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Breast ; 45: 36-42, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30826525


The primary aim of the international advance breast cancer (ABC) guidelines are to guide treatment decisions in many different healthcare settings, but need adaptations due to different access to care. These guidelines are based on the most up-to-date evidence. However, Chinese experts have a different national condition and policies to face. The Chinese Anti-Cancer Association Committee of Breast Cancer Society guideline (CBCS guideline) is to guide treatments and to reflect unmet needs of Chinese breast cancer patients. Although, most of the recommendations in the two guidelines are the same, some of them are different. In this article, with regard to country-specific peculiarities, a working group of Chinese breast cancer experts compare the similarities and differences between the ABC guideline and CBCS guideline and commented on the voting results of the ABC panelists. We also discuss why these differences exist, such as lack of access, different tumor biology and epidemiology, and even different culture. The money which patients have to pay out of pocket for their medical cost and the availability of drugs lie at the heart of the issues of guideline differences.

Protocolos Antineoplásicos/normas , Neoplasias da Mama , Guias de Prática Clínica como Assunto/normas , Sociedades Médicas/normas , China , Consenso , Feminino , Humanos
BMJ Open ; 8(10): e019505, 2018 10 18.
Artigo em Inglês | MEDLINE | ID: mdl-30341109


INTRODUCTION: Oral mucositis is an iatrogenic condition of erythematous inflammatory changes which tends to occur on buccal and labial surfaces, the ventral surface of the tongue, the floor of the mouth and the soft palate of patients receiving chemotherapy. This protocol of ongoing randomised parallel group clinical trial aims to access the therapeutic effect of an herbal gel containing 2.5% Arrabidaea chica Verlot standardised extract on oral mucositis in patients with head and neck cancer compared with low-level laser therapy. METHODS AND ANALYSIS: Patients with head and neck cancer held at Clinics Hospital of University of Campinas, Sao Paulo, who develop early signs/symptoms of oral mucositis are eligible. Baseline characteristics of participants include oral mucositis grade and quality of life assessments. Enrolment started in November 2017 with allocation of patients to one of the study groups by means of randomisation. Patients will be treated either with Arrabidaea chica or laser until wound healing. Monitoring includes daily assessment of mucositis grade and diameter measurement by photographs and millimetre periodontal probe. Treatments will be concluded once mucositis is healed. A blinded assessor will evaluate mucositis cure after referred by the study team. At this point, the gel tube will be weighed to indirectly assess patient's compliance. At close-out, data will be analysed by a blinded researcher following the procedures described in the statistical analyses. ETHICS AND DISSEMINATION: This clinical trial was approved by the ethics committee of research in humans at the Faculty of Medical Sciences of University of Campinas (report no. 1,613,563/2016). Results from this trial will be communicated in peer-reviewed publications and scientific presentations. TRIAL REGISTRATION NUMBER: RBR-5×4397.

Protocolos Antineoplásicos/normas , Bignoniaceae , Terapia com Luz de Baixa Intensidade/métodos , Extratos Vegetais/uso terapêutico , Estomatite/tratamento farmacológico , Feminino , Neoplasias de Cabeça e Pescoço/complicações , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto
Rev. esp. patol ; 51(3): 154-159, jul.-sept. 2018.
Artigo em Espanhol | IBECS | ID: ibc-179070


La medicina de precisión es un enfoque emergente para el tratamiento y prevención de las enfermedades que tiene en cuenta la variabilidad individual en los genes, el medio ambiente y el estilo de vida de cada persona. La medicina de precisión está transformando la investigación clínica y biomédica así como la asistencia sanitaria, tanto desde un punto de vista conceptual como metodológico, ofertando oportunidades extraordinarias para mejorar la salud pública y reducir los costes del sistema sanitario. Sin embargo, la implementación de la medicina de precisión supone un reto a nivel ético-legal, regulatorio, organizativo y de conocimiento. Sin una estrategia nacional, la medicina de precisión, que se implantará en cualquier caso, lo podría hacer sin la adecuada planificación que permita garantizar la calidad técnica, la equidad de los ciudadanos en el acceso a las mejores prácticas, vulnerando los derechos de pacientes y profesionales y arriesgando la solvencia del sistema de salud. Con este artículo de las sociedades españolas de Oncología Médica (SEOM), Anatomía Patológica (SEAP) y Farmacia Hospitalaria (SEFH), señalamos la necesidad de establecer una estrategia nacional consensuada para el desarrollo de la medicina de precisión en nuestro país, revisamos el contexto nacional e internacional, comentamos las oportunidades y los retos para la implementación de la medicina de precisión, y delineamos los objetivos de una estrategia nacional sobre medicina de precisión en cáncer

Precision medicine is an emerging approach to the prevention and treatment of disease that takes into account variability in genes, environment and lifestyle for each individual. Precision medicine is transforming clinical and biomedical research, as well as health care itself, from a conceptual, as well as a methodological viewpoint, providing extraordinary opportunities to improve public health and lower the costs of the healthcare system. However, the implementation of precision medicine poses ethical-legal, regulatory, organizational and knowledge-related challenges. Without a national strategy, precision medicine -which eventually will be implemented one way or another- could take place without the appropriate planning to guarantee technical quality and equal access to the best practices for all citizens, thus violating the rights of patients and professionals as well as jeopardizing the solvency of the healthcare system. This paper from the Spanish Societies of Medical Oncology (SEOM), Pathology (SEAP) and Hospital Pharmacy (SEFH), highlights the need to institute a consensual national strategy for the development of precision medicine in our country, reviews the national and international context, comments on the opportunities and challenges for implementing precision medicine and outlines the objectives of a national strategy on precision medicine in cancer

