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Ceritinib compassionate use for patients with crizotinib-refractory, anaplastic lymphoma kinase-positive advanced
Giulio Metro1, Antonio Passaro2, Giuseppe Lo Russo3
1Medical Oncology, Santa Maria della Misericordia Hospital, AOU di Perugia, Perugia, Italy.
Aim:
Ceritinib was evaluated within a compassionate use program of Italian patients.
Patients & Methods:
70 patients with anaplastic lymphoma kinase-positive crizotinib-refractory advanced non-small-cell lung cancer received ceritinib.
Results:
Overall response was 40.6%, median progression-free survival was 8.2 months and median survival was 15.5 months. Dose reduction due to treatment-related adverse events occurred in 50.8% of patients starting at 750 mg/day. No significantly different progression-free survival was observed between patients who underwent any time dose reduction (n = 38) versus those who remained on the recommended dose of 750 mg/day (n = 32; p = 0.07).
Conclusion:
The efficacy of ceritinib compassionate use program resembled that of clinical trials. Dose reductions and adjustments did not appear to negatively affect clinical outcome.
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