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1.
Eur J Cancer ; 147: 154-160, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33676266

RESUMO

The worldwide spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the associated infectious coronavirus disease (COVID-19) has posed a unique challenge to medical staff, patients and their families. Patients with cancer, particularly those with haematologic malignancies, have been identified to be at high risk to develop severe COVID-19. Since publication of our previous guideline on evidence-based management of COVID-19 in patients with cancer, research efforts have continued and new relevant data has come to light, maybe most importantly in the field of vaccination studies. Therefore, an update of our guideline on several clinically important topics is warranted. Here, we provide a concise update of evidence-based recommendations for rapid diagnostics, viral shedding, vaccination and therapy of COVID-19 in patients with cancer. This guideline update was prepared by the Infectious Diseases Working Party (AGIHO) of the German Society for Haematology and Medical Oncology by critically reviewing the currently available data on these topics applying evidence-based medicine criteria.


Assuntos
/normas , Neoplasias , Eliminação de Partículas Virais/fisiologia , Antivirais/uso terapêutico , /epidemiologia , /virologia , Medicina Baseada em Evidências/normas , Medicina Baseada em Evidências/estatística & dados numéricos , Alemanha/epidemiologia , Neoplasias Hematológicas/diagnóstico , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/terapia , Neoplasias Hematológicas/virologia , Hematologia/organização & administração , Hematologia/normas , Humanos , Imunização Passiva/métodos , Imunização Passiva/normas , Infectologia/organização & administração , Infectologia/normas , Oncologia/organização & administração , Oncologia/normas , Neoplasias/diagnóstico , Neoplasias/epidemiologia , Neoplasias/terapia , Neoplasias/virologia , Sociedades Médicas/normas , Vacinação/métodos , Vacinação/normas
2.
Trials ; 22(1): 116, 2021 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-33546739

