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dc.contributor.authorRini, BI
dc.contributor.authorDorff, TB
dc.contributor.authorElson, P
dc.contributor.authorRodriguez, CS
dc.contributor.authorShepard, D
dc.contributor.authorWood, L
dc.contributor.authorHumbert, J
dc.contributor.authorPyle, L
dc.contributor.authorWong, Y-N
dc.contributor.authorFinke, JH
dc.contributor.authorRayman, PA
dc.contributor.authorLarkin, JMG
dc.contributor.authorGarcia, JA
dc.contributor.authorPlimack, ER
dc.date.accessioned2017-04-13T09:56:51Z
dc.date.issued2016-09
dc.identifier.citationThe Lancet. Oncology, 2016, 17 (9), pp. 1317 - 1324
dc.identifier.issn1470-2045
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/595
dc.identifier.eissn1474-5488
dc.identifier.doi10.1016/s1470-2045(16)30196-6
dc.description.abstractBackground A 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.Methods 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.Findings 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.Interpretation 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.Funding None.
dc.formatPrint-Electronic
dc.format.extent1317 - 1324
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://www.rioxx.net/licenses/all-rights-reserved
dc.subjectHumans
dc.subjectCarcinoma, Renal Cell
dc.subjectKidney Neoplasms
dc.subjectTomography, X-Ray Computed
dc.subjectNeoplasm Staging
dc.subjectPrognosis
dc.subjectNephrectomy
dc.subjectPopulation Surveillance
dc.subjectSurvival Rate
dc.subjectFollow-Up Studies
dc.subjectProspective Studies
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectUnited States
dc.subjectSpain
dc.subjectFemale
dc.subjectMale
dc.subjectUnited Kingdom
dc.titleActive surveillance in metastatic renal-cell carcinoma: a prospective, phase 2 trial.
dc.typeJournal Article
dcterms.dateAccepted2016-05-19
rioxxterms.versionofrecord10.1016/s1470-2045(16)30196-6
rioxxterms.licenseref.urihttps://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2016-09
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfThe Lancet. Oncology
pubs.issue9
pubs.notes12 months
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.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-statusPublished
pubs.volume17
pubs.embargo.terms12 months
icr.researchteamMelanoma and Kidney Canceren_US
dc.contributor.icrauthorLarkin, Jamesen


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