Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG

Melissa Bersanelli; Diana Giannarelli; Ugo De Giorgi; Sandro Pignata; Massimo Di Maio; Elena Verzoni; Alberto Clemente; Valentina Guadalupi; Diego Signorelli; Marcello Tiseo; Raffaele Giusti; Marco Filetti; Marilena Di Napoli; Lorenzo Calvetti; Alessandro Cappetta; Paola Ermacora; Diego Zara; Fausto Barbieri; Cinzia Baldessari; Vieri Scotti; Francesca Mazzoni; Antonello Veccia; Pamela Francesca Guglielmini; Marco Maruzzo; Ernesto Rossi; Francesco Grossi; Chiara Casadei; Alessio Cortellini; Francesco Verderame; Vincenzo Montesarchio; Mimma Rizzo; Manlio Mencoboni; Fable Zustovich; Lucia Fratino; Saverio Cinieri; Giorgia Negrini; Maria Banzi; Mariella Sorarù; Paolo Andrea Zucali; Gaetano Lacidogna; Antonio Russo; Nicola Battelli; Giuseppe Fornarini; Claudia Mucciarini; Sergio Bracarda; Andrea Bonetti; Debora Pezzuolo; Lucia Longo; Donata Sartori; Mauro Iannopollo; Luigi Cavanna; Fausto Meriggi; Davide Tassinari; Claudia Corbo; Angela Gernone; Veronica Prati; Simona Carnio; Pasqualina Giordano; Angela Maria Dicorato; Claudio Verusio; Francesco Atzori; Francesco Carrozza; Stefania Gori; Antonino Castro; Sara Pilotto; Vanja Vaccaro; Elisabetta Garzoli; Francesco Di Costanzo; Evaristo Maiello; Roberto Labianca; Carmine Pinto; Michele Tognetto; Sebastiano Buti

doi:10.1177/1758835920968463

Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG

Melissa Bersanelli, Diana Giannarelli, Ugo De Giorgi, Sandro Pignata, Massimo Di Maio, Elena Verzoni, Alberto Clemente, Valentina Guadalupi, Diego Signorelli, Marcello Tiseo, Raffaele Giusti, Marco Filetti, Marilena Di Napoli, Lorenzo Calvetti, Alessandro Cappetta, Paola Ermacora, Diego Zara, Fausto Barbieri, Cinzia Baldessari, Vieri ScottiFrancesca Mazzoni, Antonello Veccia, Pamela Francesca Guglielmini, Marco Maruzzo, Ernesto Rossi, Francesco Grossi, Chiara Casadei, Alessio Cortellini, Francesco Verderame, Vincenzo Montesarchio, Mimma Rizzo, Manlio Mencoboni, Fable Zustovich, Lucia Fratino, Saverio Cinieri, Giorgia Negrini, Maria Banzi, Mariella Sorarù, Paolo Andrea Zucali, Gaetano Lacidogna, Antonio Russo, Nicola Battelli, Giuseppe Fornarini, Claudia Mucciarini, Sergio Bracarda, Andrea Bonetti, Debora Pezzuolo, Lucia Longo, Donata Sartori, Mauro Iannopollo, Luigi Cavanna, Fausto Meriggi, Davide Tassinari, Claudia Corbo, Angela Gernone, Veronica Prati, Simona Carnio, Pasqualina Giordano, Angela Maria Dicorato, Claudio Verusio, Francesco Atzori, Francesco Carrozza, Stefania Gori, Antonino Castro, Sara Pilotto, Vanja Vaccaro, Elisabetta Garzoli, Francesco Di Costanzo, Evaristo Maiello, Roberto Labianca, Carmine Pinto, Michele Tognetto, Sebastiano Buti

Research output: Contribution to journal › Article › peer-review

Abstract

Background: This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint was the incidence of influenza-like illness (ILI) until 30 April 2020. All the ILI episodes, laboratory tests, complications, hospitalizations and pneumonitis were recorded. Therefore, the study prospectively recorded all the COVID-19 ILI events.

