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Background The switch from the intravenous (IV) formulation to the subcutaneous (SC) formulation of abatacept (ABA) had been analysed in clinical trials but there are few data regarding the effectiveness and safety of the SC formulation in clinical practice. Purpose To evaluate the impact of switching from IV to SC abatacept (SC ABA) in patients who were controlled on the IV formulation in a real world setting. Material and methods Observational retrospective study of patients switched from IV to SC ABA, 125 mg once weekly, between September 2013 and April 2015. Data were collected by reviewing patient clinical records and the database of the local advisory committee for rheumatoid arthritis (RA). Measured parameters were: disease activity score at 28 joints (DAS28), treatment duration, reasons for withdrawal and new biologic agent introduced. Results 19 patients were included in our study, 17 women (89.5%) and 2 men (10.5%), mean age 59.6 years. All the patients had low RA activity at the beginning of SC ABA treatment (mean DAS28=3.1). 6 patients (31.6%) discontinued; all experienced an arthritic flare (mean DAS28=4.21; p = 0.02 vs baseline) but no adverse effects were described. 5 (83.3%) returned to IV administration after a mean of 7.1 months (range 2.7–10.8). The other patient (16.7%) switched to etanercept. 13 patients (68.4%) have continued SC administration to date with good disease control and no adverse reactions. All five patients that returned to IV ABA also have good disease control to date. Conclusion In our small case series, SC ABA showed a risk of relapse in 31.6% of cases but reinsertion of IV administration seemed to reinstate disease control. It could be possible that an eventual failure of the SC formulation does not compromise the effectiveness of the ABA therapy itself. Further research with a greater number of patients is needed. References and/or Acknowledgements 1. Reggia R, et al . J Rheumato. 2015;42:193–5 References and/or Acknowledgements No conflict of interest.

Background As the result of Resolution SC 0403/10 of December 22, 2010 in the region of Andalucia (Spain) some medicines for outpatient treatment are no longer dispensed in community pharmacies but in hospital pharmacies, given that they require special surveillance, supervision and control. Purpose To determine the savings made by dispensing oral cytostatic drugs in a third-level hospital. Materials and methods Descriptive observational study of the oral cytostatics dispensed between December 2010 and March 2013. Data were collected from APD software. We determined: The total expenditure on dispensing cytostatics for out-patients, The percentage of this expenditure relative to the total expenditure on all oral medicines for outpatients, The cost savings, The most expensive active ingredients. Results The value of oral cytostatics totalled 6,731,547.87 € during the period of study. This meant 6.37% of the total amount of out-patient prescriptions for oral medicines for the same period. These prescriptions would have cost € 7,141,037.52 if they had been made at community pharmacies. Therefore, these results equate to a saving of € 409,489.64. The active ingredients that affected the cost most were imatinib and sunitinib. Conclusions Hospital dispensing of oral cytostatics led to a cost saving of 5.73% when compared to community pharmacy dispensing. Two factors explain this cost saving: The Avoidance of Any Commercial Expenditure Undertaken by Community Pharmacies The Optimisation of Resources Driven by Patients Taking the Exact Amount Needed of the Drug as They Are Required to Return Any Untaken Medicine When Completing or Changing Their Treatment No conflict of interest.

