Effectiveness and safety of neoadjuvant therapy in triple-negative breast cancer in a real-world population.

OBJECTIVE: Triple-negative breast cancer is a subtype of aggressive breast cancer. Our aim is to evaluate the effectiveness and safety of neoadjuvant treatment in early-stage triple-negative breast cancer and to identify predictors of pathological complete response. METHODS: This is a single-center, retrospective study involving 79 patients with triple-negative breast cancer who initiated neoadjuvant treatment between January 2017 and October 2022. Descriptive analyses were performed as appropriate. Statistical analysis utilized bivariate logistic regression to explore the presence of factors related to pathological complete response, and the Kaplan-Meier method was employed for survival analysis. RESULTS: In the overall population, 27 patients (n=78; 34.6%) achieved pathological complete response in the breast and axillary lymph nodes, and 31 (n=73; 42.5%) achieved a grade 5 pathological complete response in the breast, according to the Miller and Payne classification. The addition of platinum to standard therapy improved both breast and axillary lymph node pathological complete response rates. Age less than 40 years was identified as a predictor of pathological complete response in our study population through bivariate analysis, while Ki67 levels lower than 70% were associated with a lower pathological complete response rate. Adverse events were reported in 72 patients (91.1%), with grade 3-5 adverse events observed in 33 (41.8%). There was a particularly notable increase in gastrointestinal and hematological adverse events when platinum was added. CONCLUSIONS: In this population, we observed moderate rates of pathological complete response with acceptable chemotherapy tolerance. Platinum-based chemotherapy appears to enhance the likelihood of achieving pathological complete response, albeit with a less favorable safety profile. Therefore, evaluating the benefit-risk balance is crucial when selecting the optimal chemotherapy regimen for individual patients.

Real-world data of atezolizumab in patients with previously treated locally advanced or metastatic urothelial bladder cancer.

BACKGROUND: Clinical trials of atezolizumab for locally advanced or metastatic urothelial bladder cancer (mUBC) report controversial efficacy data. Furthermore, real-world evidence about this use is limited. AIM: We aimed to evaluate the effectiveness of atezolizumab in a real-world population with mUBC, to explore effectiveness with regard to selected poor prognostic criteria such as performance status by Eastern Oncology Cooperative Group (ECOG), hemoglobin levels and liver metastases, and to determine the safety profile of atezolizumab. METHOD: Multicenter, retrospective real-world study including previously treated mUBC patients who received atezolizumab. The primary endpoint was overall survival (OS). Additionally, progression-free survival (PFS), best response reached and safety data were analyzed. A descriptive analysis was performed, while OS and PFS were estimated by Kaplan-Meier method. RESULTS: A total of 185 patients (84.9% men, median age 69 years) were included. Median PFS was 4.8 months [95% confidence interval (CI) 3.6-6.0], and median OS was 20.0 months (95% CI 11.8-28.5), with an objective response rate of 28.1%. OS was higher for patients with ECOG 0-1 versus 2-3 [24.5 months (95% CI 14.5-34.6) vs. 5.2 (95% CI 4.4-6.0), p = 0.004]; and for patients without liver metastases [25.4 months (95% CI 16.2-34.6) vs. 6.4 months (95% CI 4.0-8.1), p = 0.006]. Regarding hemoglobin levels, no survival differences were detected. Adverse events were registered in 55.1% of patients. CONCLUSION: In a real-world population with previously treated mUBC, atezolizumab seems to provide clinically relevant benefit, which is even higher for patients with ECOG 0-1 and without liver metastases, with an acceptable safety profile.

