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Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy.

Identifieur interne : 000708 ( Main/Curation ); précédent : 000707; suivant : 000709

Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy.

Auteurs : Vincenzo Montesarchio [Italie] ; Roberto Parrela [Italie] ; Chiara Iommelli [Italie] ; Antonella Bianco [Italie] ; Elio Manzillo [Italie] ; Fiorentino Fraganza [Italie] ; Cristiana Palumbo [Italie] ; Gaetano Rea [Italie] ; Patrizia Murino [Italie] ; Rosanna De Rosa [Italie] ; Luigi Atripaldi [Italie] ; Maurizio D'Abbraccio [Italie] ; Marcello Curvietto [Italie] ; Domenico Mallardo [Italie] ; Egidio Celentano [Italie] ; Antonio Maria Grimaldi [Italie] ; Marco Palla [Italie] ; Claudia Trojaniello [Italie] ; Maria Grazia Vitale [Italie] ; Samuel Lewis Million-Weaver [États-Unis] ; Paolo Antonio Ascierto [Oman]

Source :

RBID : pubmed:32784217

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English descriptors

Abstract

BACKGROUND

The inflammatory pathology observed in severe COVID-19 disease caused by the 2019 novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by elevated serum levels of C reactive protein (CRP) and cytokines, including interferon gamma, interleukin 8 (IL-8), and interleukin 6 (IL-6). Initial reports from the outbreak in Italy, China and the USA have provided anecdotal evidence of improved outcomes with the administration of anti-IL-6 agents, and large-scale trials evaluating these therapies are ongoing.

STUDY DESCRIPTION

In this retrospective case series, clinical outcomes and correlates of response to treatment with the IL-6 receptor antagonist sarilumab are described for 15 patients with COVID-19 from a single institution in Southern Italy. Among 10 patients whose symptoms improved after sarilumab treatment, rapid decreases in CRP levels corresponded with clinical improvement. Lower levels of IL-6 at baseline as well as lower neutrophil to lymphocyte ratio as compared with patients whose COVID-19 did not improve with treatment were associated with sarilumab-responsive disease.

CONCLUSIONS

This observation may reflect a possible clinical benefit regarding early intervention with IL-6-modulatory therapies for COVID-19 and that CRP could be a potential biomarker of response to treatment.


DOI: 10.1136/jitc-2020-001089
PubMed: 32784217
PubMed Central: PMC7418768

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pubmed:32784217

Le document en format XML

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<name sortKey="Trojaniello, Claudia" sort="Trojaniello, Claudia" uniqKey="Trojaniello C" first="Claudia" last="Trojaniello">Claudia Trojaniello</name>
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<name sortKey="Vitale, Maria Grazia" sort="Vitale, Maria Grazia" uniqKey="Vitale M" first="Maria Grazia" last="Vitale">Maria Grazia Vitale</name>
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<title xml:lang="en">Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy.</title>
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<name sortKey="Montesarchio, Vincenzo" sort="Montesarchio, Vincenzo" uniqKey="Montesarchio V" first="Vincenzo" last="Montesarchio">Vincenzo Montesarchio</name>
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<nlm:affiliation>Department of Medical Oncology, Azienda Ospedaliera dei Colli-Monaldi Hospital, Napoli, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Medical Oncology, Azienda Ospedaliera dei Colli-Monaldi Hospital, Napoli</wicri:regionArea>
</affiliation>
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<name sortKey="Parrela, Roberto" sort="Parrela, Roberto" uniqKey="Parrela R" first="Roberto" last="Parrela">Roberto Parrela</name>
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<nlm:affiliation>Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli</wicri:regionArea>
</affiliation>
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<name sortKey="Iommelli, Chiara" sort="Iommelli, Chiara" uniqKey="Iommelli C" first="Chiara" last="Iommelli">Chiara Iommelli</name>
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<name sortKey="Fraganza, Fiorentino" sort="Fraganza, Fiorentino" uniqKey="Fraganza F" first="Fiorentino" last="Fraganza">Fiorentino Fraganza</name>
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<name sortKey="Murino, Patrizia" sort="Murino, Patrizia" uniqKey="Murino P" first="Patrizia" last="Murino">Patrizia Murino</name>
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<name sortKey="De Rosa, Rosanna" sort="De Rosa, Rosanna" uniqKey="De Rosa R" first="Rosanna" last="De Rosa">Rosanna De Rosa</name>
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<nlm:affiliation>Critical Area Department, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy.</nlm:affiliation>
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<wicri:regionArea>Critical Area Department, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli</wicri:regionArea>
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<name sortKey="Atripaldi, Luigi" sort="Atripaldi, Luigi" uniqKey="Atripaldi L" first="Luigi" last="Atripaldi">Luigi Atripaldi</name>
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<name sortKey="D Abbraccio, Maurizio" sort="D Abbraccio, Maurizio" uniqKey="D Abbraccio M" first="Maurizio" last="D'Abbraccio">Maurizio D'Abbraccio</name>
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<nlm:affiliation>Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Curvietto, Marcello" sort="Curvietto, Marcello" uniqKey="Curvietto M" first="Marcello" last="Curvietto">Marcello Curvietto</name>
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<nlm:affiliation>Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania</wicri:regionArea>
</affiliation>
</author>
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<name sortKey="Mallardo, Domenico" sort="Mallardo, Domenico" uniqKey="Mallardo D" first="Domenico" last="Mallardo">Domenico Mallardo</name>
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<nlm:affiliation>Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Celentano, Egidio" sort="Celentano, Egidio" uniqKey="Celentano E" first="Egidio" last="Celentano">Egidio Celentano</name>
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<nlm:affiliation>Epidemiology and Biostatistics Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Epidemiology and Biostatistics Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Grimaldi, Antonio Maria" sort="Grimaldi, Antonio Maria" uniqKey="Grimaldi A" first="Antonio Maria" last="Grimaldi">Antonio Maria Grimaldi</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.</nlm:affiliation>
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<name sortKey="Palla, Marco" sort="Palla, Marco" uniqKey="Palla M" first="Marco" last="Palla">Marco Palla</name>
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<nlm:affiliation>Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania</wicri:regionArea>
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<author>
<name sortKey="Trojaniello, Claudia" sort="Trojaniello, Claudia" uniqKey="Trojaniello C" first="Claudia" last="Trojaniello">Claudia Trojaniello</name>
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<nlm:affiliation>Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
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<name sortKey="Vitale, Maria Grazia" sort="Vitale, Maria Grazia" uniqKey="Vitale M" first="Maria Grazia" last="Vitale">Maria Grazia Vitale</name>
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<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania</wicri:regionArea>
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<author>
<name sortKey="Million Weaver, Samuel Lewis" sort="Million Weaver, Samuel Lewis" uniqKey="Million Weaver S" first="Samuel Lewis" last="Million-Weaver">Samuel Lewis Million-Weaver</name>
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<nlm:affiliation>Independent Investigator, Madison, Wisconsin, USA.</nlm:affiliation>
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<nlm:affiliation>Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy paolo.ascierto@gmail.com.</nlm:affiliation>
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<title level="j">Journal for immunotherapy of cancer</title>
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<term>Aged (MeSH)</term>
<term>Antibodies, Monoclonal, Humanized (therapeutic use)</term>
<term>Antiviral Agents (therapeutic use)</term>
<term>Biomarkers, Pharmacological (blood)</term>
<term>Coronavirus Infections (complications)</term>
<term>Coronavirus Infections (diagnostic imaging)</term>
<term>Coronavirus Infections (drug therapy)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Interleukin-6 (blood)</term>
<term>Italy (MeSH)</term>
<term>Lymphocyte Count (MeSH)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Neutrophils (MeSH)</term>
<term>Pandemics (MeSH)</term>
<term>Pneumonia, Viral (complications)</term>
<term>Pneumonia, Viral (diagnostic imaging)</term>
<term>Pneumonia, Viral (drug therapy)</term>
<term>Receptors, Interleukin-6 (antagonists & inhibitors)</term>
<term>Retrospective Studies (MeSH)</term>
<term>Treatment Outcome (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Adulte d'âge moyen (MeSH)</term>
<term>Anticorps monoclonaux humanisés (usage thérapeutique)</term>
<term>Antiviraux (usage thérapeutique)</term>
<term>Biomarqueurs pharmacologiques (sang)</term>
<term>Femelle (MeSH)</term>
<term>Granulocytes neutrophiles (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Infections à coronavirus (complications)</term>
<term>Infections à coronavirus (imagerie diagnostique)</term>
<term>Infections à coronavirus (traitement médicamenteux)</term>
<term>Interleukine-6 (sang)</term>
<term>Italie (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Numération des lymphocytes (MeSH)</term>
<term>Pandémies (MeSH)</term>
