Comparative Effectiveness of Sentinel Lymph Node Biopsy for Ductal Carcinoma In Situ

NCT02908178 | Completed Results

• 1 other identifier: PCORI-SW-1
• Study Type: observational
• Target: 28,291
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ductal Carcinoma In Situ

Keywords

ductal carcinoma in situ (DCIS); sentinel lymph node biopsy (SLNB)

Outcome Measures

Primary Outcomes (1)

• Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain

  Primary outcomes for Aim 1: Acute and subacute side effects include any complication, lymphedema, seroma, wound infection, and pain.

  From the first BCS to 9 months post-diagnosis.

Secondary Outcomes (7)

• Receipt of Mastectomy

  6 months within DCIS diagnosis

• Receipt of Radiation Therapy

  9 months within DCIS diagnosis

• Overall Survival

  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)

Study Arms (2)

Aim 1 Cohort

The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. This cohort includes patients diagnosed at ages 67-94 years with DCIS between January 1998 and December 2011, and received BCS as their first surgery. Patients in this cohort include those who received sentinel lymph node biopsy (SLNB) and who didn't receive SLNB. The Aim 1 Cohort and the Aim 2 Cohort can overlap.

Procedure: Sentinel lymph node biopsy (SLNB)

Aim 2 Cohort

The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2. This cohort includes patients diagnosed at ages 67-94 years with DCIS between January 2001 and December 2013, and received BCS as their first surgery. Patients in this cohort include those who received sentinel lymph node biopsy (SLNB) and who didn't receive SLNB. The Aim 1 Cohort and the Aim 2 Cohort can overlap.

Procedure: Sentinel lymph node biopsy (SLNB)

Interventions

Sentinel lymph node biopsy (SLNB) PROCEDURE

Intervention is defined as that the DCIS patient has undergone SLNB. Patients in each cohort (group) include those who underwent SLNB (intervention) and those who did not (control).

Aim 1 Cohort; Aim 2 Cohort

Eligibility Criteria

• Age: 67 Years - 94 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our study populations were generated within the SEER-Medicare linked database. The populations consist of female DCIS patients ages 67-94 years who were enrolled in a fee-for-service Medicare program and resided in the SEER areas.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

SEER-Medicare Dataset

Bethesda, Maryland, 20892, United States

Location

Related Publications (21)

• Burstein HJ, Polyak K, Wong JS, Lester SC, Kaelin CM. Ductal carcinoma in situ of the breast. N Engl J Med. 2004 Apr 1;350(14):1430-41. doi: 10.1056/NEJMra031301. No abstract available.

  PMID: 15070793 BACKGROUND

• American Cancer Society. Cancer Facts & Figure 2013. Atlanta: American Cancer Soc; 2013

  BACKGROUND

• Virnig BA, Wang SY, Shamilyan T, Kane RL, Tuttle TM. Ductal carcinoma in situ: risk factors and impact of screening. J Natl Cancer Inst Monogr. 2010;2010(41):113-6. doi: 10.1093/jncimonographs/lgq024.

  PMID: 20956813 BACKGROUND

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  PMID: 20071686 BACKGROUND

• Gierisch JM, Myers ER, Schmit KM, Crowley MJ, McCrory DC, Chatterjee R, Coeytaux RR, Kendrick A, Sanders GD. Prioritization of research addressing management strategies for ductal carcinoma in situ. Ann Intern Med. 2014 Apr 1;160(7):484-91. doi: 10.7326/M13-2548.

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• Prendeville S, Ryan C, Feeley L, O'Connell F, Browne TJ, O'Sullivan MJ, Bennett MW. Sentinel lymph node biopsy is not warranted following a core needle biopsy diagnosis of ductal carcinoma in situ (DCIS) of the breast. Breast. 2015 Jun;24(3):197-200. doi: 10.1016/j.breast.2015.01.004. Epub 2015 Feb 11.

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  PMID: 11409797 BACKGROUND

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  PMID: 11034239 BACKGROUND

• Schmale I, Liu S, Rayhanabad J, Russell CA, Sener SF. Ductal carcinoma in situ (DCIS) of the breast: perspectives on biology and controversies in current management. J Surg Oncol. 2012 Feb;105(2):212-20. doi: 10.1002/jso.22020. Epub 2011 Jul 12.

  PMID: 21751217 BACKGROUND

• Archer S, Winchester DS. Noninvasive breast cancer. In: Berger DH, Feig BW, Fuhrman GM, eds. The M.D.Anderson Surgical Oncology Handbook. Boston, Mass: Little Brown & Co; 1995:1-11.

  BACKGROUND

• Shapiro-Wright HM, Julian TB. Sentinel lymph node biopsy and management of the axilla in ductal carcinoma in situ. J Natl Cancer Inst Monogr. 2010;2010(41):145-9. doi: 10.1093/jncimonographs/lgq026.

  PMID: 20956820 BACKGROUND

• Fisher B. Role of science in the treatment of breast cancer when tumor multicentricity is present. J Natl Cancer Inst. 2011 Sep 7;103(17):1292-8. doi: 10.1093/jnci/djr240. Epub 2011 Jul 15.

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• Virnig BA, Shamliyan T, Tuttle TM, Kane RL, Wilt TJ. Diagnosis and management of ductal carcinoma in situ (DCIS). Evid Rep Technol Assess (Full Rep). 2009 Sep;(185):1-549.

  PMID: 20629475 BACKGROUND

• SEER. Attachment A for the SEER-MEDICARE PEDSF File. Available at http://healthcaredelivery.cancer.gov/seermedicare/aboutdata/pedsf_attachment_a.pdf. Accessed on March 18, 2016.

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  PMID: 18471657 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Results Point of Contact

• Title: Shi-Yi Wang, MD, PhD
• Organization: Yale University

shiyi.wang@yale.edu

2037852886

Study Officials

• Shi-Yi Wang, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 20, 2016
• Study Start: January 25, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 29, 2018
• Last Updated: May 15, 2019
• Results First Posted: April 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)