Impact of COVID-19 Infection on Patients with Cancer: Experience in a Latin American Country: The ACHOCC-19 Study.

INTRODUCTION: The ACHOCC-19 study was performed to characterize COVID-19 infection in a Colombian oncological population. METHODOLOGY: Analytical cohort study of patients with cancer and COVID-19 infection in Colombia. From April 1 to October 31, 2020. Demographic and clinical variables related to cancer and COVID-19 infection were collected. The primary outcome was 30-day mortality from all causes. The association between the outcome and the prognostic variables was analyzed using logistic regression models and survival analysis with Cox regression. RESULTS: The study included 742 patients; 72% were >51 years. The most prevalent neoplasms were breast (132, 17.77%), colorectal (92, 12.34%), and prostate (81, 10.9%). Two hundred twenty (29.6%) patients were asymptomatic and 96 (26.3%) died. In the bivariate descriptive analysis, higher mortality occurred in patients who were >70 years, patients with lung cancer, ≥2 comorbidities, former smokers, receiving antibiotics, corticosteroids, and anticoagulants, residents of rural areas, low socioeconomic status, and increased acute-phase reactants. In the logistic regression analysis, higher mortality was associated with Eastern Cooperative Oncology Group performance status (ECOG PS) 3 (odds ratio [OR] 28.67; 95% confidence interval [CI], 8.2-99.6); ECOG PS 4 (OR 20.89; 95% CI, 3.36-129.7); two complications from COVID-19 (OR 5.3; 95% CI, 1.50-18.1); and cancer in progression (OR 2.08; 95% CI, 1.01-4.27). In the Cox regression analysis, the statistically significant hazard ratios (HR) were metastatic disease (HR 1.58; 95% CI, 1.16-2.16), cancer in progression (HR 1.08; 95% CI, 1.24-2.61) cancer in partial response (HR 0.31; 95% CI, 0.11-0.88), use of steroids (HR 1.44; 95% CI, 1.01-2.06), and use of antibiotics (HR 2.11; 95% CI, 1.47-2.95). CONCLUSION: In our study, patients with cancer have higher mortality due to COVID-19 infection if they have active cancer, metastatic or progressive cancer, ECOG PS >2, and low socioeconomic status. IMPLICATIONS FOR PRACTICE: This study's findings raise the need to carefully evaluate patients with metastatic cancer, in progression, and with impaired Eastern Cooperative Oncology Group status to define the relevance of cancer treatment during the pandemic, consider the risk/benefit of the interventions, and establish clear and complete communication with the patients and their families about the risk of complications. There is also the importance of offering additional support to patients with low income and residence in rural areas so that they can have more support during cancer treatment.

Safety and efficacy of P2Et extract from Caesalpinia spinosa in breast cancer patients: study protocol for a randomized double blind phase II clinical trial (CS003-BC).

BACKGROUND: Chemotherapy in breast cancer is effective but can generate significant toxicity and lead to tumor resistance. Joint treatment with standardized plant extracts can be an alternative to improve the response and allow an effective activation of the antitumor immune response that favors recovery in the short and long term. The P2Et extract of Caesalpinia spinosa presents antitumor activity in cells and animal models of breast cancer, improves the tumor microenvironment, and induces activation of the specific immune response against the tumor and is synergistic when used together with anthracyclines, which makes it a good candidate for evaluation in patients. METHODS: Conducted at a single center, this phase II study is a randomized, double-blind, placebo-controlled trial aimed at assessing the safety and efficacy of P2Et extract in patients diagnosed with stage II and III breast cancer, who are eligible for neoadjuvant treatment. The study aims to determine the safety profile at the previously established optimal biological dose from phase I trial while investigating various efficacy outcomes. These outcomes include improvements in quality of life, immunomodulation, metabolic profile, microbiome, as well as clinical indicators such as tumor reduction, disease-free survival, and pathological response, assessed at different stages of the treatment regimen. DISCUSSION: Treatment with the P2Et extract in breast cancer patients is hypothesized to enhance overall well-being, positively influencing their quality of life, while also triggering an antitumor immune response and enhancing immune infiltration. These combined effects have the potential to contribute to improved long-term survival outcomes for patients receiving the phytomedicine alongside neoadjuvant chemotherapy treatment. TRIAL REGISTRATION: This trial was registered in the US National Library of Medicine with identifier NCT05007444. First Registered August 16th, 2021. Last Updated: August 9th, 2022.

