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Observational Study
. 2021 May;9(5):e002619.
doi: 10.1136/jitc-2021-002619.

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

Melissa Bersanelli  1   2 , Diana Giannarelli  3 , Ugo De Giorgi  4 , Sandro Pignata  5 , Massimo Di Maio  6   7 , Alberto Clemente  8 , Elena Verzoni  9 , Raffaele Giusti  10 , Marilena Di Napoli  5 , Giuseppe Aprile  11 , Paola Ermacora  12 , Annamaria Catino  13 , Vieri Scotti  14 , Francesca Mazzoni  15 , Pamela Francesca Guglielmini  16 , Antonello Veccia  17 , Marco Maruzzo  18 , Ernesto Rossi  19 , Francesco Grossi  20 , Chiara Casadei  4 , Corrado Ficorella  21 , Vincenzo Montesarchio  22 , Francesco Verderame  23 , Mimma Rizzo  24 , Giorgia Guaitoli  25 , Lucia Fratino  26 , Caterina Accettura  27 , Manlio Mencoboni  28 , Fable Zustovich  29 , Cinzia Baldessari  25 , Saverio Cinieri  30 , Andrea Camerini  31 , Letizia Laera  32 , Mariella Sorarù  33 , Paolo Andrea Zucali  34   35 , Valentina Guadalupi  36 , Francesco Leonardi  2 , Marcello Tiseo  37   2 , Michele Tognetto  2 , Francesco Di Costanzo  38 , Carmine Pinto  39   40 , Giorgia Negrini  41 , Antonio Russo  42 , Maria R Migliorino  43 , Marco Filetti  44 , Sebastiano Buti  2 ; FICOG group (Federation of Italian Cooperative Oncology Groups)
Collaborators, Affiliations
Observational Study

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

Melissa Bersanelli et al. J Immunother Cancer. 2021 May.

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.

Keywords: antibodies; immunization; immunogenicity; immunotherapy; neoplasm; vaccination; vaccine.

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Conflict of interest statement

Competing interests: The Federation of Italian Cooperative Oncology Groups (FICOG) received funding for the present study by Seqirus and Roche S.p.A.; also received funding outside the present study by Astra Zeneca, Bristol-Myers Squibb (BMS), Sanofi.Melissa Bersanelli received funding for the present study by Seqirus and Roche S.p.A. (FICOG as Institution, no personal fees). She also received, outside the present work, research funding from Pfizer and Novartis (Institution); honoraria as a speaker at scientific events (personal fees) by Astra Zeneca, Bristol-Myers Squibb (BMS), Novartis and Pfizer; as consultant for advisory role (personal fees) by Novartis, BMS and Pfizer; for copyright transfer by Sciclone Pharmaceuticals.Ugo De Giorgi has served as a consultant for Astellas, Bayer, BMS, Ipsen, Janssen, Novartis, Pfizer, Sanofi and Pharmamar; he received research funding from AstraZeneca, Roche, and Sanofi; and received travel funds from BMS, Ipsen, Janssen, Pfizer, and Roche during the conduct of the study.Massimo Di Maio reports personal fees from Bristol Myers Squibb, personal fees from Merck Sharp MSD, Ipsen, Roche S.p.A., Eli-Lilly, AstraZeneca and Novartis; he also received research funding from Novartis.Vieri Scotti participated, with personal fees, to advisory boards and speaker’s bureaus for Roche S.p.A. Saverio Cinieri declared international board for Eli Lilly international. Paolo Andrea Zucali acts in a consultant or advisory role for Sanofi, BMS, Pfizer, MSD, Astellas, Janssen, Ipsen, Novartis, all outside the scope of work. Marcello Tiseo received speakers’ and consultants’ fee from Astra-Zeneca, Pfizer, Eli-Lilly, BMS, Novartis, Roche, MSD, Boehringer Ingelheim, Otsuka, Takeda, Pierre Fabre, and institutional research grants from Astra-Zeneca, Boehringer Ingelheim. All remaining authors have declared no conflicts of interest.

Figures

Figure 1
Figure 1
Patient disposition in the INfluenza Vaccine Indication During therapy with Immune checkpoint inhibitors (INVIDIa-2) study.
Figure 2
Figure 2
Clinical heatmap representing the pattern of symptoms in patients developing influenza-like illness (each row represents a single patient) according to the European Centre for Disease Prevention and Control definition.
Figure 3
Figure 3
Kaplan-Meier curve representing the time to influenza-like-illness (ILI) in vaccinated and unvaccinated patients.
Figure 4
Figure 4
Pie charts representing the rates of influenza-like illness (ILI)-related complications in vaccinated and unvaccinated patients.
See this image and copyright information in PMC

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