factors for the time to first flatus, start of feeding and discharge were analysed (eg, taking promotility agents, such as metoclopramide), but no significant differences were found between the two groups (p=0.375, 0.162, 0.960). Conclusion and relevance Could evidence based medicine lead to an equally satisfying practice? The implementation of the interprofessional team was essential (eg, the core physician team had not participated at the beginning and thus missed many possible cases).
Material and methods An observational, retrospective, descriptive study was conducted between January 2018 and October 2020. Age, sex, Barcelona Clinic Liver Cancer (BCLC) staging, adverse events (AEs), need for dose reduction or discontinuation, and time to progression or death were collected from our electronic records. None of the patients had received previous systemic therapy. The analysis was performed using R 4.0.3. Results 47 patients with metastatic HCC were treated with sorafenib. Patient characteristics are shown in table 1. Median overall survival (mOS) was 17.9 months (range 0.5-24.0; 95% CI 15.5 to not reached). The main AEs observed were: fatigue (42.5%), hand-foot skin reactions (42.5%), anorexia (40.4%), diarrhoea (38.3%), hypertension (14.9%), abdominal pain (14.9%), digestive bleeding (12.7%) and pruritus (10.6%). The most common reasons for treatment discontinuation were AEs (14 patients) and progression (22 patients). The rate of discontinuation due to AEs was 29.8%. 34 patients (72.3%) required dose reduction. Conclusion and relevance In our setting, mOS was superior to that reported in the pivotal clinical trial even though baseline characteristics were similar. Some of the AEs were more frequent, such as fatigue, hand-foot skin reactions, hypertension and anorexia, although the rate of discontinuation due to AEs was lower than reported in the SHARP trial. Sex M/F (n (%)) 42 (91.5)/5 (8.5) BCLC stage (n (%)) B (intermediate): 2 (4.3
BackgroundIt is known, although the estimates are very varied, that use of drugs in conditions other than those authorised or out of technical data, is particularly frequent in the onco-haematology area.PurposeTo describe the use of chemo-therapies on off-label practices in the Pharmacy Department of a tertiary hospital.Material and methodsThis study included all patients treated between March 2015 and March 2017 with an off-label chemotherapeutic agent prescription. The data were collected from the clinical history of the patients and from the pharmacy programs: athos prisma®. We analysed these variables: demographic (age, sex) and treatment-related (drug involved, off-label indication, stage disease, number of previous treatment lines, treatment duration and adverse drug reactions (ADRs)).ResultsA total of six types off-label drugs were requested and administered to 39 patients for eight different diseases.Abstract 4CPS-102 Table 1 Off-label indication Number of patients Stage disease Number of previous treatment lines Median treatment duration (cycles) Bendamustine Non-Hodgkin’s lymphomas (NHL) without previous rituximab 4 II 0 5 Lenalidomide Diffuse large B-cell non-Hodgkin’s lymphoma 2 IV 3 4 Doxorubicin liposomal NHL 5 III 0:3 patients1:1patient>3:1 patient 6 Mercaptopurine Histiocytosis X 1 III 1 12 Fotemustine Glioblastoma 15 IV 2 5 Oligodendroglioma 1 III 3 8 Astrocytoma 1 IV 2 1 Bevazicumab Glioblastoma 6 IV 2 3 Oligodendroglioma 1 IV 1 3 Astrocytoma 2 III 1 3 Ependymoma 1 IV 2 5 Concerning haematologic indications, nine patients (23%) presented a complete response.Patients had to discontinue treatment due to ADRs: bendamustine, doxorubicin liposomal, and fotemustine (one patient each). Treatment-related ADRs of any grade were reported in 15 (38.5%) patients. The most common were thrombocytopenia (18%) with fotemustine.ConclusionIn our assessment, off-label therapies have been effective in most patients (77%), and safe.Evaluation of the cost of off-label therapies, in terms of medication risk and effects on the cost of healthcare, will be essential to its widespread clinical utility.Off-label use may also become the only treatment option, especially in the case of rare tumours.No conflict of interest
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