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1.
Radiother Oncol ; 195: 110231, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38518958

RESUMO

BACKGROUND: There is lack of evidence on chronic fatigue (CF) following radiotherapy (RT) in survivors of head and neck cancer (HNC). We aimed to compare CF in HNC survivors > 5 years post-RT with a reference population and investigate factors associated with CF and the possible impact of CF on health-related quality of life (HRQoL). MATERIAL AND METHODS: In this cross-sectional study we included HNC survivors treated in 2007-2013. Participants filled in patient-reported outcome measures and attended a one-day examination. CF was measured with the Fatigue Questionnaire and compared with a matched reference population using t-tests and Cohen's effect size. Associations between CF, clinical and RT-related factors were investigated using logistic regression. HRQoL was measured with the EORTC Quality of Life core questionnaire. RESULTS: The median age of the 227 HNC survivors was 65 years and median time to follow-up was 8.5 years post-RT. CF was twice more prevalent in HNC survivors compared to a reference population. In multivariable analyses, female sex (OR 3.39, 95 % CI 1.82-6.31), comorbidity (OR 2.17, 95 % CI 1.20-3.94) and treatment with intensity-modulated RT (OR 2.13, 95 % CI 1.16-3.91) were associated with CF, while RT dose parameters were not. Survivors with CF compared to those without, had significantly worse HRQoL. CONCLUSIONS: CF in HNC survivors is particularly important for female patients, while specific factors associated with RT appear not to play a role. The high CF prevalence in long-term HNC survivors associated with impaired HRQoL is important information beneficial for clinicians and patients to improve patient follow-up.


Assuntos
Sobreviventes de Câncer , Fadiga , Neoplasias de Cabeça e Pescoço , Qualidade de Vida , Humanos , Feminino , Masculino , Neoplasias de Cabeça e Pescoço/radioterapia , Estudos Transversais , Idoso , Fadiga/etiologia , Pessoa de Meia-Idade , Doença Crônica , Inquéritos e Questionários , Medidas de Resultados Relatados pelo Paciente
2.
Radiother Oncol ; 190: 110044, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38061420

RESUMO

BACKGROUND: Although dysphagia is a common side effect after radiotherapy (RT) of head and neck cancer (HNC), data on long-term dysphagia is scarce. We aimed to 1) compare radiation dose parameters in HNC survivors with and without dysphagia, 2) investigate factors associated with long-term dysphagia and its possible impact on health-related quality of life (HRQoL), and 3) investigate how our data agree with existing NTCP models. METHODS: This cross-sectional study conducted in 2018-2020, included HNC survivors treated in 2007-2013. Participants attended a one-day examination in hospital and filled in patient questionnaires. Dysphagia was measured with the EORTC QLQ-H&N35 swallowing scale. Toxicity was scored with CTCAE v.4. We contoured swallowing organs at risk (SWOAR) on RT plans, calculated dose-volume histograms (DVHs), performed logistic regression analyses and tested our data in established NTCP models. RESULTS: Of the 239 participants, 75 (31%) reported dysphagia. Compared to survivors without dysphagia, this group had reduced HRQoL and the DVHs for infrahyoid SWOAR were significantly shifted to the right. Long-term dysphagia was associated with age (OR 1.07, 95% CI 1.03-1.10), female sex (OR 2.75, 95% CI 1.45-5.21), and mean dose to middle pharyngeal constrictor muscle (MD-MPCM) (OR 1.06, 95% CI 1.03-1.09). NTCP models overall underestimated the risk of long-term dysphagia. CONCLUSIONS: Long-term dysphagia was associated with higher age, being female, and high MD-MPCM. Doses to distally located SWOAR seemed to be risk factors. Existing NTCP models do not sufficiently predict long-term dysphagia. Further efforts are needed to reduce the prevalence and consequences of this late effect.


