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Poster display session

3521 - Efficacy and safety data from patients with advanced non-squamous NSCLC and brain metastases from the nivolumab Expanded Access Programme (EAP) in Italy


09 Sep 2017


Poster display session


Cancers in Adolescents and Young Adults (AYA);  Immunotherapy;  Non-Small Cell Lung Cancer


Lucio Crinò


Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380


L. Crinò1, P. Bidoli2, F. Roila3, E. Cortesi4, M. Garassino5, F. Cappuzzo6, F. Grossi7, G. Tonini8, G. Sarobba9, G. Pinotti10, G. Numico11, R. Samaritani12, L. Ciuffreda13, A. Frassoldati14, M. Bregni15, A. Santo16, F.V. Piantedosi17, I. Alfonso18, F. De Marinis19, A. Delmonte20

Author affiliations

  • 1 Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)- IRCCS, 47014 - Meldola/IT
  • 2 Medical Oncology Unit, San Gerardo Hospital, Monza (MI)/IT
  • 3 Medical Oncology, Azienda Ospedaliera Sta Maria, 5100 - Terni/IT
  • 4 Medical Oncology Unit, Policlinico Umberto I, 161 - Roma/IT
  • 5 Clinical Oncology, Isituto Nazionale dei Tumori, 20133 - Milano/IT
  • 6 Oncology And Hematology, Ospedale Civile di Ravenna - S.ta Maria delle Croci, 48121 - Ravenna/IT
  • 7 Medical Oncology Unit, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, 16132 - Genova/IT
  • 8 Oncology, Campus Bio-Medico di Roma, 128 - Roma/IT
  • 9 Medical Oncology, AUSL3, Nuoro/IT
  • 10 Oncology, Ospedale di Circolo Fondazione Macchi, 21050 - Varese/IT
  • 11 Medical Oncology, Ospedale SS. Antonio e Biagio, Alessandria/IT
  • 12 Oncology, PTP Nuovo Regina Margherita, 153 - Roma/IT
  • 13 Oncology, Città della salute e della Scienza di Torino, Torino/IT
  • 14 Medical Oncology, Azienda Ospedaliera di Ferrara St. Anna, 44100 - Ferrara/IT
  • 15 Oncology, Ospedale di Busto Arsizio, 21052 - Busto Arsizio/IT
  • 16 Medical Oncology, University of Verona, 37134 - Verona/IT
  • 17 Oncology, Azienda Ospedaliera Dei Colli-Monaldi, 80131 - Napoli/IT
  • 18 Ao Del Colli, Ospedale Monaldi-Cotugno-CTO, Napoli/IT
  • 19 Oncologia, Istituto Europeo di Oncologia, Milano/IT
  • 20 Oncology, Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT


Abstract 3521


Brain metastases are a very common secondary localization of disease in patients (pts) with lung cancer. The prognosis of these pts is still poor and they are usually excluded from clinical trials. The EAP offered an opportunity to evaluate nivolumab treatment in these patients outside of a controlled clinical trial in Italy.


Nivolumab was available upon physician request for pts aged ≥18 years with a diagnosis of non-squamous non-small cell lung cancer (non-Sq-NSCLC) who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV non-Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events using Common Terminology Criteria for Adverse Events. Pts with brain metastasis were eligible if asymptomatic, neurologically stable and either off corticosteroids or on a stable dose or decreasing dose of ≤ 10 mg daily prednisone.


Of 1588 patients with non-Sq-NSCLC participating in the EAP in Italy, 409 (26%) had asymptomatic and controlled brain metastases. With a median number of 7 doses (1-45) and a median follow-up of 6.1 months (0.1-21.9), the disease control rate was 40%, including 3 pts with a complete response, 65 patients with a partial response and 96 with stable disease. As of March 2017, median overall survival among patients with brain metastases was 8.1 (6.2-10.1) months. Among these pts, 117 were receiving steroid therapy at baseline and 74 received concomitant radiotherapy. Overall, safety profile and discontinuations for drug-related toxicity were consistent with what observed in the general population.


These preliminary data showed efficacy of nivolumab in patients with non-Sq-NSCLC with brain metastases, with safety results consistent to what already reported in controlled clinical trials, thus supporting the use of nivolumab in this population with poor prognosis.

Clinical trial identification


Legal entity responsible for the study

Lucio Crinò




All authors have declared no conflicts of interest.

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