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BackgroundBenboubker et al. recently reported the results of lenalidomide + dexamethasone (Ld) in transplant-ineligible patients with melanoma versus the standard treatment, with a difference between medians of 4.3 months in progression-free survival (PFS). Nevertheless, as seen in the shape of the curves, difference in median survival (DMS) may not provide a good estimate of the survival benefit.PurposeTo reanalyse the survival benefit of lenalidomide from the PFS curves using an area-under-the curve (AUC)-based method.Material and methodsKaplan-Meier PFS and OS curves were extracted from Benboubker et al.’s article. Graphical AUC methods were applied to continuous Ld vs. standard treatment curves and compared to DMS. The AUC was calculated according to a previously published method.1 Vertical cutting lines at the tail ends of the graphs were made based on the number of patients at risk. It was agreed that this cut-off point was defined as placing at least 10 at-risk patients in each group or 30 in total. The AUC method quantified the difference between areas, and the results were expressed in time units. Photoshop-CS6 was used for graphical AUC calculation.ResultsAUC-based reanalysis of PFS curves included 67.5% patients with 47 months of follow-up, at least 30 patients remaining at risk. PFS was 17.0 vs. 14.3 months, a benefit of 2.7 months in favour of continuous Ld. For OS, with 43.5% patients analysed and 50 months of follow-up, the AUC method showed a benefit of 5.3 months (25.5 vs. 20.2).Abstract CP-148 Figure 1ConclusionAUC-based analysis showed a shorter survival benefit than the difference in median survival. This is probably related to the shape of the curves, which diverged at the medium zone of the graph. OS reanalysis is very limited because the observation time is insufficient to provide mature data.References and/or AcknowledgementsAlegre-DelRey EJ, et al. Area-based measures for assessing survival benefit in Kaplan-Meier’s curves. ESMO Congress, Amsterdam 2013. URL: (accessed 08/10/2014)No conflict of interest.

BackgroundBiological drugs are effective treatments for chronic plaque psoriasis. The doses tend to be reduced when the drug has demonstrated sustained effectiveness.PurposeThe main objective was to assess the average cost per patient of each anti-TNF drug based on its prescribed doses. The secondary objective was two-fold: to estimate the annual costs per responder and the incremental cost.Material and methodsA cross-sectional observational study was conducted from January to June 2014. Patients with psoriasis who had received biological treatment for at least six months were included. The effectiveness endpoint was the proportion of patients with at least 75% improvement in the psoriasis area-and-severity index (PASI75). Mean prescribed doses of each anti-TNF drug were calculated and translated into a percentage of the label doses. The average cost per patient for each drug was assessed with the mean prescribed doses (real costs, RC) and the theoretical costs (TC) were estimated based on the label doses of the drugs. The incremental cost (IC) was calculated by comparing the theoretical vs. real costs. For the purpose of calculating the annual costs, the real costs of six months of treatment were extrapolated. This study was performed from the pharmacoeconomic perspective of the hospital.ResultsWe included 143 patients.Abstract CP-142 Table 1Adalimumab (N = 45)Etanercept (N = 44)Ustekinumab (N = 32)Infliximab (N = 22)Cost per patient based on the doses prescribed€4,777.06 €4,722.38 €5,337.34 €6,546.82 Cost per patient based on its label doses€6.245.72 €5.788.19 €5,689.02 €6,546.82 Proportion of patients with PASI7598% 90% 90% 100% Estimated annual real costs per responder€9,771.27 €10,389.24 €11,778.95 €13,093.65 Estimated TC€12,491.44€11,576.38€11,378.05€13,093.65Estimated RC€9,554.13€9,444.76€10,674.68€13,093.65IC€-2,937.30€-2,131.62€-703.360€ConclusionThe average RC of each biological drug was lower than TC, except for infliximab. Both the annual RC and the IC of adalimumab were better than the other drugs, followed by etanercept and ustekinumab. Infliximab did not allow dose reduction. Reducing doses of biological treatments permits cost minimisation while maintaining clinical effectiveness.References and/or AcknowledgementsNo conflict of interest.

