Different Pathological Complete Response Rates According to PAM50 Subtype in HER2+ Breast Cancer Patients Treated With Neoadjuvant Pertuzumab/Trastuzumab vs. Trastuzumab Plus Standard Chemotherapy: An Analysis of Real-World Data.

Background: Double blockade with pertuzumab and trastuzumab combined with chemotherapy is the standard neoadjuvant treatment for HER2-positive early breast cancer. Data derived from clinical trials indicates that the response rates differ among intrinsic subtypes of breast cancer. The aim of this study is to determine if these results are valid in real-world patients. Methods: A total of 259 patients treated in eight Spanish hospitals were included and divided into two cohorts: Cohort A (132 patients) received trastuzumab plus standard neoadjuvant chemotherapy (NAC), and Cohort B received pertuzumab and trastuzumab plus NAC (122 patients). Pathological complete response (pCR) was defined as the complete disappearance of invasive tumor cells. Assignment of the intrinsic subtype was realized using the research-based PAM50 signature. Results: There were more HER2-enriched tumors in Cohort A (70 vs. 56%) and more basal-like tumors in Cohort B (12 vs. 2%), with similar luminal cases in both cohorts (luminal A 12 vs. 14%; luminal B 14 vs. 18%). The overall pCR rate was 39% in Cohort A and 61% in Cohort B. Better pCR rates with pertuzumab plus trastuzumab than with trastuzumab alone were also observed in all intrinsic subtypes (luminal PAM50 41 vs. 11.4% and HER2-enriched subtype 73.5 vs. 50%) but not in basal-like tumors (53.3 vs. 50%). In multivariate analysis the only significant variables related to pCR in both luminal PAM50 and HER2-enriched subtypes were treatment with pertuzumab plus trastuzumab (Cohort B) and histological grade 3. Conclusions: With data obtained from patients treated in clinical practice, it has been possible to verify that the addition of pertuzumab to trastuzumab and neoadjuvant chemotherapy substantially increases the rate of pCR, especially in the HER2-enriched subtype but also in luminal subtypes, with no apparent benefit in basal-like tumors.

¿Qué piensan las mujeres sobre la mamografía de cribado? Encuesta en el programa de diagnóstico precoz de cáncer de mama / What do women think about screening mammography? Survey in a breast cancer screening programme

Objetivos. En España las mujeres no toman una decisión informada sobre su participación en el programa de cribado mamográfico. Se analizó si proporcionar información individualizada y precisa sobre los beneficios y riesgos del programa de cribado mamográfico incrementaba su grado de conocimiento. Pacientes y método. Se realizó un ensayo clínico aleatorizado y controlado en el que participaron 434 mujeres de entre 45 y 69 años, convocadas a la mamografía de cribado. Doscientas dieciocho fueron aleatorizadas al grupo control y 216 al de intervención. Se evaluó el grado de conocimiento sobre beneficios y riesgos del cribado mamográfico mediante un cuestionario específico, en la segunda entrevista, al mes. Secundariamente se analizaron la actitud, la ansiedad y la depresión, así como la preocupación por el cáncer de las participantes. Resultados. Adquirieron un buen conocimiento 15 de 178 mujeres (8,4%) en el grupo control y 32 de 177 (18,1%) en el de intervención (p=0,008). Las mujeres del grupo de intervención tienen un riesgo relativo 2,39 veces mayor de adquirir un buen conocimiento que las del grupo control (IC 95% 1,24-4,60). No se hallaron diferencias en ninguno de los objetivos secundarios evaluados. Conclusiones. Las mujeres poseen un nivel de conocimientos muy pobre sobre el programa de cribado con mamografía, siendo la televisión su principal fuente de información. La información individualizada incrementó significativamente el grado de buen conocimiento, aunque persistió en porcentajes muy bajos. Tienen una actitud muy positiva sobre el mismo y no se aprecia un impacto negativo en la esfera psicosocial por su participación en este tipo de procedimientos

