PERFIL EPIDEMIOLÓGICO DOS PACIENTES ATENDIDOS NO SERVIÇO DE CUIDADOS PALIATIVOS ENTRE 2009 A 2011 EM UM HOSPITAL REFERÊNCIA EM ONCOLOGIA DE CURITIBA-PR

Isabella Valvassori Catenacci - Universidade Positivo

OBJETIVOS Analisar o perfil epidemiológico e clínico dos pacientes do Serviço de Cuidados Paliativos e Tratamento da Dor de hospital referência na área de oncologia em Curitiba-PR entre 2009 a 2011.

MÉTODOS Estudo retrospectivo de casos realizado por revisão de prontuários de 380 pacientes atendidos entre 2009 a 2011. As variáveis quantitativas e qualitativas foram elaboradas por estatística descritiva. O método de Kaplan-Meier foi utilizado para caracterizar os tempos de sobrevida dos pacientes.

RESULTADOS Média de idade de 60,1 anos, 50,5% do sexo masculino, 93,7% com cor de pele branca e 76,6% procedentes de Curitiba e região metropolitana. O câncer de órgãos digestivos e o estádio clínico IV ao diagnóstico e ao encaminhamento foram mais frequentes com 33,4%, 43,1% e 82,3% respectivamente. Dor foi o sintoma mais prevalente (82,1%), e 66,8% dos pacientes iniciaram tratamento com opióides antes de serem encaminhados ao Serviço de Cuidados Paliativos. A cirurgia curativa foi o tratamento mais realizado (43,2%) e a maioria dos pacientes foi encaminhada por impossibilidade de tratamento curativo (42,4%). Evoluíram a óbito 84,3% dos pacientes e, desses, 46,6% morreram em ambiente hospitalar. A sobrevida mediana a partir da entrada no hospital foi de 16,1 meses e a partir do encaminhamento foi de 1,2 meses.

CONCLUSÃO O perfil dos pacientes é caracterizado por idade média de 60 anos, proporção semelhante entre homens e mulheres, cor de pele branca, procedentes de Curitiba e região metropolitana, na maioria com câncer de órgãos digestivos e estádio avançado (IV). O encaminhamento ocorreu principalmente por impossibilidade de tratamento curativo. A dor foi o
sintoma mais prevalente, a cirurgia curativa foi o tratamento mais utilizado e a maior parte dos pacientes já havia iniciado o tratamento com opióides previamente, indo a óbito em curto período de tempo, geralmente em ambiente hospitalar.

Poster in:  VIII CONGRESSO FRANCO BRASILEIRO DE ONCOLOGIA. 09 a 11 de Outubro de 2014. Rio de Janeiro. Brazil.

CONTROL DE PRODUCCIÓN CUALITATIVO-CUANTITATIVO Y TRAZABILIDAD EN LA PREPARACIÓN DE CITOSTÁTICOS

Pérez Ricart A, Mestre Galofré L, Farriols Danés A, Carreras Soler MJ, Renedo Miró B, Martínez Cutillas J.

Hospital Universitario Vall D’Hebron. Barcelona. España.

OBJETIVOS: Evaluar los datos de rechazo de preparaciones en el control de calidad cuantitativo tras la implantación de un sistema de control de producción y trazabilidad (SCPT), cualitativo y cuantitativo, de preparación de fármacos antineoplásicos y anticuerpos monoclonales en un servicio de farmacia onco-hematológico.

MÉTODOS: A partir de la base de datos del sistema de control de producción y trazabilidad (SCPT) se recogieron los registros de las preparaciones elaboradas con este sistema desde abril de 2012 hasta marzo de 2013, que no superaron el control cuantitativo y necesitaron la intervención del farmacéutico. El control cualitativo se realiza mediante la lectura del código de barras EAN 13 serigrafiado en el envase primario o la dicción por voz del lote, ambos serigrafiados en el envase primario. Si no se supera este control, el sistema no permite seguir con la preparación, evitándose así los errores de contaminación cruzada o confusión de la especialidad farmacéutica. El control cuantitativo utilizado es la gravimetría, mediante el cual se aceptan automáticamente, de forma parametrizada, diferencias de peso antes y después de la incorporación del fármaco en el contenedor de hasta el 5% de peso del citostático o de hasta el 7,5% para pequeños volúmenes de fármaco. En caso de no superar el control de calidad, la preparación es revisada por el farmacéutico, quien decide la actitud a tomar: aceptar la preparación si la desviación respecto el peso teórico se encuentra entre el ± 5% y el ± 10%, modificarlo (añadir o retirar citostático, o repetirlo en caso de desviaciones del peso >10%.

