INfluenza Vaccine Indication during therapy with Immune checkpoint inhibitors: A multicenter prospective observational study (INVIDIa-2)

Melissa Bersanelli, Diana Giannarelli, Ugo De Giorgi, Sandro Pignata, Massimo Di Maio, Alberto Clemente, Elena Verzoni, Raffaele Giusti, Marilena Di Napoli, Giuseppe Aprile, Paola Ermacora, Annamaria Catino, Vieri Scotti, Francesca Mazzoni, Pamela Francesca Guglielmini, Antonello Veccia, Marco Maruzzo, Ernesto Rossi, Francesco Grossi, Chiara CasadeiCorrado Ficorella, Vincenzo Montesarchio, Francesco Verderame, Mimma Rizzo, Giorgia Guaitoli, Lucia Fratino, Caterina Accettura, Manlio Mencoboni, Fable Zustovich, Cinzia Baldessari, Saverio Cinieri, Andrea Camerini, Letizia Laera, Mariella Sorarù, Paolo Andrea Zucali, Valentina Guadalupi, Francesco Leonardi, Marcello Tiseo, Michele Tognetto, Francesco Di Costanzo, Carmine Pinto, Giorgia Negrini, Antonio Russo, Maria R. Migliorino, Marco Filetti, Sebastiano Buti

Research output: Contribution to journalArticlepeer-review

Abstract

Background Until now, no robust data supported the efficacy, safety and recommendation for influenza vaccination in patients with cancer receiving immune checkpoint inhibitors (ICIs). Methods The prospective multicenter observational INfluenza Vaccine Indication During therapy with Immune checkpoint inhibitors (INVIDIa-2) study investigated the clinical effectiveness of influenza vaccination in patients with advanced cancer receiving ICIs, enrolled in 82 Italian centers from October 2019 to January 2020. The primary endpoint was the time-adjusted incidence of influenza-like illness (ILI) until April 30, 2020. Secondary endpoints regarded ILI severity and vaccine safety. Results The study enrolled 1279 patients; 1188 patients were evaluable for the primary endpoint analysis. Of them, 48.9% (581) received influenza vaccination. The overall ILI incidence was 8.2% (98 patients). Vaccinated patients were significantly more frequently elderly (p<0.0001), males (p=0.004), with poor European Cooperative Oncology Group performance status (p=0.009), affected by lung cancer (p=0.01), and by other non-cancer comorbidities (p<0.0001) when compared with unvaccinated. ILI incidence was not different basing on influenza vaccination: the time-to-ILI was similar in vaccinated and unvaccinated patients (p=0.62). ILI complications were significantly less frequent for patients receiving the vaccination (11.8% vs 38.3% in unvaccinated, p=0.002). ILI-related intravenous therapies were significantly less frequent in vaccinated patients than in unvaccinated (11.8% vs 29.8%, p=0.027). ILI lethality was, respectively, 0% in vaccinated and 4.3% in unvaccinated patients. Vaccine-related adverse events were rare and mild (1.5%, grades 1-2). Conclusion The INVIDIa-2 study results support a positive recommendation for influenza vaccination in patients with advanced cancer receiving immunotherapy.

Original languageEnglish
Article numbere002619
JournalJournal for ImmunoTherapy of Cancer
Volume9
Issue number5
DOIs
Publication statusPublished - May 20 2021

Keywords

  • antibodies
  • immunization
  • immunogenicity
  • immunotherapy
  • neoplasm
  • vaccination
  • vaccine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Molecular Medicine
  • Oncology
  • Pharmacology
  • Cancer Research

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