Humanos , Neoplasias/terapia , Protocolos Antineoplásicos/normas , Medicina de Precisão/métodos , Estratégias Nacionais , Padrões de Prática Médica , Conferências de Consenso como Assunto
Breast ; 40: 54-59, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29698925


OBJECTIVES: Certified multi-disciplinary breast cancer centres (CBCs) have been established worldwide. Development of CBCs, guideline-adherent systemic therapy and surgical management should now show an impact on outcomes. This analysis aimed to investigate whether guideline adherence (GA) rates, relapse-free survival (RFS) and overall survival (OS) have significantly improved at CBCs compared to the pre-certification period. MATERIALS AND METHODS: 8323 patients with primary breast cancer were treated in 17 German CBCs, which had been certified between 2003 and 2007 [2003 (n = 1), 2004 (n = 6), 2005 (n = 3), 2006 (n = 6) and 2007 (n = 1)]. 3544 patients (42.6%) were treated before certification and 4779 patients (57.4%) after certification. RESULTS AND CONCLUSION: A highly significant (p < 0.001) difference in 100%-GA was found between the various hospitals before certification (min 25.0%; max 54.6%). In 2008, when all participating hospitals were certified, the GA rate was 61.8% (min 39.5%, max 74.4%) and 69.2% (min 45.9%, max 86.4%) for patients <75 y (n = 6675). The difference between pre-certification 100%-GA (46.9%) and post-certification (57.2%) was highly significant (p < 0.001). RFS and OS were both significantly better after certification compared to the pre-certification period (RFS: HR = 0.79; 95% CI: 0.68-0.92; p = 0.003; OS: HR = 0.75; 95% CI: 0.65-0.85; p < 0.001). 5-year RFS (OS) of patients <75 y was 89.6% (85.4%) pre-certification and 91.4% (89.5%) post-certification. Since improvement in GA and outcomes correlated as well, GA remains a highly significant prognostic factor for RFS and OS regardless of NPI, intrinsic subtype and adjuvant systemic therapy. This suggests that the certification process is strongly associated with improvements in outcome.

Instituições de Assistência Ambulatorial/normas , Protocolos Antineoplásicos/normas , Neoplasias da Mama/mortalidade , Fidelidade a Diretrizes/estatística & dados numéricos , Melhoria de Qualidade/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/terapia , Certificação , Intervalo Livre de Doença , Feminino , Alemanha , Humanos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/mortalidade , Resultado do Tratamento , Adulto Jovem
PLoS One ; 13(3): e0193904, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29505589


In particle radiotherapy, range uncertainty is an important issue that needs to be overcome. Because high-dose conformality can be achieved using a particle beam, a small uncertainty can affect tumor control or cause normal-tissue complications. From this perspective, the treatment planning system (TPS) must be accurate. However, there is a well-known inaccuracy regarding dose computation in heterogeneous media. This means that verifying the uncertainty level is one of the prerequisites for TPS commissioning. We evaluated the range accuracy of the dose computation algorithm implemented in a commercial TPS, and Monte Carlo (MC) simulation against measurement using a CT calibration phantom. A treatment plan was produced for eight different materials plugged into a phantom, and two-dimensional doses were measured using a chamber array. The measurement setup and beam delivery were simulated by MC code. For an infinite solid water phantom, the gamma passing rate between the measurement and TPS was 97.7%, and that between the measurement and MC was 96.5%. However, gamma passing rates between the measurement and TPS were 49.4% for the lung and 67.8% for bone, and between the measurement and MC were 85.6% for the lung and 100.0% for bone tissue. For adipose, breast, brain, liver, and bone mineral, the gamma passing rates computed by TPS were 91.7%, 90.6%, 81.7%, 85.6%, and 85.6%, respectively. The gamma passing rates for MC for adipose, breast, brain, liver, and bone mineral were 100.0%, 97.2%, 95.0%, 98.9%, and 97.8%, respectively. In conclusion, the described procedure successfully evaluated the allowable range uncertainty for TPS commissioning. The TPS dose calculation is inefficient in heterogeneous media with large differences in density, such as lung or bone tissue. Therefore, the limitations of TPS in heterogeneous media should be understood and applied in clinical practice.

Protocolos Antineoplásicos/normas , Neoplasias/radioterapia , Terapia com Prótons , Algoritmos , Calibragem , Humanos , Método de Monte Carlo , Imagens de Fantasmas , Radiometria , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador/métodos , Radioterapia de Intensidade Modulada/métodos
J Neurooncol ; 136(1): 73-78, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28887756


