Drug-related problems in patients admitted for SARS-CoV-2 infection during the COVID-19 pandemic.

Introduction: Drug-related problems (DRP) are events or circumstances in which drug therapy does or could interfere with desired health outcomes. In December 2019, a new coronavirus, SARS-CoV-2, appeared. Little knowledge about this type of infection resulted in the administration of various drugs with limited use in other pathologies. Evidence about DRP in patients with COVID-19 is lacking. Objective: The aim of the present study is to describe identified cases of DRP and those drugs involved in the first wave of patients with COVID-19, and evaluate associated risk factors. Material and methods: Observational, retrospective study performed in a tertiary university hospital between 14th March 2020 and 31 May 2020 (corresponding to the first COVID-19 wave). We recruited patients admitted during the study period. Exclusion criteria included age < 18 years; admission to critically ill units; and care received either in the emergency room, at-home hospitalization or a healthcare center. Results: A total of 817 patients were included. The mean age was 62.5 years (SD 16.4) (range 18-97), and 453 (55.4%) were male. A total of 516 DRP were detected. Among the patients, 271 (33.2%) presented at least one DRP. The mean DRP per patient with an identified case was 1.9. The prevailing DRPs among those observed were: incorrect dosage (over or underdosage) in 145 patients (28.2%); wrong drug combination in 131 (25.5%); prescriptions not in adherence to the then COVID-19 treatment protocol in 73 (14.1%); prescription errors due to the wrong use of the computerized physician order entry in 47 (9.2%); and incorrect dosage due to renal function in 36 (7%). The logistic regression analysis showed that patients who received only prescriptions of antibacterials for systemic use (J01 ATC group) faced a higher likelihood of experiencing a DRP (OR 2.408 (1.071-5.411), p = 0.033). Conclusion: We identified several factors associated with an increased risk of DRPs, similar to those reported in other pre-pandemic studies, including a prolonged length of stay, higher number of prescribed drugs and antimicrobial administration. The relevance of pharmacists and tools like pharmacy warning systems can help prevent, identify and resolve DRP efficiently.

¿Es fiable una muestra de gasometría para hemoglobinas en rango transfusional? / Is a blood sample for hemoglobins in the transfusional range reliable?

Objetivo: Evaluar la correlación y la concordancia en nuestra unidad y en la población de la cifra de hemoglobina en gasometría versus hematimetría estándar; valorar errores en transfusión o falta de la misma. Resultados: Fuerte asociación entre los resultados del gasómetro (POC) y la hematimetría, con p<0,001, con un coeficiente de determinación r2 de 0,56, un coeficiente de correlación intraclase de 0,63 y un coeficiente de correlación de Lin de 0,65. Valores similares para el hematocrito. Para hemoglobinas menores de 7g/dl se obtiene una tasa de acierto del 29,41%. Conclusiones: Concordancia baja-moderada de la hemoglobina del POC con la hematimetría estándar. Alta probabilidad de errores en la indicación de transfusión en base a hemoglobinas de gasómetro, sobre todo en hemoglobinas bajas

Objective: To evaluate the correlation and agreement in our unit and population of hemoglobin in gasometry versus hematology analyzer, to evaluate errors in transfusion or lack thereof. Results: strong association between Point-of-care (POC) and hematimetry, with P<.001, with a coefficient of determination r2 of 0.56, an intraclass correlation coefficient of 0.63 and a Lin's concordance correlation coefficient of 0.65. For hemoglobins less than 7g/dL, a success rate of 29.41% was obtained. Conclusions: Low-moderate agreement of POC hemoglobin with standard haemothymetry. High probability of errors in the indication of transfusion based on gasometer hemoglobins, especially in low hemoglobins

Is a blood sample for hemoglobins in the transfusional range reliable? / ¿Es fiable una muestra de gasometría para hemoglobinas en rango transfusional?

