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1.
Med. clín (Ed. impr.) ; 151(12): 469-475, dic. 2018. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-182276

RESUMO

Antecedentes y objetivos: En el cáncer de mama hormonosensible, HER-2 negativo, con ganglios negativos, la presencia de un riesgo genómico bajo permite tratar solo con hormonoterapia adyuvante, obteniendo unas excelentes tasas de supervivencia. La justificación de este estudio es demostrar que también se obtienen unas excelentes tasas de supervivencia tratando solo con hormonoterapia adyuvante mediante la evaluación del riesgo clínico. Pacientes y métodos: Estudio descriptivo, observacional y retrospectivo entre 2006 y 2016 de la cohorte de cáncer de mama hormonosensible, HER-2 negativo, con ganglios negativos, tamaño del tumor mayor de 1cm o entre 0,6 y 1cm con características desfavorables. Revisión retrospectiva de los registros de salud. Datos de mortalidad del Registro Nacional de Defunciones. Resultados: Un total de 203 pacientes fueron evaluables para la supervivencia. Ciento veintitrés (60,50%) fueron tratadas solo con hormonoterapia adyuvante, 77 (37,90%) con quimioterapia-hormonoterapia, una (0.50%) solo con quimioterapia y 2 (1%) no recibieron ningún tratamiento. La tasa de supervivencia global a los 5 años fue del 97% (intervalo de confianza [IC] del 95% 94-100). La tasa de intervalo libre de metástasis a distancia fue del 94% (IC 95% 90-98). En el subgrupo de pacientes tratadas solo con hormonoterapia la tasa de supervivencia global y del intervalo libre de metástasis a distancia a los 5 años fue del 98% (IC 95% 95-100) y 97% (IC 95% 93-100), respectivamente. Conclusiones: Las pacientes con cáncer de mama hormonosensible, HER-2-negativo, con ganglios negativos, tratadas solo con hormonoterapia según su riesgo clínico, obtienen resultados de supervivencia similares a los descritos cuando son tratadas solo con hormonoterapia según su riesgo genómico


Background and objectives: In endocrine-sensitive, HER-2 negative, node negative breast cancer, the presence of a low genomic risk allows treatment with adjuvant endocrine therapy alone, obtaining excellent survival rates. The justification for this study is to show that excellent survival rates are also obtained by treating with adjuvant hormone therapy alone, based on clinical risk assessment. Patients and methods: A descriptive, observational and retrospective study was performed between 2006 and 2016 with endocrine-sensitive, HER-2 negative, node negative breast cancer, greater than 1cm or between 0.6 and 1cm with unfavourable features. Retrospective review of health records. Mortality data of the National Registry of Deaths. Results: A total of 203 patients were evaluable for survival. One hundred and twenty-three (60.50%) were treated with adjuvant endocrine therapy alone, 77 (37.90%) with chemotherapy and endocrine therapy, one (0.50%) with chemotherapy alone and 2 (1%) were not treated. The overall survival rate at 5 years was 97% (95% confidence interval [CI] 94-100). Distant recurrence-free interval was 94% (95% CI 90-98). In the subgroup of patients treated with endocrine therapy alone, overall survival and distant recurrence-free interval rates at 5 years were 98% (95% CI 95-100) and 97% (95% CI 93-100), respectively. Conclusions: Patients with endocrine-sensitive, HER-2-negative, node negative breast cancer treated with endocrine therapy alone according to their clinical risk have similar survival outcomes as those treated with endocrine therapy according to their genomic risk


Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/diagnóstico , Genes erbB-2 , Quimioterapia Adjuvante/métodos , Análise de Sobrevida , Neoplasias da Mama/tratamento farmacológico , Estudos Retrospectivos , Receptor ErbB-2/genética
2.
Clin. transl. oncol. (Print) ; 20(7): 862-869, jul. 2018. tab, graf
Artigo em Inglês | IBECS | ID: ibc-173637

RESUMO

Introduction: This study aimed to describe the efficacy of fulvestrant 500 mg in postmenopausal women with estrogen receptor (ER)-positive advanced/metastatic breast cancer who had disease progression after receiving anti-estrogen therapy in clinical practice, getting real-world data. Materials and methods: Multicenter, retrospective, observational study conducted in Spain. Postmenopausal women with locally advanced/metastatic ER-positive breast cancer who received treatment with fulvestrant 500 mg after progression with a previous anti-estrogen therapy were eligible. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), clinical benefit rate (CBR), duration of clinical benefit (DoCB), and safety profile. Results: A total of 263 women were evaluated (median age, 65.8 years). At a median follow-up of 21.5 months, median PFS and OS were 10.6 and 43.2 months, respectively. PFS according to 1st, 2nd, 3rd, and ≥ 4th lines were 11.5, 10.6, 9.9, and 8.5 months, respectively (p = 0.0245). PFS in patients with visceral involvement was 10 months vs 10.6 months in patients without visceral involvement (p = 0.6604), 9.6 months in patients with high Ki67 vs 10 months in patients with low Ki67 (p = 0.7224), and 10.2 months in HER2+ patients vs 10.3 months in HER2− patients (p = 0.6809). The CBR was 56.5% and the DoCB was 18.4 months. The most frequently adverse events were injection site pain (10.3%) and musculoskeletal disorders (7.6%). Conclusions: Fulvestrant 500 mg administered in clinical practice was shown to be effective (PFS, 10.6 months; CBR, 56.5%) and well tolerated, in accordance with previous trials


