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Impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (INVIDIa-2): final results of the multicentre, prospective, observational study

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 p...

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Autores principales: Bersanelli, Melissa, Verzoni, Elena, Cortellini, Alessio, Giusti, Raffaele, Calvetti, Lorenzo, Ermacora, Paola, Di Napoli, Marilena, Catino, Annamaria, Guadalupi, Valentina, Guaitoli, Giorgia, Scotti, Vieri, Mazzoni, Francesca, Veccia, Antonello, Guglielmini, Pamela Francesca, Perrone, Fabiana, Maruzzo, Marco, Rossi, Ernesto, Casadei, Chiara, Montesarchio, Vincenzo, Grossi, Francesco, Rizzo, Mimma, Travagliato Liboria, Maria Grazia, Mencoboni, Manlio, Zustovich, Fable, Fratino, Lucia, Accettura, Caterina, Cinieri, Saverio, Camerini, Andrea, Sorarù, Mariella, Zucali, Paolo Andrea, Ricciardi, Serena, Russo, Antonio, Negrini, Giorgia, Banzi, Maria Chiara, Lacidogna, Gaetano, Fornarini, Giuseppe, Laera, Letizia, Mucciarini, Claudia, Santoni, Matteo, Mosillo, Claudia, Bonetti, Andrea, Longo, Lucia, Sartori, Donata, Baldini, Editta, Guida, Michele, Iannopollo, Mauro, Bordonaro, Roberto, Morelli, Maria Francesca, Tagliaferri, Pierosandro, Spada, Massimiliano, Ceribelli, Anna, Silva, Rosa Rita, Nolè, Franco, Beretta, Giordano, Giovanis, Petros, Santini, Daniele, Luzi Fedeli, Stefano, Nanni, Oriana, Maiello, Evaristo, Labianca, Roberto, Pinto, Carmine, Clemente, Alberto, Tognetto, Michele, De Giorgi, Ugo, Pignata, Sandro, Di Maio, Massimo, Buti, Sebastiano, Giannarelli, Diana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10331809/
https://www.ncbi.nlm.nih.gov/pubmed/37434748
http://dx.doi.org/10.1016/j.eclinm.2023.102044
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author Bersanelli, Melissa
Verzoni, Elena
Cortellini, Alessio
Giusti, Raffaele
Calvetti, Lorenzo
Ermacora, Paola
Di Napoli, Marilena
Catino, Annamaria
Guadalupi, Valentina
Guaitoli, Giorgia
Scotti, Vieri
Mazzoni, Francesca
Veccia, Antonello
Guglielmini, Pamela Francesca
Perrone, Fabiana
Maruzzo, Marco
Rossi, Ernesto
Casadei, Chiara
Montesarchio, Vincenzo
Grossi, Francesco
Rizzo, Mimma
Travagliato Liboria, Maria Grazia
Mencoboni, Manlio
Zustovich, Fable
Fratino, Lucia
Accettura, Caterina
Cinieri, Saverio
Camerini, Andrea
Sorarù, Mariella
Zucali, Paolo Andrea
Ricciardi, Serena
Russo, Antonio
Negrini, Giorgia
Banzi, Maria Chiara
Lacidogna, Gaetano
Fornarini, Giuseppe
Laera, Letizia
Mucciarini, Claudia
Santoni, Matteo
Mosillo, Claudia
Bonetti, Andrea
Longo, Lucia
Sartori, Donata
Baldini, Editta
Guida, Michele
Iannopollo, Mauro
Bordonaro, Roberto
Morelli, Maria Francesca
Tagliaferri, Pierosandro
Spada, Massimiliano
Ceribelli, Anna
Silva, Rosa Rita
Nolè, Franco
Beretta, Giordano
Giovanis, Petros
Santini, Daniele
Luzi Fedeli, Stefano
Nanni, Oriana
Maiello, Evaristo
Labianca, Roberto
Pinto, Carmine
Clemente, Alberto
Tognetto, Michele
De Giorgi, Ugo
Pignata, Sandro
Di Maio, Massimo
Buti, Sebastiano
Giannarelli, Diana
author_facet Bersanelli, Melissa
Verzoni, Elena
Cortellini, Alessio
Giusti, Raffaele
Calvetti, Lorenzo
Ermacora, Paola
Di Napoli, Marilena
Catino, Annamaria
Guadalupi, Valentina
Guaitoli, Giorgia
Scotti, Vieri
Mazzoni, Francesca
Veccia, Antonello
Guglielmini, Pamela Francesca
Perrone, Fabiana
Maruzzo, Marco
Rossi, Ernesto
Casadei, Chiara
Montesarchio, Vincenzo
Grossi, Francesco
Rizzo, Mimma
Travagliato Liboria, Maria Grazia
Mencoboni, Manlio
Zustovich, Fable
Fratino, Lucia
Accettura, Caterina
Cinieri, Saverio
Camerini, Andrea
Sorarù, Mariella
Zucali, Paolo Andrea
Ricciardi, Serena
Russo, Antonio
Negrini, Giorgia
Banzi, Maria Chiara
Lacidogna, Gaetano
Fornarini, Giuseppe
Laera, Letizia
Mucciarini, Claudia
Santoni, Matteo
Mosillo, Claudia
Bonetti, Andrea
Longo, Lucia
Sartori, Donata
Baldini, Editta
Guida, Michele
Iannopollo, Mauro
Bordonaro, Roberto
Morelli, Maria Francesca
Tagliaferri, Pierosandro
Spada, Massimiliano
Ceribelli, Anna
Silva, Rosa Rita
Nolè, Franco
Beretta, Giordano
Giovanis, Petros
Santini, Daniele
Luzi Fedeli, Stefano
Nanni, Oriana
Maiello, Evaristo
Labianca, Roberto
Pinto, Carmine
Clemente, Alberto
Tognetto, Michele
De Giorgi, Ugo
Pignata, Sandro
Di Maio, Massimo
Buti, Sebastiano
Giannarelli, Diana
