RESUMO
BACKGROUND: Limited data are available regarding the real-world effectiveness and safety of Cyclin Dependent Kinase 4/6 inhibitor (CDK4/6i) (palbociclib/ribociclib) just as a first-line treatment for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2â) metastatic breast cancer (MBC). OBJECTIVE: To assess whether clinical or demographic characteristics limit access to first-line CDK4/6i treatment in clinical practice in the Autonomous Community of Andalusia (Spain) between November 2017 and April 2020. In addition, effectiveness will be described in an exploratory analysis. METHODS: Physicians from 12 centers participated in selecting demographic and clinical characteristics, treatment, and outcome data from women with HR + /HER2- MBC treated with or without CDK4/6i in addition to hormonal in the first-line setting, in a 3:1 proportion. Kaplan-Meier analysis estimated progression-free rates (PFRs) and survival rates (SRs). RESULTS: A total of 212 patients were included, of whom 175 (82.5%) were in the CDK4/6i treatment group and 37 (17.5%) were in the non-CDK4/6i treatment group (control group). Patients in the CDK 4/6i treatment group were younger (p = 0.0011), the biopsies of the metastatic site at the moment of the relapse were most commonly performed (p = 0.0454), and had multiple metastatic sites (p = 0.0025). The clinical benefit rate (CBR) was 82.3% in the CDK4/6i group and 67.8% in the control group. Median time to a progression event or death (PFS) was 20.4 months (95%CI 15.6-28) in the CDK4/6i group and 12.1 months (95%CI 7.9-not reached) in the control group. CONCLUSIONS: Younger patients, biopsies of metastatic disease and with multiple metastatic sites were more frequently treated with CDK4/6i in our daily clinical practice.
RESUMO
PURPOSE: HER2-targeted therapies have dramatically improved outcomes of patients with HER2-positive breast cancer (BC), as demonstrated in neoadjuvant trials. This study aims to provide real-world evidence on the use and effectiveness of combined pertuzumab, trastuzumab and chemotherapy (CT) in early-stage HER2-positive BC. METHODS: A retrospective, multicentre study was conducted on patients diagnosed with HER2-positive early BC treated with neoadjuvant pertuzumab and trastuzumab plus CT at 13 Spanish sites. The primary endpoint was pathological complete response (pCR). RESULTS: A total of 310 patients were included. Pertuzumab and trastuzumab were combined with anthracyclines and taxanes, carboplatin and docetaxel, and taxane-based CT in 77.1%, 16.5%, and 6.5% of patients, respectively. Overall, the pCR rate was 62.2%. The pCR was higher amongst patients with hormone receptor-negative tumours and with tumours expressing higher levels of Ki-67 (> 20%). After postoperative adjuvant treatment, 13.9% of patients relapsed. Those patients who did not achieve pCR, with tumours at advanced stages (III), and with node-positive disease were more likely to experience distant relapse. Median overall survival (OS) and distant disease-free survival (D-DFS) were not reached at the study end. The estimated mean OS and D-DFS times were 7.5 (95% CI 7.3-7.7) and 7.3 (95% CI 7.1-7.5) years, respectively (both were significantly longer amongst patients who achieved pCR). Grade 3-4 anti-HER2 related toxicities were reported in six (1.9%) patients. CONCLUSION: Neoadjuvant pertuzumab and trastuzumab plus CT achieve high pCR rates in real-life patients with HER2-positive early BC, showing an acceptable safety profile. Innovative adjuvant strategies are essential in patients at high risk of distant disease recurrence.
