Ceritinib Compassionate Use for Patients with Crizotinib-Refractory, Anaplastic Lymphoma Kinase-Positive Advanced Non-Small-Cell Lung Cancer

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

Acknowledgements

Presented in abstract form at European Lung Cancer Conference 2017.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

Ceritinib CUP was conducted in accordance with local regulatory requirements (approved by a local independent Ethics Committee) and the Declaration of Helsinki.