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Michele Veneziani



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    MA03 - Clinomics and Genomics (ID 119)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA03.03 - CEA and CYFRA 21-1 as Prognostic Biomarkers of Benefit from Nivolumab and as a Tool in Treatment Monitoring in Advanced NSCLC (Now Available) (ID 1370)

      10:30 - 12:00  |  Author(s): Michele Veneziani

      • Abstract
      • Presentation
      • Slides

      Background

      To assess the role of pre-therapy levels of Carcinoembryonic antigen (CEA) and Cytokeratin-19 Fragments (CYFRA 21-1) as prognostic marker in advanced NSCLC patients treated with nivolumab, and their change as an early predictor of treatment outcome.

      Method

      This is a retrospective cohort study including all patients with stage IIIB – IV NSCLC who received nivolumab after first-line chemotherapy in 2 Italian institutions. Median Overall Survival (OS), Overall Response Rate (ORR), Disease Control Rate (DCR) and Time to Treatment Failure (TTF) were chosen as endpoints.

      Result

      100 patients were included. Cyfra 21-1 > ULN resulted correlated with OS (FIG.1A) both in univariate (HR 2.77, 95% CI 1.53 – 5.30, p 0.001) and multivariate analysis (HR 2.72, 95% CI 1.44 – 5.16, p 0.002). The only other factor correlated with OS in multivariate was ECOG PS (0-1 vs 2) (HR 5.46, 95% CI 3.07 – 9.91, p< 0.001) (Table 1).

      ECOG PS (0-1 vs 2) and CYFRA 21-1 (≤ 3.5 vs > 3.5) where combined to create a prognostic score (FIG.1B). Median OS was 23.9 months for patients without risk factors, 6.3 months with one (HR 2.75, 95% CI 1.40 – 5.40 p 0.003) and 1.3 months with 2 risk factors (HR 14.50, 95% CI 6.35 – 33.09, p< 0.001).

      Early 20% reduction after 3rd cycle was correlated with OS for CEA, HR 0.05 (95% CI 0.01–0.41), p 0,003 and borderline for CYFRA 21-1, HR 0.29 (95% CI 0.09 – 1.01), p 0.052. (FIG.1C-1D)imm per abstr.jpg.

      Univariate

      Multivariate

      Covariate

      HR (95% CI)

      P value

      HR (95%CI)

      P value

      ECOG PS 2 vs 0-1

      5.40 (3.21 – 9.09)

      < 0.001

      5.46 (3.07 – 9.91)

      < 0.001

      Cyfra > vs ≤ ULN

      2.77 (1.53 – 5.03)

      0.001

      2.72 (1.44 – 5.16)

      0.002

      Liver metastasis yes vs no

      2.19 (1.26 – 3.78)

      0.005

      0.102

      Neutrophil/lymphocyte ratio ≥ 4 vs < 4

      1.99 (1.23 – 3.20)

      0.005

      0.105

      KRAS mutated vs wild type*

      0.39 (0.21 – 0.74 )

      0.004

      0.262

      Bone metastasis yes vs no

      1.75 (1.10 – 2.79)

      0.018

      0.362

      Response to previous therapy yes vs no

      0.51 (0.29 – 0.91)

      0.023

      0.376

      CEA > vs ≤ ULN

      1.41 (0.88 – 2-25)

      0.150

      0.418

      Stage IV vs IIIB

      1.63 (0.75 – 3.54)

      0.22

      0.449

      Squamous vs non squamous

      0.79 (0.48 – 1.28)

      0.334

      0.689

      Smoker vs never smoker

      0.88 (0.65 – 1.18)

      0.386

      0.694

      Second-line vs third or more

      0.94 (0.60 – 1.47)

      0.77

      0.843

      Brain metastasis yes vs no

      1.16 (0.66 – 2.04)

      0.603

      0.594

      Conclusion

      Our data suggests that Cyfra 21-1 pre-therapy assessment, both alone and in combination with other factors in a prognostic/predictive score, may provide clinicians with further information on the prognosis of patients treated with nivolumab.

      CEA and CYFRA 21-1 repeated measures could be useful as an early surrogate marker of clinical benefit.

      Further analysis are warranted to confirm these findings.

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