Assuntos
Transtornos de Deglutição , Neoplasias de Cabeça e Pescoço , Humanos , Feminino , Masculino , Transtornos de Deglutição/epidemiologia , Transtornos de Deglutição/etiologia , Qualidade de Vida , Estudos Transversais , Neoplasias de Cabeça e Pescoço/radioterapia , Deglutição/efeitos da radiação
3.
Clin Transl Radiat Oncol ; 42: 100654, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37415638

RESUMO

Purpose: Describe the clinical outcome of hyperfractionated re-irradiation (HFRT) in patients with recurrent or second primary (SP) head and neck cancer (HNC). Methods: This prospective observational study included HNC patients eligible for HFRT. Inclusion criteria: age ≥18 years, recurrent or SP HNC, planned re-irradiation and ability to respond to questionnaires. Patients received 1.5 Gy twice daily, five days a week for three (palliative) or four (curative/local control) weeks, total dose 45/60 Gy. Toxicity was scored with CTCAE v3 at baseline, end of treatment, at three, six, 12 and 36 months follow-up. Health-related quality of life (HRQoL) was measured with EORTC QLQ-C30 and EORTC QLQ-H&N35, pre-treatment and eight times until 36 months. In the main outcome (Global quality of life and H&N Pain), a change score of ≥10 was considered clinically significant, and p-values < 0.05 (two-sided) statistically significant. The Kaplan-Meier method was used for survival analyses. Results: Over four years from 2015, 58 patients were enrolled (37 recurrent and 21 SP). All, but two patients completed treatment as planned. Toxicity (≥grade 3) increased from pre-treatment to end of treatment with improvement in the follow-up period. The mean Global quality of life (QoL) and H&N Pain scores were stable from pre-treatment to three months. Maintained/ improved Global QoL was reported by 60% of patients at three months and 56% of patients at 12 months. For patients with curative, local control and palliative intent, the median survival (range) was 23 (2-53), 10 (1-66) and 14 (3-41) months respectively. Of those alive, the proportion of disease-free patients at 12 and 36 months, were 58% and 48%, respectively. Conclusion: Most HNC patients reported maintained HRQoL at three and 12 months after HFRT despite serious toxicity observed in many patients. Long-term survival can be achieved in a limited proportion of the patients.

4.
Lancet Oncol ; 24(6): e270-e283, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37269858

RESUMO

Patient-reported outcomes (PROs), such as symptoms, functioning, and other health-related quality-of-life concepts are gaining a more prominent role in the benefit-risk assessment of cancer therapies. However, varying ways of analysing, presenting, and interpreting PRO data could lead to erroneous and inconsistent decisions on the part of stakeholders, adversely affecting patient care and outcomes. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) Consortium builds on the existing SISAQOL work to establish recommendations on design, analysis, presentation, and interpretation for PRO data in cancer clinical trials, with an expanded set of topics, including more in-depth recommendations for randomised controlled trials and single-arm studies, and for defining clinically meaningful change. This Policy Review presents international stakeholder views on the need for SISAQOL-IMI, the agreed on and prioritised set of PRO objectives, and a roadmap to ensure that international consensus recommendations are achieved.


Assuntos
Neoplasias , Qualidade de Vida , Humanos , Medidas de Resultados Relatados pelo Paciente , Neoplasias/tratamento farmacológico , Consenso
5.
Lancet Oncol ; 24(5): e197-e206, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-37142381

RESUMO

Patient-reported outcomes (PROs) are increasingly used in single-arm cancer studies. We reviewed 60 papers published between 2018 and 2021 of single-arm studies of cancer treatment with PRO data for current practice on design, analysis, reporting, and interpretation. We further examined the studies' handling of potential bias and how they informed decision making. Most studies (58; 97%) analysed PROs without stating a predefined research hypothesis. 13 (22%) of the 60 studies used a PRO as a primary or co-primary endpoint. Definitions of PRO objectives, study population, endpoints, and missing data strategies varied widely. 23 studies (38%) compared the PRO data with external information, most often by using a clinically important difference value; one study used a historical control group. Appropriateness of methods to handle missing data and intercurrent events (including death) were seldom discussed. Most studies (51; 85%) concluded that PRO results supported treatment. Conducting and reporting of PROs in cancer single-arm studies need standards and a critical discussion of statistical methods and possible biases. These findings will guide the Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Data in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) in developing recommendations for the use of PRO-measures in single-arm studies.


