Journal article
GLASS: Global Lorlatinib for ALK(+) and ROS1(+) retrospective Study: real world data of 123 NSCLC patients.
- Peled N The Legacy Heritage Oncology Center & Dr. Larry Norton Institute, Soroka Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University, Beer-Sheva, Israel. Electronic address: peled.nir@gmail.com.
- Gillis R The Legacy Heritage Oncology Center & Dr. Larry Norton Institute, Soroka Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University, Beer-Sheva, Israel.
- Kilickap S Department of Preventive Oncology, Hacettepe University Cancer Institute, Ankara, Turkey.
- Froesch P Oncology Institute of the Southern Switzerland, Bellinzona, Switzerland.
- Orlov S Pavlov First Saint Petersburg State Medical University, St Petersburg, Russia.
- Filippova E Pavlov First Saint Petersburg State Medical University, St Petersburg, Russia.
- Demirci U Uskudar University, Faculty of Medicine, Department of Medical Oncology, Turkey.
- Christopoulos P Department of Thoracic Oncology, Thoraxklinik at Heidelberg University Hospital, and Translational Lung Research Heidelberg, Member of the German Center for Lung Research (DZL), Germany.
- Cicin I Trakya University, Faculty of Medicine, Department of Medical Oncology, Turkey.
- Basal FB University of Health Sciences, Dr. A.Y. Ankara Oncology Hospital, Department of Medical Oncology, Turkey.
- Yilmaz C Ege University, Faculty of Medicine, Department of Medical Oncology, İzmir, Turkey.
- Fedor M N.N. Petrov National Medical Research Center of Oncology, St. Petersburg, 197798, Russian Federation; St. PetersburgClinical Research and Practical Center for Specialized Types of Medical Care (Oncologic), St. Petersburg, 197758, Russian Federation.
- Korkmaz T Acibadem MAA University Hospital, School of Medicine, Department of Medical Oncology, Maslak Hospital, İstanbul, Turkey.
- Paydas S Department of Oncology, Cukurova University Faculty of Medicine, Adana, Turkey.
- Gautschi O University of Berne and Cantonal Hospital of Lucerne, Switzerland.
- Zirtiloglu A Department of Medical Oncology, Bakirkoy Sadi Konuk Training and Research Hospital, Istanbul, Turkey.
- Eralp Y Acibadem MAA University Hospital, School of Medicine, Department of Medical Oncology, Maslak Hospital, İstanbul, Turkey.
- Cinkir HY Gaziantep University, Faculty of Medicine, Department of Medical Oncology, Gaziantep, Turkey.
- Sezer A Adana Baskent University, Faculty of Medicine, Department of Medical Oncology, Adana, Turkey.
- Erman M Department of Preventive Oncology, Hacettepe University Cancer Institute, Ankara, Turkey.
- Tural D Department of Medical Oncology, Bakirkoy Sadi Konuk Training and Research Hospital, Istanbul, Turkey.
- Turna H Cerrahpasa University, Faculty of Medicine Department of Medical Oncology, Istanbul, Turkey.
- Mazieres J Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France.
- Dudnik E Thoracic Cancer Service, Davidoff Cancer Center, Rabin Medical Center, Beilinson Campus, Petah Tikva, 49100, Israel.
- Reguart N Division of Medical Oncology, Hospital Clínic, Barcelona,Spain; Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.
- Camidge DR Division of Medical Oncology, Department of Medicine, University of Colorado School of Medicine, 1665 North Aurora Court, Aurora, CO, 80045, USA.
- Ng TL Ankara University Faculty of Medicine, Department of Medical Oncology, Ankara, Turkey.
- Şenler FÇ Department of Medical Oncology, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.
- Beypınar İ Yildirim Beyazit University Faculty of Medicine, Department of Medical Oncology, Ankara, Turkey.
- Yazılıtaş D Dokuz Eylul University Faculty of Medicine, Department of Medical Oncology, Izmir, Turkey.
- Demirkazık A Department of Medical Oncology, Faculty of Medicine, Afyon Kocatepe University, Afyon, Turkey.
- Karaoğlu A Medicalpark Bahçelievler Hospital, Department of Medical Oncology, Istanbul, Turkey.
- Okutur K Akdeniz University Faculty of Medicine, Department of Medical Oncology, Antalya, Turkey.
- Coşkun HŞ Dicle University Faculty of Medicine, Department of Medical Oncology, Diyarbakir, Turkey.
- Şendur MAN Dokuz Eylul University Faculty of Medicine, Department of Medical Oncology, Izmir, Turkey.
- Isikdogan A Dicle University Faculty of Medicine, Department of Medical Oncology, Diyarbakir, Turkey.
- Cabuk D Kocaeli University, Division of Medical Oncology, Kocaeli, Turkey.
- Yumuk PF Marmara University Faculty of Medicine, Department of Medical Oncology, Istanbul, Turkey.
