RESUMEN
PURPOSE: The Spanish Society of Medical Oncology (SEOM, for its Spanish acronym) would like to attest to the relevance of training in Oncology as part of the undergraduate education in Medicine program and issue recommendations to improve said training, with the aim of responding better to the challenges that cancer poses to our society. MATERIALS AND METHODS: The curricula of 42 schools of medicine were reviewed with interviews with at least one teaching medical oncologist from each faculty. The qualitative and opinion analysis was completed by means of an online questionnaire targeting lecturers, resident tutors, and residents in Medical Oncology (MO), enabling the detection of needs and areas for improvement at an organizational level and in terms of skill acquisition. RESULTS: While the number of medical schools with a specific, mandatory program in MO has grown by up to 90%, it has not been accompanied by an increase in independent programs. Instead, they largely consist of programs shared with other specialties (61% of the medical faculties). In most of the undergraduate education programs, Oncology contents are fragmented and approached from the perspective of each organ system. CONCLUSIONS: Despite the positive evolution in recent years, the heterogeneity in Oncology contents during undergraduate education training continues to be remarkable. Cross-sectional programs with an integral vision, taught in the final years of undergraduate medical education would be desirable. Among the recommendations for improvement of training in Medical Oncology, the SEOM proposes that updated, theoretical content be incorporated and clinical practice in Medical Oncology departments be promoted.
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Curriculum , Educación de Pregrado en Medicina , Oncología Médica/educación , Competencia Clínica , Docentes Médicos , Humanos , Medicina Paliativa/educación , Sociedades Médicas , España , Encuestas y Cuestionarios , EnseñanzaRESUMEN
PURPOSE: To evaluate the effect of boost radiotherapy on ipsilateral breast tumor recurrence (IBTR) for ductal carcinoma in situ (DCIS) after breast-conserving surgery and whole breast radiotherapy (WBRT) with or without boost. METHODS AND MATERIALS: Retrospective, multicentre study of 622 patients (624 tumors) diagnosed with pure DCIS from 1993-2011. RESULTS: Most tumors (377/624; 60.4%) received a boost. At a median follow-up of 8.8 years, IBTR occurred in 64 cases (10.3%). A higher percentage of patients with risk factors for IBTR received a boost (p < 0.05). Boost was not associated with lower rates of IBTR than WBRT alone (HR 0.75, 95% CI 0.42-1.35). On the univariate analyses, IBTR was significantly associated with tumor size (11-20 mm, HR 2.32, 95% CI 1.27-4.24; and > 20 mm, HR 2.10, 95% CI 1.14-3.88), re-excision (HR 1.76, 95% CI 1.04-2.96), and tamoxifen (HR 2.03, 95% CI 1.12-3.70). Boost dose > 16 Gy had a protective effect (HR 0.39, 95% CI 0.187-0.824). Multivariate analyses confirmed the independent associations between IBTR and 11-20 mm (p = 0.02) and > 20 mm (p = 0.009) tumours, and re-excision (p = 0.006). On the margin-stratified multivariate analysis, tamoxifen was a poor prognostic factor in the close/positive margin subgroup (HR 4.28 95% CI 1.23-14.88), while the highest boost dose ( > 16 Gy) had a significant positive effect (HR 0.34, 95% CI 0.13-0.86) in the negative margin subgroup. CONCLUSIONS: Radiotherapy boost did not improve the risk of IBTR. Boost radiotherapy was more common in patients with high-risk disease. Tumor size and re-excision were significant independent prognostic factors.
