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dc.contributor.authorRini, BIen_US
dc.contributor.authorDorff, TBen_US
dc.contributor.authorElson, Pen_US
dc.contributor.authorRodriguez, CSen_US
dc.contributor.authorShepard, Den_US
dc.contributor.authorWood, Len_US
dc.contributor.authorHumbert, Jen_US
dc.contributor.authorPyle, Len_US
dc.contributor.authorWong, Y-Nen_US
dc.contributor.authorFinke, JHen_US
dc.contributor.authorRayman, PAen_US
dc.contributor.authorLarkin, JMGen_US
dc.contributor.authorGarcia, JAen_US
dc.contributor.authorPlimack, ERen_US
dc.date.accessioned2017-04-13T09:56:51Z
dc.date.issued2016-09en_US
dc.identifier.citationThe Lancet. Oncology, 2016, 17 (9), pp. 1317 - 1324en_US
dc.identifier.issn1470-2045en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/595
dc.identifier.eissn1474-5488en_US
dc.identifier.doi10.1016/s1470-2045(16)30196-6en_US
dc.description.abstractA subset of patients with metastatic renal-cell carcinoma show indolent growth of metastases. Because of the toxicity and non-curative nature of systemic therapy, some of these patients could benefit from initial active surveillance. We aimed to characterise the time to initiation of systemic therapy in patients with metastatic renal-cell carcinoma under active surveillance.In this prospective phase 2 trial, we enrolled patients with treatment-naive, asymptomatic, metastatic renal-cell carcinoma from five hospitals in the USA, Spain, and the UK. Patients were radiographically assessed at baseline, every 3 months for year 1, every 4 months for year 2, then every 6 months thereafter. Patients continued on observation until initiation of systemic therapy for metastatic renal-cell carcinoma; a decision that was made at the discretion of the treating physician and patient. The primary endpoint of the study was time to initiation of systemic therapy in the per-protocol population. The follow-up of patients is ongoing.Between Aug 21, 2008, and June 7, 2013, we enrolled 52 patients. Median follow-up of patients in the study was 38·1 months (IQR 29·4-48·9). In the 48 patients included in analysis, median time on surveillance from registration on study until initiation of systemic therapy was 14·9 months (95% CI 10·6-25·0). Multivariate analysis showed that higher numbers of International Metastatic Database Consortium (IMDC) adverse risk factors (p=0·0403) and higher numbers of metastatic disease sites (p=0·0414) were associated with a shorter surveillance period. 22 (46%) patients died during the study period, all from metastatic renal-cell carcinoma.A subset of patients with metastatic renal-cell carcinoma can safely undergo surveillance before starting systemic therapy. Additional investigation is required to further define the benefits and risks of this approach.None.en_US
dc.formatPrint-Electronicen_US
dc.format.extent1317 - 1324en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://www.rioxx.net/licenses/all-rights-reserveden_US
dc.subjectHumansen_US
dc.subjectCarcinoma, Renal Cellen_US
dc.subjectKidney Neoplasmsen_US
dc.subjectTomography, X-Ray Computeden_US
dc.subjectNeoplasm Stagingen_US
dc.subjectPrognosisen_US
dc.subjectNephrectomyen_US
dc.subjectPopulation Surveillanceen_US
dc.subjectSurvival Rateen_US
dc.subjectFollow-Up Studiesen_US
dc.subjectProspective Studiesen_US
dc.subjectAgeden_US
dc.subjectMiddle Ageden_US
dc.subjectUnited Statesen_US
dc.subjectSpainen_US
dc.subjectFemaleen_US
dc.subjectMaleen_US
dc.subjectUnited Kingdomen_US
dc.titleActive surveillance in metastatic renal-cell carcinoma: a prospective, phase 2 trial.en_US
dc.typeJournal Article
dcterms.dateAccepted2016-05-19en_US
rioxxterms.versionofrecord10.1016/s1470-2045(16)30196-6en_US
rioxxterms.licenseref.startdate2016-09en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfThe Lancet. Oncologyen_US
pubs.issue9en_US
pubs.notes12 monthsen_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/Melanoma and Kidney Cancer
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublisheden_US
pubs.volume17en_US
pubs.embargo.terms12 monthsen_US
icr.researchteamMelanoma and Kidney Canceren_US
dc.contributor.icrauthorLarkin, Jamesen_US


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