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dc.contributor.authorMerseburger, AS
dc.contributor.authorCastellano, D
dc.contributor.authorPowles, T
dc.contributor.authorLoriot, Y
dc.contributor.authorRetz, M
dc.contributor.authorVoortman, J
dc.contributor.authorHuddart, RA
dc.contributor.authorGedye, C
dc.contributor.authorVan Der Heijden, MS
dc.contributor.authorGurney, H
dc.contributor.authorOng, M
dc.contributor.authorde Ducla, S
dc.contributor.authorPavlova, J
dc.contributor.authorFear, S
dc.contributor.authorSternberg, CN
dc.date.accessioned2021-07-02T11:22:26Z
dc.date.available2021-07-02T11:22:26Z
dc.date.issued2021-04-09
dc.identifier.citationThe Journal of urology, 2021, pp. 101097JU0000000000001768 - ?
dc.identifier.issn0022-5347
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4669
dc.identifier.eissn1527-3792
dc.identifier.eissn1527-3792en_US
dc.identifier.doi10.1097/ju.0000000000001768
dc.identifier.doi10.1097/ju.0000000000001768en_US
dc.description.abstractPurpose Atezolizumab is an established treatment option for pretreated urothelial carcinoma, demonstrating efficacy in phase II/III trials. The SAUL study enrolled a broader patient population to determine safety and efficacy in under represented subgroups.Materials and methods Patients with metastatic urinary tract carcinoma received atezolizumab 1,200 mg every 3 weeks until disease progression, unacceptable toxicity, loss of clinical benefit or patient/physician decision. The primary endpoint was safety. Efficacy was a secondary endpoint. Analyses by programmed cell death ligand-1 (PD-L1) status, age, Eastern Cooperative Oncology Group performance status (ECOG PS) and renal impairment were prespecified; post hoc analyses explored outcomes by tumor location.Results A total of 1,004 patients were enrolled. Subgroup analyses in patients with older age, renal impairment or upper tract urothelial carcinoma showed safety and efficacy similar to those in patients without these characteristics. Patients with ECOG PS 2 had clinical features typically associated with aggressive disease; median overall survival was 2.3 months versus 10.0 months in patients with ECOG PS 0/1. Patients with PD-L1 expression on ≥5% of tumor-infiltrating immune cells tended to have better outcomes than those with <5% PD-L1 expression, although conclusions on the relative efficacy of atezolizumab cannot be drawn from this single-arm study.Conclusions The under studied populations included in the SAUL study had similar outcomes to those in more selected populations included in phase II/III trials of atezolizumab, except for those with ECOG PS 2. Age ≥80 years and/or creatinine clearance <30 ml/minute does not preclude administration of atezolizumab; however, treatment risk vs benefit must be carefully assessed in patients with ECOG PS 2.
dc.formatPrint-Electronic
dc.format.extent101097JU0000000000001768 - ?
dc.languageeng
dc.language.isoeng
dc.rights.urihttp://www.rioxx.net/licenses/under-embargo-all-rights-reserved
dc.titleSafety and Efficacy of Atezolizumab in Under Studied Populations with Pretreated Urinary Tract Carcinoma: Subgroup Analyses of the SAUL Study in Real-World Practice.
dc.typeJournal Article
dcterms.dateAccepted2021-04-09
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1097/ju.0000000000001768
rioxxterms.licenseref.startdate2021-04-09
rioxxterms.licenseref.startdate2021-04-09en_US
dc.relation.isPartOfThe Journal of urology
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
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.publication-statusPublished
pubs.embargo.termsNot known
icr.researchteamClinical Academic Radiotherapy (Huddart)
icr.researchteamClinical Academic Radiotherapy (Huddart)en_US
dc.contributor.icrauthorHuddart, Roberten


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