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1.
Support Care Cancer ; 29(4): 1883-1891, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32789684

RESUMO

PURPOSE: Inclusion of brain tumour patients in oncological protocols may be hampered by their neurological impairment. The goal of this study was to assess the reliability of Karnofsky Performance Scale (KPS) and WHO Performance Scale (WHO-PS) scores in this population. METHODS: A cross-sectional survey was conducted through the Association des Neuro-Oncologues d'Expression Française (ANOCEF) and European Neuro-Oncology Association (EANO) networks. Clinicians were asked to write a text defining their operative definition of a patient with ≥ 70 KPS and to assess KPS and WHO-PS in six different clinical case vignettes. RESULTS: Two hundred seventy-six clinicians sent a response. The operative definition mentioned a normal life (89%), what patients were able (26%) or unable (29%) to do, normal cognitive processing (8%) and caregivers (6%). Older physicians mentioned more often what patients were unable to do (p = 0.005). The two scales were homogeneous in less severely handicapped patients only. More patients were excluded for hemiplegia than for expressive aphasia. Older physicians significantly excluded more patients for KPS and WHO-PS. Speciality of the physician significantly influenced scoring. On multivariable analysis, age and speciality of the physicians were correlated with KPS and WHO-PS rating even if adjusted on cases. Discordant scoring increased with severity of the deficit: in nearly all cases, the KPS would have denied, while WHO-PS would have allowed, access to a trial. CONCLUSION: Performance scores assigned to brain tumour patients are clinician and score dependant. WHO-PS would allow more access to a trial. Specific criteria should be developed for patients with neurological deficits to facilitate their access to trials.


Assuntos
Neoplasias Encefálicas/epidemiologia , Avaliação de Estado de Karnofsky/normas , Adulto , Viés , Estudos Transversais , Feminino , Humanos , Masculino , Organização Mundial da Saúde
3.
J Neurosurg ; 134(6): 1743-1750, 2020 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-32534490

RESUMO

OBJECTIVE: Decision-making for intracranial tumor surgery requires balancing the oncological benefit against the risk for resection-related impairment. Risk estimates are commonly based on subjective experience and generalized numbers from the literature, but even experienced surgeons overestimate functional outcome after surgery. Today, there is no reliable and objective way to preoperatively predict an individual patient's risk of experiencing any functional impairment. METHODS: The authors developed a prediction model for functional impairment at 3 to 6 months after microsurgical resection, defined as a decrease in Karnofsky Performance Status of ≥ 10 points. Two prospective registries in Switzerland and Italy were used for development. External validation was performed in 7 cohorts from Sweden, Norway, Germany, Austria, and the Netherlands. Age, sex, prior surgery, tumor histology and maximum diameter, expected major brain vessel or cranial nerve manipulation, resection in eloquent areas and the posterior fossa, and surgical approach were recorded. Discrimination and calibration metrics were evaluated. RESULTS: In the development (2437 patients, 48.2% male; mean age ± SD: 55 ± 15 years) and external validation (2427 patients, 42.4% male; mean age ± SD: 58 ± 13 years) cohorts, functional impairment rates were 21.5% and 28.5%, respectively. In the development cohort, area under the curve (AUC) values of 0.72 (95% CI 0.69-0.74) were observed. In the pooled external validation cohort, the AUC was 0.72 (95% CI 0.69-0.74), confirming generalizability. Calibration plots indicated fair calibration in both cohorts. The tool has been incorporated into a web-based application available at https://neurosurgery.shinyapps.io/impairment/. CONCLUSIONS: Functional impairment after intracranial tumor surgery remains extraordinarily difficult to predict, although machine learning can help quantify risk. This externally validated prediction tool can serve as the basis for case-by-case discussions and risk-to-benefit estimation of surgical treatment in the individual patient.


Assuntos
Neoplasias Encefálicas/diagnóstico , Neoplasias Encefálicas/cirurgia , Avaliação de Estado de Karnofsky/normas , Microcirurgia/efeitos adversos , Complicações Pós-Operatórias/diagnóstico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias Encefálicas/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Valor Preditivo dos Testes , Estudos Prospectivos , Sistema de Registros/normas , Reprodutibilidade dos Testes , Estudos Retrospectivos , Adulto Jovem
4.
Lancet Gastroenterol Hepatol ; 5(3): 285-294, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31953079