Measures of treatment intensity for childhood cancer are needed in research in order to control for variability in treatments. Existing measures of treatment intensity for childhood cancers do not reflect the complexities of treatment protocols for central nervous system (CNS) tumors. This paper describes the development of the Pediatric Neuro-Oncology Rating of Treatment Intensity (PNORTI). PNORTI development occurred in three phases. Phase 1: five experts in pediatric neuro-oncology created a 5-point scale of treatment intensity and 42 pediatric neuro-oncology providers completed a three-part online questionnaire to evaluate the classification system and apply the rating system to 16 sample patients. Validity was determined by respondents classifying therapy modalities into intensity levels. Inter-rater reliability was calculated from ratings of the 16 sample patients. Phase 2: three experts revised the PNORTI based on survey results and 18 pediatric neuro-oncology providers evaluated the classification system. Phase 3: ten experts in pediatric neuro-oncology refined and finalized the PNORTI and rated 10 sample patients using the PNORTI. Agreement between median ratings of the survey respondents and criterion raters for chemotherapy intensity (r's = .82 and 1.0) and overall treatment intensity level (r's = .91 and .94) were high in Phases 1 and 2. Inter-rater reliability also was very high when using the PNORTI to classify the 16 sample patients in Phase 1 (median agreement of r = .93 and rICC = .99) and the 10 sample patients in Phase 3 (median agreement of r = .92 and rICC = .98). The PNORTI is a valid and reliable method for classifying the intensity of different treatment modalities used in pediatric neuro-oncology.

Protocolos Antineoplásicos/normas , Neoplasias Encefálicas/terapia , Oncologia/métodos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Criança , Humanos , Oncologia/normas , Determinação de Necessidades de Cuidados de Saúde , Variações Dependentes do Observador , Psicometria , Reprodutibilidade dos Testes
Rev. ABENO ; 18(1): 155-160, 2018. ilus
Artigo em Português | LILACS, BBO - Odontologia | ID: biblio-884118


O uso de antibióticos é amplamente difundido em Odontologia, devido ao risco de exposição do paciente a agentes infecciosos durante a prática clínica. Desta forma, é importante que o profissional da área esteja apto a utilizar protocolos antimicrobianos. Este trabalho visa relatar a experiência de construção de mapas conceituais no ensino de antibioticoprofilaxia em Odontologia. Foram considerados os seguintes temas: tipos de fármaco, seleção do fármaco, dosagem, e conduta clínica nas infecções agudas. Inicialmente foi realizada revisão bibliográfica acerca de protocolos profiláticos e da aprendizagem significativa, a fim de apropriar os estudantes ao método em que este trabalho está baseado. Foram montados três mapas conceituais, cada um por dois estudantes. Apesar da dificuldade visível em organizar todas as ideias a serem utilizadas e até a falta de algumas, a estruturação dos mapas conceituais foi considerada satisfatória, dentro de seu papel pedagógico de suscitar a aprendizagem (AU).

The use of antibiotics is widespread in Dentistry because of the risk of exposure of the patient to infectious agents during clinical practice. Thus, it is important that the professional in the area can use antimicrobial protocols. This paper aims to report the experience of conceptual mapping in the teaching of antibiotic prophylaxis in Dentistry. The following topics were considered: drug types, drug selection, dosage, and clinical management in acute infections. Initially, a bibliographic review was performed on prophylactic protocols and meaningful learning in order to appropriate the students to the method on which this work is based. Three conceptual maps were assembled, each by two students. Despite the visible difficulty in organizing all the ideas to be used and even the lack of some, the structuring of conceptual maps was considered satisfactory, within its pedagogical role of provoking learning (AU).

Humanos , Antibacterianos/uso terapêutico , Antibioticoprofilaxia , Protocolos Antineoplásicos/normas , Educação em Odontologia , Aprendizagem Baseada em Problemas/métodos , Brasil , Profilaxia Dentária/métodos , Epidemiologia Experimental
Leuk Res ; 60: 58-62, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28704720


BACKGROUND: The use of intensive pediatric protocols for the treatment of ALL is being extended to older adults. AIM OF THE STUDY: Analysis of the efficacy and toxicity results of pediatric DFCP vs. classic Hyper-CVAD protocol for the treatment of patients with ALL < 50 Y. PATIENTS AND METHODS: A retrospective single center comparative analysis of DFCP & classic Hyper-CVAD for first line treatment of patients with ALL < 50 Y. RESULTS: 73 patients were included, 43 received DFCP and 30 received Hyper-CVAD protocol. CR rate was 90.7% for DFCP vs. 83.7 for Hyper-CVAD (p 0.7). 3 Y Leukemia free survival was 57.4% (70.9% for DFCP vs. 41.6% Hyper-CVAD P 0.1) while 3Y OS was 62.6%% for the whole group, 72.6% DFCP vs. 48.5% Hyper-CVAD, P 0.04. Those with age <21 Y, had significantly longer 3 Y LFS and OS (P 0.04, 0.02, respectively). TOXICITY: pancreatitis occurred in 5 patients with DFCP and it was related to Asparginase and in 1 patient on Hyper-CVAD related to gall stones. Osteonecrosis affected 5 patients on DFCP. IN CONCLUSION: pediatric protocols are feasible in patients younger than 50 Y and they are more active than classic adult protocols. Although modifications of adult protocols may improve their results, this had to be investigated in randomized controlled trials.

Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos Antineoplásicos/normas , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Adolescente , Adulto , Fatores Etários , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Criança , Ciclofosfamida/efeitos adversos , Ciclofosfamida/uso terapêutico , Dexametasona/efeitos adversos , Dexametasona/uso terapêutico , Intervalo Livre de Doença , Doxorrubicina/efeitos adversos , Doxorrubicina/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Leucemia-Linfoma Linfoblástico de Células Precursoras/complicações , Leucemia-Linfoma Linfoblástico de Células Precursoras/mortalidade , Estudos Retrospectivos , Taxa de Sobrevida , Vincristina/efeitos adversos , Vincristina/uso terapêutico , Adulto Jovem
Digestion ; 95(4): 262-268, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28384644


The origin of gastrointestinal stromal tumors (GIST) from interstitial cells of Cajal or their precursor cells has been understood since the early 1990s. The first mutations within the KIT-gene have been described in the late 1990s. Even though these mutations were the breakthrough of small molecular therapy, we still do not know the factors responsible for their malignant transformation. Until then, we can only speak of recurrence risk. This review gives an introduction on the current understanding of GIST and highlights the remaining questions for diagnosis, tumor progression, and treatment in progressive disease.

