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The efficacy of adjuvant denosumab in combination with hormonotherapy in breast cancer patients was investigated in two randomized trials, ABCSG-18 and D-Care, but the results were mixed with respect to the impact of this drug on disease-free survival. However, the ABCSG-18 study has achieved its primary goal: prevention of clinical fractures. Therefore, the protective role of Denosumab on bone fragility induced by estrogen deprivation, already demonstrated in post-menopausal women, has been validated in the breast cancer setting. [ABSTRACT FROM AUTHOR]

The impact of dietary counseling on body composition in early breast cancer patients (EBC) treated with aromatase inhibitors (AIs) is uncertain. The aim of this study was to assess the effects of a diet counseling program on weight, BMI, total and regional body composition in patients treated with AIs. This observational study involved 194 EBC patients, of which 97 attended a 6-month personalized counseling program, based on Mediterranean diet principles (cohort A) and 97 did not (cohort B). Dual-energy X-ray absorptiometry (DXA) scan was used to measure the total and regional fat and lean body mass, before (baseline) and after at least 18 months of AI-therapy. Weight and BMI increased significantly, on the average, in cohort B, but not in cohort A. In the cohorts A and B, fat mass increased by 10 % and 7.7 % respectively, while lean mass decreased by 3.3 % and 2.6 % from before to after AI therapy, without statistically significant differences between them using the Mann-Whitney test. The changes in body composition were greater in premenopausal than in postmenopausal women at cancer diagnosis. The proportion of patients with sarcopenia, obesity and sarcopenic obesity increased from before to after AI therapy, similarly in both cohorts. Patients treated with AIs reported an increase in fat mass and a decrease in lean mass, and consequently an increase in sarcopenia and obesity, regardless of the participation in a dietary counseling program. A combined dietary counseling and physical exercise program may be necessary for preventing these unfavourable changes in these patients. • Lifestyle is still considered the keystone for preventing obesity and sarcopenia. • Patients treated with AIs reported an increase in fat mass and a decrease in lean mass. • Dietary counseling with physical exercise program could prevent these unfavourable changes. [ABSTRACT FROM AUTHOR]

Whether adjuvant therapy with aromatase inhibitors (AIs) causes sleep disturbances or not in postmenopausal women with early breast cancer (EBC) is still a controversial issue. Between March 2014 and November 2017, validated questionnaires for assessing insomnia, anxiety, depression, quality of life (QoL) and restless legs syndrome (RLS) were administered to 160 EBC patients at baseline and after 3, 6, 12, and 24 months of AI therapy. AI therapy significantly decreased the patients' QoL, but did not influence insomnia, anxiety or depression. However, it significantly increased the frequency and severity of RLS. Patients with RLS at baseline (19%) or who developed RLS during AI therapy (26.3%) reported statistically lower quality of sleep, higher anxiety and depression, and worse QoL compared to patients who never reported RLS (54.7%). Although AI therapy does not affect sleep quality, it may increase RLS frequency. The presence of RLS could identify a group of EBC patients who may benefit from psychological support. • Aromatase inhibitors (AIs) are the main adjuvant treatment in hormone receptor-positive early breast cancer (EBC) in postmenopausal patients. • Sleep disturbances are common in cancer patients and the role of AIs is not clearly defined. • AI therapy did not worsen sleep disturbances, anxiety, and depression, but increases frequency and severity of restless legs syndrome (RLS). • EBC patients with RLS are more fragile and suffer from higher levels of. • Insomnia, anxiety, depression, and worse overall quality of life. [ABSTRACT FROM AUTHOR]

Eribulin mesylate (EM) is a non-taxane microtubule inhibitor approved for use in patients with metastatic breast cancer. With this pooled analysis of retrospective studies, we evaluated the efficacy and toxicity profile of EM in older patients with breast cancer in the real-world setting. We performed a systematic database search for studies published up to March 2019 and reporting outcome and adverse events with EM in older patients (≥70 years). Overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) were described and aggregated in a pooled analysis. Main toxicity rates (G1–2 and G3–4) were also described. The analysis included five studies for a total of 301 patients. The median age was 71 to 74 years. Pooled ORR, median PFS and OS were 23.2%, 4.8 and 13.1 months, respectively. The disease control rate was 47%. Grade 3–4 neutropenia was 0 to 49%, G3–4 anemia and thrombocytopenia were rare. The most frequent G3–4 adverse events among non-hematological toxicities were fatigue (5–16.5%) and neurotoxicity (0–10.1%). Dose reduction rate was reported in three studies and carried out in 40% of patients (18.6–84%). This pooled analysis shows that the median OS in older patients with breast cancer is 13 months, with an ORR of 23%. Control of disease was achieved in about 50% of patients. Dose reduction was relatively frequent and severe toxicities were rare. EM treatment of older patients with breast cancer is feasible and reflects the outcomes for the general population. [ABSTRACT FROM AUTHOR]

