Real-World Molecular Testing and Treatment Patterns in Brazilian Patients with Newly Diagnosed Locally Advanced or Metastatic NSCLC.

OBJECTIVES: To evaluate the molecular testing and treatment patterns in a retrospective cohort of newly diagnosed treatment-naïve patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC). METHODS: This is an observational retrospective cohort study conducted across 10 cancer centers in Brazil. Treatment-naïve patients with locally advanced or metastatic NSCLC were enrolled from January to December 2014. The following data were collected from the medical records of patients from diagnosis until the last record (death, loss to follow-up, or the end of the maximum follow-up period): demographics; medical history; smoking status; disease characteristics; previous treatments; and molecular testing patterns and results. The overall survival (OS) was also estimated. RESULTS: A total of 391 patients from 8 different Brazilian states were included, with a median age of 64.1 years (23.7-98.7), with most patients being males (60.1%). The smoking status of 74.2% of patients was a 'former' or 'current smoker'. Stage IV NSCLC at diagnosis was observed in 82.4% of patients, with 269 of them (68.8%) presenting adenocarcinoma (ADC). Among the stage IV ADC patients, 54.0% were referred for molecular testing. Among the patients with an available epidermal growth factor receptor (EGFR) mutation status, 31 (24.0%) were EGFR-positive. The first-line treatment was a platinum-based chemotherapy for 98 patients (25.1%), while non-platinum-based regimens were used in 54 patients (13.8%). OS data were available for 370 patients, with a median OS of 10.8 months. Never smokers had a significantly higher median OS versus current or former smokers (14.6 versus 9.1 months; log-rank p=0.003). Among the patients for whom molecular testing data were available, those with EGFR-positive results had a longer median OS (34.6 versus 12.8 months; log-rank p=0.003). CONCLUSION: Our findings provide relevant information for prescribers and policy decision-makers by highlighting the unmet needs of patients and the importance of molecular testing in newly diagnosed locally advanced or metastatic lung adenocarcinoma. We also highlight the respective EGFR-tyrosine kinase inhibitor treatment when the result is positive and the areas in which further efforts are required to grant access to effective treatment.

Real-world molecular testing and treatment patterns in brazilian patients with newly diagnosed locally advanced or metastatic NSCLC

OBJECTIVES: To evaluate the molecular testing and treatment patterns in a retrospective cohort of newly diagnosed treatment-naïve patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC). METHODS: This is an observational retrospective cohort study conducted across 10 cancer centers in Brazil. Treatment-naïve patients with locally advanced or metastatic NSCLC were enrolled from January to December 2014. The following data were collected from the medical records of patients from diagnosis until the last record (death, loss to follow-up, or the end of the maximum follow-up period): demographics; medical history; smoking status; disease characteristics; previous treatments; and molecular testing patterns and results. The overall survival (OS) was also estimated. Results: A total of 391 patients from 8 different Brazilian states were included, with a median age of 64.1 years (23.7-98.7), with most patients being males (60.1%). The smoking status of 74.2% of patients was a 'former' or 'current smoker'. Stage IV NSCLC at diagnosis was observed in 82.4% of patients, with 269 of them (68.8%) presenting adenocarcinoma (ADC). Among the stage IV ADC patients, 54.0% were referred for molecular testing. Among the patients with an available epidermal growth factor receptor (EGFR) mutation status, 31 (24.0%) were EGFR-positive. The first-line treatment was a platinum-based chemotherapy for 98 patients (25.1%), while non-platinum-based regimens were used in 54 patients (13.8%). OS data were available for 370 patients, with a median OS of 10.8 months. Never smokers had a significantly higher median OS versus current or former smokers (14.6 versus 9.1 months; log-rank p=0.003). Among the patients for whom molecular testing data were available, those with EGFR-positive results had a longer median OS (34.6 versus 12.8 months; log-rank p=0.003). Conclusion: Our findings provide relevant information for prescribers and policy decision-makers by highlighting the unmet needs of patients and the importance of molecular testing in newly diagnosed locally advanced or metastatic lung adenocarcinoma. We also highlight the respective EGFR-tyrosine kinase inhibitor treatment when the result is positive and the areas in which further efforts are required to grant access to effective treatment.

