Return to work after breast cancer diagnosis: An observational prospective study in Brazil.

BACKGROUND: In North America and Europe, return-to-work (RTW) rates vary among breast cancer (BC) survivors, from 24% to 66% and from 53% to 82% at 6 and 36 months after diagnosis, respectively. To date, there is a lack of data on RTW rates after BC diagnosis in Latin America. Therefore, the primary objectives of this study were to define RTW rates at 12 and 24 months after BC diagnosis and to identify the factors associated with RTW in this population. METHODS: In total, 125 employed women from a single institution with newly diagnosed BC were interviewed by telephone at 6, 12, and 24 months after diagnosis. Those who had inoperable or metastatic disease were excluded. RESULTS: Overall, RTW rates were 30.3% and 60.4% at 12 and 24 months after BC diagnosis, respectively. Most women reported that they received support from their employer, but only 29.1% reported having been offered work adjustments. In multivariate analysis, the factors associated with positive RTW outcomes included higher household income (odds ratio [OR], 17.76; 95% confidence interval [CI], 3.33-94.75; P = .001), breast-conserving surgery (OR, 9.77; 95% CI, 2.03-47.05; P = .004), and work adjustments (OR, 37.62; 95% CI, 2.03-47.05; P = .004). The factors associated with negative RTW outcomes included adjuvant endocrine therapy (OR, 0.11; 95% CI, 0.02-0.74; P = .023), and depression diagnosed after BC (OR, 0.07; 95% CI, 0.01-0.63; P = .017). CONCLUSIONS: RTW rates in the current study were lower than those observed in developed countries but similar to the rates among low-income Americans. Workplace adjustments, higher income, breast-conserving surgery, endocrine therapy, and depression after BC played an important role in the RTW decision.

Neoadjuvant chemotherapy with six cycles of carboplatin and paclitaxel in advanced ovarian cancer patients unsuitable for primary surgery: Safety and effectiveness.

OBJECTIVE: Three cycles of neoadjuvant chemotherapy (NACT) followed by interval debulking (ID) surgery is an alternative for patients with advanced ovarian cancer unresectable disease. This study aimed to determine the efficacy and safety of six cycles of NACT followed by cytoreduction. METHODS: Retrospective analysis of all patients with advanced epithelial ovarian cancer, tubal carcinoma, or primary peritoneal carcinoma treated with platinum based NACT between January 2008 and February 2012. RESULTS: Eighty-two patients underwent NACT; 78% and 18.2% had extensive stage IIIC or IV disease at diagnosis, respectively. Their median age was 60 years (41-82). On histology, serous adenocarcinoma was found in 90.2%. Patients did not receive chemotherapy after debulking surgery. 35.4% suffered grade 3/4 toxicity; the most commonly observed toxicities were hematologic and nausea. After NACT, 23.1% experienced clinical complete response, 57.4% partial response, and 12.1% disease progression. Complete resection of all macroscopic and microscopic disease (R0) was performed in 63.7%. Surgical complications were uncommon; however, four (6.2%) patients needed a second procedure due to operative complications and 18 (27.3%) needed blood transfusion after debulking. Over a median follow-up period of 19.2 months, median overall survival and chemotherapy-free interval were 37.5 months (confidence interval not reached) and 16 months, respectively. CONCLUSION: Six cycles of neoadjuvant carboplatin and paclitaxel was safe and effective and did not increase perioperative or postoperative complications in patients with stage IIIC/IV disease who were unsuitable for optimal PDS. The overall survival of this cohort was higher than that of those treated with ID surgery.

Activity and safety of sunitinib in poor risk metastatic renal cell carcinoma patients.

