BONE MARROW & SENTINEL NODE MICROMETASTASES IN BREAST CA
BONE MARROW & SENTINEL NODE MICROMETASTASES IN BREAST CA
批准号:
6377815
负责人:
RICHARD JAMES COTE
金额:
$45.52万
依托单位国家:
美国
项目类别:
财政年份:
2000
资助国家:
美国
项目状态:
已结题
起止时间:
2000-06-20 至 2005-05-31
中文摘要
描述:(改编自研究者摘要)乳腺癌是
是妇女最常见的癌症,也是癌症死亡的第二大原因。
大多数患者存在可手术的疾病。事实上,大多数患者
淋巴结阴性的患者将通过手术切除肿瘤而治愈
一个人然而,由于已证实的疗效,大多数浸润性乳腺癌患者
癌症将经历完整的腋窝清扫以进行淋巴结评估,
并且被认为是辅助(全身)治疗的候选者。本科目
大部分患者以淋巴结阴性疾病为代价而方
腋窝淋巴结清扫和全身化疗的效果。一级处理
失败是继发于不可检测的肿瘤扩散,这种隐匿性肿瘤是
辅助治疗的目标。他发明了一种极其敏感的方法
用于检测骨髓(BM)和区域淋巴中的隐匿性转移
乳腺癌患者的淋巴结。他们的实验室和其他人的研究
强烈提示存在隐匿性区域和全身转移
与复发率增加和生存率降低有关。此外,委员会认为,
他已经证明,前哨淋巴结的识别和分析,
(SLN引流肿瘤床的第一个淋巴结)可以减少对
完全腋窝淋巴结清扫,特别是淋巴结阴性患者
疾病他们的中心假设是,
早期乳腺癌患者的BM和SLN确定了
复发和死亡的风险增加,并确定了具体的目标,
辅助化疗具体目标是:(1)识别和量化
乳腺癌患者BM和SLN中的隐匿性转移。本研究将
由NIH/NCI资助的美国外科医生学院肿瘤学小组组织
(ACOS-OG),(方案Z 0010)。(2)因为他们明白
目前的方法来检测隐匿性转移,他已经开发,并将评估
新的影像学和分子检测方法的隐匿性转移。(三)
通过ACOS-OG数据管理和后续能力,
骨髓和前哨淋巴结隐匿性转移的临床意义。本研究将
为ACOS-OG提供必要的相关研究组件
多中心临床试验Z 0010,应提供明确证据
关于在乳腺癌患者中使用隐匿性转移检测,
癌在BM和SLN中检测到隐匿性转移,
根治性腋窝淋巴结清扫术,可以允许更具体,但侵入性更小
评估患者风险,重新定义手术和全身治疗
乳腺癌患者的选择。
英文摘要
DESCRIPTION: (Adapted from the investigator's abstract) Breast cancer is the
most common cancer and the second leading cause of cancer deaths among women.
The majority of patients present with operable disease. In fact, most patients
with node-negative disease will be cured by surgical resection of their tumor
alone. However, due to proven efficacy, most patients with invasive breast
cancer will undergo a complete axillary dissection for lymph node evaluation,
and are considered candidates for adjuvant (systemic) therapy. This subjects
the majority of patients with node-negative disease to the expense and side
effects of axillary dissection and systemic chemotherapy. Primary treatment
failure is secondary to undetectable spread of tumor, and this occult tumor is
the target of adjuvant therapy. He has developed extremely sensitive methods
for the detection of occult metastases in bone marrow (BM) and regional lymph
nodes in patients with breast cancer. Studies from their laboratory and others
strongly suggest that the presence of occult regional and systemic metastases
are associated with increased recurrence and decreased survival. Furthermore,
he has shown that the identification and analysis of the sentinel lymph node
(SLN, the first lymph node draining the tumor bed) may reduce the need for
complete axillary dissection, particularly in patients with node-negative
disease. Their central hypothesis is that the presence of occult metastases to
BM and SLN in patients with early stage breast cancer identifies patients at
increased risk of recurrence and death, and identifies the specific target of
adjuvant chemotherapy. The specific aims are: (1) To identify and quantitate
occult metastases in BM and SLN of patients with breast cancer. This study will
be organized by the NIH/NCI funded American College of Surgeons Oncology Group
(ACOS-OG), (protocol Z0010). (2) Because they understand the difficulties of
current methods to detect occult metastases, he has developed and will evaluate
novel imaging and molecular methods for the detection of occult metastases. (3)
To evaluate, through the ACOS-OG data management and follow up capabilities,
the clinical significant of occult metastases to BM and SLN. This study will
provide the essential correlative research component for the ACOS-OG
multi-center clinical trial Z0010, and should provide definitive evidence
regarding the use of occult metastasis detection in patients with breast
cancer. The detection of occult metastases in BM and SLN, in place of more
radical axillary dissection, could allow for more specific yet less invasive
assessment of patient risk, and redefine the surgical and systemic treatment
options for patients with breast cancer.
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