Comparative Effectiveness of Sentinel Lymph Node Biopsy (SLNB) for Ductal Carcinoma In Situ (DCIS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28,291
- 试验地点
- 1
- 主要终点
- Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain
研究概览
简要总结
Patients with ductal carcinoma in situ (DCIS) treated with available therapies have experienced excellent outcomes and very low mortality rates due to the disease's non-invasive nature. However, considerable debate exists as to how the DCIS lesion should be treated. As a result, determining strategies to manage DCIS has been identified as a research priority. The role of sentinel lymph node biopsy (SLNB) for DCIS management is controversial in general and needs further scrutiny. Our study addresses this evidence gap as the investigators propose a retrospective cohort study to investigate the outcome of SLNB among DCIS patients. Specifically, the investigators will compare the outcomes, including survival outcomes and treatment side effects, among women older than 67 years of age with DCIS receiving SLNB vs. not receiving SLNB within 6 months of DCIS diagnosis. The investigators have two primary aims in this study: Aim 1: the investigators select our study sample using SEER-Medicare database. The investigators will determine associations between SLNB and acute/subacute side effects, including lymphedema, pain, and limitation of movement of upper extremity from the first breast conserving surgery to 9 months post-diagnosis. Aim 2: the investigators will determine associations between SLNB and long-term outcomes, including breast cancer specific mortality, ipsilateral invasive breast cancer diagnosis, subsequent mastectomy as treated recurrence, and lasting side effects, from >9 months post-diagnosis to death or the end of this study period.
Given the nature of our observational study design, the investigators will apply standard multivariate analyses and propensity score methodology to reduce the influence from confounders. The investigators will control for patient demographics, comorbidities, functional status, tumor characteristics, and prior healthcare utilization. Using distance to the nearest provider that uses SLNB for DCIS or surgeon's tendency in using SLNB for stage I/II breast cancer, the investigators also plan to conduct instrument variable analyses if necessary. Stratifying patients by key DCIS characteristics (including grade, comedonecrosis, and tumor size) and their predicted life expectancy (given their age and comorbidities), the investigators also hope to identify patient subgroups who may safely forgo SLNB. The study would provide evidence on the efficacy and safety outcome of SLNB for DCIS management.
详细描述
Because of the non-invasive nature of ductal carcinoma in situ (DCIS), patients treated with available therapies have excellent outcomes and very low rates of breast cancer mortality. Considerable debate exists as to how the DCIS lesion should be treated, although there is a movement toward less intensive intervention by the identification of patient subsets with favorable prognoses. Some prospective studies have found that the rate of ipsilateral invasive cancer occurrence is still high after receiving breast conserving surgery (BCS) alone, even among patients with favorable pathologic characteristics. Such findings argue against active surveillance for DCIS treatment. However, evidence exists that older DCIS patients have a lower rate of ipsilateral recurrence because DCIS among older patients tends to be indolent. Identifying suitable subgroups among this lower risk group who may be safe to receive a less aggressive treatment could change the current practice pattern of aggressive treatment.
Even when DCIS patients opt to receive a less intensive treatment such as BCS without radiation therapy, they and their providers need to decide whether to undergo sentinel lymph node biopsy (SLNB). A systematic review has shown that evidence gaps exist regarding the benefits of SLNB for DCIS. Given that the likelihood of axillary recurrence is low among DCIS patients who received radiation therapy, routine SLNB is not recommended for DCIS patients. Of note, radiation therapy can control axillary disease if present. If the investigators plan to empower DCIS patients to choose less intensive management options, such as BCS forgoing radiation therapy (RT), it will be crucial for patients and providers to understand the role of SLNB.
The overarching goals of this study are to compare side effects and outcomes between receiving SLNB vs. not receiving SLNB among older DCIS patients who received BCS. With this data, the investigators also aim to identify sub-populations for whom less intensive treatments may be appropriate. Using the Surveillance, Epidemiology, and End Result (SEER)-Medicare linked data, our project's overarching aims are:
Among older women with DCIS who have received BCS as their first surgery, to compare the outcomes of receiving sentinel lymph node biopsy (SLNB) vs. not receiving SLNB within 6 months of DCIS diagnosis:
Aim 1: The investigators will determine associations between SLNB and acute/subacute side effects, including lymphedema, pain, and limitation of movement of upper extremity from the first BCS to 9 months post-diagnosis Aim 2: The investigators will determine associations between SLNB and long-term outcomes, including breast cancer specific mortality, ipsilateral invasive breast cancer diagnosis, subsequent mastectomy as treated recurrence, and lasting side effects, from > 9 months' post-diagnosis to death or the end of the study period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 67 Years 至 94 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female DCIS patients older than 67 years and younger than 94 years who were enrolled in a fee-for-service Medicare program and resided in the SEER areas.
- •Aim 1: DCIS patients who received breast conserving surgery (BCS) as their first surgery
- •Aim 1: DCIS patients who were diagnosed DCIS between January 1998 and December 2011
- •Aim 2: DCIS patients who were diagnosed DCIS between January 2001 and December 2013
排除标准
- •Aim 1: DCIS patients who received mastectomy as their first surgery
- •Aim 2: DCIS patients who received BCS at the beginning yet received mastectomy in the end
结局指标
主要结局
Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain
时间窗: From the first BCS to 9 months post-diagnosis.
Primary outcomes for Aim 1: Acute and subacute side effects include any complication, lymphedema, seroma, wound infection, and pain.
次要结局
- Receipt of Mastectomy(6 months within DCIS diagnosis)
- Receipt of Radiation Therapy(9 months within DCIS diagnosis)
- Treated Recurrence(From 9 months post-diagnosis to death/end of study period (up to 1.5 years))
- Lasting Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain(From 9 months post-diagnosis to death/end of study period (up to 1.5 years))
- Breast Cancer Specific Mortality(From 9 months post-diagnosis to death/end of study period (up to 1.5 years))
- Overall Survival(From 9 months post-diagnosis to death/end of study period (up to 1.5 years))
- Ipsilateral Invasive Breast Cancer Occurrence(From 9 months post-diagnosis to death/end of study period (up to 1.5 years))