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Carcinoma de Mama in situ/radioterapia , Neoplasias de la Mama/radioterapia , Recurrencia Local de Neoplasia/prevención & control , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma de Mama in situ/patología , Carcinoma de Mama in situ/cirugía , Neoplasias de la Mama/patología , Neoplasias de la Mama/cirugía , Femenino , Humanos , Mastectomía Segmentaria , Persona de Mediana Edad , Recurrencia Local de Neoplasia/epidemiología , Pronóstico , Radioterapia Adyuvante , Reirradiación , Estudios Retrospectivos , Factores de RiesgoRESUMEN
The objective of the study was to determine whether or not there is a correlation between thermoresistance tests (TT) after semen thawing and pregnancy rate (PR) after fixed-time artificial insemination (FTAI). Four different TT were performed on ten samples used for AI; a rapid test (RTT) (30min / 46°C) and three slow tests (STT): STT1 (60min/38°C), STT2 (180min/38°C), and STT3 (300min/38°C). Two hundred and fifteen multiparous crossbred cows were submitted to FTAI under the following protocol: on day zero (d0) the animals received a P4 device +EB; on d7 PGF2α; on d8 P4 was removed and eCG+EC were administered; IATF was performed on d10. Three gestational diagnoses (G D) were performed on d40, d70 and d120. The mean sperm motility (%) in RTT and STTs were 19.84±6.13, 28.55±10.48, 17.62±5.87 and 8.63±3.46, respectively, and TP in the three DG 61.86%, 57.67%, and 55.81%, respectively. Through Person test a significant negative correlation (P< 0.05) was found between STT2 and PR at 60 days (r= -0.644) and between STT3 and all TPs (r= -0.774, -0.752, 0.748). It was concluded that TT parameters are not able to determine correlation between semen quality and TP.(AU)
O objetivo do presente estudo foi determinar se há ou não correlação entre testes de termorresistência (TT) após descongelamento do sêmen e taxa de prenhez (TP) após inseminação artificial em tempo fixo (IATF). Quatro diferentes TT foram realizados nas 10 amostras utilizadas para a IA; um teste rápido (RTT) (30min/46°C) e três testes lentos (STT): STT1 (60min/38°C), STT2 (180min/38°C) e STT3 (300min/38°C). Duzentas e quinze vacas cruzadas multíparas foram submetidas à IATF sob o seguinte protocolo: no dia zero (d0), os animais receberam um dispositivo de P4+EB; em d7, PGF2α; em d8, retirou-se P4 e eCG+EC administrados; no d10, foi realizada IATF. Três diagnósticos gestacionais (DG) foram feitos, em d40, d70 e d120. As médias de motilidade espermática (%) em RTT e STTs foram 19,84±6,13, 28,55±10,48, 17,62±5,87 e 8,63±3,46, respectivamente, e TP nos três DG 61,86%, 57,67% e 55,81%, respectivamente. Por meio do teste de Person, uma correlação negativa significativa (P<0,05) foi encontrada entre os resultados de STT2 e PR aos 60 dias (r=-0,644) e entre STT3 e todas TPs (r=-0,774, -0,752 e -0,748). Concluiu-se que parâmetros de TT não são capazes de determinar correlação entre qualidade do sêmen e TP.(AU)
Asunto(s)
Animales , Masculino , Femenino , Embarazo , Bovinos , Motilidad Espermática , Regulación de la Temperatura Corporal , Índice de Embarazo , Respuesta al Choque Térmico , Análisis de Semen/métodos , Inseminación Artificial/veterinariaRESUMEN
INTRODUCTION: An increase in the number of cancer cases is expected in the near future. Breast cancer (BC) mortality rates increase with age even when adjusted for other variables. Here we analyzed BC disease-free survival (BCDFS) and BC specific survival (BCSS) in the El Alamo III BC registry of GEICAM Spanish Breast Cancer Group. MATERIALS AND METHODS: El Alamo III is a retrospective registry of BC patients diagnosed between 1998 and 2001. Patients with stage I-III invasive BC of age groups 55-64 years (y), 70-74 years and ≥ 75 years were included. Patients and tumors characteristics, treatments and recurrences and deaths were analyzed. RESULTS: 4343 patients were included within the following age intervals: 2288 (55-64 years), 960 (70-74 years), and 1095 (≥ 75 years). Older patients (≥ 70 years) were diagnosed with more advanced tumors (stage III) than younger patients (21.5% versus 13.4%, p < 0.0001). Mastectomies were performed more on older patients and they received less chemotherapy than younger patients (66.6% versus 43.1%, p < 0.00001 and 30.8% versus 71.6%, p < 0.0001, respectively). With a median follow-up of 5.9 years, 17.7% patients had BCDFS events in the younger group and 19.8% in the older group (p < 0.0001). A decrease in BCSS was also observed in older patients, either when analyzing patients ≥ 70y (p < 0.0001) and when differentiating by the two older groups (p < 0.0001). CONCLUSIONS: Our study suggests that older BC patients have worse outcomes what can be a consequence of receiving inadequate adjuvant treatments. Specific trials for these patients are warranted to allow us to treat them with the same scientific rigor than younger patients.
