Febrile neutropenia incidence and the variable toxicity profile between brand and generic docetaxel in the adjuvant treatment of breast cancer with docetaxel and cyclophosphamide regimen

ABSTRACT Objective To assess the incidence of febrile neutropenia without primary granulocyte colony-stimulating factor prophylaxis in patients undergoing chemotherapy with adjuvant docetaxel and cyclophosphamide, and to evaluate the toxicity profile of brand-name docetaxel (Taxotere ® ) and the generic formulation. Methods This retrospective study was conducted using data obtained from electronic medical records of patients treated at a Brazilian cancer center. Patients with breast cancer who underwent adjuvant treatment between January 2016 and June 2019 were selected. Data were analyzed using chi-square and Fisher correlation of variables, and multivariate analyses were adjusted for propensity score. Results A total of 231 patients with a mean age of 55.9 years at the time of treatment were included in the study. The majority (93.9%) had luminal histology, 84.8% were at clinical stage I, and 98.2% had a good performance status. The overall incidence of febrile neutropenia in the study population was 13.4% (31 cases). The use of brand-name docetaxel (Taxotere ® ) was the only factor associated with febrile neutropenia occurrence (OR= 3.55, 95%CI= 1.58-7.94, p=0.002). Conclusion In patients with breast cancer who require treatment with adjuvant docetaxel and cyclophosphamide regimen, the toxicity profile differs between brand-name and generic docetaxel. Regardless of the formulation used, the incidence of febrile neutropenia was less than 20%, which may allow for the omission of primary prophylactic granulocyte colony-stimulating factor use in this setting.

Role of intrathecal chemotherapy in the management of meningeal carcinomatosis in patients with breast cancer

ABSTRACT Objective To evaluate whether intrathecal chemotherapy improves clinical outcomes in patients with meningeal carcinomatosis. Methods This retrospective cohort study included consecutive patients with breast cancer diagnosed with meningeal carcinomatosis. Clinical and treatment data were collected from the patients' medical charts. The primary outcome was overall survival, and the secondary outcomes were time to neurological deterioration and reporting of clinical benefit. Logistic regression and Cox proportional hazard models adjusted for potential confounders were used to evaluate the clinical response and overall survival, respectively. Results Overall, 109 female patients were included, 50 (45.9%) of whom received intrathecal chemotherapy with methotrexate and dexamethasone. The median treatment duration was 3 weeks (range, 1-13 weeks). Patients treated with intrathecal chemotherapy were more likely to report clinical benefit (74% versus 57.7%, adjusted odds ratio [OR] = 9.0, 95%CI=2.6-30.9, p<0.001). However, there was no difference in the time to neurologic deterioration (hazard ratio [HR] = 0.96, 95%CI= 0.57-1.59, p=0.86). Patients who received intrathecal chemotherapy did not show an increase in overall survival compared with that of patients who did not receive intrathecal chemotherapy (median overall survival = 1.8 months, 95%CI= 1.27-3.0 versus 2.5, 95%CI= 1.9-3.9, adjusted HR = 0.71, 95%CI= 0.41-1.22, p=0.21). There was a significant interaction between intrathecal chemotherapy and systemic treatment, and patients who received systemic therapy without intrathecal chemotherapy had better overall survival than that of the no-treatment group (adjusted HR = 0.38, 95%CI= 0.20-0.70, p=0.002). Conclusion Intrathecal chemotherapy did not increase overall survival or time to neurological deterioration and should not preclude or postpone systemic treatments.

International trends in pulmonary neuroendocrine cancer studies:a scientometric study

ABSTRACT Introduction Pulmonary neuroendocrine tumors account for approximately 20% of all primary lung tumors. Few studies summarize the current body of pulmonary neuroendocrine tumors studies worldwide. Objective A quantitative scientometric analysis was conducted to evaluate the development of applications and innovations and to analyze their contribution to various areas of improvement in treatment and diagnosis of pulmonary neuroendocrine tumors. Methods We searched for studies published in the last 20 years in the databases United States National Library of Medicine (PubMed), Scientific Electronic Library Online (SciELO), Scopus, and Web of Science, using the terms 'pulmonary neuroendocrine tumors', 'bronchial neuroendocrine tumors', 'bronchial carcinoid tumors', 'pulmonary carcinoid', 'typical pulmonary carcinoid', 'atypical pulmonary carcinoid', 'pulmonary carcinoid and diagnosis', 'pulmonary carcinoid and treatment', 'pulmonary carcinoid and epidemiology' and 'pulmonary carcinoid and prognosis'. Results Our results showed the number of publications increased significantly over the study period and was strongly associated with the economic or financial situation of the publications' countries of origin. We observed a predominance of studies on histological diagnosis compared to treatment, and among the studies related to treatment, a predominance of retrospective studies relative to prospective studies was found. Conclusion Based on the published literature, we concluded research on pulmonary neuroendocrine tumors still seems to be incipient, because it favors studies related to histological characterization of the disease, and therapeutic studies are still predominantly of a retrospective nature.

