Background Off-label prescription of intravenous immunoglobulin (IVIg) has long been widely accepted, but periodically, verification with the latest available evidence-based efficacy data is needed. Purpose To assess the suitability of the current prescription of IVIg at our hospital according to latest evidence-based efficacy data for possible interventions required. Materials and methods The research was based on the colour classification introduced by the British ‘Clinical guidelines for immunoglobulin use. 2nd edition. July 2011 update. Department of Health’ adapted for Spain by the Spanish Society of Hospital Pharmacy in 2012. For each patient who received IVIg at our hospital during the year 2012, indication and total grams received were recorded. Results In the year 2012, 20,917.8 g of IVIg were administered at our hospital to 77 patients for 16 different indications. 43.57% of the total was administered for highest priority indications. 33.73% was used for diseases for which there is a reasonable evidence base but where other treatment options are available. 22.70% was used to treat pathologies for which the evidence base was weak. There were no prescriptions for disrecommended indications. For each category, the annual grams per patient were 233.71, 243.28 and 527.56 g/patient respectively. The indication for which the highest doses were used (22.70%) was severe axonal neuropathy. Conclusions The bulk of the IVIg is being used at our hospital either for indications with a good or reasonable evidence base. Nevertheless, when it comes to grams prescribed per indication, severe axonal neuropathy, an indication not included in the aforementioned guide, proves to be the one with the highest rate. As remarked in the guide, indications not included shall be considered to have a weak evidence base; consequently IVIg treatment in severe axonal neuropathy should be closely monitored in each patient to weigh the benefits. No conflict of interest.
Background Bevacizumab added to carboplatin and paclitaxel is indicated for first-line treatment in advanced non squamous non-small cell lung cancer (NSCLC) and has been associated with improved median overall survival (OS) and progression-free survival (PFS) compared with platinum-based chemotherapy. Purpose To determine the demographic characteristics of a group of patients with advanced NSCLC who received carboplatin - paclitaxel - bevacizumab based chemotherapy in our hospital and also to calculate the OS and PFS of these patients. Materials and methods Observational retrospective study. Information about patients’ characteristics and their treatment was extracted from a cytostatic prescription program (Oncofarm) and electronic medical history program (Global Clinic). SPSS statistics was used to determinate descriptive characteristics and survival analysis (Kaplan-Meier method). Results 33 patients received the treatment from 20/11/2008 to 31/08/2011, men accounted for 66.7% and the median age was 56.4 years. 54.5% of patients had performance status (PS) 1 followed by PS 0 in 18.2% of cases. All patients had stage IV at diagnosis. The most frequent histology was poorly differentiated (11 patients) followed by 10 with adenocarcinoma. 3 patients had squamous cell histology (this treatment is not indicated but compassionate use was granted). In August 2012, 28 of 33 patients suffered disease progression. 22 completed 6 cycles of combined treatment and 15 patients continued with bevacizumab monotherapy. The median OS was 17.0 months (95% CI: 5.3–28.7) and the median PFS was 7.0 months (95% CI: 5.6–8.4). In Sandler’s study,1 median OS was 12.3 months and median PFS was 6.2 months. Conclusions Demographic characteristics of patients, median OS and PFS were similar to published randomised clinical trials, except for histology (adenocarcinoma is not the most frequent type in our observational study). But the observational retrospective design, low number of patients, and dosage differences limited the extrapolation of these results. Reference Sandler A, et al. Paclitaxel – carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006;355(24):2542-2550 No conflict of interest.
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
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