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Neoplasias de la Mama/mortalidad , Sistema de Registros/estadística & datos numéricos , Factores de Edad , Anciano , Anciano de 80 o más Años , Antineoplásicos/uso terapéutico , Neoplasias de la Mama/química , Neoplasias de la Mama/patología , Neoplasias de la Mama/terapia , Supervivientes de Cáncer , Causas de Muerte , Quimioterapia Adyuvante/estadística & datos numéricos , Supervivencia sin Enfermedad , Femenino , Humanos , Mastectomía/estadística & datos numéricos , Persona de Mediana Edad , Recurrencia Local de Neoplasia , España/epidemiología , Análisis de SupervivenciaRESUMEN
Cancer of unknown primary site is a histologically confirmed cancer that manifests in advanced stage, with no identifiable primary site following standard diagnostic procedures. Patients are initially categorized based on the findings of the initial biopsy: adenocarcinoma, squamous-cell carcinoma, neuroendocrine carcinoma, and poorly differentiated carcinoma. Appropriate patient management requires understanding several clinical and pathological features that aid in identifying several subsets of patients with more responsive tumors.
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Neoplasias Primarias Desconocidas/diagnóstico , Neoplasias Primarias Desconocidas/patología , Neoplasias Primarias Desconocidas/terapia , HumanosRESUMEN
INTRODUCCIÓN Y OBJETIVOS: La ecografía ganglionar locorregional como parte de la estadificación previa a la biopsia del ganglio centinela (BSGC) en pacientes con melanoma no se incluye habitualmente en las guías de manejo. El objetivo de este estudio es evaluarla desde la perspectiva clínica y económica. PACIENTES Y MÉTODOS: Estudio retrospectivo de 384 pacientes con melanoma primario de estadios clínicos I-II, en el periodo 2004-2015, a los que se les realizó una ecografía ganglionar locorregional (±biopsia ecodirigida) previa a la BSGC. Se evaluó la fiabilidad de la técnica y se realizó un análisis de su coste efectividad. RESULTADOS: En 23 pacientes (6%) se pudo evitar la realización de la BSGC mediante la técnica. La ecografía mostró una sensibilidad del 46% y una especificidad del 76% para la detección de ganglios metastásicos clínicamente no palpables. Los falsos negativos fueron significativamente más frecuentes en pacientes mayores de 60 años y con tumores <2mm. El coste unitario del proceso de estadificación mediante BSGC con ecografía-biopsia ecodirigida generó un sobrecoste de 16,30 €. El análisis coste-efectividad identificó como estrategia dominante desde ese punto de vista el protocolo de estadificación con ecografía y BSGC, con una ratio coste-efectividad inferior a la de la alternativa consistente en BSGC (8.095,24 vs. 28.605,00 € CONCLUSIONES: La ecografía con biopsia ecodirigida como método diagnóstico de estadificación previo a la BSGC es una herramienta útil y coste-efectiva, que no sustituye a la BSGC, pero que permite en un porcentaje no desdeñable de casos evitar su realización
