Phase II study of docetaxel, cisplatin, and fluorouracil in patients with distantly metastatic penile cancer as first-line chemotherapy.

PURPOSE: Patients with distantly metastatic (M1) penile squamous carcinoma have extremely poor prognosis and few prospective clinical trials evaluating systemic treatment have ever been performed for this population.

METHODS: Patients (aged ≥ 18 years) with histologically confirmed, distantly metastatic, measurable penile squamous carcinoma were enrolled. They were treated with docetaxel 75 mg/m2 (day1), cisplatin 70 mg/m2 (day1), and fluorouracil 500 mg/m2/d (days 1 to 5) every 3 weeks as first line chemotherapy. The primary endpoint was objective response rate (ORR).

RESULTS: 39 patients received chemotherapy with a median of four cycles (range two to six). The median follow-up time was 11 months. 15 patients had a confirmed objective response (38.5%, 95% CI 23.36-55.38), all of which were partial responses. The median progression-free survival (PFS) was 3 months (95% CI 2.92-3.09), and the median overall survival (OS) was 7 months (95% CI 5.99-8.03). Toxicity was manageable and the most frequently recorded adverse events of grade 3 or higher were neutropenia (13 of 39; 33%), nausea/vomiting (7 of 39;18%). There was no treatment-related death.

CONCLUSION: The palliative regimen of docetaxel, fluorouracil, and cisplatin induced moderate responses and can be used as a choice for the treatment of patients with distantly metastatic penile cancer. However, efforts to improve efficacy and minimize toxicity for this regimen should be made in the future.