Comparative Effectiveness of Sentinel Lymph Node Biopsy for Ductal Carcinoma In Situ
NCT ID: NCT02908178
Last Updated: 2019-05-15
Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Total Enrollment
28291 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-01-25
Study Completion Date
2018-06-29
Brief Summary
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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.
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.
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Detailed Description
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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.
Our study is a retrospective cohort study with the study population being DCIS patients older than 67 years (hereafter referred to as older women) who were enrolled in a fee-for-service Medicare program and resided in the SEER areas from 1998 to 2011 (2001 to 2013 for Aim 2) and who were followed up to 2012 (2015 for Aim 2). The investigators selected age 67 years as a cut-off value because the investigators plan to use two years of claims data to identify patient comorbidities and control for them in our statistical models, and data is first available at age 65. 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.
In comparisons of baseline characteristics between intervention and control groups, the investigators will conduct standard descriptive statistics using chi-square tests for categorical variables and t-tests for continuous variables. The investigators will tabulate the frequencies of outcomes of interests by the intervention vs. control group. For multivariable analyses, the investigators will apply proportional hazards models to test whether the intervention is associated with better outcomes.
the investigators plan to control for this issue using propensity score matching methodology. Prior literature has suggested inclusion of either all measured variables or those variables that are associated with treatment selection (SLNB status) when conducting an analysis using the propensity score method. Specifically, our approach to matching will be based on the Mahalanobis distance calculated using age, race, residence in a metropolitan county, comorbidity, prior influenza vaccination or prior visit to a primary care physician (both as proxies for access to care), income, preoperative MRI use, and tumor characteristics. Tumor characteristics include size, grade, comedonecrosis, and estrogen receptor status. By incorporating these factors in matching, the investigators expect to substantially decrease bias and balance the risk for outcomes of interest between the SLNB and non-SLNB groups. The difference in outcomes between the control and intervention groups will be estimated in a Kaplan-Meier curve. The investigators will estimate the relative risk in the propensity score matched sample using the standard method for matched-pair data. The investigators will use the Cox proportional hazards models to investigate the association between various factors (grade, tumor size, and estrogen receptor status) and outcomes.
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.
Our study is a retrospective cohort study with the study population being DCIS patients older than 67 years (hereafter referred to as older women) who were enrolled in a fee-for-service Medicare program and resided in the SEER areas from 1998 to 2011 (2001 to 2013 for Aim 2) and who were followed up to 2012 (2015 for Aim 2). The investigators selected age 67 years as a cut-off value because the investigators plan to use two years of claims data to identify patient comorbidities and control for them in our statistical models, and data is first available at age 65. 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.
In comparisons of baseline characteristics between intervention and control groups, the investigators will conduct standard descriptive statistics using chi-square tests for categorical variables and t-tests for continuous variables. The investigators will tabulate the frequencies of outcomes of interests by the intervention vs. control group. For multivariable analyses, the investigators will apply proportional hazards models to test whether the intervention is associated with better outcomes.
the investigators plan to control for this issue using propensity score matching methodology. Prior literature has suggested inclusion of either all measured variables or those variables that are associated with treatment selection (SLNB status) when conducting an analysis using the propensity score method. Specifically, our approach to matching will be based on the Mahalanobis distance calculated using age, race, residence in a metropolitan county, comorbidity, prior influenza vaccination or prior visit to a primary care physician (both as proxies for access to care), income, preoperative MRI use, and tumor characteristics. Tumor characteristics include size, grade, comedonecrosis, and estrogen receptor status. By incorporating these factors in matching, the investigators expect to substantially decrease bias and balance the risk for outcomes of interest between the SLNB and non-SLNB groups. The difference in outcomes between the control and intervention groups will be estimated in a Kaplan-Meier curve. The investigators will estimate the relative risk in the propensity score matched sample using the standard method for matched-pair data. The investigators will use the Cox proportional hazards models to investigate the association between various factors (grade, tumor size, and estrogen receptor status) and outcomes.
Conditions
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Ductal Carcinoma In Situ
Study Design
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Observational Model Type
COHORT
Study Time Perspective
RETROSPECTIVE
Study Groups
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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.
Sentinel lymph node biopsy (SLNB)
Intervention Type
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 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.
Sentinel lymph node biopsy (SLNB)
Intervention Type
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).
Interventions
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Sentinel lymph node biopsy (SLNB)
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).
