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  1 / 4522 MEDLINE  
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[PMID]:29480881
[Au] Autor:Wu YH; Liu KT; Yeh IJ; Chang CW
[Ad] Endereço:Department of Emergency Medicine, Kaohsiung Medical University Hospital.
[Ti] Título:Cheiro-Oral syndrome caused by thalamus hemorrhage: A case report.
[So] Source:Medicine (Baltimore);97(2):e9652, 2018 Jan.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Cheiro-Oral syndrome (COS) is a pure sensory deficit confined to the perioral area and ipsilateral distal fingers or hand. Owing to relatively minor clinical findings and various presentations in different cases, the insidious and severe illness it implies may be overlooked at acute settings. PATIENT CONCERNS: A 70-year-old man with history of hypertension and type II diabetes mellitus under regular medication control came to our emergency department with chief complaint of sudden onset of right perioral region and right upper limb numbness. General physical and neurological examinations were normal except for subtle hypoesthesia to light touch, and pinprick in the right corner of mouth and right forearm to distal fingers. DIAGNOSES: Routine blood analysis was all in normal range including white blood cell count, hemocrit platelet, renal and liver function, and electrolytes such as sodium and potassium. Noncontrast brain computed tomography showed abnormal high-attenuation collection in the left thalamus. INTERVENTION: Follow-up computed tomography showed absorption of the hemorrhage after strict control of his blood pressure. OUTCOMES: The patient was discharged 7 days later from our hospital with stable condition. LESSONS: We demonstrated type I COS associated with thalamic hemorrhage to highlight the neurological implication of COS. It is crucial for emergency clinicians to recognize the symptoms and promptly order a neuroimaging study to exclude large infarction/hemorrhage, which would deeply affect the disposition and following treatment of the patient.
[Mh] Termos MeSH primário: Hemorragia Cerebral/complicações
Transtornos das Sensações/etiologia
[Mh] Termos MeSH secundário: Idoso
Hemorragia Cerebral/diagnóstico por imagem
Hemorragia Cerebral/terapia
Diagnóstico Diferencial
Seres Humanos
Masculino
Boca
Transtornos das Sensações/diagnóstico por imagem
Transtornos das Sensações/terapia
Síndrome
Tálamo/diagnóstico por imagem
Tomografia Computadorizada por Raios X
Extremidade Superior
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180305
[Lr] Data última revisão:
180305
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180227
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000009652


  2 / 4522 MEDLINE  
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[PMID]:29191030
[Au] Autor:Parker G; Paterson A; Romano M; Graham R
[Ad] Endereço:From the School of Psychiatry and the Black Dog Institute, University of New South Wales, Sydney, Australia.
[Ti] Título:Altered Sensory Phenomena Experienced in Bipolar Disorder.
[So] Source:Am J Psychiatry;174(12):1146-1150, 2017 12 01.
[Is] ISSN:1535-7228
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Transtorno Bipolar/psicologia
Transtornos das Sensações/psicologia
[Mh] Termos MeSH secundário: Transtorno Bipolar/complicações
Feminino
Seres Humanos
Masculino
Transtornos das Sensações/complicações
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180213
[Lr] Data última revisão:
180213
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171202
[St] Status:MEDLINE
[do] DOI:10.1176/appi.ajp.2017.16121379


  3 / 4522 MEDLINE  
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[PMID]:29187688
[Au] Autor:Abe S; Okazaki S; Tonomura S; Miyashita K; Ihara M
[Ad] Endereço:Department of Neurology, National Cerebral and Cardiovascular Center, Osaka.
[Ti] Título:[Progressive dysarthria and bilateral sensory disturbance in a case of bilateral ventrolateral pontine infarction].
[So] Source:Rinsho Shinkeigaku;57(12):764-768, 2017 Dec 27.
