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Nintedanib in combination with docetaxel for second-line treatment of advanced non-small-cell lung cancer; GENESIS-SEFH drug evaluation report.

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Date
2016-06-01
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Aula Médica Editores
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Abstract
Nintedanib es un inhibidor de la angiogénesis tumoral que está autorizado por la EMA en combinación con docetaxel para el tratamiento de pacientes adultos con cáncer de pulmón no microcítico (CPNM) localmente avanzado, metastásico o localmente recurrente con histología tumoral de adenocarcinoma después de la quimioterapia de primera línea. De acuerdo con los resultados del ensayo LUME-Lung 1, la combinación de nintedanib más docetaxel frente a monoterapia con docetaxel muestra una mejora en la supervivencia libre de progresión (SLP) en los pacientes con CPNM y mejora la supervivencia global en el grupo de pacientes con histología de adenocarcinoma, sobre todo en aquellos cuya progresión tras el inicio a la primera línea fue antes de 9 meses. El perfil de toxicidad de la combinación muestra un aumento en la incidencia de neutropenia, trastornos digestivos y aumento de transaminasas; sin embargo, esto no produjo mayor deterioro en la calidad de vida de los pacientes. Según los datos del citado ensayo, con la adición de nintedanib a docetaxel el coste estimado de cada año de vida con SLP en la población global con el precio notificado sería de 134.274,47€. En el grupo de adenocarcinoma, por cada año de vida ganado (AVG) con la adición de nintedanib al docetaxel el coste eficacia incremental (CEI) sería de 40.886,14 €, mientras que aplicando un análisis de sensibilidad que supusiera un descuento de un 25% el coste por AVG sería de 32.364,05 €, situándose cerca del umbral de coste-efectividad generalmente considerado en nuestro medio como aceptable. A la vista de los resultados de eficacia y seguridad, el posicionamiento propuesto es recomendar su inclusión en la Guía Farmacoterapéutica solo en pacientes adultos con CPNM metastásico o localmente recurrente con histología tumoral de adenocarcinoma después de la quimioterapia de primera línea y en los que la progresión sea < 9 meses desde el inicio de primera línea teniendo en cuenta los criterios de inclusión y exclusión del ensayo pivotal.
Nintedanib is a triple angiokinase inhibitor that has been approved by the European Agency Medicines (EMA) in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy. In LUME-Lung 1 clinical trial, the combination of nintedanib plus docetaxel vs. placebo plus docetaxel improved progression free survival (PFS) in NSCLC patients, and improved overall survival in the population of adenocarcinoma patients, particularly in those with progression within 9 months after first line treatment initiation, median 10.9 months ( [95% CI 8.5-12.6] vs. 7.9 months [6.7-9.1]; HR 0.75 [95% CI 0.60-0.92], p=0.0073). The toxicity profile of the combination included a higher incidence of neutropenia, gastro-intestinal (GI) disorders, and liver enzyme elevations; however, this did not cause a detrimental effect on patient quality of life. According to data from the clinical trial mentioned, the addition of nintedanib to docetaxel would lead to an estimated incremental cost-effectiveness ratio (ICER) per year of life with PFS in the overall population of 134,274.47 € (notified price). In the adenocarcinoma population per each life of year gained (LYG), the ICER of adding nintedanib to docetaxel would be 40,886.14 €; while by implementing a sensitivity analysis with a 25% discount in the drug price, the cost per LYG would be 32,364.05 €, and would place it close to the threshold of cost-effectiveness usually considered acceptable in our setting. In view of efficacy and safety results the proposed positioning is to recommend its inclusion in the Hospital Formulary only for adult patients with metastatic or locally recurrent NSCLC with adenocarcinoma histology after first line chemotherapy, with progression < 9 months from the initiation of first line treatment, taking into account the inclusion and exclusion criteria in the pivotal clinical trial.
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MeSH Terms
Medical Subject Headings::Diseases::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Adenocarcinoma
Medical Subject Headings::Named Groups::Persons::Age Groups::Adult
Medical Subject Headings::Diseases::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Carcinoma, Non-Small-Cell Lung
Medical Subject Headings::Health Care::Health Care Economics and Organizations::Economics::Costs and Cost Analysis::Cost-Benefit Analysis
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Survival Analysis::Disease-Free Survival
Medical Subject Headings::Information Science::Information Science::Communications Media::Publications::Books::Reference Books::Formularies as Topic::Formularies, Hospital
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Data Collection::Vital Statistics::Morbidity::Incidence
Medical Subject Headings::Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 2-Ring::Indoles
Medical Subject Headings::Anatomy::Digestive System::Liver
Medical Subject Headings::Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Neoplastic Processes::Neoplasm Recurrence, Local
Medical Subject Headings::Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Leukocyte Disorders::Leukopenia::Agranulocytosis::Neutropenia
Medical Subject Headings::Disciplines and Occupations::Social Sciences::Quality of Life
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Hydrocarbons::Hydrocarbons, Cyclic::Hydrocarbons, Alicyclic::Cycloparaffins::Cyclodecanes::Taxoids
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Keywords
Non small cell lung cancer, Nintedanib, Cost-effectiveness, Docetaxel, Cáncer de pulmón no microcítico, Coste-efectividad, Adenocarcinoma, Adulto, Carcinoma de pulmón de células no pequeñas, Análisis costo-beneficio, Supervivencia sin enfermedad, Formularios de hospitales, Humanos, Incidencia, Indoles, Hígado, Recurrencia local de neoplasia, Neutropenia, Calidad de vida, Taxoides
Citation
Espinosa Bosch M, Asensi Diez R, García Agudo S, Clopes Estela A. Nintedanib in combination with docetaxel for second-line treatment of advanced non-small-cell lung cancer; GENESIS-SEFH drug evaluation report. Farm Hosp. 2016; 40(4):316-27