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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.identifier.citationBritish journal of cancer, 2021
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.titleVinCaP: a phase II trial of vinflunine in locally advanced and metastatic squamous carcinoma of the penis.
dc.typeJournal Article
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfBritish journal of canceren_US
pubs.notesNot known
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.embargo.termsNot known
icr.researchteamClinical Trials & Statistics Unit
dc.contributor.icrauthorHall, Emmaen_US
dc.contributor.icrauthorCruickshank, Clareen_US
dc.contributor.icrauthorBurnett, Stephanieen_US

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