Cost-effectiveness analysis of Ado-trastuzumab emtansine for the treatment of residual invasive HER2-positive breast cancer

ABSTRACT Objective Human epidermal growth factor receptor 2 (HER2) overexpression occurs in up to 30% of breast cancer cases. Ado-trastuzumab emtansine (T-DM1) is approved to treat residual HER2-positive breast cancer after neoadjuvant therapy. The aim of this study was to determine the quality-adjusted time with symptoms or toxicity and without symptoms or toxicity (Q-TWiST) of T-DM1 compared to trastuzumab for residual invasive HER2-positive breast cancer. Methods The authors developed an analytical model extracting individual patient data and estimated invasive disease-free survival and overall survival over a 30-year time horizon. Only direct costs from adjuvant treatment were considered as well as relapse treatment from Brazilian and American payer perspectives. Heart events were considered for utility and cost analysis. Results The 30-year projection utilizing the Weibull method estimated a mean invasive disease-free survival of 16.4 years for T-DM1 and 10.4 for Trastuzumab, in addition to a mean overall survival of 18.1 and 15.4 years, respectively. We determined a Q-TWiST gain of 3,812 years for the T-DM1 arm when compared to trastuzumab and an Incremental cost-effectiveness ratio per Q-TWiST of US$ 11,467.65 in the United States and US$ 3,332.73 in Brazil. Conclusion Ado-trastuzumab emtansine is cost-effective from both Brazilian and American perspectives.

Cross-cultural translation and adaptation of Functional Assessment of Cancer Therapy - Multiple Myeloma tool - MM1 and LEU3 - for Portuguese

ABSTRACT Objective To describe of the translation from English to Portuguese and adaption process of subitems of the Functional Assessment of Cancer Therapy - Multiple Myeloma. Methods In the first phase, translations from English into Portuguese of two subitems of Functional Assessment of Cancer Therapy - Multiple Myeloma were performed. Subsequently, a consensus and back translation were conducted, and, finally, translation and back translations were reviewed by four independent bilingual experts. In the second phase, the translated subitems were applied, along with a questionnaire, to 10 native Portuguese speakers patients with multiple myeloma. Results There was a recognition of the translation process in its first version applied to 10 patients with multiple myeloma, whose reported no difficult to understand the translated and validated instrument. Patients also did not find the content irrelevant or offensive, and they did not suggested changes. Conclusion The subitems of the Functional Assessment of Cancer Therapy - Multiple Myeloma were translated from English into Portuguese following the proposed methodology and there was not need of readjustments. This process allowed this instrument of quality of life, which is widely known to be beneficial in the management of patients with multiple myeloma, to be used among our population.

High mortality among patients with cancer and COVID-19 infection: the experience of a Brazilian cancer center / Alta mortalidade entre pacientes com câncer e infecção por COVID-19: a experiência de um centro oncológico brasileiro

ABSTRACT Objective To evaluate the severity of COVID-19 in cancer patients to describe clinical and epidemiological factors associated with poor outcomes (mortality and need of intensive care unit admission or mechanical ventilation). Methods Retrospective data from patients with cancer and laboratory diagnosis of COVID-19, obtained between March 16 and May 29, 2020, were retrieved out of a cancer center database. Data analyzed included patient history, age, sex, comorbidities, types of cancer and anticancer therapy. Results This sample comprised 105 patients aged 18-92 years, 80.9% of whom were females. Dyspnea was the most prevalent initial symptom (30.4%) among patients who died (p<0.0001). Overall, 57.1% of patients had metastatic disease and 60% had poor performance status (Eastern Cooperative Oncologic Group ≥2) at the time of COVID-19 diagnosis. The overall mortality rate was 40.95%. Mortality rates were higher in male patients and those with poor performance status (p<0.0001). Conclusion This cohort is one of the largest Brazilian studies describing clinical and epidemiological features of patients with cancer and concurrent COVID-19. Findings of this study emphasize the vulnerability of cancer patients in the current pandemic, and indicate high mortality from COVID-19 among male cancer patients and cancer patients with poor performance status. This analysis may assist the selection of patients who may benefit from strict isolation and eventual discontinuation of anticancer therapy to reduce exposure to infection.

RESUMO Objetivo Avaliar a gravidade da infecção por COVID-19 em pacientes oncológicos, determinando os aspectos clínicos e epidemiológicos associados ao pior desfecho, seja em termos de mortalidade, necessidade de internação em unidade de terapia intensiva ou ventilação mecânica. Métodos Pacientes com câncer e diagnóstico confirmado por laboratório de COVID-19 foram identificados nos bancos de dados de um hospital oncológico entre 16 de março e 29 de maio de 2020. Os dados coletados incluíram história, idade, sexo e comorbidades dos pacientes, além dos tipos de câncer e do tratamento anticâncer. Resultados Dentre os 105 pacientes analisados, a idade variou de 18 a 92 anos, e 80,9% eram do sexo feminino. Dispneia foi o sintoma inicial mais prevalente entre os que morreram (30,4%). No momento do diagnóstico da infecção, 57,1% apresentavam doença metastática e 60% performance status ruim (Eastern Cooperative Oncologic Group ≥2). A taxa de mortalidade geral foi 40,95% e superior entre os homens e pacientes com baixo nível de performance status (p<0,0001). Conclusão Este coorte é um dos estudos mais robustos do Brasil, descrevendo características clínicas e epidemiológicas de pacientes com câncer e COVID-19. Os achados do estudo alertam para a vulnerabilidade dos pacientes oncológicos na pandemia atual e demonstram alta mortalidade por COVID-19 em pacientes do sexo masculino e com pior performance status. Essa análise pode ajudar a selecionar os pacientes que podem se beneficiar de isolamento rigoroso e até mesmo da interrupção do tratamento, reduzindo a exposição à infecção.