Exploring the safety and efficacy of phytomedicine Petiveria alliacea extract (Esperanza) in patients with metastatic gastrointestinal tumors and acute leukemias: study protocol for a phase Ib/randomized double blind phase II trial (PA001).

BACKGROUND: The energy metabolism of drug-resistant tumor cells can provide a survival advantage during therapy, and treatment itself may influence metabolic reprogramming. Petiveria alliacea (Traditional name: Anamu) could inhibit glycolysis and OXPHOX modulating tumor metabolism, making it a potential treatment for tumors with altered metabolism. This clinical study aims to evaluate the safety and efficacy of a standardized Anamu phytomedicine called Esperanza in treating gastric tumors and acute leukemias. METHODS: This is a prospective, open label, phase I/ randomized, double-blind single-center phase II study designed to evaluate the safety and efficacy of Esperanza extract in patients with metastatic gastrointestinal tumors and acute leukemias. In stage 1, the study will determine the MTD and assess safety. In stage 2, safety at the MTD will be evaluated, and the efficacy of Esperanza extract will be explored in both metastatic gastric tumors and acute leukemias. Quality of life improvement will be the primary outcome in the gastric tumor group, while different efficacy outcomes will be assessed in the acute leukemia group. A placebo group will be used for comparison in the gastric tumor group, and a historical control group will be used in the acute leukemia arm. DISCUSSION: This clinical trial aims to evaluate the safety profile of the Esperanza extract in patients with metastatic gastrointestinal tumors and acute leukemias, while exploring its potential efficacy in conjunction with standard treatment for these pathologies. TRIAL REGISTRATION: This trial was registered in the US National Library of Medicine with identifier NCT05587088. Registered October 19th, 2022.

Impact of vaccination against COVID-19 on patients with cancer in ACHOC-C19 study: Real world evidence from one Latin American country.

Introduction: During the pandemic, it has been recommended that vaccination against COVID-19 be a priority for patients with cancer; however, these patients were not included in the initial studies evaluating the available vaccines. Objective: To define the impact of vaccination against COVID-19 in preventing the risk of complications associated with the infection in a cohort of patients with cancer in Colombia. Methods: An analytical observational cohort study, based on national registry of patients with cancer and COVID 19 infection ACHOC-C19, was done. The data was collected from June 2021, until October 2021. Inclusion criteria were: Patients older than 18 years with cancer diagnosis and confirmed COVID-19 infection. Data from the unvaccinated and vaccinated cohorts were compared. Outcomes evaluated included all-cause mortality within 30 days of COVID-19 diagnosis, hospitalization, and need for mechanical ventilation. The estimation of the effect was made through the relative risk (RR), the absolute risk reduction (ARR) and the number needed to treat (NNT). Multivariate analysis was performed using generalized linear models. Results: 896 patients were included, of whom 470 were older than 60 years (52.4%) and 59% were women (n=530). 172 patients were recruited in the vaccinated cohort and 724 in the non-vaccinated cohort (ratio: 1 to 4.2). The cumulative incidence of clinical outcomes among the unvaccinated vs vaccinated patients were: for hospitalization 42% (95% CI: 38.7%-46.1%) vs 29%; (95% CI: 22.4%-36.5%); for invasive mechanical ventilation requirement 8.4% (n=61) vs 4.6% (n=8) and for mortality from all causes 17% (n=123) vs 4.65% (n=8). Conclusion: In our population, unvaccinated patients with cancer have an increased risk of complications for COVID -19 infection, as hospitalization, mechanical ventilation, and mortality. It is highly recommended to actively promote the vaccination among this population.

Urological Cancer Treatment by a Multidisciplinary Teamthroughout the Covid-19 Pandemic: What Have We Learned? / Tratamiento del cáncer urológico por un equipo multidisciplinario durante la pandemia de Covid-19: ¿Qué hemos aprendido?