author_sort Bersanelli, Melissa
collection PubMed
description 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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spelling pubmed-103318092023-07-11 Impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (INVIDIa-2): final results of the multicentre, prospective, observational study Bersanelli, Melissa Verzoni, Elena Cortellini, Alessio Giusti, Raffaele Calvetti, Lorenzo Ermacora, Paola Di Napoli, Marilena Catino, Annamaria Guadalupi, Valentina Guaitoli, Giorgia Scotti, Vieri Mazzoni, Francesca Veccia, Antonello Guglielmini, Pamela Francesca Perrone, Fabiana Maruzzo, Marco Rossi, Ernesto Casadei, Chiara Montesarchio, Vincenzo Grossi, Francesco Rizzo, Mimma Travagliato Liboria, Maria Grazia Mencoboni, Manlio Zustovich, Fable Fratino, Lucia Accettura, Caterina Cinieri, Saverio Camerini, Andrea Sorarù, Mariella Zucali, Paolo Andrea Ricciardi, Serena Russo, Antonio Negrini, Giorgia Banzi, Maria Chiara Lacidogna, Gaetano Fornarini, Giuseppe Laera, Letizia Mucciarini, Claudia Santoni, Matteo Mosillo, Claudia Bonetti, Andrea Longo, Lucia Sartori, Donata Baldini, Editta Guida, Michele Iannopollo, Mauro Bordonaro, Roberto Morelli, Maria Francesca Tagliaferri, Pierosandro Spada, Massimiliano Ceribelli, Anna Silva, Rosa Rita Nolè, Franco Beretta, Giordano Giovanis, Petros Santini, Daniele Luzi Fedeli, Stefano Nanni, Oriana Maiello, Evaristo Labianca, Roberto Pinto, Carmine Clemente, Alberto Tognetto, Michele De Giorgi, Ugo Pignata, Sandro Di Maio, Massimo Buti, Sebastiano Giannarelli, Diana eClinicalMedicine Articles 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. Elsevier 2023-06-29 /pmc/articles/PMC10331809/ /pubmed/37434748 http://dx.doi.org/10.1016/j.eclinm.2023.102044 Text en © 2023 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Articles
Bersanelli, Melissa
Verzoni, Elena
Cortellini, Alessio
Giusti, Raffaele
Calvetti, Lorenzo
Ermacora, Paola
Di Napoli, Marilena
Catino, Annamaria
Guadalupi, Valentina
Guaitoli, Giorgia
Scotti, Vieri
Mazzoni, Francesca
Veccia, Antonello
Guglielmini, Pamela Francesca
Perrone, Fabiana
Maruzzo, Marco
Rossi, Ernesto
Casadei, Chiara
Montesarchio, Vincenzo
Grossi, Francesco
Rizzo, Mimma
Travagliato Liboria, Maria Grazia
Mencoboni, Manlio
Zustovich, Fable
Fratino, Lucia
Accettura, Caterina
Cinieri, Saverio
Camerini, Andrea
Sorarù, Mariella
Zucali, Paolo Andrea
Ricciardi, Serena
Russo, Antonio
Negrini, Giorgia
Banzi, Maria Chiara
Lacidogna, Gaetano
Fornarini, Giuseppe
Laera, Letizia
Mucciarini, Claudia
Santoni, Matteo
Mosillo, Claudia
Bonetti, Andrea
Longo, Lucia
Sartori, Donata
Baldini, Editta
Guida, Michele
Iannopollo, Mauro
Bordonaro, Roberto
Morelli, Maria Francesca
Tagliaferri, Pierosandro
Spada, Massimiliano
Ceribelli, Anna
Silva, Rosa Rita
Nolè, Franco
Beretta, Giordano
Giovanis, Petros
Santini, Daniele
Luzi Fedeli, Stefano
Nanni, Oriana
Maiello, Evaristo
Labianca, Roberto
Pinto, Carmine
Clemente, Alberto
Tognetto, Michele
De Giorgi, Ugo
Pignata, Sandro
Di Maio, Massimo
Buti, Sebastiano
Giannarelli, Diana
Impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (INVIDIa-2): final results of the multicentre, prospective, observational study
title Impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (INVIDIa-2): final results of the multicentre, prospective, observational study
title_full Impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (INVIDIa-2): final results of the multicentre, prospective, observational study
title_fullStr Impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (INVIDIa-2): final results of the multicentre, prospective, observational study
title_full_unstemmed Impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (INVIDIa-2): final results of the multicentre, prospective, observational study
title_short Impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (INVIDIa-2): final results of the multicentre, prospective, observational study
title_sort impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (invidia-2): final results of the multicentre, prospective, observational study
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10331809/
https://www.ncbi.nlm.nih.gov/pubmed/37434748
http://dx.doi.org/10.1016/j.eclinm.2023.102044
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