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Use and Timeliness of Radiation Therapy After Breast-Conserving Surgery in Low-Income Women With Early-Stage Breast Cancer

Article · April 2012with131 Reads
DOI: 10.3109/07357907.2012.658937 · Source: PubMed
Abstract
To characterize overall receipt and timeliness of radiation therapy (RT) following breast-conserving surgery among Medicaid-insured patients. State cancer registry data linked with Medicaid claims from 2003 to 2009 were analyzed. Multivariate logistic and Cox proportional hazards regressions were employed. Overall, 81% of patients received guideline-recommended RT. Significant variation in timing of RT initiation was documented. Having fewer comorbitidies and receiving chemotherapy were correlated with higher odds of RT initiation within 1 year. Although RT use in Medicaid-insured women appears to have improved since earlier studies, documented delays in RT are troublesome and warrant further investigation.
Cancer Investigation, 30:258–267, 2012
ISSN: 0735-7907 print / 1532-4192 online
Copyright C
Informa Healthcare USA, Inc.
DOI: 10.3109/07357907.2012.658937
CAUSATION AND PREVENTION
Use and Timeliness of Radiation Therapy After Breast-Conserving
Surgery in Low-Income Women With Early-Stage Breast Cancer
Stephanie B. Wheeler,1Yang Wu,2Anne-Marie Meyer,2William R. Carpenter,1Lisa C. Richardson,3
Judith Lee Smith,3Megan A. Lewis,4and Bryan J. Weiner1
Department of Health Policy and Management, Gillings School of Global Public Health,1Lineberger Comprehensive Cancer
Center, University of North Carolina, Chapel Hill, North Carolina, USA,2Division of Cancer Prevention and Control, Centers for
Disease Control and Prevention, Atlanta, Georgia, USA,3RTI International, Research Triangle Park, North Carolina, USA4
Purpose: To characterize overall receipt and timeliness of
radiation therapy (RT) following breast-conserving surgery
among Medicaid-insured patients. Method:Statecancer
registry data linked with Medicaid claims from 2003 to 2009
were analyzed. Multivariate logistic and Cox proportional
hazards regressions were employed. Results: Overall, 81% of
patients received guideline-recommended RT. Significant
variation in timing of RT initiation was documented. Having
fewer comorbitidies and receiving chemotherapy were
correlated with higher odds of RT initiation within 1 year.
Conclusion: Although RT use in Medicaid-insured women
appears to have improved since earlier studies, documented
delays in RT are troublesome and warrant further investigation.
Keywords Breast cancer; Quality; Medicaid; Radiation therapy;
Breast-conserving surgery
INTRODUCTION
In 1990, a National Institutes of Health (NIH) Consensus
Conference recommended breast-conserving surgery (BCS)
followed by radiation therapy (RT) for women with stage
I or II breast cancer (1). The recommendation was based
on evidence from clinical trials showing that women with
early-stage invasive carcinoma who underwent BCS with RT
had overall survival rates comparable with women who un-
derwent mastectomy with axillary dissection and that breast
tissue could safely be preserved (2–5). Recent studies con-
tinue to support this recommendation. For example, a 2005
meta-analysis of clinical trials involving tens of thousands of
women found that the addition of RT following BCS was as-
sociated with a 19% absolute reduction in local recurrence
rates and a 5% reduction in breast cancer mortality com-
pared with BCS alone (6). In population-based observational
studies, the use of BCS without RT has been associated with
higher mortality rates (7–9). Current quality metrics rec-
ommend that all women undergoing BCS for early-stage
Correspondence to: Stephanie B Wheeler, MPH, PhD, Department of Health Policy and Management, Gillings School of Global Public Health,
University of North Carolina, 1103C McGavran-Greenberg Hall, 135 Dauer Drive, CB 7411, Chapel Hill, NC 27599-7411, USA. E-mail:
Stephanie wheeler@unc.edu
breast cancer initiate RT within 1 year of diagnosis (10). Al-
though this time interval was specified to allow for sequenc-
ing and planning of chemotherapeutic and other cancer-
directed treatment regimens, a year may be too lenient. Some
evidence suggests that earlier initiation of RT, in particular
within 6 months of diagnosis, confers a significant health
benefit (11–13).
Despite an overall increase in the use of RT after BCS
since 1990, significant variation in guideline adherence
exists across studies, with the omission of RT post-BCS
ranging from 0% to 33% (14–22). Additionally, the omission
of RT after BCS appears to be especially problematic in
low-income women (23–25). This socioeconomic disparity
persists even after accounting for personal characteristics,
such as patient age, race, cancer stage, tumor size, and
comorbidities that could impact the receipt of RT (14, 26,
27). Such underuse may contribute to substantial disparities
in cancer outcomes, wherein women in high poverty areas
experience poorer survival compared with those in low
poverty areas, regardless of stage at diagnosis (16, 27–31).
Evidence of socioeconomic as well as racial disparities in the
receipt of guideline-recommended breast cancer treatment
is persistent and troubling (16, 24, 32–38). However, several
questions remain unanswered. First, most of the studies
thathaveexaminedthisissuehavefocusedontheMedicare
population living in regions covered by the Surveillance,
Epidemiology, and End Results (SEER) Program (16, 28, 29,
39). Consequently, it is not clear whether women who are
younger than 65 years of age or who live in geographic areas
notcoveredbySEERarelesslikelytoreceiveRTpost-BCS.
Second, it is not clear whether the socioeconomic disparities
in receipt of RT following BCS previously observed (15,
24) persist today. The few studies that have examined this
issue in the Medicaid population mostly rely upon data
from the 1990s, the period during which patterns of care
were still changing to reflect the NIH consensus conference
guidelines. Finally, few studies have examined whether
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socioeconomic and racial disparities exist in the timing of
RT initiation post-BCS. Therefore, it is not clear whether
low-income women are receiving RT in a timely manner.
