Department of Medical Oncology, University General Hospital of Heraklion Crete Voutes, 711 10, Iraklio, Greece.
1st Department of Medical Oncology, Agios Savvas Anticancer Hospital, 171 Alexandras Av, 115 22, Athens, Greece.
BMC Cancer. 2019 Jan 18;19(1):88. doi: 10.1186/s12885-019-5301-5.
The "EMERGE" study, aimed to capture real-life management patterns and outcomes in metastatic breast cancer (MBC) in Greece, also accounting for hormone (HR) and human epidermal growth factor receptor 2 (HER2) status.
"EMERGE" was a multicenter, retrospective cohort study of adult MBC patients diagnosed between 01-Janaury-2010 and 30-June-2012, either de novo or having progressed from a non-metastatic state. Patient data, including treatment patterns and outcomes, were mainly abstracted through medical chart review.
386 patients were enrolled by 16 hospital-based oncologists between 12-March-2013 and 31-March-2015. The median look-back period was 29.1 months. At MBC diagnosis, 56.1% of the patients were HR/HER2, 16.6% HR/HER2, 14.5% HR/HER2, and 12.8% HR/HER2. In the first line setting, chemotherapy, targeted therapy and endocrine therapy were received by 76.7, 52.4, and 28.3% of the overall population, and by 66.5/36.2/42.0%, 80.4/80.4/28.6%, 88.4/90.7/0.0, and 95.6%/56.5/6.5% of the HR/HER2, HR/HER2, HR/HER2, HR/HER2 subpopulations, respectively. In the overall population, the disease progression incidence rate was 0.57 [95% confidence interval (CI): 0.48-0.67] per person-year; median progression-free survival (PFS) was 22.4 (95% CI: 20.4-24.7) and overall survival (OS) was 45.0 (95% CI: 40.9-55.0) months. Median PFS was 24.6 (95% CI: 21.3-27.9) in HR/HER2, 19.7 (95% CI: 12.9-25.9) in HR/HER2, 23.0 (95% CI: 16.6-29.7) in HR/HER2 and 18.3 (95% CI: 10.0-24.7) months in HR/HER2 subpopulations. A multivariable Cox proportional hazards model, adjusted among other factors for age and duration of diagnosis, HR and HER2 status, demonstrated that in the overall population PFS was better among those receiving first line endocrine therapy (hazard ratio: 0.70; 95%CI: 0.51-0.95; p = 0.024).
"EMERGE" demonstrates differences between HR/HER2 subtypes in clinical outcomes and divergence from evidence-based guideline recommendations for MBC management, especially as it pertains to the HR/HER2 patients in which chemotherapy was favored over endocrine therapy in the first line setting.
The study has been registered on the electronic Registry of Non-Interventional Studies (RNIS) posted on the website of the Hellenic Association of Pharmaceutical Companies (SFEE): https://www.dilon.sfee.gr/studiesp_d.php?meleti_id=NIS-OGR-XXX-2012/1.
“EMERGE”研究旨在描述希腊转移性乳腺癌(MBC)的真实管理模式和结局,并同时考虑激素(HR)和人表皮生长因子受体 2(HER2)状态。
“EMERGE”是一项多中心、回顾性队列研究,纳入了 2010 年 1 月 1 日至 2012 年 6 月 30 日期间新诊断或从非转移性状态进展而来的成年 MBC 患者。主要通过病历回顾来收集患者的治疗模式和结局数据。
在 2013 年 3 月 12 日至 2015 年 3 月 31 日期间,由 16 位医院肿瘤学家共纳入了 386 名患者。中位回溯期为 29.1 个月。在 MBC 诊断时,56.1%的患者为 HR/HER2 阳性,16.6%为 HR/HER2 阴性,14.5%为 HR/HER2 阳性,12.8%为 HR/HER2 阴性。在一线治疗中,76.7%、52.4%和 28.3%的患者接受了化疗、靶向治疗和内分泌治疗,整体人群和 HR/HER2 阳性、HR/HER2 阴性、HR/HER2 阳性、HR/HER2 阴性患者分别有 66.5%/36.2%/42.0%、80.4%/80.4%/28.6%、88.4%/90.7%/0.0%和 95.6%/56.5%/6.5%接受了化疗、靶向治疗和内分泌治疗。在整体人群中,疾病进展发生率为 0.57 [95%置信区间(CI):0.48-0.67]人年;中位无进展生存期(PFS)为 22.4 个月(95%CI:20.4-24.7),总生存期(OS)为 45.0 个月(95%CI:40.9-55.0)。HR/HER2 阳性患者的中位 PFS 为 24.6 个月(95%CI:21.3-27.9),HR/HER2 阴性患者为 19.7 个月(95%CI:12.9-25.9),HR/HER2 阳性患者为 23.0 个月(95%CI:16.6-29.7),HR/HER2 阴性患者为 18.3 个月(95%CI:10.0-24.7)。多变量 Cox 比例风险模型显示,在调整了年龄和诊断持续时间、HR 和 HER2 状态等因素后,与接受一线内分泌治疗的患者相比,接受一线化疗的患者 PFS 更好(风险比:0.70;95%CI:0.51-0.95;p=0.024)。
“EMERGE”研究显示,HR/HER2 亚组在临床结局方面存在差异,并且与转移性乳腺癌管理的循证指南建议存在分歧,尤其是在 HR/HER2 患者中,一线治疗中更倾向于化疗而非内分泌治疗。
该研究已在希腊制药公司协会(SFEE)网站上的非干预性研究电子注册处(RNIS)上注册:https://www.dilon.sfee.gr/studiesp_d.php?meleti_id=NIS-OGR-XXX-2012/1。