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

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.