Meta-analysis of adjunctive non-NK1 receptor antagonist medications for the control of acute and delayed chemotherapy-induced nausea and vomiting.

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) is a distressing chemotherapy-induced symptom that may adversely impact the quality of life of cancer patients. METHODS: We conducted a systematic search of the Pubmed, Bireme, and Cochrane databases for randomized clinical trials that were published in English and that evaluated the combination of adjunctive non-neurokinin 1 (NK1) antagonist drugs (i.e., neuroleptics, anticonvulsants, benzodiazepines, and cannabinoids) with 5-hydroxytryptamine 3 (5-HT3) antagonists for adult cancer patients who were scheduled to receive moderate or highly emetogenic chemotherapy. We employed the Review Manager (RevMan) Computer program Version 5.2 for statistical calculations. RESULTS: We included 13 studies with a total of 1,669 patients. We observed a higher complete protection for acute CINV with adjunctive medications (risk ratio (RR) = 0.55; 95% confidence interval (CI) 0.30-1.01; p = 0.05; I2 = 47%), which was not the case for the delayed period (RR = 0.89; 95% CI 0.73-1.10, p = 0.29, I2 = 15%). We also observed that these adjunctive medications significantly increased the complete control of nausea (RR = 0.72; 95% CI 0.55-0.95; p = 0.02, I2 = 83%) and vomiting (RR = 0.61; 95% CI 0.50-0.75; p < 0.00001; I2 = 60%). There was no subgroup analysis evidence of the superiority of any single group of adjunctive medications. CONCLUSIONS: We conclude that adjunctive non-NK1 antagonist medications may be useful for CINV control. Prospective randomized studies incorporating these low-cost medications into new regimens combining 5-HT3 and NK1 antagonists may be warranted.

Clinical Outcomes of Patients With B-Cell Non-Hodgkin Lymphoma in Real-World Settings: Findings From the Hemato-Oncology Latin America Observational Registry Study.

PURPOSE: Real-world evidence on non-Hodgkin lymphoma (NHL) management in Latin America is currently lacking. The objective of this study was to describe treatment characteristics and outcomes of NHL in Latin America. METHODS: A total of 2,967 patients with NHL with aggressive and indolent subtypes, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle-cell lymphoma (MCL), and mucosa-associated lymphoid tissue (MALT) lymphoma, with incident or prevalent diagnosis between 2006 and 2015, were retrospectively identified using clinical charts registered in the Hemato-Oncology Latin America Observational Registry. Associations between treatment regimen and age at diagnosis with clinical outcomes within each subtype were estimated using Cox proportional hazard regression. RESULTS: Most patients with NHL received 1L chemoimmunotherapy, most commonly cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with/without rituximab. Five-year survival rates were higher for MALT lymphoma (90.8%) and FL (87.6%) versus DLBCL (69.0%) and MCL (57.1%), with variations between countries. The median overall survival from first relapse for patients with DLBCL was 6.6 years, with lower risk of death for those diagnosed at age < 65 years (hazard ratio = 0.732; P = .0161). Patients achieved a longer median progression-free survival with 1L rituximab-CHOP (R-CHOP) versus CHOP or rituximab, cyclophosphamide, vincristine, and prednisone (RCVP) (7.7 v 3.0 or 1.8 years, respectively). Use of regimens other than R-CHOP was associated with a higher risk of death/progression for patients with DLBCL (rituximab, ifosfamide, carboplatin, and etoposide/ifosfamide, carboplatin, and etoposide) and FL (CHOP). There was no relationship between treatment prescribed and age at diagnosis with outcomes from first/second relapse in DLBCL and FL. CONCLUSION: Differences in treatment outcomes between NHL subtypes were observed, reflecting variations in NHL management and barriers to treatment access in Latin America. These data provide necessary evidence to understand NHL management in this region and highlight the need to improve treatment outcomes for these patients.

Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma.

