Therapeutic Advances in Medical Oncology (Oct 2020)

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

  • 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 Scotti,
  • Francesca 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

DOI
https://doi.org/10.1177/1758835920968463
Journal volume & issue
Vol. 12

Abstract

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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.