This study characterized receipt and timeliness of
guideline-recommended RT following BCS in a popula-
tion of low-income women with early-stage breast cancer
and identified clinical, sociodemographic, temporal, and
geographic correlates of underuse and delayed initiation
of RT in 2003–2009. Study results offer policy-makers,
providers, and other stakeholders more current informa-
tion about the extent to which disparities persist in the
receipt of guideline-recommended breast cancer care among
nonelderly, low-income women living in a largely rural,
non-SEER state.
MATERIAL AND METHODS
Data and sampling frame
The North Carolina Central Cancer Registry (NCCCR) was
used to identify all women in North Carolina diagnosed with
primary breast cancer in years 2003–2007. To mitigate the
risk of sampling bias, 2007 was used as the last year for case
ascertainment as it takes approximately 2 years for North
Carolina incidence reporting to be deemed “complete. Case
data were linked to North Carolina Medicaid administrative
data to identify those who were enrolled in Medicaid at any
point from 1 month prior to diagnosis through 2009. Our ap-
proach allows comparison with national trends in breast can-
cer treatment (40) and permits the systematic examination of
statewide data to validate a recent study’s findings in a lim-
ited subset of 30 North Carolina counties indicating that the
problemofnonreceiptofRTpost-BCSmayhaveimproved
since earlier studies (15).
Inclusion/exclusion criteria
From this target population of 1,271 unique matches, several
inclusion/exclusion criteria were applied to generate an an-
alytic sample. We limited our analytic sample to cases aged
18–64, inclusive, who were diagnosed in 2003–2007 (see Fig-
ure1).Becausewewereinterestedinveryearly-stagebreast
cancer, cases with stage III or IV disease were excluded, where
stage was defined by the derived American Joint Commit-
tee on Cancer (AJCC) staging field in the NCCCR. If derived
AJCC stage was missing, we used SEER summary stage. If
derived AJCC stage and SEER summary stage were missing,
we used information from the tumor node metastasis (TNM)
fields to characterize patients by stage. We excluded Medicare
dual eligibles” due to incomplete claims. We also excluded
patients with a previous history of cancer, another cancer di-
agnosis within 12 months of the index breast cancer diagno-
sis, and/or cancers diagnosed at autopsy or by death certifi-
cate. Finally, we excluded women who died within 1 year of
diagnosis.
For the primary analysis, we limited our examination to
women who had BCS as the first indication of surgery post-
diagnosis (thereby excluding women who received mastec-
tomy alone [n=144] and women who received mastectomy
firstinonebreastfollowedbyBCSinthecontralateralbreast
[n=3]). Both cancer registry and Medicaid claims data were
analyzed to assess each patient’s definitive surgical experience
after diagnosis, and patients were categorized as receiving
complete mastectomy, BCS, or no surgical intervention. In-
ternational Classification of Disease (ICD)-9-CM codes and
Current Procedural Terminology (CPT) procedure codes
were examined to identify claims for cancer-directed treat-
ment. Because receipt of mastectomy after initial BCS pre-
cludes the necessity of RT (and thus is an important clini-
cal indicator of approp r iate nonreceipt of RT), we excluded
women who received mastectomy post-BCS. For the primary
analysis, we also limited our examination to those women
who were continuously enrolled in Medicaid from 1 month
prior to diagnosis through 12 months postdiagnosis. Finally,
because relevant cancer care quality guidelines are focused
oninvasivedisease(10)intheprimaryanalysis,weexcluded
in situ/stage 0 patients.
Measures of interest
Primary dependent variables included any indication of re-
ceipt of RT and timing in days of the first indication of RT.
We also examined initiation of RT within several time inter-
vals of interest, including within 180 days and 1 year. Claims
data were analyzed to determine postoperative treatment pat-
terns, including follow-up surgical procedures, utilization of
chemotherapy, and utilization of RT, based upon ICD-9-CM
codes and CPT procedure codes. Diagnosis and service dates
were retained, allowing identification of the treatment win-
dow between diagnosis, surgery, and follow-up procedures.
Patient-level demographic characteristics such as age
and race were examined to determine whether there were
significant differences in treatment patterns. Age was col-
lapsed into four categories: 18–40, 41–50, 51–60, and 61–64
years old. Race data were collapsed into “White,” “Black,
and “Other” to accommodate different coding schemes
usedbyNCCCRandMedicaid;theMedicaidmeasurewas
used if there were discrepancies in race coding between the
datasets. Rural/urban patient residence was examined to
elucidate the relationships between physical access to care
and RT omission and was determined by using county at
diagnosis from the NCCCR data and the US Department
of Agriculture (USDA) rural-urban continuum definition
(http://www.ers.usda.gov/briefing/rurality/ruralurbcon).
We simplified this coding scheme into “rural” and “urban”
by considering North Carolina counties with a USDA code
of 1–3 as “urban” counties and counties with a USDA code
of 4–9 as “rural” counties. Using this definition, among 100
North Carolina counties, 40% were characterized as urban.
Other variables of interest in multivariate models included
tumor stage, Medicaid aid eligibility category (which we
categorized as blind/disabled or Temporary Assistance for
Needy Families [TANF]/child-based eligibility), year of
diagnosis,receiptofadjuvantchemotherapypriortoRT,
and NCI combined index comorbidity score, which was
specifically designed to predict mortality using claims data
from a population of breast cancer patients (41).
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 S. B. W  .
