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1.
Blood ; 138(SUPPL 1):3525, 2021.
Article in English | EMBASE | ID: covidwho-1770434

ABSTRACT

Background - The WINDOW-1 regimen introduced first-line ibrutinib with rituximab (IR) followed by 4 cycles of R-HCVAD for younger mantle cell lymphoma (MCL) patients (pts) demonstrating 90% CR on IR alone and we aimed to improve the CR rate with the addition of venetoclax. We therefore investigated the efficacy and safety of IR and venetoclax (IRV) followed by risk-stratified observation or short course R-HCVAD/MTX-ARA-C as consolidation in previously untreated young patients with mantle cell lymphoma (MCL). Our aim was to use a triplet chemotherapy-free induction to reduce the toxicity, complications and minimize chemotherapy exposure in MCL pts. Methods - We enrolled 50 previously untreated pts in this single institution, single arm, phase II clinical trial - NCT03710772. Pts received IR induction (Part-1) for initial 4 cycles. Pts were restaged at cycle 4 and received IRV for up to eight cycles (Cycle 5 to Cycle 12) starting with ramp up venetoclax dosing in Cycle 5. All pts who achieved CR prior to cycle 12 continued to receive IRV for 4 cycles (maximum 12 cycles) and then moved to part 2. Pts were stratified into three disease risk groups: high, moderate and low risk categories from the baseline data for assignment to R-HCVAD/MTX-ARA-C as consolidation in part 2 (4 cycles, 2 cycles, or no chemotherapy for high, medium and low risk pts respectively). Briefly, low risk pts were those with Ki-67 ≤30%, largest tumor mass <3 cm, low MIPI score and no features of high risk disease (Ki-67 ≥50%, mutations in the TP53, NSD2 or in NOTCH genes, complex karyotype or del17p, MYC positive, or largest tumor diameter >5 cm or blastoid/pleomorphic histology or if they remain in PR after 12 cycles of part 1. Medium risk are pts which did not belong to low or high-risk category. Those who experienced progression on part 1 went to part 2 and get 4 cycles of part 2. Patient were taken off protocol but not off study, if they remained in PR after 4 cycles of chemotherapy, these patients were followed up for time to next treatment and progression free survival on subsequent therapies. After part 2 consolidation, all pts received 2 years of IRV maintenance. The primary objective was to assess CR rates after IRV induction. Adverse events were coded as per CTCAE version 4. Molecular studies are being performed. Results - Among the 50 pts, the median age was 57 years (range - 35-65). There were 20 pts in high-risk group, 20 pts in intermediate-risk group and 10 pts in low-risk group. High Ki-67 (≥30%) in 18/50 (36%) pts. Eighteen (36%) had high and intermediate risk simplified MIPI scores. Six (12%) pts had aggressive MCL (blastoid/pleomorphic). Among the 24 TP53 evaluable pts, eight pts (33%) had TP53 aberrations (mutated and/or TP53 deletion by FISH). Forty-eight pts received IRV. Best response to IRV was 96% and CR of 92%. After part 2, the best ORR remained unaltered, 96% (92% CR and 4% PR). The median number of cycles of triplet IRV to reach best response was 8 cycles (range 2-12). Fifteen pts (30%) did not receive part 2 chemotherapy, two pts (4%) received 1 cycle, 16 pts (32%) 2 cycles and 13 pts (26%) got 4 cycles of chemotherapy. With a median follow up of 24 months, the median PFS and OS were not reached (2 year 92% and 90% respectively). The median PFS and OS was not reached and not significantly different in pts with high and low Ki-67% or with/without TP53 aberrations or among pts with low, medium or high-risk categories. The median PFS and OS was inferior in blastoid/pleomorphic MCL pts compared to classic MCL pts (p=0.01 and 0.03 respectively). Thirteen pts (26%) came off study - 5 for adverse events, 3 for on study deaths, and 2 for patient choice, 2 patients lost to follow up and one for disease progression. Overall, 5 pts died (3 on trial and 2 pts died off study, one due to progressive disease and another due to COVID pneumonia). Grade 3-4 toxicities on part 1 were 10% myelosuppression and 10% each with fatigue, myalgia and rashes and 3% mucositis. One pt developed grade 3 atrial flutter on part 1. None had grade 3-4 bleeding/bruising. Conclusions - Chemotherapy-free induction with IRV induced durable and deep responses in young MCL pts in the frontline setting. WINDOW-2 approach suggests that pts with low risk MCL do not need chemotherapy but further follow up is warranted. This combined modality treatment approach significantly improves outcomes of young MCL pts across all risk groups. Detailed molecular analyses will be reported. (Figure Presented).

