1. VinCaP: a phase II trial of vinflunine in locally advanced and metastatic squamous carcinoma of the penis
- Author
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Stephanie Burnett, Amit Bahl, Bruno Morgan, Lucy Tregellas, Lisa Pickering, Alastair Thomson, Emma Hall, Tony Elliott, Rachel Slade, Balaji Venugopal, Steve Nicholson, Naveen S. Vasudev, Holly Tovey, Clare Cruickshank, Peter Kirkbride, Alison Hassall, and Anita Mitra
- Subjects
Adult ,Male ,Oncology ,Cancer Research ,medicine.medical_specialty ,Vinblastine ,Article ,chemistry.chemical_compound ,Stable Disease ,Internal medicine ,Clinical endpoint ,Humans ,Chemotherapy ,Medicine ,Neoplasm Metastasis ,Adverse effect ,Penile Neoplasms ,Aged ,Aged, 80 and over ,Vinflunine ,business.industry ,Cancer ,Middle Aged ,Penile cancer ,medicine.disease ,Tubulin Modulators ,Squamous carcinoma ,Survival Rate ,Treatment Outcome ,medicine.anatomical_structure ,chemistry ,Toxicity ,Carcinoma, Squamous Cell ,Patient Safety ,Neoplasm Recurrence, Local ,business ,Penis - 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 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.
- Published
- 2021
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