BACKGROUND AND OBJECTIVES: Locoregional lymph node ultrasound is not typically included in guidelines as part of the staging process prior to sentinel lymph node biopsy (SLNB). The objective of the present study was to make a clinical and economic analysis of lymph node ultrasound prior to SLNB. MATERIALS AND METHODS: We performed a retrospective study of 384 patients with clinical stage I-II primary melanoma who underwent locorregional lymph node ultrasound (with or without ultrasound-guided biopsy) prior to SLNB between 2004 and 2015. We evaluated the reliability and cost-effectiveness of the strategy. RESULTS: Use of locorregional lymph node ultrasound avoided SLNB in 23 patients (6%). Ultrasound had a sensitivity of 46% and specificity of 76% for the detection of metastatic lymph nodes that were not clinically palpable. False negatives were significantly more common in patients aged over 60 years and in tumors with a thickness of less than 2mm. The staging process using SLNB and ultrasound with ultrasound-guided biopsy produced an increase of €16.30 in the unit price. Our cost-effectiveness analysis identified the staging protocol with ultrasound and SLNB as the dominant strategy, with a lower cost-effectiveness ratio than the alternative, consisting of SLNB alone (8,095.24 vs. € 28,605.00). CONCLUSIONS: Ultrasound with ultrasound-guided biopsy for the diagnostic staging of melanoma prior to SLNB is a useful and cost-effective tool. This procedure does not substitute SLNB, though it does allow to avoid SLNB in a not insignificant proportion of patients
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Humanos , Biopsia del Ganglio Linfático Centinela/métodos , Metástasis Linfática/diagnóstico por imagen , Melanoma/patología , Neoplasias Cutáneas/patología , Análisis Costo-Beneficio/estadística & datos numéricos , Estudios Retrospectivos , Estadificación de Neoplasias/métodos , Biopsia Guiada por Imagen/métodosRESUMEN
BACKGROUND AND OBJECTIVES: Locoregional lymph node ultrasound is not typically included in guidelines as part of the staging process prior to sentinel lymph node biopsy (SLNB). The objective of the present study was to make a clinical and economic analysis of lymph node ultrasound prior to SLNB. MATERIALS AND METHODS: We performed a retrospective study of 384 patients with clinical stage I-II primary melanoma who underwent locorregional lymph node ultrasound (with or without ultrasound-guided biopsy) prior to SLNB between 2004 and 2015. We evaluated the reliability and cost-effectiveness of the strategy. RESULTS: Use of locorregional lymph node ultrasound avoided SLNB in 23 patients (6%). Ultrasound had a sensitivity of 46% and specificity of 76% for the detection of metastatic lymph nodes that were not clinically palpable. False negatives were significantly more common in patients aged over 60 years and in tumors with a thickness of less than 2mm. The staging process using SLNB and ultrasound with ultrasound-guided biopsy produced an increase of 16.30 in the unit price. Our cost-effectiveness analysis identified the staging protocol with ultrasound and SLNB as the dominant strategy, with a lower cost-effectiveness ratio than the alternative, consisting of SLNB alone (8,095.24 vs. 28,605.00). CONCLUSIONS: Ultrasound with ultrasound-guided biopsy for the diagnostic staging of melanoma prior to SLNB is a useful and cost-effective tool. This procedure does not substitute SLNB, though it does allow to avoid SLNB in a not insignificant proportion of patients.
