Effectiveness of Primary Tumour Surgery in Oligometastatic Breast Cancer for Improving Overall Survival: A Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 110
- 试验地点
- 1
研究概览
简要总结
Breast cancer is the most common malignancy in women, with stage IV disease at diagnosis in 5-10% of cases. Oligometastatic breast cancer (OMBC), defined as limited metastases (≤3-5 in ≤1-2 organs), may have better outcomes. Systemic therapy is the cornerstone of treatment, while the role of surgery or radiotherapy for the primary tumour remains controversial. Current European Society for Medical Oncology(ESMO )and National Comprehensive Cancer Network(NCCN) guidelines advise systemic therapy as standard, reserving surgery mainly for palliation of local disease. Few Retrospective studies offering primary tumour surgery to oligometastatic breast cancer responding to systemic therapy suggest survival benefit, but several randomised trials to date showed inconsistent results. In Pakistan, data regarding survival pattern after breast surgery in oligometastatic breast cancer are scanty and this study would bridge this knowledge gap.
详细描述
Oligometastatic breast cancer (OMBC) is an entity is metastatic breast cancer with limited tumour burden. Usual nomenclature suggests total number of metastases to be less than 5 in up to 3 organs. It is considered an intermediate stage between localised and metastatic breast cancer. As compared to Multi metastatic stage 4 breast cancer oligometastatic breast cancer may have a favourable outcome (1,3) Currently the standard treatment for OMBC is systemic therapy (chemotherapy, hormone therapy or immunotherapy), with surgery or radiotherapy to primary tumour and metastatic sites as palliation only, as per ESMO and NCCN guidelines. (4,5) Retrospective observational studies suggested a possible survival benefit with primary tumour surgery (6,7). On the other hand, several Randomised controlled trials (Badwe et al., MF07-01, ECOG-ACRIN E2108, ABCSG-28) have shown inconsistent overall survival benefit with surgery in de novo metastatic breast cancer (8-10). The survival benefit has been observed where primary tumor surgery was performed in patients who respond well to systemic therapy in the form of complete or partial radiological response of metastasis, especially in patients with low metastatic burden, bone-only disease, or favorable biology may have differential outcomes after surgery (9,11).
Existing evidence is conflicting. So, case to case-based decision is being made for the oligometastatic breast cancer patients. There is a knowledge gap specific to oligometastatic disease among Pakistani patients as well. There are few Pakistani studies on this research question (12) The objective of this study is to determine whether surgical resection of the primary tumour in addition to standard systemic therapy improves overall survival compared with systemic therapy alone in patients with oligometastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Histologically confirmed breast carcinoma
- •Oligometastatic disease (≤5 lesions, less than 3 organs)
- •ECOG performance status 0-2
- •Eligible for systemic therapy and surgery
- •Informed consent obtained
排除标准
- •Unfit for surgery
- •Prior locoregional surgery on primary tumor
- •Visceral crisis
研究者
Ghazia Qasmi
Associate Professor Surgery
Sharif Medical Research Center
