Efficacy and safety of niraparib in platinum-sensitive recurrent ovarian cancer: retrospective observational study in a tertiary hospital.

BACKGROUND: Niraparib has been authorized for maintenance treatment of epithelial ovarian cancer after first-line treatment with platinum, in partial or complete response. OBJECTIVES: To evaluate the effectiveness and safety of maintenance niraparib in platinum-sensitive recurrent ovarian cancer (PSROC) patients in a tertiary hospital. MATERIALS AND METHODS: This retrospective observational unicentre study included women diagnosed with ovarian adenocarcinoma who received niraparib. Eligibility criteria encompassed women with PSROC, in response to platinum chemotherapy, and not previously treated with other PARPis. Data on demographics, comorbidities, BRCA mutation status, disease stage, treatment history and adverse events were recorded. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. RESULTS: A total of 33 patients were included, with a median age of 63.5 years. The majority of patients received niraparib at 200 mg/day based on Research on Adverse Drug Events and Report criteria. Median OS was 30 months (95% CI: 16.76-43.23), and median PFS was 8 months (95% CI: 2.48-13.52). Adverse effects were more frequent during the initial months of treatment, with most classified as CTCAE v5 grade 1-2. Dose reductions, interruption of treatment and discontinuations were observed due to haematologic toxicities primarily. CONCLUSION: This real-world study showed that maintenance niraparib in PSROC patients had effectiveness and safety profiles consistent with clinical trials and other observational studies. Median PFS and OS were comparable to previous reports, and most adverse events were manageable with dose modifications. The results support the use of niraparib as a maintenance therapy option in this patient population.

Gender bias in clinical trials of biological agents for migraine: A systematic review.

Migraine is considered one of the most disabling diseases. Currently, there are few studies on clinical migraine treatment based on sex-related differences, despite the important role of sex in migraine. Our aim was to evaluate gender bias in published clinical trials on monoclonal antibodies (erenumab, galcanezumab, fremanezumab and eptinezumab). We performed a systematic review of controlled clinical trials of erenumab, galcanezumab, fremanezumab and eptinezumab, searching the PubMed/MEDLINE database for articles published before December 2021. The search identified 760 articles, 25 of which met the inclusion criteria. Of all the patients included in these trials, 85.1% were women. Only one study had female lead authors. Two of the 25 studies included a sex-based analysis of the primary endpoint. None of the articles discussed the results separately for men and for women. The proportion of men recruited in trials is scarce and more studies are needed to guarantee the safety and tolerability of monoclonal antibodies used in male migraine. As observed in our study, despite the high number of women recruited, only 2 studies analysed the results separately by sex. Thus, a potential risk of gender bias was found in these clinical trials.

Validation protocol of the LESS-CHRON deprescription tool in multimorbidity patients. LESS-CHRON-VALIDATION Project.

OBJECTIVE: Deprescribing is considered one of the main strategies available for  preparing an individualized therapeutic plan in patients with multiple pathologies or complex chronic conditions. However, despite the practice has been in place for some years, there is a need for studies that support the achievement of satisfactory health outcomes, as well as tools that help implement deprescribing in routine clinical practice. The  bjective of this project is to analyze the impact of reducing polypharmacy,  through the LESS-CHRON deprescribing tool, on a population  of elderly polymedicated patients with multiple conditions. METHOD: This will be a quasi-experimental, pre-and-post intervention multicenter cohort study. The variables to be analyzed will be  divided into two large groups: those related to pharmacology and those related to health outcomes. They will be collected at baseline, at 3 and at 6-12  months. A first screening phase will be carried out to recruit candidate patients  and obtain information about the identified deprescribing  opportunities. The second phase will constitute the intervention phase, where  the LESS-CHRON tool will be applied and the actual deprescribing of the drugs  will be carried out. DISCUSSION: LESS-CHRON has been proclaimed as a suitable deprescribing tool in clinical practice. Validation of LESS-CHRON will seek to show the results that can be achieved following the deprescribing of drugs,  in addition to demonstrating that the tool can reliably be used by clinicians in  their routine practice. On the other hand, the results of this project may  provide information leading to improving or adapting the tool itself, giving rise  to a second generation of more efficient version.

OBJETIVO: La desprescripción se considera una de las principales estrategias disponibles para el abordaje del plan terapéutico individualizado en  pacientes pluripatológicos o crónicos complejos. Sin embargo, a pesar de ser una práctica ya instaurada desde hace algunos años, se reclama la necesidad de estudios que avalen la obtención de buenos resultados en salud, además de herramientas que ayuden a su desarrollo en la práctica clínica habitual. El objetivo de este proyecto es analizar el impacto en  la disminución de la farmacoterapia mediante la desprescripción de fármacos, aplicando la herramienta LESS-CHRON, en una población de  pacientes de edad avanzada, polimedicada y con múltiples patologías.Método: Estudio cuasiexperimental, pre-post, multicéntrico. Las variables a analizar se dividirán en dos grandes grupos: referidas a la esfera  farmacológica y referidas a resultados en salud. Se recogerán en el momento  basal, a los 3 y a los 6-12 meses. Se realizará una primera fase de screening  para localizar a los pacientes candidatos, que permitirá obtener la información relativa a las oportunidades de desprescripción identificadas. La  segunda constituirá la fase de intervención, en la que se aplicará la  herramienta LESS-CHRON y se llevará a cabo la desprescripción real de los  fármacos.Discusión: LESS­CHRON se ha proclamado como una herramienta adecuada para llevar a cabo la desprescripción de fármacos en la práctica clínica. La validación de la herramienta LESS-CHRON tratará de poner  de manifiesto los resultados que se logran tras efectuar la desprescripción,  además de demostrar su fiabilidad como herramienta, de modo que los clínicos puedan usarla como parte de su actividad asistencial con total  confianza. Por otro lado, los resultados de este proyecto podrán arrojar  información para la mejora o adaptación de la propia herramienta, dando lugar  a una segunda generación o futuras versiones mejoradas y más  eficientes.