Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/32763
Title: LOREALAUS: LOrlatinib REAL-World AUStralian Experience in Advanced ALK-Rearranged NSCLC.
Austin Authors: Alexander, Marliese;Wei, Joe;Parakh, Sagun ;John, Thomas ;Kao, Steven;Nagrial, Adnan;Bowyer, Samantha;Warburton, Lydia;Moore, Melissa;Hughes, Brett G M;Clay, Timothy D;Pavlakis, Nick;Solomon, Benjamin J;Itchins, Malinda
Affiliation: Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.;Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Victoria, Australia.
Department of Medical Oncology, Royal North Shore Hospital, St. Leonards, New South Wales, Australia.;Northern Clinical School, The University of Sydney, St. Leonards, New South Wales, Australia.
Olivia Newton-John Cancer Research Institute
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.;Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Victoria, Australia.
Chris O'Brien Lifehouse, Sydney, New South Wales, Australia.;Faculty of Medicine and Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.
Department of Medical Oncology, Westmead Hospital, Westmead, New South Wales, Australia.;Blacktown Hospital, Blacktown, New South Wales, Australia.;Westmead Clinical School, The University of Sydney, Westmead, New South Wales, Australia.
Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.;University of Western Australia, Perth, Western Australia, Australia.
Department of Medical Oncology, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.
Department of Medical Oncology, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia.;Department of Medicine, The University of Melbourne, Carlton, Victoria, Australia.
Department of Medical Oncology, The Prince Charles Hospital, Brisbane, Queensland, Australia.;Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.
Department of Medical Oncology, Saint John of God Subiaco Hospital, Perth, Western Australia, Australia.;Icon Cancer Care Midland, Western Australia, Australia.;School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.
Department of Medical Oncology, Royal North Shore Hospital, St. Leonards, New South Wales, Australia.;Northern Clinical School, The University of Sydney, St. Leonards, New South Wales, Australia.
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.;Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Victoria, Australia.
Department of Medical Oncology, Royal North Shore Hospital, St. Leonards, New South Wales, Australia.;Northern Clinical School, The University of Sydney, St. Leonards, New South Wales, Australia.
Issue Date: Apr-2023
Date: 2023
Publication information: JTO Clinical and Research Reports 2023-04; 4(4)
Abstract: Over the past decade, ALK tyrosine kinase inhibitors have delivered unprecedented survival for individuals with ALK-positive (ALK+) lung cancers. Real-world data enhance the understanding of optimal drug sequencing and expectations for survival. Multicenter real-world study of individuals with pretreated advanced ALK+ lung cancers managed on a lorlatinib access program between 2016 and 2020. Key outcomes were lorlatinib efficacy, tolerability, and treatment sequencing. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method among all individuals (PFSa and OSa), with at least 30 days (one-cycle) lorlatinib exposure (PFSb and OSb), and with good performance status (PFSc and OSc). Subgroups of interest were analyzed to assess signals of potential clinical applicability. Two OS index dates were analyzed, from lorlatinib initiation and advanced ALK+ diagnosis. The population (N = 38, 10 sites) was heavily pretreated (23 had ≥2 previous treatment lines) with a high disease burden (26 had 2-4 sites and 11 had >4 sites of metastatic disease, 19 had brain metastases). The overall response rate was 44% and the disease control rate was 81%. Lorlatinib dose reduction (18%), interruption (16%), and discontinuation (3%) were consistent with the trial experience. From advanced ALK+ diagnosis, the median OS for populations a, b, and c was 45.0 months, 69.9 months and 61.2 months respectively. From lorlatinib initiation, the median PFSa, PFSb and PFSc was 7.3 months, 13.2 months and 27.7 months and the median OSa, OSb and OSc was 19.9 months, 25.1 months and 27.7 months. The median PFSa with versus without brain metastases was 34.6 months versus 5.8 months (p = 0.09). The intracranial median PFS was 14.2 months. Previous good response versus poor response to the first ALK-directed therapy median PFSa was 27.7 months versus 4.7 months with a hazard ratio of 0.3 (p = 0.01). Lorlatinib is a potent, highly active brain-penetrant third-generation ALK tyrosine kinase inhibitors with benefits for most individuals in the later-line setting in a real-world evaluation, consistent with clinical trial data.
URI: https://ahro.austin.org.au/austinjspui/handle/1/32763
DOI: 10.1016/j.jtocrr.2023.100490
ORCID: 
Journal: JTO Clinical and Research Reports
Start page: 100490
PubMed URL: 37077199
ISSN: 2666-3643
Type: Journal Article
Subjects: ALK
Anaplastic Lymphoma Kinase
Lorlatinib
NSCLC
Non–small cell lung cancer
Real-World
Appears in Collections:Journal articles

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