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

M. Bersanelli, D. Giannarelli, U. De Giorgi, S. Pignata, M. Di Maio, E. Verzoni, A. Clemente, V. Guadalupi, D. Signorelli, M. Tiseo, R. Giusti, M. Filetti, M. Di Napoli, L. Calvetti, A. Cappetta, P. Ermacora, D. Zara, F. Barbieri, C. Baldessari, V. ScottiF. Mazzoni, A. Veccia, P.F. Guglielmini, M. Maruzzo, E. Rossi, F. Grossi, C. Casadei, A. Cortellini, F. Verderame, V. Montesarchio, M. Rizzo, M. Mencoboni, F. Zustovich, L. Fratino, S. Cinieri, G. Negrini, M. Banzi, M. Sorarù, P.A. Zucali, G. Lacidogna, A. Russo, N. Battelli, G. Fornarini, C. Mucciarini, S. Bracarda, A. Bonetti, D. Pezzuolo, L. Longo, D. Sartori, M. Iannopollo, L. Cavanna, F. Meriggi, D. Tassinari, C. Corbo, A. Gernone, V. Prati, S. Carnio, P. Giordano, A.M. Dicorato, C. Verusio, F. Atzori, F. Carrozza, S. Gori, A. Castro, S. Pilotto, V. Vaccaro, E. Garzoli, F. Di Costanzo, E. Maiello, R. Labianca, C. Pinto, M. Tognetto, S. Buti

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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. © The Author(s), 2020.
Original languageEnglish
Article number1758835920968463
JournalTherapeutic Advances in Medical Oncology
Publication statusPublished - 2020


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