Prognostic Factors Associated with Tumor Recurrence and Overall Survival in Soft Tissue Sarcomas of the Extremities in a Colombian Reference Cancer Center.

Introduction: Soft tissue sarcomas (STS) are low-incidence tumors whose clinical and histopathological factors are associated with adverse oncological outcomes. This study evaluated prognostic factors (PF) associated with tumor recurrence and overall survival (OS) in patients diagnosed with STS of the extremities, treated at the Instituto Nacional de Cancerología (INC), Bogotá, Colombia. Materials and Methods: An analytical observational study of a historical cohort was carried out, including patients diagnosed with STS and managed surgically in the Functional Unit for Breast and Soft Tissue Tumors of the INC from January 2008 to December 2018. Results: A total of 227 patients were included; 74.5% had tumors greater than 5 cm. Most patients (29.1%) were in stage IIIB at diagnosis. Age was associated with higher mortality (HR = 1.01; CI95%: 1-1.02; p = 0.048). Tumor persistence at admission to the INC (HR = 2.34; CI95%: 1.25-4.35; p = 0.007) and histologic grade III (HR = 5.36; CI95%: 2.29-12.56; p = <0.001) showed statistical significance in the multivariate analysis for recurrence of any type, as did the PFs associated with a higher risk of local recurrence (HR = 2.85; CI95%: 1.23-6.57; p = 0.014 and HR = 6.09; CI95%: 2.03-18.2; p = 0.001), respectively. Tumor size (HR = 1.03; CI95%: 1-1.06; p = 0.015) and histologic grade III (HR = 4.53; CI95%: 1.42-14.49; p = 0.011) were associated with a higher risk of distant recurrence. Conclusions: This cohort showed that in addition to histologic grade and tumor size, tumor persistence at the time of admission has an impact on disease recurrence, so STS should be managed by a multidisciplinary team with experience in this pathology in high-volume reference centers.

Association of Healthcare Fragmentation and the Survival of Patients with Colorectal Cancer in Colombia.

OBJECTIVES: The objective of this study was to identify the association between healthcare fragmentation and survival for patients with colorectal cancer in Colombia. METHODS: A retrospective cohort study was performed using administrative databases, with an electronic algorithm to identify patients with colorectal cancer based on codes. The patients were enrolled between January 1, 2013, and December 31, 2016. The exposure variable was fragmentation, which was measured based on the number of different healthcare institutions that treated a patient during the first year after diagnosis. Matching was performed using propensity scores to control for confounding, and the hazard ratio for exposure to higher fragmentation was calculated for the matched sample. RESULTS: A total of 5036 patients with colorectal cancer were identified, 2525 (49.88%) of whom were women. The mean number of network healthcare institutions for the total sample was 5.71 (SD 1.98). The patients in the quartile with higher fragmentation had the highest mortality rate, 35.67 (95% CI 33.63-38.06) per 100 patients. The comparison of higher and lower quartiles of fragmentation resulted in an incidence rate ratio of 1.23 (95% CI 1.04-1.45; P = .02). Of the 5036 patients, 422 (8.38%) were classified as the exposed cohort (higher fragmentation). The total matched sample consisted of 844 subjects, and an HR of 1.26 (95%CI; 1.05-1.51) was estimated. CONCLUSIONS: Exposure to more highly fragmented healthcare networks decreases overall 4-year survival for patients with colorectal cancer in Colombia.

Soluble HLA-G (sHLA-G) measurement might be useful as an early diagnostic biomarker and screening test for gastric cancer.

Gastric cancer (GC) is the fifth most frequent malignancy worldwide and has a high mortality rate related to late diagnosis. Although the gold standard for the GC diagnosis is endoscopy with biopsy, nonetheless, it is not cost-effective and is invasive for the patient. The Human leukocyte antigen G (HLA-G) molecule is a checkpoint of the immune response. Its overexpression in cancer is associated with immune evasion, metastasis, poor prognosis, and lower overall survival. We evaluate the plasma levels of soluble HLA-G, (sHLA-G) in patients with GC and benign gastric pathologies using an ELISA test. A higher concentration of sHLA-G in patients with GC than in those with benign pathologies, higher levels of plasma sHLA-G in women with GC compared with men and significant differences in the sHLA-G levels between the benign gastric pathologies evaluated, was our main findings. As no significant differences were found between the GC assessed stages in our study population, we suggest that sHLA-G is not an adequate marker for staging GC, but it does have diagnostic potential. In addition to providing information on the potential of sHLA-G as a diagnostic marker for GC, our study demonstrate that HLA-G molecules can be found in the membrane of exosomes, which highlights the need to perform studies with a larger number of samples to explore the functional implications of HLA-G positive exosomes in the context of gastric cancer, and to determine the clinical significance and possible applications of these findings in the development of non-invasive diagnostic methods.

Toma de decisiones para la adecuación del esfuerzo terapéutico al final de la vida en pacientes oncológicos del instituto Nacional de Cancerología de Colombia

Propósito: la adecuación del esfuerzo terapéutico es una decisión clínica basada en la evidencia que pretende evitar la futilidad médica. Se han señalado diferentes factores que pueden influir en esta toma de decisiones los cuales se relacionan con el paciente, el profesional médico que toma de las decisiones, barreras del sistema, cultura y economía, entre otros. El presente estudio pretende identificar aquellos factores que influyen en los médicos especialistas que laboran en la institución referente del cáncer en Colombia, a fin de planear acciones que mejoren el abordaje de la toma de decisiones con respecto a la adecuación del esfuerzo terapéutico en pacientes con cáncer. Metodología: diseño cualitativo basado en 13 entrevistas en profundidad a médicos especialistas del Instituto Nacional de Cancerología de Colombia. Resultados: participaron 3 mujeres y 10 hombres, con un promedio de edad de 36 años, 7 pertenecientes a la especialidad de oncología de adultos, 2 a oncohematología pediátrica, 1 a cuidados intensivos de adultos y 3 a cuidados intensivos pediátricos. Los factores hallados se agruparon en cuatro categorías: 1) conocimiento, 2) aspectos relacionados con la toma de decisiones, 3) quién decide, 4) tipo de decisión que se toma; a su vez, estas categorías se agruparon en temas que hacen alusión a los factores que influyen en la toma de decisiones de los especialistas para adecuar los esfuerzos terapéuticos. Conclusión: la adecuación de los esfuerzos terapéuticos es importante para evitar procedimientos médicos fútiles que prolonguen el sufrimiento. Se evidenciaron algunos factores que influyen en la toma de decisiones de los especialistas: falta de preparación de los profesionales de salud en el tema de toma de decisiones al final de la vida, uso reducido de escalas que permitan mejorar la información del pronóstico y desconocimiento sobre voluntades anticipadas; estos son algunos de aquellos factores que deben fortalecerse para generar acciones que mejoren el abordaje de esta temática.