Perception of risk factors for cancer in the ABC population

SUMMARY OBJECTIVE To evaluate the knowledge about risk factors for cancer in patients treated at the ABC Medical School (FMABC). METHODS Cross-sectional observational study conducted in 2019. The American Cancer Institute's Cancer Risk Awareness Survey questionnaire was used with 29 cancer risk factors, 14 of which were proven to cause cancer and 15 without consensus or scientific evidence of causality with cancer but that are often reminded by most of the population. Qualitative variables were described by frequency and percentage, and quantitative variables by mean and standard deviation or median and range depending on normality, assessed by the Shapiro-Wilk test. The study was conducted in accordance with the Helsinki Declaration for Research and approved by the Research Ethics Committee. RESULTS 191 patients were included. Median age 54 (20 to 90), 64% female. 35.6% reported current or previous smoking. 3.1% consumed alcohol more than 5 drinks/week. 56% reported sedentary lifestyle. 44% had at least 1 case of cancer in relatives up to 2nd degree. The average of correct answers in the analyzed population was 12.83 ± 3.06. A weak positive correlation was observed between income and number of cases (rho = 0.177, p = 0.02). No relationship was observed between the number of correct answers and level of education, age, sex, marital status, race or patients with a positive family history for cancer. CONCLUSION The knowledge about risk factors for cancer in the ABC population is low, which may contribute to the adoption of risk behaviors for the disease.

RESUMO OBJETIVO Avaliar o conhecimento sobre fatores de risco para câncer em pacientes atendidos nos ambulatórios da Faculdade de Medicina do ABC (FMABC). MÉTODOS Estudo transversal e observacional conduzido em 2019. Foi utilizado o questionário Cancer Risk Awarness Survey do American Institute for Cancer Research com 29 fatores de risco para câncer, sendo 14 fatores comprovadamente causadores de câncer e 15 sem consenso ou evidência científica de causalidade com o câncer, mas que são frequentemente citados pela população. Variáveis qualitativas foram descritas por frequência e porcentagem, e variáveis quantitativas por média e desvio padrão ou mediana e intervalo a depender da normalidade, avaliada pelo teste de Shapiro-Wilk. Estudo realizado de acordo com a Declaração de Helsinque para pesquisa e aprovado pelo Comitê de Ética em Pesquisa. RESULTADOS Foram incluídos 191 pacientes. Mediana de idade 54 (20 a 90), 64% do sexo feminino; 35,6% reportaram tabagismo atual ou anterior; 3,1% consumiam mais que cinco doses de álcool por semana; 56% reportaram sedentarismo; 44% tinham pelo menos um caso de câncer em parentes de até segundo grau. A média de acertos na população analisada foi 12,83 ± 3,06. Foi observada correlação positiva fraca entre renda e número de acertos (rho=0,177, p=0,02). Não foram observadas relações entre o número de acertos e nível de escolaridade, idade, sexo, estado civil, cor ou pacientes com história familiar positiva para câncer. CONCLUSÃO O conhecimento sobre fatores de risco para câncer na população do ABC é baixo, o que pode contribuir para a adoção de comportamentos de risco para a doença.

Depression, anxiety and spirituality in oncology patients

SUMMARY OBJECTIVE To relate anxiety and depression levels to the spirituality levels of oncology patients in the ABC region. METHODS Cross-sectional study performed at the ABC University Center oncology outpatient clinics. For the evaluation of spirituality, the Religiosity, Spirituality, and Personal Beliefs instrument of the World Health Organization (SRPB-WHO) was applied. To evaluate the levels of depression and anxiety, the Hospital Anxiety and Depression Scale (HADS) was applied. Qualitative variables were described by frequency and percentage, and quantitative variables by mean and standard deviation or median and range. Relationships were established using either the T-test or Wilcoxon-Mann-Whitney test and correlations with Pearson or Spearman tests, depending on the normality assessed by the Shapiro-Wilk test. RESULTS We included 99 patients, 68% female, with a median age of 60 years (19 to 81). A total of 24% had high or borderline levels of anxiety and 21% of depression. There was a negative correlation between levels of depression and spirituality (rho = -0.44, p <0.001), and anxiety and spirituality (rho=-0.232, p=0.02). We found no significant difference between levels of anxiety, depression, or spirituality when stratified by schooling, income, ethnicity, or marital status. There was a positive correlation between levels of anxiety and depression (cor = 0.477, p <0.001). CONCLUSION Spirituality can be a complementary tool in the treatment of patients with cancer.

RESUMO OBJETIVO Relacionar os níveis de ansiedade e depressão com os de espiritualidade dos pacientes oncológicos da região do ABC. MÉTODO Estudo transversal realizado nos ambulatórios de oncologia do Centro Universitário ABC. Para avaliação da espiritualidade, foi aplicado o questionário Religiosidade, espiritualidade e crenças pessoais da Organização Mundial da Saúde (SRPB-WHO). Para avaliar os níveis de depressão e ansiedade foi aplicado a Hospital Anxiety and Depression Scale (Hads). Variáveis qualitativas foram descritas por frequência e porcentagem, as quantitativas por média e desvio padrão ou mediana e intervalo. Relações foram feitas por meio do teste de t ou Wilcoxon-Mann-Whitney e correlações pelo teste de Pearson ou Spearman, a depender da normalidade avaliada pelo teste de Shapiro-Wilk. RESULTADO Foram incluídos 99 pacientes; 68% do sexo feminino, mediana de idade 60 (19 a 81); 24% tiveram níveis altos ou limítrofes para ansiedade e 21% para depressão. Foi observada correlação negativa entre os níveis de depressão e espiritualidade (rho=-0,44, p<0,001) e ansiedade e espiritualidade (rho=-0,232, p=0,02). Não foi observada diferença entre os níveis de ansiedade, depressão ou espiritualidade ao estratificar por escolaridade, renda, etnia ou estado civil. Houve correlação positiva entre os níveis de ansiedade e depressão (cor=0,477, p<0,001). CONCLUSÃO A espiritualidade pode ser uma ferramenta complementar a ser utilizada no tratamento do paciente com câncer.