[Is] ISSN:1882-0654
[Cp] País de publicação:Japan
[La] Idioma:jpn
[Ab] Resumo:A rare case of bilateral ventrolateral pontine infarction in a 70-year-old man who developed progressive dysarthria and bilateral sensory disturbance is reported with literature review. He had been diagnosed with hypertension, dyslipidemia, and impaired glucose tolerance 10 years earlier. Ten days before admission, he was aware of the difficulty in walking and speaking, which gradually worsened. On admission he showed bilateral thermal hypoalgesia of face and lower extremities, dysarthria, dysphagia, and ataxic gait. High resolution three-dimensional MRI revealed bilateral ventrolateral pontine infarction with a large atherosclerotic plaque in the ventral side of the basilar artery, which led to a diagnosis of atherothrombotic brain infarction. The atherosclerotic plaque in the basilar artery was thought to be responsible for simultaneous occlusion of the bilateral short circumflex arteries of the pons.
[Mh] Termos MeSH primário: Infarto Cerebral/etiologia
Disartria/etiologia
Ponte/irrigação sanguínea
Transtornos das Sensações/etiologia
[Mh] Termos MeSH secundário: Idoso
Artéria Basilar/diagnóstico por imagem
Infarto Cerebral/diagnóstico por imagem
Progressão da Doença
Seres Humanos
Imagem por Ressonância Magnética
Masculino
Placa Aterosclerótica/complicações
Placa Aterosclerótica/diagnóstico por imagem
Ponte/diagnóstico por imagem
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180112
[Lr] Data última revisão:
180112
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171201
[St] Status:MEDLINE
[do] DOI:10.5692/clinicalneurol.cn-001090


  4 / 4522 MEDLINE  
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[PMID]:29095298
[Au] Autor:Gao Y; Zhang Q; Yan J; Niu X; Han P; Yuan H; Hu J; Liu B; Xu M
[Ad] Endereço:aDepartment of Otorhinolaryngology Head and Neck Surgery, Ear Institute, Second Affiliated Hospital, Xi'an Jiaotong University College of Medicine, Xi'an, Shaanxi Province bDepartment of Otorhinolaryngology Head and Neck Surgery, Ear Institute, First Affiliated Hospital, Xi'an Jiaotong University College of Medicine, Xi'an, Shaanxi Province cDepartment of Otolaryngology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hebei Province, P.R. China.
[Ti] Título:Sudden onset of static equilibrium dysfunction in patients receiving a cochlear implant.
[So] Source:Medicine (Baltimore);96(44):e8465, 2017 Nov.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: We investigated the sudden onset of static equilibrium dysfunction caused by cochlear implantation (CI) in congenital hearing loss patients. METHOD: Twenty-five patients were selected from a cohort of unilateral CI recipients to form the CI group. Static posturography was performed 1 to 3 days before and 3 to 5 days after CI. Each patient underwent the test with eyes open (EO) and eyes closed (EC) for 30 seconds, separately. Another group of age- and sex-matched patients with no history of hearing impairment undergoing unrelated surgeries formed the control group, and were examined with the same tests pre- and post-surgery. A third group of patients undergoing middle ear surgery formed the otitis media (OM) group. Postural sway parameters including sway velocity (SV) in the X-axis, SV in the Y-axis, length of sway locus length (LNG), and environmental area (ENV) were measured and recorded. RESULTS: Comparison of pre-surgery posturographical parameters between the CI and control groups revealed no significant differences. Significant differences were found in most parameters in pre- and post-surgery comparisons in the CI group. Mean SV values in the X-axis pre- and post-surgery were 8.48 and 11.52 mm/s, respectively, in the EO condition (P < .05), and 14.94 and 20.16 mm/s, respectively, in the EC condition (P < .05). In the Y-axis, mean SV values were 15.36 and 20.24 mm/s pre- and post-surgery, respectively, in the EC condition (P < .05). The LNG values in the CI group pre- and post-surgery were 319.60 and 469.88 mm in the EO condition (P < .05), and 571.40 and 764.12 mm in the EC condition (P < .05). No significant functional equilibrium change was observed in the control group between pre- and post-surgery (P > .05) except SV in the X-axis and LNG in the EO condition (P < .05). No significant pre- and post-surgery differences were found in the OM group. CONCLUSION: CI appeared to influence static equilibrium function within 1 week post-surgery. This influence was greater when eyes were closed.