Purpose: Adjusting therapeutic efforts is an evidence-based clinical decision that aims to avoid medical futility. Varied factors that can influence this decision-making have been pointed out, related to the patient, the medical professional who makes the decisions, system barriers, culture, and the economy, among others. The present study aims to identify those factors that help the specialists working in a cancer referral institution in Colombia to plan actions that improve the approach to decision-making regarding the adequacy of therapeutic efforts in cancer patients. Methodology: This qualitative design is based on 13 in-depth interviews with Colombia's National Cancer Institute specialists. Results: Three women and ten men participated, with an average age of 36 years; seven belonged to the specialty of adult oncology, two to pediatric oncohematology, one to adult intensive care, and three to pediatric intensive care. The factors found were grouped into four categories: 1) knowledge, 2) aspects related to decision-making, 3) the decision-maker, and 4) the type of decision made. These categories were clustered into themes that allude to the factors swaying specialists' decision-making to adjust therapeutic efforts. Conclusion: Adjusting therapeutic actions is vital to avoid futile medical procedures that prolong suffering. Some factors that influence the specialists' decision-making were noted: lack of preparation of health professionals on end-of-life decision-making, reduced use of scales to improve prognostic information, and ignorance about advance directives. These factors must be strengthened to improve the approach to this issue.

Introdução: a adequação do esforço terapêutico é uma decisão clínica baseada em evidências que pretende evitar a futilidade médica. Diferentes fatores que podem influenciar nessa tomada de decisão vêm sendo identificados e estão relacionados com o paciente, com o profissional médico que toma as decisões, com as barreiras do sistema, com a cultura e a economia, entre outros. Objetivo: este estudo pretende identificar aqueles fatores que influenciam os médicos especialistas que trabalham na instituição referente do câncer na Colômbia, a fim de propor ações que melhorem a abordagem da tomada de decisões a respeito da adequação do esforço terapêutico em pacientes com câncer. Metodologia: desenho qualitativo baseado em 13 entrevistas em profundidade com médicos especialistas do Instituto Nacional de Cancerologia da Colômbia. Resultados: participaram 3 mulheres e 10 homens, com média de idade de 36 anos - 7 pertencentes à especialidade de oncologia de adultos; 2, onco-hematologia pediátrica; 1, terapia intensiva de adultos e 3, terapia intensiva pediátrica. Os fatores achados foram agrupados em quatro categorias: 1) conhecimento; 2) aspectos relacionados com a tomada de decisões; 3) quem decide; 4) tipo de decisão tomada. Por sua vez, essas categorias foram agrupadas em temas que fazem alusão aos fatores que influenciam a toma de decisões dos especialistas para adequar os esforços terapêuticos. Conclusões: a adequação dos esforços terapêuticos é importante para evitar procedimentos médicos fúteis que prolonguem o sofrimento. Foram evidenciados alguns fatores que influenciam a tomada de decisões dos especialistas: falta de preparação dos profissionais de saúde no tema, uso reduzido de escalas que permitam melhorar a informação do prognóstico e desconhecimento sobre vontades antecipadas; estes são alguns dos fatores que devem ser fortalecidos para gerar ações que melhorem a abordagem da temática.

Morbilidad y mortalidad en pacientes llevados a gastrectomía por cáncer gástrico / Morbidity and mortality in patients undergoing gastrectomy for gastric cancer

Introducción. El cáncer gástrico es la cuarta causa de muerte por cáncer a nivel mundial, con más de un millón de casos diagnosticados cada año. La cirugía con intención curativa sigue siendo el pilar del manejo para los pacientes resecables. La identificación de pacientes con mayor riesgo de morbimortalidad es importante para el proceso de toma de decisiones, sin existir hasta el momento una herramienta ideal. La revisión y el análisis de la experiencia de un centro oncológico de referencia pueden generar información útil. Métodos. Estudio observacional de cohorte histórica, en el que se incluyeron los pacientes llevados a gastrectomía por adenocarcinoma gástrico en el Instituto Nacional de Cancerología, Bogotá, D.C., Colombia, entre el 1° de enero del 2010 y el 31 de diciembre del 2017. Resultados. Se evaluaron 332 pacientes, de los cuales el 57,2 % eran hombres con edad promedio de 61 años. La mortalidad en esta serie fue del 4,5 % y la morbilidad de 34,9 %. El factor asociado con mayor riesgo de muerte fue la edad, con un HR de 1,05 (p=0,021). Se encontró un mayor riesgo en el grupo de pacientes con ASA mayor a II (p=0,009).El 17,4 % presentaron complicaciones mayores a IIIA de la clasificación de Clavien-Dindo. Conclusiones. En el presente trabajo las cifras de morbilidad y mortalidad son similares a las reportadas en la literatura. Solo la edad y la clasificación de ASA mostraron asociación con valor estadístico significativo para complicaciones postoperatorias

Introduction. Gastric cancer is the fourth leading cause of cancer death worldwide with more than one million cases diagnosed each year. Surgery with curative intent remains the mainstay of management for resectable patients. Identify patients at increased risk of morbidity and mortality is important for the decision making process, with no ideal tool available yet. Review and analysis of the experience of a referral cancer center may generate useful information. Methods. Historical cohort observational study. Patients undergoing gastrectomy for gastric adenocarcinoma at the National Cancer Institute in Bogotá, Colombia, between January 1, 2010 and December 31, 2017 were included. Results. We included 332 patients of which 57.2% were men with mean age of 61 years. Mortality in this series was 4.5% and morbidity was 34.9%. The factor associated with higher risk of death was age with a HR of 1.05 statistically significant value (p=0.021). A higher risk was found in the group of patients with ASA greater than II (p=0.009). The 17.4% presented complications greater than IIIA of the Clavien Dindo classification. Conclusions. In this study morbidity and mortality seem similar to those reported in the literature. Only age and ASA score showed an association with significant statistical value for postoperative complications

Fungemia in Hospitalized Adult Patients with Hematological Malignancies: Epidemiology and Risk Factors.