PURPOSE: To assess the activity, safety and treatment patterns of sunitinib in patients with poor-risk metastatic renal cell carcinoma (mRCC). MATERIALS AND METHODS: We retrospectively reviewed the charts of poor risk patients treated with sunitinib from October 2006 to July 2013 who met the eligibility criteria. The primary endpoint was overall survival (OS). Tumor radiological response was measured according to RECIST 1.1 and adverse events (AEs) were assessed through standard criteria. RESULTS: Median OS was 8.16 months (95% CI, 5.73-10.59). Of the 53 patients included in this analysis, 9 (17.0%) achieved partial response, 12 (22.6%) had stable disease. Median treatment duration was 3.30 months (95% CI: 1.96-4.63) and 26.4% of patients discontinued treatment due to toxicity. Grade 3 or higher AEs occurred in 39.6% of patients, the most common being fatigue (15.1%), neutropenia (9.5%), nausea, vomiting and diarrhea (7.5% each). DISCUSSION: Sunitinib may benefit some unselected poor-risk patients, although the rates of AEs and drug discontinuation suggest a need for careful patient monitoring.

Antibody-Drug Conjugates in Breast Cancer: A Comprehensive Review of How to Selectively Deliver Payloads.

Antibody-drug conjugates (ADCs) have surfaced as a promising group of anticancer agents employing the precise targeting capacity of monoclonal antibodies to transport highly effective cytotoxic payloads. Compared to conventional chemotherapy, they aim to selectively eradicate cancer cells while minimizing off-target toxicity on healthy tissues. An increasing body of evidence has provided support for the efficacy of ADCs in treating breast cancer across various contexts and tumor subtypes, resulting in significant changes in clinical practice. Nevertheless, unlocking the full potential of these therapeutic agents demands innovative molecular designs to address complex clinical challenges, including drug resistance, tumor heterogeneity, and treatment-related adverse events. This thorough review provides an in-depth analysis of the clinical data on ADCs, offering crucial insights from pivotal clinical trials that assess the efficacy of ADCs in diverse breast cancer settings. This aids in providing a comprehensive understanding of the current state of ADCs in breast cancer therapy, while also providing valuable perspectives for the future.

Gabapentin for the prevention of chemotherapy- induced nausea and vomiting: a pilot study.

INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) is a distressing side effect that affects many patients undergoing emetogenic chemotherapy, despite the use of antiemetic medications. The purpose of this trial was to evaluate the efficacy and safety of gabapentin for the prevention of CINV during the first cycle of treatment in patients receiving moderately or highly emetogenic chemotherapy. METHODS: Eighty chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy, were enrolled in this randomised, double-blind, placebo-controlled clinical trial. All patients received intravenous ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg twice a day on days 2 and 3. Patients were randomly assigned to take gabapentin 300 mg or placebo on the following schedule: 5 and 4 days before chemotherapy once daily, 3 and 2 days before chemotherapy twice daily, 1 day before to 5 days after chemotherapy thrice daily. The primary endpoint was complete overall protection from both vomiting and nausea over the course of the entire study (day 1 through day 5), and complete protection during the delayed period (24-120 h after chemotherapy). RESULTS: The proportion of patients achieving complete response improved from 40% to 62.5%, (p = 0.04) when comparing the control group and the gabapentin group, respectively. In the subset of patients who achieved complete control in the acute phase, the percentage of patients who achieved delayed complete control was higher in the gabapentin group (89.3 × 60.7%, p = 0.01). Adverse events did not significantly differ between study arms. CONCLUSIONS: Gabapentin is a low-cost strategy to improve complete control of CINV, specially delayed CINV control.

Use of unnecessary medications by patients with advanced cancer: cross-sectional survey.

BACKGROUND: Cancer patients at the end of life take numerous medications. However, it has not been assessed what proportion of patients take unnecessary medications and which patients are at risk for doing so. METHODS: Cross-sectional survey of medications utilized by terminally ill ambulatory cancer patients, with the aim of identifying medications considered unnecessary as per explicit criteria. The criteria took into account whether drugs could benefit patients with terminal cancer. RESULTS: Among 87 patients, 21 (24%, 95% confidence interval [CI] 15.6-34.5%) were taking at least one unnecessary medication, the most common being gastric protectors. In multivariable analyses, patients with Charlson Comobidity Index≤1 (OR: 4.49, CI95% 1.32-15.26; p=0.01) or whose medication list had not been reconciled by physicians (OR: 6.38, CI95% 1.21-33.40; p=0.02) were more likely to use an unnecessary medication. CONCLUSION: Patients with advanced cancer take many medications considered unnecessary. Medication reconciliation should be performed routinely for these patients.

