Publications by authors named "Cleyton Zanardo DE Oliveira"

19 Publications

  • Page 1 of 1

Thromboembolic and bleeding events in intensive care unit patients with COVID-19: results from a Brazilian tertiary hospital.

Int J Infect Dis 2021 Dec 17;113:236-242. Epub 2021 Oct 17.

BP- A Beneficência Portuguesa de São Paulo, São Paulo, Brazil; BRICnet - Brazilian Research in Intensive Care Network.

Objectives: To describe the incidence of thromboembolic events in adult patients with severe COVID-19 and identify clinical and laboratory factors associated with these events.

Design: Observational retrospective cohort study of 243 adult patients with severe COVID-19 admitted to an intensive care unit (ICU) at a Brazilian tertiary hospital.

Results: The incidence of all thromboembolic events was 14.8%, in which 3.8% developed deep vein thrombosis, 7.8% pulmonary embolism, 2.5% acute myocardial infarction, 1.2% stroke, and 1.2% peripheral artery occlusion. Risk factors identified were D-dimer at admission >3000 ng/mL (P=<0.0013) and major bleeding (P=0.001). The cumulative risk of developing thromboembolic events at day 28 after ICU admission was 16.0%. The rate of major bleeding was 4.1%. After receiver operating characteristic curve analysis, the D-dimer cut-off at admission correlating with thromboembolic events was 1140.5 ng/mL.

Conclusions: The rate of thromboembolic events in our study was lower than previously described. High D-dimer level at admission was the leading risk factor; the optimal cut-off was 1140.5 ng/mL. The occurrence of thromboembolic events did not have an impact on the median overall survival rate. The optimal anticoagulant strategy in this context still needs to be established.
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http://dx.doi.org/10.1016/j.ijid.2021.10.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8520502PMC
December 2021

Rationale and design of the "Tocilizumab in patients with moderate to severe COVID-19: an open-label multicentre randomized controlled" trial (TOCIBRAS).

Rev Bras Ter Intensiva 2020 Jul-Sep;32(3):337-347

BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.

Introduction: Pro-inflammatory markers play a significant role in the disease severity of patients with COVID-19. Thus, anti-inflammatory therapies are attractive agents for potentially combating the uncontrolled inflammatory cascade in these patients. We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.

Methods And Analysis: This open-label multicentre randomized controlled trial will compare clinical outcomes of tocilizumab plus standard of care versus standard of care alone in patients with moderate to severe COVID-19. Two of the following four criteria are required for protocol enrolment: D-dimer > 1,000ng/mL; C reactive protein > 5mg/dL, ferritin > 300mg/dL, and lactate dehydrogenase > upper limit of normal. The primary objective will be to compare the clinical status on day 15, as measured by a 7-point ordinal scale applied in COVID-19 trials worldwide. The primary endpoint will be assessed by an ordinal logistic regression assuming proportional odds ratios adjusted for stratification variables (age and sex).

Ethics And Dissemination: The TOCIBRAS protocol was approved by local and central (national) ethical committees in Brazil following current national and international guidelines/directives. Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment. The data derived from this trial will be published regardless of the results. If proven active, this strategy could alleviate the consequences of the inflammatory response in COVID-19 patients and improve their clinical outcomes.
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http://dx.doi.org/10.5935/0103-507X.20200060DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7595725PMC
October 2020

Symptom screening in paediatrics tool for screening multiple symptoms in Brazilian patients with cancer: a cross-sectional validation study.

BMJ Open 2019 08 2;9(8):e028149. Epub 2019 Aug 2.

Oncology Graduate Program and Research Group on Palliative Care and Health-Related Quality of Life (GPQual), Barretos Cancer Hospital, BARRETOS, Brazil

Objective: The objective of this study was to translate, culturally adapt and validate the Symptom Screening in Paediatrics Tool (SSPedi) into the Brazilian Portuguese language to be used by paediatric oncology patients in Brazil.

Design: A descriptive, cross-sectional study that follows an established methodology for translation and cultural adaptation, developed in two phases: phase I, linguistic translation and cultural adaptation of the SSPedi scale and phase II, psychometric properties evaluation.

Setting: Children's Hospital for Cancer Treatment in Latin America.

Participants: Paediatric patients between 7 and 18 years of age and proxies of patients between 2 and 6 years of age, diagnosed with cancer and undergoing chemotherapy treatment. Patients and proxies with significant neuropsychiatric disorders and/or visual impairment that prevented the ability to read were excluded.

