Long-term effectiveness and safety of tolvaptan in autosomal dominant polycystic kidney disease.

Background And Objectives: Evidence on the long-term use of tolvaptan in autosomal dominant polycystic kidney disease (ADPKD) is limited. The aim was to evaluate the tolvaptan effectiveness and safety in real clinical setting.

Material And Methods: A single-center observational study (2016-2022) involving ADPKD patients treated with tolvaptan was conducted.

Risk factors determining adherence to tyrosine kinase inhibitors in chronic myeloid leukaemia.

Objective: Tyrosine kinase inhibitors (TKIs) have successfully changed the natural course of chronic myeloid leukaemia (CML). Although they are highly effective drugs, their clinical benefit is conditioned by adherence. This study aims to analyse the adherence of CML patients treated with TKIs and to identify the main factors influencing their adherence to TKIs treatment.

Imatinib plasma levels in patients with gastrointestinal stromal tumour under routine clinical practice conditions.

Objectives: Imatinib is the first therapeutic option for the treatment of unresectable or metastatic gastrointestinal stromal tumours. Previous studies have shown an improvement in patient survival rates following the use of imatinib. Nevertheless, adequate plasma concentrations of imatinib are necessary to achieve such improvement in survival and limit the toxicity of the drug.

Vancomycin versus daptomycin for the treatment of confirmed gram-positive catheter-related bloodstream infections in oncology patients.

Objective: To analyse the effectiveness and safety of daptomycin versus vancomycin on the management catheter-related bloodstream  nfections in oncology patients.

Method: A retrospective study was carried out including all patients admitted  at the Medical Oncology Unit between 2010 and 2018 with positive blood  cultures confirmed catheter-related bloodstream infections due to gram- positive microorganism, who were treated with either vancomycin or  daptomycin. The primary end point was all cause 30-days mortality, 30-days  hospital readmission and length of hospital stay (length of hospital stay).

Efficacy and Safety of Erenumab, Galcanezumab, and Fremanezumab in the Treatment of Drug-Resistant Chronic Migraine: Experience in Real Clinical Practice.

Background: Due to the recent introduction of new biologic drugs for chronic migraine, a global evaluation in real clinical practice is necessary.

Objective: The objective was to evaluate the effectiveness and safety in real clinical practice of drugs targeting the calcitonin gene-related peptide receptor (CGRPr) in patients with chronic migraine.

Methods: Single-center, restrospective study (2019-2022), including patients with chronic migraine treated with erenumab, galcanezumab, or fremanezumab.

Definition of a therapeutic range for predicting long-term infliximab response in patients with inflammatory bowel disease.

Introduction: Monitoring plasma levels of Infliximab plays an important role in optimising treatment in patients with inflammatory bowel disease (IBD). The aim of the following study has been to determine the predictive potential of monitoring infliximab plasma levels for sustained clinical response and evaluate its usefulness to improve treatment efficacy and symptom control, in patients with IBD.

Methods: This single-centre retrospective study (2017-2019) included patients diagnosed with IBD treated with infliximab.

Hepatitis C virus infection screening reduces mortality and is cost-effective independently of the intervention test.

Introduction: Chronic infection due to hepatitis C virus (HCV) is frequently asymptomatic even in advanced stages of liver disease. Implementation of a screening program based on different HCV tests may enable an earlier diagnosis of HCV liver disease and subsequent application of highly effective treatment.

Patients And Methods: A Markov model which compares three different screening strategies for hepatitis C versus no screening in low-risk prevalence (general population) and high-risk prevalence population (people who inject drugs or prison population) was designed, taking into account age at the start of screening and participation.

Imatinib plasma levels in patients with chronic myeloid leukaemia under routine clinical practice conditions.

Introduction: The addition of imatinib to the therapeutic arsenal for chronic myeloid leukaemia (CML) has changed the natural course of the disease, in such a way that it is now considered a chronic pathology. However, to achieve therapeutic success, it is necessary to reach adequate plasma concentrations to ensure efficacy and safety.In this study, we aimed to evaluate the plasma concentration of imatinib, analysing its influence on effectiveness and safety in patients with CML.

Extended Stability of Reconstituted Lyophilized Erwinia L-asparaginase in Vials.

Background/aim: L-Asparaginase (L-ASNase) is used as a tumor-inhibitory drug on paediatric acute lymphoblastic leukemia (ALL). ERW-ASNase is commercialised as a lyophilized powder stable only for 8 hours once reconstituted and, consequently, the leftover is usually discarded. The aim of this study will be to analyse the stability of the reconstituted lyophilised ERW-ASNase.