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Ganglios Linfáticos/diagnóstico por imagen , Metástasis Linfática/diagnóstico por imagen , Melanoma/secundario , Estadificación de Neoplasias/métodos , Biopsia del Ganglio Linfático Centinela , Neoplasias Cutáneas/patología , Ultrasonografía/métodos , Análisis Costo-Beneficio , Reacciones Falso Negativas , Reacciones Falso Positivas , Humanos , Biopsia Guiada por Imagen/economía , Ganglios Linfáticos/patología , Linfadenitis/diagnóstico por imagen , Metástasis Linfática/patología , Melanoma/diagnóstico por imagen , Melanoma/patología , Estadificación de Neoplasias/economía , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Sensibilidad y Especificidad , Biopsia del Ganglio Linfático Centinela/economía , Ultrasonografía/economía , Procedimientos InnecesariosAsunto(s)
Humanos , Femenino , Embarazo , Adolescente , Neumotórax/diagnóstico por imagen , Enfisema Subcutáneo/diagnóstico por imagen , Enfisema Mediastínico/diagnóstico por imagen , Enfisema Subcutáneo/complicaciones , Tórax/diagnóstico por imagen , Vulva/lesiones , Dolor en el Pecho/complicaciones , Tomografía Computarizada por Rayos XAsunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama Masculina/tratamiento farmacológico , Neoplasias Primarias Múltiples/tratamiento farmacológico , Neoplasias de la Próstata/tratamiento farmacológico , Anciano , Neoplasias de la Mama Masculina/patología , Estradiol/administración & dosificación , Estradiol/análogos & derivados , Fulvestrant , Hormona Liberadora de Gonadotropina/administración & dosificación , Hormona Liberadora de Gonadotropina/análogos & derivados , Humanos , Letrozol , Masculino , Neoplasias Primarias Múltiples/patología , Nitrilos/administración & dosificación , Neoplasias de la Próstata/patología , Tamoxifeno/administración & dosificación , Triazoles/administración & dosificaciónRESUMEN
PURPOSE: While much progress has been made in the treatment of breast cancer, cardiac complications resulting from therapy remain a significant concern. Both anthracyclines and novel targeted agents can inflict cardiac damage. The present study aimed to evaluate the difference between what it is currently done and what standards of care should be used to minimizing and managing cardiac toxicity in breast cancer survivors. METHODS: A two-round multicenter Delphi study was carried out. The panel consisted of 100 oncologists who were asked to define the elected therapies for breast cancer patients, the clinical definition and patterns of cancer drug-derived cardiac toxicity, and those protocols focused on early detection and monitoring of cardiovascular outcomes. RESULTS: Experts agreed a more recent definition of cardiotoxicity. Around 38 % of patients with early-stage disease, and 51.3 % cases with advanced metastatic breast cancer had preexisting risk factors for cardiotoxicity. Among risk factors, cumulative dose of anthracycline ≥450 mg/m2 and its combination with other anticancer drugs, and a preexisting cardiovascular disease were considered the best predictors of cardiotoxicity. Echocardiography and radionuclide ventriculography have been the proposed methods for monitoring changes in cardiac structure and function. Breast cancer is generally treated with anthracyclines (80 %), so that the panel strongly stated about the need to plan a strategy to managing cardiotoxicity. A decline of left ventricular ejection fraction (LVEF) >10 %, to an LVEF value <53 % was suggested as a criterion for changing the dose schedule of anthracyclines, or suspending the treatment of chemotherapy plus trastuzumab until the normalization of the left ventricular function. The use of liposomal anthracyclines was strongly suggested as a treatment option for breast cancer patients. CONCLUSIONS: The present report is the first to produce a set of statements on the prevention, evaluation and monitoring of chemotherapy-induced cardiac toxicity in breast cancer patients.
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Antraciclinas/efectos adversos , Antineoplásicos/efectos adversos , Neoplasias de la Mama/tratamiento farmacológico , Cardiotoxicidad/etiología , Cardiotoxicidad/prevención & control , Técnica Delphi , Función Ventricular Izquierda/efectos de los fármacos , Anciano , Femenino , Estudios de Seguimiento , Humanos , Estadificación de Neoplasias , Pronóstico , Factores de RiesgoRESUMEN
Inhibitors of the mechanistic target of rapamycin (mTOR) are currently used to treat advanced metastatic breast cancer. However, whether an aggressive phenotype is sustained through adaptation or resistance to mTOR inhibition remains unknown. Here, complementary studies in human tumors, cancer models and cell lines reveal transcriptional reprogramming that supports metastasis in response to mTOR inhibition. This cancer feature is driven by EVI1 and SOX9. EVI1 functionally cooperates with and positively regulates SOX9, and promotes the transcriptional upregulation of key mTOR pathway components (REHB and RAPTOR) and of lung metastasis mediators (FSCN1 and SPARC). The expression of EVI1 and SOX9 is associated with stem cell-like and metastasis signatures, and their depletion impairs the metastatic potential of breast cancer cells. These results establish the mechanistic link between resistance to mTOR inhibition and cancer metastatic potential, thus enhancing our understanding of mTOR targeting failure.