Fungemia in hematologic malignancies (HM) has high mortality. This is a retrospective cohort of adult patients with HM and fungemia between 2012 and 2019 in institutions of Bogotá, Colombia. The epidemiological, clinical, and microbiological characteristics are described, and risk factors related to mortality are analyzed. One hundred five patients with a mean age of 48 years (SD 19.0) were identified, 45% with acute leukemia and 37% with lymphomas. In 42%, the HM was relapsed/refractory, 82% ECOG > 3, and 35% received antifungal prophylaxis; 57% were in neutropenia, with an average duration of 21.8 days. In 86 (82%) patients, Candida spp. was identified, and other yeasts in 18%. The most frequent of the isolates were non-albicans Candida (61%), C. tropicalis (28%), C. parapsilosis (17%), and C. krusei (12%). The overall 30-day mortality was 50%. The survival probability at day 30 in patients with leukemia vs. lymphoma/multiple myeloma (MM0 group was 59% (95% CI 46-76) and 41% (95% CI 29-58), p = 0.03, respectively. Patients with lymphoma or MM (HR 1.72; 95% CI 0.58-2.03) and ICU admission (HR 3.08; 95% CI 1.12-3.74) were associated with mortality. In conclusion, in patients with HM, non-albicans Candida species are the most frequent, and high mortality was identified; moreover, lymphoma or MM and ICU admission were predictors of mortality.

Clinical Outcomes of Adjuvant Hormone Therapy in a Cohort of Patients With Infiltrating Non-metastatic Breast Cancer in a Latin American Cancer Center.

INTRODUCTION: Breast cancer (BC) is the most commonly diagnosed cancer in women. This study evaluated the clinical outcomes and prognostic factors associated with disease-free survival (DFS) and overall survival (OS) in a cohort of patients diagnosed with hormone receptor-positive non-metastatic BC managed with adjuvant hormone therapy. METHODS: An observational, analytical, historical cohort study was conducted. DFS and OS rates were estimated, Kaplan-Meier survival functions were calculated, and Cox models were developed to assess the association between time to event (all-cause mortality or relapse) and hormone therapy exposure with a set of established variables. RESULTS: Inclusion criteria were met by 685 patients; the mean age at diagnosis was 58 years (SD=11.9 years). The most commonly used drug was tamoxifen for five years in 241 (35.7%) patients; 470 (69.6%) patients received initial therapy, 112 (16.5%) underwent switch therapy, and 93 (13.8%) had extended therapy. The factors associated with better rates of DFS and OS were early clinical stage (p=0.00), luminal A and luminal B Her2-positive biological subtypes (p=0.00), and adherence to adjuvant hormone therapy (p=0.001). Mortality rate was 0.77 deaths per 100 patients/year (95% CI, 0.51-1.2). CONCLUSION: This cohort demonstrated that adjuvant hormone therapy improves DFS and OS rates in locally advanced tumors. The main factor for reducing disease progression in this cohort was adequate adherence to treatment.

Factors Associated with Time to Progression and Overall Survival in Patients with De Novo Metastatic Breast Cancer: A Colombian Cohort.

PURPOSE: About 10% of breast cancer (BC) is diagnosed in stage IV. This study sought to identify factors associated with time to progression (TTP) and overall survival (OS) in a cohort of patients diagnosed with de novo metastatic breast cancer (MBC), from a single cancer center in Colombia, given that information on this aspect is limited. METHODOLOGY: An observational, analytical, and retrospective cohort study was carried out. Time to progression and OS rates were estimated using the Kaplan-Meier survival functions. Cox models were developed to assess association between time to progression and time to death, using a group of fixed variables. RESULTS: Overall, 175 patients were included in the study; 33.7% of patients had luminal B HER2-negative tumors, 49.7% had bone involvement, and 83.4% had multiple metastatic sites. Tumor biology and primary tumor surgery were the variables associated with TTP and OS. Patients with luminal A tumors had the lowest progression and mortality rates (10 per 100 patients/year (95% CI: 5.0-20.0) and 12.6 per 100 patients/year (95% CI: 6.9-22.7), respectively), and patients with triple-negative tumors had the highest progression and mortality rates (40 per 100 patients/year (95% CI: 23.2-68.8) and 44.1 per 100 patients/year (95% CI: 28.1-69.1), respectively). Across the cohort, the median TTP was 2.1 years (95% CI: 1.6; the upper limit cannot be reached) and the median OS was 2.4 years (95% CI: 2-4.3). CONCLUSIONS: In this cohort, patients with luminal A tumors and those who underwent tumor surgery given that they presented clinical benefit (CB) after initial systemic treatment, had the lowest progression and mortality rates. Overall, OS was inferior to other series due to high tumor burden and difficulties in accessing and continuing oncological treatments.

Miasis en pacientes con cáncer en el Instituto Nacional de Cancerología entre 2008 y 2018: Serie de Casos / Myiasis in cancer patients receiving medical care at a reference center in Bogotá, Colombia: 2008-2018. A case series

Resumen Introducción: La miasis puede ser considerada una enfermedad desatendida; corresponde a la infestación de larvas de dípteros en piel, heridas o cavidades naturales. La literatura para pacientes oncológicos con infestación es limitada para Colombia. Métodos: Se realizó una serie de casos de miasis en pacientes atendidos en el Instituto Nacional de Cancerología de 2008 a 2018; se obtuvieron datos de las historias clínicas con el fin de caracterizar variables sociodemográficas, oncológicas y tratamiento recibido. Resultados: Se encontraron 32 registros: 27 cumplieron con los criterios de inclusión, mediana de edad 69 años, 74% fueron hombres, 48% procedían de área rural, 33,3% de áreas con alturas superiores a 2000 msnm, 70% presentaban cáncer de cabeza y cuello, seguidos por cáncer de mama 14%; 40% ECOG 2-3; 77% visualizaron larvas antes de consultar; ningún paciente presentó sepsis al momento de consultar, 29% presentaban secreción en zona infestada, 85% recibieron ivermectina y curaciones por parte de enfermería; 70% recibió antibióticos sistémicos, y 60% otros tratamientos además de la remoción mecánica e ivermectina, la mediana de leucocitos al ingreso fue de 10280 y de eosinófilos 110. Conclusión: Ésta es la primera serie de casos informada de miasis en pacientes oncológicos para América. Es más frecuente en pacientes con neoplasias en áreas expuestas, aunque se puede presentar en zonas no expuestas; la infestación por larvas tiende a no ser purulenta. Se deben hacer estudios sobre el uso de ivermectina, otros antibióticos y las implicaciones pronósticas de esta patología en los pacientes con cáncer avanzado.

