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Background and Aim: Monoclonal antibodies (mAb) are a promising treatment for patients with COVID-19. The primary objective of this analysis was to evaluate the effectiveness and safety of mAb, using real-world data relating to patients belonging to the HUB COVID of the Varese Hospital. Materials and Methods: A retrospective analysis was carried out on patients treated with mAb from April 2021 to January 31, 2022. Information was collected on: disease status, immediate and late adverse drug reactions (ADRs), and outcome at 10 and 30 days after mAb administration. Results: Three hundred twenty-eight patients (M/F 191/137;median age 59.3 yrs) were treated: 176 with bamlanivimab/etesevimab, 117 with casirivimab/imdevimab, 35 with sotrovimab. One hundred eight (32.9%) patients were not fully vaccinated and 10 (3%) vaccinated with only 2 doses more than 120 days. Eighty (24.4%) were affected by cardiovascular disease, 73 (22.2%) immunodeficiency, 69 (21%) BMI>=30, 52 (15.8%) diabetes, 35 (10.7%) chronic lung disease and 7 (2.1%) end-stage renal failure. Severe ADRs did not occur. The median time between treatment and symptom resolution was 4 days. Among the 190 outpatients, only 9 (4.7%) needed hospitalization for COVID pneumonia, with a favorable outcome. In addition, 89.8% of hospitalized patients (60 with pneumonia and negative serology, 78 hospitalized not for COVID pneumonia) had symptom resolution without disease progression. Conclusions: Our study confirms the effectiveness and safety of the early treatment with mAb for COVID-19 to reduce the risk of disease progression.
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INTRODUCTION: COVID-19 has disrupted the global health care system since March 2020. Lung cancer (LC) patients (pts) represent a vulnerable population highly affected by the pandemic. This multicenter Italian study aimed to evaluate whether the COVID-19 outbreak had an impact on access to cancer diagnosis and treatment of LC pts compared with pre-pandemic time. METHODS: Consecutive newly diagnosed LC pts referred to 25 Italian Oncology Departments between March and December 2020 were included. Access rate and temporal intervals between date of symptoms onset and diagnostic and therapeutic services were compared with the same period in 2019. Differences between the 2 years were analyzed using the chi-square test for categorical variables and the Mann-Whitney U test for continuous variables. RESULTS: A slight reduction (-6.9%) in newly diagnosed LC cases was observed in 2020 compared with 2019 (1523 versus 1637, P = 0.09). Newly diagnosed LC pts in 2020 were more likely to be diagnosed with stage IV disease (P < 0.01) and to be current smokers (someone who has smoked more than 100 cigarettes, including hand-rolled cigarettes, cigars, cigarillos, in their lifetime and has smoked in the last 28 days) (P < 0.01). The drop in terms of new diagnoses was greater in the lockdown period (percentage drop -12% versus -3.2%) compared with the other months included. More LC pts were referred to a low/medium volume hospital in 2020 compared with 2019 (P = 0.01). No differences emerged in terms of interval between symptoms onset and radiological diagnosis (P = 0.94), symptoms onset and cytohistological diagnosis (P = 0.92), symptoms onset and treatment start (P = 0.40), and treatment start and first radiological revaluation (P = 0.36). CONCLUSIONS: Our study pointed out a reduction of new diagnoses with a shift towards higher stage at diagnosis for LC pts in 2020. Despite this, the measures adopted by Italian Oncology Departments ensured the maintenance of the diagnostic-therapeutic pathways of LC pts.
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COVID-19 , Lung Neoplasms , Communicable Disease Control , Humans , Italy/epidemiology , Lung Neoplasms/diagnosis , Lung Neoplasms/epidemiology , Lung Neoplasms/therapy , PandemicsABSTRACT
Background: The coronavirus disease 2019 (COVID-19) had an unprecedent impact on the global health care system since March 2020. Lung cancer (LC) patients (pts) represent a vulnerable population, and diagnostic/therapeutic delays might affect the years to come. Aim of the multicenter, real-world, Italian COVID-DELAY study was to evaluate how the 2020 COVID-19 pandemic impacted on LC pts' access to diagnosis and treatment compared to pre-pandemic time. Patients and methods: All consecutive newly diagnosed LC pts referred to 25 Italian Oncology Departments between March and December 2020 were reviewed. Monthly access rate and temporal intervals between date of symptom onset, diagnosis and treatment start were analyzed and compared to the same period of 2019. Differences between the two years were analyzed using Fisher's exact test or chi-square test for categorical variables and unpaired Student t test, or the Mann-Whitney U test for continuous variables. Results: Less LC cases (1523 vs 1637, -6.9%) were diagnosed during the 2020 pandemic compared to 2019. LC pts in 2020 were more likely to be diagnosed with stage IV disease (p < 0.01) and to be current smokers (p < 0.01). A major drop of new LC cases was seen during the lockdown period (percentage drop -13.2% vs -5.1%) compared to the other months included. Moreover, a geographic migration was observed with more LC patients referring to low/ medium volume hospital in 2020 compared to 2019 (p = 0.01). Looking at pts management, no differences emerged in terms of interval between symptom onset and radiological diagnosis (p = 0.94), symptom onset and cytohistological diagnosis (p = 0.92), symptoms onset and treatment start (p = 0.40), treatment start and first radiological revaluation (p = 0.36). However, less LC patients were treated in the context of clinical trials during 2020 (5% vs 7%, p = 0.07). Conclusions: Our study pointed out a decrease of new LC cases and a shift towards a higher stage at diagnosis in 2020. Despite this, the efforts put in place by the Italian Oncology Departments ensured the maintenance of the diagnostic-therapeutic pathways of LC patients.
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Description of the case: A 38-year-old patient of Moroccan ethnicity, who had vaginally delivered a healthy baby girl in the obstetric ward the previous night, was transferred to the CoViD Hub of Varese Hospital due to the onset of nausea and emesis and severe hypertransaminasemia. The patient was known to be positive for SARS-CoV-2 infection but was not taking any medications at home. Physical examination was normal, except for scleral icterus. Laboratory tests were significant for bilirubin 2.52 mg/dl, AST 2729 U/L, ALT 513 U/L, LDH>1800 U/L;we also found mild thrombocytopenia (104,000/L), INR 1.24, d-dimer>9000 ng/ml, prolonged prothrombin time, and reduced fibrinogen levels. Serological tests were negative for hepatitis A, B, C, and E, EBV, CMV, HSV type 1 and 2, and HIV. Autoimmune or toxic hepatitis was excluded. No teardrop-shaped erythrocytes were visualized. No vaginal bleeding was found. HRCT showed diffuse multiple bilateral consolidations, and abdomen CT excluded portal thrombosis. Infusive fluid and prophylactic therapy with sodium enoxaparin were started. During hospitalization, the detection of SARS-CoV-2 RNA in the nasopharynx sample was persistently positive. On the tenth day post-hospitalization, the patient was discharged with normalization of liver values and clinical well-being. Conclusions: Severe acute hepatitis has been reported in patients with severe CoViD-19, but it is rare in pregnant women with asymptomatic SARS-CoV-2 infection without other pregnancy-related disorders, as in the present case.