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OBJECTIVE: To describe the aspects with the greatest impact on the satisfaction of patients treated in a multidisciplinary unit specialising in immune-mediated inflammatory diseases (IMIDs) and to identify areas for improvement in the care model. METHODS: Cross-sectional descriptive study using a satisfaction survey structured in three blocks: sociodemographic variables, functional aspects of the unit and satisfaction with the professionals. Immediate satisfaction was measured on aspects related to the care received, the physical structure and the likelihood of recommending the unit. RESULTS: A total of 168 patients completed the surveys, the mean score of overall satisfaction with the unit was 4.75 (SD:0.4). The regression model showed the relationship between overall satisfaction and unit signage (OR:3.558, p=0.045, 95% CI: 1.027-12.33), coordination between professionals (OR:9.043, p=0.000, 95% CI: 2.79-29.28) and participation in decision making (OR: 44.836, p=0.000, 95% CI: 5.49-365.97). In terms of immediate satisfaction, the overall Net Promoter Score (NPS) was 87 (excellent). The mean score for coordination with Primary Care was 4.54 (SD:0.8) and they scored waiting time to be seen with 4.49 (SD:0.8), so they have been considered an area for improvement The mean score for coordination with Primary Care was 4.54 (SD:0.8) and they scored waiting time to be seen with 4.49 (SD:0.8), so both were considered areas for improvement. CONCLUSIONS: Coordination between intra-centre professionals and patient participation in decision-making explain the excellent level of patient satisfaction. The monitoring of satisfaction has made it possible to implement immediate improvement actions.
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BACKGROUND: Conventional cytotoxic drugs are not effective in alveolar soft-part sarcoma (ASPS). Immune checkpoint (programmed cell death protein 1/programmed death-ligand 1) inhibitors (ICIs) are promising drugs in ASPS. A worldwide registry explored the efficacy of ICI in ASPS. MATERIALS AND METHODS: Data from adult patients diagnosed with ASPS and treated with ICI for advanced disease in expert sarcoma centers from Europe, Australia and North America were retrospectively collected, including demographics and data related to treatments and outcome. RESULTS: Seventy-six ASPS patients, with a median age at diagnosis of 25 years (range 3-61 years), were registered. All patients received ICI for metastatic disease. Immunotherapy regimens consisted of monotherapy in 38 patients (50%) and combination in 38 (50%) (23 with a tyrosine kinase inhibitor). Among the 68 assessable patients, there were 3 complete responses and 34 partial responses, translating into an overall response rate of 54.4%. After a median follow-up of 36 months [95% confidence interval (CI) 32-40 months] since the start of immunotherapy, 45 (59%) patients have progressed on ICI, with a median progression-free survival (PFS) of 16.3 months (95% CI 8-25 months). Receiving ICI in first line (P = 0.042) and achieving an objective response (P = 0.043) correlated with a better PFS. Median estimated overall survival (OS) from ICI initiation has not been reached. The 12-month and 24-month OS rates were 94% and 81%, respectively. CONCLUSIONS: This registry constitutes the largest available series of ASPS treated with ICI. Our results suggest that the ICI treatment provides long-lasting disease control and prolonged OS in patients with advanced ASPS, an ultra-rare entity with limited active therapeutic options.
