Author of

• 14306

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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
  • Moderators:
  • Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

  • 14331

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    P2.01-025 - Crizotinib in Advanced ALK-Positive NSCLC - A Retrospective Multicenter Study in the Slovak Republic (ID 3014)

    09:30 - 09:30  |  Author(s): Z. Pribulova
    • Abstract
    • Slides

    Background:
    Crizotinib has been available in Slovakia since October 2012 for the treatment of adults with previously treated ALK-positive advanced non-small cell lung cancer (NSCLC), based on the therapeutic indication approved by the European Medicines Agency. Purpose of this study was to assess the results achieved with crizotinib in the treatment of advanced NSCLC in clinical practice in Slovakia.
    
    Methods:
    In this multicenter retrospective study, approved by the Ethical Committee of the Specialized Hospital of St Zoerardus Zobor, the data of 30 ALK-positive patients were reviewed. FISH with break-apart probes was used for the confirmation of ALK rearrangement in all cases. MedCalc[®] was used for the statistical analyses.
    
    Results:
    Between October 2012 and August 2014, 20 out of 30 ALK-positive patients were treated with crizotinib. Ten patients did not receive crizotinib: five due to on-going first-line chemotherapy, five due to other reasons. Characteristics of the treated patients: M/W: 6/14, age (years) median 56, range 23-77, PS (ECOG/WHO): 0/1/2/3: 1/10/4/5, Histology: 19 patients adenocarcinoma, 1 NSCLC, NOS. Treatment results: RR was evaluated in 20 patients: PR + CR: 13 (12+1), 65% (95% CI: 41-85), SD: 3, 15% (95% CI: 3-38), PD: 3, 15% (95% CI: 3-38), NS: 1, 5%, DCR: 16, 80% (95% CI: 56-94), PFS: Kaplan-Meier estimate: 13 months (95% CI: 7 -18), 0S (with 60% of patients censored): 19 months (95%CI: 12 - NR), PS: significant improvement within 2 months (mean dif. –0.95, P=0.0021), toxicities grade 3/4 occurred in 11 of 20 patients (55%), hematologic: 0, non-hematologic: hepatotoxicity 3/1, pneumonitis: 1/0, diarrhea 1/0, nausea: 3/0, vomiting: 1/1, vision disorder: 1/0, peripheral edema: 1/0, QT-interval prolongation: 1/0. Crizotinib was permanently discontinued due to toxicity in only two patients.
    
    Conclusion:
    Treatment results seen in this retrospective study are encouraging and consistent with the published data from the prospective trials.
    
    

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