Assuntos
Neoplasias , Qualidade de Vida , Humanos , Medidas de Resultados Relatados pelo Paciente , Neoplasias/terapia , Oncologia , Projetos de Pesquisa
6.
Int J Mol Sci ; 23(7)2022 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-35409074

RESUMO

Patients with head and neck cancer (HNC) and patients with primary Sjögren's syndrome (pSS) may exhibit similar symptoms of dry mouth and dry eyes, as a result of radiotherapy (RT) or a consequence of disease progression. To identify the proteins that may serve as promising disease biomarkers, we analysed saliva and tears from 29 radiated HNC patients and 21 healthy controls, and saliva from 14 pSS patients by mass spectrometry-based proteomics. The study revealed several upregulated, and in some instances overlapping, proteins in the two patient groups. Histone H1.4 and neutrophil collagenase were upregulated in whole saliva of both patient groups, while caspase-14, histone H4, and protein S100-A9 were upregulated in HNC saliva only. In HCN tear fluid, the most highly upregulated protein was mucin-like protein 1. These overexpressed proteins in saliva and tears play central roles in inflammation, host cell injury, activation of reactive oxygen species, and tissue repair. In conclusion, the similarities and differences in overexpressed proteins detected in saliva from HNC and pSS patients may contribute to the overall understanding of the different pathophysiological mechanisms inducing dry mouth. Thus, the recurring proteins identified could possibly serve as future promising biomarkers.


Assuntos
Neoplasias de Cabeça e Pescoço , Síndrome de Sjogren , Xerostomia , Biomarcadores/metabolismo , Neoplasias de Cabeça e Pescoço/metabolismo , Neoplasias de Cabeça e Pescoço/radioterapia , Histonas/metabolismo , Humanos , Recidiva Local de Neoplasia/metabolismo , Proteômica , Saliva/metabolismo , Síndrome de Sjogren/metabolismo , Lágrimas/metabolismo , Xerostomia/metabolismo
7.
Qual Life Res ; 31(3): 841-853, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34272632

RESUMO

PURPOSE: The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43. METHODS: In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods. RESULTS: From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |r|< 0.4 in 17 out of 19 scales; hence, performance status was regarded as an unsuitable anchor. The ROC approach yielded an implausible MIC and was also discarded. The remaining approaches worked well and delivered MID values ranging from 10 to 14; the MIC for deterioration ranged from 8 to 16 and the MIC for improvement from - 3 to - 14. CONCLUSIONS: For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate.


Assuntos
Deglutição , Neoplasias de Cabeça e Pescoço , Neoplasias de Cabeça e Pescoço/terapia , Humanos , Qualidade de Vida/psicologia , Inquéritos e Questionários
8.
Qual Life Res ; 31(3): 659-669, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34350566

RESUMO

PURPOSE: Several guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specific criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted. METHODS: A literature search was conducted in MEDLINE to identify eligible publications. To assess the number of publications, all abstracts were screened for eligibility by pairs of reviewers. Compliance with PRO-specific criteria and other key characteristics was assessed in a random sample of 150 eligible full-text publications from each year. Randomized controlled trials (RCTs) were assessed according to the full CONSORT-PRO checklist. RESULTS: The search identified 1692 publications in 2008 and 4290 in 2018. After screening of abstracts, 1240 from 2008 and 2869 from 2018 were clinical studies using PROs. By full-text review, the proportion of studies discussing PRO-specific limitations and implications was higher in 2018 than in 2008, but there were no differences in the other selected PRO-specific criteria. In 2018, a higher proportion of studies were longitudinal/cohort studies, included ≥ 300 patients, and used electronic administration of PRO than in 2008. The most common patient groups studied were those with cancer or diseases of the musculoskeletal system or connective tissue. CONCLUSION: The number of clinical studies from Europe using PROs was higher in 2018 than in 2008, but there was little difference in compliance with the PRO-specific criteria. The studies varied in terms of study design and PRO instruments used in both publication years.


