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dc.contributor.authorYang, JC-Hen_US
dc.contributor.authorOu, S-HIen_US
dc.contributor.authorDe Petris, Len_US
dc.contributor.authorGadgeel, Sen_US
dc.contributor.authorGandhi, Len_US
dc.contributor.authorKim, D-Wen_US
dc.contributor.authorBarlesi, Fen_US
dc.contributor.authorGovindan, Ren_US
dc.contributor.authorDingemans, A-MCen_US
dc.contributor.authorCrino, Len_US
dc.contributor.authorLena, Hen_US
dc.contributor.authorPopat, Sen_US
dc.contributor.authorAhn, JSen_US
dc.contributor.authorDansin, Een_US
dc.contributor.authorGolding, Sen_US
dc.contributor.authorBordogna, Wen_US
dc.contributor.authorBalas, Ben_US
dc.contributor.authorMorcos, PNen_US
dc.contributor.authorZeaiter, Aen_US
dc.contributor.authorShaw, ATen_US
dc.date.accessioned2017-07-20T13:56:46Z
dc.date.issued2017-10en_US
dc.identifier.citationJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2017, 12 (10), pp. 1552 - 1560en_US
dc.identifier.issn1556-0864en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/738
dc.identifier.eissn1556-1380en_US
dc.identifier.doi10.1016/j.jtho.2017.06.070en_US
dc.description.abstract<h4>Introduction</h4>Alectinib demonstrated clinical efficacy and an acceptable safety profile in two phase II studies (NP28761 and NP28673). Here we report the pooled efficacy and safety data after 15 and 18 months more follow-up than in the respective primary analyses.<h4>Methods</h4>Enrolled patients had ALK receptor tyrosine kinase gene (ALK)-positive NSCLC and had progressed while taking, or could not tolerate, crizotinib. Patients received oral alectinib, 600 mg twice daily. The primary end point in both studies was objective response rate assessed by an independent review committee (IRC) using the Response Evaluation Criteria in Solid Tumors, version 1.1. Secondary end points included disease control rate, duration of response, progression-free survival, overall survival, and safety.<h4>Results</h4>The pooled data set included 225 patients (n = 138 in NP28673 and n = 87 in NP28761). The response-evaluable population included 189 patients (84% [n = 122 in NP28673 and n = 67 in NP28761]). In the response-evaluable population, objective response rate as assessed by the IRC was 51.3% (95% confidence interval [CI]: 44.0-58.6 [all PRs]), the disease control rate was 78.8% (95% CI: 72.3-84.4), and the median duration of response was 14.9 months (95% CI: 11.1-20.4) after 58% of events. Median progression-free survival as assessed by the IRC was 8.3 months (95% CI: 7.0-11.3) and median overall survival was 26.0 months (95% CI: 21.4-not estimable). Grade 3 or higher adverse events (AEs) occurred in 40% of patients, 6% of patients had treatment withdrawn on account of AEs, and 33% had AEs leading to dose interruptions/modification.<h4>Conclusions</h4>This pooled data analysis confirmed the robust systemic efficacy of alectinib in ALK-positive NSCLC with a durable response rate. Alectinib also had an acceptable safety profile with a longer duration of follow-up.en_US
dc.formatPrint-Electronicen_US
dc.format.extent1552 - 1560en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.subjectHumansen_US
dc.subjectCarcinoma, Non-Small-Cell Lungen_US
dc.subjectLung Neoplasmsen_US
dc.subjectPiperidinesen_US
dc.subjectCarbazolesen_US
dc.subjectTreatment Outcomeen_US
dc.subjectAdulten_US
dc.subjectAgeden_US
dc.subjectMiddle Ageden_US
dc.subjectFemaleen_US
dc.subjectMaleen_US
dc.titlePooled Systemic Efficacy and Safety Data from the Pivotal Phase II Studies (NP28673 and NP28761) of Alectinib in ALK-positive Non-Small Cell Lung Cancer.en_US
dc.typeJournal Article
dcterms.dateAccepted2017-06-29en_US
rioxxterms.versionofrecord10.1016/j.jtho.2017.06.070en_US
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by-nc-nd/4.0en_US
rioxxterms.licenseref.startdate2017-10en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfJournal of thoracic oncology : official publication of the International Association for the Study of Lung Canceren_US
pubs.issue10en_US
pubs.notesNot knownen_US
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/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublisheden_US
pubs.volume12en_US
pubs.embargo.termsNot knownen_US
icr.researchteamThoracic Oncologyen_US
dc.contributor.icrauthorPopat, Sanjayen_US
dc.contributor.icrauthorMarsden,en_US


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