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. © The Author(s), 2020.
Original languageEnglish
Number of pages12
JournalTher. Adv. Med. Oncol.
Publication statusPublished - 2020


  • cancer patients
  • COVID-19
  • immune-checkpoint inhibitors
  • influenza-like illness
  • SARS-CoV-2
  • cytotoxic T lymphocyte antigen 4 antibody
  • immunomodulating agent
  • programmed death 1 ligand 1
  • adult
  • advanced cancer
  • aged
  • allele specific real time polymerase chain reaction
  • Article
  • cancer chemotherapy
  • cancer immunotherapy
  • cancer patient
  • cancer staging
  • comorbidity
  • computer assisted tomography
  • coronavirus disease 2019
  • dyspnea
  • female
  • fever
  • flu like syndrome
  • follow up
  • hospitalization
  • human
  • hypertension
  • immunotherapy
  • influenza vaccination
  • life expectancy
  • lymphocyte count
  • major clinical study
  • male
  • middle aged
  • mortality rate
  • multicenter study
  • observational study
  • overall survival
  • prevalence
  • priority journal
  • prospective study
  • real time polymerase chain reaction
  • thorax radiography
  • throat culture
  • virus pneumonia

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