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

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% 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.

Associations of influenza vaccination with severity of immune-related adverse events in patients with advanced thoracic cancers on immune checkpoint inhibitors

“…The INVIFIa-2 study results, therefore, supported the recommendation for FV in patients with advanced cancers on ICI based on the overall reduction of influenza-relevant complications (10). This study, however, did not discuss the association of FV with IRAE.…”

Influenza Vaccination in Cancer Patients Treated With Immune Checkpoint Inhibitors: A Systematic Review and Meta-analysis

“…Among 1046 articles initially retrieved, 25 were found to fulfill the inclusion criteria and were included in the systematic review 19,20,29–50. Fourteen studies were peer-reviewed19,20,29–40 and 11 nonpeer-reviewed (conference abstracts) 41–50.…”

“…It is interesting to note that, a trend toward increased mortality in vaccinated patients was observed. However, in most studies vaccinated patients had significantly different baseline demographics than nonvaccinated patients (eg, older age),29,33,38 introducing major bias in studies’ conclusions. More severely ill patients with comorbidities and poor prognosis might have been more frequently selected to be vaccinated (indication bias) 29.…”

“…This observation raises concerns about the appropriateness of influenza syndrome as a primary efficacy outcome in these studies. Recently, Bersanelli et al29 performed a prospective trial and analyzed data from 1188 patients, among which nearly half received the influenza vaccine during influenza season 2019–2020 (INVIDIa-2 study, 2021). Endpoints used were similar to those used in the retrospective INVIDIa study 39.…”

Patients avec cancers thoraciques et COVID-19 : au cœur de la tempête

“…Ainsi les patients avec cancer n’étaient-ils pas classés dans les catégories prioritaires pour la vaccination fin janvier 2021, tant par le gouvernement, que le Comité scientifique ou l’HAS. Par ailleurs des doutes existaient quant à l’efficacité des vaccins chez ces populations fragiles et souvent âgées certes, mais immunodéprimées de par la maladie cancéreuse, et surtout les chimiothérapies lymphopéniantes, par comparaison aux résultats du vaccin anti-grippal chez ces patients [ 42 , 43 ], quand des craintes se faisaient aussi jour quant au risque d’effets indésirables chez les patients traités par immunothérapie [ 44 ]. Le moment idéal de la vaccination était discuté mais rapidement, une recommandation empirique s’est faite jour, d’administration juste avant une cure de chimiothérapie, en évitant la période du nadir hématologique post-chimiothérapie.…”