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dc.contributor.authorNicholson, S
dc.contributor.authorTovey, H
dc.contributor.authorElliott, T
dc.contributor.authorBurnett, SM
dc.contributor.authorCruickshank, C
dc.contributor.authorBahl, A
dc.contributor.authorKirkbride, P
dc.contributor.authorMitra, AV
dc.contributor.authorThomson, AH
dc.contributor.authorVasudev, N
dc.contributor.authorVenugopal, B
dc.contributor.authorSlade, R
dc.contributor.authorTregellas, L
dc.contributor.authorMorgan, B
dc.contributor.authorHassall, A
dc.contributor.authorHall, E
dc.contributor.authorPickering, LM
dc.date.accessioned2021-11-23T14:13:37Z
dc.date.available2021-11-23T14:13:37Z
dc.date.issued2021-10-20
dc.identifier.citationBritish journal of cancer, 2021en_US
dc.identifier.issn0007-0920
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4894
dc.identifier.eissn1532-1827en_US
dc.identifier.eissn1532-1827
dc.identifier.doi10.1038/s41416-021-01574-9en_US
dc.identifier.doi10.1038/s41416-021-01574-9
dc.description.abstractWe investigated the first-line activity of vinflunine in patients with penis cancer. Cisplatin-based combinations are commonly used, but survival is not prolonged; many patients are unfit for such treatment or experience toxicity that outweighs clinical benefit. Twenty-five patients with inoperable squamous carcinoma of the penis were recruited to a single-arm, Fleming-A'Hern exact phase II trial. Treatment comprised 4 cycles of vinflunine 320 mg/m2, given every 21 days. Primary endpoint was clinical benefit rate (CBR: objective responses plus stable disease) assessed after 4 cycles. Seven or more objective responses or disease stabilisations observed in 22 evaluable participants would exclude a CBR of <15%, with a true CBR of >40% being probable. Twenty-two participants were evaluable. Ten objective responses or disease stabilisations were confirmed. CBR was 45.5%, meeting the primary endpoint; partial response rate was 27.3%. Seven patients received >4 cycles of vinflunine. Dose reduction or treatment delay was required for 20% of cycles. In all, 68% of patients experienced at least one grade 3 adverse event. Two deaths on treatment were not caused by disease progression. Pre-specified clinical activity threshold was exceeded. Toxicity was in keeping with experience in other tumours. Vinflunine merits further study in this disease. NCT02057913.en_US
dc.formatPrint-Electronicen_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.titleVinCaP: a phase II trial of vinflunine in locally advanced and metastatic squamous carcinoma of the penis.en_US
dc.typeJournal Article
dcterms.dateAccepted2021-09-30
rioxxterms.versionVoRen_US
rioxxterms.versionofrecord10.1038/s41416-021-01574-9en_US
rioxxterms.licenseref.startdate2021-10-20
dc.relation.isPartOfBritish journal of canceren_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/Clinical Trials & Statistics Unit
pubs.publication-statusPublisheden_US
pubs.embargo.termsNot knownen_US
icr.researchteamClinical Trials & Statistics Unit
dc.contributor.icrauthorHall, Emmaen_US
dc.contributor.icrauthorCruickshank, Clareen_US
dc.contributor.icrauthorBurnett, Stephanieen_US


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