2.
Transplantation ; 105(7): 1433-1444, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1707615

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) fatality rate is high among kidney transplant recipients. Among survivors, kidney outcomes, seroconversion, and persistence of viral shedding are unexplored. METHODS: Single-center prospective cohort study including data from kidney transplant recipients with confirmed COVID-19 between March 20, 2020 and July 31, 2020. Outcomes were adjudicated until August 31, 2020 or the date of death. RESULTS: There were 491 patients with COVID-19 among the 11 875 recipients in follow-up. The majority were middle aged with ≥1 comorbidities. Thirty-one percent were treated at home, and 69% required hospitalization. Among the hospitalized, 61% needed intensive care, 75% presented allograft dysfunction, and 46% needed dialysis. The overall 28-day fatality rate was 22% and among hospitalized patients it was 41%. Age (odds ratio, 3.08; 95% confidence interval, 1.86-5.09), diabetes mellitus (odds ratio, 1.69; 95% confidence interval, 1.06-2.72), and cardiac disease (odds ratio, 2.00; 95% confidence interval, 1.09-3.68) were independent factors for death. Among the 351 survivors, 19% sustained renal graft dysfunction, and there were 13 (4%) graft losses. Biopsy (n = 20) findings were diverse but decisive to guide treatment and estimate prognosis. Seroconversion was observed in 79% of the survivors and was associated with disease severity. Persistence of viral shedding was observed in 21% of the patients without detectable clinical implications. CONCLUSIONS: This prospective cohort analysis confirms the high 28-day fatality rate of COVID-19, associated primarily with age and comorbidities. The high incidence of allograft dysfunction was associated with a wide range of specific histologic lesions and high rates of sequelae and graft loss. Seroconversion was high and the persistence of viral shedding deserves further studies.


Subject(s)
COVID-19/etiology , Kidney Transplantation , Postoperative Complications , Adult , Aged , COVID-19/diagnosis , COVID-19/mortality , COVID-19/therapy , Disease Progression , Female , Follow-Up Studies , Humans , Male , Middle Aged , Postoperative Complications/diagnosis , Postoperative Complications/mortality , Postoperative Complications/therapy , Prognosis , Prospective Studies
3.
Allergy: European Journal of Allergy and Clinical Immunology ; 76(SUPPL 110):489-490, 2021.
Article in English | EMBASE | ID: covidwho-1570372

ABSTRACT

Background: In order to prevent infection with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) an active approach is necessary. On December 2020 the commercialization of the COVID-19 vaccines was made. In Spain the first one to arrive was Pfizer-BioNtech vaccine. Initially, several reports of anaphylactic reactions due to the vaccine in the USA and in the UK were reported, which lead to an early recommendation to avoid the administration in patients with allergic history. The objective of this study is to describe and characterize the allergenic profiles of patients attended in our clinic for allergy testing to prevent reactions with the COVID-19 vaccine. Method: The allergological profile of 85 patients diagnosed with previous history of allergic disorders was analysed between January 18th and March 16th 2021. The allergological study included skin-prick test with polyethylene glycol (PEG), Tween 20, Tween 80, and COVID-19 vaccine (Pfizerâ), together with latex and other allergens when necessary. After the double dose of vaccine was completed, a follow up was done by telephone. Results: Risk stratification and approach is exposed in figure 1. Clinical and allergological characteristics of 85 patients are shown in table 1. Out of them, 88.2% had an allergic comorbidity and 48.2% had drug allergy. The reason for consultation was in 92.9% due to their allergic history, 76.5% were referred from the Occupational Health Service, and 80.6% of the patients have had previous vaccination with other anti-infective vaccines without reactions. Also, table 1 shows the prick-test results with COVID vaccine an its excipients, without any positive result. 70.7% of our population has completed the vaccination. Only 9 patients had a possible allergic reaction to the first dose, 8 of them had cutaneous and the remaining had respiratory symptoms. Out of these 9 patients, 6 had their second dose without any symptoms. Conclusion: None of the patients studied showed a positive test for neither the components of the vaccine nor the vaccine itself. More studies are required with a larger sample size to reach final conclusions. (Table Presented).

4.
Acupuncture and Electro-Therapeutics Research ; 46(1):4-5, 2021.
Article in English | EMBASE | ID: covidwho-1264566

ABSTRACT

On March 11, 2020, the World Health Organization had a pandemic caused by COVID-19, which promoted an instruction in the interpretation of the disease, as well as in its conduct in assessment, prevention, and therapy. Currently the origin of the pandemic is doubtful the evolution of the virus, spread and approach. In 1997 the H5N1 virus, Influenza A, was very virulent, and some studies believe that its etiology is questionable. The Bi-Digital O-Ring Test (BDORT) is a technique that is based on the alteration of muscle tone resulting from the identical resonance, being thus useful in the evaluation in the measurement of tumor markers, interleukins, bacteria, viruses, fungi, as well as accurate in the evaluation organic function. In this present work, we will use the BDORT technique to assess a viral resonance of the SARS-CoV-2, H5N1 and H1N1 viruses against 16 other viruses, containing 1 ng, through the BDORT slide. In this present work, we applied BDORT to investigate the presence or absence of monoclonal antibody resonance from 16 viruses that we have compared as images of the SARS-CoV-2, H5N1 and H1N1 viruses.

