ABSTRACT
The distinctive clinical course and outcomes of COVID-19 infection in multiple myeloma patients are still not well established. In this study, we aimed to assess the clinical outcomes and associated factors of COVID-19 in patients with multiple myeloma (MM). This is a multi-center retrospective cohort study. Multiple myeloma patients treated in two tertiary centers were investigated, and the patients diagnosed with COVID-19 during follow-up were included. The main characteristics and clinical outcomes of patients were analyzed. A total of thirty patients were included for analysis. In this cohort, autologous hematopoietic stem cell transplantation (AHSCT) was performed in 63.3% of the patients, and 36.7% were in complete remission when COVID-19 was detected. The total fatality rate (FR) was 36%, and the COVID-19-related case fatality rate (CFR) was 30% for MM patients in our cohort. There was two non-COVIDrelated mortality. The CFR was associated with intensive care unit admission (26.7%, p< 0.001), mechanical ventilation (26.6%, p< 0.001), increased lactate dehydrogenase (p= 0.008) and lymphopenia (p= 0.042). Older age (> 65-years), stem cell transplantation, and comorbidities were not effective on the fatality rate. This study shows that the CFR rate was high in MM patients, irrespective of AHSCT status. Therefore, we suggest strict monitoring and adequate vaccination in this group. However, further studies, including vaccination data with a larger group of patients, are needed to clarify the literature.
ABSTRACT
Background: Severe aplastic anemia (SAA) is a rare bone marrow failure disorder associated with significant morbidity and mortality. SAA is characterized by severe pancytopenia and a hypocellular (<25%) bone marrow. The standard of care treatment is hemopoietic stem cell transplant or immunosuppressive therapy (IST) for patients (pts) who are ineligible for transplant. IST usually comprises an antithymocyte globulin (ATG) derived from horse or rabbit, and cyclosporine A (CsA). Although IST can be an effective treatment, individual intolerance, insufficient response, relapse, and clonal evolution remain significant limitations. The lack of global availability of the more effective horse ATG also leaves many pts with limited treatment options and poorer outcomes. In addition, pts with SAA often require transfusions which can be burdensome and negatively impact their quality of life. Eltrombopag (ETB) is indicated for use in pts with SAA who have had an insufficient response to IST (FDA PI, 2014) or are refractory to IST (EMA SmPC, 2015). More recently in the USA, ETB may also be used in combination with IST as first-line (1L) treatment (FDA PI, 2018). Aims: To assess the efficacy and safety of ETB + CsA (without ATG) as 1L therapy in adult pts with SAA. Methods: SOAR (NCT02998645) is a Phase 2, single-arm, multicenter, open-label study. Treatment-naive pts with SAA received ETB + CsA for 6 months;responders continued CsA therapy for an additional 24 months (later reduced to 18 months). The primary efficacy endpoint was overall response rate (ORR) by 6 months. ORR was defined as the proportion of pts with complete response ([CR] = absolute neutrophil count [ANC] ≥1000/μL AND platelet count ≥100,000/μL AND hemoglobin ≥10 g/dL) plus the proportion of pts with partial response ([PR] = any 2 of the following counts: ANC ≥500/μL;platelet count ≥20,000/μL;automated reticulocyte count ≥60,000/μL, but not sufficient for a CR). CR and PR were confirmed by 2 assessments ≥7 days apart;transfusion restrictions were also applied. For the primary endpoint to be considered ‘clinically meaningful’ at least 17/54 pts treated were required to have a response. Other endpoints included ORR by 3 months, ORR at 6 months (ie, confirmed response at the 6-month visit), and transfusion independence, which was