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Real-World Evidence Study of Factors Associated With Breast Cancer Conserving Surgery for Females Diagnosed With Early Stage Breast Cancer Judy George, PhD, 1 Joseph Tkacz, MS, 1 M. Christopher Roebuck, PhD, MBA, 2 Fredy Reyes, PhD, 1 Yull E. Arriaga, MD, 1 Gretchen P. Jackson, MD, PhD 1,3 Irene Dankwa-Mullan, MD, MPH 1 . 1 IBM Watson Health, Cambridge, MA, USA 2 RXECONOMICS LLC, Hunt Valley, MD, USA 3 Vanderbilt University Medical Center, Nashville TN National and Regional Time Trends in BCS Logistic Model of BCS versus Mastectomy Results (n=57,299) Problem Breast Conserving Surgery (BCS) is now considered an acceptable alternative to mastectomy for patients with non-metastatic invasive breast cancer (BCa). Limited research examining factors influencing BCS reveal important predictors such as insurance, sociodemographic characteristics, and availability of health care services Research Objective Examine factors associated with BCS in a large, contemporary cohort of commercially insured females with breast cancer. This retrospective observational study of the IBM® MarketScan® Commercial and Medicare Supplemental Database: 1/1/2012 3/31/2018. This study showed increased BCS with older age, access to and use of genetic services, living in communities with a higher density of physicians specialized in medical genetics & nuclear medicine physicians, and decreased BCS use with certain co-morbid conditions and the regions of the South, Midwest, or West. This real-world evidence study contributes to informing clinical practice on the significant patient- and community-level factors influencing BCS in a non-metastatic invasive breast cancer cohort. Higher BCS use was significantly associated with (Figure 3): Older age (OR: 1.96-2.44, p<.0001) Genetic testing (OR: 1.25, p<.0001) More recent year of diagnosis (OR: 1.08-1.72, p<.0001-p=.02) Neoadjuvant radiation therapy (OR: 4.20, p<.0001) Higher density of physicians in specialties of medical genetics (OR: 6.50, p<.01; ME=.41) or nuclear medicine (OR: 2.24, p=.04; ME=.17) Lower BCS use was associated with: Residing in the South, Midwest, or West (OR: 0.71- .89, p<.0001-p=.01) Comorbid dementia (OR: 0.58, p=.01) and comorbid congestive heart failure (OR: 0.79, p=.01) Higher density of hospitals with medical/surgical services (OR: 0.26, p<0.01; ME=-.29) or plastic surgeons (OR: 0.66, p<.0001; ME=-.09) BACKGROUND METHODS 57,299 met inclusion criteria of which, 67.1% (38,474) had BCS, ranging from 62.9% in 2012 to 73.3% in 2017 (Figure 2). While BCS increased overall, differences were observed on most factors considered between patients who had BCS and those who did not (Table 1). However, of 15 comorbidities measured, only two (diabetes [p<.001] and chronic obstructive pulmonary disease [p=.04]) varied significantly. CONCLUSIONS This cross-sectional study relied upon privately-insured commercial claims data and results may not be generalizable. We inferred community-level characteristics based on county-level data. Additionally, clinical data sources (e.g., biomarker, hormone receptor status) may further explain BCS vs. mastectomy selection. LIMITATIONS RESULTS A Figure 2. National and Regional Trends in BCS. Average of BCS proportions across US census regions (A) Proportion of BCS (2012-2017) in each US Census region per year (B).. Figure 3. Odds Ratios (ORs) with 95% confidence intervals (A, B) and Marginal Effects (MEs) (C) of factors influencing BCS. Factors are categorized according to patient-level and Community(ZIP3)-level (+) data. # represents number per 10,000 residents. Significance levels are designated (*= p<.05; **= p<.001). ZIP3-level p-values were based on clustered standard errors. Comparison of Patients Receiving BCS or Mastectomy n=57,299 B A C Patients 60 years and older were at least more likely to receive BCS relative to those younger than 50 Patients with BRCA 1 or 2 genetic testing were more likely to receive BCS Patients in communities with a higher density of medical geneticists and nuclear medicine physicians were more likely to receive BCS Figure 1. Cohort selection process Table 1. Characteristics of study population. Results from Kruskal-Wallis Equality of Populations Tests. B Patient-Level Factors Breast Conserving Surgery (N=38,474) Mastectomy (N=18,825) p-value* Age (in Years) Under 50 18.1% 35.0% p<.001 50-59 34.0% 32.6% 0.01 60-69 30.1% 20.9% p<.001 70-79 12.4% 7.6% p<.001 80+ 5.3% 3.9% 0.004 Region Northeast 21.5% 16.4% p<.001 Midwest 24.9% 22.3% p<.001 South 37.7% 45.7% p<.001 West 15.9% 15.6% 0.59 Plan Type PPO, POS, or Comprehensive 74.3% 73.0% 0.01 HMO or Exclusive Provider Organization (EPO) 12.3% 11.6% 0.20 Consumer Directed Health Plan (CDHP) 7.7% 8.8% 0.04 High Deductible Health Plan (HDHP) 4.5% 5.3% 0.13 BRCA 1/2 Testing Status Had a Genetic Test 87.2% 84.9% p<.001 In Situ Diagnosis Status Also Had In Situ on Index Date 18.4% 18.1% 0.55 Also Had In Situ pre-Index Date 24.6% 28.4% p<.001 Neoadjuvant Therapy Chemotherapy Prior to Surgery 4.1% 10.5% p<.001 Radiation Therapy Prior to Surgery 1.7% 0.4% 0.01

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Page 1: Real-World Evidence Study of Factors Associated With ......Real-World Evidence Study of Factors Associated With Breast Cancer Conserving Surgery for Females Diagnosed With Early Stage

