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M. Pagano



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    P2.01 - Advanced NSCLC (ID 618)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.01-075d - Analysis of Early Survival in Patients with Advanced Non-Squamous NSCLC Treated with Nivolumab: The Italian Expanded Access Program Experience (ID 9237)

      09:00 - 09:00  |  Author(s): M. Pagano

      • Abstract

      Background:
      In the Checkmate 057 trial, it was observed a slightly higher number of deaths in the nivolumab arm within the first 3 months of treatment. A post-hoc analysis from this study suggested that pts with poorer prognostic factors and/or more aggressive disease combined with low or no PD-L1 expression appeared to be at higher risk of death with nivolumab. Nevertheless, most of pts with these factors were still alive > 3 months in the nivolumab arm and no factors have been identified for selection. Here, we report a similar analysis conducted on pts treated with nivolumab in the Expanded Access Programme (EAP) in Italy.

      Method:
      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 non-Squamous NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received at least one dose of nivolumab and were monitored for adverse events (AE) using Common Terminology Criteria for Adverse Events.

      Result:
      In the Italian EAP, of 1559 pts with available survival data, 365 (23.4%) died within the first 3 months. This data is comparable to what observed in the 057 study where (nivolumab arm 20.2% pts died <3 months). Baseline characteristics of the two groups (deaths ≤3 or >3 months) are summarized in the table below. In univariate and multivariate analysis, factors associated with early death were:bone and liver metastases, ECOG PS2 and no prior maintenance therapy. However, majority of pts with these factors did not die within the first 3 months.

      OS >3 months (1194) OS ≤3 months (n=365)
      Gender, Male (%) 760 (64) 251 (69)
      AGE (median; range) ≥70 yrs, n (%) ≥75 yrs, n (%) 66 (27-89) 397 (33) 181 (15) 65 (36-83) 116 (32) 48 (13)
      SMOKING HABITS, n (%) Former/current smoker Never smoker NA - 865 (79) 232 (21) 97 - 250 (78) 72 (22) 43
      ECOG PS, n (%) 0 1 2 NA - 538 (45) 591 (50) 53 (5) 12 - 101 (28) 207 (57) 53 (15) 4
      METASTASIS, n (%) Brain Liver Bone Nodes - 296 (25) 208 (17) 429 (36) 877 (73) - 107 (29) 114 (31) 189 (52) 283 (77)
      EGFR, n (%) 74/1065 (7) 23/312 (7)
      Maintenance 303 (25) 69 (19)


      Conclusion:
      These results confirm the pivotal 057 trial suggesting that no single clinical factor can be used for pts selection. PS2, liver or bone metastastatic pts should be followed with attention after starting Nivolumab.