dc.contributor.author | Nicholson, S | |
dc.contributor.author | Tovey, H | |
dc.contributor.author | Elliott, T | |
dc.contributor.author | Burnett, SM | |
dc.contributor.author | Cruickshank, C | |
dc.contributor.author | Bahl, A | |
dc.contributor.author | Kirkbride, P | |
dc.contributor.author | Mitra, AV | |
dc.contributor.author | Thomson, AH | |
dc.contributor.author | Vasudev, N | |
dc.contributor.author | Venugopal, B | |
dc.contributor.author | Slade, R | |
dc.contributor.author | Tregellas, L | |
dc.contributor.author | Morgan, B | |
dc.contributor.author | Hassall, A | |
dc.contributor.author | Hall, E | |
dc.contributor.author | Pickering, LM | |
dc.date.accessioned | 2021-11-23T14:13:37Z | |
dc.date.available | 2021-11-23T14:13:37Z | |
dc.date.issued | 2022-01-01 | |
dc.identifier.citation | British journal of cancer, 2021 | |
dc.identifier.issn | 0007-0920 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4894 | |
dc.identifier.eissn | 1532-1827 | |
dc.identifier.doi | 10.1038/s41416-021-01574-9 | |
dc.description.abstract | BACKGROUND: We 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Pre-specified clinical activity threshold was exceeded. Toxicity was in keeping with experience in other tumours. Vinflunine merits further study in this disease. TRIAL REGISTRATION: NCT02057913. | |
dc.format | Print-Electronic | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | SPRINGERNATURE | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.title | VinCaP: a phase II trial of vinflunine in locally advanced and metastatic squamous carcinoma of the penis. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2021-09-30 | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1038/s41416-021-01574-9 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2021-10-20 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | British journal of cancer | |
pubs.notes | Not 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/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit | |
pubs.publication-status | Published | |
pubs.embargo.terms | Not known | |
icr.researchteam | Clinical Trials & Statistics Unit | |
dc.contributor.icrauthor | Tovey, Holly | |
dc.contributor.icrauthor | Burnett, Stephanie | |
dc.contributor.icrauthor | Cruickshank, Clare | |
dc.contributor.icrauthor | Hall, Emma | |