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- W4248794150 abstract "4514 Background: Platinum-based combination chemotherapy regimens are active in the treatment of penis cancer, but toxicity limits their value for patients with metastatic disease. VinCaP aims to define both the toxicity and the disease control rate for the non-platinum cytotoxic agent Vinflunine. Methods: A phase II single-arm trial was conducted. Eligible patients had measurable, histologically-proven squamous cell carcinoma (SCC) of the penis, staged M1; or M0,Tx,N3; or M0,Tx,N2 and deemed inoperable by multidisciplinary team; or M0, T4 any N, ECOG performance status 0-2 and adequate hepatic and renal function. Treatment was 4x21-day cycles of vinflunine (320mg/m2). In 22 evaluable patients ≥7 responses/stabilisations were required to conclude a clinical benefit rate (CBR(CR/PR/SD)) of at least 40% and exclude a rate of < 15% (p0 = 0.15, p1 = 0.40, α = 0.05, β = 0.80, Fleming-A’Hern exact design). Primary endpoint was CBR after 4 cycles of vinflunine. Secondary endpoints included objective response rate (ORR: CR/PR), safety, tolerability, progression-free survival (PFS) and overall survival (OS). Results: 25 patients (median age 68 years) were recruited from 8 UK centres between June 2014 and May 2017. 19 patients were M1. Of 22 patients who received treatment: 15 (68%) experienced grade 3/4 adverse events (AE); neutropenia was the most common AE (n = 5, 23%). Recruitment halted in Sep 2016 to investigate 2 treatment-related deaths (1 sepsis, not neutropenic; 1 neutropenic, not septic); re-opened Nov 2016. 10 patients had clinical benefit, CBR = 45.5%, 95%CI: 24.4-67.8, in the evaluable population (n = 22). ORR: 27.3%, (10.7-50.2) in evaluable population; 35.5%, (14.2-61.7) in measurable population (n = 17). Median PFS: 2.9 months, 95%CI: 1.4-6.4; 12 month PFS: 16.7% (4.6-35.3). Median OS: 8.4 months, (3.2-14.1); 12 month OS: 33.7%, (15.4-53.1). Conclusions: CBR exceeded the threshold to recommend further research and ORR was comparable to other recent phase II trials in penis cancer. Toxicity profile in keeping with known profile for vinflunine. Vinflunine is an active agent in the treatment of locally advanced and metastatic SCC of the penis. Clinical trial information: NCT02057913." @default.
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- W4248794150 date "2018-05-20" @default.
- W4248794150 modified "2023-10-01" @default.
- W4248794150 title "VinCaP: A phase II trial of vinflunine chemotherapy in locally-advanced and metastatic carcinoma of the penis (CRUK/12/021)." @default.
- W4248794150 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.4514" @default.
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