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RESEARCH PRODUCT
INfluenza Vaccine Indication during therapy with Immune checkpoint inhibitors: A multicenter prospective observational study (INVIDIa-2)
Diana GiannarelliSandro PignataVincenzo MontesarchioMassimo Di MaioMelissa BersanelliSebastiano ButiRaffaele GiustiMarcello TiseoMarco FilettiCorrado FicorellaElena VerzoniUgo De GiorgiCarmine PintoErnesto RossiEvaristo MaielloMaria R MigliorinoAnnamaria CatinoFrancesca MazzoniFrancesco GrossiGiorgia GuaitoliMarco MaruzzoGiuseppe AprileMarilena Di NapoliGiorgia NegriniAntonio RussoSaverio CinieriMimma RizzoFable ZustovichVieri ScottiAlberto ClementePaola ErmacoraPamela Francesca GuglielminiAntonello VecciaChiara CasadeiFrancesco VerderameLucia FratinoCaterina AccetturaManlio MencoboniCinzia BaldessariAndrea CameriniLetizia LaeraMariella SorarùPaolo Andrea ZucaliValentina GuadalupiFrancesco LeonardiMichele TognettoFrancesco Di CostanzoFrancesco Di CostanzoRoberto LabiancaLuigi Bernardisubject
MaleCancer ResearchTime Factors2435immunogenicity0302 clinical medicineRisk FactorsNeoplasmsvaccineClinical endpointImmunology and Allergyantibodiesantibodies; immunization; immunogenicity; immunotherapy; neoplasm; vaccination; vaccine1506Prospective Studies030212 general & internal medicineImmune Checkpoint InhibitorsRC254-282Clinical/Translational Cancer ImmunotherapyAged 80 and overIncidenceIncidence (epidemiology)virus diseasesNeoplasms. Tumors. Oncology. Including cancer and carcinogensMiddle AgedVaccinationTreatment OutcomeItalyOncologyInfluenza Vaccines030220 oncology & carcinogenesisMolecular MedicineFemaleimmunotherapyAdultmedicine.medical_specialtyInfluenza vaccineImmunologyVaccine EfficacyimmunizationRisk AssessmentYoung Adult03 medical and health sciencesInternal medicineInfluenza HumanmedicineHumansLung cancerAdverse effectAgedPharmacologybusiness.industryCancermedicine.diseasevaccinationImmunizationbusinessneoplasmdescription
BackgroundUntil now, no robust data supported the efficacy, safety and recommendation for influenza vaccination in patients with cancer receiving immune checkpoint inhibitors (ICIs).MethodsThe 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.ResultsThe 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).ConclusionThe INVIDIa-2 study results support a positive recommendation for influenza vaccination in patients with advanced cancer receiving immunotherapy.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2021-05-01 |