Hormone receptor-negative as a predictive factor for pathologic complete response to neoadjuvant therapy in breast cancer / Receptor hormonal negativo como fator preditivo para resposta patológica completa ao tratamento neoadjuvante de câncer de mama

ABSTRACT Objective To define a predictive factor for pathologic complete response, compare the oncologic outcomes associated with the degree of pathologic response after neoadjuvant chemotherapy, and to analyze pathologic complete response as a prognostic factor for overall survival and progression-free survival. Methods A retrospective study of patients admitted to Hospital Estadual Mário Covas and Hospital Anchieta from 2008 to 2012, with locally advanced breast cancer. Hormone receptor status, HER2 status, histologic and nuclear grade, age upon diagnosis and histological type of the tumor were analyzed. Pathologic evaluation of the tumor was subdivided into pathologic complete response, defined by the absence of tumor; intermediate response, considered as a favorable stage; and poor response, considering low-responder patients. Data obtained were submitted to statistical analysis. Results The study included 243 patients. There was an association of pathologic complete response with HER-2 negative, histological grade 3, stage III, hormone receptor negative, positive lymph node, older age and more advanced tumors. However, after multivariate analysis the only predictor of pathologic complete response was the presence of negative hormone receptor. By analyzing the prognostic factors, hormone receptor negative was considered as an independent risk factor, and pathologic complete response was considered as an independent protective factor. Conclusion Hormone receptor negative is predictive of pathologic complete response and is an isolated risk factor for lower progression-free survival and overall survival. Pathologic complete response is a protective factor for these same survival analyses.

RESUMO Objetivo Definir um fator preditivo para resposta patológica completa, comparar os resultados oncológicos associados com o grau de resposta patológica, após quimioterapia neoadjuvante, e analisar a resposta patológica completa como fator prognóstico para sobrevivência global e livre de progressão de doença. Métodos Estudo retrospectivo de pacientes admitidas no Hospital Estadual Mário Covas e Hospital Anchieta, no período de 2008 a 2012, com câncer de mama localmente avançado. Foram utilizados status dos receptores hormonais, proteína HER2, grau histológico e nuclear, idade do paciente ao diagnóstico e tipo histológico do tumor. A avaliação patológica do tumor foi subdividida em resposta patológica completa, definida com ausência de tumor; resposta intermediária, considerada como um estádio favorável; e resposta ruim, considerando os pacientes pouco respondedores. As informações obtidas foram submetidas à análise estatística. Resultados Foram incluídas 243 pacientes. Verificou-se associação de resposta patológica completa entre HER-2 negativo, grau histológico 3, estadiamento III, receptor hormonal negativo, linfonodo positivo, maior idade e tumores mais avançados. Porém, após análise multivariada, o único fator preditivo de resposta patológica completa foi presença de receptor hormonal negativo. Ao analisar fatores prognósticos, receptor hormonal negativo permaneceu como variável independente de risco, e resposta patológica completa, como variável independente de proteção. Conclusão O receptor hormonal negativo é fator preditivo isolado de resposta patológica completa e fator de risco para menor sobrevida livre de doença e sobrevida global. Já a resposta patológica completa é fator protetor para estas mesmas análises de sobrevivência.

Epidemiological profile of Brazilian oncological patients seen by a reference oncology center of the public health system and who migrate in search of adequate health care

SUMMARY INTRODUCTION Structural disparities between different Brazilian regions in public health system cause patients to migrate in search of better conditions to treat their diseases. Besides patient's discomfort, there is a concentration of care in large centres, causing overload to current capacity. OBJECTIVE To evaluate migratory flow and associated factors in a reference service in oncology. METHODS Cross-sectional study conducted at a referral oncology service in Great ABC region of São Paulo. Patients were interviewed, and clinical and demographic data collected. RESULTS Between March-July 2016, 217 patients were included. Analysis showed a divergence between the postal code registered in the medical record and that recorded during the interview in approximately 10% of cases. Of these, 42.9% were residents of other states. Search for treatment motivated most patients to seek service outside their city. CONCLUSION Results reflect the informal search for medical care outside the home area. Besides the direct impact on patients' quality of life, migratory flow has an economic-social impact because these patients place a burden and impose costs on services of cities where they do not perform their responsibilities as citizens. Confirmation of the existence of a significant migratory flow demonstrates the need to discuss restructuring public health policies.