RESUMO

OBJECTIVES: Baricitinib is supposed to have a double effect on SARS-CoV2 infection. Firstly, it reduces the inflammatory response through the inhibition of the Januse-Kinase signalling transducer and activator of transcription (JAK-STAT) pathway. Moreover, it reduces the receptor mediated viral endocytosis by AP2-associated protein kinase 1 (AAK1) inhibition. We propose the use of baricinitib to prevent the progression of the respiratory insufficiency in SARS-CoV2 pneumonia in onco-haematological patients. In this phase Ib/II study, the primary objective in the safety cohort is to describe the incidence of severe adverse events associated with baricitinib administration. The primary objective of the randomized phase (baricitinib cohort versus standard of care cohort) is to evaluate the number of patients who did not require mechanical oxygen support since start of therapy until day +14 or discharge (whichever it comes first). The secondary objectives of the study (only randomized phase of the study) are represented by the comparison between the two arms of the study in terms of mortality and toxicity at day+30. Moreover, a description of the immunological related changes between the two arms of the study will be reported. TRIAL DESIGN: The trial is a phase I/II study with a safety run-in cohort (phase 1) followed by an open label phase II randomized controlled trial with an experimental arm compared to a standard of care arm. PARTICIPANTS: The study will be performed at the Institut Català d'Oncologia, a tertiary level oncological referral center in the Catalonia region (Spain). The eligibility criteria are: patients > 18 years affected by oncological diseases; ECOG performance status < 2 (Karnofsky score > 60%); a laboratory confirmed infection with SARS-CoV-2 by means of real -time PCR; radiological signs of low respiratory tract disease; absence of organ dysfunction (a total bilirubin within normal institutional limits, AST/ALT≤2.5 X institutional upper limit of normal, alkaline phosphatase ≤2.5 X institutional upper limit of normal, coagulation within normal institutional limits, creatinine clearance >30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal); absence of HIV infection; no active or latent HBV or HCV infection. The exclusion criteria are: patients with oncological diseases who are not candidates to receive any active oncological treatment; hemodynamic instability at time of study enrollment; impossibility to receive oral medication; medical history of recent or active pulmonary embolism or deep venous thrombosis or patients at high-risk of suffering them (surgical intervention, immobilization); multi organ failure, rapid worsening of respiratory function with requirement of fraction of inspired oxygen (FiO2) > 50% or high-flow nasal cannula before initiation of study treatment; uncontrolled intercurrent illness (ongoing or severe active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements); allergy to one or more of study treatments; pregnant or breastfeeding women; positive pregnancy test in a pre-dose examination. Patients should have the ability to understand, and the willingness to sign, a written informed consent document; the willingness to accept randomization to any assigned treatment arm; and must agree not to enroll in another study of an investigational agent prior to completion of Day +28 of study. An electronic Case Report Form in the Research Electronic Data Capture (REDCap) platform will be used to collect the data of the trial. Removal from the study will apply in case of unacceptable adverse event(s), development of an intercurrent illness, condition or procedural complication, which could interfere with the patient's continued participation and voluntary patient withdrawal from study treatment (all patients are free to withdraw from participation in this study at any time, for any reasons, specified or unspecified, and without prejudice). INTERVENTION AND COMPARATOR: Treatment will be administered on an inpatient basis. We will compare the experimental treatment with baricitinib plus the institutional standard of care compared with the standard of care alone. During the phase I, we will define the dose-limiting toxicity of baricitinib and the dose to be used in the phase 2 part of the study. The starting baricitinib dose will be an oral tablet 4 mg-once daily which can be reduced to 2 mg depending on the observed toxicity. The minimum duration of therapy will be 5 days and it can be extended to 7 days. The standard of care will include the following therapies. Antibiotics will be individualized based on clinical suspicion, including the management of febrile neutropenia. Prophylaxis of thromboembolic disease will be administered to all participants. Remdesivir administration will be considered only in patients with severe pneumonia (SatO2 <94%) with less than 7 days of onset of symptoms and with supplemental oxygen requirements but not using high-flow nasal cannula, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). In the randomized phase, tocilizumab or interferon will not be allowed in the experimental arm. Tocilizumab can be used in patients in the standard of care arm at the discretion of the investigator. If it is prescribed it will be used according to the following criteria: patients who, according to his baseline clinical condition, would be an ICU tributary, interstitial pneumonia with severe respiratory failure, patients who are not on mechanical ventilation or ECMO and who are still progressing with corticoid treatment or if they are not candidates for corticosteroids. Mild ARDS (PAFI <300 mmHg) with radiological or blood gases deterioration that meets at least one of the following criteria: CRP >100mg/L D-Dimer >1,000µg/L LDH >400U/L Ferritin >700ng/ml Interleukin 6 ≥40ng/L. The use of tocilizumab is not recommended if there are AST/ALT values greater than 10 times the upper limit of normal, neutrophils <500 cells/mm3, sepsis due to other pathogens other than SARS-CoV-2, presence of comorbidity that can lead to a poor prognosis, complicated diverticulitis or intestinal perforation, ongoing skin infection. The dose will be that recommended by the Spanish Medicine Agency in patients ≥75Kg: 600mg dose whereas in patients <75kg: 400mg dose. Exceptionally, a second infusion can be assessed 12 hours after the first in those patients who experience a worsening of laboratory parameters after a first favourable response. The use of corticosteroids will be recommended in patients who have had symptoms for more than 7 days and who meet all the following criteria: need for oxygen support, non-invasive or invasive mechanical ventilation, acute respiratory failure or rapid deterioration of gas exchange, appearance or worsening of bilateral alveolar-interstitial infiltrates at the radiological level. In case of indication, it is recommended: dexamethasone 6mg/d p.o. or iv for 10 days or methylprednisolone 32mg/d orally or 30mg iv for 10 days or prednisone 40mg day p.o. for 10 days. MAIN OUTCOMES: Phase 1 part: to describe the toxicity profile of baricitinib in COVID19 oncological patients during the 5-7 day treatment period and until day +14 or discharge (whichever it comes first). Phase 2 part: to describe the number of patients in the experimental arm that will not require mechanical oxygen support compared to the standard of care arm until day +14 or discharge (whichever it comes first). RANDOMISATION: For the phase 2 of the study, the allocation ratio will be 1:1. Randomization process will be carried out electronically through the REDcap platform ( https://www.project-redcap.org/ ) BLINDING (MASKING): This is an open label study. No blinding will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The first part of the study (safety run-in cohort) will consist in the enrollment of 6 to 12 patients. In this population, we will test the toxicity of the experimental treatment. An incidence of severe adverse events grade 3-4 (graded by Common Terminology Criteria for Adverse Events v.5.0) inferior than 33% will be considered sufficient to follow with the next part of the study. The second part of the study we will perform an interim analysis of efficacy at first 64 assessed patients and a definitive one will analyze 128 assessed patients. Interim and definitive tests will be performed considering in both cases an alpha error of 0.05. We consider for the control arm this rate is expected to be 0.60 and for the experimental arm of 0.80. Considering this data, a superiority test to prove a difference of 0.20 with an overall alpha error of 0.10 and a beta error of 0.2 will be performed. Considering a 5% of dropout rate, it is expected that a total of 136 patients, 68 for each study arm, will be required to complete study accrual. TRIAL STATUS: Version 5.0. 14th October 2020 Recruitment started on the 16th of December 2020. Expected end of recruitment is June 2021. TRIAL REGISTRATION: AEMPs: 20-0356 EudraCT: 2020-001789-12, https://www.clinicaltrialsregister.eu/ctr-search/search (Not publically available as Phase I trial) Clinical trials: BARCOVID19, https://www.clinicaltrials.gov/ (In progress) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol."


