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

ACCESS DATA

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

Similar Datasets

Project description:BackgroundEarly 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.Patients and methodsPostmenopausal 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.ResultsA 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.ConclusionChanges 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.Implications for practiceEarly 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:ImportanceAdjuvant endocrine therapy (AET) reduces breast cancer recurrence, but symptom burden is a key barrier to adherence. Black women have lower AET adherence and worse health outcomes than White women.ObjectiveTo investigate the association between symptom burden and AET adherence differences by race.Design, setting, and participantsA retrospective cohort study using electronic health records with patient-reported data from a large cancer center in the US. Patients included Black and White women initiating AET therapy for early-stage breast cancer from August 2007 to December 2015 who were followed for 1 year from AET initiation. Sixty symptoms classified into 7 physical and 2 psychological symptom clusters were evaluated. For each cluster, the number of symptoms with moderate severity at baseline, and symptoms with 3-point or greater increases during AET were counted. Adherence was measured as the proportion of days covered by AET during the first-year follow-up. Multivariable regressions for patients' adherence adjusting for race, symptom measures, sociodemographic characteristics, and clinical characteristics were conducted. Kitagawa-Blinder-Oaxaca decomposition was used to quantify racial differences in adherence explained by symptoms and patient characteristics. Analyses were conducted from July 2021 to January 2022.ExposuresPhysical and psychological symptoms at baseline and changes during AET.ResultsAmong 559 patients (168 [30.1%] Black and 391 [69.9%] White; mean [SD] age 65.5 [12.1] years), Black women received diagnoses younger (mean [SD] age at diagnosis, 58.7 [13.7] vs 68.5 [10.0] years old) than White women, with more advanced stages (30 Black participants [17.9%] vs 31 White participants [7.9%] had stage III disease at diagnosis), and lived in areas with fewer adults attaining high school education (mean [SD], 78.8% [7.8%] vs 84.0% [9.3%]). AET adherence in the first year was 78.8% for Black and 82.3% for White women. Black women reported higher severity in most symptom clusters than White women. Neuropsychological, vasomotor, musculoskeletal, cardiorespiratory, distress, and despair symptoms at baseline and increases during the follow-up were associated with 1.2 to 2.6 percentage points decreases in adherence, which corresponds to 4 to 9 missed days receiving AET in the first year. After adjusting for psychological symptoms, being Black was associated with 6.5 percentage points higher adherence than being White.Conclusions and relevanceIn this cohort study, severe symptoms were associated with lower AET adherence. Black women had lower adherence rates that were explained by their higher symptom burden and baseline characteristics. These findings suggest that better symptom management with a focus on psychological symptoms could improve AET adherence and reduce racial disparities in cancer outcomes.

Project description:BackgroundTAILORx (Trial Assigning Individualized Options for Treatment) prospectively assessed fatigue and endocrine symptoms among women with early-stage hormone receptor-positive breast cancer and a midrange risk of recurrence who were randomized to endocrine therapy (E) or chemotherapy followed by endocrine therapy (CT+E).MethodsParticipants completed the Functional Assessment of Chronic Illness Therapy-Fatigue, the Patient-Reported Outcomes Measurement Information System-Fatigue Short Form, and the Functional Assessment of Cancer Therapy-Endocrine Symptoms at the baseline and at 3, 6, 12, 24, and 36 months. Linear regression was used to model outcomes on baseline symptoms, treatment, and other factors.ResultsParticipants (n = 458) in both treatment arms reported greater fatigue and endocrine symptoms at early follow-up in comparison with the baseline. The magnitude of change in fatigue was significantly greater for the CT+E arm than the E arm at 3 and 6 months but not at 12, 24, or 36 months. The CT+E arm reported significantly greater changes in endocrine symptoms from the baseline to 3 months in comparison with the E arm; change scores were not significantly different at later time points. Endocrine symptom trajectories by treatment differed by menopausal status, with the effect larger and increasing for postmenopausal patients.ConclusionsAdjuvant CT+E was associated with greater increases in fatigue and endocrine symptoms at early time points in comparison with E. These differences lessened over time, and this demonstrated early chemotherapy effects more than long-term ones. Treatment arm differences in endocrine symptoms were more evident in postmenopausal patients.Lay summaryParticipants in TAILORx (Trial Assigning Individualized Options for Treatment) with early-stage hormone receptor-positive breast cancer and an intermediate risk of recurrence were randomly assigned to endocrine or chemoendocrine therapy. Four hundred fifty-eight women reported fatigue and endocrine symptoms at the baseline and at 3, 6, 12, 24, and 36 months. Both groups reported greater symptoms at early follow-up versus the baseline. Increases in fatigue were greater for the chemoendocrine group than the endocrine group at 3 and 6 months but not later. The chemoendocrine group reported greater changes in endocrine symptoms in comparison with the endocrine group at 3 months but not later.

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.

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets