scholarly journals Fifth-week immunogenicity and safety of anti-SARS-CoV-2 BNT162b2 vaccine in patients with multiple myeloma and myeloproliferative malignancies on active treatment: preliminary data from a single institution

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Fulvia Pimpinelli ◽  
Francesco Marchesi ◽  
Giulia Piaggio ◽  
Diana Giannarelli ◽  
Elena Papa ◽  
...  

Abstract Background Safety and immunogenicity of BNT162b2 mRNA vaccine are unknown in hematological patients; both were evaluated prospectively in 42 patients with multiple myeloma (MM) and 50 with myeloproliferative malignancies (MPM) (20 chronic myeloid leukemias and 30 myeloproliferative neoplasms), all of them on active anti-cancer treatment, in comparison with 36 elderly controls not suffering from cancer. Subjects serologically and/or molecularly (by nasal/throat swab) positives at basal for SARS-CoV-2 were excluded. Primary endpoint was to compare titers of neutralizing anti-SARS-CoV-2 IgG and seroprotection rates among the cohorts at 3 and 5 weeks from first dose. Methods Titration was done using LIAISON® SARS-CoV-2 S1/S2 IgG test, a quantitative chemiluminescent immunoassay approved by FDA on the basis of robust evidences of concordance (94.4%) between the test at cutoff of 15 AU/mL and the Plaque Reduction Neutralization Test 90% at 1:40 ratio. Cutoff of 15 AU/mL was assumed to discriminate responders to vaccination with a protective titer. Cohorts were compared using Fisher’ exact test and the Mann–Whitney test as appropriated. Geometric mean concentrations (GMCs), geometric mean ratios and response rates after 1st and 2nd dose were compared in each cohort by Wilcoxon and McNemar tests, respectively. Results At 5 weeks, GMC of IgG in elderly controls was 353.3 AU/mL versus 106.7 in MM (p = 0.003) and 172.9 in MPM patients (p = 0.049). Seroprotection rate at cutoff of 15 AU/mL was 100% in controls compared to 78.6% in MM (p = 0.003) and 88% in MPM patients (p = 0.038). In terms of logarithm of IgG titer, in a generalized multivariate linear model, no gender effect was observed (p = 0.913), while there was a significant trend toward lower titers by increasing age (p < 0.001) and in disease cohorts with respect to controls (MM: p < 0.001 and MPM: p < 0.001). An ongoing treatment without daratumumab was associated with higher likelihood of response in MM patients (p = 0.003). No swabs resulted positive on each time point. No safety concerns were observed. Conclusions BNT162b2 has demonstrated to be immunogenic at different extent among the cohorts. Response was 88% and robust in MPM patients. MM patients responded significantly less, particularly those on anti-CD38-based treatment. These latter patients should be advised to maintain masks and social distancing regardless of vaccination status, and their cohabiting family members need to be vaccinated in order to reduce the risk of contagion from the family. Additional boosters and titer monitoring could be considered. Trial registration Study was formally approved by the IRCCS Central Ethical Committee of Regione Lazio in January 2021 (Prot. N-1463/21).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5119-5119
Author(s):  
Rachid Baz ◽  
Steven M. Fruchtman ◽  
Jerome B. Zeldis ◽  
Esteban Walker ◽  
Mohamad A. Hussein