Assuntos
Antivirais/efeitos adversos , Azetidinas/efeitos adversos , Neoplasias Hematológicas/complicações , Purinas/efeitos adversos , Pirazóis/efeitos adversos , Insuficiência Respiratória/prevenção & controle , Sulfonamidas/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , /epidemiologia , /virologia , Ensaios Clínicos Fase I como Assunto , Ensaios Clínicos Fase II como Assunto , Estudos de Coortes , Feminino , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Oxigenoterapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Reação em Cadeia da Polimerase em Tempo Real , Insuficiência Respiratória/epidemiologia , Espanha/epidemiologia , Resultado do Tratamento , Adulto Jovem
3.
Mymensingh Med J ; 30(1): 28-34, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33397847

RESUMO

The global burden of cancer is gradually rising. In our context we are also facing the same problem. Hematological malignancies (HMs) are important component of cancer. Early diagnosis and proper treatment at right time, a good number of HMs patients can be cured or lengthening the survival period. For this purpose a proper diagnostic criteria should be developed in our settings. This research work is carried out to find out the clinicopathological findings of HMs in our population. This was a cross-sectional descriptive type of observational study conducted in the Department of Medicine and Hematology of Mymensingh Medical College Hospital, Bangladesh from July 2016 to June 2017. Total 45 patients were purposively selected on the basis of inclusion and exclusion criteria with a view to observe the clinical and laboratory findings. Mean age of the patients was 44.5 years. Highest average age (70 years) was found in chronic lymphocytic leukaemia (CLL) and lowest (29 years) in acute lymphoblastic leukaemia (ALL). Majority of the respondents were male in all HMs except in non-Hodgkin's lymphoma (NHL) where male-female ratio was 0.3:7. Among male most of them were farmers or day laborers and most of the females were housewife. Almost all patients were exposed to single or multiple exposures like smoking, betel nut, betel leaf, tobacco leaf, fertilizer or pesticides. Acute myeloblastic leukaemia (AML) was the leading HMS with 31.11% representation followed by non-Hodgkin's lymphoma (NHL) 20%, Hodgkin's lymphoma (HL) 15.56%, acute lymphoblastic leukaemia (ALL) 11.11%, chronic myeloid leukaemia (CML) 11.11%, multiple myeloma (MM)6.67% and chronic lymphocytic leukaemia (CLL) 4.44%. Duration of symptoms was vary from 2 days to 5 years. In acute leukaemia duration was short (average 2 months). Common clinical findings were anaemia (95.5%), fever (80.0%), hepatosplenomegaly (42.2%), lymphadenopathy (40.0%), bony tenderness (22.2%) and bleeding manifestations (15.5%). Some uncommon findings were also reported like menorrhagia, facial nerve palsy, arthritis and disorientation. Common laboratory abnormalities were high ESR, anaemia, leukocytosis, thrombocytopenia and immature cell in PBF especially in acute leukaemia. Clinical suspicion along with history of positive exposure indicates strong possibilities of haematological malignancies. It should be kept in mind that haematological malignancies may also present with some isolated uncommon findings.


Assuntos
Neoplasias Hematológicas , Linfoma não Hodgkin , Adulto , Idoso , Bangladesh , Estudos Transversais , Feminino , Neoplasias Hematológicas/epidemiologia , Hospitais , Humanos , Linfoma não Hodgkin/epidemiologia , Masculino
4.
Ann Hematol ; 100(3): 743-752, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33427909

RESUMO

To overcome the delayed or failed engraftment after unrelated cord blood transplantation (CBT), we conducted a multicenter phase II study of intrabone single-unit CBT without antithymocyte globulin (ATG) for adult patients with hematological malignancies (UMIN-CTR, UMIN000020997). Sixty-four patients received an intrabone injection of unwashed (n = 61) or washed (n = 3) cord blood after local anesthesia. All injection-related adverse events were mild and resolved spontaneously. Sixty-two patients were evaluable for the efficacy of intrabone CBT of serological HLA-A, -B, and -DR ≥ 4/6 matched cord blood with a median number of 2.57 × 107/kg cryopreserved total nucleated cells. The probability of survival with neutrophil engraftment on day 28 was 77.4% (95% confidence interval, 67.0-85.8%), which exceeded the threshold value. The cumulative incidences of neutrophils ≥ 0.5 × 109/L on day 60 was 80.6% (68.2-88.6%), with a median time to recovery of 21 days after transplantation. The cumulative incidences of platelets ≥ 20 × 109/L and platelets ≥ 50 × 109/L on day 100 were 75.8% (62.6-84.9%) and 72.6% (59.4-82.1%), respectively, with median time to platelets ≥ 20 × 109/L and platelets ≥ 50 × 109/L of 38 and 45 days after transplantation, respectively. The cumulative incidences of grade II-IV and III-IV acute graft-versus-host disease were 29.0% and 6.5%, respectively. All responded to steroid therapy, and secondary treatments were not required. The present study suggests the efficacy of intrabone single-unit CBT without ATG in terms of early engraftment and controllable acute graft-versus-host disease.


