Eribulin in metastatic breast cancer: Real world data.

BACKGROUND: Metastatic breast cancer (MBC) is incurable. Systemic therapy is the standard treatment; however, an optimal sequence of chemotherapy has not been established. OBJECTIVE: Evaluating effectiveness and safety of eribulin in MBC treatment and comparing the results obtained with published literature. METHODS: Observational, descriptive and retrospective study of patients with MBC treated with eribulin from 01/12/2015 to 30/10/2021. Effectiveness was analysed using Kaplan-Meier-survival-curves, for the overall number of patients treated and stratified by treatment line. Safety was measured according to adverse events (AE) based on CTCAE v5.0. Data analysis was performed using R v4.0.1. RESULTS: They were included in this study 53 women who received eribulin (median age 58 years). Comparison of median survival from this study versus published data were: progression-free-survival (PFS) 3 (IC95%: 3-4) versus 3.7 months and overall-survival (OS) 8 (IC95%: 3-4) versus 13.2 months for the overall number of patients. For the 1-3 line treatment group, PFS was 6 (IC95%: 3-NA) and OS was 15 (IC95%: 6-NA). There were 322 AEs, the most frequent being blood disorders 16% (52), general disorders 12% (38), and gastrointestinal disorders 12% (38). CONCLUSIONS: The median PFS was similar to that reported previously, with lower OS. There was a tendency to achieve better results when eribulin was used earlier. Eribulin is a less well-tolerated drug than published literature.

Dose reduction and toxicity of lenalidomide-dexamethasone in multiple myeloma: A machine-learning prediction model.

PURPOSE: Lenalidomide remains an effective drug for multiple myeloma, but it is often associated with adverse events and requires dose adjustments. The objective of this study was to propose a model for predicting whether a patient would require dose adjustment. METHODS: This retrospective observational study included patients treated with lenalidomide and dexamethasone from June 2014 to September 2018 at a tertiary hospital. Demographic variables, patient functional status, disease, analytical data specific to myeloma, and treatment-related variables were collected. Univariate and machine learning (logistic regression and classification and regression trees model) analyses were also performed. Kaplan-Meier analysis was used to determine the time of toxicity onset. Only lenalidomide (and not dexamethasone) related dose reductions are included. RESULTS: A total of 64 patients received lenalidomide-dexamethasone. 69% (44) required dose reduction or discontinuation of treatment due to lenalidomide-related adverse events. The median time between treatment beginning and lenalidomide dose reduction or discontinuation was 8.0 months (95% CI: 6.0-17.0). Age, platelet count, and neutrophil count were related to dose reduction in the univariate model. In the multivariate models, age and neutrophil count were significant in the logistic regression model, renal clearance, and neutrophil count in the classification and regression trees model. CONCLUSION: Elderly patients and those with low bone marrow reserves are prone to dose-limiting adverse events. This study can aid in making follow-up, prophylaxis, and dosing decisions to achieve better pharmacotherapeutic results.

Real-world Data Study of the Efficacy and Toxicity of Nivolumab vs. Cetuximab and Predictors of Response to Nivolumab in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck in a European Population.

BACKGROUND/AIM: This study aimed to assess the effectiveness and safety of nivolumab versus cetuximab in patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M HNSCC), as well as to analyze possible prognostic factors for response to treatment with nivolumab. PATIENTS AND METHODS: We conducted an observational, retrospective, descriptive study of patients with R/M HNSCC who initiated treatment with nivolumab or cetuximab monotherapy in two periods of equivalent duration. Overall efficacy was measured in terms of progression-free survival (PFS) and overall survival (OS). Safety was evaluated using the Common Terminology Criteria for Adverse Events classification version 5.0 of the National Cancer Institute. RESULTS: Median OS was 9.1 months with nivolumab (n=34) and 6.3 months with cetuximab (n=12). PFS was 4.3 months for nivolumab and 4.65 months for cetuximab. Any grade adverse events (AEs) were reported in 97% and 100% of the patients treated with nivolumab and cetuximab. Serious AEs were observed in 26% and 58% of the patients, respectively. Elevated albumin values, lymphocytosis, neutropenia, and elevated neutrophil/lymphocyte ratio values were found to have positive prognostic value on the response to nivolumab in R/M HNSCC. CONCLUSION: Effectiveness of nivolumab in terms of OS remains superior to cetuximab. OS, PFS and severe or any grade AEs were superior in both arms of our study compared to those in clinical trials. The AEs profile of nivolumab differed in our study from that in the clinical trials' observations. We have identified four statistically significant prognostic variables on the response to nivolumab in R/M HNSCC.

Effectiveness of risk minimization measures for the use of cilostazol in United Kingdom, Spain, Sweden, and Germany.

PURPOSE: The purpose of the study is to evaluate the effectiveness of risk minimization measures-labeling changes and communication to health care professionals-recommended by the European Medicines Agency for use of cilostazol for the treatment of intermittent claudication in Europe. METHODS: Observational study of cilostazol in The Health Improvement Network (United Kingdom), EpiChron Cohort (Spain), SIDIAP (Spain), Swedish National Databases, and GePaRD (Germany). Among new users of cilostazol, we compared the prevalence of conditions targeted by the risk minimization measures in the periods before (2002-2012) and after (2014) implementation. Conditions evaluated were prevalence of smoking, cardiovascular conditions, concurrent use of ≥2 antiplatelet agents, concurrent use of potent CYP3A4/CYP2C19 inhibitors and high-dose cilostazol, early monitoring of all users, and continuous monitoring of users at high cardiovascular risk. RESULTS: We included 22 593 and 1821 new users of cilostazol before and after implementation of risk minimization measures, respectively. After implementation, the frequency of several conditions related to the labeling changes improved in all the study populations: prevalence of use decreased between 13% (EpiChron) and 57% (SIDIAP), frequency of cardiovascular contraindications decreased between 8% (GePaRD) and 84% (EpiChron), and concurrent use of high-dose cilostazol and potent CYP3A4/CYP2C19 inhibitors decreased between 6% (Sweden) and 100% (EpiChron). The frequency of other conditions improved in most study populations, except smoking, which decreased only in EpiChron (48% reduction). CONCLUSIONS: This study indicates that the risk minimization measures implemented by the EMA for the use of cilostazol have been effective in all European countries studied, except for smoking cessation before initiating cilostazol, which remains an area of improvement.