Introduction It is known that cancer care is best approached by a multidisciplinary team (MDT). This became specifically true in the Covid-19 pandemic in which choices for urological cancer treatment are influenced by many factors. In some cases, delayed treatment may have consequences regarding the patient's oncological outcomes. The aim of the present article is to report our experience throughout the Covid-19 pandemic treating patients with urological neoplasms at a high-volume center. Methods We used a convenience sampling method. Cases were evaluated and discussed on an individual basis at the MDT meetings, and, after a consensus regarding delaying or scheduling treatment, patients were scheduled according to the risk of postponing the procedures. The Medically Necessary, Time-Sensitive (MeNTS) scoring system was measured in each patient; all patients answered the Centers for Disease Control and Prevention (CDC) Covid-19 self-screening questionnaire prior to surgery. The Covid-19-free survival rate was estimated. Results A total of 194 patients were assessed by themultidisciplinary team and finally treated, with median follow-up of 4 (interquartile range [IQR]: 2.75 to 6) months. Only two patients had Covid-19 confirmed by real-time polymerase chain reaction (RT-PCR). In total, 54 patients underwent oncological surgery, 129 were treated with radiotherapy, and 11 were treated with intravenous chemotherapy. Themedian age was 66 years (IQR: 59 to 94 years), and the median MeNTS score in the surgically-treated cohort was 35 points (IQR: 31 to 47 points). Conclusions The evaluation and treatment of urological cancer should be conducted by an MDT; this is of utmost importance, especially during the Covid-19 pandemic. The data collected in our institution showed that most patients could be safely treated by taking all necessary precautions and discussing each case individually in the MDT meetings and performing a close follow-up.

Introduccion La atención del cáncer se aborda mejor con un equipo multidisciplinario (EMD), aspecto que se tornó más importante en la pandemia por Covid-19, en que las opciones para tratar el cáncer urológico están influenciadas por muchos factores. En algunos casos, el tratamiento retrasado puede tener consecuencias en los resultados oncológicos del paciente. El objetivo de este estudio es describir nuestra experiencia en un centro de referencia y de alto volumen para el tratamiento de neoplasias urológicas durante la pandemia por Covid-19. Métodos Realizamos un muestreo por conveniencia. Posteriormente, los casos fueron evaluados y discutidos de forma individual en las reuniones del EMD. Posterior a la obtención de un consenso sobre el tratamiento del paciente, los pacientes fueron programados según el riesgo individual de posponer el manejo. Se midió la puntuación de cada paciente en el sistema Medically Necessary Time-Sensitive (MeNTS, "Médicamente necesario, sensibles al tiempo"). Todos los pacientes respondieron el cuestionario de autoevaluación del Centers for Disease Control and Prevention (CDC) COVID-19 antes de la cirugía. Se estimó la tasa de supervivencia libre de Covid-19. Resultados Un total de 194 pacientes fueron evaluados por el EMD y finalmente tratados, con una mediana de seguimiento de 4 (rango intercuartil [RIC]: 2,75 a 6) meses. Solo dos tenían Covid-19 confirmado por reacción en cadena de la polimerasa en tiempo real (RCP-TR). Un total de 54 pacientes fueron sometidos a cirugía oncológica, 129 fueron tratados con radioterapia, y 11 fueron tratados con quimioterapia intravenosa. La mediana de edad fue de 66 años (RIC: 59 a 94 años), la puntuación mediana en el MeNTS de la cohorte tratada quirúrgicamente fue de 35 puntos (RIC: 31 a 47 puntos). Conclusiones La evaluación y el tratamiento del cáncer urológico debe ser realizado por un EMD durante la pandemia de Covid-19. Los datos recopilados en nuestra institución mostraron que la mayoría de los pacientes podrían ser tratados de manera segura, discutiendo cada caso individualmente y haciendo un seguimiento cercano.

A major asymmetric dust trap in a transition disk.

The statistics of discovered exoplanets suggest that planets form efficiently. However, there are fundamental unsolved problems, such as excessive inward drift of particles in protoplanetary disks during planet formation. Recent theories invoke dust traps to overcome this problem. We report the detection of a dust trap in the disk around the star Oph IRS 48 using observations from the Atacama Large Millimeter/submillimeter Array (ALMA). The 0.44-millimeter-wavelength continuum map shows high-contrast crescent-shaped emission on one side of the star, originating from millimeter-sized grains, whereas both the mid-infrared image (micrometer-sized dust) and the gas traced by the carbon monoxide 6-5 rotational line suggest rings centered on the star. The difference in distribution of big grains versus small grains/gas can be modeled with a vortex-shaped dust trap triggered by a companion.

