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[PMID]:28463152
[Au] Autor:Yang DD; Muralidhar V; Mahal BA; Labe SA; Nezolosky MD; Vastola ME; King MT; Martin NE; Orio PF; Choueiri TK; Trinh QD; Spratt DE; Hoffman KE; Feng FY; Nguyen PL
[Ad] Endereço:Harvard Medical School, Boston, Massachusetts.
[Ti] Título:National Trends and Predictors of Androgen Deprivation Therapy Use in Low-Risk Prostate Cancer.
[So] Source:Int J Radiat Oncol Biol Phys;98(2):338-343, 2017 06 01.
[Is] ISSN:1879-355X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: Androgen deprivation therapy (ADT) is not recommended for low-risk prostate cancer because of its lack of benefit and potential for harm. We evaluated the incidence and predictors of ADT use in low-risk disease. METHODS AND MATERIALS: Using the National Cancer Database, we identified 197,957 patients with low-risk prostate cancer (Gleason score of 3 + 3 = 6, prostate-specific antigen level <10 ng/mL, and cT1-T2a) diagnosed from 2004 to 2012 with complete demographic and treatment information. We used multiple logistic regression to evaluate predictors of ADT use and Cox regression to examine its association with all-cause mortality. RESULTS: Overall ADT use decreased from 17.6% in 2004 to 3.5% in 2012. In 2012, 11.5% of low-risk brachytherapy patients and 7.6% of external beam radiation therapy patients received ADT. Among 82,352 irradiation-managed patients, predictors of ADT use included treatment in a community versus academic cancer program (adjusted odds ratio [AOR], 1.60; 95% confidence interval [CI], 1.50-1.71; P<.001; incidence, 14.0% vs 6.0% in 2012); treatment in the South (AOR, 1.51), Midwest (AOR, 1.81), or Northeast (AOR, 1.90) versus West (P<.001); and brachytherapy use versus external beam radiation therapy (AOR, 1.32; 95% CI, 1.27-1.37; P<.001). Among 25,196 patients who did not receive local therapy, predictors of primary ADT use included a Charlson-Deyo comorbidity score of ≥2 versus 0 (AOR, 1.42; 95% CI, 1.06-1.91; P=.018); treatment in a community versus academic cancer program (AOR, 1.61; 95% CI, 1.37-1.90; P<.001); and treatment in the South (AOR, 1.26), Midwest (AOR, 1.52), or Northeast (AOR, 1.28) versus West (P≤.008). Primary ADT use was associated with increased all-cause mortality in patients who did not receive local therapy (adjusted hazard ratio, 1.28; 95% CI, 1.14-1.43; P<.001) after adjustment for age and comorbidity. CONCLUSIONS: ADT use in low-risk prostate cancer has declined nationally but may remain an issue of concern in certain populations and regions.
[Mh] Termos MeSH primário: Antagonistas de Androgênios/uso terapêutico
Neoplasias da Próstata/tratamento farmacológico
[Mh] Termos MeSH secundário: Centros Médicos Acadêmicos/estatística & dados numéricos
Centros Médicos Acadêmicos/tendências
Adulto
Idoso
Idoso de 80 Anos ou mais
Braquiterapia/utilização
Institutos de Câncer/estatística & dados numéricos
Institutos de Câncer/tendências
Centros Comunitários de Saúde/estatística & dados numéricos
Centros Comunitários de Saúde/tendências
Crioterapia/utilização
Bases de Dados Factuais/estatística & dados numéricos
Seres Humanos
Modelos Logísticos
Masculino
Meia-Idade
National Cancer Institute (U.S.)/estatística & dados numéricos
Gradação de Tumores
Modelos de Riscos Proporcionais
Prostatectomia/utilização
Neoplasias da Próstata/epidemiologia
Neoplasias da Próstata/radioterapia
Neoplasias da Próstata/cirurgia
Radioterapia/utilização
Risco
Estados Unidos/epidemiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Androgen Antagonists)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170503
[St] Status:MEDLINE


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[PMID]:29233280
[Au] Autor:Amerine LB; Valgus JM; Moore JD; Arnall JR; Savage SW
[Ad] Endereço:University of North Carolina Medical Center, Division of PACE, UNC Eshelman School of Pharmacy, 101 Manning Dr., CB #7600, Chapel Hill, NC 27514, United States. Electronic address: lindsey.amerine@unchealth.unc.edu.
