V. Ziller

Adherence to adjuvant endocrine therapy in postmenopausal women with breast cancer

BACKGROUND The level of adherence of various pharmacological therapies in chronic diseases varies, but is predominantly low. With tamoxifen (TAM), 23% and 50% nonadherence after 1 and 4 years have been reported. Day-to-day clinical observation suggests that adherence may even be lower with aromatase inhibitors, but limited data exist on the situation in daily clinical routine. The aim of this study was to evaluate the rate of adherent patients in a randomly selected sample of postmenopausal women with primary breast cancer, who had been assigned to an adjuvant endocrine treatment with TAM or anastrozole (ANA). MATERIALS AND METHODS We investigated a random sample of 100 postmenopausal women with breast cancer (50 TAM and 50 ANA) who had received surgery for their primary breast cancer at our hospital in 2004/2005 and thereafter had been assigned to an adjuvant endocrine treatment. We evaluated the adherence rate with a detailed questionnaire and additionally carried out a retrospective prescription check of the hospital chart as well as calling the local physicians of our patients. A patient was counted as adherent with a self-reported tablet intake of 80% or more and if a medication possession ratio of 80% or more was achieved. RESULTS Regarding the baseline characteristics, a significant difference in mean age was noticed in women on ANA versus TAM [65 (+/-3) and 72 (+/-3); P<0.001]. All women on TAM and ANA reported to be adherent (100%). After controlling for prescriptions, only 40 (80%) and 27 (69%) of the women on TAM and ANA were still classified as adherent (P<0.01 and P<0.01 versus self-report). We found no significant correlation of adherence to any baseline characteristics or side-effects in a logistic regression model. CONCLUSIONS An important goal of any therapeutic intervention is to achieve comparable efficacy in routine clinical practice to that demonstrated in randomised clinical trials. However, a similar magnitude of adherence will be necessary in routine clinical practice to assure comparable clinical effects. Our results further support the data on suboptimal adherence of women with breast cancer on adjuvant TAM treatment. Here, we evaluated for the first time the patient reported and real-world adherence on adjuvant ANA and were able to show a similarly low adherence compared with TAM. More prospective studies are needed to increase our understanding of the underlying reasons for nonadherence in women with breast cancer.

Influence of pregnancy and breast-feeding on quantitative ultrasonometry of bone in postmenopausal women

Objective: Reproductive factors such as parity and breast-feeding may be associated with low bone mass and osteoporotic fractures in later years. In this study, os calcis quantitative ultrasonometry was used to elucidate the relationship between parity, lactation and bone mass in postmenopausal women. Design: This was a comparison study using subsequent matched pairs analysis as well as multiple linear regression analysis. The study was carried out at five centers in Germany. The study included 2080 postmenopausal women (age (mean ± SD) 58.8 ± 8.2 years), who were attending for routine check-up and in whom diseases and drug treatments known to affect bone metabolism had been excluded. Methods and outcome measures: Women underwent quantitative ultrasonometry (QUS) measurement at the heel. Values of the ultrasonometry variables –speed of sound, broadband ultrasound attenuation and stiffness index –were calculated and compared for nulliparous and parous women and for women who had and had not breast-fed. Because of some significant intergroup differences, and to determine any effect of the number of live births and the duration of breast-feeding on ultrasonometry results, second analyses were undertaken using equally sized samples, matched for possible confounding variables such as age and body mass index (matched pairs). In these analyses, nulliparous women were compared with parous women, grouped according to number of live births, and women who had never breast-fed were compared with women who had breast-fed, grouped according to duration of breast-feeding. Furthermore, a multiple linear regression analysis was performed to examine the combined effects of reproductive factors on QUS variables. Results: No statistically significant associations were found between ultrasonometry variables and parity or breast-feeding, even after controlling for confounding variables in matched-pairs analysis or in a multiple linear regression analysis.

Prevalence of menopausal symptoms and their influence on adherence in women with breast cancer.