Objectives. Spanish women do not make an informed choice about their participation in breast cancer screening. Our study hypothesised that providing individualised and accurate information about the benefits and risks of the mammography screening programme in Spain would increase their knowledge. Patients and method. A randomised controlled clinical trial was conducted in 434 women aged between 45 and 69 years: 216 were assigned to the intervention group and 218 to the control group. The degree of knowledge about the benefits and risks of mammography screening was determined from questionnaires administered at baseline and after one month. Secondarily, the participants’ attitudes, anxiety and depression and cancer worry were analysed. Results. Good knowledge was acquired by 15 of 178 women (8.4%) in the control group and 32 of 177 (18.1%) in the intervention group (P=.008). The relative risk of acquiring a good level of knowledge about the programme was 2.39 times higher in women in the intervention group than in those in the control group (95% CI 1.24-4.60). No differences were found in the secondary endpoints. Conclusions. Women have a very poor level of knowledge about mammography screening, with their main information source being television. Individualized information significantly increased the proportion of women with good knowledge but the percentages remained very low. Women had a very positive attitude to screening and a negative impact in the psychosocial sphere due to their participation was not observed

Epidemiología de las intoxicaciones accidentales en el servicio de pediatría del Hospital Dr. Gustavo Fricke / Epidemiology of accidental poisonings in the Dr. Gustavo Fricke Hospital pediatric unit

Introducción: Las intoxicaciones son una causa frecuente de consulta al servicio de urgencia, particularmente en niños. La incidencia y características de éstas varían de acuerdo al país y a la edad del paciente. Objetivos: Describir el perfil epidemiológico de los pacientes con el diagnóstico de intoxicación hospitalizados en un servicio de pediatría. Diseño: Estudio descriptivo retrospectivo. Materiales y métodos: Se revisó los registros anuales de ingresos y egresos del servicio de pediatría desde abril del 2012 a diciembre del 2015 y se incluyó a aquellos pacientes con diagnóstico de intoxicación hasta los 10 años de edad. Se realizó análisis descriptivo según características generales de los pacientes, tipo de tóxico y aparición de complicaciones, entre otras variables. Resultados: Fueron analizados 60 casos. De éstos, un 61,67% correspondió a pacientes de sexo femenino y la mayoría fueron preescolares (53,33%). El lugar de ocurrencia fue el hogar en un 93,33% y el tipo de tóxico más frecuentemente involucrado fueron los medicamentos (70%), seguidos por los productos de uso doméstico (16,67%) y los pesticidas (6,67%). Discusión y conclusiones: Los resultados obtenidos son similares a los reportados en la literatura nacional e internacional en cuanto a frecuencia por edad y tipo de tóxico. En la mayoría de los casos el evento de intoxicación ocurrió en el hogar e involucró a medicamentos, lo que sugiere que el manejo de esta problemática de salud debe ser enfocado a la prevención y a la educación acerca del tema tanto a padres como a cuidadores

Introduction: Poisonings are a frequent cause of emergency department visits, particularly in children. The incidence and characteristics of these vary with the country and the patient´s age. Objectives: To describe the epidemiological profile of patients presenting with poisoning who were hospitalized in the pediatric unit. Design: Descriptive and retrospective study. Materials and methods: The annual records of all patients hospitalized in the pediatric unit between 2012 and 2015 were revised. The study included patients up to 10 years of age with a diagnosis of poisoning. Descriptive analysis was performed listing the patient's general characteristics, toxin type, and the occurrence of complications among other variables. Results: 60 cases were analyzed. Of these, 61.67% were female and most were pre-school children (53.33%). 93.33% of poisonings occurred in the home and the most frequently involved toxin types were medications (70%), followed by household products (16.67%) and pesticides (6.67%). Discussion and conclusions: The results are similar in frequency by age and toxin types to those reported in the national and international literature. In most cases the intoxication happened at home and involved medications, suggesting that the management of this health issue should be focused on prevention and education to both parents and caregivers.

Using an informed consent in mammography screening: a randomized trial.

Spanish women do not make an informed choice regarding breast cancer screening (BCS). Our aim was to evaluate the impact of receiving information regarding real BCS benefits and risks on knowledge, attitude, decision, feelings, and worries about cancer. Randomized controlled clinical trial of 355 women aged between 45 and 67 years, 177 and 178 assigned to the intervention group (IG) and control group (CG), respectively. After breast screening, women received either Nordic Cochrane Centre information on BCS or standard information. The primary outcome (knowledge) was determined from questionnaire administered at baseline and after a month. Answers were scored from 0 to 10 and scores of 5 or more indicated that women were well informed (had "good knowledge"). Questionnaires regarding attitudes, future screening intentions, and psychosocial impact were also administered. The Chi-squared and Student's t-tests were used to compare qualitative and quantitative variables, respectively. Good knowledge was acquired by 32 (18.10%) IG women and 15 (8.40%) CG women (P = 0.008). Mean scores from first to second interview increased from 2.97 (SD 1.16) to 3.43 (SD 1.39) in the CG and from and from 2.96 (SD 1.23) to 3.95 (SD 1.78) (P = 0.002) in the IG. No differences were found in the secondary endpoints. Women receiving information based on the Nordic Cochrane Centre document were better informed. This means of providing information is not very efficacious, nor does it modify attitude, decision, feelings, or worries about cancer.