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Antineoplásicos , Sarcoma de Parte Blanda Alveolar , Adulto , Humanos , Preescolar , Niño , Adolescente , Adulto Joven , Persona de Mediana Edad , Inhibidores de Puntos de Control Inmunológico/farmacología , Inhibidores de Puntos de Control Inmunológico/uso terapéutico , Estudios Retrospectivos , Sarcoma de Parte Blanda Alveolar/tratamiento farmacológico , Sarcoma de Parte Blanda Alveolar/patología , Antineoplásicos/uso terapéutico , Inhibidores de Proteínas Quinasas/uso terapéuticoRESUMEN
BACKGROUND: Poly(ADP-ribose) polymerase (PARP) inhibitor maintenance therapy is the standard of care for some patients with advanced ovarian cancer. We evaluated the efficacy and safety of PARP inhibitor rechallenge. PATIENTS AND METHODS: This randomized, double-blind, multicenter trial (NCT03106987) enrolled patients with platinum-sensitive relapsed ovarian cancer who had received one prior PARP inhibitor therapy for ≥18 and ≥12 months in the BRCA-mutated and non-BRCA-mutated cohorts, respectively, following first-line chemotherapy or for ≥12 and ≥6 months, respectively, following a second or subsequent line of chemotherapy. Patients were in response following their last platinum-based chemotherapy regimen and were randomized 2 : 1 to maintenance olaparib tablets 300 mg twice daily or placebo. Investigator-assessed progression-free survival (PFS) was the primary endpoint. RESULTS: Seventy four patients in the BRCA-mutated cohort were randomized to olaparib and 38 to placebo, and 72 patients in the non-BRCA-mutated cohort were randomized to olaparib and 36 to placebo; >85% of patients in both cohorts had received ≥3 prior lines of chemotherapy. In the BRCA-mutated cohort, the median PFS was 4.3 months with olaparib versus 2.8 months with placebo [hazard ratio (HR) 0.57; 95% confidence interval (CI) 0.37-0.87; P = 0.022]; 1-year PFS rates were 19% versus 0% (Kaplan-Meier estimates). In the non-BRCA-mutated cohort, median PFS was 5.3 months for olaparib versus 2.8 months for placebo (HR 0.43; 95% CI 0.26-0.71; P = 0.0023); 1-year PFS rates were 14% versus 0% (Kaplan-Meier estimates). No new safety signals were identified with olaparib rechallenge. CONCLUSIONS: In ovarian cancer patients previously treated with one prior PARP inhibitor and at least two lines of platinum-based chemotherapy, maintenance olaparib rechallenge provided a statistically significant, albeit modest, PFS improvement over placebo in both the BRCA-mutated and non-BRCA-mutated cohorts, with a proportion of patients in the maintenance olaparib rechallenge arm of both cohorts remaining progression free at 1 year.
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Antineoplásicos , Carcinoma Epitelial de Ovario , Neoplasias Ováricas , Inhibidores de Poli(ADP-Ribosa) Polimerasas , Femenino , Humanos , Antineoplásicos/uso terapéutico , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Quimioterapia de Mantención , Recurrencia Local de Neoplasia/tratamiento farmacológico , Recurrencia Local de Neoplasia/genética , Recurrencia Local de Neoplasia/inducido químicamente , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/genética , Ftalazinas , Inhibidores de Poli(ADP-Ribosa) Polimerasas/uso terapéuticoRESUMEN
Diffuse large B-cell lymphoma (DLBCL) patients with relapsed or refractory (RR) disease have poor outcomes with current salvage regimens. We conducted a phase 2 trial to analyse the safety and efficacy of adding lenalidomide to R-ESHAP (LR-ESHAP) in patients with RR DLBCL. Subjects received 3 cycles of lenalidomide 10 mg/day on days 1-14 of every 21-day cycle, in combination with R-ESHAP at standard doses. Responding patients underwent autologous stem-cell transplantation (ASCT). The primary endpoint was the overall response rate (ORR) after 3 cycles. Centralized cell-of-origin (COO) classification was performed. Forty-six patients were included. The ORR after LR-ESHAP was 67% (35% of patients achieved complete remission). Patients with primary refractory disease (n = 26) had significantly worse ORR than patients with non-refractory disease (54% vs. 85%, p = 0.031). No differences in response rates according to the COO were observed. Twenty-eight patients (61%) underwent ASCT. At a median follow-up of 41 months, the estimated 3-year PFS and OS were 42% and 48%, respectively. The most common grade ≥3 adverse events were thrombocytopenia (70% of patients), neutropenia (67%) and anaemia (35%). There were no treatment-related deaths during LR-ESHAP cycles. In conclusion, LR-ESHAP is a feasible salvage regimen with promising efficacy results for patients with RR DLBCL.
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Linfoma de Células B Grandes Difuso , Linfoma no Hodgkin , Neutropenia , Trombocitopenia , Humanos , Lenalidomida/efectos adversos , Linfoma no Hodgkin/tratamiento farmacológico , Linfoma de Células B Grandes Difuso/patología , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neutropenia/etiología , Trombocitopenia/inducido químicamente , Rituximab/uso terapéuticoRESUMEN
Alveolar soft part sarcoma (ASPS) accounts for less than 1 % of all soft tissue sarcomas. ASPS presents a poor prognosis and develops frequent metastases, especially in the lungs, brain and bones. Current therapies, such as surgery, radiotherapy and chemotherapy, are not fully effective and other alternative treatments are currently being studied. ASPS is predominantly found in the deep soft tissues of the lower extremities. To our knowledge, only thirteen primary intraosseous ASPS have been reported in the literature. In this study, we report two new cases of this exceedingly rare entity. Both cases already had multiple metastases since diagnosis; one of them represents the first case of a primary bone ASPS in the ulna and is also the primary intraosseous ASPS with the longest reported case of survival, after having maintained long periods of stabilization despite not having received any systemic treatment.
