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R. Giusti



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    Poster Display Session (ID 63)

    • Event: ELCC 2017
    • Type: Poster Display Session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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      104P - Efficacy of ceritinib in a "real-world" population of crizotinib-refractory ALK-positive NSCLCs: Results of the Italian compassionate use program (ID 422)

      12:30 - 13:00  |  Author(s): R. Giusti

      • Abstract

      Background:
      Ceritinib has been approved by EMA for the treatment of patients (pts) with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who progress on crizotinib. Nevertheless, this drug is not reimbursed in Italy by the National Health Care System as of January 2017. The aim of this study was to assess the efficacy of ceritinib administered within a compassionate use (CU) program made available to crizotinib-refractory patients.

      Methods:
      This collaborative study involved multiple institutions in Italy. Clinical data from crizotinib-refractory pts with ALK-positive NSCLC who were requested ceritinib compassionate use (CU) were collected and analyzed.

      Results:
      Twenty-four centres took part to the study, for a total of 70 pts who were requested ceritinib CU. Of these, 63 pts received at least one dose of ceritinib 750 mg/d from July 2014 to January 2017. Pts characteristics were as follows: median age 56 years (22-86), 34/63 (54%) female, 43/63 (68%) never smokers, 12/63 (19%) ECOG PS ≥ 2, 13/63 (21%) pretreated with ≥ 2 lines of chemotherapy, 49/63 (78%) metastatic to the brain. Median time on prior crizotinib was 370 days (51-1644). The most common any grade treatment-related adverse events (TRAEs) were nausea (60%, 6% grade 3 or 4), vomiting (49%, 5% grade 3 or 4), diarrhea (51% 2% grade 3 or 4), ALT elevation (48%, 17% grade 3 or 4), AST elevation (49%, 17% grade 3 or 4), and fatigue (59%, 8% grade 3 or 4). Dose reduction due to TRAEs occurred in 31/63 pts (49%). Out of 31 pts, 15 pts (49%) reduced the dose to 600 mg/d, 10 pts (32%) to 450 mg/d, and 6 pts (19%) to 300 mg/d. Unusual TRAEs consisted of an increase in serum creatinine in 3 pts. Of the 55 patients who were evaluable for response, 21 pts (38%) responded to treatment. Overall, at a median follow-up of 6.2 months (0.5-26), median progression-free survival (PFS) was 7.6 months and 6-month PFS was 59%.

      Conclusions:
      The ceritinib CU program in Italy confirms the efficacy of the drug in a "real-world" setting, with a safety profile that is similar to that observed in clinical trials. A high rate of dose adjustments due to TRAEs was observed, which, however, did not appear to influence the activity of the drug.

      Clinical trial identification:
      NA

      Legal entity responsible for the study:
      N/A

      Funding:
      Associazione Italiana per la Ricerca contro il Cancro

      Disclosure:
      All authors have declared no conflicts of interest.