<term>Pneumopathie virale (complications)</term>
<term>Pneumopathie virale (imagerie diagnostique)</term>
<term>Pneumopathie virale (traitement médicamenteux)</term>
<term>Récepteurs à l'interleukine-6 (antagonistes et inhibiteurs)</term>
<term>Résultat thérapeutique (MeSH)</term>
<term>Sujet âgé (MeSH)</term>
<term>Études rétrospectives (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en">
<term>Receptors, Interleukin-6</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en">
<term>Biomarkers, Pharmacological</term>
<term>Interleukin-6</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en">
<term>Antibodies, Monoclonal, Humanized</term>
<term>Antiviral Agents</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en">
<term>Italy</term>
</keywords>
<keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr">
<term>Récepteurs à l'interleukine-6</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en">
<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic imaging" xml:lang="en">
<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="imagerie diagnostique" xml:lang="fr">
<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="sang" xml:lang="fr">
<term>Biomarqueurs pharmacologiques</term>
<term>Infections à coronavirus</term>
<term>Interleukine-6</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr">
<term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr">
<term>Anticorps monoclonaux humanisés</term>
<term>Antiviraux</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Aged</term>
<term>Female</term>
<term>Humans</term>
<term>Lymphocyte Count</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neutrophils</term>
<term>Pandemics</term>
<term>Retrospective Studies</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Granulocytes neutrophiles</term>
<term>Humains</term>
<term>Italie</term>
<term>Mâle</term>
<term>Numération des lymphocytes</term>
<term>Pandémies</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Études rétrospectives</term>
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<term>Italie</term>
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<front>
<div type="abstract" xml:lang="en">
<p>
<b>BACKGROUND</b>
</p>
<p>The inflammatory pathology observed in severe COVID-19 disease caused by the 2019 novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by elevated serum levels of C reactive protein (CRP) and cytokines, including interferon gamma, interleukin 8 (IL-8), and interleukin 6 (IL-6). Initial reports from the outbreak in Italy, China and the USA have provided anecdotal evidence of improved outcomes with the administration of anti-IL-6 agents, and large-scale trials evaluating these therapies are ongoing.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>STUDY DESCRIPTION</b>
</p>
<p>In this retrospective case series, clinical outcomes and correlates of response to treatment with the IL-6 receptor antagonist sarilumab are described for 15 patients with COVID-19 from a single institution in Southern Italy. Among 10 patients whose symptoms improved after sarilumab treatment, rapid decreases in CRP levels corresponded with clinical improvement. Lower levels of IL-6 at baseline as well as lower neutrophil to lymphocyte ratio as compared with patients whose COVID-19 did not improve with treatment were associated with sarilumab-responsive disease.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSIONS</b>
</p>
<p>This observation may reflect a possible clinical benefit regarding early intervention with IL-6-modulatory therapies for COVID-19 and that CRP could be a potential biomarker of response to treatment.</p>
</div>
</front>
</TEI>
<pubmed>
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<PMID Version="1">32784217</PMID>
<DateCompleted>
<Year>2020</Year>
<Month>09</Month>
<Day>02</Day>
</DateCompleted>
<DateRevised>
<Year>2020</Year>
<Month>09</Month>
<Day>17</Day>
</DateRevised>
<Article PubModel="Print">
<Journal>
<ISSN IssnType="Electronic">2051-1426</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>8</Volume>
<Issue>2</Issue>
<PubDate>
<Year>2020</Year>
<Month>08</Month>
</PubDate>
</JournalIssue>
<Title>Journal for immunotherapy of cancer</Title>
<ISOAbbreviation>J Immunother Cancer</ISOAbbreviation>
</Journal>
<ArticleTitle>Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy.</ArticleTitle>
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<ELocationID EIdType="doi" ValidYN="Y">10.1136/jitc-2020-001089</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND">The inflammatory pathology observed in severe COVID-19 disease caused by the 2019 novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by elevated serum levels of C reactive protein (CRP) and cytokines, including interferon gamma, interleukin 8 (IL-8), and interleukin 6 (IL-6). Initial reports from the outbreak in Italy, China and the USA have provided anecdotal evidence of improved outcomes with the administration of anti-IL-6 agents, and large-scale trials evaluating these therapies are ongoing.</AbstractText>
<AbstractText Label="STUDY DESCRIPTION">In this retrospective case series, clinical outcomes and correlates of response to treatment with the IL-6 receptor antagonist sarilumab are described for 15 patients with COVID-19 from a single institution in Southern Italy. Among 10 patients whose symptoms improved after sarilumab treatment, rapid decreases in CRP levels corresponded with clinical improvement. Lower levels of IL-6 at baseline as well as lower neutrophil to lymphocyte ratio as compared with patients whose COVID-19 did not improve with treatment were associated with sarilumab-responsive disease.</AbstractText>
<AbstractText Label="CONCLUSIONS">This observation may reflect a possible clinical benefit regarding early intervention with IL-6-modulatory therapies for COVID-19 and that CRP could be a potential biomarker of response to treatment.</AbstractText>
<CopyrightInformation>© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</CopyrightInformation>
</Abstract>
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<LastName>Montesarchio</LastName>
<ForeName>Vincenzo</ForeName>
<Initials>V</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology, Azienda Ospedaliera dei Colli-Monaldi Hospital, Napoli, Italy.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Parrela</LastName>
<ForeName>Roberto</ForeName>
<Initials>R</Initials>
<AffiliationInfo>
<Affiliation>Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli, Italy.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Iommelli</LastName>
<ForeName>Chiara</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Department of Medical Oncology, Azienda Ospedaliera dei Colli-Monaldi Hospital, Napoli, Italy.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Bianco</LastName>
<ForeName>Antonella</ForeName>
<Initials>A</Initials>
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<Affiliation>Department of Medical Oncology, Azienda Ospedaliera dei Colli-Monaldi Hospital, Napoli, Italy.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Manzillo</LastName>
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<Initials>E</Initials>
<AffiliationInfo>
<Affiliation>Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli, Italy.</Affiliation>
</AffiliationInfo>
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</AffiliationInfo>
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<Affiliation>Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.</Affiliation>
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<LastName>Vitale</LastName>
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