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    Pembrolizumab in Combination with Neoadjuvant Chemoradiotherapy for Patients with Resectable Adenocarcinoma of the Gastroesophageal Junction
    (2022)
    Mojun Zhu
    ;
    Chunhua Chen
    ;
    Nathan R. Foster
    ;
    Christopher Hartley
    ;
    Taofic Mounajjed
    <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Purpose:</jats:title> <jats:p>This phase Ib/2 trial investigated pembrolizumab-containing trimodality therapy in patients with gastroesophageal junction (GEJ) adenocarcinoma.</jats:p> </jats:sec> <jats:sec> <jats:title>Patients and Methods:</jats:title> <jats:p>Patients with GEJ adenocarcinoma (cT1–3NanyM0) received neoadjuvant pembrolizumab-containing chemoradiation (CROSS regimen) followed by surgical resection and adjuvant pembrolizumab. The primary endpoints were tolerability in the first 16 patients and pathologic complete response [pCR (ypT0N0)]. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). An independent propensity-score-matched cohort (treated with CROSS without immunotherapy) was used for comparison. Exploratory analyses included immune biomarkers in the tumor microenvironment (TME) and plasma.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p>We enrolled 31 eligible patients, of whom 29 received all expected doses of neoadjuvant pembrolizumab and 28 underwent R0 resection. Safety endpoints were met. The primary efficacy endpoint was not met [7/31 (22.6%) achieved pCR]. Patients with high [i.e., combined positive score (CPS) ≥ 10] baseline expression of programmed death (PD)-L1 in the TME had a significantly higher pCR rate than those with low expression [50.0% (4/8) vs. 13.6% (3/22); P = 0.046]. Patients with high PD-L1 expression also experienced longer PFS and OS than propensity-score-matched patients. Among trial patients with PD-L1 CPS &amp;lt; 10, unprespecified analysis explored whether extracellular vesicles (EV) could identify further responders: an elevated plasma level of PD-L1–expressing EVs was significantly associated with higher pCR.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>Adding pembrolizumab to trimodality therapy showed acceptable tolerability but did not meet the pre-specified pCR endpoint. Exploratory analyses suggested that high PD-L1 expression in the TME and/or on EVs may identify patients most likely to achieve tumor response.</jats:p> </jats:sec>
      13Scopus© Citations 73
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    Respiratory drive, inspiratory effort, and work of breathing: review of definitions and non-invasive monitoring tools for intensive care ventilators during pandemic times
    (2022)
    Francisco Ríos-Castro
    ;
    Felipe González-Seguel
    ;
    Jorge Molina
    <jats:p>Technological advances in mechanical ventilation have been essential to increasing the survival rate in intensive care units. Usually, patients needing mechanical ventilation use controlled ventilation to override the patient’s respiratory muscles and favor lung protection. Weaning from mechanical ventilation implies a transition towards spontaneous breathing, mainly using assisted mechanical ventilation. In this transition, the challenge for clinicians is to avoid under and over assistance and minimize excessive respiratory effort and iatrogenic diaphragmatic and lung damage. Esophageal balloon monitoring allows objective measurements of respiratory muscle activity in real time, but there are still limitations to its routine application in intensive care unit patients using mechanical ventilation. Like the esophageal balloon, respiratory muscle electromyography and diaphragmatic ultrasound are minimally invasive tools requiring specific training that monitor respiratory muscle activity. Particularly during the coronavirus disease pandemic, non invasive tools available on mechanical ventilators to monitor respiratory drive, inspiratory effort, and work of breathing have been extended to individualize mechanical ventilation based on patient’s needs. This review aims to identify the conceptual definitions of respiratory drive, inspiratory effort, and work of breathing and to identify non invasive maneuvers available on intensive care ventilators to measure these parameters. The literature highlights that although respiratory drive, inspiratory effort, and work of breathing are intuitive concepts, even distinguished authors disagree on their definitions.</jats:p>
    Scopus© Citations 1  12