Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG
Authors: 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 
Published: November 2020

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.