Phase II clinical trial of nab-paclitaxel plus gemcitabine in elderly patients with previously untreated locally advanced or metastatic pancreatic adenocarcinoma: the BIBABRAX study.

PURPOSE: To evaluate the health-related quality of life (HRQoL), global health status (GHS), and deterioration-free survival of an elderly population (> 70 years) with unresectable locally advanced (LAPC) or metastatic pancreatic cancer (mPC) treated with nab-paclitaxel in combination with gemcitabine. METHODS: In this open-label, single-arm, multicenter, phase II trial, patients received 4-week cycles of intravenous (i.v.) nab-paclitaxel at a dose of 125 mg/m2, followed by i.v. injections of gemcitabine at a dose of 1000 mg/m2 on days 1, 8 and 15 until disease progression or unacceptable toxicity was observed. The primary outcome was the HRQoL (deterioration-free rate at 3 months as evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. RESULTS: Eighty patients (median age: 74.6 years) were enrolled (56 with mPC, 24 with LAPC). The percentage of patients who had not experienced deterioration at 3 months was 54.3% (95% CI 41.6-67.0%). The median (interquartile range) time until definite deterioration was 1.6 (1.1-3.7) months. The objective response rate and clinical benefit rate were achieved by 11 (13.8%, 95% CI 6.2-21.3%) and 54 patients (67.5%, 95% CI 57.2-77.8%), respectively. The median overall survival was 9.2 months (95% CI 6.9-11.5), and the median progression-free survival was 7.2 months (95% CI 5.8-8.5). Only fatigue and neutropenia demonstrated a grade 3-4 toxicity incidence > 20%. CONCLUSIONS: Our study confirms the clinical benefit of the combination of nab-paclitaxel and gemcitabine in an elderly population with pancreatic cancer in terms of improved survival and clinical response. However, we were unable to confirm a benefit in terms of quality-of-life.

Dasatinib and FLAG-IDA Is an Effective Therapy for Initial Myeloid Blast Crisis but Involves a High Risk of Opportunistic Infections.

Blast crisis (BC) continues to be the major challenge in the treatment of chronic myeloid leukemia. Best results have been observed in a few patients who were successfully transplanted after returning to chronic phase. Recent studies focus on the combination of chemotherapy with imatinib, but results remain unsatisfactory. Since dasatinib induces deeper and faster responses, a reasonable strategy might be to combine it with chemotherapy, taking into account the alterations in T-cell response induced by dasatinib. However, there are no published studies or case reports supporting the use of dasatinib as first line treatment for initial myeloid BC, and very little is known about infectious complications associated with this drug. Based on this, we present the case of a patient diagnosed with an initial nonlymphoid phenotype BC, who achieved molecular response (MR4.5) with dasatinib and FLAG-IDA, but he suffered a pulmonary aspergillosis, CMV infection, and a CMV reactivation, prior to an allogeneic hematopoietic stem cell transplantation (HSCT). In conclusion, dasatinib and FLAG-IDA is an effective therapy for initial BC. However, a warning call is needed owing to the high risk of opportunistic infections, such as CMV.

Mejora de los conocimientos sobre higiene de manos del personal sanitario tras un curso de formación del Hospital Universitario La Paz y sus percepciones sobre la higiene de manos / No disponible

OBJETIVOS: analizar el grado de conocimientos y las percepciones en higiene de manos de las personas involucradas en la asistencia sanitaria del Hospital Universitario La Paz. MATERIAL Y MÉTODOS: estudio cuasiexperimental. Durante el período 2016-2017 se empleó una encuesta de conocimientos y de percepciones en una muestra de 2614 sujetos, seguida de formación, tras la que se repitió la encuesta de conocimientos. Se realizaron las pruebas: ji-cuadrado y Test-T sobre los resultados de las encuestas de conocimientos, pre y post curso. Además, se realizó una regresión logística multivariante donde la variable dependiente era las puntuaciones excelentes (14-15 puntos) y las independientes el sexo, la edad y las categorías profesionales de mayor participación en la muestra. RESULTADOS: la puntuación media de la encuesta de conocimientos pre y post formación fue de 11,9 y 12,7 (p < 0,001), respectivamente. Ser mujer, tener entre 10 y 18 años de experiencia profesional y pertenecer a la categoría profesional de enfermería, se asoció a una mayor probabilidad de obtener una puntuación excelente (OR = 1,8 95%; IC = 1,3-2,4). Predominaron las percepciones favorables y la falta de tiempo se identificó como la principal causa de incumplimiento. «Descripción de un brote polimicrobiano en una unidad de cuidados intensivos durante la ola pandémica de COVID-19 de marzo 2020». CONCLUSIONES: el nivel de conocimientos en higiene de manos fue alto y mejoró mediante una actividad formativa en todo el personal. La sobrecarga laboral es un escollo importante para un buen cumplimiento de la higiene de manos

