VinCaP: a phase II trial of vinflunine in locally advanced and metastatic squamous carcinoma of the penis.
Br J Cancer
; 126(1): 34-41, 2022 01.
Article
em En
| MEDLINE
| ID: mdl-34671131
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.
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Neoplasias Penianas
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Vimblastina
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Carcinoma de Células Escamosas
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Recidiva Local de Neoplasia
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Aged80
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article