Malignant Phyllodes Tumor of the Breast: A Practice Review.

INTRODUCTION: Phyllodes tumor (PT) of the breast, particularly malignant phyllodes tumor (mPT), is a rare fibroepithelial neoplasm. A complex diagnosis is based on pathologic, radiologic, and clinical findings, with controversies about what is the best therapeutic strategy. OBJECTIVE: Our objective was to provide an overview of the clinical, pathologic, and therapeutic aspects of this rare tumor. CONCLUSIONS: mPT is a rare presentation of breast cancer and a challenge in clinical practice. A multidisciplinary approach should take into account some aspects like pathogenic mutations and hereditary syndromes. Oncologic surgery is the fundamental approach, and the use of adjuvant therapies is still controversial due to the lack of clinical trials. Treatment recommendations should be individualized according to patient risk and preferences. Prospective studies are fundamental to clarifying the best treatment for these tumors.

Metronomic chemotherapy combined with endocrine therapy: are we challenging some dogmas?

INTRODUCTION: Metronomic chemotherapy exerts its effects via inhibition of angiogenesis, immune modulation of the tumoral stroma, induction of senescence and apoptosis of tumor cells. Due to its favorable toxicity profile and its oral administration, metronomic chemotherapy arises as a promising alternative to be combined with endocrine therapy for the treatment of patients with luminal breast cancer. AREAS COVERED: The present manuscript reviews the rationale supporting the combination of metronomic chemotherapy and endocrine therapy, discussing the studies that evaluated this regimen in the treatment of early-stage and metastatic breast cancer patients. Finally, we conclude by providing an expert opinion on the current role and perspectives for the combination of metronomic chemotherapy and endocrine therapy in the management of patients with luminal breast cancer. EXPERT OPINION: Retrospective series and early-phase clinical trials have shown promising signs of activity and a favorable toxicity profile with this regimen, which warrants further investigation as a treatment option for luminal breast cancer patients.

[How to consent without understanding?]. / Como consentir sem entender?

BACKGROUND: The Consent Form (CF) is an important document that informs patients about benefits and risks of a study, it assures patients the right to accept or reject participation in a procedure related to their health. Some authors believe that Consent Forms are complex and difficult to read for most people. OBJECTIVE: Correlate the difficulty of understanding CF, through the Flesch Index (FI) and Flesch-Kincaid Index (FKI), used in our oncology outpatient clinic, with the profile of our patient's education. We also wanted to verify readability and presence of the information which must be part of these CF according to item IV.1 from Resolution 196/96 of the Brazilian Health Council. RESULTS: We obtained 10 CFs, according to FI and FKI the mean was 38.5 and 18.16 respectively, indicating that, at least, 18 years of study are needed for the comprehension. This result is incompatible with the Brazilian population where more than 50% have less than 8 years of study. According to the quality of the CF, they were well elaborated, and had most of the necessary contents. When the authors correlated FKI and quality of CF, they concluded that the quality of CF does not correlate with readability (p= 0.884, Pearson correlation coefficients 0.053). CONCLUSION: Despite the good content quality of most of the analyzed CF, their level of reading difficulty is not compatible with the literacy skills of a major part of the Brazilian population.

Formal statistical testing and inference in randomized phase II trials in medical oncology.