Application of CMO (capacity, motivation, and opportunity) methodology in pharmaceutical care to optimize the pharmacotherapy in older people living with HIV. DISPIMDINAC project / Intervención farmacéutica basada en la metodología CMO para optimizar la farmacoterapia en pacientes VIH mayores. Proyecto DISPIMDINAC

Objective. To determine the effectiveness of a pharma ceutical intervention, based on the CMO methodology (capac ity, motivation and opportunity), to decrease the prevalence of the PIMDINAC concept (potentially inappropriate medica tion+drug interactions+non-adherence to concomitant med ication) in people living with HIV infection. Material and methods. Longitudinal prospective multi center study, conducted between October 2021 and October 2022. Patients living with HIV older than 65 years, on antiret roviral treatment and concomitant drug prescription were included. Demographic, clinical, and pharmacotherapeutic variables were collected. Pharmaceutical care was provided for 6 months according to the CMO model in each patient. The main variable was the percentage of patients who simultane ously fulfilled the PIMDINAC concept, comparing the baseline value with the same value at the end of the study. In addi tion, the percentage of patient’s adherent to concomitant and antiretroviral treatment and the percentage of patients meet ing the pharmacotherapeutic targets established for the pre scribed medication at 24 weeks of follow-up were compared. Results. Sixty-eight patients were included. Seventy-two percent were men, with a median age of 68 years. The medi an number of concomitant drugs was 7. A 60.6% of the pa tients had polypharmacy. The prevalence of the presence of the PIMDINAC concept decreased significantly (10.3 vs. 0%). In isolation, each of the aspects also decreased significantly (p <0.031) The percentage of patients who met the objectives improved significantly from 48,5 at baseline to 88.2 (p <0.001). Conclusions. The pharmaceutical intervention based on the CMO methodology significantly decreased the prevalence of the PIMDINAC concept and increased the number of pa tients who achieved the objectives, optimising their pharma cotherapy (AU)

Objetivo. Determinar la efectividad de una intervención farmacéutica, basada en la metodología CMO (Capacidad, Motivación y oportunidad) para disminuir la prevalencia de criterios PIMDINAC (medicación potencialmente inapropiada interacciones farmacológica-no adherencia a la medicación concomitante) en pacientes VIH+. Material y métodos. Estudio multicéntrico prospectivo longitudinal, realizado entre octubre-2021 y octubre-2022. Se incluyeron pacientes VIH+ ≥65 años, en tratamiento an tirretroviral activo y medicación concomitante prescrita. Se recogieron variables demográficas, clínicas y farmacote rapéuticas. La intervención de atención farmacéutica se rea lizó durante los 6 meses de seguimiento a través de la me todología CMO. La variable principal fue la diferencia en el porcentaje de pacientes que presentaban los tres criterios PIMDINAC de forma simultánea al inicio-fin del estudio. Se analizó la variación del porcentaje de pacientes adheren tes tanto al TAR y a la medicación concomitante, así como el porcentaje de pacientes que alcanzaron sus objetivos farma coterapéuticos previamente definidos a los 6 meses de segui miento. Resultados. Se incluyeron 67 pacientes, 72.0% varones con una mediana de edad de 68 años. El 60.6% de los pacientes tenían polifarmacia de forma basal con una mediana de fárma cos de 7.0. La presencia de criterios PIMDINAC disminuyó sig nificativamente de un 10.3 a 0%. De forma individual se redujo el porcentaje de cada criterio de forma significativa (p=0.031). Se incrementó el porcentaje de pacientes que alcanzaron sus objetivos farmacoterapéuticos (48,5% vs 88,2%; p<0.001). Conclusiones. La estrategia basada en la metodología CMO disminuye significativamente la prevalencia de los cri terios PIMDINAC, así como incrementa la consecución de los objetivos farmacoterapéuticos de los pacientes, optimizando su farmacoterapia (AU)

Hypogammaglobulinemia after front-line immunochemotherapy in patients with follicular lymphoma.