Abstract Introduction: Myiasis can be considered a neglected disease; it corresponds to the infestation of dipteran larvae in skin, wounds, or natural cavities. Literature for oncological patients with this infestation is limited for Colombia. Methods: A case series of myiasis was carried out in patients treated at the National Cancer Institute of Colombia from 2008 to 2018. Data were obtained from medical records in order to characterize sociodemographic and oncological variables and the treatment received. Results: Thirty-two records were found, 27 of them met the inclusion criteria. Median age was 69 years, 74% were men, 48% came from rural areas, 33.3% from areas with altitudes greater than 2,000 meters above sea level, 70% had head and neck cancer, followed by breast cancer in 14%; 40% had ECOG 2-3, and 77% visualized larvae before consulting. No patient presented with sepsis at the time of consultation, 29% presented with discharge in the infested area, 85% received ivermectin and treatment by the nursing staff; 70% received systemic antibiotics, and 60% other treatments in addition to mechanical removal and ivermectin. Median of leukocytes at admission was 10,280, while median of eosinophils was 110. Conclusion: This is the first reported case series of myiasis in cancer patients for Latin America. It is more common in patients with neoplasms in exposed areas, although it can occur in unexposed areas too. Larval infestation tends not to be purulent. Further studies are needed on the use of ivermectin, other antibiotics, and the prognostic implications of this pathology in patients with advanced cancer.

When is Sentinel Lymph Node Biopsy Useful in Ductal Carcinoma In Situ? The Experience at a Latin American Cancer Center.

Introduction Ductal carcinoma in situ (DCIS) accounts for 15% of breast cancers. Surgery is the main treatment, and the use of sentinel node biopsy (SLNB) is restricted to patients at risk of infiltration, which is estimated to be around 26%. Materials and methods Aimed at evaluating the benefit of SLNB in patients with DCIS at the Breast and Soft Tissue Functional Unit of the National Cancer Institute (INC for its initials in Spanish), a descriptive observational study of a retrospective cases series was conducted between August 1, 2013, and September 30, 2018. Results A total of 40 patients with a median age of 57 years were included in the study; 62.5% of them underwent mastectomy with SLNB, and the remaining 37.5% underwent conservative surgery with SLNB. 100% of sentinel nodes were identified, by using lymphoscintigraphy in 95%. Sentinel node was positive in four patients (10%), three of whom had infiltration in the surgical specimen reported. With a follow-up of 49 months, only one patient had a local relapse. None of the patients had axillary or distant recurrence. Conclusions SLNB in DCIS should be limited to patients with risk factors for infiltration (tumor size greater than 3 cm, comedo-type histology, and high-grade DCIS), and patients with an indication for mastectomy. Its percentage of complications is low, and a high identification percentage in surgical groups with adequate training.

Gastrectomía por cáncer gástrico: abordaje mínimamente invasivo / Gastrectomy for gastric cancer: Minimally invasive approach

Introducción. El cáncer gástrico en nuestro país es una de las neoplasias más comunes y su diagnóstico generalmente se realiza en estadios avanzados. El objetivo de este estudio fue describir las características sociodemográficas y clínicas, la experiencia quirúrgica, y las complicaciones en los pacientes con cáncer gástrico.Métodos. Se presenta una serie de casos en la que se revisaron las historias clínicas de pacientes con diagnóstico histológico de adenocarcinoma gástrico, a quienes se les practicó gastrectomía mínimamente invasiva en el Instituto Nacional de Cancerología de Bogotá D.C., Colombia, entre enero de 2012 y diciembre de 2018.Resultados. Se realizó gastrectomía por laparoscopia convencional en 31 pacientes (75,6 %) y por laparoscopia asistida por robot en 10 pacientes (24,4 %). Los estadios clínicos fueron IA en 20 pacientes (48,7 %), IB en tres (7,3 %), IIA en nueve (21,9%), IIB en cinco (12,2 %) y IIIA en cuatro pacientes (9,7 %). Se realizaron 24 gastrectomías totales (58,5 %) y 17 distales (41,4 %). No hubo muertes intraoperatorias ni posoperatorias a 30 días. La disección ganglionar predominante fue D2 en el 92,6 % (n=38) de los casos. Se presentaron complicaciones posoperatorias en el 17,1 % (n=7).Discusión. La gastrectomía por cáncer gástrico realizada por vía laparoscópica convencional y la asistida por robot, parecen ser procedimientos seguros y factibles. La determinación de supervivencia libre de enfermedad y mortalidad asociada a cáncer será necesaria para establecer la seguridad oncológica de este tipo de procedimientos en nuestro medio

Introduction. In our country, gastric cancer is one of the most common neoplasms and its diagnosis is generally made in advanced stages. The objective of this study was to describe the sociodemographic and clinical characteristics, surgical experience, and complications in patients with gastric cancer. In our country, gastric cancer is one of the most common neoplasms and its diagnosis is generally made in advanced stages. The objective of this study was to describe the sociodemographic and clinical characteristics, surgical experience, and complications in patients with gastric cancer.Methods. A series of cases is presented in which the medical records of patients with a histological diagnosis of gastric adenocarcinoma, who underwent minimally invasive gastrectomy at the National Cancer Institute of Bogotá, Colombia, between January 2012 and December 2018. Results. Conventional laparoscopic gastrectomy was performed in 31 patients (75.6%) and by robot-assisted laparoscopy in 10 patients (24.4%). The clinical stages were IA in 20 patients (48.7%), IB in three (7.3%), IIA in nine (21.9%), IIB in five (12.2%), and IIIA in four patients (9.7%). Twenty-four total gastrectomies (58.5%) and 17 distal gastrectomies (41.4%) were performed. There were no intraoperative or postoperative deaths at 30 days. The predominant lymph node dissection was D2 in 92.6% (n = 38) of the cases. Postoperative complications occurred in 17.1% (n=7). Discussion. Gastrectomy due to gastric cancer, performed by conventional laparoscopic and robot-assisted approaches, appear to be safe and feasible procedures. The determination of disease-free survival and cancer-associated mortality will be necessary to establish the oncological safety of this type of procedure in our environment

