ABSTRACT
We performed a subanalysis of cancer patients enrolled in a clinical trial that compared long-term (6 months) treatment with a low-molecular-weight heparin (LMWH) administered subcutaneously or with acenocoumarol. The subanalysis assessed whether the characteristics of the tumor had an influence on the clinical response. A randomized open trial included 69 patients with cancer and symptomatic proximal deep vein thrombosis of the lower limbs. The tumor characteristics and treatment type were recorded. The main assessment criterion was the 12-month incidence of recurrent symptomatic venous thromboembolism (VTE). Sixty-one patients (88.4%) were analyzed. At the time of inclusion, the cancer characteristics and treatment were comparable between the 2 groups. Over the course of 12 months, the recurrent VTE was significantly greater in the elderly patients (71.5 ± 6.4 vs. 62.0 ± 15.1; p=.006). The logistic regression analysis showed no association between VTE recurrence and the location or extent of the tumor. However, the use of thrombogenic chemotherapy (p=.045) was independently associated with VTE recurrence, and longterm treatment with tinzaparin was almost a protective factor (p=.15). In this small sample, we observed an association between thrombogenic chemotherapy and recurrent VTE. The tendency towards a reduction in VTE recurrence at 12 months in patients with cancer in the LMWH group could be attributed to the effect of the full LMWH dosage.
Subject(s)
Acenocoumarol/therapeutic use , Anticoagulants/therapeutic use , Fibrinolytic Agents/therapeutic use , Heparin, Low-Molecular-Weight/therapeutic use , Neoplasms/complications , Venous Thrombosis/drug therapy , Adult , Aged , Drug Administration Schedule , Female , Humans , Logistic Models , Male , Middle Aged , Recurrence , Risk Factors , Treatment Outcome , Venous Thrombosis/etiologyABSTRACT
Realizamos un subanálisis de los pacientes con cáncer incluidos en un ensayo clínico en el que se comparaba el tratamiento a largo plazo (6 meses) con una heparina de bajo peso molecular (HBPM) subcutánea o con acenocumarol, para evaluar si las características del tumor tenían alguna influencia sobre la respuesta clínica. En un ensayo aleatorizado y abierto se incluyó a 69 pacientes con cáncer y trombosis venosa profunda proximal sintomática de miembros inferiores. Se registraron las características del tumor y el tipo de tratamiento. El criterio de valoración principal fue la incidencia a 12 meses de tromboembolia venosa (TEV) sintomática recurrente. Se analizó a 61 pacientes (88,4%). En el momento de la inclusión, las características y tratamiento del cáncer eran comparables entre ambos grupos. A lo largo del período de 12 meses, la TEV recurrente fue significativamente mayor en los pacientes ancianos (71,5 ± 6,4 frente a 62,0 ± 15,1; p = 0,006). En el análisis de regresión logística no se encontró ninguna asociación entre la recurrencia de TEV y la localización o la extensión del tumor. Sin embargo, el uso de quimioterapia trombogénica (p = 0,045) se asoció de forma independiente a la recurrencia de la TEV y el tratamiento a largo plazo con tinzaparina estuvo cerca de ser un factor de protección (p = 0,15). En esta pequeña muestra se observó una asociación entre la quimioterapia trombogénica y la TEV recurrente. La tendencia a una disminución de la recurrencia de la TEV a los 12 meses en pacientes con cáncer del grupo de la HBPM podría atribuirse al efecto de la dosis plena de HBPM (AU)
We performed a subanalysis of cancer patients enrolled in a clinical trial that compared long-term (6 months) treatment with a low-molecular-weight heparin (LMWH) administered subcutaneously or with acenocoumarol. The subanalysis assessed whether the characteristics of the tumor had an influence on the clinical response. A randomized open trial included 69 patients with cancer and symptomatic proximal deep vein thrombosis of the lower limbs. The tumor characteristics and treatment type were recorded. The main assessment criterion was the 12-month incidence of recurrent symptomatic venous thromboembolism (VTE). Sixty-one patients (88.4%) were analyzed. At the time of inclusion, the cancer characteristics and treatment were comparable between the 2 groups. Over the course of 12 months, the recurrent VTE was significantly greater in the elderly patients (71.5±6.4 vs. 62.0±15.1; p=.006). The logistic regression analysis showed no association between VTE recurrence and the location or extent of the tumor. However, the use of thrombogenic chemotherapy (p=.045) was independently associated with VTE recurrence, and longterm treatment with tinzaparin was almost a protective factor (p=.15). In this small sample, we observed an association between thrombogenic chemotherapy and recurrent VTE. The tendency towards a reduction in VTE recurrence at 12 months in patients with cancer in the LMWH group could be attributed to the effect of the full LMWH dosage (AU)
Subject(s)
Humans , Heparin, Low-Molecular-Weight/pharmacokinetics , Vitamin K/antagonists & inhibitors , Venous Thromboembolism/drug therapy , Neoplasms/complications , Acenocoumarol/pharmacokinetics , Time/statistics & numerical data , Injections, Subcutaneous , Treatment Outcome , Antineoplastic AgentsABSTRACT
The objective of the present study was to evaluate the efficacy, safety and healthcare resource utilization of long-term treatment with tinzaparin in symptomatic patients with acute pulmonary embolism as compared to standard therapy. In this open-label trial, 102 patients with objectively confirmed pulmonary embolism were randomized to receive, after initial treatment with tinzaparin, either tinzaparin (175 IU/kg/day) or international normalized ratio-adjusted acenocoumarol for 6 months. Clinical endpoints were assessed during the 6 months of treatment. A pharmacoeconomic analysis was carried out to evaluate the cost of the long-term treatment with tinzaparin in comparison with the standard one. In an intention-to-treat analysis, one of 52 patients developed recurrent venous thromboembolism in the tinzaparin group compared with none of the 50 patients in the acenocoumarol group. One patient in each group had a major haemorrhagic complication. Six patients in the acenocoumarol group had minor bleeding compared with none in the tinzaparin group (P = 0.027). Median hospital length of stay was shorter in the tinzaparin group compared to the acenocoumarol group (7 versus 9 days; P = 0.014). When all the direct and indirect cost components were combined for the entire population, we found a slight, nonstatistically significant (mean difference 345; 95% CI 1382-2071; P = 0.69) reduction in total cost with tinzaparin. Symptomatic acute pulmonary embolism treatment with full therapeutic doses of tinzaparin for 6 months is a feasible alternative to conventional treatment with vitamin K antagonists.