[Ti] Título:Implementation of a longitudinal early immersion student pharmacist health system internship program.
[So] Source:Curr Pharm Teach Learn;9(3):421-426, 2017 May.
[Is] ISSN:1877-1300
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: The initiation, implementation, and benefits of a longitudinal early immersion student pharmacist health system internship are described. EDUCATIONAL ACTIVITY: A two-year longitudinal internship experience was implemented to provide exposure into distributional operations, direct patient care activities, and health-system pharmacy administration. The intent of the program was to create an opportunity for student pharmacists to enhance the quality of their education with practical experience by immersing them early in their careers within the healthcare system. Early in their academic training the student interns were exposed to a broad range of services and programs while contributing longitudinally to the service line through quality improvement projects and distributional operations. The first year primarily focuses on distributional operations with direct patient care shadowing, while the second year targets intern involvement in hematology/oncology direct patient care activities. In this role, they are able to serve as pharmacist extenders. SUMMARY: Our comprehensive, longitudinal two-year health-system pharmacy internship program offers student pharmacists a unique early immersion experience that builds upon itself throughout their didactic training but is outside of the academic requirements. Students are exposed to distributional operations, direct patient care activities, and health system pharmacy administration prior to APPE rotations.
[Mh] Termos MeSH primário: Sistemas de Medicação no Hospital
Assistência ao Paciente
Administração Farmacêutica
Residências em Farmácia/organização & administração
Desenvolvimento de Programas
[Mh] Termos MeSH secundário: Institutos de Câncer
Seres Humanos
Residências em Farmácia/métodos
Serviço de Farmácia Hospitalar
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180214
[Lr] Data última revisão:
180214
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171214
[St] Status:MEDLINE


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[PMID]:29243869
[Au] Autor:Carpén O; Helander T
[Ti] Título:Biobanks and Comprehensive Cancer Center Finland (FICAN) as institutions enabling clinical drug testing.
[So] Source:Duodecim;133(6):592-8, 2017.
[Is] ISSN:0012-7183
[Cp] País de publicação:Finland
[La] Idioma:eng
[Ab] Resumo:Clinical trials aiming at developing targeted drug therapies require the identification of appropriate patient groups, utilizing both clinical information and the biological profile of the disease. The Finnish healthcare system provides exceptional possibilities for utilizing health data in identifying patient groups, planning of clinical sample studies and recruiting patients. Biobanks established at university hospitals together with the regional cancer centers play a central role in collecting biological specimens and attaching health data to the specimens. Combined with longitudinal health data, the collections of tissue specimens obtained in connection with the diagnosis offer versatile possibilities for the development of companion diagnostics of targeted drugs. Specimens collected on the basis of informed consent in connection with diagnosis and treatment enable the identification of patients suitable for drug trials, and a contact according to the consent. In the development of new functions, national collaboration - both geographical and between research infrastuctures - becomes of paramount importance. Combining the resources of biobanks, the genome strategy and the Comprehensive Cancer Center, an enabling legislation and, above all, patients with a positive attitude towards examinations, offer excellent possibilities for Finland to become the model country of individualized treatment.
[Mh] Termos MeSH primário: Bancos de Espécimes Biológicos
Institutos de Câncer/organização & administração
Ensaios Clínicos como Assunto
Neoplasias/tratamento farmacológico
[Mh] Termos MeSH secundário: Finlândia
Seres Humanos
Consentimento Livre e Esclarecido
Seleção de Pacientes
Medicina de Precisão
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180115
[Lr] Data última revisão:
180115
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171216
[St] Status:MEDLINE


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[PMID]:29215513
[Au] Autor:Pal N; Broaddus RR; Urbauer DL; Balakrishnan N; Milbourne A; Schmeler KM; Meyer LA; Soliman PT; Lu KH; Ramirez PT; Ramondetta L; Bodurka DC; Westin SN
[Ad] Endereço:Department of Gynecologic Oncology and Reproductive Medicine and the Division of Quantitative Sciences, University of Texas MD Anderson Cancer Center, Houston, Texas.
[Ti] Título:Treatment of Low-Risk Endometrial Cancer and Complex Atypical Hyperplasia With the Levonorgestrel-Releasing Intrauterine Device.
