跳至主要内容
临床试验/NCT02251353
NCT02251353Unknown不适用

Intervention to Hepatic and Pulmonary Metastasis in Breast Cancer Patients: Prospective, Observational, Multi-institutional Registration Study - IMET

Federation of Breast Diseases Societies1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Overall survival (OS)

研究概览

简要总结

The number of intervention performed for metastatic breast cancer has dramatically increased over the past 2 decades. Hepatectomy and pulmonary resection for stage IV colorectal cancer is now considered the standard of care for resectable patients with isolated hepatic and/or pulmonary disease and acceptable performance status. However, the indications for resection / intervention of breast cancer origin metastases are not as clearly defined. The aim of this study to focus on emerging data for the intervention (resection and/or radiofrequency ablation (RFA), transcatheter arterial chemoembolization (TACE), cyberKnife stereotactic radiosurgery) of breast cancer metastatic disease to the lung and liver, with a focus on indications for resection / intervention.

详细描述

Purpose Despite breast cancer being the most common cancer in women in the developed world, only a minority of patients (< 10%) has stage IV disease at diagnosis (1). In addition, 20-30% of patients with early breast cancer will experience distant metastatic relapse (2). Due to advances in available multimodality therapies and a better understanding of tumor biology, survival of stage IV patients is constantly improving (3-5).

Clinically, oligometastatic breast cancer is characterized by solitary/few detectable lesions, usually limited to single organs, in which local therapy with curative intent could impact survival. This population of 'potentially curable' stage IV disease is estimated to be 1-10% of newly diagnosed patients with metastatic breast cancer (5). A multimodal approach is endorsed for these selected patients (5,6). The identification of patients with truly oligometastatic disease is challenging. Most published series refer to an era before modern imaging (i.e. positron emission tomography-computed tomography), and thus many patients were probably understaged, potentially leading to underestimation of the global effect of an aggressive local management.

Patients with oligometastatic disease can be divided into 3 cohorts (7,8): 1) patients who present with oligometastases; 2) patients with residual oligometastases after systemic therapy; and 3) those with relapsed oligometastases after curative locoregional therapy. These different groups have possibly distinct prognoses, and may need differential approaches.

Several series have reported on lung and liver metastases resection in oligometastatic breast cancer and most data are from small series of patients collected over many years. The largest dataset comes from the International Registry of Lung Metastases and presents results of lung metastasectomy in 467 breast cancer patients (9). Complete resection was possible in 84% of patients and led to a median survival of 37 months (5-year OS = 38%, 10-year OS = 22%). Identified prognostic factors for lung resection include disease-free interval and number of metastases (disease-free interval >36 months and solitary metastases being the most favorable), ER status, size of metastases, completeness of resection, and use of anatomical resection (as opposite to wedge resection) (9-19). Obviously, the reported data refer to a subset of patients who were selected for favorable prognostic factors, and any comparison with surgically untreated patients is threatened by serious biases.

Pulmonary resection in metastatic breast cancer patients, apart from its potential therapeutic value, is also an important diagnostic tool, especially in patients with a suspected first recurrence, allowing for differential diagnosis with second primary lung cancers and benign lesions (19,20). The proportion of lesions proved not to be breast cancer metastases in various series ranges from 7% to 66% (9,14,18,21). As the morbidity and mortality of pulmonary resection has decreased substantially over the last decades, this potentially beneficial procedure can be discussed in a selected group of patients (9,19,21).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Metastatic breast cancer (lung and/or hepatic metastasis) 18 years and older Antineoplastic treatment

排除标准

  • No lung and/or hepatic metastasis Below 18 years No antineoplastic treatment

研究组 & 干预措施

lung and/or hepatic metastasis

intervention to metastasis (resection and/or radiofrequency ablation (RFA), transcatheter arterial chemoembolization (TACE), cyberKnife stereotactic radio surgery) vs no intervention (only systemic treatment)

干预措施: intervention (Procedure)

lung and/or hepatic metastasis

intervention to metastasis (resection and/or radiofrequency ablation (RFA), transcatheter arterial chemoembolization (TACE), cyberKnife stereotactic radio surgery) vs no intervention (only systemic treatment)

干预措施: systemic treatment (Drug)

结局指标

主要结局

Overall survival (OS)

时间窗: 3 years

Time interval between diagnosis and death

次要结局

  • Morbidity due to treatment modality(6 months)
  • Progression free survival (PFS)(3 years)

研究者

发起方
Federation of Breast Diseases Societies
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hasan Karanlık

Professor

Federation of Breast Diseases Societies

研究点 (1)

Loading locations...

相似试验