Primary Outcome Measures: Construct validation of SSPedi using convergent validity and contrasted groups. Reliability was evaluated using Cronbach's alpha test and assessing the retest using the intraclass correlation coefficient (ICC).

Results: The psychometric properties of the symptom screening tool were evaluated using 157 participants, of which 116 were patients and 41 were proxies. Convergent validity and hypothesised correlations (Spearman's r>0.4) were confirmed for both self- and proxy-reported versions of the assessment tool. No significant differences found between the two contrasting groups. Assessment of SSPedi resulted in an internal consistency of reliability of α=0.77 (95% CI 0.70 to 0.82) for the self and α=0.81 (95% CI 0.71 to 0.88) for the proxy and overall reproducibility ICC values of (95% CI), 0.54 (0.15 to 0.77) and 0.77 (0.64 to 0.86).

Conclusion: SSPedi was found to be culturally and linguistically adaptable and considered valid and reliable for use by paediatric oncology patients in Brazil. The new translated and adapted version was named SSPedi-BR.
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http://dx.doi.org/10.1136/bmjopen-2018-028149DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6687019PMC
August 2019

Validation of the Brazilian version of the Shame and Stigma Scale (SSS-Br) for patients with head and neck cancers.

Palliat Support Care 2020 04;18(2):186-192

Health-Related Quality of Life Research Group (GPQual), Learning and Research Institute, Barretos Cancer Hospital, Barretos, São Paulo, Brazil.

Objective: To evaluate the psychometric properties of the Brazilian version of the Shame and Stigma Scale (SSS) in a sample of patients with head and neck cancers (HNC).

Methods: This is a validation study carried out in a Brazilian cancer hospital. Patients over 18 years old who knew about their HNC diagnosis were consecutively recruited, answering the SSS, the Functional Assessment of Cancer Therapy (General and Head and Neck supplement) questionnaire, and the University of Washington Quality of Life Questionnaire. Internal consistency, test-retest procedure, convergent validity, and responsiveness analysis were the psychometric properties evaluated.

Results: A total of 122 HNC patients were included. The SSS showed appropriate internal consistency (alphas ranging from 0.71 to 0.86), test-retest reliability (higher than 0.92 with exception of the "Regret domain"), and convergent validity. The responsiveness analysis with 38 patients was able to discriminate the scores before and after prosthetic procedures.

Significance Of The Results: The Brazilian Portuguese version of the SSS may be considered a valid and reliable instrument for the evaluation of Brazilian patients with HNC. Future SSS validation studies are welcome in other developing countries in order to make cancer health providers aware of these negative feelings in their HNC patients.
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http://dx.doi.org/10.1017/S1478951519000488DOI Listing
April 2020

Adverse events during intrahospital transport of critically ill patients in a large hospital.

Rev Bras Ter Intensiva 2019 28;31(1):15-20. Epub 2019 Feb 28.

Grupo de Transporte, Hospital BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.

Objective: To describe the incidence of clinical and non-clinical events during intrahospital transport of critically ill patients and to analyze the associated risk factors.

Methods: Cohort study with retrospective data collected from October 2016 to October 2017. All cases of intrahospital transport for diagnostic and therapeutic purposes in a large hospital with six adult intensive care units were analyzed, and the adverse events and related risk factors were evaluated.

Results: During the study period, 1,559 intrahospital transports were performed with 1,348 patients, with a mean age of 66 ± 17 years and a mean transport time of 43 ± 34 minutes. During transport, 19.8% of the patients were using vasoactive drugs; 13.7% were under sedation; and 10.6% were under mechanical ventilation. Clinical events occurred in 117 transports (7.5%), and non-clinical events occurred in 125 (8.0%) transports. Communication failures were prevalent; however, the multivariate analysis showed that the use of sedatives, noradrenaline and nitroprusside and a transport time greater than 36.5 minutes were associated with adverse clinical events. The use of dobutamine and a transport time greater than 36.5 minutes were associated with non-clinical events. At the end of transport, 98.1% of the patients presented unchanged clinical conditions compared with baseline.

Conclusion: Intrahospital transport is related to a high incidence of adverse events, and transport time and the use of sedatives and vasoactive drugs were related to these events.
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http://dx.doi.org/10.5935/0103-507X.20190003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6443312PMC
August 2019

Development and validation of a prognostic nomogram for ambulatory patients with advanced cancer.