Assuntos
Neoplasias , Qualidade de Vida , Europa (Continente) , Humanos , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida/psicologia , Projetos de Pesquisa
9.
Sci Rep ; 11(1): 22419, 2021 11 17.
Artigo em Inglês | MEDLINE | ID: mdl-34789830

RESUMO

Patients undergoing intensity-modulated radiotherapy (IMRT) for head and neck cancer may have increased incidence of dry eye disease and the exact mechanism is unclear. The present study aims to assess tear film and meibomian gland (MG) features in patients who received IMRT for head and neck cancer not involving the orbital area. Twenty-seven patients (64.7 ± 9.8 years) and 30 age-matched controls (61.4 ± 11.0 years) underwent a comprehensive dry eye work-up. Compared to the control group, the patients had more lid margin abnormalities, and worse meibum quality. The MG loss, calculated as (tarsal area-MG area)/tarsal area, was higher in the patient group in both the upper (53.0 ± 12.0% vs. 35.1 ± 10.3%, p < 0.001) and lower lids (69.5 ± 12.6% vs. 48.5 ± 12.5%, p < 0.001). In the patient group, more MG loss in the lower lids correlated with worse meibum quality (r = 0.445, p = 0.029). In contrast, there was no significant difference in aqueous tear production level, measured with Schirmer test. Patients treated with IMRT for head and neck cancer seemed to have comparable lacrimal gland function to the controls despite more dry eye symptoms. However, the patients had MG functional and morphological changes, which may present a higher risk for developing dry eye disease.


Assuntos
Síndromes do Olho Seco/epidemiologia , Síndromes do Olho Seco/etiologia , Neoplasias de Cabeça e Pescoço/radioterapia , Glândulas Tarsais/efeitos da radiação , Radioterapia de Intensidade Modulada/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Estudos Transversais , Feminino , Humanos , Incidência , Masculino , Glândulas Tarsais/patologia , Pessoa de Meia-Idade , Doses de Radiação , Fatores de Risco , Gases Lacrimogênios , Lágrimas
10.
Sci Rep ; 11(1): 4026, 2021 02 17.
Artigo em Inglês | MEDLINE | ID: mdl-33597629

RESUMO

A broader understanding of oral and ocular late effects in head and neck cancer (HNC) patients who underwent intensity-modulated radiotherapy (IMRT) may provide valuable information in follow-up and improve quality of life. Twenty-nine HNC patients treated at least 6 months earlier and 30 age-matched controls were recruited. After completing several questionnaires: Oral Health Impact Profile-14 (OHIP-14), Shortened Xerostomia Inventory (SXI), Ocular Surface Disease Index (OSDI) and McMonnies Dry Eye questionnaire (MDEQ), participants underwent oral and ocular examinations. Oral examination included clinical oral dryness score (CODS) and secretion rates of unstimulated and stimulated saliva (UWS, SWS). Ocular examination included tear film break-up time, Schirmer test and ocular surface staining. The patients had more problems related to dry mouth than controls based on CODS and SXI, and more complaints of dry eye disease based on OSDI and MDEQ. UWS and SWS rates and oral health related quality of life were significantly lower in the patient group. Subjective oral dryness (SXI) correlated significantly with subjective ocular dryness (OSDI and MDEQ). Our study demonstrates that HNC patients treated with IMRT experience late effects in terms of xerostomia and ocular dryness underlining the importance of interdisciplinary approach in the evaluation and follow-up of HNC patients.


Assuntos
Neoplasias de Cabeça e Pescoço/radioterapia , Radioterapia de Intensidade Modulada/efeitos adversos , Radioterapia/efeitos adversos , Idoso , Síndromes do Olho Seco , Oftalmopatias/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Noruega , Qualidade de Vida , Radioterapia de Intensidade Modulada/métodos , Saliva/química , Doenças das Glândulas Salivares/etiologia , Salivação , Doenças Estomatognáticas/etiologia , Inquéritos e Questionários , Xerostomia
11.
Acta Oncol ; 59(7): 859-865, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32324079