Colangiopancreatografía retrógrada endoscópica en una institución de referencia en cáncer / Endoscopic retrograde cholangiopancreatography at a leading cancer center

Resumen Introducción: la endoscopia es una de las herramientas necesarias para el manejo de las enfermedades biliares y pancreáticas. La colangiopancreatografía retrógrada endoscópica (CPRE) es uno de los procedimientos técnicamente más demandantes y de mayor riesgo de complicaciones realizados en el tratamiento de los desórdenes hepatopancreatobiliares. Objetivo: caracterizar los resultados clínicos de los pacientes llevados a CPRE en un centro de pacientes con cáncer exclusivamente. Métodos: estudio de serie de casos observacional, retrospectivo, descriptivo con base en datos clínicos de pacientes llevados a CPRE en una población diagnosticada con cáncer de distintos orígenes primarios y en diferentes estadios de enfermedad desde enero de 2010 hasta enero de 2017. Resultados: se analizaron 255 procedimientos en los que predominó el sexo femenino con 140 casos (54,9 %), el promedio de edad fue 62,9 años (desviación estándar [DE]: 12,9 años). Todos los procedimientos se hicieron con intención terapéutica. La indicación más frecuente fue cáncer de páncreas (n = 47; 18,43 %), compresión extrínseca de la vía biliar (n = 42; 16,47 %), disfunción de prótesis (n = 36; 14,12%), colecistocoledocolitiasis (n = 32; 12,55 %), otras causas (n = 32; 12,55 %), cáncer de vesícula (n = 24; 9,41 %), colangiocarcinoma extrahepático (n = 21; 8,24 %), coledocolitiasis recidivante (n = 9; 3,53%), coledocolitiasis residual (n = 6; 2,35 %) y tumor de Klatskin (n = 6; 2,35 %). La canalización exitosa se presentó en 222 casos (87,06 %). Durante el procedimiento, 10 pacientes presentaron complicaciones (4,3 %), de las cuales la pancreatitis y las perforaciones fueron las más frecuentes (n = 3; 1,18 %), seguidas por sangrado, colangitis (n = 2; 0,78 %) y dolor post-CPRE 1 (0,39 %). Conclusiones: en la población evaluada, la causa predominante para realizar el procedimiento está relacionada con cáncer y la frecuencia tanto de canalización exitosa como de complicaciones es similar a la de los reportes en las poblaciones generales.

Abstract Introduction: Endoscopy is one of the tools necessary to treat biliary and pancreatic diseases. Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most technically demanding procedures with the highest risk of complications when treating hepato-pancreato-biliary disorders. Objective: To characterize the clinical outcomes of ERCP patients in a cancer patient center. Methodology: Observational, retrospective, descriptive case series study based on clinical data of patients brought to ERCP in a population diagnosed with cancer of different primary origins and in different stages of the disease from January 2010 to January 2017. Results: A total of 255 procedures were analyzed. The female sex was predominant with 140 cases (54.9%), and the average age was 62.9 years (SD 12.9 years). All procedures were done with therapeutic intent. The most frequent indication was pancreatic cancer (N=47; 18.43%), extrinsic compression of the common bile duct (N=42; 16.47%), biliary prosthesis dysfunction (N=36; 14.12%), cholecystocholedocholithiasis (N=32; 12. 55%), other causes (N=32; 12.55%), gallbladder cancer (N=24; 9.41%), extrahepatic cholangiocarcinoma (N=21; 8.24%), recurrent choledocholithiasis (N=9; 3.53%), residual choledocholithiasis (N=6; 2.35%), and Klatskin tumor (N=6; 2.35%). Successful cannulation was reported in 222 cases (87.06%). During the procedure, 10 patients presented complications (4.3%), with pancreatitis and perforations being the most frequent (N=3; 1.18%), followed by bleeding, cholangitis (N=2; 0.78%), and post-ERCP pain (N=1; 0.39%). Conclusions: In the population studied, the principal reasons for performing the procedure were related to cancer. The frequency of successful cannulation and complications reported here are similar to other results in the general population.

Validation of a Spanish version of the health-related quality of life (HRQoL) measure for Chronic Otitis Media (COMQ-12).

BACKGROUND: Evaluation of health-related quality of life (HRQoL) is considered an important aspect of clinical assessment and health research. Chronic Otitis Media (COM) is related to the quality of life deterioration subsequent to COM symptoms, social communication impairments, and lower work performance. However, there is no reliable information regarding the impact of this disease on health and quality of life in many resource-poor countries. Therefore, we translated into Spanish the Chronic Otitis Media Questionnaire-12 (COMQ-12) for the evaluation of HRQoL of Chronic Otitis Media (COM) in adult patients. Also, we assessed the psychometric properties of the Spanish version of the questionnaire. METHODS: Two otology referral centers in Bogotá, Colombia were included. The Spanish version of COMQ-12 was applied twice to 200 adult patients with confirmed COM diagnosis and 31 healthy controls to perform the validation process and assess the internal consistency of this questionnaire. Psychometric characteristics (internal consistency, test-retest reliability, and construct validity) of the COMQ-12 were assessed. Exploratory Factor Analysis and Confirmatory Factor Analysis were conducted via structural equation modeling to test the questionnaire's structure. RESULTS: The Spanish version of the COMQ-12 showed good internal consistency (Cronbach's Alpha: 0.86, McDonald's Omega: 0.89). Coefficients corresponding to Lin's Concordance test and test-retest reliability were 0.95 and 0.83 respectively. Correlation between the Visual Analogue Scale (VAS) and the COMQ-12 was 0.68 (95% CI 0.59-0.75, p value < 0.001). Factor analysis of the Spanish version of the COMQ-12 indicated a questionnaire structure with three domains: smelly discharge related symptoms; hearing loss related symptoms; and impact on work, lifestyle, and health services. CONCLUSION: This Spanish version of the COMQ-12 showed high reliability and high internal consistency. This questionnaire can be used as an objective clinical tool to assess the HRQoL of patients who have a COM diagnosis. TRIAL REGISTRATION: Hospital Universitario Fundación Santa Fe, Ethical Committee Registration ID: CCEI-8807-2018. Hospital de San José, Ethical Committee: Record number 500, DI-I-0632-18.