Patients and methods: Patients were included in this non-prespecified COVID-19 analysis, if alive on 31 January 2020, when the Italian government declared the national emergency. The prevalence of confirmed COVID-19 cases was detected as ILI episode with laboratory confirmation of SARS-CoV-2. Cases with clinical-radiological diagnosis of COVID-19 (COVID-like ILIs), were also reported.

Results: Out of 1257 enrolled patients, 955 matched the inclusion criteria for this unplanned analysis. From 31 January to 30 April 2020, 66 patients had ILI: 9 of 955 cases were confirmed COVID-19 ILIs, with prevalence of 0.9% [95% confidence interval (CI): 0.3-2.4], a hospitalization rate of 100% and a mortality rate of 77.8%. Including 5 COVID-like ILIs, the overall COVID-19 prevalence was 1.5% (95% CI: 0.5-3.1), with 100% hospitalization and 64% mortality. The presence of elderly, males and comorbidities was significantly higher among patients vaccinated against influenza versus unvaccinated (p = 0.009, p < 0.0001, p < 0.0001). Overall COVID-19 prevalence was 1.2% for vaccinated (six of 482 cases, all confirmed) and 1.7% for unvaccinated (8 of 473, 3 confirmed COVID-19 and 5 COVID-like), p = 0.52. The difference remained non-significant, considering confirmed COVID-19 only (p = 0.33).

Conclusion: COVID-19 has a meaningful clinical impact on the cancer-patient population receiving ICIs, with high prevalence, hospitalization and an alarming mortality rate among symptomatic cases. Influenza vaccination does not protect from SARS-CoV-2 infection.

Original language	English
Pages (from-to)	1758835920968463
Journal	Therapeutic Advances in Medical Oncology
Volume	12
DOIs	https://doi.org/10.1177/1758835920968463
Publication status	Published - 2020

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Bersanelli, M., Giannarelli, D., De Giorgi, U., Pignata, S., Di Maio, M., Verzoni, E., Clemente, A., Guadalupi, V., Signorelli, D., Tiseo, M., Giusti, R., Filetti, M., Di Napoli, M., Calvetti, L., Cappetta, A., Ermacora, P., Zara, D., Barbieri, F., Baldessari, C., ... Buti, S. (2020). Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG. Therapeutic Advances in Medical Oncology, 12, 1758835920968463. https://doi.org/10.1177/1758835920968463

Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors : prospective analysis from a multicentre observational trial by FICOG. / Bersanelli, Melissa; Giannarelli, Diana ; De Giorgi, Ugo ; Pignata, Sandro; Di Maio, Massimo; Verzoni, Elena; Clemente, Alberto; Guadalupi, Valentina; Signorelli, Diego; Tiseo, Marcello; Giusti, Raffaele; Filetti, Marco; Di Napoli, Marilena; Calvetti, Lorenzo; Cappetta, Alessandro; Ermacora, Paola; Zara, Diego; Barbieri, Fausto; Baldessari, Cinzia; Scotti, Vieri; Mazzoni, Francesca; Veccia, Antonello; Guglielmini, Pamela Francesca; Maruzzo, Marco; Rossi, Ernesto; Grossi, Francesco ; Casadei, Chiara; Cortellini, Alessio; Verderame, Francesco; Montesarchio, Vincenzo; Rizzo, Mimma; Mencoboni, Manlio; Zustovich, Fable; Fratino, Lucia; Cinieri, Saverio; Negrini, Giorgia; Banzi, Maria; Sorarù, Mariella; Zucali, Paolo Andrea; Lacidogna, Gaetano; Russo, Antonio; Battelli, Nicola; Fornarini, Giuseppe; Mucciarini, Claudia; Bracarda, Sergio; Bonetti, Andrea; Pezzuolo, Debora; Longo, Lucia; Sartori, Donata; Iannopollo, Mauro; Cavanna, Luigi; Meriggi, Fausto; Tassinari, Davide; Corbo, Claudia; Gernone, Angela; Prati, Veronica; Carnio, Simona; Giordano, Pasqualina; Dicorato, Angela Maria; Verusio, Claudio; Atzori, Francesco; Carrozza, Francesco; Gori, Stefania; Castro, Antonino; Pilotto, Sara; Vaccaro, Vanja; Garzoli, Elisabetta; Di Costanzo, Francesco; Maiello, Evaristo; Labianca, Roberto; Pinto, Carmine; Tognetto, Michele; Buti, Sebastiano.

