Cumulative incidence rates for CNS and non-CNS progression in two phase II studies of alectinib in ALK-positive NSCLC
Journal
British Journal of Cancer
Journal Volume
118
Journal Issue
1
Pages
38-42
Date Issued
2018
Author(s)
Gadgeel S
Shaw A.T
Barlesi F
Crinò L
Dingemans A.-M.C
Kim D.-W
De Marinis F
Schulz M
Liu S
Gupta R
Kotb A
Ou S.-H.I.
Abstract
Background:We evaluated the cumulative incidence rate (CIR) of central nervous system (CNS) and non-CNS progression in alectinib-treated patients with anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) to determine the extent to which alectinib may treat or control CNS disease.Methods:Patients with crizotinib-pretreated locally advanced or metastatic disease received alectinib 600 mg orally twice daily in two phase II trials. All patients underwent baseline imaging and regular centrally reviewed scans.Results:At 24 months, the CIR for CNS progression was lower in patients without vs with baseline CNS metastases (8.0 vs 43.9%). Patients with baseline CNS disease and prior radiotherapy had a higher CIR of CNS progression than radiotherapy-naive patients (50.5 vs 27.4%) and a lower CIR of non-CNS progression (25.8 vs 42.5%). Adverse events leading to withdrawal occurred in 5.9% and 6.7% of patients with and without baseline CNS metastases, respectively.Conclusions:This analysis indicates a potential role for alectinib in controlling and preventing CNS metastases.
Subjects
alectinib; ALK positive; central nervous system; cumulative incidence rates; disease progression; non-small-cell lung cancer; phase II
SDGs
Other Subjects
alectinib; anaplastic lymphoma kinase; alectinib; ALK protein, human; anaplastic lymphoma kinase; carbazole derivative; piperidine derivative; protein kinase inhibitor; adult; Article; brain metastasis; cancer chemotherapy; cancer incidence; cancer patient; central nervous system; central nervous system disease; controlled study; disease course; female; human; major clinical study; male; non small cell lung cancer; patient history of radiotherapy; phase 2 clinical trial; priority journal; response evaluation criteria in solid tumors; treatment duration; aged; central nervous system tumor; clinical trial; disease exacerbation; genetics; incidence; lung tumor; middle aged; non small cell lung cancer; oral drug administration; secondary; treatment outcome; young adult; Administration, Oral; Adult; Aged; Anaplastic Lymphoma Kinase; Carbazoles; Carcinoma, Non-Small-Cell Lung; Central Nervous System Neoplasms; Disease Progression; Female; Humans; Incidence; Lung Neoplasms; Male; Middle Aged; Piperidines; Protein Kinase Inhibitors; Treatment Outcome; Young Adult
Publisher
Nature Publishing Group
Type
journal article
