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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A 53-year-old man developed neutropenia during treatment with hydroxycarbamide and off-label gilteritinib for acute myeloid leukaemia (AML). Additionally, he exhibited lack of efficacy with remdesivir for COVID-19 pneumonia.
The man presented with abdominal pain, splenomegaly, temperature of 37.8°C, thrombocytopenia and anaemia. He tested positive for SARS-CoV-2 infection. Following investigations, he was diagnosed with AML and on admission, he started receiving hydroxycarbamide [Hydroxyurea]. FLT3 mutation was noted, which indicated poor prognosis. Therefore, he started receiving off-label gilteritinib. Due to leukaemia, he started receiving empirical treatment with vancomycin and cefepime. On hospital day 4, he developed sudden dizziness, upper extremity weakness and dysarthria with left-sided facial droop, suggestive of transient ischaemic attack (TIA). Investigations revealed elevated fibrinogen and D-dimer levels and a WBC of 220 00/mL 3. The symptoms resolved within 24 hours, but over the following 7 days, he developed fever, hypoxaemia and dyspnoea.
The man was treated with remdesivir [dosages and routes not stated] for COVID-19 pneumonia and isavuconazole for potential fungal infection. He also received platelets and red blood cells between days 5 and 10. Subsequently, he developed haemoptysis with worsening hypoxaemia despite high-flow oxygen. Progression of bilateral pulmonary infiltrates was noted, requiring emergency intubation and mechanical ventilation (lack of efficacy). Bacterial and fungal cultures were found to be negative. Bronchoscopy with serial BAL revealed diffuse alveolar haemorrhage. After 3 days, he was weaned from mechanical ventilation and was extubated however, he experienced ongoing neutropenic fever. He was discharged on day 36. Peripheral blood flow cytometry demonstrated chemotherapy-induced neutropenia [duration of treatment to reaction onset and outcome not stated]. Rotational thromboelastometry (ROTEM) showed abnormally elevated clot firmness in the fibrin-based extrinsically activated test along with tissue factor and the platelet inhibitor cytochalasin D. The tests were consistent with diagnosis of COVID-19-induced factor-driven hypercoagulability.
Reference
- Olson LB, et al. Key Pathogenic Factors in Coronavirus Disease 2019-Associated Coagulopathy and Acute Lung Injury Highlighted in a Patient With Copresentation of Acute Myelocytic Leukemia: A Case Report. A and A Practice 15: e01432, No. 4, Apr 2021. Available from: URL: 10.1213/XAA.0000000000001432 [DOI] [PMC free article] [PubMed]