Neoplasias Gastrointestinais/terapia , Tumores do Estroma Gastrointestinal/terapia , Protocolos Antineoplásicos/normas , Humanos
Rio de Janeiro; s.n; 2017. 70 p. ilus, tab, graf.
Tese em Português | BBO - Odontologia | ID: biblio-999350


O mieloma múltiplo se desenvolve a partir de células neoplásicas de plasmócitos, causando um desequilíbrio na reabsorção e formação óssea, resultando no surgimento de lesões osteolíticas, as quais apresentam uma diversidade de aspectos imaginológicos. O objetivo neste estudo foi estabelecer um protocolo de avaliação por meio de tomografia computadorizada de feixe cônico, para a identificação e descrição das variações imaginológicas destas lesões, baseado em critérios padronizados. Um total de 33 exames de pacientes portadores de mieloma múltiplo foi avaliado, sendo subdivididos em dois grupos distintos caracterizando os pacientes usuários de bisfosfonatos e não usuários. Para a descrição das lesões foram definidos os seguintes critérios de análise: localização anatômica, tamanho, margens, aspecto interno, relação com estruturas adjacentes, caracterização ou não do padrão saca-bocado (punched-out). Foram identificadas lesões osteolíticas em 100% da amostra tanto na maxila como na mandíbula. O padrão saca-bocado não foi encontrado em nenhuma imagem avaliada, sendo predominante o aspecto de reabsorção óssea generalizada, apresentando áreas com aspecto multilocular, se estendendo por toda a maxila e/ou mandíbula. Observou-se que um número significativamente maior de pacientes não usuários de bisfosfonatos apresentavam margens indefinidas que aqueles com história de uso. Concluise que foi possível estabelecer um protocolo de avaliação para a descrição destas lesões garantindo a padronização das análises. As lesões osteolíticas nos maxilares de pacientes portadores de mieloma múltiplo são predominantes, sendo possíveis de serem diferenciadas apenas com exames acurados, portanto a tomografia computadorizada de feixe cônico demonstrou ser um importante recurso para este fim. (AU)

Multiple myeloma develops from neoplastic cells of plasma cells causing an imbalance in the reabsorption and bone formation, resulting in the appearance of osteolytic lesions, which present a diversity of imaging aspects. The objective of this study was to establish an evaluation protocol, using cone beam computed tomography, based on standardized criteria for the identification and description of the imaging variations of these lesions. A total of 33 examinations of patients with multiple myeloma were evaluated, being subdivided into two distinct groups characterizing users bisphosphonates and nonusers. For the description of the lesions, the following criteria of analysis were defined: anatomical location, size, limits, internal aspect, relation with adjacent structures, characterization or not of the punched-out pattern. Osteolytic lesions were identified in 100% of the sample in the maxilla and the mandible. The punched-out pattern was not found in any of the evaluated images. Generalized bone resorption was predominant, presenting areas with multilocular appearance, extending throughout the maxilla and/or mandible. It was observed a significantly higher number of patients bisphosphonate nonusers presented lesions with indefinite limits than the users. It was concluded that it was possible to establish an evaluation protocol for the description of these lesions, ensuring the standardization of the analyzes. The osteolytic lesions in the jaws of patients with multiple myeloma are predominant, being possible to be differentiated only with accurate exams, therefore cone beam computed tomography has proved to be an important resource for this purpose. (AU)

Humanos , Protocolos Antineoplásicos/normas , Tomografia Computadorizada de Feixe Cônico/normas , Mieloma Múltiplo/diagnóstico por imagem , Neoplasias Maxilares/diagnóstico por imagem
Radiología (Madr., Ed. impr.) ; 58(6): 460-467, nov.-dic. 2016. tab, mapa
Artigo em Espanhol | IBECS | ID: ibc-158679


Objetivos. Conocer los protocolos de exploración de tomografía computarizada empleados en la estadificación del carcinoma broncopulmonar en España. Material y métodos. Mediante correo electrónico se enviaron encuestas a radiólogos de 129 hospitales. Las encuestas incluían preguntas sobre la organización del servicio, tipo y marca del escáner, extensión del estudio, técnica empleada y protocolo de administración del contraste. Resultados. Cincuenta y nueve hospitales respondieron con datos de 91 equipos. La mayoría de los hospitales fueron universitarios con organización por órganos y sistemas. Los modelos empleados incluyen cuatro marcas, el 68% de 16 o 64 detectores. En un 61% de los hospitales solo se modificaba la dosis de contraste en pacientes con pesos extremos y en el 22% no existía individualización. La mayoría de los hospitales realizaba un estudio del tórax y abdomen superior con contraste, un 42,4% con una única adquisición toracoabdominal y un 55,9% con dos adquisiciones independientes, existiendo relación significativa de ambos protocolos con dos marcas de escáner y con el carácter universitario del hospital. Los parámetros técnicos más empleados fueron 120kV con modulación de dosis y miliamperaje variable. Conclusión. El tipo de escáner empleado, la extensión del estudio y los parámetros técnicos empleados en la estadificación del cáncer broncopulmonar muestran escasa variabilidad entre los hospitales. La mayoría individualiza la dosis de contraste solo en pesos extremos. Hay una amplia división entre el empleo de una o dos adquisiciones para el tórax y el abdomen, existiendo relación entre número de adquisiciones con la marca del escáner y el carácter universitario del hospital (AU)