RESUMO

BACKGROUND: Treatment options for patients with unresectable locally advanced pancreatic cancer are scarce. Results from a subanalysis of the phase 3 MPACT trial in metastatic pancreatic cancer suggested potential activity of nab-paclitaxel plus gemcitabine against locally advanced pancreatic cancer. The objective of this phase 2 trial was to evaluate safety and efficacy of nab-paclitaxel plus gemcitabine in previously untreated locally advanced pancreatic cancer. METHODS: This international, open-label, multicentre, phase 2 trial (LAPACT) took place at 35 sites in five countries (USA, France, Spain, Canada, and Italy). Patients with Eastern Cooperative Oncology Group performance status of up to 1 underwent six cycles of induction with nab-paclitaxel 125 mg/m2 plus gemcitabine 1000 mg/m2 (days 1, 8, and 15 of each 28-day cycle). After induction, patients without progressive disease or unacceptable adverse events were eligible to receive continued therapy per investigator's choice: continued nab-paclitaxel plus gemcitabine, chemoradiation, or surgery. The primary endpoint was time to treatment failure; secondary endpoints were disease control rate, overall response rate, progression-free survival, overall survival, safety, and quality of life. The reported efficacy outcomes were analysed in the intention-to-treat population, and safety outcomes were analysed in the treated population. This trial is registered with ClinicalTrials.gov, NCT02301143, and EudraCT, 2014-001408-23 and is complete. FINDINGS: Between April 21, 2015, and April 26, 2018, 107 patients were enrolled in the study. 106 received the study treatment; one patient enrolled but did not receive treatment. 44 (41%) of 107 enrolled patients discontinued induction; the most common reason for discontinuing induction was adverse events (22 [21%] patients). 62 (58%) of 107 enrolled patients completed induction treatment and 47 (44%) patients subsequently received continued treatment per investigator's choice: 12 (11%) continued nab-paclitaxel plus gemcitabine, 18 (17%) received chemoradiation, and 17 (16%) underwent surgery (seven had R0 resection status, nine had R1). 15 (14%) patients completed induction treatment but did not receive continued treatment. Median time to treatment failure was 9·0 months (90% CI 7·3-10·1); median progression-free survival was 10·9 months (90% CI 9·3-11·6), and median overall survival was 18·8 months (90% CI 15·0-24·0). During induction, 83 patients achieved disease control and the disease control rate was 77·6% (90% CI 70·3-83·5). 36 patients had a best response of partial response; the overall response rate during induction was 33·6% (90% CI 26·6-41·5). The most common treatment-emergent adverse events that were grade 3 or higher in the treated population during induction were neutropenia (35 [33%] of 106 patients), anaemia (12 [11%]), and fatigue (11 [10%]). The most common treatment-emergent serious adverse events during induction were pneumonia (five [5%] patients), pyrexia (five [5%]), and febrile neutropenia (three [3%]). No deaths were caused by treatment-related adverse events during the induction phase, and global quality of life was maintained in most patients. INTERPRETATION: The data from this trial support the tolerability and activity of nab-paclitaxel plus gemcitabine for locally advanced pancreatic cancer, and a potential to convert unresectable, locally advanced disease to surgically resectable disease. The safety profile was generally consistent with previous findings. FUNDING: Celgene.


Assuntos
Albuminas/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Desoxicitidina/análogos & derivados , Paclitaxel/uso terapêutico , Neoplasias Pancreáticas/tratamento farmacológico , Neoplasias Pancreáticas/patologia , Idoso , Albuminas/administração & dosagem , Albuminas/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Canadá/epidemiologia , Quimiorradioterapia Adjuvante/métodos , Desoxicitidina/administração & dosagem , Desoxicitidina/efeitos adversos , Desoxicitidina/uso terapêutico , Feminino , França/epidemiologia , Humanos , Infusões Intravenosas , Análise de Intenção de Tratamento/métodos , Itália/epidemiologia , Avaliação de Estado de Karnofsky/normas , Avaliação de Estado de Karnofsky/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos , Neoplasias Pancreáticas/radioterapia , Neoplasias Pancreáticas/cirurgia , Intervalo Livre de Progressão , Qualidade de Vida , Segurança , Espanha/epidemiologia , Procedimentos Cirúrgicos Operatórios/métodos , Resultado do Tratamento , Estados Unidos/epidemiologia , Gencitabina
5.
BMJ Support Palliat Care ; 10(2): 129-135, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31806655

RESUMO

INTRODUCTION: Performance status is an essential consideration for clinical practice and for patient eligibility for clinical trials in oncology. Assessment of performance status is traditionally done by clinicians, but there is an increasing interest in patient-completed assessment. The aim of this systematic review and meta-analysis was to summarise inter-rater concordance between patient and clinician ratings of performance status. METHODS: A search strategy was developed and executed in the databases of Ovid MEDLINE, Embase and Cochrane Central Register of Controlled Trials, from inception until 15 August 2019. Articles were eligible for inclusion if there was mention of both (1) use of performance status tool Karnofsky Performance Status (KPS) or Eastern Cooperative Oncology Group Performance Status (ECOG), and (2) assessment of performance status by both clinicians and patients. Pearson correlation coefficients were calculated for each study and were meta-analysed according to a random-effect analysis model. Analyses were conducted using Comprehensive Meta-Analysis (V.3) by Biostat. RESULTS: Sixteen articles were included in our review, reporting on a cumulative sample size of 6619 patients. The quality of evidence was moderate, as determined by the GRADE tool.Concordance ranged from fair to moderate for both the KPS and ECOG tools. The Pearson correlation coefficient was 0.449 for KPS and 0.584 for ECOG. CONCLUSIONS: There is fair to moderate concordance of patient and clinician performance status ratings. Future studies should examine the reasoning behind clinician and patient ratings to better understand discrepancies between ratings.


