Abstract
BackgroundWe 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.MethodsTwenty-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.ResultsTwenty-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.ConclusionsPre-specified clinical activity threshold was exceeded. Toxicity was in keeping with experience in other tumours. Vinflunine merits further study in this disease.Trial registrationNCT02057913.
Highlights
We investigated the first-line activity of vinflunine in patients with penis cancer
We investigated the activity and tolerability of vinflunine, a thirdgeneration vinca alkaloid whose toxicity profile was expected to be more tolerable for patients with advanced squamous penile carcinoma
Recruitment of any patient of Eastern Cooperative Oncology Group (ECOG) PS2 triggered an embargo on recruitment of PS2 patients for 4 weeks, with recommencement of PS2 enrolment subject to safety review by the Independent Data Monitoring Committee (IDMC)
Summary
Platinum-based combination chemotherapy has been a conventional treatment of penis cancer for 25 years [1,2,3]. Objective response rates to older regimens containing bleomycin [5], methotrexate [6], and vinca alkaloids [7, 8] were 20–30%, and often short-lived. Cisplatin, and 5-fluorouracil (5FU) (TPF) had an objective response rate of 38.5%, 2/3 of patients experienced at least one grade 3/4 adverse event [9]. Grade 3/4 adverse events were seen, but TIP was deliverable in this group and is an appropriate neoadjuvant therapy where it might render resection feasible: it has not been investigated in the setting of advanced disease. We investigated the activity and tolerability of vinflunine, a thirdgeneration vinca alkaloid whose toxicity profile was expected to be more tolerable for (predominantly elderly) patients with advanced squamous penile carcinoma
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