Department of Cancer Medicine, Gustave Roussy, 114 Rue Edouard Vaillant, Villejuif, 94800, France; Department of Medical Oncology, CHU de Limoges, France.
Department of Biostatistics, Centre Léon Bérard, 28 Promenade Léa et Napoléon Bullukian, Lyon, 69008, France.
Eur J Cancer. 2020 Apr;129:60-70. doi: 10.1016/j.ejca.2020.01.016. Epub 2020 Mar 2.
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).
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.
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.
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.
真实世界数据可用于比较结果并帮助制定新的治疗策略。为此，我们旨在描述一个大型全国性当代转移性乳腺癌（MBC）观察性数据库——Epidemiological Strategy and Medical Economics（ESME）队列中患者的全部特征和结局。
纳入 2008 年 1 月至 2016 年 12 月期间在法国 18 个综合癌症中心之一诊断为新发性 MBC 且开始 MBC 治疗的年龄≥18 岁的女性（N=22109）。我们评估了全队列和 3 个主要亚组（激素受体阳性且 HER2 阴性 [HR+/HER2-]，n=13656；HER2 阳性 [HER2+]，n=4017；三阴性 [TN]，n=2963）中患者的全部特征、一线治疗、总生存期（OS）和一线无进展生存期，以及整个队列和各亚组中的最新预后因素。
全队列的中位 OS 为 39.5 个月（95%置信区间[CI]，38.7-40.3）。5 年 OS 为 33.8%。3 个亚组之间的 OS 差异显著（p<0.0001），HR+/HER2-亚组的中位 OS 为 43.3（95%CI，42.5-44.5），HER2+亚组为 50.1（95%CI，47.6-53.1），TN 亚组为 14.8 个月（95%CI，14.1-15.5）。除了体能状态外，以下变量在全队列和各亚组中对 OS 具有持续显著的负面预后影响：转移时的年龄较大（TN 亚组除外）、无转移间隔 6-24 个月、存在内脏转移和转移灶≥3 个。
ESME 计划代表了一项独特的大型 MBC 真实世界队列研究。该研究强调了 MBC 患者存在大量医疗需求的重要情况。
clinicaltrials.gov 标识符 NCT032753。