No disponible


Assuntos
Humanos , Feminino , Neoplasias da Mama/tratamento farmacológico , Carcinoma Ductal de Mama/tratamento farmacológico , Carcinoma Lobular/tratamento farmacológico , Neoplasias da Mama/secundário , Resistencia a Medicamentos Antineoplásicos , Antineoplásicos Hormonais/uso terapêutico , Carcinoma Ductal de Mama/patologia , Carcinoma Lobular/patologia , Metástase Linfática/patologia , Pós-Menopausa , Estudos Retrospectivos , Receptor ErbB-2/genética
3.
Clin. transl. oncol. (Print) ; 20(6): 695-702, jun. 2018. tab, graf
Artigo em Inglês | IBECS | ID: ibc-173617

RESUMO

Purpose: Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric cancer (AGC). However, the clinicopathologic factors that predict the outcome of routine trastuzumab therapy remain unclear. Methods: The outcome and safety profile of trastuzumab therapy in untreated HER2 positive AGC was evaluated in this prospective observational study. Clinical and pathological data including demographics, treatment profiles, expression level of HER2 were analyzed to identify predictive factors of trastuzumab-based first-line therapy for their progression-free survival (PFS). Results: Overall, 107 patients were eligible. The median number of treatment cycles was 9 (range 1-44), the median PFS and median overall survival (OS) were 7.7 months (95% CI 6.5-8.9) and 16.0 months (95% CI 13.2-18.8), respectively. The confirmed response rate was 58.9%, and the disease control rate was 82.2%. Patients with liver metastasis (HR 1.616) and poor performance status (PS, HR 2.518) were independently associated with a worse PFS, while the other clinicopathological factors including demographics, treatment profiles and some other clinical characteristics did not predict the survival. Conclusions: In routine clinical practice, the addition of trastuzumab to chemotherapy was effective and safe in real-world setting in Chinese patients with HER2 positive AGC, regardless of most of the clinicopathological factors. Further studies are needed to improve the prognosis of HER2 positive patients with liver metastasis or poor PS


No disponible


Assuntos
Humanos , Trastuzumab/uso terapêutico , Neoplasias Gástricas/tratamento farmacológico , Receptor ErbB-2 , Neoplasias Gástricas/patologia , Prognóstico , Estudos Prospectivos , Fatores Imunológicos/uso terapêutico , Taxa de Sobrevida
4.
Clin. transl. oncol. (Print) ; 20(6): 753-760, jun. 2018. tab
Artigo em Inglês | IBECS | ID: ibc-173624

RESUMO

Background: Everolimus with exemestane has shown promising activity in patients with hormone-receptor (HR)-positive HER2-negative endocrine-resistant advanced breast cancer. It is necessary, therefore, to characterize the safety profile of this new combination in the real-world clinical setting and in the broadest possible population. Patients and methods: Post-menopausal women with HR-positive HER2-negative advanced breast cancer progressing after prior non-steroidal aromatase inhibitors (NSAIs) were included. The objectives of this analysis were to evaluate the safety profile of this combination in a subset of Spanish patients in the BALLET trial and to characterize grade 3 and 4 adverse events (AEs) in routine clinical practice in Spain. Results: Between September 2012 and July 2013, 429 patients (20% of the overall study population) were included in the BALLET study in 52 hospitals in Spain, of whom 100 (23%) were ≥ 70 years. The median treatment duration was 3.14 and 3.03 months for exemestane and everolimus, respectively. The most common reasons for discontinuation of treatment were local reimbursement of everolimus (43%), followed by disease progression (31%) and the incidence of AEs (15%). The most frequent AEs causing permanent discontinuation were pneumonitis (4%), asthenia (2%) and stomatitis (2%). Overall, 87% of patients experienced at least one AE of any grade, 30% of patients at least one grade 3 AE and 2% of patients a grade 4 AE. Conclusion: The safety profile in Spanish patients of the BALLET trial is consistent with the results obtained in the overall population of the trial, as well as in previous clinical trials


No disponible


Assuntos
Humanos , Feminino , Neoplasias da Mama/tratamento farmacológico , Everolimo/uso terapêutico , Androstadienos/uso terapêutico , Receptor ErbB-2/isolamento & purificação , Neoplasias da Mama/patologia , Segurança do Paciente/estatística & dados numéricos , Receptores Estrogênicos/isolamento & purificação , Receptores de Progesterona/isolamento & purificação , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Invasividade Neoplásica/patologia , Metástase Neoplásica/tratamento farmacológico
5.
Ars pharm ; 58(4): 171-174, oct.-dic. 2017. graf, tab
Artigo em Inglês | IBECS | ID: ibc-172560

RESUMO

Objective: identify the main adverse reactions presented by patients with HER2 positive breast cancer from an outpatient clinic specialized in chemotherapy in the city of Caruaru-PE, after the use of Trastuzumab. Methods: The data were obtained through the analysis of the medical records of the patients attended at the outpatient clinic from January 2015 to December 2016. Results: Twenty-four patients were selected, of whom 12.5% presented cardiotoxicity and 4.16% presented abdominal pain, nausea among other adverse events. Conclusion: Identifying such adverse events makes it possible to better assist the oncological patient and to better adhesion to the treatment. Because they are specific target drugs, few studies are concerned with evaluating these adverse events, which often makes clinical care difficult


Objetivo: identificar las principales reacciones adversas presentadas por pacientes con cáncer de mama HER2 positivo desde una clínica ambulatoria especializada en quimioterapia en la ciudad de Caruaru- PE (Brasil), después del uso de Trastuzumab. Métodos: los datos se obtuvieron mediante el análisis de los registros médicos de los pacientes atendidos en la consulta externa entre enero de 2015 y diciembre de 2016. Resultados: se seleccionaron 24 pacientes, de los cuales 12.5% presentaron cardiotoxicidad y 4.16% presentaron dolor abdominal, náuseas entre otros eventos adversos. Conclusión: la identificación de tales eventos adversos permite una mejor asistencia al paciente oncológico y una mejor adhesión al tratamiento. Debido a que son medicamentos específicos, pocos estudios se preocupan por evaluar estos efectos adversos, lo que a menudo dificulta la atención clínica


