GLASS: Global Lorlatinib for ALK(+) and ROS1(+) retrospective Study: real world data of 123 NSCLC patients
| Autor: | Deniz Tural, Terry L. Ng, Noemi Reguart, Ömer Fatih Ölmez, Ozgur Ozyilkan, Ahmet Sezer, Ilhan Oztop, Mehmet Ali Kaplan, Laila C. Roisman, E. Filippova, Irfan Cicin, Aziz Karaoglu, Umut Demirci, Petros Christopoulos, Elizabeth Dudnik, Fatma Buğdaycı Başal, Perran Fulden Yumuk, D.R. Camidge, Sergei V. Orlov, Mehmet Ali Nahit Sendur, Nezih Meydan, Saadettin Kilickap, Mustafa Erman, Oliver Gautschi, Havva Yesil Cinkir, Patrizia Froesch, Kerem Okutur, Ismail Beypinar, Nir Peled, Kübra Aydın, Devrim Cabuk, Julien Mazieres, Hasan Şenol Coşkun, Alisan Zirtiloglu, Hande Turna, Taner Korkmaz, Abdurrahman Isikdogan, Roni Gillis, Ahmet Demirkazik, R. Grinberg, Doğan Yazılıtaş, Cengiz Yilmaz, Adnan Aydiner, Yesim Eralp, Semra Paydas, Filiz Çay Şenler, Ibrahim Yildiz, Moiseenko Fedor |
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| Přispěvatelé: | Ege Üniversitesi |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
0301 basic medicine Pulmonary and Respiratory Medicine Cancer Research medicine.medical_specialty Lung Neoplasms Lactams Lactams Macrocyclic Peripheral edema Aminopyridines ROS1(+) Gastroenterology 03 medical and health sciences 0302 clinical medicine Proto-Oncogene Proteins hemic and lymphatic diseases Internal medicine Hyperlipidemia ROS1 Humans Medicine ALK(+) Adverse effect Retrospective Studies Lorlatinib business.industry Receptor Protein-Tyrosine Kinases Retrospective cohort study Protein-Tyrosine Kinases medicine.disease Real-world data respiratory tract diseases 030104 developmental biology Oncology ALK 030220 oncology & carcinogenesis Cohort Pyrazoles Female medicine.symptom business Real world data |
| Zdroj: | Web of Science |
| ISSN: | 5323-4545 |
| Popis: | 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. PfizerPfizer [IIS 53234545] We grateful to Pfizer for the funding of the grant IIS 53234545. |
| Databáze: | OpenAIRE |
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