[Mh] Termos MeSH primário: Implante Coclear/efeitos adversos
Implantes Cocleares/efeitos adversos
Perda Auditiva/cirurgia
Equilíbrio Postural
Transtornos das Sensações/etiologia
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Estudos de Casos e Controles
Criança
Implante Coclear/métodos
Feminino
Perda Auditiva/congênito
Perda Auditiva/fisiopatologia
Seres Humanos
Masculino
Meia-Idade
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171109
[Lr] Data última revisão:
171109
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171103
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000008465


  5 / 4522 MEDLINE  
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[PMID]:28925664
[Au] Autor:Moncada LVV; Mire LG
[Ad] Endereço:Louisiana State University School of Medicine, University Hospital and Clinics, Lafayette, LA, USA.
[Ti] Título:Preventing Falls in Older Persons.
[So] Source:Am Fam Physician;96(4):240-247, 2017 Aug 15.
[Is] ISSN:1532-0650
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The American Geriatrics Society and British Geriatrics Society recommend that all adults older than 65 years be screened annually for a history of falls or balance impairment. The U.S. Preventive Services Task Force and American Academy of Family Physicians recommend exercise or physical therapy and vitamin D supplementation to prevent falls in community-dwelling older adults who are at increased risk of falls. Although the U.S. Preventive Services Task Force and American Academy of Family Physicians do not recommend routine multifactorial intervention to prevent falls in all community-dwelling older adults, they state that it may be appropriate in individual cases. The Centers for Disease Control and Prevention developed an algorithm to aid in the implementation of the American Geriatrics Society/British Geriatrics Society guideline. The algorithm suggests assessment and multifactorial intervention for those who have had two or more falls or one fall-related injury. Multifactorial interventions should include exercise, particularly balance, strength, and gait training; vitamin D supplementation with or without calcium; management of medications, especially psychoactive medications; home environment modification; and management of postural hypotension, vision problems, foot problems, and footwear. These interventions effectively decrease falls in the community, hospital, and nursing home settings. Fall prevention is reimbursed as part of the Medicare Annual Wellness Visit.
[Mh] Termos MeSH primário: Acidentes por Quedas/prevenção & controle
Avaliação Geriátrica/métodos
Equilíbrio Postural
Transtornos das Sensações/diagnóstico
Ferimentos e Lesões/prevenção & controle
[Mh] Termos MeSH secundário: Idoso
Conservadores da Densidade Óssea/uso terapêutico
Difosfonatos/uso terapêutico
Fraturas Ósseas/prevenção & controle
Seres Humanos
Monitorização Ambulatorial/instrumentação
Guias de Prática Clínica como Assunto
Medição de Risco/métodos
Medição de Risco/normas
Transtornos das Sensações/reabilitação
Ferimentos e Lesões/etiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Bone Density Conservation Agents); 0 (Diphosphonates)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171004
[Lr] Data última revisão:
171004
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170920
[St] Status:MEDLINE


  6 / 4522 MEDLINE  
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[PMID]:28841616
[Au] Autor:Feng SM; Sun QQ; Cheng J; Wang AG; Li CK
[Ad] Endereço:Xuzhou, Jiangsu, People's Republic of China From the Hand and Foot Microsurgery Department, Xuzhou Central Hospital, Xuzhou Clinical School of Xuzhou Medical College.
[Ti] Título:Superficial Radial Nerve Transection Improves Sensory Outcomes in First Dorsal Metacarpal Artery Flaps.