Abstract Background: Erythropoietic agents (EPO) have recently been implicated with higher rates of thromboembolic events (VTE) in multiple myeloma (MM) patients receiving lenalidomide (R) and dexamethasone (Knight et al. NEJM 2006). Uncontrolled erythrocytosis, a recognized risk factor for VTE, may complicate therapy with EPO, but was not evaluated as a causative factor for VTE in the above report. We sought to evaluate the putative interactions between erythrocytosis, immunomodulator therapy, EPO and VTE. Patients and Methods: We retrospectively reviewed patients’ records from 2 studies of anthracycline-based chemotherapy with immunomodulators: pegylated liposomal doxorubicin, vincristine, dexamethasone and thalidomide (T) (study A) or lenalidomide (study B) in MM. Demographic variables, aspirin therapy, EPO therapy, immunomodulator therapy (T vs R), as well as laboratory variables (which included all hemoglobin values while on study) were reviewed. Results: From August 2001 to December 2005, 184 multiple myeloma patients with active disease were treated on study A (105) and B (79). The median age for patients was 63 and 62 years on study A and B respectively. Aspirin prophylaxis (81mg daily) was administered for all patients on study B and for all but 19 patients on study A. Among all patients, 113 patients (61%) received EPO. Twenty-six patients on study A and 7 patients on study B developed a VTE. Treatment with EPO was not associated with a higher rate of VTE compared to no treatment with EPO (19% versus 22%, Fisher exact test, p=0.8). The mean peak hemoglobin for patients with a VTE was not statistically different from patients without a VTE (14.2 vs. 13.8 g/dL, p=0.3). Similarly, the mean on study hemoglobin was not different among patients with a VTE and those without a VTE (11.7 vs. 11.6 g/dL, p=0.8). The mean hemoglobin at the time of the VTE was 12.0 g/dL (S.D. 1.5g/dL). Conclusion: Our results do not indicate an association between EPO and VTE in MM patients receiving anthracycline-based chemotherapy with an immunomodulator and aspirin prophylaxis. Uncontrolled erythrocytosis does not appear to be associated with VTE in this patient population. Of note, target hemoglobins were not commonly exceeded. Low dose Aspirin (81mg) is an effective prophylaxis for VTE in multiple myeloma patients receiving anthracycline based therapy with thalidomide or lenalidomide in conjunction with the use of erythropoietin therapy.


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1493-1493
Author(s):  
Tommasina Guglielmelli ◽  
Susanna Cappia ◽  
Emilia Giugliano ◽  
Roberta Merlini ◽  
Stefano Mussino ◽  
...  

Abstract INTRODUCTION The mammalian target of rapamycin (mTOR) is a serine/threonine-specific protein kinase, downstream of the phoshatidylinositol 3-kinase (P13K)/AKT pathway. It controls many aspects of cellular physiology, including transcription, translation, cell size, cytosckeletal organization, autophagy and progression from the G1 to S phase of the cell cycle. Constitutive activation of the mTOR related downstream effectors including P13K, AKT, p70S6K and 4EPB1 was found in numerous malignancies. Rapamycin and its analogues are mTOR inhibitor currently being tested in solid and hematological tumours. Previous studies demonstrated that rapamycin have preclinical potential as therapy for multiple myeloma, especially when associated with other drugs. We first determined the frequency of the activation status of AKT/mTOR/p70S6K pathway in multiple myeloma patients and correlated its activation with FISH analysis and clinical data. METHODS Immunohistochemical analysis with phospo-AKT (Ser 473), phospho-mTOR (Ser2448) and phosphor-p70S6K (Thr389) (Cell Signaling Technology) was performed on a series of 44 multiple myeloma bone marrow sections. Slides were scored by two independent observers and staining was defined as weakly positive (&gt;10–30, +), moderately positive (&gt;30–70, ++) and strongly positive (&gt;70, +++). FISH analysis was performed on CD138 purified plasma cells of 31 myeloma patients with specific probes for the detection of the t (4;14)(p16.3;q32) and del 13q14 (Vysis). Clinical data of all patients including age, presence of bone lesion, isotype, serum beta2-microglobulin, C-reactive protein, haemoglobin level and albumin were evaluated and Fisher exact test was used to compare the expression of p-mTOR with p-AKT and p-p70S6K signaling protein and clinical data. RESULTS p-mTOR and p-AKT were expressed respectively in 26 of 44 (59.9%) and 23 of 44 (52.3%) patients, with a predominance of cytoplasmic staining pattern. p-mTOR immunoreactivity was strongly, moderately and weakly positive in 36%, 36% and 28% of the samples, respectively. p-p70S6S was detected in 26 patients (59.9%) with a predominantly nuclear staining pattern. Of the 26 myelomas stained positive for p-mTOR, 22 expressed p-AKT and all of them demonstrated p-p70S6S positivity. p-mTOR expression significantly correlated with both p-AKT (p&lt;0.05) and p-p70S6K (p&lt;0.001) expression consistent with the hypothesis that the AKT/mTOR/p70S6K pathway is activated in multiple myeloma. t(4;14) and del 13 were detected respectively in 5 and 10 out 31 of 44 patients and all of them demonstrated p-mTOR positivity. Fisher exact test significantly correlated p-mTOR expression with high beta2-microglobulin (P&lt;0.01). CONCLUSION mTOR signaling protein are activated in a fraction of multiple myeloma cases and may contribute to tumour cell proliferation and survival of myeloma cells. Our results also suggest that the AKT/mTOR/p70S6K pathway may have prognostic implications and may provide novel therapeutical targets in this subset of myeloma patients.


