Early Incorporation to Palliative Care (EPC) in Patients With Advanced Non-Small Cell Lung Cancer: The PACO Randomized Clinical Trial.

BACKGROUND: Patients with non-small cell lung cancer (NSCLC) experience a considerable disease burden, evident in symptomatic and psychological spheres. Advanced cancer represents a complex scenario for patients and the healthcare team. Early palliative care (EPC) has been proven as a clinically meaningful strategy in this context by several randomized trials but not in a resource-limited setting. This study aimed to evaluate the effect of EPC compared with standard oncological care (SOC) in patients with metastatic NSCLC in Mexico. MATERIALS AND METHODS: A prospective, randomized clinical trial was conducted at Instituto Nacional de Cancerologia in Mexico. All patients had histologically confirmed metastatic NSCLC without previous treatment. Patients were randomly assigned (1:1) to receive SOC or SOC + EPC. The EPC group was introduced to the palliative care team at baseline after randomization, which was integrated by psychologists, bachelor's in nutrition, specialized nurses, and physicians. Patients randomized to this arm had programmed visits to meet with the team at baseline and through the 2nd, 4th-, and 6th cycles thereafter. The primary endpoint was overall survival (OS); secondary outcomes included quality of life (QoL), anxiety and depression, and symptom intensity. They were assessed using the instruments EORTC QLQ-C30 questionnaire, Edmonton Symptom Assessment Scale (ESAS), and the Hospital Anxiety and Depression Scale (HADS) (clinicaltrials.gov [NCT01631565]). Questionnaires were completed at baseline, at 2nd, 4th, and 6th cycles of treatment. RESULTS: Between March 2012 and June 2015, 201 patients were assessed for eligibility and 146 were enrolled and allocated to receive EPC (73) or SOC (73). Median OS for patients in the EPC vs SOC arm was 18.1 months (95% CI, 7.9-28.4) and 10.5 months (95% CI, 4.7-16.2) (P = .029). Having a poor performance status (HR 1.7 [1.2-2.5]; P = .004) and allocation to the control group (HR 1.5 [1.03-2.3]; P = .034) were independently associated with a worse OS. Those patients with a global QoL > 70 at baseline had a better OS if they were In the EPC arm (38.7 months (95% CI, 9.9-67.6) vs SOC 21.4 months (95% CI, 12.4-30.3)). Mean QoL had a numerical improvement in patients allocated to EPC after 6 cycles of follow-up, nonetheless this difference was not statistically significant (55.1 ±â€…23.7 vs 56.9 ±â€…25.3; P = .753). There were no significant differences in anxiety and depression at all study points. CONCLUSIONS: EPC is associated with a significant improvement in OS, although, we observed that the greatest benefit of providing EPC was observed in those with a global QoL > 70 at baseline. This study did not identify significant changes in terms of QoL or symptom burden between the study groups after follow-up. Evidence robustly suggests that EPC should be considered part of the multidisciplinary treatment of metastatic NSCLC patients since diagnosis. According to our study, EPC can be implemented in low- or middle-income countries (LMIC).

Clinical effects of hydration, supplementary vitamins, and trace elements during end-of-life care for cancer patients.

Introduction: Introduction: current data regarding the decision on rehydration of patients with terminal-stage cancer remain controversial. Objective: the present study was to evaluate the effect of intravenous hydration and supplementary vitamins and trace elements on clinical symptoms and biochemical parameters in palliative cancer patients. Methods: a randomized clinical trial including 72 palliative cancer patients aged 18 years and older was performed at the National Cancer Institute in Mexico. Patients were divided into two groups: intervention and control, both receiving intravenous saline solution weekly for 4 weeks, but the former was also supplemented with vitamins and trace elements. Symptoms were assessed at baseline and 4 weeks after with the Edmonton Symptom Assessment Scale. Same measurements applied to biochemical parameters. Results: the mean age of the patients was 58.75 years. The most frequent cancer diagnoses were gastrointestinal (32 %). In the between-groups analysis significant improvements were found for the intervention group in anorexia (p = 0.024), pain (p = 0.030), chloride (p = 0.043), phosphorus (p = 0.001), potassium (p = 0.006), and total proteins (< 0.0001). Conclusion: we highlight the improvement in the control of most symptoms and some biochemical parameters in the intervention group receiving vitamins and oligoelements along with intravenous hydration. Further studies are needed.

