Concordance between 21-gene recurrence score assay and clinicopathological predictive models in early-breast cancer patients cared for at a cancer center in Colombia.

INTRODUCTION: The genomic-based 21-gene recurrence score assay (21-GRSA) allows to determine the usefulness of adjuvant chemotherapy in patients with luminal-type early breast cancer (LTEBC). Additional predictive models have also been developed, such as Magee equations (ME), the Predict model (PM), and the Tennessee nomogram score (TNS). OBJECTIVE: To evaluate the concordance between 21-GRSA, ME, PM and TNS. METHODS: Patients with unifocal LTEBC and 21-GRSA, ME, PM and TNS results were included. A subgroup analysis of women older than 50 years was carried out. Concordance between the models and 21-GRSA was evaluated using Cohen's kappa index (KI). RESULTS: One-hundred and twenty-two women were included. Concordance between 21-GRSA and ME (KI = 0.35) and PM (KI = 0.24) was fair (p < 0.001). Concordance between 21-GRSA and TNS was inferior (KI = 0.16, p = 0.04). Eighty patients older than 50 years with sufficient data to calculate all three predictive models were included. Concordance was found between the low-risk classification on 21-GRSA and all three combined models in 36/37 patients (negative predictive value of 97.3%). CONCLUSION: 21-GRSA can be omitted in women older than 50 years with LTEBC classified with low risk scores on all three predictive models.

INTRODUCCIÓN: La prueba genómica de recurrencia de 21 genes (PGR21) permite determinar la utilidad de la quimioterapia adyuvante en pacientes con cáncer de mama temprano luminal (CMTL). Se han desarrollado modelos predictivos adicionales, como las ecuaciones de Magee (EM), el modelo Predict (MP) y la puntuación del nomograma de la Universidad de Tennessee (NT). OBJETIVO: Evaluar la concordancia entre PGR21, EM, MP y NT. MÉTODOS: Se incluyeron pacientes con CMTL unifocal y con resultados de PGR21, EM, MP y NT. Se efectuó subanálisis de mujeres mayores de 50 años. La concordancia se evaluó mediante índice kappa de Cohen (IK). RESULTADOS: Se incluyeron 122 mujeres. La concordancia entre PGR21 y EM (IK = 0.35) y MP (IK = 0.24) fue aceptable (p < 0.001); entre PGR21 y NT fue inferior (IK = 0.16, p = 0.04). Se incluyeron 80 pacientes mayores de 50 años con datos suficientes para calcular los tres modelos. Se encontró concordancia entre la clasificación de bajo riesgo mediante PGR21 y los tres modelos combinados en 36/37 pacientes (valor predictivo negativo de 97.3 %). CONCLUSIÓN: Se puede omitir la PGR21 en las mujeres mayores de 50 años con CMTL que se clasifica de bajo riesgo en los tres modelos predictivos.

Epidemiology and genetic diversity of circulating dengue viruses in Medellin, Colombia: a fever surveillance study.

BACKGROUND: Dengue fever is a major public health problem in Colombia. A fever surveillance study was conducted for evaluation of the clinical, epidemiological, and molecular patterns of dengue, prior to Chikungunya and Zika epidemics. METHODS: In November 2011-February 2014, a passive facility-based surveillance was implemented in Santa Cruz Hospital, Medellin, and enrolled eligible febrile patients between 1 and 65 years-of-age. Acute and convalescent blood samples were collected 10-21 days apart and tested for dengue using IgM/IgG ELISA. RNA was extracted for serotyping using RT-PCR on acute samples and genotyping was performed by sequencing. RESULTS: Among 537 febrile patients enrolled during the study period, 29% (n = 155) were identified to be dengue-positive. Only 7% of dengue cases were hospitalized, but dengue-positive patients were 2.6 times more likely to be hospitalized, compared to non-dengue cases, based on a logistic regression. From those tested with RT-PCR (n = 173), 17 were dengue-confirmed based on PCR and/or virus isolation showing mostly DENV-3 (n = 9) and DENV-4 (n = 7) with 1 DENV-1. Genotyping results showed that: DENV-1 isolate belongs to the genotype V or American/African genotype; DENV-3 isolates belong to genotype III; and DENV-4 isolates belong to the II genotype and specifically to the IIb sub-genotype or linage. CONCLUSIONS: Our surveillance documented considerable dengue burden in Santa Cruz comuna during non-epidemic years, and genetic diversity of circulating DENV isolates, captured prior to Chikungunya epidemic in 2014 and Zika epidemic in 2015. Our study findings underscore the need for continued surveillance and monitoring of dengue and other arboviruses and serve as epidemiological and molecular evidence base for future studies to assess changes in DENV transmission in Medellin, given emerging and re-emerging arboviral diseases in the region.

