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Background: Vaccination is considered the most effective preventive strategy to fight COVID-19. The aim of this study was to evaluate two critical concerns about: 1) the kinetic response of IgG and IgM, and: 2) the hematological abnormalities in a longitudinal cohort of health-care workers (HCW) who had received 2 doses of BNT162b2 mRNA-based vaccine. Method(s): Blood and nasopharyngeal swabs were collected from 46 volunteers' participants, previous written consensus, with presumable no symptoms of COVID-19. Anti-SARS-CoV-2 serum immunoglobulin G (IgG) and M (IgM) and hematological parameters were examined. Multivariable mixed-effects models for repeated measure analysis were adopted to evaluate time changes in IgG, IgM and hematological parameters, and to investigate associations with vaccination response. Result(s): Forty-six subjects (N.=46;31.8% men;68.2% women;mean age near 36 years-old) were enrolled among healthcare workers of IRCCS MultiMedica (Milan, Italy). Overall, increase in serological IgG concentration appeared mainly between 21-28 days after the 1st dose, whereas IgM did not reach positivity in all cases. Mean blood cells counts were in normal range but we observed a significant reduction of total white blood cells and absolute lymphocyte counts after the 1st dose, persisting until the day 28. The increase of monocytes and neutrophils the day after the 1st dose subsequently decayed significantly. Eosinophils concentration showed a tendency to increase over time. Peripheral blood smear showed a growing frequency of atypical lymphocytes (lympho-variants), and of plasmacytoid forms, whereas no difference was found in large granular lymphocytes (LGL), although a decay after the boost was evident. The stratification of subjects, relative to the timing of IgG increase, showed the occurrence of 3 different patterns after vaccination, namely early-responders (R+), late-responders (R-) and pauci-responders (PR) with a peculiar kinetics of hematological parameters. Lymphocytes were significantly associated with total IgG: lower in R+ and PR compared to R- (P=0.0193 and P=00054, respectively). Conclusion(s): In healthy subjects, anti SARS-CoV-2 vaccination induced a variety of non-pathologic abnormalities. The response to vaccination was not equal in the groups examined. In PR group a major difference occurred with respect to R- and R+. This work adds novel insight into the puzzle of changes induced by SARS-CoV-2 virus.Copyright © 2022 EDIZIONI MINERVA MEDICA.
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Background: The prevalence of moderate or severe emotional distress in cancer patients ranges from 30 to 45%. There is evidence that distress and depression can impair the immune system's response to vaccines, and this effect may be greatest in vulnerable groups such as cancer patients. We have previously shown that chemotherapy, targeted therapy, hormone therapy, lymphocyte count < 1x109/L and increasing age predicted poor antibody response at 6 weeks (Buttiron Webber T. et al, Eur J Cancer. 2021). Here we assessed the effect of psychological distress on the antibody response at 6 months after two doses of vaccine. Material (patients) and methods: Before the first dose of vaccine, after 42 days and at six months the clinical research nurse administered the Distress Thermometer questionnaire to the participants. The main outcome measure was the antibody response at 6 months. Multivariable logistic and linear mixed-effects models for repeatedmeasures analysis were applied adjusting for possible confounding variables. Result(s): Between March and July 2021, 320 subjects were recruited, and 290 were assessable both for distress and antibody response at 6 months. Main patient characteristics were the following: median age 68.2, female 59%, stage IV 59%, no treatment 22%, chemo 39%, hormone 24%, target or immuno 15%. At baseline, high distress (5+) was present in 26% of subjects, with a higher rate in women vs men (34.4% vs 23.8%, p=0.08). Women with the highest educational level (degree) were significantly more distressed during time (p=0.04). Younger age predicted a higher risk of elevated distress in terms of personal relationships (p=0.004) and practical problems (p=0.01). The percentage of non-responders at 6 months was 10.1% in patients with low distress vs 20.6% in those with high distress (Odds Ratio [OR]=2.5;95% Confidence Interval [CI] 1.1-5.8, p=0.04). Also advanced stage and increasing age significantly predicted a poor seroconversion. High distress at baseline was also associated with lower CRP response, a marker of vaccine response (p=0.003). Depression was also associated with lower antibody response at 6 months (p=0.003). Conclusion(s): Distress and depression are important predictor of poor seroconversion to SARS-CoV-2 vaccine. These findings indicate the need for a multidisciplinary approach with the contribution of a psycho-oncologist to manage psychological disorders in cancer patients and further studies by the clinical research nurse.
