Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC.

BACKGROUND: Among patients with resected, epidermal growth factor receptor (EGFR)-mutated, stage IB to IIIA non-small-cell lung cancer (NSCLC), adjuvant osimertinib therapy, with or without previous adjuvant chemotherapy, resulted in significantly longer disease-free survival than placebo in the ADAURA trial. We report the results of the planned final analysis of overall survival. METHODS: In this phase 3, double-blind trial, we randomly assigned eligible patients in a 1:1 ratio to receive osimertinib (80 mg once daily) or placebo until disease recurrence was observed, the trial regimen was completed (3 years), or a discontinuation criterion was met. The primary end point was investigator-assessed disease-free survival among patients with stage II to IIIA disease. Secondary end points included disease-free survival among patients with stage IB to IIIA disease, overall survival, and safety. RESULTS: Of 682 patients who underwent randomization, 339 received osimertinib and 343 received placebo. Among patients with stage II to IIIA disease, the 5-year overall survival was 85% in the osimertinib group and 73% in the placebo group (overall hazard ratio for death, 0.49; 95.03% confidence interval [CI], 0.33 to 0.73; P<0.001). In the overall population (patients with stage IB to IIIA disease), the 5-year overall survival was 88% in the osimertinib group and 78% in the placebo group (overall hazard ratio for death, 0.49; 95.03% CI, 0.34 to 0.70; P<0.001). One new serious adverse event, pneumonia related to coronavirus disease 2019, was reported after the previously published data-cutoff date (the event was not considered by the investigator to be related to the trial regimen, and the patient fully recovered). Adjuvant osimertinib had a safety profile consistent with that in the primary analysis. CONCLUSIONS: Adjuvant osimertinib provided a significant overall survival benefit among patients with completely resected, EGFR-mutated, stage IB to IIIA NSCLC. (Funded by AstraZeneca; ADAURA ClinicalTrials.gov number, NCT02511106.).

Efficacy and Safety of ELOM-080 as Add-On Therapy in COVID-19 Patients with Acute Respiratory Insufficiency: Exploratory Data from the Prospective Placebo-Controlled COVARI Trial.

INTRODUCTION: Enhancement of mucociliary clearance (MCC) might be a potential target in treating COVID-19. The phytomedicine ELOM-080 is an MCC enhancer that is used to treat inflammatory respiratory diseases. PATIENTS/METHODS: This randomised, double-blind exploratory study (EudraCT number 2020-003779-17) evaluated 14 days' add-on therapy with ELOM-080 versus placebo in patients with COVID-19 hospitalised with acute respiratory insufficiency. RESULTS: The trial was terminated early after enrolment of 47 patients as a result of poor recruitment. Twelve patients discontinued prematurely, leaving 35 in the per-protocol set (PPS). Treatment with ELOM-080 had no significant effect on overall clinical status versus placebo (p = 0.49). However, compared with the placebo group, patients treated with ELOM-080 had less dyspnoea in the second week of hospitalisation (p = 0.0035), required less supplemental oxygen (p = 0.0229), and were more often without dyspnoea when climbing stairs at home (p < 0.0001). CONCLUSION: These exploratory data suggest the potential for ELOM-080 to improve respiratory status during and after hospitalisation in patients with COVID-19.

[Update 2021: Pulmonary Sequelae of COVID-19 Pneumonia]. / Update 2021: Pulmonale Folgen nach COVID-19-Pneumonie.

Acute COVID-19 pneumonia may result in persistent changes with various imaging and histopathological patterns, including organizing pneumonia and pulmonary fibrosis. In addition, SARS-CoV-2 infection is associated with increased risk of pulmonary vascular endothelialitis and thrombosis. Herein, current findings on pulmonary consequences of COVID-19 with implications for clinical management are summarized based on a selective literature review.

[Post-COVID sequela of the lung - follow up and treatment]. / Post-COVID und die Lunge.

Most people recover completely after an acute infection with the novel corona virus SARS-CoV2. But some people continue to experience symptoms after their recovery. This phenomenon is called post-acute or long-COVID (from week 4 after the infection up to week 12) and persistent post-COVID (symptoms for effects that persist 12 or more weeks after onset). The exact processes that cause long COVID remain unknown.Most of those patients suffer from long-term symptoms of lung damage, including breathlessness, coughing, fatigue and limited ability to exercise. Today, 18 months after the first infections in Europe we have access to the first practical guidelines for the long-/post-COVID syndrome. Further on first prospective studies analysing the incidence of post-COVID are now available.In this review we will discuss some questions about treatment and follow up of patients suffering from pulmonary sequelae after their COVID-19 infection, based on the actual literature.

[COVID-19: A Pneumological Point of View - Long-Term Sequelae of COVID-19 - Implications For Follow-up In Respiratory Medicine]. / COVID-19 aus Sicht der Pneumologie ­ Langzeitfolgen und Implikationen für die pneumologische Nachsorge.

The long-term sequelae of COVID-19 on are not yet predictable. Radiological and histopathological data on COVID-19 and observational studies after the SARS-CoV-1 pandemic 2003/2004 suggest that in a proportion of COVID-19 patients, functional limitations due to pulmonary fibrosis and other patterns of lung damage may persist. Systematic follow-up, based on prudent pulmonary function testing, is warranted for the correct diagnosis, graduation and treatment of the underlying pathology at an early stage. This review summarizes the potential spectrum of Post-COVID-19 pulmonary disease patterns and provides recommendations for the follow-up care of COVID-19 patients in the field of respiratory medicine.