INTRODUCTION: Hypogammaglobulinemia after front-line immunochemotherapy for follicular lymphoma is a poorly studied adverse event that could be related to the appearance of severe and/or recurrent non-neutropenic infections which could affect the quality of life of the patients, even motivating a need of long-term replacement therapy with human immunoglobulins. METHODS: Observational, retrospective study aiming to estimate the incidence of hypogammaglobulinemia, as well as its severity and clinical consequences, and to explore possible predictive factors for its development. Specific immunoglobulin deficiencies were also studied. RESULTS: 76.5% of patients had hypogammaglobulinemia during or after front-line treatment, mostly grade 1-2; with 38.8% patients who developed clinically relevant infections and 20% patients requiring human immunoglobulins replacement therapy. A high-risk FLIPI score was identified as a risk factor for hypogammaglobulinemia (ods ratio: 4.51; 95% confidence interval: 1.29-15.68; p < 0.001) and basal gamma globulin level as a protective factor (odds ratio: 0.92; 95% confidence interval: 0.988-0.996; p = 0.018). Any type of immunochemotherapy regimen was associated with different risks of hypogammaglobulinemia in our study. CONCLUSIONS: Hypogammaglobulinemia appears in a high percentage of patients with follicular lymphoma in a real-world population, identifying a high-risk FLIPI score as a risk factor for its development and basal gamma globulins as a protective factor.

Prevalencia y factores asociados con la presencia de criterios PIMDINAC en pacientes VIH de edad avanzada / Prevalence of PIMDINAC criteria and associated factors in elderly HIV patients

IntroducciónEl envejecimiento de la población infectada por VIH podría relacionarse con prescripciones de medicación potencialmente inadecuadas, interacciones medicamentosas y falta de adherencia terapéutica. Los criterios PIMDINAC buscan analizar conjuntamente estos problemas. El objetivo del estudio es determinar la prevalencia de los criterios PIMDINAC en una población VIH de edad avanzada.MétodosEstudio observacional, transversal y multicéntrico que incluyó pacientes mayores de 65 años en seguimiento farmacoterapéutico entre febrero-abril de 2020. La variable principal fue el porcentaje de cumplimiento de los criterios PIMDINAC.ResultadosSe incluyeron 47 pacientes, registrándose un PIMDINAC total en un 12,5%. De forma aislada, se detectó no adherencia al tratamiento concomitante en un 65,6% de los pacientes, medicación potencialmente inadecuada en un 48,9% e interacciones medicamentosas en un 25,2%. El número de fármacos y la polifarmacia se relacionaron con una mayor aparición de criterios PIMDINAC.ConclusiónLa prevalencia de criterios PIMDINAC en pacientes VIH de edad avanzada es elevada.

IntroductionAging of people living with HIV could be related to potentially inappropriate medication prescriptions, drugs interactions and lack of drugs adherence. PIMDINAC criteria seek to jointly analyze these problems. The objective of this study is to determine the prevalence of PIMDINAC criteria in an elderly HIV population.MethodsObservational, cross-sectional, multicenter study that included patients older than 65 years in pharmacotherapeutic follow-up between February-April 2020. The main endpoint was the percentage of PIMDINAC criteria identified in the study population.ResultsForty-seven patientes were included, identifying total PIMDINAC in 12.5%. Non-adherence to concomitant treatment was detected in 65.6% of patients, potentially inappropriate medication in 48.9% and drugs interactions in 25.2%. The number of concomitant drugs and polypharmacy were associated with a higher appearance of PIMDINAC criteria.ConclusionThe prevalence of PIMDINAC criteria in elderly HIV patients is high.

Combination of mifepristone and misoprostol vs misoprostol monotherapy for treatment of second-trimester pregnancy loss.

OBJECTIVE: Our main goal was to evaluate whether a treatment protocol based on the combination of mifepristone and misoprostol for second-trimester foetal loss was more effective than misoprostol monotherapy. METHODS: This was an observational, retrospective, cross-sectional two-centre study of women receiving treatment for second-trimester pregnancy loss. Patients were recruited in two centres that used different treatment protocols: combined mifepristone-misoprostol treatment or misoprostol monotherapy. RESULTS: A total of 99 patients were included in the study: 41 in the mifepristone-misoprostol combined treatment group and 58 in the misoprostol monotherapy group. The combined treatment group had shorter times to expulsion and shorter hospitalisations, as well as higher rates of hospital discharge within 24 h and complete abortion within the first 6 h and 12 h. There were no differences regarding secondary effects and complication rates. CONCLUSION: A combination of mifepristone and misoprostol appears to be a feasible option for the treatment of second-trimester pregnancy loss.

