Journal
BRITISH JOURNAL OF CANCER
Volume 126, Issue 1, Pages 34-41Publisher
SPRINGERNATURE
DOI: 10.1038/s41416-021-01574-9
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Funding
- Cancer Research UK [C8262/A14509, C1491/A25351]
- National Institute for Health Research (NIHR) Cancer Research Network (CRN)/NHS Research Scotland/Health and Care Research Wales
- National Institute for Health Research (NIHR) Biomedical Research Centre at The Royal Marsden NHS Foundation Trust
- Institute of Cancer Research, London
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This study investigated the first-line activity of vinflunine in patients with penile cancer, showing promising results with a clinical benefit rate of 45.5%. Despite some toxicity issues, the study concludes that vinflunine warrants further investigation for this disease.
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/m(2), 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.
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