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Brigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer

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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.publisherMassachusetts Medical Society-
dc.relation.isPartOfNew England Journal of Medicine-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHAnaplastic Lymphoma Kinase/analysis-
dc.subject.MESHAnaplastic Lymphoma Kinase/antagonists & inhibitors*-
dc.subject.MESHAntineoplastic Agents/adverse effects-
dc.subject.MESHAntineoplastic Agents/therapeutic use*-
dc.subject.MESHBrain Neoplasms/secondary-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung/chemistry-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung/drug therapy*-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung/secondary-
dc.subject.MESHCrizotinib/adverse effects-
dc.subject.MESHCrizotinib/therapeutic use*-
dc.subject.MESHKaplan-Meier Estimate-
dc.subject.MESHLung Neoplasms/chemistry-
dc.subject.MESHLung Neoplasms/drug therapy*-
dc.subject.MESHLung Neoplasms/pathology-
dc.subject.MESHMiddle Aged-
dc.subject.MESHOrganophosphorus Compounds/adverse effects-
dc.subject.MESHOrganophosphorus Compounds/therapeutic use*-
dc.subject.MESHProgression-Free Survival-
dc.subject.MESHPyrimidines/adverse effects-
dc.subject.MESHPyrimidines/therapeutic use*-
dc.titleBrigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorD.R. Camidge-
dc.contributor.googleauthorH.R. Kim-
dc.contributor.googleauthorM.-J. Ahn-
dc.contributor.googleauthorJ.C.-H. Yang-
dc.contributor.googleauthorJ.-Y. Han-
dc.contributor.googleauthorJ.-S. Lee-
dc.contributor.googleauthorM.J. Hochmair-
dc.contributor.googleauthorJ.Y.-C. Li-
dc.contributor.googleauthorG.-C. Chang-
dc.contributor.googleauthorK.H. Lee-
dc.contributor.googleauthorC. Gridelli-
dc.contributor.googleauthorA. Delmonte-
dc.contributor.googleauthorR. Garcia Campelo-
dc.contributor.googleauthorD.-W. Kim-
dc.contributor.googleauthorA. Bearz-
dc.contributor.googleauthorF. Griesinger-
dc.contributor.googleauthorA. Morabito-
dc.contributor.googleauthorE. Felip-
dc.contributor.googleauthorR. Califano-
dc.contributor.googleauthorS. Ghosh-
dc.contributor.googleauthorA. Spira-
dc.contributor.googleauthorS.N. Gettinger-
dc.contributor.googleauthorM. Tiseo-
dc.contributor.googleauthorN. Gupta-
dc.contributor.googleauthorJ. Haney-
dc.contributor.googleauthorD. Kerstein-
dc.contributor.googleauthorS. Popat-
dc.contributor.alternativeNameKim, Hye Ryun-
dc.identifier.bibliographicCitationNew England Journal of Medicine, Vol.379(21) : 2027-2039, 2018-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers


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