[So] Source:Obstet Gynecol;131(1):109-116, 2018 Jan.
[Is] ISSN:1873-233X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To assess efficacy of the levonorgestrel-releasing intrauterine device (LNG-IUD) for treatment of complex atypical hyperplasia or low-grade endometrial cancer. METHODS: This retrospective case series included all patients treated with the LNG-IUD for complex atypical hyperplasia or early-grade endometrial cancer from January 2003 to June 2013. Response rates were calculated and the association of response with clinicopathologic factors, including age, body mass index, and uterine size, was determined. RESULTS: Forty-six patients diagnosed with complex atypical hyperplasia or early-grade endometrial cancer were treated with the LNG-IUD. Of 32 evaluable patients at the 6-month time point, 15 had complex atypical hyperplasia (47%), nine had G1 endometrial cancer (28%), and eight had grade 2 endometrial cancer (25%). Overall response rate was 75% (95% CI 57-89) at 6 months; 80% (95% CI 52-96) in complex atypical hyperplasia, 67% (95% CI 30-93) in grade 1 endometrial cancer, and 75% (CI 35-97) in grade 2 endometrial cancer. Of the clinicopathologic features evaluated, there was a trend toward the association of lack of exogenous progesterone effect in the pathology specimen with nonresponse to the IUD (P=.05). Median uterine diameter was 1.3 cm larger in women who did not respond to the IUD (P=.04). CONCLUSION: Levonorgestrel-releasing IUD therapy for the conservative treatment of complex atypical hyperplasia or early-grade endometrial cancer resulted in return to normal histology in a majority of patients.
[Mh] Termos MeSH primário: Hiperplasia Endometrial/tratamento farmacológico
Hiperplasia Endometrial/patologia
Neoplasias do Endométrio/tratamento farmacológico
Neoplasias do Endométrio/patologia
Dispositivos Intrauterinos Medicados
Levanogestrel/administração & dosagem
[Mh] Termos MeSH secundário: Adulto
Biópsia por Agulha
Institutos de Câncer
Estudos de Coortes
Progressão da Doença
Feminino
Seres Humanos
Imuno-Histoquímica
Meia-Idade
Invasividade Neoplásica/patologia
Estadiamento de Neoplasias
Lesões Pré-Cancerosas/tratamento farmacológico
Lesões Pré-Cancerosas/patologia
Estudos Retrospectivos
Medição de Risco
Texas
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
5W7SIA7YZW (Levonorgestrel)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180108
[Lr] Data última revisão:
180108
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171208
[St] Status:MEDLINE
[do] DOI:10.1097/AOG.0000000000002390


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[PMID]:28458120
[Au] Autor:Kempf E; Tournigand C; Rochigneux P; Aubry R; Morin L
[Ad] Endereço:AP-HP, Henri Mondor University Hospital, Medical Oncology Department, 51 avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France.
[Ti] Título:Discrepancies in the use of chemotherapy and artificial nutrition near the end of life for hospitalised patients with metastatic gastric or oesophageal cancer. A countrywide, register-based study.
[So] Source:Eur J Cancer;79:31-40, 2017 07.
[Is] ISSN:1879-0852
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:AIM: To evaluate the frequency and the factors associated with the use of chemotherapy and artificial nutrition near the end of life in hospitalised patients with metastatic oesophageal or gastric cancer. METHODS: Nationwide, register-based study, including all hospitalised adults (≥20 years) who died with metastatic oesophageal or gastric cancer between 2010 and 2013, in France. Chemotherapy and artificial nutrition during the final weeks of life were considered as primary outcomes. RESULTS: A total of 4031 patients with oesophageal cancer and 10,423 patients with gastric cancer were included. While the proportion of patients receiving chemotherapy decreased from 35.9% during the 3rd month before death to 7.9% in the final week (p < 0.001 for trend), the use of artificial nutrition rose from 9.6% to 16.0% of patients. During the last week before death, patients with stomach cancer were more likely to receive chemotherapy (adjusted odds ratio (aOR) = 1.35, 95% CI = 1.17-1.56) but less likely to receive artificial nutrition (aOR = 0.80, 95%CI = 0.73-0.88) than patients with cancer of the oesophagus. The adjusted rates of chemotherapy use during the last week of life varied from 1.6% in rural hospitals to 11.2% in comprehensive cancer centres, while the adjusted probability to receive artificial nutrition varied from 12.1% in private for-profit clinics up to 19.9% in rehabilitation care facilities (p < 0.001). CONCLUSIONS: Our study shows that in hospitalised patients with metastatic oesophageal or gastric cancer, the use of chemotherapy decreases while the use of artificial nutrition increases as death approaches. This raises important questions, as clinical guidelines clearly recommend to limit the use of artificial nutrition in contexts of limited life expectancy.
