GLASS: Global Lorlatinib for ALK(+) and ROS1(+) retrospective Study: real world data of 123 NSCLC patients

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dc.authoridBeypınar, İsmail/0000-0002-0853-4096
dc.authoridRoisman, Laila C./0000-0001-8455-9327
dc.authoridKilickap, Saadettin/0000-0003-1637-7390
dc.authoridPaydas, Semra/0000-0003-4642-3693
dc.authoridSEZER, AHMET/0000-0002-6445-1439
dc.authoridOzyilkan, Ozgur/0000-0001-8825-4918
dc.authoridEralp, Yesim/0000-0001-9603-4755
dc.authorwosidSendur, Mehmet Ali Nahit/H-7555-2014
dc.authorwosidBeypınar, İsmail/AAN-1107-2020
dc.authorwosidYumuk, Perran Fulden/A-6189-2018
dc.authorwosidRoisman, Laila C./P-9129-2019
dc.authorwosidKaraoglu, Aziz/HKM-3509-2023
dc.authorwosidCoşkun, Hasan Şenol/C-2070-2016
dc.authorwosidYildiz, Ibrahim/AAF-9885-2019
dc.contributor.authorPeled, Nir
dc.contributor.authorGillis, Roni
dc.contributor.authorKilickap, Saadettin
dc.contributor.authorFroesch, Patrizia
dc.contributor.authorOrlov, Sergei
dc.contributor.authorFilippova, Elena
dc.contributor.authorDemirci, Umut
dc.date.accessioned2024-06-12T11:07:52Z
dc.date.available2024-06-12T11:07:52Z
dc.date.issued2020
dc.departmentTrakya Üniversitesien_US
dc.description.abstractLorlatinib 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.en_US
dc.description.sponsorshipPfizer [IIS 53234545]en_US
dc.description.sponsorshipWe grateful to Pfizer for the funding of the grant IIS 53234545.en_US
dc.identifier.doi10.1016/j.lungcan.2020.07.022
dc.identifier.endpage54en_US
dc.identifier.issn0169-5002
dc.identifier.issn1872-8332
dc.identifier.pmid32799090en_US
dc.identifier.scopus2-s2.0-85089217036en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage48en_US
dc.identifier.urihttps://doi.org/10.1016/j.lungcan.2020.07.022
dc.identifier.urihttps://hdl.handle.net/20.500.14551/22197
dc.identifier.volume148en_US
dc.identifier.wosWOS:000573480700007en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherElsevier Ireland Ltden_US
dc.relation.ispartofLung Canceren_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectLorlatiniben_US
dc.subjectReal-World Dataen_US
dc.subjectALKen_US
dc.subjectROS1en_US
dc.subjectCell Lung-Canceren_US
dc.subjectHybrid Captureen_US
dc.subjectSingle-Armen_US
dc.subjectOpen-Labelen_US
dc.subjectCrizotiniben_US
dc.subjectRearrangementen_US
dc.subjectImmunohistochemistryen_US
dc.subjectMulticenteren_US
dc.subjectCriteriaen_US
dc.subjectReten_US
dc.titleGLASS: Global Lorlatinib for ALK(+) and ROS1(+) retrospective Study: real world data of 123 NSCLC patientsen_US
dc.typeArticleen_US

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