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Neoplasias Encefálicas , Neoplasias Pulmonares , Sarcoma de Parte Blanda Alveolar , Neoplasias de los Tejidos Blandos , Humanos , Sarcoma de Parte Blanda Alveolar/diagnóstico por imagen , Sarcoma de Parte Blanda Alveolar/patología , Neoplasias de los Tejidos Blandos/patología , Neoplasias Pulmonares/secundario , Encéfalo/patologíaRESUMEN
Bird migratory journeys are often long and hostile, requiring high energetic expenditure, and thus forcing birds to pause between migratory flights. Stopover sites allow migrants to replenish fuel reserves and rest, being crucial for the success of migration. Worldwide, the increasing accumulation of waste on landfills and rubbish dumps has been described to provide superabundant food resources for many bird species not only during the breeding and wintering seasons but also during migration, being used as stopover sites. Using GPS-tracking data of juvenile white storks (Ciconia ciconia) during their first migration from the Iberia Peninsula to the sub-Saharan wintering grounds, we uncover the effects of stopping en route on individual migratory performance. Particularly, we examine the benefits of stopping at artificial sites (landfills and rubbish dumps) when compared to natural stopover sites (wetlands, agricultural or desert areas) and explore the influence of anthropogenic food resources on storks' migratory strategies. Overall, white storks spent up to one-third of the migration in stopovers. We found that birds that stopped for longer periods made more detours, increasing migration duration by half a day for each stopover day. Stopping more often did not reflect on increasing in-flight energetic efficiency nor the likelihood of completing the migration. Juvenile storks used artificial sites in 80 % of the stopover days, spending 45 % less time and 10 % less energy foraging than when using natural stopovers. While stopping in landfills did not translate into differences in migratory performance, individuals in poor body condition possibly rely on these sites to improve body weight before proceeding, enabling them to successfully complete migration. Artificial stopover sites are attractive and likely increase the number and duration of stops for white storks. Even though the consequences of arriving late at the wintering grounds are unknown, it can lead to cascading consequences, influencing individual fitness and population dynamics.
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Migración Animal , Ejercicio Físico , Humanos , África del NorteRESUMEN
BACKGROUND AND AIM: To determine the impact of the COVID-19 pandemic on the epidemiology of safety incidents (SI) and medication errors (ME) reported to the CISEMadrid notification system in the hospital and primary care settings of the Madrid Health Service (SERMAS). MATERIALS AND METHODS: Observational and descriptive study with a retrospective analysis of data including all CISEMadrid notifications from 01-Jan-2018 to 31-Dec-2020, from 33 hospitals and 262 health care centres of the SERMAS. The two periods in 2020 with the greatest increase in COVID-19 cases were identified to compare incidents reported in the pre-pandemic and pandemic periods. RESULTS: 36,494 incidents were reported. Comparing both periods, an overall decrease in pandemic notifications of 60.7% was observed, being higher in primary care, falling to 33% of previous levels. The reduction in notifications was similar in the peaks and valleys of the waves. The three most frequent SIs in both periods and care settings were: diagnostic tests, medical devices/equipment/clinical furniture and organisational management/citations. In ME, dose failure and inappropriate selection were the most frequent in both settings and periods. There were no relevant differences in patient consequences in both periods. CONCLUSIONS: During the pandemic, patient safety notifications decreased although the most frequent types remained the same, as did their impact on the patient, both in hospitals and in primary care. The safety culture of organisations is a critical aspect for the maintenance of reporting systems.