RESULTADOS: Se extrajeron datos de 27.172 preparaciones elaboradas con el SCPT, de las cuales un 99,47% (27.028) superó el control de calidad cuantitativo. Sólo fueron retenidas 144 preparaciones, lo que supone un 0,53% del total. De éstas, 102 (70,83%) fueron aceptadas por el farmacéutico y 37 (25,69%) se tuvieron que repetir.

CONCLUSIONES: El porcentaje de preparaciones retenidas y repetidas fue muy bajo. Con la utilización de este SCPT, todas las preparaciones pudieron ser dispensadas correctamente. El sistema mejoró la calidad y la seguridad de las preparaciones. El sistema mantiene el registro de todas las transacciones realizadas durante la preparación, permite laextracción de los datos necesarios (trazabilidad), y se muestra útil como herramienta de gestión del proceso.

Comunicaciones científicas presentadas en formato póster Farm Hosp. 2013;Supl. 1:65-499 - 397

FLUORURACILA

Fluoruracila.............................................................................................................................2,5 g

Propilenoglicol q.s.p..............................................................................................................100 g

Na cabine de fluxo laminar, misturar o fluoruracila com o propilenoglicol, até a obtenção de uma preparação homogênea. Em recipientes adequados, este produto deve ser armazenado em temperatura ambiente e protegido da luz. Para uso tópico.

Referência bibliográfica: Clavijo MJL, Comes VB. Formulario Básico de Medicamentos Magistrales, 2ª Edición. España, 2007.

MEJORA DE LA CALIDAD EN LA NOTIFICACIÓN, REGISTRO Y ACTUACIÓN ANTE UNA EXTRAVASACIÓN: INTERRELACIÓN FARMACIA-ENFERMERÍA EN UN HOSPITAL DE DÍA ONCO-HEMATOLÓGICO

Serrano Vicente MC, Viñuales Armengol MC, Martínez Crespo A, Aguilá Villacampa MD, Rodríguez Amador MP.

Hospital San Jorge. Huesca. España.

OBJETIVOS Analizar las extravasaciones registradas por el farmacéutico de hospital de día que fueron tratadas y seguidas desde la consulta de enfermería. Plantear actuaciones de mejora para el manejo de las extravasaciones en las unidades de hospitalización.

MATERIAL Y MÉTODOS Estudio retrospectivo de las extravasaciones de citostáticos ocurridas, notificadas y/o tratadas en nuestro hospital entre junio de 2010 y marzo 2013. Se recogieron las siguientes variables: procedencia de la notificación, extravasación confirmada o sospecha, citostático implicado, cumplimiento del protocolo, síntomas post-extravasación y evolución y seguimiento.

RESULTADOS Hubo un total de 20 extravasaciones registradas, de las cuales un 90% tuvieron lugar en hospital de día y un 10% en plantas de hospitalización que solicitaron la colaboración del personal de enfermería de hospital de día para su manejo. El 65% fueron extravasaciones confirmadas «in situ» mientras que en el 35% restante se sospechó una extravasación tras la aparición de lesiones días después de la administración de citostáticos. El 50%, 15% y 35% se debió a citostáticos irritantes, vesicantes y no agresivos respectivamente. Los fármacos implicados según su incidencia fueron: derivados de platino (45%), antimetabolitos (30%), taxanos (10%), alcaloides de la vinca (5%), alquilantes (5%) y anticuerpos monoclonales (5%). En todos los casos se cumplió el protocolo del hospital. Los síntomas asociados a la extravasación fueron: eritema 60%, inflamación/edema 45%, dolor 35%, aparición de vesículas 25%, quemazón 20% e induración 10%. Un 75% de los pacientes evolucionaron favorablemente en las 48 horas posteriores a la extravasación, mientras que en el 25% restante de casos fue necesario un seguimiento desde la consulta de enfermería de hospital de día durante un tiempo mayor, que fue desde 1 mes hasta un caso en que el seguimiento fue de 5 meses. Las medidas farmacológicas adoptadas para el tratamiento de las extravasaciones en aquellas que lo requirieron fueron: tratamiento tópico (45%), antibióticos orales (15%) y analgésicos orales (15%), en 2 casos fue necesaria alguna actuación adicional (consulta a cirugía vascular y eco-doppler respectivamente).