Real-world evidence of nivolumab for non-small-cell lung cancer in a developing country.

Nivolumab is a human programmed death receptor-1 blocking antibody, used as treatment option in patients with advanced non-small-cell lung cancer (NSCLC). We assessed the nivolumab efficacy in terms of survival and response to treatment as second-line (2L) or third-line (3L) therapy in patients with advanced NSCLC. This is a multicentric observational study. Data of patients with advanced NSCLC who received nivolumab as 2L or 3L treatment were analyzed retrospectively. Information regarding patient demographics and clinical backgrounds, treatment patterns from diagnosis to post-nivolumab treatment, effectiveness, and safety of nivolumab treatment were collected. The outcomes evaluated were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) to treatment. OS and PFS were estimated with the Kaplan-Meier method and the differences were evaluated through the log-rank test. Data of 178 patients were included. The median follow-up was 26.8 months (interquartile range (IQR): 20.3-40.4). Nivolumab was commonly used as a 2L treatment (77.5%). The outcomes in this setting (2L) were as follows: ORR was 21.0%, and the median PFS and OS were 5.5 months (95% confidence interval (CI): 4.5-6.5) and 12.4 months (95% CI: 10.8-14.0), respectively. In 3L, the ORR with nivolumab was 15.0%, the median PFS and OS were 4.1 months (95% CI: 3.1-5.1) and 10.1 months (95% CI: 9.4-10.6), respectively. Three patients (1.7%) required discontinuation due to toxicity. Nivolumab effectiveness and safety in this scenario was consistent with that reported by previous trials and other real-world data.

Emergency Embolization of Pelvic Vessels in Patients With Locally Advanced Cervical Cancer and Massive Vaginal Bleeding: A Case Series in a Latin American Oncological Center.

PURPOSE: Locally advanced cervical cancer may present with uncontrollable vaginal bleeding in up to 70% of cases. Pelvic vessel embolization has been used as an urgent maneuver for achieving fast hemostatic control. This report describes outcomes of selective pelvic vessel embolization in patients with severe bleeding due to a locally advanced cervical cancer. METHODS: In this retrospective study, technical aspects, clinical variables, and bleeding-related morbidity were described. The frequency of recurrent disease and the vital status at 1 year of follow-up were determined. Analysis was performed with statistical software R, version 3.6.2. The setting was Instituto Nacional de Cancerología- Bogotá, Colombia, between January 2009 and July 2017. RESULTS: A total of 47 patients were included. Median age was 44 years (range, 26-70 years). The pre-embolization median hemoglobin level was 7.9 g/dL (range, 5.0-11.3 g/dL). Blood transfusions were administered to 41 women (87.2%). Bleeding control was achieved in 95.7% of cases in the first 24 hours after the embolization. There were no major complications. In 17 cases (36.2%), minor complications were reported; the most common was pelvic pain. In 17.1% of cases, a second embolization was required. After 12 months of follow-up, 27.7% of patients were alive without disease, 44.7% were alive with disease, and 25.5% of them have died of cervical cancer progression. CONCLUSION: Selective pelvic vessel embolization is a useful alternative in patients with locally advanced cervical cancer and life-threatening bleeding. Its impact on recurrent disease and death due to oncologic cause is not clear.

