during the past 5 years. Collected variables: age, sex, ECOG, adjuvant chemotherapy, treatment line, dose reduction and adverse events (AE). Efficacy endpoints were progression-free survival (PFS) and overall survival (OS) obtained by the Kaplan-Meier method. Adverse effects (AE) were collected for safety profile assessment. Descriptive statistical analysis was performed using the SPSS Statistics program V22.0. Results Forty-seven patients (30 men and 17 women) were included. The median age was 59 years . At the beginning of the treatment, more than 80% presented ECOG 0-1: 23.4% had received previous adjuvant chemotherapy (gemcitabine and/or fluoropyrimidines). They were treated with nab-paclitaxel 125 mg/m 2 and gemcitabine 1000 mg/m 2 on days 1, 8 and 15 every 28 days. In 89.4% of the patients it was prescribed as first-line treatment. Dose reduction was performed in 68.1%. The median duration of treatment was 4.5 months (0.5-22.9), with four long survivors (longer than 15 months). The median PFS was 9.1 months (95% CI 8.36 to 9.73) and the median OS was 9.11 months (95% CI 4.0 to 14.2). Eighty-three per cent of patients (n=39) had AE of some grade and 17% (n=8) of grade 3-4. The most common AE were: asthaenia (n=17), neutropaenia (n=16), thrombocytopaenia (n=15), neuropathy (n=13), alopecia (n=5), diarrhoea (n=7), mucositis (n=3), vomiting (n=3), oedema (n=3) and dermatitis (n=2). These were grade 3-4: neutropaenia (n=7), thrombocytopaenia (n=4), mucositis (n=1), alopecia (n=1) and neuropathy (n=1). The causes of treatment discontinuation were mainly due to progression in 42.6% and deterioration of general health in 29.8%. At the end of the study, five patients continued treatment. ConclusionThe PFS obtained in our study is greater than those described in the pivotal trial MPACT or CA046. This difference may be due to the four patients with a considerably longer treatment than the average and a small sample. Regarding OS, there are no significant differences with the pivotal trial. The AE described were similar to those published in the literature REFERENCE AND/OR ACKNOWLEDGEMENTS BMC Cancer 2016;16:817. No conflict of interest.
Background After evaluation of ranibizumab and bevacizumab by the Pharmacy and Therapeutics Committee of a tertiary hospital, for the treatment of macular oedema secondary to retinal vein occlusion (RVO), based on the available evidence, both drugs were considered equivalent therapeutic alternatives and ‘off label’ use of bevacizumab was approved. 1.25 mg intravitreal prefilled syringes are prepared by the Pharmacy department, administered every 6 weeks for four doses and repeated as required. Purpose To evaluate the efficacy and safety of bevacizumab as an antiangiogenic drug in the treatment of macular oedema secondary to RVO. Materials and methods Data were collected from patients diagnosed with macular oedema secondary to RVO from November 2012 to April 2013. For each patient, the following data were collected: age and gender, type of occlusion and adverse reactions detected. The variable used to evaluate the efficacy of the treatment was the improvement in the visual acuity, measured by the Snellen fraction adapted to decimal between 0.05 and 1. Results 18 patients with macular oedema secondary to RVO were treated, with a total of 46 doses, and an average of 2.5 (1–5) doses/patient. The average age was 67 and 61% were women. In all cases we used intravitreal bevacizumab as the antiangiogenic drug. 14 cases were branch RVO and 4 cases were central RVO. 14 patients showed great improvement after being given the drug, 2 patients showed a slight improvement and the other 2 patients maintained the same visual acuity and continue with the treatment. No loss of visual acuity has been recorded in any patients. No adverse reactions have been reported. Conclusions In our group of patients, intravitreal bevacizumab was an effective and safe treatment of macular oedema secondary to RVO. The efficacy data obtained are consistent with the reported bibliography. No conflict of interest.