Assuntos
Anticorpos Monoclonais Humanizados , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias da Mama , Terapia Neoadjuvante , Receptor ErbB-2 , Trastuzumab , Humanos , Feminino , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Neoplasias da Mama/metabolismo , Trastuzumab/uso terapêutico , Trastuzumab/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Pessoa de Meia-Idade , Estudos Retrospectivos , Receptor ErbB-2/metabolismo , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/administração & dosagem , Adulto , Idoso , Carboplatina/administração & dosagem , Carboplatina/uso terapêutico , Taxoides/administração & dosagem , Taxoides/uso terapêutico , Docetaxel/administração & dosagem , Docetaxel/uso terapêutico , Estadiamento de NeoplasiasRESUMO
La hidatidosis es una zoonosis parasitaria causada por Echinococcus granulosus. Es endémica en Argentina y en la Provincia de Buenos Aires, especialmente al sur de la cuenca del río Salado. Durante 2014 y 2016, se notificaron al Departamento de Zoonosis Rurales 479 casos de hidatidosis; el 12,1% fueron casos confirmados en menores de 18 años de edad. El 59% correspondió al sexo masculino y el grupo de 13 a 17 años fue el más prevalente (47%). El 64% tuvo afectación hepática; 22%, pulmonar; 5%, hepatopulmonar; 5%, esplénica y 4%, cerebral. El 33% de los casos fueron asintomáticos. El 60% residía en el área urbana y, de estos, un 20% no presentó nexo epidemiológico. Esta es una enfermedad de denuncia obligatoria y existen programas provinciales y nacionales que contemplan acciones gratuitas tendientes a controlarla, pero, a pesar de esto, continúa siendo un problema de difícil solución.
Hydatidosis is a parasitic zoonosis caused by Echinococcus granulosus. It is endemic in Argentina and in the province of Buenos Aires, especially to the south of the Rio Salado basin. During 2014 and 2016, the Department of Rural Zoonoses was notified of479 cases of hydatidosis, with 12.1% confirmed in children under 18 years of age. Fifty-nine percent corresponded to males and the group of 13 to 17 years was the most prevalent one (47%). Sixty-four percent had liver involvement, 22% pulmonary involvement, 5% hepatopulmonary involvement, 5% splenic involvement and 4% cerebral involvement. Thirty-three percent of the cases were asymptomatic. Sixty percent resided in urban areas and of these 20% did not present an epidemiological link. This is a disease of mandatory reporting and there are provincial and national programs that contemplate free actions tending to control it, but despite this, it continues to be a difficult problem to solve.
Assuntos
Humanos , Masculino , Feminino , Recém-Nascido , Lactente , Pré-Escolar , Criança , Adolescente , Zoonoses/epidemiologia , Echinococcus granulosus/isolamento & purificação , Equinococose/epidemiologia , Argentina/epidemiologia , População Urbana/estatística & dados numéricos , Zoonoses/parasitologia , Prevalência , Distribuição por Sexo , Distribuição por Idade , AnimaisRESUMO
Hydatidosis is a parasitic zoonosis caused by Echinococcus granulosus. It is endemic in Argentina and in the province of Buenos Aires, especially to the south of the Rio Salado basin. During 2014 and 2016, the Department of Rural Zoonoses was notified of 479 cases of hydatidosis, with 12.1% confirmed in children under 18 years of age. Fifty-nine percent corresponded to males and the group of 13 to 17 years was the most prevalent one (47%). Sixty-four percent had liver involvement, 22% pulmonary involvement, 5% hepatopulmonary involvement, 5% splenic involvement and 4% cerebral involvement. Thirtythree percent of the cases were asymptomatic. Sixty percent resided in urban areas and of these 20% did not present an epidemiological link. This is a disease of mandatory reporting and there are provincial and national programs that contemplate free actions tending to control it, but despite this, it continues to be a difficult problem to solve.
La hidatidosis es una zoonosis parasitaria causada por Echinococcus granulosus. Es endémica en Argentina y en la Provincia de Buenos Aires, especialmente al sur de la cuenca del río Salado. Durante 2014 y 2016, se notificaron al Departamento de Zoonosis Rurales 479 casos de hidatidosis; el 12,1% fueron casos confirmados en menores de 18 años de edad. El 59% correspondió al sexo masculino y el grupo de 13 a 17 años fue el más prevalente (47%). El 64% tuvo afectación hepática; 22%, pulmonar; 5%, hepatopulmonar; 5%, esplénica y 4%, cerebral. El 33% de los casos fueron asintomáticos. El 60% residía en el área urbana y, de estos, un 20% no presentó nexo epidemiológico. Esta es una enfermedad de denuncia obligatoria y existen programas provinciales y nacionales que contemplan acciones gratuitas tendientes a controlarla, pero, a pesar de esto, continúa siendo un problema de difícil solución.
