BACKGROUND:The DigniCap System is an effective scalp cooling device for the prevention of chemotherapy-induced alopecia in early breast cancer patients.AIM:This prospective study was designed to confirm the efficacy and tolerability of the device, to explore potential factors associated with its efficacy and to collect data on patient perceptions and satisfaction.METHODS:Between January 2016 and June 2018, 163 early breast cancer patients eligible for adjuvant chemotherapy were enrolled. Hair loss was assessed using the Dean scale, where a score of 0-2 (hair loss ≤50%) was defined as successful.RESULTS:Hair preservation was successful in 57% of patients in the overall series. The proportion was even higher (81%) in the patient subgroup treated with a paclitaxel and trastuzumab regimen. Side effects (feeling cold, headache, head heaviness, scalp and cervical pain) were mild to moderate and did not correlate with the rate of hair loss. Lifestyle, anthropometric factors and hair characteristics failed to be associated with device efficacy.CONCLUSIONS:The DigniCap System was well tolerated and found to be effective in preventing alopecia in early breast cancer patients. Our study failed to identify factors other than type of chemotherapy regimen associated with hair preservation.

Abstract Background: Dysgeusia is a frequent side effect in breast cancer patients undergoing adjuvant chemotherapy. The effect of dysgeusia on changes in diet and patient weight has been poorly investigated. We evaluated prospectively dysgeusia in a consecutive series of early breast cancer patients (EBCP) with the aim to explore its impact on food selection and weight changes. Patients and methods: From May 2014 to April 2017, 130 consecutive EBCP were enrolled at the Oncology and Breast Units at Spedali Civili in Brescia. Dysgeusia was categorized as present or absent, changes in types and frequencies of food consumptions during chemotherapy were assessed by a specific questionnaire and photography atlas. Evaluations were performed at baseline, after 3 cycles, at the end of chemotherapy plan and during follow-up. Results: all 130 pts were evaluable. Median age was 53 years (range 26-76), median weight 64 Kg (range 45-115), median BMI 23,86 Kg/m2 (range 17,01-35,49), 73 pts (56%) performed physical activity, 57 pts (44%) were abstemious, 22 pts (17%) received neoadjuvant and 108 pts (83%) adjuvant chemotherapy, 25 pts (19%) were treated with antracycline based schemes, 83 (64%) with antracycline and taxane plus or minus trastuzumab, and 22 pts (17%) other regimens. Seventy-three per cent of pts developed dysgeusia during chemotherapy (p=< 0.001), and in 19% this side effect persisted three months after chemotherapy. Dysgeusia was associated with the length of chemotherapy treatment and taxane use. A statistically significant increase of taste alteration was reported for all metallic, sweet, bitter, salted and acid taste (p<0.001). Dysgeusia was more frequent in pts reporting meteorism and fatigue and in pts without oral mucositis (p=0.002). Dysgeusia correlated with a lower intake of bread, cheese, fat salami, butter and wine and a high intake of biscuits and cakes. However, no correlation was observed with weight and BMI changes. Conclusion: Dysgeusia was frequent in EBCP undergoing adjuvant chemotherapy. It directly correlated with fatigue and meteorism and inversely correlated with mucositis. This adverse event had no impact on weight and BMI but significantly influenced food intake with a preference of glucose containing instead of fat containing foods. Acknowledgments: a thank you to Beretta foundation for the costant support to Breast Unit and Oncology Department. Citation Format: Pedersini R, Zanini A, Romelli M, Coccoli V, Guerra M, Bosio S, Schivardi G, Rodella F, Vassalli L, Amoroso V, Claps M, Simoncini EL, Berruti A. Dysgeusia, weight and eating habits changes in breast cancer patients undergoing chemotherapy: A prospective cohort study [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-16.

Objectives: The aim of this study was to investigate efficacy and safety of eribulin in heavily pretreated patients with advanced breast cancer (BC) in a real-life setting. Methods: This retrospective monocentric study included patients with HER-2-negative metastatic BC, pretreated with anthracyclines and taxanes, who were referred to the Oncology Department of Spedali Civili of Brescia from May 2012 to April 2017. Patients received the same dose of eribulin as that used in the EMBRACE trial: 1.4 mg/m2 on days 1 and 8 every 21 days. Results: In a total of 53 patients, 32% obtained a partial response, 11% a stable disease, and 43% a clinical benefit (CB). After a median follow-up of 36 months, median progression-free survival (PFS) was 4.7 months and median overall survival (OS) 13.53 months. Median PFS was significantly longer in patients who reported a CB compared to those with no CB, while survival outcomes (PFS and OS) were better in patients who received > 6 cycles of eribulin. Eribulin showed a good tolerability profile with acceptable toxicities, similar to those reported in EMBRACE. Conclusions: Our experience in a real-world setting confirms the activity, efficacy, and good tolerability profile of eribulin in heavily pretreated BC patients.

