1. Impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (INVIDIa-2): final results of the multicentre, prospective, observational studyResearch in context
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Melissa Bersanelli, Elena Verzoni, Alessio Cortellini, Raffaele Giusti, Lorenzo Calvetti, Paola Ermacora, Marilena Di Napoli, Annamaria Catino, Valentina Guadalupi, Giorgia Guaitoli, Vieri Scotti, Francesca Mazzoni, Antonello Veccia, Pamela Francesca Guglielmini, Fabiana Perrone, Marco Maruzzo, Ernesto Rossi, Chiara Casadei, Vincenzo Montesarchio, Francesco Grossi, Mimma Rizzo, Maria Grazia Travagliato Liboria, Manlio Mencoboni, Fable Zustovich, Lucia Fratino, Caterina Accettura, Saverio Cinieri, Andrea Camerini, Mariella Sorarù, Paolo Andrea Zucali, Serena Ricciardi, Antonio Russo, Giorgia Negrini, Maria Chiara Banzi, Gaetano Lacidogna, Giuseppe Fornarini, Letizia Laera, Claudia Mucciarini, Matteo Santoni, Claudia Mosillo, Andrea Bonetti, Lucia Longo, Donata Sartori, Editta Baldini, Michele Guida, Mauro Iannopollo, Roberto Bordonaro, Maria Francesca Morelli, Pierosandro Tagliaferri, Massimiliano Spada, Anna Ceribelli, Rosa Rita Silva, Franco Nolè, Giordano Beretta, Petros Giovanis, Daniele Santini, Stefano Luzi Fedeli, Oriana Nanni, Evaristo Maiello, Roberto Labianca, Carmine Pinto, Alberto Clemente, Michele Tognetto, Ugo De Giorgi, Sandro Pignata, Massimo Di Maio, Sebastiano Buti, and Diana Giannarelli
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Influenza-like illness ,Influenza vaccination ,Flu vaccine ,Immune checkpoint inhibitors ,Cancer patients ,ICI ,Medicine (General) ,R5-920 - Abstract
Summary: 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.
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- 2023
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