Assuntos
Pessoal de Saúde/estatística & dados numéricos , Avaliação de Estado de Karnofsky/estatística & dados numéricos , Oncologia/estatística & dados numéricos , Bases de Dados Factuais , Humanos , Avaliação de Estado de Karnofsky/normas , Oncologia/normas , Variações Dependentes do Observador , Reprodutibilidade dos Testes , Autoavaliação (Psicologia)
7.
Rev. esp. med. nucl. imagen mol. (Ed. impr.) ; 36(2): 91-98, mar.-abr. 2017. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-160780

RESUMO

La terapia con péptidos análogos de la somatostatina marcados con radionúclidos es un nuevo tratamiento prometedor para tratar tumores neuroendocrinos. El objetivo del presente estudio preliminar es presentar nuestra experiencia en la terapia con 177Lu-DOTATATE y evaluar la tolerabilidad y la eficacia a corto plazo en pacientes con tumores que expresan receptores para la somatostatina. Se han tratado 7 pacientes con tumores neuroendocrinos metastásicos, cada uno con 4 dosis de 177Lu-DOTATATE y se ha evaluado su respuesta al tratamiento en forma de respuesta bioquímica (marcadores tumorales y analítica), según métodos de imagen (gammagrafía de receptores de somatostatina, tomografía computarizada y resonancia magnética) y respuesta funcional y de calidad de vida (mediante la Escala de actividad de Karnofsky). Se ha evaluado también la toxicidad del tratamiento. Los resultados obtenidos han sido los siguientes: respuesta bioquímica: el 60% de los pacientes mostraron una normalización de sus niveles de marcadores tumorales, mientras que en el 40% disminuyeron de manera significativa; respuesta en técnicas de imagen: el 85,7% presentaron una respuesta parcial, mientras que el 14,3% mostraron enfermedad estable; mejoría de la calidad de vida: el 100% de los pacientes mostraron una mejoría significativa en la calidad de vida con un incremento de la Escala de actividad de Karnofsky, y en cuanto a la toxicidad: ningún paciente presentó toxicidad aguda o crónica, y el 42,8% de los pacientes presentaron toxicidad subaguda hematológica transitoria. A pesar de tratarse de un estudio preliminar podemos afirmar que el tratamiento con 177Lu-DOTATATE es un tratamiento seguro, con pocos efectos adversos y que consigue una respuesta objetiva en la mayoría de los pacientes (AU)


Therapy with radiolabelled somatostatin analogue peptides is a promising new therapy to treat neuroendocrine tumours. The aim of this preliminary study is to present our experience with 177Lu-DOTATATE therapy, and evaluate tolerability and short-term efficacy in patients with tumours expressing somatostatin receptors. A total of 7 patients with metastatic neuroendocrine tumours were treated, each with 4 doses of 177Lu-DOTATATE. The treatment response was evaluated in the form of biochemical response (tumour markers), imaging methods (somatostatin receptor scintigraphy, computed tomography, and magnetic resonance), and functional and quality of life responses using the Karnofsky performance status scale. Treatment toxicity was also evaluated. The results obtained were as follows: Biochemical response: 60% of patients showed tumour marker levels returning to normal, while they decreased significantly in the remaining 40%. Imaging response: 85.7% had a partial response, while 14.3% showed stable disease. All (100%) patients showed a significant improvement in quality of life, with increased Karnofsky scale scores. No patient had acute or chronic toxicity, and subacute transient haematological toxicity was observed in 42.8% of patients. Despite being a preliminary study, it was found that treatment with 177Lu-DOTATATE is a safe treatment with few side effects, and an objective response was achieved in most patients (AU)


Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Tumores Neuroendócrinos/radioterapia , Tumores Neuroendócrinos , Somatostatina/análogos & derivados , Radioisótopos/uso terapêutico , Qualidade de Vida , Compostos Radiofarmacêuticos/análise , Fluordesoxiglucose F18/administração & dosagem , Cintilografia/métodos , Imageamento por Ressonância Magnética/métodos , Espectroscopia de Ressonância Magnética/métodos , Medicina Nuclear/métodos , Avaliação de Estado de Karnofsky/normas , Tomografia por Emissão de Pósitrons/métodos
8.
Arch. bronconeumol. (Ed. impr.) ; 52(8): 40-424, ago. 2016. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-154771