e12504 Background: Aromatase-inhibitors (AIs) decrease the bone mineral density (BMD) and increase the risk of clinical fractures but the mechanism underlying the increased fracture risk (FR) is not fully elucidated. In healthy post menopausal women obesity is associated with lower FR due the protective effect of elevated estrogen levels. However this mechanism cannot be extended to AI treated pts since estrogens are deeply inhibited. We designed a cross sectional study to explore the effect of Fat body mass (FBM) on the risk of morphometric vertebral fracture (VF) in postmenopausal estrogen receptor positive breast carcinoma (BC) submitted to adjuvant AI therapy. Methods: From October 2013 to May 2017 315 EBC patients (pts) were recruited. All pts underwent a dual-energy X-ray absorptiometry (DXA) for the assessment of BMD, morphometric evaluation of VFs and body composition at baseline and after at least one year of AI therapy. Results: 187 pts were AI naive and 128 AI treated, and the prevalence of VFs was 21,9% and 31.2%, respectively. VFs in AI naïve pts were associated with older age (68 vs 62 years, p = 0.000) and lower BMD values at femoral neck (0.656 vs 0.698 gr/cm2, p = 0.02). Conversely, they were associated with higher Body Mass Index (27.26 vs 24.97, p = 0,046) and Fat Body Mass (29296.6 vs 23605.6 g, p = 0,022) in AI-treated patients. Conclusions: A high prevalence of radiological VFs was detected in EBC pts on AIs. Contrary to expectation VFs were associated with BMI and FBM but not with BMD. These data suggest a major contribution of altered bone quality in the fracture risk in AI treated pts. Data on trabecular bone score (a parameter of bone quality) TBS will be available at the meeting

Abstract Background: Alopecia is a common and distressing adverse effect in breast cancer (BC) patients (pts) receiving adjuvant chemotherapy. The aim of the study was to assess the effectiveness and safety of this device to prevent chemotherapy-induced alopecia in early breast cancer patients (EBCP) receiving adjuvant treatment. The quality of life of pts was also evaluated. Patients and methods: From January to December 2016, a sensor-controlled scalp cooling system (DigniCap:Sysmex Europe GmbH, Norderstedt, Germany) was proposed to a consecutive group of EBCP submitted to adjuvant chemotherapy at the Breast Unit of Spedali Civili Hospital of Brescia. Degree of hair loss was assessed by two nurse using Dean's alopecia scale by digital photographs at baseline and each chemotherapy cycle. EORTC QLQ-C30 questionnaire and self-reported visual analogical scale (VAS) of symptoms (anxiety, tone of mood, fatigue, nausea,well-being, activity) were collected at baseline and after the first two cycles of chemotherapy. Results: 70 pts were enrolled and 49 (70%) completed the chemotherapy plan and were evaluable. Median age was 51 years, 8 pts (16%) received neoadjuvant and 41 pts (84%) adjuvant chemotherapy, 21 (43%) were treated with 4 cycle of chemotherapy (TC, EC or paclitaxel alone), and 28 (57%) with sequential chemotherapy with antracycline and taxane +- trastuzumab. Fifteen pts (30%) stopped the treatment because of loss of hair in 9 pts, for headache in 4 pts and for other problems in 2 pts. At the end of chemotherapy, 13 pts (27%) had no loss of hair (Dean score 0), 25 pts (51%) had a minimal loss of hair (Dean score 1), 9 pts (18%) had a 50% hair loss (Dean score 2), 2 pts (4%) had a 75% hair loss (Dean score 3). No pts reported hair loss more than 75% (Dean score 4). There wasn't a significant difference between mean score value of QLQ-C30 at baseline and after chemotherapy and between the groups with and without hair loss. VAS documented an increase of fatigue and decrease of anxiety from baseline to final evaluation. The side effects presented with the use of DigniCap were the following: headache in 32% of pts and cold feeling in 57 % of pts. Conclusion: Scalp cooling with cold caps appears to be effective in preventing CIA among the majority of women undergoing treatment chemotherapy. The quality of life did not change in scalp-cooled patients. Acknowledgments: a thank you to the ESA association that donated Dignicap to Oncology Department. Citation Format: Vassalli L, Pedersini R, Romelli M, Claps M, Fornaro C, Conti E, Tagliani M, Baronchelli A, Ragni D, Lombardi E, Rodella F, Amoroso V, Berruti A, Simoncini EL. Efficacy and patient acceptability of the DigniCaP ScalpCooler to prevent hair loss in breast cancer patients receiving adjuvant chemotherapy [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-19.

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.

Leptomeningeal metastasis (LM) is a severe complication in the natural history of malignancies that occurs in 4–15 % of patients (pts) with solid tumors. Clinical presentation, cerebrospinal fluid cytology (CSF), and gadolinium magnetic resonance imaging (gdMRI) of the brain and spine are the methods routinely used to diagnose LM. Treatment encompasses involved-field radiotherapy of bulky or symptomatic disease sites and chemotherapy; however, no standard therapy has been established yet. We collected and reviewed retrospectively the clinical, pathological, radiological findings as well as the outcomes of 50 consecutive patients with LM from solid tumors to determine whether the diagnostic modalities and therapeutic procedures affected the outcomes. The results of this study confirm the role of gdMRI in the diagnosis of LM in clinical practice and suggest that an aggressive treatment may improve survival in patients with this debilitating and increasingly frequent neurological complication.