RESUMO

Background: Over the past two decades, hybrid and total minimally invasive esophagectomy for esophageal cancer (EC) has increasingly been implemented with the aim to improve morbidity, functional result and ultimately the prognosis in these patients. However, more results are warranted and in this single-center study we report long-time outcome in a cohort of cancer patients treated with hybrid esophagectomy (HE).Material and methods: Hundred and nine patients with EC operated with HE from November 2007 to June 2013 were included. Clinical, pathological and survival data were retrieved from the patient administration system and the Norwegian Cause of Death Registry. Patients alive were asked to fill out the Ogilvie dysphagia score, EORTC QLQ-C30 and EORTC QLQ-OG25. Survival was analyzed by Kaplan-Meier's method and prognostic factors by uni- and multivariable Cox regression analyses.Results: Median overall follow-up time was 55 months (range 2-135) after R0-2 resection (n = 109) and 76 months (5-135) for R0 resection (n = 100). Five-year overall survival rate was 49% and 53%, respectively. Anastomotic leakage rate and 90-days mortality were 5% and 2%, respectively. Six patients (6%) had later surgery for metastases to mediastinum, hepatoduodenal ligament, brain, lung, liver or bladder median 26 months (4-51) after HE. Forty-one out of 51 patients alive (80%) filled out questionnaires after median 65.5 months (63-123) follow-up. All patients could eat normal food without (n = 37) or with (n = 4) problems. Nearly, half of the patients reported problems with reflux, one-third experienced fatigue and anxiety while one out of four had weight loss and episodes of dyspnea.Conclusions: In this patient series, HE offered low postoperative mortality and good overall long-term survival. Most survivors maintained good quality of life more than five years post treatment. There was a low rate of serious postoperative complications.


Assuntos
Adenocarcinoma/cirurgia , Carcinoma de Células Escamosas/cirurgia , Neoplasias Esofágicas/patologia , Neoplasias Esofágicas/cirurgia , Esofagectomia/métodos , Qualidade de Vida , Adenocarcinoma/secundário , Adulto , Idoso , Idoso de 80 Anos ou mais , Fístula Anastomótica/etiologia , Carcinoma de Células Escamosas/secundário , Transtornos de Deglutição/etiologia , Ingestão de Alimentos , Esofagectomia/efeitos adversos , Feminino , Seguimentos , Refluxo Gastroesofágico/etiologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Neoplasia Residual , Modelos de Riscos Proporcionais , Reoperação , Inquéritos e Questionários , Taxa de Sobrevida , Fatores de Tempo , Resultado do Tratamento
12.
Radiother Oncol ; 140: 54-61, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31177043

RESUMO

BACKGROUND AND PURPOSE: Standardized uptake value (SUV) and related parameters derived from 2-deoxy-2-[18F]-fluoro-d-glucose (FDG) PET/CT prior to radiochemotherapy of head and neck cancer (HNC) were significantly associated with survival in a number of studies. The aim of this study was to validate these findings and to evaluate the prognostic role of PET parameters also including clinical factors and HPV status. MATERIALS AND METHODS: We reviewed 166 HNC cases with a radiotherapy planning FDG PET/CT scan. All patients received radiotherapy, 68-70 Gy with or without concomitant cisplatin. Primary endpoint was disease-free survival (DFS). Twelve clinical factors, including HPV, performance status, stage and treatment parameters and ten PET/CT image parameters including gross tumor volume (GTV), metastatic lymph node volume, SUVmax, metabolic tumor volume (MTV) and total lesion glycolysis (TLG), were collected. Univariate and multivariate Cox regression analyses were employed. RESULTS: Of the 166 patients included, 48 had locoregional and 23 had metastatic recurrence. None of the FDG PET parameters were significant in the univariate analysis using DFS as endpoint. HPV status, ECOG status and GTV-U (primary tumor and lymph node volume from CT) were statistically significant (p < 0.01). Only in the subgroup of HPV-unrelated HNC (HPV negative oropharyngeal cancer [OPC] and non-OPC; n = 73), the multivariate model could be improved by including MTV (p < 0.001). DFS events were 29 (31%) in HPV-related and 53 (73%) in HPV-unrelated HNC. CONCLUSION: FDG PET parameters appear less important for overall prognostication of radiochemotherapy outcome for HNC. Still, the association between the FDG PET parameters and survival is strong for HNC not related to HPV. Tumor volume from CT is generally more closely related to outcome than parameters derived from FDG PET/CT.


