A phase II trial of docetaxel, cisplatin, and 5-fluorouracil (TPF) in locally advanced and metastatic carcinoma of the penis (CRUK/09/001).

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TPS240 Background: Chemotherapy for penile cancer is used mainly as palliation of metastatic disease. It also has a role as treatment for locally advanced disease but the rarity of the disease has hampered attempts to define an evidence base for its use. Combined cisplatin (P) and 5-fluororacil (F) has been used for treatment of squamous cell carcinoma (SCC) of the penis since 1990. Pathological similarities to head and neck SCC suggest that addition of docetaxel (T) to an established platinum-based regimen may lead to improved therapeutic benefits. The purpose of the trial is to determine the activity ofTPF chemotherapy in penile cancer Methods: This single stage phase II trial is the only UK-wide trial for penile cancer. Eligible patients (pts) have histologically proven SCC of the penis staged M1; M0, T4 any N; M0, any T, N3 or inoperable N2; or M0, any T, N1 where chemotherapy is to be offered as first-line therapy. Pts must have measurable disease and be fit to receive TPF as palliative or definitive treatment or as treatment for relapse. All pts receive three 21 day cycles of: T 75mg/m2 day 1, P 60mg/m2 day 1, F 750mg/m2/day (days 1-5). Fourteen or more responses in 26 pts are required to conclude a response rate of 60% or more (p0=0.35, p1=0.60, α=0.1, β=0.2; Fleming-A'Hern exact methods). The primary endpoint is overall response rate (RECIST) assessed by MRI/CT scan at completion/discontinuation of trial treatment. The proportion of pts with inoperable locoregional disease rendered operable following TPF, safety, tolerability, and progression-free and overall survival are secondary endpoints. The trial opened in September 2009. To end 2009, 4 pts have been recruited of which two have completed trial treatment and remain on follow-up. The National Cancer Research Institute's Penile Cancer Studies Group plans further studies. If results suggest a high response rate, they are likely to lead to an expanded phase II TPF programme in two settings: as neoadjuvant therapy (in operable and inoperable disease); and as palliation of metastatic disease. The trial also takes the first steps to defining a standard of care for synchronous chemoradiotherapy as consolidation for inoperable locoregional disease. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration GlaxoSmithKline, Pfizer, Roche, sanofi-aventis sanofi-aventis