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Neoplasias de la Mama/genética , Proteínas de Unión al ADN/genética , Neoplasias Pulmonares/genética , Proto-Oncogenes/genética , Factor de Transcripción SOX9/genética , Serina-Treonina Quinasas TOR/genética , Factores de Transcripción/genética , Proteínas Adaptadoras Transductoras de Señales/genética , Adulto , Anciano , Neoplasias de la Mama/patología , Proteínas Portadoras/genética , Proliferación Celular/genética , Femenino , Regulación Neoplásica de la Expresión Génica , Humanos , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/secundario , Células MCF-7 , Proteína del Locus del Complejo MDS1 y EV11 , Proteínas de Microfilamentos/genética , Persona de Mediana Edad , Metástasis de la Neoplasia , Osteonectina/genética , Proteína Reguladora Asociada a mTOR , Transducción de Señal/genética , Serina-Treonina Quinasas TOR/antagonistas & inhibidores , Ensayos Antitumor por Modelo de XenoinjertoRESUMEN
Bone metastases are common in many advanced solid tumours, being breast, prostate, thyroid, lung, and renal cancer the most prevalent. Bone metastases can produce skeletal-related events (SREs), defined as pathological fracture, spinal cord compression, need of bone irradiation or need of bone surgery, and hypercalcaemia. Patients with bone metastases experience pain, functional impairment and have a negative impact on their quality of life. Several imaging techniques are available for diagnosis of this disease. Bone-targeted therapies include zoledronic acid, a potent biphosfonate, and denosumab, an anti-RANKL monoclonal antibody. Both reduce the risk and/or delay the development of SREs in several types of tumours. Radium 233, an alpha-particle emitter, increases overall survival in patients with bone metastases from resistant castration prostate cancer. Multidisciplinary approach is essential and bone surgery and radiotherapy should be integrated in the treatment of bone metastases when necessary. This SEOM Guideline reviews bone metastases pathogenesis, clinical presentations, lab tests, imaging techniques for diagnosis and response assessment, bone-targeted agents, and local therapies, as radiation and surgery, and establishes recommendations for the management of patients with metastases to bone.
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Neoplasias Óseas , Neoplasias/patología , Guías de Práctica Clínica como Asunto , Neoplasias Óseas/diagnóstico , Neoplasias Óseas/secundario , Neoplasias Óseas/terapia , Humanos , EspañaRESUMEN
Chemotherapy and radiotherapy often result in reduced fertility in cancer patients. With increasing survival rates, fertility is an important quality-of-life concern for many young cancer patients. Around 70-75% of young cancer survivors are interested in parenthood but the numbers of patients who access fertility preservation techniques prior to treatment are significantly lower. Moreover, despite existing guidelines, healthcare professionals do not address fertility preservation issues adequately. There is a critical need for improvements in clinical care to ensure patients are well informed about infertility risks and fertility preservation options and to support them in their reproductive decision-making prior to cancer treatment.
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Preservación de la Fertilidad/métodos , Neoplasias/terapia , Guías de Práctica Clínica como Asunto , Antineoplásicos/efectos adversos , Femenino , Preservación de la Fertilidad/tendencias , Humanos , Masculino , Radioterapia/efectos adversos , España , SobrevivientesRESUMEN
No disponible
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Humanos , Masculino , Femenino , Lactante , Válvula Mitral/cirugía , Válvula Mitral , Insuficiencia de la Válvula Mitral/epidemiología , Insuficiencia de la Válvula Mitral/prevención & control , Insuficiencia de la Válvula Mitral/cirugía , Heparina/uso terapéutico , Prótesis e Implantes/normas , Prótesis e Implantes/tendencias , Prótesis e Implantes , Acenocumarol , Anticoagulantes/uso terapéuticoRESUMEN
Energy restriction from a low-calorie diet and increased energy expenditure induced by physical activity (PA) could promote weight loss/maintenance and be important determinants of breast cancer (BC) prognosis. The aim of this study was to assess participation and adherence of overweight and obese BC survivors to a lifestyle intervention and to demonstrate the capacity of this intervention to induce weight loss and nutritional changes. This single-arm pre-post study, which involved one-hourly weekly diet sessions delivered by a dietician and 75-min bi-weekly PA sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment. Before and after the intervention, anthropometry, dietary information, quality of life (QoL) and cardiorespiratory fitness (CRF) were collected. A total of 112 BC survivors were invited to participate: 42 of them started the intervention and 37 completed it. Participants attended more than 90 % of the sessions offered and showed a significant weight loss of 5.6 ± 2.0 kg, as well as significant decreases in body mass index, fat mass and waist circumference. Significant decreases in total energy (-25 %), fat (-35 %), saturated fat (-37 %) and carbohydrate (-21 %) intakes were observed while QoL and CRF showed significant increases. This feasibility study demonstrated the success of a short-term diet and PA intervention to induce weight loss and promote healthful changes in BC survivors. Assessing the long-term effects of these changes, and in particular their possible impact of BC prognosis, and designing interventions reaching a wider number of BC survivors are still issues to be addressed.
