Intravitreal melphalan therapy for vitreous seeds in retinoblastoma: Implementation and outcomes of a new chemotherapy protocol.

Retinoblastoma is the most common paediatric ocular tumour, which appears in the retina. Without treatment, retinoblastoma grows and destroys the internal ocular globe architecture, even leading to metastasis. When treated, overall survival is close to 97%, the alkylating drug melphalan being the most extensively used chemotherapeutic agent in localised treatment. The aim of this study is to describe the implementation of a new intravitreal chemotherapy retinoblastoma treatment protocol for children implanting vitreous seeds through intravitreal melphalan injections and to evaluate the patients' health outcomes treated with it. Between December 2014 and July 2018, seven patients were treated with this protocol. They received a mean of 3.3 cycles of intravitreal melphalan with standard doses of 30 mcg per cycle. In the seven eyes treated in our hospital, the response was as expected; three eyes with vitreous seedings (43%) were successfully treated. The main adverse effects presented by all patients were scars at cryogenisation points. In two patients, the appearance of 'salt and pepper' retinopathy was reported. Oncology pharmacists, as part of the treatment team, can provide information about recommended doses, expected adverse effects, stability of preparations, most appropriate method of processing, packaging, and methods of drug administration, to ensure efficacy and especially safety in the administration of these drugs.

BK Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation in the Pediatric Population.

OBJECTIVE: To study the incidence, risk factors, and treatment of hemorrhagic cystitis secondary to BK-virus reactivation (HC-BKV) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the pediatric population. METHODS: Case-control study in which all pediatric patients (0-18 years) who underwent allo-HSCT from September 2009 to January 2014 were followed. RESULTS: Twenty-nine patients underwent an allo-HSCT. The median age was 9 years (range = 6 months to 15 years), 61% male. The primary diagnosis was acute lymphoblastic leukemia (72.4%). Six (20.7%) developed HC-BKV. In a multivariate analysis of risk factors, it was observed that the reactivation of BK virus was associated with age more than 10 years ( P = .098) and those with positive serology for Epstein-Barr virus ( P = .06). Five of the 6 patients with HC-BKV received cidofovir (CDV) at doses of 3 to 5 mg/kg/week. The treatment lasted a median of 3 cycles (range = 2-5). One of the patients (20%) developed nephrotoxicity. Of the 5 patients treated with CDV, 3 (60%) had a complete response, 1 (20%) partial response, and 1 (20%) no response. CONCLUSION: We conclude that HC-BKV is a frequent complication after allo-HSCT. CDV therapy can be effective but controlled clinical trials are needed.

[Applying dose banding to the production of antineoplastic drugs: a narrative review of the literature]. / Dose banding aplicado a la elaboración de antineoplásicos: una revisión narrativa de la literatura.

The dosage of antineoplastic drugs has historically been based on individualized prescription and preparation according to body surface area or patient´s weight. Lack of resources and increased assistance workload in the areas where chemotherapy is made, are leading to the development of new systems to optimize the processing without reducing safety. One of the strategies that has been proposed is the elaboration by dose banding. This new approach standardizes the antineoplastic agents doses by making ranges or bands accepting a percentage of maximum variation. It aims to reduce processing time with the consequent reduction in waiting time for patients; to reduce errors in the manufacturing process and to promote the rational drug use. In conclusion, dose banding is a suitable method for optimizing the development of anticancer drugs, obtaining reductions in oncologic patients waiting time but without actually causing a favorable impact on direct or indirect costs.

La dosificación de los fármacos antineoplásicos se ha basado históricamente en la prescripción y elaboración individualizada según la superficie corporal o peso del paciente. La falta de recursos y el aumento de la carga asistencial en las áreas de elaboración de quimioterapia están propiciando que se desarrollen nuevos sistemas que optimicen la elaboración sin reducir la seguridad. Una de las estrategias que se ha propuesto es la elaboración mediante dose banding. Este nuevo enfoque estandariza las dosis de antineoplásicos en rangos o bandas aceptando un porcentaje de variación máxima. Pretende reducir los tiempos de elaboración con la consiguiente reducción de los tiempos de espera de los pacientes, disminuir los errores en la elaboración y fomentar el uso racional de los fármacos. En definitiva, el dose banding es un método adecuado para la optimización de la elaboración de antineoplásicos, obteniendo reducciones del tiempo de espera de los pacientes oncológicos, aunque sin llegar a causar un impacto favorable sobre los costes directos o indirectos.

Dose banding aplicado a la elaboración de antineoplásicos: una revisión narrativa de la literatura / Applying dose banding to the production of antineoplastic drugs: a narrative review of the literature

La dosificación de los fármacos antineoplásicos se ha basado históricamente en la prescripción y elaboración individualizada según la superficie corporal o peso del paciente. La falta de recursos y el aumento de la carga asistencial en las áreas de elaboración de quimioterapia están propiciando que se desarrollen nuevos sistemas que optimicen la elaboración sin reducir la seguridad. Una de las estrategias que se ha propuesto es la elaboración mediante dose banding. Este nuevo enfoque estandariza las dosis de antineoplásicos en rangos o bandas aceptando un porcentaje de variación máxima. Pretende reducir los tiempos de elaboración con la consiguiente reducción de los tiempos de espera de los pacientes, disminuir los errores en la elaboración y fomentar el uso racional de los fármacos. En definitiva, el dose banding es un método adecuado para la optimización de la elaboración de antineoplásicos, obteniendo reducciones del tiempo de espera de los pacientes oncológicos, aunque sin llegar a causar un impacto favorable sobre los costes directos o indirectos (AU)

The dosage of antineoplastic drugs has historically been based on individualized prescription and preparation according to body surface area or patient ́s weight. Lack of resources and increased assistance workload in the areas where chemotherapy is made, are leading to the development of new systems to optimize the processing without reducing safety. One of the strategies that has been proposed is the elaboration by dose banding. This new approach standardizes the antineoplastic agents doses by making ranges or bands accepting a percentage of maximum variation. It aims to reduce processing time with the consequent reduction in waiting time for patients; to reduce errors in the manufacturing process and to promote the rational drug use. In conclusion, dose banding is a suitable method for optimizing the development of anticancer drugs, obtaining reductions in oncologic patients waiting time but without actually causing a favorable impact on direct or indirect costs (AU)

Selective ophthalmic intra-arterial melphalan therapy for advanced retinoblastoma: implementation and outcomes of a new chemotherapy protocol.

Retinoblastoma is a relatively uncommon childhood tumor. If untreated, RB grows to fill the eye and destroys the ocular globe's internal architecture. Metastatic spread usually begins after the first 6 months, and death occurs within a matter of years. When treated, overall survival rounds 97%, the alkylating drug melphalan being the most extensively used chemotherapeutic agent in localized treatment. In our hospital, pediatric oncologists asked the Pharmacy Department for assessment in order to implement a new chemotherapy protocol for the treatment of advanced intraocular elegible retinoblastoma cases using melphalan administered directly through the ophthalmic artery. In this paper, we describe the protocol implementation carried out by our collaborative interdisciplinary team as well as the clinical outcomes of five cases treated with ophthalmic intra-arterial melphalan therapy. Oncology pharmacists can contribute with their knowledge to the implementation process of new collaborative practice protocols recommending doses, predicting possible adverse effects and assessing about drug stability and elaboration, packaging and administration methods.