2003--2007 CCR-Medicaid
breast cancer cases
n = 1
,
271
p
atients
Age 18--64 inclusive
n = 1,268 patients
Not diagnosed at
autopsy/death certificate
n = 1,101 patients
Ages 65 and older
n = 3 patients
Breast cancer is the
first cancer
n = 1,133 patients
Breast cancer is not
the first cancer
n = 135 patients
No secondary cancer;
or secondary cancer
diagnosis 12 months
after index diagnosis
n = 1,109 patients
Secondary cancer
diagnosis within 12-
months of index
n = 24 patients
No
No
Stage I/II, in situ, or
NOS breast cancer
n = 1,095 patients
Continuously enrolled
1 month pre- and 12
months post diagnosis
n = 421 patients
No
No
No
No
Diagnosed at autopsy
or death certificate
n = 8 patients
Stage III/IV breast
cancer
n = 6 patients
Not continuously
enrolled in Medicaid
n = 674 patients
No mastectomy
following BCS
n = 190 patients
Received breast
conserving surgery
(BCS) as first surgery
n = 274 patients
No BCS; or BCS was
not the first surgery
postdiagnosis
n = 147 patients
No
Included in analytic
dataset
n = 126 patients
Had mastectomy after
BCS and before
radiation therapy
n = 84 patients
Not in situ/stage 0 tumors
n = 126 patients
In situ/stage 0 tumors
n = 64 patients
No
No
Figure 1. Inclusion and exclusion criteria owchart.
Analysis
Descriptive statistics and data reliability assessment
Descriptive statistics were examined for all variables and
checked for outliers. Outlier observations were carefully au-
dited for possible miscoding and factors associated with out-
lier variation. We also carefully assessed reliability of redun-
dant information between NCCCR and Medicaid files (e.g.,
date of birth, gender, race, etc.) and in instances of mismatch,
determined which source of data was most reliable based on
expert consultation with the State Center for Health Statistics
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and the Division of Medical Assistance. For example, in
circumstances where date of birth differed between NCCCR
and Medicaid, we used Medicaid data as the gold standard
since it is based on Social Security Administration data.
Among those women meeting clinical and Medicaid
enrollment eligibility criteria for the primary analysis, we
calculatedthenumberofwomenreceivingRTwithin3,
6, 9, and 12 months of diagnosis. Bivariate statistics were
calculated using frequencies, proportions, and chi-squared
test statistics. Treatment status (BCS only vs. BCS +RT) was
examined as a function of previously described patient-level,
temporal, and geographic characteristics. To determine pre-
dictors of the primary dichotomous outcome (e.g., overall
presence/absence of RT among women who received BCS),
a multivariate logistic regression model was used.
This study also explored issues related to timing of care.
Temporal analyses examined the time window in days for re-
ceipt of RT from diagnosis to assess whether RT was initiated
within the recommended time interval (10). For time to RT
initiation analyses, Kaplan–Meier curves were constructed
and the proportional hazards assumption tested for each
independent variable of interest. Because chemotherapy
regimens are usually prescribed over several months and
usually administered prior to RT, receipt of chemotherapy
is a clinical valid reason for delay in RT. Indeed, in our
analysis, the proportional hazards assumption was not met
forthevariableindicatingreceiptofchemotherapy,andas
such, final multivariate hazards models were stratified by
receipt of chemotherapy. This decision is important not
only for statistical fidelity, but also because recent data have
indicated that among women not receiving chemotherapy,
delays in post-BCS RT of 20 weeks or more are associated
with inferior outcomes (42).
Sensitivity analyses
We explored the effects of several key decisions related to
inclusion/exclusion criteria and analytic file development
through sensitivity analyses. Because the requirement for
continuous Medicaid enrollment resulted in the loss of nearly
700womenfromthestudyandbecausewewereinterestedin
the effect that exclusion of these women had on study find-
ings,werepeatedouranalysesinthefullsampleofwomen
enrolled in Medicaid at any time during the 3 months prior to
and 12 months postdiagnosis, regardless of enrollment con-
tinuity. Also, because guidelines for the use of RT after BCS
for in situ/stage 0 breast disease are less clear than for stage
I–II disease and because we were interested in patterns of care
within this particular group of patients, we repeated our anal-
ysesinthefullsampleofwomenwithstage0,I,orIIdisease.
This study was conducted following protocol review and
approval from the University of Nor th Carolina at Chapel Hill
Institutional Review Board. For all analyses, pvalues less than
.05 were considered statistically significant. All analyses were
conducted using SAS (SAS Corporation, Cary, NC, USA).
RESULTS
Of 1,271 breast cancer cases identified from NCCCR data
with matching Medicaid claims, 126 women met all inclusion
criteria and were included in the primary analytic dataset
(Figure 1). In the analytic sample, 60 patients were White
(48%) and 57 were Black (45%). The mean age was 51 years
old,andthemajorityofwomenwerediagnosedwithstageI
tumors (62.5%). Sixty-three percent of women lived in urban
areas (Table 1).
Overall, 81% of patients ever received guideline-
recommended RT at any time after BCS, with significant
variation in timing of RT initiation (Table 1). The median
time to initiation of RT was 170 days. Just over one quarter of
the analytic sample (n=126) received RT within 90 days of
diagnosis, 55% received RT within 180 days of diagnosis, and
79% received RT within 1 year. Statistically significant racial
differences in time to RT initiation were not observed, and
measuring time zero as the diagnosis date versus the date of
BCSmadenodifferenceintheoverallshapeorbehaviorof
the curves (Figure 2).
Multivariate logistic models examining receipt of RT
post-BCS at several time endpoints indicated that receipt of
adjuvant chemotherapy and comorbidity score were closely
related to overall receipt and timing of initiation of RT
(Table 2). In models of RT initiation within 1 year, receipt
of adjuvant chemotherapy prior to RT was associated with
higher odds of RT initiation (OR: 3.92, 95% CI: 1.28–12.06).
Higher comorbidity burden was significantly associated
with a decreased odds of RT initiation at 1 year (OR: 0.37,
95% CI: 0.15–0.92) and ever initiating RT (OR: 0.36; 95%
CI: 0.14–0.92; Table 2).