RESUMO INTRODUÇÃO As disparidades estruturais entre diferentes regiões brasileiras no sistema de saúde pública fazem com que os pacientes migrem em busca de melhores condições para tratar suas doenças. Além do desconforto do paciente, há uma concentração de cuidados em grandes centros, causando sobrecarga da capacidade atual. OBJETIVO Avaliar o fluxo migratório e fatores associados em um serviço de referência em oncologia. MÉTODOS Estudo transversal realizado em um serviço de oncologia de referência na região do Grande ABC, em São Paulo. Os pacientes foram entrevistados e dados clínicos e demográficos coletados. RESULTADOS Entre março e julho de 2016 foram incluídos 217 pacientes. A análise mostrou uma divergência entre o código de endereçamento postal registrado no prontuário médico e o registrado durante a entrevista em aproximadamente 10% dos casos. Desses, 42,9% eram residentes de outros estados. A busca de tratamento motivou a maioria dos pacientes a buscar serviços fora de sua cidade. CONCLUSÃO Os resultados refletem a busca informal de cuidados médicos fora da área de residência. Além do impacto direto na qualidade de vida dos pacientes, o fluxo migratório tem um impacto econômico-social porque esses pacientes colocam um fardo e impõem custos aos serviços das cidades onde não executam suas responsabilidades como cidadãos. A confirmação da existência de um fluxo migratório significativo demonstra a necessidade de discutir a reestruturação das políticas de saúde pública.

Quimioterapia em idosos: tradução do escore de toxicidade de hurria para o português / Chemotherapy in the elderly: translation of Hurria's toxicity score to portuguese

Objetivo: Traduzir e realizar a adaptação transcultural para a Língua Portuguesa do escore de toxicidade de Hurria, instrumento utilizado para avaliação de toxicidade à quimioterapia em idosos. Métodos: Realizada a tradução e adaptação transcultural do escore, seguindo a técnica proposta por Guilemin de tradução/retrotradução. Resultados: A tradução foi realizada por dois brasileiros fluentes em inglês, sendo um médico e um tradutor profissional. Sequencialmente, realizou-se a retrotradução do escore por dois profissionais independentes ao estudo, ligados a um serviço especializado de tradução linguística. Finalmente, um comitê formado por especialistas em Oncologia, Geriatria e Hematologia checou a consistência da tradução/retrotradução, chegando a um modelo final na Língua Portuguesa. Posteriormente, esse modelo sofreu avaliação prática em uma amostra de prontuários de um ambulatório de Oncogeriatria, com versão em português do instrumento atingindo alto grau de confiabilidade pelo teste estatístico de Kappa. Conclusão: A versão final do escore de toxicidade de Hurria em português mostrou-se clara, simples e de rápida aplicação, estando adequada para o uso na prática clínica.

Objective: To describe the translation and transcultural adaptation of Hurria's chemotherapy toxicity score, a prediction tool to estimate chemotherapy toxicity in the elderly. Methods: The original English version of the score was translated to Portuguese using the forward and backward translation technique, as described by Guilemin. Results: The translation was performed by two Brazilians (a physician and a professional translator), both fluent in English. Two professionals from a specialized linguistic service, not related to the study, then carried out the backward translation. Finally, a medical committee composed of oncologists, geriatricians, and hematologists discussed the consistency of the score, choosing a final version of the instrument in Portuguese. This version was piloted-tested in medical charts in an Oncogeriatric service, with high reliability as tested by Kappa statistic test. Conclusion: The final version of Hurria's chemotherapy toxicity score in Portuguese proved to be an easy, clear, and quick tool, suitable for use in clinical practice.

Application of prognostic score IPSET-thrombosis in patients with essential thrombocythemia of a Brazilian public service / Aplicação do escore prognóstico IPSET-trombose nos pacientes com trombocitemia essencial em um hospital público brasileiro

Summary Introduction: In patients with essential thrombocythemia (ET), the vascular complications contribute to morbidity and mortality. To better predict the occurrence of thrombotic events, an International Prognostic Score for Thrombosis in Essential Thrombocythemia (IPSET-thrombosis) has recently been proposed. We present the application of this score and compare its results with the usual classification system. Method: We retrospectively evaluated the characteristics and risk factors for thrombosis of 46 patients with a diagnosis of ET seen in the last 6 years at Faculdade de Medicina do ABC (FMABC). Results: Thrombosis in the arterial territory was more prevalent than in venous sites. We observed that cardiovascular risk factors (hypertension, hypercholesterolemia, diabetes mellitus, and smoking) were also risk factors for thrombosis (p<0.001). Age over 60 years and presence of JAK2 V617F mutation were not associated with the occurrence of thrombotic events. No patient classified by IPSET-thrombosis as low risk had a thrombotic event. Furthermore, using the IPSET-thrombosis scale, we identified two patients who had thrombotic events during follow-up and were otherwise classified in the low-risk group of the traditional classification. Leukocytosis at diagnosis was significantly associated with arterial thrombosis (p=0.02), while splenomegaly was associated with venous thrombotic events (p=0.01). Conclusion: Cardiovascular risk factors and leukocytosis were directly associated with arterial thrombosis. IPSET-thrombosis appears to be better than the traditional classification at identifying lower risk patients who do not need specific therapy.

Resumo Introdução: em pacientes com trombocitemia essencial (TE), complicações vasculares contribuem para morbidade e mortalidade. Para melhor predizer a ocorrência de eventos trombóticos, um escore prognóstico internacional de trombose para TE (IPSET-trombose) foi recentemente desenvolvido. Apresentamos aqui a aplicação desse escore e comparamos seus resultados com o sistema de classificação usual. Método: avaliamos retrospectivamente as características e os fatores de risco para trombose em 46 pacientes com diagnóstico de TE que foram atendidos nos últimos 6 anos na Faculdade de Medicina do ABC. Resultados: trombose em território arterial é mais prevalente que em sítio venoso. Observamos que fatores de risco cardiovascular (hipertensão, hipercolesterolemia, diabetes mellitus e tabagismo) foram considerados fatores de risco para trombose (p<0,001). Idade > 60 anos e presença de mutação JAK2 V617F não se associaram à ocorrência de eventos trombóticos. Nenhum paciente classificado como baixo risco pelo IPSET-trombose apresentou evento trombótico. Quando comparado à classificação de risco tradicional, IPSET-trombose foi capaz de identificar dois pacientes que evoluíram com trombose no seguimento e estavam categorizados no grupo de baixo risco. Leucocitose ao diagnóstico foi mais prevalente em pacientes que apresentaram trombose arterial (p=0,02), e esplenomegalia, entre aqueles com evento trombótico venoso (p=0,01). Conclusão: fatores de risco cardiovascular e leucocitose se associaram de forma direta com trombose arterial. IPSET-trombose parece ser melhor que a classificação tradicional na identificação de pacientes de baixo risco que não precisam de terapia específica.