Cancer Med 2018 Jun 1. Epub 2018 Jun 1.

Department of Palliative Care and Rehabilitation Medicine, M.D. Anderson Cancer Center, The University of Texas, Houston, TX, USA.

Predicting survival of advanced cancer patients (ACPs) is a difficult task. We aimed at developing and testing a new prognostic tool in ACPs when they were first referred to palliative care (PC). A total of 497 patients were analyzed in this study (development sample, n = 221; validation sample, n = 276). From 35 initial putative prognostic variables, 14 of them were selected for multivariable Cox regression analyses; the most accurate final model was identified by backward variable elimination. Parameters were built into a nomogram to estimate the probability of patient survival at 30, 90, and 180 days. Calibration and discrimination properties of the Barretos Prognostic Nomogram (BPN) were evaluated in the validation phase of the study. The BPN was composed of 5 parameters: sex, presence of distant metastasis, Karnofsky Performance Status (KPS), white blood cell (WBC) count, and serum albumin concentration. The C-index was 0.71. The values of the area under the curve (AUC) of the receiver operating characteristic (ROC) curve were 0.84, 0.74, and 0.74 at 30, 90, and 180 days, respectively. There were good calibration results according to the Hosmer-Lemeshow test. The median survival times were 313, 129, and 37 days for the BPN scores <25th percentile (<125), 25th to 75th percentile (125-175), and >75th percentile (>175), respectively (P < .001). The BPN is a new prognostic tool with adequate calibration and discrimination properties. It is now available to assist oncologists and palliative care physicians in estimating the survival of adult patients with advanced solid tumors.
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http://dx.doi.org/10.1002/cam4.1582DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6051167PMC
June 2018

The Brazilian version of Skindex-16 is a valid and reliable instrument to assess the health-related quality of life of patients with skin diseases.

PLoS One 2018 22;13(3):e0194492. Epub 2018 Mar 22.

Palliative Care and Health-Related Quality of Life Research Group, Barretos, Brazil.

Introduction: The aim of this study was to assess the psychometric properties of the Brazilian version of Skindex-16 in patients with various skin diseases.

Methods: Dermatologic assessments were performed for the diagnosis and classification of the severity of skin conditions. The clinical feasibility of Skindex-16 was assessed based on the time required to complete the questionnaire and the number of unanswered items. The participants (n = 110) answered the Hospital Anxiety and Depression Scale (HADS), the Dermatology Life Quality Index (DLQI) and the Skindex-16 (Portuguese/Brazil version) questionnaires. Convergent validity was assessed based on the correlation of the Skindex-16 with the DLQI and HADS subscales. Known-groups validity was assessed based on the comparison of the mild, moderate and severe disease groups using the Kruskal-Wallis test. Internal consistency was assessed using Cronbach's alpha and test-retest reproducibility using the intraclass correlation coefficient (ICC) obtained with 29 participants who answered the Skindex-16 a second time 3 to 10 days after the first assessment.

Results: The mean time to answer the questionnaire was 2 min 41 sec. Cronbach's alpha scores were 0.867, 0.930 and 0.888 for the Skindex-16 domains symptoms, emotions and functioning, respectively. The ICCs were 0.947, 0.860 and 0.843 for the Skindex-16 domains symptoms, emotions and functioning, respectively. All three Skindex-16 scales exhibited strong correlations with DLQI. Moderate correlations were found between HADS subscales and the Skindex-16 emotions domain. Known-groups validity showed differences in all three Skindex-16 domains between the mild and moderate skin disease groups (emotions: p < 0.001; symptoms: p = 0.049; functioning: p < 0.001) and between the mild and severe skin disease groups (emotions: p = 0.002; symptoms: p = 0.001; functioning: p = 0.002).

Conclusion: The Portuguese/Brazil version of Skindex-16 is a valid and reliable instrument to assess the quality of life of patients with skin diseases.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0194492PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5864026PMC
July 2018

The feasibility and benefit of a brief psychosocial intervention in addition to early palliative care in patients with advanced cancer to reduce depressive symptoms: a pilot randomized controlled clinical trial.

BMC Cancer 2017 Aug 23;17(1):564. Epub 2017 Aug 23.

Health-Related Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Barretos, SP, Brazil.

