A prospective study of aromatase inhibitor therapy initiation and self-reported side effects

Gallicchio, Lisa; Calhoun, Carla; Helzlsouer, Kathy J.

doi:10.1007/s00520-017-3678-8

Cited by 12 publications

(5 citation statements)

References 32 publications

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“…Studies on breast cancer have demonstrated that patients commonly reported suffering from physical and psychological inconvenience due to AI therapies [ 41 ]. As compared to women without a history of cancer, breast cancer patients, reported significantly higher odds of new onset of forgetfulness, difficulty in concentrating, hair loss and numbness or tingling in the extremities after the first 6 months of AI therapy, with odds ratio ranging between 2 to 4 folds [ 41 ]. A German study also showed that age contributed to the difference in medication adherence amongst breast cancer women who were treated with AI [ 42 ].…”

Section: Discussionmentioning

confidence: 99%

Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder

Tan

Wong

et al. 2018

BMC Cancer

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BackgroundMedication adherence refers to whether a patient takes medication according to the frequency prescribed, or continues to take a prescribed medication. Inadequate adherence to medication may cause alterations in risk-benefit ratios, resulting in reduced benefits, increased risks or both, and is significantly associated with adverse clinical outcomes and higher healthcare costs. We aim to examine the effect of a computer generated short message service (SMS) reminder in improving medication adherence, and inhibiting the aromatisation process amongst breast cancer women receiving oral aromatase inhibitor therapy.Methods/DesignIn this randomised controlled trial, eligible patients will be equally allocated to receive either SMS reminder or standard care. The former receives weekly SMS reminder to take medication while the latter does not receive any. The primary endpoint of medication adherence at 1-year is assessed using the Simplified Medication Adherence Questionnaire, and compared using the χ2 test. Adjustment for baseline covariate and potential confounders will be made using the logistic regression. Secondary outcomes involving estrone and androstenedione levels will be compared using the analysis of covariance, whereas the estradiol levels (< 18.4 pmol/L versus ≥18.4 pmol/L) will be compared using the χ2 test, and the logistic regression. Further, the assessment of knowledge, attitude, behaviour, and barriers and facilitating factors of medication adherence will be made via logistic regression.DiscussionThis will be the first study to evaluate short-term clinical outcomes from SMS reminder for breast cancer patients on aromatase inhibitor therapy. Random allocation to SMS reminder or control arm ensures that patients in both arms will be comparable with respect to demographic and clinical characteristics, and any difference in outcomes can be attributed to the intervention. Participants are not blinded to the assignment of intervention, thus there may be potential for bias in outcome assessments.Trial registrationNCT02524548. Retrospectively registered on 17 August 2015.

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Section: Discussionmentioning

confidence: 99%

Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder

Tan

Wong

et al. 2018

BMC Cancer

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“…Several negative cognitive side effects, such as difficulty concentrating and forgetfulness, are commonly reported among women in AI therapies ( 138 ). The main cognitive impairments associated with AI therapy are verbal episodic memory and executive function impairments ( 139 ).…”

Section: Human Aromatase Studiesmentioning

confidence: 99%

“…The mechanism by which AI induce cognitive deficits presumably involves suppression of E2 signaling, with AI therapy in postmenopausal women resulting in undetectable blood concentrations of E2 ( 140 ). Tamoxifen (TAM), a competitive inhibitor of ER, has also been linked with cognitive dysfunction when used to treat post-menopausal breast cancer ( 138 ), suggesting that memory deficits associated with AI may involve suppression of ER signaling. Indeed, the vast majority of studies that have compared the cognitive effects of AI and tamoxifen have concluded that they result in analogous cognitive disruptions ( 27 , 139 , 141 – 143 ), although one study reported enhanced disturbances with TAM ( 142 ).…”

Section: Human Aromatase Studiesmentioning

confidence: 99%

“…However, both treatments are associated with bone health impairments ( 145 ). AI therapy among breast cancer patients was most likely to cause forgetfulness, followed by difficulty concentrating, hair loss, and numbness/tingling of extremities ( 138 ). A meta-analyses of 911 breast cancer patients treated with various AI treatments or TAM compared to control women further revealed that those treated with AI or TAM showed similar verbal learning and memory impairments ( 146 ).…”

Section: Human Aromatase Studiesmentioning

confidence: 99%

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Cognitive Effects of Aromatase and Possible Role in Memory Disorders