Women's perceptions of breast cancer screening. Spanish screening programme survey.

OBJECTIVES: Participants in breast cancer screening programmes may benefit from early detection but may also be exposed to the risks of overdiagnosis and false positives. We surveyed a sample of Spanish women to assess knowledge, information sources, attitudes and psychosocial impact. MATERIALS AND METHODS: A total of 434 breast cancer screening programme participants aged 45-69 years were administered questionnaires regarding knowledge, information sources, attitudes and psychosocial impact. Scores of 5 or more (out of 10) and 12 or less (out of 24) were established as indicating adequate knowledge and a positive attitude, respectively. Psychosocial impact was measured using the Hospital Anxiety and Depression Scale and the Cancer Worry Scale. RESULTS: Only 42 women (9.7%) had adequate knowledge. The mean (SD) knowledge score was 2.97 (1.16). Better educated women and women without previous false positives had higher scores. The main sources of information were television, press, Andalusian Health Service documentation and family and friends. Most participants (99.1%) had a positive attitude, with a mean (SD) score of 3.21 (2.66). Mean (SD) scores for anxiety, depression and cancer worry were 1.86 (3.26), 0.72 (1.99) and 9.4 (3.04), respectively. CONCLUSION: Women have a very positive attitude to breast cancer screening, but are poorly informed and use television as their main information source. They experience no negative psychosocial impact from participation in such programmes.

Influencia de los factores clínicos y biográficos en el retraso en iniciar la quimioterapia adyuvante en las pacientes con cáncer de mama / Influence of clinical and biographical factors on the delay in starting adjuvant chemotherapy treatment among breast cancer patients

Background and objetive: Previous studies have related the delay in starting chemotherapy (>3 months from date of surgery) with worse survival. The study objective is to analyse the delay in the start of chemotherapy and associated biomedical, sociodemographic and cultural factors. Patients and methods: A cohort of women operated on for breast cancer, candidates for receiving adjuvant chemotherapy and participants in a clinical trial of non-pharmacological intervention, were surveyed regarding the delay in starting their chemotherapy, measured by the number of days from date of surgery. Differences in function of the clinical and biographical variables were studied. Results: In 197 women, mean delay was 42.32 (15.29) days; this was associated with tumour stage ( i , 40.06 days; ii , 44.76 days; iii , 38.7 days; P=.049), age (≤35, 37.36 days; 36-64, 41.49 days; ≥65, 52.61 days; P=.007) and occupational situation (active, 36.91 days; unemployed, 45.5 days; pensioner, 40.07 days; housewife, 43.17 days; P=.038). F r patients older than 65 years, the delay in starting adjuvant chemotherapy was longer than for those in the 2 lower age groups -less than 35 years, and between 35 and 65 years- (P=.023 and P=.009 respectively). In the multivariate analysis, the variables associated independently with the delay in starting chemotherapy were again age (P=.019), tumour stage (P=.037) and occupational situation (P=.022). Conclusion: Patients began receiving adjuvant chemotherapy within the time period (3 months from surgery) defined as appropriate, and during which no evidence exists of worse survival results. Length of delay varied according to age, tumour stage and occupational situation (AU)