Introducción: Introducción: los datos actuales sobre la decisión de rehidratación de pacientes con cáncer en fase terminal siguen siendo controvertidos. Objetivo: el presente estudio fue evaluar el efecto de la hidratación intravenosa y la suplementación con vitaminas y oligoelementos sobre los síntomas clínicos y parámetros bioquímicos en pacientes con cáncer paliativo. Métodos: en el Instituto Nacional del Cáncer de México se realizó un ensayo clínico aleatorizado que incluyó a 72 pacientes con cáncer paliativo de 18 años o más. Los pacientes se dividieron en dos grupos: intervención y control, ambos recibieron solución salina intravenosa semanalmente durante 4 semanas, pero el primero también se complementó con vitaminas y oligoelementos. Los síntomas se evaluaron al inicio del estudio y 4 semanas después con la escala de evaluación de síntomas de Edmonton. Mismas medidas aplicadas a los parámetros bioquímicos. Resultados: la edad media de los pacientes fue de 58,75 años. El diagnóstico de cáncer más frecuente fue el gastrointestinal (32 %). En el análisis entre grupos se encontraron mejoras significativas para el grupo de intervención en anorexia (p = 0,024), dolor (p = 0,030), cloro (p = 0,043), fósforo (p = 0,001), potasio (p = 0,006) y proteínas totales (< 0,0001). Conclusión: destacamos la mejoría en el control de la mayoría de los síntomas y algunos parámetros bioquímicos en el grupo de intervención que recibió vitaminas y oligoelementos junto con hidratación endovenosa. Se necesitan más estudios.

Effect of vitamin C on immune reconstitution after bone marrow transplantation.

BACKGROUND: Vitamin C is an essential nutrient for the adequate function and maturation of the immune system. In vitro studies show that the development, proliferation, and functioning of T cells requires vitamin C, especially for natural killer (NK) cells. Their deficiency during the acute phase post-transplantation could cause greater morbidity and mortality in these patients. A prospective clinical trial using high-dose vitamin C was performed to determine if vitamin C supplementation improves reconstitution of NK lymphocytes after hematopoietic stem cell transplantation (HSCT). MATERIALS AND METHODS: We enrolled 24 patients who underwent autologous HSCT for multiple myeloma and lymphoma. Patients were randomized to receive standard treatment or standard treatment plus 20 g vitamin C once daily (1 - 10 days) and 500 mg twice daily (11 - 100 days) after transplantation. RESULTS: NK and CD3+ lymphocytes showed an increase from days +30 to +100 only in the vitamin C-treated group. Patients in the vitamin C group had a lower frequency of infections. No severe adverse events were reported. CONCLUSION: Our results suggest that high-dose vitamin C supplementation is an effective and safe therapeutic option to decrease the frequency of infections and enhance immune reconstitution after HSCT.

Nutritional status in patients with COVID-19 and cancer: the experience of the National Cancer Institute in Mexico.

INTRODUCTION: Background: nutritional status might vary according to different underlying illnesses such as cancer or infectious diseases, including COVID-19. In this context, data from developing countries remain scarce. Objectives: the objective of this study was to assess the nutritional status and outcomes of Mexican cancer patients diagnosed with COVID-19 at a tertiary care center. Methods: this was a retrospective study including 121 consecutive cancer patients diagnosed with COVID-19 at the National Cancer Institute, Mexico City, during four months. Results: the most frequent oncological diagnoses were gynecological (19 %) and hematological (17 %). Most patients were overweight (35 %). In the univariate analysis, ≥ 65 years, intubation, hypoalbuminemia, high creatinine, lymphopenia, nutrition-impact symptoms, and ECOG 2-4 were statistically associated with lower survival. The median survival of the cohort was 41 days. Conclusions: to our best knowledge, this is the first study of its kind performed in Mexico, and as other studies from other regions, our results might aid in identifying cancer patients most at risk for severe COVID-19, and could be potentially useful to enhance public health messaging on self-isolation and social distancing among Mexican cancer patients.

