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dc.contributor.authorCamidge, DR
dc.contributor.authorKim, HR
dc.contributor.authorAhn, M-J
dc.contributor.authorYang, JC-H
dc.contributor.authorHan, J-Y
dc.contributor.authorLee, J-S
dc.contributor.authorHochmair, MJ
dc.contributor.authorLi, JY-C
dc.contributor.authorChang, G-C
dc.contributor.authorLee, KH
dc.contributor.authorGridelli, C
dc.contributor.authorDelmonte, A
dc.contributor.authorGarcia Campelo, R
dc.contributor.authorKim, D-W
dc.contributor.authorBearz, A
dc.contributor.authorGriesinger, F
dc.contributor.authorMorabito, A
dc.contributor.authorFelip, E
dc.contributor.authorCalifano, R
dc.contributor.authorGhosh, S
dc.contributor.authorSpira, A
dc.contributor.authorGettinger, SN
dc.contributor.authorTiseo, M
dc.contributor.authorGupta, N
dc.contributor.authorHaney, J
dc.contributor.authorKerstein, D
dc.contributor.authorPopat, S
dc.date.accessioned2019-09-18T13:51:36Z
dc.date.issued2018-11
dc.identifier.citationThe New England journal of medicine, 2018, 379 (21), pp. 2027 - 2039
dc.identifier.issn0028-4793
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3348
dc.identifier.eissn1533-4406
dc.identifier.doi10.1056/nejmoa1810171
dc.description.abstractBackground Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, has robust efficacy in patients with ALK-positive non-small-cell lung cancer (NSCLC) that is refractory to crizotinib. The efficacy of brigatinib, as compared with crizotinib, in patients with advanced ALK-positive NSCLC who have not previously received an ALK inhibitor is unclear.Methods In an open-label, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with advanced ALK-positive NSCLC who had not previously received ALK inhibitors to receive brigatinib at a dose of 180 mg once daily (with a 7-day lead-in period at 90 mg) or crizotinib at a dose of 250 mg twice daily. The primary end point was progression-free survival as assessed by blinded independent central review. Secondary end points included the objective response rate and intracranial response. The first interim analysis was planned when approximately 50% of 198 expected events of disease progression or death had occurred.Results A total of 275 patients underwent randomization; 137 were assigned to brigatinib and 138 to crizotinib. At the first interim analysis (99 events), the median follow-up was 11.0 months in the brigatinib group and 9.3 months in the crizotinib group. The rate of progression-free survival was higher with brigatinib than with crizotinib (estimated 12-month progression-free survival, 67% [95% confidence interval {CI}, 56 to 75] vs. 43% [95% CI, 32 to 53]; hazard ratio for disease progression or death, 0.49 [95% CI, 0.33 to 0.74]; P<0.001 by the log-rank test). The confirmed objective response rate was 71% (95% CI, 62 to 78) with brigatinib and 60% (95% CI, 51 to 68) with crizotinib; the confirmed rate of intracranial response among patients with measurable lesions was 78% (95% CI, 52 to 94) and 29% (95% CI, 11 to 52), respectively. No new safety concerns were noted.Conclusions Among patients with ALK-positive NSCLC who had not previously received an ALK inhibitor, progression-free survival was significantly longer among patients who received brigatinib than among those who received crizotinib. (Funded by Ariad Pharmaceuticals; ALTA-1L ClinicalTrials.gov number, NCT02737501 .).
dc.formatPrint-Electronic
dc.format.extent2027 - 2039
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://www.rioxx.net/licenses/all-rights-reserved
dc.subjectHumans
dc.subjectCarcinoma, Non-Small-Cell Lung
dc.subjectBrain Neoplasms
dc.subjectLung Neoplasms
dc.subjectOrganophosphorus Compounds
dc.subjectPyrimidines
dc.subjectAntineoplastic Agents
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectKaplan-Meier Estimate
dc.subjectCrizotinib
dc.subjectAnaplastic Lymphoma Kinase
dc.subjectProgression-Free Survival
dc.titleBrigatinib versus Crizotinib in ALK-Positive Non-Small-Cell Lung Cancer.
dc.typeJournal Article
rioxxterms.versionofrecord10.1056/nejmoa1810171
rioxxterms.licenseref.urihttps://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2018-11
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfThe New England journal of medicine
pubs.issue21
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Thoracic Oncology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Thoracic Oncology/Thoracic Oncology (hon.)
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Thoracic Oncology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Thoracic Oncology/Thoracic Oncology (hon.)
pubs.publication-statusPublished
pubs.volume379
pubs.embargo.termsNot known
icr.researchteamThoracic Oncologyen_US
dc.contributor.icrauthorPopat, Sanjayen


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