Cost-effectiveness of new targeted therapy sunitinib malate as second line treatment in metastatic renal cell carcinoma in Argentina

Objetivo: el objetivo del estudio fue estimar el costo-efectividad del malato de sunitinib versus el mejor cuidado paliativo (best supportive care BSC) en el tratamiento de carcinoma de células renales metastásico resistente a citoquinas (mRCC) en pacientes que fallaron a interleuquina 2 (IL-2), interferón alfa o una combinación de ambos. Métodos: se desarrollo un modelo de Markov y se adaptó a las circunstancias argentinas. Los resultados de efectividad fueron tomados de estudios clínicos y de la base de datos de US Medicare. Los datos fueron ajustados con las estimaciones de mortalidad general de la población tomadas de fuentes argentinas. Las utilidades fueron colectadas con la ayuda del cuestionario EQ-5D en el estudio clínico. La principal fuente de datos de uso de recursos y costos fueron tomados de un instituto oncológico de Argentina. Los costos fueron calculados en pesos argentinos (AR$) de 2006. Tanto los costos como la efectividad fueron descontados a una tasa anual de 3%. El costo-efectividad incremental fue calculado por mes libre de progresión (PFM), año de vida ganado (YLG) y año de vida ajustado por calidad (QALY). Se efectuó un análisis de sensibilidad determinístico y probabilístico para las variables de efectividad y costo.

Introduction: The objective of this study was to estimate the cost-effectiveness of sunitinib malate versus the best palliative care (BSC best supportive care) in the treatment of metastatic renal cell carcinoma resistant to cytokines (MRCC) in patients who failed to interleukin 2 ( IL-2), interferon alpha or a combination of both. Methods: We developed a Markov model and was adapted to the circumstances in Argentina. The results of effectiveness were obtained from clinical studies and the database of U.S. Medicare. The data were adjusted by the estimates of mortality of the population taken from Argentine sources. The utilities were collected with the help of the EQ-5D questionnaire in the clinical study. The main source of data for resource use and costs were taken from an oncology institute in Argentina. The costs were calculated in Argentine pesos (AR $), 2006. Both the costs and effectiveness were discounted at an annual rate of 3%. The cost-effectiveness was estimated by progression-free months (PFM), year of life gained (YLG) and years of life adjusted for quality (QALY). An analysis of deterministic and probabilistic sensitivity for the variables of cost and effectiveness.

[Arterialization of the distal veins of the foot for limb salvage in arteritis. Techniques and results]. / L'artérialisation des veines du pied pour sauvetage de membre chez l'artéritique. Technique et résultats.

STUDY AIM: The aim of this retrospective study was to report the long term results with arterialisation of the veins of the foot as the final attempt to save an ischaemic limb when classical techniques have proved ineffective or impossible. PATIENTS AND METHOD: From January 1974 to July 2000, 60 arterialisations of the distal veins of the foot were performed in 59 patients with arteritis, associated in 25 of them with diabetes mellitus. There were 41 men and 18 women, their mean age was 72 years (range from 49 to 95 years). There were 50 stage IV patients and 9 stage III patients. The arterialisation was performed by a reversed venous bypass between the femoral or popliteal artery and an internal vein of the foot, after destruction of the valvulas of the forefoot veins. The distal anastomosis was made termino lateral in order to provide tissular nutrition and to avoid blood congestion. RESULTS: The result was considered good when a major amputation was avoided during one year at least, with a bypass permeability longer than one month. Among the 60 arterialisations, 36 were successful (60%), 7 in the short term (between one month and one year), 15 in the medium term (between one and five years), 14 in the long term (more than 5 years). Among the 15 medium-term good results, the mean time of bypass permeability was one year; three patients died, six were lost of follow-up, and six were still alive, four of them with a permeable bypass, at the time of the study. Among the 14 long term results, spontaneous bypass occlusion occurred after a 26-month mean time; despite this occlusion, the favourable result persisted till the death of the patient after a mean delay of 9 years (range from 5 to 15 years). The 24 other patients had a poor result followed by a major amputation. There were no deaths in relation with the reversed circulation. CONCLUSION: These results suggest that the arterialisation of the distal veins of the foot may be considered a useful revascularization technique for limb salvage when all the classical methods have failed or are impossible.