Assuntos
Fluordesoxiglucose F18 , Neoplasias de Cabeça e Pescoço/diagnóstico por imagem , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Compostos Radiofarmacêuticos , Adulto , Idoso , Idoso de 80 Anos ou mais , Quimiorradioterapia , Feminino , Fluordesoxiglucose F18/metabolismo , Neoplasias de Cabeça e Pescoço/mortalidade , Neoplasias de Cabeça e Pescoço/terapia , Neoplasias de Cabeça e Pescoço/virologia , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Carga Tumoral
13.
Head Neck ; 41(6): 1725-1737, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30636188

RESUMO

BACKGROUND: We validated the new European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43). METHODS: We enrolled 812 patients with head and neck cancer from 18 countries. Group 1 completed the questionnaire before therapy, and 3 and 6 months later. In group 2 (survivors), we determined test-retest reliability using intraclass correlation coefficients (ICC). Internal consistency was assessed using Cronbach's Alpha, the scale structure with confirmatory factor analysis, and discriminant validity with known-group comparisons. RESULTS: Cronbach's alpha was >0.70 in 10 of the 12 multi-item scales. All standardized factor loadings exceeded 0.40. The ICC was >0.70 in all but two scales. Differences in scale scores between known-groups were >10 points in 17 of the 19 scales. Sensitivity to change was found to be sufficient in 18 scales. CONCLUSIONS: Evidence supports the reliability and validity of the EORTC QLQ-HN43 as a measure of quality of life.


Assuntos
Neoplasias de Cabeça e Pescoço/psicologia , Qualidade de Vida , Inquéritos e Questionários , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Europa (Continente) , Feminino , Neoplasias de Cabeça e Pescoço/complicações , Neoplasias de Cabeça e Pescoço/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Estudos Prospectivos , Psicometria , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
14.
Acta Oncol ; 56(10): 1286-1294, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28686501

RESUMO

BACKGROUND: Patients with esophageal cancer seldom achieve long-term survival. This prospective cohort study investigated the selection of patients likely to benefit from curative treatment and whether information on patients' health-related quality of life (HRQL) would assist treatment decisions in the multidisciplinary team. METHODS: Consecutive patients completed HRQL assessments and clinical data were collected before start of treatment. Logistic regression analyses identified clinical factors associated with treatment intent in patients with stage-III disease. Kaplan-Meier method was used for survival analyses and Cox proportional hazards models were used to assess the impact of clinical factors and HRQL on survival in patients planned for curative treatment. RESULTS: Patients with curative treatment intent (n = 90) were younger, had better WHO performance status and less fatigue than patients with palliative treatment intent (n = 89). Median survival for the total cohort (n = 179) and patients with palliative or curative treatment intent was nine, five and 19 months, respectively. In multivariate Cox regression analyses, performance status (0-1 favorable) and comorbidity (ASA I favorable) were factors of importance for survival, whereas measures of HRQL were not. CONCLUSIONS: Patients performance status and comorbidity must be considered in addition to stage of disease to avoid extensive curative treatment in patients with short life expectancy. This study did not provide evidence to support that information on patients HRQL adds value to the multidisciplinary team's treatment decision process.


Assuntos
Neoplasias Esofágicas/terapia , Estudos de Coortes , Neoplasias Esofágicas/mortalidade , Humanos , Estudos Prospectivos , Qualidade de Vida
15.
Radiother Oncol ; 107(3): 428-33, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23647761

RESUMO

PURPOSE: To investigate whether a combination of self-expanding metal stent (SEMS) and brachytherapy provided more rapid and prolonged effect on dysphagia without increased pain compared to brachytherapy alone in patients with incurable oesophageal cancer. METHODS: 41 Patients were randomised to SEMS followed by brachytherapy, 8 Gy×3 (n=21) or brachytherapy alone, 8 Gy×3 (n=20). Change in dysphagia and pain three and seven weeks after randomisation (FU1 and FU2) was assessed by patient-reported outcome. Dysphagia, other symptoms and health-related quality of life were assessed every four weeks thereafter. The study was closed before the estimated patient-number was reached due to slow recruitment. RESULTS: Patients receiving SEMS followed by brachytherapy had significantly improved dysphagia at FU1 compared to patients receiving brachytherapy alone (n=35). Difference in pain was not observed. At FU2, patients in both arms (n=21) had less dysphagia. Four patients in the combined treatment arm experienced manageable complications, no complications occurred after brachytherapy alone. CONCLUSION: For the relief of dysphagia, SEMS followed by brachytherapy is preferable and safe for patients in need of immediate alleviation, while brachytherapy with or without preceding SEMS provides relief within a few weeks after treatment.