Multivariate hazards models, stratified by prior adjuvant
chemotherapy use, mirrored similar findings with respect to
comorbidity burden (Table 3). Among women who did not
receive adjuvant chemotherapy, higher comorbidity corre-
sponded to later initiation of RT (hazard ratio [HR]: 0.51,
95% CI: 0.28–0.93). In the hazards model of the stratum
of patients who received adjuvant chemotherapy before RT,
the HR for comorbidity burden was statistically nonsignifi-
cant. Also, within this subgroup/stratum of patients who re-
ceivedchemotherapy,weobservedsignificantlylowerratesof
RT initiation, on average, across time intervals among Black
women (HR: 0.44; 95% CI: 0.21–0.91) and more rapid RT ini-
tiation in the 51–60 years old group (relative to 18–40 years
old; HR: 4.24; 95% CI: 1.06–17.0). Timeliness of receipt of
breast-conserving surgery (within 1 month of diagnosis), ur-
ban residence, and Medicaid aid eligibility category were not
significant predictors of time to receipt of RT, regardless of
prior chemotherapy use. In sensitivity analyses, interestingly,
84 patients who initially received BCS subsequently received
a mastectomy procedure (and were therefore excluded from
our analytic sample), the reasons for which are unclear.
Inlightofthesmallsamplesizeresultingfrominclu-
sion/exclusion criteria (namely, omission of in situ/stage 0
patients and omission of patients with noncontinuous Medi-
caid enrollment), we repeated our analyses in (1) the sample
ofpatientswithstage0,I,orIIdisease(n=274); (2) the sam-
pleofpatientswithstageIorIIdiseasewhowereenrolledin
Medicaid at any time during the 3-month period prediagno-
sisandthe12-monthperiodpostdiagnosis,ratherthancon-
tinuously enrolled (n=416); and (3) the sample of patients
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 S. B. W  .
Figure 2. (a) Cumulative percentage of patients receiving RT aer diagnosis by race/ethnic group. (b) Cumulative percentage of patients receiving
RT aer BCS, over time by race/ethnic group.
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Table 1. Patient Characteristics
All BCS Patients RT at Any Time Aer BCS
No RT at Any Time
Aer BCS
Patient Characteristics n(%) n(%) n(%)
All patients 126 (100) 102 (100) 24 (100)
Race
White 60 (47.6) 49 (48.0) 11 (45.9)
Black 57 (45.3) 46 (45.1) 11 (45.8)
Age (in years)
Mean (SD) 51.3 (8.8) 51.1 (8.4) 52.3 (10.6)
Range 18–64 32–64 18–64
18–40 14 (11.1) 12 (11.8) +
41–50 42 (33.3) 35 (34.3) +
51–60 49 (38.9) 39 (38.2) 10 (41.7)
61–64 21 (16.7) 16 (15.7) +
Tum or st age
Stage I 81 (64.3) 66 (64.7) 15 (62.5)
Stage II 32 (25.4) ++
Unstaged or missing 13 (10.3) ++
Medicaid aid category
Blind/disabled 87 (69.0) ++
TANF/aged 39 (31.0) ++
Urban/rural
Urban 80 (63.5) 66 (64.7) 14 (58.3)
Rural 46 (36.5) 36 (35.3) 10 (41.7)
Year of diagno s i s
2003 20 (15.9) ++
2004 25 (19.9) ++
2005 25 (19.8) ++
2006 28 (22.2) ++
2007 28 (22.2) ++
Chemotherapy before radiation
Yes 54 (42.9) ++
No 72 (57.1) 53 (52.0) 19 (79.2)
NCI combined comorbidity score
Mean (SD) 0.3 (0.5) 0.2 (0.5) 0.5 (0.6)
Range 0–3.1 0–3.1 0–2.1
Radiation at any time post-BCS
Yes 102 (81.0)
No 24 (19.0)
Radiation within 90 days postdiagnosis
Yes 35 (27.8)
No 91 (72.2)
Radiation within 180 days postdiagnosis
Yes 69 (54.8)
No 57 (45.2)
Radiation within 1 year postdiagnosis
Yes 100 (79.4)
No 26 (20.6)
Note:+indicates that for condentiality reasons, cell sizes with fewer than 10 observations were suppressed; “RT at any time” was assessed using claims fromtherst18months
postdiagnosis.
withstage0,I,orIIdiseasewhowereenrolledinMedicaid
at any time during the 3-month period prediagnosis and the
12-month period postdiagnosis (n=558). Statistical signif-
icance and magnitude of parameter estimates of results were
similar across secondary analyses.
DISCUSSION
We combined data from the North Carolina Central Can-
cer Registry and Medicaid claims for the population of
women diagnosed with early-stage breast cancer in the
years 2003–2007 to elucidate cancer treatment quality across
low-income, nonelderly women, as defined by receipt of RT
after BCS. We also explored potential causes of variance in
treatment by patient characteristics, year of diagnosis, and
geographic region of the state. In this population, reassur-
ingly, previously documented underutilization in Medicaid-
enrolled women appears to have improved compared with
earlier studies; observed rates of RT use were similar to those
reported in the Medicare population (9, 15, 19, 35, 43, 44).
Although our sample size was limited, over 80% of eligible
patients received RT after BCS. Importantly, we documented
significant variation in time to initiation of RT; only 55%
of women receiving RT initiate therapy within 180 days or
6 months of diagnosis, possibly indicating inappropriate
delays in care. Some evidence suggests that initiation of RT
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 S. B. W  .