defined as transfusion not being required in a period of ≥28 days for platelet transfusions and ≥56 days for red blood cell (RBC) transfusions. Results: Pts (N=54) had a median (interquartile range [IQR]) age of 55.0 (40.0-67.0) years and 63.0% were male. The majority of pts were White (40.7%) or Asian (40.7%). The median (IQR) duration of exposure to ETB and CsA was 5.7 (2.5-5.8) months and 5.7 (2.4-8.1) months, respectively, and the median (IQR) daily ETB dose was 150.0 (100.0-150.0) mg/day. In the full analysis set, the primary endpoint was met, with 25/54 pts having a CR or PR by 6 months (ORR 46.3%;95% confidence interval [CI], 32.6-60.4%). Of the 25 responders, 2 (3.7%) achieved a CR by 6 months. ORR by 3 months was 40.7% (95% CI, 27.6-55.0%;n=22/54), and ORR at 6 months was 37.0% (95% CI, 24.3-51.3%;n=20/54). 70.4% of all pts qualified for ≥1 period of RBC and/or platelet transfusion independence by 6 months, including all 25 (100%) responders and 13/29 (44.8%) non-responders (Fig. 1). 40.7% of all pts (responders: 68.0%;non-responders: 17.2%) qualified for ≥1 period of RBC transfusion independence (corresponding percentages for platelet transfusion independence were the same as for the combined RBC and/or platelet endpoint). Adverse events (AEs) occurred in 52/54 (96.3%) pts;45 (83.3%) pts experienced treatment-related AEs (TAEs), 23 (42.6%) of whom had a grade ≥3 TAE. The most common all-grade AEs were increased blood bilirubin (40.7%), nausea (29.6%), increased alanine aminotransferase (22.2%), and diarrhea (22.2%). Seven (13.0%) pts discontinued treatment due to grade ≥3 AEs. There were 8 on-treatment deaths (aplastic anemia [n=3];COVID-19, hemorrhage, multi-organ dysfunction syndrom , pyrexia, and thrombosis [all n=1]);no deaths were considered treatment-related. Conclusion: Data from the SOAR study indicate that ETB + CsA may be beneficial for pts with SAA ineligible for transplant who cannot access or tolerate ATG. All responders and almost half of non-responders qualified for ≥1 period of transfusion independence by 6 months, suggestive of a decreased transfusion burden. No new safety signals were identified. [Formula presented] Disclosures: Vallejo: Novartis: Honoraria;Sanofi: Honoraria;Pfizer: Honoraria. Finelli: Takeda: Consultancy;Celgene BMS: Consultancy, Research Funding, Speakers Bureau;Novartis: Consultancy, Speakers Bureau. Calado: Agios: Membership on an entity's Board of Directors or advisory committees;AA&MDS International Foundation: Research Funding;Alexion Brasil: Consultancy;Instituto Butantan: Consultancy;Novartis Brasil: Honoraria;Team Telomere, Inc.: Membership on an entity's Board of Directors or advisory committees. Peffault De Latour: Novartis: Consultancy, Honoraria, Research Funding;Pfizer: Consultancy, Honoraria, Research Funding;Amgen: Research Funding;Alexion: Consultancy, Honoraria, Research Funding;Apellis Pharmaceuticals Inc: Consultancy, Honoraria;Swedish Orphan Biovitrum AB: Consultancy, Honoraria. Kriemler-Krahn: Novartis: Current Employment. Haenig: Novartis: Current Employment. Maier: Novartis: Current Employment. Scheinberg: Alexion pharmaceuticals: Consultancy, Honoraria, Speakers Bureau;Novartis: Consultancy, Honoraria, Speakers Bureau;BioCryst Pharmaceuticals: Consultancy;Roche: Consultancy;Abbvie: Consultancy. OffLabel Disclosure: In the United States, eltrombopag is a thrombopoietin receptor agonist indicated in combination with standard immunosuppressive therapy (ATG + CsA) for the first-line treatment of adult and pediatric patients aged 2 years and older with severe aplastic anemia (SAA). It is also indicated for the treatment of patients with SAA who have had an insufficient response to immunosuppressive therapy. The SOAR trial aims to assess the efficacy and safety of eltrombopag + CsA (without ATG) as first-line therapy in adult patients with SAA.
