Trial Outcomes & Findings for Comparative Effectiveness of Sentinel Lymph Node Biopsy for Ductal Carcinoma In Situ (NCT NCT02908178)

Last Updated: 2019-05-15

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

28291 participants

Primary outcome timeframe

From the first BCS to 9 months post-diagnosis.

Results posted on

2019-05-15

Participant Flow

Because this study is 1) secondary data analysis of an existing database, 2) has two aims using the most recent data when conducting the analyses, and 3) uses Mehalanobis matching, the number of participants in Enrollment is the number of patients who are eligible to our inclusion criteria.

Participant milestones

Participant milestones
Measure	Aim 1 Cohort - SLNB The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population include patients older than 67 years old who have received BCS as their first surgery. The time period for defining the cohort is between January 1998 and December 2011. Patients in this group received SLNB. 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).	Aim 1 Cohort - No SLNB The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population include patients older than 67 years old who have received BCS as their first surgery. The time period for defining the cohort is between January 1998 and December 2011. Patients in this group did not receive SLNB. 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).	Aim 2 Cohort - SLNB The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population include patients older than 67 years old who have received BCS as the final treatment for their DCIS. The time period for defining the cohort is between January 2001 and December 2013. Patients in this group received sentinel lymph node biopsy (SLNB). 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).	Aim 2 Cohort - No SLNB The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population include patients older than 67 years old who have received BCS as the final treatment for their DCIS. The time period for defining the cohort is between January 2001 and December 2013. Patients in this group did not receive sentinel lymph node biopsy (SLNB). 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).
Overall Study STARTED	2409	13106	1992	10784
Overall Study COMPLETED	2409	4718	1992	3965
Overall Study NOT COMPLETED	0	8388	0	6819