Adaptación transcultural del componente de síntomas gastrointestinales de la escala CTCAE versión 4. 02 / Transcultural adaptation of the component of gastrointestinal symptoms of the CTCAE scale version 4. 02

Resumen Objetivo: Realizar la traducción y adaptación transcultural del componente de síntomas gastrointestinales (SGI) de la escala CTCAE versión 4.02 en pacientes ambulatorios tratados con quimioterapia en el Instituto Nacional de Cancerología en Bogotá. Métodos: Se realizó una búsqueda manual en medios electrónicos de escalas en idioma inglés o español que evaluarán la presencia, frecuencia o intensidad de SGI en pacientes oncológicos. La selección de los ítems fue efectuada por consenso informal de un comité técnico, el cual verificó la concordancia entre los principales SGI descritos en la literatura y los incluidos en la escala, ya que estos podrían afectar el estado nutricional. Posteriormente, para la adaptación transcultural, se siguieron los pasos y recomendaciones del manual ISPOR y del grupo de calidad de vida EORTC. La prueba piloto se efectuó en 30 pacientes seleccionados por conveniencia, quienes cumplieron los criterios de inclusión. Resultados: El 52% eran hombres; la edad promedio fue de 54,2 años (+/- 15,3 años). Los cánceres más frecuentes fueron: colorrectal (28%), estómago (16%) y mama (12%). Los 14 SGI incluidos en la escala fueron experimentados por todos los pacientes, por lo cual se conservaron, y no se requirió adicionar ningún otro. El tiempo promedio de aplicación del instrumento fue de 5 minutos y el 90% de los participantes lo consideró adecuado. Conclusiones: Se generó un instrumento de 14 ítems para medir SGI en pacientes oncológicos ambulatorios sometidos a quimioterapia, el cual es de rápida aplicación y utiliza lenguaje de fácil comprensión para el paciente. Aunque todavía quedan por definir sus propiedades clinimétricas.

Abstract Objective: To carry out the translation and transcultural adaptation of the gastrointestinal symptoms component (GIS) of the CTCAE, scale version 4.02, in outpatient patients treated with chemotherapy at the National Cancer Institute, Bogotá (Colombia). Methods: It was performed a manual search of scales on electronic media, in English or Spanish languages, which will evaluate the presence and intensity of GIS in oncological patients. The selection of the items was made by an informal consensus of a technical committee, which verified the concordance between the main GIS described in the literature and those included in the scale, all of which could affect the nutritional status. For transcultural adaptation, there were followed the steps and recommendations of the ISPOR Handbook, as well as those of the EORTC quality of life group. The pilot test was conducted in 30 patients selected for convenience, who met the inclusion criteria. Results: 52% were men; the average age was 54.2 years (+/-15.3 years). The most frequent cancers were: colorectal (28%), stomach (16%) and breast (12%). The 14 GIS included in the scale were experienced by all patients, so they were retained, and no other addition was required. The average time of application of the instrument was 5 minutes, and 90% of the participants considered it appropriate. Conclusions: A 14-item instrument was generated to measure GIS in cancer patients who undergo outpatient chemotherapy, which is of fast application and uses a language that is easily understood by patients. Its clinimetrics properties remain to be defined.

Development and validation of a scoring system for predicting cancer patients at risk of extended-spectrum b-lactamase-producing Enterobacteriaceae infections.

BACKGROUND: Extended-spectrum beta-lactamase producing Enterobacteriaceae (ESBL-PE) infections are frequent and highly impact cancer patients. We developed and validated a scoring system to identify cancer patients harboring ESBL-PE at the National Institute of Cancer of Colombia. METHODS: We retrospectively analyzed medical records of 1695 cancer patients. Derivation phase included 710 patients admitted between 2013 to 2015, ESBL-PE positive culture (n = 265) paired by month and hospitalization ward with Non-ESBL-PE (n = 445). A crude and weighted score was developed by conditional logistic regression. The model was evaluated in a Validation cohort (n = 985) with the same eligibility criteria between 2016 to 2017. RESULTS: The score was based on eight variables (reported with Odds Ratio and 95% confidence interval): Hospitalization ≥7 days (5.39 [2.46-11.80]), Hospitalization during the previous year (4, 87 [2.99-7.93]), immunosuppressive therapy during the previous 3 months (2.97 [1.44-6.08]), Neutropenia (1.90 [1.12-3.24]), Exposure to Betalactams during previous month (1.61 [1.06-2.42]), Invasive devices (1.51 [1.012-2.25]), Neoplasia in remission (2.78 [1.25-1.17]), No chemotherapy during the previous 3 months (1.90 [1.22-2.97]). The model demonstrated an acceptable discriminatory capacity in the Derivation phase, but poor in the Validation phase (Recipient Operating Characteristic Curve: 0.68 and 0.55 respectively). CONCLUSIONS: Cancer patients have a high prevalence of risk factors for ESBL-PE infection. The scoring system did not adequately discriminate patients with ESBL-PE. In a high-risk population, other strategies should be sought to identify patients at risk of resistant ESBL-PE infection.