Table 2. Results of Multivariate Logistic Regressions to Predict the Receipt of Radiation erapy for Breast-Conserving Surgery Patients
Variabl e RT Within 180 Days RT Within 1 Year RT at Any Time
Race (reference =White)
Black 0.44 [0.19–1.05] 0.58 [0.20–1.70] 0.73 [0.23–2.28]
Other 1.52 [0.23–9.88] 0.62 [0.08–4.71] 0.47 [0.06–3.70]
Age (reference =18–40 years)
41–50 0.51 [0.11–2.36] 0.82 [0.10–6.50] 1.42 [0.16–12.67]
51–60 0.38 [0.07–2.01] 1.21 [0.13–11.33] 2.28 [0.21–25.30]
61–64 0.62 [0.09–4.29] 1.64 [0.14–18.83] 2.83 [0.21–37.29]
Tumor stage (reference =unstaged/missing)
Stage I 7.94 [1.59–39.66]1.97 [0.41–9.54] 2.13 [0.42–10.69]
Stage II 5.73 [1.05–31.41]3.71 [0.62–22.09] 3.87 [0.63–23.97]
Medicaid aid categor y (reference =TANF/aged)
Blind/disabled 1.85 [0.62–5.53] 0.49 [0.11–2.27] 0.29 [0.05–1.74]
Year of diagnosis (reference =2003)
2004 1.37 [0.36–5.24] 1.14 [0.24–5.51] 1.15 [0.23–5.69]
2005 5.92 [1.35–26.02]4.92 [0.81–30.06] 8.79 [1.13–68.27]
2006 1.34 [0.36–4.90] 2.63 [0.53–13.09] 3.85 [0.69–21.46]
2007 2.68 [0.71–10.08] 2.55 [0.53–12.20] 2.38 [0.49–11.65]
Urban area
Yes 1 .42 [0.60–3.37] 1.76 [0.62–5.06] 1.25 [0.41–3.79]
Chemotherapy before RT (reference =no)
Yes 0 .61 [0.26–1.42] 3.92 [1.28–12.06]4.47 [1.34–14.96]
NCI comorbidity score 0.70 [0.31–1.57] 0.37 [0.15–0.92]0.36 [0.14–0.92]
Note: Median survival time from the K-M curve =170 days.
Signicant at 5%.
within 6 months of diagnosis confers a significant survival
benefit and reduces the likelihood of recurrence (11–13, 42).
OurstudysfindingthatoverallreceiptofRTpost-BCS
has improved over time compared with earlier studies (15)
may be due to changing practices over time reflecting wider
dissemination and adoption of evidence-based guidelines or
may be due to study design differences between studies. For
example, our study excluded more advanced stage III pa-
tients. Additionally, in sensitivity analyses, we found that a
significant proportion of women who initially received BCS
as primary surgical procedure after diagnosis subsequently
underwent mastectomy (n=84; 31.5% of the initial sam-
ple of women who received BCS), thereby clinically pre-
cluding the need for RT. This is a vitally important con-
sideration in quality of care studies of this nature; failure
to account for a mastectomy procedure subsequent to BCS
Table 3. Results of the Multivariate Cox Hazards Regressions to Predict the Timing of the Initiation of Radiation erapy for Breast-Conserving
Surgery Patients (Reported as Hazard Ratios [HR])
Variable Cox Regression All Patients
Subgroup Analysis: No Chemo Before
RT
Subgroup
Analysis: Chemo
Before RT
Race (reference =White)
Black 0.75 [0.47–1.17] 1.16 [0.58–2.31] 0.44 [0.21–0.91]
Other 1.02 [0.42–2.45] 0.99 [0.30–3.25] 2.86 [0.54–15.13]
Age (reference =18–40 years)
41–50 0.91 [0.42–1.97] 0.92 [0.24–3.50] 1.68 [0.54–5.25]
51–60 1.11 [0.47–2.62] 0.86 [0.22–3.37] 4.24 [1.06–17.00]
61–64 1.45 [0.53–3.95] 1.74 [0.37–8.23] 1.09 [0.15–7.99]
Tumor stage (reference =unstaged/missing)
Stage I 2.55 [1.13–5.78]4.05 [1.11–14.84]1.35 [0.40–4.52]
Stage II 2.13 [0.88–5.18] 2.74 [0.72–10.33] 0.78 [0.18–3.38]
Medicaid aid categor y (reference =TANF/aged)
Blind/disabled 1.05 [0.61–1.79] 1.03 [0.47–2.29] 1.13 [0.47–2.73]
Year of diagnosis (reference =2003)
2004 1.17 [0.57–2.42] 0.64 [0.21–1.97] 2.55 [0.86–7.61]
2005 2.04 [0.98–4.22] 1.25 [0.48–3.28] 5.71 [1.60–20.40]∗∗
2006 1.86 [0.90–3.82] 1.49 [0.55–4.04] 2.06 [0.72–5.91]
2007 1.66 [0.82–3.36] 1.21 [0.45–3.28] 1.62 [0.48–5.50]
Urban area
Yes 1 .24 [0.77–1.99] 1.55 [0.78–3.09] 0.80 [0.40–1.62]
NCI comorbidity score 0.67 [0.42–1.07] 0.51 [0.28–0.93]1.02 [0.39–2.68]
BCS within 30 days of diagnosis (reference =no)
Yes 0 .79 [0.49–1.28] 1.02 [0.52–2.00] 1.14 [0.45–2.86]
Signicant at 5%; ∗∗ signicant at 1%.
Cancer Investigation
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R T  L-I B C P 
and prior to RT may cause researchers to underestimate RT
utilization.
Observed delays in initiation of RT warrant further study.
Earlier initiation of RT, in particular within 6 months gener-
ally and within 20 weeks specifically for women who do not
receive chemotherapy, has been shown previously to correlate
with better health outcomes among women with early-stage
breast cancer (11–13, 42). Although the receipt of another
adjuvant therapeutic regimen such as chemotherapy and the
presence of serious comorbidity are clinically valid reasons
for delays in RT, significant variation observed in timeli-
ness of RT initiation within chemotherapy subgroup/stratum
may indicate potentially inappropriate delays. Because tim-
ing of RT may affect long-term health outcomes including
breast cancer recurrence and breast cancer-specific mortal-
ity, delays of this nature are potentially problematic; however,
strongconsensushasnotbeenreachedabouttheeffectsofRT
timing on health outcomes (39, 42, 45–47). Importantly, pa-
tients receiving chemotherapy may have worse disease (e.g.,
they may be node positive); as such, the effect of earlier tim-
ing of RT on mortality and other health outcomes may be
confounded by unmeasured differences in clinical disease or
health status. Despite these unresolved issues in timing of
adjuvant therapy, understanding why timing of RT is dif-
ferent across patients is important, particularly in terms of
how access to care (e.g., distance to RT providers), age-related
disability, poor functional status, transportation constraints,
and provider characteristics affect timeliness of RT decision-
making, referral, and administration.