OBJECTIVES: to analyze the degree of knowledge and perceptions in hand hygiene of the people involved in health care at Hospital Universitario La Paz. MATERIAL AND METHODS: quasi-experimental study. During the period 2016-2017 a survey of knowledge and perceptions was carried out in a sample of 2,614 subjects. This was followed by training, after which the knowledge survey was repeated. The tests were performed: chi-square and Test-T on the results of the survey of knowledge, before and after the course. In addition, a multivariate logistic regression was performed and the dependent variable was excellent scores (14-15 points) and the independent variables were sex, age and the professional categories with the highest participation in the sample. RESULTS: the mean score of the pre and post training knowledge survey was 11.9 and 12.7 (p < 0.001), respectively. Being a woman, having between 10 and 18 years of professional experience and belonging to the professional category of nursing, was associated with a greater probability of obtaining an excellent score (OR = 1.8, 95%; IC 1,3-2,4). Favorable perceptions predominated and lack of time was identified as the main cause of noncompliance. CONCLUSIONS: the level of knowledge in hand hygiene was high and improved through a training activity for all staff. Work overload is a major stumbling block for good hand hygiene compliance

Oxicodona en altas dosis por vía subcutánea: a propósito de un caso / High-dose subcutaneous oxycodone: case report

Presentamos el caso de una paciente de 57 años de edad, que presentaba un cáncer epidermoide de canal anal metastásico. En su evolución presentó un intenso dolor glúteo somático con crisis de dolor irruptivo sacras 8/10 controladas con oxicodona oral. A pesar de la impresión inicial, la etiología de las crisis resultó ser secundaria, en parte, a secuelas de tratamiento radioterápico previo. Posteriormente, la aparición de metástasis cerebelosas condicionó la presencia de vómitos de difícil manejo, finalmente controlados con antihistamínicos y olanzapina parenterales. Por este mismo motivo, se procedió a la rotación de la vía de administración a oxicodona en perfusión subcutánea continua. La oxicodona parenteral se mantuvo durante 43 días, a dosis de 300 mg/día, y en la perfusión se combinaron diversos fármacos (haloperidol, metoclopramida, escopolamina, midazolam, butilbromuro de escopolamina). Esta perfusión resultó claramente eficaz para el control de la sintomatología, sin que se evidenciaran problemas de incompatibilidad en la combinación de fármacos. Se observó una discreta reacción cutánea a partir de la semana de infusión, fácilmente controlable rotando el punto de inserción de la palomilla (AU)

We report the case of a 57 year-old patient with a metastatic anal epidermoid cancer. She progressively developed severe somatic pain in her buttocks, with breakthrough pain crises 8/10 located in the sacrum, which were well managed with oral oxycodone. Despite initial impressions, the pain crises were found to be partially related to radiotherapy side effects. She subsequently had intractable vomiting related to metastases in the cerebellum which was controlled with parenteral antihistamines and olanzapine. For this same reason, a switch in the route of administration to continuous subcutaneous infusion of oxycodone was performed. Parenteral oxycodone was maintained for 43 days at a dose of 300 mg/day, and was combined with several drugs (haloperidol, metoclopramide, hyoscine hydrobromide, midazolam, hyoscine butylbromide). The infusion was found to be quite effective in dealing with the symptoms, and no problems of incompatibility were detected with the co-administration of the various drugs. A skin reaction was detected one week after starting the infusion, which was easily managed by rotation of the injection site (AU)

Addition of bevacizumab to XELOX induction therapy plus concomitant capecitabine-based chemoradiotherapy in magnetic resonance imaging-defined poor-prognosis locally advanced rectal cancer: the AVACROSS study.

