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dc.contributor.authorSternberg, C
dc.contributor.authorArmstrong, A
dc.contributor.authorPili, R
dc.contributor.authorNg, S
dc.contributor.authorHuddart, R
dc.contributor.authorAgarwal, N
dc.contributor.authorKhvorostenko, D
dc.contributor.authorLyulko, O
dc.contributor.authorBrize, A
dc.contributor.authorVogelzang, N
dc.contributor.authorDelva, R
dc.contributor.authorHarza, M
dc.contributor.authorThanos, A
dc.contributor.authorJames, N
dc.contributor.authorWerbrouck, P
dc.contributor.authorBögemann, M
dc.contributor.authorHutson, T
dc.contributor.authorMilecki, P
dc.contributor.authorChowdhury, S
dc.contributor.authorGallardo, E
dc.contributor.authorSchwartsmann, G
dc.contributor.authorPouget, J-C
dc.contributor.authorBaton, F
dc.contributor.authorNederman, T
dc.contributor.authorTuvesson, H
dc.contributor.authorCarducci, M
dc.date.accessioned2017-04-21T16:33:49Z
dc.date.issued2016-08
dc.identifier.citationJournal of clinical oncology : official journal of the American Society of Clinical Oncology, 2016, 34 (22), pp. 2636 - 2643
dc.identifier.issn0732-183X
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/613
dc.identifier.eissn1527-7755
dc.identifier.doi10.1200/jco.2016.66.9697
dc.description.abstractPurpose Tasquinimod, a novel oral therapy targeting the tumor microenvironment, significantly improved progression-free survival (PFS) in a randomized, placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). This phase III study was conducted to confirm the phase II results and to detect an overall survival (OS) benefit.Patients and methods Men with chemotherapy-naïve mCRPC and evidence of bone metastases were assigned (2:1) to receive tasquinimod once per day or placebo until progression or toxicity. The primary end point was radiographic PFS (rPFS; time from random assignment to radiologic progression or death) per Prostate Cancer Working Group 2 criteria and RECIST 1.1. The study had 99.9% power to detect an rPFS hazard ratio (HR) of 0.6 with a two-sided alpha error of .05 and 80% power to detect a target HR of 0.8 for OS, the key secondary end point.Results In all, 1,245 patients were randomly assigned to either tasquinimod (n = 832) or placebo (n = 413) between March 2011 and December 2012 at 241 sites in 37 countries. Baseline characteristics were balanced between groups: median age, 71 years; Karnofsky performance status ≥ 90%, 77.3%; and visceral metastases, 21.1%. Estimated median rPFS by central review was 7.0 months (95% CI, 5.8 to 8.2 months) with tasquinimod and 4.4 months (95% CI, 3.5 to 5.5 months) with placebo (HR, 0.64; 95% CI, 0.54 to 0.75; P < .001). Median OS was 21.3 months (95% CI, 19.5 to 23.0 months) with tasquinimod and 24.0 months (95% CI, 21.4 to 26.9 months) with placebo (HR, 1.10; 95% CI, 0.94 to 1.28; P = .25). Grade ≥ 3 adverse events were more frequent with tasquinimod (42.8% v 33.6%), the most common being anemia, fatigue, and cancer pain.Conclusion In chemotherapy-naïve men with mCRPC, tasquinimod significantly improved rPFS compared with placebo. However, no OS benefit was observed.
dc.formatPrint-Electronic
dc.format.extent2636 - 2643
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://www.rioxx.net/licenses/all-rights-reserved
dc.subjectHumans
dc.subjectNeoplasm Metastasis
dc.subjectQuinolones
dc.subjectAntineoplastic Agents
dc.subjectDouble-Blind Method
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectMale
dc.subjectProstatic Neoplasms, Castration-Resistant
dc.titleRandomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer.
dc.typeJournal Article
dcterms.dateAccepted2016-06-13
rioxxterms.versionofrecord10.1200/jco.2016.66.9697
rioxxterms.licenseref.urihttps://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2016-08
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfJournal of clinical oncology : official journal of the American Society of Clinical Oncology
pubs.issue22
pubs.notesNot known
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/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Prostate and Bladder Cancer Research
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/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Prostate and Bladder Cancer Research
pubs.publication-statusPublished
pubs.volume34
pubs.embargo.termsNot known
icr.researchteamClinical Academic Radiotherapy (Huddart)en_US
icr.researchteamProstate and Bladder Cancer Researchen_US
dc.contributor.icrauthorHuddart, Roberten
dc.contributor.icrauthorJames, Nicholasen


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