ABSTRACT
Hematology patients are extremely vulnerable to COVID-19 infection due to the immunosuppression arising from the direct effect of the disease and the medicines administered. Our purpose is to analyze the results of the patients that both have a hematological disease and receive treatment for COVID-19 infection in our hospital. Four hundred COVID-19 positive patients that received inpatient treatment between March 12, 2020 and October 1, 2020 in our center and got a diagnosis by using real -time polymerase chain reaction (RT-PCR) test were scanned retrospectively. Eighty one patients were included in the study. Nineteen patients had a hematological disease;62 had a chronic disease but didn't have a hematological disease. We found that the group with hematological disease had a high level of ferritin (p= 0.0001). While the use of steroids in COVID-19 treatments is more frequent in the group with hematological disease (p= 0.01), the use of LMWH (low molecular weight heparin) is more frequent in the group with no hematological diseases (p= 0.02). Intensive care treatment and mechanical ventilatory support were required more for the patients with hematological disease than the others (p= 0.03. p= 0.008). While the mortality rate is 42.1% in the patients with hematological disease, it is 9.7% in the patients with chronic disease (p= 0.003). In cox regression analysis, the study found that hematological diseases (HR: 4.02, 95% CI: 1.7-1844.5, p= 0.02), cardiac diseases (HR: 2.28, 95% CI: 1.2-77.9, p= 0.03), and intensive care treatment (HR: 4.60, 95% CI: 3.1-3115.0, p= 0.009) are significant risk factors. Hematological patients infected with COVID-19 have a more severe and mortal clinical manifestation than the patients with other chronical disease.
ABSTRACT
Objective: In the early stages of any epidemic caused by new emerging pathogens healthcare personnel is subject to a great risk. Pandemic caused by SARS-CoV-2, proved to be no exception. Many healthcare workers died in the early stages of pandemic due to inadequate precautions and insufficient protection. It is essential to protect and maintain the safety of healthcare personnel for the confinement of pandemic as well as continuity of qualified healthcare services which is already under strain. Educating healthcare personnel on appropiate use of personal protective equipment (PPE) is as essential as procuring them. Material and Methods: A survey is conducted on 4927 healthcare personnel working solely with pediatric patients from 32 different centers. Education given on PPE usage were questioned and analyzed depending on age, sex, occupation and region. Results: Among four thousand nine hundred twelve healthcare personnel from 32 different centers 91% (n= 4457) received education on PPE usage. Of those who received education only 36% was given both theoretical and applied education. Although there was no differences among different occupation groups, receiving education depended on regions. Conclusion: It is essential to educate healthcare personnel appropiately nationwidely for the continuity of qualified healthcare services during the pandemic.
ABSTRACT
Objective: In the early stages of any epidemic caused by new emerging pathogens healthcare personnel is subject to a great risk. Pandemic caused by SARS-CoV-2, proved to be no exception. Many healthcare workers died in the early stages of pandemic due to inadequate precautions and insufficient protection. It is essential to protect and maintain the safety of healthcare personnel for the confinement of pandemic as well as continuity of qualified healthcare services which is already under strain. Educating healthcare personnel on appropiate use of personal protective equipment (PPE) is as essential as procuring them. Material and Methods: A survey is conducted on 4927 healthcare personnel working solely with pediatric patients from 32 different centers. Education given on PPE usage were questioned and analyzed depending on age, sex, occupation and region. Results: Among four thousand nine hundred twelve healthcare personnel from 32 different centers 91% (n=4457) received education on PPE usage. Of those who received education only 36% was given both theoretical and applied education. Although there was no differences among different occupation groups, receiving education depended on regions. Conclusion: It is essential to educate healthcare personnel appropiately nationwidely for the continuity of qualified healthcare services during the pandemic.