OBJECTIVES: With the growing number of new anticancer therapies, randomized phase II trials have been used more often in oncology. Although the primary objective of such trials is not to formally compare results between arms, this practice seems frequent. We sought to quantify the frequency of use of formal statistical testing or inference through the use of P values and confidence intervals (CIs) in randomized phase II trials. METHODS: We searched PubMed for randomized phase II trials assessing systemic cancer therapies published in the years 1995/1996 and 2005/2006. For each study, 2 reviewers independently abstracted data, including reporting of P values and CIs for the primary endpoint. RESULTS: We retrieved 288 articles, 107 of which were eligible for analysis. The median number of patients per trial was 94, the primary endpoint was response rate in 71 (66.4%) cases, and a control arm was present in 55 (51.4%) trials. Either P values or CIs for the primary endpoint were reported in 85 (79.4%; 95% CI, 70.8%-86.1%) cases. Year of publication, source of funding, and use of a control group were not associated with this practice. CONCLUSIONS: Formal statistical comparisons between arms of randomized phase II trials are frequently undertaken in medical oncology. The extent to which such a practice abrogates phase III testing is unknown.

Adverse drug reactions and drug interactions as causes of hospital admission in oncology.

CONTEXT: Although several studies have evaluated the frequency of adverse drug reactions (ADRs) and drug-drug interactions (DDIs) in general medicine, few studies have looked at the epidemiology of adverse drug events (ADEs) in oncology. OBJECTIVES: We sought to investigate how many hospital admissions in oncology are related to a DDI or an ADR. METHODS: All cancer patients admitted to an oncology ward during an eight-month period had their charts retrospectively evaluated for reasons of hospitalization, using a 4-point scale (definitely, probably, possibly, or unlikely associated) to classify admissions by their probability of being associated with either a DDI or an ADR. RESULTS: From September 2007 to May 2008, there were 550 hospital admissions and 458 were eligible. Among unplanned admissions (n=298), 39 (13.0%, 95% confidence interval [CI] 9.4%-17.4%) were considered to be associated with an ADE, 33 (11.0%, 95% CI 7.7%-15.2%) with an ADR, and six (2.0%, 95% CI 0.7%-4.3%) with a DDI. The most common DDIs involved warfarin, captopril, and anti-inflammatory agents, and the most frequent ADR was neutropenic fever post-chemotherapy. Most patients were discharged completely recovered, but two patients died. CONCLUSION: Approximately one in 10 unplanned hospitalizations of cancer patients is associated with an ADE. Prospective and population-based studies are warranted to evaluate their magnitude in oncology.

Experience with the ABC Foundation School of Medicine undergraduate meeting.

OBJECTIVE: To quantify the number of studies that were presented during oral sessions, selected for awards and published from 2002 to 2007 at the Undergraduate Medical Congress of ABC at the ABC Foundation School of Medicine. METHODS: A retrospective systematic survey of papers selected for oral presentation and award at these undergraduate meeting from 2002 to 2007 was carried out by searching Medline and Lilacs databases and the annals of other medical meetings in order to ascertain which papers would eventually be published. RESULTS: From 2002 to 2007, 408 papers were selected for oral presentation and 71 (17.4%) received at least one award. The total number of papers published was 138 (33.8%), of which 33 (8.1%) were in Medline, 57 (14%) in Lilacs and 48 (11.7%) in the annals of other scientific meetings. Receiving an award by the scientific committee was an independent variable for publication (OR: 2.05 95% CI 1.22-3.46, p = 0.006) as well as for publication in Medline (OR: 2.62 95% CI 1.21 - 5.69, p = 0.01). CONCLUSION: The institutional scientific production of undergraduate medical students presented in Undergraduate Medical Meetings is relevant and should continue to be stimulated.

Activity and safety of sunitinib in poor risk metastatic renal cell carcinoma patients

Purpose To assess the activity, safety and treatment patterns of sunitinib in patients with poor-risk metastatic renal cell carcinoma (mRCC). Materials and Methods We retrospectively reviewed the charts of poor risk patients treated with sunitinib from October 2006 to July 2013 who met the eligibility criteria. The primary endpoint was overall survival (OS). Tumor radiological response was measured according to RECIST 1.1 and adverse events (AEs) were assessed through standard criteria. Results Median OS was 8.16 months (95% CI, 5.73-10.59). Of the 53 patients included in this analysis, 9 (17.0%) achieved partial response, 12 (22.6%) had stable disease. Median treatment duration was 3.30 months (95% CI: 1.96-4.63) and 26.4% of patients discontinued treatment due to toxicity. Grade 3 or higher AEs occurred in 39.6% of patients, the most common being fatigue (15.1%), neutropenia (9.5%), nausea, vomiting and diarrhea (7.5% each). Discussion Sunitinib may benefit some unselected poor-risk patients, although the rates of AEs and drug discontinuation suggest a need for careful patient monitoring. .