Background: The aim of this study was to assess the feasibility and potential benefit of a brief psychosocial intervention based on cognitive-behavioral therapy performed in addition to early palliative care (PC) in the reduction of depressive symptoms among patients with advanced cancer.

Methods: An open-label randomized phase II clinical trial with two intervention arms and one control group. Patients with advanced cancer starting palliative chemotherapy and who met the selection criteria were included. The participants were randomly allocated to three arms: arm A, five weekly sessions of psychosocial intervention combined with early PC; arm B, early PC only; and arm C, standard cancer treatment. Feasibility was investigated by calculating rates (%) of inclusion, attrition, and contamination (% of patients from Arm C that received PC). Scores of depression (primary aim), anxiety, and quality of life were measured at baseline and 45, 90, 120, and 180 days after randomization.

Results: From the total of 613 screened patients (10.3% inclusion rate), 19, 22, and 22 patients were allocated to arms A, B, and C, respectively. Contamination and attrition rates (180 days) were 31.8% and 38.0%, respectively. No interaction between the arms and treatments were found. Regarding effect sizes, there was a moderate benefit in arm A over arms B and C in emotional functioning (-0.66 and -0.61, respectively) but a negative effect of arm A over arm C in depression (-0.74).

Conclusions: Future studies to be conducted with this population group need to revise the eligibility criteria and make them less restrictive. In addition, the need for arm C is questioned due to high contamination rate. The designed psychosocial intervention was not able to reduce depressive symptoms when combined with early PC. Further studies are warrant to evaluate the intervention on-demand and in subgroups of high risk of anxiety/depression.

Trial Registration: Clinical Trials identifier NCT02133274 . Registered May 6, 2014.
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http://dx.doi.org/10.1186/s12885-017-3560-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5569457PMC
August 2017

High Expression of HULC Is Associated with Poor Prognosis in Osteosarcoma Patients.

PLoS One 2016 2;11(6):e0156774. Epub 2016 Jun 2.

Pediatric Oncology Laboratory, Molecular Oncology Research Center, Barretos Cancer Hospital, Barretos, SP, Brazil.

Osteosarcoma (OS) is the most common primary bone cancer in childhood. OS is an aggressive disease, and metastatic patients evolve with very poor clinical outcomes. Genetically, OSs are extremely complex tumors, and the related metastatic process is not well understood in terms of the biology of the disease. In this context, long non-coding RNAs (lncRNAs) have emerged as an important class of gene expression regulators that play key roles in the invasion and metastasis of several human tumors. Here, we evaluated the expression of HULC, which is an lncRNA that is associated with the tumor metastatic process, and assessed its potential role as a prognostic marker in OS. HULC expression was evaluated in primary OS samples using real-time RT-PCR. HULC expression status was determined by receiver operating characteristic (ROC) analysis, and its association with survival was assessed using the Kaplan-Meier method. The HULC expression level was not significantly associated with the clinicopathological characteristics of the OS patients. However, our data demonstrated that higher levels of expression of HULC were associated with lower survival rates in OS patients, both in terms of overall and event-free survival. Elevated HULC expression was associated with poor clinical outcomes among the OS patients, which suggests that HULC could be a potential prognostic biomarker in OS.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0156774PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4890737PMC
July 2017

Risk Factors for Arm Lymphedema in a Cohort of Breast Cancer Patients Followed up for 10 Years.

Breast Care (Basel) 2016 Feb 14;11(1):45-50. Epub 2015 Dec 14.

Mastology and Breast Reconstruction Department, Barretos Cancer Hospital, Pio XII Foundation, Barretos, Brazil.

Background: The etiology of lymphedema is multifactorial, and definition criteria of lymphedema, its limitation, and follow-up must be considered in studies related to risk factors. The aim of this study is to evaluate risk factors related to arm lymphedema in a cohort study with a long follow-up.

Patients And Methods: The study was performed in 622 breast cancer patients. The main endpoint reported was the presence of clinical lymphedema reported in medical records. Univariate and multivariate regression analyses were performed to identify factors related to lymphedema.