OBJECTIVE: To evaluate the correlation and agreement in our unit and population of hemoglobin in gasometry versus hematology analyzer, to evaluate errors in transfusion or lack thereof. RESULTS: strong association between Point-of-care (POC) and hematimetry, with P<.001, with a coefficient of determination r2 of 0.56, an intraclass correlation coefficient of 0.63 and a Lin's concordance correlation coefficient of 0.65. For hemoglobins less than 7g/dL, a success rate of 29.41% was obtained. CONCLUSIONS: Low-moderate agreement of POC hemoglobin with standard haemothymetry. High probability of errors in the indication of transfusion based on gasometer hemoglobins, especially in low hemoglobins.

Correction to: SEOM clinical guidelines for endometrial cancer (2017).

In the original version of this article Figure 1 was shown incorrectly. The correct Figure 1 is shown here.

SEOM clinical guidelines for endometrial cancer (2017)

Endometrial cancer (EC) is the most common gynecological cancer in developed countries. Most patients are diagnosed at an early stage with a low risk of relapse. However, there is a group of patients with a high risk of relapse and poor prognosis. Despite the recent publication of randomized trials, the adjuvant treatment of high-risk EC is still to be defined and there are many open questions about the best approach and the right timing. Unfortunately, the survival of metastatic or recurrent EC is short, due to the poor results of chemotherapy and the lack of a second line of treatment. Advances in the knowledge of the molecular abnormalities in EC have permitted the development of promising targeted therapies (AU)

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SEOM clinical guidelines for endometrial cancer (2017).

Endometrial cancer (EC) is the most common gynecological cancer in developed countries. Most patients are diagnosed at an early stage with a low risk of relapse. However, there is a group of patients with a high risk of relapse and poor prognosis. Despite the recent publication of randomized trials, the adjuvant treatment of high-risk EC is still to be defined and there are many open questions about the best approach and the right timing. Unfortunately, the survival of metastatic or recurrent EC is short, due to the poor results of chemotherapy and the lack of a second line of treatment. Advances in the knowledge of the molecular abnormalities in EC have permitted the development of promising targeted therapies.

Utilidad de la PET/TC en el manejo del cáncer de vulva / Utility of the PET/CT in vulvar cancer management

Objetivo: Describir el impacto clínico de la PET/TC en el manejo delas pacientes con cáncer de vulva. Material y métodos: Análisis retrospectivo de 13 estudios de PET/TC con 18F-FDG (6 de estadificación y 7 por sospecha de recurrencia), correspondientes a 10 pacientes diagnosticadas de cáncer de vulva mediante biopsia, con una edad media de 64,5 años. Se analizó cualitativamente el estudio PET/TC preoperatorio, según la región de la lesión. Se realizó exéresis quirúrgica, abordando todas las zonas sospechosas según el estudio de PET/TC. Se comparó con el análisis histopatológico. Resultados: Se encontró captación patológica vulvar en 9 de los 13 estudios, e invasión de estructuras adyacentes (uretra, ano o vagina) en 5 de ellos. En 3 estudios se consideró afectados los ganglios inguinofemorales, y en uno de ellos apareció también afectación ganglionar pélvica. Cuatro de los estudios presentaron diseminación extralinfática: 3 en el pulmón y uno en la fosa isquiorrectal. La PET/TC mostró una sensibilidad para la detección de la lesión vulvar del 100% en carcinoma epidermoide y del 60% en el no epidermoide. Se encontró un falso positivo en cuanto a invasión local debido a contaminación urinaria. Uno de los estudios con metástasis pulmonares procedía de un tumor de mama sincrónico. Todos los niveles ganglionares patológicos detectados en la PET/TC fueron confirmados en el estudio histopatológico. No se identificaron nuevas lesiones en la cirugía. La PET/TC cambió el manejo terapéutico en 8 de los 13 estudios (61,5%). Conclusiones: La PET/TC se postula como una prueba de imagen útil en el manejo del cáncer de vulva, particularmente en la identificación de la afectación ganglionar, pudiendo influir tanto en la planificación quirúrgica como en el manejo clínico. Se necesitan series más extensas que confirmen nuestros hallazgos (AU)