[Mh] Termos MeSH primário: Antineoplásicos/uso terapêutico
Neoplasias Esofágicas/terapia
Apoio Nutricional/utilização
Neoplasias Gástricas/terapia
[Mh] Termos MeSH secundário: Adulto
Idoso
Idoso de 80 Anos ou mais
Institutos de Câncer/estatística & dados numéricos
Feminino
França
Hospitalização/estatística & dados numéricos
Hospitais Urbanos/estatística & dados numéricos
Seres Humanos
Masculino
Meia-Idade
Metástase Neoplásica
Estado Nutricional
Sistema de Registros
Estudos Retrospectivos
Saúde da População Rural/estatística & dados numéricos
Assistência Terminal/métodos
Assistência Terminal/estatística & dados numéricos
Saúde da População Urbana/estatística & dados numéricos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171230
[Lr] Data última revisão:
171230
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170502
[St] Status:MEDLINE


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[PMID]:28942077
[Au] Autor:Yendamuri S; Battoo A; Dy G; Chen H; Gomez J; Singh AK; Hennon M; Nwogu CE; Dexter EU; Huang M; Picone A; Demmy TL
[Ad] Endereço:Department of Thoracic Surgery, Roswell Park Cancer Institute, Buffalo, New York; Department of Surgery, Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York. Electronic address: sai.yendamuri@roswellpark.org.
[Ti] Título:Transcervical Extended Mediastinal Lymphadenectomy: Experience From a North American Cancer Center.
[So] Source:Ann Thorac Surg;104(5):1644-1649, 2017 Nov.
[Is] ISSN:1552-6259
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Accurate staging of the mediastinum is a critical element of therapeutic decision making in non-small cell lung cancer. We sought to determine the utility of transcervical extended mediastinal lymphadenectomy (TEMLA) in staging non-small cell lung cancer for large central tumors and after induction therapy. METHODS: A retrospective record review was performed of all patients who underwent TEMLA at our institution from 2010 to 2015. Clinical stage as assessed by positron emission tomography integrated with computed tomography (PET-CT), stage as assessed by TEMLA, final pathologic stage, lymph node yield, and clinical characteristics of tumors were assessed along with TEMLA-related perioperative morbidity. Accuracy of staging by TEMLA for restaging the mediastinum after neoadjuvant therapy was compared with that of PET-CT. RESULTS: Of 164 patients who underwent TEMLA, 157 (95.7%) were completed successfully. Combined surgical resection along with TEMLA was performed in 138 of these patients, with 131 (94.2%) undergoing a video-assisted thoracoscopic resection. The recurrent laryngeal nerve injury rate was 6.7%. TEMLA was performed in 118 of 164 patients for restaging after neoadjuvant therapy, and 101 of these patients were also restaged by PET-CT. Based on TEMLA, 7 patients did not go on to have resection. Of the 101 patients who did have a resection, TEMLA was more accurate than PET-CT in staging the mediastinum (95% vs 73%, p < 0.0001). However, the pneumonia rate in this subgroup of patients was 13%. CONCLUSIONS: TEMLA is a safe procedure and superior to PET-CT for restaging of the mediastinum after neoadjuvant therapy for non-small cell lung cancer. However, this increased accuracy comes with a high postoperative pneumonia rate.