RESUMO

Antecedentes. La molécula antígeno leucocitario humano G (HLA-G), en sus formas unida a membrana y soluble, tiene como función principal inhibir la respuesta inmune actuando sobre los linfocitos T/CD4+, T/citotóxicos, células NK y células dendríticas. El cáncer de pulmón es una de las principales causas de muerte en el mundo, con una alta tasa de incidencia anual tanto en mujeres como en hombres. Algunos estudios han reportado un incremento de HLA-G sérica en el cáncer de pulmón, probablemente como un mecanismo de escape de la célula tumoral a la respuesta inmune antitumoral. En este estudio se midió la concentración de HLA-G soluble, en el lavado broncoalveolar (LBA), en pacientes con cáncer de pulmón primario y metastásico para determinar su relación con el tipo histológico tumoral y estado general del paciente usando la escala de Karnofsky. Métodos. Se incluyeron 31 pacientes con diagnóstico de cáncer de pulmón y mediante fibrobroncoscopia se tomó biopsia de la neoplasia para determinar el tipo de tumor usando la coloración de hematoxilina y eosina, y líquido del lavado broncoalveolar para medir la concentración de la molécula HLA-G soluble mediante un ELISA tipo sándwich. Resultados. El valor medio de la HLA-G soluble fue de 49,04ng/ml. No se observó ninguna correlación entre los niveles de HLA-G soluble y la edad, género o índice de tabaquismo. Se observó una diferencia altamente significativa en los niveles de HLA-G soluble en LBA de pacientes con diversos tipos histológicos de cáncer de pulmón, principalmente en tumores metastásicos. El índice de Karnofsky mostró una correlación significativa e inversa con el nivel de HLA-G soluble en LBA. Conclusiones. La proteína HLA-G soluble puede ser útil como marcador pronóstico del cáncer pulmonar al asociarse significativamente a los tumores metastásicos y a los pacientes con menor índice de Karnofsky


Background. The main function of the HLA-G molecule in its membrane-bound and soluble forms is to inhibit the immune response by acting on CD4+ T cells, cytotoxic T cells, NK cells and dendritic cells. Lung cancer is a leading cause of death worldwide, and annual incidence is high in both women and men. Some studies have reported an increase of HLA-G serum levels in lung cancer, probably generated by tumor cells escaping the antitumor immune response. In this study the concentration of soluble HLA-G in bronchoalveolar lavage (BAL) in patients with primary and metastatic lung cancer was measured to determine its relation with tumor histological type and overall patient status according to the Karnofsky scale. Methods. Thirty-one lung cancer patients were included. A tumor biopsy was obtained by bronchoscopy and the tumor type was determined by hematoxylin and eosin staining. BAL samples were obtained to measure soluble HLA-G concentrations in an ELISA sandwich assay. Results. The average value of soluble HLA-G was 49.04ng/mL. No correlation between soluble HLA-G levels and age, gender or smoking was observed. A highly significant difference was observed in the levels of soluble HLA-G in BAL from patients with different histological types of lung cancer, especially in metastatic tumors. The Karnofsky index showed a significant and inverse correlation with soluble HLA-G levels in BAL. Conclusions. Soluble HLA-G protein is significantly associated with metastatic tumors and patients with lower Karnofsky index and may be useful as a prognostic marker in lung cancer


Assuntos
Humanos , Masculino , Feminino , Lavagem Broncoalveolar/métodos , Lavagem Broncoalveolar , Neoplasias Pulmonares/complicações , Neoplasias Pulmonares/diagnóstico , Antígenos HLA-G/administração & dosagem , Antígenos HLA-G/análise , Broncoscopia/métodos , Broncoscopia , Adenocarcinoma/complicações , Adenocarcinoma/diagnóstico , Avaliação de Estado de Karnofsky/normas , Ensaio de Imunoadsorção Enzimática/métodos , Ensaio de Imunoadsorção Enzimática , Radiografia Torácica/métodos , Radiografia Torácica , 28599
9.
Medicine (Baltimore) ; 94(36): e1477, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26356706

RESUMO

Our aim was to investigate the association between self-rated health (SRH) and use of hospital services (ie, medical outpatient department, emergency department, and general ward. admissions). Cross-sectional study data were collected from 230 consecutive patients admitted to medical departments of a 2000-bed academic medical center in Taiwan using standardized operating procedures for data collection of SRH (ie, a single-item question inquiring overall perceived health status), medical disorders, depressive symptoms, and combined service utilization over a 1-year period (ie, number of visits to outpatient department, number of visits to emergency department, and number of hospitalizations). Electronic medical records were retrieved, with self-reported external medical visits added to in-hospital frequencies of service use to provide better estimation of health service utilization. Fifty-two percent of study patients rated their health as poor or very poor. Poor SRH was associated with more visits to medical outpatient department, emergency department, and hospital admission. Multivariate logistic regression demonstrated an independent association between poor SRH and services utilization after adjustment for age, gender, hypertension, diabetes, metastatic cancer, number of chronic illness, life-threatening event, life-time suicidal ideation, and depression. SRH may be a useful research tool to model medical service use for inpatients with chronic conditions.


Assuntos
Doença Crônica , Autoavaliação Diagnóstica , Serviços de Saúde/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Aceitação pelo Paciente de Cuidados de Saúde , Adulto , Idoso , Doença Crônica/epidemiologia , Doença Crônica/psicologia , Estudos Transversais , Feminino , Mau Uso de Serviços de Saúde/prevenção & controle , Mau Uso de Serviços de Saúde/estatística & dados numéricos , Nível de Saúde , Humanos , Classificação Internacional de Doenças , Avaliação de Estado de Karnofsky/normas , Avaliação de Estado de Karnofsky/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Inquéritos e Questionários , Taiwan/epidemiologia
10.
BMC Cancer ; 15: 501, 2015 Jul 05.
Artigo em Inglês | MEDLINE | ID: mdl-26142726

