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Efficacy and Safety of Brigatinib Compared With Crizotinib in Asian vs. Non-Asian Patients With Locally Advanced or Metastatic ALK-Inhibitor-Naive ALK plus Non-Small Cell Lung Cancer: Final Results From the Phase III ALTA-1L Study
DC Field | Value | Language |
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dc.contributor.author | Ahn, Myung J. | - |
dc.contributor.author | Kim, Hye R. | - |
dc.contributor.author | Yang, James C. H. | - |
dc.contributor.author | Han, Ji-Yu | - |
dc.contributor.author | Li, Jacky Yu-Chung | - |
dc.contributor.author | Hochmair, Maximilian J. | - |
dc.contributor.author | Chang, Gee-Chen | - |
dc.contributor.author | Delmonte, Angelo | - |
dc.contributor.author | Lee, Ki H. | - |
dc.contributor.author | Campelo, Rosario G. | - |
dc.contributor.author | Gridelli, Cesare | - |
dc.contributor.author | Spira, Alexander, I | - |
dc.contributor.author | Califano, Raffaele | - |
dc.contributor.author | Griesinger, Frank | - |
dc.contributor.author | Ghosh, Sharmistha | - |
dc.contributor.author | Felip, Enriqueta | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Liu, Yuyin | - |
dc.contributor.author | Zhang, Pingkuan | - |
dc.contributor.author | Popat, Sanjay | - |
dc.contributor.author | Camidge, D. Ross | - |
dc.date.accessioned | 2023-03-20T08:35:56Z | - |
dc.date.available | 2023-03-20T08:35:56Z | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.created | 2023-01-17 | - |
dc.date.issued | 2022-12 | - |
dc.identifier.citation | Clinical Lung Cancer, Vol.23 No.8, pp.720-730 | - |
dc.identifier.issn | 1525-7304 | - |
dc.identifier.uri | https://hdl.handle.net/10371/189405 | - |
dc.description.abstract | We evaluated brigatinib efficacy and safety compared with crizotinib in an analysis of Asian (n = 108) and non -Asian (n = 167) subgroups from the phase III ALTA-1L study. Brigatinib showed better BIRC-assessed PFS over crizotinib in Asians and non-Asians (HR [95% CI], log-rank: Asians, 0.35 [0.20-0.59], P = .0 0 01; non-Asians, 0.56 [0.38-0.84], P = .0041). Overall safety was similar between groups. Background: Brigatinib is a next-generation anaplastic lymphoma kinase (ALK) inhibitor with demonstrated efficacy in locally advanced and metastatic non-small cell lung cancer (NSCLC) in crizotinib-refractory and ALK inhibitor-naive settings. This analysis assessed brigatinib in Asian vs. non-Asian patients from the first-line ALTA-1L trial. Patients and Methods: This was a subgroup analysis from the phase III ALTA-1L trial of brigatinib vs. crizotinib in ALK inhibitor-naive ALK+ NSCLC. The primary endpoint was progression-free survival (PFS) as assessed by blinded independent review committee (BIRC). Secondary endpoints included confirmed objective response rate (ORR) and overall survival (OS) in the overall population and BIRC-assessed intracranial ORR and PFS in patients with brain metastases. Results: Of the 275 randomized patients, 108 were Asian. Brigatinib showed consistent super ior ity in BIRC-assessed PFS vs. crizotinib in Asian (hazard ratio [HR]: 0.35 [95% CI: 0.20-0.59]; log-rank P = .0001; median 24.0 vs. 11.1 months) and non-Asian (HR: 0.56 [95% CI: 0.38-0.84]; log-rank P = .0041; median 24.7 vs. 9.4 months) patients. Results were consistent with investigator-assessed PFS and BIRC-assessed intracranial PFS. Brigatinib was well tolerated. Toxicity profiles and dose modification rates were similar between Asian and non-Asian patients. Conclusion: Efficacy with brigatinib was consistently better than with crizotinib in Asian and non-Asian patients with locally advanced or metastatic ALK inhibitor -naive ALK-+ NSCLC. There were no clinically notable differences in overall safety in Asian vs. non-Asian patients. | - |
dc.language | 영어 | - |
dc.publisher | Cancer Information Group | - |
dc.title | Efficacy and Safety of Brigatinib Compared With Crizotinib in Asian vs. Non-Asian Patients With Locally Advanced or Metastatic ALK-Inhibitor-Naive ALK plus Non-Small Cell Lung Cancer: Final Results From the Phase III ALTA-1L Study | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.cllc.2022.07.008 | - |
dc.citation.journaltitle | Clinical Lung Cancer | - |
dc.identifier.wosid | 000905581000019 | - |
dc.identifier.scopusid | 2-s2.0-85136735466 | - |
dc.citation.endpage | 730 | - |
dc.citation.number | 8 | - |
dc.citation.startpage | 720 | - |
dc.citation.volume | 23 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | EML4-ALK FUSION GENE | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | ALECTINIB | - |
dc.subject.keywordPlus | EGFR | - |
dc.subject.keywordAuthor | ALK TKI-naive | - |
dc.subject.keywordAuthor | Anaplastic lymphoma kinase | - |
dc.subject.keywordAuthor | Clinical trial | - |
dc.subject.keywordAuthor | First line | - |
dc.subject.keywordAuthor | Tyrosine kinase inhibitor | - |
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