[Mh] Termos MeSH primário: Carcinoma Pulmonar de Células não Pequenas/patologia
Carcinoma Pulmonar de Células não Pequenas/cirurgia
Neoplasias Pulmonares/patologia
Neoplasias Pulmonares/cirurgia
Excisão de Linfonodo/métodos
Linfonodos/patologia
[Mh] Termos MeSH secundário: Adulto
Idoso
Institutos de Câncer
Carcinoma Pulmonar de Células não Pequenas/mortalidade
Estudos de Coortes
Endossonografia/métodos
Feminino
Seres Humanos
Neoplasias Pulmonares/mortalidade
Metástase Linfática
Masculino
Mediastino/patologia
Mediastino/cirurgia
Meia-Idade
Invasividade Neoplásica/patologia
Estadiamento de Neoplasias
América do Norte
Tomografia Computadorizada com Tomografia por Emissão de Pósitrons/métodos
Prognóstico
Estudos Retrospectivos
Medição de Risco
Análise de Sobrevida
Cirurgia Torácica Vídeoassistida/métodos
Resultado do Tratamento
[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:170925
[St] Status:MEDLINE


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[PMID]:28885712
[Au] Autor:Blum Murphy M; Xiao L; Patel VR; Maru DM; Correa AM; G Amlashi F; Liao Z; Komaki R; Lin SH; Skinner HD; Vaporciyan A; Walsh GL; Swisher SG; Sepesi B; Lee JH; Bhutani MS; Weston B; Hofstetter WL; Ajani JA
[Ad] Endereço:Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
[Ti] Título:Pathological complete response in patients with esophageal cancer after the trimodality approach: The association with baseline variables and survival-The University of Texas MD Anderson Cancer Center experience.
[So] Source:Cancer;123(21):4106-4113, 2017 Nov 01.
[Is] ISSN:1097-0142
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Reports are limited regarding clinical and pretreatment features that might predict a pathological complete response (pathCR) after treatment in patients with esophageal cancer (EC). This might allow patient selection for different strategies. This study examines the association of a pathCR with pretreatment variables, overall survival (OS), recurrence-free survival (RFS), and patterns of recurrence in a large cohort from a single institution. METHODS: The baseline clinical features of 911 consecutive patients with EC who were treated with trimodality therapy from January 2000 to November 2013 were analyzed. A pathCR was defined as a surgical specimen with no residual carcinoma (primary or nodes). Logistic regressions were used to identify independent baseline features associated with a pathCR. We applied log-rank testing and Cox models to determine the association between a pathCR and the time-to-event outcomes (OS and RFS). RESULTS: Of 911 patients, 218 (23.9%) achieved a pathCR. The pathCR rate was 23.1% for adenocarcinoma and 32.2% for squamous cell carcinoma. A lower pathCR rate was observed for 1) older patients (>60 years), 2) patients with poorly differentiated tumors, 3) patients with signet ring cells (SRCs), and 4) patients with a higher T stage. Patients with a pathCR had longer OS and RFS than those without a pathCR (P = .0021 and P = .0011, respectively). Recurrences occurred more in non-pathCR patients. Distant metastases were the most common type of recurrence. PathCR patients developed brain metastases at a marginally higher rate than non-pathCR patients (P = .051). CONCLUSIONS: In this large cohort study, a pathCR is confirmed to be associated with better OS and RFS. The presence of a poorly differentiated tumor or SRCs reduces the likelihood of a pathCR. Future research should focus on molecular classifiers. Cancer 2017;123:4106-4113. © 2017 American Cancer Society.
[Mh] Termos MeSH primário: Adenocarcinoma/mortalidade
Adenocarcinoma/patologia
Carcinoma de Células Escamosas/mortalidade
Carcinoma de Células Escamosas/patologia
Neoplasias Esofágicas/mortalidade
Neoplasias Esofágicas/patologia
[Mh] Termos MeSH secundário: Adenocarcinoma/secundário
Adenocarcinoma/terapia
Adulto
Idoso
Idoso de 80 Anos ou mais
Neoplasias Encefálicas/secundário
Institutos de Câncer
Carcinoma de Células Escamosas/secundário
Carcinoma de Células Escamosas/terapia
Quimiorradioterapia/métodos
Terapia Combinada/métodos
Intervalo Livre de Doença
Neoplasias Esofágicas/terapia
Feminino
Seres Humanos
Modelos Lineares
Masculino
Meia-Idade
Recidiva Local de Neoplasia/patologia
Estadiamento de Neoplasias
Indução de Remissão
Texas
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171030
[Lr] Data última revisão:
171030
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170909
[St] Status:MEDLINE
[do] DOI:10.1002/cncr.30953


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[PMID]:28884996
[Au] Autor:Fox M
[Ti] Título:CoC Chair Dr. Shulman works to improve quality of cancer care.
[So] Source:Bull Am Coll Surg;102(7):19-22, 2017 07.