BackgroundInfliximab is one of the most widely used alternatives in ulcerative colitis (UC). The recent appearance of a biosimilar makes it necessary to assess its use.PurposeTo assess the effectiveness and safety of biosimilar infliximab in patients with UC.Material and methodsRetrospective observational study performed in a tertiary hospital. Patients included were those with UC who were being treated with Remicade and then switched to Remsima (biosimilar infliximab) from March to June 2015.Effectiveness and safety were assessed 3 months after the switch. The following variables were collected: age, sex, concomitant therapy, disease classification according to the Montreal Scale (severity and extention) in UC, effectiveness and adverse effects. Effectiveness was measured using the True-Love-Witts Scale and C reactive protein (CRP) levels before and 3 months after the switch. Safety was assessed by collecting all adverse events that occurred during treatment.Results25 patients were included, 52% were women with an average age of 45 years (21–71). At inclusion, 20% of patients were treated concomitantly with corticosteroids and 36% with azathioprine/mercaptopurine. According to the Montreal Scale, 28% of patients had an extension level of E2, 72% had E3 and none had E1. On the other hand, the severity variable was distributed as follows: 8% of patients S0, 32% S1, 48% S2 and 12% S3. At baseline, 23 patients had stabilised disease and 2 had minor outbreaks. Effectiveness was assessed in 12 patients who were reviewed 3 months after the switch. One patient had a minor outbreak at the beginning and no clinical change occurred after the use of the biosimilar. As for the remaining evaluated patients, 8 maintained the same Tru-Love-Witts score and 4 had a decrease. There was no clinically relevant increase in CRP. No adverse events were detected after the switch.ConclusionDespite being a preliminary assessment with just a few patients, initial data showed that the switch to an infliximab biosimilar did not represent a decrease in effectivenees and/or safety in patient with UC.Long term assessment of these patients is required to confirm these results.No conflict of interest.
Background After the Pharmacy and Therapeutics Committee of a tertiary hospital had evaluated ranibizumab and bevacizumab for the treatment of macular oedema secondary to retinal vein occlusion (RVO) based on the available evidence, the two drugs were considered equivalent therapeutic alternatives and ‘off label’ bevacizumab use was approved (1.25 mg intravitreal prefilled syringe prepared by the Pharmacy department, administered every 6 weeks for four doses and subsequently as required). Purpose To quantify the financial impact of the use of bevacizumab as anti-VEGF of choice in the treatment of macular oedema secondary to RVO. Materials and methods Data were collected from patients diagnosed with macular oedema secondary to RVO from November 2012 to April 2013, and from the treatment given. In order to calculate the savings generated by using bevacizumab, rather than ranibizumab, during this period, the direct cost difference between the two alternatives was used. Results 18 patients with macular oedema secondary to RVO were treated, with a total of 46 doses. In all the cases, we used intravitreal bevacizumab as the antiangiogenic drug. The saving generated by using a dose of intravitreal bevacizumab rather than intravitreal ranibizumab was 1,291 €. The impact of cost savings for the hospital during the six months studied was 11,626 €. According to the established protocol, the incremental cost of one year’s treatment is 7,767–15,534 € (depending on the number of injections). Therefore, the annual impact on the hospital budget (assuming 36 patients/year) would be around 280,000–560,000 €. Conclusions Selecting bevacizumab as the antiangiogenic drug in patients with macular oedema secondary to RVO generates significant cost savings for the healthcare system. No conflict of interest.
Background Patient safety is a priority issue for health services. There has been an increase in patients included in clinical trials and these are increasingly complex and therefore establishing safe procedures is crucial. Purpose To identify potential causes of failure in all procedures followed in the area of clinical trials by the pharmacy unit, in a tertiary hospital, as well as estimating their potential effects and proposing possible improvements. Materials and methods A multidisciplinary team involved in clinical trial samples was formed in order to establish all the sub-processes, the potential ways of failure and their possible causes. The higher risk modalities of failure were identified by estimating the risk priority number (RPN). To do this, on the basis of Failure Mode and Effects Analysis (FMEA), the severity of the failure and the possibility of its occurrence and its detection were estimated (scoring from 1 to 10). Preventive actions were suggested for those modes of failure with an RPN of > 100 and the new RPN value was calculated. Results Eight sub-processes were identified: initial visit, reception of samples, prescription, custody, preparation, dispensing, destruction/return of samples and final visit. In total, 36 modes of failure were evaluated, with 61 causes and effects, whose severity value varied from 1 to 9. 24 RPNs had values higher than 100. The modes of failure showing greater reduction of risk after implementation of the measure were: Initial visit: for ‘incorrect verbal information’ due to an uninformed clinical research associate, the RPN decreased from 160 to 36 if the pharmacy unit would request the information in advance and in writing. Sample preparation: In cases of ‘erroneous sample preparation’ due to inexperienced staff, the RPN decreased from 189 to 48 after elaborating preparation sheets prior to the beginning of the trial, specific for the medicine and aimed at nursing staff. For an ‘incorrect design in the chemotherapy programme’, the RPN decreased from 360 to 56 if the sponsor validated it prior to the first preparation. Conclusions The FMEA methodology is a useful tool for improving quality in the area of clinical trials. Its application allows the prioritisation of risk-prevention actions in line with their occurrence, severity and possibility of detection. No conflict of interest.
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