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.