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Intracranial efficacy of crizotinib versus chemotherapy in patients with advanced ALK-positive non-small-cell lung cancer: Results from PROFILE 1014
DC Field | Value | Language |
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dc.contributor.author | Solomon, Benjamin J. | - |
dc.contributor.author | Cappuzzo, Federico | - |
dc.contributor.author | Felip, Enriqueta | - |
dc.contributor.author | Blackhall, Fiona H. | - |
dc.contributor.author | Costa, Daniel B. | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Nakagawa, Kazuhiko | - |
dc.contributor.author | Wu, Yi-Long | - |
dc.contributor.author | Mekhail, Tarek | - |
dc.contributor.author | Paolini, Jolanda | - |
dc.contributor.author | Tursi, Jennifer | - |
dc.contributor.author | Usari, Tiziana | - |
dc.contributor.author | Wilner, Keith D. | - |
dc.contributor.author | Selaru, Paulina | - |
dc.contributor.author | Mok, Tony S. K. | - |
dc.date.accessioned | 2020-04-27T11:14:35Z | - |
dc.date.available | 2020-04-27T11:14:35Z | - |
dc.date.created | 2018-09-06 | - |
dc.date.issued | 2016-08 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.34 No.24, pp.2858-2865 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 51412 | - |
dc.identifier.uri | https://hdl.handle.net/10371/165308 | - |
dc.description.abstract | Purpose Intracranial efficacy of first-line crizotinib versus chemotherapy was compared prospectively in the phase III PROFILE 1014 study in ALK-positive non-small-cell lung cancer. Patients and Methods Patients were randomly assigned to receive crizotinib (250 mg twice daily; n = 172) or chemotherapy (pemetrexed 500 mg/m(2) plus cisplatin 75 mg/m(2) or carboplatin at area under the curve 5 to 6, every 3weeks for <= six cycles; n = 171). Patients with stable treated brain metastases (tBM) were eligible. Intracranial efficacy was assessed at baseline and every 6 or 12 weeks in patients with or without known brain metastases (BM), respectively; intracranial time to tumor progression (IC-TTP; per protocol) and intracranial disease control rate (IC-DCR; post hoc) were measured. The intent-to-treat population was also assessed. Results Of 343 patients in the intent-to-treat population, 23% had tBM at baseline. A nonsignificant IC-TTP improvement was observed with crizotinib in the intent-to-treat population (hazard ratio [HR], 0.60; P = .069), patients with tBM (HR, 0.45; P = .063), and patients without BM (HR, 0.69; P = .323). Among patients with tBM, IC-DCR was significantly higher with crizotinib versus chemotherapy at 12 weeks (85% v 45%, respectively; P < .001) and 24 weeks (56% v 25%, respectively; P = .006). Progression-free survival was significantly longer with crizotinib versus chemotherapy in both subgroups (tBM present: HR, 0.40; P < .001; median, 9.0 v 4.0 months, respectively; BM absent: HR, 0.51; P < .001; median, 11.1 v 7.2 months, respectively) and in the intent-to-treat population (HR, 0.45; P < . 001; median, 10.9v 7.0months, respectively). Conclusion Compared with chemotherapy, crizotinib demonstrated a significantly higher IC-DCR in patients with tBM. Improvements in IC-TTP were not statistically significant in patients with or without tBM, although sensitivity to detect treatment differences in or between the two subgroups was low. | - |
dc.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | Intracranial efficacy of crizotinib versus chemotherapy in patients with advanced ALK-positive non-small-cell lung cancer: Results from PROFILE 1014 | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1200/JCO.2015.63.5888 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000382469100010 | - |
dc.identifier.scopusid | 2-s2.0-84979027920 | - |
dc.citation.endpage | 2865 | - |
dc.citation.number | 24 | - |
dc.citation.startpage | 2858 | - |
dc.citation.volume | 34 | - |
dc.identifier.sci | 000382469100010 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | KINASE INHIBITOR CRIZOTINIB | - |
dc.subject.keywordPlus | BRAIN METASTASES | - |
dc.subject.keywordPlus | ANAPLASTIC LYMPHOMA | - |
dc.subject.keywordPlus | CSF CONCENTRATION | - |
dc.subject.keywordPlus | CLINICAL BENEFIT | - |
dc.subject.keywordPlus | CNS METASTASES | - |
dc.subject.keywordPlus | REARRANGEMENT | - |
dc.subject.keywordPlus | PROGRESSION | - |
dc.subject.keywordPlus | PATTERNS | - |
dc.subject.keywordPlus | THERAPY | - |
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