Efficacy and safety of systemic chemotherapy for radically resectable esophago-gastric adenocarcinoma in older patients: A systematic review and meta-analysis.

INTRODUCTION: A significant proportion of locally-advanced esophago-gastric adenocarcinoma (EGA) is diagnosed in patients ≥70 years old (y.o.) who are commonly underrepresented in clinical trials. MATERIALS AND METHODS: The PubMed database was searched for phase 2/3 clinical trials enrolling patients ≥70 y.o and reporting efficacy/safety information of chemotherapy for resectable EGA. The main outcomes were overall survival (OS) and recurrence-free survival (RFS). RESULTS: Among 6,128 records, only seven studies reported these outcomes (three peri-operative, three adjuvant, and one neoadjuvant), including 1004 older patients, <20% of the overall population. No significant benefit in terms of OS and RFS was observed for perioperative or adjuvant chemotherapy vs surgery alone. No trial reported safety endpoints in this subgroup. DISCUSSION: This work did not show any significant benefit in OS or RFS for chemotherapy vs surgery alone or conventional vs de-escalated chemotherapy in the curative setting of EGA in ≥70 y.o patients. Specific ad hoc trials should be performed to derive reliable data.

[Numerical expression of the clinical course of the disease. Data management]. / Expresión numérica del curso clínico de la enfermedad. Manejo de datos.

Data management "behind the scenes" refers to collection, cleaning, imputation, and demarcation; and despite of being indispensable processes, they are usually neglected and thus, generate erroneous information. During the collection are errors: omission of covariates, deviation from the objective, and insufficient quality. The omission of covariates distorts the result attributed to the main manoeuvre. Deviation from the primary objective commonly occurs when the outcome is rare, delayed, or subjective and promotes substitution by non-equivalent surrogate variables. Moreover, insufficient quality occurs due to inadequate instruments, omission of the measurement procedure, or measurements out of context, such as attribution at the wrong time or equivalent. Furthermore, cleaning implies identifying erroneous, extreme, and missing values, which may or may not be imputed, depending on the percentage. The values of the manoeuvre or the outcome are never imputed, nor are patients eliminated due to a lack of values. Finally, the demarcation of each variable seeks to give it a clinical meaning about the outcome, for which a hierarchical sequence of criteria is followed: 1) previous clinical study, 2) expert agreement, 3) clinical judgment of the investigator/investigators, and 4) statistics. Acting without quality controls in data management frequently causes involuntary lies and confuses instead of clarifying.

El manejo de datos "tras bambalinas" se refiere a los procesos de recopilación, limpieza, imputación y demarcación; los cuales, aun siendo indispensables, usualmente suelen ser descuidados, por lo que generan información errónea. Durante la recopilación son errores: omisión de covariables, desvío del objetivo, y calidad insuficiente. La omisión de covariables distorsiona el resultado atribuido a la maniobra principal. El desvío del objetivo primario es común cuando el desenlace es raro, tardado o subjetivo y promueve la sustitución por variables subrogadas no equivalentes. Además, la calidad insuficiente, sucede por instrumentos inadecuados, omisión del procedimiento de medición, o medición fuera de contexto -como atribución a destiempo o equivalente-. Por otro lado, la limpieza implica identificar valores erróneos, extremos y faltantes, que podrán ser o no imputados, dependiendo del porcentaje se imputará comúnmente por la medida de resumen. Nunca se imputan los valores de la maniobra ni del desenlace, ni se eliminan pacientes por falta de valores. Finalmente, la demarcación de cada variable busca un significado clínico en referencia al desenlace, para ello se sigue una secuencia jerárquica de criterios: 1) estudio clínico previo, 2) acuerdo de expertos, 3) juicio clínico del investigador/investigadores y 4) estadística. Actuar sin controles de calidad en el manejo de datos provoca frecuentemente mentiras involuntarias y confunde en lugar de esclarecer.

SARS-CoV-2 Infection Rate in Patients With Cancer and Health Care Workers in a Chemoradiotherapy Unit During the Pandemic: A Prospective Cohort in Mexico.

PURPOSE: Cancer treatment during the COVID-19 pandemic represents a challenge. Hospital visits to receive treatment and interaction with health care workers (HCW) represent potential contagious events. We aimed to determine SARS-CoV-2 infection rate among patients with cancer and HCW of a chemoradiotherapy unit localized in a center designated as a COVID-19 priority facility in Mexico City. We also determined the diagnostic performance of a clinical questionnaire (CQ) as a screening tool and anti-SARS-CoV-2 antibody seroconversion rate. METHODS: HCW and patients with solid tumors attending the chemoradiotherapy unit signed informed consent. To determine SARS-CoV-2 infection rate prospectively, a nasopharyngeal swab for SARS-CoV-2 real-time quantitative reverse transcriptase polymerase chain reaction (RT-qPCR) was performed every 2 weeks in asymptomatics. An electronic CQ interrogating COVID-19-related symptoms was sent daily. Anti-SARS-CoV-2 immunoglobulin G (IgG) antibodies were measured at baseline and at the end of the study period. RESULTS: From June to September 2020, we included 130 asymptomatic participants, 44.6% HCW and 55.4% patients with cancer. During a median follow-up of 85 days, 634 nasopharyngeal swabs were performed. Average SARS-CoV-2 monthly incidence was 4.6% (3.15%-7.47%), and cumulative infection rate was 13.8% (18 of 130). Cases were mostly asymptomatic (66%), and no hospitalizations or deaths were recorded. The CQ as a screening tool provided a sensitivity of 27.7%, a positive predictive value of 26.3%, and a positive likelihood ratio of 12. SARS-CoV-2 IgG seroconversion rate was 27.7% among those with a positive RT-PCR. CONCLUSION: Patients with cancer on treatment can have uncomplicated COVID-19 outcomes. Biweekly RT-qPCR testing detects asymptomatic infections, prevents transmission, and should be implemented in units to increase patient safety. CQ increase RT-qPCR diagnostic yield and may prioritize testing in resource-deprived settings. Post-infection IgG seroconversion is unreliable.