Assuntos
Transplante de Células-Tronco de Sangue do Cordão Umbilical/métodos , Neoplasias Hematológicas/terapia , Infusões Intraósseas/métodos , Adolescente , Adulto , Idoso , Soro Antilinfocitário , Osso e Ossos , Transplante de Células-Tronco de Sangue do Cordão Umbilical/efeitos adversos , Feminino , Sangue Fetal/fisiologia , Doença Enxerto-Hospedeiro/epidemiologia , Doença Enxerto-Hospedeiro/etiologia , Doença Enxerto-Hospedeiro/patologia , Neoplasias Hematológicas/epidemiologia , Humanos , Incidência , Infusões Intraósseas/efeitos adversos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Adulto Jovem
5.
BMC Infect Dis ; 21(1): 117, 2021 Jan 26.
Artigo em Inglês | MEDLINE | ID: mdl-33499826

RESUMO

BACKGROUND: Herpes zoster (HZ) infection of hematopoietic stem cell transplant (HSCT) patients is of clinical concern. Vaccination could help restore immunity to varicella zoster virus (VZV); however, temporal changes in immunogenicity and safety of live HZ vaccines after HSCT is still unclear. The aim of this study was to elucidate the temporal immunogenicity and safety of the HZ vaccine according to time since HSCT and to determine optimal timing of vaccination. METHODS: Live HZ vaccine was administered to patients 2-5 years or > 5 years post-HSCT. Control groups comprised patients with a hematologic malignancy who received cytotoxic chemotherapy and healthy volunteers. Humoral and cellular immunogenicity were measured using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) and an interferon-γ (IFN-γ) enzyme-linked immunospot (ELISPOT) assay. Vaccine-related adverse events were also monitored. RESULTS: Fifty-six patients with hematologic malignancy (41 in the HSCT group and 15 in the chemotherapy group) along with 30 healthy volunteers were enrolled. The geometric mean fold rises (GMFRs) in humoral immune responses of the 2-5 year and > 5 year HSCT groups, and the healthy volunteer group, were comparable and significantly higher than that of the chemotherapy group (3.15, 95% CI [1.96-5.07] vs 5.05, 95% CI [2.50-10.20] vs 2.97, 95% CI [2.30-3.83] vs 1.42, 95% CI [1.08-1.86]). The GMFR of cellular immune responses was highest in the HSCT 2-5 year group and lowest in the chemotherapy group. No subject suffered clinically significant adverse events or reactivation of VZV within the follow-up period. CONCLUSION: Our findings demonstrate that a live HZ vaccine is immunogenic and safe when administered 2 years post-HSCT.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Vacina contra Herpes Zoster , Herpes Zoster/prevenção & controle , Herpesvirus Humano 3/imunologia , Transplantados , Vacinas Vivas não Atenuadas , Idoso , Anticorpos Antivirais/imunologia , Estudos de Casos e Controles , Feminino , Seguimentos , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/imunologia , Neoplasias Hematológicas/terapia , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/estatística & dados numéricos , Vacina contra Herpes Zoster/efeitos adversos , Vacina contra Herpes Zoster/imunologia , Humanos , Imunogenicidade da Vacina/fisiologia , Masculino , Pessoa de Meia-Idade , Transplantados/estatística & dados numéricos , Resultado do Tratamento , Vacinação/efeitos adversos , Vacinação/métodos , Vacinação/estatística & dados numéricos , Vacinas Vivas não Atenuadas/efeitos adversos , Vacinas Vivas não Atenuadas/imunologia
6.
Ann Hematol ; 100(3): 763-777, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33491135

RESUMO

Allogeneic hematopoietic cell transplant (allo-HCT) is a potentially curative therapeutic strategy that showed encouraging long-term outcomes in hematological diseases. A number of factors can influence post-transplant clinical outcomes. While Epstein-Barr virus (EBV) constitutes a trigger for development of various adverse conditions, no clinical study yet has been powered to assess the effect of EBV serostatus on the clinical outcomes in allo-HCT population. To systematically summarize and analyze the impact of donor and recipient EBV serostatus on transplant outcomes in allo-HCT recipients, meta-analyses were conducted. Selected endpoints were overall survival (OS), relapse-free survival (RFS), relapse incidence (RI), non-relapse mortality (NRM), acute graft-versus-host disease (aGVHD), chronic graft-versus-host disease (cGVHD), and de novo cGVHD. Three studies with 26,650 patients, transplanted for acute leukemias, lymphomas, chronic hematological malignancies, or non-malignant hematological diseases were included in the meta-analysis. In the whole population, with a total of 53,300 donors and recipients, the rate of EBV seropositivity was 85.1%, including 86.6% and 83.6% among transplant recipients and healthy donors, respectively. Donor EBV seropositivity increased the risk of cGVHD by 17%, de novo cGVHD by 14%, and aGHVD by 5%. Recipient EBV seropositivity increased the risk of cGVHD by 12%, de novo cGVHD by 17%; increased NRM by 11%, increased RI by 11%, decreased OS by 14%, and decreased RFS by 11%. In performed meta-analyses, donor and recipient EBV seropositivity was found to have a significant impact on transplant outcomes in patients after allo-HCT.