Assuntos
Humanos , Feminino , Anticorpos Monoclonais/efeitos adversos , Receptor ErbB-2/efeitos adversos , Trastuzumab/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Receptor ErbB-2/uso terapêutico , Cardiotoxicidade/complicações , Dor Abdominal/complicações , Dor Abdominal/etiologia , Náusea/complicações , Estudos Retrospectivos
6.
Rev. esp. patol ; 50(3): 142-147, jul.-sept. 2017. tab
Artigo em Espanhol | IBECS | ID: ibc-163522

RESUMO

El diagnóstico del biomarcador HER2 es un factor imprescindible en el manejo de los pacientes de carcinoma infiltrante de mama. La sobreexpresión del HER2, observada en aproximadamente el 15% de los pacientes, se asocia a mal pronóstico. La determinación del HER2 se realiza o bien por IHQ, o bien por HIS, siendo ambas técnicas válidas, intercambiables y necesarias para los casos equívocos. Las guías clínicas ASCO/CAP son un instrumento útil para la estandarización y mejora del diagnóstico, sin embargo, tienen sus puntos débiles; por ejemplo, la categoría de resultados equívocos genera inconvenientes en la práctica clínica. Al tratarse de documentos vivos y cambiantes, estas guías son susceptibles de cambio bajo la luz de nuevas observaciones. Se realiza el estudio de 3 series consecutivas y distintas de 1.568 casos HER2 equívocos (IHQ 2+) de carcinoma infiltrante de mama, procedentes de distintos hospitales españoles. El objetivo de este estudio es comparar los resultados de HIS obtenidos, en nuestro centro de referencia, al aplicar las distintas guías clínicas para el HER2 (2007 y 2013), además de comparar distintas técnicas de HIS entre sí (CISH e IQ-FISH). Nuestros resultados indican que la aplicación de la guía 2013 aumenta el porcentaje (%) de resultados equívocos respecto a la del 2007. Y también nos permiten afirmar que cualquiera de las 2 técnicas de HIS es válida para el estudio del HER2 (AU)


HER2 biomarker assessment is essential for the correct management of invasive breast carcinoma. Overexpression of HER2, observed in approximately 15% of the patients, is associated with a bad prognosis. HER2 determination can be carried out either by IHQ or by HIS as both are valid, interchangeable and necessary techniques for equivocal cases. Although the clinical guidelines ASCO/CAP are a useful tool for diagnostic standardization and improvement, they have drawbacks; for instance, the category of equivocal results can create problems in routine clinical practice. As they are on-going documents, they are susceptible to change in the light of new observations. We studied three consecutive and different series of 1,568 HER2 equivocal invasive breast carcinoma (IHQ 2+), from different Spanish hospitals. The aim of this study was to compare both the ISH results in our laboratory when applying the different clinical guidelines for the HER2 (2007 and 2013) and the different ISH techniques (CISH and IQ-FISH). Our results indicate that the use of the 2013 guidelines increases the percentage of equivocal results with respect 2007. We confirmed that both of the ISH techniques are valid for the study of the HER2 biomarker (AU)


Assuntos
Humanos , Feminino , Carcinoma Ductal de Mama/diagnóstico , Hibridização In Situ/métodos , Hibridização In Situ , Receptor ErbB-2/análise , Biomarcadores Farmacológicos/análise , Erros de Diagnóstico/tendências , Prognóstico , Carcinoma Ductal de Mama/patologia , Estudos Retrospectivos , Erros de Diagnóstico/prevenção & controle , Estudos Prospectivos , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/patologia
7.
Clin. transl. oncol. (Print) ; 19(8): 976-988, ago. 2017. tab, ilus, graf
Artigo em Inglês | IBECS | ID: ibc-164676

RESUMO

Background. Human epidermal growth factor receptor 2 (Her2, an orphan receptor of ErbB family) is considered as an important biomarker as it plays a key role in the development and progression of aggressive types of breast, ovarian, stomach and gastric cancer. In the present study, we developed novel DNA aptamers against the extra-cellular domain (ECD) of Her2 protein for detection of Her2-positive carcinomas. Methods. We cloned and expressed Her2-ECD protein in E. coli system. After purification, the protein was used as a bait for screening of specific DNA aptamer candidate from a pool of 1014-15 random oligonucleotides through in vitro Systematic Evaluation of Ligands by Exponential Enrichment (SELEX) process. The aptamer-protein binding kinetics was elucidated by isothermal calorimetry. The specificity of FAM-labelled ECD_Apt1 towards Her2-positive cell lines was estimated by FACS and immunofluorescence assay. The specificity of the candidate was also verified with the tissue samples of breast cancer patients by immunohistochemistry process. Results. Among four selected candidates, ECD_Apt1 (having minimum ∆G = -3.24) showed the highest binding affinity (Kd = 6.33 ± 0.86 nM) to Her2-ECD protein. The aptamer-protein sandwich assay showed a linear rise in chemiluminescence (at 490 nm wavelength) in the dynamic range of 100−700 nM ECD_Apt1 with a detection limit of 12.5 ± 2.5 ng/mL. Biotinylated ECD_Apt1 showed stronger cytoplasmic staining in Her2-positive breast cancer cell lines (SKBR3) compared to Her2-negative cells (MDA MB 231, MCF7). In paraffin-embedded breast cancer tissue sections, it showed specific and selective localization in the cytoplasmic niche of malignant duct cancer cells without any cross-reactivity to fibroblasts, inflammatory cells and adipocytes. Conclusions. Binding assays, cytochemical and histochemical studies support ECD_Apt1 as a potential theranostic agent for Her2-positive carcinomas. ECD_Apt1 could be an effective low-cost alternative to conventional anti-Her2 antibody in solid phase immunoassays for cancer diagnosis and related applications (AU)


