Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG
Background: This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint...
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2020-10-01
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| Series: | Therapeutic Advances in Medical Oncology |
| Online Access: | https://doi.org/10.1177/1758835920968463 |
| _version_ | 1818340901133484032 |
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| author | Melissa Bersanelli Diana Giannarelli Ugo De Giorgi Sandro Pignata Massimo Di Maio Elena Verzoni Alberto Clemente Valentina Guadalupi Diego Signorelli Marcello Tiseo Raffaele Giusti Marco Filetti Marilena Di Napoli Lorenzo Calvetti Alessandro Cappetta Paola Ermacora Diego Zara Fausto Barbieri Cinzia Baldessari Vieri Scotti Francesca Mazzoni Antonello Veccia Pamela Francesca Guglielmini Marco Maruzzo Ernesto Rossi Francesco Grossi Chiara Casadei Alessio Cortellini Francesco Verderame Vincenzo Montesarchio Mimma Rizzo Manlio Mencoboni Fable Zustovich Lucia Fratino Saverio Cinieri Giorgia Negrini Maria Banzi Mariella Sorarù Paolo Andrea Zucali Gaetano Lacidogna Antonio Russo Nicola Battelli Giuseppe Fornarini Claudia Mucciarini Sergio Bracarda Andrea Bonetti Debora Pezzuolo Lucia Longo Donata Sartori Mauro Iannopollo Luigi Cavanna Fausto Meriggi Davide Tassinari Claudia Corbo Angela Gernone Veronica Prati Simona Carnio Pasqualina Giordano Angela Maria Dicorato Claudio Verusio Francesco Atzori Francesco Carrozza Stefania Gori Antonino Castro Sara Pilotto Vanja Vaccaro Elisabetta Garzoli Francesco Di Costanzo Evaristo Maiello Roberto Labianca Carmine Pinto Michele Tognetto Sebastiano Buti |
| author_facet | Melissa Bersanelli Diana Giannarelli Ugo De Giorgi Sandro Pignata Massimo Di Maio Elena Verzoni Alberto Clemente Valentina Guadalupi Diego Signorelli Marcello Tiseo Raffaele Giusti Marco Filetti Marilena Di Napoli Lorenzo Calvetti Alessandro Cappetta Paola Ermacora Diego Zara Fausto Barbieri Cinzia Baldessari Vieri Scotti Francesca Mazzoni Antonello Veccia Pamela Francesca Guglielmini Marco Maruzzo Ernesto Rossi Francesco Grossi Chiara Casadei Alessio Cortellini Francesco Verderame Vincenzo Montesarchio Mimma Rizzo Manlio Mencoboni Fable Zustovich Lucia Fratino Saverio Cinieri Giorgia Negrini Maria Banzi Mariella Sorarù Paolo Andrea Zucali Gaetano Lacidogna Antonio Russo Nicola Battelli Giuseppe Fornarini Claudia Mucciarini Sergio Bracarda Andrea Bonetti Debora Pezzuolo Lucia Longo Donata Sartori Mauro Iannopollo Luigi Cavanna Fausto Meriggi Davide Tassinari Claudia Corbo Angela Gernone Veronica Prati Simona Carnio Pasqualina Giordano Angela Maria Dicorato Claudio Verusio Francesco Atzori Francesco Carrozza Stefania Gori Antonino Castro Sara Pilotto Vanja Vaccaro Elisabetta Garzoli Francesco Di Costanzo Evaristo Maiello Roberto Labianca Carmine Pinto Michele Tognetto Sebastiano Buti |
| author_sort | Melissa Bersanelli |
| collection | DOAJ |
| description | Background: This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint was the incidence of influenza-like illness (ILI) until 30 April 2020. All the ILI episodes, laboratory tests, complications, hospitalizations and pneumonitis were recorded. Therefore, the study prospectively recorded all the COVID-19 ILI events. Patients and methods: Patients were included in this non-prespecified COVID-19 analysis, if alive on 31 January 2020, when the Italian government declared the national emergency. The prevalence of confirmed COVID-19 cases was detected as ILI episode with laboratory confirmation of SARS-CoV-2. Cases with clinical-radiological diagnosis of COVID-19 (COVID-like ILIs), were also reported. Results: Out of 1257 enrolled patients, 955 matched the inclusion criteria for this unplanned analysis. From 31 January to 30 April 2020, 66 patients had ILI: 9 of 955 cases were confirmed COVID-19 ILIs, with prevalence of 0.9% [95% confidence interval (CI): 0.3–2.4], a hospitalization rate of 100% and a mortality rate of 77.8%. Including 5 COVID-like ILIs, the overall COVID-19 prevalence was 1.5% (95% CI: 0.5–3.1), with 100% hospitalization and 64% mortality. The presence of elderly, males and comorbidities was significantly higher among patients vaccinated against influenza versus unvaccinated ( p = 0.009, p < 0.0001, p < 0.0001). Overall COVID-19 prevalence was 1.2% for vaccinated (six of 482 cases, all confirmed) and 1.7% for unvaccinated (8 of 473, 3 confirmed COVID-19 and 5 COVID-like), p = 0.52. The difference remained non-significant, considering confirmed COVID-19 only ( p = 0.33). Conclusion: COVID-19 has a meaningful clinical impact on the cancer-patient population receiving ICIs, with high prevalence, hospitalization and an alarming mortality rate among symptomatic cases. Influenza vaccination does not protect from SARS-CoV-2 infection. |
| first_indexed | 2024-12-13T15:50:15Z |
| format | Article |
| id | doaj.art-56f65524e4484c51b38e78016965cac1 |
| institution | Directory Open Access Journal |
| issn | 1758-8359 |
| language | English |
| last_indexed | 2024-12-13T15:50:15Z |
| publishDate | 2020-10-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Medical Oncology |