Abstract Objectives The use of aromatase inhibitors for the adjuvant treatment of breast cancer may affect the quality of life of patients, as well as adherence to treatment. Methods Here we report the 2-year results of the 180 patients in the COMPAS study. This is the first randomized, controlled study reporting on menopausal symptoms under endocrine treatment with aromatase inhibitors in breast cancer patients, based on the Menopause Rating Scale. We analyzed the prevalence of menopausal symptoms as well as their associations with patient adherence. Results Baseline characteristics showed no significant differences among the control and the intervention groups. The majority of women experienced the symptoms at various severities. Overall, we found an increase in the prevalence of hot flushes, sleep disorders, bladder problems, dryness of the vagina as well as of joint and muscular discomfort between the 12- and 24-month visits. In compliant patients, all symptoms except for vaginal dryness improved between the 12- and 24-month visits while, in non-compliant women, hot flushes, irritability, dryness of the vagina as well as joint and muscular discomfort deteriorated. When comparing compliant and non-compliant patients, we found a significant difference only for anxiety (p = 0.028) in the 12-month analysis, as well as a large but non-significant difference for heart discomfort (p = 0.089) in the 24-month visit. Conclusions Our results indicate that the majority of women treated with aromatase inhibitors are experiencing menopausal symptoms at various severities. We showed that the mean symptom values in compliant patients improve with longer therapy duration. Furthermore, anxiety correlates with better compliance, while heart discomfort may lead to therapy discontinuation.

Adherence and persistence in patients with severe osteoporosis treated with teriparatide.

Abstract Introduction: Medical intervention plays a key role in the treatment of postmenopausal osteoporosis and patients’ adherence to therapy is essential for optimal clinical outcomes. While adherence in RCTs is usually around 70–90%, a previous study showed that in clinical practice only 27.8% and 46.5% of the women on oral daily vs. weekly alendronate were still on treatment after 12 months. Data on adherence to teriparatide (TPTD) treatment of severe postmenopausal osteoporosis are available from only few countries. This study assessed adherence and persistence with TPTD in Germany. Material and methods: A sample of 50 women with severe postmenopausal osteoporosis treated with TPTD in accordance to the German osteoporosis guidelines was included. Treatment was initiated 12–24 months before recruitment. Patient self report was assessed using a validated questionnaire. In addition medication possession ratio (MPR) was calculated by counting prescription refills, and therefore all physicians who were treating the patients for any disease were contacted. Patients were classified adherent at 12 months of therapy if self-reported adherence and an MPR of ≥80% were achieved. Persistence was calculated in months and analysed with a Kaplan–Meier estimate. Results: Apart from a significantly lower age at menopause in the adherent group (46.1 vs. 50.0; p < 0.006) there were no significant differences in baseline demographics between adherent and non-adherent patients. After 12 months, 80% of the patients treated with TPTD were adherent, while 20% were non-adherent. A significant correlation with treatment adherence was found for self-reported medication tolerability (p < 0.001). Furthermore 79% of patients were persistent after 12 months. Conclusion: These results indicate that more patients seem to be adherent and persistent with TPTD than with oral treatments of postmenopausal osteoporosis. As these patients suffered from severe osteoporosis and sustained several fragility fractures, the generalisability of our retrospective study analysing a small sample is limited. The major factor that reduced adherence and persistence was tolerability. These findings are of practical relevance as numerous studies on antiresorptive therapies have shown that high adherence and persistence were needed to ensure an optimal therapeutic outcome.

The Effect of Age, Sex Hormones, and Bone Turnover Markers on Calcaneal Quantitative Ultrasonometry in Healthy German Men