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aim 1 Cohort: No SLNB n=4718 Participants The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis. Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group).	Aim 1 Cohort: SLNB n=2409 Participants The Aim 1 Cohort is constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis. Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group).	Aim 2 Cohort: No SLNB n=3965 Participants The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 2001 and December 2013, and had received BCS as their first surgery within 6 months of diagnosis. Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group).	Aim 2 Cohort: SLNB n=1992 Participants The Aim 2 Cohort is constructed to perform analysis to address study objective Aim 2.The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 2001 and December 2013, and had received BCS as their first surgery within 6 months of diagnosis. Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group).	Total n=13084 Participants Total of all reporting groups
Age, Customized 67-69 years old	981 Participants n=5 Participants	573 Participants n=7 Participants	808 Participants n=5 Participants	478 Participants n=4 Participants	2840 Participants n=21 Participants
Age, Customized 70-74 years old	1592 Participants n=5 Participants	783 Participants n=7 Participants	1309 Participants n=5 Participants	651 Participants n=4 Participants	4335 Participants n=21 Participants
Age, Customized 75-79 years old	1263 Participants n=5 Participants	614 Participants n=7 Participants	1110 Participants n=5 Participants	503 Participants n=4 Participants	3490 Participants n=21 Participants
Age, Customized 80-84 years old	670 Participants n=5 Participants	333 Participants n=7 Participants	567 Participants n=5 Participants	272 Participants n=4 Participants	1842 Participants n=21 Participants
Age, Customized 85+ years old	212 Participants n=5 Participants	106 Participants n=7 Participants	171 Participants n=5 Participants	88 Participants n=4 Participants	577 Participants n=21 Participants
Sex: Female, Male Female	4718 Participants n=5 Participants	2409 Participants n=7 Participants	3965 Participants n=5 Participants	1992 Participants n=4 Participants	13084 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	221 Participants n=5 Participants	135 Participants n=7 Participants	190 Participants n=5 Participants	106 Participants n=4 Participants	652 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4497 Participants n=5 Participants	2274 Participants n=7 Participants	3775 Participants n=5 Participants	1886 Participants n=4 Participants	12432 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	4099 Participants n=5 Participants	2148 Participants n=7 Participants	3494 Participants n=5 Participants	1778 Participants n=4 Participants	11519 Participants n=21 Participants
Race/Ethnicity, Customized Black	386 Participants n=5 Participants	170 Participants n=7 Participants	271 Participants n=5 Participants	129 Participants n=4 Participants	956 Participants n=21 Participants
Race/Ethnicity, Customized Other	233 Participants n=5 Participants	91 Participants n=7 Participants	200 Participants n=5 Participants	85 Participants n=4 Participants	609 Participants n=21 Participants
Region of Enrollment United States	4718 participants n=5 Participants	2409 participants n=7 Participants	3965 participants n=5 Participants	1992 participants n=4 Participants	13084 participants n=21 Participants
Marital Status Married	2286 Participants n=5 Participants	1227 Participants n=7 Participants	1977 Participants n=5 Participants	1038 Participants n=4 Participants	6528 Participants n=21 Participants
Marital Status Unmarried	2196 Participants n=5 Participants	1085 Participants n=7 Participants	1798 Participants n=5 Participants	867 Participants n=4 Participants	5946 Participants n=21 Participants
Marital Status Other	236 Participants n=5 Participants	97 Participants n=7 Participants	190 Participants n=5 Participants	87 Participants n=4 Participants	610 Participants n=21 Participants
Tumor Grade Well differentiated	498 Participants n=5 Participants	254 Participants n=7 Participants	424 Participants n=5 Participants	207 Participants n=4 Participants	1383 Participants n=21 Participants
Tumor Grade Moderately differentiated	1371 Participants n=5 Participants	629 Participants n=7 Participants	1278 Participants n=5 Participants	536 Participants n=4 Participants	3814 Participants n=21 Participants
Tumor Grade Poorly differentiated	1449 Participants n=5 Participants	802 Participants n=7 Participants	1262 Participants n=5 Participants	730 Participants n=4 Participants	4243 Participants n=21 Participants
Tumor Grade Undifferentiated	601 Participants n=5 Participants	321 Participants n=7 Participants	434 Participants n=5 Participants	226 Participants n=4 Participants	1582 Participants n=21 Participants
Tumor Grade Unknown	799 Participants n=5 Participants	403 Participants n=7 Participants	567 Participants n=5 Participants	293 Participants n=4 Participants	2062 Participants n=21 Participants
Tumor size <2.0 cm	2552 Participants n=5 Participants	1264 Participants n=7 Participants	2407 Participants n=5 Participants	1148 Participants n=4 Participants	7371 Participants n=21 Participants
Tumor size 2.0-<5.0 cm	749 Participants n=5 Participants	434 Participants n=7 Participants	550 Participants n=5 Participants	347 Participants n=4 Participants	2080 Participants n=21 Participants
Tumor size >5.0 cm	149 Participants n=5 Participants	89 Participants n=7 Participants	80 Participants n=5 Participants	42 Participants n=4 Participants	360 Participants n=21 Participants
Tumor size Missing	1268 Participants n=5 Participants	622 Participants n=7 Participants	928 Participants n=5 Participants	455 Participants n=4 Participants	3273 Participants n=21 Participants
Hormone receptors ER- and PR-	631 Participants n=5 Participants	341 Participants n=7 Participants	485 Participants n=5 Participants	284 Participants n=4 Participants	1741 Participants n=21 Participants
Hormone receptors ER+ and PR+	2608 Participants n=5 Participants	1329 Participants n=7 Participants	2316 Participants n=5 Participants	1170 Participants n=4 Participants	7423 Participants n=21 Participants
Hormone receptors Missing	1479 Participants n=5 Participants	739 Participants n=7 Participants	1164 Participants n=5 Participants	538 Participants n=4 Participants	3920 Participants n=21 Participants
Comedonecrosis Yes	524 Participants n=5 Participants	297 Participants n=7 Participants	428 Participants n=5 Participants	259 Participants n=4 Participants	1508 Participants n=21 Participants
Comedonecrosis No	4194 Participants n=5 Participants	2112 Participants n=7 Participants	3537 Participants n=5 Participants	1733 Participants n=4 Participants	11576 Participants n=21 Participants
Surgeon Volume 1	2182 Participants n=5 Participants	1140 Participants n=7 Participants	1986 Participants n=5 Participants	945 Participants n=4 Participants	6253 Participants n=21 Participants
Surgeon Volume 2	1099 Participants n=5 Participants	578 Participants n=7 Participants	969 Participants n=5 Participants	496 Participants n=4 Participants	3142 Participants n=21 Participants
Surgeon Volume 3	596 Participants n=5 Participants	329 Participants n=7 Participants	465 Participants n=5 Participants	267 Participants n=4 Participants	1657 Participants n=21 Participants
Surgeon Volume 4+	727 Participants n=5 Participants	300 Participants n=7 Participants	509 Participants n=5 Participants	266 Participants n=4 Participants	1802 Participants n=21 Participants
Surgeon Volume Not assigned	114 Participants n=5 Participants	62 Participants n=7 Participants	36 Participants n=5 Participants	18 Participants n=4 Participants	230 Participants n=21 Participants
Elixhauser Comorbidity None	2229 Participants n=5 Participants	1219 Participants n=7 Participants	1955 Participants n=5 Participants	980 Participants n=4 Participants	6383 Participants n=21 Participants
Elixhauser Comorbidity 1 to 2	1914 Participants n=5 Participants	935 Participants n=7 Participants	1548 Participants n=5 Participants	780 Participants n=4 Participants	5177 Participants n=21 Participants
Elixhauser Comorbidity 3 or more	575 Participants n=5 Participants	255 Participants n=7 Participants	462 Participants n=5 Participants	232 Participants n=4 Participants	1524 Participants n=21 Participants
Year of Diagnosis 1998-1999	63 Participants n=5 Participants	30 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	93 Participants n=21 Participants
Year of Diagnosis 2000-2003	806 Participants n=5 Participants	395 Participants n=7 Participants	605 Participants n=5 Participants	240 Participants n=4 Participants	2046 Participants n=21 Participants
Year of Diagnosis 2004-2005	863 Participants n=5 Participants	431 Participants n=7 Participants	531 Participants n=5 Participants	264 Participants n=4 Participants	2089 Participants n=21 Participants
Year of Diagnosis 2006-2007	986 Participants n=5 Participants	508 Participants n=7 Participants	647 Participants n=5 Participants	329 Participants n=4 Participants	2470 Participants n=21 Participants
Year of Diagnosis 2008-2009	1048 Participants n=5 Participants	539 Participants n=7 Participants	713 Participants n=5 Participants	380 Participants n=4 Participants	2680 Participants n=21 Participants
Year of Diagnosis 2010-2011	952 Participants n=5 Participants	506 Participants n=7 Participants	753 Participants n=5 Participants	395 Participants n=4 Participants	2606 Participants n=21 Participants
Year of Diagnosis 2012-2013	0 Participants n=5 Participants	0 Participants n=7 Participants	716 Participants n=5 Participants	384 Participants n=4 Participants	1100 Participants n=21 Participants
Geographic Region Midwest	583 Participants n=5 Participants	296 Participants n=7 Participants	460 Participants n=5 Participants	229 Participants n=4 Participants	1568 Participants n=21 Participants
Geographic Region Northeast	979 Participants n=5 Participants	488 Participants n=7 Participants	763 Participants n=5 Participants	378 Participants n=4 Participants	2608 Participants n=21 Participants
Geographic Region South	1141 Participants n=5 Participants	588 Participants n=7 Participants	1026 Participants n=5 Participants	522 Participants n=4 Participants	3277 Participants n=21 Participants
Geographic Region West	2015 Participants n=5 Participants	1037 Participants n=7 Participants	1716 Participants n=5 Participants	863 Participants n=4 Participants	5631 Participants n=21 Participants

