Arthralgia in women with early-stage breast cancer taking aromatase inhibitors:

Breast Cancer Adjuvant Therapy (BCAT)(BRE0939) Team-Oncologists Meeting

Liana Castel, PhD, MSPHTonya L. Brown, MBA

Bradley Shields, BSVanderbilt Institute for Medicine and Public Health

Vanderbilt Epidemiology Center

Monday March 18, 2013

Aims of the prospective cohort

Among women with early breast cancer initiating adjuvant endocrine therapy with an aromatase inhibitor, and among postmenopausal women without breast cancer, to:

• AIM 1: Estimate arthralgia time-to-onset, prevalence, incidence, background rate, trajectories, and risk factors

• AIM 2: Measure the impact of arthralgia on health-related quality of life and medication adherence (adherence for AI pts only)

• SECONDARY AIM: Develop a roster of current physician-advised or prescribed treatments, as well as self-management techniques being used for AI-induced arthralgia (AI pts only), to further inform intervention development.

INDIVIDUAL LEVEL•Demographic•Clinical•Psychosociobehavioral(e.g., level of social support)

MEDICAL CARE LEVEL•Non-cancer treatments•Cancer treatments, including aromatase inhibitor (AI) therapy

RISK FACTORS

•Prevalence•Incidence•Time to onset•Severity•Trajectory•Background rate

ARTHRALGIA•Sleep •Depression•Physical function

HEALTH-RELATED QUALITY OF LIFE

ARTHRALGIA TREATMENTS

INDIVIDUAL LEVEL•Exercise•Self-care•Complementary medicine

MEDICAL CARE LEVEL•Evidence-based anticipatory guidance•Prescription medication•Over the counter medication•Non-pharmaceutical interventions

Recurrence rates/ disease-free survival

CLINICAL EFFECTIVENESS OF AROMATASE INHIBITORS

ADHERENCE

•AI adherence level(self-report)

•AI persistence at 1, 3, and 12 months(self-report)

•AI persistence(MEMS)

•Switch from AI to tamoxifen

Aim 1

Aim 3

Aim 2

INDIVIDUAL LEVEL•Demographic•Clinical•Psychosociobehavioral(e.g., level of social support)

MEDICAL CARE LEVEL•Non-cancer treatments•Cancer treatments, including aromatase inhibitor (AI) therapy

RISK FACTORS

•Prevalence•Incidence•Time to onset•Severity•Trajectory•Background rate

ARTHRALGIA•Sleep •Depression•Physical function

HEALTH-RELATED QUALITY OF LIFE

ARTHRALGIA TREATMENTS

INDIVIDUAL LEVEL•Exercise•Self-care•Complementary medicine

MEDICAL CARE LEVEL•Evidence-based anticipatory guidance•Prescription medication•Over the counter medication•Non-pharmaceutical interventions

Recurrence rates/ disease-free survival

CLINICAL EFFECTIVENESS OF AROMATASE INHIBITORS

ADHERENCE

•AI adherence level(self-report)

•AI persistence at 1, 3, and 12 months(self-report)

•AI persistence(MEMS)

•Switch from AI to tamoxifen

Aim 1

Aim 3

Aim 2

Conceptual model: arthralgia and other outcomes

Design and methods• Current sample size = 300 women

100 AI and 200 comparison group women • Multi-level identification and recruitment• 1 year of enrollment and 1 year per-participant follow up• 8 surveys (paper) per patient• Domains:

– Pain in joints, stiffness in joints, pain impact on activities– Quality of life (depression, sleep, physical function, symptoms)– Medications– Treatments– Nonpharmacologic pain management– Clinical and demographic characteristics– Exercise

Findings to date

52-week arthralgia trajectories and CIs (N=303) 

Manuscript and grant submissions1. MS: Descriptive epidemiology – preliminary findings2. R01: Arthralgia, health outcomes, and adherence3. MS: Validity and reliability of the Patient-Reported Arthralgia

Inventory4. MS: AI switching5. MS: Arthralgia and HRQoL6. MS: Arthralgia and AI adherence7. MS: Adherence measurement methods validation

Funding

• Vanderbilt Institute for Clinical and Translational Research• American Cancer Society • National Institutes of Health: Building Interdisciplinary

Careers in Women’s Health Research

Clinic recruitment

– Prescreening part 1: possible AI candidates– In-person clinic presence– Prescreening part 2: prescribed AI– Starpanel referrals: “BCAT-CastelLiana PhD”

Feedback/discussion