Prevalence of PIMDINAC criteria and associated factors in elderly HIV patients.

INTRODUCTION: Aging of people living with HIV could be related to potentially inappropiate medication prescriptions, drugs interactions and lack of drugs adherence. PIMDINAC criteria seek to jointly analyze these problems. The objective of this study is to determine the prevalence of PIMDINAC criteria in an elderly HIV population. METHODS: Observational, cross-sectional, multicenter study that included patients older than 65 years in pharmacotherapeutic follow-up between February-April 2020. The main endpoint was the percentage of PIMDINAC criteria identified in the study population. RESULTS: Forty-seven patientes were included, identifying total PIMDINAC in 12.5%. Non-adherence to concomitant treatment was detected in 65.6% of patients, potentially inappropiate medication in 48.9% and drugs interactions in 25.2%. The number of concomitant drugs and polypharmacy were associated with a higher appearance of PIMDINAC criteria. CONCLUSION: The prevalence of PIMDINAC criteria in elderly HIV patients is high.

Effectiveness and safety of eribulin for human epidermal growth factor receptor 2 negative metastatic breast cancer in a real-world population.

BACKGROUND: Eribulin's clinical benefit remains unclear; so, studies analyzing its effectiveness in routine clinical practice are interesting. PATIENTS AND METHODS: This is a multicenter, retrospective study including patients with human epidermal growth factor receptor-2-negative metastatic breast cancer which assesses effectiveness and safety of eribulin. RESULTS: A total of 140 women were included, with a median age of 57 years. The median overall survival and progression-free survival were 8.8 (95% confidence interval: 6.1-11.4) and 2.8 months (95% confidence interval: 2.5-3.1), respectively. For patients with hormonal receptor expression, a significantly longer progression-free survival was observed: 3.4 (95%confidence interval: 2.3-4.5) versus triple negative: 2.0 (95%confidence interval: 1.7-2.3) months, p = 0.003. Also, those who had received capecitabine prior to eribulin had a higher median overall survival than those who had not received it (9.5 months, 95% confidence interval: 6.6-12.5 vs. 4.8 months, 95% confidence interval: 3.4-6.2; p = 0.001). When only triple-negative patients were included, median overall survival was 6.5 (95% confidence interval: 0.1-16.2) for those who had received previous capecitabine versus 4.3 (95% confidence interval: 2.8-5.8) months for patients who had not received it; p =0.006. The safety profile of eribulin was adequate. CONCLUSION: Effectiveness of eribulin in a real-life human epidermal growth factor receptor-2--negative population is lower than that observed in clinical trials. Its benefit seems to be higher in patients with hormonal receptor expression and patients who had received capecitabine prior to eribulin. The safety profile of eribulin is adequate.

Prevalence of PIMDINAC criteria and associated factors in elderly HIV patients. / Prevalencia y factores asociados con la presencia de criterios PIMDINAC en pacientes VIH de edad avanzada.

INTRODUCTION: Aging of people living with HIV could be related to potentially inappropriate medication prescriptions, drugs interactions and lack of drugs adherence. PIMDINAC criteria seek to jointly analyze these problems. The objective of this study is to determine the prevalence of PIMDINAC criteria in an elderly HIV population. METHODS: Observational, cross-sectional, multicenter study that included patients older than 65 years in pharmacotherapeutic follow-up between February-April 2020. The main endpoint was the percentage of PIMDINAC criteria identified in the study population. RESULTS: Forty-seven patientes were included, identifying total PIMDINAC in 12.5%. Non-adherence to concomitant treatment was detected in 65.6% of patients, potentially inappropriate medication in 48.9% and drugs interactions in 25.2%. The number of concomitant drugs and polypharmacy were associated with a higher appearance of PIMDINAC criteria. CONCLUSION: The prevalence of PIMDINAC criteria in elderly HIV patients is high.

