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

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, P. F.; 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.; Soraru, M.; Zucali, P. A.; 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, A. M.; 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.

doi:10.1177/1758835920968463

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.