GLASS: Global Lorlatinib for ALK(+) and ROS1(+) retrospective Study: real world data of 123 NSCLC patients.
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Peled Nir, Gillis Roni, Kilickap Saadettin, Froesch Patrizia, Orlov Sergei, Filippova Elena, Demirci Umut, Christopoulos Petros, Cicin Irfan, Basal Fatma Bugdayci, Yilmaz Cengiz, Fedor Moiseenko, Korkmaz Taner, Paydas Semra, Gautschi Oliver, Zirtiloglu Alisan, Eralp Yesim, Cinkir Havva Yesil, Sezer Ahmet, Erman Mustafa, Tural Deniz, Turna Hande, Mazieres Julien, Dudnik Elizabeth, Reguart Noemi, Camidge David Ross, Ng Terry L, Şenler Filiz Çay, Beypınar İsmail, Yazılıtaş Doğan, Demirkazık Ahmet, Karaoğlu Aziz, Okutur Kerem, Coşkun Hasan Şenol, Şendur Mehmet Ali Nahit, Isikdogan Abdurrahman, Cabuk Devrim, Yumuk Perran Fulden, Yıldız Ibrahim, Kaplan M Ali, Özyılkan Özgür, Öztop İlhan, Olmez Omer Fatih, Aydin Kübra, Aydıner Adnan, Meydan Nezih, Grinberg Roxana Denisa, Roisman Laila C
Аннотация
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.