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COVID-19 , Seguridad del Paciente , Humanos , Gestión de Riesgos , COVID-19/epidemiología , Pandemias , Estudios Retrospectivos , Errores de MedicaciónRESUMEN
Introducción y objetivos: La posición final de las neocomisuras en el implante percutáneo de válvula aórtica (TAVI) es aleatoria, lo que podría dificultar el acceso coronario y procedimientos futuros. Nuestro objetivo es desarrollar un método estandarizado para conseguir el alineamiento de las comisuras con ACURATE neo. Métodos: La relación entre las comisuras nativas y las neocomisuras de la válvula se analizó en 11 pacientes con estenosis aórtica grave sometidos a TAVI. Con base en la tomografía computarizada, se desarrolló un modelo in silico para predecir la posición final de los postes comisurales. A continuación, se desarrolló una técnica modificada de implante con alineamiento comisural adecuado (ACA) y un dispositivo específico para orientar el sistema de liberación. Por último, el implante de TAVI con alineamiento comisural se simuló en modelos impresos en 3D e in vivo. Se analizó el grado de mal alineamiento y de solapamiento coronario (SC). Resultados: El modelo in silico predijo con precisión la posición de los postes comisurales tanto para implantes convencionales (2) como aquellos con técnica de ACA (9) (coeficiente de correlación=0,994; IC95%, 0,989-0,998; p <0,001). El TAVI con una rotación del sistema específica para cada paciente se simuló con éxito en biomodelos y en 9 pacientes (mal alineamiento comisural medio in vivo, 7,7±3,9°). Ninguno de los implantes con técnica ACA presentó SC, mientras que la simulación in silico para los mismos casos pero mediante implante convencional predijo SC en 6 de los 9 casos. Conclusiones: El alineamiento comisural preciso del dispositivo ACURATE neo es factible mediante la inserción del sistema de liberación rotado específicamente para cada paciente basándose en el análisis de la tomografía computarizada. Este método sencillo y reproducible de alineamiento comisural podría utilizarse con todo tipo de dispositivos para TAVI (AU)
Introduction and objectives: Final position of the neo-commissures is uncontrolled during transcatheter aortic valve implantation (TAVI), potentially hindering coronary access and future procedures. We aimed to develop a standard method to achieve commissural alignment with the ACURATE neo valve. Methods: The relationship between native and TAVI neo-commissures was analyzed in 11 severe aortic stenosis patients undergoing TAVI. Based on computed tomography analysis, an in silico model was developed to predict final TAVI commissural posts position. A modified implantation technique, accurate commissural alignment (ACA) and a dedicated delivery system were developed. TAVI implants were tested in 3-dimensional (3D) printed models and in vivo. Commissural misalignment and coronary overlap (CO) were analyzed. Results: The in silico model accurately predicted final position of commissural posts irrespective of the implantation technique performed (correlation coefficient, 0.994; 95%CI, 0.989-0.998; P<.001). TAVI implant with patient-specific rotation was simulated in 3D printed models and in 9 patients. ACA-oriented TAVI implants presented adequate commissural alignment in vivo (mean commissural misalignment of 7.7 ±3.9°). None of the ACA oriented implants showed CO, whereas in silico conventional implants predicted CO in 6 of the 9 cases. Conclusions: Accurate commissural alignment of the ACURATE neo device is feasible by inserting the delivery system with a patient-specific rotation based on computed tomography analysis. This is a simple and reproducible method for commissural alignment that can be potentially used for all kinds of TAVI devices (AU)
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Humanos , Reemplazo de la Válvula Aórtica Transcatéter , Estenosis de la Válvula Aórtica/terapia , Tomografía Computarizada por Rayos X , Índice de Severidad de la Enfermedad , PronósticoAsunto(s)
Humanos , Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Algoritmos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Tomografía Computarizada por Rayos X , Angiografía CoronariaRESUMEN
BACKGROUND: There is limited evidence for the benefit of olaparib in platinum-resistant ovarian cancer (PROC) patients with BRCA wild-type tumors. This study investigated whether this combination of a DNA-damaging chemotherapy plus olaparib is effective in PROC regardless BRCA status. PATIENTS AND METHODS: Patients with high-grade serous or endometrioid ovarian carcinoma and one previous PROC recurrence were enrolled regardless of BRCA status. Patients with ≤4 previous lines (up to 5 in BRCA-mut) with at least one previous platinum-sensitive relapse were included; primary PROC was allowed only in case of BRCA-mut. Patients initially received six cycles of olaparib 300 mg b.i.d. (biduum) + intravenous pegylated liposomal doxorubicin (PLD) 40 mg/m2 (PLD40) every 28 days, followed by maintenance with olaparib 300 mg b.i.d. until progression or toxicity. The PLD dose was reduced to 30 mg/m2 (PLD30) due to toxicity. The primary endpoint was progression-free survival (PFS) at 6 months (6m-PFS) by RECIST version 1.1. A proportion of 40% 6m-PFS or more was considered of clinical interest. RESULTS: From 2017 to 2020, 31 PROC patients were included. BRCA mutations were present in 16%. The median of previous lines was 2 (range 1-5). The overall disease control rate was 77% (partial response rate of 29% and stable disease rate of 48%). After a median follow-up of 10 months, the 6m-PFS and median PFS were 47% and 5.8 months, respectively. Grade ≥3 treatment-related adverse events occurred in 74% of patients, with neutropenia/anemia being the most frequent. With PLD30 serious AEs were less frequent than with PLD40 (21% versus 47%, respectively); moreover, PLD30 was associated with less PLD delays (32% versus 38%) and reductions (16% versus 22%). CONCLUSIONS: The PLD-olaparib combination has shown significant activity in PROC regardless of BRCA status. PLD at 30 mg/m2 is better tolerated in the combination.