BACKGROUND: Concomitant chemoradiotherapy followed by total mesorectal excision is standard treatment for locally advanced rectal cancer. This approach, however, focuses on local disease control and delays systemic treatment. Induction chemotherapy has the advantage of earlier administration of systemic therapy and may improve distant control. The objective of the current study was to assess the efficacy and toxicity of adding bevacizumab to induction chemotherapy followed by preoperative bevacizumab-based chemoradiotherapy in patients with locally advanced rectal cancer. PATIENTS AND METHODS: Eligible patients had high-risk rectal adenocarcinoma defined by magnetic resonance imaging criteria. Treatment consisted of four 21-day cycles of bevacizumab (7.5 mg/kg) and XELOX (capecitabine plus oxaliplatin), followed by concomitant radiotherapy (50.4 Gy) plus bevacizumab (5 mg/kg every 2 weeks) and capecitabine (825 mg/m2 twice daily on days 1-15). Surgery was scheduled for 6-8 weeks after chemoradiotherapy. The primary endpoint was pathologic complete response (pCR). RESULTS: Between July 2007 and July 2008, 47 patients were recruited. Among 45 patients who underwent surgery, pCR was achieved in 16 patients (36%; 95% confidence interval: 22.29%-51.27%), and an additional 17 patients (38%) had Dworak tumor regression grade 3. R0 resection was performed in 44 patients (98%). Most grade 3/4 adverse events occurred during the induction phase and included diarrhea (11%), asthenia (4%), neutropenia (6%), and thrombocytopenia (4%). Eleven patients (24%) required surgical reintervention. CONCLUSIONS: Addition of bevacizumab to induction chemotherapy and chemoradiotherapy is feasible, with impressive activity and manageable toxicity. However, caution is recommended regarding surgical complications.

Evolución de un caso de arteritis de células gigantes sin tratamiento / No disponible

No disponible

Cetuximab given every 2 weeks plus irinotecan is an active and safe option for previously treated patients with metastatic colorectal cancer.

BACKGROUND: We gathered data from multiple institutions on the cetuximab regimen of patients with metastatic colorectal cancer. METHODS: 126 patients from 19 centers were included from July 2006 to July 2007 in this prospective non-controlled study. Irinotecan-refractory metastatic colorectal cancer patients with Karnofsky >or=70 received cetuximab 500 mg/m(2) every 2 weeks (q2w) in combination with irinotecan 180 mg/m(2) q2w until disease progression or unacceptable toxicity. The primary endpoint was the progression-free rate at 12 weeks. RESULTS: Median age was 65 years; 65.9% male; colon/rectum 64.3/34.1%; Karnofsky status or=90% in 45.3/54.7% of the patients. The progression-free rate was 42.7 (95% CI 32.8-52.6) and 22.4% (95% CI 14.2-30.7) at 12 and 24 weeks, respectively. The main grade 3 or 4 toxicities were: diarrhea 13.5% and acne-like rash 10.3%. No grade 3 or 4 infusional or allergic reactions were reported. CONCLUSIONS: The progression-free rates confirm that cetuximab q2w in combination with irinotecan is an option, and is as active and safe as the standard weekly regimen.

Methylene blue-photoinactivated plasma versus quarantine fresh frozen plasma in thrombotic thrombocytopenic purpura: a multicentric, prospective cohort study.

Plasma exchange (PE) with plasma infusion is the treatment of choice for thrombotic thrombocytopenic purpura (TTP) but doubts remain as to whether all kinds of plasma are equally effective. A multicentric cohort study was conducted to compare methylene blue-photoinactivated plasma (MBPIP) with quarantine fresh frozen plasma (qFFP) in the treatment of TTP. One hundred and two episodes of idiopathic TTP were included; MBPIP was used in 63 and qFFP in 39. The treatment schedule consisted of daily PE and costicosteroids, and the main end-point was remission status on day 8. Patients treated with MBPIP required more PEs (median: 11 vs. 5, P = 0.002) and a larger volume of plasma (median: 485 ml/kg vs. 216 ml/kg, P = 0.007) to achieve a remission, and presented more recrudescences while on PE therapy (29 of 63 vs. 8 of 39, P = 0.02) than those receiving qFFP. After adjustment for possible confounding factors, the use of MBPIP was associated with a lower likelihood of remission on day 8 [Odds ratio (OR): 0.17; 95% confidence interval (CI): 0.06-0.47] and a higher risk of recrudescence while on treatment (OR: 4.2; 95% CI: 1.6-10.8). In conclusion, MBPIP is less effective than qFFP in the treatment of TTP.