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* Aim 2: DCIS patients who received BCS at the beginning yet received mastectomy in the end
Minimum Eligible Age
67 Years
Maximum Eligible Age
94 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Sponsor Role
collaborator
Yale University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Shi-Yi Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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SEER-Medicare Dataset
Bethesda, Maryland, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
American Cancer Society. Cancer Facts & Figure 2013. Atlanta: American Cancer Soc; 2013
Reference Type
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.
Reference Type
BACKGROUND
Allegra CJ, Aberle DR, Ganschow P, Hahn SM, Lee CN, Millon-Underwood S, Pike MC, Reed SD, Saftlas AF, Scarvalone SA, Schwartz AM, Slomski C, Yothers G, Zon R. National Institutes of Health State-of-the-Science Conference statement: Diagnosis and Management of Ductal Carcinoma In Situ September 22-24, 2009. J Natl Cancer Inst. 2010 Feb 3;102(3):161-9. doi: 10.1093/jnci/djp485. Epub 2010 Jan 13.
Reference Type
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Francis AM, Haugen CE, Grimes LM, Crow JR, Yi M, Mittendorf EA, Bedrosian I, Caudle AS, Babiera GV, Krishnamurthy S, Kuerer HM, Hunt KK. Is Sentinel Lymph Node Dissection Warranted for Patients with a Diagnosis of Ductal Carcinoma In Situ? Ann Surg Oncol. 2015 Dec;22(13):4270-9. doi: 10.1245/s10434-015-4547-7. Epub 2015 Apr 24.
Reference Type
BACKGROUND
Julian TB, Land SR, Fourchotte V, Haile SR, Fisher ER, Mamounas EP, Costantino JP, Wolmark N. Is sentinel node biopsy necessary in conservatively treated DCIS? Ann Surg Oncol. 2007 Aug;14(8):2202-8. doi: 10.1245/s10434-007-9353-4. Epub 2007 May 30.
Reference Type
BACKGROUND
Cox CE, Nguyen K, Gray RJ, Salud C, Ku NN, Dupont E, Hutson L, Peltz E, Whitehead G, Reintgen D, Cantor A. Importance of lymphatic mapping in ductal carcinoma in situ (DCIS): why map DCIS? Am Surg. 2001 Jun;67(6):513-9; discussion 519-21.
Reference Type
BACKGROUND
Klauber-DeMore N, Tan LK, Liberman L, Kaptain S, Fey J, Borgen P, Heerdt A, Montgomery L, Paglia M, Petrek JA, Cody HS, Van Zee KJ. Sentinel lymph node biopsy: is it indicated in patients with high-risk ductal carcinoma-in-situ and ductal carcinoma-in-situ with microinvasion? Ann Surg Oncol. 2000 Oct;7(9):636-42. doi: 10.1007/s10434-000-0636-2.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
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.
Reference Type
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.
Reference Type
BACKGROUND
D'Agostino RB Jr. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med. 1998 Oct 15;17(19):2265-81. doi: 10.1002/(sici)1097-0258(19981015)17:193.0.co;2-b.
Reference Type
BACKGROUND
Yu JB, Soulos PR, Herrin J, Cramer LD, Potosky AL, Roberts KB, Gross CP. Proton versus intensity-modulated radiotherapy for prostate cancer: patterns of care and early toxicity. J Natl Cancer Inst. 2013 Jan 2;105(1):25-32. doi: 10.1093/jnci/djs463. Epub 2012 Dec 14.
Reference Type
BACKGROUND
Austin PC. Statistical criteria for selecting the optimal number of untreated subjects matched to each treated subject when using many-to-one matching on the propensity score. Am J Epidemiol. 2010 Nov 1;172(9):1092-7. doi: 10.1093/aje/kwq224. Epub 2010 Aug 28.
Reference Type
BACKGROUND
Agresti A, Min Y. Effects and non-effects of paired identical observations in comparing proportions with binary matched-pairs data. Stat Med. 2004 Jan 15;23(1):65-75. doi: 10.1002/sim.1589.
Reference Type
BACKGROUND
Austin PC. The performance of different propensity-score methods for estimating relative risks. J Clin Epidemiol. 2008 Jun;61(6):537-45. doi: 10.1016/j.jclinepi.2007.07.011. Epub 2008 Feb 14.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PCORI-SW-1
Identifier Type: -
Identifier Source: org_study_id
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