Validación para utilización en Colombia de la escala EORTC QLQ C-30 para evaluación de la calidad de vida de los pacientes con cáncer / Validation of the EORTC QLQ C-30 scale for evaluating the quality of life of patients with cancer in colombia

Resumen Objetivo: Validar la versión colombiana de la escala EORTC QLQ C-30 para medir calidad de vida en pacientes con diagnóstico de cáncer en Colombia. Métodos: La validez de la escala se determinó usando métodos de análisis factorial exploratorio y confirmatorio. Adicionalmente, para medir la validez de criterio concurrente se utilizaron análisis de correlación entre dominios de las escalas EORTC QLQ C-30 y FACIT-G. Para evaluar la confiabilidad se efectuaron tanto análisis de consistencia interna (se usaron coeficientes Alfa de Cronbach, Omega de McDonald y GLB) como análisis de medidas repetidas (confiabilidad test-retest). Resultados: En el estudio se incluyó un total de 486 pacientes ubicados en el Instituto Nacional de Cancerología. El modelo estándar de 14 dominios y una solución empírica con cinco dominios (físico, psicológico, debilidad, socioeconómico y puntaje global) demostraron tener una adecuada representatividad del constructo. La correlación entre dominios del EORTC QLQ C-30 y del FACT-G mostró valores bajos en el dominio relacionado con funcionamiento social. La correlación entre medidas repetidas tuvo valores de correlación-concordancia entre 0,51 y 0,8; los límites de acuerdo de Bland y Altman estuvieron entre -38 y 43 alrededor de un valor esperado de cero. Los valores de Alfa de Cronbach, GLB y Omega de McDonald tuvieron valores de 0,94 - 0,96 y 0,93 respectivamente. Conclusión: La escala EORTC QLQ C-30 es un instrumento válido y confiable para medir calidad de vida en pacientes con cáncer en Colombia.

Abstract Objective: To validate the Colombian version of the EORTC QLQ-C30 questionnaire for measuring the quality of life in patients with cancer in Colombia. Methods: The validity of the questionnaire was evaluated using exploratory and confirmatory analyses. In addition, correlation between domains of EORTC QLQ-C30 and FACT-G was used to measure concurrent validity. For measuring reliability, internal consistency analyses (Cronbach Alpha, McDonald's Omega and GLB coefficients) and repeated measures analyses were performed. Results: A total of 486 patients recruited at the National Cancer Institute (Instituto Nacional de Cancerología), in Colombia, were included in the study. Both, the standard model (14 domains) and an empirical solution having 5 domains (Physical, Psychological, Weakness, Socioeconomic and Global Score) showed to be adequate for representing the construct. The correlation between domains of FACT-G and EORTC QLQ-C30 showed low values in the domains related with social functioning. The correlation between repeated measures had values of correlation-concordance between 0.51 and 0.8; the limits of agreement of Bland and Altman scored between -38 and 43 around an expected value of 0. The values of Cronbach's Alpha, GLB and McDonald's Omega had values of 0.94 - 0.96 and 0.93, respectively. Conclusion: The EORTC QLQ-C30 questionnaire is a valid and reliable tool for measuring the quality of life of patients with cancer in Colombia.

Spatio-temporal dynamics of Plasmodium falciparum transmission within a spatial unit on the Colombian Pacific Coast.

As malaria control programmes concentrate their efforts towards malaria elimination a better understanding of malaria transmission patterns at fine spatial resolution units becomes necessary. Defining spatial units that consider transmission heterogeneity, human movement and migration will help to set up achievable malaria elimination milestones and guide the creation of efficient operational administrative control units. Using a combination of genetic and epidemiological data we defined a malaria transmission unit as the area contributing 95% of malaria cases diagnosed at the catchment facility located in the town of Guapi in the South Pacific Coast of Colombia. We provide data showing that P. falciparum malaria transmission is heterogeneous in time and space and analysed, using topological data analysis, the spatial connectivity, at the micro epidemiological level, between parasite populations circulating within the unit. To illustrate the necessity to evaluate the efficacy of malaria control measures within the transmission unit in order to increase the efficiency of the malaria control effort, we provide information on the size of the asymptomatic reservoir, the nature of parasite genotypes associated with drug resistance as well as the frequency of the Pfhrp2/3 deletion associated with false negatives when using Rapid Diagnostic Tests.

Clinical Behavior of Triple Negative Breast Cancer in a Cohort of Latin American Women.

INTRODUCTION: Breast cancer is a worldwide public health problem. In Colombia, there are 13,000 new cases, having the highest incidence and mortality among cancers. This article describes the clinical behavior of patients with triple negative breast cancer (TNBC) treated at the National Cancer Institute (NCI) in Bogota, Colombia. METHODS: A historical cohort and analytical study that included elderly patients diagnosed with TNBC treated at the National Cancer Institute Functional Breast Cancer Unit (NCI-FBCU) was conducted. RESULTS: Of the 1,066 patients registered in the unit from September 1st 2013 to December 31st 2016: 146 (13.7 %) had triple negative tumors. The average age was 57.3 years; 61% of patients had locally advanced tumors. The majority of patients received neoadjuvant chemotherapy as their first treatment (69.1%), and in 41.2% of the cases platinum was added to the chemotherapy regimen. The most common surgery conducted was modified radical mastectomy in 57.8% of cases. The pathological complete response (pCR) (Chevallier 1 and 2) was reached in 22.6% and, in this group of patients, a greater overall survival (OS) was found [hazard ratio (HR) 0.08, 95% CI 0.01-0.63; p = 0.016]. Progression of the disease occurred in 36.5% of cases, being lungs the most frequent location (44.4%). The death incidence rate was 1.21 deaths per 100 patients/month. The median event-free survival (EFS) was 18.2 months. CONCLUSION: TNBC occurs in Latin American women at advanced clinical stages with aggressive clinical behavior, with lower OS rates, and higher risk of metastasis compared to other molecular subtypes.

Cáncer gástrico: una enfermedad prevenible. Estrategias para intervención en la historia natural / Gastric cancer is a preventable disease: Strategies for intervention in its natural history

