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Poster display session

3514 - Use of nivolumab in elderly patients with advanced Non-Squamous NSCLC: results from the Italian Expanded Access Program (EAP)

Date

09 Sep 2017

Session

Poster display session

Topics

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

Presenters

Maria Rita Migliorino

Citation

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

Authors

M.R. Migliorino1, A. Gelibter2, F. Grossi3, D. Fagnani4, P. Bordi5, T. Franchina6, D. Turci7, L. Di Lauro8, S. Cascinu9, L. Calabro10, M. Brighenti11, N. Tedde12, A. Bearz13, S. Giusti14, E. Vasile15, G. Surico16, G. Cartenì17, P. Marchetti18, F. Verderame19, B. Melotti20

Author affiliations

  • 1 Pulmonary Oncology Unit, Azienda Ospedaliera S. Camillo Forlanini, 152 - Roma/IT
  • 2 Oncology, Policlinico Umberto I, 00162 - Rome/IT
  • 3 Medical Oncology, Policlinico San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, 16132 - Genova/IT
  • 4 Vimercate, ASST, Vimercate/IT
  • 5 Medical Oncology Unit, University Hospital of Parma, 43126 - Parma/IT
  • 6 Medical Oncology, AO Papardo e Università di Messina, 98158 - Messina/IT
  • 7 Medical Oncology, Ospedale “S.Maria delle Croci, 48400 - Ravenna/IT
  • 8 Medical Oncology, IFO Regina Elena, 00144 - Rome/IT
  • 9 Department Of Oncology  , Università di Modena e Reggio Emilia, 41124 - Modena/IT
  • 10 Medical Oncology And Immunotherapy, University Hospital of Siena, 53100 - Siena/IT
  • 11 Medical Oncology, Istituti Ospitalieri, Cremona, 26100 - Cremona/IT
  • 12 Medical Oncology, Presidio Ospedaliero di Olbia, olbia/IT
  • 13 Medical Oncology, Cro, 33081 - Pordenone/IT
  • 14 Medical Oncology, Azienda ASL 8, Arezzo, arezzo/IT
  • 15 Medical Oncology, AOU Pisana "Spedali Riuniti di S. Chiara, pisa/IT
  • 16 Medical Oncology, Presidio Ospedaliero “Vito Fazzi”, Lecce/IT
  • 17 Medical Oncology, AO del Colli, Monaldi-Cotugno-CTO, napoli/IT
  • 18 Medical Oncology, Azienda Ospedaliera St. Andrea, 00189 - Roma/IT
  • 19 Medical Oncology, Azienda Ospedaliera "Villa Sofia - Cervello", Palermo/IT
  • 20 Medical Oncology, Policlinico Sant'Orsola-Malpighi, bologna/IT
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Resources

Abstract 3514

Background

The efficacy and safety of nivolumab in patients with non-squamous non-small cell lung cancer (Non-Sq-NSCLC) have been demonstrated in several trials including the phase 3, randomized, controlled CheckMate 057 study which led to the approval of the product for this indication. However, data on the use of nivolumab in the real-BVLworld setting is still limited. The Italian nivolumab EAP for Non-Sq-NSCLC represents an important source of information. The current analysis describes results of the use of nivolumab in the group of EAP patients (pts) aged >70 and >75 years.

Methods

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/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 (AEs) using Common Terminology Criteria for Adverse Events.

Results

Of 1588 Italian pts with advanced non-Sq-NSCLC participating in the EAP in Italy, 522 (33%) were ≥70 years and 232 (15%) were ≥75 years. The median follow up was 7.6 months (0.1-20.8) and 8.3 (0.1-20), respectively. For pts aged ≥70, median number of doses was 9 (1-44) and the disease control rate (DCR) was 48%, including 2 pts with a complete response (CR), 106pts with a partial response (PR) and 145 with stable disease (SD). For pts aged ≥75, median number of doses was 11 (1-39) and the DCR was 53%, including 58pts with a PR and 64 with SD. Among pts aged >70, 403 discontinued treatment for any reason, with only 25 (5%) discontinuation due to related AEs vs 177 discontinuation for any reason, with only 13 (6%) due to related AEs among pts aged >75. As of March 2017, median overall survival was 11.5 months (10.0-13.0) and 12.0 months (9.2-14.8) respectively in ptsaged ≥70 and ≥75. The efficacy, safety and drug-related discontinuation results are in line with what observed in the general population.

Conclusions

These results suggest that elderly population receive similar benefit from nivolumab treatment both in term of efficacy and safety than younger patients, supporting the use of nivolumab in this subpopulation.

Clinical trial identification

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

All authors have declared no conflicts of interest.

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