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Comparative effectiveness of sentinel lymph node biopsy for ductal carcinoma in situ
Investigator (PI): Wang, Shiyi
Performing Organization (PO): (Current): Yale University, Yale School of Public Health, Chronic Disease Epidemiology Department / (203) 737-1443
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2019
Record Source/Award ID: PCORI/CER-1507-31631
Funding: Total Award Amount: $438,751
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Ductal carcinoma in situ (DCIS) accounts for approximately 25 percent of all new breast cancer diagnosed in the United States. Concerns about overtreatment have increased because although DCIS may not progress to an invasive breast cancer, it is often treated aggressively. While there is a movement toward less intensive treatment for DCIS, such as observation/active surveillance or breast conserving surgery (BCS) alone, the safety of such approaches is under contentious debate. Evidence exists that DCIS among older patients tends to be indolent. Identifying suitable subgroups among this lower-risk group that may be safe to receive a less-intensive treatment could change the current practice pattern of aggressive treatment. The overarching goals of this study are to compare benefits, treatment burdens, and side effects between less-intensive treatment strategies among older DCIS patients. We aim to identify the population for whom less-intensive treatments may be appropriate. Using existing data linking tumor registries to Medicare claims, our project has two primary goals: 1) among women older than 67 years with DCIS, to compare the outcomes of "biopsy only plus observation/active surveillance" versus "immediate BCS without radiation therapy," in terms of breast cancer-specific mortality, invasive breast cancer diagnosis, subsequent mastectomy, receipt of RT, and treatment burdens (including follow-up biopsy, imaging tests, and outpatient clinic visits); and 2) among older women with DCIS who have received BCS without radiation therapy, to compare the outcomes of receiving sentinel lymph node biopsy versus not receiving it, in terms of breast cancer-specific mortality, invasive breast cancer diagnosis, subsequent mastectomy, receipt of RT, and side effects (including lymphedema, pain, and limitation of movement of upper extremity). This study has been planned in partnership with an existing group involved in breast cancer treatment for the older population, including patients, patient advocates, and clinicians. Outcomes of interest are identified based on the input of our patient and professional partners. We will examine the impact of different management strategies on clinical outcomes of women with newly diagnosed DCIS among the fee-for-service Medicare population. Using rigorous approaches and targeting patients who received less intensive treatment, we will produce timely results to help DCIS patients and their physicians make treatment decisions. Our results will also allow for the design of future randomized controlled trials.
MeSH Terms:
  • Biopsy
  • Breast Neoplasms /*diagnosis
  • /economics /therapy
  • Carcinoma, Intraductal, Noninfiltrating /*diagnosis
  • /economics /therapy
  • Comparative Effectiveness Research
  • Fee-for-Service Plans
  • Female
  • Humans
  • Insurance Claim Review
  • Medicare
  • Outcome Assessment, Health Care
  • Randomized Controlled Trials as Topic
  • Registries
  • Sentinel Lymph Node Biopsy /economics
  • /*methods
  • United States
Country: United States
State: Connecticut
Zip Code: 06520
UI: 20163062
Project Status: Completed
Record History: ('2019: Project extended to 2019',)