Multivitamins do not improve radiation therapy-related fatigue: results of a double-blind randomized crossover trial.

BACKGROUND: Fatigue is a common symptom in cancer patients receiving radiation therapy. PATIENTS AND METHODS: We conducted a double-blind randomized crossover trial of multivitamins versus placebo in patients with breast cancer undergoing radiation therapy to evaluate fatigue and quality of life. RESULTS: : We randomized 40 patients to either placebo or Centrum Silver. At the middle of the radiation treatments, patients were switched from placebo to multivitamins and vice versa. Patients answered the EORTC QLQ C-30 quality of life (QOL) and Chalder fatigue questionnaires at the beginning, middle, and end of radiation therapy. Both groups experienced decreases in general (P = 0.009; P = 0.001) and physical fatigue scores (P = 0.031; P = 0.029) at the end of the course of placebo compared with the assessment prior to this treatment. We also observed significant improvements in functional (P = 0.026) and symptoms (P = 0.016) score scales of the QOL questionnaire in the patients on placebo. No significant changes were elicited with the use of multivitamins. We also observed significantly lower rates of fatigue in the patients who had just finished a course of placebo as compared with patients finishing a course of multivitamins (0 vs. 25% P = 0.035). CONCLUSION: Multivitamins do not improve radiation-related fatigue in patients with breast cancer.

Salvage radiotherapy for biochemical relapse after complete PSA response following radical prostatectomy: outcome and prognostic factors for patients who have never received hormonal therapy.

OBJECTIVES: To evaluate the results of salvage conformal radiation therapy (3DC-EBRT) for patients submitted to radical prostatectomy (RP) who have achieved complete PSA response and who have never been treated with hormonal therapy (HT).To present the results of biochemical control, a period free from hormonal therapy and factors related to its prognosis. MATERIALS AND METHODS: from August 2002 to December 2004, 43 prostate cancer patients submitted to RP presented biochemical failure after achieving a PSA < 0.2 ng/ml. They have never received HT and were submitted to salvage 3DC-EBRT. Median age was 62 years, median preoperative PSA was 8.8 ng/ml, median Gleason Score was 7. Any PSA rise above 0.2 was defined as biochemical failure after surgery. Median 3DC-EBRT dose was 70 Gy, biochemical failure after EBRT was defined as 3 consecutive rises in PSA or a single rise enough to trigger HT. RESULTS: 3-year biochemical non-evidence of disease (BNED) was 71%. PSA doubling time lower than 4 months (p = 0.01) and time from recurrence to salvage EBRT (p = 0.04) were associated with worse chance of biochemical control. Biochemical control of 76% was achieved when RT had been introduced with a PSA lower than 1 ng/ml vs. 48% with a PSA higher than 1 (p = 0.19). Late toxicity was acceptable. CONCLUSION: 70% of biochemical control in 3 years can be achieved with salvage radiotherapy in selected patients. The importance of PSADT was confirmed in this study and radiotherapy should be started as early as possible. Longer follow up is necessary, but it is possible to conclude that a long interval free from hormonal therapy was achieved with low rate of toxicity avoiding or at least delaying several important adverse effects related to hormonal treatment.