Clinical features and overall survival among elderly cancer patients in a tertiary cancer center / Características clínicas e de sobrevida global em pacientes oncológicos idosos num centro oncológico terciário

ABSTRACT Objective To evaluate the epidemiological profile and overall survival of a large population of elderly individuals diagnosed with solid tumors in a tertiary hospital. Methods This retrospective study included patients aged >65 years, diagnosed with solid tumors between January 2007 and December 2011, at Hospital Israelita Albert Einstein, São Paulo, Brazil. The medical records were reviewed to obtain information about clinical variables and overall survival. Results A total of 806 patients were identified, and 58.4% were male. Mean age was 74 years (65 to 99 years). The most common types were prostate (22%), colorectal (21%), breast (19%), and lung cancer (13%), followed by bladder (8%), pancreas (6%), and other types (11%). The majority of patients were diagnosed at early stage disease. After a median follow-up of 27 months (15 to 45 months), 29% of the patients (234/806) died, predominantly in the group older than 70 years. For the entire cohort, the median 2-year survival rate was 71%. Median overall survival was not reached within the study period. In a multivariate analysis, age (HR: 1.35; 95%CI: 1.25-1.45; p<0.001) and disease stage (HR: 1.93; 95%CI: 1.75-2.14; p<0.001) were independent negative predictors of poor survival. Conclusion The most prevalent tumors were prostate, colorectal, breast, and lung cancer, with the larger proportion diagnosed at initial stages, reflecting the great number of patients alive at last follow-up.

RESUMO Objetivo Avaliar o perfil epidemiológico e a sobrevida global em uma grande população de indivíduos idosos diagnosticados com tumores sólidos, em um hospital terciário. Métodos Estudo retrospectivo que incluiu pacientes com idade >65 anos, diagnosticados com tumores sólidos entre janeiro de 2007 e dezembro de 2011, no Hospital Israelita Albert Einstein, São Paulo, Brasil. Os prontuários médicos foram revisados para se obterem informações sobre variáveis clínicas e sobrevida global. Resultados Foi identificado um total de 806 pacientes, sendo 58,4% deles do sexo masculino. A média de idade foi de 74 anos (65 a 99 anos). Os tipos mais comuns de câncer foram de próstata (22%), colorretal (21%), de mama (19%) e de pulmão (13%), seguidos pelos de bexiga (8%), pâncreas (6%) e outros tipos (11%). A maioria dos pacientes foi diagnosticada em estágios iniciais. Depois de um seguimento médio de 27 meses (15 a 45 meses), 29% (234/806) estavam mortos, predominantemente no grupo com idade >70 anos. Para toda a coorte, a mediana de taxa de sobrevida em 2 anos foi 71%. A mediana de sobrevida global não foi alcançada dentro do período de estudo. Em análise multivariada, idade (HR: 1,35; IC95%: 1,25-1,45; p<0,001) e estadiamento (HR: 1,93; IC95%: 1,75-2,14; p<0,001) foram preditores negativos independentes de pior sobrevida. Conclusão Os tumores mais prevalentes foram de próstata, colorretal, mama e pulmão, com uma grande proporção diagnosticada em estádios iniciais, o que reflete em um grande número de pacientes vivos até o último seguimento.

Adjuvant treatment delay in breast cancer patients / Atraso no tratamento adjuvante em pacientes com câncer de mama

Summary Background: to evaluate if time between surgery and the first adjuvant treatment (chemotherapy, radiotherapy or hormone therapy) in patients with breast cancer is a risk factor for lower overall survival (OS). Method: data from a five-year retrospective cohort study of all women diagnosed with invasive breast cancer at an academic oncology service were collected and analyzed. Results: three hundred forty-eight consecutive women were included. Time between surgery and the first adjuvant treatment was a risk factor for shorter overall survival (HR=1.3, 95CI 1.06-1.71, p=0.015), along with negative estrogen receptor, the presence of lymphovascular invasion and greater tumor size. A delay longer than 4 months between surgery and the first adjuvant treatment was also associated with shorter overall survival (cumulative survival of 80.9% for delays ≤ 4 months vs. 72.6% for delays > 4 months; p=0.041, log rank test). Conclusion: each month of delay between surgery and the first adjuvant treatment in women with invasive breast cancer increases the risk of death in 1.3-fold, and this effect is independent of all other well-established risk factors. Based on these results, we recommend further public strategies to decrease this interval.