Pharmaceutical care to hospital outpatients during the COVID-19 pandemic. Telepharmacy.

Hospital Pharmacy Service (HPS) in Spain have been impacted by the health  crisis caused by the COVID-19 pandemic. Thus, the outbreak has forced HPSs to adapt their outpatient consultation services to Telepharmacy to optimize clinical  outcomes and reduce the risk of contagion. The purpose of this article is to  describe and analyze the experience of HPSs with outpatient Telepharmacy  during the COVID-19 pandemic and expose the lessons learned. Measures have  been adopted in on-site outpatient pharmacy clinics to prevent exposure of  patients and professionals to the virus. These measures are based on national  and international recommendations on social distancing and hygiene. With  regard to remote outpatient pharmacy services, teleconsultation with drug  dispensing has been promoted based on five basic procedures, each with its  advantages and limitations: home drug delivery from HPSs, with the advantage  of universal access and the limitation of entailing a substantial investment in  resources; HPS coordination with primary care pharmacists, which requires no  investments but with limited access to some geographic areas; HPS coordination with community pharmacists based on a large network of pharmacies, which  requires the patient to go to the pharmacy, without confidentiality being  guaranteed for any patient; geolocation and hospital-based medication  dispensing, which provides universal access and direct traceability, but entails  investment in human resources; and HPS coordination with associations of  patients, which does not entail any additional cost but limits the information  available on the diseases of society members. Three main lessons have been learned during the pandemic: the satisfactory capacity of HPS to provide outpatient pharmacy consultation services in the setting of a public health crisis; the usefulness of Telepharmacy for the clinical follow-up, healthcare coordination, outpatient counseling, and informed dispensing and delivery of  medication (with a high level of satisfaction among patients); and the need to  foster Telepharmacy as a complementary tool through a mixed model of  outpatient pharmacy consultation service that incorporates the advantages of  each procedure and adapts to the individual needs of each patient in a context of humanized healthcare.

Los servicios de farmacia hospitalaria (SFH) en España se han visto afectados  por la crisis sanitaria provocada por SARS-CoV-2 y han tenido que adoptar sus  procedimientos de atención farmacéutica (AF) al paciente externo (PE) mediante estrategias de Telefarmacia, con los objetivos de maximizar los resultados en  salud y reducir el riesgo de contagio. El objetivo de ese artículo es describir y  analizar los procedimientos AFPE durante la pandemia SARS-CoV-2 y comunicar  las lecciones aprendidas en los SFH. En relación con las consultas externas de AF presenciales, se han adoptado medidas para minimizar el contagio viral de  pacientes y profesionales, siguiendo las recomendaciones nacionales e  internacionales de referencia de distanciamiento temporal, espacial y  recomendaciones higiénicas. En cuanto a las consultas externas de AF no  presenciales, se han potenciado las teleconsultas con dispensación del  tratamiento en base a cinco procedimientos básicos, cada uno de ellos con sus  ventajas y limitaciones: dispensación domiciliaria desde SFH que presenta las  ventajas de la universalidad de acceso, pero requiere una elevada inversión en  recursos; coordinación del SHF con farmacéuticos de atención primaria, que  conlleva una nula inversión en recursos, pero limita el acceso a determinadas zonas geográficas; coordinación del SFH con farmacéuticos comunitarios, que  utiliza una amplia red de oficinas de farmacia, pero exige el desplazamiento del  paciente sin garantías de confidencialidad para todos los casos; geolocalización y dispensación hospitalaria, que permite un acceso universal y trazabilidad directa, pero requiere un incremento en recursos humanos; y coordinación del SFH con  asociaciones de pacientes, que no requiere inversión económica, pero limita el  acceso a las patologías de los asociados. Destacamos finalmente tres lecciones  aprendidas: la capacidad de AFPE de SFH españoles ante una crisis sanitaria; la  utilidad de la Telefarmacia para el seguimiento clínico, la coordinación  asistencial, información al PE, dispensación y entrega informada (con elevada  satisfacción de los pacientes); y la necesidad de potenciar la Telefarmacia como herramienta complementaria, en un modelo mixto de AFPE que incorpore las  ventajas de cada uno de los procedimientos adaptándose a las necesidades individuales de los pacientes en un entorno de humanización de la asistencia  sanitaria.