Aplicação do instrumento termômetro de estresse em pacientes idosos com câncer: estudo piloto / Application of the distress thermometer in elderly patients with cancer: pilot study

JUSTIFICATIVA E OBJETIVOS: Evidências apontam que cerca de metade dos pacientes com câncer apresentam altos níveis de estresse, condição que ainda permanece pouco diagnosticada e tratada. Este estudo piloto visou investigar a utilização do instrumento Termômetro de Estresse (TE) aplicando-o a pacientes idosos em vigência de tratamento quimioterápico, de forma a identificar possíveis fatores preditivos de estresse nessa população. MÉTODO: Foram selecionados aleatoriamente 40 pacientes com idade igual ou superior a 65 anos, portadores de neoplasia sólida ou hematológica, em tratamento quimioterápico nos serviços vinculados à Faculdade de Medicina do ABC. Estes responderam ao TE e a questionários para avaliação de qualidade de vida, atividades da vida diária, escala de sintomas relacionados à quimioterapia, escala de depressão geriátrica, mini-exame do estado mental e mini-avaliação nutricional. RESULTADOS: A pontuação média do TE foi de 4,20, sendo que 65% dos pacientes apresentaram alto nível de estresse (pontuação de corte maior ou igual a 4). Verificou-se a correlação do TE ao Questionário de Atividades Instrumentais de Lawton (p = 0,035), à Escala de Sintomas de Edmonton (p = 0,043) e à Escala de Depressão Geriátrica (p = 0,030). CONCLUSÃO: Pacientes idosos em tratamento quimioterápico sofrem de estresse, que pode estar relacionado à diminuição da capacidade de desenvolver atividades instrumentais da vida diária, aos próprios sintomas do regime quimioterápico e à manifestação de sintomas de depressão.

BACKGROUND AND OBJECTIVES: Up to half of all cancer patients experience clinically significant levels of stress and much of this stress goes unrecognized and untreated. This pilot study aimed to evaluate the Distress Thermometer (DT) in elderly patients undergoing chemotherapy in oncology services related to the School of Medicine of ABC and to identify possible predictors. METHOD: We randomly selected 40 patients aged over 65 years with hematologic or solid tumors undergoing chemotherapy treatment. They were asked to respond to the DT and questionnaires for assessing quality of life, activities of daily living, symptoms related to chemotherapy, geriatric depression scale, mini-mental state and mini-nutritional assessment. RESULTS : Regarding the DT, the average score was 4.20 and 26 patients (65% of total) had scores above 4 (the optimal DT cutoff score). In the correlation analysis, we obtained a correlation of TD to the questionnaires of Instrumental Activities of Daily Living (p= 0.035), Edmonton Symptom Assessment Scale (p =0.043) and Geriatric Depression Scale (p=0.030). CONCLUSION: Elderly patients undergoing chemotherapy suffer from stress that can be related to the decline in their ability to develop instrumental daily activities, to the symptoms related to the chemotherapy and to the development of depression symptoms.

Experience with The ABC Foundation School of Medicine Undergraduate Meeting / Experiência do Congresso Médico Universitário da Faculdade de Medicina da Fundação ABC

OBJECTIVE: To quantify the number of studies that were presented during oral sessions, selected for awards and published from 2002 to 2007 at the Undergraduate Medical Congress of ABC at the ABC Foundation School of Medicine. METHODS: A retrospective systematic survey of papers selected for oral presentation and award at these undergraduate meeting from 2002 to 2007 was carried out by searching Medline and Lilacs databases and the annals of other medical meetings in order to ascertain which papers would eventually be published. RESULTS: From 2002 to 2007, 408 papers were selected for oral presentation and 71 (17.4 percent) received at least one award. The total number of papers published was 138 (33.8 percent), of which 33 (8.1 percent) were in Medline, 57 (14 percent) in Lilacs and 48 (11.7 percent) in the annals of other scientific meetings. Receiving an award by the scientific committee was an independent variable for publication (OR: 2.05 95 percent CI 1.22-3.46, p = 0.006) as well as for publication in Medline (OR: 2.62 95 percent CI 1.21 - 5.69, p = 0.01). CONCLUSION: The institutional scientific production of undergraduate medical students presented in Undergraduate Medical Meetings is relevant and should continue to be stimulated.

