Aim

Real-world data inform the outcome comparisons and help the development of new therapeutic strategies. To this end, we aimed to describe the full characteristics and outcomes in the Epidemiological Strategy and Medical Economics (ESME) cohort, a large national contemporary observational database of patients with metastatic breast cancer (MBC).

Methods

Women aged ≥18 years with newly diagnosed MBC and who initiated MBC treatment between January 2008 and December 2016 in one of the 18 French Comprehensive Cancer Centers (N = 22,109) were included. We assessed the full patients’ characteristics, first-line treatments, overall survival (OS) and first-line progression-free survival, as well as updated prognostic factors in the whole cohort and among the 3 major subtypes: hormone receptor positive and HER2-negative (HR+/HER2−, n = 13,656), HER2-positive (HER2+, n = 4017) and triple-negative (n = 2963) tumours.

Results

The median OS of the whole cohort was 39.5 months (95% confidence interval [CI], 38.7–40.3). Five-year OS was 33.8%. OS differed significantly between the 3 subtypes (p < 0.0001) with a median OS of 43.3 (95% CI, 42.5–44.5) in HR+/HER2−; 50.1 (95% CI, 47.6–53.1) in HER2+; and 14.8 months (95% CI, 14.1–15.5) in triple-negative subgroups, respectively. Beyond performance status, the following variables had a constant significant negative prognostic impact on OS in the whole cohort and among subtypes: older age at diagnosis of metastases (except for the triple-negative subtype), metastasis-free interval between 6 and 24 months, presence of visceral metastases and number of metastatic sites ≥ 3.

Conclusions

The ESME program represents a unique large-scale real-life cohort on MBC. This study highlights important situations of high medical need within MBC patients.

Database registration

clinicaltrials.gov Identifier NCT032753.

中文翻译：

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2008–2016年来自多中心ESME队列的22,000名妇女的当代转移性乳腺癌结局

目标

现实世界的数据可用于结果比较，并有助于开发新的治疗策略。为此，我们旨在描述流行病学策略和医学经济学（ESME）队列的全部特征和结果，该队列是一个大型的当代美国国家转移性乳腺癌（MBC）患者观察数据库。

方法

纳入年龄≥18岁且新诊断为MBC且在2008年1月至2016年12月之间在法国18个综合癌症中心之一（N = 22,109）中开始MBC治疗的女性。我们评估了整个患者群以及三种主要亚型中激素受体阳性和HER2-的全部患者的特征，一线治疗，总生存期（OS）和一线无进展生存期，以及更新的预后因素。阴性（HR + / HER2-，n = 13,656），HER2阳性（HER2 +，n = 4017）和三阴性（n = 2963）肿瘤。

结果

整个队列的中位OS为39.5个月（95％置信区间[CI]，38.7–40.3）。五年OS为33.8％。3种亚型之间的OS差异显着（p <0.0001），HR + / HER2-中OS的中位数为43.3（95％CI，42.5-44.5）。在HER2 +中为50.1（95％CI，47.6–53.1）；三阴性亚组分别为14.8个月和14.8个月（95％CI，14.1–15.5）。除了表现状态外，以下变量对整个队列和亚型的OS都有持续的显着负面预后影响：诊断转移的年龄较大（三阴性亚型除外），6至24个月的无转移间隔，内脏转移的存在和转移部位的数量≥3。

结论

ESME计划代表了MBC上独一无二的大规模真实人群。这项研究突出了MBC患者内医疗需求很高的重要情况。

数据库注册

Clinicaltrials.gov标识符NCT032753。