58P - INfluenza Vaccine Indication During anticancer therapy with Immune-checkpoint inhibitors: a transversal challenge for patient’s counselling – preli...

Date 08 December 2017
Event ESMO Immuno-Oncology Congress 2017
Session Lunch & Poster Display session
Topics Bioethics, Legal, and Economic Issues
Presenter Melissa Bersanelli
Citation Annals of Oncology (2017) 28 (suppl_11): xi6-xi29. 10.1093/annonc/mdx711
Authors M. Bersanelli1, P. Castrignanò1, E. Gambale2, A. Cortellini3, M. Tiseo1, C. Natoli2, C. Ficorella4, S. Panni5, S. Rossetti6, A. Papa7, F. Mazzoni8, G. Facchini6, U. De Giorgi9, G. Procopio10, F. Atzori11, T. Sava12, E. De Luca13, A. Maestri14, F. Massari15, S. Buti1
  • 1Medical Oncology, University Hospital of Parma, 43126 - Parma/IT
  • 2Medical Science Department, University G. D'Annunzio of Chieti and Pescara, Chieti/IT
  • 3Dipartimento Di Scienze Cliniche Applicate E Biotecnologiche, University of L'Aquila, 67100 - L'Aquila/IT
  • 4Dipartimento Di Scienze Cliniche Applicate E Biotecnologiche, University of L'Aquila, L'Aquila/IT
  • 5Medical Oncology, ASST Istituti Ospitalieri di Cremona, Cremona/IT
  • 6Medical Oncology, Istituto Nazionale Tumori 'Fondazione G. Pascale', Napoli/IT
  • 7Dipartimento Di Scienze Medico-chirurgiche E Biotecnologie, University of Rome "La Sapienza", Latina/IT
  • 8Medical Oncology, University Hospital Careggi, Firenze/IT
  • 9Medical Oncology, stituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS, Meldola/IT
  • 10Genitourinary Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano/IT
  • 11Medical Oncology, University Hospital of Cagliari, Cagliari/IT
  • 12Medical Oncology, Camposampiero Hospital, Padova/IT
  • 13Medical Oncology, Ordine Mauriziano Hospital, Torino/IT
  • 14Medical Oncology, Ospedale Santa Maria della Scaletta, AUSL di Imola, Imola/IT
  • 15Medical Oncology, University Hospital Sant'Orsola-Malpighi of Bologna, Bologna/IT



Split vaccines are allowed during treatment with immune-checkpoint inhibitors (CKI) and flu vaccine is recommended in cancer patients, despite it seem to amplify immune-related adverse events of CKI and it may be not necessary, since immunotherapy enhances cellular and humoral immunity. We planned a retrospective study at 24 Italian centers, to compare the occurrence of flu syndrome in advanced cancer patients treated with CKI receiving or not flu vaccine. Overall survival (OS) was also evaluated.


For this preliminary analysis, consecutive data from patients undergoing treatment with CKI at 14 Italian centers from November 2016 to May 2017 were analyzed. Only patients who started CKI after 1th of January 2016 were enrolled.


203 patients (I-VII treatment line; 77 renal carcinoma, 73 lung cancer, 40 melanoma, 13 others) were enrolled. Median OS was not reached at the median follow-up of 10.2 months (172 censored). 50 patients received flu vaccine. Median time from CKI starting to vaccine was 2 months (mean 3 months). Overall, 29 patients developed flu syndrome: its incidence among vaccinated patients was 30% vs 9.2% of unvaccinated (OR 3.28 95%CI 1.70-6.33, p 0.001). Median time from vaccine to flu syndrome was 2 months (mean 3 months). At 18 months, OS of vaccine group was 83% vs 63% of unvaccinated (p 0.134). Patients who developed flu syndrome had a non-statistically significant trend for better OS compared with unaffected patients (92% vs 63% at 18 months, p 0.127). The 64 patients who had vaccine and/or influenza had significantly better OS (OR 0.52, p 0.049) compared with those not vaccinated nor infected (85% vs 59% at 18 months). At multivariate analysis only treatment response was significantly related to OS (OR 7.3, 95%CI 3.9-13.5, p 


With the limit of retrospective study and immature data, it seems that the incidence of influenza among advanced cancer patients treated with CKI is boosted by flu vaccine. Nevertheless, to receive flu vaccine or to develop flu syndrome may prolong survival. Flu vaccine seems to be ineffective in these patients, but it might have positive effect on outcome.

Clinical trial identification

Not applicable.This retrospective observational study has been approved by the local Ethic Committee.

Legal entity responsible for the study

Medical Oncology Unit of the University Hospital of Parma, Italy, Principal Investigator Dr. Sebastiano Buti




All authors have declared no conflicts of interest.