Background Intravenous immunoglobulins (IgIV) represent a therapeutic option with high cost and limited availability. As a consequence it is necessary to evaluate their use basing it on the scientific evidence and prioritising the indications. Purpose To examine the suitability of immunoglobulin prescriptions regarding the indication and recommended dose. Materials and methods We studied patients treated with IgIV between January 2012 and June 2013. We checked the prescriptions against The Clinical Guidelines for Immunoglobulin Use edited by the British Department of Health. We recorded the prescribing department, indication for the prescription, dosing regimens and approved or non-approved indications. Results A total of 34 patients were treated with a standard dose of 0.4 g/kg, 44% of prescriptions came from Haematology, 24% from Oncology, 15% Immunology, 9% Neurology and 8% from other services. The distribution of patients according to the prescribing indication was: idiopathic thrombocytopenic purpura (38%), primary immunodeficiencies (23%), secondary immunodeficiencies (15%), autoimmune haemolytic anaemia (6%), Rasmussen’s syndrome (3%) and others (15%). 91% of the prescriptions were for an approved indication, 3% were approved but not scientifically supported and 6% not approved or accepted. The most frequent patterns were 30 g for 4 days and 35 g every 28 days. Conclusions Most of the prescriptions written were for approved indications. A low percentage of prescriptions were for unapproved indications, which were required as compassionate use. The pattern and duration of treatment were appropriate to the treated pathologies. No conflict of interest.

Background At the end of 2010, the FDA issued an alert regarding the use of a new method for serum creatinine determination. The IDMS method appears to underestimate serum creatinine values compared to older methods when the serum creatinine values are relatively low (e.g., ~0.7 mg/dL). This could lead to higher doses than necessary and carboplatin toxicity. It was therefore recommended the use of fixed maximum doses for each target AUC value. Purpose To determine compliance with FDA recommendations about carboplatin dosage, and to assess the toxicity that emerged at doses higher than recommended. Materials and methods The overall number of patients and carboplatin courses, sex, age, diagnosis and percentage overdose were extracted from the Farmis database on cytostatics management, from January 2011 to September 2013. Overdoses were designated: carboplatin dosing >900 mg for a target AUC = 6; carboplatin dosing >750 mg for a target AUC = 5; carboplatin dosing >600 mg for a target AUC = 4. In the event of overdosing (Common Terminology Criteria for Adverse Events (CTCAE) criteria), blood tests were sought before the next round of treatment and the need to delay the chemotherapy treatment were evaluated. Results A total of 195 patients and 763 courses of carboplatin were identified; 18 patients (2%) had been given an excessive dose. Toxicity was caused in 3 women and 4 men by overdosing with carboplatin, with an average of 48 years and different cancers: lung (N = 2), stomach (N = 1), ovary (N = 2) and unknown origin (N = 2). Following evaluation of the eighteen patients who had received an excessive dose, 22.2% of their chemotherapy courses were delayed. Conclusions As so many patients are exposed to toxicity in this way, it is necessary to set up an automated alert system based on FDA recommendations. Neutropenia was the only adverse event for which chemotherapy had to be postponed; there was no thrombocytopenia. Abstract GM-006 Table 1 Chemotherapy courses Percentage overdose Need to delay the next chemotherapy course? (1 week) Adverse events 1 2% No – 5 3% Yes, N = 2 Neutropenia, grade 1 (N = 3)Neutropenia, grade 2 (N = 1) 2 7% Yes, N = 1 Neutropenia, grade 3 (N = 1) 1 9% No – 1 10% No – 2 13% No – 1 15% No – 3 20% Yes, N = 1 Neutropenia, grade 3 (N = 1) 1 22% No – 1 29% No – No conflict of interest.