[So] Source:Plast Reconstr Surg;140(3):558-564, 2017 Sep.
[Is] ISSN:1529-4242
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: This article reports the operative technique and clinical effect of repairing thumb pulp defects using a modified first dorsal metacarpal artery flap method. In this method, the dorsal branches of the radial and ulnar proper digital nerves of the index finger were preserved but the superficial branches of the radial nerve were transected. METHODS: Data obtained from 121 patients with thumb pulp defects who were admitted to the authors' hospital from June of 2011 to December of 2014 were retrospectively analyzed. Patients were divided into two groups based on whether the superficial branches of the radial nerve were transected. The dorsal branches of the radial and ulnar proper digital nerves of the index finger and the proper digital nerves in the wound were coapted using the end-to-end style. Static two-point discrimination, Semmes-Weinstein monofilament scores, pain, cold intolerance of the reconstructed finger, allachesthesia, and patient satisfaction were compared between the two groups. RESULTS: The authors observed significant differences in static two-point discrimination, Semmes-Weinstein monofilament flap score, pain of finger pulp, allachesthesia duration, and patient satisfaction (p < 0.05). The transection group presented slightly better discriminatory sensation in the flap and higher patient satisfaction. In addition, the duration of allachesthesia in the transection group was significantly shorter than that in the preservation group. CONCLUSION: In the repair of thumb pulp defects using a modified first dorsal metacarpal artery flap carrying the dorsal branches of the radial and ulnar proper digital nerves of the index finger, transecting the superficial branches of the radial nerve achieved better clinical outcome compared with preserving them. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
[Mh] Termos MeSH primário: Traumatismos dos Dedos/cirurgia
Transferência de Nervo/métodos
Nervo Radial/cirurgia
Procedimentos Cirúrgicos Reconstrutivos/métodos
Transtornos das Sensações/cirurgia
Retalhos Cirúrgicos/irrigação sanguínea
[Mh] Termos MeSH secundário: Adolescente
Adulto
Feminino
Seres Humanos
Masculino
Meia-Idade
Estudos Retrospectivos
Transtornos das Sensações/etiologia
Polegar/cirurgia
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170918
[Lr] Data última revisão:
170918
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170826
[St] Status:MEDLINE
[do] DOI:10.1097/PRS.0000000000003582


  7 / 4522 MEDLINE  
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[PMID]:28809659
[Au] Autor:Beaudry-Bellefeuille I; Lane SJ
[Ad] Endereço:Isabelle Beaudry-Bellefeuille, MScOT, is PhD Candidate, University of Newcastle, School of Health Sciences, Callaghan, New South Wales, Australia, and Occupational Therapist, private practice, Oviedo, Spain. At the time of the study, she was MOT Student, Virginia Commonwealth University, Richmond; ibbergo@gmail.com.
[Ti] Título:Examining Sensory Overresponsiveness in Preschool Children With Retentive Fecal Incontinence.
[So] Source:Am J Occup Ther;71(5):7105220020p1-7105220020p8, 2017 Sep/Oct.
[Is] ISSN:0272-9490
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The development of bowel control is an important activity of daily living in early childhood, and challenges in this area can limit participation in key occupations. Retentive fecal incontinence (RFI) is a common disorder in children. Up to 50% of children do not respond adequately to initial medical intervention, and behaviors around toileting, some related to sensory overresponsivity (SOR), may be partly responsible. Therefore, this study investigated the relationship between RFI and SOR and also examined the discriminative validity of the Toileting Habit Profile Questionnaire (THPQ). Per parent report, children with RFI (n = 16) showed significantly more behaviors related to SOR compared with typically developing children (n = 27). In addition, results indicated that the THPQ effectively discriminates between children with RFI and typically developing children. Results are discussed regarding RFI and SOR, the impact of RFI on childhood occupational engagement, and the role of occupational therapy with this population.