Objectives. To know the protocols used for staging bronchopulmonary carcinoma by computed tomography in Spain. Material and methods. Radiologists in 129 hospitals were sent email questionnaires about the organization of their department, scanner type and manufacturer, study extension, techniques employed, and protocol for administering contrast material. Results. A total of 109 hospitals responded with data from 91 teams. Most hospitals were affiliated with a university, and most departments were organized by organ-systems. Scanners were from four manufacturers, and 68% had either 16 or 64 detectors. In 61% of the hospitals, the dose of contrast agent is modified only in patients with extreme body weights, and in 22% the dose is not individualized. Most hospitals do contrast-enhanced studies of the chest and upper abdomen, 42.4% through a single thoracoabdominal acquisition and 55.9% through independent chest and abdominal acquisitions; there was a significant association between these approaches and the scanner manufacturer's protocols and whether the hospital was affiliated with a university. The most commonly used technical parameters were 120kV with dose modulation and variable milliamperage. Conclusion. There is very little variability among hospitals in the type of scanner used, the study extension, and the technical parameters used to stage bronchopulmonary carcinoma. Most centers individualize the dose of contrast agent only in extreme weights. There is a broad division between using one or two acquisitions to image the thorax and abdomen, and the number of acquisitions is related to the scanner manufacturer and whether the hospital is affiliated with a university (AU)

Humanos , Masculino , Feminino , Protocolos Antineoplásicos/classificação , Protocolos Antineoplásicos/normas , Tomografia Computadorizada de Emissão/instrumentação , Neoplasias Pulmonares/classificação , Neoplasias Pulmonares , Tomografia Computadorizada Multidetectores/instrumentação , Tomografia Computadorizada Multidetectores/métodos , Estadiamento de Neoplasias/classificação , Estadiamento de Neoplasias/métodos , Inquéritos e Questionários/normas , Inquéritos e Questionários , Radiologia/estatística & dados numéricos , Serviço Hospitalar de Radiologia/estatística & dados numéricos , Radiologia Intervencionista/estatística & dados numéricos
Rev. senol. patol. mamar. (Ed. impr.) ; 29(4): 163-169, oct.-dic. 2016. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-158727


Objetivo. La intraoperative radiotherapy (IORT, «radioterapia intraoperatoria») en pacientes seleccionadas con cáncer de mama permite un tratamiento corto y preciso durante la cirugía conservadora sobre el lecho tumoral in situ. Presentamos nuestra experiencia inicial de IORT con dispositivo Intrabeam®. Pacientes y métodos. Se seleccionaron inicialmente 120 pacientes con cáncer de mama para IORT con Intrabeam® según protocolo TARGIT-A, desde enero de 2013 hasta febrero de 2015. Las indicaciones fueron: candidatas a cirugía conservadora, mayores de 45 años, diagnóstico histológico de carcinoma ductal infiltrante≤3cm hormonodependiente y axila clínica, ecográfica e histológicamente negativa. Resultados. De las pacientes seleccionadas, 34 (28%) no recibieron IORT debido al tamaño de la cavidad quirúrgica (28 casos) o problemas técnicos (6 casos). Finalmente, 86 pacientes (72%) recibieron IORT. La edad media fue de 64 años (DE±8,4). En 22 pacientes (26%) fue preciso administrar radioterapia externa a toda la mama. Trece pacientes (15%) tuvieron complicaciones: 3 casos de seroma que precisaron de más de 3 punciones para resolución (4%), 6 casos de absceso-mastitis (7%), 2 casos de hematoma (2%) y 2 casos de dehiscencia parcial de la herida quirúrgica (2%). No hubo toxicidad grave (grado iii-iv). El resultado estético fue bueno o muy bueno en el 87% de las pacientes (75). Conclusión. La IORT con Intrabeam® es una alternativa segura y bien tolerada frente a la radioterapia externa en pacientes seleccionadas, con un buen resultado estético a corto plazo (AU)

Objective. Intraoperative radiotherapy (IORT) in selected patients with breast cancer allows a short and precise treatment on the tumor bed in situ during conservative surgery. We present our initial experience of IORT with the Intrabeam® device. Patients and methods. From January 2013 to February 2015, 120 patients with breast cancer were pre-selected for IORT with Intrabeam® according to the TARGIT-A protocol. The indications were as follows: candidates for conservative surgery, age older than 45 years, a histological diagnosis of hormone-dependent infiltrating ductal carcinoma≤3cm and absence of axillary involvement on physical, ultrasound and histological examination. Results. Among the selected patients, 34 (28%) did not receive IORT due to the size of the surgical cavity (28 patients) or technical problems (6 patients). Finally, 86 patients (72%) received IORT. The average age was 64 years (SD±8.4). In 22 patients (26%), it was necessary to administer external beam radiotherapy to the whole breast. Thirteen patients (15%) had complications: 3 cases of seroma requiring more than 3 attempts for resolution (4%), 6 cases of abscess-mastitis (7%), 2 cases of hematoma (2%) and 2 cases of partial dehiscence of the surgical wound (2%). There was no severe toxicity (grade iii-iv). The aesthetic result was good or very good in 87% of the patients (n=75). Conclusion. IORT with Intrabeam® is a safe and well tolerated alternative versus external radiotherapy in selected patients and provides a good short-term aesthetic result (AU)

Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Radioterapia/instrumentação , Radioterapia/métodos , Neoplasias da Mama/radioterapia , Carcinoma Ductal de Mama/radioterapia , Monitorização Intraoperatória/instrumentação , Protocolos Antineoplásicos/classificação , Protocolos Antineoplásicos/normas , Biópsia de Linfonodo Sentinela/instrumentação , Análise de Dados/métodos
Health Policy ; 120(12): 1378-1382, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27823827


Starting in 2015, the Swedish government has initiated a national reform to standardize cancer patient pathways and thereby eventually speed up treatment of cancer. Cancer care in Sweden is characterized by high survival rates and a generally high quality albeit long waiting times. The objective with the new national program to standardize cancer care pathways is to reduce these waiting times, increase patient satisfaction with cancer care and reduce regional inequalities. A new time-point for measuring the start of a care process is introduced called well-founded suspicion, which is individually designed for each cancer diagnosis. While medical guidelines are well established earlier, the standardisation is achieved by defining time boundaries for each step in the process. The cancer reform program is a collaborative effort initiated and incentivized by the central government while multi-professional groups develop the time-bound standardized care pathways, which the regional authorities are responsible for implementing. The broad stakeholder engagement and time-bound guidelines are interesting approaches to study for other countries that need to streamline care processes.

Protocolos Antineoplásicos/normas , Reforma dos Serviços de Saúde/métodos , Política , Continuidade da Assistência ao Paciente , Política de Saúde , Humanos , Programas Nacionais de Saúde , Satisfação do Paciente , Suécia , Listas de Espera
Lancet Haematol ; 3(12): e581-e591, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27890073


BACKGROUND: Optimal management of patients with chronic myeloid leukaemia in chronic phase with suboptimal cytogenetic response remains undetermined. This study aimed to investigate the safety and efficacy of switching to nilotinib vs imatinib dose escalation for patients with suboptimal cytogenetic response on imatinib. METHODS: We did a phase 3, open-label, randomised trial in patients with chronic myeloid leukaemia in chronic phase with suboptimal cytogenetic response to imatinib according to the 2009 European LeukemiaNet criteria, in Latin America, Europe, and Asia (59 hospitals and care centres in 12 countries). Eligible patients were aged 18 years or older with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase and Eastern Cooperative Oncology Group performance status of 0-2. Before enrolment, all patients had received 3-18 months of imatinib 400 mg once daily and had a suboptimal cytogenetic response according to 2009 ELN recommendations, established through bone marrow cytogenetics. By use of an interactive response technology using fixed blocks, we randomly assigned patients (1:1) to switch to nilotinib 400 mg twice per day or an escalation of imatinib dose to 600 mg once per day (block size of 4). Investigators and participants were not blinded to study treatment. Crossover was allowed for loss of response or intolerance at any time, or for patients with no complete cytogenetic response at 6 months. The primary endpoint was complete cytogenetic response at 6 months in the intention-to-treat population. Efficacy endpoints were based on the intention-to-treat population, with all patients assessed according to the treatment group to which they were randomised (regardless of crossover); the effect of crossover was assessed in post-hoc analyses, in which responses achieved after crossover were excluded. We present the final results at 24 months' follow-up. This study is registered with (NCT00802841). FINDINGS: Between July 7, 2009, and Aug 29, 2012, we enrolled 191 patients. 96 patients were randomly assigned to nilotinib and 95 patients were randomly assigned to imatinib. Complete cytogenetic response at 6 months was achieved by 48 of 96 patients in the nilotinib group (50%, 95·18% CI 40-61) and 40 of 95 in the imatinib group (42%, 32-53%; difference 7·9% in favour of nilotinib; 95% CI -6·2 to 22·0, p=0·31). Excluding responses achieved after crossover, 48 (50%) of 96 patients in the nilotinib group and 34 (36%) of 95 patients in the imatinib group achieved complete cytogenic response at 6 months (nominal p=0·058). Grade 3-4 non-haematological adverse events occurring in more than one patient were headache (nilotinib group, n=2 [2%, including 1 after crossover to imatinib]; imatinib group, n=1 [1%]), blast cell crisis (nilotinib group, n=1 [1%]; imatinib group, n=1 [1%]), and QT prolongation (nilotinib group, n=1 [1%]; imatinib group, n=1 [1%, after crossover to nilotinib]). Serious adverse events on assigned treatment were reported in 11 (11%) of 96 patients in the nilotinib group and nine (10%) of 93 patients in the imatinib group. Seven (7%) of 96 patients died in the nilotinib group and five (5%) of 93 patients died in the imatinib group; no deaths were treatment-related. INTERPRETATION: While longer-term analyses are needed to establish whether the clinical benefits observed with switching to nilotinib are associated with improved long-term survival outcomes, our results suggest that patients with suboptimal cytogenetic response are more likely to achieve improved cytogenetic and molecular responses with switching to nilotinib than with imatinib dose escalation, although the difference was not statistically significant when responses achieved after crossover were included. FUNDING: Novartis Pharmaceuticals.

Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Mesilato de Imatinib/administração & dosagem , Mesilato de Imatinib/efeitos adversos , Mesilato de Imatinib/uso terapêutico , Leucemia Mieloide de Fase Crônica/tratamento farmacológico , Cromossomo Filadélfia/efeitos dos fármacos , Pirimidinas/efeitos adversos , Pirimidinas/uso terapêutico , Adulto , Antineoplásicos/administração & dosagem , Antineoplásicos/uso terapêutico , Protocolos Antineoplásicos/normas , Ásia , Biomarcadores Farmacológicos/química , Medula Óssea/química , Pesquisa Comparativa da Efetividade , Análise Citogenética/métodos , Progressão da Doença , Europa (Continente) , Exantema/induzido quimicamente , Feminino , Febre/induzido quimicamente , Seguimentos , Cefaleia/induzido quimicamente , Doenças Hematológicas/induzido quimicamente , Humanos , América Latina , Leucemia Mieloide de Fase Crônica/mortalidade , Masculino , Doenças Metabólicas/induzido quimicamente , Pessoa de Meia-Idade , Distribuição Aleatória , Falha de Tratamento
Breast ; 29: 208-12, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27344290


OBJECTIVE: Biomarkers uPA and PAI-1 are guideline recommended by ASCO (USA) and AGO (Germany) in primary breast cancer to avoid unnecessary CTX in patients at medium risk for recurrence. For clinical quality assurance of uPA/PAI-1 testing, analysis of test-therapy concordance was performed. METHODS: Prospective non-interventional multi-center study over 2 years among six Certified Breast Centers in Germany to investigate uPA/PAI-1 results in consecutive decision making for tumor board recommendation and actual therapy in uninfluenced clinical setting. Concordance and discordance rates of uPA/PAI-1 testing were calculated and individual reasons for decision making analyzed. RESULTS: Among n = 93 uPA/PAI-1 tests evaluated n = 42/93 (45.2%) were uPA + PAI-1 negative and n = 51/93 (54.8%) uPA and/or PAI-1 positive. In uPA + PAI-1 negative test results in n = 35/42 (83.3%) CTX was avoided as recommended. But in n = 7/42 (16.7%) CTX was performed despite, resulting in over treatment. In uPA and/or PAI-1 positive test results in n = 26/51 (51.0%) CTX was performed but in n = 25/51 (49.0%) not despite recommendation for CTX which is under treatment. The conformity of uPA/PAI-1 test result vs. tumor board decision was n = 73/93 (78.5%). The overall concordance of uPA/PAI-1 test result vs. consecutive therapy was n = 61/93 (65.6%). A variety of reasons for individual result-deviating decisions were identified. CONCLUSIONS: Clinical quality assurance of uPA/PAI-1 biomarker testing showed inconsistency of test results with consecutive tumor board decision and/or final therapy performed in up to 1/3 of patients. To close this clinical quality gap in application of uPA/PAI-1 biomarkers, individual analysis of deviations is suggested with process optimization accordingly.

Protocolos Antineoplásicos/normas , Neoplasias da Mama/tratamento farmacológico , Tomada de Decisão Clínica/métodos , Fidelidade a Diretrizes/estatística & dados numéricos , Guias de Prática Clínica como Assunto/normas , Adulto , Fatores Etários , Idoso , Biomarcadores Tumorais/sangue , Neoplasias da Mama/sangue , Feminino , Alemanha , Humanos , Pessoa de Meia-Idade , Inibidor 1 de Ativador de Plasminogênio/sangue , Estudos Prospectivos , Fatores de Risco , Ativador de Plasminogênio Tipo Uroquinase/sangue , Adulto Jovem
Rev. senol. patol. mamar. (Ed. impr.) ; 29(1): 4-12, ene.-mar. 2016. tab
Artigo em Espanhol | IBECS | ID: ibc-149865


Objetivo. Revisar nuestra experiencia en la biopsia selectiva del ganglio centinela (BGC) en pacientes con cáncer de mama operable tratadas con quimioterapia neoadyuvante (QTN). Material y métodos. Estudio prospectivo, enero de 2008/diciembre de 2014, 235 BGC en pacientes con cáncer de mama infiltrante T1-3/N0-1, tratadas con epirrubicina/ciclofosfamida, docetaxel y trastuzumab en Her2/neu positivas. El estatus axilar se estableció por exploración física, ecografía axilar y punción de ganglios sospechosos. El día antes de la cirugía se inyectaron periareolarmente 74-111 MBq de 99mTc-nanocoloide de albúmina. Al finalizar el tratamiento se realizó BGC y linfadenectomía axilar. El GC se analizó por cortes de congelación, hematoxilina-eosina, inmunohistoquímica o one-step nucleic acid amplification. Se determinaron tasa de identificación (Id.GC) y falsos negativos (FN). Resultados. Grupo I BGC pre-QTN pacientes cN0 de inicio: n = 73, Id.GC 97,2% (IC 95% 90,5-99,2). Grupo II 2.a BGC pos-QTN pacientes pN1(gc) de inicio: n = 31, Id.GC 61,3% (IC 95% 43,8-76,3), FN 18,2% (IC 95% 5,1-47,7). Grupo III BGC pos-QTN pacientes cN0 de inicio: n = 54, Id.GC 96,3% (IC 95% 87,5-99,0), FN 9,5% (IC 95% 2,7-28,9). Grupo IV BGC pos-QTN pacientes cN1 de inicio, ycN0 posneoadyuvancia: n = 77, Id.GC 83,1% (IC 95% 73,2-89,8), FN 8,3% (IC 95% 2,9-21,8). Conclusiones. La identificación de la BGC pre-QTN es excelente. En pacientes pN1(gc) al diagnóstico, una 2.a BGC pos-QTN no es válida para su aplicación clínica. La BGC pos-QTN puede realizarse con fiabilidad en pacientes cN0 y cN1 de inicio, con axila clínicamente negativa al finalizar la neoadyuvancia (ycN0), y linfadenectomía axilar si el resultado del GC es positivo o no se identifica en la cirugía, en el ámbito de un equipo multidisciplinar con experiencia (AU)