OBJETIVO: Quantificar e descrever o número de trabalhos premiados e não premiados em apresentação oral no Congresso Médico Universitário do ABC no período de 2002 a 2007, que obtiveram posterior publicação em revistas científicas, a fim de avaliar se o trabalho premiado teria maior potencial para publicação. Mapear áreas por produtividade científica na instituição. MÉTODOS: Busca retrospectiva dos trabalhos inscritos no período de 2002 a 2007 que obtiveram publicação em periódicos indexados nas bases de dados Medline (Pubmed) e Lilacs ou em anais de congressos científicos de especialidades nacionais ou internacionais. RESULTADOS: Entre 2002 e 2007, foram inscritos 408 trabalhos e 71 foram premiados. O total de trabalhos publicados foi de 138 (33,8 por cento), sendo 8,1 por cento na base Medline, 14 por cento na base Lilacs e 11,7 por cento encontrados a partir da plataforma Lattes. Premiação pela banca examinadora foi variável independente para publicação (OR: 2,05 IC95 por cento 1,22-3,46; p=0,006) assim como para publicação na base Medline (OR: 2,62 IC95 por cento 1,21- 5,69; p=0,01). CONCLUSÃO: O papel de alunos de graduação na produção científica institucional refletido na produção de um Congresso Médico Universitário é relevante e deve continuar a ser estimulado.

Como consentir sem entender? / How consent without knowing?

INTRODUÇÃO: Termo de Consentimento Livre e Esclarecido (TCLE) é o documento que informa sobre os benefícios e riscos de um estudo. Alguns autores concluíram que os TCLE são de difícil compreensão. OBJETIVO: Correlacionar grau de dificuldade dos TCLE, pelos índices de Flesch (IF) e Flesch-Kincaid (ILFK), utilizados num ambulatório de oncologia ao perfil de escolaridade dos usuários desse mesmo serviço, bem como verificar a legibilidade e a presença das informações obrigatórias segundo o item IV.1 da Resolução 196/96 do Conselho Nacional de Saúde. RESULTADOS: Foram obtidos 10 TCLE; segundo o IF e ILFK, a média foi de 38,5 e 18,16 respectivamente, mostrando ser necessário aproximadamente 18 anos de estudo para a compreensão, dado incompatível com a realidade de nossa população, em que mais de 50 por cento tem menos de oito anos de estudos. Em relação à qualidade dos termos, estes eram bem elaborados tecnicamente, contendo a maior parte dos itens necessários. Ao correlacionarmos o ILFK com a qualidade dos TCLEs, pôde-se observar que a qualidade dos termos não apresentou correlação com a legibilidade (p= 0.884, coeficiente de correlação de Pearson 0.053). CONCLUSÃO: O grau de dificuldade dos TCLE é incompatível com a escolaridade de nossa população e nossos TCLE apresentavam informações suficientes. Esperávamos relacionar a quantidade de informações ao grau de dificuldade de compreensão do texto, não sendo confirmada, mostrando a possibilidade de um TCLE ser completo ao mesmo tempo fácil de ler.

BACKGROUND: The Consent Form (CF) is an important document that informs patients about benefits and risks of a study, it assures patients the right to accept or reject participation in a procedure related to their health. Some authors believe that Consent Forms are complex and difficult to read for most people. OBJECTIVE: Correlate the difficulty of understanding CF, through the Flesch Index (FI) and Flesch-Kincaid Index (FKI), used in our oncology outpatient clinic, with the profile of our patient's education. We also wanted to verify readability and presence of the information which must be part of these CF according to item IV.1 from Resolution 196/96 of the Brazilian Health Council. RESULTS: We obtained 10 CFs, according to FI and FKI the mean was 38.5 and 18.16 respectively, indicating that, at least, 18 years of study are needed for the comprehension. This result is incompatible with the Brazilian population where more than 50 percent have less than 8 years of study. According to the quality of the CF, they were well elaborated, and had most of the necessary contents. When the authors correlated FKI and quality of CF, they concluded that the quality of CF does not correlate with readability (p= 0.884, Pearson correlation coefficients 0.053). CONCLUSION: Despite the good content quality of most of the analyzed CF, their level of reading difficulty is not compatible with the literacy skills of a major part of the Brazilian population.