In: Therapeutic Advances in Medical Oncology, Vol. 12, 2020, p. 1758835920968463.

Research output: Contribution to journal › Article › peer-review

Bersanelli, M, Giannarelli, D , De Giorgi, U , Pignata, S, Di Maio, M, Verzoni, E, Clemente, A, Guadalupi, V, Signorelli, D, Tiseo, M, Giusti, R, Filetti, M, Di Napoli, M, Calvetti, L, Cappetta, A, Ermacora, P, Zara, D, Barbieri, F, Baldessari, C, Scotti, V, Mazzoni, F, Veccia, A, Guglielmini, PF, Maruzzo, M, Rossi, E, Grossi, F , Casadei, C, Cortellini, A, Verderame, F, Montesarchio, V, Rizzo, M, Mencoboni, M, Zustovich, F, Fratino, L, Cinieri, S, Negrini, G, Banzi, M, Sorarù, M, Zucali, PA, Lacidogna, G, Russo, A, Battelli, N, Fornarini, G, Mucciarini, C, Bracarda, S, Bonetti, A, Pezzuolo, D, Longo, L, Sartori, D, Iannopollo, M, Cavanna, L, Meriggi, F, Tassinari, D, Corbo, C, Gernone, A, Prati, V, Carnio, S, Giordano, P, Dicorato, AM, Verusio, C, Atzori, F, Carrozza, F, Gori, S, Castro, A, Pilotto, S, Vaccaro, V, Garzoli, E, Di Costanzo, F, Maiello, E, Labianca, R, Pinto, C, Tognetto, M & Buti, S 2020, 'Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG', Therapeutic Advances in Medical Oncology, vol. 12, pp. 1758835920968463. https://doi.org/10.1177/1758835920968463

Bersanelli, Melissa ; Giannarelli, Diana ; De Giorgi, Ugo ; Pignata, Sandro ; Di Maio, Massimo ; Verzoni, Elena ; Clemente, Alberto ; Guadalupi, Valentina ; Signorelli, Diego ; Tiseo, Marcello ; Giusti, Raffaele ; Filetti, Marco ; Di Napoli, Marilena ; Calvetti, Lorenzo ; Cappetta, Alessandro ; Ermacora, Paola ; Zara, Diego ; Barbieri, Fausto ; Baldessari, Cinzia ; Scotti, Vieri ; Mazzoni, Francesca ; Veccia, Antonello ; Guglielmini, Pamela Francesca ; Maruzzo, Marco ; Rossi, Ernesto ; Grossi, Francesco ; Casadei, Chiara ; Cortellini, Alessio ; Verderame, Francesco ; Montesarchio, Vincenzo ; Rizzo, Mimma ; Mencoboni, Manlio ; Zustovich, Fable ; Fratino, Lucia ; Cinieri, Saverio ; Negrini, Giorgia ; Banzi, Maria ; Sorarù, Mariella ; Zucali, Paolo Andrea ; Lacidogna, Gaetano ; Russo, Antonio ; Battelli, Nicola ; Fornarini, Giuseppe ; Mucciarini, Claudia ; Bracarda, Sergio ; Bonetti, Andrea ; Pezzuolo, Debora ; Longo, Lucia ; Sartori, Donata ; Iannopollo, Mauro ; Cavanna, Luigi ; Meriggi, Fausto ; Tassinari, Davide ; Corbo, Claudia ; Gernone, Angela ; Prati, Veronica ; Carnio, Simona ; Giordano, Pasqualina ; Dicorato, Angela Maria ; Verusio, Claudio ; Atzori, Francesco ; Carrozza, Francesco ; Gori, Stefania ; Castro, Antonino ; Pilotto, Sara ; Vaccaro, Vanja ; Garzoli, Elisabetta ; Di Costanzo, Francesco ; Maiello, Evaristo ; Labianca, Roberto ; Pinto, Carmine ; Tognetto, Michele ; Buti, Sebastiano. / Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors : prospective analysis from a multicentre observational trial by FICOG. In: Therapeutic Advances in Medical Oncology. 2020 ; Vol. 12. pp. 1758835920968463.

