학술논문
GLASS: Global Lorlatinib for ALK(+) and ROS1(+) retrospective Study: real world data of 123 NSCLC patients.
Document Type
Academic Journal
Author
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.
Source
Publisher: Elsevier Scientific Publishers Country of Publication: Ireland NLM ID: 8800805 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1872-8332 (Electronic) Linking ISSN: 01695002 NLM ISO Abbreviation: Lung Cancer Subsets: MEDLINE
Subject
Language
English
Abstract
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.
(Copyright © 2020. Published by Elsevier B.V.)
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.
(Copyright © 2020. Published by Elsevier B.V.)