Objective: To describe the clinical impact of PET/CT in the management of patients with vulvar cancer. Material and methods: Retrospective analysis of 13 PET/CT studies with 18F-FDG (6 staging and 7 suspected recurrence) corresponding to 10 patients diagnosed with vulvar cancer by biopsy, with a mean age of 64.5 years. The preoperative PET/CT study was analyzed qualitatively according to the lesion region. Surgical excision was carried out, covering all the suspected areas according to the PET/CT study. This was compared with the histopathologic analysis. Results: Abnormal vulvar PET/CT uptake was found in 9 out of the 13 studies and invasion of adjacent structures in 5 of them (urethra, perineal, vagina). The inguinal-femoral lymph nodes were considered as affected in 3 studies and one pelvic lymph node was also affected. Four of the studies had extralymphatic involvement: 3 in lung and 1 in ischiorectal fossa. The PET/CT showed a 100% sensitivity for the detection of the vulvar lesion in squamous cell carcinomas and 60% in non-squamous cell ones. There was a false positive result for local invasion due to urine contamination. One of the studies with lung metastases was related to a synchronous breast tumor. All the pathological lymph node levels detected in the PET/CT study were confirmed in the histopathology study. No new lesions were identified by surgery. PET/CT changed the therapeutic management in 8/13 studies (61.5%). Conclusions: PET/CT is postulated as a useful imaging test for the management of vulvar cancer, mainly in the identification of nodal metastases. It may affect both surgical planning and clinical management. Larger series are needed to confirm our findings (AU)

[Utility of the PET/CT in vulvar cancer management]. / Utilidad de la PET/TC en el manejo del cáncer de vulva.

OBJECTIVE: To describe the clinical impact of PET/CT in the management of patients with vulvar cancer. MATERIAL AND METHODS: Retrospective analysis of 13 PET/CT studies with (18)F-FDG (6 staging and 7 suspected recurrence) corresponding to 10 patients diagnosed with vulvar cancer by biopsy, with a mean age of 64.5 years. The preoperative PET/CT study was analyzed qualitatively according to the lesion region. Surgical excision was carried out, covering all the suspected areas according to the PET/CT study. This was compared with the histopathologic analysis. RESULTS: Abnormal vulvar PET/CT uptake was found in 9 out of the 13 studies and invasion of adjacent structures in 5 of them (urethra, perineal, vagina). The inguinal-femoral lymph nodes were considered as affected in 3 studies and one pelvic lymph node was also affected. Four of the studies had extralymphatic involvement: 3 in lung and 1 in ischiorectal fossa. The PET/CT showed a 100% sensitivity for the detection of the vulvar lesion in squamous cell carcinomas and 60% in non-squamous cell ones. There was a false positive result for local invasion due to urine contamination. One of the studies with lung metastases was related to a synchronous breast tumor. All the pathological lymph node levels detected in the PET/CT study were confirmed in the histopathology study. No new lesions were identified by surgery. PET/CT changed the therapeutic management in 8/13 studies (61.5%). CONCLUSIONS: PET/CT is postulated as a useful imaging test for the management of vulvar cancer, mainly in the identification of nodal metastases. It may affect both surgical planning and clinical management. Larger series are needed to confirm our findings.

Linfoma no Hodgkin primario de vagina / Primary non Hodgkin's lymphoma of the vagina

La afectación primaria del tracto genital femenino de los linfomas no Hodgkin es poco frecuente (2 por ciento de los linfomas primarios extraganglionares). Los órganos más afectados son los ovarios seguidos del cérvix, siendo la localización endometrial y vaginal extremadamente rara. Presentamos el caso de una paciente de 44 años diagnosticada de linfoma primario de vagina, estadio IE A, con remisión completa tras tratamiento combinado quimioterápico y quirúrgico. Es importante tener presente estas raras aunque posibles localizaciones de linfomas para evitar que se puedan confundir con lesiones inflamatorias u otros tipos de tumores que nos lleven a un fracaso terapéutico.