Concordancia entre la prueba de puntuación de recurrencia de 21 genes y modelos clínico-patológicos predictivos en pacientes con cáncer de mama temprano en un centro oncológico en Colombia / Concordance between 21-gene recurrence score assay and clinicopathological predictive models in early-breast cancer patients cared for at a cancer center in Colombia

Resumen Introducción: La prueba genómica de recurrencia de 21 genes (PGR21) permite determinar la utilidad de la quimioterapia adyuvante en pacientes con cáncer de mama temprano luminal (CMTL). Se han desarrollado modelos predictivos adicionales, como las ecuaciones de Magee (EM), el modelo Predict (MP) y la puntuación del nomograma de la Universidad de Tennessee (NT). Objetivo: Evaluar la concordancia entre PGR21, EM, MP y NT. Métodos: Se incluyeron pacientes con CMTL unifocal y con resultados de PGR21, EM, MP y NT. Se efectuó subanálisis de mujeres mayores de 50 años. La concordancia se evaluó mediante índice kappa de Cohen (IK). Resultados: Se incluyeron 122 mujeres. La concordancia entre PGR21 y EM (IK = 0.35) y MP (IK = 0.24) fue aceptable (p < 0.001); entre PGR21 y NT fue inferior (IK = 0.16, p = 0.04). Se incluyeron 80 pacientes mayores de 50 años con datos suficientes para calcular los tres modelos. Se encontró concordancia entre la clasificación de bajo riesgo mediante PGR21 y los tres modelos combinados en 36/37 pacientes (valor predictivo negativo de 97.3 %). Conclusión: Se puede omitir la PGR21 en las mujeres mayores de 50 años con CMTL que se clasifica de bajo riesgo en los tres modelos predictivos.

Abstract Introduction: The genomic-based 21-gene recurrence score assay (21-GRSA) allows to determine the usefulness of adjuvant chemotherapy in patients with luminal-type early breast cancer (LTEBC). Additional predictive models have also been developed, such as Magee equations (ME), the Predict model (PM), and the Tennessee nomogram score (TNS). Objective: To evaluate the concordance between 21-GRSA, ME, PM and TNS. Methods: Patients with unifocal LTEBC and 21-GRSA, ME, PM and TNS results were included. A subgroup analysis of women older than 50 years was carried out. Concordance between the models and 21-GRSA was evaluated using Cohen's kappa index (KI). Results: One-hundred and twenty-two women were included. Concordance between 21-GRSA and ME (KI = 0.35) and PM (KI = 0.24) was fair (p < 0.001). Concordance between 21-GRSA and TNS was inferior (KI = 0.16, p = 0.04). Eighty patients older than 50 years with sufficient data to calculate all three predictive models were included. Concordance was found between the low-risk classification on 21-GRSA and all three combined models in 36/37 patients (negative predictive value of 97.3%). Conclusion: 21-GRSA can be omitted in women older than 50 years with LTEBC classified with low risk scores on all three predictive models.

Dengue virus serological prevalence and seroconversion rates in children and adults in Medellin, Colombia: implications for vaccine introduction.