[Is] ISSN:0002-8045
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Melhoria de Qualidade
Oncologia Cirúrgica/normas
[Mh] Termos MeSH secundário: Institutos de Câncer
Seres Humanos
Assistência Centrada no Paciente
Sociedades Médicas
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171010
[Lr] Data última revisão:
171010
[Sb] Subgrupo de revista:H
[Da] Data de entrada para processamento:170909
[St] Status:MEDLINE


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[PMID]:28870611
[Au] Autor:van Zandwijk N; Pavlakis N; Kao SC; Linton A; Boyer MJ; Clarke S; Huynh Y; Chrzanowska A; Fulham MJ; Bailey DL; Cooper WA; Kritharides L; Ridley L; Pattison ST; MacDiarmid J; Brahmbhatt H; Reid G
[Ad] Endereço:Asbestos Diseases Research Institute, Sydney, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia. Electronic address: nico.vanzandwijk@sydney.edu.au.
[Ti] Título:Safety and activity of microRNA-loaded minicells in patients with recurrent malignant pleural mesothelioma: a first-in-man, phase 1, open-label, dose-escalation study.
[So] Source:Lancet Oncol;18(10):1386-1396, 2017 Oct.
[Is] ISSN:1474-5488
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: TargomiRs are minicells (EnGeneIC Dream Vectors) loaded with miR-16-based mimic microRNA (miRNA) and targeted to EGFR that are designed to counteract the loss of the miR-15 and miR-16 family miRNAs, which is associated with unsuppressed tumour growth in preclinical models of malignant pleural mesothelioma. We aimed to assess the safety, optimal dosing, and activity of TargomiRs in patients with malignant pleural mesothelioma. METHODS: In this first-in-man, open-label, dose-escalation phase 1 trial at three major cancer centres in Sydney (NSW, Australia), we recruited adults (aged ≥18 years) with a confirmed diagnosis of malignant pleural mesothelioma, measurable disease, radiological signs of progression after previous chemotherapy, Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of 3 months or more, immunohistochemical evidence of tumour EGFR expression, and adequate bone marrow, liver, and renal function. Patients were given TargomiRs via 20 min intravenous infusion either once or twice a week (3 days apart) in a traditional 3 + 3 dose-escalation design in five dose cohorts. The dose-escalation steps planned were 5 × 10 , 7 × 10 , and 9 × 10 TargomiRs either once or twice weekly, but after analysis of data from the first eight patients, all subsequent patients started protocol treatment at 1 × 10 TargomiRs. The primary endpoints were to establish the maximum tolerated dose of TargomiRs as measured by dose-limiting toxicity, define the optimal frequency of administration, and objective response (defined as the percentage of assessable patients with a complete or partial response), duration of response (defined as time from the first evidence of response to disease progression in patients who achieved a response), time to response (ie, time from start of treatment to the first evidence of response) and overall survival (defined as time from treatment allocation to death from any cause). Analyses were based on the full analysis set principle, including every patient who received at least one dose of TargomiRs. The study was closed for patient entry on Jan 3, 2017, and registered with ClinicalTrials.gov, number NCT02369198, and the Australian Registry of Clinical Trials, number ACTRN12614001248651. FINDINGS: Between Sept 29, 2014, and Nov 24, 2016, we enrolled 27 patients, 26 of whom received at least one TargomiR dose (one patient died before beginning treatment). Overall, five dose-limiting toxicities were noted: infusion-related inflammatory symptoms and coronary ischaemia, respectively, in two patients given 5 × 10 TargomiRs twice weekly; anaphylaxis and cardiomyopathy, respectively, in two patients given 5 × 10 TargomiRs once weekly but who received reduced dexamethasone prophylaxis; and non-cardiac pain in one patient who received 5 × 10 TargomiRs once weekly. We established that 5 × 10 TargomiRs once weekly was the maximum tolerated dose. TargomiR infusions were accompanied by transient lymphopenia (25 [96%] of 26 patients), temporal hypophosphataemia (17 [65%] of 26 patients), increased aspartate aminotransferase or alanine aminotranferase (six [23%] of 26 patients), and increased alkaline phosphatase blood concentrations (two [8%]). Cardiac events occurred in five patients: three patients had electrocardiographic changes, one patient had ischaemia, and one patient had Takotsubo cardiomyopathy. Of the 22 patients who were assessed for response by CT, one (5%) had a partial response, 15 (68%) had stable disease, and six (27%) had progressive disease. The proportion of patients who achieved an objective response was therefore one (5%) of 22, and the duration of the objective response in that patient was 32 weeks. Median overall survival was 200 days (95% CI 94-358). During the trial, 21 deaths occurred, of which 20 were related to tumour progression and one was due to bowel perforation. INTERPRETATION: The acceptable safety profile and early signs of activity of TargomiRs in patients with malignant pleural mesothelioma support additional studies of TargomiRs in combination with chemotherapy or immune checkpoint inhibitors. FUNDING: Asbestos Diseases Research Foundation.
