RESUMO
Introdução: O câncer colorretal (CCR) é o segundo mais incidente e, quando metastático, apresenta taxa de sobrevida de 14% em cinco anos. Regorafenibe é um inibidor de tirosina-quinase (ITQ) aprovado para CCR metastático (CCRm) com aumento comprovado de sobrevida global (SG). Objetivo: Explorar resultados de eficácia e segurança de regorafenibe em pacientes com CCRm e características de bom prognóstico (CBP). Método: Análise de subgrupo do estudo CORRECT, com participantes divididos de acordo com CBP, seguindo os critérios: Eastern Cooperative Oncology Group (ECOG) 0, tempo de doença metastática maior que 18 meses, até três sítios metastáticos e ausência de metástase hepática. Eficácia comparada com teste de log-rank estratificado e hazad ratios (HR) calculados com o modelo de Cox. Resultados: Dos 760 participantes randomizados, 292 (34,5%) apresentavam CBP; 185 (63,4%) receberam regorafenibe; 107 (35,6%), placebo. Para o grupo CBP, a mediana SG foi 10,9 meses (IC95%:8,8-12,3) para regorafenibe e 7,3 meses (IC95%:5,6-9,1) para placebo, com 39% de redução no risco de morte (HR 0,61; IC95%:0,43-0,88; p=0,0069). A mediana de sobrevida livre de progressão (SLP) foi de 3,5 meses (IC95%:3,0-3,9) versus 1,8 mês (IC95%:1,7-1,8) respectivamente, com 61% de redução no risco de progressão da doença ou morte (HR 0,39; IC95%:0,30-0,52; p<0,0001). Os eventos adversos graus 3 e 4 foram mais frequentes para regorafenibe. Após definição de valor basal para escores de qualidade de vida (EQ-5D), estes decaíram menos para regorafenibe comparados com placebo (0,687 versus 0,592) com diferença significativa de 0,09. Conclusão: Pacientes com CBP que receberam regorafenibe melhoraram SG e SLP com menor deterioração da qualidade de vida comparado com placebo
Introduction: Colorectal cancer (CRC) is the second most common and when metastatic, it has a five-year survival rate of 14%. Regorafenib is an approved TKI for metastatic colorectal cancer (mCRC) with a proven increase in overall survival (OS). Objective: To investigate the efficacy and safety results of regorafenib in patients with mCRC and good prognostic characteristics (GPC). Method: Subgroup analysis of the CORRECT study, with participants divided according to GPC, following the criteria: Eastern Cooperative Oncology Group (ECOG) 0, duration of metastatic disease greater than 18 months, up to three metastatic sites and absence of liver metastasis. Efficacy compared with stratified log-rank test and hazard ratios (HR) calculated with the Cox model. Results: Of the 760 participants randomized, 292 (34.5%) had GPC; 185 (63.4%) received regorafenib; and 107 (35.6%) received placebo. For the GPC group, the median OS was 10.9 months (95%CI:8.8-12.3) for regorafenib and 7.3 months (95%CI:5.6-9.1) for placebo, with 39% of reduction of the risk of death (HR 0.61; 95% CI:0.43-0.88; p=0.0069). The median progression-free survival (PFS) was 3.5 months (95%CI:3.0-3.9) versus 1.8 months (95%CI:1.7-1.8) respectively, with 61% of reduced risk of disease progression or death (HR 0.39; 95%CI:0.30-0.52; p<0.0001). Grade 3 and 4 adverse events were more frequent for regorafenib. After setting baseline for quality of life scores (EQ-5D), these declined less for regorafenib compared to placebo (0.687 versus 0.592) with a significant difference of 0.09. Conclusion:GPC patients who received regorafenib improved OS and PFS with less deterioration of quality-of-life compared to placebo
Introducción: El cáncer colorrectal (CCR) es el segundo más frecuente y cuando presenta metástasis tiene una supervivencia a los cinco años del 14%. Regorafenib es un inhibidor de la tirosina quinasa (ITQ) aprobado para CCR metastásico (CCRm) con un aumento comprobado en la supervivencia general (SG). Objetivo: Explorar los resultados de eficacia y seguridad de regorafenib en pacientes con CCRm y características de buen pronóstico (CBP). Método: Análisis de subgrupos del estudio CORRECT, con participantes divididos según CBP, siguiendo los criterios: Eastern Cooperative Oncology Group (ECOG) 0, duración de la enfermedad metastásica mayor a 18 meses, hasta tres sitios metastásicos y ausencia de metástasis hepática. Eficacia comparada con la prueba de log-rank estratificada y hazad ratios (HR) calculados con el modelo de Cox.Resultados: De los 760 participantes aleatorios, 292 (34,5%) tenían CBP; 185 (63,4%) recibieron regorafenib; 107 (35,6%) recibieron placebo. Para el grupo de CBP, la mediana de SG fue de 10,9 meses (IC95%:8,8-12,3) para regorafenib y de 7,3 meses (IC95%:5,6-9,1) para placebo, con una reducción del riesgo de muerte del 39% (HR 0,61; IC95%:0,43-0,88; p=0,0069). La mediana de supervivencia libre de progresión (PFS) fue de 3,5 meses (IC95%:3,0-3,9) frente a 1,8 meses (IC95%:1,7-1,8) respectivamente, con un 61% de riesgo reducido de progresión de la enfermedad o muerte (HR 0,39; IC95%:0,30-0,52; p<0,0001). Los eventos adversos de grado 3 y 4 fueron más frecuentes con regorafenib. Después de establecer la línea de base para las puntuaciones de calidad de vida (EQ-5D), estas disminuyeron menos con regorafenib en comparación con placebo (0,687 frente a 0,592) con una diferencia significativa de 0,09. Conclusión: Los pacientes con CBP que recibieron regorafenib mejoraron la SG y la SLP con un menor deterioro en la calidad de vida en comparación con el placebo
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Neoplasias Colorretais , Análise de Sobrevida , Inibidores de Proteínas Quinases , Metástase NeoplásicaRESUMO
OBJECTIVES: The aim of this study was to evaluate the direct costs of type 2 diabetes mellitus patients treated in a Brazilian public hospital. METHODS: This was an exploratory retrospective cost-of-illness study with quantitative approach, using medical records of patients treated in a public hospital (2012-14), with at least one consultation over a period of 12 months. Data on patient's profile, exams, number of consultations, medications, hospitalizations, and comorbidities were collected. The cost per patient per year (pppy) was calculated as well as the costs related to glycated hemoglobin (HbA1c) values, using thresholds of 7 and 8 percent. RESULTS: Data of 726 patients were collected with mean age of 62 ± 11 years (68.3 percent female). A total of 67.1 percent presented HbA1c > 7 percent and 44.9 percent > 8 percent. The median cost of diabetes was United States dollar (USD) 197 pppy. The median costs of medication were USD 152.49 pppy, while costs of exams and consultations were USD 40.57 pppy and 8.70 pppy, respectively. Thirty-eight patients (4 percent) were hospitalized and presented a median cost of 3,656 per patient per hospitalization with a cost equivalent to 53.1 percent of total expenses. Total costs of patients with HbA1c ≤ 7 percent were lower for this group and also costs of medications and consultations, whereas for patients with HbA1c ≤ 8 percent, only total costs and costs of medications were lower when compared with HbA1c > 8 percent patients. CONCLUSIONS: Medications and hospitalizations were the major contributor of diabetes expenses. Preventing T2DM, or reducing its complications through adequate control, may help avoid the substantial costs related to this disease.