Background The impact of long-term adjuvant therapy with aromatase inhibitors (AIs) on vertebral fracture (VF) risk is still unclear. Objective In this cross-sectional study, we explored the prevalence and determinants of VFs in breast cancer (BC) patients before and during AI therapy. Each woman underwent a dual-energy X-ray absorptiometry (DXA) to evaluate bone mineral density (BMD) and identify VFs by a quantitative morphometric approach. Blood samples were collected to measure serum hormone and calcium levels. Results We consecutively included 263 postmenopausal women with hormone receptor-positive early BC. One-hundred-sixty-nine women were AI-naïve, and 94 were AI-treated. AI-treated patients had lower BMD at total hip ( p = 0.01) and lumbar spine ( p = 0.03), higher serum vitamin D ( p < 0.001) and parathyroid hormone ( p = 0.006) values as compared to AI-naïve patients. The prevalence of VFs was 18.9% in AI-naïve patients, and 31.2% in those assessed during AI therapy (odds ratio 1.90, 95% CI 1.1–3.5, p = 0.03). In AI-naïve patients, VFs were associated with older age ( p = 0.002) and lower BMD values at femoral neck ( p = 0.04) and total hip ( p = 0.007), whereas VFs occurred without association with any parameter analyzed in AI-treated patients. In AI-treated group, the prevalence of VFs was not significantly different between patients with osteoporosis and those with normal BMD (36.7% vs. 20.0%; p = 0.31). Conclusions In women with early BC, AI therapy is associated with high prevalence of radiological VFs, which were shown to be independent of BMD values during the adjuvant treatment. These findings may be clinically relevant since they may lead to a change in management of AI-induced skeletal fragility. Specifically, the results of this study provide a rationale for performing a morphometric evaluation of VFs in all women undergoing treatment with AIs. [ABSTRACT FROM AUTHOR]

• In females under estrogen-deprivation therapies, risk of vertebral fractures was associated with FRAX score for major fractures, with the best therapeutic threshold of 6.5%. • In males under androgen-deprivation therapy, risk of vertebral fractures was high when BMD T-score was lower than −1.0 SD or when subjects were treated with abiraterone. • High body mass index was an independent risk factor for vertebral fractures in males exposed to androgen-deprivation therapy. • In the setting of hormonal deprivation therapies, FRAX and BMD thresholds were lower than those used in post-menopausal osteoporosis and primary male osteoporosis. Prediction of fractures in cancer survivors exposed to hormone-deprivation therapies (HDTs) is a challenge since bone loss is rapid and severe, and determinants of fractures in this setting are still largely unknown. In this study we investigated reliability of the WHO Fracture Risk Assessment Tool (FRAX) and bone mineral density (BMD) to identify subjects developing vertebral fractures during HDTs. Five-hundred-twenty-seven consecutive subjects (429 females with breast cancer, 98 males with prostate cancer; median age 61 years), under HDTs for at least 6 months, were evaluated for vertebral fractures by a radiological and morphometric approach, in relationship with FRAX score, body mass index (BMI), BMD, age and duration of HDTs. Vertebral fractures were found in 140 subjects (26.6%) and spine deformity index was significantly associated with duration of HDTs (rho 0.38; p < 0.001). Only in females, vertebral fractures were significantly associated with FRAX score for major fractures [OR 1.08; P < 0.001]. The best cut-off of FRAX score for major fractures, as calculated by receiving operating characteristic (ROC) analysis was 6.35%. In males, however, vertebral fractures were significantly and independently associated with BMI ≥ 25 Kg/m2 (OR 17.63; P < 0.001), BMD T-score below −1.0 SD at any skeletal site (OR 7.79; P < 0.001) and gonadotropin-releasing hormone agonists (GnRHa) plus abiraterone treatment (OR 11.51; P = 0.001). FRAX and BMD may be useful for predicting vertebral fractures in subjects undergoing HDTs, but the thresholds seem to be lower than those used in the general population. High BMI is a determinant of vertebral fractures in males under HDT. [ABSTRACT FROM AUTHOR]