Glass: Global lorlatinib for ALK(+) and ROS1(+) retrospective study: Real world data of 123 NSCLC patients

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dc.authorid0000-0001-7934-7039
dc.contributor.authorPeled, Nir
dc.contributor.authorGillis, Roni
dc.contributor.authorKılıçkap, Saadettin
dc.contributor.authorFroesch, Patrizia
dc.contributor.authorOrlov, Sergei
dc.contributor.authorFilippova, Elena
dc.contributor.authorDemirci, Umut
dc.contributor.authorChristopoulos, Petros
dc.contributor.authorÇiçin, İrfan
dc.contributor.authorBuğdaycı Basal, Fatma
dc.contributor.authorYılmaz, Cengiz
dc.contributor.authorFedor, Moiseenko
dc.contributor.authorKorkmaz, Taner
dc.contributor.authorPaydaş, Semra
dc.contributor.authorGautschi, Oliver
dc.contributor.authorZırtıloğlu, Alişan
dc.contributor.authorEralp, Yeşim
dc.contributor.authorYeşil Çınkır, Havva
dc.contributor.authorSezer, Ahmet
dc.contributor.authorErman, Mustafa
dc.contributor.authorTural, Deniz
dc.contributor.authorTurna, Hande
dc.contributor.authorMazieres, Julien
dc.contributor.authorDudnik, Elizabeth
dc.contributor.authorReguart, Noemi
dc.contributor.authorCamidge, David Ross
dc.contributor.authorNg, Terry L.
dc.contributor.authorÇay Şenler, Filiz
dc.contributor.authorBeypınar, İsmail
dc.contributor.authorYazılıtaş, Doğan
dc.contributor.authorDemirkazık, Ahmet
dc.contributor.authorKaraoğlu, Aziz
dc.contributor.authorOkutur, Kerem
dc.contributor.authorCoşkun, Hasan Şenol
dc.contributor.authorŞendur, Mehmet Ali Nahit
dc.contributor.authorIşıkdoğan, Abdurrahman
dc.contributor.authorÇabuk, Devrim
dc.contributor.authorYumuk, Perran Fulden
dc.contributor.authorYıldız, İbrahim
dc.contributor.authorKaplan, Mehmet Ali
dc.contributor.authorÖzyılkan, Özgür
dc.contributor.authorÖztop, İlhan
dc.contributor.authorÖlmez, Ömer Fatih
dc.contributor.authorAydın, Kübra
dc.contributor.authorAydıner, Adnan
dc.contributor.authorMeydan, Nezih
dc.contributor.authorGrinberg, Roxana Denisa
dc.contributor.authorRoisman, Laila C.
dc.date.accessioned2020-10-16T10:52:57Z
dc.date.available2020-10-16T10:52:57Z
dc.date.issued2020
dc.departmentİstanbul Medipol Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, İç Hastalıkları Ana Bilim Dalı
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.
dc.description.sponsorshipPfizeren_US
dc.identifier.citationPeled, N., Gillis, R., Kılıçkap, S., Froesch, P., Orlov, S., Filippova, E. ... Roisman, L. C. (2020). Glass: Global lorlatinib for ALK(+) and ROS1(+) retrospective study: Real world data of 123 NSCLC patients. Lung cancer, 148, 48-54. https://dx.doi.org/10.1016/j.lungcan.2020.07.022
dc.identifier.doi10.1016/j.lungcan.2020.07.022
dc.identifier.endpage54
dc.identifier.issn0169-5002
dc.identifier.issn1872-8332
dc.identifier.scopusqualityQ1
dc.identifier.startpage48
dc.identifier.urihttps://dx.doi.org/10.1016/j.lungcan.2020.07.022
dc.identifier.urihttps://hdl.handle.net/20.500.12511/5930
dc.identifier.volume148
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.language.isoen
dc.publisherElsevier Ireland Ltd
dc.relation.ispartofLung canceren_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectLorlatinib
dc.subjectReal-World Data
dc.subjectALK
dc.subjectROS1
dc.titleGlass: Global lorlatinib for ALK(+) and ROS1(+) retrospective study: Real world data of 123 NSCLC patients
dc.typeArticle

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