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P. Tagliaferri



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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): P. Tagliaferri

      • 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.

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    P2.07 - Immunology and Immunotherapy (ID 708)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Immunology and Immunotherapy
    • Presentations: 1
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      P2.07-046 - Nivolumab Exerts Remarkable Antitumor Activity in NSCLC After an Immune-Modulating Biochemotherapy Regimen (ID 10170)

      09:30 - 09:30  |  Author(s): P. Tagliaferri

      • Abstract

      Background:
      Dose-dense cisplatin and daily oral etoposide +/- bevacizumab, mAb to the vascular endothelial-growth factor is a safe and active treatment for un-resectable NSCLC patients. It elicited remarkable Immunological effects, including rise in central-memory-T-cells and activated-dendritic cells and decline in regulatory-T-cells, potentially additive to anti-PD-1/PDL-1 immune-checkpoint inhibition. We therefore, performed a retrospective analysis aimed to evaluate both overall survival (OS) and progression free survival (PFS) in patients receiving treatment with Nivolumab, a mAb to PD-1, after they had received different first line chemotherapy regimens.

      Method:
      Statistical analysis (Log-rank test) was performed on forty-nine consecutive NSCLC pts engaged to receive Nivolumab (3mg/kg every 15 days) between October 2015 and December 2016. All of them had received frontline platinum-based doublets for advanced disease and 15 of them had received the mPEBev regimen.

      Result:
      A prolonged PFS was found in patients who received frontline mPEBev compared to the other treatments (mPEBev vs. standard doublets: 14.30 vs. 7.9 months; p=0.038). In this group, we also detected a trend to longer survival (mPEBev vs. standard doublets: 15.6 vs. 11.34 months; p=0.107 with a 12-month-OS-rate of 79% and 32.6%, respectively). We finally recorded that baseline neutrophil and LDH values were correlated with both PFS (neutrophil counts < vs. ≥ median value: 6.28 vs. 14.4 months; P=0.095. LDH < vs. ≥ median value: 14.25 vs. 8.53 months; p= 0.036) and OS (neutrophil counts < vs. ≥ median value: 9.6 vs. 16.8 months; p= 0.101, with a 12-month OS-rate of 42% vs 63%, respectively; LDH < vs. ≥ median value: 16.66 vs. 11.51 months; p=0.039).

      Conclusion:
      Frontline chemotherapy may affect the efficacy of Nivolumab treatment; the mPEBev regimen, in particular, may induces immunological patterns able to improve the effectiveness of PD-1/PDL-1 blockade. Perspective studies and immunological correlations are presently ongoing.