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Neoplasias de la Mama/fisiopatología , Dieta , Terapia por Ejercicio , Obesidad/complicaciones , Sobrepeso , Adulto , Anciano , Antropometría , Índice de Masa Corporal , Peso Corporal , Neoplasias de la Mama/terapia , Sistema Cardiovascular , Estudios de Evaluación como Asunto , Estudios de Factibilidad , Femenino , Humanos , Estilo de Vida , Persona de Mediana Edad , Ciencias de la Nutrición , Obesidad/terapia , Cooperación del Paciente , Pronóstico , Calidad de Vida , Sobrevivientes , Programas de Reducción de PesoRESUMEN
OBJECTIVE: To provide estimates of the efficiency for chemotherapy strategies used in Spain. METHODS: Published reports of the phase-III clinical trials for chemotherapies used for the most prevalent solid tumours in Spain were retrieved. The incremental cost-effectiveness ratio (ICER) was calculated for each strategy compared to the control group in the clinical trial, with the National Health System perspective. The total cost (?, 2012) including only drug cost (exfactory price) was estimated based on the total units of each drug required for administration (no vial wastage), with the dosification and number of cycles specified in the publication for each treatment arm. Effectiveness was measured as month of overall survival (OS) and/or month of progression free survival (PFS). RESULTS: A total of 40 chemotherapies for 13 different advanced or metastatic tumours were assessed. OS ranged from 5.3 to 33.3 months for the 34 therapies that included the information with hazard ratios (HR) values from 0.49 to 1.15 when compared with its control group. PFS ranged, from 39 therapies with these data, between 1.5 to 12.4 months, with HR from 0.33 to 1.52. ICERs were between ?2,142.57 and ?60,996.37 per each OS month gained, and from ?2,102.54 to ?661,845.27 per PFS month gained. CONCLUSION: The variety and heterogenicity of survival and ICERs results, suggest disparity of criteria in the price and reimbursement process of drugs in Spain. The continuous advances in oncology seem to require economic revaluations of drugs.
