RESUMEN
Introduction: This study aims to assess safety and effectiveness of pertuzumab in combination with trastuzumab and docetaxel in the neoadjuvant treatment (NeoT) of HER2-positive breast cancer. Methods: Two consecutive retrospective cohorts (n = 94, 2012-2015 and 2015-2017) of adult women with HER2-positive breast cancer, receiving NeoT at the breast clinic in Portugal (IPO-Porto), were followed. All patients had surgery and received trastuzumab as adjuvant therapy. The 2012-2015 cohort received doxorubicin, cyclophosphamide, docetaxel plus trastuzumab, whereas the 2015-2017 cohort was treated with the same protocol plus pertuzumab. Results: The 2012-2015 cohort was older (median 53 years), with locally advanced tumors (48.1%), mostly hormone receptor positive (59.3%). The 2015-2017 cohort was younger (median 43 years) with 60% operable tumors. Pathologic complete response (pCR) improved in the second cohort, while maintaining a good safety profile and tolerability. Clinical staging (p = 0.001) and hormone receptor (p = 0.003) were significant predictors of pCR, but not treatment regimen (p = 0.304). Conclusion: Further research with larger samples and longer follow-up is needed to understand the clinical differences. Clinical effectiveness of treatment should also be measured through overall and progression-free survival.
RESUMEN
INTRODUCTION: High values of lipoprotein(a), related to atherosclerosis progression, are often considered a marker of thrombosis. We assessed the lipoprotein(a) profile in a group of patients with high vascular risk and no cardiovascular events, established its correlation with other cardiovascular risk factors and inferred the results for patients with metabolic disorders and, at least, two risk factors. MATERIAL AND METHODS: This longitudinal observational study included 516 patients, who had at least two cardiovascular risk factors and regularly attended, for at least two years, the outpatient consultations at a clinic of metabolism and vascular risk for primary prevention. Sociodemographic, clinical and anthropometric parameters were obtained at the baseline visit. Hepatic morphology was assessed in 509 patients (98.6%) by ultrasonography. The 10-year vascular risk was estimated using Framingham risk score, atherosclerotic cardiovascular disease and systematic coronary risk evaluation tables. RESULTS: Significant correlations were found between lipoprotein(a) levels and the addressed vascular risk factors, as well as between lipoprotein(a), and Framingham risk score, atherosclerotic cardiovascular disease and systematic coronary risk evaluation charts. Lipoprotein(a) values were also considerably higher in patients with steatosis. DISCUSSION: Increased lipoprotein(a) values were directly associated with all markers of cardiovascular risk and with non-alcoholic hepatic steatosis. CONCLUSION: Due to its high availability and low cost, lipoprotein(a) should become part of the routine evaluation of patients at vascular risk.
Introdução: Valores elevados de lipoproteína(a), relacionados com a progressão da aterosclerose, são frequentemente considerados marcadores de trombose. O perfil de lipoproteína(a) foi avaliado num grupo de doentes sem eventos cardiovasculares mas com elevado risco vascular, estabelecendo-se a correlação com outros fatores de risco cardiovascular e inferindo-se os resultados para doentes com alterações metabólicas e, pelo menos, dois fatores de risco vascular. Material e Métodos: Este estudo observacional longitudinal incluiu 516 doentes com, pelo menos, dois fatores de risco cardiovascular e que frequentavam, regularmente e há pelo menos dois anos, a consulta ambulatória de metabolismo e risco vascular para prevenção primária. Os parâmetros sociodemográficos, clínicos e antropométricos foram recolhidos na primeira visita. A morfologia hepática foi avaliada por ultrassonografia em 509 doentes (98,6%). O risco vascular a 10 anos foi estimado através de tabelas de cálculo de risco de Framingham, doença cardiovascular e risco coronário sistemático. Resultados: Foram encontradas correlações significativas entre os níveis de lipoproteína(a) e os fatores de risco vasculares analisados, assim como entre lipoproteína(a) e as escalas de risco de Framingham, doença cardiovascular e risco coronário sistemático. Os valores de lipoproteína(a) apresentaram-se mais elevados em doentes com esteatose. Discussão: Os valores elevados de lipoproteína(a) estão diretamente associados com todos os marcadores de risco cardiovascular e com esteatose hepática não alcoólica. Conclusão: Como tal, considerando a sua elevada acessibilidade e custo reduzido, o marcador lipoproteína(a) deverá ser integrado na avaliação de rotina de doentes com risco vascular.
Asunto(s)
Enfermedades Cardiovasculares/sangre , Lipoproteína(a)/sangre , Adulto , Anciano , Biomarcadores/sangre , Composición Corporal , Enfermedades Cardiovasculares/etiología , Femenino , Humanos , Estilo de Vida , Estudios Longitudinales , Masculino , Enfermedades Metabólicas/sangre , Persona de Mediana Edad , Portugal , Factores de Riesgo , Factores Socioeconómicos , Estadísticas no ParamétricasRESUMEN
Risk-sharing agreements between pharmaceutical companies and payers stand out as a recent practice, the use of which has been increasing in the case of innovative medicines, particularly in the field of oncology, which aims to ensure better budgetary control and a lower risk of spending on medicinal products without full evidence of clinical benefit. In this article, the authors discuss the types of existing agreements, as well as those used in Portugal, their advantages, disadvantages and future challenges of implementation, as well as their potential role in access to therapeutic innovation, namely medicines for cancer treatment. For this purpose, a nonsystematic review of indexed and nonconventional literature was carried out. There is a tendency for the risk-sharing agreements established between payers and pharmaceutical companies to include a component of monitoring the use of medicines and outcomes measurement, involving real life data collection. Portugal is no exception and, although most agreements are still financial in nature, there is already a strong desire for other agreements, in particular clinical outcomes based. It is concluded that there is not yet a gold standard methodology in relation to the type of agreements to be practiced. Moreover, its opportunity cost, including the cost of implementation, remains to be scrutinised. However, regardless of the type of agreement, the advantages of adopting these agreements are well known, inevitably related with challenges of implementation. The need for an infrastructure to support information sharing is undisputed and urgent. The future of therapeutic innovation and increased pressure on health budgets will require alternative, more flexible models, personalized reimbursement models that allow alignment of medicines prices with the value they deliver in treating the several diseases.