No disponible


Assuntos
Humanos , Aptâmeros de Nucleotídeos/análise , Imuno-Histoquímica , Carcinoma de Células Escamosas/diagnóstico , Receptor ErbB-2/análise , Carcinoma/diagnóstico , Técnicas In Vitro , Carcinoma/genética , Sensibilidade e Especificidade , Calorimetria , Ensaio de Imunoadsorção Enzimática/métodos
8.
Clin. transl. oncol. (Print) ; 19(5): 606-615, mayo 2017. tab, graf
Artigo em Inglês | IBECS | ID: ibc-162195

RESUMO

Purpose. The human epidermal growth factor receptor 2 (HER2) status in breast cancer is important for prognostic prediction and the determination of optimal treatment. Current methods rely on protein expression, as determined by immunohistochemistry (IHC), as well as gene amplification as determined by in situ hybridisation (ISH). We explored whether quantitative droplet digital PCR (ddPCR) can be used for the detection and absolute quantitation of HER2 mRNA. Methods. Digital droplet PCR (ddPCR) was performed for HER2 mRNA on 178 formalin-fixed paraffin-embedded (FFPE) breast cancer specimens. HER2 positive, equivocal and negative cases as defined by standard criteria were included and both core biopsies and tissue sections were assessed. Results. HER2 positive cases contained significantly higher levels of HER2 mRNA (169-1,000,000 copies/µl) by ddPCR compared with equivocal (112-139 copies/µl, p = 0.025) and negative cases (6.2-644 copies/µl. p < 0.001). A continuum of transcript quantity was observed but a cutoff of 490 copies/µl distinguished between HER2 positive and negative cases. Results were consistent between core biopsy and tissue sections. Conclusions. ddPCR can be used to quantify HER2 mRNA transcripts in FFPE breast cancer specimens. Our results highlight the potential of ddPCR on FFPE tissue to be used to accurately quantify HER2 transcripts. Validation in large cohorts will be required to determine a clinically applicable cutoff (AU)


No disponible


Assuntos
Humanos , Feminino , Neoplasias da Mama/genética , Neoplasias da Mama , RNA Mensageiro/genética , Receptor ErbB-2/análise , Receptor ErbB-2/genética , Genes Supressores de Tumor , Reação em Cadeia da Polimerase/tendências , Biópsia/métodos , Prognóstico
9.
Clin. transl. oncol. (Print) ; 19(5): 616-624, mayo 2017. tab
Artigo em Inglês | IBECS | ID: ibc-162196

RESUMO

Purpose. To converge on an expert opinion to define aggressive disease in patients with HER2-negative mBC using a modified Delphi methodology. Methods. A panel of 21 breast cancer experts from the Spanish Society of Medical Oncology agreed upon a survey which comprised 47 questions that were grouped into three sections: relevance for defining aggressive disease, aggressive disease criteria and therapeutic goals. Answers were rated using a 9-point Likert scale of relevance or agreement. Results. Among the 88 oncologists that were invited to participate, 81 answered the first round (92%), 70 answered the second round (80%), and 67 answered the third round (76%) of the survey. There was strong agreement regarding the fact that identifying patients with aggressive disease needs to be adequately addressed to help practitioners to decide the best treatment options for patients with HER2-negative mBC. The factors that were considered to be strongly relevant to classifying patients with aggressive HER2-negative mBC were a high tumor burden, a disease-free interval of less than 12-24 months after surgery, the presence of progressive disease during adjuvant or neoadjuvant chemotherapy and having a triple-negative phenotype. The main therapeutic goals were controlling symptoms, improving quality of life and increasing the time to progression and overall survival. Conclusions. High tumor burden, time to recurrence after prior therapy and having a triple-negative phenotype were the prognostic factors for which the greatest consensus was found for identifying patients with aggressive HER2-negative mBC. Identifying patients with aggressive disease leads to different therapeutic approaches (AU)


No disponible


Assuntos
Humanos , Feminino , Neoplasias da Mama/diagnóstico , Metástase Neoplásica/diagnóstico , Conferências de Consenso como Assunto , Biomarcadores Tumorais/normas , Receptor ErbB-2/análise , Receptor ErbB-2/genética , Sociedades Médicas/normas , Oncologia/educação , Metástase Neoplásica/tratamento farmacológico , Oncologia , Oncologia/normas
10.
Clin. transl. oncol. (Print) ; 19(2): 149-161, feb. 2017. tab
Artigo em Inglês | IBECS | ID: ibc-159447

RESUMO

Metastatic breast cancer is a heterogeneous disease that presents in varying forms, and a growing number of therapeutic options makes it difficult to determine the best choice in each particular situation. When selecting a systemic treatment, it is important to consider the medication administered in the previous stages, such as acquired resistance, type of progression, time to relapse, tumor aggressiveness, age, comorbidities, pre- and post-menopausal status, and patient preferences. Moreover, tumor genomic signatures can identify different subtypes, which can be used to create patient profiles and design specific therapies. However, there is no consensus regarding the best treatment sequence for each subgroup of patients. During the SABCC Congress of 2014, specialized breast cancer oncologists from referral hospitals in Europe met to define patient profiles and to determine specific treatment sequences for each one. Conclusions were then debated in a final meeting in which a relative degree of consensus for each treatment sequence was established. Four patient profiles were defined according to established breast cancer phenotypes: pre-menopausal patients with luminal subtype, post-menopausal patients with luminal subtype, patients with triple-negative subtype, and patients with HER2-positive subtype. A treatment sequence was then defined, consisting of hormonal therapy with tamoxifen, aromatase inhibitors, fulvestrant, and mTOR inhibitors for pre- and post-menopausal patien ts; a chemotherapy sequence for the first, second, and further lines for luminal and triple-negative patients; and an optimal sequence for treatment with new antiHER2 therapies. Finally, a document detailing all treatment sequences, that had the agreement of all the oncologists, was drawn up as a guideline and advocacy tool for professionals treating patients with this disease (AU)