INTRODUCCIÓN: Antecedentes: el estado nutricional puede variar según las diferentes enfermedades subyacentes, como el cáncer o las enfermedades infecciosas, por ejemplo, la COVID-19. En este contexto, los datos de los países en desarrollo siguen siendo escasos. Objetivos: el objetivo de este estudio fue evaluar el estado nutricional y los resultados de pacientes mexicanos con cáncer diagnosticados de COVID-19 en un centro de atención terciaria. Métodos: se trata de un estudio retrospectivo que incluyó a 121 pacientes consecutivos con cáncer diagnosticados de COVID-19 en el Instituto Nacional del Cáncer de la Ciudad de México durante cuatro meses. Resultados: los diagnósticos oncológicos más frecuentes fueron los ginecológicos (19 %) y hematológicos (17 %). La mayoría de los pacientes tenían sobrepeso (35 %) y obesidad (31 %). En el análisis univariado, ≥ 65 años, intubación, hipoalbuminemia, creatinina alta, linfopenia, síntomas de impacto nutricional y ECOG 2-4 se asociaron estadísticamente con una menor supervivencia. La mediana de supervivencia de la cohorte fue de 41 días. Conclusiones: hasta donde sabemos, este es el primer estudio de este tipo realizado en México y, al igual que otros estudios de otras regiones, nuestros resultados podrían ayudar a identificar a los pacientes con cáncer y mayor riesgo de COVID-19 grave; también podrían ser potencialmente útiles para mejorar los mensajes de salud sobre el autoaislamiento y el distanciamiento social entre los pacientes mexicanos con cáncer.

Incidence and characteristics of metabolic syndrome in patients of the National Cancer Institute of Mexico.

INTRODUCTION: Objective: the exact prevalence of obesity in Mexico is not well known and varies between sources, but more than 30% of Mexico's population are obese. Obesity is associated with several diseases such as metabolic syndrome; the latter, along with cancer, have become public health concerns worldwide, and their association has been widely studied in developed countries. The aim of this study was to identify the overall prevalence of metabolic syndrome and to describe its characteristics among first-time cancer patients at a referral center in Mexico. Methods: a prospective, observational, cohort study of first-time patients of the National Cancer Institute of Mexico in the period of September 2016-2017. We identified 1,165 first-time patients, and 316 patients with known or recently diagnosed metabolic syndrome were included. Results: median age was 55 years old and most were female (81%). The most frequent tumors were breast, gynecological, and hematological. Obesity (class 1-3) and abnormal glucose and/or previous diabetes mellitus diagnosis were mostly observed in patients with skin and soft tissue tumors; dyslipidemia, high triglycerides, and/or low HDL-cholesterol were mostly observed in patients with gastrointestinal tumors. Conclusion: the prevalence of metabolic syndrome among first-time cancer patients was 27%. As obesity and cancer are of public concern in Mexico, the implementation of preventive strategies for metabolic syndrome patients, focusing on the first level of care during early stages in order to reduce the risk of cancer, is needed.

INTRODUCCIÓN: Objetivo: la prevalencia de la obesidad en México es mayor del 30% de la población total. La obesidad se asocia con diversas enfermedades, entre ellas el síndrome metabólico; este y el cáncer se han convertido en problemas de salud pública a nivel mundial, y su asociación ha sido ampliamente estudiada en países desarrollados. El objetivo de este estudio fue identificar la prevalencia del síndrome metabólico y describir las características entre pacientes oncológicos de primera vez en un hospital de tercer nivel en México. Métodos: estudio prospectivo, observacional y de cohortes que incluye a pacientes oncológicos atendidos por primera vez en el Instituto Nacional de Cancerología durante el periodo de septiembre 2016 a 2017. Identificamos 1165 pacientes; 316 tenían el diagnóstico de síndrome metabólico y fueron incluidos en el presente estudio. Resultados: la mediana de edad fue de 55 años y la mayoría de los pacientes eran del sexo femenino (81%). Las neoplasias más frecuentes fueron las de mama, ginecológicas y hematológicas. La obesidad (clase 1-3) y la glucosa anormal y/o un diagnóstico previo de diabetes mellitus se observaron mayormente en pacientes con neoplasias de piel y tejidos blandos; los pacientes con neoplasias gastrointestinales presentaron mayormente dislipidemia, triglicéridos elevados y/o HDL bajo. Conclusiones: la prevalencia del síndrome metabólico en nuestros pacientes oncológicos fue de 27%. Al ser la obesidad y el cáncer problemas de salud pública en México, la implementación de medidas preventivas para pacientes con síndrome metabólico debe enfocarse en el primer nivel de atención, durante etapas tempranas, para poder reducir el riesgo de cáncer.