[Mh] Termos MeSH primário: Constipação Intestinal/fisiopatologia
Incontinência Fecal/fisiopatologia
Transtornos das Sensações/fisiopatologia
[Mh] Termos MeSH secundário: Estudos de Casos e Controles
Pré-Escolar
Constipação Intestinal/complicações
Incontinência Fecal/complicações
Incontinência Fecal/diagnóstico
Feminino
Seres Humanos
Masculino
Terapia Ocupacional
Transtornos das Sensações/complicações
Transtornos das Sensações/diagnóstico
Inquéritos e Questionários
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171102
[Lr] Data última revisão:
171102
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170816
[St] Status:MEDLINE
[do] DOI:10.5014/ajot.2017.022707


  8 / 4522 MEDLINE  
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[PMID]:28759596
[Au] Autor:Rando-Matos Y; Pons-Vigués M; López MJ; Córdoba R; Ballve-Moreno JL; Puigdomènech-Puig E; Benito-López VE; Arias-Agudelo OL; López-Grau M; Guardia-Riera A; Trujillo JM; Martin-Cantera C
[Ad] Endereço:Centre d'Atenció Primària (CAP) Florida Nord. Gerència d'Àmbit d'Atenció Primària Metropolitana Sud, Institut Català de la Salut (ICS), Hospitalet de Llobregat, Barcelona, Spain.
[Ti] Título:Smokefree legislation effects on respiratory and sensory disorders: A systematic review and meta-analysis.
[So] Source:PLoS One;12(7):e0181035, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:AIMS: The aim of this systematic review and meta-analysis is to synthesize the available evidence in scientific papers of smokefree legislation effects on respiratory diseases and sensory and respiratory symptoms (cough, phlegm, red eyes, runny nose) among all populations. MATERIALS AND METHODS: Systematic review and meta-analysis were carried out. A search between January 1995 and February 2015 was performed in PubMed, EMBASE, Cochrane Library, Scopus, Web of Science, and Google Scholar databases. Inclusion criteria were: 1) original scientific studies about smokefree legislation, 2) Data before and after legislation were collected, and 3) Impact on respiratory and sensory outcomes were assessed. Paired reviewers independently carried out the screening of titles and abstracts, data extraction from full-text articles, and methodological quality assessment. RESULTS: A total number of 1606 papers were identified. 50 papers were selected, 26 were related to symptoms (23 concerned workers). Most outcomes presented significant decreases in the percentage of people suffering from them, especially in locations with comprehensive measures and during the immediate post-ban period (within the first six months). Four (50%) of the papers concerning pulmonary function reported some significant improvement in expiratory parameters. Significant decreases were described in 13 of the 17 papers evaluating asthma hospital admissions, and there were fewer significant reductions in chronic obstructive pulmonary disease admissions (range 1-36%) than for asthma (5-31%). Six studies regarding different respiratory diseases showed discrepant results, and four papers about mortality reported significant declines in subgroups. Low bias risk was present in 23 (46%) of the studies. CONCLUSIONS: Smokefree legislation appears to improve respiratory and sensory symptoms at short term in workers (the overall effect being greater in comprehensive smokefree legislation in sensory symptoms) and, to a lesser degree, rates of hospitalization for asthma.
[Mh] Termos MeSH primário: Doença Pulmonar Obstrutiva Crônica/prevenção & controle
Transtornos Respiratórios/prevenção & controle
Transtornos das Sensações/prevenção & controle
Fumar/legislação & jurisprudência
[Mh] Termos MeSH secundário: Asma/prevenção & controle
Tosse
Expiração
Promoção da Saúde/legislação & jurisprudência
Hospitalização
Seres Humanos
Admissão do Paciente
Espirometria
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; REVIEW
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171017
[Lr] Data última revisão:
171017
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170801
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0181035


  9 / 4522 MEDLINE  
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[PMID]:28661377
[Au] Autor:Silverman F; Tyszka AC
[Ad] Endereço:Fern Silverman, EdD, OTR/L, is Associate Professor and Doctoral Program Director, Department of Occupational Therapy, College of Education and Rehabilitation, Salus University, Elkins Park, PA; fsilverman@salus.edu.
