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E. Olmedo



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    P3.02c - Poster Session with Presenters Present (ID 472)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 2
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      P3.02c-075 - Could Blood Levels of Lymphocytes and Eosinophils Help Us to Identify the Efficacy or Toxicity of Immunotherapy?  (ID 5960)

      14:30 - 14:30  |  Author(s): E. Olmedo

      • Abstract

      Background:
      Immune checkpoint blockade have demonstrated durable responses and improvement in overall survival (OS) in approximately 20% of unselected patients with advanced non-small cell lung cancer (NSCLC). To develop reliable, validated biomarkers to identify those subgroups of patients most likely to benefit remains a challenge.

      Methods:
      We retrospectively analyzed pretreated advanced NSCLC patients (p) receiving anti-PD1 or anti-PDL-1 inhibitors at our institution. The immune-related response Criteria (IRC) was used for response evaluation. Basal and at 6 weeks lymphocytes and eosinophils counts were correlated with efficacy and toxicity.

      Results:
      44 p were treated between April 2014 and December 2015. We realized evaluation of response in 40 p. 13 p received Atezolizumab, 23 p Nivolumab and 4 p Pembrolizumab. Patients characteristics: 68% males, median age 63 years, 62 % non-squamous histology, 3 % never-smoker, PS 0/1/2 in 43/50/7%. The molecular status assessed in 32 p (KAS mutation 10p). Immunotherapy was the second-line treatment in 26p with a median number of doses received of 5 (range 2-27). Median OS was 12 months (95%CI 3–21) and median PFS was 4 months (95%CI 0.7–7) from the start of checkpoints inhibitors. Overall survival rate at 12 months was 40%. Immune-related adverse events were observed in 15p (37.5%), including 7 grade 3–4 events (17.5%). No drug-related death occurred. We found that there was a significant association between the risk of toxicity and the increased number of eosinophils between the first reassessment and the baseline measurement OR 6, p 0.014. At the time of the first reevaluation, 28p had progression disease (PD), 6 partial response (PR) and 6 stable disease(SD). In 22/28p with progression at first evaluation, CT was realized ≥4 weeks. Pseudoprogression was confirmed in 6/22p (21%). No differences were found in response by gender, ECOG, histology, KRAS status, smoking status, antiPD-1 vs antiPD-L1, or drug used. 15/18p with clinical benefit (PR+SD+pseudoprogression) had basal level of eosinophils ≥100 mm3, (p 0.003 OR 0.114) whilst correlation between response and basal lymphocytes was not statistically significant (p 0.35 OR 0.58). One of 18p with clinical benefit had levels of lymphocytes at the first evaluation <1000 mm3 versus 10/22p with PD(p 0.013, HR 0.13) whilst levels of eosinophils ≥100 mm3 at the first evaluation was not statistically significant (p 0.052 HR 0.26).

      Conclusion:
      Our very preliminary results suggest that lymphocytes and eosinophils could help us to characterize activity and toxicity of immunotherapy treatments. Further studies are guaranteed.

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      P3.02c-079 - Immunotherapy in Non Small Cell Lung Cancer (NSCLC): Biomarkers Associated with Early Death (ID 5979)

      14:30 - 14:30  |  Author(s): E. Olmedo

      • Abstract

      Background:
      Inmune checkpoint blockade monoclonal antibodies have demonstrated an improvement in the overall survival (OS) of patients with NSCLC. The aim of our research was to explore biomarkers of early death among the routinely used biological parameters in the population diagnosed with advanced lung cancer treated with immunotherapy.

      Methods:
      In this retrospective study, we collected blood levels of lymphocytes, eosinophils and lactate dehydrogenase (LDH) before inmunotherapy infusion. Inclusion criteria were a diagnosis of stage IV NSCLC, at least one previous line of chemotherapy.

      Results:
      44 patients (p) were treated between April 2014 and December 2015. Thirteen p received atezolizumab,27 p nivolumab and 4 p pembrolizumab. 70.5% males with a median age of 63 (range 42-82), 29.5% squamous and 2.3% never-smoker patients. Eighteen p had PS 0 (41%), 22p PS1 (50%) and 4p PS 2 (9%). Thirty-one p had ≥ 2 metastatic sites. Immunotherapy was the second-line treatment in 27p. The median number of doses received was 4.5 (range 1-27). Median OS was 12 months (95% CI 3–21) from the start of checkpoints inhibitors. Median PFS was 4 months (95% CI 0.7–7) from the start of checkpoints inhibitors. At 1 year, the overall survival rate was 40%. Eighteen p (41%) died within the first 3 months. The risk of early death based in terms of PS (15p PS0-1), smoking status (1p never-smoker), histology (14p non-squamous), molecular status (5p KRAS), metastases (3p brain metastases), response of previous line and line of treatment (second line in 8/14 p (55 %), was not statistically significant. The risk of early death was higher in 14/18p (78%) had basal LDH levels above the normal range with a difference statistically significant, p 0.036; OR =4.6. However, 11/18 p (62%) had baseline eosinophils <100 mm3, the risk of early death was higher compared to the patients with eosinophils >100 mm3, p 0.04; OR 0.28. The risk of early death based on basal lymphocytes level ≥1000 mm3 or lymphocytes level ≥1500 was not statistically significant. In the multivariate analysis, baseline LDH levels remained as an independent predictor of overall survival but not of early death, p 0.055; HR 4.3 (95% IC 0.9-19).

      Conclusion:
      Our study suggests that baseline serum determination of LDH and eosinophils might help us to identify patients with NSCLC who achieve more benefit from immunotherapy. Futher studies are guaranteed.