2014 ◽  
Vol 60 (1) ◽  
pp. 63-69 ◽  
Author(s):  
Fernanda Carneiro Mussi ◽  
Andreia Santos Mendes ◽  
Tassia Lacerda de Queiroz ◽  
Ana Lúcia Siqueira Costa ◽  
Álvaro Pereira ◽  
...  

Objective To estimate the time of decision (TD) to look for medical care and the time of arrival (TA) at the health service for men (M) and women (W) suffering from acute myocardial infarction and to analyze the influence of the interpretation of pain and pain resistance behaviors during these times. Methods This is an exploratory research, performed at the university hospital in Salvador/Bahia. 43 W and 54 M were interviewed. To study the dependence among sociodemographic and gender variables, the Fisher Exact Test was used. To analyze times, a geometric mean (GM) was used. In order to verify the association between the GM of TD and TA and the judgment of pain, and between the GM of TD and TA and the behavior of resistance to pain, as well as to test the time of interaction between the gender variable and other variables of interest, the robust regression model was used. The statistical significance adopted was 5%. Results The GM of the TD for M was 1.13 h; for W, 0.74 h. The GM of the TA was 1.74 h for M and 1.47 h for W. Those who did not recognize the symptoms of AMI and presented behavior of resistance to pain had higher TD and TA, being the associations significant. Gender did not change the associations of interest. Conclusion The findings demonstrate the importance of health education aiming at the benefits of early treatment.


2021 ◽  
Vol 5 (3) ◽  
pp. 299
Author(s):  
Melynda Trilamsari Putri ◽  
Ashon Sa'adi ◽  
Ivon Diah Wittiarika ◽  
Gadis Meinarsari

 AbstractBackground: Intra Uterine Device (IUD) which is placed after delivery of the placenta is an attempt to reduce the rate of population growth. However, the achievement is still very low, especially in the post-placental IUD insertion. It is this high expulsion rate that continues to be a concern for service providers, so this method is acceptable. The purpose of this study is to compare the sustainability of IUD acceptors in post-placental and intra-cesareann placement. Methods: The design of this study was cross sectional with an observational analytic method. Location of this research  in the family planning clinic of Dr. Soedono Madiun Hospital, Banjarejo Health Center, Tawangrejo Health Center, and PMB Ny. “P” Madiun City in 2019.The sample used consecutive sampling as many as 114 acceptors. The independent variable was the time of IUD insertion. The dependent variable is the discontinuity of the IUD acceptor. The instrument used was the 2019 IUD acceptor medical record. The Fisher Exact Test on SPSS was used to perform data analysis. Results: From 114 acceptors, there was no difference in the discontinuity of IUD acceptors in post-placental and intra-cesarean placement (p=0.1). The incidence of expulsion was found in post-placental insertion (p=0.02). In intra-cesarean IUD acceptors more confirmed using ultrasound examination (p = 0.03). There was no perforation in both. Conclusion: There is no difference in IUD acceptor discontinuity in post-placental and intra-cesarean placement. 


1993 ◽  
Vol 70 (03) ◽  
pp. 393-396 ◽  
Author(s):  
Mandeep S Dhami ◽  
Robert D Bona ◽  
John A Calogero ◽  
Richard M Hellman

SummaryA retrospective study was done to determine the incidence of and the risk factors predisposing to clinical venous thromboembolism (VTE) in patients treated for high grade gliomas. Medical records of 68 consecutive patients diagnosed and treated at Saint Francis Hospital and Medical Center from January 1986 to June 1991 were reviewed. The follow up was to time of death or at least 6 months (up to December 1991). All clinically suspected episodes of VTE were confirmed by objective tests. Sixteen episodes of VTE were detected in 13 patients for an overall episode rate of 23.5%. Administration of chemotherapy (p = 0.027, two tailed Fisher exact test) and presence of paresis (p = 0.031, two tailed Fisher exact test) were statistically significant risk factors for the development of VTE. Thrombotic events were more likely to occur in the paretic limb and this difference was statistically significant (p = 0.00049, chi square test, with Yates correction). No major bleeding complications were seen in the nine episodes treated with long term anticoagulation.We conclude that venous thromboembolic complications are frequently encountered in patients being treated for high grade gliomas and the presence of paresis and the administration of chemotherapy increases the risk of such complications.


