Subcutaneous tocilizumab treatment in patients with severe COVID-19-related cytokine release syndrome: An observational cohort study.

BACKGROUND: Patients with severe coronavirus disease 2019 (COVID-19) have elevated levels of acute phase reactants and inflammatory cytokines, including interleukin-6, indicative of cytokine release syndrome (CRS). The interleukin-6 receptor inhibitor tocilizumab is used for the treatment of chimeric antigen receptor T-cell therapy-induced CRS. METHODS: Patients aged 18 years or older with laboratory-confirmed COVID-19 admitted to the Annunziata Hospital in Cosenza, Italy, through March 7, 2020, who received at least one dose of tocilizumab 162 mg subcutaneously for the treatment of COVID-19-related CRS in addition to standard care were included in this retrospective observational study. The primary observation was the incidence of grade 4 CRS after tocilizumab treatment. Chest computed tomography (CT) scans were evaluated to investigate lung manifestations. FINDINGS: Twelve patients were included; all had fever, cough, and fatigue at presentation, and all had at least one comorbidity (hypertension, six patients; diabetes, five patients; chronic obstructive lung disease, four patients). Seven patients received high-flow nasal cannula oxygen therapy and five received non-invasive mechanical ventilation for lung complications of COVID-19. No incidence of grade 4 CRS was observed within 1 week of tocilizumab administration in all 12 patients (100%) and within 2 days of tocilizumab administration in 5 patients (42%). The predominant pattern on chest CT scans at presentation was ground-glass opacity, air bronchograms, smooth or irregular interlobular or septal thickening, and thickening of the adjacent pleura. Follow-up CT scans 7 to 10 days after tocilizumab treatment showed improvement of lung manifestations in all patients. No adverse events or new safety concerns attributable to tocilizumab were reported. INTERPRETATION: Tocilizumab administered subcutaneously to patients with COVID-19 and CRS is a promising treatment for reduction in disease activity and improvement in lung function. The effect of tocilizumab should be confirmed in a randomised controlled trial.

[Value-based cancer care. From traditional evidence-based decision making to balanced decision making within frameworks of shared values]. / La decisione oncologica basata sui valori Dal tradizionale processo decisionale oncologico evidence-based a scelte basate su valori bilanciati e condivisi.

Clinical decision making in oncology is based so far on the evidence of efficacy from high-quality clinical research. Data collection and analysis from experimental studies provide valuable insight into response rates and progression-free or overall survival. Data processing generates valuable information for medical professionals involved in cancer patient care, enabling them to make objective and unbiased choices. The increased attention of many scientific associations toward a more rational resource consumption in clinical decision making is mirrored in the Choosing Wisely campaign against the overuse or misuse of exams and procedures of little or no benefit for the patient. This cultural movement has been actively promoting care solutions based on the concept of "value". As a result, the value-based decision-making process for cancer care should not be dissociated from economic sustainability and from ethics of the affordability, also given the growing average cost of the most recent cancer drugs. In support of this orientation, the National Comprehensive Cancer Network (NCCN) has developed innovative and "complex" guidelines based on values, defined as "evidence blocks", with the aim of assisting the medical community in making overall sustainable choices.