The aim of this cross-sectional study was to determine the age-dependent variations of calcaneal quantitative ultrasonometry (QUS) and the association with sex hormones and biochemical bone turnover markers in a large sample of unselected healthy German men. Bone measurements are expected to behave differently among men and women. The speed of sound (SOS), broadband ultrasound attenuation (BUA), and stiffness index (SI) of the os calcaneus were measured in 506 German men aged 20-79 yr (mean age: 45.7 yr). Additionally, follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, prolactin, testosterone, dehydroepiandrosterone sulfate (DHEA-S), sex hormone-binding globulin (SHBG) as well as N-terminal propeptide of human procollagen type I (PINP), C-terminal telopeptide of type I collagen (ICTP), osteocalcin, bone-specific alkaline phosphatase, and CrossLaps were measured with standardized essays and correlated with the QUS results. The QUS results comprised an overall change of 12.4%, 3.2%, and 23.2% for BUA, SOS, and SI, respectively, between the 20-29 and 70-79 yr age groups (p ≤ 0.001). The annual rate of the age-related differences was 0.33% (standard deviation [SD]: 0.31), 0.06% (SD: 0.08), and 0.53% (SD: 0.56) for BUA, SOS, and SI, respectively. Testosterone and DHEA-S were significantly associated with QUS parameters and increasing age, whereas SHBG showed an age-related increase and was inversely related with QUS values (p < 0.05). Bone turnover markers present lower values gradually, and we found a significant correlation between carboxy-terminal collagen crosslinks (CTX), osteocalcin (OC), bone alkaline phosphatase (BAP), and QUS variables (p < 0.05).

The Impact of Breast Care Nurses on Patients' Satisfaction, Understanding of the Disease, and Adherence to Adjuvant Endocrine Therapy

Background: Breast care nurses (BCNs) are specialized caregivers in certified breast cancer center teams. The impact of a BCN’s work remains unknown. Patients and Methods: The role of BCN care was evaluated in a post-discharge mail survey of 360 patients. Results: A total of 207 (87%) of 237 (66%) returned questionnaires were analyzed; 171 (83%) patients had BCN contact, 36 (17%) did not. The mean global quality of life scores (EORTC-QLQ-C30) were 66.3 for women with contact to a BCN versus 62.5 for women without such contact (p < 0.05). Women with a BCN contact had better results than women without (p < 0.001) for the following parameters: receipt of information material (84 vs. 64%), information about hospital procedures (93 vs. 72%) and treatment plan (91 vs. 63%), and knowledge of own tumor hormone receptor status (83 vs. 53%). Medication adherence correlated with the knowledge about the tumor hormone receptor status and was significantly higher in women having contact with a BCN (79 vs. 56%). The high recommendation rate (81%) reflects the high level of satisfaction with BCNs. A qualitative analysis of comments and suggestions identified aspects to improve BCN services. Conclusions: BCN improve satisfaction and treatment adherence in breast cancer patients.

Fracture risk in women with breast cancer: can baseline assessment of risk be used to guide treatment?.

Abstract #6130 Background: Breast cancer (BC) therapies have been associated with decreases in bone health. Recent studies have shown that BC survivors have a 31% increased fracture risk compared with their peers, elevating the importance of monitoring bone health in women diagnosed with BC. Bone mineral density (BMD) has been the standard used by clinical guidelines (WHO, ASCO) to direct therapeutic decisions. However, emerging guidelines place BMD in the context of several other clinical risk factors that have been correlated with overall fracture risk. This retrospective, case-controlled study uses current and emerging guidelines to estimate the percentage of patients with newly diagnosed breast cancer who may be at increased risk for fracture and who require preventive therapy. Methods: Baseline data from 88 pre- and 402 postmenopausal women (PMW) with BC were compared with data from an equal number of healthy age- and body mass index-matched women. BMD was assessed by 2 methods; dual-energy x-ray absorptiometry (DXA) at the lumbar spine (LS) and total hip, and quantitative ultrasonometry (QUS) at the os calcaneus and phalanges. Baseline BMD measurements were collected at a mean duration of 15 and 242 days after diagnosis of cancer in pre- and PMW, respectively. Results: Baseline LS and total hip BMD was similar between the healthy control groups and patients with BC. Among estrogen receptor-positive (ER+) BC patients, 18.8% of premenopausal women and 36.9% of PMW were osteopenic, and 8.9% of PMW were osteoporotic (according to LS BMD). Among ER+ PMW with BC, 15.9% of patients > 65 years of age, 8.3% of patients 55 to 65 years of age, and 1.4% of patients Conclusions: Current treatment thresholds seem to inadequately identify patients who would benefit from bone-protective therapy. The results presented here support the use of overall fracture risk assessment in PMW with breast cancer. Using both BMD and clinical risk factors may more effectively identify patients at risk for fracture, although further studies are needed. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6130.