Índices de oxigenación como predictores de ventilación mecánica en neumonía a 2600 metros de altitud / Oxygen indexes as predictors of mechanical ventilation in pneumonia at 2600 meters above sea level

Resumen Antecedentes: los valores de la diferencia alveolo arterial de oxígeno D(A-a)O2 y de la relación presión alveolar de oxígeno y fracción inspirada de oxígeno (PaO2/FiO2), son pobremente conocidos a gran altitud para predecir ventilación mecánica (VM) en pacientes con neumonía adquirida en comunidad (NAC) mayores de 65 años. Objetivo: conocer los valores de D(A-a)O2 y PaO2/FiO2 en pacientes con NAC que requirieron soporte ventilatorio. Métodos: estudio de cohorte prospectivo donde se obtuvo la D(A-a)O2 y PaO2/FiO2 de los gases arteriales de ingreso a urgencias, con cálculo de sensibilidad (S), especificidad (E), valor predictivo positivo (VPP), valor predictivo negativo VPN) y área bajo la curva ROC para el requerimiento de VM en las primeras 72 horas. Resultados: se siguieron 247 pacientes, 37 (15%) requirieron VM, no se encontraron diferencias en edad, género, y comorbilidades entre los grupos de VM y no VM. El área bajo la curva ROC para D(A-a) O2 como predictor de VM fue de 0.84 (IC95%:0.77-0.92), para la PaO2/FiO2 de 0.85 (IC 5%: 0.78-0.92) (p<0.0001). Para una D(A-a)O2 en 55 se obtuvo una sensibilidad para predecir VM en 70.27%, especificidad 86.19%, VPP: 47%, VPN: 94%, razón de verosimilitud positiva (LR+): 5.1, razón de verosimilitud negativa (LR-): 0.3. Una PaO2/FiO2 de 180 tiene una sensibilidad para predecir VM de: 86.65%, especificidad: 70.27%, VPP: 34%, VPN: 97%, LR+: 2.9, LR-: 0.2. La mortalidad global fue 3.2%. Conclusión: los valores de D(A-a)O2 y PaO2/FiO2 se relacionan con el requerimiento de VM en pacientes mayores de 65 años con NAC. (Acta Med Colomb 2016; 41: 169-175).

Abstract Background: the values of the difference of alveolar arterial oxygen D(A-a)O2 and ratio of the alveolar oxygen pressure and fraction of inspired oxygen (PaO2/FiO2) are poorly known at high altitude to predict mechanical ventilation (MV) in patients over 65 years with community-acquired pneumonia (CAP). Objective: to know the values of D(A-a)O2 and PaO2/FiO2 in CAP patients requiring ventilatory support. Methods: prospective cohort study where D(A-a)O2 y PaO2/FiO2 were obtained from arterial blood gases at entrance to the emergency room, with calculation of sensitivity (S), specificity (E), positive predictive value (PPV), negative predictive value (NPP) and area under the ROC curve for MV requirement within the first 72 hours. Results: 247 patients were followed; 37 (15%) required MV. No differences were found in age, gender and comorbidities between the groups of MV and no MV. The area under the ROC curve for D(A-a) O2 as a predictor of MV was 0.84 (95% CI: 0.77 to 0.92), for the la PaO2/FiO2 of 0.85 (95% CI: 0.78 to 0.92) (p <0.0001). For a D(A-a)O2 in 55 patients was obtained a sensibility to predict MV in 70.27%, specificity 86.19%, PPV 47%, NPV 94%, positive likelihood ratio (LR +): 5.1, negative likelihood ratio (LR -): 0.3. A PaO2/FiO2 of 180 has a sensitivity to predict MV of 86.65%, specificity: 70.27%, PPV 34%, NPV 97%, LR +: 2.9, LR: 0.2. Overall mortality was 3.2%. Conclusion: the values of D(A-a)O2 and PaO2/FiO2 relate to the requirement of MV in patients older than 65 with CAP. (Acta Med Colomb 2016; 41: 169-175).