INTRODUCTION: Daratumumab is a CD38-targeting monoclonal antibody with established efficacy and safety in patients with relapsed or refractory multiple myeloma (RRMM). We report results of an early access protocol (EAP) of daratumumab monotherapy for RRMM in a cohort of Brazilian patients. METHODS: Patients with RRMM and ≥3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or who were double refractory to both a PI and IMiD received daratumumab, 16 mg/kg, intravenously weekly for 8 weeks, biweekly for 16 weeks, and every 4 weeks thereafter until disease progression, unacceptable toxicity, loss of clinical benefit, or study conclusion or if daratumumab became available with reimbursement. RESULTS: Forty-nine patients received ≥1 dose of daratumumab. The median (range) duration of treatment was 6.4 (0.3-11.8) months, with a median (range) of 8 (1-13) treatment cycles. Grade 3/4 treatment-emergent adverse events (TEAEs) were reported in 38.8% of patients, most frequently neutropenia and pneumonia (10.2% each). Seven (14.3%) patients discontinued treatment due to TEAEs; 3 patients discontinued due to daratumumab-related TEAEs. Serious TEAEs occurred in 38.8% of patients. Infusion-related reactions were reported in 25 (51.0%) patients, were primarily grade 1/2, and the majority (23 patients) occurred during the first infusion. Twenty (40.8%) patients achieved a partial response or better; median progression-free survival was 8.25 (95% confidence interval, 5.55-17.54) months. CONCLUSION: In this EAP, daratumumab monotherapy in Brazilian patients showed a safety and efficacy profile consistent with clinical studies of daratumumab monotherapy in patients with heavily pretreated RRMM. ClinicalTrials.gov identifier: NCT02477891.

Hormone receptor-negative as a predictive factor for pathologic complete response to neoadjuvant therapy in breast cancer.

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.

[Analysis of delays in diagnosis and treatment of breast cancer patients at a public hospital]. / Análise do atraso no diagnóstico e tratamento do câncer de mama em um hospital público.

BACKGROUND: To identify potential delays in the management of patients with breast cancer examined at a public hospital, from time of suspicion until diagnosis and beginning of treatment. METHODS: Retrospective study which analyzed data related to time elapsed in different intervals between suspicion, diagnosis and onset of systemic cancer-directed treatments, of consecutive breast cancer patients cared for at the medical oncology clinic of the Mario Covas Hospital during 2006. RESULTS: Sixty-eight women, with a mean age of 56.3 years (standard deviation: 12.2 years), were included. Of all the intervals, the longest delay occurred between the mammographic suspicion of cancer and performance of biopsy (median of 72 days, range: 4 - 1095 days); this was significantly longer (P<0.001) than in the other intervals analyzed. Furthermore, this interval in particular, was significantly longer in patients with advanced stage breast cancer when compared to those at the initial stage (P=0.014). CONCLUSION: Breast cancer patients treated in a public hospital in Brazil suffer delays, especially during the diagnosis of their disease. Minimizing the time between mammography and biopsy of suspicious lesions appears to be the most critical step to correct this situation.

[Positive/total dissected lymph nodes ratio as a prognostic factor in colon cancer]. / Razão entre linfonodos positivos e dissecados como fator prognóstico em câncer de cólon.

BACKGROUND: To evaluate the prognostic value of the ratio between positive and total dissected lymph nodes in patients with colon cancer who underwent primary tumor surgical resection. METHODS: Retrospective chart review of consecutive patients with colon cancer treated at hospitals affiliated to the ABC Foundation School of Medicine, Santo André. Demographic data were collected as well as information on colon cancer, treatment and clinical outcomes. RESULTS: One hundred and six patients were included. Mean age was 62.82+/-11.6 years and most were men (53.8%). Median number of lymph nodes dissected per patient was 11.5 (3-45 lymph nodes) and 58.5% had more than 10 dissected lymph nodes. The median follow-up was 25.05+/-15.21 months (2-64 months). In univariate analysis for overall survival, lymph node ratio (p=0.044), tumor stage (p=0.001) and tumor recurrence (p=0.058) were considered significant. In multivariate analysis only tumor stage was significantly associated with overall survival (p=0.001). CONCLUSION: In this limited retrospective series, the ratio between positive and dissected lymph nodes was not independently associated with overall survival among patients with colon cancer, when considered together with the pathological stage. Larger and prospective studies are warranted to define the impact of such ratio on the overall survival of colon cancer patients.

Cushing's syndrome secondary to bronchopulmonary carcinoid tumor: report of two cases and literature review.