[A hand hygiene education program. Comparison between handwashing and the use of alcohol solutions]. / Programa de formación sobre la higiene de las manos. Estudio comparativo aleatorizado del lavado higiénico y el uso de soluciones alcohólicas.

OBJECTIVE: To analyze the results of a hand hygiene education program in nursing staff, and to compare the efficacy of handwashing with and without the application of alcohol solutions. METHOD: A hand hygiene educational program was applied in nursing professionals through theoretical and practical workshops. The workshops were evaluated through a student satisfaction survey. During the training period, a prospective randomized study was performed and the students were divided into 3 groups. The results of routine handwashing, handwashing after the training period, and the application of alcohol solutions were compared. A hand culture was taken from all participants before and after each intervention and the reduction in the number of colony-forming units (CFU) was evaluated. In a fourth group, artificial contamination was performed and the effectiveness of routine handwashing was analyzed by detection of residual contamination with ultraviolet light. RESULTS: Seventy-three workshops were imparted, with 792 students (462 nurses, 26 midwives and 304 nursing auxiliaries). Overall evaluation of the course was 8.3/10 and the trainers' score was 9/10. The mean reduction in CFU was 100.7 in the routine handwashing group, 100.3 in the group performing handwashing according to the protocol, and 118.2 in the alcohol solution group (p = 0.026). CONCLUSIONS: The hand hygiene training program was well regarded by the nursing staff. The reduction in bacterial count was greater when alcohol solutions were used than in other forms of handwashing.

Programa de formación sobre la higiene de las manos. Estudio comparativo aleatorizado del lavado higiénico y el uso de soluciones alcohólicas / A hand hygiene education program. Comparison between handwashing and the use of alcohol solutions

Objetivo. Analizar los resultados de un programa de formación sobre higiene de las manos en el personal de enfermería y comparar la eficacia del lavado higiénico de las manos con la aplicación de soluciones alcohólicas. Método. Se aplicó un programa de formación en higiene de las manos mediante talleres teoricoprácticos a personal de enfermería. La metodología docente se evaluó mediante una encuesta de valoración. Durante la formación se realizó un estudio prospectivo aleatorizado en 3 grupos, y se compararon los resultados del lavado de manos habitual, el lavado de manos tras la enseñanza de un protocolo y la aplicación de soluciones alcohólicas. Se recogió un cultivo de manos antes y después de cada intervención, y se analizó la reducción del número de unidades formadoras de colonias (UFC). A un cuarto grupo se le aplicó contaminación artificial y se valoró la efectividad del lavado de manos mediante la detección de restos con luz ultravioleta. Resultados. Se realizaron 73 talleres en los que se formaron 792 alumnos (462 enfermeras, 26 matronas y 304 auxiliares de enfermería). La valoración global del curso fue de 8,3/10 y la de los docentes de 9/10. El descenso medio de UFC fue de 100,7 en el grupo de lavado habitual, 100,3 en el de lavado según protocolo y 118,2 (p = 0,026) en el de solución alcohólica. Conclusiones. El programa de formación sobre higiene de las manos es un método de enseñanza bien valorado por el personal de enfermería. Las soluciones alcohólicas logran una mayor reducción del recuento bacteriano que el lavado de manos

Objective. To analyze the results of a hand hygiene education program in nursing staff, and to compare the efficacy of handwashing with and without the application of alcohol solutions. Method. A hand hygiene educational program was applied in nursing professionals through theoretical and practical workshops. The workshops were evaluated through a student satisfaction survey. During the training period, a prospective randomized study was performed and the students were divided into 3 groups. The results of routine handwashing, handwashing after the training period, and the application of alcohol solutions were compared. A hand culture was taken from all participants before and after each intervention and the reduction in the number of colony-forming units (CFU) was evaluated. In a fourth group, artificial contamination was performed and the effectiveness of routine handwashing was analyzed by detection of residual contamination with ultraviolet light. Results. Seventy-three workshops were imparted, with 792 students (462 nurses, 26 midwives and 304 nursing auxiliaries). Overall evaluation of the course was 8.3/10 and the trainers' score was 9/10. The mean reduction in CFU was 100.7 in the routine handwashing group, 100.3 in the group performing handwashing according to the protocol, and 118.2 in the alcohol solution group (p = 0.026). Conclusions. The hand hygiene training program was well regarded by the nursing staff. The reduction in bacterial count was greater when alcohol solutions were used than in other forms of handwashing

Randomised study of tegafur and oral leucovorin versus intravenous 5-fluorouracil and leucovorin in patients with advanced colorectal cancer.