VASCULAR COMPLICATIONS IN PATIENTS WITH TYPE 2 DIABETES: PREVALENCE AND COMORBIDITIES IN 6 COUNTRIES OF LATIN AMERICA (A COHORT OF THE DISCOVER STUDY PROGRAM).

Objective: To provide real world observational data about glucose control, the burden of diabetes, comorbidities, and cardiovascular risk factors among patients initiating second-line therapy in Latin America (LA). Methods: This report is a cross-sectional analysis of the LA cohort of the DISCOVER study, describing the regional prevalence of microvascular and macrovascular complications in Mexico, Costa Rica, Panama, Colombia, Argentina, and Brazil. Results: One thousand six hundred and sixteen patients were included in 69 investigational sites. Hemoglobin A1c was >7% (42 mmol/mol) in 81.3% of subjects. Macrovascular complications were reported by 13.8% of the subjects. Microvascular conditions were reported in 15.2% of the subjects. The prevalence of hypertension and of hyperlipidemia was 55.5% and 45.9%, respectively. Blood pressure, total cholesterol, and low-density lipoprotein were out of target levels in 38.5%, 51.2%, and 81.7% of the patients, respectively. Overweight or obesity was reported in 83.8% of the cases. Conclusion: Our study shows that patients with type 2 diabetes in LA are not reaching their glucose, lipids, blood pressure, and weight targets. The prevalence of microvascular (15.2%), macrovascular (13.8%), and uncontrolled comorbidities in patients at an early stage of the disease (initiating a second-line therapy) highlights the need for more aggressive risk factor screening as well as treatment in LA. Abbreviations: CV = cardiovascular; CVD = cardiovascular disease; DM = diabetes mellitus; HbA1c = hemoglobin A1c; LA = Latin America/Latin American; LDL = low density cholesterol; T2DM = type 2 diabetes mellitus.

Correction to: Chronic obstructive pulmonary disease, bronchial asthma and allergic rhinitis in the adult population within the commonwealth of independent states: rationale and design of the CORE study.

After publication of this work [1] it was noticed three author names were spelt incorrectly. Liudmila Iashyna should be Liudmyla Iashyna, Marina Polyanskaya should be Maryna Polianska and Elcan Mamamdbayov should be Eljan Mammadbayov.

Chronic obstructive pulmonary disease, bronchial asthma and allergic rhinitis in the adult population within the commonwealth of independent states: rationale and design of the CORE study.

BACKGROUND: Main treatable Chronic Respiratory Diseases (CRDs) like Chronic Obstructive Pulmonary Disease (COPD), Bronchial Asthma (BA) and Allergic Rhinitis (AR) are underdiagnosed and undertreated worldwide. CORE study was aimed to assess the point prevalence of COPD, BA and AR in the adult population of major cities of Commonwealth of Independent States (CIS) countries - Azerbaijan, Kazakhstan, and Ukraine based on study questionnaires and/or spirometry, and to document risk factors, characterize the COPD, BA and AR population to provide a clearer "epidemiological data". METHODS: A descriptive, cross-sectional, population-based epidemiological study conducted from 2013 to 2015 with two-stage cluster geographical randomization. Interviewers conducted face-to-face visits at respondent's household after informed consent and eligibility assessment including interviews, anthropometry, spirometry (with bronchodilator test) and completion of disease-specific questionnaires. RESULTS: Two thousand eight hundred forty-two respondents (Ukraine: 964 from Ukraine; 945 from Kazakhstan; 933 Azerbaijan) were enrolled. Mean age was 40-42 years and males were 37%-42% across three countries. In Kazakhstan 62.8% were Asians, but in Ukraine and in Azerbaijan 99.7% and 100.0%, respectively, were Caucasians. Manual labourers constituted 40.5% in Ukraine, 22.8% in Kazakhstan and 22.0% in Azerbaijan, while office workers were 16.1%, 31.6% and 36.8% respectively. 51.3% respondents in Ukraine, 64.9% in Kazakhstan and 69.7% in Azerbaijan were married. CONCLUSION: CORE study collected information that can be supportive for health policy decision makers in allocating healthcare resources in order to improve diagnosis and management of CRDs. The detailed findings will be described in future publications. TRIAL REGISTRATION: Study Protocol Summary is disclosed at GlaxoSmithKline Clinical Study Register on Jun 06, 2013, study ID 116757 .