No disponible


Assuntos
Humanos , Feminino , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/terapia , Congressos como Assunto/normas , Metástase Neoplásica/terapia , Hormônios/uso terapêutico , Tamoxifeno/uso terapêutico , Inibidores da Aromatase/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama , Pós-Menopausa , Pré-Menopausa , Receptor ErbB-2/análise , Bevacizumab/uso terapêutico , Capecitabina/uso terapêutico
11.
Clin. transl. oncol. (Print) ; 19(2): 197-203, feb. 2017. tab, graf
Artigo em Inglês | IBECS | ID: ibc-159452

RESUMO

Purpose. We aim to investigate the correlation of HER2 expression with liver metastasis and the impact of HER2 status and trastuzumab therapy on the prognosis of gastric cancer with liver metastasis (GCLM) patients. Methods. This prospective observational study was carried out in Shanghai Zhongshan Hospital, Fudan University, from January 2012 to June 2015. HER2 status and baseline characteristics were collected from the patient record. GCLM patients were divided into three groups according to HER2 status and trastuzumab therapy. Results. A total of 290 patients were included, and94 patients were diagnosed with liver metastasis. The HER2 positivity was 37.2 % (35/94) in GCLM patients and 21 % (61/290) in the overall GC patients. Among 94 GCLM patients, 28 HER2-positive patients received trastuzumab-based therapy (group A), 7 HER2-positive patients received chemotherapy alone (group B) and the other 59 patients were HER2 negative (group C). The median progression-free survival (PFS) for groups A, B and C was 7.83, 6.30 and 5.33 months, respectively (P = 0.007). The median overall survival (OS) for groups A, B and C was 12.00, 10.47 and 8.67 months, respectively (P = 0.056). Further Cox analysis showed that there was no significant difference in OS (P = 0.917) and PFS (P = 0.456) between group B and C. Conclusions. HER2 positivity was higher in GCLM patients. HER2 status itself was not an independent prognostic factor in GCLM patients. Trastuzumab-based therapy could significantly improve survival in HER2-positive GCLM patients (AU)


No disponible


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Receptor ErbB-2/análise , Neoplasias Gástricas/complicações , Neoplasias Gástricas/diagnóstico , Trastuzumab/uso terapêutico , Neoplasias Hepáticas/complicações , Neoplasias Hepáticas/diagnóstico , Metástase Neoplásica/diagnóstico , Metástase Neoplásica/patologia , Prognóstico , Estudos Prospectivos , Declaração de Helsinki , Análise Estatística , Análise Multivariada
12.
Clin. transl. oncol. (Print) ; 17(11): 862-869, nov. 2015. tab, ilus
Artigo em Inglês | IBECS | ID: ibc-143456

RESUMO

Purpose. Trastuzumab has proven to improve the prognosis of HER2-positive breast cancer, but the information available about its administration for small tumors is still limited. Therefore, we assessed the use of adjuvant regimens with trastuzumab for the treatment of small HER2-positive breast cancer in routine clinical practice. Methods. This observational study was conducted in patients with HER2-positive breast adenocarcinoma ≤1.5 cm who received trastuzumab-based adjuvant treatment in clinical practice. Clinical/histopathological data were retrieved from patients’ medical charts. Results. A total of 101 evaluable patients were enrolled (median age [range], 56.7 [49.0–64.8] years; ECOG 0, 98.0 %; ductal carcinoma, 88.1 %; lymph nodes N0, 79.2 %). Only five (5.0 %) patients received neoadjuvant treatment, while all patients underwent tumor surgery. Adjuvant trastuzumab was administered at a mean (±SD) dose of 5.9 ± 1.5 mg/kg/cycle, and mostly in a three-weekly schedule (89 [89.0 %] patients). The most frequent adjuvant therapy used with trastuzumab was chemotherapy (87 [86.1 %] patients), followed by radiotherapy (63 [62.4 %] patients) and hormone therapy (52 [51.5 %] patients). Chemotherapy regimens mainly included doxorubicin, cyclophosphamide and paclitaxel/docetaxel (n = 30), docetaxel and cyclophosphamide (n = 15), docetaxel and carboplatin (n = 13). Hormone therapy mainly included letrozole (n = 17) and tamoxifen (n = 17). Nine (8.9 %) patients reported trastuzumab-related adverse events; only one allergic reaction reached grade 3 toxicity. Conclusion. This study shows that trastuzumab-based adjuvant treatment of small HER2-positive breast cancer is mostly based on chemotherapy—mainly paclitaxel/docetaxel. Adjuvant administration of trastuzumab for small HER2-positive breast cancer seems to be similar to that used for larger tumors (AU)


No disponible


Assuntos
Feminino , Humanos , Neoplasias da Mama/tratamento farmacológico , Quimioterapia Adjuvante/instrumentação , Quimioterapia Adjuvante/métodos , Quimioterapia Adjuvante , Ciclofosfamida/uso terapêutico , Paclitaxel/uso terapêutico , Carboplatina/uso terapêutico , Receptor ErbB-2/análise , Receptor ErbB-2 , Anticorpos Monoclonais/uso terapêutico , Tamoxifeno/uso terapêutico , Imuno-Histoquímica/métodos , Imuno-Histoquímica
13.
Clin. transl. oncol. (Print) ; 17(8): 647-656, ago. 2015. ilus
Artigo em Inglês | IBECS | ID: ibc-138180