Resumo Objetivo: avaliar se o tempo da cirurgia até o primeiro tratamento adjuvante (quimioterapia, radioterapia ou hormonioterapia) em pacientes com câncer de mama é um fator de risco para pior sobrevivência global (SG). Métodos: estudo retrospectivo em que foram coletados dados dos prontuários de todas as mulheres com câncer de mama invasivo, diagnosticadas entre janeiro de 2005 e dezembro de 2010, atendidas consecutivamente em um serviço acadêmico de oncologia. Resultados: foram incluídas 348 mulheres, com mediana de tempo entre a cirurgia e o primeiro tratamento adjuvante de 2 meses. A sobrevivência global foi pior entre as mulheres com maior tempo entre a cirurgia e o primeiro tratamento adjuvante. Após análise multivariada, essa variável permaneceu como fator de risco independente para SG, juntamente com receptor de estrógeno negativo, presença de invasão angiolinfática e maior tamanho tumoral. Conclusão: o tempo entre a cirurgia e o primeiro tratamento adjuvante é um fator de risco independente para a sobrevivência global de mulheres com câncer de mama invasivo.

Carbamazepine for prevention of chemotherapy-induced nausea and vomiting: a pilot study / Carbamazepina para prevenção de náusea e vômito induzidos por quimioterapia: um estudo piloto

CONTEXT AND OBJECTIVE: Nausea and vomiting are major inconveniences for patients undergoing chemotherapy. Despite standard preventive treatment, chemotherapy-induced nausea and vomiting (CINV) still occurs in approximately 50% of these patients. In an attempt to optimize this treatment, we evaluated the possible effects of carbamazepine for prevention of CINV. DESIGN AND LOCATION: Prospective nonrandomized open-label phase II study carried out at a Brazilian public oncology service. METHODS: Patients allocated for their first cycle of highly emetogenic chemotherapy were continuously recruited. In addition to standard antiemetic protocol that was made available, they received carbamazepine orally, with staggered doses, from the third day before until the fifth day after chemotherapy. Considering the sparseness of evidence about the efficacy of anticonvulsants for CINV prevention, we used Simon's two-stage design, in which 43 patients should be included unless overall complete prevention was not achieved in 9 out of the first 15 entries. The Functional Living Index-Emesis questionnaire was used to measure the impact on quality of life. RESULTS: None of the ten patients (0%) presented overall complete prevention. In three cases, carbamazepine therapy was withdrawn because of somnolence and vomiting before chemotherapy. Seven were able to take the medication for the entire period and none were responsive, so the study was closed. There was no impact on the patients' quality of life. CONCLUSION: Carbamazepine was not effective for prevention of CINV and also had a deleterious side-effect profile in this population. .

CONTEXTO E OBJETIVO: Náusea e vômito são inconvenientes importantes para pacientes submetidos a quimioterapia. A despeito do tratamento preventivo padrão, náuseas e vômitos induzidos por quimioterapia (NVIQ) ocorrem em aproximadamente 50% dos pacientes. Na tentativa de otimizar este tratamento, avaliamos os possíveis efeitos da carbamazepina na prevenção de náuseas e vômitos induzidos por quimioterapia. TIPO DE ESTUDO E LOCAL: Estudo fase II, prospectivo, não randomizado, aberto, realizado em um serviço público brasileiro de oncologia. MÉTODOS: Recrutaram-se continuamente pacientes alocados para o primeiro ciclo de quimioterapia altamente emetogênica. Além do protocolo anti-emético padrão disponibilizado, os pacientes receberam carbamazepina, por via oral, em doses escalonadas, a partir do terceiro dia anterior até o quinto dia após a quimioterapia. Dada a escassa evidência de eficácia dos anticonvulsivantes na prevenção de NVIQ, adotamos o desenho de Simon em duas fases, que deveria incluir 43 pacientes a não ser que prevenção completa global não fosse alcançada em 9 dos primeiros 15 participantes. O questionário "Functional Living Index-Emesis" foi usado para avaliar o impacto na qualidade da vida. RESULTADOS: Nenhum dos 10 pacientes (0%) apresentou prevenção completa global. Três tiveram a carbamazepina suspensa por sonolência e vômito antes da quimioterapia. Sete foram capazes de tomar a medicação por todo o período proposto e nenhum obteve resposta, sendo então interrompido o estudo. Não houve impacto na qualidade da vida. CONCLUSÃO: Carbamazepina não foi efetiva para prevenção de NVIQ e apresentou perfil deletério de efeitos adversos nesta população. .

Paullinia cupana para o controle de fogachos em pacientes com câncer de mama: um estudo piloto / Paullinia cupana for control of hot flashes in breast cancer patients: a pilot study

OBJETIVO: Avaliar se a Paullinia cupana diminui o número e a gravidade dos fogachos em mulheres após diagnóstico de câncer de mama. MÉTODOS: Estudo piloto prospectivo fase II realizado com mulheres que sobreviveram ao câncer de mama, que completaram o tratamento pelo menos 3 meses antes e que apresentavam ao menos 14 episódios de fogachos por semana. Utilizando o desenho de Simon para que a primeira etapa fosse considerada positiva, ao menos 9 de 15 mulheres deveriam ter a gravidade dos fogachos diminuída em pelo menos 50%. As pacientes receberam 50mg do extrato seco de Guaraná oralmente 2 vezes por dia por 6 semanas. Foram avaliadas, a gravidade e a frequência dos fogachos. RESULTADOS: Dezoito pacientes iniciaram o tratamento com Paullinia cupana e 15 completaram o estudo. Três pacientes deixaram o estudo imediatamente após iniciarem o tratamento em razão de dificuldade na participação e não adesão. Das 15 pacientes que completaram o estudo, 10 obtiveram diminuição de mais de 50% dos índices de gravidade de fogachos. Durante as 6 semanas de tratamento, diminuições estatisticamente significativas foram observadas tanto no número de fogachos (p=0,0009), quanto nos índices de gravidade (p<0,0001). Paullinia cupana foi bem tolerada, e não houve relato de toxicidade como causa de saída do estudo. CONCLUSÕES: Paullinia cupana pareceu promissora para o controle de fogachos. Estudos mais extensivos são necessários.