@article{b8496ffa26b849a99912123771829c50,

title = "Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG",

abstract = "Background: This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint was the incidence of influenza-like illness (ILI) until 30 April 2020. All the ILI episodes, laboratory tests, complications, hospitalizations and pneumonitis were recorded. Therefore, the study prospectively recorded all the COVID-19 ILI events.Patients and methods: Patients were included in this non-prespecified COVID-19 analysis, if alive on 31 January 2020, when the Italian government declared the national emergency. The prevalence of confirmed COVID-19 cases was detected as ILI episode with laboratory confirmation of SARS-CoV-2. Cases with clinical-radiological diagnosis of COVID-19 (COVID-like ILIs), were also reported.Results: Out of 1257 enrolled patients, 955 matched the inclusion criteria for this unplanned analysis. From 31 January to 30 April 2020, 66 patients had ILI: 9 of 955 cases were confirmed COVID-19 ILIs, with prevalence of 0.9% [95% confidence interval (CI): 0.3-2.4], a hospitalization rate of 100% and a mortality rate of 77.8%. Including 5 COVID-like ILIs, the overall COVID-19 prevalence was 1.5% (95% CI: 0.5-3.1), with 100% hospitalization and 64% mortality. The presence of elderly, males and comorbidities was significantly higher among patients vaccinated against influenza versus unvaccinated (p = 0.009, p < 0.0001, p < 0.0001). Overall COVID-19 prevalence was 1.2% for vaccinated (six of 482 cases, all confirmed) and 1.7% for unvaccinated (8 of 473, 3 confirmed COVID-19 and 5 COVID-like), p = 0.52. The difference remained non-significant, considering confirmed COVID-19 only (p = 0.33).Conclusion: COVID-19 has a meaningful clinical impact on the cancer-patient population receiving ICIs, with high prevalence, hospitalization and an alarming mortality rate among symptomatic cases. Influenza vaccination does not protect from SARS-CoV-2 infection.",

author = "Melissa Bersanelli and Diana Giannarelli and {De Giorgi}, Ugo and Sandro Pignata and {Di Maio}, Massimo and Elena Verzoni and Alberto Clemente and Valentina Guadalupi and Diego Signorelli and Marcello Tiseo and Raffaele Giusti and Marco Filetti and {Di Napoli}, Marilena and Lorenzo Calvetti and Alessandro Cappetta and Paola Ermacora and Diego Zara and Fausto Barbieri and Cinzia Baldessari and Vieri Scotti and Francesca Mazzoni and Antonello Veccia and Guglielmini, {Pamela Francesca} and Marco Maruzzo and Ernesto Rossi and Francesco Grossi and Chiara Casadei and Alessio Cortellini and Francesco Verderame and Vincenzo Montesarchio and Mimma Rizzo and Manlio Mencoboni and Fable Zustovich and Lucia Fratino and Saverio Cinieri and Giorgia Negrini and Maria Banzi and Mariella Sorar{\`u} and Zucali, {Paolo Andrea} and Gaetano Lacidogna and Antonio Russo and Nicola Battelli and Giuseppe Fornarini and Claudia Mucciarini and Sergio Bracarda and Andrea Bonetti and Debora Pezzuolo and Lucia Longo and Donata Sartori and Mauro Iannopollo and Luigi Cavanna and Fausto Meriggi and Davide Tassinari and Claudia Corbo and Angela Gernone and Veronica Prati and Simona Carnio and Pasqualina Giordano and Dicorato, {Angela Maria} and Claudio Verusio and Francesco Atzori and Francesco Carrozza and Stefania Gori and Antonino Castro and Sara Pilotto and Vanja Vaccaro and Elisabetta Garzoli and {Di Costanzo}, Francesco and Evaristo Maiello and Roberto Labianca and Carmine Pinto and Michele Tognetto and Sebastiano Buti",