The greatest limitation of this analysis is our small sample
size after applying inclusion/exclusion criteria (all of which
were methodologically and/or clinically valid and necessary).
For example, multivariate logistic regressions indicated that
race, age, and rural/urban residence were not strong predic-
tors of overall receipt of RT and timing of receipt of RT, de-
spite our expectations and previous studies’ findings (15, 25,
27, 32, 48, 49). However, the lack of an observed associa-
tionmaybemisleading,sincewemayhavehadinsufficient
power to fully assess racial, age-related, and rural/urban dif-
ferences. That said, many of the previously cited studies re-
flect older data, older patient populations (i.e., the Medicare
population), and/or different study endpoints (e.g., RT com-
pletion, rather than RT initiation). Thus, although our sample
size precludes our ability to report definitively on racial, age-
related, or rural/urban disparities in RT initiation, our study
presents recent data from a younger, low-income, relatively
understudied population and provides encouraging evidence
of improved guideline adherence compared with earlier stud-
ies in this particular group (15, 25). In addition, consistent
with other studies in low-income, insured populations, racial
disparities in RT receipt were not observed, indicating per-
haps that income and insurance status are more important
predictors of cancer care quality (15, 23).
Continuous enrollment in Medicaid for the entire study
period (1 month prediagnosis and 12 months postdiagnosis)
was an important factor in sample size reduction and worthy
of discussion. On one hand, including all women regardless
of continuous enrollment included nearly 700 more women
for whom we could assess some proportion of breast cancer
treatment experiences. On the other hand, doing so provides
a potentially incomplete picture of health services rendered.
Medicaid claims data cannot reflect services not covered/not
reimbursed by Medicaid, or services provided during a time
in which the individual was ineligible or not enrolled in Med-
icaid; so, any services paid for out of pocket or by another
third-party payer cannot be identified. This situation is par-
ticularly relevant for those women transitioning in and out of
eligibility/enrollment, for whom we know nothing during the
period of time when Medicaid coverage lapsed. Women who
are intermittently enrolled in Medicaid may differ from con-
tinuously enrolled women in important ways; for example,
they may have worse access to health care and social services.
Inlightofthisissue,werepeatedouranalysesonthefullsam-
ple of women regardless of continuous eligibility to explore
the extent to which Medicaid coverage lapses affected out-
comes and found no differences between continuously and
noncontinuously enrolled samples.
General limitations of analyses using cancer registry data
linked to insurance claims include the following: limited abil-
ity to directly assess patient-provider decision-making in the
absence of chart reviews or patient/provider interviews, lim-
ited provider/facility information, limited ability to validate
that the extent of treatment was sufficient (e.g., whether the
patient received the full dose or less than the full dose), in-
ability to identify procedural claims for RT that occurred out-
side of the state of North Carolina, and limited ability to iden-
tify intermediate outcomes that do not have an explicit diag-
nosis code, such as breast cancer recurrence/relapse. While
thestudysoughttounderstandreceiptofguidelineconcor-
dant care, these data only allow partial insight into this com-
plex clinical issue. For example, women may delay receipt
of RT for clinically legitimate reasons, such as pregnancy. In
addition, because we only included a single state and only
Medicaid-insured women, results may not be generalizable
to other populations. Regardless, it is possible to character-
ize overall treatment decisions, care provision, and outcomes
of treatment at the population level for low-income North
Carolina women, which was the primary focus of this study.
Importantly, our study included patients from 55 counties
across the state, representing 76% of the North Carolina
breast cancer population; as such, we believe that a diversity
of treatment centers, providers, and patients is represented.
Our study has several notable strengths. This work sys-
tematicallylinkedNCCCRcasefilestoMedicaidclaims,
enabling us to characterize the experiences of low-income
breast cancer patients. Importantly, women in our study sam-
ple were younger than 65 years old, an understudied age
group, and nearly half were African American. We had multi-
ple years of data, including claims data from 2003 to 2009. We
provide evidence that overall quality of breast cancer care in
low-income populations, as measured by receipt of RT post-
BCS, has improved over time; however, timeliness of RT ini-
tiation varies significantly across subgroups, leading to ques-
tions about timely access to care.
Future studies should seek to understand (1) whether
there is geographic clustering of RT omission, (2) to what
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2012 Informa Healthcare USA, Inc.
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 S. B. W  .
extent provider and facility-level factors influence timing of
treatment, (3) whether other minority groups (such as Latino,
Native American, and Asian) experience differential adher-
ence to breast cancer treatment guidelines, and (4) why care is
delayed (appropriately or inappropriately) in some patients.
Given the benefits of earlier initiation of RT (39, 45–47), the
timing component of the quality metrics may need to be
revisited. Moreover, low-income breast cancer populations
may benefit from targeted efforts to improve timely assess-
ment of RT suitability and geographic access to RT providers.
Supplementing registry-linked-claims data with better clini-
cal information, in particular detailed medical records, phar-
macy, and patient-reported outcomes data, may further elu-
cidate clinically valid reasons for treatment delays. Finally,
ongoing programmatic interventions may be needed to as-
sure stable, efficient, and equitable provision of RT and other
breast cancer treatments going forward.
