Abstract
Objectives: The real-world intracranial efficacy data of ceritinib at a dose of 450mg quaque die (QD, once a day) are still unavailable, thus this study aims to explore the intracranial efficacy of ceritinib (450mg QD) in anaplastic lymphoma kinase (ALK)-rearrangement non-small cell lung cancer (NSCLC) patients in China.Materials and Methods: The intracranial efficacy [objective response rate (ORR) and disease control rate (DCR)] was evaluated according to the Response Assessment in Neuro-Oncology (RANO) standard, along with progression-free survival (PFS) and adverse events (AEs) obtained through follow-ups.Results: A total of 57 ALK-rearrangement NSCLC patients with brain metastases (BM) were enrolled in this study. Among them, 53 patients experienced progression at baseline during or after prior crizotinib, and 24 patients received prior brain radiotherapy. The intracranial ORR and DCR were 73.7% and 93.0%, respectively. The median intracranial PFS in patients reaching the endpoint was 8.75 months; while that in all patients was not reached and predicted to be not evaluable (NE) (95% CI: 12.9-NE). The estimated 12-month event-free probability (EFP) of intracranial lesions was 68.1%. Subgroup analysis showed the estimated 12-month EFP of intracranial lesions was relatively higher in patients with prior brain radiotherapy (93.8% vs 47.1%, P=0.0006). Additionally, we reported a 74-year-old female ALK-rearrangement NSCLC patient with BM achieved continuous response (intracranial PFS: 12.9 months) to ceritinib reduced to 150mg QD due to intolerable AE and administered for 7.5 months.Conclusion: Ceritinib administered at a dose of 450mg QD to ALK-rearrangement NSCLC patients with BM in China demonstrates superior ORR and DCR, as well as PFS and EFP that are expected to be improved. Especially the estimated 12-month EFP of intracranial lesions was improved in patients with prior brain radiotherapy.
Success of Crizotinib Combined with Whole-Brain Radiotherapy for Brain Metastases in a Patient with Anaplastic Lymphoma Kinase Rearrangement-Positive Non-Small-Cell Lung Cancer