RESUMO

Purpose. Human epithelial growth factor receptor 2 (HER2) is over-expressed in several malignancies and represents an important therapeutic target. Aptamers are oligonucleotides that may potentially serve as tumor-homing ligand with excellent affinity and specificity for targeted cancer therapy. However, aptamers need to have nuclease resistance in order to function in vivo. The aim of this study was to generate a novel HER2 thioaptamer with enhanced nuclease resistance. Methods. The HER2 thioaptamer is selected in an evolutionary process called systematic evolution of ligands by exponential enrichment. Results. The thioaptamer could bind to the extracellular domain of HER2 with a K d of 172 nM and had minimal cross reactivity to trypsin or IgG. Moreover, the thioaptamer was found capable of binding with the HER2-positive breast cancer cells SK-BR-3 and MDA-MB-453, but not the HER2-negative cells MDA-MB-231. Notably, the thioaptamer HY6 largely maintained its structural integrity facing the nucleases in serum, while regular DNA aptamers were mostly digested. Additionally, the thioaptamer retained the capability of binding with the HER2-positive cells in the presence of serum, whereas non-thionated HER2 aptamer lost the binding function. Conclusion. The results indicated that the selected thioaptamer was more resistant to nuclease than regular DNA aptamers and might potentially function as a HER2-targeting ligand in complicated environment (AU)


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Assuntos
Feminino , Humanos , Masculino , Receptor ErbB-2/análise , Aptâmeros de Nucleotídeos , Neoplasias/diagnóstico , Oligonucleotídeos/análise , Inibidores da Tripsina/análise , Imunoglobulina G/análise , Citometria de Fluxo , Aptâmeros de Nucleotídeos/isolamento & purificação , Neoplasias/genética , Citometria de Fluxo/métodos
14.
Clin. transl. oncol. (Print) ; 17(7): 530-538, jul. 2015. tab, ilus
Artigo em Inglês | IBECS | ID: ibc-138449

RESUMO

Purpose. Over the last decade a dramatic improvement in the treatment and prognosis of human epidermal growth factor receptor-2 (HER2) positive metastatic breast cancer (MBC) has been achieved. This study aimed to describe pattern, timing of metastases, and time to progression (TTP) of MBC patients (pts) treated with multiple lines of therapy with trastuzumab and/or lapatinib. Methods. Clinical-pathologic features, treatment-lines and metastatic sites were collected from the institutional database; TTP was evaluated for each treatment-line. A meta-analysis of treatment-line estimates was performed; Q test and I 2-index were used to detect and estimate heterogeneity. Cox’s proportional hazards model and Fine and Gray’s proportional subhazards model in a competing risks setting were used to detect differences in hazard rate and to estimate relative risks. Results. 112 pts were analyzed. The median number of treatment-lines administered was 6 (range 1–17) and 524 (86 %) disease progression events were observed (median follow up 4.2 years). Distribution of metastases at baseline remained consistent across all lines. Having a given site affected by metastasis was a major risk factor of progression in that site. Hormone-receptor-positive pts resulted more likely to progress on bone (HR = 1.88). Elderly pts were less likely to progress on CNS (HR = 0.73). Median TTP resulted superior to 5 months up to the 6th line of treatment, reaching a plateau at the 9th treatment-line. Conclusions. These data suggest that risk factors for progression in HER2 positive MBC do not significantly differ between various distributions of metastases, and that MBC pts benefit from anti-HER2 therapy even in late treatment-lines (AU)


No disponible


Assuntos
Feminino , Humanos , Pessoa de Meia-Idade , Receptor ErbB-2/análise , Receptor ErbB-2 , Receptor ErbB-2/isolamento & purificação , Receptor ErbB-3 , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/terapia , Progressão da Doença , Metástase Neoplásica/diagnóstico , Metástase Neoplásica/tratamento farmacológico , Metástase Neoplásica/patologia , Anticorpos Monoclonais/uso terapêutico
15.
Clin. transl. oncol. (Print) ; 13(5): 335-340, mayo 2011. tab
Artigo em Inglês | IBECS | ID: ibc-124445

RESUMO

BACKGROUND: Accurate HER2 testing is of great clinical value for the identification of breast cancer patients who are eligible for trastuzumab therapy. The aim of this study is to review breast carcinomas diagnosed from 2001 to 2007 at a Spanish National Reference Centre for HER2 testing, evaluating the agreement between HER2 immunohistochemical (IHC) tests and fluorescence in situ hybridisation (FISH) tests. METHODS: Demographic and clinical information was obtained from 2751 breast carcinoma patients. HER2 IHC and FISH tests were performed both in a local laboratory and in the reference centre. The HER2 IHC0/1+, IHC2+, IHC3+ and FISH-positive patients comprised 64%, 20%, 16% and 24% of the available population, respectively (results from the reference centre). Using statistical approaches, we evaluated the agreement between: (1) HER2 IHC and FISH tests, and (2) results provided by the local and the reference laboratories. RESULTS: The data confirmed a statistically significant relation between HER2 overexpression and amplification. We also found that instances of polysomy 17 and heterogeneous patterns of HER2 expression (heterogeneous staining distribution in different areas of the same tumour) are more frequently observed in HER2-positive tumours. Finally, since the diagnoses were made from 2001 to 2007, we could also observe a rising agreement rate between laboratories/pathologists with time. CONCLUSIONS: HER2 testing is most accurate when performed by experienced pathologists and at a high-volume reference laboratory. Polysomy 17 and HER2 heterogeneous staining patterns should also be considered for a better understanding of the variation in the anti-HER2 therapeutic response (AU)


Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Carcinoma/genética , Regulação Neoplásica da Expressão Gênica , Resultado do Tratamento , Genes erbB-2 , Receptor ErbB-2 , Anticorpos Monoclonais Humanizados , Anticorpos Monoclonais/uso terapêutico , Antineoplásicos/uso terapêutico , Carcinoma/metabolismo , Cromossomos Humanos Par 17/ultraestrutura , Imuno-Histoquímica/métodos , Hibridização in Situ Fluorescente/métodos , Hibridização in Situ Fluorescente , Espanha/epidemiologia
16.
Actas urol. esp ; 35(4): 189-194, abr. 2011. ilus, tab, graf
Artigo em Espanhol | IBECS | ID: ibc-88534

RESUMO

Objetivo: evaluar el valor pronóstico de la expresión de la HER2 en carcinoma vesical de células transicionales (CCT) no músculo invasivo, poniendo especial énfasis en la población con alto grado. Materiales y métodos (pacientes): se realizaron micromatrices de tejidos (TMA) con especímenes TUR-B representativos de 84 pacientes con CCT vesical no músculo invasivo (40 pT1GII y44 pT1GIII) a los que se trataba en nuestra institución. El mismo patólogo que había llevado a cabo la prueba ciega de análisis inmunohistoquímico con Hercep realizó el proceso de asignación de profundidades de invasión y grados de manera uniforme: se consideró el valor 3+ como signo altamente positivo de sobreexpresión de la HER2. También se evaluaron otras variables clínico-patológicas. Resultados: se detectó sobreexpresión de proteína HER2 en 30/ 44 (68,2%) lesiones pT1GIII, prediciendo recaídas en este subgrupo de CCT vesical (p < 0,01). Se detectó expresión negativa de la HER2 en 26/ 40 (65%) casos con CCT pT1GII, dándose esta situación con mayor frecuencia en tumores unifocales y sin angiogénesis, con baja tasa de recaída y sin evolución. La supervivencia libre de recidiva puede también preverse mediante la expresión de la HER 2 en los tumorespT1GII (p < 0,01). Conclusión: la expresión de la HER2 mediante test Hercep puede ser de utilidad en la predicción de recaídas en CCT vesical no músculo invasivo. El potencial de aplicación de este estudio, sobre todo en lo que se refiere a la predicción de la respuesta a BCG, debe confirmarse de forma prospectiva en ensayos multicéntricos (AU)


Objective: to evaluate the prognostic value of HER2 expression in non-muscle invasive bladder transitional cell carcinoma (TCC) with special emphasis in the high grade population. Materials and methods (patients): Tissue microarrays (TMA) were performed with representative TUR-B specimens from 84 patients with non-muscle invasive bladder TCC (40 pT1GII and 44 pT1GIII) treated in our institution. Depth of invasion and grade were uniformly assigned by the same pathologist who performed blind immunohistochemical analysis with Hercep test: 3+was considered strong positive HER2 over expression. Other clinico-pathological variables were also assessed. Results: HER2 protein over expression was detected in 30/44 (68.2%) pT1GIII lesions and predicted recurrence in this subgroup of bladder TCC (p < 0.01). Negative HER2 expression was detected in 26/40 (65%) cases with pT1GII TCC, and this condition was more frequent in unifocal tumours, without angiogenesis, with low recurrence rate and without progression. Recurrence-free survival can also be anticipated by HER 2 expression within pT1GII tumours (p < 0.01). Conclusion: HER2 expression using Hercep test may be useful to predict recurrence in non-muscle invasive bladder TCC. The potential application of this study, especially regarding prediction of response to BCG, should be prospectively confirmed in multi-institutional trials (AU)


Assuntos
Humanos , Neoplasias da Bexiga Urinária/patologia , Estadiamento de Neoplasias , Receptor ErbB-2/análise , /análise , Recidiva Local de Neoplasia/patologia , Carcinoma de Células de Transição/patologia , Invasividade Neoplásica/patologia
17.
Med. oral patol. oral cir. bucal (Internet) ; 16(1): e11-e14, ene. 2011. ilus
Artigo em Inglês | IBECS | ID: ibc-95831

RESUMO

Oral postinflammatory pigmentation (OPP) is a discoloration of the oral mucosa caused by an excess of melaninproduction and deposition with in the basal layer of the epithelium and connective tissue of areas affected by chronicinflammation. Therefore, it is mandatory to demonstrate the association with a previous or concomitant inflammatoryprocess in the same area of oral mucosa. Clinically OPP appears as a localized or diffuse, black to brownpigmentation. OPP may persist for many years even though the disappearing of the pigmentation after the resolution of the inflammatory state has been reported. We reviewed retrospectively the medical records and, when performed,biopsy examinations of 7 cases of OPP. Four cases were associated with oral lichen planus, two cases with lichenoid lesions and one case with proliferative verrucous leukoplakia. Despite a possible high prevalence of OPP, only a fewreports concerning diagnosis, etiopathogenesis and clinical manifestation have been published so far (AU)


Assuntos
Humanos , Feminino , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Mucina-1/análise , Receptor ErbB-2/análise , Saliva/química , Antígeno Carcinoembrionário/análise , Anticoncepcionais Orais/farmacologia
18.
Med. oral patol. oral cir. bucal (Internet) ; 16(1): e29-e32, ene. 2011. tab
Artigo em Inglês | IBECS | ID: ibc-95835