[Mh] Termos MeSH primário: Neoplasias Pulmonares/tratamento farmacológico
Mesotelioma/tratamento farmacológico
MicroRNAs/administração & dosagem
Recidiva Local de Neoplasia/tratamento farmacológico
Segurança do Paciente
Neoplasias Pleurais/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Idoso
Austrália
Biópsia por Agulha
Institutos de Câncer
Intervalo Livre de Doença
Relação Dose-Resposta a Droga
Esquema de Medicação
Feminino
Seguimentos
Seres Humanos
Imuno-Histoquímica
Infusões Intravenosas
Estimativa de Kaplan-Meier
Neoplasias Pulmonares/diagnóstico por imagem
Neoplasias Pulmonares/mortalidade
Neoplasias Pulmonares/patologia
Masculino
Dose Máxima Tolerável
Mesotelioma/diagnóstico por imagem
Mesotelioma/mortalidade
Mesotelioma/patologia
Meia-Idade
Recidiva Local de Neoplasia/mortalidade
Recidiva Local de Neoplasia/patologia
Seleção de Pacientes
Neoplasias Pleurais/diagnóstico por imagem
Neoplasias Pleurais/mortalidade
Neoplasias Pleurais/patologia
Tomografia Computadorizada com Tomografia por Emissão de Pósitrons/métodos
Medição de Risco
Análise de Sobrevida
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE I; JOURNAL ARTICLE; MULTICENTER STUDY
[Nm] Nome de substância:
0 (MicroRNAs)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171012
[Lr] Data última revisão:
171012
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170906
[St] Status:MEDLINE


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[PMID]:28817185
[Au] Autor:Khera N; Holland JC; Griffin JM
[Ad] Endereço:Division of Hematology/Oncology, Mayo Clinic Phoenix, Phoenix, Arizona.
[Ti] Título:Setting the stage for universal financial distress screening in routine cancer care.
[So] Source:Cancer;123(21):4092-4096, 2017 Nov 01.
[Is] ISSN:1097-0142
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Financial burden from cancer treatment is increasingly being recognized as a threat to optimal access, quality, and outcomes of cancer care for patients. Although research in the area is moving at a fast pace, multiple questions remain unanswered, such as how to practically integrate the assessment and management of financial burden into routine health care delivery for patients with cancer. Although psychological distress screening for patients undergoing cancer treatment now is commonplace, the authors raise the provocative idea of universal screening for financial distress to identify and assist vulnerable groups of patients. Herein, the authors outline the arguments to support screening for financial burden in addition to psychological distress, examining it as an independent patient-reported outcome for all patients with cancer at various time points during their treatment. The authors describe the proximal and downstream impact of such a strategy and reflect on some challenges and potential solutions to help integrate this concept into routine cancer care delivery. Cancer 2017;123:4092-4096. © 2017 American Cancer Society.
[Mh] Termos MeSH primário: Efeitos Psicossociais da Doença
Financiamento Pessoal/economia
Neoplasias/economia
Neoplasias/psicologia
Estresse Psicológico/diagnóstico
Estresse Psicológico/economia
[Mh] Termos MeSH secundário: Acreditação
Antineoplásicos/economia
Institutos de Câncer
Custos de Medicamentos
Comportamentos Relacionados com a Saúde
Seres Humanos
Imunoterapia/economia
Neoplasias/terapia
Qualidade de Vida
Estresse Psicológico/terapia
Inquéritos e Questionários
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171030
[Lr] Data última revisão:
171030
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170818
[St] Status:MEDLINE
[do] DOI:10.1002/cncr.30940



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