note = "{\textcopyright} The Author(s), 2020.",

year = "2020",

doi = "10.1177/1758835920968463",

language = "English",

volume = "12",

pages = "1758835920968463",

journal = "Therapeutic Advances in Medical Oncology",

issn = "1758-8340",

publisher = "SAGE Publications Inc.",

}

TY - JOUR

T1 - Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors

T2 - prospective analysis from a multicentre observational trial by FICOG

AU - Bersanelli, Melissa

AU - Giannarelli, Diana

AU - De Giorgi, Ugo

AU - Pignata, Sandro

AU - Di Maio, Massimo

AU - Verzoni, Elena

AU - Clemente, Alberto

AU - Guadalupi, Valentina

AU - Signorelli, Diego

AU - Tiseo, Marcello

AU - Giusti, Raffaele

AU - Filetti, Marco

AU - Di Napoli, Marilena

AU - Calvetti, Lorenzo

AU - Cappetta, Alessandro

AU - Ermacora, Paola

AU - Zara, Diego

AU - Barbieri, Fausto

AU - Baldessari, Cinzia

AU - Scotti, Vieri

AU - Mazzoni, Francesca

AU - Veccia, Antonello

AU - Guglielmini, Pamela Francesca

AU - Maruzzo, Marco

AU - Rossi, Ernesto

AU - Grossi, Francesco

AU - Casadei, Chiara

AU - Cortellini, Alessio

AU - Verderame, Francesco

AU - Montesarchio, Vincenzo

AU - Rizzo, Mimma

AU - Mencoboni, Manlio

AU - Zustovich, Fable

AU - Fratino, Lucia

AU - Cinieri, Saverio

AU - Negrini, Giorgia

AU - Banzi, Maria

AU - Sorarù, Mariella

AU - Zucali, Paolo Andrea

AU - Lacidogna, Gaetano

AU - Russo, Antonio

AU - Battelli, Nicola

AU - Fornarini, Giuseppe

AU - Mucciarini, Claudia

AU - Bracarda, Sergio

AU - Bonetti, Andrea

AU - Pezzuolo, Debora

AU - Longo, Lucia

AU - Sartori, Donata

AU - Iannopollo, Mauro

AU - Cavanna, Luigi

AU - Meriggi, Fausto

AU - Tassinari, Davide

AU - Corbo, Claudia

AU - Gernone, Angela

AU - Prati, Veronica

AU - Carnio, Simona

AU - Giordano, Pasqualina

AU - Dicorato, Angela Maria

AU - Verusio, Claudio

AU - Atzori, Francesco

AU - Carrozza, Francesco

AU - Gori, Stefania

AU - Castro, Antonino

AU - Pilotto, Sara

AU - Vaccaro, Vanja

AU - Garzoli, Elisabetta

AU - Di Costanzo, Francesco

AU - Maiello, Evaristo

AU - Labianca, Roberto

AU - Pinto, Carmine

AU - Tognetto, Michele

AU - Buti, Sebastiano

PY - 2020

Y1 - 2020

N2 - Background: This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint was the incidence of influenza-like illness (ILI) until 30 April 2020. All the ILI episodes, laboratory tests, complications, hospitalizations and pneumonitis were recorded. Therefore, the study prospectively recorded all the COVID-19 ILI events.Patients and methods: Patients were included in this non-prespecified COVID-19 analysis, if alive on 31 January 2020, when the Italian government declared the national emergency. The prevalence of confirmed COVID-19 cases was detected as ILI episode with laboratory confirmation of SARS-CoV-2. Cases with clinical-radiological diagnosis of COVID-19 (COVID-like ILIs), were also reported.Results: Out of 1257 enrolled patients, 955 matched the inclusion criteria for this unplanned analysis. From 31 January to 30 April 2020, 66 patients had ILI: 9 of 955 cases were confirmed COVID-19 