CONCLUSIONES Las consecuencias de una extravasación dependen en gran medida de la rapidez de actuación y el conocimiento de los protocolos por parte de enfermería. Ante las dudas consultadas por las plantas ante una extravasación se decidió crear un grupo multidisciplinar (farmacia, enfermería y oncología) para revisar el protocolo de extravasación y proporcionarlo en formato póster a las unidades de hospitalización recordando los procedimientos al personal implicado en el manejo de citostáticos. La integración del farmacéutico en el equipo de hospital de día ha facilitado el desarrollo de estas iniciativas multidiciplinares.

Farm Hosp. 2013;Supl. 1:65-499

DRUG-VIGILANCE IN ONCOLOGY: MONITORING THE ADVERSE DRUG REACTIONS OF ANTINEOPLASIC TREATMENT AND SEVERITY DEGREES

CÍNTHIA MADEIRA DE SOUZA, MARÍLIA BERLOFA VISACRI, GRAZIELE BALDAN FERRARI, ANNA PAULA LOURENÇO COSTA, CARMEN SILVIA PASSOS LIMA, PRISCILA GAVA MAZZOLA, PATRICIA MORIEL

Faculty of Medical Sciences, State University of Campinas, Brazil

Adverse drug reactions (ADRs) are common in oncology patients, predictable and, at least, probably preventable in many instances. The improved use of preventive measures has the potential to contribute to reducing the incidence and severity of ADRs. The aim of this study was to assess frequency and severity of ADRs in oncology patients. This is a quantitative, descriptive and exploratory study in drug-vigilance.

The patients, during and after chemotherapy sessions at a University Hospital in Brazil from august 2011 to June 2012, were selected for interviews about symptoms related to their chemotherapy. A clinical pharmacist investigated ADRs and their severity was classified by Common Terminology Criteria of Adverse Events (version 4.0) (grade 0 to 4). A total of 100 patients were interviewed, (54.0 % men, 46.0% women; age: 56.8 ± 12.1). The most frequent kinds of cancer were gastrointestinal cancer (n=76; 76.0%), head and neck cancer (n=8; 8.0%) and gynecological cancer (n=4; 4.0%).

The most prevalent treatment protocols were: fluorouracil + leucovorin + oxaliplatin (FLOX, n=24; 24.0%), irinotecan + fluorouracil + leucovorin (IFL-SALTZ, n=17, 17.0%) and fluorouracil + leucovorin (MACDONALD, n=16, 16.0%). Oncology patients had 10.5 ± 4.9 ADRs (range 2-26). The three most incident ADRs were nausea (66.2%; 55.3% grade 1), xerostomia (59.2%; 68.4% grade 1) and fatigue (57.8%; 43.1% grade 1). It was found that 69.3% of symptoms presented grade 1 of severity, 25.0% grade 2, 4.9% grade 3 and 0.8% grade 4.

The effects with grade 3 and 4 should have been notified to the drug-vigilance system, but these were not consistently reported, contributing to under-reporting. Therefore, pharmaceutical follow-up is essential to characterize the ADRs, and to assist in prevention, detection, notification and resolution of these events. Supported by: Pibic/CNPQ; Funcamp.

