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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
European Respiratory Society
2018
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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 |
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author | 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 |
author_facet | 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 |
author_sort | Cadranel, Jacques |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5810621 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | European Respiratory Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-58106212018-02-15 Real-life experience of ceritinib in crizotinib-pretreated ALK(+) advanced non-small cell lung cancer patients 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 ERJ Open Res Original Articles 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. European Respiratory Society 2018-02-13 /pmc/articles/PMC5810621/ /pubmed/29450203 http://dx.doi.org/10.1183/23120541.00058-2017 Text en Copyright ©ERS 2018 http://creativecommons.org/licenses/by-nc/4.0/ This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. |
spellingShingle | Original Articles 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 Real-life experience of ceritinib in crizotinib-pretreated ALK(+) advanced non-small cell lung cancer patients |
title | Real-life experience of ceritinib in crizotinib-pretreated ALK(+) advanced non-small cell lung cancer patients |
title_full | Real-life experience of ceritinib in crizotinib-pretreated ALK(+) advanced non-small cell lung cancer patients |
title_fullStr | Real-life experience of ceritinib in crizotinib-pretreated ALK(+) advanced non-small cell lung cancer patients |
title_full_unstemmed | Real-life experience of ceritinib in crizotinib-pretreated ALK(+) advanced non-small cell lung cancer patients |
title_short | Real-life experience of ceritinib in crizotinib-pretreated ALK(+) advanced non-small cell lung cancer patients |
title_sort | real-life experience of ceritinib in crizotinib-pretreated alk(+) advanced non-small cell lung cancer patients |
topic | Original Articles |
url | 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 |
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