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
N1 - © The Author(s), 2020.
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 -