Bronchopulmonary carcinoid tumors have been associated with a variety of endocrine disorders including Cushing's syndrome (CS), which is caused by ectopic adrenocorticotrophic hormone (ACTH) secretion. We report two cases of CS secondary to bronchopulmonary carcinoid tumors. The first patient, a 29-year-old woman, presented hypokalemia, high serum ACTH level and high free-urinary cortisol, raising suspicion of an ectopic ACTH syndrome. Chest computed tomography and Octreoscan showed a peripheral nodule in the left-superior lobe of the lung. After lobectomy, a typical bronchopulmonary carcinoid was diagnosed. The second patient, a 16-year-old boy, presented "moon face" and progressive asthenia, high serum ACTH level and high free-urinary cortisol, raising the same hypothesis. Chest computed tomography and Octreoscan showed a peripheral nodule in the middle lobe. After lobectomy, an atypical bronchopulmonary carcinoid was diagnosed. Both cases had IA stage (T1N0M0), positively immunostaining for chromogranin and ACTH. Neither of these patients had hypophysary microadenomas, adrenal adenomas or recurrence of CS after surgical treatment, demonstrating that CS was caused solely by the presence of the bronchopulmonary carcinoid tumors.

Fatigue in Patients With Advanced Terminal Cancer Correlates With Inflammation, Poor Quality of Life and Sleep, and Anxiety/Depression.

PURPOSE: To assess which laboratory and clinical factors are associated with fatigue in patients with terminal cancer. METHODS: We evaluated 51 patients with advanced incurable solid tumors using the Chalder Fatigue Questionnaire (CFQ) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale for fatigue; the Pittsburgh Sleep Quality Index (PSQI-BR) for sleep quality; the Hospital Anxiety and Depression Scale (HADS) for anxiety and depression; the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire, Version 3.0 (QLQ C-30); and Functional Assessment of Cancer Therapy (FACT) for quality of life. We also analyzed several inflammatory markers and the modified Glasgow prognostic score (mGPS). RESULTS: We observed severe fatigue in 19 (38%) patients (FACIT-F score >36). There was a significant correlation between fatigue as evaluated by the CFQ and quality of sleep and between the CFQ mental fatigue subscale scores and TNF-α level. When fatigue was evaluated using the FACIT-F scale, we observed a significant association between fatigue and anxiety/depression, quality of sleep, mGPS, and hemoglobin levels. Fatigue measured both with the CFQ and FACIT-F scale correlated with poor quality of life according to the EORTC QLQ C-30. CONCLUSION: In patients with advanced cancer, fatigue is a common symptom associated with the presence of inflammation, poor quality of sleep, depression/anxiety, and poor quality of life.

Application of prognostic score IPSET-thrombosis in patients with essential thrombocythemia of a Brazilian public service.

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.

Epidemiological profile and prognostic factors in patients with lung cancer.

OBJECTIVE: To describe the epidemiological profile of patients with lung cancer treated at a public tertiary referral hospital specializing in oncology, and to explore variables that may be related to the overall survival (OS) of these patients. METHOD: Data from the medical records of all patients with invasive lung cancer consecutively seen at the Oncology Department of Hospital Estadual Mário Covas between August 2008 and December 2013 were extracted. The information obtained was submitted to statistical analysis. RESULTS: Of the total 210 patients, 39 were excluded from analysis due to lack of information in the medical record. The most common histological type was adenocarcinoma, representing 39.41% of the sample, followed by squamous cell carcinoma with 25.29% and small-cell carcinoma with 13.53%. Other histological types were responsible for the remaining 21.76%. There was a statistically significant association between Karnofsky performance status (KPS) ≤ 70%, palliative chemotherapy lines performed and stage at diagnosis, and OS. Additionally, administration of target therapy to patients with EGFR mutation was associated with significantly better overall survival. However, analysis of laboratory variables (hemoglobin, albumin and LDH) as possible prognostic factors for survival showed no statistically significant relationship. Among patients with stage III and IV, the median OS was 10.1 months. CONCLUSION: The risk factors for shorter OS were KPS score ≤ 70%, less than two lines of palliative chemotherapy, and stage III and IV at diagnosis. The implementation of CT screening for risk patients may allow earlier diagnosis of cases and improve these results.

Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma

ABSTRACT Introduction: Daratumumab is a CD38-targeting monoclonal antibody with established efficacy and safety in patients with relapsed or refractory multiple myeloma (RRMM). We report results of an early access protocol (EAP) of daratumumab monotherapy for RRMM in a cohort of Brazilian patients. Methods: Patients with RRMM and ≥3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or who were double refractory to both a PI and IMiD received daratumumab, 16 mg/kg, intravenously weekly for 8 weeks, biweekly for 16 weeks, and every 4 weeks thereafter until disease progression, unacceptable toxicity, loss of clinical benefit, or study conclusion or if daratumumab became available with reimbursement. Results: Forty-nine patients received ≥1 dose of daratumumab. The median (range) duration of treatment was 6.4 (0.3-11.8) months, with a median (range) of 8 (1-13) treatment cycles. Grade 3/4 treatment-emergent adverse events (TEAEs) were reported in 38.8% of patients, most frequently neutropenia and pneumonia (10.2% each). Seven (14.3%) patients discontinued treatment due to TEAEs; 3 patients discontinued due to daratumumab-related TEAEs. Serious TEAEs occurred in 38.8% of patients. Infusion-related reactions were reported in 25 (51.0%) patients, were primarily grade 1/2, and the majority (23 patients) occurred during the first infusion. Twenty (40.8%) patients achieved a partial response or better; median progression-free survival was 8.25 (95% confidence interval, 5.55-17.54) months. Conclusion: In this EAP, daratumumab monotherapy in Brazilian patients showed a safety and efficacy profile consistent with clinical studies of daratumumab monotherapy in patients with heavily pretreated RRMM. ClinicalTrials.gov identifier: NCT02477891.

Adjuvant treatment delay in breast cancer patients.

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.

Complete pathologic response as a prognostic factor for squamous cell carcinoma of the oropharynx post-chemoradiotherapy.

INTRODUCTION: Chemoradiotherapy for squamous cell carcinoma of the oropharynx (SCCO) provides good results for locoregional disease control, with high rates of complete clinical and pathologic responses, mainly in the neck. OBJECTIVE: To determine whether complete pathologic response after chemoradiotherapy is related to the prognosis of patients with SCCO. METHODS: Data were prospectively extracted from clinical records of N2 and N3 SCCO patients submitted to a planned neck dissection after chemoradiotherapy. RESULTS: A total of 19 patients were evaluated. Half of patients obtained complete pathologic response in the neck. Distant or locoregional recurrence occurred in approximately 42% of patients, and 26% died. Statistical analysis showed an association between complete pathologic response and lower disease recurrence rate (77.8% vs. 20.8%; p=0.017) and greater overall survival (88.9% vs. 23.3%; p=0.049). CONCLUSION: The presence of a complete pathologic response after chemoradiotherapy positively influences the prognosis of patients with SCCO.

Applicability of modified Glasgow Prognostic Score in the assessment of elderly patients with cancer: A pilot study.

OBJECTIVES: To evaluate the relationship between inflammatory parameters through the modified Glasgow Prognostic Score (mGPS) and other clinical characteristics of elderly patients with cancer, including frailty evaluated by the Edmonton Frailty Scale (EFS). MATERIALS AND METHODS: We included patients from the oncology service at Faculdade de Medicina do ABC with a confirmed diagnosis of solid tumor aged 65 years or more at diagnosis. Patients were assessed by applying the translated and validated to Portuguese version of the EFS and also had blood sample collection for the evaluation of C-reactive protein (CRP) and albumin for calculation of the mGPS. RESULTS: We included 52 patients of both sexes, with median age of 72.5 years, of these 67.3% had localized disease and 32.7% metastatic disease. The mGPS presented 17.3% of high-risk patients. The frailty evaluated by EFS occurred in 57.6% of patients. Patients with both abnormal parameters (CRP and albumin) in the mGPS had significantly higher scores on EFS when compared to those with no change (6 vs. 9.56 points, p=0.021). The mGPS correlated also with clinical staging (p=0.019) and performance status (p=0.039). CONCLUSIONS: Inflammatory parameters correlate significantly with frailty, more advanced clinical stage and poor functional status.

Uncaria tomentosa (cat's claw) improves quality of life in patients with advanced solid tumors.