ILIs, with prevalence of 0.9% [95% confidence interval (CI): 0.3-2.4], a hospitalization rate of 100% and a mortality rate of 77.8%. Including 5 COVID-like ILIs, the overall COVID-19 prevalence was 1.5% (95% CI: 0.5-3.1), with 100% hospitalization and 64% mortality. The presence of elderly, males and comorbidities was significantly higher among patients vaccinated against influenza versus unvaccinated (p = 0.009, p < 0.0001, p < 0.0001). Overall COVID-19 prevalence was 1.2% for vaccinated (six of 482 cases, all confirmed) and 1.7% for unvaccinated (8 of 473, 3 confirmed COVID-19 and 5 COVID-like), p = 0.52. The difference remained non-significant, considering confirmed COVID-19 only (p = 0.33).Conclusion: COVID-19 has a meaningful clinical impact on the cancer-patient population receiving ICIs, with high prevalence, hospitalization and an alarming mortality rate among symptomatic cases. Influenza vaccination does not protect from SARS-CoV-2 infection.

AB - Background: This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint was the incidence of influenza-like illness (ILI) until 30 April 2020. All the ILI episodes, laboratory tests, complications, hospitalizations and pneumonitis were recorded. Therefore, the study prospectively recorded all the COVID-19 ILI events.Patients and methods: Patients were included in this non-prespecified COVID-19 analysis, if alive on 31 January 2020, when the Italian government declared the national emergency. The prevalence of confirmed COVID-19 cases was detected as ILI episode with laboratory confirmation of SARS-CoV-2. Cases with clinical-radiological diagnosis of COVID-19 (COVID-like ILIs), were also reported.Results: Out of 1257 enrolled patients, 955 matched the inclusion criteria for this unplanned analysis. From 31 January to 30 April 2020, 66 patients had ILI: 9 of 955 cases were confirmed COVID-19 ILIs, with prevalence of 0.9% [95% confidence interval (CI): 0.3-2.4], a hospitalization rate of 100% and a mortality rate of 77.8%. Including 5 COVID-like ILIs, the overall COVID-19 prevalence was 1.5% (95% CI: 0.5-3.1), with 100% hospitalization and 64% mortality. The presence of elderly, males and comorbidities was significantly higher among patients vaccinated against influenza versus unvaccinated (p = 0.009, p < 0.0001, p < 0.0001). Overall COVID-19 prevalence was 1.2% for vaccinated (six of 482 cases, all confirmed) and 1.7% for unvaccinated (8 of 473, 3 confirmed COVID-19 and 5 COVID-like), p = 0.52. The difference remained non-significant, considering confirmed COVID-19 only (p = 0.33).Conclusion: COVID-19 has a meaningful clinical impact on the cancer-patient population receiving ICIs, with high prevalence, hospitalization and an alarming mortality rate among symptomatic cases. Influenza vaccination does not protect from SARS-CoV-2 infection.

U2 - 10.1177/1758835920968463

DO - 10.1177/1758835920968463

M3 - Article

C2 - 33224275

VL - 12

SP - 1758835920968463

JO - Therapeutic Advances in Medical Oncology

JF - Therapeutic Advances in Medical Oncology

SN - 1758-8340

ER -