Subject(s)
COVID-19 , Melanoma , Delivery of Health Care , Humans , Italy/epidemiology , Melanoma/epidemiology , Pandemics , SARS-CoV-2ABSTRACT
Introduction: A better understanding of the reality for cancer patients during COVID-19 will help us readapt current predication models. To further inform future clinical guidelines, we need a deep dive into rich data sources from apex Cancer Centres. We report on the outcomes of cancer patients receiving radical surgery between March-September 2020 (as well as 2019) in the European Institute of Oncology (EIO) in Milan and the South East London Cancer Alliance (SELCA). Methods: IEO is one of the largest cancer hospitals in Italy. SELCA includes 3 major hospital trust, treating about 8,000 new cancer patients per annum. Both institutions implemented a COVID-19 minimal pathway, whereby patients were required to shield for 14 days prior to admission and were swabbed for COVID-19 within 3 days of surgery. Positive patients had surgery deferred until a negative swab. Surgical outcomes assessed were: ASA grade, surgery time, theatre time, ICU stay>24h, pneumonia, length of stay (LOS), and admissions. For COVID-19, we focused on infection rate and mortality. Results: At IEO the number of radical surgeries (270 for gynaecological, 339 for head and neck, 377 for thoracic, and 491 for urological cancers) declined by 6% as compared to the same period in 2019 (n=1477 vs 1560). The main decline was observed for thoracic surgery (377 vs 460, i.e. -18%). Age, sex, SES, ethnicity, comorbidities, and performance status were all comparable between both periods (e.g. 58% male, 38% aged 70+, 48% high SES, 15% with existing cardiovascular diseases). Readmissions were required for 39%, and <1% (n=9) developed COVID-19, of which only 1 had severe disease and died. 11 died of other causes during follow-up (1%). At SELCA, the number of radical surgeries (321 for breast, 129 for colorectal, 114 for gynaecological, 152 for head and neck, 92 for liver, 56 for plastics/skin, 305 for thoracic, 72 for upper gastrointestinal, and 312 for urology) declined by 29% (n=1553 vs 2182). Even though a different geographical setting, characteristics were fairly comparable with the IEO: 58% males, 30% aged 70+, 34% high SES, 16% with existing cardiovascular diseases. Readmissions were required for 22%, <1% (n=7) developed COVID-19, and none died from it. 19 died of other causes within 30 days (1%). Conclusion: Milan and London were both at the epicentre of the first COVID-19 wave. Whilst a decline in number of surgeries was observed, the implemented COVID-19 minimal pathways have shown to be safe for cancer patients requiring radical treatment, with limited complications and almost no COVID-19 infections.
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We reviewed the diagnostic accuracy of SARS-CoV-2 serological tests. Random-effects models yielded a summary sensitivity of 82% for IgM, and 85% for IgG and total antibodies. For specificity, the pooled estimate were 98% for IgM and 99% for IgG and total antibodies. In populations with 5% of seroconverted individuals, unless the assays have perfect (i.e. 100%) specificity, the positive predictive value would be 88%. Serological tests should be used for prevalence surveys only in hard-hit areas.
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Background: cancer have been reported to experience severe complications and poor outcomes to severe acute respiratory syndrome coronavirus 2 (SARSCoV-2)-related disease (COVID-19). Anti-SARS-CoV-2 immunoglobulin-G (IgG) can be detected within three weeks after infection. However, scant information is available on the seroconversion rates of patients with cancer and COVID-19. Material: This is a multicenter, observational, prospective study that enrolled patients and oncology health professionals with SARS-CoV-2 infection confirmed by RT-PCR assay, patients and oncology health professionals with clinical or radiological suspicious of infection by SARS-CoV-2, and patients with cancer who are considered at high risk for infection. All subjects were tested with the 2019-nCoV IgG/IgM Rapid Test Cassett, which is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to SARS-CoV-2. The aim of the study was to evaluate anti-SARS-CoV-2 seroconversion rate in patients with cancer and healthcare professionals with confirmed or clinically suspected COVID-19. Results: Between March 30 and May 11, 2020, 166 subjects were enrolled in the study. Cancer patients and health workers were 61 (36.7%) and 105 (63.3%), respectively. Seventyfour subjects (44.6%) had confirmed SARS-CoV-2 diagnosis by RT-PCR testing on nasopharyngeal swab specimen, while 49 (29.5%) had a clinical suspicious of COVID-19 in absence of RT-PCR confirmation. Median time between symptom onset/ RT-PCR confirmation to serum antibody test was 17 days (IQR, 26). Considering the population with confirmation by RT-PCR, 83.8% was IgG positive. Neither differences in terms of IgG positivity rate nor in median time from SARS-CoV-2 diagnosis to IgG detection were observed between cancer patients and health workers (87.9% vs 80.5%;P=0.39;23.0 vs 28.0 days;P=0.21). Conclusions: Our data indicate that SARS-CoV-2-specific IgG antibody detection does not differ between cancer patients and healthy subjects. Fast test for antibody detection can be complementary to RNA RT-PCR testing for the diagnosis of COVID-19 in this vulnerable patient population.
