RESUMEN
PURPOSE: Gemcitabine and capecitabine are 2 anticancer drugs with a mechanism of action involving metabolism of pyrimidine nucleotides. Both are among the few agents active in patients with metastatic breast cancer (MBC) progressing after therapy with anthracyclines and taxanes. We have conducted a phase II trial of gemcitabine/capecitabine in patients with disease progression after treatment with anthracyclines and taxanes. PATIENTS AND METHODS: Treatment included gemcitabine 2000 mg/m2 on day 1 every 3 weeks and capecitabine 2500 mg/m2 daily (divided into 2 doses) on days 1-14 every 3 weeks; treatment was administered until disease progression or unacceptable toxicity was documented. All patients received concomitant oral pyridoxine 300 mg twice daily to prevent hand-foot syndrome (HFS). Of 39 patients treated, 33 had received previous treatment with anthracyclines, 6 had medical contraindication to anthracyclines, 35 had previously received taxanes, and 23 had received vinorelbine. Fourteen patients had previous high-dose chemotherapy with stem cell rescue and 5 had previously received trastuzumab. Patients were 31-79 years of age (median, 55 years) and, altogether, were given 386 courses of therapy (range, 1-36 courses per patient; median, 6 courses). RESULTS: Grade 3/4 toxicities included HFS (11 courses, 6 patients), stomatitis (6 courses, 2 patients), diarrhea (5 courses, 4 patients), anemia (5 courses, 2 patients), thrombocytopenia (5 courses, 2 patients), and neutropenia (1 course, 1 patient). Response rate (all 39 patients were evaluable) was 48.7% (partial response, n = 19; stable disease, n = 7; progressive disease, n = 13). Thirty-six patients died because of disease progression, and 3 are alive with progressive disease. Median follow-up was 26 months or until death. Median duration of response was 15 months (range, 3-26 months). Median time to disease progression was 5 months (range, 1-26 months). Median overall survival duration was 10 months (range, 1-37 months). CONCLUSION: In this cohort of patients heavily pretreated with anthracyclines and taxanes, the response rate to gemcitabine/capecitabine is encouraging, although response duration is limited.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Adulto , Anciano , Antraciclinas/farmacología , Antraciclinas/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de la Mama/patología , Capecitabina , Desoxicitidina/administración & dosificación , Desoxicitidina/análogos & derivados , Progresión de la Enfermedad , Resistencia a Antineoplásicos , Femenino , Fluorouracilo/análogos & derivados , Humanos , Infusiones Intravenosas , Persona de Mediana Edad , Recurrencia Local de Neoplasia/tratamiento farmacológico , Taxoides/farmacología , Taxoides/uso terapéutico , Resultado del Tratamiento , GemcitabinaRESUMEN
OBJECTIVE: To evaluate the cost-effectiveness of samarium [153Sm-EDTMP] (Quadramet) compared to conventional therapy in the treatment of pain in patients with prostate cancer and bone metastases. METHOD: A decision tree model for the treatment of bone pain due to metastases was adapted to the Spanish context. The model represents the standard treatment patterns in Spain for the study population. The time-course of the model is 4 months and it computes an estimate for the cost of pain control per patient. The effectiveness data for the model derive from a randomised trial. The current treatment patterns have been established according to the consensus opinions of a group of medical experts. RESULTS: The cost of pain control per patient is euro 12,515.39 for conventional therapy and euro 5,595.52 for samarium-153 (Quadramet) therapy. The incremental cost-effectiveness analysis shows that samarium-153 (Quadramet) is a dominant therapy. It presents lower costs and higher efficacy than the conventional strategy. The sensitivity analyses showed these results to be robust. CONCLUSION: Samarium-153 (Quadramet) is cost-effective in treating pain in patients with prostate cancer and bone metastases.
Asunto(s)
Adenocarcinoma/economía , Analgésicos no Narcóticos/economía , Neoplasias Óseas/economía , Compuestos Organometálicos/economía , Compuestos Organofosforados/economía , Neoplasias de la Próstata/economía , Radioisótopos/economía , Adenocarcinoma/tratamiento farmacológico , Adenocarcinoma/secundario , Analgésicos no Narcóticos/uso terapéutico , Neoplasias Óseas/tratamiento farmacológico , Neoplasias Óseas/secundario , Análisis Costo-Beneficio , Costos de los Medicamentos , Humanos , Masculino , Modelos Económicos , Compuestos Organometálicos/uso terapéutico , Compuestos Organofosforados/uso terapéutico , Dimensión del Dolor/métodos , Neoplasias de la Próstata/tratamiento farmacológico , Neoplasias de la Próstata/patología , Samario/economía , Resultado del TratamientoRESUMEN
Objetivo. Realizar un análisis coste-efectividad de samario [153Sm-EDTMP] (Quadramet®) respecto a la terapia convencional, para el tratamiento del dolor causado por metástasis óseas en pacientes con cáncer de próstata. Metodología. Se ha adaptado un modelo de árbol de decisión, que representa el tratamiento del dolor óseo metastásico, al contexto español. El modelo muestra las opciones terapéuticas habituales en el contexto sanitario español para la población del estudio. El horizonte temporal del modelo es de 4 meses y calcula el cociente coste-efectividad por paciente controlado. Los datos de eficacia del modelo provienen de un ensayo clínico aleatorizado. Las pautas de tratamiento habituales en España han sido indicadas por varios especialistas médicos. Resultados. El coste por paciente controlado para la terapia convencional es de 12.515,39 y para la terapia con samario-153 (Quadramet®) es de 5.595,52 . El análisis coste-efectividad incremental muestra que samario-153 (Quadramet®) es una terapia dominante, es decir, que presenta una mayor eficacia y un menor coste que la terapia convencional. Los resultados obtenidos han demostrado ser robustos en un extenso análisis de sensibilidad. Conclusiones. La terapia con samario-153 (Quadramet®) es eficiente en el tratamiento del dolor de pacientes con cáncer de próstata y metástasis óseas
Objective. To evaluate the cost-effectiveness of samarium [153Sm-EDTMP] (Quadramet®) compared to conventional therapy in the treatment of pain in patients with prostate cancer and bone metastases. Method. A decision tree model for the treatment of bone pain due to metastases was adapted to the Spanish context. The model represents the standard treatment patterns in Spain for the study population. The time-course of the model is 4 months and it computes an estimate for the cost of pain control per patient. The effectiveness data for the model derive from a randomised trial. The current treatment patterns have been established according to the consensus opinions of a group of medical experts. Results. The cost of pain control per patient is 12,515.39 for conventional therapy and 5,595.52 for samarium-153 (Quadramet®) therapy. The incremental cost-effectiveness analysis shows that samarium-153 (Quadramet®) is a dominant therapy. It presents lower costs and higher efficacy than the conventional strategy. The sensitivity analyses showed these results to be robust. Conclusion. Samarium-153 (Quadramet®) is cost-effective in treating pain in patients with prostate cancer and bone metastases