Rev.Bras. Farm. – 94 (4); 2013

CHEMOTHERAPY: A LOT IS STILL UNKNOWN, NEW PERSPECTIVES ON THE INFUSION SEQUENCE

S Borchetto, D Zenoni, MT Fratelli Benzoni, A Barcella

Azienda Ospedaliera Bolognini, Farmacia, Bergamo, Italy

Background The different metabolic enzymatic involvement of the drugs used for chemotherapy infusions make them difficult to manage because drugs that build up a poly-chemotherapeutic scheme can increase the cytotoxicity or oppose the desired effect.

Purpose We would like to stimulate the scientific community to start thinking about building a database designed to standardise the infusion sequence of chemotherapy as a foundation for the
medical treatment. In order to show all the problems that pharmacists face daily, we conducted a literature search for a scheme used in chemotherapy for lung and ovary cancer: the association between carboplatin and gemcitabine.

Materials and methods We analysed phase I, II and III trials from 1996 to 2006 with a careful evaluation of the documents and considering the pharmacokinetic and pharmacodynamic properties of the two molecules. Most of the studies do not specify in detail the sequence of infusions, they only describe gemcitabine and/or/plus carboplatin in chemotherapeutic regimen or the other way around. Therefore we analysed only the documents that described the infusion sequence in detail.

Results We analysed 16 papers discussing the chemotherapeutic scheme analyses: in 3 studies carboplatin was administered before gemcitabine, 5 studies were designed so that gemcitabine was infused before the carboplatin.

Conclusions With this short paper we have demonstrated that there are a lot of doubts about the ‘right’ infusion sequence of chemotherapy drugs. Our hope is that scientific societies will perform additional clinical trials to find the best sequence in order to standardise medical treatment to ensure high quality.

Eur J Hosp Pharm 2014:21(Suppl 1):A1–224

GUIDELINES FOR CHEMOTHERAPY EXTRAVASATION

M Morgado, M Mendes, R Oliveira, S Morgado.

Hospital Centre of Cova da Beira, Pharmaceutical Services, Covilhã, Portugal; University of Beira Interior, Health Sciences Faculty, Covilhã, Portugal

Background The administration of intravenous cytotoxic drugs plays a key role in cancer treatment and due to the overall increase in intravenous chemotherapy there has been an increasing incidence of chemotherapy extravasation. Therefore, it is advisable to have updated guidelines that direct the treatment of intravenous cytotoxics extravasation.

Purpose To develop guidelines for the treatment of cytotoxic extravasation, which contained the management algorithms,antidotes and treatments that should be performed, as well as risk factors and strategies to prevent extravasation.

Materials and Methods A literature review was performed, through research and analysis of guidelines and articles obtained from PubMed since January/2000 to September/2012, intersecting
the terms ‘cytotoxic extravasation’, ‘chemotherapy extravasation’ and ‘extravasation treatment’. The summary of product characteristics of all of intravenous cytotoxics available in Portugal was also reviewed. Some holders of market authorization were also contacted whenever we considered additional information was required.

Results A total of 42 intravenous antineoplastics available in Portugal were analysed, distributed as follows based on tissue injury after extravasation: 16 vesicant products, 16 irritants and 10 neutral products. A summary table was created with the risk factors (e.g., vesicant drugs, higher drug concentrations, previous vinca alkaloids, elderly, impaired sensory perception, generalised vascular disease) and measures that prevent extravasation (e.g. ensure that the IV site can be clearly visualised, do not use a butterfl y needle with a vesicant drug). Nine individual algorithms were developed, according to the latest guidelines, which guide the work of healthcare professionals in case of extravasation (e.g., measures for immediate treatment, applying heat/cold, recommended antidote and instructions for its use). A list was drawn up with all cytotoxics, each being identified with a colour, which corresponded to the colour of the separator with the algorithm to treat its extravasation. An extravasation kit was also designed and a model for document the appropriate recording of extravasation and clinical monitoring of the patient.

Conclusions The guidelines developed are a valuable tool for all hospital services that prepare and administer injectable chemotherapy, contributing to responding quickly and effectively to episodes
of extravasation.