Resumen El cáncer gástrico es un problema de salud pública. Las cifras de mortalidad y supervivencia son impresentables en nuestro país. En Colombia no existe ningún programa ni estrategias de diagnóstico temprano, ni tampoco es priorizado como un problema de salud. Los trabajos existentes demuestran que la mayoría de los pacientes cuando son diagnosticados presentan estadios avanzados. Un 90 % de los canceres gástricos se consideran consecuencia de un largo proceso inflamatorio sobre la mucosa gástrica. La infección por Helicobacter pylori es la principal etiología de la gastritis, la cual puede progresar a atrofia, metaplasia, displasia y cáncer. La atrofia gástrica establece un campo de cancerización más propenso a cambios moleculares y fenotípicos que terminan en un cáncer en crecimiento. Es claro que la historia natural proporciona un racional entendimiento clínico patológico para estrategias de prevención primaria y secundaria. Una evidencia bien establecida demuestra que la combinación de las estrategias primarias (erradicación del H. pylori) y secundarias (diagnóstico y seguimiento endoscópico de lesiones premalignas) pueden prevenir o limitar la progresión de la carcinogénesis gástrica. El riesgo de cáncer gástrico asociado con la gastritis por H. pylori puede ser estratificado de acuerdo con la gravedad y extensión de la atrofia de la mucosa gástrica. Esta aproximación está adaptada a diferentes países, de acuerdo con su incidencia específica de cáncer gástrico, condición socioeconómica y factores culturales, que requiere de la participación complementaria de los gastroenterólogos, los cirujanos, los oncólogos y patólogos. Frente a este problema de salud pública no hay ninguna acción por parte de las autoridades de salud ni del gremio médico. Por tanto, se revisan las estrategias de manejo que permitan intervenir la historia natural de la enfermedad con el objetivo de disminuir la incidencia y mortalidad. La implementación y estandarización de estas estrategias de manejo en nuestro medio podrán beneficiar a los pacientes con riesgo incrementado para cáncer gástrico y pueden implementarse (en países sin programas de tamizaje) de una forma racional, similar a como se está haciendo con el cáncer colorrectal, en todo el mundo.

Abstract Gastric cancer is a public health problem, but there are no usable mortality and survival statistics for Colombia. The country has no early diagnosis program or strategy, and gastric cancer is not prioritized as a health problem. Existing studies show that most patients are in advanced stages by the time they are diagnosed. Ninety percent of gastric cancers are considered to be consequences of long inflammatory processes in the gastric mucosa. H Pylori infections are the most common etiology of gastritis which can progress to atrophy, metaplasia, dysplasia and cancer. Gastric atrophy establishes a cancerization field which is prone to molecular and phenotypic changes that end in cancerous growth. It is well understood that a disease's natural history provides a rational pathological clinical understanding for primary and secondary prevention strategies. Well-established evidence shows that the combination of primary (H pylori eradication) and secondary strategies (diagnosis and endoscopic follow-up of pre-malignant lesions) can prevent or limit the progression of gastric carcinogenesis. The risk of gastric cancer associated with H pylori gastritis can be stratified according to the severity and extent of atrophy of the gastric mucosa. This approach has been adapted to many different countries according to specific incidences of gastric cancer, socio-economic conditions and cultural factors. This requires the complementary participation of gastroenterologists, surgeons, oncologists and pathologists. In the face of this public health problem, there has been no action by health authorities or the medical association. For this reason, we have reviewed management strategies that allow intervening into the natural history of the disease to reduce its incidence and mortality rate. The implementation and standardization of these management strategies in our environment may benefit patients who are at high risk for gastric cancer. These strategies can be implemented in a rational way, similar to what is being done with rectal cancer, in countries without screening programs all over the world.

Trastornos de ansiedad y depresión en relación con la calidad de vida de pacientes con cáncer de mama en estadio localmente avanzado o diseminado / Anxiety and Depression Disorders in Relation to the Quality of Life of Breast Cancer Patients with Locally Advanced or Disseminated Stage

RESUMEN Objetivo: Evaluar patrones de asociación entre ansiedad y depresión y los diferentes elementos del constructo de calidad de vida en pacientes con cáncer de mama en estadio localmente avanzado o diseminado. Métodos: Se aplicó una sola medición mediante las escalas FACIT-B y HADS a 107 mujeres con diagnóstico de cáncer de mama en estadios IIB, IIIA, IIIB, HIC y IV, confirmado histológicamente. Para analizar patrones de asociación, se utilizaron métodos de análisis factorial y escalamiento multidimensional. Resultados: Se encontró ansiedad clínica en el 84,1% (IC95%, 75,8-90,5%) de las pacientes y depresión clínica en el 25,2% (IC95%, 17,3-34,6%). El análisis factorial agrupa los ítems de los 2 instrumentos en 4 dominios, que dieron cuenta del 59% de la varianza total, donde 2 ítems (H11 y B8) presentaron valores de unicidad altos y cargas factoriales bajas. El escalamiento multidimensional señala 5 agrupaciones, que muestran proximidad entre síntomas depresivos y síntomas físicos, así como entre síntomas ansiosos y lo referente a funcionalidad y ambiente sociofamiliar. Conclusiones: En pacientes con enfermedad neoplásica, la HADS detecta una alta frecuencia de síntomas depresivos y especialmente ansiosos, lo que hace recomendable revaluar sus propiedades sicométricas para pacientes con cáncer. La asociación entre síntomas depresivos de la HADS y síntomas físicos del constructo de calidad de vida apunta a la dificultad para el diagnóstico de trastorno depresivo en pacientes con cáncer, por lo que puede ser necesario desarrollar instrumentos que permitan ubicar síntomas o características clínicas que faciliten este diagnóstico.

abstract Objective: To evaluate patterns of association between anxiety and depression and the different elements of the construct of quality of life, in patients with locally advanced breast cancer or disseminated stages. Methods: With a single measure over time, HADS and FACIT-B scales were applied in 107women histologically confirmed to have breast cancer, in stages IIB, IIIA, IIIB, IIIC and IV. Factor analysis and multidimensional scaling methods were used to analyze patterns of association. Results: In 84.1% of the patients clinical anxiety was found (95%CI, 75.8-90.5%) and clinical depression in 25.2% (95%CI, 17.3-34.6%). Factor analysis groups items of the two scales in 4 domains which accounted for 59% of the total variance, where 2 items (H11 and B8) showed high values of uniqueness and low factor loadings. Multidimensional scaling suggests five groups, showing proximity between depressive symptoms and physical symptoms, as well as between anxious symptoms and related to functionality and social and family environment. Conclusions: The HADS in patients with neoplastic disease detects a high frequency of depressive and especially anxious symptoms, which makes it advisable to reevaluate their psychometric properties in patients with cancer. The association between depressive symptoms of HADS and physical symptoms of quality of life construct is in favor of the difficulty of diagnosing depressive disorder in patients with cancer, so it may be necessary to develop instruments that allow locating symptoms or clinical characteristics that facilitate this diagnosis.