Nutritional Assessment Tools for the Identification of Malnutrition and Nutritional Risk Associated with Cancer Treatment.

Malnutrition and muscle wasting are common features of cancer cachexia that may interfere with the patient's response to cancer treatment, survival, and quality of life. An accurate nutritional screening at the time of diagnosis and throughout the patient's treatment fosters better control of the disease. Several screening tools have proven to be useful for this purpose. Nevertheless, nutritional evaluation is not a routine practice in this clinical setting and procedures must be standardized. Nutritional risk screening (NRS), malnutrition screening tool (MST), and patient-generated subjective global assessment (PG-SGA) are the most common screening tools, and each one possesses some benefits when screening patients for malnutrition; however, weight loss over a specific time period, dietary intake and anorexia must also be considered. The body mass index-adjusted weight loss grading system predicts survival. We recommend the application of MST or NRS, followed by PG-SGA, food intake determination, measurement of body weight, and its changes as well as body composition, biochemical nutritional markers, muscle function, and physical performance.

[Anorexia-cachexia frequency and its gastrointestinal symptoms association in paliative patients at the Instituto Nacional de Cancerología, México]. / Frecuencia de anorexia-caquexia y su asociación con síntomas gastrointestinales, en pacientes paliativos del Instituto Nacional de Cancerología, México.

BACKGROUND: Anorexia-cachexia is a frequent syndrome among cancer patients, specially in late stages: the global prevalence of para-neoplastic anorexia-cachexia ranges between 20-40% in the diagnostic stage and between 70-80% in the late stage of the disease. The co-existence of functional or structural digestive abnormalities is frequently observed among cancer patients; this is a consequence of the tumor growth and of those systemic phenomena related to metabolism, which are affected by the relationship tumor-host specific to anorexia- cachexia. OBJECTIVE: This study aimed at establishing the frequency of anorexia-cachexia, as well as its relationship to GI symptoms in the context of palliative care patients at the Instituto Nacional de Cancerología, México City. METHODS AND MATERIAL: Analytic cross-sectional study including 100 patients diagnosed with late-stage cancer, age range 18-80, and a Karnofsky score > 50, as well as an ECOG <2; patients with a bad general health status were not allowed in the study. After reviewing inclusion and exclusion criteria, participants fulfilled the FAACT questionnaire, as well as the EGS. Patients recruitment was carried out by the Instituto Nacional de Cancerología. Results and discussion: Results show that 61% (n=61)of the patients had anorexia-cachexia, and 39% (n=39)did not. 56% of the sample participants (n=34) were women, and 44% (n=27) were men. GI symptoms associated with anorexia-cachexia were: nausea (p= 0.0001), vomiting (p=0.004), early satiety (p=0.0005), dysgeusia(p=0.0005) and dysphagia (p=0.001). CONCLUSION: Anorexia and cachexia are among the most devastating and frequent symptoms in late-stage cancer patients and they are also associated with GI symptoms affecting the physical, psychosocial and existential aspects of the patient's life. Data from this research validate the importance of an early nutrition support in palliative patients so that they can achieve a better quality of life.

