Association of Modifiable Risk Factors With Early Discontinuation of Adjuvant Endocrine Therapy

Yanez, Betina R.; Gray, Robert J.; Sparano, Joseph A.; Carlos, Ruth C.; Sadigh, Gelareh; Garcia, Sofia F.; Gareen, Ilana F.; Whelan, Timothy J.; Sledge, George W.; Cella, David; Wagner, Lynne I.

doi:10.1001/jamaoncol.2021.1693

Cited by 19 publications

(19 citation statements)

References 41 publications

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“…However, for reasons discussed below and as has been pointed out by other groups, it is likely our data are underestimating the true rate of non-persistence. Similar to others [31], we found that social support is a key factor associated with persistence to endocrine therapy, with 92% of persistent patients reporting strong or satisfactory support, compared with 84% of non-persistent patients (p=0.002). It has been hypothesized that clinical social support can mitigate low personal social support [51], although we did not measure this directly in our study, a surrogate may have been participation in RN/NP teaching prior to surgery.…”

Section: Discussionsupporting

confidence: 89%

“…While side effects and their management are clearly important, a wealth of literature reveals the issue to be even more complex. Non-persistence has been associated with factors such as patient age [20]- [22], race and ethnicity [23]- [25], fertility concerns [26], presence of baseline symptoms [27], [28] and comorbidities [27] such as mental health disorder [29]- [31] and substance use disorder [29], receipt of nonspecialist care [32], communication with providers [33]-[36], cost concerns [23], [25], [37]- [40], and individual beliefs and perceptions about AET [37], [41]- [43]. Lower tumor stage and negative lymph node status are also associated with non-persistence [19], [44], [45].…”

Section: Introductionmentioning

confidence: 99%

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Preventing metastatic recurrence in low-risk ER/PR+ breast cancer patients – a retrospective clinical study exploring the evolving challenge of persistence with adjuvant endocrine therapy

Kuhn

Pirruccello

Boothe

et al. 2022

Preprint

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Purpose: In the genomic era, more women with low-risk breast cancer will forego chemotherapy and rely on adjuvant endocrine therapy (AET) to prevent metastatic recurrence. However, some of these patients will unfortunately relapse. We sought to understand this outcome. Preliminary work suggested that early discontinuation of AET, also known as non-persistence, may play an important role. A retrospective analysis exploring factors related to our breast cancer patients’ non-persistence with AET was performed. Methods: Women who underwent Oncotype DX® testing between 2011-2014 with minimum 5-year follow-up were included. ‘Low risk’ was defined as Oncotype score < 26. Outcomes of recurrence and persistence were determined by chart review. Patient, tumor and treatment factors were collected, and persistent vs non-persistent groups compared using multivariable ANOVA and Fisher Chi square exact test. Results: We identified 6 cases of distant recurrence among low-risk patients with a median follow-up of 7.7 years. Among them, 5 of 6 patients (83%) were non-persistent with AET. The non-persistence rate in our cohort regardless of recurrence was 57/228 (25%). Non-persistent patients reported more severe side effects compared with persistent patients (p=0.002) andwere more likely to be offered a switch in endocrine therapy, rather than symptom-relief (p=0.006). In contrast, persistent patients were 10.3 times more likely to have been offeredsymptom-alleviating medications compared with non-persistent patients (p<0.001). A subset analysis revealed that patients who persisted with therapy had a higher Oncotype-DX® score than patients who discontinued early (p=0.028). Conclusions: Metastatic recurrence in low-risk breast cancer patients may be primarily due to non-persistence with endocrine therapy. Further work is needed to optimize care for patients who struggle with side effects. To our knowledge, these are the first published data suggesting that Oncotype-DX® score may influence persistence with AET.

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Section: Discussionsupporting

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Preventing metastatic recurrence in low-risk ER/PR+ breast cancer patients – a retrospective clinical study exploring the evolving challenge of persistence with adjuvant endocrine therapy

Kuhn

Pirruccello

Boothe

et al. 2022

Preprint

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“…Yet, TAILORx demonstrated a significantly lower risk of early endocrine therapy discontinuation among women on CT+E. 39 Although we speculated that the chronic symptom burden may diminish endocrine therapy's tolerability, 40 the results indicate that further study is needed. Endocrine therapy adherence remains a complex challenge; interventions must be comprehensive, 41 and PROs have predictive value in identifying women at risk for early discontinuation.…”

Section: Original Article 542mentioning

confidence: 87%

Fatigue and endocrine symptoms among women with early breast cancer randomized to endocrine versus chemoendocrine therapy: Results from the TAILORx patient‐reported outcomes substudy

Garcia

Gray

Sparano

et al. 2021

Cancer

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BACKGROUND: TAILORx (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). METHODS: Participants 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. RESULTS: Participants (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. CONCLUSIONS: Adjuvant 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.

