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Alectinib versus crizotinib in untreated ALK-positive non–small-cell lung cancer
DC Field | Value | Language |
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dc.contributor.author | Peters, Solange | - |
dc.contributor.author | Camidge, D. Ross | - |
dc.contributor.author | Shaw, Alice T. | - |
dc.contributor.author | Gadgeel, Shirish | - |
dc.contributor.author | Ahn, Jin S. | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Ou, Sai-Hong I. | - |
dc.contributor.author | Perol, Maurice | - |
dc.contributor.author | Dziadziuszko, Rafal | - |
dc.contributor.author | Rosell, Rafael | - |
dc.contributor.author | Zeaiter, Ali | - |
dc.contributor.author | Mitry, Emmanuel | - |
dc.contributor.author | Golding, Sophie | - |
dc.contributor.author | Balas, Bogdana | - |
dc.contributor.author | Noe, Johannes | - |
dc.contributor.author | Morcos, Peter N. | - |
dc.contributor.author | Mok, Tony | - |
dc.date.accessioned | 2020-04-27T11:10:11Z | - |
dc.date.available | 2020-04-27T11:10:11Z | - |
dc.date.created | 2018-09-10 | - |
dc.date.issued | 2017-08 | - |
dc.identifier.citation | New England Journal of Medicine, Vol.377 No.9, pp.829-838 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.other | 52524 | - |
dc.identifier.uri | https://hdl.handle.net/10371/165267 | - |
dc.description.abstract | BACKGROUND Alectinib, a highly selective inhibitor of anaplastic lymphoma kinase (ALK), has shown systemic and central nervous system (CNS) efficacy in the treatment of ALK-positive non-small-cell lung cancer (NSCLC). We investigated alectinib as compared with crizotinib in patients with previously untreated, advanced ALK-positive NSCLC, including those with asymptomatic CNS disease. METHODS In a randomized, open-label, phase 3 trial, we randomly assigned 303 patients with previously untreated, advanced ALK-positive NSCLC to receive either alectinib (600 mg twice daily) or crizotinib (250 mg twice daily). The primary end point was investigator-assessed progression-free survival. Secondary end points were independent review committee-assessed progression-free survival, time to CNS progression, objective response rate, and overall survival. RESULTS During a median follow-up of 17.6 months (crizotinib) and 18.6 months (alectinib), an event of disease progression or death occurred in 62 of 152 patients (41%) in the alectinib group and 102 of 151 patients (68%) in the crizotinib group. The rate of investigator-assessed progression-free survival was significantly higher with alectinib than with crizotinib (12-month event-free survival rate, 68.4% [95% confidence interval (CI), 61.0 to 75.9] with alectinib vs. 48.7% [95% CI, 40.4 to 56.9] with crizotinib; hazard ratio for disease progression or death, 0.47 [95% CI, 0.34 to 0.65]; P<0.001); the median progression-free survival with alectinib was not reached. The results for independent review committee-assessed progression-free survival were consistent with those for the primary end point. A total of 18 patients (12%) in the alectinib group had an event of CNS progression, as compared with 68 patients (45%) in the crizotinib group (cause-specific hazard ratio, 0.16; 95% CI, 0.10 to 0.28; P<0.001). A response occurred in 126 patients in the alectinib group (response rate, 82.9%; 95% CI, 76.0 to 88.5) and in 114 patients in the crizotinib group (response rate, 75.5%; 95% CI, 67.8 to 82.1) (P = 0.09). Grade 3 to 5 adverse events were less frequent with alectinib (41% vs. 50% with crizotinib). CONCLUSIONS As compared with crizotinib, alectinib showed superior efficacy and lower toxicity in primary treatment of ALK-positive NSCLC. (Funded by F. Hoffmann-La Roche; ALEX ClinicalTrials.gov number, NCT02075840.) | - |
dc.language | 영어 | - |
dc.publisher | Massachusetts Medical Society | - |
dc.title | Alectinib versus crizotinib in untreated ALK-positive non–small-cell lung cancer | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1056/NEJMoa1704795 | - |
dc.citation.journaltitle | New England Journal of Medicine | - |
dc.identifier.wosid | 000408626400006 | - |
dc.identifier.scopusid | 2-s2.0-85027524894 | - |
dc.citation.endpage | 838 | - |
dc.citation.number | 9 | - |
dc.citation.startpage | 829 | - |
dc.citation.volume | 377 | - |
dc.identifier.sci | 000408626400006 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | 1ST-LINE CRIZOTINIB | - |
dc.subject.keywordPlus | INHIBITOR ALECTINIB | - |
dc.subject.keywordPlus | ANTITUMOR-ACTIVITY | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | METASTASES | - |
dc.subject.keywordPlus | RESISTANCE | - |
dc.subject.keywordPlus | PHASE-3 | - |
dc.subject.keywordPlus | MODELS | - |
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