ACKNOWLEDGMENTS
Financial support for this study was provided by the Cen-
ters for Disease Control and Prevention, Division of Can-
cer Prevention and Control, contract no. S3665–25/26,
and by Dr. Wheeler’s Agency for Healthcare Research and
Quality (AHRQ) Mentored Clinical Scientists Comparative
Effectiveness Development Award (K12), grant no. K-12
HS019468–01 (PI: Weinberger). Analytic support for this
study was provided by the Integrated Cancer Information
and Surveillance System (ICISS), UNC Lineberger Compre-
hensive Cancer Center, with funding provided by the Uni-
versityCancerResearchFund(UCRF)viatheStateofNorth
Carolina.
DECLARATION OF INTEREST
The authors report no conflicts of interest. The findings and
conclusions in this report are those of the authors and do not
necessarily represent the official position of the Centers for
DiseaseControlandPrevention.
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    • The ICISS data and the ICISS team enable a diverse portfolio of research. ICISS is currently being used for studies of comparative effectiveness (eg, the article by Goyal and colleagues on pages 231–238), treatment dispari- ties [10, 19], access to care [8], and investments within the public health system (eg, a 2011 study by Mays and Smith [20], which linked increases in public health spending to declines in preventable deaths). The availability of longitudinal data allows researchers to examine the effect of health policies such as Medicare Part D or the Patient Protection and Affordable Care Act of 2010, as well as temporal trends such as the 2008 economic recession [21] .
    [Show abstract] [Hide abstract] ABSTRACT: The Integrated Cancer Information and Surveillance System (ICISS) facilitates population-based cancer research by developing extensive information technology systems that can link and manage large data sets. Taking an interdisciplinary 'team science' approach, ICISS has developed data, systems, and methods that allow researchers to better leverage the power of big data to improve population health.
    Full-text · Article · Jul 2014
    • Clinical control variables included cancer stage and comorbidity index, the latter of which was determined using a previously described [10, 15] modification of the National Cancer Institute Combined Index algorithm. Cancer stage was derived using the American Joint Committee on Cancer (AJCC) stage grouping, if possible; the Surveillance, Epidemiology, and End Results (SEER) summary staging was used if AJCC stage grouping was not available, or tumor, node, and metastasis (TNM) staging was used if neither AJCC stage grouping nor SEER summary staging was avail- able [16].
    [Show abstract] [Hide abstract] ABSTRACT: Background: Chemotherapy-related health care utilization by breast cancer patients can be expensive for payers and patients. This study evaluated the patient-centered medical home program Community Care of North Carolina (CCNC) in terms of its potential to reduce health care utilization associated with chemotherapy-related adverse events (AEs). Methods: Early-stage breast cancer cases diagnosed during the 5-year period 2003-2007 were identified in the North Carolina Central Cancer Registry; these cases were then linked to North Carolina Medicaid claims data. We measured health care utilization associated with chemotherapy-related AEs by setting (inpatient, outpatient, or emergency department) during a 15-month postdiagnosis follow-up period. Descriptive and multivariate analyses were performed to examine associations between CCNC enrollment and health care utilization associated with chemotherapy-related AEs. Results: A large proportion of breast cancer patients had at least 1 health care visit associated with a chemotherapy-related AE (n = 412 [72.3%]). The mean numbers of AE-related visits occurring in inpatient, outpatient, and emergency department settings were 0.30 (standard deviation [SD] = 0.83), 6.92 (SD = 10.94), and 0.46 (SD = 1.26), respectively. CCNC enrollment was associated with significantly fewer inpatient admissions (marginal effect, -0.1421; 95% confidence interval, -0.280 to -0.004). Limitations: In this observational study, we were unable to draw conclusions about the causality of these associations. Conclusions: Patients enrolled in CCNC had fewer inpatient health care visits associated with chemotherapy-related AEs. Future research should continue to explore the extent to which patient-centered medical homes can monitor and help manage the effects of cancer treatments.
    Full-text · Article · Jul 2014
    • A substantial variation in the use of RT after BCS has been reported by existing studies, ranging 57–95 % based on geographical region and study population [7, 11, 23, 44]. However, many of these studies have mostly explored the rate of RT receipt as opposed to rate of RT consideration , omitted physician-related factors [44], have been limited to patients with early-stage BC [11, 47], carcinoma in situ [1, 13], smaller sample sizes [7, 23, 33, 44], included only older patients [39, 40]. The rate of RT receipt observed in this study (84 %) is similar to studies using insured populations.
    [Show abstract] [Hide abstract] ABSTRACT: Radiotherapy (RT) after breast conserving surgery (BCS) represents the standard for local control of breast cancer (BC). However, variations in practice persist. We aimed to characterize the rate of RT consideration (or referral) after BCS and identify predictors in Quebec, Canada, where universal health insurance is in place. A historical prospective cohort study using the provincial hospital discharge and medical services databases was conducted. All women with incident, non-metastatic BC (stages I-III) undergoing BCS (1998-2005) were identified. Odds ratios (ORs) and 95 % confidence intervals (CIs) for RT consideration were estimated with a generalized estimating equations regression model, adjusting for clustering of patients within physicians. Of the 27,483 women selected, 90 % were considered for RT and 84 % subsequently received it. Relative to women 50-69 years old, younger and older women were less likely to be considered: ORs of 0.82 (95 % CI 0.73-0.93) and 0.10 (0.09-0.12), respectively. Emergency room visits and hospitalizations unrelated to BC were associated with decreased odds of RT consideration: 0.85 (0.76-0.94) and 0.83 (0.71-0.97). Women with regional BC considered for chemotherapy were more likely to be considered for RT: 3.41 (2.83-4.11). RT consideration odds increased by 7 % (OR of 1.07, 95 % CI 1.03-1.10) for every ten additional BCSs performed by the surgeon in the prior year. Social isolation, comorbidities, and greater distance to a referral center lowered the odds. Demographic and clinical patient-related risk factors, health service use, gaps in other aspects of BC management, and surgeon's experience predicted RT consideration.