2020 ◽  
Vol 41 (3) ◽  
pp. 192-197
Author(s):  
Sherry S. Zhou ◽  
Alan P. Baptist

Background: There has been a striking increase in electronic cigarette (EC) use in the United States. The beliefs and practices toward ECs among physicians are unknown. Objective: The purpose of this study was to investigate EC practice patterns among allergists, pulmonologists, and primary care physicians. Methods: An anonymous survey was sent to physicians. The survey contained 32 questions and addressed issues related to demographics, cessation counseling behaviors, personal use, and knowledge and beliefs about ECs. Statistical analysis was performed by using analysis of variance, the Pearson χ2 test, Fisher exact test, and logistic regression. Results: A total of 291 physicians completed the survey (222 primary care physicians, 33 pulmonologists, and 36 allergists) for a response rate of 46%. The allergists asked about tobacco cigarette use as frequently as did the pulmonologists and more than the primary care physicians (p < 0.001), but they rarely asked about EC use. The pulmonologists scored highest on self-reported knowledge on ECs, although all the groups answered <40% of the questions correctly. The allergists did not feel as comfortable about providing EC cessation counseling as did the pulmonologists and primary care physicians (p < 0.001). All three groups were equally unlikely to recommend ECs as a cessation tool for tobacco cigarette users. Conclusion: Allergists lacked knowledge and confidence in providing education and cessation counseling for EC users. As the number of patients who use these products continues to increase, there is an urgent need for all physicians to be comfortable and knowledgeable with counseling about ECs.


2018 ◽  
Vol 1 (2) ◽  
pp. 166
Author(s):  
Sutriswanto Sutriswanto ◽  
Sugito Sugito

Abstract: Staphylococcus is a cause of infection. Infection can be transmitted from a source by an indirect through fomite. Paper money can act as transmission of infectious agents, money acts as a fomite. Smaller denominations of value have higher contamination. This study aims to analyze differences in contamination bacterial Staphylococcus sp on denomination of paper money Rp.2.000, 5.000, Rp.10,000 and Rp.20.000 that currently shop on Adi Sucipto street town Pontianak. The research method used in this research is in the form of difference and the sample in this research is denomination of paper money curently with sampling technique using cluster sampling. Checkup of Staphylococcus spon denomination of paper money using rinse method. On these result of study, denomination of paper money Rp.2.000 that is contaminated staphylococcus sp is 80%, denomination of paper money Rp.5.000 that is contaminated staphylococcus sp is 70%, denomination of paper money Rp.10.000 and Rp.20.000 that is contaminated staphylococcus sp is 80%. The data from result of study has been obtained were analyzed statistically by using fisher exact test, the result of p (0,477) >α (0,05) which mean as H1 is rejected. So it can be concluded there is no difference of contamination bacteria staphylococcus sp on denominations of paper money rupiah.Abstrak: Staphylococcus merupakan penyebab terjadinya infeksi. Infeksi dapat ditularkan dari suatu sumber dengan mekanisme tidak langsung melalui fomite. Uang kertas dapat bertindak sebagai transmisi agens infeksius ,uang berperan sebagai fomite. Pecahan uang yang lebih kecil nilainya memiliki kontaminasi yang lebih tinggi. Penelitian ini bertujuan untuk menganalisis perbedaan cemaran bakteri Staphylococcus sp pada pecahan uang kertas Rp.2.000, 5.000, Rp.10.000 dan Rp.20.000 yang beredar di warung jalan Adi Sucipto kota Pontianak. Metode penelitian yang digunakan dalam penelitian berbentuk komperatif dan sampel pada penelitian ini adalah pecahan uang kertas rupiah dengan.teknik pengambilan sampel menggunakan purposive sampling. Pemeriksaan Staphylococcus sp pada pecahan uang kertas rupiah menggunakan metode rinse. Pada hasil penelitian pecahan uang kertas Rp.2.000 yang tercemar staphylococcus sp adalah 80%, pecahan uang kertas Rp.5.000 yang tercemar staphylococcus spadalah 70%, pecahan uang kertas Rp.10.000 dan Rp.20.000 yang tercemar staphylococcus spadalah 50%. Berdasarkan data dari hasil penelitian yang telah didapat dianalisis menggunakan uji statistik fisher exact, didapatkan hasil p (0,477) >α (0,05) yang diartikan sebagai H1 ditolak. Sehingga dapat disimpulkan tidak ada perbedaan cemaran bakteri staphylococcus sp pada pecahan uang kertas rupiah.


