Evidence map›Paper›PMID 34016723›Full record

Observational studyJournal for immunotherapy of cancer2021

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 and 37 more

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Vaccines for preventing infections in adults with solid tumours.The Cochrane database of systematic reviews · 2025
    Pooled it
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  13. Revue des maladies respiratoires actualites · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

47 authors at 20 institutions in 1 country.

Melissa BersanelliMedicine and Surgery Department, University of Parma, Parma, Italy bersamel@libero.it.ORCID 0000-0002-6527-6281
Diana GiannarelliBiostatistical Unit, Regina Elena National Cancer Institute, IRCCS, Rome, Italy.
Ugo De GiorgiDepartment of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Sandro PignataUC Oncologia Medica Uro-Ginecologica, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Napoli, Italy.
Massimo Di MaioDepartment of Oncology, University of Turin, Torino, Italy.
Alberto ClementeBiostatistics and Clinical Research Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Elena VerzoniSS.Oncologia Genitourinaria, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
Raffaele GiustiMedical Oncology Unit, Sant'Andrea Hospital, Roma, Italy.
Marilena Di NapoliUC Oncologia Medica Uro-Ginecologica, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Napoli, Italy.
Giuseppe AprileDepartment of Oncology, San Bortolo General Hospital, Vicenza, Italy.
Paola ErmacoraDipartimento di Oncologia, Presidio Ospedaliero Universitario Santa Maria della Misericordia, Azienda sanitaria universitaria integrata Friuli Centrale, Udine, Italy.
Annamaria CatinoMedical Thoracic Oncology Unit, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy.
Vieri ScottiRadiation Oncology Unit, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy.
Francesca MazzoniMedical Oncology Unit, University Hospital Careggi, Firenze, Italy.
Pamela Francesca GuglielminiSC Oncologia, AO SS Antonio e Biagio e C. Arrigo, Alessandria, Italy.
Antonello VecciaMedical Oncology, Santa Chiara Hospital, Trento, Italy.
Marco MaruzzoOncologia Medica 1, Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy.
Ernesto RossiMedical Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Francesco GrossiMedical Oncology Department, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Chiara CasadeiDepartment of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Corrado FicorellaDepartment of Biotechnological and Applied Clinical Sciences, St Salvatore Hospital, University of L'Aquila, L'Aquila, Italy.
Vincenzo MontesarchioUOC Oncologia, Azienda Ospedaliera Specialistica dei Colli, Ospedale Monaldi, Napoli, Italy.ORCID 0000-0001-5545-8105
Francesco VerderameOncology Department, Ospedali Riuniti Villa Sofia Cervello, Palermo, Italy.
Mimma RizzoOncologia Traslazionale, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy.
Giorgia GuaitoliMedical Oncology Unit, Universita degli Studi di Modena e Reggio Emilia, Modena, Italy.
Lucia FratinoMedical Oncology Unit, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.
Caterina AccetturaMedical Oncology Unit, Ospedale Vito Fazzi, Lecce, Italy.
Manlio MencoboniOncologia Medica, Ospedale Villa Scassi, Genova, Italy.
Fable ZustovichUOC Oncologia di Belluno, Dipartimento di Oncologia Clinica, AULSS 1 Dolomiti, Ospedale S.Martino, Belluno, Italy.
Cinzia BaldessariMedical Oncology Unit, Universita degli Studi di Modena e Reggio Emilia, Modena, Italy.
Saverio CinieriMedical Oncology Division and Breast Unit, Senatore Antonio Perrino Hospital, Brindisi, Italy.
Andrea CameriniOncologia Medica, Ospedale della Versilia, Lido di Camaiore, Italy.
Letizia LaeraMedical Oncology, Ospedale Generale Regionale F Miulli, Acquaviva delle Fonti, Puglia, Italy.
Mariella SorarùMedical Oncology, Camposampiero Hospital, ULSS 6 Euganea, Padova, Italy.
Paolo Andrea ZucaliDepartment of Oncology, Humanitas Clinical and Research Center, IRCCS, Milan, Italy.
Valentina GuadalupiUC Oncologia Medica Uro-Ginecologica, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
Francesco LeonardiMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Marcello TiseoMedicine and Surgery Department, University of Parma, Parma, Italy.
Michele TognettoMedical Oncology Unit, University Hospital of Parma, Parma, Italy.
Francesco Di CostanzoFederation of Italian Cooperative Oncology Groups (FICOG), Milano, Italy.
Carmine PintoMedical Oncology Unit, AUSL-IRCCS of Reggio Emilia, Reggio Emilia, Italy.
Giorgia NegriniOncology, ASST Papa Giovanni XXIII, Bergamo, Italy.
Antonio RussoDipartimento di Discipline Chirurgiche, Oncologiche e Stomatologiche, Università degli Studi di Palermo, Palermo, Italy.
Maria R MigliorinoMedical Oncology, San Camillo Forlanini Hospital, Roma, Italy.
Marco FilettiDepartment of Clinical and Molecular Medicine, Oncology Unit, Sant'Andrea Hospital, Sapienza University of Rome, Roma, Italy.
Sebastiano ButiMedical Oncology Unit, University Hospital of Parma, Parma, Italy.ORCID 0000-0003-0876-0226
FICOG group (Federation of Italian Cooperative Oncology Groups)
University of Parma · ITIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITAzienda Ospedaliero-Universitaria Careggi · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITUniversity of Modena and Reggio Emilia · ITAgostino Gemelli University Polyclinic · ITA. O. Ordine Mauriziano di Torino · ITAzienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo · ITAzienda Sanitaria Unità Locale di Reggio Emilia · ITCarlo Forlanini Hospital · ITCentro di Riferimento Oncologico · ITCTO Andrea Alesini · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITHumanitas University · ITIstituti Clinici Scientifici Maugeri · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITIstituto Oncologico Veneto · ITIstituto Tumori Bari · ITItalian Oncology Group of Clinical Research · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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%

conclusionThe INVIDIa-2 study results support a positive recommendation for influenza vaccination in patients with advanced cancer receiving immunotherapy.

Indexed as

VaccinationVaccine EfficacyAdultAgedAged, 80 and overFemaleHumansImmune Checkpoint InhibitorsIncidenceInfluenza, HumanInfluenza VaccinesItalyMaleMiddle AgedNeoplasmsProspective StudiesImmune Checkpoint InhibitorsInfluenza Vaccinesantibodiesimmunizationimmunogenicityimmunotherapyneoplasmvaccinationvaccine

Identifiers

PMID34016723
PMCPMC8141439
OpenAlexW3161290847

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.