Results: 66.4% of the patients were submitted to mastectomy, 88.4% to level III axillary lymphadenectomy, 34.9% to radiotherapy in the supraclavicular fossa, and 4.3% to axillary radiotherapy. The mean follow-up was 96.7 months. 45 patients (7.2%) developed lymphedema, of which 82.2% had developed lymphedema at 60 months. Univariate regression analysis showed that supraclavicular radiotherapy, adjuvant/palliative chemotherapy, ≥ 15 lymph nodes dissected, and axillary surgery increase the lymphedema rate by 1.87, 2.28, 2.03, and 6.17, respectively. Adjusted multivariate regression analysis showed that the combination of axillary dissection and number of lymph nodes dissected was the main factor related to lymphedema (p = 0.017).

Conclusion: In the pre-sentinel era, axillary dissection and the number of lymph nodes resected are related to 10-year lymphedema.
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http://dx.doi.org/10.1159/000442489DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4813649PMC
February 2016

Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

J Cancer Educ 2017 Jun;32(2):344-351

Biostatistics and Epidemiology Nucleous, Barretos, Brazil.

The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p < 0.001) improvement in post-test evaluation (average grade 73.9 %). The correct pre-test (p = 0.556) and post-test (p = 0.729) evaluation and the retention of information (p = 0.408) were not different between the two groups. The course in PHO allowed significant acquisition of knowledge to undergraduate students, but the level of information retention was statistically similar between the traditional classroom form and the e-learning, a fact that encourages the use of e-learning in oncology.

Clinical Trial Registration Number: REBECU1111-1142-1963.
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http://dx.doi.org/10.1007/s13187-015-0979-9DOI Listing
June 2017

Lowered Cisplatin Dose and No Bleomycin in the Treatment of Pediatric Germ Cell Tumors: Results of the GCT-99 Protocol From the Brazilian Germ Cell Pediatric Oncology Cooperative Group.

J Clin Oncol 2016 Feb 4;34(6):603-10. Epub 2016 Jan 4.

Luiz Fernando Lopes, Brazilian Society of Pediatric Oncology; Carla Renata Pacheco Donato Macedo, Instituto de Oncologia Pediatrica-GRAACC, Universidade Federal de São Paulo; Viviane Sonaglio, Hospital A.C. Camargo; Maria Teresa de Assis Almeida, Universidade de São Paulo, ITACI FMUSP; Maria Lydia Mello D'Andrea, Hospital Infantil Darcy Vargas; Renato Melaragno, Hospital Santa Marcelina; Sonia Maria Rossi Vianna, Hospital do Servidor Publico Estadual; Paula Bruniera, Santa Casa de Misericordia de São Paulo, São Paulo; Luiz Fernando Lopes and Gisele Eiras Martins, Hospital de Cancer Infanto Juvenil de Barretos; Cleyton Zanardo de Oliveira, Hospital de Cancer de Barretos, Barretos; Simone dos Santos Aguiar, Centro Infantil Boldrini & CIPED/FCM/Unicamp, Campinas; Marcelo Milone, Centro de Tratamento Fabiana Macedo de Morais/GACC, São Jose dos Campos; Jose Henrique S. Barreto, Hospital São Rafael/ONCO Bahia, Salvador; Eduardo Ribeiro Lima, Hospital da Baleia, Belo Horizonte; Paula Maria Azevedo Allemand Lopes, Hospital da Criança de Brasilia Jose Alencar, Brasilia; Flora Mitie Watanabe, Hospital Infantil Pequeno Principe; Mara Albonei Pianovski, Hospital Erasto Gaertner, Curitiba; and Mauber Eduardo Schultz Moreira, Hospital Universitario de Santa Maria, Santa Maria, Brazil.

Purpose: We describe the results of a risk-adapted, response-based therapeutic approach from the Brazilian GCT-99 study on germ cell tumors.

Patients And Methods: From May 1999 to October 2009, 579 participants were enrolled in the Brazilian GCT-99 study. Treatment, defined as specific chemotherapy regimen and number of cycles, was allocated by means of risk-group assignment at diagnosis with consideration for stage and primary tumor site. Patients at low risk received no chemotherapy. Patients at intermediate risk (IR) with a good response (GR) received four cycles of platinum and etoposide (PE), for total doses of platinum 420 mg/m(2) and etoposide 2,040 mg/m(2). Patients at IR with a partial response (PR) received three cycles of PE plus three cycles of ifosfamide, vinblastine, and bleomycin. Patients at high risk (HR) with a GR received four cycles of PE and ifosfamide (PEI) at total doses of platinum 420 mg/m(2), etoposide 1,200 mg/m(2), and ifosfamide 30 g/m(2). Patients at HR with a PR received six cycles of PEI.