BACKGROUND: Dengue is an important public health problem worldwide. A vaccine has recently been licensed in some countries of Latin America and Asia. Recommendations for dengue vaccine introduction include endemicity and a high serological prevalence of dengue in the territories considering its introduction. METHODS: A community-based survey was conducted to estimate dengue seroprevalence and age-specific seroconversion rates in a community in Medellin, Colombia, using a dengue serological test (IgG indirect ELISA). Residents were selected at random and were first screened for dengue infection; they were then followed over 2.5 years. RESULTS: A total of 3684 individuals aged between 1 and 65 years participated in at least one survey. The overall dengue seroprevalence was 61%, and only 3.3% of seropositive subjects self-reported a past history of dengue. Among dengue virus (DENV)-naïve subjects with more than two visits (n=1002), the overall seroconversion rate was 8.7% (95% confidence interval 7.3-10.4) per 1000 person-months, over the study period. Overall, the mean age of DENV prevalent subjects was significantly higher than the mean age of seroconverted subjects. Specifically, DENV seropositivity over 70% was observed in participants over 21 years old. Serotype-specific plaque-reduction neutralization tests (PRNT) revealed that all four dengue serotypes were circulating, with DENV4 being most prevalent. CONCLUSIONS: These laboratory-based findings could inform dengue vaccine decisions, as they provide age-specific seroprevalence and seroconversion data, evidencing permanent and ongoing dengue transmission in the study area. This study provides evidence for the existing rates of secondary and heterotypic responses, presenting a challenge that must be addressed adequately by the new vaccine candidates.

Nuevos hallazgo de flebotomíneos (diptera: psyhodidae) en la sierra nevada dee santa marta, Colombia / New Records of Phlebotomine Sand Flies (Diptera: Psychodidae) at Sierra Nevada de Santa Marta, Colombia

Los insectos relacionados con la transmisión de los patógenos causantes de las leishmaniasis han sido poco estudiados en la Sierra Nevada de Santa Marta, Colombia, incluido el departamento de Magdalena, donde a la fecha están registradas trece especies del género Lutzomyia. En la presente nota se informa el hallazgo de tres especies y un subgénero adicionales en la región. Se recolectaron 885 flebotomíneos en Seywiaka y las veredas Las Tinajas y Calabazo, estribaciones de la Sierra Nevada de Santa Marta (117-130 m s.n.m.). El 84 % de los ejemplares se obtuvieron con trampa CDC, el 11 % con trampa Shannon y el 5 % fueron capturados, en reposo, con un dispositivo eléctrico de succión. Se identificaron nueve especies, Lu. gomezi, Lu. panamensis, Lu. trinidadensis, Lu. carpenteri, Lu. evansi, Lu. dysponeta, Lu. dubitans, Lu. shannoni, y Lu. micropyga, la más abundante fue Lu. gomezi (69 %), seguida por Lu. panamensis (14 %). También se recolectaron ejemplares de la serie Lu. osornoi del subgénero Helcocyrtomyia. Entre el material hallado sobresalen Lu. carpenteri, Lu. dubitans y Lu. dysponeta como primeros registros para el departamento del Magdalena, además de Lu. (Helcocyrtomyia) sp., que representa el primer informe del subgénero en el Caribe colombiano.

Phlebotomine sand flies, vectors of leishmaniasis, have not been well studied in the Sierra Nevada de Santa Marta, and likewise, are not well known in other regions of the Department of Magdalena, Colombia. To date only thirteen species of Lutzomyia have been recorded as occurring in the Department. The present note adds three species and includes an additional subgenus. Collections were made in the lower foothills of the Sierra Nevada de Santa Marta at elevations ranging from 117-130 m in the communities of Seywiaka, Las Tinajas and Calabazo. Eighty-four percent of the 885 phlebotomines sand flies collected were obtained from CDC light traps, 11 % from Shannon trap and 5 % from typical resting sites using an electric aspirator. The following nine species were identified from the collections: Lutzomyia gomezi, Lu. panamensis, Lu. trinidadensis, Lu. carpenteri, Lu. evansi, Lu. dysponeta, Lu. dubitans, Lu. shannoni, and Lu. micropyga. The most abundant species were Lu. gomezi and Lu. panamensis, which, respectively, accounted for 69 % and 14 % of the specimens. Of the nine species, Lu. carpenteri, Lu. dubitans and Lu. dysponeta represent new records for the Department of Magdalena. Also, a few female specimens were encountered of a species belonging to the Lu. osornoi series of the subgenus Helcocyrtomyia, which represents the first record of this subgenus in the Caribbean region of Colombia.