Primary non-Hodgkin lymphomas rarely involve the female genital tract (2 percent of primary extranodal lym-phomas). The ovaries followed by the cervix are the most common affected sites while the involvement of the endometrium and vagina is extremely rare. We report the case of a 44 year old woman with a primary lymphoma of the vagina, stage IE A, with complete remission after combined chemotherapy and surgical treatment. These rare but possible locations must be kept in mind to avoid misdiagnosis with inflammatory lesions or other types of tumors which may lead us to a therapeutic failure.

Carcinoma sarcomatoide monofásico de mama: caso clínico / Monophasic sarcomatoid carcinoma of the breast: clinical case

El carcinoma sarcomatoide de mama es una variante histológica del carcinoma metaplásico, compuesto predominantemente por células fusiformes. Presentamos el caso de un tumor en mujer de 54 años, en que las características clínicas y de imagen sugerían un tumor maligno, y finalmente la histología y la inmuno-histoquímica confirmaron el diagnóstico de carcinoma sarcomatoide monofásico. En esta variante no es posible identificar un componente epitelial claro, por lo que plantea problemas de diagnóstico diferencial con sarcomas y otras lesiones mesenquimatosas. La demostración mediante inmunohistoquímica de la naturaleza epitelial de las células fusiformes, resultó fundamental para establecer el diagnóstico.

Sarcomatoid carcinoma of the breast is a histological variant of metaplastic carcinoma, composed predominantly of spindle cells. We report a case of a tumor in a woman of 54 years old, which suggested a clinical and radiological malignant tumor. Finally the histology and immunohistochemistry confirmed the diagnostic of monophasic sarcomatoid carcinoma. In this variant of sarcomatoid carcinoma, is not possible to identify a clear epithelial component, creating problems of differential diagnosis between sarcomas and other mesenchymal damages. The immunohistochemical demonstration of epithelial nature of the spindle cells was essential for the diagnosis.

Indications for adjuvant radiotherapy treatment after surgery and novel modalities for treatment.

Carcinoma of the uterine cervix is a frequent common cancer in women. Patients diagnosed with early stage cervix cancer are managed with surgery. Overall survival for stage IB (IB1-IB2) and IIA, is in the range of 80-90% at 5 years. Only patients with poor prognostic factors as: large tumors (>or=4 cm), positive lymph nodes, positive and/or close margins <3 mm; can benefit from adjuvant radiotherapy. Radiotherapy has been also recommended for a subgroup of patients with intermediate-risk factors as: large tumor diameter, deep stromal invasion and presence of tumor in capillary lymphatic space adjuvant. In the presence of 2 of the 3 adverse risk factors, radiotherapy reduces tumor recurrence in stage IB cervical cancer with negative lymph nodes. Radiotherapy plays an important role in the management of cervical cancer. Conventional radiotherapy may treat a large amount of normal tissue resulting in acute toxicity. The most frequent acute adverse events after external three-dimensional radiotherapy are bowel, bladder and hematological side effects. With standard doses of external beam radiotherapy 45 Gy-50 Gy (1.8 Gy-2 Gy) grade 3-4 late toxicity occurs in about 10%-12%. Intensity modulated radiation therapy (IMRT) represents an advance in treatment delivery with doses that conform tightly to the target, and may reduce the acute gastrointestinal and chronic toxicity when compared with conventional 3D radiotherapy. Also IMRT treats less bone marrow and may lead to a better tolerance of chemotherapy.

Novel chemotherapy approaches in chemoradiation protocols.