Importance of cancer among the Brazilian elderly population from 2000 to 2005 / A importância das neoplasias na população idosa brasileira de 2000 a 2005

Objective: To describe cancer hospital morbidity and mortality in the Brazilian elderly population according to the primary site of neoplasms per Brazilian region and their importance on Public Health System expenses. Methods: The data were obtained from the Ministry of Health records from 2000 to 2005. Results: From 2000 to 2005, there were 507,174 deaths due to neoplasms of the population older than 60 years old. The largest mortality rates were found in South and South-East regions. Among women, breast cancer was the most fatal neoplasm; among men, prostate cancer and trachea, bronchi and lung cancer. In situ neoplasms accounted for the highest average hospitalizations and the highest average expenses of the total amount paid for hospitalizations, while brain neoplasms accounted for the highest average amount spent per hospitalization. Conclusions: The elderly population corresponds to the majority of deaths due to neoplasms in the Brazilian population and for most of the hospitalizations expenses due to oncologic causes and subsequent expenses of the public health system.

Objetivo: Descrever a mortalidade e a morbidade hospitalar por câncer em idosos no Brasil de acordo com o sítio primário das neoplasias por regiões do Brasil e o valor gasto no Sistema Público de Saúde. Métodos: Os dados foram obtidos dos registros do Ministério da Saúde, no Sistema de Informação sobre Mortalidade (SIM) e Sistema de Informação Hospitalar (SIH) no período de 2000 a 2005. Resultados: Nos anos de 2000 a 2005 ocorreram 507.174 óbitos por neoplasias em pessoas com mais de 60 anos. As maiores taxas de mortalidade foram encontradas nas regiões Sul e Sudeste. Entre as mulheres, o câncer de mama foi a neoplasia que apresentou maior mortalidade e, entre os homens, foi o câncer de próstata e o de traqueia, brônquios e pulmão. As neoplasias in situ apresentaram a maior média de internações e a maior média anual do valor total pago em internações enquanto as neoplasias de encéfalo apresentaram o maior valor médio gasto em reais por internação. Conclusões: A população geriátrica corresponde à maior parcela dos óbitos por neoplasia na população brasileira e por grande parte dos gastos em internações por causa oncológica e consequentes gastos com o sistema de saúde público.

Biochemical Relapse for Prostate Cancer Following Radical Prostatectomy: Salvage Radiotherapy Without HormonalTherapy

Objectives: This paper aims to study biochemical control, hormonal therapy-free survival, and prognostic factors related tosalvage radiation for prostate cancer patients submitted to radical prostatectomy (RP) without hormonal therapy (HT) before orduring radiation. Materials and Methods: from August 2002 to July 2004, 39 prostate cancer patients submitted to RPpresented biochemical failure after achieving PSA nadir (<0.2ng/ml). All patients were submitted to three-dimensional conformalexternal beam radiation therapy (3DC-EBRT) and no patients had received HT. Median age was 62 years, median preoperativePSA was 9.4ng/ml, median Gleason Score was 7. We defined PSA rise above 0.2 as biochemical failure after surgery. Median3DC-EBRT dose was 70Gy, and biochemical failure after EBRT was defined as three consecutive rises in PSA or a single risesufficient to trigger HT. Results: Biochemical non-evidence of disease (BNED) in 3 years was 72%. PSA doubling time (PSADT)lower than 4 months (p=0.04), and delay to salvage EBRT (p=0.05) were associated to worse chance of successful salvagetherapy. Late morbidity was acceptable. Conclusion: Expressive PSA control (72% BNED / 3years) could be achieved withsalvage radiotherapy in well-selected patients. The importance of PSADT was confirmed, and radiotherapy should be started asearly as possible. Follow-up is somewhat short, but it is possible to conclude that it is possible to achieve a long interval freefrom hormonal therapy with low rate of toxicity, avoiding or at least delaying morbidity related to hormonal treatment.radiotherapy