Cisplatin and 5-fluorouracil in inoperable, stage IV squamous cell carcinoma of the penis

OBJECTIVE: • To investigate the activity and toxicity of 5-fluorouracil (5-FU) as a first-line treatment in metastatic squamous cell carcinoma of the penis (SCCP). METHODS: • The medical records of 78 patients with SCCP treated between January 2000 and June 2011 at the four participating centres were reviewed. • Data regarding patients treated with first-line 5-FU were extracted. • Patients were included in the study if radiological reports were available for determination of response and progression-free survival (PFS) according to response evaluation criteria in solid tumours (RECIST) 1.1. RESULTS: • Between January 2000 and June 2011, 25 patients were treated with i.v. cisplatin on day 1 followed by 5-FU as a continuous 24-h infusion for 4 days every 3 weeks until disease progression or unacceptable toxicity. Partial responses and stable disease were observed in eight (32%) and 10 (40%) patients, respectively, with a disease control rate of 72%. • Severe neutropenia was the most important grade 3 - 4 side effect observed, occurring in 20% of patients. • The median (interquartile range [ IQR ] ) PFS was 20 (11 - 20) weeks and the median (IQR) overall survival (OS) was 8 (7 - 12) months. CONCLUSION: • 5-FU is associated with a moderate response rate and is well tolerated in patients with metastatic SCCP. © 2012 BJU International.