RESUMO

BACKGROUND: Performance status (PS) assessment is an integral part of the decision-making process in cancer care. Karnofsky Performance Status (KPS) and Eastern Cooperative Oncology Group (ECOG) PS are the most widely used tools. In some studies, the absolute agreement rate of these tools between observers has been moderate to low. The present study aimed to evaluate the inter-observer reliability and construct validity of the new Functionality Assessment Flowchart (FAF) and compare it with ECOG PS and KPS in a sample of cancer patients. METHODS: The patients were recruited by convenience from the waiting rooms of the Breast and Gynecology Ambulatory in a cross-sectional study. Two trained medical students (observer A) and five medical oncologists (observers B) independently rated women according to the ECOG PS, KPS and FAF. After the determining the PS scores, observer A administered the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaire to the participants. The agreements between observers A and B were investigated using the absolute agreement rate (%), weighted and unweighted kappa and Spearman's correlation test. For construct validity, the PS scores were correlated with functional and fatigue scores by performing correlation analysis. RESULTS: Eighty women with a median age of 57 years were included in the study (86% accrual rate). Among these women, 39 (48.8%) had advanced cancer. The overall absolute agreement rate between observers was 49.4% for KPS, 67% for ECOG PS, and 78.2% for FAF. When using unweighted kappa values, the inter-observer reliability was "fair", "moderate" and "substantial" for KPS, ECOG PS and FAF, respectively. However, when using weighted kappa statistics, "substantial" agreement was observed for KPS and ECOG PS and "nearly perfect" agreement was observed for FAF. All of the PS scales correlated very well with the functional and fatigue scores. CONCLUSIONS: We present a new instrument with moderate to high inter-observer agreement and adequate construct validity to measure PS in cancer patients.


Assuntos
Neoplasias da Mama/diagnóstico , Neoplasias da Mama/epidemiologia , Tomada de Decisões , Avaliação de Estado de Karnofsky/normas , Adulto , Neoplasias da Mama/fisiopatologia , Feminino , Humanos , Pessoa de Meia-Idade , Variações Dependentes do Observador , Prognóstico , Inquéritos e Questionários/normas
11.
Oncologist ; 19(10): 1069-75, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25170014

RESUMO

INTRODUCTION: Cancer societies, research cooperatives, and countless publications have urged the development of clinical trials that facilitate the inclusion of older patients and those with comorbidities. We set out to determine the characteristics of currently recruiting clinical trials with hematological patients to assess their inclusion and exclusion of elderly patients. METHODS: The NIH clinical trial registry was searched on July 1, 2013, for currently recruiting phase I, II or III clinical trials with hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. RESULTS: Although 5% of 1,207 included trials focused exclusively on elderly or unfit patients, 69% explicitly or implicitly excluded older patients. Exclusion based on age was seen in 27% of trials, exclusion based on performance status was seen in 16%, and exclusion based on stringent organ function restrictions was noted in 51%. One-third of the studies that excluded older patients based on age allowed inclusion of younger patients with poor performance status; 8% did not place any restrictions on organ function. Over time, there was a shift from exclusion based on age (p value for trend <.001) toward exclusion based on organ function (p = .2). Industry-sponsored studies were least likely to exclude older patients (p < .001). CONCLUSION: Notably, 27% of currently recruiting clinical trials for hematological malignancies use age-based exclusion criteria. Although physiological reserves diminish with age, the heterogeneity of the elderly population does not legitimize exclusion based on chronological age alone. Investigators should critically review whether sufficient justification exists for every exclusion criterion before incorporating it in trial protocols.


Assuntos
Ensaios Clínicos como Assunto , Neoplasias Hematológicas/terapia , Seleção de Pacientes , Idoso , Idoso de 80 Anos ou mais , Etarismo/ética , Etarismo/estatística & dados numéricos , Ensaios Clínicos Fase I como Assunto/ética , Ensaios Clínicos Fase I como Assunto/métodos , Ensaios Clínicos Fase II como Assunto/ética , Ensaios Clínicos Fase II como Assunto/métodos , Ensaios Clínicos Fase III como Assunto/ética , Ensaios Clínicos Fase III como Assunto/métodos , Humanos , Avaliação de Estado de Karnofsky/normas , Escores de Disfunção Orgânica , Sistema de Registros
12.
BMC Med Inform Decis Mak ; 13: 72, 2013 Jul 19.
Artigo em Inglês | MEDLINE | ID: mdl-23870327

RESUMO

BACKGROUND: For over 60 years, the Karnofsky Performance Status (KPS) has proven itself a valuable tool with which to perform measurement of and comparison between the functional statuses of individual patients. In recent decades conditions for patients have changed, and so too has the KPS undergone several adjustments since its initial development. DISCUSSION: The most important works regarding the KPS tend to focus upon a variety of issues, including but not limited to reliability, validity and health-related quality of life. Also discussed is the question of what quantity the KPS may in fact be said to measure. The KPS is increasingly used as a prognostic factor in patient assessment. Thus, questions regarding if and how it affects survival are relevant. SUMMARY: This review honors the original intention of the discoverer and gives an overview of adaptations made in recent years. The proposed algorithm suggests specific updates with the goal of ensuring continued adequacy and expediency in the determination of the KPS.


