VinCaP: a phase II trial of vinflunine in locally advanced and metastatic squamous carcinoma of the penis.
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Embargo End Date
ICR Authors
Authors
Nicholson, S
Tovey, H
Elliott, T
Burnett, SM
Cruickshank, C
Bahl, A
Kirkbride, P
Mitra, AV
Thomson, AH
Vasudev, N
Venugopal, B
Slade, R
Tregellas, L
Morgan, B
Hassall, A
Hall, E
Pickering, LM
Tovey, H
Elliott, T
Burnett, SM
Cruickshank, C
Bahl, A
Kirkbride, P
Mitra, AV
Thomson, AH
Vasudev, N
Venugopal, B
Slade, R
Tregellas, L
Morgan, B
Hassall, A
Hall, E
Pickering, LM
Document Type
Journal Article
Date
2022-01-01
Date Accepted
2021-09-30
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.
Citation
British journal of cancer, 2021
Source Title
Publisher
SPRINGERNATURE
ISSN
0007-0920
eISSN
1532-1827
Collections
Research Team
Clinical Trials & Statistics Unit