RT Journal Article SR Electronic T1 Real-life experience of ceritinib in crizotinib-pretreated ALK+ advanced non-small cell lung cancer patients JF ERJ Open Research JO erjor FD European Respiratory Society SP 00058-2017 DO 10.1183/23120541.00058-2017 VO 4 IS 1 A1 Cadranel, Jacques A1 Cortot, Alexis B. A1 Lena, Hervé A1 Mennecier, Bertrand A1 Do, Pascal A1 Dansin, Eric A1 Mazieres, Julien A1 Chouaid, Christos A1 Perol, Maurice A1 Barlesi, Fabrice A1 Robinet, Gilles A1 Friard, Sylvie A1 Thiberville, Luc A1 Audigier-Valette, Clarisse A1 Vergnenegre, Alain A1 Westeel, Virginie A1 Slimane, Khemaies A1 Buturuga, Alexandru A1 Moro-Sibilot, Denis A1 Besse, Benjamin YR 2018 UL http://openres.ersjournals.com/content/4/1/00058-2017.abstract AB Here we report our experience of ceritinib in crizotinib-pretreated patients with anaplastic lymphoma kinase (ALK) positive (ALK+) 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 ALK+ or ROS proto-oncogene 1 positive (ROS1+) tumours. Patients received oral ceritinib (750 mg·day−1 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 ALK+ NSCLC and 13 had ROS1+ NSCLC. The median age of ALK+ 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 ALK+ 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% versus 42.4%) and those receiving prior crizotinib for >5 months (51.6% versus 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−1) demonstrated efficacy similar efficacy to ASCEND-1, ASCEND-2 and phase 3 ASCEND-5 trials with manageable safety in crizotinib-pretreated patients with ALK+ NSCLC.Ceritinib (750 mg per day) showed similar efficacy as in clinical trials in crizotinib-pretreated ALK+ NSCLC patients http://ow.ly/8oXe30h27D0