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M. Gulyás



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    P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P2.01-061 - COX-2 Expression Does Not Predict Outcome of Celecoxib in Addition to Standard Chemotherapy in Advanced Non-Small Cell Lung Cancer (ID 2100)

      09:30 - 17:00  |  Author(s): M. Gulyás

      • Abstract
      • Slides

      Background:
      Increased expression of cyclooxygenase-2 (COX-2) is common in non-small cell lung cancer (NSCLC), and is therefore a potential target for treatment. However, phase III trials have failed to demonstrate beneficial survival effects of adding COX-2 inhibitors to standard chemotherapy. We investigated whether COX-2 expression in tumor and stromal cells had any predictive impact on the effects of celecoxib, a selective COX-2 inhibitor.

      Methods:
      In a previously published multicenter phase III trial, 316 patients with NSCLC stage IIIB or IV and WHO performance status 0-2 were randomized to receive celecoxib 400 mg b.i.d. or placebo up to one year in addition to a two-drug platinum-based chemotherapy regimen. In a subset of 122 patients, archive tumor tissue was available for further analyses. Immune stainings for COX-2 expression were undertaken. Intensity and extent of positively stained cells in tumor and stroma cells were scored on a 0 to 3 scale, and the product of these scores was used as a co-variable in the predictive analysis.

      Results:
      An updated analysis of all 316 patients included in the original trial, and of the 122 patients with available tumor tissue showed no survival differences between the celecoxib or placebo arms (HR 0.99; 95% CI 0.79-1.24 and HR 0.89; 95% CI 0.62-1.28, respectively). Similarly, in patients with high COX-2 expression in tumor cells (n=71) or stroma cells (n=55), survival did not differ significantly between patients who received celecoxib or placebo (HR 0.96; 95% CI 0.60-1.54 and HR 0.66; 95% CI 0.38-1.16). The p-value for interaction effect between COX-2 score in tumor or stroma cells and celecoxib effect on survival was 0.48 and 0.25, respectively.

      Conclusion:
      In this subgroup analysis of patients with advanced NSCLC treated in a randomized trial, we could not detect any significant interaction between COX-2 expression in tumor or stroma cells and outcome of celecoxib treatment in addition to standard chemotherapy.

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