This randomised, open-label trial compared oral tegafur (FT)/leucovorin (LV) with the intravenous bolus 5-fluorouracil (5-FU)/LV as first-line chemotherapy for advanced colorectal cancer (CRC). Patients were randomised to receive oral FT 750 mg/m2/day for 21 days and LV 15 mg/m2 every 8 h in cycles repeated every 28 days (n=114), or intravenous LV 20 mg/m2 followed by 5-FU 425 mg/m2 daily for 5 days every 4 weeks for 2 cycles, and later every 5 weeks (n=123). Response rate was significantly higher in the FT/LV arm (27%, 95% CI 19-35) than in the 5-FU/LV arm (13%, 95% CI 7-19) (p<0.004). The median time to progression was 5.9 months (95% CI, 5.3-6.5; FT/LV arm) and 6.2 months (95% CI, 5.4-6.9; 5-FU/LV arm). Median overall survival was 12.4 months (95% CI, 10.3-14.5 months; FT/LV arm) and 12.2 months (95% CI, 8.9-15.7 months; 5-FU/LV arm) (p=n.s.; hazard ratio FT/LV:5-FU/LV=1.02). 5-FU/LV showed a higher incidence of grade 3/4 neutropenia (4.1 vs. 0%). Non-hematological toxicities showed similar incidences in the two treatment arms. Oral FT/LV was more active than IV 5-FU/LV in terms of objective response rate with similar overall survival, and with a favorable toxicity profile. This makes FT/LV a valid alternative to the IV 5-FU schedule in CRC patients.

[Diagnostics upon hospital release of immigrants in the city of Valencia, Spain (2001-2002)]. / Diagnósticos al alta hospitalaria de las personas inmigrantes en la ciudad de Valencia (2001-2002).

BACKGROUND: Immigration has increased remarkably in Spain over the past ten years. For theoretical reasons, the question has been raised as to whether this population may possibly be responsible for a rise in the incidence and/or transmission of infectious diseases. However, very few studies have been conducted regarding the diseases among this group which would afford the possibility of ascertaining the importance of this statement. This study is aimed at quantifying the hospital care provided to this population in the city of Valencia. METHODS: The hospital release records were obtained from the Admissions Departments of the public hospitals in the city of Valencia. A one-year retrospective observational study was conducted throughout the October 1, 2001-September 30, 2002 period. RESULTS: We retrieved 8,444 hospital admissions identifying 1,577 hospital admissions of immigrants. Similar percentages of immigrants recorded with their documentation in proper order (841; 51.16%) and immigrants supposedly undocumented (803; 48.84%) were found. Females (68.3%) were predominant over males (31.7%), and a mean age of under 30 years of age. The most frequent diagnosis on release was "pregnancy, childbirth and post-partum-related complications", totaling 37.7% of all releases, others involving, "injuries and poisoning" (12.9%), "digestive tract diseases" (7.8%) and "respiratory tract diseases" (5.4%), "Infectious and parasitic diseases" totaled 4.4%. CONCLUSIONS: The percentage of infectious and infectious-contagious diseases found did not contribute to encouraging the opinions disseminated regarding the importing or re-emergence of diseases from the immigrant groups. The en masse immigration which has taken place requires many adaptations of the Healthcare System to afford the possibility of setting out the health profile for this group based on population estimates.

[Multiple organ resections in surgery of the colon and rectum]. / Ressecções multiorgânicas na cirurgia dos tumores do colon e recto.

Colorectal cancer patients with regional invasion or metastatic disease present low life expectancy. Radical surgical treatment is the only potentially curative procedure, with significant good results being reported. Thirty two patients with either regional invasion or metastatic disease were submitted to surgery with good survival rate.