Author of

• 16722

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  P1.04 - Poster Session with Presenters Present (ID 456)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Pulmonology
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 16734

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    P1.04-012 - Single Center Experience with Nivolumab Administration in NSCLC Patients from EAP Program (ID 4862)

    14:30 - 14:30  |  Author(s): G.-. Krakorova
    • Abstract

    Background:
    Immunotherapy using monoclonal antibody against PD-1 receptor (nivolumab) offers another possibility to improve tumor control in patients with advanced squamous (SQ) and non-squamous (NSQ) NSCLC.
    
    Methods:
    We present first experience with nivolumab in Early Access Program (EAP). Nivolumab tolerability, safety data, frequency of therapeutic responses and ADRs will be presented in 42 patients with advanced SQ and NSQ NSCLC.
    
    Results:
    22 patients with SQ-NSCLC entered EAP, 3 patients did not start therapy (2 early deaths and 1 refusal) and 19 patients received treatment (16 males, 3 females). Therapy was discontinued in 9 patients (7x disease progression, 2x serious ADR). Therapy is currently withold in 4 patients due to management of ADRs and 7 patients continue to receive nivolumab. 5 patients died (26%) with median follow up of 9 months in this group. 20 patients with NSQ histology were included in EAP, 2 patients from this group died before initiation of therapy and 1 patient did not receive nivolumab due to worsening of her performance status. 17 patients were treated with at least one dose of nivolumab (10 males, 7 females). Therapy was discontinued in 8 patients (7x disease progression, 1x due to gastrointestinal toxicity with grade 3 diarrhea). Treatment is currently withold in 6 patients due to management of ADRs and 4 patients continue to receive nivolumab. 5 patients (29%) in this group died with median follow up of 5 months. So far, we have seen 7 partial remissions in all 36 treated patients with NSCLC (19%) which corresponds to data from registration studies of nivolumab. Disease stabilization was reported in other 7 patients giving the disease control rate of 38%. As expected from nivolumab mechanism of action, adverse drug reactions are usually immune related. Serious ADRs were rarely observed including neurological toxicity (difficulty to swallow and diplopia), diarrhea, pneumonitis and skin toxicity (lichen ruber planus).
    
    Conclusion:
    In general, patients from EAP program were more pretreated compared to patients in registration studies (therapy allowed in 3rd and 4th line), also patients with PS2 were included (only PS 0 and 1 in the trials). Treatment with nivolumab was well tolerated and it brings the benefit for some patients after 1-3 lines of previous anticancer therapy. Although serious ADRs are relatively rare, management of side effects requires good cooperation with the patients as well as cooperation with highly specialized departments (gastroenterologists, endocrinologists, dermatologists).