breast cancer disparities: co-morbidities and clinical trials

7/30/2019 Breast Cancer Disparities: Co-Morbidities and Clinical Trials

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Lucile Adams-Campbell, Ph.D.Professor of Oncology

Associate Director, Minority Health & Health DisparitiesResearch

Georgetown Lombardi Comprehensive Cancer Center


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Any inequity of treatment or services whetherbased on ethnicity, geography, gender, age,disability, mental health, education, andoccupation; as well as, differences in healthconditions attributed to environment or socialissues that create inequality


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1927 First funding for cancer research 1937 Congress established NCI 1971 War on Cancer declared

1973 SEER Program established 1985 Heckler Report on health disparities 1990 DHHS Healthy People 2000 report 1999, 2002 IOM Reports

2000 DHHS Healthy People 2010 report 2006 IOM Report on health disparities

research


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Combined data from the National Program of Cancer Registries as submitted to CDC and from the Surveillance, Epidemiology and

End Results program as submitted to the National Cancer Institute in November 2010.

http://www.cdc.gov/cancer/breast/statistics/race.htm
http://www.cdc.gov/cancer/breast/statistics/race.htmhttp://www.cdc.gov/cancer/breast/statistics/race.htm


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U.S. Mortality Files, National Center for Health Statistics, CDC. http://www.cdc.gov/cancer/breast/statistics/race.htm
http://www.cdc.gov/cancer/breast/statistics/race.htmhttp://www.cdc.gov/cancer/breast/statistics/race.htm


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Higher stage at diagnosis

More aggressive tumors

Higher incidence among younger women

Less breast conserving surgery

Less adjuvant therapy

???Long-term treatment adherence

More weight gain

Higher obesity Poorer physical functioning

More comorbid conditions Weight reduction mayimprove survivaloutcomes


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Flegal et al, JAMA, February 1, 2012Vol 307, No. 5


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1995 1998 2000

2005 2008


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Age-adjusted Percentage of U.S. Adults WhoWere Obese or Who Had Diagnosed Diabetes

Obesity (BMI 30 kg/m2)

Diabetes

1994

1994

2000

2000

No Data 26.0%

No Data 9.0%

CDCs Division of Diabetes Translation. National Diabetes Surveillance System available athttp://www.cdc.gov/diabetes/statistics

2008

2008


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Figure 3: Trec Conceptual Model

Socio-culturalFactors

EnvironmentalFactors

Institutional/Policy Factors

PhysiologicalFactors*

BehavioralFactors*

GeneticFactors

Energy Balance, Obesity,

Weight, Energetics

Cancer

Macro-Level

Factors

(Contextual)

Micro-LevelFactors

(Individual)

*Physiological and Behavioral Factors contribute to the additional factors of Personality (e.g. extraversion), Psychological Factors (e.g. , stress), and Cognitive Factors (e.g. beliefs)Macro-level factors represent variables outside the individual that serve as the context s in which obesity and energy imbalance develop. Micro-level factors represent variables within the individual

that contribute to obesity, energy imbalance, and the links between energy balance and carcinogenesis. These macro- and micro-level factors are complex and interactive. Physiological and

behavioral factors also form psychological (e.g., stress), personality, and cognitive factors (e.g., efficacy) that contribute to energy balance (not displayed).


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Metabolic syndrome is a cluster isconditions that increases the risk of heart

disease, stroke, and diabetes. This definition includes 3 or more of the

following conditions:- Insulin Resistance

- Central Obesity

- Hypertension

- Low HDL Cholesterol

- High TriglyceridesBeilby, J. Definition of Metabolic Syndrome: Report of the National Heart,

Lung, and Blood Institute/American Heart Association Conference on

Scientific Issues Related to Definition. Clin Biochem Rev. 2004 August; 25(3):

195

198.


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No. of MetabolicAbnormalities,% (SE)

>1 >2 >3 >4 5

White 68.4(1.5) 40.7(1.5) 22.8(1.1) 9.2(0.6) 3.0(0.3)

African-

American

80.0(1.0) 51.3(1.3) 25.7(1.3) 10.0(0.9) 2.3(0.5)

Mexican-

American

84.0(0.9) 57.7(1.4) 35.6(1.5) 14.7(1.3) 3.1(0.6)

Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome

among US adults: findings from the third National Health and NutritionExamination Survey. JAMA. 2002; 287: 356359


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Rosato et al, Annals of Oncology, Volume 22 December 2011


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BreastCancern=81

n %

Controlsn=81

n %

OR(95% CI)

p

MetabolicSyndrome

48 59.2 30 37.0 2.47 (1.31-4.65)

0.0005

High BloodPressure

49 60.5 24 29.6 3.64 (1.89-6.98) 0.00001

AbdominalObesity

70 86.4 54 66.7 3.18 (1.45-6.98) 0.003

Porto, LA, Lora, KJ, Soares, JC, Costa LO. Metabolic syndrome

is an independent risk factor for breastCancer Arch Gynecol Obs. January 2011

Bold values represent significant differences or associations between groups


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New York Times Editorial, April 24, 2010

Repairing the clinical trials system is critical not only

for health care reform but for the health of millions of

Americans.