5.
Transplantation ; 105(7): 1433-1444, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1228580

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) fatality rate is high among kidney transplant recipients. Among survivors, kidney outcomes, seroconversion, and persistence of viral shedding are unexplored. METHODS: Single-center prospective cohort study including data from kidney transplant recipients with confirmed COVID-19 between March 20, 2020 and July 31, 2020. Outcomes were adjudicated until August 31, 2020 or the date of death. RESULTS: There were 491 patients with COVID-19 among the 11 875 recipients in follow-up. The majority were middle aged with ≥1 comorbidities. Thirty-one percent were treated at home, and 69% required hospitalization. Among the hospitalized, 61% needed intensive care, 75% presented allograft dysfunction, and 46% needed dialysis. The overall 28-day fatality rate was 22% and among hospitalized patients it was 41%. Age (odds ratio, 3.08; 95% confidence interval, 1.86-5.09), diabetes mellitus (odds ratio, 1.69; 95% confidence interval, 1.06-2.72), and cardiac disease (odds ratio, 2.00; 95% confidence interval, 1.09-3.68) were independent factors for death. Among the 351 survivors, 19% sustained renal graft dysfunction, and there were 13 (4%) graft losses. Biopsy (n = 20) findings were diverse but decisive to guide treatment and estimate prognosis. Seroconversion was observed in 79% of the survivors and was associated with disease severity. Persistence of viral shedding was observed in 21% of the patients without detectable clinical implications. CONCLUSIONS: This prospective cohort analysis confirms the high 28-day fatality rate of COVID-19, associated primarily with age and comorbidities. The high incidence of allograft dysfunction was associated with a wide range of specific histologic lesions and high rates of sequelae and graft loss. Seroconversion was high and the persistence of viral shedding deserves further studies.


Subject(s)
COVID-19/etiology , Kidney Transplantation , Postoperative Complications , Adult , Aged , COVID-19/diagnosis , COVID-19/mortality , COVID-19/therapy , Disease Progression , Female , Follow-Up Studies , Humans , Male , Middle Aged , Postoperative Complications/diagnosis , Postoperative Complications/mortality , Postoperative Complications/therapy , Prognosis , Prospective Studies
6.
Hepatology ; 72(1 SUPPL):281A-282A, 2020.
Article in English | EMBASE | ID: covidwho-986156

ABSTRACT

Background: Some comorbidities have been associated with a negative impact in the severity of COVID-19 course Patients with advanced chronic liver disease (CLD) may be at increased risk of severe course due to the cirrhosisassociated immune dysfunction However the actual data is scare The aim of our study was to determine the prevalence of CLD in COVID-19 patients and to analyse the course of the infection comparing with patients with non-liver disease Methods: This was a retrospective single centre study in which we included all positive SARS-Cov2 polymerase chainreactions (PCR) from March 23 2020 to April 30 2020 Clinical and biochemical data of patients with and without CLD and COVID-19 were collected using medical records Results: 447 patients with SARS-Cov2 PCR were included, 6 3% had CLD 69 7% of patients with CLD were male, with a median age of 65 5 years, with active alcohol and smoke use 75% had non-advanced liver fibrosis, most of them NAFLD. Patients with advanced liver fibrosis were younger, with a mean age of 58 (SD 9 69) years, underlying COPD (57 2%) Meanwhile patients with CLD without advanced liver fibrosis were older, with a mean age of 68 (SD 12 08) years, and had multiples comorbidities like hypertension in 71 4% and diabetes in 47 6% Hospital admission rate (92 9% vs 47 7% p<0 001) was higer in patients with CLD than those without CLD Concomitant comorbidities (diabetes 38 5 vs 16 5% p=0 011;obesity 30 8 vs 8 5% p=0 033;cancer 23 1 vs 5% p=0 027 and COPD 19 2 vs 9% p=0 009), and concomitant antibiotics treatment (19 3 vs 5%;p= 0 018) were higher in patients with CLD than those without CLD The rate of intesive care admission, respiratory support (invasive mechanical ventilation 7 7 vs 9 5% p=0 055;and continuous positive airway pressure CPAP or non-invasive positive pressure 19 2 vs 19 0% p=0 577) and median stay length (8 (5-15) vs 7 (5-13) p=0 696) were similar in both groups Mortality rate was similar in patients with and without CLD (30 8 vs 19 6% p=0 289) However, in the univariate analysis male (OR= 11 20;95% IC= 1 25-100 31;p=0 031);presence of obesity (OR= 7 20;95% CI= 1 13-45 96;p=0 037), antibiotics concomitant treatment (OR= 12;95% CI= 1 95 -73 97;p=0 007);and presence of COPD (OR=5 25 95% CI= 1-254 9 p=0 050) in multivariate analysis were associated with mortality in patients with CLD 87 5% patients with CLD died due to respiratory failure In the general mortality analysis;CLD was not a risk factor associated with mortality (OR= 1 06;95% CI= 0 35-3 18;p=0 924) like the cardiovascular diseases ( Coronary artery disease OR= 4 95;95% CI 1 51-16 27;p=0 008 and Congestive heart failure OR= 5 66;95% CI= 1 64-19 54;p=0 006) Conclusion: Patients with CLD had a low incidence of SARS-Cov2 infection, but higher risk of hospital admission with worse outcomes associated to other concomitant comorbidities and advanced fibrosis.

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