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Background Leptomeningeal metastasis (LM) is a rare complication of metastatic breast cancer (MBC), with high morbidity/mortality rates. Our study aimed to describe the largest-to-date real-life population of MBC patients treated with intrathecal (IT) therapy and to evaluate prognostic models. Methods The Epidemiological Strategy and Medical Economics (ESME) MBC database (NCT03275311) includes all consecutive patients who have initiated treatment for MBC since 2008. Overall survival (OS) of patients treated with IT therapy was estimated using the Kaplan–Meier method. Prognostic models were constructed using Cox proportional hazards models. Performance was evaluated using C-index and calibration plots. Results Of the 22 266 patients included in the database between 2008 and 2016, 312 received IT therapy and were selected for our analysis. Compared with non-IT-treated patients, IT-treated patients were younger at MBC relapse (median age: 52 years versus 61 years) and more often had lobular histology (23.4% versus 12.7%) or triple-negative subtype (24.7% versus 13.3%) (all P < 0.001). Median OS was 4.5 months [95% confidence interval (CI) 3.8-5.6] and 1-year survival rate was 25.6%. Significant prognostic factors associated with poorer outcome on multivariable analysis were triple-negative subtype (hazard ratio 1.81, 95% CI 1.32-2.47), treatment line ≥3 (hazard ratio 1.88, 95% CI 1.30-2.73), ≥3 other metastatic sites (hazard ratio 1.33, 95% CI 1.01-1.74) and IT cytarabine or thiotepa versus methotrexate (hazard ratio 1.68, 95% CI 1.28-2.22), while concomitant systemic therapy was associated with better OS (hazard ratio 0.47, 95% CI 0.35-0.62) (all P < 0.001). We validated two previously published prognostic scores, the Curie score and the Breast-graded prognostic assessment, both with C-index of 0.57. Conclusions MBC patients with LM treated with IT therapy have a poor prognosis. We could identify a subgroup of patients with better prognosis, when concomitant systemic therapy and IT methotrexate were used., Highlights • The outcome of BC patients with IT-treated LM is poor, with a median OS of 4.5 months. • Concomitant systemic therapy may improve the outcome in IT-treated patients. • Patients treated with IT methotrexate had better outcome than those treated with IT cytarabine/thiotepa. • The Curie and Breast-graded prognostic assessment scores were prognostic for IT-treated patients.

Background: To determine the quality of life of women with early breast cancer treated with Tamoxifen, Letrozole, Anastrazole, Exemestane, after 2 years of treatment. Materials and Methods: A total of 237 women treated in the period 2001–2009 with adjuvant hormonotherapy, were selected to complete the EORTC-C30 and EORTC BR-23 questionnaire. From these women, 115 patients were treated with Tamoxifen and 122 have received aromatase inhibitors: 60 patients have received letrozole, 29 patients anastrazole and 33 patients exemestane. The women had completed the questionnaires after 2 years of hormonal treatment. The primary end point was the comparison of global health status among the groups receiving tamoxifen, letrozole, anastrazole and exemestane. The secondary end point was the analysis of functional scales, emotional scales, cognitive scales and symptom scales of every hormonal treatment group. Results: The assessments available for analysis were in proportion of 88% from questionnaire completion target. There were no differences between the tamoxifen group and the aromatase inhibitors group (letrozole, anastrazole and exemestane) after 2 years of hormonal therapy. Evaluating separately the scales, there is a superiority of the group receiving aromatase inhibitors (anastrazole, letrozole and exemestane) comparing with tamoxifen group regarding symptom scale (sexual function and fatigability) and emotional scale. Among the three groups treated with letrozole, anastrazole and exemestane, was found a statistically significant difference in symptom scale (nausea, dizziness) in favour of anastrazole compared with letrozole. Conclusions: After two years of adjuvant hormonal treatment, the treatment with tamoxifen or aromatase inhibitors has a similar overall impact regarding quality of life. The statistic significant differences appears to be related with symptom scale and emotional scale, where aromatase inhibitors are superior.