Reference Eur J Hosp Pharm 2013;20(Suppl 1):A1–238

1ª Ed. 2014 Editora Medfarma
ISBN 9788589248136
Nº de págs.: 962
Capa flexível
Formato: 16 x 23 cm

    Manual de Medicamentos Citostáticos é um livro com todos os fundamentos necessários para uso pela Equipe Multiprofissional que atuam em Unidades ou Centros de Assistência de Alta Complexidade em Oncologia (CACON), que apresenta informações sobre medicamentos citostáticos para todos os estudantes e profissionais da área de saúde, com o objetivo de complementar uma abordagem multiprofissional ao paciente oncológico. Livro contendo 184 medicamentos e com os seguintes capítulos: glossário farmacêutico, glossário de oncologia, lista de abreviaturas e siglas, tabela geral de diluição, manipulação de drogas citostáticas, PGRSS com pictogramas e símbolos de identificação de grupos de resíduos, medicamentos com resumo das toxicidades e as monografias dos medicamentos. Neste sentido, o livro aborda as seguintes informações:  nome genérico do produto,  nomes comerciais, sinonímia e outras denominações, forma farmacêutica, categoria terapêutica, farmacocinética, posologia, reações adversas, regimes especiais de posologia, alertas de administração, precauções, interações medicamentosas, condutas na superdose, medidas após a contaminação acidental, protocolo para extravasamento, biossegurança ocupacional, normas internacionais de transporte do produto, PGRSS, estabilidade da solução reconstituída no frasco de vidro, concentração após reconstituição no frasco de vidro,  vias e formas de administração, diluentes, volume final e tempo de infusão, compatibilidade com as soluções e com os equipamentos,  incompatibilidade com as soluções e com os equipamentos, estabilidade em seringa plástica, estabilidade em bolsa plástica de PVC, poliolefina, PEBD e de EVA. Considero este livro uma futura publicação multiprofissional indispensável para todos os profissionais da área de saúde, que necessitam de informações atualizadas e precisas, abordando de maneira clara, simples e objetiva os estudos, principalmente, sobre protocolos para extravasamento, em condutas na superdose e na contaminação acidental, normas do PGRSS, assim como a diluição, compatibilidade e estabilidade de medicamentos citostáticos.

PROSPECTIVE REGISTRY FOR EVALUATING THE EFFECTIVENESS OF BEVACIZUMAB ALONE OR WITH IRINOTECAN IN RECURRENT GLIOBLASTOMA

M Vaiani, M Cecchi, S Colombini, E Agostino, F Attanasio, M Ceroti, R Banfi.

Careggi Hospital, Pharmacy Department, Florence, Italy; 2ISPO, Molecular and Nutritional Epidemiology Unit, Florence, Italy

Background Recurrent glioblastoma is nearly always fatal, with median survival rates of approximately 12–14 months. Previous phase II clinical trials showed promising results with bevacizumab, alone or in combination with irinotecan, in patients with recurrent glioblastoma.

Purpose To assess whether the survival of patients with recurrent glioblastoma receiving bevacizumab alone or with irinotecan in everyday practise is comparable to that reported in clinical trials.

Materials and Methods This was a retrospective observational study conducted at a single hospital in Italy. Patients with recurrent glioblastoma who had received bevacizumab alone or with irinotecan from January 2009 to September 2011 were included in our study. The main outcome measures were progression-free survival (PFS), overall survival (OS), and rates of PFS and OS at 6 months.

Results Median PFS was 5.1 months in the bevacizumab group (n = 9) and 15.4 months in the bevacizumab + irinotecan group (n = 10), with 6-month PFS rates of 45% and 69%, respectively. Median OS was 6.8 months for bevacizumab alone and 11.1 months for bevacizumab + irinotecan, with 6-month OS rates of 100% and 90%, respectively.

Conclusions Although the number of patients included is not sufficient to allow a conclusive statement about the place of bevacizumab in the treatment of recurrent glioblastoma, the data appear promising, and are consistent with the results of clinical trials.

Reference Eur J Hosp Pharm 2013;20(Suppl 1):A1–238

THE PRESCRIPTION OF ANTHRACYCLINES DURING PREGNANCY IN HAEMATOLOGY: CASE REPORTS AND LITERATURE REVIEW

C Peloso, MT Baylatry, E Elefant, F Isnard, C Fernandez, AC Joly.