Assuntos
Avaliação de Estado de Karnofsky/normas , Psicometria/métodos , Algoritmos , Humanos , Psicometria/instrumentação
13.
Ann R Coll Surg Engl ; 94(1): 28-33, 2012 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-22524919

RESUMO

INTRODUCTION: Management of metastatic spinal disease has changed significantly over the last few years. Different prognostic scores are used in clinical practice for predicting survival. The aim of this study was to assess the accuracy of prognostic scores and the role of delayed presentation in predicting the outcome in patients with metastatic spine disease. METHODS: Retrospectively, four years of data were collected (2007-2010). Medical records review included type of tumour, duration of symptoms, expected survival and functional status. The Karnofsky performance score was used for functional assessment. Modified Tokuhashi and Tomita scores were used for survival prediction. RESULTS: A total of 55 patients who underwent surgical stabilisation were reviewed. The mean age was 63 years (range: 32-87 years). The main primary sources of tumours included myeloma, breast cancer, lymphoma, lung cancer, renal cell cancer and prostate cancer. Of the cases studied, 29 patients had posterior instrumented stabilisation alone, 10 patients had an anterior procedure alone and 16 patients (with an expected survival of more than one year) had both anterior and posterior procedures performed. Twenty-three patients presented with spinal cord compression. The mean follow-up duration was 9 months (range: 1-39 months). Patients who were treated within one week of referral survived longer than anticipated. Patients were divided into three groups based on their expected survival. Actual survival was better in all three groups after surgery. Discrepancies in scores were prominent in patients with myeloma, breast and prostate cancers. Functional outcome was better in patients under 65 years of age. CONCLUSIONS: The prognostic scoring systems are not uniformly effective in all types of primary tumours. However, they are useful in decision making for surgical intervention, taking other factors into account, in particular the age of the patient, the type and stage of the primary tumour and general health.


Assuntos
Descompressão Cirúrgica/métodos , Neoplasias da Coluna Vertebral/secundário , Adulto , Idoso , Idoso de 80 Anos ou mais , Tomada de Decisões , Descompressão Cirúrgica/mortalidade , Pessoas com Deficiência , Feminino , Humanos , Avaliação de Estado de Karnofsky/normas , Masculino , Pessoa de Meia-Idade , Prognóstico , Recuperação de Função Fisiológica , Estudos Retrospectivos , Sensibilidade e Especificidade , Compressão da Medula Espinal/etiologia , Neoplasias da Coluna Vertebral/fisiopatologia , Neoplasias da Coluna Vertebral/cirurgia
14.
Eur J Cancer ; 46(18): 3175-83, 2010 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-20674334

RESUMO

PURPOSE: To construct empirically a conversion table to convert performance status scores among the Eastern Cooperative Oncology Group (ECOG), Karnofsky Performance Status (KPS) and Palliative Performance Scale (PPS) measures, using a large sample of patients with advanced cancer. METHODS: Seven physicians completed assessments on 1385 consecutive patients attending an oncology palliative care clinic, or admitted to an acute cancer palliative care unit. The three measures were distributed as a questionnaire package; the order in which they were presented was randomly assigned for each week. Scales were compared using the hit rate and the weighted kappa coefficient (κ(w)). The KPS and PPS were compared directly; for comparisons of either scale with the ECOG, all 70 possible categorisations of KPS and PPS were computed. An 'ideal' categorisation was selected based on maximisation of both statistical methods. RESULTS: The KPS and PPS matched in 1209 out of 1385 assessments (hit rate 87%; κ(w) 0.97). For both the KPS and the PPS, the categorisation of 100 (ECOG 0), 80-90 (1), 60-70 (2), 40-50 (3), 10-30 (4) had the highest hit rate (75%), and the second highest κ(w) (0.84, p<0.0001). One other combination had a slightly higher κ(w) (0.85 for both KPS and PPS), but a lower hit rate (73% for KPS, 72% for PPS). CONCLUSIONS: We have derived empirically a conversion scale among the ECOG, KPS and PPS scales. The proposed scale provides a means of translating amongst these measures, which may improve accuracy of communication about performance status amongst oncology clinicians and researchers.


Assuntos
Neoplasias/terapia , Cuidados Paliativos/métodos , Índice de Gravidade de Doença , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Avaliação de Estado de Karnofsky/normas , Masculino , Pessoa de Meia-Idade , Sensibilidade e Especificidade , Adulto Jovem
15.
Haematologica ; 95(5): 810-8, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-20007143