2018

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Diverse cognitive functions in many vertebrate species are influenced by local conversion of androgens to 17β-estradiol (E2) by aromatase. This enzyme is highly expressed in various brain regions across species, with some inter-species variation in terms of regional brain expression. Since women with breast cancer and men and women with other disorders are often treated with aromatase inhibitors (AI), these populations might be especially vulnerable to cognitive deficits due to low neuroE2 synthesis, i.e., synthesis of E2 directly within the brain. Animal models have been useful in deciphering aromatase effects on cognitive functions. Consequences of AI administration at various life cycle stages have been assessed on auditory, song processing, and spatial memory in birds and various aspects of cognition in rodent models. Additionally, cognitive deficits have been described in aromatase knockout (ArKO) mice that systemically lack this gene throughout their lifespan. This review will consider evidence to date that AI treatment in male and female rodent models, birds, and humans results in cognitive impairments. How brain aromatase regulates cognitive function throughout the lifespan, and gaps in current knowledge will be considered, along with future directions to better define how aromatase might guide learning and memory from early development through the geriatric period. Better understanding the importance of E2 synthesis on neurobehavioral responses at various ages will likely aid in the discovery of therapeutic strategies to prevent potential cognitive deficits, including Alzheimer's Disease, in individuals treated with AI or those possessing CYP19 gene polymorphisms, as well as cognitive effects of normal aging that may be related to changes in brain aromatase activity.

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“…However, AIs are also associated with adverse events (AEs) in a significant proportion of patients. The most common AEs associated with AI administration consist of arthralgias and myalgias [4-6]; menopause-type symptoms such as hair thinning or loss [7, 8]; hot flashes, night sweats, and vaginal dryness [8, 9]; cognitive dysfunction [10]; dry eyes [11]; and weight gain [12, 13]. Since adjuvant AI therapy is administered for long time intervals (2–7 years depending on patient and tumor characteristics, as well as on previous use of tamoxifen), and owing to the fact that most of these AEs are chronic, that is, they do not resolve spontaneously a few weeks/months after treatment initiation, they could have a negative impact on patient quality of life (QoL).…”

Section: Introductionmentioning

confidence: 99%

Aromatase Inhibitors in Postmenopausal Women with Hormone Receptor-Positive Breast Cancer: Profiles of Psychological Symptoms and Quality of Life in Different Patient Clusters

et al. 2020

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Background: Aromatase inhibitors (AIs) as adjuvant therapy after breast cancer (BC) surgery have demonstrated to reduce the risk of disease recurrence, to lower the risk of contralateral BC, and to improve survival when compared to tamoxifen in patients with limited-stage hormone receptor-positive (HR+) BC. However, AIs are associated with adverse events that can have a significant impact on patient quality of life (QoL). Aim: This study aimed to identify profiles of psychological symptoms and QoL in HR+ BC patients undergoing AI therapy. Method: Data were collected with questionnaires administered at three time points: AI initiation (t0); 3 months after AI initiation (t1); and 6 months after AI initiation (t2). The FACT-G, FACT-B, and FACT-ES questionnaires were used to assess QoL; psychological symptoms were assessed using the SCL-90-R. Results: 43 women were enrolled in the study (t0), and 37 completed the t1 evaluation and 29 the t2 evaluation. We found (1) a progressive decrease over time in FACT-G and FACT-ES scores, in particular in the Physical, Emotional, and Endocrine subscales, and an increase in the SOM (somatization) subscale of the SCL-90-R; (2) the presence of 4 clusters related to different psychological symptoms and QoL evolution over time; (3) that patients belonging to the cluster characterized by worsening symptoms and QoL during time differed from the others in the Emotional subscale of the FACT-B and in the GSI (Global Score), OCD (obsessive-compulsive), DEP (depression), ANX (anxiety), and SLP (sleep disorders) dimensions of the SCL-90-R and had significantly higher BMI levels; and (4) that 3 items from the SCL-90-R and 2 items from FACT Emotional Well-Being subscale were predictive of the “worst” cluster. Conclusions: Although larger studies are needed to confirm these results, our data open up new ways of investigation into the effects of AIs on QoL in HR+ BC patients.

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A prospective study of aromatase inhibitor therapy initiation and self-reported side effects

Abstract: AI-related symptoms should be monitored and addressed so that adherence to therapy is maintained.

Cited by 12 publications

References 32 publications

Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder

Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder

Cognitive Effects of Aromatase and Possible Role in Memory Disorders

Aromatase Inhibitors in Postmenopausal Women with Hormone Receptor-Positive Breast Cancer: Profiles of Psychological Symptoms and Quality of Life in Different Patient Clusters

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