Saint-Antoine Hospital (APHP), Pharmacy, Paris, France; Trousseau Hospital (APHP), Crat, Paris,
France; Saint-Antoine Hospital (APHP), Haematology, Paris, France

Background Anthracyclines are one of the most important groups of drugs used nowadays in cancer chemotherapy. Chemotherapy is essential in the management of haematological malignancies (HM). When acute leukaemia (AL), aggressive non-Hodgkin’s lymphoma (NHL) or Hodgkin’s lymphoma (HL) occur during pregnancy, chemotherapy is an emergency but foetal risk must be considered.

Purpose To evaluate foetal and maternal outcomes associated with the prescription of anthracyclines in pregnant women with HM.

Materials and Methods Cases of pregnant women with AL, NHL or HL treated by anthracyclines were collected from the Teratogenic Agent Information Centre (TAIC), a French reference centre providing specialised information for clinicians about drug use in pregnancy. A literature review was performed in the PubMed and Embase databases until May 2012 (keywords: pregnancy, acute leukaemia, Hodgkin lymphoma, non-Hodgkin lymphoma, cancer chemotherapy, doxorubicin, daunorubicin and idarubicin). Selection criteria of articles: diagnosis of HM and anthracycline prescription during pregnancy, foetal outcome.

Results We report 5 cases of pregnant women with HM (4 AL, 1 HL) treated early in the 3rd trimester by chemotherapy with doxorubicin or daunorubicin at standard dosage. All 5 newborns were normal, but 2 were premature deliveries. 3 maternal outcomes were complete remission (2 unknown). 81 articles were selected, corresponding to 134 pregnant women with AL (95 cases), HL (16) or NHL (23) treated by chemotherapy with daunorubicin (65 cases), doxorubicin (59) or idarubicin (10). Normal neonatal outcomes (100/134) were 88%, 68% and 40% for doxorubicin, daunorubicin and idarubicin respectively, 79%, 77% and 45% for exposure from 3rd (26 cases), 2nd (69) and 1st trimester (11) respectively and 96%, 81% and 68% in NHL, LH and AL respectively. Foetal toxicities were death (20), growth retardation (8) and congenital abnormalities (6). Only idarubicin was associated with foetal cardiomyopathy. 97 maternal outcomes were known with remissions (71 cases) and progressions, relapses or deaths (26 cases).

Conclusions Embryo-foetal toxicity depends on gestational age, anthracycline and HM. 2nd or 3rd trimester exposures were mainly associated with favourable neonatal outcomes. Idarubicin was specifically associated with a risk of foetal cardiotoxicity, probably due to its lipophilic nature, facilitating placental transfer. Unfavourable foetal outcomes were more frequent in AL compared to lymphomas, probably refl ecting that chemotherapy can never be delayed till post-partum in AL. It is possible to prescribe anthracyclines for HM in the 2nd and 3rd trimesters of pregnancy with minimal risk to the developing foetus but then the treatment must be conducted by a multidisciplinary team.

Reference Eur J Hosp Pharm 2013;20(Suppl 1):A1–238

TRABECTEDIN FOR METASTATIC SOFT TISSUE SARCOMA – A RETROSPECTIVE ANALYSIS

AR Gaspar, PF Tavares, J Casanova. Centro Hospitalar e Universitário de Coimbra, UTAL – Bone and Soft Tissue Sarcoma Unit, Coimbra, Portugal

Background: soft tissue sarcomas (STSs) are rare tumours arising from connective tissues characterised by high morphologic and biologic heterogeneity, as well as by limited responsiveness to cytotoxic chemotherapeutic agents. Trabectedin was approved in 2007 for patients with advanced STS after failure of anthracyclines and ifosfamide, or for patients unsuited to receive these agents.

Purpose: to obtain basic epidemiological information on patients with soft tissue sarcomas, standard treatment procedures and results of trabectedin treatment in clinical practise.