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BACKGROUND: Patients with cancer have high risk for severe complications and poor outcome to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related disease [coronavirus disease 2019 (COVID-19)]. Almost all subjects with COVID-19 develop anti-SARS-CoV-2 immunoglobulin G (IgG) within 3 weeks after infection. No data are available on the seroconversion rates of cancer patients and COVID-19. PATIENTS AND METHODS: We conducted a multicenter, observational, prospective study that enrolled (i) patients and oncology health professionals with SARS-CoV-2 infection confirmed by real-time RT-PCR assays on nasal/pharyngeal swab specimens; (ii) patients and oncology health professionals with clinical or radiological suspicious of infection by SARS-CoV-2; and (iii) patients with cancer who are considered at high risk for infection and eligible for active therapy and/or major surgery. All enrolled subjects were tested with the 2019-nCoV IgG/IgM Rapid Test Cassette, which is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to SARS-CoV-2. The aim of the study was to evaluate anti-SARS-CoV-2 seroconversion rate in patients with cancer and oncology health care professionals with confirmed or clinically suspected COVID-19. RESULTS: From 30 March 2020 to 11 May 2020, 166 subjects were enrolled in the study. Among them, cancer patients and health workers were 61 (36.7%) and 105 (63.3%), respectively. Overall, 86 subjects (51.8%) had confirmed SARS-CoV-2 diagnosis by RT-PCR testing on nasopharyngeal swab specimen, and 60 (36.2%) had a clinical suspicious of COVID-19. Median time from symptom onset (for cases not confirmed by RT-PCR) or RT-PCR confirmation to serum antibody test was 17 days (interquartile range 26). In the population with confirmed RT-PCR, 83.8% of cases were IgG positive. No difference in IgG positivity was observed between cancer patients and health workers (87.9% versus 80.5%; P = 0.39). CONCLUSIONS: Our data indicate that SARS-CoV-2-specific IgG antibody detection do not differ between cancer patients and healthy subjects.
Subject(s)
COVID-19 , Neoplasms , Antibodies, Viral , Health Personnel , Humans , Immunoglobulin M , Neoplasms/epidemiology , Prospective Studies , SARS-CoV-2 , Sensitivity and Specificity , SeroconversionABSTRACT
Background: Poor outcomes for patients with cancer and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related disease (COVID-19) have been reported so far. Although anti-SARS-CoV-2 IgG response is usually detectable within three weeks after infection, limited information on the seroconversion rate of patients with cancer infected by SARS-CoV-2 is available. Methods: This is a multicenter, observational, prospective study that included patients and oncology healthcare workers (HCWs) with SARS-CoV-2 infection confirmed by RT-PCR or clinical/radiological suspicious of infection as well as patients with cancer who are considered at high risk for infection. All subjects were tested with the 2019-nCoV IgG/IgM Rapid Test Cassett for the fast detection of IgG and IgM antibodies against SARS-CoV-2. The aim of the study was to evaluate anti-SARS-CoV-2 seroconversion rates by qualitative assay in patients with cancer and HCWs with confirmed or clinically suspected COVID-19. Results: At first interim analysis, 166 subjects were enrolled in the study. Cancer patients and HCWs were 61 (36.7%) and 105 (63.3%), respectively. HCWs were younger than patients with cancer (median age 41 vs 62 years;P<0.001). Eighty-six subjects (51.8%) had confirmed SARS-CoV-2 diagnosis by RT-PCR testing on nasopharyngeal swab specimen, while forty-nine (29.5%) had a clinical suspicious of COVID-19 in absence of RT-PCR confirmation. In patients with RT-PCR-confirmed SARS-CoV-2 infection, 62 (83.8%) were IgG-positive. Neither differences in terms of IgG positivity (87.9% vs 80.5%;P=0.39) nor in median time from COVID-19 diagnosis to IgG detection (23.0 vs 28.0 days;P=0.21) were found between patients with cancer and HCWs. Conclusions: Our data show that SARS-CoV-2-specific IgG antibody response is not different between cancer patients and healthy subjects. Qualitative rapid test for antibody detection represents an useful support to RNA RT-PCR testing for the diagnosis of COVID-19 in high-risk populations, including patients with cancer. Legal entity responsible for the study: Istituto Europeo di Oncologia IRCCS. Funding: This work was partially supported by the Italian Ministry of Health with Ricerca Corrente and 5x1000 funds. MEDnoTE srl (Spin-off of University of Trieste) supported the present study by providing the rapid test used for anti-SARS-CoV-2 antibody detection. Disclosure: D.G. Generali: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis, Pfizer, Lilly. G. Curigliano: Speaker Bureau/Expert testimony: MSD;Advisory/Consultancy: Mylan, Daichii Sankyo;Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly, Pfizer, Merck, Foundation Medicine, Samsung, Celltrion;Advisory/Consultancy, Speaker Bureau/Expert testimony: Seattle Genetics, Nanostring;Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche;Speaker Bureau/Expert testimony: Novartis, BMS;Honoraria (self): Ellipsis. All other authors have declared no conflicts of interest.