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Neoplasias Ováricas , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Supervivencia sin Enfermedad , Doxorrubicina/análogos & derivados , Femenino , Humanos , Recurrencia Local de Neoplasia/tratamiento farmacológico , Recurrencia Local de Neoplasia/genética , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/genética , Ftalazinas , Piperazinas , PolietilenglicolesRESUMEN
Background Cancer and cancer therapies have been associated with an increased incidence of venous thromboembolic events (VTE). However, the incidence of VTE in patients on immunotherapy has not been well characterized. The aim of this study was to assess the incidence of VTE in cancer patients receiving immunotherapy and ascertain its prognostic utility. Materials and methods We conducted a single-institution retrospective study, including all cancer patients treated with anti-Programmed cell Death 1 (PD-1), anti-Programmed cell Death Ligand-1 (PD-L1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA4), a combination of anti-PD-1/anti-PD-L1 and anti-CTLA4 or a combination including any of these drugs with chemotherapy, antiangiogenic agents or both between June 2013 and April 2019 at La Paz University Hospital, Madrid (Spain). Results We selected 229 patients. VTE occurred in 16 of 229 patients (7%). VTE occurred more frequently in patients with lung cancer followed by melanoma. Female sex and melanoma were independently associated with an increased risk of VTE. 12 of 16 VTE (75%) were symptomatic. Progressive disease to immunotherapy [HR 31.60 (95% CI 11.4487.22), p = 0.00], lung cancer [HR 2.55 (95% CI 1.344.86), p = 0.00] and melanoma [HR 2.42 (1.204.86), p = 0.01] were independently associated with shorter OS. VTE occurrence was not independently associated with shorter OS [HR 1.33 (95% CI 0.632.80), p = 0.44]. Conclusions The incidence of VTE in cancer patients receiving immunotherapy in our study appeared to be similar to the incidence previously reported in other series of cancer patients treated with systemic therapies. VTE occurrence did not correlate with the prognosis. Further and prospective studies are needed to derive definitive conclusions (AU)
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Humanos , Masculino , Femenino , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Antineoplásicos Inmunológicos/efectos adversos , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/etiología , Neoplasias/terapia , Estudios Retrospectivos , Pronóstico , IncidenciaRESUMEN
Purpose Treatment of recurrent ovarian carcinoma is a challenge, particularly for the clear cell (CCC) subtype. However, there is a preclinical rationale that these patients could achieve a benefit from antiangiogenic therapy. To assess this hypothesis, we used the growth modulation index (GMI), which represents an intrapatient comparison of two successive progression-free survival (PFS). Methods We conducted a retrospective real-world study performed on 34 patients with recurrent ovarian cancer, treated with bevacizumab-containing regimens from January 2009 to December 2017. The primary endpoint was GMI. An established cut-off > 1.33 was defined as a sign of drug activity. Results 73.5% of patients had high-grade serous ovarian carcinoma (HGSOC), and 17.7% had CCC; 70.6% of patients received carboplatin/gemcitabine/bevacizumab, and 29.4% received weekly paclitaxel/bevacizumab. According to histological subtype, the overall response rate and median PFS were 52% and 14 months for HGSOC and 83.3% and 20 months for CCC, respectively. The overall population median GMI was 0.99; it was 0.95 and 2.36 for HGSOC and CCC, respectively. CCC subtype was significantly correlated with GMI > 1.33 (odds ratio 41.67; 95% confidence interval 3.6486.94; p = .03). Conclusion Adding bevacizumab to chemotherapy in recurrent CCC is associated with a remarkable benefit in this cohort. The efficacy of antiangiogenic drugs in CCC warrants further prospective evaluation (AU)