Assuntos
Infecções por Vírus Epstein-Barr/epidemiologia , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/terapia , Transplante de Células-Tronco Hematopoéticas , Doadores de Tecidos/estatística & dados numéricos , Transplantados/estatística & dados numéricos , Adolescente , Adulto , Idoso , Infecções por Vírus Epstein-Barr/complicações , Infecções por Vírus Epstein-Barr/diagnóstico , Feminino , Doença Enxerto-Hospedeiro/diagnóstico , Doença Enxerto-Hospedeiro/etiologia , Doença Enxerto-Hospedeiro/mortalidade , Neoplasias Hematológicas/complicações , Neoplasias Hematológicas/diagnóstico , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/mortalidade , Transplante de Células-Tronco Hematopoéticas/estatística & dados numéricos , Herpesvirus Humano 4/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Recidiva , Estudos Soroepidemiológicos , Análise de Sobrevida , Transplante Homólogo/efeitos adversos , Transplante Homólogo/mortalidade , Resultado do Tratamento , Adulto Jovem
7.
Ann Hematol ; 100(3): 779-787, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33515310

RESUMO

The immunomodulatory fusion protein abatacept has recently been investigated for the treatment of steroid-refractory chronic graft-versus-host disease (cGvHD) in a phase 1 clinical trial. We analyzed the safety and efficacy of abatacept for cGvHD therapy in a retrospective study with 15 patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) and received abatacept for cGvHD with a median age of 49 years. Grading was performed as part of the clinical routine according to the National Institute of Health's (NIH) consensus criteria at initiation of abatacept and 1, 3, 6, 9 and 12 months thereafter. The median time of follow-up was 191 days (range 55-393 days). Best overall response rate (ORR) was 40%. In particular, patients with bronchiolitis obliterans syndrome showed significant clinical improvement and durable responses following abatacept treatment with a response rate of 89% based on improvement in lung severity score (n = 6) or stabilized lung function (n = 4) or both (n = 3). Infectious complications CTCAE °III or higher were observed in 3/15 patients. None of the patients relapsed from the underlying malignancy. Thus, abatacept appears to be a promising treatment option for cGvHD, in particular for patients with lung involvement. However, further evaluation within a phase 2 clinical trial is required.


Assuntos
Abatacepte/uso terapêutico , Doença Enxerto-Hospedeiro/tratamento farmacológico , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Terapia de Salvação/métodos , Abatacepte/efeitos adversos , Adolescente , Adulto , Idoso , Bronquiolite Obliterante/tratamento farmacológico , Bronquiolite Obliterante/etiologia , Criança , Pré-Escolar , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Seguimentos , Alemanha/epidemiologia , Doença Enxerto-Hospedeiro/mortalidade , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Espanha/epidemiologia , Suécia/epidemiologia , Transplante Homólogo/efeitos adversos , Adulto Jovem
8.
Cancer Discov ; 11(2): 233-236, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33355178

RESUMO

Published series on COVID-19 support the notion that patients with cancer are a particularly vulnerable population. There is a confluence of risk factors between cancer and COVID-19, and cancer care and treatments increase exposure to the virus and may dampen natural immune responses. The available evidence supports the conclusion that patients with cancer, in particular with hematologic malignancies, should be considered among the very high-risk groups for priority COVID-19 vaccination.


Assuntos
/prevenção & controle , Alocação de Recursos para a Atenção à Saúde/organização & administração , Neoplasias Hematológicas/complicações , Neoplasias Hematológicas/epidemiologia , Humanos , Imunidade , Programas de Imunização/organização & administração , Razão de Chances , Modelos de Riscos Proporcionais , Saúde Pública/métodos , Risco , Fatores de Risco , Resultado do Tratamento , Vacinação
9.
Blood Cells Mol Dis ; 87: 102525, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33338697

RESUMO

BACKGROUND: There is scarcity of data on outcome of COVID-19 in patients with hematological malignancies. Primary objective of study was to analyse the 14-day and 28-day mortality. Secondary objectives were to correlate age, comorbidities and remission status with outcome. METHODS: Retrospective multicentre observational study conducted in 11 centres across India. Total 130 patients with hematological malignancies and COVID-19 were enrolled. RESULTS: Fever and cough were commonest presentation. Eleven percent patients were incidentally detected. Median age of our cohort was 49.5 years. Most of our patients had a lymphoid malignancy (n = 91). One-half patients (52%) had mild infection, while moderate and severe infections contributed to one-fourth each. Sixty seven patients (52%) needed oxygen For treatment of COVID-19 infection, half(n = 66) received antivirals. Median time to RT-PCR COVID-19 negativity was 17 days (7-49 days). Nearly three-fourth (n = 95) of our patients were on anticancer treatment at time of infection, of which nearly two-third (n = 59;64%) had a delay in chemotherapy. Overall, 20% (n = 26) patients succumbed. 14-day survival and 28-day survival for whole cohort was 85.4% and 80%, respectively. One patient succumbed outside the study period on day 39. Importantly, death rate at 1 month was 50% and 60% in relapse/refractory and severe disease cohorts, respectively. Elderly patients(age ≥ 60) (p = 0.009), and severe COVID-19 infection (p = 0.000) had a poor 14-day survival. The 28-day survival was significantly better for patients in remission (p = 0.04), non-severe infection (p = 0.00), and age < 60 years (p = 0.05). CONCLUSIONS: Elderly patients with hematological malignancy and severe covid-19 have worst outcomes specially when disease is not in remission.