Prevalence and cumulative 5-year incidence of chronic lymphocytic leukemia in the adult population in the Russian Federation and Ukraine: Data from the LEUKOSPECT study.

OBJECTIVES: LEUKOSPECT was a retrospective, multicenter, epidemiologic study carried out in Russia and Ukraine, aiming to assess the prevalence and cumulative 5-year incidence of chronic lymphocytic leukemia (CLL) in the adult population. METHODS: All data were collected manually from patient medical records at each of the study sites and from official censuses. CLL prevalence and incidence were determined from a count of CLL cases (previously diagnosed and new cases) in the population who made at least one clinic visit for CLL during the period from 1 January 2009 to 31 December 2013. RESULTS: The recorded cumulative 5-year incidence of CLL during the study ranged from 1.46 per 100 000 persons (95% CI: 0.85-2.34) in Yekaterinburg, Russia, to 4.34 per 100 000 persons (95% CI: 2.48-7.04) in Luhansk, Ukraine. In 2013, the lowest prevalence of CLL was also recorded in Yekaterinburg: 7.11 per 100 000 persons (95% CI: 5.67-8.81). This was approximately 3.1 times lower than in Luhansk (21.92 per 100 000 population; 95% CI: 17.38-27.28). CONCLUSION: The results of this study show diverse CLL incidence and prevalence patterns in the adult population of the Russian Federation and Ukraine. Authors propose a more comprehensive study with large region involvement to provide a more precise description of the incidence and prevalence of CLL in Eastern European countries and to better understand disparities reported versus the USA and other Western countries.

Programas de benefício farmacêutico privados no Brasil e Estados Unidos: uma análise comparativa / Private pharmaceutical benefit programs in Brazil and the United States: a comparative analysis

Esta tese analisa os programas de benefício farmacêutico (PDF's) pelas operadoras de saúde suplementar no Brasil e nos planos de saúde privados americanos. O estudo se desenvolveu a partir de 3 capítulos principais. No primeiro capítulo foi elaborado um modelo que permitisse a comparação entre os diversos PBF's praticados no Brasil e nos Estados Unidos. Para tal foram analisadas as seguintes variáveis: características operacionais dos PBF's; o Sistema de Informação, como uma ferramenta importante para gerenciamento do programa; a adesão ao tratamento e as ferramentas destinadas ao controle se custo e fraude. No segundo capítulo foram analisadas as mudanças recentes ocorridas no mercado americano e as implicações sobre os PBF's e sobre o mercado farmacêutico. Foram avaliadas as formas de disponibilização de medicamentos, com destaque para o surgimento e consolidação das empresas de gerenciamento dos PBF's (PBM's). As ferramentas de controle de custo e farude aplicadas, bem como o impacto da não adesão e as iniciativas no gerenciamento de doentes crônicos. No terceiro capítulo foram analisadas as mudanças pelas quais vem passando o sistema de saúde suplementar no Brasil, foram obtidas informações acerca das iniciativas que vêm sendo praticadas no setor. No final do trabalho foi observado que os PBF's, apesar de recentemente consolidados no mercado americano, são praticados pela grande maioria dos planos privados deste país, com grande impacto sobre o mercado farmacêutico, que viu seu faturamento quase que dobrar em uma década. No Brasil, as iniciativas ainda são esparsas e fragmentadas, sobretudo pela transição que ainda passa o nosso sistema de saúde suplementar. Entretanto, ainda que os PBF's fossem uma prática usual, acreditamos que eles teriam pouco impacto sobre mercado e/ou acesso ao consumo de medicamentos.