2009 ◽  
Vol 95 (1) ◽  
pp. 6-12
Author(s):  
Kusuma Madamala ◽  
Claudia R. Campbell ◽  
Edbert B. Hsu ◽  
Yu-Hsiang Hsieh ◽  
James James

ABSTRACT Introduction: On Aug. 29, 2005, Hurricane Katrina made landfall along the Gulf Coast of the United States, resulting in the evacuation of more than 1.5 million people, including nearly 6000 physicians. This article examines the relocation patterns of physicians following the storm, determines the impact that the disaster had on their lives and practices, and identifies lessons learned. Methods: An Internet-based survey was conducted among licensed physicians reporting addresses within Federal Emergency Management Agency-designated disaster zones in Louisiana and Mississippi. Descriptive data analysis was used to describe respondent characteristics. Multivariate logistic regression was performed to identify the factors associated with physician nonreturn to original practice. For those remaining relocated out of state, bivariate analysis with x2 or Fisher exact test was used to determine factors associated with plans to return to original practice. Results: A total of 312 eligible responses were collected. Among disaster zone respondents, 85.6 percent lived in Louisiana and 14.4 percent resided in Mississippi before the hurricane struck. By spring 2006, 75.6 percent (n = 236) of the respondents had returned to their original homes, whereas 24.4 percent (n = 76) remained displaced. Factors associated with nonreturn to original employment included family or general medicine practice (OR 0.42, 95 percent CI 0.17–1.04; P = .059) and severe or complete damage to the workplace (OR 0.24, 95 percent CI 0.13–0.42; P &lt; .001). Conclusions: A sizeable proportion of physicians remain displaced after Hurricane Katrina, along with a lasting decrease in the number of physicians serving in the areas affected by the disaster. Programs designed to address identified physician needs in the aftermath of the storm may give confidence to displaced physicians to return.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
Y Krasko ◽  
J Marianowska ◽  
M Duplaga

Abstract Background According to recent projections, even 10% of Polish gross domestic product is contributed by Ukrainian immigrants. There is also a considerable number of Ukrainians continuing university education in Poland. The level of health literacy in Ukrainian society has not been studied so far. The aim of the study was the comparison of health literacy (HL) and e-health literacy (eHL) of young adult Ukrainian (UA) women with their Polish (PL) counterparts Methods A snowball technique was used to recruit a sample of UA women working or studying in Poland to the Internet-based survey. The questionnaire used in the study consisted of the 16-item European HL Survey questionnaire (HLS-EU-16), eHealth Literacy Scale (eHEALS), the set of the questions asking about health behaviours (HB), self-assessment of health status (HS) and items exploring sociodemographic variables. For comparison, the data of an age-matched sample of 100 respondents was extracted from the online survey performed in a representative sample of PL women. Results The mean age (standard deviation, SD) of 57 UA respondents was 20.23 (1.78) years and in Polish sample 20.25 (1.79). HL did not differ between both groups (11.06 (4.22) vs 11.44 (4.34), respectively, p = 0.53), but eHL was significantly lower in UA group (25.91 (5.36) vs 28.17 (5.37), U Mann-Whitney test, p = 0.01). Only 58.5% of UA respondents vs 80.5% of PL ones assessed their HS as at least good (Fisher exact test, p &lt; 0.001). The rates of active smoking (34.6% vs. 35.0%, p = 0.55), using e-cigarettes (35.3% vs 34.0%, p = 0.99), frequent alcohol consumption (26.9% vs. 20%, p = 0.41), and intensive physical activity (49.0% vs. 38.0%, p = 0.22) did not differ between study groups. Conclusions Young UA women show lower eHL than PL counterparts. Although HL and HB in both groups did not differ significantly, UA respondents have assessed their HS much lower than PL participants. Key messages E-health literacy and self-assessed health status were significantly lower among young Ukrainian than among Polish women. Both groups did not differ for health literacy and health behaviours.


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