Estudio en vida real de pertuzumab-trastuzumabquimioterapia frente a trastuzumab-quimioterapia en neoadyuvancia en cáncer de mama / Real world study of pertuzumab-trastuzumab-chemotherapy versus trastuzumab-chemotherapy in neoadjuvant treatment of breast cance

OBJETIVO: El objetivo primario del estudio es comparar la efectividad de trastuzumab-quimioterapia con y sin pertuzumab. Como objetivo secunda-rio se busca evaluar la seguridad cardiaca del tratamiento. MÉTODO: Estudio observacional retrospectivo que incluyó todas las pa-cientes tratadas con pertuzumab-trastuzumab-quimioterapia (n = 10) o trastuzumab-quimioterapia (n = 13) (enero 2015-diciembre 2018) en un hospital de especialidades, que cumplían los criterios establecidos por la Comisión Central para la Optimización y Armonización de la farma-coterapia del Servicio Andaluz de Salud para uso de pertuzumab en neoadyuvancia: tumor HER2 positivo, receptores hormonales negativos, con alto riesgo de recaída (tumor > 2 cm o afectación ganglionar). Para valorar la efectividad se utilizó la respuesta completa patológica, y para la seguridad cardiaca, el descenso de la fracción de eyección del ven-trículo izquierdo superior al 10%. RESULTADOS: La respuesta completa patológica fue superior en el grupo con pertuzumab (70,0% versus 30,8%). La seguridad cardiaca fue similar en ambos. CONCLUSIONES: Para las pacientes con tumores HER2 positivo y recep-tores hormonales negativos con criterios de alto riesgo que reciben pertu-zumab, la respuesta completa patológica resulta superior, sin observarse incremento de la toxicidad cardiaca

OBJECTIVE: The primary objective of the study is to compare the effec-tiveness of trastuzumab-chemotherapy with and without pertuzumab. As a secondary objective, we seek to evaluate the cardiac safety of the treatment. METHOD: Retrospective observational study including all patients treated with either pertuzumab-trastuzumab-chemotherapy (n = 10) or trastuzu-mab-chemotherapy (n = 13) (January 2015-December 2018) in a special-ty hospital, which met the criteria established by the Commission Central for the Optimization and Harmonization of the pharmacotherapy of the Andalusian Health Service for the use of pertuzumab in neoadjuvance: HER2 positive tumor, negative hormonal receptors, with high risk of relapse (tumor > 2 cm or lymph node involvement). To assess effectiveness, the complete pathological response was used. For cardiac safety, the de-crease in left ventricular ejection fraction greater than 10% was employed. RESULTS: Complete pathological response was superior in the pertuzu-mab group (70.0% vs. 30.8%). Cardiac safety was similar in both.CONCLUSIONS: For patients with HER2 positive tumors and negative hormonal receptors with high risk criteria that receive pertuzumab, the complete pathological response is superior, with no increase in cardiac toxicity

Indirect comparison of anti-interleukin 17 targeted biological treatments for moderate-to-severe psoriasis.