Objetivo: Proporcionar estimadores de la eficiencia de esquemas oncológicos empleados en España. Métodos: Se seleccionaron las publicaciones de ensayos clínicos en fase III usados para indicación de las terapias oncológicas de alto impacto empleadas para tratamiento de tumores sólidos en estadíos III-IV. Para cada esquema se calculó la relación costeeficacia incremental (RCEI) respecto al comparador del ensayo, con la perspectiva del Sistema Nacional de Salud. El coste (?, 2012) farmacológico, en PVL, de cada esquema y comparador se estimó con las unidades de medicamento requeridas en cada administración (aprovechamiento máximo de viales) considerando la posología y el número de ciclos especificado en el ensayo para cada una de las ramas. La efectividad se expresó en meses de supervivencia global (SG) y/o supervivencia libre de progresión (SLP). Resultados: Se analizaron 40 esquemas oncológicos para trece tumores metastásicos. La SG osciló entre 5,3 y 33,3 meses para las 34 terapias que incluían esa información, con valores de Hazard ratio (HR) respecto a sus comparadores de 0,49 a 1,15. La SLP osciló entre 1,5 y 12,4 meses para las 39 terapias con este dato, con HR de 0,33 a 1,52. Los valores de RCEI oscilaron entre 2.142,57 ?-60.996,37 ?/mes de SG adicional y entre 2.102,54 ?-661.845,27 ?/mes de SLP adicional. Conclusión: La dispersión y heterogeneidad de la supervivencia y RCEI estimadas, sugieren disparidad de criterios en la decisión de precio y financiación de las terapias, en España. Los continuos avances en terapias oncológicas parecen requerir reevaluaciones económicas de los medicamentos.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma/tratamiento farmacológico , Neoplasias/tratamiento farmacológico , Antineoplásicos/administración & dosificación , Antineoplásicos/clasificación , Antineoplásicos/economía , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Carcinoma/economía , Carcinoma/mortalidad , Ensayos Clínicos Fase III como Asunto/estadística & datos numéricos , Análisis Costo-Beneficio , Supervivencia sin Enfermedad , Costos de los Medicamentos/estadística & datos numéricos , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Neoplasias/economía , Neoplasias/mortalidad , Modelos de Riesgos Proporcionales , España/epidemiología , Resultado del TratamientoRESUMEN
PURPOSE: The primary aim of this trial was to assess the rate of pathologic complete responses (pCR) of doxorubicin/cyclophosphamide (AC) followed by bevacizumab/docetaxel (BT), as neoadjuvant therapy for breast cancer (BC). Furthermore, the association between biomarkers and the pCR was explored. METHODS: Patients with HER-negative operable stage II-III BC ≥ 2 cm were enrolled. Four cycles of AC (A 60 mg/m(2) and C 600 mg/m(2), every 3 weeks) followed by 4 cycles of BT (B 15 mg/kg and T 75 mg/m(2), every 3 weeks), were planned. A core-biopsy was performed for biological markers assessment. RESULTS: Seventy-two women were included. Forty-three (63 %) patients were hormone receptor-positive. Sixty-four (89 %) completed the planned treatment, and 66 evaluable patients underwent surgery (92 %): a pCR was achieved in 16 of them (24, 95 % CI 15-36 %). pCR was significantly higher in tumors hormone receptor-negative, and in those with Angiotensin II type 1 receptor (AGTR1) protein overexpression. The overall clinical response rate was 86 % (95 % CI 76-93 %), including 42 complete responses. No unexpected toxicities or treatment-related deaths were observed. CONCLUSION: This regimen showed a remarkable clinical and pathological activity: the suggested relation between pCR and AGTR1 overexpression should be confirmed in larger trials.
Asunto(s)
Inhibidores de la Angiogénesis/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Carcinoma Ductal de Mama/tratamiento farmacológico , Carcinoma Lobular/tratamiento farmacológico , Receptor ErbB-2/metabolismo , Adulto , Anciano , Bevacizumab , Biomarcadores de Tumor/metabolismo , Neoplasias de la Mama/metabolismo , Neoplasias de la Mama/patología , Carcinoma Ductal de Mama/metabolismo , Carcinoma Ductal de Mama/secundario , Carcinoma Lobular/metabolismo , Carcinoma Lobular/secundario , Ciclofosfamida/administración & dosificación , Docetaxel , Doxorrubicina/administración & dosificación , Femenino , Estudios de Seguimiento , Humanos , Metástasis Linfática , Persona de Mediana Edad , Terapia Neoadyuvante , Estadificación de Neoplasias , Cuidados Preoperatorios , Pronóstico , Receptores de Estrógenos/metabolismo , Receptores de Progesterona/metabolismo , Inducción de Remisión , Taxoides/administración & dosificaciónRESUMEN
Fulvestrant is a selective estrogen receptor downregulator, behaving as a complete antagonist. It was initially approved, at a dose of 250 mg, to treat hormone dependant breast cancer in second line setting. However, a series of pharmacological and pre-clinical studies have suggested that a higher dose of 500 mg may be more effective. The present work summarizes and discusses clinical trials that have aimed to test the benefits of administering fulvestrant at a higher dose. The data support the use of a higher, and more possibly, effective dose of the agent.