| spelling | doaj.art-56f65524e4484c51b38e78016965cac12022-12-21T23:39:33ZengSAGE PublishingTherapeutic Advances in Medical Oncology1758-83592020-10-011210.1177/1758835920968463Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOGMelissa BersanelliDiana GiannarelliUgo De GiorgiSandro PignataMassimo Di MaioElena VerzoniAlberto ClementeValentina GuadalupiDiego SignorelliMarcello TiseoRaffaele GiustiMarco FilettiMarilena Di NapoliLorenzo CalvettiAlessandro CappettaPaola ErmacoraDiego ZaraFausto BarbieriCinzia BaldessariVieri ScottiFrancesca MazzoniAntonello VecciaPamela Francesca GuglielminiMarco MaruzzoErnesto RossiFrancesco GrossiChiara CasadeiAlessio CortelliniFrancesco VerderameVincenzo MontesarchioMimma RizzoManlio MencoboniFable ZustovichLucia FratinoSaverio CinieriGiorgia NegriniMaria BanziMariella SorarùPaolo Andrea ZucaliGaetano LacidognaAntonio RussoNicola BattelliGiuseppe FornariniClaudia MucciariniSergio BracardaAndrea BonettiDebora PezzuoloLucia LongoDonata SartoriMauro IannopolloLuigi CavannaFausto MeriggiDavide TassinariClaudia CorboAngela GernoneVeronica PratiSimona CarnioPasqualina GiordanoAngela Maria DicoratoClaudio VerusioFrancesco AtzoriFrancesco CarrozzaStefania GoriAntonino CastroSara PilottoVanja VaccaroElisabetta GarzoliFrancesco Di CostanzoEvaristo MaielloRoberto LabiancaCarmine PintoMichele TognettoSebastiano ButiBackground: This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint was the incidence of influenza-like illness (ILI) until 30 April 2020. All the ILI episodes, laboratory tests, complications, hospitalizations and pneumonitis were recorded. Therefore, the study prospectively recorded all the COVID-19 ILI events. Patients and methods: Patients were included in this non-prespecified COVID-19 analysis, if alive on 31 January 2020, when the Italian government declared the national emergency. The prevalence of confirmed COVID-19 cases was detected as ILI episode with laboratory confirmation of SARS-CoV-2. Cases with clinical-radiological diagnosis of COVID-19 (COVID-like ILIs), were also reported. Results: Out of 1257 enrolled patients, 955 matched the inclusion criteria for this unplanned analysis. From 31 January to 30 April 2020, 66 patients had ILI: 9 of 955 cases were confirmed COVID-19 ILIs, with prevalence of 0.9% [95% confidence interval (CI): 0.3–2.4], a hospitalization rate of 100% and a mortality rate of 77.8%. Including 5 COVID-like ILIs, the overall COVID-19 prevalence was 1.5% (95% CI: 0.5–3.1), with 100% hospitalization and 64% mortality. The presence of elderly, males and comorbidities was significantly higher among patients vaccinated against influenza versus unvaccinated ( p = 0.009, p < 0.0001, p < 0.0001). Overall COVID-19 prevalence was 1.2% for vaccinated (six of 482 cases, all confirmed) and 1.7% for unvaccinated (8 of 473, 3 confirmed COVID-19 and 5 COVID-like), p = 0.52. The difference remained non-significant, considering confirmed COVID-19 only ( p = 0.33). Conclusion: COVID-19 has a meaningful clinical impact on the cancer-patient population receiving ICIs, with high prevalence, hospitalization and an alarming mortality rate among symptomatic cases. Influenza vaccination does not protect from SARS-CoV-2 infection.https://doi.org/10.1177/1758835920968463 |
| spellingShingle | Melissa Bersanelli Diana Giannarelli Ugo De Giorgi Sandro Pignata Massimo Di Maio Elena Verzoni Alberto Clemente Valentina Guadalupi Diego Signorelli Marcello Tiseo Raffaele Giusti Marco Filetti Marilena Di Napoli Lorenzo Calvetti Alessandro Cappetta Paola Ermacora Diego Zara Fausto Barbieri Cinzia Baldessari Vieri Scotti Francesca Mazzoni Antonello Veccia Pamela Francesca Guglielmini Marco Maruzzo Ernesto Rossi Francesco Grossi Chiara Casadei Alessio Cortellini Francesco Verderame Vincenzo Montesarchio Mimma Rizzo Manlio Mencoboni Fable Zustovich Lucia Fratino Saverio Cinieri Giorgia Negrini Maria Banzi Mariella Sorarù Paolo Andrea Zucali Gaetano Lacidogna Antonio Russo Nicola Battelli Giuseppe Fornarini Claudia Mucciarini Sergio Bracarda Andrea Bonetti Debora Pezzuolo Lucia Longo Donata Sartori Mauro Iannopollo Luigi Cavanna Fausto Meriggi Davide Tassinari Claudia Corbo Angela Gernone Veronica Prati Simona Carnio Pasqualina Giordano Angela Maria Dicorato Claudio Verusio Francesco Atzori Francesco Carrozza Stefania Gori Antonino Castro Sara Pilotto Vanja Vaccaro Elisabetta Garzoli Francesco Di Costanzo Evaristo Maiello Roberto Labianca Carmine Pinto Michele Tognetto Sebastiano Buti Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG Therapeutic Advances in Medical Oncology |
| title | Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG |
| title_full | Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG |
| title_fullStr | Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG |
| title_full_unstemmed | Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG |
| title_short | Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG |
| title_sort | symptomatic covid 19 in advanced cancer patients treated with immune checkpoint inhibitors prospective analysis from a multicentre observational trial by ficog |
| url | https://doi.org/10.1177/1758835920968463 |
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