RT Journal Article
SR Electronic
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
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 &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