[Ti] Título:Supporting Participation for Children With Sensory Processing Needs and Their Families: Community-Based Action Research.
[So] Source:Am J Occup Ther;71(4):7104100010p1-7104100010p9, 2017 Jul/Aug.
[Is] ISSN:0272-9490
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: This qualitative study was part of efforts to develop and analyze specialized sensory-friendly, community-based programming at a local museum for families with children or young adults with sensory processing issues. METHOD: A qualitative, descriptive framework was used, aimed at uncovering the experience of families in attendance. Using convenience sampling, 46 participants were recruited from six separate cohorts of parents across a 1.5-yr period, using a community-based action research approach. RESULTS: Survey and interview data suggest that specialized programs with appropriate modifications in place improved the quality and the duration of museum visits for families with children or young adults with sensory processing needs, promoting both participation and well-being. CONCLUSION: Adapted community events that increase participation in context may be a promising intervention to support well-being for people with disabilities and their families.
[Mh] Termos MeSH primário: Transtorno do Espectro Autista
Participação da Comunidade
Museus
Pais
Transtornos das Sensações
[Mh] Termos MeSH secundário: Adolescente
Criança
Pré-Escolar
Feminino
Pesquisa sobre Serviços de Saúde
Seres Humanos
Masculino
Avaliação de Programas e Projetos de Saúde
Pesquisa Qualitativa
Participação Social
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171102
[Lr] Data última revisão:
171102
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170630
[St] Status:MEDLINE
[do] DOI:10.5014/ajot.2017.025544


  10 / 4522 MEDLINE  
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[PMID]:28651929
[Au] Autor:Harrington KJ; Ferris RL; Blumenschein G; Colevas AD; Fayette J; Licitra L; Kasper S; Even C; Vokes EE; Worden F; Saba NF; Kiyota N; Haddad R; Tahara M; Grünwald V; Shaw JW; Monga M; Lynch M; Taylor F; DeRosa M; Morrissey L; Cocks K; Gillison ML; Guigay J
[Ad] Endereço:Royal Marsden NHS Foundation Trust/The Institute of Cancer Research, London, UK. Electronic address: kevin.harrington@icr.ac.uk.
[Ti] Título:Nivolumab versus standard, single-agent therapy of investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised, phase 3 trial.
[So] Source:Lancet Oncol;18(8):1104-1115, 2017 Aug.
[Is] ISSN:1474-5488
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck have few treatment options and poor prognosis. Nivolumab significantly improved survival of this patient population when compared with standard single-agent therapy of investigator's choice in Checkmate 141; here we report the effect of nivolumab on patient-reported outcomes (PROs). METHODS: CheckMate 141 was a randomised, open-label, phase 3 trial in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who progressed within 6 months after platinum-based chemotherapy. Patients were randomly assigned (2:1) to nivolumab 3 mg/kg every 2 weeks (n=240) or investigator's choice (n=121) of methotrexate (40-60 mg/m of body surface area), docetaxel (30-40 mg/m ), or cetuximab (250 mg/m after a loading dose of 400 mg/m ) until disease progression, intolerable toxicity, or withdrawal of consent. On Jan 26, 2016, the independent data monitoring committee reviewed the data at the planned interim analysis and declared overall survival superiority for nivolumab over investigator's choice therapy (primary endpoint; described previously). The protocol was amended to allow patients in the investigator's choice group to cross over to nivolumab. All patients not on active therapy are being followed for survival. As an exploratory endpoint, PROs were assessed at baseline, week 9, and every 6 weeks thereafter using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30), the EORTC head and neck cancer-specific module (EORTC QLQ-H&N35), and the three-level European Quality of Life-5 Dimensions (EQ-5D) questionnaire. Differences