Assuntos
Braquiterapia , Neoplasias Esofágicas/radioterapia , Cuidados Paliativos , Stents , Idoso , Idoso de 80 Anos ou mais , Braquiterapia/efeitos adversos , Transtornos de Deglutição/etiologia , Neoplasias Esofágicas/mortalidade , Neoplasias Esofágicas/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida
16.
Acta Oncol ; 52(4): 679-90, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23190360

RESUMO

BACKGROUND: Patient-reported outcomes (PROs) and assessments of treatment-related toxicity provide important information on the effect of palliative chemotherapy and/or radiotherapy. The aim of this study was to review the effect of palliative radiotherapy and/or chemotherapy on symptoms and quality of life assessed by PROs and measurement of toxicity for patients with oesophageal cancer. METHODS: The Central, Medline and Embase databases (1990 to November 2011) were systematically searched for prospective studies of palliative chemotherapy and/or radiotherapy in patients with advanced oesophageal cancer with PRO- and/or toxicity outcomes. The risks of bias were assessed. RESULTS: Of 2677 records identified, only 32 included PROs, of which eight were randomised controlled trials. In studies with sufficient standard of PRO (n = 18), either Health Related Quality of Life (HRQL) (n = 14) or patient-reported dysphagia (n = 4), were assessed. Docetaxel added to cisplatin + fluorouracil (CF) improved HRQL compared to CF only, even though toxicity increased. Epirubicin added to CF resulted in longer preserved HRQL than its comparator in two trials, and non-inferiority in one. All phase II chemotherapy studies reported maintained HRQL or improved dysphagia combined with low level of toxicity. Brachytherapy resulted in better HRQL compared to stent placement in two trials, and external radiotherapy relieved dysphagia. The quality of the HRQL methodology and the interpretation and presentation of the PRO results varied, and clinical significance was seldom discussed. CONCLUSION: PRO endpoints are seldom used and further studies of homogenous patient groups with valid measures and methodology of PROs should be encouraged in the evaluation of palliative treatment. Brachytherapy, external radiotherapy and combination chemotherapy improved HRQL and dysphagia in the few identified studies with sufficient PRO methodology.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma/tratamento farmacológico , Carcinoma/radioterapia , Neoplasias Esofágicas/tratamento farmacológico , Neoplasias Esofágicas/radioterapia , Cuidados Paliativos , Autorrelato , Braquiterapia/métodos , Braquiterapia/psicologia , Carcinoma/epidemiologia , Carcinoma/psicologia , Neoplasias Esofágicas/epidemiologia , Neoplasias Esofágicas/psicologia , Humanos , Cuidados Paliativos/psicologia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Resultado do Tratamento
17.
Acta Oncol ; 49(2): 209-18, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-19929566

RESUMO

BACKGROUND: Over a 10-year period from 1990, 445 patients with carcinoma of the oesophagus were admitted to the Norwegian Radium Hospital and 184 of these patients received treatment with curative intent. Even though surgery is the treatment of choice for these patients, many of them suffer from medical conditions that increase the risk for postoperative mortality and morbidity. In a retrospective study, the effect of the curative treatment offered to patients was explored with a particular focus on patients unfit for surgery. METHODS: Medical data of the 184 patients treated with curative intent were reviewed and additional clinical information was retrieved from local hospitals and general practitioners. Preoperative radiotherapy followed by surgery was the standard curative treatment for operable patients. Medically inoperable patients were offered radical split-course hyperfractionated radiotherapy followed by a brachytherapy boost. RESULTS: More than 50% (103/184) received non-surgical treatment only. Patients who received radical surgery (n = 81) were younger, had better performance status, less weight loss and dysphagia compared to patients treated with radical radiotherapy (n = 102). One patient received only photodynamic therapy. The 3-year survival was 29% for patients treated with radical surgery, and 8% for patients who received radical radiotherapy. The overall median crude survival for the two groups of patients were 20 months and seven months respectively. CONCLUSION: The hyperfractionated radiotherapy provided symptom relief without extensive toxicity and with a possibility for cure for patients with oesophageal cancer who are unfit for surgery and chemoradiotherapy. The literature supports the curative potential of high dose accelerated hyperfractionated radiotherapy even though the optimal radiotherapy regimen still needs to be explored.


Assuntos
Neoplasias Esofágicas/radioterapia , Neoplasias Esofágicas/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Procedimentos Cirúrgicos do Sistema Digestório , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Noruega , Radioterapia/métodos
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