dc.contributor.author | Camidge, DR | |
dc.contributor.author | Kim, HR | |
dc.contributor.author | Ahn, M-J | |
dc.contributor.author | Yang, JC-H | |
dc.contributor.author | Han, J-Y | |
dc.contributor.author | Lee, J-S | |
dc.contributor.author | Hochmair, MJ | |
dc.contributor.author | Li, JY-C | |
dc.contributor.author | Chang, G-C | |
dc.contributor.author | Lee, KH | |
dc.contributor.author | Gridelli, C | |
dc.contributor.author | Delmonte, A | |
dc.contributor.author | Garcia Campelo, R | |
dc.contributor.author | Kim, D-W | |
dc.contributor.author | Bearz, A | |
dc.contributor.author | Griesinger, F | |
dc.contributor.author | Morabito, A | |
dc.contributor.author | Felip, E | |
dc.contributor.author | Califano, R | |
dc.contributor.author | Ghosh, S | |
dc.contributor.author | Spira, A | |
dc.contributor.author | Gettinger, SN | |
dc.contributor.author | Tiseo, M | |
dc.contributor.author | Gupta, N | |
dc.contributor.author | Haney, J | |
dc.contributor.author | Kerstein, D | |
dc.contributor.author | Popat, S | |
dc.date.accessioned | 2019-09-18T13:51:36Z | |
dc.date.issued | 2018-11 | |
dc.identifier.citation | The New England journal of medicine, 2018, 379 (21), pp. 2027 - 2039 | |
dc.identifier.issn | 0028-4793 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/3348 | |
dc.identifier.eissn | 1533-4406 | |
dc.identifier.doi | 10.1056/nejmoa1810171 | |
dc.description.abstract | Background 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.format | Print-Electronic | |
dc.format.extent | 2027 - 2039 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.rights.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
dc.subject | Humans | |
dc.subject | Carcinoma, Non-Small-Cell Lung | |
dc.subject | Brain Neoplasms | |
dc.subject | Lung Neoplasms | |
dc.subject | Organophosphorus Compounds | |
dc.subject | Pyrimidines | |
dc.subject | Antineoplastic Agents | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Male | |
dc.subject | Kaplan-Meier Estimate | |
dc.subject | Crizotinib | |
dc.subject | Anaplastic Lymphoma Kinase | |
dc.subject | Progression-Free Survival | |
dc.title | Brigatinib versus Crizotinib in ALK-Positive Non-Small-Cell Lung Cancer. | |
dc.type | Journal Article | |
rioxxterms.versionofrecord | 10.1056/nejmoa1810171 | |
rioxxterms.licenseref.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2018-11 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | The New England journal of medicine | |
pubs.issue | 21 | |
pubs.notes | Not 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-status | Published | |
pubs.volume | 379 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Thoracic Oncology | en_US |
dc.contributor.icrauthor | Popat, Sanjay | |