Materials and methods: this retrospective study analysed 31 STS patients treated with trabectedin between January 2009 and September 2012. A retrospective cohort study of all patients with a diagnosis of STS treated with trabectedin 1.5 mg/m2, D1, 24 hours’ continuous IV infusion, every 3 weeks. Toxicity was evaluated using Common Terminology Criteria for Adverse Events (CTCAE). Progression-free survival curves (PFS) and Overall Survival (a 95% confi dence interval was used) were estimated by using the Kaplan-Meier method.

Results: median age at the initiation of trabectedin therapy was 52 years (18–79 years). Leiomyosarcoma was the most frequent tumour (25.8%) and liposarcoma occurred in 16.2% of the patients. Median number of cycles administered was 6.7 (2–16 cycles). Thrombocytopenia, leukopenia (16.1% of patients), asthenia (12.9%) and elevation of liver transaminases (9.7% of patients) were the most frequent adverse effects. Nine patients achieved a partial remission (PR) and in 3 the disease stabilised (SD). Median overall survival (95% CI) was 6.0 months (0.8; 36.1), median progression-free survival (PFS) (95% CI) was 11.48 months. PFS for all patients was 90.3% at three months and 79.0% at six months.

Conclusions: our results indicate that trabectedin shows promise as an effective and tolerable new drug for the treatment of patients with STS.

No conflict of interest.

Eur J Hosp Pharm 2013;20(Suppl 1):A1–238

IPILIMUMAB FOR ADVANCED MELANOMA: DRUG USE REVIEW

AR Rubio Salvador, J Medina Martínez, JM Martínez Sesmero, P Moya Gómez, MA Cruz Mora, JI Chacón López-Muñiz, JJ Cía Lecumberri.

Hospital Virgen de la Salud, Pharmacy, Toledo, Spain; Hospital Virgen de la Salud, Oncology, Toledo, Spain

Background: ipilimumab is a recombinant, fully human monoclonal antibody (IgG1) which blocks the inhibitory effects of cytotoxic T-lymphocyte antigen 4 (CTLA4), a negative regulator of T-cell activation. It has been approved for the treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic treatment for advanced disease.

Purpose: to review the effectiveness and safety profi le of ipilimumab in the treatment of adult patients with advanced melanoma.

Materials and methods: medical record review and retrospective analysis (January 2011 to September 2012) of prescriptions recorded in the Integral Oncology Patient Information System (ONCOBASS) in a teaching general hospital. Previous drug use, dose, line of chemotherapy, number of cycles administered, objective response rate and toxicity were analysed.

Results: a total of 5 patients with metastatic melanoma were prescribed ipilimumab (2 male, 3 female), median age 45 (36–60). The 4 cycles of treatment planned were completed by 3 patients, 1 continues in active treatment at the moment of fi nishing this study and the other one has been lost to follow-up due to change of hospital. In the group of four patients who received treatment, 2 were prescribed ipilimumab as a second line after failure of a temozolomide- based regimen, and 2 were prescribed ipilimumab as third line after two regimens based on immunotherapy, temozolomide or vemurafenib. After completing the 4 cycles planned, 1 patient maintained complete response (16 months) and 1 patient showed stable disease (maintained for 5 months), and the other one is in evaluation. No patients suffered grade 3–4 toxicity and the treatment was well tolerated.

Conclusions: ipilimumab has shown effectiveness and safety in the treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic treatment for advanced disease in our patients, although data from more patients and longer-term studies are required.

No confl ict of interest.

Eur J Hosp Pharm 2013;20(Suppl 1):A1–238

Vidarabina pomada

Vidarabina............................................................................3 g 
Vaselina Sólida Branca q.s.p............................................100 g

Este produto deve ser preparado em área classificada, seguindo protocolo para reconstituição de soluções de drogas citostáticas. Misturar os componentes da formulação até aspecto homogêneo. Estocado em pote de vidro e plástico âmbar na concentração de 3%. Estabilidade de 21 dias em temperatura ambiente.

Referência bibliográfica: Trissel LA. Trissel’s Stability of Compounded Formulations, 2^nd ed. Washington, DC: American Pharmaceutical Association; 2000.