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“…Despite these benefits, patients live with AET‐related physical and emotional sequelae that interfere with quality of life (QOL) and ability to take the medication daily as prescribed. The most prominent symptoms include myalgias/arthralgias, hot flashes, sleep disturbances/insomnia, sexual dysfunction, fatigue, weight gain, cognitive impairment, and mood fluctuations 5–10 . Given patients' difficulties managing these symptoms, adherence to AET (i.e., taking medication as prescribed) is alarmingly low and presents an ongoing concern in breast cancer care 11–13 …”

Section: Introductionmentioning

confidence: 99%

“…The most prominent symptoms include myalgias/arthralgias, hot flashes, sleep disturbances/ insomnia, sexual dysfunction, fatigue, weight gain, cognitive impairment, and mood fluctuations. [5][6][7][8][9][10] Given patients' difficulties managing these symptoms, adherence to AET (i.e., taking medication as prescribed) is alarmingly low and presents an ongoing concern in breast cancer care. [11][12][13] Up to 59% of patients are not adherent to their AET regimen, 14,15 and adherence declines each year following treatment initiation.…”

Section: Introductionmentioning

confidence: 99%

A telehealth intervention for symptom management, distress, and adherence to adjuvant endocrine therapy: A randomized controlled trial

Jacobs

Post

Massad

et al. 2022

Cancer

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BACKGROUND:Patients taking adjuvant endocrine therapy (AET) after breast cancer face adherence challenges and symptom-related distress. We conducted a randomized trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth intervention (Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy [STRIDE]) for patients taking AET. METHODS: From October 2019 to June 2021, 100 patients reporting difficulty with AET were randomly assigned to either STRIDE or a medication monitoring (MedMon) control group. STRIDE included six weekly small-group videoconferencing sessions and two individual calls. We defined feasibility as having >50% of eligible patients enroll, >70% complete the 12-week assessment, and > 70% of STRIDE patients complete ≥4/6 sessions. We monitored adherence with the Medication Event Monitoring System Caps (MEMS Caps). At baseline and 12-and 24-weeks after baseline, patients self-reported adherence (Medication Adherence Report Scale), AET satisfaction (Cancer Therapy Satisfaction Questionnaire), symptom distress (Breast Cancer Prevention Trial-Symptom Checklist), self-management of symptoms (Selfefficacy for Symptom Management-AET), coping (Measure of Current Status), quality of life (QOL; Functional Assessment of Cancer Therapy-Breast), and mood (Hospital Anxiety and Depression Scale). We used linear mixed effects models to assess the effect of STRIDE on longitudinal outcomes. RESULTS: We enrolled 70.9% (100/141) of eligible patients; 92% completed the 12-week assessment, and 86% completed ≥4/6 STRIDE sessions. Compared with MedMon, STRIDE patients reported less symptom distress (B[difference] = −1.91; 95% CI, −3.29 to −0.52; p = .007) and better self-management of AET symptoms, coping, QOL, and mood. We did not observe significant differences in AET satisfaction or adherence. CONCLUSIONS: STRIDE is feasible and acceptable, showing promise for improving outcomes in patients taking AET after breast cancer.

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Association of Modifiable Risk Factors With Early Discontinuation of Adjuvant Endocrine Therapy

Cited by 19 publications

References 41 publications

Preventing metastatic recurrence in low-risk ER/PR+ breast cancer patients – a retrospective clinical study exploring the evolving challenge of persistence with adjuvant endocrine therapy

Preventing metastatic recurrence in low-risk ER/PR+ breast cancer patients – a retrospective clinical study exploring the evolving challenge of persistence with adjuvant endocrine therapy

Fatigue and endocrine symptoms among women with early breast cancer randomized to endocrine versus chemoendocrine therapy: Results from the TAILORx patient‐reported outcomes substudy

A telehealth intervention for symptom management, distress, and adherence to adjuvant endocrine therapy: A randomized controlled trial

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