Assuntos
/epidemiologia , Neoplasias Hematológicas/epidemiologia , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Comorbidade , Feminino , Neoplasias Hematológicas/terapia , Humanos , Índia/epidemiologia , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Estudos Retrospectivos , Análise de Sobrevida , Resultado do Tratamento , Adulto Jovem
13.
Cancer ; 126(23): 5069-5076, 2020 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-32910456

RESUMO

BACKGROUND: Patients with cancer are considered highly vulnerable to the recent coronavirus disease 2019 (COVID-19) pandemic. However, there are still few data on COVID-19 occurring in hematologic patients. METHODS: One hundred two patients with COVID-19 symptoms and a nasopharyngeal swab positive for severe acute respiratory syndrome coronavirus 2 seen at 2 hematologic departments located in Lombardy, Italy, during March 2020 were studied. Risk factors for acquiring COVID-19 were analyzed by comparisons of patients with COVID-19 and the standard hematologic population managed at the same institutions in 2019. Thirty-day survival was compared with the survival of matched uninfected control patients with similar hematologic disorders and nonhematologic patients affected by COVID-19. RESULTS: Male sex was significantly more prevalent in patients with COVID-19. The infection occurred across all different types of hematologic disease; however, the risk of acquiring a COVID-19 infection was lower for patients with chronic myeloproliferative neoplasms, including chronic myeloid leukemia, and higher for patients with immune-mediated anemia on immunosuppressive-related treatments. The 30-day mortality rate was 39.2%, which was higher than the rates for nonhematologic patients with COVID-19 (23.5%; P = .02) and uninfected hematologic controls (3%; P < .001). The severity of the respiratory syndrome at presentation and active hematologic treatment were independently associated with a worse prognosis. Neither diagnosis nor disease status affected the prognosis. The worst prognosis was demonstrated among patients on active hematologic treatment and those with more severe respiratory syndrome at COVID-19 presentation. CONCLUSIONS: During the COVID-19 pandemic, patients should be advised to seek medical attention at the earliest signs of dyspnea and/or respiratory infection. Physicians should perform a risk-benefit analysis to determine the impact of temporarily deferring nonlifesaving treatments versus the risk of adverse outcomes associated with COVID-19. LAY SUMMARY: Coronavirus disease 2019 (COVID-19) infection occurs across all different types of hematologic disease; however, the risk of acquiring it is lower for patients with chronic myeloproliferative neoplasms, including chronic myeloid leukemia, and higher for patients with immune-mediated anemia on immunosuppressive treatment. The 30-day mortality rate is 39.2%, which is far higher than the rates for both uninfected hematologic controls (3%; P < .001) and nonhematologic patients with COVID-19 (23.5%; P = .02) despite matching for age, sex, comorbidities, and severity of disease. Variables independently associated with a worse prognosis are the severity of the respiratory syndrome at presentation and any type of active hematologic treatment. Neither diagnosis nor disease status influence the prognosis.


Assuntos
Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/complicações , Neoplasias Hematológicas/mortalidade , Neoplasias Hematológicas/patologia , Pneumonia Viral/complicações , Idoso , Infecções por Coronavirus/transmissão , Infecções por Coronavirus/virologia , Feminino , Seguimentos , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/virologia , Humanos , Itália/epidemiologia , Masculino , Pandemias , Pneumonia Viral/transmissão , Pneumonia Viral/virologia , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida
14.
Cancer Med ; 9(22): 8412-8422, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32931637

RESUMO

BACKGROUND: Patients with cancer are considered a high-risk group for viral pneumonia, with an increased probability of fatal outcome. Here, we investigated the clinical characteristics and outcome of patients with solid and hematological cancers and concomitant Covid-19 at a Comprehensive Cancer Center in a Covid-19 hotspot area in Germany. METHODS: We performed a retrospective single center cohort study of 39 patients with hematological and solid cancers who were hospitalized at the University Hospital Freiburg for Covid-19. Using univariate and multivariate Cox regression models we compared time to severe events and overall survival to an age-matched control cohort of 39 patients with confirmed Covid-19 without a cancer diagnosis. RESULTS: In the cancer cohort 29 patients had a diagnosis of a solid tumor, and 10 had a hematological malignancy. In total, eight patients (21%) in the cancer and 14 patients (36%) from the noncancer cohort died during the observation period. Presence of a malignancy was not significantly associated with survival or time to occurrence of severe events. Major influences on mortality were high IL-6 levels at Covid-19 diagnosis (HR = 6.95, P = .0121) and age ≥ 65 years (HR = 6.22, P = .0156). CONCLUSIONS: Compared to an age-matched noncancer cohort, we did not observe an association between a cancer diagnosis and a more severe disease course or higher fatality rate in patients with Covid-19. Patients with a hematological malignancy showed a trend towards a longer duration until clinical improvement and longer hospitalization time compared to patients with a solid cancer. Cancer per se does not seem to be a confounder for dismal outcome in Covid-19.


