RESUMO
OBJECTIVE: To review the available literature on the administration of oral antineoplastic drugs in patients with swallowing disorders and ystematize the information obtained. METHOD: Between September 2019 and April 2020, two hospital harmacists drew up a list of the oral antineoplastic drugs available in Spain, which was then distributed to three hospital pharmacists, each of whom carried out a literature search and a review. An analysis was made of the prescribing information and searches were performed in Pubmed, Micromedex, Uptodate, the Cancer Care Ontario website, different pharmaceutical bulletins, feeding tube administration guidelines, and tertiary information sources. Lastly, the pharmaceutical industry was contacted. The group systematized the information obtained, after which a fourth hospital pharmacist and an independent physician reviewed the work carried out. RESULTS: A total of 64 oral antineoplastic drugs were reviewed. Relevant information was obtained for 48 drugs, of which 44 were amenable to administration to these patients (69% of the investigated drugs). A systematization of the information found was carried out. Conclusions: Despite having found different methods for preparing and administering most of the oral antineoplastic drugs reviewed, the information compiled was rather scarce and with a low level of evidence. Further studies, based on pharmacokinetic and stability studies, are necessary in this field as there is a sore need for oral liquid pharmaceutical forms or extemporaneous preparations allowing administration of oral antineoplastic drugs to these patients.
Objetivo: Revisar la literatura disponible sobre la administración de antineoplásicos orales en pacientes con trastornos de la deglución y realizar una síntesis de la información hallada.Método: En el periodo septiembre 2019-junio 2020, tres farmacéuticos hospitalarios elaboraron una lista con los antineoplásicos orales disponibles en España, la cual fue repartida, y cada cual llevó a cabo la búsqueda y revisión bibliográfica de los medicamentos asignados. Se revisaron las fichas técnicas y así como Pubmed, Micromedex, Uptodate, la página web del Cancer Care Ontario, diferentes boletines farmacéuticos, guías de administración por sonda y otras fuentes terciarias de información. En último lugar, se contactó con la industria farmacéutica. Posteriormente cada uno sintetizó la información que había hallado y para concluir, un médico y un cuarto farmacéutico hospitalario revisaron todo el trabajo llevado a cabo.Resultados: Se revisaron un total de 64 fármacos antineoplásicos orales. Se obtuvo información pertinente en el caso de 48, de los cuales 44 presentaban posibilidad de administración en estos pacientes (un 69% de los fármacos investigados). Se realizó una síntesis de la información hallada.Conclusiones: Pese a haber encontrado posibles métodos de preparación y administración para la mayoría de los antineoplásicos orales revisados, se constata que la información es más bien escasa y con bajo nivel de evidencia. Es necesario seguir investigando en este campo, ya que se precisan formas farmacéuticas líquidas, o preparaciones extemporáneas, que en base a estudios farmacocinéticos y de estabilidad permitan la administración de antineoplásicos orales en este grupo de pacientes.
Assuntos
Antineoplásicos , Transtornos de Deglutição , Preparações Farmacêuticas , Administração Oral , Antineoplásicos/efeitos adversos , Transtornos de Deglutição/tratamento farmacológico , Humanos , FarmacêuticosRESUMO
Background Immunotherapy has become a standard treatment for lung cancer; however, the high cost makes it necessary to assess health outcomes. Objective The aim of this study was to evaluate the effectiveness, safety and economic cost of nivolumab in real-world clinical practice. Setting Fifteen regional and academic hospitals from Spain participated in this study. Methods This study was a retrospective, multicentre and observational study involving patients who experienced progression after first-line therapy for non-small-cell lung cancer and were treated with nivolumab between January 2016 and July 2017. Effectiveness and safety were evaluated by the oncologist, and the data from the electronic clinical records of the patients were collected by the research team. Economic cost was calculated using the cost of acquiring nivolumab for the public health system. Main outcome measures Effectiveness variables were overall survival (OS) and progression-free survival (PFS). The safety variable was the incidence of adverse events (AEs), and the cost per life-year gained (LYG) was the economic variable. Results A total of 221 patients were enrolled (83.7% men). The mean age was 64.5 years, and 84.6% of the patients had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-1. Squamous tumours accounted for 59.7% of the total, and 78.7% of the patients presented a time since platinum therapy (TPT) > 6 months. The mean nivolumab dose was 216 mg (SD 211), and the treatment duration was 7.0 months (95% CI 5.8-8.1). The median PFS was 5.3 months (95% CI 3.2-7.3), and OS was 9.7 months (95% CI 7.6-11.8). The median PFS and OS values were statistically significantly superior for patients with an ECOG score of 0-1 and for patients with a TPT > 6 months. The median OS was also statistically significantly superior for patients with non-squamous histology. Regarding safety, 71% of the patients presented AEs of any grade, and in 18.6%, the nivolumab treatment had to be delayed or discontinued. The cost of nivolumab per patient was 19,910.00 (SD 19,369), and the cost per LYG was 110,026.00 (77,557.00-231,171.00). Conclusions This study confirms that the efficacy and safety of nivolumab treatment in a real population are comparable to the results obtained in clinical trials. A greater clinical benefit of nivolumab therapy was observed in patients with an ECOG score of 0-1, a TPT > 6 months or non-squamous histology. Despite the benefit observed, the cost per LYG is above the threshold of efficiency established by public health institutes.