PMID- 29450203
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240315
IS  - 2312-0541 (Print)
IS  - 2312-0541 (Electronic)
IS  - 2312-0541 (Linking)
VI  - 4
IP  - 1
DP  - 2018 Jan
TI  - Real-life experience of ceritinib in crizotinib-pretreated ALK(+) advanced 
      non-small cell lung cancer patients.
LID - 00058-2017 [pii]
LID - 10.1183/23120541.00058-2017 [doi]
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.
FAU - Cadranel, Jacques
AU  - Cadranel J
AD  - Service de Pneumologie, Hopital Tenon, Assistance Publique-Hopitaux de Paris 
      (AP-HP) and Universite Pierre-et-Marie-Curie (Paris 6), Paris, France.
FAU - Cortot, Alexis B
AU  - Cortot AB
AD  - Thoracic Oncology, Centre Hospitalier Universitaire (CHU) and Universite de 
      Lille, Lille, France.
FAU - Lena, Herve
AU  - Lena H
AD  - Pneumologie, CHU and INSERM ERL440-OSS, Rennes, France.
FAU - Mennecier, Bertrand
AU  - Mennecier B
AD  - Pneumologie, Nouvel Hopital Civil, Strasbourg, France.
FAU - Do, Pascal
AU  - Do P
AD  - Pathologies Thoraciques, Centre Francois Baclesse, Caen, France.
FAU - Dansin, Eric
AU  - Dansin E
AD  - Departement de cancerologie cervico-faciale et thoracique, CLCC Oscar Lambret, 
      Lille, France.
FAU - Mazieres, Julien
AU  - Mazieres J
AD  - Pneumologie, CHU, Toulouse, France.
FAU - Chouaid, Christos
AU  - Chouaid C
AD  - Service de Pneumologie, Centre Hospitalier Intercommunal Creteil (CHIC), Creteil, 
      France.
FAU - Perol, Maurice
AU  - Perol M
AD  - Cancerologie poumon, tumeurs thoraciques, Centre Leon Berard, Lyon, France.
FAU - Barlesi, Fabrice
AU  - Barlesi F
AD  - Multidisciplinary Oncology & Therapeutic Innovations Dept, Assistance 
      Publique-Hopitaux de Marseille (AP-HM) and Universite Aix-Marseille, Marseille, 
      France.
FAU - Robinet, Gilles
AU  - Robinet G
AD  - Institut de Cancerologie, CHU, Brest, France.
FAU - Friard, Sylvie
AU  - Friard S
AD  - Pneumologie, Hopital Foch, Suresnes, France.
FAU - Thiberville, Luc
AU  - Thiberville L
AD  - Pneumologie, CHU, Rouen, France.
FAU - Audigier-Valette, Clarisse
AU  - Audigier-Valette C
AD  - Pneumologie, Centre Hospitalier Intercommunal (CHI), Toulon, France.
FAU - Vergnenegre, Alain
AU  - Vergnenegre A
AD  - Pneumologie, CHU, Limoges, France.
FAU - Westeel, Virginie
AU  - Westeel V
AD  - Pneumologie, CHU, Besancon, France.
FAU - Slimane, Khemaies
AU  - Slimane K
AD  - Novartis Oncology, Rueil-Malmaison, France.
FAU - Buturuga, Alexandru
AU  - Buturuga A
AD  - Novartis Oncology, Rueil-Malmaison, France.
FAU - Moro-Sibilot, Denis
AU  - Moro-Sibilot D
AD  - Pneumologie, CHU Grenoble-Alpes, Grenoble, France.
FAU - Besse, Benjamin
AU  - Besse B
AD  - Institut d'Oncologie Thoracique, Institut Gustave Roussy, Villejuif, France.
AD  - Universite Paris-Sud, Orsay, France.
LA  - eng
PT  - Journal Article
DEP - 20180213
PL  - England
TA  - ERJ Open Res
JT  - ERJ open research
JID - 101671641
PMC - PMC5810621
COIS- Conflict of interest: Disclosures can be found alongside this article at 
      openres.ersjournals.com
EDAT- 2018/02/17 06:00
MHDA- 2018/02/17 06:01
PMCR- 2018/02/13
CRDT- 2018/02/17 06:00
PHST- 2017/04/28 00:00 [received]
PHST- 2017/11/21 00:00 [accepted]
PHST- 2018/02/17 06:00 [entrez]
PHST- 2018/02/17 06:00 [pubmed]
PHST- 2018/02/17 06:01 [medline]
PHST- 2018/02/13 00:00 [pmc-release]
AID - 00058-2017 [pii]
AID - 10.1183/23120541.00058-2017 [doi]
PST - epublish
SO  - ERJ Open Res. 2018 Feb 13;4(1):00058-2017. doi: 10.1183/23120541.00058-2017. 
      eCollection 2018 Jan.