RESUMO

Objectives: Oral contraceptives (OCP) are highly effective, safe and widely used. Higher exposure to endogenous and exogenous estrogens is generally thought to increase the risk of breast cancer. Therefore, this study was conducted to determine if oral contraceptive use affected the expression of CA 15-3, CEA and C-erb B-2 in the saliva of healthy women.Study design: The participants consisted of 87 healthy women (43 controls and 44 using oral contraceptives) ranging in age from 20 to 54 years. The volunteers participated by giving one – time stimulated whole saliva samples.Then the samples were analysed for CA 15-3, CEA and C-erb B-2 concentrations. Results: The student t-test was used to compare group means for variables with comparable variability. The meanof C-erb B-2, CEA, and CA 15-3 concentrations (in the case and control groups) was (1.93, 1.70), (34.46, 31.62) and(12.58, 16.19) respectively. These differences were not statistically significant.Conclusions: Our findings suggest that the levels of the cancer biomarkers C-erb B-2, CEA and CA 15-3 were not affected by increased levels of estrogens in the body (AU)


Assuntos
Humanos , Feminino , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Antígeno Carcinoembrionário/análise , Anticoncepcionais Orais/farmacologia , Mucina-1/análise , Receptor ErbB-2/análise , Saliva/química
19.
Rev. senol. patol. mamar. (Ed. impr.) ; 23(4): 168-172, ago.-oct. 2010. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-85953

RESUMO

La importancia en la detección de la amplificación del gen HER2 es esencial en el cáncer de mama puesto que estas pacientes no responden a los tratamientos de quimioterapia y hormonales convencionales. La determinación del HER2 tiene un papel crucial como diana terapéutica del trastuzumab. A continuación discutiremos la efectividad y utilidad clínica de la técnica hibridación in situ fluorescente (FISH), la hibridación in situ cromogénica (CISH) y la hibridación in situ cromogénica con plata (SISH), como métodos usados para el estudio del gen HER2 en la selección correcta de las pacientes con cáncer de mama, que son candidatas a recibir trastuzumab(AU)


The importance of determining HER2 status lays on the fact that breast cancer patients with HER2 amplification are more reluctant to conventional chemotherapy and hormonal treatments. Thus the HER2 analysis is an essential requisite to determine which patients are eligible to be treated with trastuzumab. The aim of this article is reviewing the effectiveness and clinical utility of HER 2 diagnostic test with fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH) and silver chromogenic in situ hybridization (SISH) to correctly select breast cancer patients who are candidates to be treated with trastuzumab(AU)


Assuntos
Humanos , Feminino , Hibridização In Situ/métodos , Receptor ErbB-2/administração & dosagem , Receptor ErbB-2/análise , Neoplasias da Mama/diagnóstico , Citogenética/métodos , Análise Citogenética/instrumentação , Hibridização In Situ/tendências , Hibridização In Situ , Genes erbB-2 , Corantes Fluorescentes
20.
Rev. esp. patol ; 43(2): 79-85, abr.-jun. 2010. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-79825

RESUMO

Antecedentes. El cáncer de mama es un grupo heterogéneo de tumores. Los estudios de microarrays de ADN han llevado a la clasificación del carcinoma invasor de mama en diferentes clases moleculares. El objetivo de este estudio fue determinar la expresión de p63 y citoqueratina 5/6 en carcinomas ductales invasores y su relación con las diferentes clases moleculares, en especial con el subgrupo de tipo basal. Métodos. Se realizó estudio inmunohistoquímico con los anticuerpos p63 y CK5/6 en 200 muestras de carcinoma ductal invasor sin otra especificación. En cada caso se había determinado previamente el estado de los receptores de estrógeno y progesterona (RE, RP), y de HER2. De acuerdo a estos datos, los tumores se clasificaron como luminal A, luminal B, HER2+ y tipo basal (triple negativo). Resultados. Se observó expresión de p63 en 5 casos de HER2+ y 19 casos de tumores del tipo basal (23,2%), se demostró una fuerte relación entre la expresión de CK5/6 y los tumores de tipo basal (59,8%, p<0,0001), pero también se expresó en un caso luminal A, 3 luminal B y 8 HER2+. Conclusiones. No todos los casos triple negativo son de tipo basal. Es necesario estandarizar la clasificación molecular basada en inmunohistoquímica, así como el panel de anticuerpos a utilizar, en especial para la identificación del tipo basal(AU)


Background. Breast cancer is a heterogeneous group of tumors. DNA microarray profiling studies have led to the classification of invasive breast carcinoma called molecular classes. AIMS: To study the expression of p63 and cytokeratin (CK) 5/6 in invasive ductal carcinomas and their relationship to the different molecular classes, especially the basal like subgroup. Methods. Immunohistochemistry with the antibodies p63 and CK5/6 was performed in 200 samples of invasive ductal carcinomas with no other specification. Each case had previous results of estrogen and progesterone receptor (ER, PR), and HER2. According to these data they were classified as luminal A, luminal B, HER2+ and basal like (triple negative). Results. p63 was expressed in 5 cases of HER2+ and 19 cases of basal like tumours (19.5%). There was a strong relationship between CK5/6 expression and basal like tumours (68.9%, p<0.0001), but it was also expressed in one luminal A, three luminal B and eight HER2+ cases. Conclusions. Not every triple negative tumors express basal markers. It is necesary to standarize the molecular classification of breast cancer and the panel of markers to use in its caracterization, especially for the basal like(AU)


Assuntos
Humanos , Feminino , DNA , Queratinas , Neoplasias Ductais, Lobulares e Medulares/diagnóstico , Neoplasias Ductais, Lobulares e Medulares/patologia , Imuno-Histoquímica , Receptor ErbB-2/análise , Análise em Microsséries/métodos , Análise em Microsséries , /análise , Proteínas Supressoras de Tumor/análise , Neoplasias da Mama/química , Carcinoma/química , Análise em Microsséries/classificação , Análise em Microsséries/instrumentação , Análise em Microsséries/tendências
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