Abstract
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.
Keywords:
ALK; ceritinib; non-small-cell lung cancer.
MeSH terms
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Adult
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Aged
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Aged, 80 and over
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Anaplastic Lymphoma Kinase
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Carcinoma, Non-Small-Cell Lung / drug therapy*
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Carcinoma, Non-Small-Cell Lung / genetics
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Carcinoma, Non-Small-Cell Lung / pathology
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Compassionate Use Trials
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Crizotinib
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Disease-Free Survival
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Dose-Response Relationship, Drug
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Drug Resistance, Neoplasm / drug effects
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Female
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Gene Rearrangement
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Humans
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Male
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Middle Aged
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Mutation
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Protein Kinase Inhibitors / administration & dosage*
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Protein Kinase Inhibitors / adverse effects
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Pyrazoles / administration & dosage
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Pyrazoles / adverse effects
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Pyridines / administration & dosage
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Pyridines / adverse effects
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Pyrimidines / administration & dosage*
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Pyrimidines / adverse effects
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Receptor Protein-Tyrosine Kinases / antagonists & inhibitors
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Receptor Protein-Tyrosine Kinases / genetics*
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Sulfones / administration & dosage*
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Sulfones / adverse effects
Substances
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Protein Kinase Inhibitors
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Pyrazoles
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Pyridines
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Pyrimidines
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Sulfones
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Crizotinib
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ALK protein, human
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Anaplastic Lymphoma Kinase
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Receptor Protein-Tyrosine Kinases
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ceritinib