RESUMO

BACKGROUND: Disease stage is the most important prognostic parameter in allogeneic hematopoietic cell transplantation (HCT) for acute lymphoblastic leukemia, but other factors such as donor/host histocompatibility and gender combination, recipient age, performance status and comorbidities need to be considered. Several scoring systems are available to predict outcome in HCT recipients; however, their prognostic relevance in acute lymphoblastic leukemia is not well defined. DESIGN AND METHODS: In the present study we evaluated a modified EBMT risk score (mEBMT) and the HCT-specific comorbidity index (HCT-CI) in 151 adult acute lymphoblastic leukemia patients who received allogeneic HCT from 1995 until 2007 at our center. RESULTS: Disease status was first complete remission (CR1) (47%), CR>1 (21%) or no CR (32%). Overall survival (OS) at one, two and five years was 62%, 51% and 40% and non-relapse mortality (NRM) was 21%, 24% and 32%. Median mEBMT was 3 (0-6). Higher mEBMT was associated with inferior OS (hazard ratio per score unit (HR): 1.50, P<0.001), higher NRM (HR: 1.36, P=0.042) and higher relapse mortality (HR: 1.68, P<0.001). Disease stage was the predominant prognostic factor in this score. Comorbidities were present in 71% of patients with mild hepatic disease (29%), moderate pulmonary disease (28%) and infections (23%) being the most common. Median HCT-CI was 1 (0-9). In univariate analysis a trend for inferior OS (HR: 1.08, P=0.20) and higher NRM (HR: 1.14, P=0.11) with increasing HCT-CI was observed but the level of significance was not reached. In additional analyses we found that reduced Karnofsky Performance Status (KPS) was associated with inferior OS (HR: 1.34, P=0.023) and higher relapse mortality (HR: 1.71, P=0.001) when analyzed univariately. However, KPS was associated with disease stage and significance was lost in multivariate analysis. CONCLUSIONS: The mEBMT was prognostic in our patient cohort with predominant influence of disease stage, whereas a trend but no significant prognostic value was observed for the HCT-CI.


Assuntos
Transplante de Células-Tronco Hematopoéticas/normas , Avaliação de Estado de Karnofsky/normas , Leucemia-Linfoma Linfoblástico de Células Precursoras/cirurgia , Cuidados Pré-Operatórios/normas , Condicionamento Pré-Transplante/normas , Adolescente , Adulto , Idoso , Estudos de Coortes , Comorbidade , Feminino , Seguimentos , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Leucemia-Linfoma Linfoblástico de Células Precursoras/diagnóstico , Leucemia-Linfoma Linfoblástico de Células Precursoras/mortalidade , Cuidados Pré-Operatórios/efeitos adversos , Projetos de Pesquisa/normas , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Condicionamento Pré-Transplante/efeitos adversos , Adulto Jovem
16.
Support Care Cancer ; 18(5): 609-16, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-19629537

RESUMO

INTRODUCTION: Performance status (PS) scales are used widely in oncology practice and research. We compared inter-rater agreement, between nurses and physicians, for three commonly used PS scales. MATERIALS AND METHODS: Patients attending an oncology palliative care clinic were assessed by a physician and nurse who blindly completed Eastern Cooperative Oncology Group (ECOG), Karnofsky PS (KPS), and palliative PS (PPS) scales. Patients completed the Edmonton symptom assessment system (ESAS). RESULTS: Inter-rater agreement (weighted kappa) for the 457 patients was 0.67 for the ECOG, 0.74 for the KPS, and 0.72 for the PPS. There was no difference between proportions of physicians' vs. nurses' ratings of KPS, >60 vs.

Assuntos
Assistência Ambulatorial/métodos , Avaliação de Estado de Karnofsky/estatística & dados numéricos , Enfermeiras e Enfermeiros , Cuidados Paliativos , Médicos , Adulto , Idoso , Idoso de 80 Anos ou mais , Institutos de Câncer , Feminino , Humanos , Avaliação de Estado de Karnofsky/normas , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Ontário , Adulto Jovem
17.
Arch Neurol ; 66(1): 74-8, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19139302

RESUMO

BACKGROUND: The prognostic significance of Karnofsky performance status in neoplastic meningitis (NM) has not been demonstrated in patient groups similarly matched for known prognostic variables. OBJECTIVE: To determine the effect of performance status on survival in NM. DESIGN: Retrospective comparison. SETTING: A university tertiary medical center. PATIENTS: Two well-matched cohorts with cytologically positive NM with (n = 30; group A) and without (n = 30; group B) independence in activities of daily living as defined by a Karnofsky performance status score of 70 or greater or less than 70, respectively. MAIN OUTCOME MEASURES: Groups were matched on age, primary tumor, site of NM disease (cranial nerves or spinal cord), treatment (radiotherapy and chemotherapy; systemic and intraventricular), and absence of cerebrospinal fluid compartmentalization, NM-related encephalopathy, and neuroradiographic bulky central nervous system disease. Primary tumor histologic diagnoses included breast cancer (20 patients), non-Hodgkin lymphoma (10 patients), lung cancer (10 patients), melanoma (8 patients), and others (12 patients). At presentation, NM revealed cranial neuropathy (30 patients) or spinal cord dysfunction (39 patients). Radiotherapy was administered to 49 patients (whole brain only in 12 patients; restricted spine only in 35; whole brain and restricted spine in 2). All the patients received intraventricular chemotherapy, and 49 received concurrent tumor-specific systemic chemotherapy. RESULTS: Median survival was 6 weeks (range, 3-10 weeks) in group B compared with 15.5 weeks (range, 8-58 weeks) in group A (P < .001). No treatment-related deaths were observed. All the patients demonstrated progressive disease and died of either NM or systemic cancer. CONCLUSIONS: A low Karnofsky performance status score predicts poor survival in patients with NM. Patients with a low Karnofsky performance status score may be best served by offering supportive care.