Pharmacokinetics of Trastuzumab After Subcutaneous and Intravenous Administration in Obese Patients.

Subcutaneous trastuzumab (T-SC) administration does not allow the historical target concentration of 20 µg/mL for efficacy to be reached, from the start of treatment in patients with a body mass index (BMI) >30 kg/m. To analyze the influence of the strategy of dosification (fixed vs adjusted patient's body weight dose) on the initial minimum plasma concentration () of trastuzumab in obese patients. This was an observational, prospective study, which included patients with HER2-positive nonmetastatic breast cancer treated with trastuzumab.

Long-term stability of trastuzumab in plasma and whole blood samples stored under different conditions.

Objective: The present work analyzed the stability of trastuzumab  concentrations in blood and plasma samples stored at 4 °C and -20 °C.

Method: Blood samples of patients treated with trastuzumab (Herceptin ®)  were analyzed. Stability of trastuzumab was analyzed under different conditions: whole blood stored at 4 °C during 72 hours, blood  plasma stored at 4 °C during 120 hours and blood plasma stored at -20 °C during 365 days.

Effect of UGT, SLCO, ABCB and ABCC polymorphisms on irinotecan toxicity.

Background And Objectives: Evaluate the relationship between the presence of polymorphisms in genes involved in the pharmacodynamics of irinotecan (UGT1A, SLCO1B1, ABCB1 and ABCC2) and the safety of irinotecan in the treatment of metastatic colorectal cancer (mCRC).

Patients And Methods: Prospective observational, single-centre study of 30 months duration, which included patients diagnosed with mCRC treated with FOLFIRI was carried out. Toxicity was evaluated in each treatment cycle according to the Common Terminology Criteria for Adverse Events (CTCAE) v.

Cost-effectiveness study of closed system transfer devices for the preparation of antineoplastic agents.

Most cytostatic drugs cannot be administered directly to patients in their marketed presentation, but require previous reconstitution conducted in the Pharmacy Unit areas for cytostatic preparation. There are systems that allow drug reconstitution and transfer once it has been diluted, in order to protect staff from any potential contamination during handling. These are commonly known as Closed Systems, and generally have a piece for vial attachment and a syringe adapter with a built-in filter, that replace the traditional needles.

Influence of Anthropometric Characteristics in Patients With Her2-Positive Breast Cancer on Initial Plasma Concentrations of Trastuzumab.

Background: Plasma concentrations of trastuzumab <20 µg/mL in patients with gastric cancer are associated with reduced progression-free and overall survival. In breast cancer treatment, this relationship has not yet been studied, but a suboptimal pharmacodynamic exposure to trastuzumab could be a reason for therapeutic failure of treatment of HER2-positive breast cancer.

Objective: The objective of the present study was to determine the proportion of nonmetastatic HER2-positive breast cancers that do not reach a minimum plasma concentration ( C) of 20 µg/mL after first drug administration, established as therapeutically effective in clinical trials.

Cost-effectiveness of pemetrexed in combination with cisplatin as first line treatment for patients with advanced non-squamous non-small-cell lung cancer in Spain.

Introduction: Lung cancer is the third most frequent neoplastic tumour in Spain, with around 27 000 new cases diagnosed per year; 80-95% of these are non-small-cell cancer (NSCLC), and the majority of cases are diagnosed in advanced stages of the disease, and for this reason it is one of the oncologic conditions with higher mortality rates (21.4% mean survival at 5 years). The main treatment regimens used for first-line treatment of NSCLC are: cisplatin/pemetrexed (cis/pem), cisplatin/gemcitabine/ bevacizumab (cis/gem/bev), and carboplatin/paclitaxel/ bevacizumab (carb/pac/bev).

Reducing the degree of colonisation of venous access catheters by continuous passive disinfection.

Introduction: The advent of Luer-type needleless venous access catheters has been accompanied by a growing number of catheter-related bloodstream infections. Our main objective was to compare rates of colonisation and phlebitis between our standard of care and the new passive disinfection system, using a Luer SwabCap bearing a sponge impregnated with 70% isopropyl alcohol.

Methods: We performed a prospective experimental study involving patients attending our day hospital oncology unit, with central venous (CV) or peripheral venous (PV) access lines with needleless connectors for antineoplastic treatment delivery.