%)和 279(6.6%)例患者分别接受了一线、二线和三线 ET+靶向治疗。一线、二线和三线 ET+靶向治疗的中位 PFS 分别为 11.5(95%置信区间[CI],10.8-12.1)、5.8(95%CI,5.3-6.1)和 5.5(95%CI,4.6-6.3)个月。多变量分析显示,从诊断到转移性复发的时间(P<0.0001)、转移性复发时的症状存在(P=0.01)、转移性部位的数量(P=0.0003)及其局部化(P<0.0001)是 PFS1 的预后因素。先前 PFS 的持续时间是后续 PFS 的唯一预后因素(10%阈值)。10%的患者对 ET 有长期反应,化疗前的总治疗持续时间≥43.6 个月。

结论

在我们的 HR+/HER2-真实队列中,中位 PFS 与临床试验中报告的一线中位 PFS 相似,无论二线和三线治疗使用何种 ET。尽管国际上普遍认为早期开始 ET,但在大多数情况下并未开具。肿瘤负荷低的患者可能会对 ET 产生延长的反应。

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