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Poster display

4057 - Efficacy and safety of nivolumab in elderly patients (pts) with advanced squamous non small cell lung cancer (Sq-NSCLC) participating in the expanded access programme (EAP) in Italy


09 Oct 2016


Poster display


Francesco Grossi


Annals of Oncology (2016) 27 (6): 359-378. 10.1093/annonc/mdw378


F. Grossi1, L. Crinò2, A. Misino3, P. Bidoli4, A. Delmonte5, F. Gelsomino6, C. Proto7, M. Mancini8, L. Landi9, D. Turci10, S. Quadrini11, P. Antonelli12, P. Marchetti13, L. Toschi14, S. Giusti15, F. Di Costanzo16, F. Rastelli17, P. Sandri18, V. Scotti19, F. de Marinis20

Author affiliations

  • 1 Lung Cancer Unit, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, 16132 - Genova/IT
  • 2 Oncology, Perugia University Hospital, Perugia/IT
  • 3 Medical Oncology, Istituto Tumori Giovanni Paolo II, Bari/IT
  • 4 Oncology, Azienda Ospedaliera S. Gerardo U.O. Oncologia Medica, 20052 - Monza/IT
  • 5 Thoracic Pathology, Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 6 Medical Oncology, Policlinico S. Orsola-Malpighi, Bologna/IT
  • 7 Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano/IT
  • 8 Medicina Sperimentale, Policlinico Umberto I, 00161 - Roma/IT
  • 9 Medical Oncology, Ospedali Riuniti Livorno, Livorno/IT
  • 10 Medical Oncology, Ospedale Sta Maria delle Croci, 48400 - Ravenna/IT
  • 11 Oncologia Medica, Ospedale SS Trinità, 03039 - Sora/IT
  • 12 Medical Oncology, Ospedale di Busto Arsizio, Busto Arsizio/IT
  • 13 Clinical And Molecular Medicine Department, Sapienza University, Sant'Andrea Hospital, 00189 - Rome/IT
  • 14 Medical Oncology, Istituto Clinico Humanitas, 20089 - Rozzano/IT
  • 15 Medical Oncology, ASL 8, Arezzo/IT
  • 16 Dipartimento Di Oncologia, Azienda Ospedaliera Careggi U.O. Medical Oncology, 50134 - Firenze/IT
  • 17 Medical Oncology, ASUR Marche Area Vasta 4, Fermo/IT
  • 18 Medical Oncology, Azienda Ospedaliera Sta Maria degli Angeli, Pordenone/IT
  • 19 Sodc Radioterapia Oncologica Dai Oncologia, Azienda Ospedaliera Universitaria Careggi, Firenze/IT
  • 20 1 Unità Operativa Di Pneumologia Oncologica, Istituto Europeo di Oncologia, 20141 - Milano/IT


Abstract 4057


As a result of an increasing life expectancy, the incidence of lung cancer diagnosed in the elderly population is rising. Despite the high frequency of NSCLC in this population, elderly pts are frequently underrepresented in clinical trials since aging is associated with a significant prevalence of comorbid diseases. The purpose of this analysis is to focus on treatment with nivolumab in the elderly population (≥75 years) with advanced Sq-NSCLC from the EAP in Italy, namely in the real word setting representing a more realistic picture of clinical practice.


Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV Sq-NSCLC. Nivolumab 3 mg/kg is 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 (AEs) using Common Terminology Criteria for Adverse Events.


Of 372 Italian pts with advanced Sq-NSCLC participating in the EAP in Italy, 70 (18.8%) were ≥75 years; of these, 68 pts were evaluable for response. With a median number of doses of 7 (range, 1–20) and a median follow-up of 4.7 months, the disease control rate was 42.9%, including 13 pts with a partial response and 17 with stable disease. Sixteen pts were treated beyond RECIST defined progression, with 5 of these who achieved a disease control. As of April 2016, median progression-free survival and median overall survival among all elderly pts were 3.2 and 7.6 months, respectively. Among 70 pts, 41 pts (58.6%) discontinued treatment for any reason except toxicity; 8 out of 70 discontinued due to AE (11.4%).


These results suggest that elderly population can benefit from nivolumab treatment with safety results consistent to what previously reported, supporting the use of nivolumab in this subpopulation.

Clinical trial identification

Legal entity responsible for the study

Bristol Myers Squibb


Bristol Myers Squibb


F. Grossi: Advisory boards of BMS during the conduct of the study. P. Bidoli: Advisory role for BMS on the Nivolumab EAP board and in other occasions. All other authors have declared no conflicts of interest.

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