Assuntos
Equinococose/epidemiologia , Echinococcus granulosus/isolamento & purificação , Zoonoses/epidemiologia , Adolescente , Distribuição por Idade , Animais , Argentina/epidemiologia , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Prevalência , Distribuição por Sexo , População Urbana/estatística & dados numéricos , Zoonoses/parasitologiaRESUMO
OBJECTIVE: To measure the vascularization and ovarian volume with three-dimensional sonography in patients diagnosed of polycystic ovary syndrome with stimulated ovulation treatment, and to analyse the differences between the patients treated with clomiphen citrate versus clomiphen citrate and metformin. MATERIAL AND METHOD: Therty patients were studied. Twenty ovulation cycles were obtained with clomiphen citrate and 17 with clomiphen citrate plus merformin (added in case of obesity or hyperglucemy/hyperinsulinemia). Ovarian volumes and vascular indexes were studied with 3D-sonography and results were analysed by treatment. RESULTS: There were no statistical differences of ovarian volume by treatment along the cycles, although bigger volume were found in ovulatory cycles compared to non-ovulatory ones (20,36 versus 13,89 ml, p = 0,026). No statistical differences were also found concerning vascular indexes, neither by treatment nor by the obtention of ovulation in the cycle. CONCLUSIONS: Ovarian volume and vascular indexes measured with three-dimensional sonography in patients diagnosed of polycystic ovary syndrome do not show differents values in patients treated with clomiphen citrate alone versus clomiphen citrate plus metformin.
Assuntos
Clomifeno/uso terapêutico , Fármacos para a Fertilidade Feminina/uso terapêutico , Metformina/uso terapêutico , Ovário/efeitos dos fármacos , Indução da Ovulação , Síndrome do Ovário Policístico/tratamento farmacológico , Adulto , Clomifeno/administração & dosagem , Clomifeno/efeitos adversos , Clomifeno/farmacologia , Quimioterapia Combinada , Feminino , Fármacos para a Fertilidade Feminina/efeitos adversos , Fármacos para a Fertilidade Feminina/farmacologia , Humanos , Hiperglicemia/diagnóstico por imagem , Hiperglicemia/tratamento farmacológico , Hiperglicemia/etiologia , Hiperglicemia/patologia , Hiperinsulinismo/diagnóstico por imagem , Hiperinsulinismo/tratamento farmacológico , Hiperinsulinismo/etiologia , Hiperinsulinismo/patologia , Metformina/administração & dosagem , Metformina/efeitos adversos , Metformina/farmacologia , Neovascularização Fisiológica/efeitos dos fármacos , Obesidade/diagnóstico por imagem , Obesidade/tratamento farmacológico , Obesidade/etiologia , Obesidade/patologia , Tamanho do Órgão/efeitos dos fármacos , Ovário/irrigação sanguínea , Ovário/diagnóstico por imagem , Síndrome do Ovário Policístico/complicações , Síndrome do Ovário Policístico/diagnóstico por imagem , Síndrome do Ovário Policístico/patologia , Estudos Prospectivos , Resultado do Tratamento , Ultrassonografia Doppler , Adulto JovemRESUMO
La acrodermatitis enteropática es una rara patología de herenciaautosómica recesiva ocasionada por una deficiente absorcióndel zinc de la dieta. Se caracteriza por la tríada de alopecía,diarrea y dermatitis acral y periorificial. Se presenta una paciente de 11 meses de edad con síntomas característicos cuyo diagnóstico fue confirmado por bajos niveles plasmáticos de zinc (37,7 µg%). Se realizó tratamiento consulfato de zinc a dosis de 5 mg/kg/día con evolución claramente favorable.
Acrodermatitis enteropathica is a rare autosomal recesive disorder, caused by impaired absorption of zinc dietary intake. It is characterized by a triad of alopecia, diarrhea and acral and periorificial dermatitis. We report an 11 month-old girl with tipical symptoms in whom the diagnosis was confirmed by decreased plasma zinc level (37,7 µg%). The patient was given zinc sulfate 5 mg/kg/day and showed marked improvement.