WHAT IS KNOWN AND OBJECTIVE: Psoriasis is an inflammatory skin disease with an important disease burden worldwide and its treatment includes systemic therapies which have advanced over time to target specific immune cytokines such as interleukin-17. The main objective of this study was to compare the relative efficacy of brodalumab, ixekizumab and secukinumab (three anti-interleukin-17 drugs) through adjusted indirect treatment comparisons (ITCs). METHODS: A search was carried out in June 2019, consulting these databases: MEDLINE, EMBASE, Web of Science and the Cochrane Library. Studies including patients with moderate to severe psoriasis randomized to receive treatment with anti-interleukin-17 drugs or ustekinumab and with outcomes such as Psoriasis Area and Severity Index (PASI) 75, PASI 90 and PASI 100 scores or static Physician's Global Assessment (sPGA), were included. ITCs were carried out using the method proposed by Bucher et al RESULTS AND DISCUSSION: Five randomized clinical trials were included. Analysing short-term data, there were no statistically significant differences between any pair of drugs in terms of PASI 75, PASI 100 or sPGA/sIGA 0/1. Analysing long-term data, statistically significant differences were only observed for secukinumab versus brodalumab in terms of PASI 100 (Absolute risk reduction -12.9%; 95% confidence interval -22.7% to -3.1%). WHAT IS NEW AND CONCLUSION: The ITCs indicated no efficacy differences between anti-interleukin-17 drugs, except for secukinumab versus brodalumab 52-week analysis in terms of achieving PASI 100. All three drugs appear to act as equivalent clinical treatments for psoriasis. However, independent head-to-head trials should be carried out.

Real world study of pertuzumab-trastuzumabchemotherapy versus trastuzumab-chemotherapy in neoadjuvant treatment of breast cancer.

OBJECTIVE: The primary objective of the study is to compare the  effectiveness of trastuzumab-chemotherapy with and without  pertuzumab. As a secondary objective, we seek to evaluate the cardiac  safety of the treatment. METHOD: Retrospective observational study including all patients treated with either pertuzumab-trastuzumab-chemotherapy (n = 10) or  trastuzumab-chemotherapy (n = 13) (January 2015-December 2018) in a specialty hospital, which met the criteria established by the  Commission Central for the Optimization and Harmonization of the  pharmacotherapy of the Andalusian Health Service for the use of  pertuzumab in neoadjuvance: HER2 positive tumor, negative hormonal  receptors, with high risk of relapse (tumor > 2 cm or lymph node  involvement). To assess effectiveness, the complete pathological  response was used. For cardiac safety, the decrease in left ventricular  ejection fraction greater than 10% was employed. RESULTS: Complete pathological response was superior in the  pertuzumab group (70.0% vs. 30.8%). Cardiac safety was similar in  both. CONCLUSIONS: For patients with HER2 positive tumors and negative hormonal receptors with high risk criteria that receive  pertuzumab, the complete pathological response is superior, with no  increase in cardiac toxicity.

Objetivo: El objetivo primario del estudio es comparar la efectividad trastuzumab-quimioterapia con y sin pertuzumab. Como  objetivo secundario se busca evaluar la seguridad cardiaca del  tratamiento.Método: Estudio observacional retrospectivo que incluyó todas las  pacientes tratadas con pertuzumab-trastuzumab-quimioterapia (n = 10) o trastuzumab-quimioterapia (n = 13) (enero 2015-diciembre 2018) en  un hospital de especialidades, que cumplían los criterios establecidos  por la Comisión Central para la Optimización y Armonización de la  farmacoterapia del Servicio Andaluz de Salud para uso de pertuzumab  en neoadyuvancia: tumor HER2 positivo, receptores hormonales  negativos, con alto riesgo de recaída (tumor > 2 cm o afectación  ganglionar). Para valorar la efectividad se utilizó la respuesta completa  patológica, y para la seguridad cardiaca, el descenso de la fracción de  eyección del ventrículo izquierdo superior al 10%.Resultados: La respuesta completa patológica fue superior en el grupo con pertuzumab (70,0% versus 30,8%). La seguridad cardiaca  fue similar en ambos.Conclusiones: Para las pacientes con tumores HER2 positivo y  receptores hormonales negativos con criterios de alto riesgo que reciben  pertuzumab, la respuesta completa patológica resulta superior,  sin observarse incremento de la toxicidad cardiaca.