Real-World Evidence Study of Factors Associated With Breast Cancer Conserving Surgery for Females Diagnosed With Early Stage Breast Cancer

Judy George, PhD,1 Joseph Tkacz, MS,1 M. Christopher Roebuck, PhD, MBA,2 Fredy Reyes, PhD,1 Yull E. Arriaga, MD, 1 Gretchen P. Jackson, MD, PhD 1,3 Irene Dankwa-Mullan, MD, MPH 1.1 IBM Watson Health, Cambridge, MA, USA 2 RXECONOMICS LLC, Hunt Valley, MD, USA 3 Vanderbilt University Medical Center, Nashville TN

National and Regional Time Trends in BCS Logistic Model of BCS versus Mastectomy Results (n=57,299)Problem• Breast Conserving Surgery (BCS) is now considered an acceptable

alternative to mastectomy for patients with non-metastatic invasivebreast cancer (BCa).

• Limited research examining factors influencing BCS reveal importantpredictors such as insurance, sociodemographic characteristics, andavailability of health care services

Research Objective• Examine factors associated with BCS in a large, contemporary cohort of

commercially insured females with breast cancer.

This retrospective observational study of the IBM® MarketScan®Commercial and Medicare Supplemental Database: 1/1/2012 –3/31/2018.

This study showed increased BCS with older age, access to and use of genetic services, living in communities with a higher density ofphysicians specialized in medical genetics & nuclear medicine physicians, and decreased BCS use with certain co-morbid conditions andthe regions of the South, Midwest, or West. This real-world evidence study contributes to informing clinical practice on the significantpatient- and community-level factors influencing BCS in a non-metastatic invasive breast cancer cohort.

Higher BCS use was significantly associated with(Figure 3):• Older age (OR: 1.96-2.44, p<.0001)• Genetic testing (OR: 1.25, p<.0001)• More recent year of diagnosis (OR: 1.08-1.72,

p<.0001-p=.02)• Neoadjuvant radiation therapy (OR: 4.20, p<.0001)• Higher density of physicians in specialties of medical

genetics (OR: 6.50, p<.01; ME=.41) or nuclearmedicine (OR: 2.24, p=.04; ME=.17)

Lower BCS use was associated with:• Residing in the South, Midwest, or West (OR: 0.71-

.89, p<.0001-p=.01)• Comorbid dementia (OR: 0.58, p=.01) and comorbid

congestive heart failure (OR: 0.79, p=.01)• Higher density of hospitals with medical/surgical

services (OR: 0.26, p<0.01; ME=-.29) or plasticsurgeons (OR: 0.66, p<.0001; ME=-.09)

BACKGROUND

METHODS

57,299 met inclusion criteria of which, 67.1% (38,474)had BCS, ranging from 62.9% in 2012 to 73.3% in 2017(Figure 2). While BCS increased overall, differences wereobserved on most factors considered between patientswho had BCS and those who did not (Table 1). However,of 15 comorbidities measured, only two (diabetes[p<.001] and chronic obstructive pulmonary disease[p=.04]) varied significantly.

CONCLUSIONSThis cross-sectional study relied upon privately-insured commercial claims dataand results may not be generalizable. We inferred community-level characteristicsbased on county-level data. Additionally, clinical data sources (e.g., biomarker,hormone receptor status) may further explain BCS vs. mastectomy selection.

LIMITATIONS

RESULTS

A

Figure 2. National and Regional Trends in BCS. Average of BCS proportionsacross US census regions (A) Proportion of BCS (2012-2017) in each USCensus region per year (B)..

Figure 3. Odds Ratios (ORs) with 95% confidence intervals (A, B) and Marginal Effects (MEs) (C) of factors influencing BCS. Factors arecategorized according to patient-level and Community(ZIP3)-level (+) data. # represents number per 10,000 residents. Significancelevels are designated (*= p<.05; **= p<.001). ZIP3-level p-values were based on clustered standard errors.

Comparison of Patients Receiving BCS or Mastectomy n=57,299

B A C

Patients 60 years and older were at least

more likely to receive BCS relative to those younger than 50

Patients with BRCA 1 or 2 genetic testing were

more likely to receive BCS

Patients in communities with a higher density of medical geneticists and nuclear medicine physicians were more likely to receive BCS

Figure 1. Cohort selection process

Table 1. Characteristics of study population. Results from Kruskal-WallisEquality of Populations Tests.

B

Patient-Level Factors

Breast Conserving

Surgery(N=38,474)

Mastectomy (N=18,825) p-value*

Age (in Years)Under 50 18.1% 35.0% p<.001 50-59 34.0% 32.6% 0.01 60-69 30.1% 20.9% p<.001 70-79 12.4% 7.6% p<.001 80+ 5.3% 3.9% 0.004RegionNortheast 21.5% 16.4% p<.001Midwest 24.9% 22.3% p<.001South 37.7% 45.7% p<.001West 15.9% 15.6% 0.59Plan TypePPO, POS, or Comprehensive 74.3% 73.0% 0.01HMO or Exclusive Provider Organization (EPO) 12.3% 11.6% 0.20Consumer Directed Health Plan (CDHP) 7.7% 8.8% 0.04High Deductible Health Plan (HDHP) 4.5% 5.3% 0.13BRCA 1/2 Testing StatusHad a Genetic Test 87.2% 84.9% p<.001In Situ Diagnosis Status

Also Had In Situ on Index Date 18.4% 18.1% 0.55Also Had In Situ pre-Index Date 24.6% 28.4% p<.001Neoadjuvant TherapyChemotherapy Prior to Surgery 4.1% 10.5% p<.001Radiation Therapy Prior to Surgery 1.7% 0.4% 0.01