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Humanos , Femenino , Adulto , Persona de Mediana Edad , Anciano , Adenocarcinoma de Células Claras/tratamiento farmacológico , Neoplasias Ováricas/tratamiento farmacológico , Bevacizumab/uso terapéutico , Antineoplásicos Inmunológicos/uso terapéutico , Inhibidores de la Angiogénesis/uso terapéutico , Recurrencia Local de Neoplasia , Resultado del TratamientoRESUMEN
Despite remarkable advances in the knowledge of molecular biology and treatment, ovarian cancer remains the leading cause of death from gynecologic cancer. In the last decade, there have been important advances both in systemic and surgical treatment. However, there is no doubt that the incorporation of PARP inhibitors as maintenance after the response to platinum-based chemotherapy, first in recurrent disease and recently also in first line, will change the natural history of the disease.The objective of this guide is to summarize the current evidence for the diagnosis, treatment, and follow-up of ovarian cancer, and to provide evidence-based recommendations for clinical practice.
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Carcinoma Epitelial de Ovario/diagnóstico , Carcinoma Epitelial de Ovario/terapia , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/terapia , Antineoplásicos Inmunológicos/uso terapéutico , Bevacizumab/uso terapéutico , Carcinoma Epitelial de Ovario/patología , Quimioterapia Adyuvante/métodos , Ensayos Clínicos Fase III como Asunto , Procedimientos Quirúrgicos de Citorreducción/métodos , Femenino , Humanos , Quimioterapia de Mantención/métodos , Oncología Médica , Recurrencia Local de Neoplasia/tratamiento farmacológico , Recurrencia Local de Neoplasia/cirugía , Estadificación de Neoplasias/métodos , Neoplasias Ováricas/patología , Inhibidores de Poli(ADP-Ribosa) Polimerasas/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Sociedades Médicas , EspañaRESUMEN
PURPOSE: Treatment of recurrent ovarian carcinoma is a challenge, particularly for the clear cell (CCC) subtype. However, there is a preclinical rationale that these patients could achieve a benefit from antiangiogenic therapy. To assess this hypothesis, we used the growth modulation index (GMI), which represents an intrapatient comparison of two successive progression-free survival (PFS). METHODS: We conducted a retrospective real-world study performed on 34 patients with recurrent ovarian cancer, treated with bevacizumab-containing regimens from January 2009 to December 2017. The primary endpoint was GMI. An established cut-off > 1.33 was defined as a sign of drug activity. RESULTS: 73.5% of patients had high-grade serous ovarian carcinoma (HGSOC), and 17.7% had CCC; 70.6% of patients received carboplatin/gemcitabine/bevacizumab, and 29.4% received weekly paclitaxel/bevacizumab. According to histological subtype, the overall response rate and median PFS were 52% and 14 months for HGSOC and 83.3% and 20 months for CCC, respectively. The overall population median GMI was 0.99; it was 0.95 and 2.36 for HGSOC and CCC, respectively. CCC subtype was significantly correlated with GMI > 1.33 (odds ratio 41.67; 95% confidence interval 3.6-486.94; p = .03). CONCLUSION: Adding bevacizumab to chemotherapy in recurrent CCC is associated with a remarkable benefit in this cohort. The efficacy of antiangiogenic drugs in CCC warrants further prospective evaluation.
