Clinical Epidemiology and Ageing

Real-life experience of ceritinib in crizotinib-pretreated advanced non-small cell lung cancer patients.

Cadranel J, Cortot AB, Lena H, Mennecier B, Do P, Dansin E, Mazières J, Chouaid C, Perol M, Barlesi F, Robinet G, Friard S, Thiberville L, Audigier-Valette C, Vergnenègre A, Westeel V, Slimane K, Buturuga A, Moro-Sibilot D, Besse B ERJ Open Res. 2018;4(1).

Here we report our experience of ceritinib in crizotinib-pretreated patients with anaplastic lymphoma kinase () positive () non-small cell lung cancer (NSCLC) in a French temporary authorisation for use (TAU) study. The French TAU study included crizotinib-pretreated patients with advanced or ROS proto-oncogene 1 positive () tumours. Patients received oral ceritinib (750 mg·day as a starting dose) and best tumour response (as evaluated by the investigator) and safety were reported every 3 months. A total of 242 TAUs were granted from March 12, 2013 to August 05, 2015. Of the 242 patients, 228 had NSCLC and 13 had NSCLC. The median age of patients (n=214) was 58.5 years, 51.9% were female, 70.8% had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 and 50.0% had brain metastases. Of the 149 efficacy evaluable NSCLC patients, 5.4% had a complete response (CR), 47.0% had a partial response (PR) and 22.8% had stable disease (SD). At September 05, 2015, the median duration of ceritinib treatment (n=182) was 3.9 months but 5.5 months for patients (n=71) with a follow-up of ≥12 months. Higher objective response rate (ORR) was observed for patients with ECOG PS 0 to 1 (55.0% 42.4%) and those receiving prior crizotinib for >5 months (51.6% 36.1%). Treatment-related adverse events (AEs) were reported in 118 of 208 patients (56.7%), the most common being diarrhoea (22.1%) and hepatic toxicity (19.7%). Ceritinib (750 mg·day) demonstrated efficacy similar efficacy to ASCEND-1, ASCEND-2 and phase 3 ASCEND-5 trials with manageable safety in crizotinib-pretreated patients with NSCLC.

DOI: 10.1183/23120541.00058-2017