Results: The risk-group distribution was 213 LR, 138 IR, and 129 HR for 480 evaluable patients. Overall survival (OS) and event-free survival (EFS) rates at 10 years were, respectively, 90% and 88.6% in the IR-GR group (n = 126) and 74.1% and 74.1% in the IR-PR group (n = 12). Ten-year rates for the HR-GR group (n = 86) were an OS of 66.8% and an EFS of 62.5%. The HR-PR group (n = 43) had an OS of 74.8% and an EFS of 73.4%. In univariable and multivariable analysis, increased serum lactate dehydrogenase level and histology for a metastatic immature teratoma were prognostic of a worsened outcome.

Conclusion: Reduction of therapy to two drugs did not compromise survival outcomes for patients in the IR-GR group, and escalation of therapy with PEI did not significantly improve OS and EFS in patients at HR.
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http://dx.doi.org/10.1200/JCO.2014.59.1420DOI Listing
February 2016

A phase II study in advanced cancer patients to evaluate the early transition to palliative care (the PREPArE trial): protocol study for a randomized controlled trial.

Trials 2015 Apr 12;16:160. Epub 2015 Apr 12.

Palliative Care and Health-Related Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil.

Background: Previous studies have demonstrated the benefit of early integration of palliative care (PC) in oncology. However, patients continue to receive late referrals to PC even in comprehensive cancer centers. Patients and health professionals may perceive PC as 'a place to die,' and this stigma is a barrier to timely referrals and to patient acceptance of treatment.

Methods/design: The primary objective is to evaluate the feasibility of psychosocial intervention and PC in patients with advanced cancer. The patients will be submitted to a series of brief psychosocial interventions that are based on cognitive behavioral therapy, and patient acceptance and satisfaction will be assessed. In addition, the impact of these interventions on depressive symptoms will be evaluated. A randomized, open-label, phase II trial with two intervention arms and a control group will be conducted. Patients who are started on palliative chemotherapy and who meet the inclusion criteria will be enrolled. The study participants will be recruited from the outpatient oncology clinics at Barretos Cancer Hospital and will be randomized into one of the following three treatment arms: Arm A, which will include five weekly psychosocial interventions based on CBT in combination with early PC; Arm B, which will include early PC only; and Arm C, which will include standard oncologic care. The Hospital Anxiety and Depression Scale (HADS), the Patient Health Questionnaire (PHQ-9), the Edmonton Symptom Assessment System (ESAS-br), the Family Satisfaction with End-of-Life Care (FAMCARE)-Patient scale, and the Disease Understanding Protocol will be used for data collection. The patients will answer these questionnaires at baseline and 45, 90, 120 and 180 days after randomization.

Discussion: Despite evidence of the positive impact of early PC, it is often provided to patients only at later stages. The inadequate awareness and stigmatization of PC as a place to die are barriers that complicate the early referral. Patients with advanced cancer may benefit from a psychosocial and educational strategy that adequately prepares them for initial PC appointments after an early referral to PC. We anticipate that benefits of psychological intervention shall be synergistic to secondary emotional benefits from the early integration of PC.

Trial Registration: This trial was registered on 6 May 2014 with ClinicalTrials.gov (identifier: NCT02133274).
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http://dx.doi.org/10.1186/s13063-015-0655-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4413544PMC
April 2015

A Comprehensive Expression Analysis of Cancer Testis Antigens in Head and Neck Squamous Cell Carcinoma Revels MAGEA3/6 as a Marker for Recurrence.

Mol Cancer Ther 2015 Mar 6;14(3):828-34. Epub 2015 Jan 6.

Laboratory for Cancer Molecular Biology, Department of Biological Sciences, Federal University of São Paulo, Diadema, Brazil. Program in Cancer and Stem Cell Biology, Duke-NUS Graduate Medical School, Singapore.