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Aging of the US population Contribution to population growth:

14% for Non-Hispanic Whites

45% for populations of Hispanic origin Growth of the Black population by 10

million

45% increase in cancer incidence 99% increase in cancer incidence

disparitiesSmith BD et al. J Clin Onc. 2009; 27:2758-65;http://www.census.gov/population/www/pop-profile/natproj.html(Accessed 11/12/10)
http://www.census.gov/population/www/pop-profile/natproj.htmlhttp://www.census.gov/population/www/pop-profile/natproj.htmlhttp://www.census.gov/population/www/pop-profile/natproj.htmlhttp://www.census.gov/population/www/pop-profile/natproj.html


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YES! But we need. Molecular risk markers to accurately identify subjects and

predict responsiveness of treatment

Better agents to improve risk/benefit ratio Targeted agents for more personalized approach

Validated biomarkers


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Physician barriers: Most physicians

do not offer clinical trials to patients

Patient barriers: Patients are more

likely to consider if recommended by

their physician Our messages and education must

be better tailored to both patient

and physician


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Renal Disease

Heart Disease

HTN

DM

Hep/Liver Dis.

Thyroid Dis. DVT

HIV/AIDS

GI + Pancreatitis

Genitourinary

Sleep ApneaArthritis

Psychiatric Dis.Active Infections2ndary cancers

Tobacco use

ETOH Use

Elicit Drugs

Pulmonary Dis.

Hyperlipidemia

Co-morbidities

Renal Disease

Heart Disease

HTN

DM

Hep/Liver Dis.

Thyroid Dis.

DVT

HIV/AIDS

GI + Pancreatitis

Genitourinary

Sleep Apnea

Arthritis

Psychiatric Dis.

Active Infections

2ndary cancers

Tobacco use

ETOH Use

Elicit Drugs

Pulmonary Dis.

Hyperlipidemia

Wolff, et al. ASCO-NCI Sym 2010


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Awareness

Opportunity

Acceptance/Refusal

AwarenessBarriers/

Promoters

Interventions

OpportunityBarriers/

Promoters

Moderators/Sociodemographic

Factors

Measuresof

Success

Acceptance/Refusal

Barriers/Promoters

Study

Design

Ford JGet al., Cancer. 2008; 112:228-42.


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0

24

68

1012

1416

1820

Mist

rust

Fear

Cultu

re

Fam

ily

Disc

omfo

rt

Prov

ider

-rela

ted

Cost

s

Tran

spor

tatio

nTi

me

Relig

ious

beli

efs

Low

healt

hlit

erac

y

Ford JGet al., Cancer. 2008; 112:228-42.


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0

12

3

4

5

6

7

8

9

Protocol

Adherence

Patient Mistrust Patient Costs Data Collection

Costs/Burden

Eligibility Clinical Trials Patient (cultural

competence)


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PatientAwareness

Opportunity

Acceptance/Refusal

YesNo

CulturalCompetency

Yes No

YesNo

Lack ofopportunityat provider

level

Lack ofopportunity at

system level

Provider Perceptions of /Attitudes toward

Method ofcommunication /

presentation

Are thereavailable trials

for thispatient?

Is provideraware of

available trials?

Doesprovider tellpatient about

trials?

CulturalCompetency

Patienteligibility

Data collectioncosts/burden

Clinical trials

Adherence tostudy protocol

Patient mistrustof research/

medical system

Costs to patient

Howerton et al., 2007


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0

1

2

3

4

5

6

7

8

9

Eligibility Protocol Length of study/visit

structure


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A "collaborative approach to researchthat equitably involves all partners inthe research process and recognizesthe unique strengths that each brings.CBPR begins with a research topic ofimportance to the community, has theaim of combining knowledge withaction and achieving social change to

improve health outcomes and


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Helps overcome mistrust Improves communication strategy

Mobilizes community resources

Yields mutual benefits Community gains experience with research process

Data more likely to inform community action

More successful recruitment strategies

Increases participation of

underrepresented populations


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To compare the impact of a supervised

facility-based and a home-based exerciseintervention on obesity, metabolic syndrome

and known breast cancer biomarkers inpostmenopausal AA women with metabolicsyndrome who are at increased risk of breastcancer


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6 months, three-arm RCT Sample size: 240 women

Supervised facility-based exercise group

1000 New Jersey Ave SE site

Supervised by an exercise physiologist 3sessions/week 150 min/week target

Home-based exercise group

Exercise amount measured in steps/day using

pedometers (10,000) Control

Instructed to maintain current habits


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Inclusion criteria African American women

Between 45-65 years of age

Postmenopausal

WC >35 inches (88cm) 5 years individual invasive breast cancer risk

>1.66% (CARE model)

At least two of the following:

Fasting glucose >100 mg/dl; HDL-C 150 mg/dL; BP >130/85 mmHG


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Awareness

Opportunity

Acceptance/Refusal

AwarenessBarriers/

Promoters

Interventions

OpportunityBarriers/

Promoters

Moderators/Sociodemographic

Factors

Measuresof

Success

Acceptance/RefusalBarriers/

Promoters

StudyDesign

Adapted from Ford JGet al., Cancer. 2008; 112:228-42.

breast cancer disparities: co-morbidities and clinical trials

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