Locally advanced cervical carcinoma had been treated with radiation therapy until 1999, when five different large clinical trials showed an overall survival benefit when chemotherapy was administered concomitantly with radiotherapy. The chemotherapy agents used in these trials were cisplatin, cisplatin combined with fluorouracil or hydroxyurea. Weekly cisplatin (40 mg/m(2)) achieved the best responses, even when compared with the combination with fluorouracil. These results led the United States National Cancer Institute (NCI) to recommend platinum-based chemotherapy for the treatment of locally advanced cervical carcinoma. Other cytotoxic agents have been tried in combination with radiotherapy for the management of the disease, including carboplatin, paclitaxel, gemcitabine and even topotecan. Gemcitabine has shown promising results and the combination of paclitaxel and carboplatin has proved safe and effective. However, to date, there has been no agent or combination of agents to have shown superiority over weekly cisplatin. Biologic agents such as bevacizumab, cetuximab, sorafenib and erlotinib are currently being tried in different trials in combination with radiotherapy and cisplatin. Celecoxib, a COX-2 inhibitor was evaluated in an RTOG study in combination with cisplatin and flourouracil with radiation therapy with no apparent effect on DFS and poor rates of locoregional control. Chemoradiation is the current standard therapy in locally advanced cervical carcinoma. The integration of novel agents will be established by the ongoing clinical trials.

The role of postradiotherapy neck dissection in supraglottic carcinoma.

PURPOSE: To evaluate our policy of performing neck dissection based on regional response after definitive radiotherapy in patients with supraglottic carcinoma and to identify the prognostic factors in this group of patients. METHODS AND MATERIALS: Between 1970 and 1995, 121 patients with node-positive squamous cell carcinoma of the supraglottic larynx were treated with definitive radiotherapy. Sixty-nine percent of patients presented with 1997 AJCC Stage IV disease. The N-stage distribution was N1, 49; N2, 62; and N3, 10. The median size of the lymph nodes was 3 cm (range, 0.5-8 cm). Forty-five patients received once-a-day treatment with a median total dose of 65 Gy (range, 58.0-70.8 Gy) in 1.8-2.0 Gy per fraction over 48 days, and 76 patients received split-course accelerated hyperfractionation with a median total dose of 67.2 Gy (range, 63.2-73.6 Gy) in 1.6 Gy twice a day over 43 days. Patients whose lymph nodes were not clinically detectable at 4-6 weeks after the completion of radiotherapy (complete response) were followed without any neck dissection. Patients with persistent neck adenopathy (partial response) underwent neck dissection whenever possible. Mean follow-up of the living patients was 6.5 years. RESULTS: Regional response was related to the size of lymph nodes at presentation. Eighty-seven percent of patients with nodal size of 3 cm or less had a complete response, whereas 43% of patients with nodal size greater than 3 cm had a partial response. The rate of regional control at 3 years for all patients in the study was 66%. The 3-year ultimate regional control rate after salvage neck dissection was 75%. A relapse in both the primary and regional sites was the most common pattern of relapse, accounting for 39% of all the failures. Local failure was associated with subsequent regional relapse with a relative risk of 4.3. For patients with complete response in whom postradiotherapy neck dissection was withheld, the regional control rates were 75% and 86% for N1 and N2, respectively. The rate of isolated regional relapse in this group of patients was 7.5%. In multivariate analysis, significant favorable factors predictive for regional control were female gender, accelerated hyperfractionation, and complete response; whereas factors predictive for overall survival were Karnofsky Performance Scale score and regional response. The rate of Radiation Therapy Oncology Group (RTOG) Grade 2 or 3 neck fibrosis was 17% and 23% for patients with and without postradiotherapy neck dissection, respectively. CONCLUSION: Isolated regional relapse is not common in patients with supraglottic carcinoma when a complete response is achieved at 4-6 weeks after definitive radiotherapy and postradiotherapy neck dissection is not performed. Female gender, accelerated hyperfractionation, and complete response are favorable predictors of regional control.