Despite significant advances in the treatment of head and neck squamous cell carcinoma (HNSCC), the survival rate has not changed in the last decades. Therefore, the development of novel therapeutic strategies is pursued. Cancer-testis antigens (CTA) are strong immunogenic proteins with a tumor-restricted expression pattern, and are considered ideal targets for tumor-specific immunotherapeutic approaches. In this study, using an in silico approach, we selected, among 139 previously described CTA, candidates to be evaluated in 89 HNSCC and 20 normal mucosa samples. SPANX-CD (71.9%), MAGEB2 (44.9%), MAGEA1 (44.9%), MAGEB6 (32.6%), and CXORF48 (27.0%) were found frequently expressed in HNSCC, and over 85% of the tumors expressed at least one of these five CTAs. The mRNA positivity of CXORF48, MAGEB6, and CRISP2 presented significant associations with recognized clinical features for poor outcome. Furthermore, MAGEA3/6 positivity was associated with significantly better disease-free survival (DFS, P = 0.014), and the expression of this antigen was shown to be an independent prognostic factor for tumor recurrence. In conclusion, one of five selected CTAs is expressed in at least 85% of the HNSCCs, suggesting a possible usage as target for immunotherapeutic approaches, and the mRNA-positivity for MAGEA3/6 is shown to be an independent marker for DFS.
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http://dx.doi.org/10.1158/1535-7163.MCT-14-0796DOI Listing
March 2015

Myofascial pain syndrome after head and neck cancer treatment: Prevalence, risk factors, and influence on quality of life.

Head Neck 2015 Dec 25;37(12):1733-7. Epub 2014 Sep 25.

Head and Neck Surgery Department, Barretos Cancer Hospital, Barretos, São Paulo, Brazil.

Background: Patients undergoing treatment for head and neck cancer may develop myofascial pain syndrome as sequelae. The purpose of this study was to determine the prevalence, risk factors, and quality of life (QOL) related to myofascial pain syndrome.

Methods: This was a prospective study including patients with head and neck cancer with at least a 1-year disease-free interval.

Results: One hundred sixty-seven patients were analyzed, and myofascial pain syndrome was diagnosed in 20 (11.9%). In the multivariate analysis, hypopharyngeal tumors (odds ratio [OR] = 6.35; 95% confidence interval [CI] = 1.58-25.56) and neck dissection (OR = 3.43; 95% CI = 1.16-10.17) were independent factors for myofascial pain syndrome. The pain (p < .001) and shoulder domain (p < .001) as well as overall University of Washington Quality of Life (UW-QOL) score (p = .006) were significantly lower in the patients with myofascial pain syndrome.

Conclusion: Myofascial pain syndrome was observed in 1 of 9 patients after head and neck cancer treatment and a worse QOL was observed among them. Tumor site and neck dissection were found to be risk factors for myofascial pain syndrome.
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http://dx.doi.org/10.1002/hed.23825DOI Listing
December 2015

TIMP3 and CCNA1 hypermethylation in HNSCC is associated with an increased incidence of second primary tumors.

J Transl Med 2013 Dec 20;11:316. Epub 2013 Dec 20.

Cancer Molecular Biology Laboratory, Department of Biological Sciences, Federal University of São Paulo, 04039-020, São Paulo, Brazil.

Background: Hypermethylation in the promoter regions is associated with the suppression of gene expression and has been considered a potential molecular marker for several tumor types, including head and neck squamous cell carcinomas (HNSCC).

Methods: To evaluate the gene hypermethylation profile as a prognostic marker, this retrospective study used a QMSP approach to determine the methylation status of 19 genes in 70 HNSCC patients.

Results: The methylation profile analysis of primary HNSCC revealed that genes CCNA1, DAPK, MGMT, TIMP3 and SFRP1 were frequently hypermethylated, with high specificity and sensitivity. TIMP3 and CCNA1 hypermethylation was significantly associated with lower rates of second primary tumor-free survival (p = 0.007 and p = 0.001; log-rank test, respectively).

Conclusion: This study, for the first time, presents CCNA1 and TIMP3 hypermethylation as a helpful tool to identify HNSCC subjects at risk of developing second primary carcinomas.
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http://dx.doi.org/10.1186/1479-5876-11-316DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3884019PMC
December 2013

Ki-67 and CD100 immunohistochemical expression is associated with local recurrence and poor prognosis in soft tissue sarcomas, respectively.

Oncol Lett 2013 May 5;5(5):1527-1535. Epub 2013 Mar 5.