Assuntos
Atividades Cotidianas , Avaliação da Deficiência , Avaliação de Estado de Karnofsky/estatística & dados numéricos , Carcinomatose Meníngea/mortalidade , Adulto , Idoso , Estudos de Coortes , Técnicas de Apoio para a Decisão , Tratamento Farmacológico/normas , Feminino , Humanos , Avaliação de Estado de Karnofsky/normas , Masculino , Carcinomatose Meníngea/terapia , Neoplasias Meníngeas/mortalidade , Neoplasias Meníngeas/secundário , Neoplasias Meníngeas/terapia , Pessoa de Meia-Idade , Invasividade Neoplásica/patologia , Invasividade Neoplásica/fisiopatologia , Seleção de Pacientes , Valor Preditivo dos Testes , Prognóstico , Radioterapia/normas , Estudos Retrospectivos , Taxa de Sobrevida , Falha de Tratamento , Suspensão de Tratamento/normas
18.
J Thorac Oncol ; 3(10): 1133-6, 2008 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-18827609

RESUMO

INTRODUCTION: The Eastern Cooperative Oncology Group (ECOG) score is a well known prognostic factor and almost always used to determine eligibility for clinical trials. The patient-rated performance status score (Pt-PS), section of the patient generated subjective global assessment scale, has identical criteria to the physician-rated ECOG scale (MD-PS). We compared the Pt-PS with MD-PS in patients with advanced non-small cell lung cancer and compared the effect of each rating on eligibility for a hypothetical clinical trial. METHODS: Consecutive patients with newly diagnosed advanced non-small cell lung cancer completed a patient generated subjective global assessment self-rated questionnaire, which was then correlated (kappa statistic) with the ECOG PS recorded at the same time. Patients were treated with standard chemotherapy. Survival was determined using Kaplan-Meier statistics. RESULTS: One hundred nine patients (M:F-54:55) were recruited. Pt-PS differed from MD-PS in 59 (54%) instances (p = 0.0001). When scores were not congruent, 41/59 (69%) patients evaluated themselves as having a worse PS than the physician's rating. Pt-PS was 0 to 1 in 60 (55%) patients whereas MD-PS was 0 to 1 in 78 (72%) patients. The functional status irrespective of evaluator was predictive of survival (p = 0.001 for MD-PS and p = 0.001 for Pt-PS). However, the median survival in those with MD-PS >/=2 was 3.3 (CI; 1.7-4.9) months whereas individuals with Pt-PS >/=2 had a median survival of 6.2 (CI; 5.4-6.9) months. CONCLUSIONS: Pt-PS and MD-PS were not congruent in over half of the cases, with Pt-PS scores usually poorer. Almost half the patients would have excluded themselves from a hypothetical clinical trial (Pt-PS >/=2). This requires prospective evaluation.


Assuntos
Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Tomada de Decisões , Definição da Elegibilidade , Avaliação de Estado de Karnofsky/normas , Neoplasias Pulmonares/tratamento farmacológico , Derrame Pleural Maligno/tratamento farmacológico , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/patologia , Ensaios Clínicos como Assunto , Terapia Combinada , Feminino , Humanos , Estimativa de Kaplan-Meier , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Masculino , Relações Médico-Paciente , Derrame Pleural Maligno/mortalidade , Derrame Pleural Maligno/patologia , Prognóstico , Estudos Prospectivos , Dosagem Radioterapêutica , Inquéritos e Questionários , Taxa de Sobrevida
20.
J Palliat Care ; 23(4): 245-52; discussion 252-4, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-18251442

RESUMO

This paper aims to reconcile the use of Palliative Performance Scale (PPSv2) for survival prediction in palliative care through an international collaborative study by five research groups. The study involves an individual patient data meta-analysis on 1,808 patients from four original datasets to reanalyze their survival patterns by age, gender, cancer status, and initial PPS score. Our findings reveal a strong association between PPS and survival across the four datasets. The Kaplan-Meier survival curves show each PPS level as distinct, with a strong ordering effect in which higher PPS levels are associated with increased length of survival. Using a stratified Cox proportional hazard model to adjust for study differences, we found females lived significantly longer than males, with a further decrease in hazard for females not diagnosed with cancer. Further work is needed to refine the reporting of survival times/probabilities and to improve prediction accuracy with the inclusion of other variables in the models.


Assuntos
Estimativa de Kaplan-Meier , Avaliação de Estado de Karnofsky/normas , Cuidados Paliativos , Modelos de Riscos Proporcionais , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Canadá/epidemiologia , Feminino , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Neoplasias/mortalidade , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Reprodutibilidade dos Testes , Projetos de Pesquisa , Estudos Retrospectivos , Índice de Gravidade de Doença , Distribuição por Sexo , Estados Unidos/epidemiologia
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