Aim. To analyze our experience of sentinel lymph node biopsy (SLNB) in patients with operable breast cancer treated with neoadjuvant chemotherapy (NAC). Material and methods. A prospective study was conducted between January 2008 and December 2014 in 235 SLNB in patients with infiltrating breast carcinoma T1-3/N0-1 treated with epirubicin/cyclophosphamide, docetaxel and trastuzumab in Her2/neu-positive patients. Axillary evaluation included physical examination and ultrasound, with guided core needle biopsy of any suspicious lymph nodes. The day before surgery, 74-111 MBq of 99mTc-albumin nanocolloid was injected periareolar. Following NAC, patients underwent SLNB and axillary lymph node dissection. SLN were examined with hematoxylin-eosin staining and immunohistochemical analysis or one-step nucleic acid amplification. The identification rate (IR) and false-negative rate (FNR) were determined. Results. Group I SLNB pre-NAC in patients cN0 at diagnosis: n = 73, IR 97.2% (95%CI: 90.5-99.2). Group II 2nd SLNB pos-NAC in patients pN1(sn) at diagnosis: n = 31, IR 61.3% (95%CI: 43.8-76.3), FNR 18.2% (95%CI: 5.1-47.7). Group III SLNB pos-NAC in patients cN0 at diagnosis: n = 54, IR 96.3% (95%CI: 87.5-99.0), FNR 9.5% (95%CI: 2.7-28.9). Group IV SLNB pos-NAC in patients cN1 at diagnosis and ycN0 post-treatment: n = 77, IR 83.1% (95%CI: 73.2-89.8), FNR 8.3% (95%CI: 2.9-21.8). Conclusions. The detection rate for SLNB prior to NAC is excellent. A second SLNB after NAC in women with a positive SLN at diagnosis is not useful. SLNB after NAC is feasible in cN0 and cN1 patients at diagnosis, clinically axillary node-negative after therapy (ycN0), with subsequent axillary lymph node dissection if the SLNB is positive or not identified during surgery, when performed by an experienced multidisciplinary team (AU)

Humanos , Masculino , Feminino , Biópsia de Linfonodo Sentinela/métodos , Biópsia de Linfonodo Sentinela/psicologia , Neoplasias da Mama/genética , Neoplasias da Mama/metabolismo , Excisão de Linfonodo/métodos , Estudos Prospectivos , Preparações Farmacêuticas/administração & dosagem , Preparações Farmacêuticas/metabolismo , Protocolos Antineoplásicos/classificação , Biópsia de Linfonodo Sentinela/instrumentação , Biópsia de Linfonodo Sentinela , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/terapia , Excisão de Linfonodo/enfermagem , Preparações Farmacêuticas/classificação , Preparações Farmacêuticas/provisão & distribução , Protocolos Antineoplásicos/normas
Proc Natl Acad Sci U S A ; 112(43): 13308-11, 2015 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-26460009


Tumor organoids are 3D cultures of cancer cells. They can be derived from the tumor of each individual patient, thereby providing an attractive ex vivo assay to tailor treatment. Using patient-derived tumor organoids for this purpose requires that organoids derived from biopsies maintain the genetic diversity of the in vivo tumor. In this study tumor biopsies were obtained from 14 patients with metastatic colorectal cancer (i) to test the feasibility of organoid culture from metastatic biopsy specimens and (ii) to compare the genetic diversity of patient-derived tumor organoids and the original tumor biopsy. Genetic analysis was performed using SOLiD sequencing for 1,977 cancer-relevant genes. Copy number profiles were generated from sequencing data using CopywriteR. Here we demonstrate that organoid cultures can be established from tumor biopsies of patients with metastatic colorectal cancer with a success rate of 71%. Genetic analysis showed that organoids reflect the metastasis from which they were derived. Ninety percent of somatic mutations were shared between organoids and biopsies from the same patient, and the DNA copy number profiles of organoids and the corresponding original tumor show a correlation of 0.89. Most importantly, none of the mutations that were found exclusively in either the tumor or organoid culture are in driver genes or genes amenable for drug targeting. These findings support further exploration of patient-derived organoids as an ex vivo platform to personalize anticancer treatment.

Técnicas de Cultura de Células/métodos , Neoplasias Colorretais/genética , Variação Genética/genética , Metástase Neoplásica/genética , Organoides/citologia , Organoides/crescimento & desenvolvimento , Protocolos Antineoplásicos/normas , Sequência de Bases , Neoplasias Colorretais/tratamento farmacológico , Genes Neoplásicos/genética , Humanos , Dados de Sequência Molecular , Organoides/química , Medicina de Precisão/métodos , Análise de Sequência de DNA