Molecular Oncology Research Center, Barretos Cancer Hospital, Pio XII Foundation, Barretos 14780-000;

Soft tissue sarcomas (STSs) are a heterogeneous group of mesenchymal tumors of >50 subtypes. However, STSs represent <1% of types of cancer. Despite this low frequency, the disease is aggressive and treatment, when possible, is based on traditional chemotherapies. A number of cases of resistance to adjuvant therapies have been reported. Metastases are commonly identified in STS patients during diagnosis and the development of effective clinical parameters is crucial for correct management of the disease. The use of biological markers in cancer is a useful tool to determine patient prognosis. Ki-67 is a protein marker for proliferation of somatic cells and is widely used in prognostic studies of various types of tumor, including STSs. Cluster of differentiation 100 (CD100) is a member of the semaphorin family. The family was initially described as axon guidance molecules important for angiogenesis, organogenesis, apoptosis and neoplasia. CD100 was previously utilized as a prognostic factor in tumors and also in STSs. In the present study, protein expression of Ki-67 and CD100 was analyzed by immunohistochemistry in samples of STS patients of the Barretos Cancer Hospital (Barretos, Brazil) to establish prognostic criteria of the disease. Results demonstrate a correlation between CD100 expression and poor prognosis, consistent with a previous study. Moreover, the expression of Ki-67 was identified to correlate with presence of local or locoregional recurrence. To the best of our knowledge, no large casuistic study has revealed this correlation between Ki-67 and local recurrence in STSs. The use of Ki-67 and CD100 as markers in clinical pathological analysis may be suitable as a prognostic criterion in disease progression.
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http://dx.doi.org/10.3892/ol.2013.1226DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3678859PMC
May 2013

Prognostic significance of TIMP3 hypermethylation in post-treatment salivary rinse from head and neck squamous cell carcinoma patients.

Carcinogenesis 2013 Jan 5;34(1):20-7. Epub 2012 Oct 5.

Department of Biological Science, Federal University of São Paulo, 04039-032, São Paulo, Brazil.

Hypermethylation in the promoter regions of genes is associated with suppression of gene expression and has been considered a potential molecular marker for several tumor types, including head and neck squamous cell carcinomas (HNSCC). Moreover, hypermethylation can be detected in body fluids such as saliva and can be useful for the diagnosis and prognosis of patients suffering from cancer. To evaluate the hypermethylation profile as a tool for early detection of tumor recurrences, this study determines the methylation status of 24 genes in salivary rinses collected from HNSCC patients at diagnosis, just after the last curative treatment and in the patients' follow-up visit at 6 months after treatment. In the analysis of salivary rinse samples taken at diagnosis of HNSCC patients, five genes (CCNA1, DAPK, DCC, MGMT and TIMP3) showed high specificity and sensitivity. Hypermethylation in any of these five genes was correlated with the presence of tumors in the oral cavity. Patients with TIMP3 methylation in samples collected 6 months after the last curative treatment had lower local recurrence-free survival (P = 0.008). Multivariate analysis confirmed that this hypermethylation pattern remained as an independent prognostic factor for local recurrence (P = 0.025). This study presents, for the first time, the detection of TIMP3 promoter hypermethylation in post-treatment salivary rinse as an independent prognostic maker for local recurrence-free survival in patients with HNSCC, justifying the use of DNA hypermethylation detection in saliva as a tool for identifying and monitoring HNSCC patients' subgroups with high risk of developing local recurrence.
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http://dx.doi.org/10.1093/carcin/bgs311DOI Listing
January 2013

Thrombotic obstruction of the central venous catheter in patients undergoing hematopoietic stem cell transplantation.

Rev Lat Am Enfermagem 2012 Jul-Aug;20(4):804-12

Instituto de Ensino e Pesquisa, Hospital de Câncer de Barretos, Brazil.

This is an integrative literature review with the aim of summarizing the prevention measures and treatment of thrombotic obstruction of long-term semi-implanted central venous catheters, in patients undergoing hematopoietic stem cell transplantation. The sample consisted of seven studies, being two randomized controlled clinical trials, three cohort studies and two case series. Regarding the prevention measures, one single study demonstrated effectiveness, which was a cohort study on the oral use of warfarin. In relation to the treatment measures, three studies evidenced effectiveness, one highlighted the efficacy of streptokinase or urokinase, one demonstrated the benefit of using low-molecular-weight heparin and the other treated the obstruction with heparin or urokinase. Catheter patency research shows a restricted evolution that does not follow the evolution of transplantations, mainly regarding nursing care.
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http://dx.doi.org/10.1590/s0104-11692012000400022DOI Listing
October 2013
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