Introducción: La anorexia-caquexia es un síndrome frecuente en pacientes oncológicos, particularmente en etapas avanzadas: la prevalencia global de anorexia-caquexia para-neoplásica oscila entre el 20-40% en los enfermos en la fase diagnóstica, y entre el 70­80% en la fase avanzada de la enfermedad. En los enfermos oncológicos es frecuente la coexistencia de alteraciones digestivas estructurales o funcionales, secundarias al crecimiento tumoral y a los fenómenos sistémicos de carácter metabólico, determinados por la interrelación tumor-huésped específicos de la anorexia-caquexia. Objetivo: El objetivo de este trabajo es conocer la frecuencia de anorexia-caquexia, y su asociación con síntomas gastrointestinales en pacientes en terreno paliativo del Instituto Nacional de Cancerología, Ciudad de México, atendidos en el servicio de Cuidados Paliativos. Material y métodos: Se realizó un estudio transversal analítico. Se incluyeron 100 pacientes con diagnóstico de cáncer avanzado, con un rango de edad de 18 y 80 años, y una puntuación de Karnofsky > 50, así como un ECOG.

[Nutritional status of patients with cancer of oral cavity]. / Estado nutricional de los pacientes con cáncer de cavidad oral.

INTRODUCTION: Cancer of the oral cavity ranks twelfth worldwide. This type of cancer is usually managed surgically followed by radiotherapy, which may be indicated alone or with chemotherapy; this type of therapies have significant functional side effects on the nutritional status of the patient. OBJECTIVE: The aim of this work is to know the impact of the different treatments on the nutritional status of patients with cancer of the oral cavity treated at the National Cancer Institute for the period comprised between 2009 and 2011. MATERIAL AND METHODS: A descriptive and retrospective study was carried out. Ninety-nine patients with cancer of the oral cavity were included. The following variables were recorded: gender, age, type of treatment (surgery, chemotherapy, radiotherapy), most important complications secondary to treatment, weight loss, body mass index (BMI) and albumin. RESULTS AND DISCUSSION: The prevalence of cancer of the oral cavity was greater in women (58.6%); the mean age was 61.22 years. Complications secondary to the therapy were xerostomia (20%) followed by odynophagia and mucositis (19%), the relationship between weight loss and symptoms was observed in 54% of the patient due to the type of feeding before, during and after the treatment, with a preponderance of the use of mush. CONCLUSION: Weight loss due to complications of the medical treatment was observed, affecting the nutritional status; therefore continuous monitoring is important in order to improve the success of a multidisciplinary approach.

Introducción: El cáncer de cavidad oral ocupa el doceavo lugar a nivel mundial. El tratamiento del cáncer de cavidad oral es habitualmente cirugía seguida de radioterapia, la cual puede estar indicada sola o con quimioterapia; este tipo de terapias tienen importantes efectos secundarios funcionales sobre el estado nutricio del paciente. Objetivo: El objetivo de este trabajo es conocer el impacto de los diferentes tratamientos sobre el estado nutricional de los pacientes con cáncer de cavidad oral atendidos en el Instituto Nacional de Cancerología durante el período comprendido del 2009 al 2011. Material y métodos: Se realizó un estudio descriptivo, y retrospectivo. Se incluyeron 99 pacientes con cáncer de cavidad oral. Se registraron las siguientes variables; género, edad, tipo de tratamiento (cirugía, quimioterapia, radioterapia), complicaciones más importantes secundarias a tratamiento, pérdida de peso, índice de masa corporal (IMC) y albumina. Resultados y discusión: La prevalencia de cáncer de cavidad oral fue mayor en mujeres (58,6%); la edad promedio fue de 61,22 años. Las complicaciones secundarias al tratamiento fueron xerostomía (20%) seguida de odinofagia y mucositis (19%), la relación de pérdida de peso y sintomatología se observó en el (54%) de los pacientes, debido al tipo de alimentación previo, durante y después del tratamiento en los cuales tuvo mayor predominio el uso de papillas. Conclusión: Se observó una pérdida de peso debido a las complicaciones del tratamiento médico que afectaron el estado nutricio, por ello es importante tener un monitoreo continuo que apoye el éxito del tratamiento multidisciplinario.