Dataset Information

Patient-reported discontinuation of endocrine therapy and related adverse effects among women with early-stage breast cancer.

ABSTRACT:

Background

Approximately 20% to 50% of women diagnosed with hormone receptor-positive breast cancer discontinue endocrine therapy early; most reports come from automated pharmacy data or small self-report evaluations. We conducted a larger self-report evaluation of endocrine therapy discontinuation associated with patient characteristics and therapy-related adverse effects.

Methods

We surveyed 538 women from a single health plan who were diagnosed with early-stage breast cancer from 2002 to 2008 and received endocrine therapy. Women reported adverse effects and reasons for discontinuation via mailed survey; tumor characteristics were obtained via registry linkage. We classified women as discontinuers if they self-reported stopping therapy and their self-reported duration of tamoxifen plus aromatase inhibitor (AI) use was < 5 years, and nondiscontinuers if they self-reported ? 5 years use or current use. We estimated odds ratios (ORs) with 95% CIs for discontinuation versus continuation by using logistic regression adjusted for age and year of diagnosis.

Results

Among 538 women, 98 (18.2%) discontinued endocrine therapy early. Women with positive lymph nodes (v negative) were significantly less likely to discontinue therapy (odds ratio [OR] = 0.54; 95% CI, 0.31 to 0.93). Almost all women (94%) experienced adverse effects. Experiencing headaches was associated with discontinuation of AIs (OR = 4.16; 95% CI, 2.16 to 8.01) and tamoxifen (OR = 2.34; 95% CI, 1.24 to 4.41); few other individual adverse effects were related to discontinuation despite most discontinuers reporting they "did not like adverse effects" (AIs: 66.7%, tamoxifen: 59.1%).

Conclusion

Few individual adverse effects or patient characteristics were significantly associated with endocrine therapy discontinuation, yet adverse effects were prevalent and were the most common reason women reported for discontinuing therapy.

SUBMITTER: Aiello Bowles EJ

PROVIDER: S-EPMC3500489 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature

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Publications

Patient-reported discontinuation of endocrine therapy and related adverse effects among women with early-stage breast cancer.

Aiello Bowles Erin J EJ Boudreau Denise M DM Chubak Jessica J Yu Onchee O Fujii Monica M Chestnut Janet J Buist Diana S M DS

Journal of oncology practice 20120717 6

<h4>Background</h4>Approximately 20% to 50% of women diagnosed with hormone receptor-positive breast cancer discontinue endocrine therapy early; most reports come from automated pharmacy data or small self-report evaluations. We conducted a larger self-report evaluation of endocrine therapy discontinuation associated with patient characteristics and therapy-related adverse effects.<h4>Methods</h4>We surveyed 538 women from a single health plan who were diagnosed with early-stage breast cancer fr ...[more]

PMID: 23598850

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Project description:Early discontinuation of aromatase inhibitors (AIs) is common and leads to poor outcomes but is challenging to predict. In the Exemestane and Letrozole Pharmacogenetics trial, a high rate of early discontinuation due to intolerance was observed. We hypothesized that early changes in patient-reported outcomes (PROs) predict AI discontinuation and that biochemical factors are associated with changes in PROs.Postmenopausal women with early-stage breast cancer enrolled in a prospective randomized trial of exemestane versus letrozole completed questionnaires at baseline and serially over 24 months to assess overall quality of life (EuroQOL Visual Analog Scale [VAS]); mood; and multiple symptoms, including a musculoskeletal symptom cluster. A joint mixed-effects/survival model was used to estimate the effect of the change in PROs on AI discontinuation. Associations between biochemical factors and change in PROs were examined.A total of 490 patients were analyzed. Worsening of EuroQOL VAS and the musculoskeletal cluster were associated with the highest risk for early discontinuation (hazard ratio [HR], 2.77 [95% confidence interval (CI), 2.72-2.81; p = .015]; HR, 4.39 [95% CI, 2.40-8.02; p < .0001], respectively). Pharmacokinetics and estrogen metabolism were not consistently associated with change in PRO measures. No clinically significant differences in any PRO between AIs were observed.Changes in PROs early during AI therapy were associated with treatment discontinuation. Identification of these changes could be used to target interventions in patients at high risk for early discontinuation.Early changes in patient-reported outcomes (PROs) can predict nonpersistence to aromatase inhibitor therapy. If used in clinical practice, PROs might identify women at highest risk for early discontinuation and allow for interventions to improve tolerance before significant toxicities develop. Further research is needed to improve capturing PROs in routine clinical practice.