OBJECTIVE: Cat's claw (Uncaria tomentosa) is a native Amazon plant that exhibits anti-inflammatory and antitumor properties. We wanted to assess its activity for symptom management of terminal cancer patients. METHODS: This prospective phase II study assessed the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day in patients with advanced solid tumors who had no further therapeutic options and a life expectancy of at least 2 months. The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and Functional Assessment of Chronic Illness Therapy - Fatigue questionnaires were used to assess the participants' quality of life, the Hospital Anxiety and Depression Scale questionnaire was used to assess anxiety and depression, and the Pittsburgh Sleep Quality Index was used to assess sleep quality. In addition, several biochemical and inflammatory parameters were analyzed. RESULTS: Fifty-one volunteers were recruited. Their median age was 64 (range, 33-85) years, and 47% of patients were female. More than 65% of patients had scores on the Karnofsky Performance Scale of 80% or less. Treatment improved the patients' overall quality of life (p=0.0411) and social functioning (p=0.0341), as assessed by the EORTC QLQ C-30, and reduced fatigue (p=0.0496) according to the Chalder Fatigue Questionnaire. None of the biochemical or inflammatory parameters assessed (interleukin-1 and -6, C-reactive protein, tumor necrosis factor-α, erythrocyte sedimentation rate, and α-1-acid glycoprotein) changed significantly. No tumor response was detected according to the Response Evaluation Criteria In Solid Tumors; however, the disease stabilized for more than 8 months in four participants. The medication was well tolerated by most patients. CONCLUSION: Use of cat's claw might be beneficial in patients with advanced cancer by improving their quality of life and reducing fatigue. The mechanism of action does not seem to be related to the anti-inflammatory properties of this plant.

The Profile of Heparanase Expression Distinguishes Differentiated Thyroid Carcinoma from Benign Neoplasms.

INTRODUCTION: The search for a specific marker that could help to distinguish between differentiated thyroid carcinoma and benign lesions remains elusive in clinical practice. Heparanase (HPSE) is an endo-beta-glucoronidase implicated in the process of tumor invasion, and the heparanase-2 (HPSE2) modulates HPSE activity. The aim of this study was to evaluate the role of heparanases in the development and differential diagnosis of follicular pattern thyroid lesions. METHODS: HPSE and HPSE2 expression by qRT-PCR, immunohistochemistry evaluation, western blot analysis and HPSE enzymatic activity were evaluated. RESULTS: The expression of heparanases by qRT-PCR showed an increase of HPSE2 in thyroid carcinoma (P = 0.001). HPSE activity was found to be higher in the malignant neoplasms than in the benign tumors (P<0.0001). On Western blot analysis, HPSE2 isoforms were detected only in malignant tumors. The immunohistochemical assay allowed us to establish a distinct pattern for malignant and benign tumors. Carcinomas showed a typical combination of positive labeling for neoplastic cells and negative immunostaining in colloid, when compared to benign tumors (P<0.0001). The proposed diagnostic test presents sensitivity and negative predictive value of around 100%, showing itself to be an accurate test for distinguishing between malignant and benign lesions. CONCLUSIONS: This study shows, for the first time, a distinct profile of HPSE expression in thyroid carcinoma suggesting its role in carcinogenesis.

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

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.

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.

From one side to the other: what is essential? Perception of oncology patients and their caregivers in the beginning of oncology treatment and in palliative care.

OBJECTIVE: To evaluate the perception of oncology patients and their caregivers upon diagnosis and beginning of the therapy and during palliative care. METHODS: A cross-sectional study at the oncology and palliative care outpatients clinics of the Faculdade de Medicina do ABC. Clinical and demographic data from patients and their caregivers were collected and questionnaires regarding the elements considered important in relation to the treatment were applied. RESULTS: We enrolled 32 patients and 23 caregivers that were initiating treatment at the oncology outpatient clinic, as well as 20 patients and 20 caregivers at the palliative care clinic. Regarding the patients treated at the oncology clinic, the issues considered most important were a physician available to discuss the disease and answer questions (84%), trust in the physician (81%), and a physician with accessible language (81%). For their caregivers, the following issues were considered extremely important: trust in the medical team that treats the patients (96%), and the same medical team taking care of their relatives (87%). As to patients treated at the palliative care clinic, trust in the physician (83%), to be with people considered important to them (78%), and to be treated preserving their dignity (72%) were considered extremely important. For their caregivers, to receive adequate information about the disease and the treatment's risks and benefits (84%), and sincere communication of information about the disease (79%) were considered extremely relevant. CONCLUSION: Confidence through good communication and consistency in care were fundamental values to achieve satisfaction among caregivers and patients with cancer during all the course of disease development.