OBJECTIVE: To evaluated whether Paullinia cupana decrease number and severity of hot flashes in breast cancer survivors. METHODS: This was a prospective phase II pilot study. We studied female breast cancer survivors who had completed the cancer treatment 3 months previously and who were experiencing at least 14 hot flashes per week. At least 9 of the 15 patients were required to have a decrease of at least 50% in hot flash severity score in keeping with the Simon Design. Patients received 50mg of dry extract of Paullinia cupana orally twice a day for 6 weeks. We assessed both frequency and severity of hot flashes. RESULTS: A total of 18 patients started the Paullinia cupana treatment, and 15 completed the study. Three patients left the study immediately after starting the treatment because of personal difficulties in participation or noncompliance. Of the 15 patients who completed the study 10 had a decrease of more than 50% in hot flash severity scores. During the 6 weeks of treatment, statistically significant decreases were seen in both numbers of hot flashes (p=0.0009) and severity scores (p<0.0001). Paullinia cupana was well tolerated, and there were no instances of discontinuation because of toxicity. CONCLUSIONS: Paullinia cupana appears promising for controlling hot flashes. More extensive studies seem warranted.

Treatment of breast cancer patients from a public healthcare system in a private center: costs of care for a pilot public-private partnership in oncology / Pacientes com câncer de mama oriundas do Sistema Único de Saúde tratadas no setor privado: custos de um piloto de parceria público-privada em oncologia

OBJECTIVE: To describe the flow and costs associated with the diagnosis and treatment of patients with breast cancer who come from the public healthcare system and were treated at Hospital Israelita Albert Einstein. METHODS: Between August 2009, and December 2011, 51 patients referred by the Unified Public Healthcare System (SUS) had access to Hospital Israelita Albert Einstein for diagnostic radiology, medical oncology, radiotherapy, and oncologic/breast reconstruction surgery. The data were collected retrospectively from the hospital records, patient charts, pharmacy records, and from the hospital billing system. RESULTS: The total sum spent for diagnosis and treatment of these 51 patients was US$ 1,457,500.00. This value encompassed expenses with a total of 85 hospitalizations, 2,875 outpatient visits, 16 emergency room visits, and all expenses associated with these stays at the hospital. The expenditure for treatment of each patient submitted to biopsy, breast conserving surgery, adjuvant chemotherapy without trastuzumab (a regime with taxane followed by anthracycline), radiotherapy, and 5 years of tamoxifen was approximately US$ 25,500.00. CONCLUSION: Strategies for cost-reduction of treatment in the private setting are necessary to enable future large-scale public-private partnerships in oncology.

OBJETIVO: Descrever os fluxos e os custos associados ao diagnóstico e tratamento de pacientes com câncer de mama provenientes do Sistema Único de Saúde e tratadas no Hospital Israelita Albert Einstein. MÉTODOS: Entre agosto de 2009 e dezembro de 2011, 51 pacientes do Sistema Único de Saúde tiveram acesso à estrutura do Hospital Israelita Albert Einstein para os serviços de radiologia, oncologia, radioterapia e cirurgia oncológica/reconstrutora de mama. Os dados foram coletados retrospectivamente, a partir do registro hospitalar de câncer, prontuários, registros de farmácia e do sistema de cobrança do hospital. RESULTADOS: O valor total gasto para o diagnóstico e tratamento dessas 51 pacientes foi de R$ 2.915.000,00. Esse valor compreendeu os gastos com um total de 85 internações, 2.875 atendimentos ambulatoriais, 16 atendimentos no pronto atendimento e todos os custos associados a essas passagens pelo hospital. O valor gasto para o tratamento de cada paciente submetida à biópsia, setorectomia, quimioterapia adjuvante sem trastuzumabe (esquema com taxano seguido de antraciclina), radioterapia e 5 anos de tamoxifeno, foi de, aproximadamente, R$ 51.000,00 CONCLUSÃO: Estratégias de redução do custo do tratamento na rede privada seriam necessárias para permitir futuras parcerias público-privadas em grande escala, em oncologia.

Multiple myeloma complicated with pseudomonas endocartiditis / Mieloma múltiplo complicado com endocardite infecciosa por pseudomonas

Patients diagnosed with multiple myeloma are more susceptible to infections which are the major causes of morbidity and mortality associated to this disease. The main infectious agents involved are Gram-positive bacteria. However, after chemotherapy an increase in the incidence of Gram-negative strains is observed. These bacteria are also responsible for most cases of urinary tract infections. Here is reported a rare case in a 73-year-old man with multiple myeloma who developed endocarditis due to pseudomonas.

Pacientes diagnosticados com mieloma múltiplo são mais suscetíveis a infecções, que é a principal causa de morbidade e mortalidade associadas a essa doença. Os principais agentes infecciosos envolvidos são as bactérias Gram-positivas, mas, após a quimioterapia, pode haver aumento na incidência de Gram-negativos, que são responsáveis, na maioria dos casos, por infecções do trato urinário. Assim, descrevese um raro caso de um paciente de 73 anos de idade, com mieloma múltiplo diagnosticado com endocardite por pseudomonas.