Atención farmacéutica al paciente externo durante la pandemia COVID-19. Telefarmacia / Pharmaceutical care to hospital outpatients during the COVID-19 pandemic. Telepharmacy

Los servicios de farmacia hospitalaria (SFH) en España se han visto afectados por la crisis sanitaria provocada por SARS-CoV-2 y han tenido que adoptar sus procedimientos de atención farmacéutica (AF) al paciente externo (PE) mediante estrategias de Telefarmacia, con los objetivos de maximizar los resultados en salud y reducir el riesgo de contagio. El objetivo de ese artículo es describir y analizar los procedimientos AFPE durante la pandemia SARS-CoV-2 y comunicar las lecciones aprendidas en los SFH. En relación con las consultas externas de AF presenciales, se han adoptado medidas para minimizar el contagio viral de pacientes y profesionales, siguiendo las recomendaciones nacionales e internacionales de referencia de distanciamiento temporal, espacial y recomendaciones higiénicas. En cuanto a las consultas externas de AF no presenciales, se han potenciado las teleconsultas con dispensación del tratamiento en base a cinco procedimientos básicos, cada uno de ellos con sus ventajas y limitaciones: dispensación domiciliaria desde SFH que presenta las ventajas de la universalidad de acceso, pero requiere una elevada inversión en recursos; coordinación del SHF con farmacéuticos de atención primaria, que con-lleva una nula inversión en recursos, pero limita el acceso a determinadas zonas geográficas; coordinación del SFH con farmacéuticos comunitarios, que utiliza una amplia red de oficinas de farmacia, pero exige el desplazamiento del paciente sin garantías de confidencialidad para todos los casos; geolocalización y dispensación hospitalaria, que permite un acceso universal y trazabilidad directa, pero requiere un incremento en recursos humanos; y coordinación del SFH con asociaciones de pacientes, que no requiere inversión económica, pero limita el acceso a las patologías de los asociados. Destacamos finalmente tres lecciones aprendidas: la capacidad de AFPE de SFH españoles ante una crisis sanitaria; la utilidad de la Telefarmacia para el seguimiento clínico, la coordinación asistencial, información al PE, dispensación y entrega informada (con elevada satisfacción de los pacientes); y la necesidad de potenciar la Telefarmacia como herramienta complementaria, en un modelo mixto de AFPE que incorpore las ventajas de cada uno de los procedimientos adaptándose a las necesidades individuales de los pacientes en un entorno de humanización de la asistencia sanitaria

Hospital Pharmacy Service (HPS) in Spain have been impacted by the health crisis caused by the COVID-19 pandemic. Thus, the outbreak has forced HPSs to adapt their outpatient consultation services to Telepharmacyto optimize clinical outcomesand reduce the risk of contagion. The purpose of this article is to describe and analyze the experience of HPSs with out-patient Telepharmacy during the COVID-19 pandemic and expose the les-sons learned. Measures have been adopted in on-site outpatient pharmacy clinics to prevent exposure of patients and professionals to the virus. These measures are based on national and international recommendations on social distancing and hygiene. With regard to remote outpatient pharmacy services, teleconsultation with drug dispensing has been promoted based on five basic procedures, each with its advantages and limitations: home drug delivery from HPSs, with the advantage of universal access and the limitation of entailing a substantial investment in resources; HPS coordination with primary care pharmacists, which requires no investments but with limited access to some geographic areas; HPS coordination with community pharmacists based on a large network of pharmacies, which requires the patient to go to the pharmacy, without confidentiality being guaranteed for any patient; geolocation and hospital-based medication dispensing, which provides universal access and direct traceability, but entails investment in human resources; and HPS coordination with associations of patients, which does not entail any additional cost but limits the information available on the diseases of society members. Three main lessons have been learned during the pandemic: the satisfactory capacity of HPS to provide outpatient pharmacy consultation services in the setting of a public health crisis; the usefulness of Telepharmacy for the clinical follow-up, healthcare coordination, outpatient counseling, and informed dispensing and delivery of medication (with a high level of satisfaction among patients); and the need to foster Telepharmacy as a complementary tool through a mixed model of outpatient pharmacy consultation service that incorporates the advantages of each procedure and adapts to the individual needs of each patient in a context of humanized healthcare