within and between treatment groups in PROs were analysed by ANCOVA among patients with baseline and at least one other assessment. All randomised patients were included in the time to clinically meaningful deterioration analyses. Median time to clinically meaningful deterioration was analysed by Kaplan-Meier methods. CheckMate 141 was registered with ClinicalTrials.org, number NCT02105636. FINDINGS: Patients were enrolled between May 29, 2014, and July 31, 2015, and subsequently 361 patients were randomly assigned to receive nivolumab (n=240) or investigator's choice (n=121). Among them, 129 patients (93 in the nivolumab group and 36 in the investigator's choice group) completed any of the PRO questionnaires at baseline and at least one other assessment. Treatment with nivolumab resulted in adjusted mean changes from baseline to week 15 ranging from -2·1 to 5·4 across functional and symptom domains measured by the EORTC QLQ-C30, with no domains indicating clinically meaningful deterioration. By contrast, eight (53%) of the 15 domains in the investigator's choice group showed clinically meaningful deterioration (10 points or more) at week 15 (change from baseline range, -24·5 to 2·4). Similarly, on the EORTC QLQ-H&N35, clinically meaningful worsening at week 15 was seen in no domains in the nivolumab group and eight (44%) of 18 domains in the investigator's choice group. Patients in the nivolumab group had a clinically meaningful improvement (according to a difference of 7 points or greater) in adjusted mean change from baseline to week 15 on the EQ-5D visual analogue scale, in contrast to a clinically meaningful deterioration in the investigator's choice group (7·3 vs -7·8). Differences between groups were significant and clinically meaningful at weeks 9 and 15 in favour of nivolumab for role functioning, social functioning, fatigue, dyspnoea, and appetite loss on the EORTC QLQ-C30 and pain and sensory problems on the EORTC QLQ-H&N35. Median time to deterioration was significantly longer with nivolumab versus investigator's choice for 13 (37%) of 35 domains assessed across the three questionnaires. INTERPRETATION: In this exploratory analysis of CheckMate 141, nivolumab stabilised symptoms and functioning from baseline to weeks 9 and 15, whereas investigator's choice led to clinically meaningful deterioration. Nivolumab delayed time to deterioration of patient-reported quality-of-life outcomes compared with single-agent therapy of investigator's choice in patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck. In view of the major unmet need in this population and the importance of maintaining or improving quality of life for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, these data support nivolumab as a new standard-of-care option in this setting. FUNDING: Bristol-Myers Squibb.
[Mh] Termos MeSH primário: Anticorpos Monoclonais/uso terapêutico
Antineoplásicos/uso terapêutico
Carcinoma de Células Escamosas/tratamento farmacológico
Neoplasias de Cabeça e Pescoço/tratamento farmacológico
Recidiva Local de Neoplasia/tratamento farmacológico
Qualidade de Vida
[Mh] Termos MeSH secundário: Anorexia/etiologia
Carcinoma de Células Escamosas/complicações
Carcinoma de Células Escamosas/secundário
Cetuximab/uso terapêutico
Progressão da Doença
Dispneia/etiologia
Fadiga/etiologia
Neoplasias de Cabeça e Pescoço/complicações
Neoplasias de Cabeça e Pescoço/patologia
Seres Humanos
Estimativa de Kaplan-Meier
Metotrexato/uso terapêutico
Recidiva Local de Neoplasia/complicações
Dor/etiologia
Medidas de Resultados Relatados pelo Paciente
Transtornos das Sensações/etiologia
Participação Social
Taxoides/uso terapêutico
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Antineoplastic Agents); 0 (Taxoids); 15H5577CQD (docetaxel); 31YO63LBSN (nivolumab); PQX0D8J21J (Cetuximab); YL5FZ2Y5U1 (Methotrexate)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170919
[Lr] Data última revisão:
170919
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170628
[St] Status:MEDLINE



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