Project description:PurposeNonadherence to aromatase inhibitors (AIs) for breast cancer is common and increases the risk of recurrence. Text messaging increases adherence to medications for chronic conditions.MethodsWe conducted a randomized clinical trial of text messaging (TM) versus no text messaging (No-TM) at 40 sites in the United States. Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months. Test messages were sent twice a week over 36 months. Content themes focused on overcoming barriers to medication adherence and included cues to action, statements related to medication efficacy, and reinforcements of the recommendation to take AIs. Both groups were assessed every 3 months. The primary outcome was time to adherence failure (AF), where AF was defined as urine AI metabolite assay results satisfying one of the following: < 10 ng/mL, undetectable, or no submitted specimen. A stratified log-rank test was conducted. Multiple sensitivity analyses were performed.ResultsIn total, 724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline. Observed adherence at 36 months was 55.5% for TM and 55.4% for No-TM. The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM v 85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05]; P = .18). Multiple time to AF sensitivity analyses showed similar nonsignificant results. Three-year self-reported time to AF (10.4% v 10.3%; HR, 1.16 [95% CI, 0.69 to 1.98]; P = .57) and site-reported time to AF (21.9% v 18.9%; HR, 1.31 [95% CI, 0.86 to 2.01]; P = .21) also did not differ by arm.ConclusionTo our knowledge, this was the first large, long-term, randomized trial of an intervention directed at improving AI adherence. We found high rates of AI AF. Twice-weekly text reminders did not improve adherence to AIs. Improving long-term adherence will likely require personalized and sustained behavioral interventions.

Project description:BACKGROUND:Endocrine therapy (ET)-based regimens are the mainstay of treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer. With the introduction of new treatment classes, it is important to examine patient symptoms and health-related quality of life (HRQoL) at the start of this changing therapeutic landscape. This real-world study describes the patient-reported outcomes (PROs) of women with HR+/HER2- advanced breast cancer receiving ET-based regimens who were naïve to systemic treatment in the advanced setting across five European countries (EU5). METHODS:Data were collected between March and July 2017 from surveyed oncologists and their patients at a single time point using the multinational Adelphi Advanced Breast Cancer Disease Specific Programme™. Patients completed PRO questionnaires on HRQoL (EORTC QLQ-C30), pain severity and interference, and work and activity impairment. A multiple linear regression model explored factors associated with HRQoL. RESULTS:Across EU5, 226 physicians provided data on 781 women with HR+/HER2- advanced breast cancer taking their first ET-based regimen for advanced disease, of whom 252 provided PRO data. This subset had a mean age of 67.1?years, 94% were postmenopausal, 89% were diagnosed with advanced breast cancer at initial presentation, 79% had stage IV disease (66% of these patients had bone metastases and 38% had visceral metastases, including 18% with liver metastases) and 77% were on endocrine-only therapy as their initial treatment for advanced disease. The mean EORTC QLQ-C30 global health score (50.9) was worse than the reference value for patients with advanced breast cancer (60.2). Fatigue, pain, and insomnia were the most severe symptoms, and mean functioning scores were also worse than reference values. "Worst pain" and "pain interference" were moderate/severe for 42 and 80% of patients. Mean activity impairment was 44%, and greater activity impairment was associated with poorer HRQoL. CONCLUSIONS:Despite receiving first-line ET-based regimens for advanced disease, these women had a poor HRQoL and high levels of symptoms, pain, pain interference and activity impairment. New treatments that maintain a stable disease state and reduce activity impairment may have a positive effect on the HRQoL of those living with advanced breast cancer.

Dataset Information

Patient-reported discontinuation of endocrine therapy and related adverse effects among women with early-stage breast cancer.

Background

Methods

Results

Conclusion

Publications

Patient-reported discontinuation of endocrine therapy and related adverse effects among women with early-stage breast cancer.

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