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Real-life experience of ceritinib in crizotinib-pretreated ALK(+) advanced non-small cell lung cancer patients

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...

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Detalles Bibliográficos
Autores principales: Cadranel, Jacques, Cortot, Alexis B., Lena, Hervé, Mennecier, Bertrand, Do, Pascal, Dansin, Eric, Mazieres, Julien, Chouaid, Christos, Perol, Maurice, Barlesi, Fabrice, Robinet, Gilles, Friard, Sylvie, Thiberville, Luc, Audigier-Valette, Clarisse, Vergnenegre, Alain, Westeel, Virginie, Slimane, Khemaies, Buturuga, Alexandru, Moro-Sibilot, Denis, Besse, Benjamin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: European Respiratory Society 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5810621/
https://www.ncbi.nlm.nih.gov/pubmed/29450203
http://dx.doi.org/10.1183/23120541.00058-2017
Descripción
Sumario: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.