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Adenocarcinoma de Células Claras/tratamiento farmacológico , Inhibidores de la Angiogénesis/uso terapéutico , Bevacizumab/uso terapéutico , Cistadenocarcinoma Seroso/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Neoplasias Ováricas/tratamiento farmacológico , Adenocarcinoma de Células Claras/mortalidad , Adenocarcinoma de Células Claras/patología , Adulto , Anciano , Antineoplásicos Inmunológicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carboplatino/uso terapéutico , Intervalos de Confianza , Cistadenocarcinoma Seroso/mortalidad , Cistadenocarcinoma Seroso/patología , Desoxicitidina/análogos & derivados , Desoxicitidina/uso terapéutico , Femenino , Humanos , Persona de Mediana Edad , Recurrencia Local de Neoplasia/mortalidad , Recurrencia Local de Neoplasia/patología , Oportunidad Relativa , Neoplasias Ováricas/mortalidad , Neoplasias Ováricas/patología , Paclitaxel/uso terapéutico , Supervivencia sin Progresión , Estudios Retrospectivos , GemcitabinaRESUMEN
BACKGROUND: Cancer and cancer therapies have been associated with an increased incidence of venous thromboembolic events (VTE). However, the incidence of VTE in patients on immunotherapy has not been well characterized. The aim of this study was to assess the incidence of VTE in cancer patients receiving immunotherapy and ascertain its prognostic utility. MATERIALS AND METHODS: We conducted a single-institution retrospective study, including all cancer patients treated with anti-Programmed cell Death 1 (PD-1), anti-Programmed cell Death Ligand-1 (PD-L1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA4), a combination of anti-PD-1/anti-PD-L1 and anti-CTLA4 or a combination including any of these drugs with chemotherapy, antiangiogenic agents or both between June 2013 and April 2019 at La Paz University Hospital, Madrid (Spain). RESULTS: We selected 229 patients. VTE occurred in 16 of 229 patients (7%). VTE occurred more frequently in patients with lung cancer followed by melanoma. Female sex and melanoma were independently associated with an increased risk of VTE. 12 of 16 VTE (75%) were symptomatic. Progressive disease to immunotherapy [HR 31.60 (95% CI 11.44-87.22), p = 0.00], lung cancer [HR 2.55 (95% CI 1.34-4.86), p = 0.00] and melanoma [HR 2.42 (1.20-4.86), p = 0.01] were independently associated with shorter OS. VTE occurrence was not independently associated with shorter OS [HR 1.33 (95% CI 0.63-2.80), p = 0.44]. CONCLUSIONS: The incidence of VTE in cancer patients receiving immunotherapy in our study appeared to be similar to the incidence previously reported in other series of cancer patients treated with systemic therapies. VTE occurrence did not correlate with the prognosis. Further and prospective studies are needed to derive definitive conclusions.
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Inmunoterapia/efectos adversos , Neoplasias/terapia , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/etiología , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Adulto JovenRESUMEN
Cancers develop by sustained growth, migration and invasion properties of tumour cells, supported by complex interactions with stromal cells within the tumour micro-environment. This review is focused on the latest discoveries regarding the highlighted role of angiogenesis and tumour micro-environment in ovarian cancer. This cancer milieu encompasses non-cancerous cells present in the tumour or nearby, including vessel-forming cells, fibroblasts and immune cells amongst others that work in a cooperative way with cancer cells, impacting tumour behaviour. Angiogenesis, migration and invasion, and more recently immune evasion, are cancer hallmarks clearly dependent on these supporting cells. Moreover, these stromal cells are more genetically stable than tumour cells and thus represent an attractive therapeutic target. A better understanding of the stromal cells function, and their complex interplay with cancer cells, will open additional areas to target, as the tumour-host interface.
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BACKGROUND: Soft tissue sarcomas (STS) have a high risk of relapse in spite of the use of (neo)adjuvant chemotherapy. In this context, looking for new prognostic biomarkers is an interesting field of research. Our aim is to analyze the prognostic impact of neutrophil-to-lymphocyte ratio (NLR) and other serum markers in patients with STS who received chemotherapy with curative intent. MATERIALS AND METHODS: This is a retrospective observational study. We included all patients with STS (primary tumor, local recurrence or resected metastatic disease) treated with high-dose ifosfamide and epirubicin with curative intent from January 2007 to December 2018. The pretreatment NLR and other serum markers were calculated, selecting the median as the cut-off value for the survival and multivariate analysis. RESULTS: Seventy-nine patients were included. Median NLR, platelet-to-lymphocyte ratio (PLR) and lymphocyte-to-monocyte ratio (LMR) were 2.83, 174.05 and 3.25, respectively. Median progression-free survival (PFS) was significantly longer in patients with low NLR [not reached (NR) vs 21, 92 months, P < 0.01]. No significant differences were found for PFS regarding PLR or LMR. For overall survival (OS), a significant survival advantage was also found for patients with low NLR (NR vs 65.45 months, P = 0.01), without differences for PLR or LMR. In multivariate analysis, NLR remains an independent prognostic factor for PFS. CONCLUSION: In our cohort, low NLR was significantly associated with a longer PFS and OS, and is consolidated as an independent prognostic factor.