Assuntos
Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/complicações , Neoplasias Hematológicas/epidemiologia , Hospitalização/estatística & dados numéricos , Neoplasias/epidemiologia , Serviço Hospitalar de Oncologia/tendências , Pneumonia Viral/complicações , Idoso , Idoso de 80 Anos ou mais , Infecções por Coronavirus/transmissão , Infecções por Coronavirus/virologia , Feminino , Alemanha/epidemiologia , Neoplasias Hematológicas/virologia , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/virologia , Pandemias , Pneumonia Viral/transmissão , Pneumonia Viral/virologia , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida
15.
Medicine (Baltimore) ; 99(35): e21376, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871864

RESUMO

BACKGROUND: COVID-19 is an international outbreak of the respiratory illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The diseases themselves, as well as the intensity of chemotherapy, lead to significant immunosuppression, leading hematological malignancy patients susceptible to infections. METHODS: This protocol will be performed according to the Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines and reported follow the Cochrane Collaboration Handbook and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Electronic databases of PubMed, MEDLINE, Google Scholar, Web of science, Cochrane Library, EMBASE, CNKI, CMB, and Wangfang database from the inception to present will be comprehensively and systematically searched without limitations of language, date, and publication status. Observational, retrospective cohort, prospective case-control, cohort studies, cross-sectional studies, or clinical trials will be included. All assessment of study selection, data extraction, and study quality assessment will be independently performed by 2 reviewers. RevMan V.5.3 program and Stata V.12.0 software will be utilized for the methodological quality assessment and statistical analysis. RESULTS: The result of this systematic review will provide evidence for clinicians on the management of COVID-19 patients with hematological malignancy. CONCLUSION: This systematic review will help raise awareness and guide management of COVID-19 patients with hematological malignancy, as well as to improve outcomes in this population. ETHIC AND DISSEMINATION: The content of this article does not involve moral approval or ethical review because no individual data will be collected. PROSPERO REGISTRATION: CRD42020187493.


Assuntos
Antineoplásicos/farmacologia , Infecções por Coronavirus , Neoplasias Hematológicas , Pandemias , Administração dos Cuidados ao Paciente/métodos , Pneumonia Viral , Betacoronavirus , Comorbidade , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/imunologia , Neoplasias Hematológicas/terapia , Humanos , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Projetos de Pesquisa , Revisões Sistemáticas como Assunto
17.
Lancet Haematol ; 7(10): e737-e745, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32798473

RESUMO

BACKGROUND: Several small studies on patients with COVID-19 and haematological malignancies are available showing a high mortality in this population. The Italian Hematology Alliance on COVID-19 aimed to collect data from adult patients with haematological malignancies who required hospitalisation for COVID-19. METHODS: This multicentre, retrospective, cohort study included adult patients (aged ≥18 years) with diagnosis of a WHO-defined haematological malignancy admitted to 66 Italian hospitals between Feb 25 and May 18, 2020, with laboratory-confirmed and symptomatic COVID-19. Data cutoff for this analysis was June 22, 2020. The primary outcome was mortality and evaluation of potential predictive parameters of mortality. We calculated standardised mortality ratios between observed death in the study cohort and expected death by applying stratum-specific mortality rates of the Italian population with COVID-19 and an Italian cohort of 31 993 patients with haematological malignancies without COVID-19 (data up to March 1, 2019). Multivariable Cox proportional hazards model was used to identify factors associated with overall survival. This study is registered with ClinicalTrials.gov, NCT04352556, and the prospective part of the study is ongoing. FINDINGS: We enrolled 536 patients with a median follow-up of 20 days (IQR 10-34) at data cutoff, 85 (16%) of whom were managed as outpatients. 440 (98%) of 451 hospitalised patients completed their hospital course (were either discharged alive or died). 198 (37%) of 536 patients died. When compared with the general Italian population with COVID-19, the standardised mortality ratio was 2·04 (95% CI 1·77-2·34) in our whole study cohort and 3·72 (2·86-4·64) in individuals younger than 70 years. When compared with the non-COVID-19 cohort with haematological malignancies, the standardised mortality ratio was 41·3 (38·1-44·9). Older age (hazard ratio 1·03, 95% CI 1·01-1·05); progressive disease status (2·10, 1·41-3·12); diagnosis of acute myeloid leukaemia (3·49, 1·56-7·81), indolent non-Hodgin lymphoma (2·19, 1·07-4·48), aggressive non-Hodgkin lymphoma (2·56, 1·34-4·89), or plasma cell neoplasms (2·48, 1·31-4·69), and severe or critical COVID-19 (4·08, 2·73-6·09) were associated with worse overall survival. INTERPRETATION: This study adds to the evidence that patients with haematological malignancies have worse outcomes than both the general population with COVID-19 and patients with haematological malignancies without COVID-19. The high mortality among patients with haematological malignancies hospitalised with COVID-19 highlights the need for aggressive infection prevention strategies, at least until effective vaccination or treatment strategies are available. FUNDING: Associazione italiana contro le leucemie, linfomi e mieloma-Varese Onlus.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Neoplasias Hematológicas/epidemiologia , Pandemias , Pneumonia Viral/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Infecções por Coronavirus/tratamento farmacológico , Feminino , Seguimentos , Neoplasias Hematológicas/terapia , Humanos , Pacientes Internados , Itália/epidemiologia , Leucemia/epidemiologia , Leucemia/terapia , Linfoma não Hodgkin/epidemiologia , Linfoma não Hodgkin/terapia , Masculino , Pessoa de Meia-Idade , Transtornos Mieloproliferativos/epidemiologia , Transtornos Mieloproliferativos/terapia , Neoplasias de Plasmócitos/epidemiologia , Neoplasias de Plasmócitos/terapia , Estudos Retrospectivos , Fatores de Risco , Adulto Jovem
18.
Orv Hetil ; 161(34): 1400-1413, 2020 08.
Artigo em Húngaro | MEDLINE | ID: mdl-32804670