Assuntos
Lactente , Acrodermatite/terapia , Zinco/administração & dosagem , Paraceratose , DifenidraminaRESUMO
La acrodermatitis enteropática es una rara patología de herenciaautosómica recesiva ocasionada por una deficiente absorcióndel zinc de la dieta. Se caracteriza por la tríada de alopecía,diarrea y dermatitis acral y periorificial. Se presenta una paciente de 11 meses de edad con síntomas característicos cuyo diagnóstico fue confirmado por bajos niveles plasmáticos de zinc (37,7 Ag%). Se realizó tratamiento consulfato de zinc a dosis de 5 mg/kg/día con evolución claramente favorable.(AU)
Acrodermatitis enteropathica is a rare autosomal recesive disorder, caused by impaired absorption of zinc dietary intake. It is characterized by a triad of alopecia, diarrhea and acral and periorificial dermatitis. We report an 11 month-old girl with tipical symptoms in whom the diagnosis was confirmed by decreased plasma zinc level (37,7 Ag%). The patient was given zinc sulfate 5 mg/kg/day and showed marked improvement.(AU)
Assuntos
Lactente , Paraceratose , Acrodermatite/terapia , Zinco/administração & dosagem , DifenidraminaRESUMO
RESUMEN Las convulsiones son un trastorno frecuente en pediatría y se producen en 3 menos 5 por ciento de los niños. Las causas son diversas y entre ellas se hallan las deorden metabólico. Presentamos una paciente de 11 meses, derivada de Santa Rosa, La Pampa, por estadoconvulsivo en estudio. Ingresó medicada con tresanticonvulsivantes y ceftriaxona más aciclovir, conelectroencefalograma y resonancia magnética decerebro normales. Al examen físico presentaba hipoplasiade esmalte dental, palidez y ligera hipertoníade miembros inferiores. Los exámenes de laboratorioal ingreso demostraron anemia normocíticanormocrómica, hipoglucemia, hipocalcemia, hiperfosfatemiay niveles bajos de PTH. Ecografía cerebral:calcificaciones talámicas bilaterales y electrocardiogramacon QT prolongado. Con diagnóstico de hipoparatiroidismo primario, se inició tratamientocon gluconato de calcio endovenoso, carbonato decalcio como quelante del fósforo y 1, 25 dihidroxicolecalciferol(calcitriol), 25 mcg/día. Se realizaronestudios para detectar otras deficiencias glandulares.Queremos destacar la importancia de recordarestas causas infrecuentes de síndrome convulsivopara instaurar un tratamiento precoz y así evitarcomplicaciones y secuelas.Palabras clave: hipoparatiroidismo, convulsiones
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Lactente , Hipoparatireoidismo , Hipoparatireoidismo/diagnóstico , Hipoparatireoidismo/etiologia , Convulsões , UltrassonografiaRESUMO
RESUMEN Las convulsiones son un trastorno frecuente en pediatría y se producen en 3 menos 5 por ciento de los niños. Las causas son diversas y entre ellas se hallan las deorden metabólico. Presentamos una paciente de 11 meses, derivada de Santa Rosa, La Pampa, por estadoconvulsivo en estudio. Ingresó medicada con tresanticonvulsivantes y ceftriaxona más aciclovir, conelectroencefalograma y resonancia magnética decerebro normales. Al examen físico presentaba hipoplasiade esmalte dental, palidez y ligera hipertoníade miembros inferiores. Los exámenes de laboratorioal ingreso demostraron anemia normocíticanormocrómica, hipoglucemia, hipocalcemia, hiperfosfatemiay niveles bajos de PTH. Ecografía cerebral:calcificaciones talámicas bilaterales y electrocardiogramacon QT prolongado. Con diagnóstico de hipoparatiroidismo primario, se inició tratamientocon gluconato de calcio endovenoso, carbonato decalcio como quelante del fósforo y 1, 25 dihidroxicolecalciferol(calcitriol), 25 mcg/día. Se realizaronestudios para detectar otras deficiencias glandulares.Queremos destacar la importancia de recordarestas causas infrecuentes de síndrome convulsivopara instaurar un tratamiento precoz y así evitarcomplicaciones y secuelas.Palabras clave: hipoparatiroidismo, convulsiones