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Background and importance The most frequent adverse effect of palbociclib is neutropenia, resulting in dose reductions and treatment interruptions. Recently, it has been reported that early palbociclib related neutropenia was associated with a prolonged progression free survival (PFS)1. However, there are no analysis data based on the real world setting, outside of clinical trials. Aim and objectives To determine whether early neutropenia in our cohort of patients was associated with disease response to palbociclib combined with fulvestrant or an aromatase inhibitor. Material and methods This was a retrospective study including all patients who started treatment with palbociclib between December 2016 and January 2020. Demographic and clinical data were obtained from the electronic clinical records. Primary endpoints included both PFS and overall survival (OS). Early neutropenia was defined as the nadir absolute neutrophil count (ANC) during the first two cycles of treatment. PFS and OS were analysed with Kaplan–Meier survival curves comparing neutropenia grades using the log rank test to check differences between survival curves. Multivariate Cox proportional hazard regression model was also used to predict OS. Results A total of 61 patients were included. Demographic and clinical characteristics are shown in table 1. 28 patients (45.9%) stopped treatment and 24 (85.7%) discontinued due to progression. 25 patients (41.0%) required ≥1 dose reduction. In the first two cycles, 54 patients (88.5%) experienced grade 1–4 neutropenia. Patients who experienced grade 2–4 neutropenia in the first two cycles were associated with significantly prolonged median OS (log rank p=0.019). However, there was no significant association with prolonged median PFS (log rank p=0.572). After adjusting for potential cofounders (baseline ACN, age and weight), grade 2–4 neutropenia remained significantly and independently associated with prolonged OS (HR 0.26, 95% CI 0.09 to 0.77, p=0.015). Conclusion and relevance Early neutropenia was significantly associated with a prolonged OS, supporting the suggestion that neutropenia could be a pharmacodynamic marker for palbociclib dosing. References and/or acknowledgements McAndrew NP, et al. Br J Cancer 2020;123:912–18. Conflict of interest No conflict of interest

Background and importance Alzheimer’s disease (AD) is a progressive neurodegenerative process caused by an accumulation of the Aβ amyloid peptide. Aim and objectives The objective of this study was to describe the current status of clinical trials (CT) for AD in our hospital pharmacy service and to analyse the investigational drugs. Material and methods An observational descriptive retrospective study was carried out in a tertiary academic hospital. All active CT in the neuropsychology service from 1 January 2014 to 31 March 2019 were reviewed. Collected data were total number of CT; total number of included patients; demographic data; total number of CT classified by CT status (active/closed); clinical trial phase; therapeutic targets (reduction of amyloid plaques (AP)/precursor amyloid peptide (PAP) attack/inhibition of GLYT1 transporter/selective antagonism of 5-HT6 receptor/partial selective agonism of α7 nicotinic receptor); administration route (oral/intravenous/subcutaneous); clinical trials with results; and type of result (positive/negative). Results Twelve CT were analysed involving a total of 59 patients (mean 5 patients per clinical trial (rank 0–8)), 34 (57.6%) women with a mean age of 77.4 years (95% CI 71.5–84.7). Six (50.0%) CT were active; 3 (25.0%) CT were phase II trials and 9 (75.0%) were phase III trials. Therapeutic targets were reduction in AP 5 (41.7%), attack of PAP 3 (25.0%), inhibition of GLYT1 transporter 1 (8.3%), selective antagonism of 5-HT6 receptor 2 (16.7%), partial selective agonism of α7 nicotinic receptor 1 (8.3%); route of administration oral 7 (58.3%), intravenous 1 (8.3%) or subcutaneous 4 (33.3%); and 3 (25.0%) CT had results, all of which were negative (3 (100%)). Conclusion and relevance The highest number of active CT were phase III trials. Only 25% of CT had results and all were negative. Almost 60% of CT studied oral administration, which was patients’ preference. There were a total of five therapeutic targets but more than 40% of the CT evaluated the reduction in APs. Based on these results, we should rethink the research on Alzheimer’s disease before continuing to develop clinical trials with the same therapeutic target. References and/or acknowledgements No conflict of interest.

Background Relative value units (RVU) as a clinical management tool prove to be useful in measuring different pharmaceutical activities. However, little is known about RVU for the management of medication in special situations. Purpose To measure productivity in the management, dispensation, elaboration and pharmaceutical care activity of oncology medication in special situations: expanded or early access (EA) and ‘off-label’ use in a pharmaceutical department by estimating RVU. Material and methods Retrospective and observational study performed in a tertiary hospital. Data from all EA and off-label use oncology drugs requests were collected from January 2015 to February 2018 (38 months). Variables collected active drug, kind of drug in special condition (EA/’off-label’) and length of treatment. Pharmaceutical processes included: management, dispensation, elaboration and pharmaceutical care. RVU assigned to each activity have been obtained from a standardised document drawn up by the Spanish Society of Hospital Pharmacists.1 Results Seventy-five oncology drug requests were analysed, of which 58 (77.3%) were EA. Nivolumab nine (13%), pertuzumab/cabonzatinib seven (10%), bevazicumab/liposomal irinotecan six (9%) and trametinib/durvalumab five (7%) were the most requested. The average length of treatment was 5.9 months. Conclusion The pharmaceutical process with the highest productivity was elaboration of cytotoxic drugs. The processing of EA vs ‘off-label’ in oncology means 92.4% of total management activity. Reference and/or acknowledgements Grupo TECNO. Servicio de Farmacia Hospitalaria. Catalogo de productos y Facturacion. Madrid, 2009. No conflict of interest.