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基于真实世界数据的绝经后雌激素受体阳性晚期乳腺癌患者总生存期延长的相关因素:JBCRG-C06 Safari 研究的随访分析。

Factors associated with prolonged overall survival in patients with postmenopausal estrogen receptor-positive advanced breast cancer using real-world data: a follow-up analysis of the JBCRG-C06 Safari study.

机构信息

Department of Breast Surgery, Matsuyama Red Cross Hospital, 1 Bunkyo-cho, Matsuyama, 790-8524, Japan.

Department of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, 540-0006, Japan.

出版信息

Breast Cancer. 2020 May;27(3):389-398. doi: 10.1007/s12282-019-01029-3. Epub 2019 Dec 6.

Abstract

BACKGROUND

Assessing survival risk is important for discussing treatment options with estrogen receptor-positive (ER+) advanced breast cancer (ABC) patients. However, there are few reports from large-scale databases on the survival risk factors in ER+ ABC. The Safari study (UMIN000015168) was a retrospective, multicenter cohort study involving 1072 Japanese patients receiving fulvestrant 500 mg mostly as a second- or later-line endocrine therapy for ER+ ABC. The follow-up data after the Safari study were examined, focusing on any relationship between clinicopathological factors and overall survival (OS) in ER+ ABC patients.

METHODS

OS in patients with ER+ ABC was analyzed by univariate and multivariate analyses with a Cox proportional hazards model in this study.

RESULTS

A total of 1031 cases were evaluable for OS analysis. Multivariate analysis showed that younger age (< 60 years), longer time from ABC diagnosis to fulvestrant use (≥ 3 years), no prior palliative chemotherapy before fulvestrant use, and progesterone receptor (PgR) negativity (PgR-) were significantly correlated with prolonged OS (median 7.0 years). For cases with histological or nuclear grade data, lower histological or nuclear grades were also correlated with longer OS. In recurrent metastatic cases, long disease-free interval (DFI) was not correlated with longer OS.

CONCLUSIONS

In ER+ ABC patients whose treatment history included fulvestrant, younger age, longer time from ABC diagnosis to fulvestrant use, no prior palliative chemotherapy use, PgR-, and lower histological or nuclear grade correlated positively with prolonged OS.

摘要

背景

评估生存风险对于讨论雌激素受体阳性(ER+)晚期乳腺癌(ABC)患者的治疗选择非常重要。然而,在大规模数据库中,关于 ER+ ABC 患者生存风险因素的报道很少。Safari 研究(UMIN000015168)是一项回顾性、多中心队列研究,涉及 1072 名接受氟维司群 500mg 治疗的日本患者,这些患者主要接受氟维司群作为 ER+ ABC 的二线或后续内分泌治疗。本研究检查了 Safari 研究后的随访数据,重点关注 ER+ ABC 患者的临床病理因素与总生存(OS)之间的任何关系。

方法

本研究采用单变量和多变量 Cox 比例风险模型分析 ER+ ABC 患者的 OS。

结果

共 1031 例患者可进行 OS 分析。多变量分析显示,年龄较小(<60 岁)、从 ABC 诊断到氟维司群使用的时间较长(≥3 年)、氟维司群使用前无姑息性化疗以及孕激素受体(PgR)阴性(PgR-)与延长 OS 显著相关(中位 OS 7.0 年)。对于有组织学或核分级数据的病例,较低的组织学或核分级也与较长的 OS 相关。在复发性转移性病例中,较长的无病间期(DFI)与较长的 OS 无关。

结论

在接受氟维司群治疗的 ER+ ABC 患者中,年龄较小、从 ABC 诊断到氟维司群使用的时间较长、无姑息性化疗史、PgR-以及较低的组织学或核分级与延长 OS 呈正相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b72/7196081/126988eb616e/12282_2019_1029_Fig1_HTML.jpg

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