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ABSTRACT: Background
The prospective multicentre observational INVIDIa-2 study investigated the clinical effectiveness of influenza vaccination in patients with advanced cancer receiving immune checkpoint inhibitors (ICI). In this secondary analysis of the original trial, we aimed to assess the outcomes of patients to immunotherapy based on vaccine administration.Methods
The original study enrolled patients with advanced solid tumours receiving ICI at 82 Italian Oncology Units from Oct 1, 2019, to Jan 31, 2020. The trial's primary endpoint was the time-adjusted incidence of influenza-like illness (ILI) until April 30, 2020, the results of which were reported previously. Secondary endpoints (data cut-off Jan 31, 2022) included the outcomes of patients to immunotherapy based on vaccine administration, for which the final results are reported herein. A propensity score matching by age, sex, performance status, primary tumour site, comorbidities, and smoking habits was planned for the present analysis. Only patients with available data for these variables were included. The outcomes of interest were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease-control rate (DCR).Findings
The original study population consisted of 1188 evaluable patients. After a propensity score matching, 1004 patients were considered (502 vaccinated and 502 unvaccinated), and 986 of them were evaluable for overall survival (OS). At the median follow-up of 20 months, the influenza vaccination demonstrated a favourable impact on the outcome receiving ICI in terms of median OS [27.0 months (CI 19.5-34.6) in vaccinated vs. 20.9 months (16.6-25.2) in unvaccinated, p = 0.003], median progression-free survival [12.5 months (CI 10.4-14.6) vs. 9.6 months (CI 7.9-11.4), p = 0.049], and disease-control rate (74.7% vs. 66.5%, p = 0.005). The multivariable analyses confirmed the favourable impact of influenza vaccination in terms of OS (HR 0.75, 95% C.I. 0.62-0.92; p = 0.005) and DCR (OR 1.47, 95% C.I. 1.11-1.96; p = 0.007).Interpretation
The INVIDIa-2 study results suggest a favourable immunological impact of influenza vaccination on the outcome of cancer patients receiving ICI immunotherapy, further encouraging the vaccine recommendation in this population and supporting translational investigations about the possible synergy between antiviral and antitumour immunity.Funding
The Federation of Italian Cooperative Oncology Groups (FICOG), Roche S.p.A., and Seqirus.
SUBMITTER: Bersanelli M
PROVIDER: S-EPMC10331809 | biostudies-literature | 2023 Jul
REPOSITORIES: biostudies-literature
Bersanelli Melissa M Verzoni Elena E Cortellini Alessio A Giusti Raffaele R Calvetti Lorenzo L Ermacora Paola P Di Napoli Marilena M Catino Annamaria A Guadalupi Valentina V Guaitoli Giorgia G Scotti Vieri V Mazzoni Francesca F Veccia Antonello A Guglielmini Pamela Francesca PF Perrone Fabiana F Maruzzo Marco M Rossi Ernesto E Casadei Chiara C Montesarchio Vincenzo V Grossi Francesco F Rizzo Mimma M Travagliato Liboria Maria Grazia MG Mencoboni Manlio M Zustovich Fable F Fratino Lucia L Accettura Caterina C Cinieri Saverio S Camerini Andrea A Sorarù Mariella M Zucali Paolo Andrea PA Ricciardi Serena S Russo Antonio A Negrini Giorgia G Banzi Maria Chiara MC Lacidogna Gaetano G Fornarini Giuseppe G Laera Letizia L Mucciarini Claudia C Santoni Matteo M Mosillo Claudia C Bonetti Andrea A Longo Lucia L Sartori Donata D Baldini Editta E Guida Michele M Iannopollo Mauro M Bordonaro Roberto R Morelli Maria Francesca MF Tagliaferri Pierosandro P Spada Massimiliano M Ceribelli Anna A Silva Rosa Rita RR Nolè Franco F Beretta Giordano G Giovanis Petros P Santini Daniele D Luzi Fedeli Stefano S Nanni Oriana O Maiello Evaristo E Labianca Roberto R Pinto Carmine C Clemente Alberto A Tognetto Michele M De Giorgi Ugo U Pignata Sandro S Di Maio Massimo M Buti Sebastiano S Giannarelli Diana D
EClinicalMedicine 20230629
<h4>Background</h4>The prospective multicentre observational INVIDIa-2 study investigated the clinical effectiveness of influenza vaccination in patients with advanced cancer receiving immune checkpoint inhibitors (ICI). In this secondary analysis of the original trial, we aimed to assess the outcomes of patients to immunotherapy based on vaccine administration.<h4>Methods</h4>The original study enrolled patients with advanced solid tumours receiving ICI at 82 Italian Oncology Units from Oct 1, ...[more]