PRIMARY outcome

Timeframe: From the first BCS to 9 months post-diagnosis.

Population: Mahalanobis matching was used to adjust for baseline characteristics to account for potential treatment selection bias, where those who received SLNB might be systematically different from those who did not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched cohort was used for analyses.

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

Outcome measures

Outcome measures
Measure	Matched Aim 1 Cohort: No SLNB n=4718 Participants The Aim 1 Cohort was constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis. Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group).	Matched Aim 1 Cohort: SLNB n=2409 Participants The Aim 1 Cohort was constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis. Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group).
Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain Number of participants with any side effects	534 Participants	404 Participants
Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain Number of participants with lymphedema	23 Participants	60 Participants
Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain Number of participants with wound Infection	453 Participants	296 Participants
Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain Number of participants with seroma	179 Participants	153 Participants
Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain Number of participants with pain	365 Participants	237 Participants

SECONDARY outcome

Timeframe: 6 months within DCIS diagnosis

Population: Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment selection bias, where those who receive SLNB might be systematically different from those who do not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched sample was used for analyses.

Secondary outcomes for Aim 1: receipt of mastectomy with and without SLNB after initial BCS through 6 months after DCIS diagnosis.

Outcome measures

Outcome measures
Measure	Matched Aim 1 Cohort: No SLNB n=4718 Participants The Aim 1 Cohort was constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis. Only those who did not receive sentinel lymph node biopsy (SLNB) were included (control group).	Matched Aim 1 Cohort: SLNB n=2409 Participants The Aim 1 Cohort was constructed to perform analysis to address study objective Aim 1. The cohort population includes patients diagnosed at age 67-94 years with DCIS between January 1998 and December 2011, and had received BCS as their first surgery within 6 months of diagnosis. Only those who received sentinel lymph node biopsy (SLNB) were included (intervention group).
Receipt of Mastectomy Yes	237 Participants	413 Participants
Receipt of Mastectomy No	4481 Participants	1996 Participants

SECONDARY outcome

Timeframe: 9 months within DCIS diagnosis

Secondary outcomes for Aim 1: Receipt of radiation therapy within 9 months of DCIS diagnosis.