ABSTRACT
Background: From the end of December 2019, the new beta coronavirus named COVID-19 has significantly affected the greater number of countries in the world. The major part of the recommendations for the treatment of ALL in the era of COVID-19 includes delaying as long as possible chemotherapy, except in cases of high risk of complications or disease progression. In Mexico, the number of cases of leukemia has diminished due to hospital conversion such as limited access to treatments. The object of this study was to describe the cases with de novo acute lymphoblastic leukemia in two institutions assigned as COVID-19 hospitals in Mexico City Aims: Describe patients' clinical and prognostic behavior with ALL and COVID-19 infection at diagnosis as at any stage of treatment. Methods: A prospective, observational study in patients de novo diagnosed with ALL according to the WHO criteria, cared for in the Hematology Department of the Hospital Regional de Alta Especialidad de Ixtapaluca and the Hospital General de México. The clinical records of the patients diagnosed with ALL from April to December 2020 were included;they received treatment based on intermediate intensity program (CALGB-10403) or high-intensity program (Hyper-CVAD), maintaining the majority of patients as outpatients. ALL the confirmed COVID-19 cases with ALL were compared with non-cancer COVID- 19 cases to describe the difference. Support treatment for COVID-19 was based on local considerations. This research was registered on the ClinicalTrials platform (NCT04745416). Results: Thirty patients were studied (April to December 2020);one case was excluded from the analysis (spontaneous remission). Of the 29 cases, 6 (20.7%) were COVID-19 confirmed cases, four at diagnosis and two during the induction period.There were no differences in gender, age (24 vs. 30 years, p=0.261), or mean leukocyte count at diagnosis (156.3 vs. 116.5 x109/L, p=0.564, 95%CI). BCR-ABL was detected in one case with COVID-19;two cases with COVID-19 showed AF4-MLL and ELN-MLL. According to risk, 66.7% (n=4) of the cases with COVID-19 were considered high risk. The treatment for COVID-19 was high-flow oxygen, azithromycin, anticoagulation. Upon analyzing the response to induction, the group negative to COVID-19 showed a higher proportion of response than the cases with a background of COVID-19 (78.3% vs. 66.7%), but without statistical significance (p=0.628). The group with COVID-19 showed a higher proportion of leukemia refractory to induction (33% vs. 17.4%), requiring a second treatment program. There were no deaths in the COVID-19 arm. Comparing the survival with non-cancer COVID-19 patients, the mortality was 51.7% for individuals without leukemia and 16.7% (n=1) for leukemia COVID-19 cases. Two female patients showed ALL patients' morphological remission: (19 years and 38 years of age). Both debuted with fever as the main manifestation, cytopenias (patient 1: WBC 0.5 x 109/L, platelets 13 x109/L;patient 2: 0.7 x109/L, platelets 123 x109/L) without cytogenetic abnormalities. From day 10 of hospital stay, they showed improvement in leukocyte and platelet counts, reaching the normal range by day 21, requiring evaluation of extended bone marrow, which showed an absence of blasts. Patient 1 had a negative finding after beginning an induction program, and patient two is still without treatment. Summary/Conclusion: The prognosis of individuals with COVID-19- ALL is better due to the null development of cytokine storm;similar to other tumors, spontaneous remission can be seen, especially in young individuals, and decreased tumor burden.
ABSTRACT
Background: Coagulopathy associated with COVID-19 is one of the main complications, especially in individuals with risk factors. Simultaneously, the use of low molecular weight heparin is the recommended strategy in hospitalized individuals, but the usefulness of other strategies such as DOACs in outpatients is still unknown. Aims: Describe the benefit of the use of rivaroxaban at discharge on the risk of thrombosis in patients discharged from COVID-19.Identify the behavior of Dimero-D at discharge and its modification with anticoagulant therapy. Methods: Randomized 1: 1 study (Rivaroxaban 10mg for 14 days versus observation) at discharge in individuals with COVID-19 who have not required mechanical ventilation. D-dimer was evaluated at 14 and 30 days after discharge in conjunction with a CT angiography at four weeks after hospital discharge. The protocol was developed in the Hospital Regional de Alta Especialidad de Ixtapaluca, authorized by the ethics committee with registration number NR-19-2020. The study is identified in ClinicalTrials.gov with the following registry NCT04508439 Results: Forty individuals were evaluated (20 in each arm) with follow- up greater than 100 days. Gender distribution was equitable in each arm, with a mean age of 50 years (21 to 74 years), 40% (n = 16) were older than 55 years, 27.5% (n = 11) had hypertension and 20% (n = 8) had diabetes. The mean length of hospital stay was 10.5 days (6 to 23 days) treated with oxygen and low molecular weight heparin. At discharge, treatment was started with rivaroxaban 10mg x 14d vs. observation;in the rivaroxaban group, four events were identified (3 hemorrhages / 1 thrombosis), this difference being significant (Log Rank 0.016). Only one thrombosis event (pulmonary embolism) was identified in the rivaroxaban group at eight treatment days. Compared to the diagnosis, DD levels were lower at both 14 and 30 days (p = 0.000, 95% CI, 440.8-1164.9) without finding a difference in those treated with rivaroxaban or observation (p = 0.721, 95% CI, -68.48 to 241.18). Summary/Conclusion: The use of DOACs at discharge does not benefit from an increased risk of hemorrhagic events;the anticoagulant strategy should be individualized, focused only on those patients at very high risk of thrombosis.