RESUMO

INTRODUCTION: During a 36-year period (between January 1, 1983 and December 31, 2018), 5159 adult patients with newly diagnosed haematological malignancy were registered in the leukaemia/lymphoma registry of Szabolcs-Szatmár-Bereg county. AIM: The review of the incidence of different haematological malignancy in the authors' county, and the changes of incidence from time to time, the associated haematological malignancies, and familial occurrence of malignant haematological diseases. METHOD: Detailed analysis of the data of the registry, with statistical analysis of incidence. RESULTS: The incidence of Hodgkin disease and non-Hodgkin's lymphoma (1.49 and 7.12 new cases, respectively/100 000 inhabitants/year) was a little smaller, that of essential thrombocythaemia was larger than in the published data. The incidence of all other haematological malignancies corresponded to the data of the literature. The change of incidence of all malignant haematological diseases was similar to the published data. In the registry, there were 35 patients with two different malignant haematological diseases appearing simultaneously or successively. During the 36-year period, 88 families with haematological malignancies were recorded in the registry. CONCLUSION: With the exception of Hodgkin disease, non-Hodgkin's lymphoma, and essential thrombocythaemia, the incidence of other haematological malignancies corresponded to the data of the literature. The change of incidence in all entities was similar to that observed by other authors. The authors in their country do not know other published data related to associated malignant haematological diseases. The observed anteposition in familial haematological diseases of uncle/aunt and nephew/cousin, and anteposition in malignant haematological diseases of siblings are equally new in the literature. Orv Hetil. 2020; 161(34): 1400-1413.


Assuntos
Neoplasias Hematológicas/epidemiologia , Adulto , Humanos , Hungria/epidemiologia , Incidência
19.
Lancet HIV ; 7(9): e641-e651, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32791045

RESUMO

People living with HIV or AIDS are at increased risk of Hodgkin and non-Hodgkin lymphoma compared with HIV-negative individuals. Data on the risk of multiple myeloma or leukaemia are inconsistent and of low quality but the risk does not seem to be increased. Specific haematological malignancies occur in different contexts of age, CD4 cell count, HIV control, viral co-infections, or chronic inflammation, and the expansion of combination antiretroviral therapy has led to varied demographic and epidemiological shifts among people with HIV. Increased use of combination antiretroviral therapy has substantially reduced the risks of diffuse large B-cell lymphoma, Burkitt lymphoma, and primary CNS lymphoma, and to a lesser extent, Hodgkin lymphoma. There is no effect of combination antiretroviral therapy use on multiple myeloma or leukaemia. Although many cases of HIV are in low-income and middle-income countries, high-quality epidemiological data for haematological malignancies from these regions are scarce. Closing this gap is an essential first step in decreasing mortality from HIV-associated haematological malignancies worldwide. Finally, although multicentric Castleman disease is not a neoplastic condition, it is an emerging precursor to neoplastic high-grade B-cell lymphoproliferation among people with HIV, especially for individuals on long-term combination antiretroviral therapy with well controlled HIV.


Assuntos
Infecções por HIV/complicações , Infecções por HIV/epidemiologia , Neoplasias Hematológicas/complicações , Neoplasias Hematológicas/epidemiologia , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Soropositividade para HIV , Neoplasias Hematológicas/diagnóstico , Neoplasias Hematológicas/terapia , Humanos , Incidência , Vigilância em Saúde Pública
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