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Linfocitos , Neutrófilos , Sarcoma/mortalidad , Adolescente , Adulto , Anciano , Plaquetas , Femenino , Humanos , L-Lactato Deshidrogenasa/sangre , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Sarcoma/sangre , Sarcoma/terapia , Adulto JovenRESUMEN
INTRODUCTION: Assessing the perceived quality of a healthcare department by its users is essential in a quality management system. In Paediatric Emergency Departments (PED), the demand for urgent care has increased in recent years, as well as an increase in frequent attendance. Paying attention to the opinions of these habitual users by means of qualitative methodology is particularly suitable for assessing the quality of care and identifying opportunities to improve the PED. METHODS: Two focus groups were held with parents of patients (with and without a chronic disease) who visited the PED on 10or more occasions per year in a third level hospital. RESULTS: The participants were satisfied overall with the PED. The treatment received was very positively valued, and they never felt that they had received poorer care due to being frequent users. As main strengths, they also highlighted the professional expertise, the friendliness of staff, the quality of information given, the medication received on discharge from hospital, and the follow-up carried out by the PED. The major improvement opportunities identified included: the contagion risks, the lack of coordination between different levels of care, and the need to improve the inclusion of families in the health care process. CONCLUSIONS: Due to the contributions made by these parents, several improvement strategies have been introduced, such as the implementation of sharing information protocols in shift changes, professional training courses, the establishment of a liaison person between the PED and Primary Care, and a proposal to the Hospital Management Department to assess the identified needs.
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Servicio de Urgencia en Hospital/normas , Padres , Satisfacción del Paciente , Pediatría , Mejoramiento de la Calidad , Calidad de la Atención de Salud , Adolescente , Niño , Preescolar , Femenino , Humanos , Lactante , MasculinoRESUMEN
Cervical cancer (CC) is the fourth most common cancer in women worldwide, strongly linked to high-risk human papilloma virus infection. In high-income countries, the screening programs have dramatically decreased the incidence of CC; however, the lack of accessibility to them in developing countries makes CC an important cause of mortality. Clinical stage is the most relevant prognostic factor in CC. The new FIGO staging system published in 2018 is more accurate than the previous one since it takes into account the lymph node status. In early stages, the primary treatment is surgery-with some concerns recently raised regarding minimally invasive surgery because it might decrease survival-or radiotherapy, whereas concomitant chemo-radiotherapy is the conventional approach in locally advanced stages. For recurrent or metastatic CC, the combination of chemotherapy plus bevacizumab is the preferred therapy. Immunotherapy approach based on checkpoint inhibitors is evolving as the election therapy following failure to platinum therapy.
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Ensayos Clínicos como Asunto/normas , Guías de Práctica Clínica como Asunto/normas , Neoplasias del Cuello Uterino/patología , Neoplasias del Cuello Uterino/terapia , Femenino , Humanos , Oncología Médica , Sociedades MédicasRESUMEN
OBJECTIVE: To analyse the effectiveness of corrective measures arising from the analysis of safety incident notifications in the Paediatric Emergency Unit. METHODS: A quasi-experimental, prospective, and single-centre study was carried out between 2015 and 2018. In the first phase, incidents notified throughout one year were analysed. Corrective measures were then implemented for 5 specific kinds of incidents. These incidents were finally compared to those notified within 12 months after the implementation of those measures. Results were expressed as relative risk and relative risk reduction. RESULTS: A total of 1587 safety incidents were notified (0.9% of patients treated) between January 2015 and December 2017. After implementation of corrective measures, there was a decrease in all kinds of incidents notifications analysed. The incidents related to patient identification were reduced by 60.9% (RR 0.39, 95% CI; 0.25-0.60), and those regarding communication between professionals were reduced by 74.5% (RR 0.25, 95% CI; 0.12-0.55). Incidents related to sedation and analgesic procedures totally disappeared. No significant reduction was found in incidents concerning the triage system, or in those related to rapid intravenous rehydration procedures. CONCLUSIONS: The implementation of improvement actions arising from the analysis of voluntary notification of incidents is an effective strategy to improve patient effective strategy to improve.