Fundamento y objetivos: Estudios previos han relacionado el retraso en iniciar la quimioterapia adyuvante (>3 meses desde la cirugía) con peor supervivencia. El objetivo de este estudio es analizar el retraso en iniciar quimioterapia y la influencia de los factores biomédicos, sociodemográficos y culturales. Pacientes y método: En una cohorte de mujeres con cáncer de mama, candidatas a quimioterapia adyuvante y participantes en un ensayo clínico de intervención no farmacológica, se recogió la demora en el inicio de quimioterapia desde la cirugía. Se estudiaron las diferencias según variables clínicas y biográficas. Resultados: En 197 mujeres, la demora media (DE) entre cirugía y quimioterapia fue de 42,32 (15,29) días y estuvo asociada al estadio tumoral ( i , 40,06 días; ii , 44,76 días; iii , 38,7 días; p=0,049), la edad (≤35 años, 37,36 días; 36-64 años, 41,49 días; ≥65 años, 52,61 días; p=0,007) y la situación laboral (en activo, 36,91 días; en paro, 45,5 días; pensionistas, 40,07 días; amas de casa, 43,1 días; p=0,038). Las pacientes mayores de 65 años recibieron quimioterapia adyuvante con más demora que las menores de 35 o entre 35 y 65 años (p=0,023 y p=0,009, respectivamente). En el análisis multivariante, las variables asociadas de forma independiente con el retraso en recibir la quimioterapia continuaron siendo la edad (p=0,019), el estadio (p=0,037) y la situación laboral (p=0,022). Conclusiones: Las pacientes recibieron quimioterapia adyuvante dentro del tiempo (3 meses desde la cirugía) definido como apropiado y durante el cual no hay pruebas de peores resultados de supervivencia. El retraso varió según la edad, el estadio y la situación laboral (AU)

[Influence of clinical and biographical factors on the delay in starting adjuvant chemotherapy treatment among breast cancer patients]. / Influencia de los factores clínicos y biográficos en el retraso en iniciar la quimioterapia adyuvante en las pacientes con cáncer de mama.

BACKGROUND AND OBJECTIVE: Previous studies have related the delay in starting chemotherapy (>3 months from date of surgery) with worse survival. The study objective is to analyse the delay in the start of chemotherapy and associated biomedical, sociodemographic and cultural factors. PATIENTS AND METHODS: A cohort of women operated on for breast cancer, candidates for receiving adjuvant chemotherapy and participants in a clinical trial of non-pharmacological intervention, were surveyed regarding the delay in starting their chemotherapy, measured by the number of days from date of surgery. Differences in function of the clinical and biographical variables were studied. RESULTS: In 197 women, mean delay was 42.32 (15.29) days; this was associated with tumour stage (i, 40.06 days; ii, 44.76 days; iii, 38.7 days; P=.049), age (≤ 35, 37.36 days; 36-64, 41.49 days; ≥ 65, 52.61 days; P=.007) and occupational situation (active, 36.91 days; unemployed, 45.5 days; pensioner, 40.07 days; housewife, 43.17 days; P=.038). For patients older than 65 years, the delay in starting adjuvant chemotherapy was longer than for those in the 2 lower age groups -less than 35 years, and between 35 and 65 years- (P=.023 and P=.009 respectively). In the multivariate analysis, the variables associated independently with the delay in starting chemotherapy were again age (P=.019), tumour stage (P=.037) and occupational situation (P=.022). CONCLUSION: Patients began receiving adjuvant chemotherapy within the time period (3 months from surgery) defined as appropriate, and during which no evidence exists of worse survival results. Length of delay varied according to age, tumour stage and occupational situation.

Use of health-care services during chemotherapy for breast cancer.

AIM OF THE STUDY: The authors analyse the effect of chemotherapy on the use of additional health-care resources and report the clinical and demographic factors associated with such use. PATIENTS AND METHODS: In women with breast cancer, eligible to receive first-line (neo)-adjuvant or palliative chemotherapy, consultations with health-care practitioners (general practitioners [GPs] and specialists) and admissions to emergency department and to hospital were prospectively recorded. Differences were studied according to these clinical and demographic variables: age, tumour stage, performance status, weight, height, body mass index, surgery type, chemotherapy type, number of courses, comorbidity, marital status, educational level, social status and occupational status. RESULTS: Among 268 patients, 124 (42.2%) required one or more non-protocol health-care encounters. 180 visits were generated (GP 23.3%, specialist 35.5%, emergency department admission 21.1%, hospital admission 8.3%, others 3.3% and more than one resource 8.3%). Of total consultations 150 (83.3%) were chemotherapy-related. The number of visits was higher in the first courses. Fever and infection were the most frequent reasons for consultation in all resources. The dependent variable: 'need for non-protocol health-care encounter in any course' was statistically associated with age (p=0.002) and marital status (p=0.021); no association was found with other variables. In multivariate analysis, age (p=0.001) and marital status (p=0.009) remained statistically significant. Younger and married patients consumed less extra health resources. CONCLUDING STATEMENT: Many patients receiving chemotherapy consume health-care resources in addition to their routine visits, usually treatment-related. Patients consult less in the later courses. Older and unmarried women in particular need extra care during chemotherapy.