1079P - Efficacy and safety of nivolumab in elderly patients (pts) with advanced squamous non small cell lung cancer (Sq-NSCLC) participating in the expand...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Immunotherapy
Presenter Francesco Grossi
Citation Annals of Oncology (2016) 27 (6): 359-378. 10.1093/annonc/mdw378
Authors 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
  • 1Lung Cancer Unit, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, 16132 - Genova/IT
  • 2Oncology, Perugia University Hospital, Perugia/IT
  • 3Medical Oncology, Istituto Tumori Giovanni Paolo II, Bari/IT
  • 4Oncology, Azienda Ospedaliera S. Gerardo U.O. Oncologia Medica, 20052 - Monza/IT
  • 5Thoracic Pathology, Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 6Medical Oncology, Policlinico S. Orsola-Malpighi, Bologna/IT
  • 7Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano/IT
  • 8Medicina Sperimentale, Policlinico Umberto I, 00161 - Roma/IT
  • 9Medical Oncology, Ospedali Riuniti Livorno, Livorno/IT
  • 10Medical Oncology, Ospedale Sta Maria delle Croci, 48400 - Ravenna/IT
  • 11Oncologia Medica, Ospedale SS Trinità, 03039 - Sora/IT
  • 12Medical Oncology, Ospedale di Busto Arsizio, Busto Arsizio/IT
  • 13Clinical And Molecular Medicine Department, Sapienza University, Sant'Andrea Hospital, 00189 - Rome/IT
  • 14Medical Oncology, Istituto Clinico Humanitas, 20089 - Rozzano/IT
  • 15Medical Oncology, ASL 8, Arezzo/IT
  • 16Dipartimento Di Oncologia, Azienda Ospedaliera Careggi U.O. Medical Oncology, 50134 - Firenze/IT
  • 17Medical Oncology, ASUR Marche Area Vasta 4, Fermo/IT
  • 18Medical Oncology, Azienda Ospedaliera Sta Maria degli Angeli, Pordenone/IT
  • 19Sodc Radioterapia Oncologica Dai Oncologia, Azienda Ospedaliera Universitaria Careggi, Firenze/IT
  • 201 Unità Operativa Di Pneumologia Oncologica, Istituto Europeo di Oncologia, 20141 - Milano/IT



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.