- Yıldız I Acibadem MAA University Hospital, School of Medicine, Department of Medical Oncology, Maslak Hospital, İstanbul, Turkey.
- Kaplan MA Dicle University Faculty of Medicine, Department of Medical Oncology, Diyarbakir, Turkey.
- Özyılkan Ö Adana Baskent University, Faculty of Medicine, Department of Medical Oncology, Adana, Turkey.
- Öztop İ Medicalpark Bahçelievler Hospital, Department of Medical Oncology, Istanbul, Turkey.
- Olmez OF Medipol University Faculty of Medicine, Department of Medical Oncology, Istanbul, Turkey.
- Aydin K Memorial Ankara Hospital, Ankara, Turkey.
- Aydıner A Istanbul University Institute of Cancer, Department of Medical Oncology, Istanbul, Turkey.
- Meydan N Adnan Menderes Univesity Faculty of Medicine, Turkey.
- Grinberg RD The Legacy Heritage Oncology Center & Dr. Larry Norton Institute, Soroka Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University, Beer-Sheva, Israel.
- Roisman LC The Legacy Heritage Oncology Center & Dr. Larry Norton Institute, Soroka Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University, Beer-Sheva, Israel.
- 2020-08-18
Published in:
- Lung cancer (Amsterdam, Netherlands). - 2020
English
Lorlatinib is a third-generation tyrosine-kinases inhibitor (TKI) targeting ALK/ROS1 fusions. The FDA has approved lorlatinib for TKI-pretreated ALK(+) NSCLC, while its approval for ROS1(+) is still pending. Here we present the largest real-world data of NSCLC patients harboring ALK/ROS1 rearrangements treated with lorlatinib.
METHODS
123 patients were enrolled retrospectively (data cut-off 1/1/2019). Lorlatinib was administered through an early access program for patients with no other available therapy. Outcome and response were defined by each investigator upon RECIST 1.1 criteria.
RESULTS
106 ALK(+) and 17 ROS1(+) patients recruited from 8 different countries. The ALK(+) cohort included 50 % males, 73 % never-smokers and 68 % with brain metastases. Extracranial (EC) and intracranial (IC) response rates (RR) were 60 % and 62 %, with disease control rates (DCR) of 91 % and 88 % respectively. Mean duration of therapy (DoT) was 23.9 ± 1.6 months and median overall survival (mOS) was 89.1 ± 19.6 months. ROS1 cohort enrolled 53 % males, 65 % never-smokers and 65 % had brain metastases. EC and IC RR were 62 % and 67 % with DCR of 92 % and 78 % respectively. Median DoT was 18.1 ± 2.5 months and mOS of 90.3 ± 24.4 months. OS and DoT in both cohorts were not significantly correlated with line of therapy nor other parameters. The most common adverse events of any grade were peripheral edema (48 %), hyperlipidemia (47 %), weight gain (25 %) and fatigue (30 %). CNS adverse events such as cognitive effect of grade 1-2 were reported in 18 % of patients.
CONCLUSION
Lorlatinib shows outstanding EC/IC efficacy in ALK/ROS1(+) NSCLC. The observed mOS of 89 ± 19 months in ALK(+) NSCLC supports previous reports, while mOS from of 90 ± 24 months is unprecedented for ROS1(+) NSCLC.
METHODS
123 patients were enrolled retrospectively (data cut-off 1/1/2019). Lorlatinib was administered through an early access program for patients with no other available therapy. Outcome and response were defined by each investigator upon RECIST 1.1 criteria.
RESULTS
106 ALK(+) and 17 ROS1(+) patients recruited from 8 different countries. The ALK(+) cohort included 50 % males, 73 % never-smokers and 68 % with brain metastases. Extracranial (EC) and intracranial (IC) response rates (RR) were 60 % and 62 %, with disease control rates (DCR) of 91 % and 88 % respectively. Mean duration of therapy (DoT) was 23.9 ± 1.6 months and median overall survival (mOS) was 89.1 ± 19.6 months. ROS1 cohort enrolled 53 % males, 65 % never-smokers and 65 % had brain metastases. EC and IC RR were 62 % and 67 % with DCR of 92 % and 78 % respectively. Median DoT was 18.1 ± 2.5 months and mOS of 90.3 ± 24.4 months. OS and DoT in both cohorts were not significantly correlated with line of therapy nor other parameters. The most common adverse events of any grade were peripheral edema (48 %), hyperlipidemia (47 %), weight gain (25 %) and fatigue (30 %). CNS adverse events such as cognitive effect of grade 1-2 were reported in 18 % of patients.
CONCLUSION
Lorlatinib shows outstanding EC/IC efficacy in ALK/ROS1(+) NSCLC. The observed mOS of 89 ± 19 months in ALK(+) NSCLC supports previous reports, while mOS from of 90 ± 24 months is unprecedented for ROS1(+) NSCLC.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1016/j.lungcan.2020.07.022
- PMID 32799090
- Persistent URL
- https://folia.unifr.ch/global/documents/47068
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