    Full-text · Article · Jul 2013
    • Another study investigated the use of complementary and alternative medicine among prostate cancer patients [26] . Additional studies explored the effectiveness of nontraditional cancer support groups, reasons for nonreceipt of appropriate treatment among low-income women [27] , and quality of life and treatment decision making for men with localized prostate cancer282930. Other survivorship issues that were being assessed included family involvement in providing informal care and caregivers' unmet needs and quality of life.
    [Show abstract] [Hide abstract] ABSTRACT: Purpose There are currently more than 12 million cancer survivors in the USA. Survivors face many issues related to cancer and treatment that are outside the purview of the clinical care system. Therefore, understanding and providing for the evolving needs of cancer survivors offers challenges and opportunities for the public health system. In 2004, the Centers for Disease Control and Prevention and the Lance Armstrong Foundation, now the Livestrong Foundation, partnered with national cancer survivorship organizations to develop the National Action Plan for Cancer Survivorship (NAPCS). This plan outlines public health strategies to address the needs of cancer survivors. To date, no assessment of NAPCS strategies and their alignment with domestic cancer survivorship activities has been conducted. Methods The activities of five national organizations with organized public health agendas about cancer survivorship were assessed qualitatively during 2003–2007. Using the NAPCS as an organizing framework, interviews were conducted with key informants from all participating organizations. Interview responses were supplemented with relevant materials from informants and reviews of the organizations’ websites. Results Strategies associated with surveillance and applied research; communication, education, and training; and programs, policy, and infrastructure represent a large amount of the organizational efforts. However, there are gaps in research on preventive interventions, evaluation of implemented activities, and translation. Conclusions Numerous NAPCS strategies have been implemented. Future efforts of national cancer survivorship organizations should include rigorous evaluation of implemented activities, increased translation of research to practice, and assessment of dissemination efforts. Implications for Cancer Survivors The results of this descriptive assessment provide cancer survivors, cancer survivorship organizations, researchers, providers, and policy makers with initial information about cancer survivorship public health efforts in the USA. Additionally, results suggest areas in need of further attention and next steps in advancing the national cancer survivorship public health agenda.
    Full-text · Article · Apr 2013
  • [Show abstract] [Hide abstract] ABSTRACT: Background: Community Care of North Carolina (CCNC) initiated an innovative medical home program in the 1990 s to improve primary care in Medicaid-insured populations. CCNC has been successful in improving asthma, diabetes, and cardiovascular outcomes but has not been evaluated in the context of cancer care. We explored whether CCNC enrollment was associated with guideline-concordant follow-up care among breast cancer survivors. Methods: Using state cancer registry records matched to Medicaid claims, we identified women 18 to 64 years old who were diagnosed with stage 0, I, II, or unstaged breast cancer from 2003 to 2007 and tracked their monthly CCNC enrollment. Using published American Society for Clinical Oncology guidelines to define our outcomes, we employed multivariate logistic regressions to examine, as a function of CCNC enrollment, receipt of mammogram and at least 2 physical examinations/history-taking visits within observational windows consistent with the guidelines. Results: Of the 840 women, approximately half were enrolled into the CCNC for some time during the study period. Between 40% and 85% received follow-up mammogram in accordance with guidelines, with significant variation by CCNC status, and 95% of women received at least 2 physical examinations/history-taking visits. In multivariate models, increasing months of CCNC enrollment was significantly positively associated with receipt of follow-up mammogram but not with physical examinations/history-taking visits. Conclusions: Results suggest that CCNC enrollment is associated with guideline-concordant follow-up care for Medicaid-insured survivors. Given the growing population of cancer survivors and increased emphasis on primary care medical homes, future studies should explore what factors are associated with medical home participation and whether similar findings are observed with extended follow-up.
    Article · Jun 2013
  • [Show abstract] [Hide abstract] ABSTRACT: Guidelines recommend radiotherapy (rt) after breast-conserving surgery (bcs) for optimal control of ductal carcinoma in situ (dcis). The aim of the present study was to characterize the rates of rt consideration and administration, and to identify factors influencing those rates in a cohort of women diagnosed between 1998 and 2005 in Quebec. Quebec's medical service claims and discharge abstract database were used. Using consultation for rt as an indicator for rt consideration, odds ratios (ors) and 95% confidence intervals (cis) were estimated using a generalized estimating equations regression model. Of 4139 women analyzed (mean age: 58 years), 3435 (83%) received a consultation for rt, and 3057 of them (89%) proceeded with treatment. The rate of rt consideration increased by 7.1% over the study period, with notable differences in the various age groups. Relative to women 50-69 years of age, the ors for being considered for rt were, respectively, 0.89 (95% ci: 0.71 to 1.12), 0.71 (95% ci: 0.55 to 0.92), and 0.20 (95% ci: 0.14 to 0.31) for women younger than 50, 70-79, and 80 years of age and older. Distance to a designated breast care centre lowered the probability of rt consideration, but the presence of comorbidities did not. A surgeon's volume of bcss increased the probability of being considered for rt by 7% for every 10 such procedures performed (or: 1.07; 95% ci: 1.04 to 1.11). Consideration for rt has increased over time. However, older women (despite being in good health) and those living far from a designated breast care centre or having a low-case-volume surgeon were less likely to be considered for rt.
    Full-text · Article · Jun 2013
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AMIGAS is a bilingual educational outreach intervention designed to help promotoras (community health workers) and other lay health educators increase cervical cancer screening among Latinas who ha…" [more]
Conference Paper
November 2009
    Introduction: Research suggests that one-third of low-income early-stage breast cancer patients do not get radiation therapy (RT) after breast conserving surgery (BCS). This study presents 2007-2008 rates of underuse of RT after BCS among Medicaid-insured women in North Carolina. Methods: UNC Rapid Case Ascertainment (RCA) worked with registrars at 40 hospitals to identify women diagnosed... [Show full abstract]
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