Background Adverse drug reactions (ADRs) are especially important with antineoplastic drugs because of their implications on patients’ health and quality of life. Purpose To study the epidemiology, clinical features, diagnosis and pharmacology of ADRs detected in hospitalised patients treated with antineoplastic drugs. Materials and Methods Analytical observational study (2011). We included all patients receiving cancer treatment. Study variables were: sociodemographic characteristics (age, sex), clinical (diagnostic, stage) and ADRs. The analysis was epidemiological: ADRs conducted (cumulative incidence, CI), clinical: (physiological system affected, type, duration, production mechanism, frequency, severity), pharmacological: (drug, administration, cycle) and diagnostic: (causality, chronological sequence). Results 125 patients (mean age 51 years), 68% male, 32% female, 90% comorbidities. The most common diagnoses were lymphoma (28%), specifically non-Hodgkin’s Lymphoma (11%), acute lymphoblastic leukaemia (9%), acute myeloid leukaemia (6%) mainly in advanced stages (68%). We detected a total of 170 ADRs with antineoplastic agents (28% CI). Physiological systems primarily affected were: blood (89%), digestive system (23%). The most common ADR was cytopenia (49%) specifically febrile neutropenia (37%). The duration was 7 days (25%). ADRs were mostly produced in a dose-dependent way (85%), were very common (94%) and according to severity were: lethal (2%), severe (5%), moderate (73%), mild (19%). The drugs involved were: cytarabine, methotrexate, idarubicin, carmustine, cisplatin by intravenous administration (97%) and during first treatment cycles: cycle 1 (53%), cycle 2 (23%). 92% of the ADRs are tested and produced after drug administration (99%). In 60% and 19% of cases the measure was the continuation and discontinuation of antineoplastic therapy, respectively. In cases of re-exposure, the emergence of drug ADRs was positive in 45% of patients and in the disappearance of ADRs discontinuation was positive in 92%. Conclusions The incidence of ADRs was high, the majority of ADRs were well known, moderate and positive outcome according to the measurements. It would be better to understand the ADRs as it can help develop other strategies to reduce their impact on the safety of cancer treatments in the first cycles. No conflict of interest.

Background Cetuximab label indication includes treatment of epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer in several possible ways: combination with irinotecan-based chemotherapy, first-line in combination with FOLFOX and as a single agent after oxaliplatin- and irinotecan-based treatment failure in irinotecan-intolerant patients. In our hospital, a multidisciplinary team drawn from the Oncology and Pharmacy services has established a consensus for the rational use of cetuximab as first or second-line agent in association with other chemotherapeutic agents and as monotherapy in third-line treatment after the failure of oxaliplatin and irinotecan-based treatment. Purpose To verify the relevance of cetuximab prescription to the local protocol and cheque the label indications for cetuximab in our hospital. Materials and Methods A retrospective study of patients diagnosed with metastatic colorectal cancer between 2006–2012 with available KRAS status. Patients were followed up for a minimum of three months after diagnosis. Results Twenty-six patients were collected (mean age: 62.2 ± 12.6 years; 53.8% male). KRAS mutation was negative in 42.3% (11/26) patients and therefore they were eligible for treatment with cetuximab. Five out of those 11 patients underwent cetuximab treatment (5/11; 45.5%): three associated with oxaliplatin in first-line treatment, one associated with irinotecan in second-line treatment and one as monotherapy in second-line treatment. Four out of these 5 prescriptions of cetuximab were in accordance to our local protocol and label (4/5; 80.0%). One prescription was not in accordance with either the local protocol or the cetuximab label; due to this the patient was treated with oral capecitabine as first-line and cetuximab monotherapy as second-line treatment. Three KRAS-negative patients (3/11; 27.3%) are currently in treatment with irinotecan as second-line therapy. Three KRAS-negative patients were lost to follow-up after undergoing second-line treatment not known to contain a cetuximab prescription (3/11; 27.3%). Fifteen patients positive for KRAS mutation (15/26; 57.7%) were not treated with cetuximab. Conclusions Ninety-five percent of cetuximab prescriptions in our hospital are in accordance with the established local protocol and the cetuximab label (19/20). No conflict of interest.

