TY - JOUR T1 - Real-life experience of ceritinib in crizotinib-pretreated <em>ALK</em><sup>+</sup> advanced non-small cell lung cancer patients JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00058-2017 VL - 4 IS - 1 SP - 00058-2017 AU - Jacques Cadranel AU - Alexis B. Cortot AU - Hervé Lena AU - Bertrand Mennecier AU - Pascal Do AU - Eric Dansin AU - Julien Mazieres AU - Christos Chouaid AU - Maurice Perol AU - Fabrice Barlesi AU - Gilles Robinet AU - Sylvie Friard AU - Luc Thiberville AU - Clarisse Audigier-Valette AU - Alain Vergnenegre AU - Virginie Westeel AU - Khemaies Slimane AU - Alexandru Buturuga AU - Denis Moro-Sibilot AU - Benjamin Besse Y1 - 2018/01/01 UR - http://openres.ersjournals.com/content/4/1/00058-2017.abstract N2 - 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 &gt;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 ER -