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

Melissa Bersanelli, Diana Giannarelli, Ugo De Giorgi, Sandro Pignata, Massimo Di Maio, Elena Verzoni, Alberto Clemente, Valentina Guadalupi, Diego Signorelli, Marcello Tiseo, Raffaele Giusti, Marco Filetti, Marilena Di Napoli, Lorenzo Calvetti, Alessandro Cappetta, Paola Ermacora, Diego Zara, Fausto Barbieri, Cinzia Baldessari, Vieri ScottiFrancesca Mazzoni, Antonello Veccia, Pamela Francesca Guglielmini, Marco Maruzzo, Ernesto Rossi, Francesco Grossi, Chiara Casadei, Alessio Cortellini, Francesco Verderame, Vincenzo Montesarchio, Mimma Rizzo, Manlio Mencoboni, Fable Zustovich, Lucia Fratino, Saverio Cinieri, Giorgia Negrini, Maria Banzi, Mariella Sorarù, Paolo Andrea Zucali, Gaetano Lacidogna, Antonio Russo, Nicola Battelli, Giuseppe Fornarini, Claudia Mucciarini, Sergio Bracarda, Andrea Bonetti, Debora Pezzuolo, Lucia Longo, Donata Sartori, Mauro Iannopollo, Luigi Cavanna, Fausto Meriggi, Davide Tassinari, Claudia Corbo, Angela Gernone, Veronica Prati, Simona Carnio, Pasqualina Giordano, Angela Maria Dicorato, Claudio Verusio, Francesco Atzori, Francesco Carrozza, Stefania Gori, Antonino Castro, Sara Pilotto, Vanja Vaccaro, Elisabetta Garzoli, Francesco Di Costanzo, Evaristo Maiello, Roberto Labianca, Carmine Pinto, Michele Tognetto, Sebastiano Buti

Research output: Contribution to journalArticlepeer-review

Abstract

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 
Original languageEnglish
Pages (from-to)1758835920968463
JournalTher. Adv. Med. Oncol.
Volume12
DOIs
Publication statusPublished - 2020

Keywords

  • cancer patients
  • COVID-19
  • SARS-CoV-2
  • immune-checkpoint inhibitors
  • influenza-like illness

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