Background Chemoembolization of hepatic melanoma metastases refractory to treatment using irinotecan-loaded DC beads [embolic Drug-Eluting Beads]: a novel palliative treatment with which there is as yet little experience. Purpose To show the progress of a clinical case of metastatic choroidal melanoma treated with irinotecan-loaded DC Beads. Materials and Methods The pharmacy department loaded the particles with irinotecan ourselves and monitored the patient through the clinical history. The patient was a 38-year-old man with stage IV choroidal melanoma in the left eye (2007). Results In October 2011, 4 hepatic nodules were detected: 3 in segment VII (23, 25, 11 mm) and 1 in segment II (16 mm). 2 cycles of dacarbazine treatment (1649 mg × 1day) stabilised the disease. The patient experienced emesis and diarrhoea. Given this intolerance and negative BRAFV600E mutation, ipilimumab reinforcement treatment was administered (225 mg × 1day q21days). After 4 cycles of ipilimumab, the disease stabilised for 5 months. In May 2012, an increase in size of the nodules was described and 6 new nodules in both hepatic lobes: segment II (42 × 34 mm), IVb (15 mm), VII (25, 26 and 61.4 × 43 mm) and VIII (14 mm) were observed. Surgery was rejected due to the presence of multinodular lesions and transarterial chemoembolization with irinotecan-loaded DC beads was attempted. Hypervascular lesions were observed in the distal branches of the hepatic artery by bilobar hepatic arteriography using selective catheterization of both hepatic arteries. Subsequently, hepatic chemoembolization was performed by administering 100 mg irinotecan-loaded beads (75–100 microns). After 2 cycles in each hepatic lobe, treatment response was assessed by the RECIST criteria. One month after the last chemoembolization, stable disease (no new nodules and arterial necrosis Conclusions Hepatic chemoembolization using irinotecan-loaded beads is a viable alternative with good prognosis for hepatic metastases of choroidal melanoma. A higher concentration of chemotherapeutical drug is achieved within the hepatic lesions using lower doses of irinotecan, which therefore has less systemic impact. No conflict of interest.

Background Medulloblastoma is one of the most frequent malignant brain tumours in infancy. Conventional treatment is based on combined radiotherapy and chemotherapy after surgical resection of the tumour. The chemotherapy consists of combinations of various anticancer agents, including methotrexate. Methotrexate is administered in intravenous infusion at high doses combined with intrathecal injection at low doses. The use of fluorescence polarisation immunoassay (FPIA) to monitor blood methotrexate levels is widely validated, but there have been few studies on its application to analyse cerebrospinal fluid (CSF) concentrations of this drug. Purpose To analyse cerebrospinal fluid (CSF) concentrations of methotrexate by fluorescence polarisation immunoassay (FPIA) in patient with medulloblastoma. Materials and methods A 22-month-old female diagnosed with medulloblastoma underwent intensive chemotherapy. The regimen was three two-month courses of chemotherapy with methotrexate and other anticancer agents. The patient has received one complete course to date. In the first week, 2 mg of methotrexate were administered intraventricularly via Ommaya reservoir for four days, followed by intravenous cyclophosphamide for three days. In week 3, 2 mg of intraventricular methotrexate was administered in combination with a 24-h intravenous infusion of 2.7 g methotrexate and INTRAVENOUS infusion of vincristine on day 1 and was administered alone on day 2. The treatment in week 5 was identical to that in week 3. Finally, in week 7, the patient received 2 mg of intraventricular methotrexate daily for four days followed by intravenous carboplatin and etoposide for three days. Methotrexate CSF samples were drawn before the first intraventricular injection and at 24 h after each intraventricular administration. CSF methotrexate levels were determined by FPIA using an Abbot TDX analyser. Results CSF methotrexate levels were measured with the following results: week 1, day 1: 14.26 x 10 -6 M, day 2: 218 x 10 −6 M, day 3: 0.75 x 10 −6 M, day 4: 0.33 x 10 −6 M; week 3, day 1: 0.05 x 10 −6 M, day 2: 2.96 x 10 −6 M; week 5, day 1: 0.02 x 10 −6 M, day 2: 2.16 x 10 −6 M; week 7, day 1: 0 x 10 −6 M, day 2: 1.46 x 10 −6 M, day 3: 0.94 x 10 −6 M, and day 4: 1.07 x 10 −6 M; the mean value was 1.38x10 −6 M. Values on day 1 of each cycle were obtained prior to the intraventricular injection and were determined solely to confirm the virtual absence of methotrexate before initiating the next intraventricular administration cycle; therefore, day 1 values were not considered in the calculation of the mean CSF concentration. Values on days 1 and 2 of week 1 were excluded from our analysis because the same route was used for the intrathecal injection and subsequent CSF sample extraction; therefore, the corresponding samples were contaminated. Conclusions FPIA proved to be a reliable method to measure CSF fluid methotrexate concentrations, within published ranges, although further studies are required to verify these findings.